Friday, February 29, 2008

Thought flu season was over? Guess again.

By Amy Lotman, CIS Regulatory Compliance Specialist
amy.lotman@cis-partners.com

According to the CDC, it‘s actually getting worse.

The flu vaccine must be reformulated every year to keep up with the fast-evolving influenza virus, and this year the government made a rare, wrong bet on which strains would cause the most disease.

The flu season got off to a slow start, but it rocketed in mid-January because of some new strains that are sickening even people who got vaccinated. It seems the vaccine is a good match for only about 40 percent of the virus now spreading in the U.S., according to the Centers for Disease Control and Prevention.

In good years, the vaccine can fend off 70 to 90 percent of flu bugs.

Infections from an unexpected strain have been booming and now are the main agent behind most of the nation's lab-confirmed flu cases.

It's too soon to know whether this will prove to be a bad flu season overall, but it's fair to say a lot of people are suffering at the moment.

Each winter, experts try to predict which strains of flu will circulate so they can develop an appropriate vaccine for the following season. Based on international surveillance and scientists' estimations about which manner of viruses will circulate in a given year, each new season's vaccine is manufactured accordingly.

An annual inoculation actually protects against three influenza viruses, each representing one of the three types that experts predict will be circulating among people during flu season: one A (H3N2) virus, one A (H1N1) virus, and one B virus, each one representing one of the recommended vaccine strains. For example, the 2007-2008 trivalent vaccine strains are A/Solomon Islands/3/2006 (H1N1)-like (new for this season), A/Wisconsin/67/2005 (H3N2)-like, and B/Malaysia/2506/2004-like viruses.
Usually, the guesswork is pretty good. In fact, the vaccines have been a good match in 16 of the last 19 flu seasons.

But the vaccine's Type B component turned out not to be a good match for the B virus that has been most common this winter. And one of the Type A components turned out to be poorly suited for the Type A H3N2/Brisbane-like strain that now accounts for the largest portion of lab-confirmed cases.

Recently, the World Health Organization (WHO) took the unusual step of recommending that next season's flu vaccine have a completely different makeup from this year's. Shortly there after, the FDA agreed with the WHO 2008-2009 vaccine recommendation. What virus strains to include in the vaccine is a decision made months in advance to give manufacturers time to brew more than 100 million doses before the next fall, a time crunch that makes keeping a step ahead of influenza difficult.

H3N2 strains are treatable by Tamiflu and other antiviral drugs, but the other, H1N1 Type A strains are more resistant. Of all flu samples tested this year, 4.6 percent have been resistant to antiviral medications. That's up from fewer than 1 percent last year.

It’s important to note that CDC officials continue to recommend that people get inoculated. The reason: The vaccine still offers partial protection and can reduce the risk of flu-related complications.

Thursday, February 28, 2008

CIS and the PCX Offer Discounts to CBI’s Medicaid Rebates Conference!

Dear Friends & Colleagues,

It’s hard to believe that we’re already talking about CBI’s Medicaid Rebate Conference in Orlando, FL from May 7th to the 9th! CIS is extremely proud to be sponsoring the event again this year! For those of you who remember last year, our Cocktail Hour featured electric blue PCXTinis and great times, conversation and networking. We enjoyed ourselves so much, we’ve decided to sponsor the main conference Cocktail Hour again! While we haven’t nailed anything down quite yet, we’re looking to offer BlogTinis at this year’s event. Any and all recipe suggestions for this proposed concoction are not only requested --- but encouraged.

Also, and most importantly, we will have some HUGE news about the Pharma Compliance Exchange (PCX) (www.cis-pcx.com/register) at the CBI conference! Perhaps we’ll have to offer the PCXTini on the menu of drinks again…

Also, please note that we are able to offer a discount to all of you if you contact CBI (Jamie McCugh: (781) 939-2406; jamie.mchugh@cbinet.com), mention CIS and use the following discount code to receive $300 off of your registration fee: BAR992. The fact that we have “BAR” in our discount code is completely coincidental --- I assure you.

Finally, we look forward to seeing all of you at the conference. We had a blast in Orlando last year as we did the official public launch of the PCX. Since then, we have gotten to know so many of you and hope that we can share some great food, drinks and knowledge during the 3-day event!

Oh --- and we promise to be genuine canoodlers...

For Your Space,

Steven Moore
stevenmoore@cis-partners.com
610-565-8007

Below is the abstract of our session:

Class of Trade (COT) is the core foundation to all Statutory Pricing calculations. Knowing your customers the nature of their business is integral to assigning an accurate customer category, or COT. In order to meet the requirements of due diligence, manufacturers must get a customer’s COT right, and in order to do so, manufacturers must have written policies and procedures related to COT assignment, COT maintenance and systems in place to maintain the customer information. Manufacturers must also have the ability to evaluate correctly commercial transactions at the customer and product level. Adding an element of difficulty is the fact that COT assignment can be one of the more challenging components of the Government Pricing world. Often, people with this responsibility do not fully understand why it is critical for accurate calculations. Source data can be vague and conflicting, and if a manufacturer has a large customer base, the task of cleaning up the data can be daunting.

In this session, Chris Cobourn (GP Practice Lead) and Katie Lapins (CIS Senior Compliance Specialist) and a panel of industry professionals will focus on best practices and potential risk areas while also providing participants with some real world examples of companies that have undergone a “scrubbing” of their COT data.

Wednesday, February 27, 2008

GROWTH IN NATIONAL HEALTH EXPENDITURES PROJECTED TO REMAIN STEADY THROUGH 2017

Department of Health & Human Services
Centers for Medicare & Medicaid Services
Room 303-D
200 Independence Avenue, SW
Washington, DC 20201
Office of Media Affairs

MEDICARE NEWS

For Immediate Release

Tuesday, February 26, 2008

GROWTH IN NATIONAL HEALTH EXPENDITURES PROJECTED TO REMAIN STEADY THROUGH 2017; HEALTH SPENDING GROWTH EXPECTED TO CONTINUE TO OUTPACE ECONOMIC GROWTH AND GROWTH IN GENERAL INFLATION

Growth in health care spending in the United States is projected to be 6.7 percent in 2007, according to a report issued today by the Centers for Medicare and Medicaid Services (CMS). Average annual growth is expected to remain near that rate through 2017, the report said.

The analysis was prepared by CMS’s Office of the Actuary and published online by the journal Health Affairs. Over the full projection period (2007-2017), annual growth in health spending is anticipated to be higher than annual growth in both the overall economy (4.9 percent) and in general inflation (2.4 percent).

As a percentage of gross domestic product, known as GDP, health care spending is projected to increase to 16.3 percent in 2007 from 16.0 percent in 2006. By the end of the projection period, health care spending in the United States is expected to reach just over $4.3 trillion and comprise 19.5 percent of GDP.

For health spending through public programs, growth is anticipated to decelerate to 6.8 percent in 2008 after the 8.2 percent growth in 2006 that was largely influenced by the implementation of the Medicare Part D drug benefit. Public health spending growth is then expected to gradually increase toward the end of the projection period, as the leading edge of the baby boom generation begins to enroll in Medicare.

“The cost of health care continues to be a real and pressing concern. Making sure we are paying for high quality health care services, not just the number of services provided, is just one of the most critical issues facing the American public and the federal government now and in the future,” said CMS Acting Administrator Kerry Weems. “This projection of health care spending reminds us that we need to accelerate our efforts to improve our health care delivery system to make sure that Medicare and Medicaid are sustainable for future generations of beneficiaries and taxpayers."

eThrough 2017, growth in health spending is expected to outpace that of GDP by an annual average of 1.9 percentage points. This projected differential in growth rates is smaller than the 2.7 percentage-point average difference experienced over the past 30 years, but wider than the average differential (0.3 percentage point) observed for 2004 through 2006.

