The Pharma Compliance Blog: Your Space. For Your Space.

The Blog Has Moved to a New Platform and URL

2010-05-06T18:00:00.003-04:00

Karen Brown, Senior Director Marketing
karenbrown@cis-partners.com

The Pharma Compliance Blog has moved to a new platform and can be found at: http://www.pharmacomplianceblog.com/.

Please add this URL to your Favorites, and join us often as we continue to write about the latest regulatory compliance issues and changes within the pharmaceutical industry.

The new blog provides drop-down menus so you can easily find articles that relate to Government Programs, Commercial Compliance, Clinical and Manufacturing. You’ll also find RSS feeds to agency sites and other useful links.
We hope that you’ll visit the new blog and share your compliance thoughts and questions.

Online Pharmacies, Are They Safe?

2010-05-06T08:00:00.000-04:00

By: Yasmeen Muhammad, CIS Senior Consultant
yasmeenmuhammad@cis-partners.com

We live in an increasingly fast paced society. There is so much to do in a short amount of time. The convenience of modern technology makes juggling our daily tasks easier by freeing up some of our time. Instead of stopping by to see a friend, we keep in touch by using our cell phones to send a quick text. We use our computers to send e-mails to our co-workers sitting three cubicles away so we can meet the deadline for an important project. In addition, the internet offers limitless modern conveniences such as shopping for Christmas gifts, personal banking, shopping for groceries and purchasing prescription or over-the-counter drugs. Although online pharmacies and drug distributors offer substantial savings for the consumer, the quality and safety of the merchandise can be questionable.

For the consumer, there are many benefits to making drug purchases online. Most online pharmacies have lower prices, which is a plus in today’s economy. They also make it easier to compare prices between other pharmacies. Most websites list the insurance plans they work with for ease of use. The consumer can also receive discounts for other health care products when purchasing online. Having the drugs delivered directly to consumers’ homes is also a benefit for the elderly and very ill patients because it eliminates their need to travel to a local pharmacy. [3]

The convenience of purchasing drugs online seems ideal from a timesaving standpoint, but do we really know what we’re purchasing and who we’re purchasing it from? There are serious risks involved. Recently the Food and Drug Administration (FDA) issued a warning about the potential dangers associated with purchasing drugs online. “Some Web sites sell prescription and over the counter drugs that may not be safe to use and could put people’s health at risk.” [1] Some of the risks mentioned are receiving drugs that don’t have the right active ingredient, drugs that contain too strong or too weak of the active ingredient, counterfeit drugs, expired drugs or drugs that are not approved by the FDA. [1]

When it comes to purchasing products that can impact our life in a major way, extra precautions must be taken to protect ourselves and our families. Law enforcement agents recently arrested two individuals from China for selling counterfeit Alli, a weight loss drug manufactured by Glaxo-Smith Kline. One of the components found in the counterfeit product was Sibutramine which can cause very serious adverse effects such as high blood pressure and seizures. The product was sold in the United States through internet auction websites. A consumer who suffered several adverse effects after taking the counterfeit product notified the authorities. [2]

Since online drug purchases can be made without a physical examination or authorization from a licensed health care provider, consumers must be proactive and take a safe approach in their decisions to make drug purchases online. The FDA has given the following tips to spot an unsafe online pharmacy website:

You receive drugs with unknown quality or origin
You receive the wrong drug or another dangerous product for your illness
The site does not provide a way to contact the Web site by phone
The site advertises prices dramatically below the competitors’ prices
The site offers to sell prescription drugs without a prescription, which is illegal
The site may not protect your personal information [1]

Another wise step to safeguard your health is to check the National Association of Boards of Pharmacy (NABP) website. NABP has a Verified Internet Pharmacy Practice Sites (VIPPS) program that lists websites that have been approved to sell drugs online after an extensive accreditation process. You can easily research an online pharmacy on their website to ensure their safety before making a decision to purchase drugs online. [4]

Taking the extra steps to look into the legitimacy of an online pharmacy may seem like a hassle. On the other hand, one can avoid wasting money on drugs that could be harmful to their health and save time from having to deal with the dangerous physical and mental side effects that could be caused by these drugs. To ensure you’ll be around to enjoy the future benefits of modern technology, put yourself first and do the research.

Sources:
[1] http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048396.htm
[2] http://www.fda.gov/ICECI/CriminalInvestigations/ucm206314.htm
[3] http://ezinearticles.com/?The-Advantages-of-Purchasing-Medicines-From-Online-Pharmacies&id=4115885
[4] http://www.nabp.net/

"Who Ya Gonna Call?" Part 3

2010-05-05T11:00:00.000-04:00

By: Bill Baxter, CIS Strategic Advisor, Government Affairs
billbaxter@cis-partners.com

Current Health Care Reform (HCR) legislation includes the obligation for manufacturers with Medicaid rebate agreements to provide the same rebates for products dispensed to valid Medicaid Managed Care Organization (MMCO) patients as required for Medicaid fee-for-service utilization. While much is still to be determined regarding the mechanics of the requirement, one question stands out very clearly: “what rebate exposure does this generate for my company?”

Two things are VERY clear; 1) this will significantly increase rebates for most if not all participating manufacturers, and 2) the impact will vary by a company’s product mix, current utilization in the fee-for-service program, and formulary position on most large MMCOs.

When estimating the full impact of this aspect of HCR, the following data points are very important to consider:

The total number of patients in a particular account
The number of Medicaid patients in that account
The ratio between total patients & Medicaid patients
The total volume of utilization of a particular product in that account
An estimate of the share of the MMCO market these accounts have
A projection of the Medicaid utilization these data points suggest
Contract language with the MMCOs that would protect a manufacturer from a “double dip” or “double hit”, i.e., discounts to the MMCO and rebates to the MDRP
A comparison of the difference between current commercial discounts and Medicaid rebate amounts

A product and/or operating company specific model can be developed combining these data points for several key MCO’s and used to estimate the fiscal impact. Data sources to assist in projecting the exposure include the attachments to this communication. These data, combined with specific product utilization can be used to generate an estimation of increased rebate exposure.

Table 1: Medicaid Managed Care Enrollment Trends[1]

1Data Footnotes:
http://www.cms.gov/MedicaidDataSourcesGenInfo/
http://www.kff.org/medicaid/upload/8046.pdf
http://www.statehealthfacts.org/healthreform.jsp

CIS presents at CBI’s Medicaid Rebates Conference, May 12th -14th in Orlando

2010-05-03T07:00:00.001-04:00

It is not too late to register for the CBI Conference this year! The Conference could not come at a better time with the recent Healthcare Legislation, and there will be a lot of healthy and informative discussion about the coming changes.

Stop by the CIS booth to pick up information and articles, written by CIS subject matter experts, on recent and potential Healthcare Reform changes and their impact on the industry.

Also, meet the newest member of the CIS team, Lisa McNair, Senior Manager, Tricare Contracting. Lisa recently worked with the DoD where she played an integral part in developing the Tricare program. She will be sharing her insight on upcoming Federal Register notices on Tricare.

Don’t miss out on our topical presentations!

Product Divestitures and Company Mergers & Acquisitions - Due Diligence on the Financial and Compliance Impact on Government Programs
Chris Cobourn, VP, Regulatory Affairs

Workshop: Best Practices for Pricing and Contracting with FSS, VA, DoD and PHS Programs
Lisa McNair, Senior Manager, Tricare Contracting

Panel: Considerations for Auditing and Monitoring within the MDRP
Amy VanDeCar, Director, GP Consulting Services

* Check out the recent Pharma Compliance INSIGHT Webinar: ‘Are you Audit-Ready?’ for a preview!

Please feel free to use the CIS code ‘ZAC795’ to receive a $300 discount off the standard registration price. Contact Jackie O’Connor (jacquelineoconnor@cis-partners.com) if you have any questions.

Thank you and we look forward to seeing you in Orlando!

Articles of the Week!

2010-04-30T08:30:00.000-04:00

Courtesy: Jess Ebert, CIS Compliance Specialist
jessicaebert@cis-partners.com

1) Pharma's Future Depends on These Three Trends
http://blogs.hbr.org/hbsfaculty/2010/04/pharmas-future-depends-on-thes.html

2) Drugmakers’ Overhaul Costs $105 Billion
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a_TC.yB.SbaY

3) Rate Proposal by WellPoint Is Withdrawn http://online.wsj.com/article/SB10001424052748704302304575214962216143580.html

4) Space experiments may aid earthly ailments
http://www.cnn.com/2010/HEALTH/04/29/discovery.space.sickness/index.html

5) FDA Urges Industry To Take Additional Steps To Prevent Cargo Theft
http://www.medicalnewstoday.com/articles/187056.php

H.R. 3590 as Amended by H.R. 4872

2010-04-28T08:00:00.002-04:00

As compliance consultants in the ever changing Healthcare Industry; it is critical for us to immediately document and implement proposed guidance’s and statutes that are constructed by our governing bodies. Therefore, when the legislation for Health Reform was signed into law, we acted as diligently as possible to create a ‘user friendly’ summary of both acts, H.R. 3590 and H.R. 4872. CIS has developed three publications to assist in understanding how the new legislation may affect you and your company, all of which can be found on our Pharma Compliance Blog :

1. Healthcare Reform Legislation Webinar – Chris Cobourn

2. The Patient Protection and Affordable Care Act; Key Impact on Pharmaceutical Manufacturers and Government Program Participation – Lauren Pellicciotti

3. H.R. 3590 as Amended by H.R. 4872 – Jordan Mummau (Read Below)

MEDICARE (H.R. 3590, Sec. 3101-3602)

2010
• Provide a $250 rebate to Medicare beneficiaries who reach the Part D coverage gap in 2010 and gradually eliminate the Medicare Part D coverage gap by 2020.
• Expand Medicare to individuals exposed to environmental health hazards.

2011
• Manufacturers to provide a 50% discount on brand-name prescriptions filled in the Medicare Part D coverage gap. o Begin phasing-in federal subsidies for generic prescriptions filled in the Medicare Part D coverage gap
• Provide a 10% Medicare bonus payment to primary care physicians and to general surgeons practicing in health professional shortage areas.

2013
• Begin phasing-in federal subsidies for brand-name prescriptions filled in the Medicare Part D coverage gap (to 25% in 2020, in addition to the 50% manufacturer brand-name discount).
• Pilot program is established, evaluates paying a bundled payment for acute, inpatient hospital services, physician services, outpatient hospital services, and post acute care services.

2014
• Reduce Medicare DSH payments by 75%
o Increase payments over time based upon the % of uninsured population and the amount of uncompensated care provided.

MEDICAID (H.R. 3590, Sec. 2501)

2010
• Increase the Medicaid drug rebate % for brand name drugs to 23.1%
o Exception: rebates for clotting factors and drugs approved exclusively for pediatric use increases to 17.1%.

• Increase the Medicaid rebate for non-innovator, multiple source drugs to 13% of AMP
o Extend drug rebate to Medicaid managed care plans

2011
• Prohibit federal payments to states for Medicaid services related to health care acquired conditions.
• State balancing incentive program

2013
• Increase Medicaid payments for primary care services provided by primary care doctors for 2013 and 2014 with 100% federal funding.

2014
• Expand Medicaid to all individuals under age 65 with incomes up to 133% FPL based on modified adjusted gross income.
• Reduce states’ Medicaid DSH allotments

Medicaid Unit Rebate Amount Line Extension – (H.R. 4872, Sec. 1206)
The House-passed reconciliation bill requires a potential substitute Medicaid rebate calculation for "line extensions" of oral solid dosage forms of innovator products. For these products, the Medicaid rebate will be the greater of:
• (a) the usual calculation or
• (b) AMP times the highest additional rebate for any strength of the original expressed as percentage of AMP.

Physician Ownership/Reporting/and Other Transparency - (H.R. 3590, Sec. 6002) better known as the Physician Sunshine Payment Act
If providing a payment or other transfer of value to a covered entity, a Manufacturer must submit:

• The name of the covered recipient.
• The business address of the covered recipient and, in the case of a covered recipient who is a physician, the specialty and National Provider Identifier of the covered recipient.
• The amount of the payment or other transfer of value.
• The dates on which the payment or other transfer of value was provided to the covered recipient.
• A description of the form of the payment or other transfer of value, indicated (as appropriate for all that apply) as cash or a cash equivalent
• In-kind items or services
• Stock, a stock option, or any other ownership interest, dividend, profit, or other return on investment; or any other form of payment or other transfer of value (as defined by the Secretary).
• A description of the nature of the payment or other transfer of value, indicated (as appropriate for all that apply) as consulting fees
• Compensation for services other than consulting
• Honoraria
• Gift
• Entertainment
• Food
• Travel (including the specified destinations
• Education
• Research
• Charitable contribution
• Royalty or license
• Current or prospective ownership or investment interest
• Direct compensation for serving as faculty or as a speaker for a medical education program
• Grant; or any other nature of the payment or other transfer of value (as defined by the Secretary).
• If the payment or other transfer of value is related to marketing, education, or research specific to a covered drug, device, biological, or medical supply, the name of that covered drug, device, biological, or medical supply.
• Any other categories of information regarding the payment or other transfer of value the Secretary determines appropriate.

Monetary penalties for non-compliance can range from $10,000 – $1,000,000. See section 1128G if you have specific questions regarding penalties.

More Information:
• Physician ownership-referral (H.R. 4872, Sec. 1106)
o Changes to December 31, 2010 the date after which physician ownership of hospitals to which they self refer is prohibited and provides a limited exception to the growth restrictions for grandfathered physician owned hospitals that treat the highest percentage of Medicaid patients in their county (and are not the sole hospital in a county).

• Drug, device, biological and medical supply manufacturers must report gifts and other transfers of value made to a physician, physician medical practice, a physician group practice, and/or a teaching hospital.

• Referring physicians for imaging services must inform patients in writing that the individual may obtain such service from a person other than the referring physician, a physician who is a member of the same group practice, or an individual who is supervised by the physician or by another physician in the group.

• Prescription drug makers and distributors must report to the HHS Secretary information pertaining to drug samples currently being collected internally.

• Pharmacy benefit managers (PBM) or health benefits plans that provide pharmacy benefit management services that contract with healthy plans under Medicare or the Exchange must report information regarding the generic dispensing rate; rebates, discounts, or price concessions negotiated by the PBM.

Drug Sampling; Reporting – (H.R. 3590, Sec. 6004)
Beginning in 2012, no later than April 1st of each year each manufacturer and authorized distributor of an applicable drug shall submit to the secretary the following information from the preceding year:

• In the case of a manufacturer or authorized distributor which makes distributions by mail or common carrier reports the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed, aggregated by the name, address, professional designation, and signature of practitioner making the request.

•In the case of a manufacturer or authorized distributor of record which makes distributions by means other than mail or common carrier reports the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by the name, address, professional designation, and signature of the practitioner making the request.

Pharmacy benefit managers transparency requirements – (H.R. 3590, Sec. 6005)
Part A of title XI of the Social Security Act (42 U.S.C. 1301 et seq) is amended by inserting after section 1150 the following new section:

The Act requires that pharmacy benefit managers ("PBM") provide the Department of Health and Human Services with information including the percentage of all prescriptions that were provided through mail order pharmacies versus retail pharmacies and the percentage of prescriptions where there is a generic drug available and dispensed. This will create transparency into the discounts achieved by PBM which serves as the middleman between the pharmaceutical manufacturers, health insurance plans and the pharmacies.

The reporting requirement applies to health benefits plan that manages prescription drug coverage under contract with (1) a prescription drug plan sponsor of a prescription drug plan or a Medicare Advantage prescription drug plan under Medicare Part D, (2) a qualified health benefits plan offered through a health insurance exchange established under the Act. In addition to mail order and generic information, PBM’s are required to disclose the aggregate amount and types of rebates, discounts or price concessions that are attributable to patient utilization under the plan. PBM’s will also be required to disclose the aggregate amount of rebates, discounts or price concessions that are passed through to the plan sponsor and the total number of prescription that were dispensed. Excluded from this reporting requirement would be: bona fide services fees such as distribution service fees, inventory management fees and fees associated with administrative service agreements and patient care programs.

Expanded Participation in the 340B Program – (H.R. 3590, Sec. 7101)
• Expansion of Covered Entities Receiving Discounted Prices – Section 340B of PHS is amended by adding:
o A children's hospital excluded from the Medicare prospective payment system pursuant to section 1886(d)(1)(B)(iii) of the Social Security Act
o free-standing cancer hospital excluded from the Medicare prospective payment system
o Critical Access Hospitals
o Rural referral centers (must have disproportionate share adjustment % equal or greater than 8%)

• Prohibition on Group Purchasing Arrangements

• Medicaid Credits on Inpatient Drugs o Not later than 90 days after the date of filing of the hospital's most recently filed Medicare cost report, the hospital shall issue a credit as determined by the Secretary to the State Medicaid program for inpatient covered drugs provided to Medicaid recipients

340B Integrity Provisions: (H.R. 3590, Sec. 7102)
• Quarterly Manufacturer Reporting: The reform bill requires the development of a system that will permit the Secretary (presumably the Health Resources and Services Administration, "HRSA") to verify the accuracy of ceiling prices. To this end, the HRSA must publish "precisely defined" standards for the calculation of ceiling prices; regularly compare HHS-calculated ceiling prices with those reported quarterly by manufacturers; perform "spot checks" of sales to Covered Entities; and investigate and resolve pricing discrepancies.

• Refunding Overpayments: The new law also includes integrity provisions to require manufacturers to issue refunds to Covered Entities that are overcharged by the manufacturers and to explain why and how the overcharge occurred, how the refunds will be calculated, and to whom the refunds will be issued. HRSA must then ensure that the refunds are issued accurately and within a reasonable period of time, both in routine instances of retroactive adjustment to relevant pricing data and in exceptional circumstances such as erroneous or intentional overcharges for covered drugs.

• Audit Rights and Penalties: The new law permits HRSA to selectively audit manufacturers’ and wholesalers’ compliance with the requirements of the 340B program. It also grants HRSA the authority to impose civil monetary penalties (not to exceed $5,000 for each instance of overcharging a Covered Entity) in the event of knowing and intentional overcharges.

Payments Excluded from AMP – (H.R. 4872, Sec. 1101 & H.R. 3590, Sec. 2503)
• The new law expands the list of statutory exclusions from AMP. It continues to exclude customary prompt pay discounts paid to wholesalers.

• The reform law excludes bona fide service fees paid to wholesalers and RCPs, and gives examples of services that are potentially bona fide:
o Distribution services,
o Inventory management agreement services,
o Stocking allowances and administrative services.

• Reimbursement for recalled, expired, damaged, and returned goods is excluded from AMP, as are the associated costs. PBM, MCO, HMO, insurer, hospital, clinic, mail order, LTC and manufacturer price concessions (and where appropriate payments) are all excluded from AMP.

• Finally, discounts under § 1860D-14A (i.e., the Medicare coverage gap discount program) are now officially out of AMP and Best Price.

• All other discounts to wholesalers and retail community pharmacies will be included in AMP.

Quick Facts/ At a Glance

Dual Eligible Coverage and Payment Coordination – (H.R. 3590, Sec. 2602)
HHS will establish a Federal Coordinated Health Care office.
• Improve coordination among the federal and state governments for individuals enrolled in both programs.

Medicare Advantage Part C – (H.R. 3590, Sec. 3311)
‘MA’ payments will be based on the average number of bids submitted by insurance plans in each market.
• MA plans will be prohibited from charging beneficiaries cost sharing for covered services greater than what is charged under fee-for-service

Medicare Prescription Drug Plan Improvements Part D – (H.R. 3590, Sec. 3315)
In order to have their drugs covered under the Medicare Part D program, dug manufacturers will provide a 50% discount to Part D beneficiaries for brand-name drugs and biologics purchased during the coverage gap beginning July 1, 2010.
• Initial coverage limit in the standard Part D benefit will be expanded by $500 for 2010.

Pharmacy Reimbursement – (Section 2503)
Use of AMP in Upper Limits – Secretary shall calculate the Federal upper reimbursement limit as no less than 175% of the weighted average of the most recently reported Monthly AMP for pharmaceutically and therapeutically equivalent multiple source drug products.

• Smoothing process will be implemented for AMP
o Similar to ASP smoothing

• Definition of AMP
o Wholesalers for drugs distributed to retail community pharmacies
o Retail community pharmacies that purchase drugs direct from the manufacturer

Medicare, Medicaid, and CHIP Program Integrity Provisions (H.R. 3590, Sec. 6401-6508)
The secretary will establish procedures to screen providers and suppliers participating in Medicare, Medicaid, and CHIP
• Providers and suppliers enrolling or re-enrolling will be subject to new requirements including a fee, disclosure of current or previous affiliations with any provider or supplier that has uncollected debt, has had their payments suspended, has been excluded from participating in a Federal health care program, or has had their billing privileges revoked.

• Secretary of HHS is authorized to deny enrollment in these programs.

Exclusion of Orphan Drugs for Certain Covered Entities (H.R. 4872, Sec. 2302)
• For the new Covered Entities, the term "covered outpatient drug" would not include a drug designated for rare conditions by the Secretary under section 526 of the Federal Food, Drug, and Cosmetic Act under the House-passed reconciliation bill.

Enhanced Medicare and Medicaid Program Integrity Provisions – (H.R. 3590, Section 1128j)
CMS will include in the integrated data repository (IDR) claims and payment data from Medicare (Parts A, B, C, and D), Medicaid, CHIP, health-related programs administered by the Departments of Veterans Affairs (VA) and Defense (DOD), the Social Security Administration, and the Indian Health Service (IHS).

• New penalties will exclude individuals who order or prescribe an item or service, make false statements on applications or contracts to participate in a Federal health care program, or who know of an overpayment and do not return the overpayment.

• Each violation would be subject to a fine of up to $50,000.

• The Secretary will take into account the volume of billing for a DME supplier or home health agency when determining the size of a surety bond.

• The Secretary may suspend payments to a provider or supplier pending a fraud investigation.

• Health Care Fraud and Abuse Control (HCFAC) funding will be increased by $10 million each year for fiscal years 2011 through 2020.

• The Secretary will establish a national health care fraud and abuse data collection program for reporting adverse actions taken against health care providers, suppliers, and practitioners, and submit information on the actions to the National Practitioner Data Bank (NPDB).

• The Secretary will have the authority to dis-enroll a Medicare enrolled physician or supplier who fails to maintain and provide access to written orders or requests for payment for durable medical equipment (DME), certification for home health services, or referrals for other items and services.

• The HHS Secretary will expand the number of areas to be included in round two of the DME competitive bidding program from 79 of the largest metropolitan statistical areas (MSAs) to 100 of the largest MSAs, and to use competitively bid prices in all areas by 2016.

Additional Medicaid Program Integrity Provisions - (H.R. 3590, Sec. 3101-3602)
States must terminate individuals or entities from their Medicaid programs if the individuals or entities were terminated from Medicare or another state's Medicaid program.

• Medicaid agencies must exclude individuals or entities from participating in Medicaid for a specified period of time if the entity or individual owns, controls, or manages an entity that:
o (1) Has failed to repay overpayments
o (2) Is suspended, excluded, or terminated from participation in any Medicaid program
o (3) Is affiliated with an individual or entity that has been suspended, excluded, or terminated from Medicaid participation.

• Agents, clearinghouses, or other payees that submit claims on behalf of health care providers must register with the state and the Secretary.

• States and Medicaid managed care entities must submit data elements for program integrity, oversight, and administration.

• States must not make any payments for items or services to any financial institution or entity located outside of the United States.

Pharmaceutical Manufacturers Fee
• The fee applies only to companies with sales of branded prescription drugs in excess of $5 million dollars per calendar year.

• Brand name pharmaceuticals (H.R. 4872, Sec. 1404)
o Delays the industry fee on sales of brand name pharmaceuticals for use in government health programs by one year to 2011, and increases revenue raised by the fee by $4.8 billion.

"Who Ya Gonna Call?" Part 2

2010-04-27T08:00:00.001-04:00

By: Bill Baxter, CIS Strategic Advisor, Government Affairs
billbaxter@cis-partners.com

Hello GP Fans, I’m sure that you’ll be interested to know that effective 4/22/10 the Centers for Medicare & Medicaid Services (CMS) forwarded guidance correspondence to State Medicaid Directors regarding health care reform legislation. It addressed changes required by two key pieces of legislation:

The Patient Protection and Affordable Care Act (PPACA), P.L.111-148
Health Care and Education Reconciliation Act of 2010 (HCERA), P.L. 111-152

This guidance addresses increased Medicaid Drug Rebate Program (MDRP) rebate minimum percentages, extension of rebates for drugs dispensed by Managed Care Organizations (MCOs) to Medicaid patients, and the rebate offset associated with the increase in rebates achieved via changes required in the above mentioned legislation. Note: it is unclear as to when such guidance will be provided directly to manufacturers.

The legislation codifies the following changes in MDRP rebate calculations, effective 1/1/10:

The minimum rebate percentage (MRP) for single source & innovator multiple source (branded) products increases from 15.1% of average manufacturer price (AMP) to 23.1% of AMP
MRP for clotting factor drugs and those exclusively approved for pediatric indications increases from 15.1% of AMP to 17.1% of AMP
MRP for non-innovator multiple source (generic) drugs increases from 11% of AMP to 13% of AMP
A line extension of an oral solid dosage form of a brand name drug requires a rebate that includes the basic rebate for that drug and the highest additional rebate (CPI “Penalty”) for any strength of the original product
MRP for brand name drugs is capped at 100% of that product’s AMP

In reviewing this correspondence you will also note that the states do not get to retain the increase in rebates generated by the changes in MDRP calculations. CMS will “offset” (retain or “claw-back”) the increase in the non-Federal share of the basic rebate, but not that from additional (CPI Penalty) rebates nor state supplemental rebates. In fact, where rebates have previously exceeded 15.1% of AMP, the states appear to lose revenue. Note: CMS will offset the non-Federal share of both the basic and additional rebates for products deemed to be “line extension drugs”.

As mentioned, this legislation also includes the requirement of rebates for covered drugs dispensed by managed care organizations (MCOs) to eligible Medicaid patients. MCOs will report such utilization to the states, where those units will be included with quarterly MDRP invoices. It is yet unclear whether or how states will identify MCO units as such. CMS will utilize the same offset policy for rebates as with fee-for-service units. Note: rebates are not required for units purchased through the Public Health Service 340B program.

A copy of the actual correspondence can be found on the GP Pharma Compliance Exchange or on the CMS website (http://www.cms.gov/home/medicaid.asp ) under Medicaid => State Medicaid Director Letters. We will advise when CMS provides additional specifics to the states and when correspondence to manufacturers is available.

TRICARE Update!

2010-04-26T13:30:00.002-04:00

By: John Avicolli, CIS FSS Manager
johnavicolli@cis-partners.com

We would like to notify manufacturers of an important TRICARE update.

TRICARE has placed on their website that they are automating the Appendix A's. This is where manufacturers provide the NDCs, NFAMP, FCP and package size for their products.

Manufacturers will receive the link to the website along with their password in the next couple of weeks. Therefore the release of the 1Q2010 utilization data has been delayed.

Here is the link to the announcement... http://www.tricare.mil/pharm_mfg/default.cfm

Please feel free to contact us with any questions and/or concerns.

Also, please continue to follow the blog and the CIS website for information on an upcoming free Tricare Webinar (or you can email Marni Schribman at CIS to make sure you are on the list to receive an invite - marnischribman@cis-partners.com). The Webinar will be facilitated by David Rick and Lisa McNair (Lisa is formerly with the DoD and is now with Compliance Implementation Services).

How will the Healthcare Reform Affect Your Government Pricing Programs?

2010-04-21T11:00:00.000-04:00

On April 14th, 2010, CIS hosted a webinar addressing how the Healthcare Reform will affect your Government Pricing programs. Due to the overwhelming request and feedback after the webinar session presented by CIS’ Chris Coburn, VP of Regulatory Compliance, Bill Baxter, Strategic Advisor of Government Affairs, and Amy VanDeCar, Director of US Commercial Compliance and Government Programs, many of our clients and outside spectators have been looking to CIS for a specific summary that addresses all of the Government Pricing impacts that have been driven from the Patient Protection and Affordable Healthcare Act (“PPCA”). Our Subject Matter Experts (“SMEs”) have been addressing the specific questions regarding the changes and thought it would be appropriate to summarize at a high-level what are the specific changes that affect GP and when they are occurring. Please feel free to reference our grid below; you can click on it to expand it another window.

Healthcare Reform Legislation Webinar

2010-04-19T11:30:00.005-04:00

Chris Cobourn, CIS, VP Regulatory Compliance
chriscobourn@cis-partners.com

CIS ran a free Webinar last week on Healthcare Reform, focusing on its impact on Government Programs.

We had an overwhelming response and, unfortunately, had to turn some people away once the Webinar service met its maximum capacity.

If you were unable to join, or just want to revisit the discussion at your leisure, click on the link below:

HOW WILL NEW HEALTHCARE REFORM LEGISLATION AFFECT YOUR GOVERNMENT PROGRAM PARTICIPATION?

