Life Science Compliance Update

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26 posts from May 2015

May 26, 2015

Continuing Medical Education: ACCME Offers New Guidance On The Role of Commercial Interest Employees In CME


The Accreditation Council for Continuing Medical Education recently provided clarity on the roles of industry employees in planning and delivering CME activities. ACCME’s Standards for Commercial Support require that accredited continuing medical education be independent and free of control of commercial interests, and employees of industry have been prohibited from participating in accredited CME. ACCME now makes clear that employees of industry can be engaged in a “specific, limited role” in certain aspects of continuing education. Murray Kopelow, President and CEO of the ACCME, notes that the new guidance fulfills ACCME’s mission to “support the free flow of scientific exchange while safeguarding accredited CME from commercial influence."

ACCME defines a commercial interest as any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients. Specifically, under Standard 1 of the ACCME’s Standards for Commercial Support, an accredited CME provider may not allow a commercial interest to control or influence:

  • (a) Identification of CME needs;
  • (b) Determination of educational objectives;
  • (c) Selection and presentation of content;
  • (d) Selection of all persons and organizations that will be in a position to control the content of the CME;
  • (e) Selection of educational methods;
  • (f) Evaluation of the activity.

“The use of employees of ACCME-defined commercial interests as faculty and planners or in other roles where they are in a position to control the content of accredited CME is prohibited, except in the specific situations specified here,” states the ACCME in its new guidance, released last week.

The ACCME identified three “special-use cases where employees of ACCME-defined commercial interests can have a specific, limited role in accredited CME activities.” ACCME notes that there are circumstances where an employee of an ACCME-defined commercial interest can make a scientific presentation within accredited CME about their company’s research and still be compliant with the ACCME Standards for Commercial Support.

  • (1) Employees of ACCME-defined commercial interests can control the content of accredited CME activities when the content of the CME activity is not related to the business lines or products of their employer.

  • (2) Employees of ACCME-defined commercial interests can control the content of accredited CME activities (e.g., as planners, authors, or speakers [including poster presentations]) when the content of the accredited CME activity is limited to basic science research (e.g., pre-clinical research, drug discovery) or the processes/methodologies of research, themselves unrelated to a specific disease or compound/drug. In these circumstances, the accredited provider must be able to demonstrate that it has implemented processes to ensure employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical applications of the research/discovery or clinical recommendations concerning the business lines or products of their employer.

  • (3) Employees of ACCME-defined commercial interests can participate as technicians in accredited CME activities that teach the safe and proper use of medical devices. In this circumstance, the accredited provider must demonstrate that it implements processes to ensure that employees of ACCME-defined commercial interests have no control of CME activity content that is related to clinical recommendations concerning the business lines or products of their employer. 

ACCME also makes clear that, as in every accredited CME activity, the expectations of ACCME’s Standards for Commercial Support for the three situations must be met.

The new guidance included FAQ-type scenarios that show how ACCME's new policies would play out in the workplace. See "Examples of Compliance and Noncompliance" here

An accredited provider would be in compliance, for example, with ACCME standards where:

  • An employee of an ACCME-defined commercial interest participates as a teacher in an accredited CME activity whose content is about the drug discovery process, itself, and is not about treatment or diagnostics. The activity is targeted to scientists whose research is focused on drug discovery.

  • An employee of an ACCME-defined commercial interest participates as an author and presenter in an accredited CME “Scientific Poster Session” where the content of their presentation is limited to reporting research results (e.g., biology, physiology, physics) early in the drug discovery process so as to not include any discussion of product development. The provider demonstrates that the CME activity does not include any discussion or clinical recommendations concerning the use of products or devices of ACCME-defined commercial interests that could be used or prescribed for patients.

  • An employee of an ACCME-defined commercial interest participates as a planning committee member, author, and trainer in an accredited CME activity on disaster management preparedness. In its Performance-in-Practice evidence, the provider demonstrates that the content of the CME activity (“disaster management”) is not related to the business lines or products of the employer, a medical device manufacturer.