Growth in private health expenditures (which includes out-of-pocket and private health insurance spending) is expected to rebound to 6.3 percent in 2007 following the somewhat slow growth of 5.4 percent in 2006 that was related to the implementation of Medicare Part D. Private spending growth is expected to peak in 2009 at 6.6 percent, then decelerate through 2017 in response to projected slower economic growth in the latter years of the projection period.

Prescription drug spending growth is expected to slow to 6.7 percent in 2007 (from 8.5 percent in 2006), driven largely by slower drug price growth. For 2008 through 2017, prescription drug spending is projected to accelerate due in part to the projected leveling off of growth in the generic dispensing rate and evolving treatment guidelines that call for earlier introductions of pharmacotherapy. The Medicare Part D benefit, on the other hand, is expected to have very little impact on total national health expenditure growth through 2017, as per capita spending growth for Medicare beneficiaries is expected to be identical to that of the rest of the population.

Hospital spending growth is expected to accelerate from 7.0 percent in 2006 to 7.5 percent in 2007, partly attributable to higher Medicaid payment rates. Hospital spending growth is then projected to decrease slightly though the rest of the projection period as the growth in demand for hospital services is expected to slow.

In December 2007, Congress passed the Medicare, Medicaid, and S-CHIP Extension Act (MMSEA), providing a 0.5 percent increase to the Medicare Physician Fee Schedule (MPFS) for the first six months of 2008, followed by a 10.6 percent reduction in the MPFS for the second six months of 2008. This CMS projection of health spending growth does not include the impacts of the MMSEA, but rather features a new simulation of an annual zero percent increase to the MPFS and compares that to the anticipated impact of negative payment updates that were in the law before the MMSEA was enacted. Based on this simulation, by 2017, annual zero percent updates to the MPFS would be expected to result in Medicare physician spending and overall Medicare spending totals that are 25.3 percent and 6.4 percent higher, respectively, when compared to the expected spending associated with negative payment updates to the MPFS.

The effect of a zero percent MPFS update on total health spending is projected to be much smaller, however, with total health care spending estimated to be 0.7 percent higher in 2017.

Medicare spending growth is expected to slow to 6.5 percent in 2007, following the 18.7 percent growth experienced in 2006. Nearly all the projected slowdown in growth for Medicare in 2007 is related to the new spending that was devoted to the Medicare Part D benefit in 2006, spending that simply continues into 2007 and is nolonger new to the program. Also contributing modestly to the projected slowdown are reduced increases in Medicare Advantage plan payments for 2007 as a result of risk adjustments made to these payments. In the latter years of the projection, Medicare growth is expected to accelerate, reaching 8.0 percent by 2017, as the baby boom generation begins to enroll in the program.



Following a decline of 0.9 percent growth in 2006 (associated with the shift in drug coverage for beneficiaries dually-eligible for Medicaid and Medicare to Medicare Part D), Medicaid spending growth is projected to be 8.9 percent in 2007. Aside from the one-time transition effects of Medicare Part D, contributing to this expected acceleration in growth are increases to payment rates for hospitals and physicians. On average, Medicaid spending is anticipated to grow 7.9 percent per year over the projection period and account for 16.8 percent of total health care spending by 2017.

The health care spending projection data can be found on the CMS Web site at http://www.cms.hhs.gov/NationalHealthExpendData/03_NationalHealthAccountsProjected.asp.

Monday, February 25, 2008

“Should drug manufacturers be granted immunity from product liability when they’ve followed the federal standards?”

By Alaina Confer, CIS Compliance Specialist
alainaconfer@cis-partners.com

Keep your eyes on the U.S. Supreme Court decision today, Monday 25 February 2008! The court will be examining the question “Should drug manufacturers be granted immunity from product liability when they’ve followed the federal standards?”

The case has risen to the Supreme Court from the state of Michigan regarding Rezulin cases which have not been settled. These cases were not settled due to the state’s immunity law which includes the following provisions:

"In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration's approval at the time the drug left the control of the manufacturer or seller." M.C.L. § 2946(5).

However the manufacturer is liable under the following conditions:

"a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted." M.C.L. § 2946(5)(a).

Due to Wednesday’s 8-1 decision regarding Medical Device liability, it is predicted that a similar decision will benefit drug manufacturers. In the Medical Device ruling, manufacturers are not able to be sued when the product is reviewed and given Pre-Market Approval (PMA) by the FDA under the Medical Devices Amendment of 1976. This may encourage device manufacturers to seek PMA, as most devices are marketed as “substantially equivalent” to another marketed device.

A press conference is scheduled today, Friday 22 February 2008, with Kimberly Kent and her attorney in Detroit at 10AM. But Monday, 25 February 2008, will bring the decision we are awaiting. Stay tuned . . .

Friday, February 22, 2008

A Tribute to Merck

In previous blog posts, we’ve wondered why pharmaceutical companies either do not or cannot create drugs that affect diseases globally, that may not be prevalent in the US. We’ve looked closely at the business reasons and put these reasons up against the notion of simply ‘doing the right thing.’ Examples of these crippling diseases, like Malaria, abound in many third world countries around the globe. CIS’s Marie Vu has penned an article that shows the warmer side of the pharmaceutical industry and sets an example that everyone in our industry should strive to achieve some day.

CIS & the PCX salute Merck for a decade’s long program that has affected millions upon millions of lives in an amazingly positive way.

For Your Space,

Steven.

By Marie Vu, CIS Compliance Specialist
marievu@cis-partners.com

How many of you have heard of a drug called Mectizan? In 1987, Merck produced Mectizan for the treatment of onchocerciasis, or "river blindness.” Onchocerciasis is one of the leading causes of preventable blindness worldwide. The disease is transmitted through the bite of black flies and can cause intense itching, disfiguring dermatitis, eye lesions and over time, blindness. In fact, around 18 million people are infected with this disease every year and almost all of them are from remote, rural areas in Africa. Mectizan relieves the excruciating itchiness that is associated with the disease and immobilizes the progression towards blindness.

Since 1987 Merck has donated Mectizan to all those who need the medication, for as long as they need it, for free. And since Mectizan is indicated for one dose annually, Merck would travel to the most remote places just to distribute it to all those suffering from onchocerciasis every single year. In 1988, Merck established the Mectizan Donation Program to provide medical, technical and administrative oversight of the donation of Mectizan. Since the program's establishment, Merck has given more than 1.8 billion tablets through the partnership with WHO, UNICEF and the World Bank, with more than 530 million treatments approved. The program currently reaches 69 million people through river blindness programs in Africa, Latin America and the Middle East (Yemen) each year. In 1998, Merck expanded the Mectizan Donation Program to prevent lymphatic filariasis (LF), or elephantiasis, in African countries where the disease co-exists with river blindness. Lymphatic filarisis is a disease that puts 300 million Africans at risk and 40 million are infected by it every year. Currently, the Mectizan Donation Program is the single largest, longest standing public/private partnership of its kind and is widely regarded as one of the most successful public-private health collaborations in the world.

After researching this story, I began to question why a pharmaceutical company would spend millions of dollars to prevent a disease that does not even affect the US and even more astonishingly, donate it completely. In fact, Merck has barely even announced their humanitarian efforts on this project to the public. I came up with two answers (and this is only my opinion):

1. To satisfy their moral obligation and responsibility, and
2. To motivate their scientists. Scientists are creative people, and in order to motivate them and retain talent, Merck gave them the freedom to “create.” This has, in return, built loyalty towards the company through astounding fulfillment.