CLICK HERE TO ACCESS THE PRE-RECORDED EVENT (50MB .WMV FILE)

The discussion included a strategic overview by me, and a discussion about what senior management at pharmaceutical companies should know about Healthcare Reform. It also included an operational overview by Bill Baxter and Amy VanDeCar about operational aspects on Medicaid Claims — with the new base rebate percentage effective retroactively to January of 2010 — and new AMP definitions (effective October of 2010).

We are also posting an updated legislative summary on the blog early next week that will summarize the PPACA and Reconciliation Bills, categorized by program impact and timing. Clearly, with Healthcare Reform, the government as a customer is growing and expanding. From increased rebate percentages, to methodology changes, to expansion of the PHS program and the upcoming “tax” on Pharmaceutical Manufacturers, the financial impact has the potential to be significant.

It is important to understand the compliance aspects, the operational requirements, as well as the potential financial impact on your organization.

Please feel free to view the Webinar at your convenience, and let us know if you want to participate in our on-going free GP Webinar series that starts this week with an online session about GP audit readiness. For more details, go to Pharma Compliance Insight.

It is recommended that pharmaceutical manufacturers maintain an authoritative guidance library to support their US Government Pricing calculations. gp.cis-pcx.com contains information on Federal Programs, including: Medicaid Drug Rebate Program, Medicare Parts B and D, Veterans Affairs Health Program, 340B Program and TRICARE Program. The GP PCX also contains information on Federal Agencies, including: CMS, OIG, VA, OPA, DoD and various State programs.

Look Who's Coming Off Patent

2010-04-19T08:30:00.001-04:00

By: Lauren Pellicciotti, CIS Project Manager
laurenpellicciotti@cis-partners.com

In 2010, ten of the industry’s “blockbuster” drugs will see patent expiration. Some of the manufacturers of these drugs managed to get a six-month extension due to pediatric exclusivity, but Teva, Apotex, Mylan and many other generic drug manufacturers will have the opportunity to enter the market and put a dent in the sales of several brand medications this year,including Flomax and Aricept[1]. Under Section 505A of the Federal Food, Drug, and Cosmetic Act, the FDA allows longer exclusivity for drugs to which FDA has granted for Pediatric Studies.[2] With the big generic players applying for the 180- exclusivity period, how will the mid-size generic companies position themselves to gain a piece of the pie? Since the healthcare reform passed under legislation, several branded, big pharma manufacturers are questioning whether it is a good idea for them to embrace the generic drug market. If you are not aware, there are differences under the Medicaid Drug Rebate Program (“MDRP”) that directly affect Single-Source “S”, Innovator “I”, and Non-Innovator “N” drugs. The main difference under the MDRP is the reimbursement percentage paid to the state on a quarterly basis. “S” and “I” drugs pay 23.1% to the states for reimbursement and “N” drugs only pay 13% to the states for reimbursement. This is a good reason for why I suggest it may be a good opportunity to enter the generic market. For generics, there is a 10% difference on what the manufacturer needs to reimburse the states.

Although I believe it is very important for the brand manufacturers of innovator drugs to continue to invest in research and development, I also encourage the companies to consider entering into the generic market.

Working in the generic field the last few years I have come to realize it’s not how you market the drug and it’s not the pricing strategy. It is getting FDA approval to enter the 180-day exclusivity period. That’s where the money is made for the generic companies. Based on my experience in working with mid-size and large generic companies, I have included the following considerations and positive attributes being part of the generic market.

Considerations

Be first in the market – 180-exclusivitiy is extremely important to a generic companies quarterly profits. The higher the profits, the bigger the employee bonus.
Understand the different reimbursement rates under the Medicaid Drug Rebate Program.
Volume – Does your company have the operational background to support the volume of packaging and labeling for a generic product?

Positive Attributes

Less Cost on Marketing and Sales – Generic companies focus on the regulatory end to ensure they get all of their appropriate applications in to the FDA when a brand is coming off patent.
Minimal Cost of Research and Development.

Below is a listing of Drugs and Manufacturers that will be losing their patent in 2010:
1. Cozaar/Hyzaar – Merck (Six Month Extension)
2. Lipitor - Pfizer
3. Flomax - Boehringer Ingelheim
4. Arimidex - AstraZeneca
5. Climara - Bayer HealthCare
6. Aricept - Eisai
7. Invirase - Roche
8. Hycamtin - GlaxoSmithKline
9. Protonix - Pfizer
10. Levaquin - Ortho-McNeil

I am interested in your feedback regarding the topic above. Please take a minute and comment on whether or not you think brand drug companies should consider entering the generic market.

[1] http://www.fiercepharma.com/special-reports/big-patent-expirations-2010
[2] http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm050005.htm

Articles of the Week!

2010-04-16T10:30:00.000-04:00

Courtesy of: Suma Kallurkar, CIS Senior Compliance Manager
sumakallurkar@cis-partners.com

1) Breaking Down the Barriers: When Health-Care Providers Exchange Electronic Medical Records, Costs Go Down and Patient Care Goes Up
http://online.wsj.com/article/SB10001424052748703382904575059703004716596.html

2) FDA Says Studies on Triclosan, Used in Sanitizers and Soaps, Raise Concerns
http://www.washingtonpost.com/wp-dyn/content/article/2010/04/07/AR2010040704621.html

3) How Gene Patents Harm Innovation
http://www.forbes.com/2010/03/31/gene-patent-myriad-business-healthcare-dna-biotech.html

4) Orphan Drugs to Create Paradigm Shift in the Pharmaceutical Industry
http://www.worldpharmanews.com/content/view/1179/1/

5) Concerns Over Unregulated Medicinal Products Containing Stem Cells
http://pharmalive.com/News/Index.cfm?articleid=698181

Cancer Vaccines

2010-04-15T09:30:00.003-04:00

By: Venessa Piper-Givler, CIS Director of Manufacturing Compliance
Vanessapiper-givler@cis-partners.com

The FDA is now reviewing the submission of the prostate cancer vaccine Provenge by the Seattle-based company Dendreon. The FDA has not yet approved any cancer vaccine submission, but Provenge has been recommended for approval by the FDA advisory committee. In 2007, the FDA decided to wait on giving the vaccine approval until the IMPACT trial was completed [1]. Provenge is for the treatment of one of the most common epithelial cancers – prostate cancer.

Dendreon has a different approach to the prostate vaccine process. They are processing the patient’s own immune cells which they then nourish with a prostate protein, prostate acid phosphatase. The processed cells are then transfused back into the patient, with the hope that the T-cells will kill the prostate cancer cells. The Phase III clinical trial showed survival benefit higher than what has been seen in the past in men with prostate cancer. The study showed that men who received Provenge had a 34% chance of being alive compared to those men who did not receive Provenge, who had less than a 10% chance [3]. It was also revealed that Provenge has shown the greatest results when combined with other cancer drugs such as chemo [2].

“The vaccine augments [drug] treatment; it does not replace it,” said Andrew T. Parsa, M.D., Ph.D., an assistant professor in the Department of Neurological Surgery at the University of California. He goes on to state that he “sees two major points to make with the vaccine. One, it is virtually nontoxic. You are using your body not drugs to fight cancer. Two, it is not a cure, per se, but you are mobilizing an army to help with whatever treatment regimen you have chosen”. [1]

The other advantage of Provenge is that the side effects are minimal in that patients are only experiencing a fever and chills. The vaccine treatment helps the immune system to work better so the side effects are similar to the effects of the body mounting an immune response against the flu. This is great news for prostate cancer patients who may have something new in the near future to help them battle this disease.

Sources:
1) http://bit.ly/VChdN
2) http://chetday.com/provengeprostatecancer.html
3) http://bit.ly/cACLlC

More Than Just a Clipboard

2010-04-14T16:00:00.000-04:00

Beth Kline, Compliance Manager
bethkline@cis-partners.com

It seems that every day we hear about some new technology that is the latest and greatest – that will make our lives easier, more convenient and save time, or that will entertain, re-connect, or motivate us toward change. The most recent “gadget” on the scene is the iPad™, the Apple® self-proclaimed “magical and revolutionary product”. [1] The iPad is an interactive touch-screen computer that gives access to and interaction with almost anything you might ever need, putting information right at your fingertips. On a personal level, this can add fun and convenience to our lives. On a professional level, this can change the way we do our jobs.

We have seen the way technology is changing our approach to clinical trials – it can touch every facet of the process from data collection to report submission. Over the years, companies have piloted ways to make clinical trial data collection and entry easier, faster and closer to the source. This month, Nextrials, Inc. has introduced the next version of their Prism™ electronic data capture (EDC) and clinical trial data management platform, which will support data access at anytime from anywhere through the iPad. [2] This could revolutionize the healthcare industry by allowing physicians and other healthcare providers the opportunity to immediately view electronic health records of patients at critical times, as well as all times, during patient care.

“With its bigger screen, imaging power and a number of medical applications in
development, the Apple iPad is expected to quickly advance the idea of entering
data at the bedside for use in both clinical trials and a patient’s permanent
electronic health record,” noted James Rogers, CEO and co-founder of Nextrials.
[3]

The thought of entering data at the bedside may not appeal to all investigator site staff, but as technology continues to develop, grow and pervade our society, it quite possibly could become routine. The amount of time saved can be astronomical – data entered into the iPad becomes the source, therefore no transcribing needs to occur. There will be fewer discrepancies in the data reported and less need for tedious queries between sponsors and sites. Not only will this free up time for site staff, it will also make reviewing the data for the sponsor easier and less time consuming. And, it will save space, since source documents will not need to be stored in a cabinet at the study site.

It seems as though the potential for the iPad in the healthcare arena is limitless. Hospital rounds can be done faster when all test results, scans and x-rays can be seen at the touch of a finger. As for clinical trials, sponsors will have instant access to “adverse event data, patient recruitment status, supply availability and other critical real-time data”. [4] With all of this new technology we are seeing, the possibilities are endless!

[1] http://www.apple.com/ipad/

[2] http://www.nextrials.com/

[3] http://www.lifescienceleader.com/index.php?option=com_content&task=view&id=1112& Itemid=139

[4] http://www.pharmaceuticalcommerce.com/frontEnd/1418-What_the_iPad_Means_for_Pharma.html

The Dust is Just Starting to Settle on the PPACA

2010-04-09T09:00:00.000-04:00

By: Chris Cobourn, VP of Regulatory Affairs
chriscobourn@cis-partners.com

It’s been almost two weeks since the enactment of major Healthcare Reform legislation, the Patient Protection and Affordable Care Act (PPACA) and the accompanying Health Care and Education Reconciliation Act, but there’s still some ambiguity in certain areas where we await to hear from CMS on specific methodology and operational aspects.

Even though it’s only been a short time since the bill was signed into law, there is already a lot of information out there to disseminate. I would like to provide a few thoughts, and also welcome you to participate in our free Webinar on April 14th from 2pm-3pm to discuss some of these changes (https://www1.gotomeeting.com/join/589887864).

There are several components of the legislation that go into effect immediately, such as the increase in base rebate percentages, and certain components that go into effect over time, the most significant of which are the AMP methodology changes that will be implemented in October.

As we mentioned in our blog article following Scott Brown’s Senate victory in Massachusetts, we felt that “the writing was on the wall,” indicating that certain changes were coming, regardless of how they came to be legislatively. It certainly appeared, and still appears, that Average Manufacturer Price (AMP) will generally increase and Medicaid liability will increase, though it is the onus of each manufacturer to look at their own calculations and methodologies to determine how they will be affected. Although there is now a much different, more restrictive definition of AMP based upon Retail Community Pharmacies, as well as fewer included discounts, there are also fewer units in the calculation, so manufacturers will have to evaluate how the changes and revised AMP math impacts them.

With that said, the key overall changes to the Medicaid program impacting manufacturers include:

Larger rebate payments by manufacturers based upon expanded eligibility, changes in AMP methodology, and increases in the base rebate percentage (it is of note that the general theme of the methodology changes align to the concepts expressed by the retail industry in response to the DRA Final Rule and the basis of the Final Rule injunction)
A shift in reimbursement to pharmacies by the states, to be based on AMP

Manufacturers must now evaluate their course of action to ensure that they will be in compliance with the evolving changes, and to re-adjust their accruals. Several key considerations include (Note: These are my thoughts from a read of the legislation and limited guidance to date, and are not intended to provide any legal advice):

The increase in the base rebate percentages are immediate, and retroactive to January, 2010.
With changes to the base rebate percentages (23.1% for Branded, 13% for Generic, and 17.1% for clotting factors and drugs approved exclusively for pediatric use), manufacturers should evaluate their payment of rebates immediately. Due to changes in AMP methodology taking effect in October, the process of the change in the rebate percentages should be driven operationally by CMS and the States (technically, the manufacturer does not calculate the Unit Rebate Amount (URA), which comes from CMS to the States, based upon AMP and BP values reported by the manufacturer to CMS.) Manufacturers should calculate and report AMP as normal, but start to accrue for and be prepared to pay the rebates based upon the revised URA calculations. This is certainly an area where we expect some immediate guidance.

Major AMP methodology changes will go in to effect in October.
Manufacturers should be prepared to incorporate methodology changes as of October 2010. Primary changes include the new definition of Retail Community Pharmacies as the basis for AMP, and the revised and more restrictive definition of Wholesalers. This will reduce the number of customers considered “retail,” and will reduce the types and number of rebates and price incentives that are included as reductions in the AMP calculation (again, theoretically increasing AMP along the general concept expressed in the AMP injunction on what prices are truly reflective of net prices at retail pharmacies.) Key activities that the manufacturer should start thinking about include:

Revise your Class of Trade (COT) schema, and your COT inclusions and exclusions
Evaluate and revise your AMP inclusions and exclusions, based upon new guidance on what should be included in AMP
Conduct financial modeling to see the true net impact of changes to COTs, inclusion and exclusions, and units to be included in GP calculations
Update your policy and procedure documentation to reflect the new legislation

Stay tuned for key CMS methodology guidance.
We have as many questions as we have answers, and I know our friends at CMS are putting in some long hours to publish guidance, operational requirements, and update systems. There are some aspects that are certainly more operational, such as when and how the new and retroactive base rebate percentages will be implemented by CMS and the States. There are also some looming methodology questions that will require further guidance, such as:

How to define drugs in your systems as exclusively pediatric
How to implement Base AMP changes for new formulations
How and when CMS will implement the maximum rebate percent (100% of AMP)
How to calculate AMP for products with no sales to Retail Community Pharmacies (such as ASP drugs)
Whether manufacturers will be able to “reset” historical Base AMP with the revised definition of AMP, as they were with the DRA Final Rule
How AMP smoothing will be impacted by a dramatic change in AMP methodology as of October, with 11 prior months being calculated under the DRA Final Rule AMP definition

Evaluate the impact of changes in the 340B program.
There will be many changes to come with the expansion of the 340B program, including the broadening of eligible entities. One key provision that was not included in the final legislation is expanding 340B purchases to include inpatient purchases. A major impact will occur when a new dispute resolution process is put in place. This is an area where a lack of clear guidance has made compliance difficult for manufacturers. Several areas for evaluation and consideration in the short term include:

How the expansion of 340B entities may impact your GPO purchasing and forecasting
How a new AMP calculation may impact your calculated PHS price

Evaluate long term financial modeling.
With the expansion of Medicaid eligibility, the increase in Medicaid rebates, and requirements that pharmaceutical manufacturers broadening their coverage of the “donut hole,” manufacturers should evaluate the growth and expansion of government programs on their products and contracting strategies, and model the longer term financial impact.

If you would like more information or have any questions, please email me at chriscobourn@cis-partners.com, and be sure to tune in to our free webinar on April 14th from 2pm-3pm.

Articles of the Week!

2010-04-09T08:30:00.000-04:00

Courtesy of: Jess Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com

1) Fruits and vegetables are no miracles in cancer prevention
http://www.cnn.com/2010/HEALTH/04/08/fruit.vegetable.cancer/index.html

2) Vaccine Reverses Type 1 Diabetes in Mice
http://www.healthday.com/Article.asp?AID=637852

3) FDA cracking down on fat-melting injections
http://news.yahoo.com/s/ap/20100407/ap_on_bi_ge/us_fat_melting_drugs_fda

4) Achoo! Pollen at its worst in years in many areas
http://bit.ly/bDSE9b

5) Scientists Grow Replacement Blood Vessels From Stem Cells
http://www.healthday.com/Article.asp?AID=637864

Common Field Sales Complaint #2 – “The company took away all of my stuff"

2010-04-06T12:00:00.000-04:00

By Judy Fox, CIS Compliance Director
judyfox@cis-partners.com

Last month I wrote my first article about my role as an auditor and a common complaint that I hear when interacting with pharmaceutical sales representatives (Common Field Sales Complaint #1- It Always Feels Like Somebody's Watching Me). I don’t know if there is enough space to detail all of the things I have seen and heard from field sales forces, but there are some common complaints that I want to share. A little investigating as the result of complaints from the field can lead to the discovery of compliance concerns.

Most of the pharmaceutical manufacturers I’ve worked with over the past few years have adopted the Pharmaceutical Manufacturers of America Code on Interactions with Healthcare Professionals (PhRMA Code) for all of their promotional activities and a few have only adopted the PhRMA Code in states that require it. From either perspective, everyone I have worked with has chosen to adopt at least a portion of the code and has eliminated all of the ‘reminder items’ for Health Care Practitioners (HCP), such as pens and mugs. All of the companies have conducted training on the PhRMA Code and the representatives have understood that the company would no longer be providing these items.

Before I get started, I have to clarify that I work with all types of sales representatives: those that are in their first job after college and others who have been selling pharmaceuticals for 20+ years. The seasoned and successful sales representatives seem relieved by last year’s change in the PhRMA Code and are grateful that they don’t have a bunch of ‘stuff’ to carry around. The less experienced representatives seem to miss being able to supply an office with pens or post-it notes. This is where Common Field Sales Complaint #2 – “The company took away all of my stuff” rears its ugly head and compliance concerns pop up.

As a compliance consultant who is often called upon to conduct ride-along assessments and audits of field sales forces, I try to engage representatives in a conversation about their work habits. A part of those conversations include questions about company policies and procedures and any Corporate Code of Conduct. Experienced representatives know that no HCP is going to write a script because of a pen. The less experienced representatives sometimes feel like they are missing out on an important business tool to such an extent that they have come up with some pretty interesting interpretations of company policy. Most of the results of these interpretations are creating a compliance risk. The following examples are true stories that may seem far-fetched at first, but some compliance concerns were uncovered. As with any compliance issue, if left alone, they can become serious.

Example #1 – Company XZY has adopted the PhRMA Code across their entire company. I was asked to conduct a sample accountability and general compliance audit of sales representative, John Doe. John was able to rattle off the Corporate Code of Conduct practically verbatim; he had received training on the PhRMA Code and said he knew ‘the company is not allowed to give us stuff like pens or notepads anymore.’ Part of the audit included an inventory of his prescription drug samples as well as an inspection of the sample storage area. We arrived at a commercial storage site and John asked me if I wanted to start with his sample storage unit or his ‘other one’. (His other one? This is the point when an auditor sees a red flag and I will admit, also gets a little rush.) As it turns out, John has two small storage units, one for his samples and the second for his marketing materials. When he opens the door to the second storage unit, it is filled with all kinds of pens, stickers and other ‘reminder items’ as well as the company supplied marketing materials such as detail aids and patient education brochures. When questioned about the items, John proudly tells me that since the company is no longer able to supply the items and they took away all of his stuff, he has used his territory’s budgeted discretionary funds to have the items made on his own. He had been having pens, prescription stampers and coffee mugs made with XYZ’s product logos on them. None of the items had gone through Company XYZ’s legal, medical and regulatory review process, because John didn’t even know there was such a thing. His interpretation was such that the items weren’t prohibited completely, but that the company just couldn’t provide such items and that it was up to each representative to figure out what they needed and to get it themselves. His major complaint was that since the company took all of his stuff away, he had to have the items made on his own. The discovery of the items led to an XYZ review of the compliance training and language in the Code of Conduct and Corporate Policies and all were revised with specific instructions.

Example #2 – Company ABC has adopted the PhRMA Code in a limited capacity. ABC has policies in place that adopt the code in the states where it, or a more restricted code, is required by law. ABC had conducted training on the PhRMA Code and company policies as well as specific training for the representatives who were impacted by state laws. ABC does provide representatives who are not impacted by the state laws with some reminder items, but they have kept them to a limited and monitored quantity to avoid sales representatives sharing the items with other colleagues. ABC’s Corporate Compliance Office contracted with CIS to conduct a corporate compliance assessment and representative ride-alongs were a part of the project. This was Jane Doe’s (no relation to John in example #1) first job as a pharmaceutical representative and she had experienced great success in her first few years with the company. Jane details ABC’s pharmaceutical products in a state requiring adherence to the PhRMA Code. When the subject of the code came up during the ride-along, she acknowledged that she could no longer give her prescribers items such as pens and coffee mugs and that she was given company approved educational items. Jane felt slighted that some of her co-workers did not get their ‘stuff’ taken away and she thought about increasing the frequency of her calls. Jane liked the idea that reminder items helped keep her products in front of the prescriber and the staff. Since Jane is limited to providing modest meals to her prescribers in their offices during ‘lunch and learn’ programs, she came up with her own solution: product stickers. She had printed her own stickers with product logos taken off of the company website. She said she made sure she did not alter the logos at all. Jane then purchased various decorative jars, filled them with candy and put product stickers on them. She then brings a jar with her as part of the meals. She also makes sure the covers for any deli trays or pizza boxes always have a product sticker on them as well. For the holidays, Jane gave the office staff gifts with product stickers on them. She made it clear that she did not give a gift to the prescribers in the office, just the staff. Oh Jane, the concern here is not just with the use of the unapproved stickers, but with Jane assuming that she could provide the office with items as long as she did not give it to the prescriber. State laws vary, but in this case, the state law Jane works in is specific in that the restrictions extend to the employees of the prescriber. The report of the activity led to an evaluation and revision of the training program. In this case, Jane’s manager, Sally was also given refresher training based on the assumption that Sally either knew what Jane was doing or should have known.

As evident in the examples above, sometimes it isn’t enough to just take away everyone’s stuff and provide employees with company policies. It usually takes very specific training that literally spells out: “Do this and don’t do that!”

CIS has the knowledge and experience to create a comprehensive training program that addresses not only Federal and State requirements, but also tackles the interpretive issues that other training programs might overlook.

Feel free to send me some of your own examples where you were left shaking your head and saying, “What were they thinking?” I would love to share them anonymously and as well as some thoughts on compliance.

The Curious Case of Scooter Boy

2010-04-04T08:00:00.002-04:00

(Disclaimer: This blog post is meant to be humorous. If you take this seriously, you should stop taking yourself so seriously. However, if you are incapable of this, I promise to buy you a discounted plate of pancakes at IHOP at 4AM next Tuesday…)

Regardless of your political affiliation and feelings on President Obama’s most recent sweeping Health Care legislation, I have found an area that needs some change and oversight: The systems and interchanges utilized for tracking certain pieces of data. Why, you ask? Well, at the ripe age of 30 years old, I was sent an official card and letter letting me know I am now eligible for an AARP membership! I posit that by renting my now infamous Scooter, that I was placed into a ‘system’ or ‘criteria’ that automatically got kicked to the fine folks at AARP.

Therefore, since AARP’s CEO Addison Barry Rand was kind enough to send this letter and list the 6 major benefits of being an AARP member, I’d like to list the 6 things I’m most looking forward to as a card-carrying member:

1) The Stuff I’m Going to Get Away With: Perhaps it’s stealing batteries. Perhaps it’s going 45 in the fast lane. Perhaps it’s an errant smack of a formative year’s bum. Perhaps it’s holding up traffic crossing the street. Perhaps it’s keeping the ball that gets hit over my fence. In the immortal words of perhaps the most underrated Seinfeld character, Uncle Leo, I shall proclaim: “I’m an old man! I’m confused.”

2) Adult Incontinence Products: I was recently on a trip to a client and a freak, unpredicted snow storm (like that’s possible) caused a traffic jam the likes of which I’ve never seen. I tend to be energetic with a rip-roaring metabolism (which could also be the 45 cups of coffee I drink every day), so I had to pee like the Dickens (what does that actually mean?). Now that I’m officially an AARP member, I will certainly enjoy my discounted supply of products that will clearly help this situation. Need I really go into more detail?

3) Discounts: The amount and array of discounts offered to folks with an AARP card is staggering! Who doesn’t love a $30 hotel room or a $1 Subway sandwich (cue, Dolla, 1 Dolla Footlong)? When the girl over the counter looks at me perplexed because I look 25 (I’m seriously 30 ladies, I shizit you not), I’ll simply whip out the card that good ‘ol Adds (we’re close) sent me and say that I’d like that Double Cheeseburger off the Nickel Menu.

4) Eating: I’m really going to dig getting up at 3:30AM, breakfast at Denny’s at 4AM, Lunch at the club at 10:30AM and dinner at 4PM.

5) Driving: When I hit my own mailbox and my neighbor’s tree with my wife chasing after me with a golf club, I’ll have a legitimate excuse and alibi. My age, of course; which is clearly better than being under the influence of alcohol and painkillers due to the recent confession of my 15 affairs, including that friendly waitress at Perkins.

6) Being a Grandparent: I’m at the age where I’m constantly being asked when children are coming. It’s kind of a personal thing, but I can certainly understand the want to be a Grandparent. Now that I’m officially in ‘The Club’, I’m thinking I’m just going to skip the Parent thing and go straight to being a Grandparent. Who doesn’t want that? The kids always want to see you, you can give them candy and get away with it, they bring you gifts, smiles and cheers and, the best part: You get to give them back at the end of the day.

There you have it. I’m totally psyched to begin my official life as an old person. After typing the above, I’m realizing more and more just how awesome it is to be old.

For Your Space,

Steven.

Not So Fast…

2010-04-01T09:30:00.002-04:00

By: Amy Lotman, CIS Compliance Manager
amylotman@cis-partners.com

Very early March 25th, 2010, the Senate parliamentarian ruled that two portions of the House's "fix" bill do not directly affect the budget, which is a violation of the Byrd rule[1]. Republicans identified problems with two provisions relating to Pell Grants for low-income students that violated the rules of the budget reconciliation process, which Democrats used to speed the bill's passage and block a filibuster. Enacted under the Congressional Budget Act of 1974, reconciliation2 is the procedure by which Congress implements budget resolution policies primarily affecting permanent spending and revenue programs.

A quick look at last week, March 21-25th, in review helps explain how the bill got to this point. Last Sunday March 21st, the House passed the Senate health bill and the Houses passed the budget reconciliation bill containing compromise amendments to the health bill. Both bills pass with no Republican support.

On Tuesday March 23rd, the Senate opened up debate on the budget reconciliation bill. Under reconciliation rules, the legislation had to get kicked back to the House because of the changes. Finally, President Obama signed the health bill into law. After he took pen to paper, more than a dozen states filed suit arguing, among other things, that the insurance mandate in the new health care law is unconstitutional and Congress has no authority to force people to buy insurance.

That takes us to Thursday March 25th, a very busy day on the Hill. Senate Republicans found language in the reconciliation bill regarding student loans that violates process rules. One by one, Democrats vote down the GOP proposals that, for example, would have rolled back cuts to Medicare and barred tax increases for families earning less than $250,000 [4]. They also defeated an amendment that would have prohibited federal money for the purchase of Viagra and other erectile-dysfunction drugs for sex offenders [4]. After the provisions were stripped from the bill, the Senate voted to pass it. The changed reconciliation bill was sent back to the House, which passed the measure that evening (passed 56-43), clearing the way for Obama's signature.

It was not immediately clear when the House would take up the legislation. The House Majority Leader Steny Hoyer of Maryland3 expected same day turnaround of the “fix” bill.

Another House vote wasn't that surprising as almost all of the two-dozen reconciliation bills in the last 30 years have had to be tweaked and re-voted on.[4]

Sources:
1 http://www.rules.house.gov/Archives/byrd_rule.htm
2 http://www.rules.house.gov/archives/bud_rec_proc.htm
3 http://thehill.com/blogs/blog-briefing-room/news/89007-hoyer-confident-house-will-re-approve-final-health-bill-fixes
4 http://www.examiner.com/x-15870-Populist-Examiner~y2010m3d25-The-public-option-back-in-the-health-care-bill-after-all

HealthCare Reform Questions…Worried about Government Pricing Changes…Can’t Sleep…Who are you going to call – CIS!

2010-03-31T13:00:00.000-04:00

By: Lauren Pellicciotti, CIS Project Manager
laurenpellicciotti@cis-partners.com

“Perfect timing!” – If you are currently working in the pharma industry, you can probably interpret the sarcasm in that comment. For all of those GP geeks out there, just when you thought the DRA Final Rule changes were implemented with consistent methodologies in place, with the new law passed there comes another indefinite change to your calculations. Yes – I said it! According to Steven Moore, who you all know as “Scooter Boy”, Healthcare Reform was the hot topic at the most recent IIR GP Summit conference. Most of our clients were consistently asking these two questions: how is healthcare reform going to affect us, and when do we need to implement changes? CIS will be posting a timeline on how it will affect our industry. Stay tuned!

