Thursday, May 6, 2010

The Blog Has Moved to a New Platform and URL

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?

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/

Wednesday, May 5, 2010

"Who Ya Gonna Call?" Part 3

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

Monday, May 3, 2010

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

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!