Pharmaceutical companies spend millions of dollars on sales & marketing and Research and Development. Why not spend millions retaining talent while creating positive global change? Through this program, Merck has successfully fulfilled their moral obligation and retained some of the greatest minds in the industry.

"I think Merck has set a standard of the highest possible quality. [The MECTIZAN Donation Program has] been one of the most remarkable and exciting and inspiring partnerships that I have ever witnessed."

— Jimmy Carter
39th President of the United States
Co-founder, The Carter Center
2002 Nobel Peace Prize Laureate

We at CIS could not agree more President Carter.

For more information, please go to the following link: http://www.merck.com/cr/enabling_access/developing_world/mectizan/

Thursday, February 21, 2008

PhRMA Applauds National Drug Prevention and Education Week

PhRMA President and CEO Tauzin
Applauds Drug Prevention Week


Washington, D.C. (February 19, 2008) — Senate Resolution 434 creates National Drug Prevention and Education Week to highlight abuse of prescription medicines - a problem that America's pharmaceutical research companies are committed to fighting.

Pharmaceutical Research and Manufacturers of America President and CEO Billy Tauzin lauded this week’s Senate Resolution (S. Res. 434) designating February 10-16, 2008 as National Drug Prevention and Education Week.

The resolution “serves to highlight an important problem in America – the growing abuse of prescription drugs and over-the-counter medicines,” he said. “This is a problem that America’s pharmaceutical research companies are committed to fighting.”

According to data from the National Survey on Drug Use, some 6.4 million American children 12 or older have reported using prescription drugs for a non-medical use. In addition, youth are not the only abusers of prescription drugs: The U.S. Justice Department has found that seven million Americans abuse prescription drugs – more than the number of those abusing cocaine, heroin, hallucinogens and Ecstasy combined. In just six years, abuse of prescription drugs has increased 80 percent.

Speaking to this, Tauzin said, “The rise in prescription medicine abuse requires action, and that is why we have been working with other national organizations to develop, for example, new, specialized tools and support programs that prevent and address the problem of legal-drug abuse among elementary school children. We are proud to be part of these efforts to protect America’s youth.”

For example, in October, PhRMA was awarded the Drug Abuse Resistance Education (D.A.R.E.) Champion Award for its assistance in providing funding and expertise to help develop the D.A.R.E. America curriculum for children in grades five, seven, nine and 12. The educational materials are intended to raise awareness among teachers, parents and students about the dangers of abusing any drug, including legal medicines. PhRMA is also a supporter of the Partnership for a Drug-Free America as well as the campaign against prescription drug abuse recently launched by the Office of National Drug Control Policy.

Tauzin said, “In focusing national attention on the critical role of prevention and education in the fight against drug abuse, the Senate has taken a critical and welcome step in helping our country’s children understand that legal medicines are good, but that using them to get high is dangerous.”

--------------------------------------------------------------------------------

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $43 billion in 2006 in discovering and developing new medicines. Industry-wide research and investment reached a record $55.2 billion in 2006.

Wednesday, February 20, 2008

The Adoption of RFID to Combat Drug Counterfeiting

By Chrissy Spicer, CIS Compliance Specialist
chrissyspicer@cis-partners.com

FDA criminal investigations of drug counterfeiting have increased six fold since 2000, and the U.S. pharmaceutical industry loses approximately $2 billion to counterfeiting every year, according to Ross Enterprise, Inc., a subsidiary of CDC Software. New York-based Center for Medicine in the Public Interest estimates sales of counterfeit drugs to reach $75 billion worldwide in 2010, an increase of more than 90%. According to the World Health Organization, 10% of the global medicine supply is counterfeit. In response to the drastic increase of the counterfeit drugs plaguing the industry, pedigree regulations have become more rigorous and in addition to the national requirements, e-pedigree requirements are being instituted at the state level.

One of the biggest challenges in the pharmaceutical industry is being able to track and trace at the item level. Radio Frequency Identification (RFID) is the data collection technology that uses electronic tags for storing data. The tag, also known as an "electronic label," "transponder" or "code plate," is made up of an RFID chip attached to an antenna.

In the article titled “Bitter Pill,” Aichlmayr (2007) indicates that the national requirement of drug pedigrees originated in 1988 with the enactment of the Prescription Drug Marketing Act (PDMA). E-pedigrees are statements of origin that identify all prior sales of a specific drug and all transaction dates, as well as the parties involved in each transaction. Aichlmayr (2007) elaborates in referencing the PDMA, “it’s the wholesaler’s responsibility to generate and maintain each drug pedigree and produce it, on demand, to an inspector or purchaser” (p.19).

The FDA has noted on several occasions their disappointment with the crawling progress of RFID adoption. The FDA continues to cite the importance of RFID and mass serialization as important constituents in preventing drug counterfeiting. In response to the slow progress of the adoption of RFID technology, states have promulgated e-pedigree requirements at the state level. Daleiden summarizes, “35 states have their own pedigree laws or are currently working on them.” (as cited in Aichlmayr, 2007, p.19).

The state e-pedigree laws are shifting the responsibility from the wholesaler to the manufacturer, which will have a domino effect on every entity involved in the distribution channel of pharmaceutical products beginning with the manufacturer. As seen with California SB 1765 law, which mandated the Pharma code for manufacturers doing business in California, California is yet again at the forefront with mandating e-pedigree requirements. Aichlmayr (2007) notes that by January 1, 2009, any manufacturer conducting business in California, requires electronic pedigrees initiated by manufacturers and verified and updated from the point or origin (manufacturer) to the final dispenser (pharmacy).

The industry as whole, I would contend, is still in premature stages of the mass adoption of the RFID technology. The main reasons for the lack of progress in implementing the new technology is related to integrating the technology from a system perspective and the lack of formalized industry standards for adopting e-pedigree requirements and this will continue to be complex as requirements become mandatory at the state level.

Monday, February 18, 2008

Where’s Waldo? (cont’d)

I failed to realize that Monday was President's Day and, for many in the industry, a day off! Therefore, I wanted to keep Clarissa's Where's Waldo Part 2 as the newest post for those who were relaxing yesterday!

Watch for two really cool articles coming on Wednesday and Friday as well --- CIS's Chrissy Spicer will tell us all about Radio Frequency Identification and its potential for our industry and then Marie Vu will give a tribute to Merck .


For Your Space,

Steven.

By Clarissa Crain, CIS GP Compliance Specialist
clarissacrain@cis-partners.com

A Sampling of the Additions and Changes

On Friday we looked into the difficulty of keeping interpretations and methodology documentation up-to-date as CMS guidance related to the DRA continues to be issued and revised. Today we look more closely at some of the specific Q&A changes and additions that have resulted in potential interpretation and methodology changes.
Over the past few months the Q&A document has evolved in several ways. Questions have been added. Subjects have been revised. Answers have changed. Formatting and layout has changed. While the Q&A may not have led to changes in methodology for all manufacturers, it has led to an overall uneasiness in the industry. Manufacturers find the evolution of the Q&A document concerning.

This review is not all encompassing of changes and updates to date, but it will provide insight into the types of changes and updates CMS has been making to the Q&A document.

Change:

In the Q&A document published on 9-28-07 the question below was documented with respects to AMP:

May a manufacturer opt to smooth sales that are excluded from AMP?

The answer provided by CMS on 9-28-07 read as follows:

No. For Medicaid, only sales included in AMP should be used in the 12-month rolling average to estimate the value of lagged price concessions.

Without explanation, the answer provided by CMS to this same question changed in the 11-27-07 edition of the Q&A:

No. For the purposes of Medicaid, only the discounts, rebates, and other price concessions associated with sales included in AMP should be used in the 12-month rolling average to estimate the value of lagged price concessions.