The Patient Protection and Affordable Care Act was signed into law by President Barack Obama on March 23, 2010[1]. Although the law was intended to help provide insurance to approximately 31 million uninsured Americans, and regulate healthcare costs, it is also going to have a huge impact on pharma companies and their internal cost containment strategies. The law has a timeline that could have a costly effect on the government and commercial operations of pharma companies beginning this year.

So how can you react to these changes? I first recommend understanding the new law. If your company does not have a Pricing Committee in place with regular meetings scheduled, I would encourage getting your internal thought leaders together to ensure the impact and changes of the law are addressed immediately. In addition, if you have not already done so, check out our summary of the Act because the 2000 plus page document can definitely put you into a deep coma – sad, but true.

In reading the law, in 2010 alone pharma companies will have to think about how to cut costs to ensure they are still hitting margins, while paying more dollars out to the states with the increase to rebate drug percentage for all drug category types. If you do not know, according to the new law, all brand name drugs will go from 15.1% to 23.1%, and for non-innovator multiple source drugs the rebate percent will increase from 11% to 13% of AMP.

CIS has the knowledge and expertise to help your company comply with these ever-changing requirements. If you have not heard about our services, please feel free to visit our website at www.cis-partners.com.

Sources:
[1] http://en.wikipedia.org/wiki/Patient_Protection_and_Affordable_Care_Act

A Summary of H.R. 3590: Patient Protection and Affordable Care Act

2010-03-31T08:00:00.009-04:00

By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com

Healthcare Reform is on the tip of everyone’s tongue, and the best way to successfully implement the required changes into your company’s government and commercials programs is to have a thorough understanding of the Patient Protection and Affordable Care Act. Understandably, that task may seem daunting, considering the Act is over 2,000 pages long. To give our readers the pertinent knowledge they need, we’ve created the following summary of the Act to highlight the most important and relevant points to the pharmaceutical industry. As always, CIS is here to answer any questions you have about Healthcare Reform and how it affects you.

MEDICARE

2010
• Provide a $250 rebate to Medicare beneficiaries who reach the Part D coverage gap in 2010 and gradually eliminate the Medicare Part D coverage gap by 2020.
• Expand Medicare to individuals exposed to environmental health hazards.

2011
• Manufacturers to provide a 50% discount on brand-name prescriptions filled in the Medicare Part D coverage gap.
• Begin phasing-in federal subsidies for generic prescriptions filled in the Medicare Part D coverage gap.
• Provide a 10% Medicare bonus payment to primary care physicians and to general surgeons practicing in health professional shortage areas.

2013
• Begin phasing-in federal subsidies for brand-name prescriptions filled in the Medicare Part D coverage gap (to 25% in 2020, in addition to the 50% manufacturer brand-name discount).
• Pilot program is established; evaluates paying a bundled payment for acute, inpatient hospital services, physician services, outpatient hospital services, and post acute care services.

2014
• Reduce Medicare Disproportionate Share Hospital (DSH) payments by 75%.
• Increase payments over time based upon the % of uninsured population and the amount of uncompensated care provided.

MEDICAID (Section 2501)

2010
• Increase the Medicaid drug rebate % for brand name drugs to 23.1%.
• Exception: rebates for clotting factor drugs and drugs approved exclusively for pediatric use increases to 17.1%.
• Increase the Medicaid rebate for non-innovator, multiple source drugs to 13% of Average Manufacturer Price (AMP).
• Extend drug rebate to Medicaid managed care plans.

2011
• Prohibit federal payments to states for Medicaid services related to health care acquired conditions.
• State balancing incentive program

2013
• Increase Medicaid payments for primary care services provided by primary care doctors for 2013 and 2014 with 100% federal funding.

2014
• Expand Medicaid to all individuals under age 65 with incomes up to 133% Federal Poverty Level (FPL) based on modified adjusted gross income.
• Reduce states’ Medicaid DSH allotments.

Physician Ownership/Reporting/and Other Transparency - (Section 1128G)

If providing a payment or other transfer of value to a covered entity, a Manufacturer must submit:
• The name of the covered recipient.
• The business address of the covered recipient and, in the case of a covered recipient who is a physician, the specialty and National Provider Identifier of the covered recipient.
• The amount of the payment or other transfer of value.
• The dates on which the payment or other transfer of value was provided to the covered recipient.
• A description of the form of the payment or other transfer of value, indicated (as appropriate for all that apply) as: cash or a cash equivalent.
• In-kind items or services.
• Stock, a stock option, or any other ownership interest, dividend, profit, or other return on investment; or any other form of payment or other transfer of value (as defined by the Secretary).
• A description of the nature of the payment or other transfer of value, indicated (as appropriate for all that apply) as: Consulting fees.
• Compensation for services other than consulting
• Honoraria
• Gift
• Entertainment
• Food
• Travel (including the specified destinations)
• Education
• Research
• Charitable contribution
• Royalty or license
• Current or prospective ownership or investment interest
• Direct compensation for serving as faculty or as a speaker for a medical education program
• Grant; or any other nature of the payment or other transfer of value (as defined by the Secretary).
• If the payment or other transfer of value is related to marketing, education, or research specific to a covered drug, device, biological, or medical supply, or to the name of that covered drug, device, biological, or medical supply.
• Any other categories of information regarding the payment or other transfer of value the Secretary determines appropriate.

Monetary penalties for non-compliance can range from $10,000 – $1,000,000. See section 1128G if you have specific questions regarding penalties.

More Information:

• Physician-owned hospitals that do not have a provider agreement prior to August 2010 will not be able to participate in Medicare.

• Drug, device, biological and medical supply manufacturers must report gifts and other transfers of value made to a physician, physician medical practice, a physician group practice, and/or a teaching hospital.

• Referring physicians for imaging services must inform patients in writing that the individual may obtain such service from a person other than the referring physician, a physician who is a member of the same group practice, or an individual who is supervised by the physician or by another physician in the group.

• Prescription drug makers and distributors must report to the Health and Human Services (HHS) Secretary information pertaining to drug samples currently being collected internally.

• Pharmacy benefit managers (PBM) or health benefits plans that provide pharmacy benefit management services that contract with healthy plans under Medicare or the Exchange must report information regarding the generic dispensing rate, rebates, discounts, or price concessions negotiated by the PBM.

Drug Sampling; Reporting – (Section 1128H)

Beginning in 2012, no later than April 1st of each year each manufacturer and authorized distributor of an applicable drug shall submit to the Secretary the following information from the preceding year:

• In the case of a manufacturer or authorized distributor which makes distributions by mail or common carrier reports: the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed, aggregated by: the name, address, professional designation, and signature of practitioner making the request.

• In the case of a manufacturer or authorized distributor of record which makes distributions by means other than mail or common carrier reports: the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by: the name, address, professional designation, and signature of the practitioner making the request.

Expanded Participation in the 340B Program – (Section 7101)

Expansion of Covered Entities Receiving Discounted Prices – Section 340B of PHS is amended by adding:

• A children's hospital excluded from the Medicare prospective payment system pursuant to section 1886(d)(1)(B)(iii) of the Social Security Act.
• A free-standing cancer hospital excluded from the Medicare prospective payment system
• Critical Access Hospitals
• Rural referral centers (must have disproportionate share adjustment percent equal or greater than 8%)
• Extension of Discount to Inpatient Drugs
• Prohibition on Group Purchasing Arrangements
• Medicaid Credits on Inpatient Drugs: not later than 90 days after the date of filing of the hospital's most recently filed Medicare cost report, the hospital shall issue a credit as determined by the Secretary to the State Medicaid program for inpatient covered drugs provided to Medicaid recipients.

Quick Facts/ At a Glance

Dual Eligible Coverage and Payment Coordination –
HHS will establish a Federal Coordinated Health Care office.

• Improve coordination among the federal and state governments for individuals enrolled in both programs.

Medicare Advantage (Part C) –
‘MA’ payments will be based on the average number of bids submitted by insurance plans in each market.

• MA plans will be prohibited from charging beneficiaries cost sharing for covered services greater than what is charged under fee-for-service.

Medicare Prescription Drug Plan Improvements (Part D) –
In order to have their drugs covered under the Medicare Part D program, drug manufacturers will provide a 50% discount to Part D beneficiaries for brand-name drugs and biologics purchased during the coverage gap beginning July 1, 2010.

• Initial coverage limit in the standard Part D benefit will be expanded by $500 for 2010.

Pharmacy Reimbursement – (Section 2503)

Use of AMP in Upper Limits – Secretary shall calculate the Federal upper reimbursement limit as no less than 175% of the weighted average of the most recently reported monthly AMP for pharmaceutically and therapeutically equivalent multiple source drug products.

• Smoothing process will be implemented for AMP (similar to Average Sales Price (ASP) smoothing)

• Definition of AMP:
o Wholesalers for drugs distributed to retail community pharmacies
o Retail community pharmacies that purchase drugs direct from the manufacturer

• AMP should exclude:
o Customary Prompt Pay Discount extended to wholesalers

o Bona fide service fees paid by manufacturers to wholesalers or retail community pharmacies, including (but not limited to) distribution service fees, inventory management fees, product stocking allowances, and fees associated with administrative services agreements and patient care programs (such as medication compliance programs and patient education programs.)

o Reimbursement by manufacturers for recalled, damaged, expired, or otherwise unsalable returned goods, including (but not limited to) reimbursement for the cost of the goods and any reimbursement of costs associated with return goods handling and processing, reverse logistics, and drug destruction.

o Payments received from, and rebates or discounts provided to, PBMs managed care organizations, health maintenance organizations, insurers, hospitals, clinics, mail order pharmacies, long term care providers, manufacturers, or any other entity that does not conduct business as a wholesaler or a retail community pharmacy.

• AMP should include:
o Any other discounts, rebates, payments, or other financial transactions that are received by, paid by, or passed through to, retail community pharmacies shall be included in the AMP for a covered outpatient drug.

Medicare, Medicaid, and CHIP Program Integrity Provisions

The Secretary will establish procedures to screen providers and suppliers participating in Medicare, Medicaid, and CHIP.

• Providers and suppliers enrolling or re-enrolling will be subject to new requirements including a fee, disclosure of current or previous affiliations with any provider or supplier that has uncollected debt, has had their payments suspended, has been excluded from participating in a Federal health care program, or has had their billing privileges revoked.

• Secretary of HHS is authorized to deny enrollment in these programs.

Enhanced Medicare and Medicaid Program Integrity Provisions – (Section 1128J)

CMS will include in the integrated data repository (IDR) claims and payment data from Medicare (Parts A, B, C, and D), Medicaid, CHIP, health-related programs administered by the Departments of Veterans Affairs (VA) and Defense (DoD), the Social Security Administration, and the Indian Health Service (IHS).

• New penalties will exclude individuals who order or prescribe an item or service, make false statements on applications or contracts to participate in a Federal health care program, or who know of an overpayment and do not return the overpayment.

• Each violation would be subject to a fine of up to $50,000.

• The Secretary will take into account the volume of billing for a Durable Medical Equipment (DME) supplier or home health agency when determining the size of a surety bond.

• The Secretary may suspend payments to a provider or supplier pending a fraud investigation.

• Health Care Fraud and Abuse Control (HCFAC) funding will be increased by $10 million each year for fiscal years 2011 through 2020.

• The Secretary will establish a national health care fraud and abuse data collection program for reporting adverse actions taken against health care providers, suppliers, and practitioners, and submit information on the actions to the National Practitioner Data Bank (NPDB).

• The Secretary will have the authority to dis-enroll a Medicare-enrolled physician or supplier who fails to maintain and provide access to written orders or requests for payment for DME, certification for home health services, or referrals for other items and services.

• The HHS Secretary will expand the number of areas to be included in round two of the DME competitive bidding program from 79 of the largest metropolitan statistical areas (MSAs) to 100 of the largest MSAs, and to use competitively bid prices in all areas by 2016.

Additional Medicaid Program Integrity Provisions

States must terminate individuals or entities from their Medicaid programs if the individuals or entities were terminated from Medicare or another state’s Medicaid program.

• Medicaid agencies must exclude individuals or entities from participating in Medicaid for a specified period of time if the entity or individual owns, controls, or manages an entity that:
o (1) Has failed to repay overpayments;
o (2) Is suspended, excluded, or terminated from participation in any Medicaid program;
o (3) Is affiliated with an individual or entity that has been suspended, excluded, or terminated from Medicaid participation.

• Agents, clearinghouses, or other payees that submit claims on behalf of health care providers must register with the state and the Secretary.
• States and Medicaid managed care entities must submit data elements for program integrity, oversight, and administration.
• States must not make any payments for items or services to any financial institution or entity located outside of the United States.

Pharmaceutical Manufacturers Fee
This provision imposes an annual flat fee of $2.3 billion on the pharmaceutical manufacturing sector beginning in 2010 allocated across the industry according to market share.

• The fee does not apply to companies with sales of branded pharmaceuticals of $5 million or less.

The Healthy, Hunger-Free Kids Act- One Step Towards Ending Childhood Hunger and Obesity

2010-03-30T08:00:00.001-04:00

By: Grete Dudek, CIS Compliance Associate
gretedudek@cis-partners.com

As much of the news focus has been on health care reform over the past few weeks, another important bill that will help reduce health care costs is quietly getting closer to becoming law. It is the Healthy, Hunger-Free Kids Act, the draft child nutrition reauthorization bill which was approved by the U.S. Senate Committee on Agriculture, Nutrition and Forestry last week as a step to ending childhood hunger by 2015 and childhood obesity within one generation. The legislation increases the number of children eligible for free or reduced cost meals in several ways, including making every child on Medicaid and every foster child eligible for meals, as well as creating provisions to make entire schools or school districts eligible for free or reduced cost meals. “According to the latest United States Department of Agriculture (USDA) data, nearly 1 in 4 children across the country are at risk of hunger (1).” As food prices have increased, and school district budgets have decreased, it has become more difficult for schools to provide healthy meals for children, so the increase in funding is more important than ever before.

The bill is historic because while fighting childhood hunger, it will also target the nation’s childhood obesity epidemic. The bill contains a provision for an additional six cent reimbursement on top of the national lunch average payment, for each lunch that meets certain nutrition standards (2). The standards will be published by the Secretary of Agriculture, based on recommendations made by the Food and Nutrition Board of the National Research Council for the National Academy of Sciences after the enactment of the bill (2). The bill has the ability to increase access to nutritious food for children not only for breakfast and lunch on school days, but also over the summer, weekends and extended school holidays (1).

The bill also includes guidelines that require any schools participating in a school lunch program to implement school wellness policies that include nutrition education, physical activity, and other activities that promote student wellness (2). Schools will also have to meet nutritional guidelines for all food sold at the school, including food outside the meal programs and sold any time during the school day (2). Childhood obesity and excess weight threaten the health of one third of American children, and children today are the first generation to face a shorter expected lifespan than their parents. Each year, $150 billion is spent treating obesity-related conditions, including diabetes, high blood pressure and heart disease, so if obesity rates are reduced, a tremendous amount of money could be spent on healthcare each year. First Lady Michelle Obama has been drawing attention the problems and solutions, by planting a garden at the Whitehouse and starting a campaign, called Let’s Move, to support healthier food in schools, help kids get more physically active, and make healthy, affordable food available everywhere (3).

President Obama took on the healthcare companies and insurance industries with the current Healthcare Reform bill. The time is right for also taking on the school lunch program to fight childhood obesity. It makes more sense to teach children healthy life habits from a young age, instead of treating diabetes, high blood pressure and heart disease down the road. The bill will be up for vote in the full Senate later this year.

Sources:
1. http://www.prnewswire.com/news-releases/feeding-america-applauds-passage-of-child-nutrition-reauthorization-legislation-by-senate-agriculture-committee-and-urges-full-senate-action-89058612.html
2. http://ag.senate.gov/Legislation/WEI10137.pdf
3. http://www.letsmove.gov/

Articles of the Week!

2010-03-26T08:30:00.000-04:00

Courtesy of: Scott Hoffman, CIS Senior Compliance Associate
scotthoffman@cis-partners.com

1) G.O.P. Forces New House Vote on Fixes to Health Bill
http://www.nytimes.com/2010/03/26/health/policy/26health.html?hp

2) Nurses' Drug Dispensing Examined
http://online.wsj.com/article/SB10001424052748704896104575140210198491910.html

3) Medicare panel eyes ESA use in kidney patients
http://www.reuters.com/article/idUSN1715734820100319

4) Gene Holds Key to Embryonic Stem Cell Rejuvenation
http://www.businessweek.com/lifestyle/content/healthday/637314.html

5) Zebrafish study may shed light on cell regeneration in human heart
http://sify.com/news/zebrafish-study-may-shed-light-on-cell-regeneration-in-human-heart-news-international-kdzp4ddieba.html

6) Teva Pharmaceuticals Wins Fight in the Generic Drug Market Battle
http://moneymorning.com/2010/03/19/teva-pharmaceutical/

A Summary of Final Contract Pharmacy Guidelines

2010-03-24T16:30:00.000-04:00

By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com

The proposed guidelines for contract pharmacy services that had once been limited to the Alternative Methods Demonstration Project (AMDP) program have now been revamped to utilize multiple contract pharmacies and suggested contract pharmacy provisions. This final notice, put in place by the Health Resources and Services Administration (HHS), comes after many of the covered entities participating in the 340B program suggested that their delivery of patient care would be more effective with a multiple contract pharmacy option. The guidelines state, “It would be a significant benefit to patients to allow the use of more easily accessible, multiple contract pharmacy arrangements by covered entities.”[i] Ultimately, this would allow the program to reach patients who otherwise would not have had access to a covered entity or if a covered entity did not have the resources ‘in-house’ to administer proper care to a patient.

Covered entities are permitted to use multiple pharmacies as long as they remain in compliance with previously established guidance. Auditable records must be maintained to demonstrate this compliance, and records must be held for as long as required by federal, state and local law. Covered entities are responsible for maintaining compliance with these requirements in order to prevent covered drugs from being dispersed to ineligible individuals, and to guard against situations where a drug is subject to both the 340B discount and a Medicaid Rebate claim. It is important to note that the use of a contract pharmacy is voluntary; thus, each covered entity should determine whether or not utilizing multiple contract pharmacies improves upon their current delivery system.

Essential Covered Entity Compliance Elements[ii]:

The covered entity will purchase and maintain the title to the drug while assuming responsibility for establishing its price
An agreement between a covered entity and a contracted pharmacy will specify the responsibility of both parties to provide comprehensive pharmacy services
It is the responsibility of the covered entity to inform the patient of his or her freedom to choose a pharmacy provider
The contracted pharmacy may provide other services to the covered entity or its patients (e.g., home care, reimbursement services)
The contracted pharmacy and covered entity will adhere to all federal, state, and local laws and requirements
The contracted pharmacy will provide the covered entity with reports consistent with customary business practices (e.g., quarterly billing statements, status reports, etc.)
The contracted pharmacy, with the assistance of the covered entity, will establish and maintain a tracking system suitable to prevent diversion of section 340B drugs to ineligible individuals
The contracted pharmacy and covered entity will develop a system to verify patient eligibility, as defined by HRSA guidelines
Neither party will use drugs purchased under section 340B to dispense Medicaid prescriptions unless the covered entity, the contracted pharmacy and the State Medicaid agency have established an arrangement to prevent duplicate discounts
The covered entity and contracted pharmacy will identify the necessary information to meet its ongoing responsibility of ensuring compliance
Both entities understand that they are subject to audits by outside parties
Upon written request to the covered entity, a copy of the contracted pharmacies service agreement will be provided to the Office of Pharmacy Affairs

[i] http://edocket.access.gpo.gov/2010/pdf/2010-4755.pdf

[ii] http://edocket.access.gpo.gov/2010/pdf/2010-4755.pdf

What to Make of the Bipartisan Meeting over Healthcare Reform

2010-03-19T16:14:00.002-04:00

By: John Jordan, CIS Compliance Consultant
johnjordan@cis-partners.com

President Obama recently met with congressional leaders to discuss the future of the stalled Healthcare reform. Democrats state that both parties are close to a solution. However, Republicans have a different story. They say that the reform should be scrapped and started over again (2). From the meeting that took place, it seems that starting over is not the likely outcome. The president’s goal is to reach a compromising solution within one month to six weeks (1).

The Republican Party wants to decentralize the health care problem and make it a piece by piece fix (1). This is a large scale down from the Democrats’ plans. Sen. Lamar Alexander, a Republican from Tennessee said, "Our country is too big, too complicated, too decentralized for Washington, a few of us here, just to write a few rules about remaking 17 percent of the economy all at once. (4)” Democrats stated that this way of going about the change has been tried, and has failed in the past.

The Democrats also have their own thoughts about the bill that was already proposed. According to the New York Times, Democrats:

“…are making the case that, in fact, comprehensive health legislation has
already passed both chambers, garnering a majority in the House and a
supermajority in the Senate. Under their tentative plan, the House would first
approve the bill that was adopted by the Senate on Christmas Eve. The Senate
majority leader, Harry Reid, and House Speaker Nancy Pelosi would also
draft a package of changes to be approved by both chambers in a separate
reconciliation bill. The reconciliation package would effectively smooth out
some of the differences between the House and Senate versions. The whole bundle
would be sent to Mr. Obama to sign into law. (3)”

This means that they would have to take into account what the Republicans have said, and would have to work to make certain compromises.

There are some key points that both parties agree on. Some of these areas are: reforming insurance markets, increasing purchasing powers for small businesses and individuals, eliminating waste, fraud and abuse, and lowering health care costs (2). An ensuing debate is scheduled to discuss the problems that both sides are stating; one of these points of disagreement is publicly funded abortions (4).

Another item that Democrats and Republicans agree on is that the status-quo is not working, and they must come together in some sort of compromise to get a health care reform in place to help the American public. However, another year-long debate is not in the best interest for the people and hopefully something will get resolved sooner, rather than later.

This all should come to a conclusion this upcoming weekend with the vote for the Health Care bill taking place.

Sources:
1. http://blogs.suntimes.com/sweet/2010/02/obama_at_bipartisan_health_mee.html
2. http://www.dotmed.com/news/story/11854
3. http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/health_insurance_and_managed_care/health_care_reform/index.html?scp=1-spot&sq=health%20care&st=cse
4. http://www.npr.org/templates/story/story.php?storyId=124105211

Key Elements of ICH-Q10 Pharmaceutical Quality System

2010-03-17T11:30:00.001-04:00

Erica Brooks, CIS Senior Compliance Manager
ericabrooks@cis-partners.com

The US Food and Drug Administration (FDA) launch of the Quality-by-Design (QbD) initiative is the foundation for the International Conference on Harmonization (ICH) Q10 Pharmaceutical Quality System guideline. [1] The QbD is a risk-based approach towards manufacturing. ICH Q10 guideline specifies the effective quality systems for the pharmaceutical industry, and is designed to be used throughout the lifecycle of a product. The guideline is a compilation of known regulations used in the industry today; it is not intended to replace Good Manufacturing Practices (GMP), but to serve as an enhancement of the concepts and laws. It applies to drug substances and drug products and includes biotechnology and biological products.

The scope of ICH Q10 defines the major components of product lifecycle as pharmaceutical development, technology transfer, manufacturing, and product discontinuation. The objectives for the guideline are to achieve product realization, establish and maintain a state of control, and to facilitate continual improvement. The Pharmaceutical Quality System consists of four key elements: Process Performance and Product Quality Monitoring system; Corrective Action and Preventive Action (CAPA) system, Change Management system, and Management Review of Process Performance and Product Quality.

A comprehensive monitoring system should demonstrate the state of control that the company has on product quality. Pharmaceutical companies should use a risk-based approach to establish the appropriate tools for measuring and analyzing the parameters. The CAPA system should include actions from complaints, investigations, product rejects, audits, etc., producing a combination of process improvements, knowledge and understanding of the product. An effective Change Management system is necessary to evaluate the impact of a change through an expert team to assure there is no impact to product quality. Lastly, the Management Review Process provides assurance that the process performance and product quality are managed and evaluated over the lifecycle of a product.

ICH Q10 encompasses GMP requirements and other ICH guidelines. The guidance presents information for pharmaceutical companies to establish a system-based management of products throughout the lifecycle. It supports four major systems for continuous improvement of process performance and product quality. Implementation of ICH Q10 is the vehicle to establishing a relationship between pharmaceutical development and manufacturing.

Sources:
1. http://www.fda.gov/RegulatoryInformation/Guidances/ucm128030.htm

Letter from a GP SME: Cardinal Health Distributes a Letter to Manufacturers on 340B Sales Reclassification

2010-03-11T08:30:00.000-05:00

By: Chris Cobourn, CIS VP of Regulatory Compliance
chriscobourn@cis-partners.com

On February 18, 2010, Cardinal Health distributed a “Dear Valued Supplier” letter to manufacturers explaining its new 340B Purchase Reclassification Policy. Cardinal states that the policy was designed to better serve “our mutual customers.” Cardinal has made the policy optional and suppliers are asked to respond via email or fax to agree or decline to participate. Note: Cardinal states that any supplier who does not respond by April 1, 2010 will be considered to be in agreement with the reclassification policy. Suppliers who do not want to adhere to the policy must check the “No” box and return the letter.

It is important to understand what is meant by “reclassifications.” According to the letter, if a customer who makes a purchase from a wholesaler, either under a contract or at WAC, subsequently dispenses the product under 340B eligible criteria, the customer can request that Cardinal Health “reclassify” the purchase as a 340B purchase. Essentially, Cardinal will consider the non-340B purchase to be a 340B purchase, as long as requests for Purchase Reclassification are received within 30 days of the close of the quarter in which the transaction took place.

So what impact could the Purchase Reclassification program have on pharmaceutical manufacturers and on Government Programs specifically? CIS has received numerous inquiries from manufacturers asking this question, and wondering what they should consider when determining whether or not to participate. One consideration is the value of Cardinal managing this process for manufacturers in an automated fashion, another is the potential complications for manufacturers who have Cardinal automatically reclassify the sales. Some of these complications could include:

Reconciling changes to historical chargebacks
The treatment of the sales in Statutory Pricing calculations, where a commercial sale in a previous period has to be reclassified as Government (potentially requiring a recalculation)
The impact on the GPO administrative fee, where the original sale would have been included in the administrative fee calculation

Another question for consideration is whether manufacturers are required to honor reclassification requests, or will have the option to do so. Given a situation in which an entity could have purchased under the 340B program but didn’t, and then subsequently asks for the price retroactively, would the manufacturer be obligated to reclassify the purchase (thus granting the price retroactively)? I am not aware of any guidance that suggests that the manufacturer is required to grant a price retroactively in that situation. Additionally, if an entity is eligible to purchase under the 340B program there are restrictions on their purchasing under a GPO contract. These are questions and issues that you may want to discuss with your legal counsel before determining how to proceed with the reclassification policy.

In evaluating this specific reclassification scenario, manufacturers should not confuse it with other common historical PHS pricing issues, such as the following basic scenarios. (Note: These thoughts represent my opinions on 340B pricing issues; I am not providing guidance or legal advice!)

A 340B entity purchases at the offered 340B price, and subsequently it is determined that the price was too high (perhaps due to restatement of Medicaid Pricing by the manufacturer). In this scenario, I think the current and expected practice is for the manufacturer to correct the overcharge and make the entity whole (if the entity was undercharged, the manufacturer has no recourse).
A Non-340B eligible entity purchases at the 340B price; however, it is subsequently identified that the entity should not have purchased at that price. It is standard practice for the manufacturer to show sufficient due diligence to recover the under charge, as to not create a potential Medicaid Best Price violation.
A 340B entity makes a purchase, but at a “commercial price,” such as off of a GPO contract, and later identifies that it could have purchased at the 340B price; this is the scenario that could allow a purchase to be reclassified under the Cardinal Health Purchase Reclassification policy. Manufacturers should consider the guidance on this, check with legal counsel if necessary, determine wither they are obligated to grant the price historically, and make a business decision on whether to grant the price.

If you are a manufacturer, make sure to fully evaluate the potential impact of the reclassification, especially on your GP calculations, as you determine how to follow Cardinal’s new policy.

Additional Note: Upon inquiry – the OPA currently has no position on this letter.

Thank you, I appreciate any questions or comments,

Chris Cobourn

Articles of the Week!