Some read this change as a clarification to the original answer provided by CMS, others see the expanded answer creating new points of ambiguity. Either way, interpretations made based on the original answer may be different than interpretations made based on the new answer. If methodologies are changed because of these changes in interpretation, then manufacturers must document the methodology change and the guidance reference leading to this change.

Update:

As of the 1-23-08 Q&A document, CMS added four new topics: Base Date AMP, Bona Fide Service Fees, Bundling, and the Injunction. This is important for manufacturers not only to be aware of but to be prepared for going forward. As stated in Friday’s blog, retention of referenced Q&A documents and maintenance of an appropriate level of documentation is imperative. If CMS publishes further Q&A, or if the current Q&A impacts a manufacturer’s methodology assumptions, the manufacturer must maintain appropriate documentation.

Bundling is a good example of additional Q&A that has led to changes in interpretation for some manufacturers. In the last bundling Q&A from 1-23-08, the question is asked:

How does the new regulation apply to the treatment of existing contractual arrangements? Are manufacturers required to revise previous quarters’ submissions to reflect the regulation? If not, is there any grandfathering for existing arrangements such that changes will not have to be made to those arrangements until they have ended according to their terms?

CMS responds:

The final rule is effective on October 1, 2007; it is not retroactive prior to October 1, 2007. It does not provide for grandfathering of any existing contractual arrangements.

Some manufacturers have read this to mean that CMS is not looking for manufacturers to apply to final rule bundling “clarifications” to prior periods. However, this is different than what most manufacturers were assuming prior to this Q&A. Previously most manufacturers were working under the assumption that the information related to bundled sales, provided by CMS in the Final Rule, was a clarification. As such, manufacturers originally expected to apply the clarification retrospectively. Now many manufacturers are questioning their course forward.

Should CMS continue to post additions or revisions to the Q&A, expect the challenges outlined above to continue. For subscribers to the CIS PCX, take comfort in at least knowing that if the Q&A changes going forward you will be notified via a PCX update. For other manufacturers, you may wish to make a check of the Q&A page part of your routine.

Friday, February 15, 2008

Where’s Waldo? (The DRA Policy Inquiry Q&A) Part 1 of 2

By Clarissa Crain, CIS GP Compliance Specialist
clarissacrain@cis-partners.com

Part 1 (Part 2 to come on Monday)

The DRA “Policy Inquiry Question and Answer” document posted by CMS in response to questions posed by stakeholders has caused some confusion across the industry. By now we’re all aware of the “evolution” of this document. Q&As are continuously evolving with only the date stamp in the bottom right hand corner of the Q&A to act as version control. However, manufacturers must be aware of changes and take action to dissect and cross compare the document in order to identify changes. It is like a “Where’s Waldo?” of the Medicaid world.

While the Q&A does not constitute law, the information provided in the Q&A has proven a vital component of many companies’ methodology assumptions. Whether utilizing a commercial system or a homegrown database, companies are tweaking their GP calculators to accommodate the interpretations derived from the Q&A document. Based on CMS’s evolutionary approach to the Q&A document, these tweaks seem to be perpetual. Manufacturers are finding that they hardly have time to get their systems appropriately updated and tested before further guidance is issued, resulting in another change or update.

With the efforts put into to updating and testing methodology changes, there is very little, if any, time left for the update of documentation. This does not even consider the additional time it takes to obtain appropriate review and approval on policies and procedures. For most manufacturers, the appropriate maintenance of methodology assumptions in policies and procedures is not feasible at this time. Unfortunately, that does not excuse the manufacturers from their obligation to be able to produce documentation of the methodology utilized for any given calculation at any point in time.

For changes in methodology, manufacturers will need to be able to point to the guidance document referenced (in this case the Q&A) and to some sort of corporate interpretation. The corporate interpretation may be something as simple as an email from a manufacturer’s internal counsel blessing a methodology assumption or an approval to move forward by senior management.

The more challenging part is maintaining the appropriate guidance reference. When a change is made to the Q&A, the previous version appears to be sucked into some black hole, never to be seen again. Therefore, it is imperative that manufacturers maintain copies of the Q&A referenced in support of a respective assumption. Without this documentation, support of methodologies based on Q&A’s that were later revised or removed could pose serious problems for the manufacturer.

(Here is where I shamelessly plug the CIS PCX (www.cis-pcx.com) which is THE industry repository for regulation, statute, and guidance issued by GP governing bodies. However, I won’t use this blog as a CIS billboard. Or perhaps I have already?)

Thursday, February 14, 2008

Alphabet Soup: CMS talks DDR Ops for MDRP at the IIR DRA Conference in Baltimore


By Chris Cobourn, CIS GP Practice Lead
chriscobourn@cis-partners.com

If you followed the acronyms in the title of this Blog article then congratulations, you truly are in the ranks of GP Geeks (and yes, that is a good thing!). We have to get badges, or at least some ID cards or something. Steve is actually working on a GP Geek Test for IIR in September, but that is a Blog article for another day.

On to the topic of today...

Last week, CMS held a very informative session at the IIR DRA conference in Baltimore regarding operational aspects of the new DDR system. As referenced in our post on February 5th, they also handed out a draft version of the Medicaid Drug Rebate Data Guide for Labelers.

I took some unofficial notes during the session which I would like to share with those Blog readers who may not have been able to attend. Meredith, CIS’ resident lawyer, tells me that I must state that these are unofficial notes, and I am certainly not trying to capture the exact content of the session, or to represent CMS in any way – does that officially qualify as paraphrasing? (Let me know, Meredith)

The topics varied during a very interactive Q&A session, then CMS revealed their thoughts on possible future functionality. I note things below in the order they were discussed, and in response to questions from the audience…

• Discussion about the Draft Medicaid Drug Rebate Data Guide for Labelers document:
It was made clear that the document distributed was considered an early draft. There is no specific timetable for it to be completed and posted on the Website, but it will be posted once they are 508 compliant. There was also discussion, which I found interesting, regarding how this document was different from the now obsolete Operations Manual. As you may remember, the Ops Manual is a fairly large document; however, the new draft document is far more streamlined and succinct. CMS explained that they are removing the policy level aspects of the old manual to make the new manual more operational and user-friendly. They are trying to create a better living document.

• Changes in the Technical Contact:
If you have to make a change to your technical contact in DDR, you will have to reactivate the related assigned designees in DDR. Their user IDs will remain in the system, but they will have to be reactivated.

• The Save button triggers certification:
This is a functional aspect of the system itself, and CMS would like to update it at some point to allow users to continue to the next screen without a save. For now, CMS recommends using the ‘Back’ button in order to avoid certification trigger.

• The relationship between DDR and MDR:
The core tables of the old MDR database have not become obsolete. MDR is still the primary system used by CMS to calculate URAs and process data to the states. DDR is an interface used by manufacturers, and it interfaces nightly to MDR with updates. MDR is also CMS’ analytical tool to evaluate submitted data.

• Out of Compliance Messages:
An “out of compliance” message may be presented as a response to specific missing data elements. The out of compliance message may not mean that you are actually out of compliance. The message may be triggered by the system, based upon whether specific required data fields are completed. There may be a difference between what you truly do have as missing data elements and what the system identifies as missing data fields. Recognizing this, you may need to evaluate the differences between what data is truly missing and what may be identified as missing data elements in the new system.

• Retroactive submission of termination date:
Manufacturers may encounter a situation where they are required to move the market date for products in the DDR system. This may be related to errors in the updates. An example would be a market date of 2000, and the manufacturer has 2000 data. The manufacturer then moves the market date to 2003. CMS is developing more analytical ability, and they are attempting to alert manufacturers of conflicts such as this.

• Export capabilities:
CMS indicated that download functionality is coming and encouraged discussion from the audience regarding format and layout. Manufacturers expressed the desire to download information primarily for the purpose of comparing what was in DDR to their systems. CMS agreed that this was a good objective but also wanted to clarify that they were not in the business of housing data.

• URA updated once a quarter:
The information that is posted to DDR is the same information that goes out to the states. It gets updated on a quarterly cycle. So if you update AMP and BP data, you may notice that your calculated URA does not match until the system is updated on the next cycle. CMS also encouraged manufacturers to communicate with them via the Operations email mailbox with any questions on how URA is calculated.

• Technical Contacts Communication:
Although the procedure is predominantly paper-based right now because of the system and volume, CMS hopes that it will become fully automated in the future

• Do not send Sensitive Data via Fax and Email:
For security purposes, manufacturers should not send sensitive information, such as Social Security Numbers or personal information, via fax or email.

• Uploading multiple files:
CMS responded to a question regarding the functionality related to multiple file uploads (submitted by yours truly). Generally, the manufacturers have a good deal of flexibility. They can upload a file and then edit the specifics online in DDR. They can also upload multiple files with either the same or different NDCs. If they have not yet certified, the new upload would either overwrite or append the existing data. If the manufacturer has already certified, then the new data would trigger the need to re-certify.

CMS also reviewed some additional functionality that they are considering. The specific list of features and timelines is still open, but CMS wanted to at least give the audience a preview of some of the things they were thinking about:

• Override Feature:
The ability to allow a temporary override feature will allow manufacturers to update read only fields. Currently, if a manufacturer has a reason to update specific read only fields (such as S, N or I designation), CMS must work with the manufacturer to make the change from their end. CMS would prefer not to be responsible for updating a manufacturer’s data. Therefore, CMS would like to provide the ability to allow for opening the fields for edit on a temporary basis.

• Data View:
The ability for CMS Central Office users to view and work with manufacturers’ submitted values would allow CMS to work more closely with manufacturers and to view and discuss details of submitted files.

• Limiting the use of Unit Type Each:
The manufacturer should limit the use of the unit type “Each”, and should not have more than one package size where unit type is Each.

Future System Enhancements:

o An indicator to show when data was submitted late.

o Ability to display base rebate agreement information.

o Ability to view deleted NDC (such as where a wrong NDC number was entered in error).

o A “Calculate URA” feature, and the ability to see the variables that went in to the URA.

o Interest Calculation information support.

In the last part of the session, CMS discussed the growing interest in data related to Medicaid Reimbursed products. Without stating specific parties or agencies, a general interest in being able to evaluate whether all the drugs that should be reported are being reported, and whether there are drugs being reported that should not be eligible under the program was expressed. The discussion also described the increased communications between CMS and the FDA when reviewing and qualifying drugs for the program. CMS also reiterated the importance of the regulatory function at the manufacturer work closely with the FDA to make sure that they have an accurate understanding of their products, so that the manufacturer can:

• Know what is considered a covered outpatient drug under the Medicaid agreement
• Know that their reporting to CMS is complete and accurate

Lastly on this topic, manufacturers are encouraged to keep in close communication with CMS on the policy side if they evaluate their list of NDCs and identify any potential issues.

In closing, I reiterate that I wrote this from notes taken during the course of the session Wednesday. I hope that it is fairly representative of the discussion, but I am not attempting to represent this posting as a complete and accurate transcript, or as any specific statements from CMS. Thanks!

Wednesday, February 13, 2008

The Legislative Push For E-Prescribing

The Medicare Electronic Medication and Safety Protection Act

Chrissy Spicer, GP and Compliance Specialist
chrissyspicer@cis-partners.com

Electronic prescribing (e-prescribing) is defined as the use of an automated data entry system to generate a prescription, rather than writing it on paper. Over time, e-prescribing is expected to mitigate the risk of adverse drug events, provide significant cost savings, and reduce error in prescription adjudication. Despite the considerable benefits realized through the adoption of the automated e-prescribing tools, many physicians are reluctant to deploy the new standards, and in response to lack of movement to adopt e-prescribing standards, lawmakers are pushing the Medicare Electronic Medication and Safety Protection Act.

According to the report titled Findings From The Evaluation of the E-Prescribing, prepared by National Opinion Research Center (NORC) (2007), experts predict that migrating towards automated e-prescribing solutions could avoid 2 million adverse drug events annually, of which 130,000 are life threatening. Additionally, experts suggest a cost savings at $27 billion per year in the United States.

In the article “Congress Considers Mandate for Medicare E-prescribing,” Hansen (2008) suggests that congressional patience with the pace at which physicians are adopting electronic prescribing seems to be wearing thin and in response to such, House and Senate lawmakers have introduced legislation that would mandate e-prescribing for Medicare beginning in 2011.

In the Medicare Prescription Drug Improvement and Modernization Act (MMA) of 2003, Congress mandated that all health plans and pharmacies participate in the Medicare Part D program and support e-prescribing. However, the support was not enough to influence physicians to adopt the e-prescribing program. On December 5, 2007, Congress introduced the Medicare Electronic Medication and Safety Protection Act. In summary, the legislation not only supports the e-prescribing program, but mandates the use of e-prescribing tools for all prescriptions after January 1, 2011, and failure to adopt e-prescribing methods will result in fines. The Act also provides Medicare grants to physicians to help off set the start up cost of deploying e-prescribing programs.

CMS conducted pilots at 5 different sites to assess the feasibility and timing of implementing six initial standards that are potentially capable of supporting e-prescribing transactions in the Medicare Part D prescription drug benefit program.

According the Agency for Healthcare Review and Quality (AHRQ) and CMS’s review, the results demonstrated that three standards were ready and capable of supporting the Part D prescription program. The standards that are recommended as being ready to implement under the Part D program include:

Medication History: The Medication History standard is intended to provide a uniform means for prescribers, dispensers, and payers to communicate about the list of drugs that have been dispensed to a patient. This standard has proved to be useful in preventing medication errors, as well as understanding medication management compliance.

Formulary and Benefits: This provides prescribers with information about a patient’s drug coverage at the point of care, such as formulary coverage, alternative medication, step therapy, and the cost of one drug option versus another.
Prescription Fill Status Notification: The notification is an alert that is sent to the prescriber about whether a patient has picked up a prescribed medication at the pharmacy. This standard can help physicians address compliance issues with their patients.

The other three standards that were assessed are prior authorization, patient instructions for use of medication, and Rx Norm, which is a system designed for federal government entities that would provide standards for the name, dose, and form of available drugs; however, these standards were not recommended for implementation at the current state and require further development before being adopted.

Despite the overall health care industry consensus with the technological advancement and support of adopting e-prescribing tools, the report titled Pilot Testing of Initial Electronic Prescribing Standards-Cooperative Agreements Under Section 1860D-(4)(e) of the Social Security Act as Amended b6y the Medicare Prescription Drug, Improvement, and Modernization Action (MMA) of 2003, by Michael Leavitt (2007), indicates the adoption of e-prescribing tools have yielded limited results. The report mentions:

According to NCVHS testimony, in any given year physicians write over three billion prescriptions, and 65% of Americans take prescription drugs; however, according to industry surveys results provided to the NCVHS, only 5 percent to 18 percent of physicians use e-prescribing. A primary reason as to why fewer than 3 percent of all prescriptions are written with integrated e-prescribing systems is the lack of e-prescribing standards. NCVHS contends that the few standards that are available often are not published with sufficient precision to be implemented in a way that is truly standard (Leavitt, 2007, p.9).