2010-03-11T08:00:00.000-05:00

Courtesy of: Jess Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com

1) Parents give kids fewer bad genes than thought: study
http://news.yahoo.com/s/afp/20100310/ts_alt_afp/scienceresearchusgenome

2) NY seeks 'fat tax' on sodas to fight rising US obesity
http://www.google.com/hostednews/afp/article/ALeqM5izMGnugDj3S1KEI5m825MmSwuLPA

3) Scientists tease DNA from eggshell of extinct birds
http://news.yahoo.com/s/afp/20100310/sc_afp/sciencepalaeontologyfossils

4) As Lice Grow Treatment-Resistant, Drug Could Help
http://www.npr.org/templates/story/story.php?storyId=124526307&ft=1&f=1027,1030,1066

5) Health Care War: Can Democrats Pass Bill by White House Deadline
http://abcnews.go.com/GMA/HealthCare/white-house-deadline-health-care-bill-irks-democrats/story?id=10068131

“TRICARE Final Rule – Tips for Manufacturers to Ensure That They Are Prepared”

2010-03-05T15:06:00.002-05:00

By: Dave Rice, FSS Director, daverice@cis-partners.com
John Avicolli, FSS Project Manager, johnavicolli@cis-partners.com
Jeff Blake, FSS Associate, jeffblake@cis-partners.com

On November 30, 2009, the U.S. District Court for the District of Columbia held that remand of the Final Rule was necessary so that TRICARE Management Activity (TMA) could exercise its discretion in implementing the statute. However, the court was clear that the Department of Defense (DoD) could, in exercising its discretion, reissue a rule with the same substantive requirements. In view of this conclusion, the court decided not to void the TRICARE Final Rule, thereby leaving the voluntary agreement program in place.

The U.S. District Court has directed TMA to reissue the Final Rule. Specifically, TMA is to remove references in the pre-amble indicating that the law requires manufacturers to pay refunds for products purchased by the government at a price that was in excess of the calculated Federal Ceiling Price. Currently, the statute requires that FCPs apply to all retail pharmacy program prescriptions filled on or after January 28, 2008. However, the statute does not address who is responsible for the cost differential between the FCP and the actual price paid. In other words, the statute does not specifically state that the manufacturer is on the hook to retroactively reimburse the government for purchase prices greater than the FCP price dating back to January 28, 2008. This was the basis of the case brought on by the Coalition for Common Sense in Government Procurement back in May 2009.

Per the U.S. District Court’s ruling, TMA was also required to show that they have considered options other than manufacturer refunds for getting to the required FCP price. However, it will be at the discretion of the agency to determine which of the different options is best for implementing the Final Rule. It is most likely that TMA will continue along the manufacturer refund course and document that they have, in fact, evaluated other options.
The court rejected the Coalition's argument that the Final Rule was impermissibly retroactive, on the grounds that it is the statute, not the rule itself, which made transactions on or after January 28, 2008 subject to FCPs. This ruling will most likely be appealed as many legal arguments remain related to this ruling. Currently, the DoD is in the process of collecting comments from the general public before the revised Final Ruling is issued. The comment period ends on March 11, 2010, and any individual who wishes to make an official comment can do so on the Federal eRulemaking Portal at http://www.regulations.gov/. [1]

Given all of this information, we are currently recommending to our clients to take a wait-and-see approach and recommend the following to ensure potential financial obligations are accounted for and to ensure that companies have unencumbered access to the TRICARE retail market:

Calculate and accrue for any retroactive liabilities.
Sign a Pricing Agreement with TMA agreeing to pay refunds going forward on a voluntary basis. (This agreement helps to ensure that products are assigned a Tier 1 or Tier 2 Uniform Formulary Status. Tier 1 and 2 products have a $3 and $9 co-pay, respectively, while Tier 3 products require a $22 co-pay [2]. Further, a pricing agreement can help ensure that there are no pre-authorizations associated with the product.)
Wait for a formal request for payment prior to making any refund payments.
Monitor progress of any appeals by individual companies or the Coalition for Common Sense in Government Procurement.

Sources:
[1] http://www.tricare.mil/pharm_mfg/downloads/PharmFCP-FR2-9-10.pdf
[2] http://www.tricare.mil/News/news.aspx?fid=306

IIR's GP Summit Update

2010-03-05T15:00:00.000-05:00

Before the snow storm hit Baltimore, CIS was scheduled to run a full-day Advanced GP Workshop during IIR’s GP Summit in February (GP 201). The Workshop was scheduled to include a Roundtable discussion involving different agencies; OIG, CMS, VA and OPA.

IIR’s GP Summit has been rescheduled for Monday, March 22nd and Tuesday, March 23rd at the Hilton, Baltimore. The Conference will consist of a full two day agenda that will cover both GP 101 and 201 topics.

A finalized agenda from IIR is expected shortly, and some of the topics CIS will present include:

GP Audit Approach
Recalculations and Restatements: Understanding the Guidance
Mergers, Acquisitions and Divestiture and the Impact on GP
Hot Topics: Agency Round Table Discussion

We hope you will be able to make it to Baltimore. If you have any questions or suggestions regarding our sessions, please feel free to contact me.
chriscobourn@cis-partners.com

Articles of the Week!

2010-03-04T09:00:00.000-05:00

Courtesy of: Dana Zelig, CIS Compliance Consultant
danazelig@cis-partners.com

FDA Criminal Division to Increase Prosecutions
http://online.wsj.com/article/SB10001424052748703862704575099942109582112.html?mod=WSJ_Pharmaceuticals_leftHeadlines

Obama Calls for ‘Up or Down’ Vote on Health Care Bill
http://www.nytimes.com/2010/03/04/health/policy/04health.html?ref=health

Sanofi’s Cancer Drug May Set New Standard
http://www.thestreet.com/_yahoo/story/10694965/1/sanofis-cancer-drug-may-set-new-standard.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

Teva Regains Exclusivity on Blood Pressure Drugs
http://finance.yahoo.com/news/Teva-regains-exclusivity-on-apf-2254947923.html?x=0&.v=1

AZ Pitches Social-Media Rules to FDA
http://www.fiercepharma.com/story/az-pitches-social-media-rules-fda/2010-03-02

*

New York Attempts to Restrict Sales & Marketing Practices – Again

2010-03-03T09:00:00.000-05:00

By: Chris Didizian, CIS Compliance Manager
chrisdidizian@cis-partners.com

New York is attempting to follow suit with states such as California, Nevada, and Massachusetts by proposing a bill, which, if passed, would limit marketing activities to healthcare professionals (“HCPs”). Not surprisingly, the proposed provisions governing promotional materials, meals, and entertainment mimic those of other states, but New York takes the provisions a step further by extending liability, not just to the manufacturers, but to the HCPs. The focus of this newsletter article is on the proposed rules per state, specifically as they apply to promotional expenses spent on HCPs.

As with all states with similar, effective legislation, Section 279 of Senate Bill 6608 attempts to “ensure that the relationship between medical manufacturing companies and HCPs does not interfere with the independent judgment of such professionals in making prescribing decisions.”[1] To do so, the New York legislation states that medical manufacturing companies are prohibited from providing HCPs “any financial support, including but not limited to any grant, scholarship, subsidy, support, consulting contract, speaker contract or educational or practice-related items to reward the professional for having prescribed particular drugs, biologics or medical devices in the past, or to induce the professional to prescribe or continue prescribing… in the future.”[2] As with the other states, this prohibition excludes compensation for bona fide consulting or speaking services.

With regards to promotional materials, the bill states that, “medical manufacturing companies are prohibited from providing any promotional materials to a HCP unless such materials: (1) are accurate and not misleading; (2) make claims about a product only when properly substantiated; (3) accurately reflect the balance between risks and benefits; and (4) are consistent with all other requirements of the FDA.”[3] Nothing within the above provisions reads differently than what is currently enacted by federal legislation, 21 USC §352 et seq. Misbranded Drugs and Devices and relevant guidance in accordance with the PhRMA Code on Interactions with Healthcare Professionals (“PhRMA Code”).

With regards to providing entertainment, recreational items, and meals, the proposed rule would prohibit a manufacturer from offering, and a HCP from accepting, any entertainment or recreational items. Meals are also prohibited to HCPs and staff unless they: “(1) are modest as judged by local standards; (2) are provided in connection with structured, oral informational presentations that provide specific or educational value; (3) are served only for consumption during an informational or educational presentation and are not offered or served at another time or place or outside the presence of the pharmaceutical company; (4) are not part of an entertainment or recreational event nor do they occur more often than on an occasional basis.”[4] Meals are also permitted outside of the professional’s office or hospital setting or manufacturer’s office if the meal is incidental, not part of a recreational event, and is conducive to informational communications. As always, meals provided in this case should be modest and occur occasionally.

In an atypical manner, as stated earlier, liability has been extended not only to manufacturers but also to HCPs, as indicated by the proposed penalties. The penalties for a medical manufacturing company for violating any section of the proposed bill are a minimum of $15,000 and a maximum of $250,000 per violation. Individual HCPs who violate any section of the proposed legislation are penalized a minimum of $5,000 and a maximum of $20,000 per violation.[5] For the most part, much of the provisions already exist within the PhRMA Code, but the increased liability to HCPs further indicates that state governments are willing to resort to further restrictions to ensure that interactions between manufacturers and HCPs are, ultimately, in the best interests of their patients.

[1] S.B. 6608. §279 et seq,
[2] Ibid.,
[3] Ibid., section 4
[4] S.B. 6608. §279 Section 5.
[5] Ibid., Section 17.

FDA Impersonators

2010-03-01T10:00:00.001-05:00

By: Venessa Piper-Givler, CIS Compliance Manager
Vanessapiper-givler@cis-partners.com

The FDA is now worried about the extortion scam for which they received reports in November 2009. The FDA has been warning the public that there are criminals posing as FDA special agents as well as other law enforcement agents such as DEA, FBI, U.S. Secret Service and U.S. Customs Service. The criminals have targeted victims that purchase their prescription drugs over the internet or “telepharmacies.” They believe that the scam started out as a theft of consumers’ personal information.

“The criminals inform the victims that purchasing drugs over the internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid.” In addition to these fines, victims might find that there are fraudulent transactions placed against their credit cards, the FDA said. (1)
The FDA also has explained that consumers should be aware that although phone calls appear to be from numbers located in the U.S., they are actually voice-over-the-internet-protocol numbers or even cell phones. (2)

“Impersonating an FDA official is a violation of federal law,” said Michael
Chappell, the FDA’s acting Associate Commissioner for Regulatory Affairs.
“The public should note that no FDA official will ever contact a consumer
by phone demanding money or any other form of payment.” (3)

It was also explained to the public that FDA special agents are not authorized to impose criminal fines. This type of action can only be taken through the court system and the fines are paid to the U.S. Treasury. The FDA also explained that they are working with various agencies to find the impersonators and will actively pursue criminal charges.

In summary, what you should watch out for:

A phone call from someone identifying themself as an FDA official or other law enforcement personnel
The phone call appears to be a U.S. number
The caller is requesting credit card information, or a wire transfer (to the Dominican Republic) to pay for fines related to purchasing drugs over the internet
The caller may have a Hispanic accent

What you should do if you receive a call like this:

Refuse all demands; be aware that the impersonators may threaten with property searches, arrest, etc.
Call the FDA's Office of Criminal Investigations Metro Washington Field Office at 800-521-5783 to report the crime.

With all of these reports about FDA impersonators, we might want to reconsider purchasing our prescription drugs over the internet and try going to the pharmacy counter again.

Sources:

1) http://www.miamiherald.com/news/action-line/v-print/story/1447413.html
2) http:///www.fiercebiotech.com/press-releases/fda-warns-public-extortion-scam-fda-impersonators
3) http://pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id=650318

The Adventures of Steven Moore, Scooter Boy, Part Tres: A Trilogy Comes to a Close

2010-02-19T15:30:00.001-05:00

It is with great regret that as I write this article I am making plans to return my Scooter to the local Home Health Care Center. I’ve laughed. I’ve cried. I’ve hurled. It’s been a whirlwind 8 weeks and I thought I’d share with all of my friends the top 10 things I’ve learned as Scooter Boy.

10. Chicks dig Scooters: I had to beat them off with a stick --- or was it a cane…? Granted, most of them were collecting Social Security, but I try and aim for quantity, not quality. In years, that is.

9. Old people are not only older than us and have whiter hair --- they’re actually a lot smarter than me: Older folks go to the doctor when something hurts. They use devices that help them cope with the issues they have. They’ve learned that listening to your body requires getting up and going to the doctor as soon as possible. Me? Nope. I demolished my Achilles Tendon on December 15th and then waited 3 days and a CIS holiday party to get to the doctor. However, this is where things changed. I saw someone at the doc’s riding on a Scooter and it hit me, “I’m a Mooreon.” Perhaps it’s time to grow up and stop acting like a tough guy and do what’s best for my body. So I researched and picked up my Scooter a few days later. It was a savior and I’m going to miss it, but I have honest, newfound respect for my elders who don’t let perception get in the way of allowing themselves to cope with their issues. This section is way too serious for this article so, to sum it up, old people kick ass. Can I say ass on the Pharma Compliance Blog? I just did. Twice. Sh*t.

8. Stevocol and Alcohol can help you deal with Protocol: Stevocol is listening to my own body. Alcohol is a substance that relaxes, depresses, angers and puts you to sleep all in the same night. Protocol is what you’re supposed to do per the doctor. By listening to myself and drinking a beer or four at aptly timed moments, I was effectively able to put myself to sleep so I listened to what the doctor said. Therefore, for the math majors and all of the compliance folks reading: Steveocol + Alcohol = Protocol or, what I like to call, Scootpliance.

7. Drinking and driving also pertains to Scooters: I had one slip during my time as Scoots the Wonder Boy. The idiot that I am decides to try and race back and forth from room to room on my Scooter while timing myself from run to run. I’m no Apolo Ohno or Lindsey Vonn, but I felt I could take anyone on a Scooter --- even the most experienced Scooter-wielding folks from the aforementioned #9. However, on this particular night, I decided to turn into Mario Scootereti and slipped off my Scooter and used my bad foot to break the fall. Mistake. Bigger mistake was consuming a couple (or a couple, couple) cold ones prior to embarking on this clearly, misguided mission. So a warning to all of you out there: Scoots don’t let Scoots drink and drive.

6. The best time to get hurt is when you get 51.5” of snow in 5 days: Granted, it would have been great if my Scooter had snow tires, but being cooped up for 8 weeks can only be tolerable during this winter in the Northeast. Quietly, without telling me, my wife called the TV show ”Haulin’ House” and moved us to Buffalo. I can’t tell you how hard it was to watch my wife do all that shoveling while sipping a warm cup of coffee inside our toasty home. Hey, don’t think of me that way! I shouted out plenty of directions and orders from time to time!

5. Birdwatching from a Scooter makes you the biggest dork on the planet: Do I really have to expand on this one?

4. The best medicine is laughter --- at yourself: I have to admit, calling yourself Scooter Boy and publishing it to the world is not something everyone would do, but I’ve learned that laughing at yourself can sometimes change your perspective on things. A lot of people have it a lot worse than me in this life and I thought that embracing my sudden transformation from 30 to 86 would be fun. I can’t believe the feedback I’ve gotten and how many clients are now emailing me starting with “Dear Scoots” or “Hey Scooter Boy”. I laugh every time, and I thank you all for the support. Not to be melodramatic, but it was a tough time for me, especially considering how active I like to be, but you indulging my want to deride myself and playing along has seriously helped contribute to my spirits and healing. Thank you. Now that I’ve gotten that out of the way, can I sell you some Compliance services?

3. I’m more thankful than ever for healthcare: My surgeon, Dr. Steven Cohen of the Rothman Institute, was astoundingly responsive and performed a flawless surgery. If you’re in the Philly area and need a great Orthopedic Surgeon, look no further. I’m walking under my own power 6 weeks after surgery and, from what I’ve read, that’s REALLY fast. Dr. Cohen was one of many impressive, kind folks I met during my ‘ride’ and tenure as Scooter Boy. If you have healthcare, be thankful for it…

2. Showering in a chair rocks: Yup, that’s right. I had to buy a chair with handle bars to shower for the first few weeks while I was unable to walk or stand. We are now at 8 weeks and it’s still in the shower despite my ability to easily get in and get out. What? Imagine you always stood up to watch TV and then someone introduced you to a recliner. Would you ever return the recliner?

1. My wife, Noreen, is the most amazing human being on Earth: Any woman that can put up with me for 8 weeks to date, and basically do everything for me for the first 4, has got to be one incredible person. I publicly thank my soul mate for keeping me grounded, sane and for making me laugh when all I really wanted to do was cry.

For Your Space,
Steven.

For those of you who missed the first installment and Part Deux, please check out these links:
http://pharmacomplianceblog.blogspot.com/2010/01/adventures-of-steven-moore-scooter-boy.html
http://pharmacomplianceblog.blogspot.com/2010/01/adventures-of-steven-moore-scooter-boy_12.html

Sebelius Requests Explanation from WellPoint on Premium Increases

2010-02-17T14:30:00.001-05:00

By: Scott Hoffman, CIS Senior Compliance Associate
scotthoffman@cis-partners.com

Healthcare reform hasn’t been in the press much in the last few weeks after the results of the Massachusetts Senate elections; however, that is most likely going to change. WellPoint, which operates Blue Cross and Blue Shield plans in 14 states [2], recently announced premium rate hikes of up to 39% and that has drawn the ire of those insured as well as the government, specifically Kathleen Sebelius, Secretary of Health and Human Services (HHS). WellPoint raised the premiums 39% for residents of California, while residents of Maine are going to see a 23% increase, Oregon 15% and Kansas up to 20% [1]. Kathleen Sebelius stated that she has some degree of skepticism about a company with profits of $2.7 billion in the fourth quarter alone needing to impose rate hikes on 800,000 customers so they can keep their profit margins going [2]. In light of the increases, she has requested an explanation as to why WellPoint needs to increase their rates to that extent.

In response WellPoint sent a letter to HHS outlining the following points in order to justify the hikes:

Healthy customers are dropping coverage to save money while sicker ones retain it and run up medical bills
Healthy customers are switching to cheaper insurance options, further reducing revenue
Some customers are moving into a higher age category that carries higher premiums
Deductibles and co-payments haven't gone up with inflation
Prices for medical care are rising
People are using more healthcare, and again, age is a factor [3]

In addition to the points made above, Brian Sassi, President of the Consumer Business Unit, stated, “We need to make sure that our premiums cover the cost of claims.” WellPoint made approximately $2.75 billion in profit during the fourth quarter of last year, (as well as an additional $2 billion from the sale of one of its businesses, but that doesn’t really count in the context of this topic), which seems to me like the cost of their premiums is more than adequately covering the cost of the claims [4]. I have to admit, a company generating $2.75 billion in one quarter from core operations, in this economy, seems to be a pretty healthy business. Granted I have only a broad understanding of the insurance business, but a quick look at Yahoo! Finance (ticker symbol WLP for those wanting to check) shows me the last three years resulted in profits of $2.5 billion in 2008, $3.3 billion in 2007 and $3.1 billion in 2006. This just further goes to show the costs of premiums are definitely covering the cost of claims year in and year out.

When Scott Brown was elected to fill the Massachusetts Senate seat, Healthcare Reform lost a lot of momentum. Now that this WellPoint rate hike is in the news and gaining attention, you can be sure Healthcare Reform will begin to be debated again. You can also be sure that both Democrats and Republicans will not be seeing eye to eye on how to combat increases like this in the future as both sides still can’t agree on how this should be addressed [5]. Should be an interesting couple of months….

Sources:
[1] http://news.yahoo.com/s/ap/20100213/ap_on_he_me/us_insurance_rates_states
[2] http://tpmdc.talkingpointsmemo.com/2010/02/california-insurers-rate-hike-becomes-rallying-point-for-health-care-reform.php
[3] http://news.yahoo.com/s/ap/20100211/ap_on_he_me/us_insurance_rates_wellpoint_glance
[4] http://www.usatoday.com/money/industries/insurance/2010-02-11-wellpoint-explains-hike_N.htm
[5] http://online.wsj.com/article/SB10001424052748704337004575059913178282490.html

Articles of the Week!

2010-02-12T09:45:00.000-05:00

Courtesy of: Scott Hoffman, Senior Compliance Associate
scotthoffman@cis-partners.com

1) No Reform? Look For More Consolidation
http://www.fiercepharma.com/story/no-reform-look-more-consolidation/2010-02-08

2) Leverage Sought In Health Summit
http://online.wsj.com/article/SB10001424052748703615904575053770388352204.html

3) WellPoint Blames Big Premium Hike On Dempgraphics
http://www.usatoday.com/money/industries/insurance/2010-02-11-wellpoint-explains-hike_N.htm

4) Medicines Not Working? There’s An App For That
http://www.reuters.com/article/idUSTRE61A0Q320100211

5) Scientists Find First Genes Linked To Stuttering
http://news.yahoo.com/s/ap/20100211/ap_on_sc/us_med_stuttering_genes

2011 White House Budget

2010-02-10T13:00:00.003-05:00

By John Jordan, Compliance Associate
johnjordan@cis-partners.com

February 1, 2010, President Obama released his proposed budget for the fiscal year of 2011. The fiscal year starts in October, 2010. The total for the 2011 budget is $3.8 trillion. With this said, the current year’s deficit will be a record breaking $1.6 trillion, and 2011 projected deficit would be $1.3 trillion. As many of us are wondering, how does this affect the Pharmaceutical area? The Department of Health and Human Services received $81.3 billion in support from the President’s budget . This is slightly down from the approximately $82 billion estimated for 2010. According to the Budget documentation some of the key highlights include:

Supports health insurance reform by expanding patient-centered health research to give patients and physicians the best available information on what treatments will work the best for them. Also in supporting investments in health information technology, expanding prevention and wellness activities, and launching payment reform demonstration programs in Medicare.
Adds $290 million for healthcare centers to expand health care access to the medically underserved.
Expands support for biomedical research, by providing an increase of $1 billion for the National Institutes of Health.
Invests approximately $1.4 billion to strengthen food safety efforts.
Supports over 8,500 healthcare professionals in medically underserved areas through the National Health Service Corps.
Continues a commitment to invest in the Indian Health Systems.
Invests more than $3 billion for HIV/AIDS prevention and treatment activities to expand access to affordable healthcare and prevention services.
Includes $25.5 billion for a 6-month extension of the American Recovery and Reinvestment Act (ARRA) temporary increase in Federal Medicaid match.
Increases funding towards bio-defense medical countermeasure development.
Places renewed emphasis on preventing, detecting, and recouping fraudulent, wasteful, and abusive payments in Medicare, Medicaid, and Children’s Health Insurance Program (CHIP).
Increase of $1.6 billion for child care to serve 235,000 more children than could be served without additional funds in 2011 for the programs Head Start and Early Head Start.
Increases help for families caring for aging relatives at home.

The $25.5 billion allocated for the 6-month extension of the ARRA is to help States maintain their Medicaid programs during a period of high enrollment and not enough funding within the State revenue systems. This provides the States with fiscal relief for an extended 6-month period. President Obama’s budget also has an increase of $250 million aimed toward the prevention of fraud. This is supposed to ensure that the government, including the Department of Justice, the Office of Inspector’s General, etc., will strongly enforce the penalties to a manufacturer if there is a case of fraud towards the Medicaid, Medicare, and CHIP programs.

In addition to those accounts within the Department of Health and Human Services, there were a few changes that took place between the 2010 budget and 2011 budget proposal. The Administration decided to terminate the funding for the projects in the Health Care Facilities and Construction, the Denali Commission, which supports the construction of health facilities in Alaska, and the Delta Health Initiative, which consists of training healthcare professionals, and the purchase of equipment in Mississippi. These programs were designated as being private health care facilities and should not be included in Federal spending.

The Administration feels that it will be saving money in the long run by investing in certain sectors of the Department of Health and Human Services. For example, it feels that for every dollar spent to prevent and fight healthcare fraud and improper payments, approximately $1.55 will be saved. Another view is that by putting forth legislation to provide additional program integrity authority to the Centers for Medicare and Medicaid Services (CMS), CMS can take specific actions against providers that do not follow appropriate Medicare payment requirements. Another method of fraud prevention is to require States to track and monitor providers’ drug billing, tracking, and utilization patterns that could help deduce whether or not payments are being paid inappropriately.

With this budget in place, the President’s advisors are predicting that the deficit will decrease in the future and that investing now will pay off in the long. According to an article in the New York Times,

“Over 10 years, according to the administration, the budget would save an
estimated $1.2 trillion, mainly by ending the Bush tax cuts for the richest
Americans and freezing some domestic spending for three years. But that total is
roughly one-fifth of the size of the debt that will pile up from now to 2020,
the budget shows.”

Peter Orszag, President Obama’s budget director, also states that Obama will keep his promise towards reducing the deficit in half by the end of his term.

There is also another side of the argument in regards to the deficit. According to some research, it is shown that the national deficit would reach $18.6 trillion in the year 2020, if everything is accepted in President Obama’s proposal. This statement was made by James Capretta, who served as an associate director at the White House Office of Management from 2001-2004. A deficit that large would likely start an economic crisis. “At some point, the flood of Treasury debt instruments worldwide would lead lenders to demand higher rates of return for their loans, or perhaps to runaway inflation — or more probably both. The result could be quite devastating to private-sector business investment, productivity and job growth, making it all the more difficult to get out from under the debt spiral that would ensue,” states Capretta.

Sources:
1. http://www.whitehouse.gov/omb/budget/Overview/
2. http://www.nytimes.com/2010/02/02/us/politics/02budget.html
3. http://www.foxnews.com/politics/2010/01/31/obama-offers-budget-deficits-far-number-crunchers/http://www.kaiserhealthnews.org/Columns/2010/February/020410Capretta.aspx

The MMR Vaccine and Autism – A Broken Link?

2010-02-10T08:30:00.001-05:00

By Suma Kallurkar, CIS Senior Manager
sumakallurkar@cis-partners.com

In 1998 a landmark study was published in the British medical journal, The Lancet, which first suggested a link between autism and the vaccine for measles, mumps and rubella (MMR). The consequences of the study were highly significant, as it spurred concerns among British parents that the MMR vaccine could cause autism. These concerns spread to the U.S. as well, and over the last decade, many parents have chosen not to have their children receive the MMR vaccine. Although there has been subsequent scientific evidence that shows no causal link between the MMR vaccine and autism, anti-vaccine sentiment has remained strong, much to the dismay of the medical community.

Now, 12 years later, The Lancet has fully retracted the study after the General Medical Council, an independent regulatory panel in the UK, investigated and found the lead author of the study, Andrew Wakefield, to have acted unethically in the conduct of the study. Of particular concern to the journal was that the children were not treated ethically and had been picked for the study rather than being referred by physicians. The unethical conduct includes:

Lack of ethics approval for certain actions conducted by some of the researchers (including Wakefield)
Certain claims in the study were false
Wakefield received payment from solicitors representing parents who believed their children had been harmed by the MMR vaccine
Blood was drawn at a child’s birthday party where the children were paid

Many argue that this retraction has come too late, and that the damage done by the study may be difficult to un-do. The study has been credited with causing a decline in MMR vaccination rates and a subsequent rise in measles. It will be difficult to allay the fear that many parents have developed with regard to vaccines, despite the strong evidence that there is no link between vaccines and autism. Fears have been exacerbated by the stark rise in diagnosis of autism over the years. The medical community will have to continue to work at convincing many of these parents of the benefits of vaccines to their children.

Sources:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2960175-7/fulltext

http://online.wsj.com/article/SB10001424052748704022804575041212437364420.html?mod=WSJ_hpp_MIDDLENexttoWhatsNewsSecond

http://news.bbc.co.uk/2/hi/health/8493753.stm

http://blogs.wsj.com/health/2010/02/02/the-end-of-a-paper-that-linked-autism-to-a-vaccine/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+wsj%2Fhealth%2Ffeed+%28WSJ.com%3A+Health+Blog%29&mod=smallbusiness

Finally - An Uplifting Story About Prescription Drugs

2010-02-09T11:30:00.000-05:00

By: Jon Dellaquila, Compliance Manager
jondellaquila@cis-partners.com

We have all heard various arguments around healthcare reform and its impact on the pharmaceutical industry, and deservedly so; healthcare is vitally important to all of our wellbeing. The rising cost of prescription drugs has become a concern to many over the years, and suffering through the worst recession in decades certainly does not help. In a 2009 survey conducted by the Consumer Reports National Research Center, 70 percent of the 2,004 participants had to modify their lifestyle in order to afford their prescription drugs. A more stunning conclusion from this study revealed that 28 percent of the people polled actually stopped filling their prescriptions because they were unable to afford them.[1] These facts are very concerning. People with potentially life-threatening conditions are putting their own health at risk in order to survive financially. Scary, very scary. Many people reading this may be affected, or may know someone who has faced a similar situation. I unfortunately, can relate to the latter. However, the situation involving this person close to me actually worked out for the best.

Growing up, I always wanted to be a Pharmaceutical Sales rep and decided to head towards a financial degree in college. However, the day before I was to leave for my sophomore year, I had to have knee surgery to repair a torn medial meniscus. Being the naturally inquisitive person I am, I asked if I could watch it. So I did, even after the nurse told me that no one actually makes it through; they typically pass out. I made it though, and after that, I switched my entire class schedule for the fall semester because I had decided I wanted to be a doctor. I never made it to med school, but did find myself working in the pharmaceutical industry and eventually working in the field of Oncology clinical research.