Due to the industry-wide implications, this Act is one to keep on the radar. The bill’s sponsor said that if it did not pass in 2007, then this bill would eagerly be pursued in 2008. If passed, the bill would be a paradigm shift in the traditional prescription filling process and allow for access to information in real time to facilitate quicker and more informed decision-making at all levels.

Tuesday, February 12, 2008

Even the Father of Medicine Worried of Regulations

By Christian P. Didizian, CIS Compliance Project Coordinator
chrisdidizian@cis-partners.com

Thank you Hippocrates – Thank you for making medicine a scientific practice.

Thank you for identifying the need to document appropriate, medical practice. Thank you for the drugs. They do work… sometimes. No longer do we have to trek to a church or temple or mosque or synagogue for spiritual healing on ailments for something as complex as epilepsy. Even though Hippocrates did not find cures or treatments that would be valid today, his contribution to the study of medicine cannot go unnoticed. In short, without Hippocrates, medicine would not exist and neither would the pharmaceutical industry.

For many who may not know, Hippocrates was the first, back in the fifth century B.C., to author medical writings that focused predominantly on research and theory of disease. With his findings in pathology, he transformed healing from spiritual practice to a more scientific one. The drugs, which he and his successors discovered (mostly herbal remedies), worked well against many of the prevalent ailments, but the democratic society of Greece quickly identified areas where this practice could be dangerous. As a result, society created its own sort of regulations.

There are three regulations to note that came out of the fifth century. The first is the notion of patient confidentiality as indicated in the works of Hippocrates. The second pertains to a physician’s credibility. In order for a physician to maintain any form of merit, he had to hold a certain social status – the higher the better. The level of social status dictated his competency thus naturally filtering out those within a lower class who would not have had the same access to resources. The third regulation was that one could not practice medicine unless he studied and understood astrology. This regulation with education was another example set by society. I know that these regulations may seem fundamental, but it is important to note, nevertheless, that they existed. What’s more is that they were enforced.

It seems safe to say that with the birth of modern medicine as a scientific practice, society felt the need to naturally defend itself and create even the most obscure regulations. In any event, we owe a great debt to Hippocrates and his achievements over two thousand years ago. We can also thank Greek society for creating this notion that regulations must be put into place for protection.

Monday, February 11, 2008

Class of Trade, Blocking & Tackling...

By Charles Cutcliffe, CIS GP Compliance Specialist
charlescutcliffe@cis-partners.com

In our world of over analyzed sports and 24 hour sports coverage, we are bombarded with discussions and debates over the latest and greatest schemes and how these make teams successful or not. However, what is often left out of these on these discussions about successful teams is their focus and mastery of the basics and the details. More to the point, if you can’t do the basics like block, tackle, run with the ball, throw the ball and catch the ball correctly it doesn’t matter what scheme that you run. The successful teams recognize this and spend time everyday mastering these skills. As you would expect the time spent on these skills decreases after the foundations are built and the focus shifts to maintaining and fine tuning, but the time and effort are still spent.

Now how does blocking and tackling apply to compliance in the Government Pricing world? We, as companies, can get caught up in our new offense (or defense depending on how you look at it) GP system and trust it to make it successful by itself. This is an understandable reaction. We spent a lot of money on developing or purchasing our system and even more money and time in its implementation. According to the design specs, it is ready and able to crunch all of the numbers and deliver the winning (correct) answer. However, here is where the potential problems lie. Just like the teams that depend on the latest systems and ignore the fundamentals, we can become dependent on our system and ignore the data that goes in. We have all heard the old saying “garbage in and garbage out.” It is simple and not very elegant, but very true.

A key example of the fundamentals of GP is Class of Trade (COT). To me, COT is the cornerstone of the GP process, because so much depends on the correct determination of retail, non-retail and government sales. No system could possibly perform the correct calculations without the correct COT being assigned to the sales data going in. Just as no team could be successful if they could not block or tackle. The initial design of a COT schema and assigning it to all of the customers is hard and time consuming. The good thing is that like the fundamentals of football, once mastered, the COT generally only requires periodic maintenance and fine tuning.

Thursday, February 7, 2008

A Recap of the Inaugural IIR Medicaid 201

CIS launched the first IIR 201 session last week at the DRA conference in Baltimore. The response from attendees was extremely positive, and we have already spoken with IIR about continuing the session in the larger IIR conference in September. IIR has offered the 101 session for some time now, but for those who have a solid background in Government Programs, the 101 had become too basic. The conference participants of the past expressed an interest in an additional session that included more advanced topics. It was not mere coincidence, therefore, when we approached Anne of IIR last September with our thoughts on a more advanced session and found that it echoed her thoughts from the feedback she had received.

When thinking about the format and content, we wanted to try and avoid covering only current topical areas, assuming that people would gain plenty of exposure to these topics over the course of the DRA conference. Instead, we tried to approach it from the perspective of Manufacturers improving their overall compliance with the Medicaid, Medicare, VA and the PHS programs. We wanted to focus on topics that GP professionals had to think about, both operationally and organizationally, in order to achieve a high level of compliance and audit readiness.

It was also important to me to put things into a context that participants could relate to. By this I mean that the topics we discussed should and could be relevant to any size or type of organization, but perhaps with a different sense of priority or focus. Audit is a good example. I believe that all companies should be considering their overall audit readiness and evaluating their own GP policies, procedures and systems. This means asking the question that: if the OIG was to audit you today, with your current policies, procedures and systems, how would you do? I think that it is a common expectation today that a pharmaceutical company should have something in place to proactively identify and mitigate potential issues related to their Statutory Price Reporting requirements. Any company, large or small, should be able to demonstrate some due diligence in the development, maintenance, and adherence to policies and procedures. With that said, the breadth, depth and priority of “audit” will vary between the large and small organizations, especially in the smaller organizations where the immediate focus is to get the calculations in place and get some documentation around it.

So, with the understanding that we wanted to be able to speak about advanced GP compliance topics that are applicable to all pharmaceutical manufacturers, as well as touch on the current hot topics, our agenda was as follows:

- GP related accountabilities across the organization and the need raise the visibility of Government Program participation
- Policy and Procedure development and maintenance and document management standards (including a GP documentation matrix)
- Evaluating the 10-Year Rule and Record Retention
- Master Support Documentation
- The Integrity and Validation of data, including G/L Reconciliation
- The importance of Class of Trade and challenges related to Class of Trade Data
- PHS Eligibility Management
- Defining Audit and Monitoring

Advanced Methodology Topicso Restatements and Methodology Changes
- Bona Fide Fee For Services
- Best Price Price Points
- Cumulative Discounts
- Lagged Price Concessions
- The Question of Smoothing Ineligible Indirect Sales
- Bundling
- PBM Rebates

For the format itself, it was a full-day session, starting with an overview and discussion of topics, the session then proceeded to a panel discussion with myself, Tim Nugent from Huron and Kathleen Peterson of Epstein Becker and Green, and finally ending the day with an interactive scenario based discussion, with the panel handing out a written scenario describing some of the GP challenges of a fictitious drug company with some serious and complex GP compliance questions! We liked the mix of things in the format, and found it to be an interactive and engaging day.

I welcome your feedback on topics and format for September.

Thank you,

Chris Cobourn
CIS GP Practice Lead
chriscobourn@cis-partners.com

The Tricare Retail Pharmacy Program Strikes Back…..and It’s Here to Stay

Andrea Wiest, CIS Compliance Specialist
andreawiest@cis-partners.com

In September 2006, the U.S. Court of Appeals handed down a unanimous decision invalidating the Department of Defense’s (DOD) attempt to obtain federal pricing for the Tricare Retail Program. On January 28, 2008, utilizing the proper legislative channels, the DOD was successful in their attempt. The President’s signature on the National Defense Authorization Act authorizes the DOD to obtain innovator drugs and biologicals at the previously sought discounted federal pricing arrangement.

Section 703, labeled “Inclusion of Tricare Retail Pharmacy Program in Federal Procurement of Pharmaceuticals,” notes the following (for those of you who are not mentally stimulated by legal jargon, please scroll down a few paragraphs for a cleaner summarization):

(a) In General, Section 1074g of title 10, United States Code, is amended-
(1) by re-designating subsections (f) and (g) as subsection (g) and (h), respectively; and

(2) by inserting after subsection (e) the following new subsection (f):
‘(f) Procurement of Pharmaceuticals by Tricare Retail Pharmacy Program. With respect to any prescription filled on or after the date of the enactment of the National Defense Authorization Act for Fiscal Year 2008, the Tricare Retail Pharmacy Program shall be treated as an element of the Department of Defense for purposes of the procurement of drugs by Federal agencies under section 8126 of title 38 to the extent necessary to ensure that pharmaceuticals paid for by the Department of Defense that are provided by pharmacies under the program to eligible covered beneficiaries under this section are subject to the pricing standards in 8126.’

(b) Regulations. The secretary of defense shall, after consultation with the other administering Secretaries under chapter 55 of title 10, under states code modify the regulations under subsection (h) of section 1074g of title 10, United States Code (as re-designated by subsection (a)(1) of this section), to implement the requirements of subsection (f) of section 1074g of title 10, United States Code (as amended by subsection (a)(2) of this section). The Secretary shall so modify such regulations not later than December 31, 2007.

So what does this mean for the legally impaired? Essentially this means, Tricare members (US armed forces, their dependants, and military retirees) can now access drugs at deeply discounted prices. The law applies to any prescription filled on or after January 28, 2008, when the National Defense Authorization Act was enacted. From a GP standpoint, it looks like this may create some additional work for the manufacturers; however, it is a small price to pay for the benefit to those who are defending and have defended our country.

Tuesday, February 5, 2008

BREAKING NEWS: CMS Distributes...

...a draft version of the Medicaid Drug Rebate Data Guide for Labelers at today's IIR MDRP 101/201 conferences in Baltimore, MD.

Could this be meant to supercede the already obsolete Medicaid Operations Manual? CMS will be issuing this document electronically in the near future. However, for those of you who would like a copy, please send an email to stevenmoore@cis-partners.com or call 610-565-8007 and we will send out copies on Friday.

For Your Space,

Steven.

Monday, February 4, 2008

Happy Super Tuesday !

By Meredith Taylor, CIS Compliance Specialist
meredithtaylor@cis-partners.com

What a great day, and what a great name! Super Tuesday, is also known as Giga Tuesday, Mega Giga Tuesday, Tsunami Tuesday, and my personal favorite, Super Duper Tuesday. Today is a historical day as it is this Country’s largest Super Tuesday ever.

What is Super Tuesday you ask? It is a Tuesday in either February or March, when the most states hold their primary elections in order to select their delegates. The delegates will then attend the national conventions and they will nominate the parties’ presidential candidates. This year, there are a record breaking 24 states participating in Super Tuesday which will confirm 52% of the Democratic delegates and 41% of the Republican delegates . After today, the nominations will theoretically be determined.

“Super Tuesday” was coined back in 1984 when more states than ever held presidential primaries on one date. States that participate in Super Tuesday range from all sizes and are in all corners of the country . Therefore, Super Tuesday has historically, and today is no exception, represent the candidates’ electability.
So why is this year’s Super Tuesday so super? It’s because many of the states who historically hold their primaries later in the year have realized that the outcome of their primaries was essentially meaningless. The majority of the delegates are usually selected by the time their primary roles around. As a result, many of the states decided to move their primary dates up to February 5, 2008, so that their delegates count. As a result , many delegate-rich states such as California, New York ,and New Jersey could be make-or-break contests for both Republicans and Democrats. It is truly anyone’s game, but the following is where the candidates stand before today’s primaries.

Democrats (Need 2025 to win)
Hillary Clinton- 232
Barack Obama - 158

Republicans (Need 1191 to win)
John McCain - 97
Mitt Romney - 92
Mike Huckabee - 29
Ron Paul – 6

There are so many historical events surrounding the 2008 Presidential election. Not only is this Year’s Super Tuesday the biggest in history, but the election itself will be historical in its own right. The candidates are no longer cookie cutter middle aged white males, and no longer are the candidates taking utterly predictable stands on the issues based on whether they are Republican or Democrat. The third most important issue (according to CNN) and the issue which hugely impacts our space and inevitably impacts every single American, is health care.

Should every American have health care? Should it be mandated? How will we pay for it? These are all questions that have been asked, and the candidates have done their best to provide the answers. Each of the candidates has a unique stand on health care coverage, and below is a brief summary of their positions.

Health Care- The Candidates’ Positions (courtesy of CNN)

Hillary Clinton: Mandates individual health insurance coverage for all Americans. Offers federal subsidies for those who cannot afford it. Allows individuals to choose from among several private plans also offered to members of Congress, as well as a new public insurance plan modeled after Medicare. Requires insurance companies to offer coverage to anyone who applies, and bars insurance companies from charging higher premiums to those with pre-existing conditions. Requires large businesses to provide or help pay for employee coverage. Expands Medicaid and federal children's health care programs. Offers tax credits to limit health care premiums to a certain percentage a family's income. Cost estimated at $110 billion annually, to be paid for by eliminating the Bush tax cuts for those earning over $250,000, as well as by reducing waste and inefficiencies in the current system. Also limits the amount employers can exclude from taxes for health care benefits for those making over $250,000

Barack Obama: Would create a national health insurance program for individuals who do not have employer-provided health care and who do not qualify for other existing federal programs. Allows individuals to choose between the new public insurance programs or from among private insurance plans that meet certain coverage standards. Requires employers who do not provide health coverage for employees to pay into the national health insurance program. Does not mandate individual coverage for all Americans, but requires coverage for all children. Allows individuals below age 25 to be covered through their parents' plans. Cost estimated between $50 billion and $65 billion, to be paid for by eliminating Bush tax cuts for those earning over $250,000.

John McCain: Opposes federally mandated universal coverage. Would increase awareness and promote the use of existing children's health insurance programs while expanding community health centers. Supports health care tax dividends for low-income Americans, medical malpractice reform, improving electronic record-keeping, expanding health savings accounts, and encouraging small businesses to band together to negotiate lower rates with health care providers.

Mitt Romney: Supports covering the uninsured without raising taxes or creating a government-controlled system. Encourages states to develop their own plans to cover the uninsured using market-based approaches. Supports providing greater financial assistance to help uninsured Americans buy private insurance. As governor, signed into law a universal health care plan that requires all residents to have health insurance, with premiums tied to income and subsidies for the poor.
Mike Huckabee Says current system is "irrevocably broken" but opposes federally mandated universal coverage. Would encourage private sector innovation to reduce health care costs. Supports market-based approaches at the state level. Would make health care more affordable by reforming medical liability, improving electronic record-keeping, promoting portable health plans, expanding health savings accounts, making health insurance tax deductible, and offering tax credits to low income families.
Ron Paul: Supports market-based reforms encouraging greater private sector competition and personal choice.

As you can see, the candidates’ positions are dramatically different, not just between Democrats and Republicans, but amongst all of the candidates. The health care system in undeniably flawed; we can only hope that one of these candidates is the solution to our problem.