A relative of mine was diagnosed with Stage IV lung cancer, and her doctors indicated that chemotherapy would probably not be effective in her particular case; instead they suggested simply monitoring her progress. For a year, everything was great and nothing had changed. Recently however, her physician suggested that it may be worthwhile for her to try a relatively new cancer treatment, which targets a specific receptor that is significantly expressed in several types of cancer. This drug is currently approved as a second line therapy; however, not as a first line therapy for her particular cancer. Since she did not receive chemotherapy and she would be using it as a first line therapy, it would not be covered by insurance. She was to take it every day for a year... at a cost of $5,000 a month. Do the math; it is a significant amount of money for one year that very few could possibly afford. What would you do?

I put on my Oncology hat and started doing some research about the drug, the company that makes it and if there were any programs she would be eligible for that provided assistance. Turns out, the company itself offered a patient assistance program; however, she was denied based on her income level. Well, a friend of hers got involved and wrote a letter to the company. A week or so later, an individual from the company called my relative and informed her that they were going to help her out. They would provide the drug to her - free of charge. It was a story that was hard to believe; one you hope for, one you pray for. One I just had to share.

As the great Jimmy Valvano said in his 1993 ESPY acceptance speech, “Don’t give up, don’t ever give up.”[2] If you or someone you know is in a similar position where a prescription drug becomes too expensive to afford or is simply unaffordable from the start, utilize the internet. Explore the drug and how it works, research the company that makes it. Do not be afraid to reach out to a friend in the industry or ask your doctor. You never know what programs may be out there that could provide assistance. Times may get tough and money can get tight, but you can never put a price tag on your life.

For assistance on programs that are available, please visit ‘Rx Assist, the Patient Assistance Program Center at http://www.rxassist.org/.[3]

Sources:
[1] http://www.consumerreports.org/health/prescription-drugs/sticker-shock-at-the-pharmacy-counter/overview/sticker-shock-at-the-pharmacy-counter.htm - Accessed on February 5, 2010.

[2] http://www.jimmyv.org/remembering-jim/espy-awards-speech.html - Accessed on February 5, 2010.

[3] http://www.rxassist.org/ - Accessed on February 5, 2010.

My 2010 Super Bowl Glog

2010-02-08T08:30:00.002-05:00

By Steven P. Moore, Director, Business Development
stevenmoore@cis-partners.com

8:20AM: As an amateur meteorologist and admitted snowstorm aficionado, I was happy and proud to proclaim 2’ of snow in Philly last Tuesday. Now my excitement has turned to concern as another potentially significant storm could drop 12” or more snow on Tuesday and Wednesday. I’m no math major, but with 28.5” on the ground in Philly, that’s like 80”. Crazy.

6:20PM: Hearing the ‘Walter Payton Award’ reminds me that I’m old enough to remember the original Super Bowl Shuffle in 1985. Man, I’m old. And I just ticked off a lot of people.

6:21PM: The National Anthem. B. Michael Jackson’s, uh, Carrie Underwood’s outfit. D-.

6:25PM: Dwight Howard and LeBron James renew the Michael Jordan and Larry Bird McDonald’s “nothing but net” commercials and say “Who’s that?” when Larry Bird shows up. That’s like a rookie golfer seeing Jack Nicklaus and asking the same question. Or, for those who are not golf fans, it’s like a new member of the Jersey Shore seeing “The Situation” and asking the same questions. C+ because the dunks were amazing --- with the potential for higher grades if the commercial ‘evolves’ throughout the game.

6:27PM: Heads. Sweet.

6:28PM: Calling Colts 31-28. Ask my wife if this actually happens.

6:34PM: Doritos. Dog takes off his collar --- puts it on his owner, then barks in order to shock his owner. I wasn’t a huge fan but my sister Allyson (shout out Ally!) texted me and said that everyone laughed where she was… so I’ll give it a B+!

6:35PM: The Saints punt. Is that the first time their punter had to kick it away this year?

6:42PM: Bud Light house commercial. C+. Were it Guinness or Dirty Martinis. A.

6:43PM: Betty White commercial from Snickers. B+ because that guy drilled her and then, when back in the huddle, the guy says, “C’mon, you’re playing like Betty White!!!”

6:45PM: Super Bowl Shuffle commercial from Boost. I absolutely have to give it an A because Jim McMahon came out on, wait for it, A SCOOTER!!!!! The Pharma Compliance Blog has apparently gone viral…

6:52PM: Russell Crowe in Robin Hood. I’m in. Of course when it comes out On Demand. What? Going to the movies is expensive!

6:53PM: Doritos kid slaps his Mom’s date and says, “Keep your hands off my Doritos and keep your hands off my momma.” C. Predictable. If he kicked him in the groin I may have given it a C+.

7:02: Colts 10-0. Dang Peyton looks good. What a throw to Garcon!

7:03PM : Coke and The Simpsons. Year after year Coke just gets it. Amazing. They have few comparators. A.

7:04PM: GoDaddy.com. They should try and use sex a bit more in their ads. I heard it sells. C-.

7:05PM: Doritos ‘playing dead’ commercial. Their 3rd commercial that has not been very good in my opinion… C. How much time does creative have to spend millions?

7:07PM: Monster.com. Groundhogs can’t play the violin. They can only predict whether there will be 6 more weeks of winter. At our pace in the Northeast, there will be 18 more weeks of winter… Did I mention there’s another foot or more coming to Baltimore and Philly. What the heck would 50” of snow look like???

7:12PM: Jabari Greer is hurt and my wife and I realize that we’ve lost yet another name choice for our first born son. First it was Plaxico, then it was Anquan. Now Jabari. The curse continues.

7:18PM: Budweiser Human Bridge Commercial. B because there was ANOTHER shot of a guy on a SCOOTER!!! Were it a Guiness or Dirty Martini truck. A.

7:20PM: “Hi. I’m Mark Sanchez and this message is to all the women out there. Peyton Manning owned us.”

7:21PM: CareerBuilder.com Casual Fridays commercial with everyone in their underwear followed by a group of grown men singing ‘I Wear No Pants’ while marching in their underwear. A combined C- for way too many unattractive people in their skivvies.

7:21PM and 6 seconds: My wife and I turn to each other and immediately break out in song: “Pants on the ground, pants on the ground, lookin’ like a fool with your pants on the ground. With the gold in yo mouth, hat turned sideways pants at the ground. Call yourself a cool cat lookin’ like a fool, walkin’ downtown with your pants on the ground. Get up, hey, get your pants off the ground, lookin’ like a fool, walkin’ talkin’ with your pants on the ground. Get up, hey, get your pants off the ground, lookin’ like a fool with your pants on the ground.”

7:23PM: Brett Favre at 50 years old and the 2020 MVP by Hyundai. 2010: I’m retiring. I’m not retiring. 2011: I’m retiring. I’m not retiring. 2012: I’m retiring. I’m not retiring. 2013: I’m retiring. I’m not retiring. 2014: I’m retiring. I’m not retiring. 2015: I’m retiring. I’m not retiring. 2016: I’m retiring. I’m not retiring. 2017: I’m retiring. I’m not retiring. 2018: I’m retiring. I’m not retiring. 2019: I’m retiring. I’m not retiring. I just wanted you to feel what it would be like if we actually had to live through that. I just threw up.

7:25PM: Dove for Men, eh Really? This is much like Old Spice for women or after shave for your legs. Good luck with that Dove.

7:36AM: Dodge Charger: Man’s Last Stand. And here I thought my Scooter was getting the ladies all excited! By the way, I’m looking into snow tires for my Scooter…

7:41PM: Alice in Wonderland. Does Johnny Depp ever play a normal human. Edward Scissorhands, Willy Wonka, Jack Sparrow and now this… He won Sexiest Man Alive and no one even knows what he really looks like. That’s impressive…

7:42PM: Punxutawney Polamalu sees his shadow. Man, missing the playoffs makes you desperate during the offseason. (My boss is a big Steelers fan and I can email you my resume if you’d like…)

7:43PM: The Saints go for it on 4th down and do not get it. Calling Bill Bellichik…

7:52PM: 10-6 Colts at the half. Nice first half but not nearly as high scoring as I predicted. Look forward to a high scoring and high flying 2nd half --- or course after I get to hear The Who. I wonder if they will they come out on Scooters? How about the NFL books something current like Green Day, John Mayer or General Larry Platt?

8:07PM: The Who is rockin’. Seriously. I take back my comment from 7:52 but still would have liked to see The General perform Pants on the Ground live! “It’s only Teenage Wasteland!” I’m singing aloud and my wife is not appreciative… Wait a second…are they lip synching?????

8:21PM: Sean Peyton. Go for it on 4th down at the 1 yard line. Fail. Onside kick to start the 2nd half. Pass. The man is fearless. Or crazy. I’m still not sure. 13-10 Saints!

8:29PM: Punch Buggy commercial --- I like it but I HATE Volkswagen. C.

8:31PM: CBS: Call Barney Stinson. Legend --- wait for it --- ary.

8:38PM: Peyton Manning goes right back down the field dissecting the Saints defense. A shot of the Manning family up in their private booth. Giants fans throw objects…

8:43PM: New E*Trade baby. I was skeptical because I loved the old baby --- and his buddy Benny with the golden pipes, “Take, these broken wings…”. However, that was hilarious. “Was that Milkaholic Lindsey over?” “Milkawhat.” A+. I laughed my arse off…

8:52PM: Oh my God. Google doesn’t even need to advertise --- have they ever? That commercial was absolutely incredible. I’m giving it the very first A++ in my Super Bowl Glog history. No damn wonder they’ve been able to do what they’ve done. That was beyond smart. Wow. Remember that KGB Sumo Wrestling commercial anymore? I didn’t think so…

8:59: Budweiser 55. At what number of calories does a beer cease to be a beer and become a flavored water? That’s become a contest between beer companies these days. It’s like someone coming out with “7 Minute Abs.”

9:25PM: Saints grab the lead!!! What a game!!! 2 point conversion fails. 22-17. Wait --- overturned! 24-17!

9:34PM: Budweiser Clydesdale and the baby steer Forrest Gump take off… Nice! B+.

9:48PM: Congrats to the New Orleans Saints! 31-17 victors. All kidding aside, it’s a great story for a city with some seriously tough circumstances the past few years!

For Your Space,
Steven.

Articles of the Week!

2010-02-05T08:30:00.000-05:00

Courtesy of: Jackie O'Connor, CIS Marketing Associate
jacquelineoconnor@cis-partners.com

1) 'Vegetative state' man responds to questions
http://www.cnn.com/2010/HEALTH/02/04/vegetative.state/index.html

2) Study fails to link saturated fat, heart disease
http://www.reuters.com/article/idUSTRE61341020100204

3) Doctors Stunned When 3-Year-Old Girl's Brain Tumor 'Disappears'
http://www.foxnews.com/story/0,2933,584921,00.html

4) FDA Concerned Dissolvable Tobacco Appeals to Kids
http://www.washingtonpost.com/wp-dyn/content/article/2010/02/04/AR2010020403627.html

5) Artificial Pancreas Helps Type 1 Diabetics During Sleep
http://news.yahoo.com/s/hsn/20100205/hl_hsn/artificialpancreashelpstype1diabeticsduringsleep

Government Programs and Pricing Compliance Summit Next Week!

2010-02-04T09:30:00.006-05:00

GP Summit Update:
MDRP 101/201 Workshops Cancelled Monday Due to Weather, Tuesday Program to Proceed for those in Attendance.

With the near record snowfall in Baltimore on Saturday and another storm approaching on Wednesday, IIR has cancelled MDRP 101 and 201 workshops at the GP Summit on Monday, February 8th and is offering a consolidated full day session on Tuesday, February 9th.

For more information, please click here.

CIS is a participating speaker and exhibitor!

Government Programs and Pricing Compliance Summit
When: February 8-10th
Where: Baltimore, MD
http://www.iirusa.com/gp/welcome.xml
Hyatt Regency Baltimore

Monday, February 8th
B2 GP Town Hall Forum
8:45AM – 5PM

GP 201 is an advanced full-day GP Town Hall Forum. It is your unique opportunity for access to top agency officials to discuss topical issues. Now in its third year, this forum has become the “talk of the town” as the place to have a working dialog between your peers in the GP environment, including the agencies, law firms and industry. The unique venue is designed for experienced GP professionals, fostering discussion on operational issues and challenges across the programs.

The GP Town Hall forum begins with a discussion on the current status of health care legislation, including the policy and operational impacts on Government Programs. Each subsequent session throughout the day focuses on general topics across programs as well as specific programs. There are no formal slides or presentations. Each program session covers topical issues and challenges and will have various perspectives, including those from agencies, legal, industry and consultants. Attendees are invited to participate in the discussion and to ask questions to the panel members.

The full day GP 201 Forum includes:

New Challenges in Managing the Government Business – What does healthcare reform mean to the government and commercial businesses? What is the timing of any reform and what are the key considerations for manufacturers when making projections?
Restatements and Recalculations – What are the rules and guidelines for recalculations and restatements across the programs? How do the requirements of the programs differ? What are the operational challenges associated with a recalculation and restatement?
Mergers, Acquisitions and Divestitures – How do companies manage their reporting responsibilities in the complex environment of the acquisition of companies and/or products, as well as sales and divestiture of products? What level of due diligence in GP should companies do when they are contemplating M&A activity?
Topical Policy and Operational Issues – What are the “hot topics” in policy and operational issues across Medicaid, Medicare Part B, OPA/PHS and the VA?
Overview of the OIG – Review of each branch and mission of the OIG

Moderators:
Christopher Cobourn, CIS VP, Regulatory Compliance
William Baxter, CIS Strategic Advisor, Government Affairs

Track B:
Tuesday, February 9th
1:45PM-2:30PM
Developing an Effective Risk Management Strategy Across Government Programs: Proactive Testing, Monitoring and Audit practices
Proactive audits are now built into the budgets of regulators and an audit could happen at any time. Are you ready? It is vital to develop a strategic Risk Management plan to manage risks across Government Programs. Effective Risk Management means a proactive Testing, Monitoring and Audit plan which uses "audit readiness" as a key benchmark of your program compliance. Topics in this session include:

Defining Risk Management
The importance of "OIG Audit Readiness"
Defining Testing, Monitoring, and Audit
Developing and Implementing a meaningful program
Developing and Implementing effective corrective actions
Working through and with infrastructure limitations

Clarissa Crain, CIS Director, Commercial Consulting Services

Track B:
Tuesday, February 9th
2:30PM-3:15PM
Panel:
Risk Management Strategies Government Program Compliance

What constitutes sufficient documentation?
How do the SOX 404 requirements affect manufacturers in terms of resource commitments, time, systems, vs. perceived, or real, value?
Determine the anticipated areas of compliance that are expected to see the greatest level of activity in the foreseeable future?
Hear new exposures areas for consideration.

Panelist: Clarissa Crain, CIS Director, Commercial Consulting Services

Track B:
Tuesday, February 9th
3:45PM-4:15PM
Panel:
Covered Products and the Product Master
Pharmaceutical Manufacturers should ensure that they have a correct understanding of “Covered Products” in the Medicaid Program, as well as the VA and PHS programs, and are in compliance with their reporting requirements under the programs. Manufacturers should be “in-synch” between their GP Reporting function and their Regulatory function to ensure that they are aligned with their product definitions and that what is entered in CMS’ DDR system is accurate. This will become increasingly important as the OIG, DOJ and states put increased scrutiny on Medicaid Reimbursement and identify where the government may be reimbursing for non-covered products. In this panel we discuss topics that include the definition of a covered product, as well as recommended best practices for manufacturers to develop and maintain an accurate and auditable product master.
Moderator: Amy VanDeCar, CIS Director, Commercial Consulting Services

Wednesday, February 10th
11:30AM-12:15PM
Roundtable (B): Current Hot Topics Government Reimbursement Programs
Moderator: Christopher Cobourn, CIS VP, Regulatory Compliance

Social Networking Sites and Pharma

2010-02-04T08:30:00.002-05:00

By Craig Kubicek, CIS Compliance Associate
craigkubicek@cis-partners.com

Social networking sites have become a hit around the world. Facebook, Myspace, and Twitter, to name a few, have revolutionized our ability to communicate with one another. Social networking has allowed us to keep in contact with friends, family, celebrities, athletes, and businesses. However, pharmaceutical companies are not as willing as most individuals to create profiles for themselves on social networking sites. There are few regulations designed primarily to govern the behavior of pharmaceutical companies in social networking contexts, but many pharmaceutical companies have made cautious and limited entries into the social networking realm.

Pharmaceutical companies understand that many guidelines and regulations designed for other communications media apply to behavior in the social networking realm, but the lack of regulations and guidelines specifically addressing conduct in the social networking sphere makes many pharmaceutical companies reluctant to make a splash in social networking.

Some pharmaceutical companies have already made it into the social networking space and have taken advantage of its unique ability to stay in constant contact with people. However, in November 2010, the U.S. Food and Drug Administration may create some rules and regulations between pharmaceutical companies and social networking. A public hearing is scheduled for November addressing, “ how pharmaceutical companies use the web and social-media tools to market their products, the first step in a long overdue process that will finally establish guidelines for how drug makers proceed in a Web 2.0 world.” [1]

Obviously, not every pharmaceutical company is using social networking sites. Without guidance on how the sites can be utilized, pharmaceutical companies are understandably cautious about entering this world. Guidelines for existing media are often not robust enough to apply to social networking, while guidelines addressing the unique issues related to social networking have yet to be written. Still, pharmaceutical companies don’t want to be left behind while the internet moves towards a Web 2.0 interface, becoming more interactive and user-oriented.

When trying to determine the appropriateness of a promotional activity, pharmaceutical companies can turn to the Division of Drug Marketing, Advertising, and Communications (DDMAC), a division of the FDA that is responsible for reviewing pharmaceutical advertisements. The DDMAC keeps an eye out for false or misleading information in drug ads, but they perform a wide variety of other tasks, as well, including:

“providing written comments to pharmaceutical sponsors on proposed promotional
materials to ensure clear and unambiguous communication of the laws and
regulations relating to prescription drug promotion; reviewing complaints about
alleged promotional violations; initiating enforcement actions on promotional
materials that are false or misleading; comparing the product labeling and
promotional materials of various closely related products to ensure that the
regulatory requirements are consistently and equitably applied; traveling to
major medical meetings and pharmaceutical conventions to monitor promotional
exhibits and activities; and acting as a liaison between DDMAC and other
divisions within the FDA on promotional issues.” [2]

While some existing guidelines and regulations governing TV, radio, print, and internet promotions undoubtedly apply to the social networking sphere, it’s not clear how these guidelines should or will be applied. Some aspects of social networking, especially those allowing for user feedback, create potential problems which simply are not possible in other, more traditional forms of media.

Joe Natale, the Vice President of Childrenwithdiabetes.com (a Johnson and Johnson subsidiary) has this to say about the role of a drug company and social networking: “There’s a tremendous responsibility that a company has to shoulder when they get into this space, where there are going to say good things about you, bad things about you, there will be adverse events that take place, there’s going to be off-label advocacy. These are things that make healthcare regulatory people extremely nervous.” [3]

When given the opportunity to provide feedback, internet users are more than happy to voice their opinions. Pharmaceutical companies have correctly identified this as a possible problem for many reasons. User feedback could be a source of negative publicity because “user-generated content will include complaints about injuries caused by their drugs' side effects. The law requires these ‘adverse events’ to be reported to the FDA. The FDA's adverse-event databases are regularly combed by lawyers looking for potential class-action suits.” [4] Users could also advocate off-label uses for drugs in a forum created by a pharmaceutical company – would this be a case of a pharmaceutical company advocating off-label drug use in violation of regulations, or would it be considered the opinion of a third party with no relation to the drug or its manufacturer? Nobody knows for sure – guidelines addressing scenarios like this have not yet been issued.

For now, it looks like most pharmaceutical companies are keeping their hands out of social networking to avoid the many regulatory grey areas that surround it. Until the industry figures out effective ways of utilizing social networking sites and is given guidelines on how social networking tools can and cannot be used, you won’t be seeing any posts on your Facebook wall from drug manufacturers.

[1] http://adage.com/digital/article?article_id=139228
[2] http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
[3] http://industry.bnet.com/pharma/1000309/a-qa-with-jjs-joe-natale-on-why-pharma-stays-stuck-in-the-webs-past/
[4] http://www.brandweek.com/bw/content_display/current-issue/e3ie08aadb553c2ade9caea50c91352c7aa

Common Field Sales Complaint #1 – “It always feels like somebody’s watching me”

2010-02-03T15:00:00.000-05:00

By Judy Fox, CIS Compliance Director
judyfox@cis-partners.com

No doubt everyone is familiar with the annoyance of having a song stuck in your head all day long, regardless of whether you like the song or not. By now everyone has seen and heard the commercials with a stack of money with eyes that feature a remix of Rockwell’s song, “Somebody’s Watching Me” playing in the background. If the commercial hits just right, that song stays with you all day long. Welcome to my world. I hear that song playing in my head constantly, but not because of the commercial.

As an auditor, I am often called upon by a Compliance Officer to interact with Field Sales Representatives for various projects such as audits, investigative interviews, and ride-along assessments. More times than not, throughout the course of my interactions, I hear the same complaint from both representatives and their direct managers, “Why can’t I just be left alone to do my job?” This is the point when the song starts playing in my head.

In my role as a Compliance Consultant, I can usually tie that type of statement into a disconnect between the Compliance Office and the Field Sales Force when it comes to communicating and understanding the importance of the compliance program. To some extent, if you are a member of a Field Sales Force, it should feel like somebody is watching you. After all, activities in the field often end up being some of the riskiest areas of compliance. So how can the Compliance Office monitor a Field Sales Force, and make sure that they understand and respect the consequences of non-compliance?

It starts at the top. Executive management has to make it clear that compliance is taken seriously and that the Compliance Office has a responsibility to monitor activities. The various departments responsible for monitoring compliance, such as Sample Accountability, also have to be empowered to discipline and enforce the consequences of non-compliant activities. Discipline for repeat non-compliant behaviors by an individual or within a district should include reprimands for individuals and their managers. In my experience, knowing that there is shared accountability has always shaken Field Sales Managers out of a “look the other way” mentality.

It seems rather simple, doesn’t it? So why is there such a problem out there? Again, I can only speak from experience, but the problem usually starts with the involvement of the Sales Department in compliance decisions. For example, Sales doesn’t want Compliance to put a damper on a national sales meeting, so they may allow only a fraction of the agenda for compliance training, or they just ignore it during a meeting all together and the training takes place over a web based session. Not that web based training isn’t effective, it just doesn’t always send a strong enough message when it is the only place compliance is mentioned. Sometimes, Sales Managers don’t want to burden a top-producing representative with the stress of an audit, so they push for a postponement. The managers can’t be blamed – it is their job to get their team selling, but they are only players in the promotional game and, as with any game, there are rules. Just like a professional athlete, breaking the rules of a game can be costly. You can’t send a team out onto the field without them knowing the rules and the consequences for breaking the rules. While I am not what one would consider an avid sports fan, I have seen my share of pee-wee, high school, college and professional games and I have never seen a coach ignore a player who made a costly mistake caused by forgetting, ignoring or flaunting the rules.

A compliance program should work in the same way. Using Sample Accountability as an example again, the most compliant and successful programs track and trend non-compliant behaviors and, most importantly, hold representatives and their managers accountable for non-compliance by imposing significant disciplinary and, ultimately, financial consequences. When someone knows that they may not qualify for their bonus because of their actions or when a manager may not qualify for a bonus because of the behavior of a direct report, they tend to all remember the rules of the game.

In addition to empowering those responsible for various compliance-based roles, Executive Management has to have clearly defined roles and authority of both Sales Management and Compliance. Sales cannot be allowed to interfere with the work done by Compliance in any way. Sales has a job to do and everyone in the company can be affected if they don’t do it well, but the role of Compliance is to determine the rules regarding how the Field Sales Force can and cannot do its job. Everyone needs to understand that the rules are based on federal and state regulations, and Executive Management needs to emphatically endorse the fact that the rules are not negotiable. Ignoring the rules should never be an option.

One of the best ways that Compliance can make sure no one is breaking the rules is by watching everyone and making it clear that, “Somebody’s Watching You.”

Ha! See if you can get that song out of your head now!

Children's Hospitals May Request "Retroactive Rebates" Under the 340B Program

2010-02-03T08:30:00.005-05:00

By: Chris Cobourn, VP of Regulatory Compliance
chriscobourn@cis-partners.com

Manufacturers have recently begun receiving letters from Children’s Hospitals seeking “retroactive rebates” dating back to February, 2006 under the new 340B program extension to Children’s Hospitals. Here are my thoughts on the matter.

Manufacturers should be mindful of the requirements that are outlined for Children’s Hospitals in the Federal Register Notice: 340B Drug Pricing Program- Children’s Hospitals from the HHS. The Notice was published in the Federal Register / Vol 74, No 168 / Tuesday, September 1, 2009 as documentation of final guidance regarding the extension of the 340B Outpatient Drug Program to Children’s Hospitals that meet requirements of the 340B Program. Children’s hospitals meeting these requirements may be eligible for retroactive rebates because, according to the rule:

“…children’s hospitals, as covered entities for purposes of the PPA,
besteffectuates the statutory scheme and therefore children’s hospitals are
coveredentities for purpose of the PPA…”

Retroactive rebates could have a substantial financial impact, with the rebates being the difference between the commercial price paid and the price the entity would have paid under the 340B program; however, it may be unlikely that many Children’s Hospitals will be able to meet the burden of proof necessary to be eligible for such rebates.

There are a few key requirements that have to be met (see section F on the notice, page 45211). Requirements include:

Hospitals have one year from the final rule (September 1, 2009) to request the rebate
Hospitals have 30 days from when they become eligible for the program to request the rebate (in writing to the manufacturer)
Hospitals must provide a listing of products, prices paid, and the retrospective rebate sought as evidence to manufacturers
In order to be eligible for a retroactive rebate, the entity would have to show that it has “satisfied all requirements for participation in the 340B program back to the date discounts are requested” (see the important note below)
The covered outpatient drugs must be evidenced to not to create issues of duplicate discounts through Medicaid

Note: Item #4 above may be the most difficult criteria for entities to demonstrate, as it includes the prohibition of entities purchasing any drug through a GPO. It should also be noted that HRSA has specifically stated that this prohibition is blanket to all drugs. In other words, just because a given product was not purchased under a GPO agreement does not mean it is eligible. If the Hospital purchased any drugs from a GPO during the period of time in question, then they are precluded from this opportunity.

It is the responsibility and obligation of the Children’s Hospital to provide manufacturers of evidence of all the requirements outlined in the Federal Register. The entity has to have auditable records supporting claims for retroactive rebates.

In the end, the fiscal impact of the allowance of rebates should be minimal to manufacturers, as most entities will not meet requirements. However, this will not mean that letters will not continue to come in to manufacturers. It seems there is a great deal of confusion in the Children’s Hospital channel as to how this opportunity is being extended, and what the requirements are. Therefore, some Children’s Hospitals are extending letters to manufacturers within the timeframe outlined in the Federal Register simply to reserve the right to pursue retro rebates should they find that they are eligible.

The bottom line for manufacturers is that they should seek for the Hospitals to meet the burden of proof outlined by the Register prior to extending rebates. It is not only the obligation of the entity to provide sufficient evidence of compliance with the requirements; it is further their obligation to work with manufacturers to resolve disputes.

Articles of the Week!

2010-01-29T08:30:00.000-05:00

Courtesy of: Jess Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com

1) More blood pressure worry: It's linked to dementia
http://news.yahoo.com/s/ap/20100126/ap_on_he_me/us_med_healthbeat_dementia_blood_pressure

2) Analysis: Smokers with cancer could quit and double survival
http://www.usatoday.com/news/health/2010-01-22-smoking-lung-cancer_N.htm?csp=34

3) 'Overweight' Adults Age 70 or Older Are Less Likely to Die Over a 10-Year Period
http://www.sciencedaily.com/releases/2010/01/100128091740.htm

4) Discovery Links Genes to Pancreatic Cancer
http://www.nlm.nih.gov/medlineplus/news/fullstory_94492.html

5) Fake Drugs Bought on the Web Pose Big Health Risks
http://www.healthday.com/Article.asp?AID=635386

Grim Repercussions

2010-01-28T07:00:00.000-05:00

By: Sabrina Skari, CIS Business Development Manager
sabrinaskari@cis-partners.com

Anyone who has ever met me knows that I am a pop culture junkie. I have no desire to live that lifestyle, I never planned a move to L.A. and I am appalled by 99% of what I see on the “entertainment news” shows. However, I continue to watch with suspended disbelief as the Hollywood elite, sports champions and billion-heir’s club continue their reign of stupidity. CNN features entertainment stories and offers Kathy Griffin hosting duties for New Year’s Eve. Barbara Walters’ “10 Most Fascinating People of 2009” included SIX from the entertainment industry in a year riddled with war, economic downturn and political regime changes.

So, one must ask why is America (including myself) along for the ride every time we hear another story that takes someone from pedestal to pedestrian? We are fascinated by repercussions. We love seeing people get their just desserts. And who doesn’t crave an “I told you so” every now and then?

When the story of Tiger Woods’ “transgressions” broke, the entire world (including the CIS office) was busy dissecting all of the measures he could have taken to prevent such a public eruption: he didn’t have to get married, he could have limited the texting, he could have limited the women and so on…Our fascination around the demise of his public image centered on the fact that Tiger Woods- the brand- is well recognized as wholesome, family-oriented and driven with purpose. But behind the scenes, Tiger Woods- the person- didn’t live up to the standards set by his brand and chances are that he heard several warnings and chose to ignore the danger signs. In the end, the repercussions of his actions have already cost him billions of dollars in endorsement deals and he has permanently altered his public image.

The same type of behavior can be true for all of us. In our personal lives, each of us has a personalized way in which we engage in “risky behavior.” Perhaps it is waiting until the last day to send in our bills, driving just 5 miles over the speed limit or having the second portion of macaroni and cheese. The repercussions for these dalliances aren’t too costly, but the point is that we know we’re doing something that is against our best interests.

Then, take it to the next level and think about these actions in a professional world…in some industries sending in an expense report late, doing personal stuff on company time or even snagging an extra half hour for lunch is as risky as it gets. However, in the pharmaceutical industry, and particularly the world of compliance, the stakes are high. When it comes to government compliance, the pharmaceutical industry can’t hold a press conference and apologize publicly for our compliance “transgressions.”

In the realm of GP compliance, there are so many crucial calculations and reporting activities that are predicated on historical data. The sheer complexity of these activities provides ample opportunity for human error, even among the most cognoscente analysts. This is the foundation upon which CIS has built its audit and assessment business, as it provides a chance for an outside party to come in with the magnifying glass and evaluate risk areas. However, after following this compliance due diligence, how many manufacturers go down the warning list of actionable items and ensure that each identified risk is mitigated effectively over the recommended timeframe? I would venture to guess that number is not 100%.

Further, let’s say that in the midst of running shadow calculations, you find a flaw or mistake. Do you go back and correct the calculation or do you correct the calculation AND also review the methodology to ensure the mistake doesn’t happen again? Then, if the methodology was incorrect, do you update the appropriate policy and procedures and notify all individuals with a hand in the process? In fact, in your procedure documentation do you have an action plan specifically laid out for instances where mistakes are found or risk areas are identified? The situations may seem circular but this is good because an effective compliance program should be a closed loop process. In the process, you are effectively closing the gap for GP compliance “transgressions.”

The same principle applies in Corporate Compliance. For example, activities are often managed by third party vendors, including Speaker Programs, Sample Accountability and Consultant Meetings. This practice is more than acceptable, there just have to be processes in place to monitor the activities and ensure compliance. Tiger relied on his associates to cover his tracks, and in the same way that it came back to haunt him, relying on others to keep you compliant will come back to haunt you. When you identify that a vendor or representative is not acting in accordance with your policies and procedures, sending a warning and insisting on change isn’t always enough. You have to track the transgressions, appropriately elevate the status for repeat offenses and track disciplinary measures. Once patterns are identified, it is the responsibility of the compliance office to heed the warning signs and identify troublesome individuals, departments or districts, or gaps in the program itself.

In the areas of manufacturing and clinical compliance, one could argue that the cost of a mistake or error has the potential to be the highest. If your company has the unfortunate circumstance of being involved in a recall by the FDA the risk can easily be millions of dollars. It may occur due to something that was not documented correctly in a clinical trial, or a manufacturing issue, but the repercussions are the same. There are fines to deal with from the FDA, not to mention potential law suits from patients who were prescribed the drug in question. In the worst case scenario, if a drug is pulled off the market, the money that was poured into its research and development is lost and there are several instances where that amount nears the $1 billion mark.

Financial losses are devastating but in many of these instances, the cost of disregarding a compliance issue can have personal repercussions as well. It may cost an individual their job and may cost a manufacturer their reputation. When all of these potential risks in different areas are combined, it’s easy to see how quickly ignoring compliance risks can have a domino effect. That said, the major differences between watching Tiger Woods’ reputation crumble in the public eye and the potential downfall of a pharmaceutical company is that the weight falls on the shoulders of many people instead of one lone individual. Also, celebrities are forced to deal with both the highs and lows as they are documented by the mainstream media. Oh, and one final piece of good news is that at least when you’re in the healthcare industry, you don’t have to worry about losing an endorsement deal with Gatorade in the process.

Changes to MDRP and PHS 340B Programs Likely After Massachusetts Senate Election

2010-01-27T12:00:00.000-05:00

By: Grete Dudek, CIS Compliance Associate
gretedudek@cis-partners.com

Since before President Obama was elected, healthcare reform has been in the spotlight, and there has been much speculation about how it could affect the pharmaceutical industry. Until a few days ago, it seemed as if the Senate version of the Healthcare Reform Bill was going to be pushed through the House of Representatives for President Obama to sign. Since some parts of the bill would have taken effect immediately, and some in a few years, more changes could have been made as different pieces of the bill went into effect.

One of these likely changes is that the Medicaid base rebate amount would increase from 15.1% to 22.1% or 23.1% of AMP for single source (S) and multiple source innovator (I) drugs, and from 11% to 13% of AMP for generic drugs (N). The additional rebates paid by manufacturers under the Medicaid Drug Rebate Program (MDRP) will add up to $23 billion dollars over 10 years, and will be used by the Federal government to help pay for health insurance for those currently without it (1). The MDRP would also be expanded to Medicaid Managed Care Organizations (MCOs) (2) and to more Americans by expanding the low-income eligibility for individuals, children, and pregnant women (5).

The changes to the MDRP will also affect the Public Health Service (PHS) 340B program price. The higher Medicaid unit rebate amount (URA) will lead to a decrease in PHS 340B prices, since the price determination is based on AMP and URA. The expansion of the 340B program to inpatients and new covered entities, including children’s hospitals, freestanding cancer hospitals, critical access hospitals, and more (2) could lead to $2 million saved each year by about 800 safety net hospitals. Hospitals have seen increases in uninsured seeking emergency medical services instead of preventative care due to the recent increase in unemployment and low insurance coverage (3).

Recently, a special Senate election was held in Massachusetts to fill the seat vacated by the death of Democratic Senator Edward Kennedy. Scott Brown, a Republican, was elected, reducing the Democrat’s advantage from 60-40 to 59-41, and giving the Republicans the ability to sustain a filibuster (4). Since the election, healthcare reform plans that seemed like a sure thing before may be no more.

Healthcare reform has quickly turned, and President Obama has indicated that he believes the plan to push the Senate bill through the House of Representatives should be scrapped, and that negotiations should not proceed until Senator-elect Brown takes office. Once he is in, the healthcare reform process will most likely be slowed down (4), and law makers have stated that the bill should be pared down to attract bipartisan support. “I would advise that we try to move quickly to coalesce around those elements of the package that people agree on,” President Obama said (5), and he has two initial goals if an immediate overhaul isn’t possible: an insurance industry regulation banning denying insurance based on pre-existing conditions, and cost containment of health care costs. From there, more discussion could take place about extending healthcare to the people who are currently uninsured. For now, the path forward has taken another unexpected turn, and there will be more anticipation of how the passage of a bill whose contents are yet to be determined will affect the pharmaceutical industry.

Sources:
1) http://www.corporatecomplianceinsights.com/2010/the-baucus-health-bill-%E2%80%93-a-mixed-bag-for-drug-makers
2) http://pssc.aphanet.org/policy/fed340blegislation.htm
3) http://www.healthleadersmedia.com/content/FIN-245095/Senate-Bill-Would-Save-Safety-Net-Hospitals-Billions-in-Inpatient-Pharmacy-Costs
4) http://www.nytimes.com/2010/01/21/health/policy/21health.html?pagewanted=2&hp
5) http://www.kff.org/healthreform/upload/7952.pdf

Healthcare Reform Legislation and the Senator Brown Effect – What Should GP Professionals Be Thinking Now?

2010-01-25T09:30:00.004-05:00

By: Chris Cobourn, VP of Regulatory Affairs
chriscobourn@cis-partners.com

Many in the industry are asking the obvious question, “What does it mean to Healthcare Reform now that Republican Scott Brown won the Senate seat in Massachusetts?” While it certainly appears that major legislative action will change direction, I think it is also important that we keep in mind that change is coming and we must be prepared.

I am of the personal opinion that substantial changes to Government Programs for Pharmaceutical Manufacturers are still coming sooner rather than later. There are large and contentious issues in the political debate around Healthcare Reform in the United States, such as the creation of a Public Option and potential taxes on expensive “Cadillac Plans.” There is little national debate over some substantial changes that would dramatically impact the industry, such as changing the definition of AMP, raising the base Medicaid rebate percentages (percent of AMP), expanding eligibility and changing the 340B program. The pharmaceutical industry itself seems to have accepted that these changes are coming and are bracing for the financial impact, while also focusing on other open issues in the debate, such as the creation of a period of exclusivity for bio-equivalent drugs.

The next important question is, “Which of the financial components, such as raising the base rebate percentage, will be included in the budget process or in other, newer and maybe smaller bills?” I think that it is still prudent to anticipate that changes to core elements such as methodology, processes and systems will have a dramatic impact on the business. Some changes to core elements that, I believe, will be incorporated in the future include:

Changes to the definition of AMP resulting in a Higher AMP.
A shift to a more restrictive definition of “community retail pharmacies”, as well as a reduction in the types of rebates that are excluded from AMP can result in a higher-calculated AMP.
An increase in base rebates.
Such as 23.1% for Branded Products, 13% for Generic Products and 17.1% for Pediatric Products.
Higher Medicaid Rebates.
An increase in the base rebate percentages will lead to a higher percentage on a higher AMP.
Medicaid Eligibility will be expanded.
The first two bullets will result in a higher Unit Rebate Amount (URA) and the number of eligible participants will increase based upon expanded eligibility in the states.
Medicaid level rebates will be expanded.
Expand the Medicaid Rebates to Managed Care Organizations (MCO) and to Dual Eligibles in Medicare Part D programs.
Base-line AMP will be applied to new formulations.
The perceived “loophole” of some new formulations setting their own new Base-line AMP will be addressed, with a major financial impact to many manufacturers.
340B Program participation will expand.
Program enhancements seem to be a certainty, with increased eligibility for additional entity types. Further, the potential impact from the changes in AMP and URA from the Medicaid side should be considered. The expansion will also have an impact on GPO purchasing.

Again, I think many, most, or all of the above items should stay on your radar. It is your role as a GP professional in the organization to keep the business informed. These changes run broader and deeper than the Final Rule. As much as the Final Rule had a deep impact, I think that the organizations saw it mainly as a compliance and operational challenge, and not a major impact on the business itself. The changes above may have a dramatic financial impact on your business and change the view of the Government Market. There may be those on the business side that saw the news of Brown’s election last week and are thinking that change is not as imminent as they may have thought. We have to identify the relevant stakeholders across the organization and keep them informed of the changes that might still occur. Although I believe that it is still very much a guessing game, I think the dust will settle in the near future on some components of Healthcare Reform, as they have a significant budget impact at the Federal and State levels.

Articles of the Week!

2010-01-22T09:30:00.000-05:00

Courtesy of: Scott Hoffman
scotthoffman@cis-partners.com

1) Obama Retreats On Health-Care Bill
http://online.wsj.com/article/SB10001424052748704320104575014982123360418.html

2) Cancer Docs Judge Drugs' Cost-Effectiveness
http://www.fiercepharma.com/story/cancer-docs-judge-drugs-cost-effectiveness/2010-01-21

3) Experts: Sitting Too Much Could Be Deadly
http://news.yahoo.com/s/ap/20100120/ap_on_he_me/eu_med_dangers_of_sitting

4) Ga. Faces $506M Medicaid Gap; Hospital Fee Mulled
http://abcnews.go.com/Business/wireStory?id=9628627

5) First U.S. Stem Cells Transplanted Into Spinal Cord
http://www.cnn.com/2010/HEALTH/01/21/stem.cell.spine/index.html

CIS will be exhibiting at CBI's 7th Annual Pharmaceutical Compliance Congress!

2010-01-21T08:30:00.003-05:00

When: Monday, January 25th – Tuesday, January 26th

Where: The Ritz Carlton, Washington, D.C.

For additional conference information, please click here.

Robert Vito – Guest Speaker at CIS’ IIR Baltimore Pre-Conference Workshop!

2010-01-21T08:00:00.000-05:00

By: Chris Cobourn, VP of Regulatory Affairs
chriscobourn@cis-partners.com

CIS’ Bill Baxter, Director of Medicaid Market and Rebate Management, and I have been coordinating with OIG’s Robert Vito, Regional Inspector, General for Evaluation and Inspections, to speak at the February IIR Government Programs Summit in Baltimore, MD.[1]

For those of you who might not be aware, CIS is hosting an all-day pre-conference workshop for advanced GP staff on Monday, February 8th. This workshop is called “Government Programs 201,” and can be found under Track B2: Agency Town Hall on the IIR Agenda.[2] As described on the Agenda,

GP 201 is an advanced full-day GP Town Hall Forum. It is your unique opportunity for access to top agency officials to discuss topical issues. Now in its third year, this forum has become the “talk of the town” as the place to have a working dialog between your peers in the GP environment, including the agencies, law firms and industry. The unique venue is designed for experienced GP professionals, fostering discussion on operational issues and challenges across the programs.[3]

GP 201, our 3rd annual pre-conference event, runs concurrent to the MDRP 101 session (Track B1) for beginners that day. During the course of the day, CIS will facilitate agency round table discussions with industry leaders and peers, as well as agency officials. The forum was very well received by all involved last year, and was a great opportunity for thoughtful discussion amongst the attendees, including manufacturers, agencies, consultants and law firms.

One area we thought would be a great addition to the day is a discussion about the OIG, including the departments and functions within the OIG, accompanied by explanations of their missions and roles. As Rob has explained before, it is important for manufacturers to understand that if, or when, they get a phone call from the OIG, they should know which department the call is coming from and why. I think that our discussion of this topic will be a great addition to the workshop, and I thank Rob for his participation.

If you have any questions about our pre-conference GP 201 workshop, please feel free to contact me.

Thank you,
Chris Cobourn

[1] http://www.iirusa.com/gp/speakers.xml
[2] http://www.iirusa.com/gp/agenda-at-a-glance.xml
[3] http://www.iirusa.com/gp/agenda-at-a-glance.xml

CMS Issued Release # 80 on January 5th – Updated Guidance on Recalculations

2010-01-20T16:00:00.003-05:00

By: Chris Cobourn, VP of Regulatory Affairs
chriscobourn@cis-partners.com

The recent Manufacturer Release # 80 from CMS provided an updated guidance on methodology-related Average Manufacturer Price (AMP) and Best Price (BP) recalculations in the Medicaid Program. As you can see below, there have been various regulations (CFRs, including the Final Rule) and guidance (Release Letters) published to provide manufacturers with information on performing recalculations and restatements. This guidance is designed to help manufacturers understand all the “ins and outs” of these calculations, including what may constitute a methodology change, versus a data-related calculation error. There will be a panel discussion at IIR Government Programs and Pricing Summit in Baltimore this February (during the February 8th pre-conference day) that will focus on recalculations and restatements. CMS will be participating in the panel discussion, and I think it will be a great opportunity to review the relevant regulations and guidance in effect now, as the rules and processes have changed significantly since Release #14 (the Office of Pharmacy Affairs (OPA) will also be present to discuss the impact of recalculations on the PHS program).

With that said, let me provide some thoughts on my reading of Release #80, starting with a summary of previously published regulations and guidance. Please remember that these are my thoughts and opinions, for discussion purposes, not intended to represent the view of CMS, to be legal advice or provide specific recommendations. I welcome any follow up questions. (FYI, I have a quick summary at the end).

First, let’s summarize a few key documents prior to Release #80 (you can also read Debbe Saez’s previous blog entry, “AMP and BP Methodology Changes Are a Go,” for additional information).

Release #14 (January, 1995):
This release provides standard guidance applied to recalculations and restatements, requiring CMS approval prior to a manufacturer making any methodology changes (retroactive or prospective), until Release #78 and the Final Rule made substantive changes to the process.

Release #61 (Sept 2003):
This release references CMS-2175-FC: REGULATION ISSUED AUGUST 29, 2003, which states that manufacturers must report revisions to AMP or BP within a period not to exceed 12 quarters from the quarter in which the data was due (establishing the 12 Quarter rule).

Release #78 (June 26, 2007):
This release states that a manufacturer may implement pending recalculation requests (which were submitted prior to Release # 78, and required CMS approval according to Release #14) on a prospective basis, beginning with the date the manufacturer notified CMS of the recalculation. Release #78 also includes the following provisions:

Manufacturers may implement the new methodology prospectively as of the date of the request (where the request pre-dates Release #78);
New recalculation requests, as of the date of Release #78, may proceed with implementation of the change in methodology without review or approval by CMS;
Manufacturers must notify CMS and receive authorization in advance of retroactive changes in methodology, and include fiscal magnitude and reasons for the change.

42 CFR Part 447: Medicaid Program; Prescription Drugs; Final Rule (AMP Final Rule, effective October, 2007):
The AMP Final Rule establishes:

A 3-year window for restatements;
That revised calculations must be reported for a period not to exceed 12 quarters;
That manufacturers must report revisions to AMP except where the revision is solely related to lagged price concession data.

Spotlight on the Policy and Reimbursement section of CMS’ website (August 26, 2009):

Requests submitted to CMS before the 12-quarter limitation took effect: Retroactive requests for methodology changes may be implemented, without prior review and approval from CMS, for the period specified in the request;
Requests submitted to CMS after the 12-quarter limitation took effect: Manufacturers may implement changes and recalculate for a period not to exceed 12 quarters.

Release #80 (January, 2009):
Release #80 appears to reiterate recent guidance on the 12-quarter period and CMS approval.
Manufacturers with pending recalculation requests, made prior to the effective date of regulations that set the 12-quarter time limitation for submission of recalculated data (which I assume is August, 2003), may implement the revised pricing methodology for the specified periods without prior review and approval by CMS.

Requests made prior to the guidance establishing the 12-quarter “window” may proceed without prior approval by CMS
Request for methodology changes received after the establishment of the 12-quarter window may proceed with the change without prior CMS approval (reiterating Release #78), and the period may not exceed 12 quarters (Release #78 did not specifically mention the 12-quarter period).
A future recalculation may be done without review and approval by CMS, but the manufacturer must notify CMS of the change in methodology, the revised AMP and BP data, the fiscal magnitude and the reason for the change. The change cannot exceed 12 quarters from the date of notification.

A summary, from my perspective:
We can talk about the history of guidance, and where newer guidance may supersede previous guidance, as well as specific times where older guidance may still be in effect if not specifically changed. But, at the end of the day, I think our ultimate goal is to understand the rules that are currently in place. With that said, my initial reading of the status of recalculation requests, as of Release #80, is (again, this is my read of it!):

The 12-quarter rule should apply to both methodology related changes and data calculation errors;
Pending recalculation requests made prior to the implementation of the 12-quarter rule may proceed without review or approval, for the period indicated in the request;
Pending requests issued after the 12-quarter rule was implemented may proceed without further review or approval, and can go back 12 quarters from the date the request is issued; for methodology changes, rationale and impact must be submitted;
Future recalculation requests, methodology- or data-related, may proceed without further review or approval, and can go back 12 quarters from the date of the request; for methodology changes, rationale and impact must be submitted.

It is also important to review Release #80 for the reiteration on CMS’ view on record retention and the 10 year rule, as well as the view that CMS is not expressing an opinion as to whether the revised pricing calculation is consistent and correct.

Thank you, I welcome your questions, and I hope to see you in Baltimore February 8th!
Chris

For all Drug Manufacturer Releases, check out the GP Pharma Compliance Exchange:
http://gp.cis-pcx.com/federal-agencies/centers_for_medicare_and_medicaid_services,8/medicaid_guidance,62/drug_manufacturer_releases,151/

If you are not currently a PCX subscriber, you can sign up for a 30-day free trial!

The Most Important Vote on Healthcare Reform?

2010-01-18T08:00:00.000-05:00

By: Jess Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com

On Tuesday, January 19th, voters in Massachusetts will go to the polls in the state’s Senate special election to fill the seat left by Senator Edward Kennedy after his 47 years of service. The special election comes on the same day that the 2nd session of the 111th congress reconvenes in order to, among other items on President Obama’s domestic agenda, vote on the healthcare bill that has been intensely debated over the prior 12 months. Not only is the race symbolically significant considering Sen. Kennedy’s years championing the cause of Healthcare in the Senate, but the outcome of the election has a critical bearing over the voting on and passing of the current healthcare bill, as a Republican victory would deliver a blow to the Democrats’ filibuster-proof majority in the Senate.

After the death of Sen. Edward Kennedy on August 25th of last year, Massachusetts democratic leaders reversed a state law which disallowed the Governor’s appointment of a replacement Senator to fill a seat in the event of it being vacated. On September 25th, Paul Kirk, a long-time Kennedy aide and former Democratic National Committee chairman was seated in the US Senate after being appointed by Massachusetts Governor Deval Patrick. Gov. Patrick also chose January 19th, 2010 as the date of the Senate special election. After the December 8th party primaries, the Republican Party nominated State Senator Scott Brown, and the Democratic Party nominated Attorney General Martha Coakley[i].

Brown has guaranteed that, if seated, he will cast his vote against the Healthcare Reform bill in the Senate. A 41st Republican seat in the Senate, coupled with the loss of the Democrats’ 60th seat would jeopardize not only the Democrats’ Healthcare Reform plans, but would cast doubts about other items on President Obama’s legislative docket at least until this fall’s mid-term Senate elections. But, even greater questions remain there with the imminent retiring of Senators Dodd and Dorgan[ii].

Are current Congressional Democrats and President Obama willing to make yet more concessions in the Healthcare Reform bill, or is Martha Coakley Healthcare Reform’s last great hope?

Sources:
[i] http://en.wikipedia.org/wiki/United_States_Senate_special_election_in_Massachusetts,_2010
[ii] http://www.latimes.com/news/nation-and-world/la-na-senate6-2010jan06,0,7077974.story

Articles of the Week!

2010-01-15T11:00:00.000-05:00

Courtesy of: Amanda Zanetti, CIS Compliance Associate
amandazanetti@cis-partners.com

1) Unions Cut Special Deal on Health Taxes
http://online.wsj.com/article/SB10001424052748704281204575003040695279432.html

2) Are Doctors Ready for Virtual Visits?
http://www.nytimes.com/2010/01/07/health/07chen.html?ref=health

3) Medicaid and Children’s Health Insurance Program Provisions in Health Reform Bills: Affordable Health Care for America Act & The Patient Protection and Affordable Care Act
http://www.kff.org/healthreform/7952.cfm

4) Expanding Medicaid: The Real Costs to the States
http://www.heritage.org/Research/HealthCare/wm2757.cfm

5) Feds vs. states: Who should run health market?
http://www.msnbc.msn.com/id/34868472/ns/health-health_care/

New Year, New Resolutions

2010-01-14T09:30:00.001-05:00

By: Amy Lotman, CIS Senior Compliance Manager
amylotman@cis-partners.com

Back in March 2009, President Barack Obama said the US food safety system is a "public health hazard" and in need of an overhaul. He sent out the warning as he appointed a new head of the federal Food and Drug Administration (FDA), New York Health Commissioner Dr. Margaret Hamburg.The President said underfunding and understaffing at the FDA had left the agency only able to conduct annual inspections on a fraction of America's 150,000 food processing premises.

And it is all supposed to change under the leadership of Dr. Hamburg.

The past decade was a difficult one for the Agency. The drugs it regulates are now more sophisticated, food importers bring in products from all over the world, and Congress wants the FDA to do more. Now, with new money and new leadership, the FDA seems ready to adapt.

One of the lowest moments for the FDA in recent years came in 2008 at a hearing of a congressional committee. Democratic Representative John Dingell grilled then-FDA chief Andrew von Eschenbach about not inspecting foreign drug manufacturing plants and the failure to prevent outbreaks of food borne illnesses. The FDA inspected just one-fifth of the food manufacturing facilities in 2000 than it did in 1980.

The FDA was taken to task time and again for failing to deal promptly with problems of popular drugs like Vioxx. New challenges cropped up: bio-terrorism, complicated bio-tech drugs, increasingly sophisticated medical devices, and then food safety.

So, the new administration brought in Dr. Hamburg and the President promised to give her the tools to do her job.

FDA Commissioner Hamburg thinks she can bring the Agency back. She is optimistic that she can make the drug review process safe and quick. She is also working with Congress in the hopes of getting new authorities in some key areas, including widely supported food safety legislation that would bring in money from food processors for inspections and give the Agency the power to assess fines. The FDA has already set up offices in China and India and it has got a lot more on its plate for the next few years. It just got the power to regulate tobacco and started monitoring drug information on the Internet. The FDA is likely to be tasked with evaluating generic versions of biotech drugs, and through all of this, Hamburg has promised to make the Agency’s inner workings more transparent.

Sources:

1) http://www.whitehouse.gov/the_press_office/Weekly-Address-President-Barack-Obama-Announces-Key-FDA-Appointments-and-Tougher-F/
2) http://www.fda.gov/AboutFDA/CommissionersPage/default.htm
3)http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106274.htm
4) http://www.fda.gov/NewsEvents/Testimony/ucm115219.htm
5) http://www.fda.gov/NewsEvents/Speeches/ucm191342.htm
6) http://www.fda.gov/NewsEvents/Testimony/ucm187566.htm
7) http://medicalinnovationsummit.clevelandclinic.org/2009/10/q-with-dr-margaret-hamburg.html

3rd Annual CIS Full Day Advanced GP Workshop at IIR’s GP Summit!

2010-01-13T08:00:00.003-05:00

If you follow Adam Fein’s interesting, and often amusing blog, http://www.drugchannels.net , you may have noticed mention of the upcoming Government Programs Summit, scheduled for February 8-10 in Baltimore, MD. If you are not aware of Adam’s blog, you may want to give it a visit, as Adam looks in to his crystal ball and shares his informed and thought provoking views of the industry. It is especially relevant now with so many potential changes in the air. It is critical these days to view the potential changes and impact of Healthcare Reform from both a business and compliance perspective. The role of “GP Experts” at a manufacturer will increasingly be to inform the business on the potential financial impact of legislative changes.

Also, if you are interested in more information about the upcoming Government Program Summit, please feel free to contact me. This is the 3rd year of our Advanced GP Full Day Workshop, held on Monday, February 8th (a pre-conference day). The day will feature an “Agency Roundtable” where agency representatives can have an open forum for discussion of topical issues. Last year’s session was very well received by all who participated and attended. CIS and IIR are committed to continuing to make this an integral part of the GP Summit conference, and I welcome your participation. If you have thoughts and ideas for the roundtable, please submit them to me in advance at chriscobourn@cis-partners.com!

Conference Information:
IIR's Gov't Programs and Pricing Summit
Monday, February 8th – Wednesday, February 10th
Baltimore, MD
Hyatt Regency Hotel
http://www.iirusa.com/gp/welcome.xml

The Adventures of Steven Moore, Scooter Boy, Part Deux

2010-01-12T08:00:00.002-05:00

Due to popular demand, I am passing along another installment of of my adventures in an almost, ‘paint by number’ style. I hope you enjoy!

1. You will see that my Scooter has multiple functions. This picture was taken by my wife during a key internal CIS WebEx meeting last week. You can see the structure slide that is up and, if you could see my face, you’d see the disbelief that I was not in the top box. I digress. You’ll also see that I have my snack in hand (apples, as I am watching my weight while laying motionless for umpteen days) and my Scooter has become the stand for my computer, as well as a holder for my new speaker phone. Who knew that Scooters did more than just alleviate crutches, get you around much better and make you as desirable as George Clooney or Hugh Jackman when you’re out in public? Beware: The Scooterazi.

2. Please notice that the TV is off. As tempting as it may be for some, I hate the TV. I just wanted it to be known that when I work from home, it’s all serious and all work --- all the time. Until, of course, Ellen comes on at 3PM.

3. These are my beloved Bird plates. For those of you who do not know, I am an avid and serious birdwatcher and can name any bird by sight or song east of the Mississippi River. That, in combination with my Scooter, officially makes me cooler than you.

4. This takes some ‘splainin. My Mom (Hi Mom!) got me and my wife a countdown to Xmas calendar that had 25 days. It has a little boot on a string that moved around as you got closer to Xmas. So, I developed (on the white sheet of paper to the left of the calendar) the 25 Achilles “Heal” Milestones (dig the pun?). These include things like: 1) Giving blood without passing out (long story --- thanks Lyme Disease), 2) Getting through surgery, 3) The first time going #1, 4) The first time going #2 (have I revealed too much?). Anyway, the goal is to move the boot (how fitting) around the calendar till we get to #25 --- The First Jog. Novel, I know. I’m currently on #11: “The first pain free night.” In typical ‘sales guy’ fashion, I simply can’t do anything without a goal or number to get after…

5. This is my hospital bracelet. I have kept it on for 12 days now to remind me to stay strong throughout this grueling recovery process. I am currently working with a vendor to replicate these and sell them as “SCOOTERSTRONG” bracelets with the proceeds going to me.