This Year’s Super Tuesday participants include: Alabama, Alaska, American Samoa, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Georgia, Idaho, Illinois, Kansas, Massachusetts, Minnesota, Missouri, Montana, New Jersey, New Mexico, New York, North Dakota, Oklahoma, Tennessee, Utah, and West Virginia. So if you live in any of these states, GET OUT AND VOTE!

Sunday, February 3, 2008

My Super Bowl Glog (Game log)

6:06PM - The Super Bowl Pre-Game show started 4 hours and 6 minutes ago. That's enough time for a round of golf and even a full day of work for many slackers. For golf fans, Phil Mickelson just lost in a playoff versus J.B. Holmes. 99.9% of you don't care.

6:07PM - Do you believe how thin the Mac Air is? That's ridiculous!

6:09PM - CIS GP Practice Lead Chris Cobourn is a New England Patriots fan. While I am a die hard fan of the Miami Dolphins, I'm rooting for the Giants with every bit of my heart. These two facts are not related.

6:13PM - The Patriots enter to Ozzy Ozbourne's "Crazy Train". Cool song. I still hope they lose by 80.

6:15PM - God Bless Ronald McDonald House charities.

6:18PM - Now how funny would it be to see Simon Cowell judge Jordin Sparks' National Anthem performance. I can hear it now, "That was quite forgettable."

6:26PM - I say 'tails'.

6:26PM and 1 second - Sweet. I'm already winning. Giant's ball.

6:27PM - By the way, CIS's first Super Bowl commercial will not be seen in 2008. I asked for the the budget from partners Jim Collins and Toni Barsh, but they felt we should use the money to go to more conferences. Conferences like IIR in Baltimore this week where Chris Cobourn will be presenting at the inaugural MDRP 201. Shameless. I know.

6:29PM - My wife and I were just discussing the fact that we are very upset that someone stole the name Plaxico from us for our first born son.

6:35PM - Eli looks good. How many of you are ticked off that these first downs are delaying the commercials. Wait a second --- an injury. Commercials!

6:36PM - Bud allows you to breathe fire. Stupid. Predictable. Remember, I'm a marketing guy and these opinions are solely mine. But you should agree with me. D.

6:37PM - Audi's in the lead. Anything that uses "The Godfather" is cool. B+.

6:45PM - Nice drive by the Giants. 3-0.

6:46PM - Pepsi commercial. Bobbing heads. C-.

6:46PM - Sales Genie. F. This will be the worst ad of the Super Bowl.

6:48PM - Bud's cheese commercial. B.

6:55PM - 'Tom Brady's Ankle' references count: 10. I wish the Pharma Compliance Blog was that popular.

7:01PM - 2 possessions in the 1st quarter. Yawn. 7-3 Bellicheats.

7:10PM - Great catch by Amani Toomer...despite the blatant offensive pass interference.

7:13PM - Bud commercial using horses, a dalmation and a Rocky theme. Fantastic. Best ad of the Super Bowl thus far. A-. There's still an A and A+ out there!

7:20PM - Zero Pharmaceutical ads thus far. I'm thinking that's a lot of coin to put up that could go into R&D. Or fines for non-compliance. Kidding, of course!

7:24PM - Did that woman's heart really jump out of her blouse and quit! B.

7:25PM - Wow. Advertisement against prescription drugs using a 'real' drug dealer. With all the politics and issues going on in the world, interesting to see that this makes the Super Bowl --- because someone spent a lot of money to get the message out. I have a hard time believing that this is a bigger issue than actual drugs among many, many other things. Sure, there may be some abuse, but I think this gives the wrong idea to the millions and millions of viewers worldwide.

7:28PM - Seeing Tom Brady get sacked twice in a row is like witnessing a beautiful Bald Eagle soaring outside your office window.

7:58PM - 7-3. See 7:01PM.

8:15PM - Gotta say. I hate Super Bowl half-time shows, but Tom Petty and the Heartbreakers were really, really good. They sounded like they actually sang and played the songs on their records. A rarity. Good stuff. But way too long. Give me FOOTBALL!!!!

8:23PM - Zantac has a commercial during a halftime that has actually been longer than the entire first half. Not prescription, but OTC. By the way, CIS can do your OTC calcuations... Shameless. I know.

8:24PM - Claritin OTC. OTC's 2 - Rx 0.

8:31PM - Sales Genie. F+. They just beat themselves for worst commercial in the Super Bowl. CIS does not use Sales Genie and it has now been solidified that we never will.

8:33PM - Shaq winning a horse race as a jockey is like... Yeah, there's no appropriate analogy.

8:34PM - The fact that you can challenge the number of people on the field in order to get a penalty called and get the ball back is stupid. The NFL is out of control with instant replay. I can't wait till you can challenge 'holding' on any given play. Games in the NFL will last 4 hours and 6 minutes. The length of the Super Bowl Pre Game show.

8:35PM - Cavemen commercials 3 - Rx 0.

8:36PM - Richard Simmons is almost hit by a car. Almost a great commercial. C.

8:47PM - The New England Patriots were the most prolific offense ever in the NFL. It's 7-3 with 4:28 in the 3rd and the Giants have the ball 1st and 10. Hi Chris Cobourn --- are ya sweatin'?

8:52PM - E*trade comercial with little baby trading stock and then spitting up on the keyboard --- nicely done. B+.

8:53PM - Bud allows you to fly. See: "6:36PM - Bud allows you to breathe fire. Stupid. Predictable. Remember, I'm a marketing guy and these opinions are solely mine. But you should agree with me. D."

9:01PM - End of the 3rd quarter. 7-3. If you like defense --- this is your kind of game.

9:02PM - The game is at its highest level of excitement and the commercials have gone local. That stinks. Watch out for CIS to sneak in late in the Super Bowl 2009.

9:06PM - Just when you think there are no good commercials left --- Coke comes through with their first ad! Stewie from the Family guy, Wonder Dog and Charlie Brown floats battle for a Coke. Nicely done, as always Coke. A-. Tied with Pepsi.

9:07PM - Big play for the Giants --- 45 yards to Kevin Boss! This is getting interesting Pats fans!

9:11PM - 10-7 Giants. YEEEEEEEEEEEEEEEEEEEEEEEESSSSS!

9:12PM - I'm really happy b/c the Giants are winning against the behated Patriots, but Coke comes up big again with a republican/democratic peaceful commercial. A- again. Coke just knows the game. (P.S. Part of the A- is because James Carville was in Old School)

9:27PM - Bud Light turns to Will Ferrell for an ad --- and gets their first B of the evening. Mostly because Will says, "Bud Light: Suck One." Still 10-7 Giants --- exciting game!!

9:31PM - For the football fans watching. Wes Welker was a Miami Dolphin last year and he now has 10 catches in the Super Bowl. Nice coaching.

9:32PM - 11 catches.

9:39PM - Randy Moss touchdown. 14-10 Pats. Kill me. Twice.

9:50PM - 6 low snaps in a row for Eli. Are you kidding me!?!?!?

9:51PM - GREATEST PLAY I'VE SEEN IN A LONG TIME! WHAT A PLAY BY MANNING AND WHAT A CATCH BY DAVID TYREE!!!!!!!!!!!!!!!!!! THAT COULD BE THE BEST CATCH I'VE EVER SEEN!

9:55PM - First down Giants!

9:56PM - TOUCHDOWN GIANTS!!!!!!!!!!!!!!!!!!!!!!! 17-14!!!!!!!!!!!!!!!! COBOURN!!!!!!!!!!!!!!!!!!!!!!!!!!!

10:03PM - Greatest upset of all time! Only the Dolphins have a PERFECT SEASON!!!

For Your Space,

Steven.