6. Pictures of Jamaica. Taunting me. Constantly. “Hi Scooter Boy. Remember where you were supposed to be during this week…” Die pictures. I know what you’re saying, “Scoots, why don’t you just take it down?” Because I want to feel it. I want to live it. I want to remember to never play pickup basketball again.

7. This is what my wife has coined “The Situation” (for those Jersey Shore fans out there). You see 12 pillows, a heating pad, my leg in a splint and back up sweatshirts and pillows.

8. Windows to the outdoors. Taunting me. Constantly. There are birds out there to watch!

In my next update, I look forward to telling you how I’ve tricked out my Scooter with massive amounts of bling and started a Twitter and Facebook following of fans…

For Your Space,
Steven “Scooter Boy” Moore

Articles of the Week!

2010-01-08T10:30:00.002-05:00

Courtesy of: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com

1) Is the FDA Too Easy On Medical Devices?
http://blogs.wsj.com/health/2009/12/30/is-the-fda-too-easy-on-medical-devices/

2) Health Cuts with Little Effect on Care
http://www.nytimes.com/2009/12/30/business/economy/30leonhardt.html

3) In Reconciling Health Bill for All, Revisiting Provisions for a Few
http://www.nytimes.com/2010/01/04/health/policy/04health.html

4) Health Care Spending Appears To Slow In 2008
http://www.npr.org/templates/story/story.php?storyId=122242722&ft=1&f=1027,1030,1066

5) Congress Proposes New Physician Payment System
http://www.npr.org/templates/story/story.php?storyId=122217323

CIS Will Be Exhibiting At DIA's Contemporary Pharmacovigilance And Risk Management Strategies!

2010-01-07T08:30:00.002-05:00

When: Monday, January 11th - Wednesday, January 13th
Where: Renaissance Hotel, Washington, D.C

For additional conference information, please click here.

Senate Rejects Low Cost Imported Drugs

2010-01-07T08:00:00.000-05:00

By: John Jordan, CIS Senior Compliance Associate
johnjordan@cis-partners.com

Senator Byron Dorgan, D – North Dakota, proposed an amendment that would allow Americans to import low-cost prescriptions from other countries. This bill was co-sponsored by a number of senators including John McCain, R – Arizona (3). “Senator Dorgan’s plan would have allowed American pharmacies and drug wholesalers to import federally approved drugs from Canada, Europe, Australia, New Zealand and Japan -- placing them within reach of average consumers (2).” Many countries have price controls that allow lower prices than what are normally seen in the United States (2).

Many Democrats were afraid that this amendment would interfere with the agreement that was made with pharmaceutical companies and the government towards the health care bill. Over the summer the pharmaceutical industry agreed to provide $80 billion in savings towards Americans and the United States government. According to Robert Pear’s article, “The industry, represented by the Pharmaceutical Research and Manufacturers of America, or PhRMA, adamantly opposes legalizing additional imports and says the government could not guarantee the safety of imported medicines (1).”

According to Pear’s article, “the Congressional Budget Office has estimated that the federal government would save over $19.4 billion dollars over the next 10 years (1)” if the amendment had passed. In addition, Senator Dorgan felt that the amendment could have saved the American consumer four times that amount. The vote for the amendment came to 51-48 in favor for it. However, 60 votes were required, under a special rule, in order for it to be passed. President Obama originally was in favor of the amendment while running for the presidency. However, many feel that this could interfere with the US Health Care Bill, which is one of the president’s top priorities (2).

Sources:
(1) http://www.nytimes.com/2009/12/11/health/policy/11health.html
(2) http://www.drugs.com/news/senate-rejects-plan-import-low-cost-drugs-21524.html
(3) http://www.law360.com/articles/138440

Send Your Ideas – CIS’ ‘Agency Town Hall Forum’, Full Day Workshop

2010-01-06T11:00:00.000-05:00

IIR’s Government Programs Summit
Monday, February 8th
Baltimore, MD
Hyatt Regency Hotel

By: Chris Cobourn, VP, Regulatory Affairs
chriscobourn@cis-partners.com

This will be our 3rd Annual Advanced GP session, with a full day agenda geared towards the experienced GP professional (Monday, February 8th is a pre-conference day, running concurrently to MDRP 101). Our format is an “Agency Town Hall Forum,” where we have the opportunity to discuss topical issues with the agencies across the Medicaid, Medicare, VA and PHS programs. We received great feedback on last year’s conference from the industry participants, as well as the agency representatives, who all enjoyed the opportunity for open dialog.

At CIS, we work closely with the industry on a variety of GP-related topics, as well as discuss issues directly with the agencies. Prior to last year’s conference we provided many of the topics and issues we have worked with throughout the year in order to facilitate a good discussion, and also to inform the audience of certain topics that could not be discussed at that time. As I said, the result was a very open and comprehensive dialogue from all sides.

I invite you to participate this year and encourage you to email me any topic ideas in advance. The source of the topic will be confidential, so no company names will be provided. Please email me at chriscobourn@cis-partners.com.

We look forward to seeing you in Baltimore in February!

For additional conference information, please visit the website:
http://www.iirusa.com/gp/welcome.xml

The Adventures of Steven Moore, "Scooter Boy"

2010-01-05T10:30:00.004-05:00

By: Steven Moore, CIS Director of Business Development

stevenmoore@cis-partners.com

I thought it would be great to kick off the New Year with a serious article.

So my wife and I had grand plans for a house-hopping, crazy holiday --- visiting family and friends and then celebrating New Year’s Eve and heading to Jamaica on January 1st for an eight day trip (mostly because NOBODY wants to hear from the ‘Sales guy’ the first week back from the holidays).

As the commercial says, life comes at you fast…

On December 15th, with the score tied at 7 in a heated pick-up basketball game to 8, I dove for a loose ball and heard and felt a very loud “POP” in the back of my leg. I went to get up, only to fall down, to try and slug the jerk that kicked me in the back of the leg but, alas, nobody was even within 10 feet of me. Houston, we have a problem. I was no longer 30 going on 18… I was 30 going on 50...

I limped off the court and got in my car and visions of Jamaica and ‘froo froo’ drinks began to sputter. My mind raced and I called my wife:

Wifey: “Hello.”
Me: “Um. Yeah. I got hurt. Bad.”

These are the calls in life you hate to make and the worries that you don’t have because you can’t predict them. I got home and said, “I think I pulled a muscle --- maybe my calf muscle.” I iced the back of my leg and was in excruciating pain --- but still waited two days and a CIS holiday party to go to the doctor’s office. After a Google search and a “Thompson Test” (which is when you squeeze your calf muscle while lying face down --- and notice that your foot doesn’t move --- try it, it’s creepy), followed by an X-ray, MRI and visit, the dreaded but expected prognosis was given by the orthopedic surgeon:

“You have fully ruptured your Achilles tendon. It will heal over time (6
months) on its own, but re-rupture is far more likely if you go that
route. Most people who are active and healthy choose surgery. You
will not be able to put any weight on it for 6 weeks post surgery and likely
won’t walk normally for 3 or 4 months.”

My holiday Cheerios were officially peed in.

Surgery is a scary thing and I don’t have too much pride (heck, that was out the window a long, long time ago) to admit that I was nervous and, well, scared. I didn’t know what to expect or what I was supposed to be afraid of. I chose not to have surgery until 12/28 so that we could still have a semi-normal Christmas celebration and it wouldn’t effect seeing both sides of our families. It was a good move, but at any moment my mind was idle, the devil was at play in his workshop.

So I was called back into the surgery and then came the IV, then waiting and then sedatives (I think I recall saying, “Wow, now I know why the Beatles were such good song writers,” to my nurse anesthetist). The last thing I remember is hearing my surgeon say, “This may sting a little.” After that, I woke up and it was all done. I think I was given Propofol, or “Milk of Amnesia”, and I can honestly say it was the wildest experiences to wake up two hours later with ZERO recollection of what occurred. That hasn’t happened since college… Kidding, of course. You guys know I don’t drink. That often.

So here’s where the ‘Scooter’ part comes in and what is relevant to the Pharma Compliance Blog. Our industry is sweet and more people need to know about the advances that are happening. First and foremost, somebody sliced open my calf and tied my tendon together without me feeling a thing, and then I awoke to some strong pain but was given medicine to deal with it (I actually only used painkillers for about 48 hours) as well as the appropriate antibiotics to guard against wound infection and, here’s the kicker: I researched my injury and decided to rent a knee walker (which we’ll affectionately call “Scooter”) to replace crutches and it’s been a revelation for me.

I can buzz around the house, use the bathroom, take a shower with my leg hanging out and do cool ‘k’ turns with my Scooter without my leg ever touching the ground or being straight up and down as it would be on crutches (and trust me, when the blood flows to the wound, I can feel it!). My uncles and cousins made fun of me and called me ‘Scooter Boy’ during Christmas, but I didn’t care since I’ve read and heard (thanks CIS’ Amy VanDeCar) that those who use the Scooter cut their healing time down and walk sooner. Give me two extra weeks of walking and I’ll take all the derision that comes my way.

In fact, when I’m up to it, I plan to take my Scooter to the mall and do ‘laps’ as exercise and cardio while the High School kids make fun of me. Heck, I might even put one of those ‘bicycle bells’ on it and wear a helmet with cool decals. And when I physically return to work in the next week or so, I’ll buzz around the office in my Scooter and will likely be made fun of as well --- but it’s all good! The truth is, when it comes to medicine and healing, we should all take our pride out of the equation and do what’s best for the recovery process. Those suffering with crutches --- and the accompanying worn out armpits and palms --- need only 5 minutes with my Scooter and I can sell them.

I’m 8 days post-surgery and am feeling great. Sure, I was SUPPOSED to be in Jamaica right now doing the reggae walk and saying ‘yeah mon’ to every offer from the resort staff (well, almost every offer) --- but life doesn’t work that way. I’ve already learned a lot through this and plan to hold onto it. My New Year’s resolution is to not take so many things for granted, like getting dressed, going to the bathroom, showering, getting a drink, making coffee and, oh yeah, walking and exercise. My wife and caretaker has been a savior and we’re very lucky she is a college professor and home these days!

Finally, I send out a big ‘cheers’ to our industry for novel medicines and devices that will help me heal faster than the ancient Greek hero warrior Achilles could himself. I’m convinced that even this great warrior wouldn’t have minded the Romans making fun of him...

Achilles, “Scooter Boy”.

"Gotta dig the holiday beard..."

For Your Space and here’s to a Fantastic 2010!

Steven “Scooter Boy” Moore

CVS Looks to Generation Health to Head Caremark

2009-12-30T08:30:00.000-05:00

By: Kerri McCutchin, CIS Compliance Associate
kerrimccutchin@cis-partners.com

On December 21, 2009, CVS Caremark Corporation announced the appointment of Per G.H. Lofberg as president of its pharmacy benefit management business (PBM), effective January 4, 2010. Lofberg has more than 30 years experience in the healthcare and PBM industry, “including the role of Chairmen for Merck Medco Managed Care LLC, which later became Medco Health Solutions.”(1) Lofberg is currently serving in the roles of President and CEO of Generation Health Inc., a company that focuses on genetic testing benefit management. By hiring Lofberg, Generation Health has become a strategic partner with CVS Caremark; this collaboration has resulted in the expansion of pharmacogenomic (which is the interaction between medications and a patient's genes) clinical and testing services for customers [1].

One of the services that CVS will offer is counseling patients with certain diseases to undergo genetic tests. Among the first patients to receive counseling are those with diseases in which genes are known to play a role in what drugs are effective in treatment. “The company said those patients will be encouraged to use a drug that has been proven to work on people with a similar genetic profile as their own.” [1]

It seems many are optimistic about the experience and knowledge Lofberg can bring to CVS Caremark Corporation. Tom Ryan, Chairman, President and CEO of CVS Caremark notes:

"Per is widely respected in the PBM and health care industry. He brings a wealth
of experience in working with key clients to understand the needs of the
marketplace and produce meaningful results. His expertise, along with his
demonstrated ability to execute growth strategies, makes him the perfect person
to guide our PBM in the evolving health care environment." [1]

One possible explanation for hiring Lofberg might be that it was an initiative taken by CVS Caremark Corporation in hopes of combining its drug benefit management services with patients' genetic profiles. In November, Generation Health Inc. and CVS Caremark Corporation established a partnership to research pharmacogenomics. In particular, pharmacogenomics can determine whether or not a drug works for specific patients [2]. The utilization of pharmacogenomics could improve treatment and reduce costs for Caremark, allowing patients to avoid drugs that would not work for them. CVS will begin to offer some pharmacogenomic services starting in the second quarter of 2010 and will focus largely on diseases such as cancer, heart disease and HIV [3].

Lofberg comments that “he is looking forward to the opportunities and challenges of running one of the nation's largest PBMs” and states, "CVS Caremark's corporate resources and its leadership position as the country's largest provider of pharmacy services offers a tremendous platform for innovation and growth in our complex and challenging health care system” [1].

Sources:
[1] http://info.cvscaremark.com/newsroom/press-releases/cvs-caremark-appoints-lofberg-president-pbm-business
[2] http://news.yahoo.com/s/ap/20091221/ap_on_bi_ge/us_cvs_caremark_generation_health_2
[3] http://www.google.com/hostednews/ap/article/ALeqM5gN_2fpJwvjczd8KMa40QOOHRLrDgD9CNVN7G0

On the Twelfth Day of CIS...

2009-12-29T08:30:00.000-05:00

As reported to Jess Ebert, CIS Compliance Specialist

On the twelfth day of CIS, the blog introduced to me…
Founding Partner and VP of Account Management, Toni Barsh
(and Jim Collins, Joe Calarco, Annette Horner, Kimberly Gilbert, Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)

Q: What’s your background?
A: I graduated with a BA and went right into pharma working for a pharmaceutical advertising agency where I held many roles, but became an Account Manager for CME programs and promotional events. I went from one agency to another, helping clients with patient education and working with brand managers on product positioning and marketing. After following the Ad Agency route for a while, I took a job at Wyeth in the Sales and Marketing Department. I helped with the launch of Norplant and worked in company positioning (as Wyeth products expired, we would allocate surplus products to indigent countries for donations).

Ready for a change, I started a little consulting company in marketing/advertising. I then changed direction and joined a clinical training/education subsidiary of Parexel, where I spent 5 years working as the training manager and transitioning into consulting sales. Due to lack of growth, I started my second business in clinical training and process consulting. After 5 years I teamed up with Jim Collins, and the rest is CIS history!

Q: Why did you decide to start CIS?
A: I ran my second consulting company for 5 years, and was burned out being a "single shingle." [CIS Co-Founder] Jim Collins and I collaborated on a new business venture that immediately interested me. We already had a 10 year working relationship, so partnering with Jim was a no brainer. My best professional decision yet!

Q: What projects and product lines do you work with at CIS?
A: I help wherever I am needed. I work primarily in Account Management supporting our managers. I also try to get a bit of Business Development in from time to time.

Q: What do you like about CIS?
A: I love the culture we have created here and the people I work with. I want and need to learn from the people who surround me, and I think we have some of the most talented employees around….people who want to learn, want to grow and want to be challenged!

Q: What’s the best holiday gift you’ve ever gotten (or given)?
A: The best gift I've ever given was a cruise to Bermuda for my parents' 25th wedding anniversary. The best gift I've ever received was the opportunity to adopt a child and become a parent!

Email Toni any time at tonibarsh@cis-partners.com!

There are 3 days left until the New Year!

On the Eleventh Day of CIS...

2009-12-28T08:30:00.000-05:00

As reported to Jess Ebert, CIS Compliance Specialist

On the eleventh day of CIS, the blog introduced to me…
Founding Partner and VP of Operations, Jim Collins
(and Joe Calarco, Annette Horner, Kimberly Gilbert, Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)

Q: What’s your background?
A: I was born in Brooklyn, NY and moved to South Jersey at age 5 when my father, who was a stock broker on Wall Street, took a job with a small start up firm on the Philadelphia Stock Exchange. I went to Rider College and majored in Accounting and Finance. I received my CPA in 1990 and quickly got out of accounting. I worked for Barnett International, a division of PAREXEL Consulting, as VP of Operations for 14 years prior to co-founding CIS in 2004.

Q: Why did you decide to start CIS?
A: After 14 years of a being part of a large public company and spending the majority of my time on internal politics and BS - I thought it would be a refreshing change to build a company where the culture is based on performance, growing professionally and financially, and helping clients.

Q: What company milestones are you proud of?
A: Our goal in year 1 was to be in business in year 2, so that is a milestone I am very proud of. Now that we are approaching our 5 year anniversary as a company, I am proud to be working with close to 50 of the smartest, most hard working and talented staff in our industry.

Q: If you could give your employees once piece of advice, what would it be?
A: You get out of your career what you put into it– there are no short cuts. By taking it easy you limit your own growth – professionally and financially.

Q: What’s your favorite holiday movie and why?
A: Elf – Buddy is the best!

Q: What are you most thankful for this holiday season?
A: The ability to get up every day and see that I have a healthy family, and I know I have the ability to be in control of my own destiny.

Email Jim any time at jimcollins@cis-partners.com!

There are 4 days until the New Year!

On the Tenth Day of CIS...

2009-12-23T09:30:00.000-05:00

As reported to Jess Ebert, CIS Compliance Specialist

On the tenth day of CIS, the blog introduced to me…
Senior Compliance Manager, Joseph Calarco
(and Annette Horner, Kimberly Gilbert, Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)

Q: What’s your background?
A: I started my career at the University of Pennsylvania’s Treatment Research Center as a site coordinator supporting clinical trials on anabolic steroid use and alcohol dependence. After a short stint as a Data Coordinator at Scirex (small CRO), I entered a full-time Clinical Social Work Graduate Program at Bryn Mawr College. I worked part-time at Aventis Behring during Social Work school and worked there for two years full-time after graduating with my M.S. in Social Services.

In 2002, I joined Merck & Co, Inc. as a project leader in Global Clinical Data Operations. In this role I led Clinical Data Management teams that filed Infectious Disease and Oncology products. For more than four years I worked as a manager responsible for the External Data Services and Clinical Pharmacology departments. As a manager, I was responsible for managing Merck’s book of business and the staff resourced to support the projects in these departments. Additionally, I was charged with several process improvement projects, one of which allowed me to complete my Six Sigma Green Belt certification.

Q: What projects and product lines do you work with at CIS?
A: My primary project at CIS has been the Shire Standard Operating Procedures project. I am thankful for the opportunity to learn a lot about R&D and Commercial Compliance concerns in a short period of time.

Q: What do you like about CIS?
A: The people I get to work with and the company’s size. Team chemistry can be elusive at most jobs. I am fortunate that the people I interact with each day are open, knowledgeable and lead by example. More importantly, they play as hard as they work. Anyone who has been in any industry long enough knows that situations like this are the exception and not the norm.

CIS’ size also means there are an abundance of opportunities to contribute to and succeed. Large corporations often struggle to make employees feel like their contributions matter.

Q: What are you most thankful for this holiday season?
A: My family’s good health and my friends.

Q: What is your favorite holiday cookie or food?
A: My mother-in-law’s French Toast Casserole. It is basically French Toast covered maple syrup and brown sugar. How can you go wrong?

Q: What is your favorite holiday song?
A: I have two favourite holiday songs. The U2 version of “Christmas (Baby Please Come Home)” and The Bare Naked Ladies version of “Auld Lang Syne”.

Email Joe any time at joecalarco@cis-partners.com!

Currently there are:
2 days until Christmas,
and 3 days until Kwanzaa!

The days are getting longer!

Articles of the Week!

2009-12-23T08:30:00.000-05:00

Courtesy of: Kerri McCutchin, CIS Compliance Associate
kerrimccutchin@cis-partners.com

1) Senate moves health bill forward
http://www.cnn.com/2009/POLITICS/12/22/health.care.senate.vote/index.html

2) Obesity, Inactivity Keeping Heart Health Stats Down
http://news.yahoo.com/s/hsn/20091218/hl_hsn/obesityinactivitykeepinghearthealthstatsdown

3) Drug Maker Sanofi-Aventis Buys Chattem for $1.9 Billion
http://www.nytimes.com/2009/12/22/business/global/22drug.html?_r=1&adxnnl=1&ref=health&adxnnlx=1261497699-LLjRGlc6Be/Ntgc/K0065w

4) Cosmetic Surgeons Get Reid to Tax Tanning Salons Instead
http://online.wsj.com/article/SB126144830913601141.html

5) COBRA Help For Laid-Off Workers May Come Before Christmas
http://www.kaiserhealthnews.org/Stories/2009/December/17/cobra-extension.aspx

All I Want For Christmas Is….Healthcare Reform?

2009-12-22T11:00:00.002-05:00

By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com

One giant leap for lawmakers, an even bigger leap for healthcare. In the waning hours of Sunday night, and into 1:00am Monday morning on December 21st, the U.S. Senate voted to end debate on the health reform bill. This vote will propel the legislation to a final vote on Christmas Eve. [1]

If this bill is passed and aligned with the one passed by the House of Representatives, 30 million uninsured Americans will be opening the gift of insurance this Christmas. However, some Republicans may argue that this bill is no gift at all, but rather will prove to be a detrimental and counterproductive mistake. Arizona Senator John McCain was quoted as saying “We must look back and say, we did everything we can to prevent this terrible mistake from taking place”.[1] As you may have guessed, both the Democratic and Republican parties tended to support party norms on this vote, with all 58 Democrats, and the Senate’s two Independents, voting in favor of the bill against unanimous Republican opposition. The vote, 60-40, was considered by both sides to be monumental.

The actual legislation aims at providing health benefits to more than 30 million people who are currently uninsured. The bill would require all Americans to pay financial penalties for failing to obtain health insurance and would provide federal subsidies to help moderate- to low-income families buy private coverage.[2] These services would be made possible by the highly criticized complex array of taxes that would yield a tax hike for individuals earning more than $200,000 and couples earning more than $250,000.[3]

Supporters of the Bill claim that its $871 billion price tag will actually assist the U.S. Government in reducing the federal budget deficit by $132 billion through new revenues and cuts in spending. However, Republicans are more apprehensive about the severe expense of the bill, charging Democrats with recklessly rushing to adopt the proposed 2,700 page bill that would reshape one sixth (1/6) of the nation’s economy.[4]

Inherent in all reforms are potential benefits and risks, and this legislation is without exception. While it may be difficult for one party to see the other’s point of view, it is certainly easy for both parties to recognize the sheer magnitude of this decision. As citizens of this country, we can only hope that the people we have elected to make these decisions do so in a way that will allow this great nation to prosper. Happy Holidays and God Bless America!

Sources:
[1] http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20091221/health_overhaul_091221/20091221?hub=
[2] http://www.nytimes.com/2009/12/21/us/21vote.html?pagewanted=1&_r=1&hp
[3] http://www.thaindian.com/newsportal/health1/senate-passes-health-care-reform-bill-in-cloture-vote_100292777.html
[4] http://www.nytimes.com/2009/12/21/us/21vote.html?pagewanted=1&_r=1&hp

On the Ninth Day of CIS...

2009-12-22T08:30:00.001-05:00

As reported to Jess Ebert, CIS Compliance Specialist

On the ninth day of CIS, the blog introduced to me…
CIS Senior Director, Clinical Consulting Services, Annette Horner
(and Kimberly Gilbert, Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)

Q: What’s your background?
A: For the past 15 years, I’ve worked as a consultant to global pharmaceutical and medical device companies to develop and implement clinical and regulatory processes resulting from large-scale clinical/regulatory re-engineering or compliance risk mitigation projects. For five years before that, my consulting work focused on developing clinical and regulatory training programs for a variety of pharmaceutical clinical research clients. Earlier in my professional life I taught literature and writing in high schools and colleges. When I decided I wanted to understand more about how organizations work, I pursued a PhD at Temple University in Organizational Design, thinking I would work in a college or university setting. By the time I finished the PhD work, I had a network of business consulting friends and entered the world of pharmaceutical consulting in that way.

Q: What projects and product lines do you work with at CIS?
A: I work on clinical compliance client projects. I’m involved in client meetings and in developing client proposals for clinical compliance services. I also work on the upfront design and planning for a new client project, and provide direct client service on SOP projects that involve creating a compliance framework. I also designed and helped implement the Clinical PCX.

Q: What do you like about CIS?
A: I had worked in another company with the CIS owners, so I was first attracted to CIS by that prior experience with the owners, both of whom I admire for their business acumen and ethics, as well as their emphasis on transferring authority to others in the company. I also like the CIS business model, especially the clear focus on providing compliance services across a single complex industry, and the fact that CIS is still strongly an entrepreneurial company which means it will attract capable and flexible staff who want to grow with the company. That’s good for CIS and for clients as well.

Q: What are you looking forward to this holiday season?
A: This has been a year of transition for me. My husband and I moved from Ohio to North Carolina last February. Now we are much closer to family and long-time friends, so I’m looking forward to spending time with my special people and maybe doing a little wintertime gardening.

Email Annette any time at annettehorner@cis-partners.com!

Currently there are:
3 days until Christmas,
and 4 days until Kwanzaa!

The days are getting longer!

On the Eighth Day of CIS...

2009-12-22T08:30:00.000-05:00

As reported to Jess Ebert, Compliance Specialist

On the eighth day of CIS, the blog introduced to me…
Compliance Manager, Kimberly Gilbert
(and Dana Zelig, Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)

Q: What’s your background?
A: I am a registered nurse with eleven years of clinical research experience in various capacities across the pharmaceutical industry including roles at the sponsor level, the investigative site, and contract research organizations (CROs). Most of my previous experience in the clinical research arena consists of managing clinical trials across all phases of the drug development cycle in a clinical role.

Q: What projects and product lines do you work with at CIS?
A: I currently work on the clinical product lines at CIS.

Q: Why did you decide to join CIS?
A: I decided to join CIS for two reasons; I wanted to work for a company where I felt valued as an employee and I was also looking for variety in my career. I have found both of these qualities at CIS. I finally feel like I am part of an organization where my ideas and opinions are valued as well as appreciated, and for that I am truly thankful. I also feel like variety is the spice of life, and here at CIS I never have the same day twice! I am able to utilize my previous experience in the pharmaceutical industry in so many different directions at CIS and that makes for interesting days!

Q: What are you looking forward to this holiday season?
A: Having some time off to relax and enjoy the wonders of the season with family and friends! OH and PRESENTS!

Email Kimberly any time at kimberlygilbert@cis-partners.com!

Currently there are:
3 days until Christmas,
and 4 days until Kwanzaa!

The days are now getting longer!

On the Seventh Day of CIS...

2009-12-21T08:30:00.001-05:00

As reported to Jess Ebert, Compliance Specialist

On the seventh day of CIS, the blog introduced to me…
PCX Product Manager, Dana Zelig
(and Beth Kline, Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)

Q: What’s your background?
A: Prior to joining CIS, I worked in Regulatory Affairs at a large pharma company, and in the Internal Audit department of a large bank. Both positions provided me with an appreciation of compliance that has served me well at CIS.

Q: What projects and product lines do you work with at CIS?
A: I am the PCX Product Manager the and co-editor of the Pharma Compliance Blog, which are great products, and great tools to stay up to date on regulations and current events in the pharma space. I also work with CIS’ GP SMEs performing audits, assessments, and calculations.

Q: Why did you decide to join CIS?
A: I decided to join CIS because it seemed totally different than the companies I came from. It is a company where hard work and a good attitude are always appreciated, which makes it a great place to be every day (or at least the days I’m not visiting clients).

Q: What’s the best gift you ever gave someone for the holidays?
A: What’s the best gift you ever received for the holidays? One year my grandmother took my whole family on a cruise for Christmas. That was definitely the best Christmas ever. We didn’t get each other big presents that year, but my brother and sister and I brought stockings for each other and filled them with crazy gifts. I got a pair of Santa boxers that I still wear all the time.

Q: What is your favorite holiday song?
A: I love Oh Holy Night. It always puts me in the holiday spirit!

Email Dana any time at danazelig@cis-partners.com!

Currently there are:
4 days until Christmas,
and 5 days until Kwanzaa!

Today is Winter Solstice!

On the Sixth Day of CIS...

2009-12-18T08:30:00.001-05:00

As reported to Jess Ebert, Compliance Specialist

On the sixth day of CIS, the blog introduced to me…
Compliance Manager, Beth Kline
(and Bill Baxter, Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)

Q: What’s your background?
A: I have a BA in Organizational Management and a MA in Teaching. I have worked in pharmaceutical consulting for over 12 years and taught English in China for two years.

Q: What projects and product lines do you work with at CIS?
A: I work in clinical and manufacturing. I am also the subject matter expert for the Clinical PCX.

Q: What do you like about CIS?
A: I like that it is a small company where you can be actively involved in all aspects of the business. I like the variety of work they do and never knowing what tomorrow might bring!

Q: Why did you decide to join CIS?
A: I wanted to get back into consulting and joining CIS provided that opportunity.

Q: What CIS accomplishments are you most proud of this year?
A: Hiring me? HAHA! Kidding – expanding into manufacturing and all of that business they are acquiring…excellent!

Q: What are you looking forward to this holiday season?
A: Having almost two weeks off. Living in New York and driving six hours roundtrip every weekend to and from home has been a bit tough on my family life, so having some extended time at home will be very welcome at this time of year.

Q: What’s your favorite holiday movie?
A: My favorite holiday movie is White Christmas.

Q: What's your favorite holiday tradition?
A: Eating cookies!

Q: What are you most thankful for this holiday season?
A: My job and an understanding and patient husband.

Q: What is your favorite holiday cookie or food?
A: I love them all!!!

Q: What is your favorite holiday song?
A: Joy to the World

Email Beth any time at bethkline@cis-partners.com!

Currently there are:
7 days until Christmas,
8 days until Kwanzaa,
and 3 days until Winter Solstice!

Tonight is the 8th night of Chanukah!

Articles of the Week!

2009-12-18T08:00:00.001-05:00

Courtesy of: Jess Ebert, CIS Compliance Specialist
jessicaebert@cis-partners.com

1) Amendment To Allow Drug Importation Fails In Senate
http://www.medicalnewstoday.com/articles/174295.php

2) Pharma Faces More Scrutiny On Drug Prices
http://www.fiercepharma.com/story/pharma-faces-scrutiny-drug-prices/2009-12-08

3) Senators: Drug Makers Will Pay More For Health Bill
http://www.drugs.com/news/senators-makers-pay-more-health-bill-21563.html

4) Democrats Drop Plan to Expand Medicare
http://online.wsj.com/article/SB126083637029991305.html

5) WHO Wants Health Issues at Heart of Climate Talks
http://www.cnn.com/2009/HEALTH/12/17/climate.change.health/index.html

On the Fifth Day of CIS...

2009-12-17T08:30:00.000-05:00

As reported to Jess Ebert, Compliance Specialist

On the fifth day of CIS, the blog introduced to me…
CIS Strategic Advisor, Government Affairs, Bill Baxter
(and Jon Dellaquila, Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)

Q: What’s your background?
A: I directed the Medicaid & State Rebate Programs for all the J&J operating companies for over 10 years. Prior to that I taught school for a couple of years before joining J&J as a sale rep, moving into sales training & management, and ultimately into government affairs.

Q: What projects and product lines do you work with at CIS?
A: My main focus is GP, working with Chris Cobourn, Clarissa Crain, Steven Moore and Sabrina Skari. My main product line would be the Pharma Compliance Exchange (PCX) and providing compliance guidance to various operating companies.

Q: What do you like about CIS?
A: The professionalism as well as the feel of a “small” (but successful and rapidly growing) company environment.

Q: Why did you decide to join CIS?
A: I liked the enthusiasm, talent and quality of the individuals here at CIS (AND, my wife was willing to pay Jim & Toni to hire me… )

Q: What CIS accomplishments are you most proud of this year?
A: As a member of the company, making the “100” listing. As an individual, I’m proud of obtaining access to a number of companies.

Q: What are you looking forward to this holiday season?
A: Spending time with our “boys”, singing the “Halleluiah Chorus” with the choir at Christmas services, and getting “Christmas Letters” from friends and family (and at the same time guessing what news is true and what are “stretched” family facts…)

Q: What’s your favorite holiday movie?
A: “Die Hard” (it takes place at Christmas doesn’t it?), and “A Christmas Story” (I always wanted a BB gun…)

Q: What's your favorite holiday tradition?
A: Opening presents on Christmas morning and watching the boys’ expressions. (I was frequently tempted to put the proverbial lumps of coal in their stockings…)

Q: What’s the best gift you ever gave someone for the holidays?
A: A cruise (but she had to take it with me…)

Q: What’s the best gift you ever received for the holidays?
A: Getting to go on the cruise I just mentioned.

Q: What are you most thankful for this holiday season?
A: That the family is safe, sound and healthy, and that the economy did not collapse as feared.

Q: What is your favorite holiday cookie or food?
A: Macadamia nut cookies and Christmas ham; does a nice Merlot count as holiday “food”?

Q: What is your favorite holiday song?
A: I have several, but if I have to pick one it’s probably “There’s no place like home for the holidays.”

Email Bill any time at billbaxter@cis-partners.com!

Currently there are:
8 days until Christmas,
9 days until Kwanzaa,
and 4 days until Winter Solstice!

Tonight is the 7th night of Chanukah!

Surprise Tricare Ruling Handed Down

2009-12-16T10:00:00.002-05:00

By: Dave Rice, CIS Director of Federal Contracting
daverice@cis-partners.com

As many of you may have heard, the United States District Court for the District of Columbia recently ruled on the Tricare Retail Pharmacy Program (TRRx) issue in a decision that surprised many, including myself. Below is some basic background information on the issue as well as analysis of the ruling that was provided to us by Joy Sturm, Partner, Hogan & Hartson LLP.

Background
On January 28, 2008, Congress enacted the National Defense Authorization Act for Fiscal Year 2008 ("NDAA-08"). Section 703 of NDAA-08 requires that pharmaceuticals paid for by the Department of Defense ("Department" or "DoD") under its TRICARE retail pharmacy program be subject to pricing standards known as Federal Ceiling Prices. The Department promulgated a final rule implementing section 703 on March 17, 2009. Under this rule, pharmaceutical manufacturers cannot receive more than the Federal Ceiling Prices for pharmaceuticals purchased by DoD for the retail pharmacy program, and must refund amounts in excess of the Federal Ceiling Prices for prescriptions filled on or after January 28, 2008. The Coalition for Common Sense in Government Procurement ("Coalition") challenged the Department's rule, asserted that the rule should be set aside because, inter alia, the Department erroneously interpreted NDAA-08 to require refunds by manufacturers to DoD and to require the statute's obligations to apply beginning on January 28, 2008.

Analysis of Ruling
In a surprising decision, on December 7 the U.S. District Court for the District of Columbia ruled that while the Department of Defense (DoD) did not follow proper procedures in issuing its Tricare Retail Pharmacy (TRRx) Final Rule (74 Fed. Reg. 11,279 (Mar. 17, 2009)) implementing Section 703 of the National Defense Authorization Act for FY 2008, the statute "requires that Federal Ceiling Prices apply to all retail pharmacy program prescriptions filled on or after January 28, 2008."

While the court found for the Coalition on its procedural challenge to the Final Rule, it sided with DoD on the substantive issue presented in the case. The court held that because Section 703 did not mandate a rebate program, DoD had been required to exercise its discretion in requiring rebates from manufacturers under its Final Rule. The court therefore concluded that DoD's statements throughout the Final Rule that such a program was required "by operation of law" by Section 703 rendered the Final Rule procedurally defective.

The court held that remand of the Final Rule was necessary so that the agency could exercise its discretion in implementing the statute. However, the court was clear that DoD could, in exercising its discretion, reissue a rule with the same substantive requirements. In view of this conclusion, the court decided not to vacate the TRRx Final Rule, thereby leaving the voluntary agreement program in place.

In addressing the substantive issue presented, the court agreed with DoD that the statute entitles DoD to FCP-based pricing as of January 28, 2008. The court rejected the Coalition's argument that the Final Rule was impermissibly retroactive, holding instead that "[i]t is the statute, not the rule, which made transactions on or after January 28, 2008, subject to Federal Ceiling Prices . . . ." The court did not analyze how a rebate could be applied absent a contractual agreement by the manufacturer.

Accordingly, pending DoD's consideration on remand, the Final Rule remains in place as do TRRx voluntary rebate agreements. DoD is required to report to the court by March 1, 2010 on its reconsideration of the Final Rule.

It is likely that DoD will now turn its attention to outstanding rebate amounts for quarters pre-dating the voluntary agreements.

Whether this decision will have any impact on Non-FAMP and AMP remains to be seen. The VA has not yet stated whether this decision will impact its earlier guidance to manufacturers to identify and exclude TRRx utilization from Non-FAMP as Federal sales.

If you have any questions regarding this new TRRx development or surrounding the program generally, please contact Joy Sturm at (301) 294-5995 or at jesturm@hhlaw.com.

For the 11/30/09 Memorandum Opinion please see the following link: http://www.fdalawblog.net/files/mem.-op.-the-coalition-for-common-sense-.-.-.-v.-u.s.-08-cv-996-d.d.c.-nov.-30-209-2.pdf
*

On the Fourth Day of CIS...

2009-12-16T08:30:00.007-05:00

As reported to Jess Ebert, Compliance Specialist

On the fourth day of CIS, the blog introduced to me...
Compliance Manager Jon Dellaquila
(and Chris Didizian, Venessa Piper-Givler, and Amy VanDeCar)

Q: What’s your background?
A: After graduating from Circle of Friends pre-school in the spring of 1985, I went on to receive my undergraduate degree in Physiology from the University of Maryland (I thought I wanted to go to med school). My career began in a large pharmaceutical company supporting the development and monitoring of a Phase I/II Pilot Plant as an analytical chemist in the quality control laboratory. After a few years, I moved into the world of clinical trials supporting several Phase I/II oncology studies from an in-house clinical research associate perspective. Prior to my current position, I spent some time working in quality monitoring and compliance overseeing in-house and clinical site trial management activities in various therapeutic areas. During this time I also received my master’s degree in Cell Biology and Biotechnology from the University of the Sciences in Philadelphia.

Q: What projects and product lines do you work with at CIS?
A: I support CIS on the pharmaceutical side of the business in the clinical R&D and manufacturing arenas. Currently I am on-site at a client where I am responsible for assessing the risk benefit/analysis of R&D QA procedures and compliance related to the development of standard operating procedures (SOPs), policies and associated documents.

Q: Why did you decide to join CIS?
A: I decided to join CIS earlier this year to gain a different view of the pharmaceutical industry – from the outside looking in. Working for various departments within the industry allowed me to gain a strong understanding of the drug development life cycle from early stage R&D through to submission and approval. I always thought I wanted to get into pharmaceutical sales and found it difficult to break into that arena. When I interviewed with CIS, I saw the potential to wear many hats and also participate in various areas of the business. With that in mind, I thought it would be a perfect fit for me to leverage my career and educational experiences while also utilizing my social skills to create, establish and improve client relationships.

Q: What’s your favorite holiday cookie?
A: My Grandmom’s pizzelles - No one could make them like she could.

Q: What’s your favorite holiday movie?
A: My favorite holiday movie is National Lampoon’s Christmas Vacation. Christmas is not the same without a little Clark Griswald and cousin Eddie Johnson.

Eddie : "You surprised to see us, Clark?"
Clark : "Oh, Eddie... If I woke up tomorrow with my head sewn to the
carpet, I wouldn't be more surprised than I am now."

Email Jon any time at jondellaquila@cis-partners.com!

Currently there are:
9 days until Christmas,
10 days until Kwanzaa,
and 5 days until Winter Solstice!

Tonight is the 6th night of Chanukah!

Reminder- Monthly GP Forum tomorrow, December 16th!!!

2009-12-15T16:00:00.000-05:00

Please join several of the subject matter experts from CIS tomorrow at 10am for an hour long discussion on GP hot topics. The dial-in phone number is (888) 206-2266, and the pass-code is 1558717.

Topics for discussion include:

Dave Rice will lead an update on the recent Tricare ruling. CIS will recode the call for an iPod download.
Bill Baxter will give an update on the Advanced GP Forum venue at IIR in Baltimore in February.
This is CIS’ 3rd year facilitating the full-day work shop, the agencies will be there to discuss topical issues in a “town hall” format.
Any other questions or topics that you would like to discuss!

On the Third Day of CIS...

2009-12-15T09:30:00.004-05:00

As reported to Jess Ebert, CIS Compliance Specialist

On the third day of CIS, the blog introduced to me...
Compliance Manager Chris Didizian
(and SCM Venessa Piper-Givler, and SCM Amy VanDeCar)

Q: What’s your background?
A: I have a degree in Ancient History & Archaeology. Right out of college, I was looking to join a law firm and had a few prospects lined up until I was contacted by CIS. Impressed with what I saw, I joined within a month of the first interview and have since worked on a variety of projects with a focus on Sales & Marketing Activities.

Q: What projects and product lines do you work with at CIS?
A: For product lines, I manage the content on PCX Sales & Marketing. As for projects, I end up on roles relating to commercial compliance, specifically promotional review (MLR), PDMA, State Reporting, followed up by a lot of process work.

Q: What do you like about CIS?
A: Where to begin? Well the easiest way might be to break this response into two parts. The first pertains to my career. CIS presents many opportunities to work on a variety of projects for all pharma, large or small. With that said, each employee brings different perspectives and experiences thus establishing a versatile, learning environment. The second part to this answer pertains to more of a personal level. The people here are passionate, knowledgeable, and fun to be around. I’d like to specifically highlight passionate because it is contagious and allows for an enjoyable work environment.

Q: What’s the best gift you ever gave someone for the holidays?
A: One year I was convinced that I had the best gift for my fiancé. The idea took me a while to come up with and when it finally came to me, I was ecstatic. This gift was sure to be a shoe-in! It was a GPS Navigation System for her car. Good idea, right?! Maybe not…it didn’t sparkle.

On Christmas Day she tore into the neatly wrapped gift (thank you Amazon for wrapping it – I still don’t know how) with a smile on her face as I sat watching giddy from the excitement. She looks at the picture on the box and with a very grim tone – smile replaced by a frown, asks, “What is it?” Please note I cleaned up her responses for our readers. After explaining the thought that went into it – trust me, the thought never counts when buying for a significant other – she made it clear, without even saying a word, that the next gift should sparkle. I guess that idea was a mistake, but we guys get at least one, right?

Q: What is your favorite holiday song?
A: I’m hoping nobody takes this the wrong way, but my favorite holiday song is “Grandma got run over by a reindeer.” I’ve often found myself driving around town volume raised, dancing, and singing to this loveable, countryesque classic. Sure, I’ve had a few close calls (driving and dancing are difficult for me!) and people may stare, laugh, or shout expletives (one time) but what’s not to love? Oh… and if you’re wondering… yes, I have it on my Ipod.

Email Chris any time at chrisdidizian@cis-partners.com!

Currently there are:
10 days until Christmas,
11 days until Kwanzaa,
and 6 days until Winter Solstice!

Tonight is the 5th night of Chanukah!

On the Second Day of CIS...

2009-12-14T09:30:00.003-05:00

As reported to Jess Ebert, CIS Compliance Specialist

On the second day of CIS, the blog introduced to me...
Senior Compliance Manager Venessa Piper-Givler
(and SCM Amy VanDeCar)

Q: What's your background?
A: I have spent the majority of my career in GMP manufacturing specifically in final dosage, Active Pharmaceutical Ingredients, Sterile final and bulk as well as biologics. I started out in Quality Control as a bench chemist and microbiologist and then became a Supervisor of a QC laboratory. From there I moved into Quality Assurance and became a QA Manager and then a Director of Quality with QC, QA and Regulatory reporting into my organization. I hold a BS in Biochemistry and a Master's in Microbiology.

Q: What projects and product lines do you work with at CIS?
A: I work in the area of GMP Manufacturing specifically in Quality/Regulatory. I work with Quality and Regulatory clients to set up quality systems, metrics, evaluate and harmonization procedures, perform internal and external audits and establish regulatory filings.

Q: What do you like about CIS?
A: As a consultant for CIS I am given the opportunity to use my skills in many areas of Quality and Regulatory. CIS also allows me to work with many clients to help them with their compliance with the regulatory guidances as well as their own internal standards. This opportunity has also allowed me to use and enhance my business skills to develop a strong manufacturing program.

Q: What's your favorite holiday tradition?
A: A Traditional Italian Christmas Eve Dinner!

Q: What are you most thankful for this holiday season?
A: I'm most thankful for my children, family and friends.

Q: What is your favorite holiday song?
A: My favorite song is Last Christmas.

Email Venessa any time at vanessapiper-givler@cis-partners.com!

There are currently:
11 days until Christmas,
12 days until Kwanzaa,
and 7 days until Winter Solstice!

Tonight is the 4th night of Chanukah!

Articles of the Week!

2009-12-11T11:00:00.000-05:00

Courtesy of: Scott Hoffman, CIS Senior Associate
scotthoffman@cis-partners.com

1) House, Senate health care bills grow further apart
http://www.cnn.com/2009/POLITICS/12/09/health.care.differences/index.html

2) Democrats Feud Over Drug Imports Amendment in Health Care Bill
http://www.foxnews.com/politics/2009/12/10/democrats-feud-drug-imports-amendment-health-care/

3) SEC probes four Pharmas for insider trading
http://www.fiercepharma.com/story/sec-probes-four-pharmas-insider-trading/2009-12-10

4) Microsoft To Acquire Healthcare Specialist http://www.informationweek.com/news/infrastructure/management/showArticle.jhtml?articleID=222001574

5) GAO: FDA yet to make safety changes post-Vioxx
http://news.yahoo.com/s/ap/20091209/ap_on_he_me/us_fda_drug_safety

6) Primary care shortages hitting communities hard
http://www.cnn.com/2009/POLITICS/12/10/king.sotu.doctors/index.html

7) Another Medical School Reports Doctors’ Industry Ties
http://blogs.wsj.com/health/2009/12/09/another-medical-school-reports-doctors-industry-ties/

On the First Day of CIS...

2009-12-10T10:00:00.003-05:00

Dear Readers,

It’s that time of the year again when we take the opportunity to introduce to you some of our talented employees who have made CIS an industry-leading provider of pharmaceutical compliance services.

For those of you who know us, you may just learn a thing or two about who we are and what makes us tick. For those of you who have not had the great pleasure of meeting us, we hope you like what you read!

Thanks, and Happy Holidays!
Dana Zelig and Jess Ebert, CIS Compliance Specialists and PCB Co-Editors

On the first day of CIS, the blog introduced to me...
Senior Compliance Manager Amy VanDeCar

Q: What's your background?
A: I have a degree in criminal justice and am working on an MBA. I got my start in pharma as a membership coordinator at a mid-sized manufacturer. I've worked in industry with chargebacks, contracts, analysis, and government pricing. After leaving industry, I spent a couple of years helping manufacturers implement and more extensively use commercial contracting and government pricing systems.

Q: What projects and product lines do you work with at CIS?
A: I am a Director in CIS' Commercial Compliance practice. In this role, I work with manufacturers on commercial and government programs audits and assessments, ongoing calculations and recalculations, and other projects intended to increase their level of compliance.

Q: What do you like about CIS?
A: I enjoy the variety of projects I am able to work on at CIS.

Q: Why did you decide to join CIS?
A: I joined CIS because of the company's unwavering commitment to compliance. I was drawn to the opportunity to work for a company that proactively informs customers about new and pending regulations and works with them to ensure a successful response.

Q: What are you looking forward to this holiday season?
A: The opportunity to slow down a bit, to take the time to enjoy family and friends.

Q: What is your favorite holiday song?
A: My favorite song is Silent Night.

Email Amy any time at amyvandecar@cis-partners.com!

There are currently:
16 days until Christmas,
2 days until Chanukah,
17 days until Kwanzaa, and
12 days until Winter Solstice!

CIS and Wrinkled Shirts

2009-12-09T11:30:00.002-05:00

By: Steven Moore, CIS Director of Business Development
stevenmoore@cis-partners.com

I do a lot of traveling by myself and that means I get to do a lot of thinking to myself. Allow myself to introduce myself. Welcome to the department of redundancy department…

Nice, opening Steven. (I had thought about starting over, but this is actually what I typed, so I’m sticking with it.)

I’m not sure if you’ve heard about this whole Tiger Woods saga or not (for those of you who are reading this from Timbuktu --- which is for Dave Rice), but it really had got me to doing some real thinking. I was perplexed with how someone who is/was married to a model, who possesses more talent than anyone I’d ever seen at his craft, who is the first BILLION dollar athlete and has all the things money can buy could be so insecure and unhappy.

I rather like the saying, “The older I get, the smarter my parents get.” Because when I asked those questions to myself, the answer smacked me in the face (thanks Mom & Dad). Because money simply can’t buy happiness! Tiger can hit a golf ball 340 yards in the air. I love my wife so much that what he’s done to his wife Elin is impossible to fathom in my head. I’m happy.

I do feel for him and his family --- especially his wife and children --- and I hope that he can learn from his mistakes and become a better man. Heck, in reality, I feel like he needs to become a man first before he can become a better man. But my sincere best wishes.

So how does Tiger Woods relate to the Pharma Compliance Blog? Good question. I’ve been doing a lot of talking with Chris Cobourn, our VP of Consulting/GP/Calamari, etc., and we’ve talked a lot about how our people are ‘real’. That there is seemingly an important distinction between the folks at CIS and many of the places and organizations that we’ve seen. Now, he has seen a lot more places because I’m a spritely 30 and he’s, well, he’s tried a lot of different types of calamari --- but we both arrived at the same place having spent many a day on the road together. And, to tie things back to Tiger Woods, he’s been a fake for years now! But it’s one thing to think it of yourself and altogether different for someone else to say it to you.

I was recently in a meeting with a current client --- one whom I have a tremendous amount of respect for --- and was told, “I want you to know that we went with CIS because you’re real people that we can relate to. Sure, you work hard and you do strong work, but it was the fact that you were real that made us go with you.”

Pinch me. If I wasn’t such a tough guy (yeah right), I might have shed a tear. Seriously though, this was it! This was what we’d been trying to accomplish years ago! I also had another client tell us that a competitor rolled up in a shiny giant SUV and Armani suits --- and here I’m thinking, “Man, I wonder if I still know how to tie a tie…?”

When I came to CIS, my responsibility was marketing and marketing alone. I had met with the likes of Jim Collins, Toni Barsh, Chris Cobourn, Clarissa Crain and Chrissy Spicer and it was astonishing how real these people were. Having come from a large company filled with politics and back-stabbing, I was overwhelmed in a good way. These were the kinds of folks that you could see grabbing a pizza working till 1AM to finish a COT deliverable (for you, Clarissa) --- just as easily as you could see having a cold beer with them after a really long day. I then realized that my job was to let the Pharma Compliance world know and then, subsequently, see it. Most companies would be aghast at the notion of a PCXTini --- a neon blue martini named for our PCX product --- to launch our product at a conference. But guess what? A martini after 8 hours of GP talk at a conference is real!

Since those days, I’ve moved on to do some consulting projects and then into business development --- but have passed the marketing gig to the far more capable than me hands of Karen Brown and Jackie O’Connor. People loved our GP Geek T-shirts and many clients have told me they wear them out --- even to the gym! People loved that we used drink stirrers that lit up and were used in our CalcTinis, used for our CalcPartner product --- which if you haven’t seen or learned about yet, you must! (selling OFF) I had one client tell me that she keeps it in her purse and uses it at the bar! Now that is some serious word of mouth advertising. Not that every club and bar is crawling with GP and Compliance Geeks but as the NY Lotto says, “Hey, you never know…”

Karen, our aforementioned Sr. Director of Marketing, once asked of the CIS team the following brilliant, angled question: If CIS were a piece of furniture, what would it be and why?

At first I was confused --- but her tact was bright and she knew what she was doing. This is my exact response from an email sent back to her (I’m an email packrat --- my apologies to our server):

“If CIS were a piece of furniture, it would be a well-constructed, reliable
desk. To me, this imagery represents roll-up-your-sleeves hard work and
dedication and that’s what we’re about now --- and hopefully well into the
future!”

This isn’t supposed to be a piece that ‘toots our own horn’, but we do hope you agree. We have and will make mistakes, but we will be the first to raise our hands, admit it and make it right no matter what it takes. In the end, we hope you see that we’re real and we’ll work our butts off for you --- and if we ever waver from this, please do let us know. We many not wear Armani suits everywhere we go, but our shirts will be pressed…

However, more importantly, we won’t be afraid to get them wrinkled by rolling up our sleeves to finish your important deliverable ahead of time so you can present to management on a tight timeline --- or get you a proposal quickly because the fits about to hit the shan and you need our help.

I know the folks here at CIS, and that’s something real that you can count on.

For Your Space,

Steven.

Articles of the Week!

2009-12-04T09:00:00.001-05:00

Courtesy of: Jess Ebert, CIS Compliance Associate
jessicaebert@cis-partners.com

1) Hawaii Opting Out Of Health Care Overhaul
http://www.npr.org/templates/story/story.php?storyId=120896275&ps=cprs

2) Costs and Consequences of Direct-to-Consumer Advertising for Clopidogrel in Medicaid
http://archinte.ama-assn.org/cgi/content/short/169/21/1969?home

3) The Uproar Over Mammography
http://economix.blogs.nytimes.com/2009/11/20/the-uproar-over-mammography/

4) Health Care Rationing, American-Style
http://economix.blogs.nytimes.com/2009/11/27/health-care-rationing-american-style/

5) Bureau of Labor Statistics' Health Care Charts:
http://www.bls.gov/spotlight/2009/health_care/

Managing Non-Compliance Incidents

2009-12-03T09:00:00.001-05:00

Karen Brown - Senior Director, Marketing
karenbrown@cis-partners.com

Does your company's Compliance Program address the significant risks of the organization? How were those risks determined and how are new compliance risks identified and incorporated into the program?

These are questions posed by the OIG in their effort to develop specific guidances that best support a Compliance Program. [1]

The OIG’s “voluntary guidelines” are intended to help identify risk areas and offer suggestions for improvements. However, the act of implementation and management of a successful Compliance Program is going to require much more than sound advice and guidelines.

Think about your own company and the programs that you run and the many rules that could be broken across the organization.

As an industry already overloaded with vast amounts of data, one of the questions that we should be asking is: How is your company evaluating compliance throughout the organization?

CIS has been working with pharma clients to address this question and has developed an easy-to-use database solution.

Join us on Dec 8th, for a free WebEx on CIS ComplianceWatch: a compliance monitoring solution that will help you track non-compliant activities and disciplinary actions within your organization. This easy-to-use database allows you to:

· Capture non-compliant activities by individuals
· Attach the disciplinary action of an incident
· Escalate disciplinary actions based on repeat offenses

The database offers reporting options that will help you evaluate the entire Compliance Program based on the frequency of certain incidents, or evaluate compliance on an individual, district or company-wide basis. And, we can tailor ComplianceWatch to fit your current Compliance Program.

Please join us at a time that is convenient for you.
Date: Tuesday, December 8th
Times Available (EST): 10-10:30am, 1-1:30pm, 3-3:30pm Simply email us and let us know which time and we'll provide the call-in details.
If you're unable to join, email us and we'll setup an individual WebEx meeting.

Source:
[1] http://oig.hhs.gov/fraud/docs/complianceguidance/040203CorpRespRsceGuide.pdf

Internet Drug Marketing Regulations

2009-12-02T14:00:00.000-05:00

By: Grete Dudek, CIS Compliance Associate
gretedudek@cis-partners.com

On November 12th and 13th, 2009 the FDA held a public hearing to discuss how drug manufacturers use the internet and social media tools to promote their products. Participation in the hearing was open to “all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, Internet vendors, advertising agencies, and the regulated industry.”[1] The hearing mainly addressed two questions:

How do [drug marketing regulations] relate to certain internet/social
media-related activities; and what are manufacturers’ responsibilities with
regard to monitoring and subsequently reporting adverse events identified on the
internet and/or through social media tools.[2]

Representatives from drug companies made the case that online marketing and social media can help consumers by getting the word out on drug safety, and educating patients about illness and its management. Until this point, drug makers have either been proceeding very cautiously on the internet and social media sites, or not at all, saying they’ve abstained because of a lack of direction from the FDA. They want to see concrete guidelines on what type of information they are responsible for, if they are responsible for correcting incorrect or misleading information on third party sites, and to what extent. But can manufacturers be responsible for every comment posted by random web surfers?

Back in March, warning letters were sent to 14 manufacturers from the FDA regarding paid Google search advertisements.[3] The letters from the FDA said that the drug advertisements were misleading because they didn’t have information on side effects, while the manufacturers warned that including that information was impossible, given the 95 character limit of Google ads. Before the letters were sent, the manufacturers believed they were in compliance if they followed the “one-click rule:” as long as risk information was provided within one click of the search ads, they thought they were in compliance with FDA regulations.[4] The letters proved this was not the case. If the safety information needs to be included in the 95 character ads, manufactures argued, the ads would become very confusing to consumers. As a result of the changes, a large drop was seen in the number of clicks the ads received.

From this example, it is clear that the FDA and manufacturers don’t always agree on how the current marketing regulations apply to internet and social media advertisements. Because the current regulations were written mainly to apply to print and television ads, and because of how the internet has grown, it is important that the FDA issue some sort of guidance. But the last time the FDA held a hearing about using the internet to promote medical products was in 1996, and that meeting yielded no guidelines on using the internet for the promotion of medical products.[2] The type of guidance that is needed is also important to consider, since the rules should be strict enough to not allow misinterpretation (as seen with the “one-click rule”), but need to be flexible enough to allow for the ever-changing internet and the world of social media.

The FDA will be accepting comments until February 28, 2010 at www.regulations.gov.

Sources:
1. http://edocket.access.gpo.gov/2009/pdf/E9-22618.pdf
2. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/11/fdas-hearing-on-social-media-more-questions-no-answers.html
3. http://www.fiercepharma.com/story/another-job-fda-online-marketing-regs/2009-04-07
4. http://pharmamkting.blogspot.com/2009/04/fdas-actions-speak-louder-than-its.html