  • The accredited provider plans an intensive hands-on course to train physicians to perform vascular interventions using new FDA-approved medical devices and equipment. The course director asks several ACCME-defined commercial interests to provide equipment and medical devices for use in the CME activity and also to provide technicians (i.e., employees of the commercial interest) to operate the equipment during the CME activity. The accredited provider tracks the loaned equipment as in-kind commercial support. The course director plans the CME activity independent of the control of ACCME-defined commercial interests; she determines what procedures will be taught, instructs the commercial interest employees on their limited roles, and is present to oversee and participate in the instruction. The course director monitors the CME activity to ensure that demonstration and comments provided by the device technologists are technical only (i.e., about the safe and proper use of the equipment) and do not include clinical recommendations about the medical devices/equipment of the manufacturer(s).

A provider would NOT be in compliance where:

  • The accredited provider uses an employee of an ACCME-defined commercial interest—a company that distributes pharmaceuticals—as faculty for a CME activity. From its Performance-in-Practice materials and subsequent accreditation Interview, it is determined that the provider failed to identify a pharmaceutical distributor as an ACCME-defined commercial interest because the forms it used to identify relevant financial relationships included language that did not accurately reflect all of the types of organizations included in the ACCME’s definition of a commercial interest.

  • The accredited provider uses employees of ACCME-defined commercial interests as members of a CME committee that determines topics and speakers for accredited CME activities related to the products of their employer(s). In its Performance-in-Practice materials, the provider shows that it identifies relevant financial relationships for members of the CME committee and manages conflicts of interest using several strategies (e.g., peer-review of content, recusal from discussions related to their financial relationships). The identification and resolution of conflicts of interest (Standard 2 of the ACCME Standards for Commercial Support) is not a valid mechanism to ensure independence, as employees of ACCME-defined commercial interests cannot control the content of CME activities related to the business lines and products of their employer, per Standard 1.

  • The accredited provider uses employees of ACCME-defined commercial interests as authors and speakers in CME activities related to the business lines and products of their employer(s). In its Self-Study Report and Interview at reaccreditation, the provider describes that it ensures the independence of its CME activities by having commercial employees attest that the content they present about commercial products is ”fair and balanced.” This is not an acceptable mechanism to ensure independence, as employees of ACCME-defined commercial interests cannot control the content of accredited CME that is related to the business lines and products of their employer.


ACCME's latest guidance and accompanying FAQs are welcomed instruction. The policies that ACCME sets forth here can be traced to a 2010 controversy involving whether industry scientists would be able to present CME at an American Heart Association conference. The ACCME and AHA eventually reached an agreement, and ACCME released guidance that closely parallels what they have now released, five years later.  


May 25, 2015

Media Outlets Using 2013 Open Payments Data To Imply Misconduct

Open Payments CMS

Open Payments, a public list of the transfers of value made from pharmaceutical and device manufacturers to physicians and teaching hospitals, has yet to be the basis for a government enforcement action. The Justice Department has not, for example, explicitly used the Centers for Medicare and Medicaid Services’ database as the foundation for bringing kickback allegations against a company. That day may be a ways off—after all the database currently lists only five months of payment data covering September through December of 2013, and a large portion of that data is aggregated, meaning it doesn't list the physician recipients by name. Furthermore, there have been multiple reports that payment data has been matched to the incorrect physician.

While the government has been patient in its enforcement, the media has not.

After 13 years of wariness, FDA approves five potentially harmful new diet drugs

Most recently, MedPage Today paired with reporters from Milwaukee Journal Sentinel to create a series “Watchdog Report” targeting diet drugs. The article’s premise centers on the idea that history provides an important lesson. Bolstering this notion is the article’s use of a timeline starting in 1890, which states simply: “Early treatments for obesity fail.”

“In recent years, seven U.S. drug companies – Orexigen, Takeda, Eisai, Arena, Vivus, Novo Nordisk and Shire Pharmaceuticals – have been at the center of efforts to get the U.S. Food and Drug Administration to allow new diet drugs on the market,” states the article. “Critics worry the new products will repeat the diet-drug mistakes of the past, which have led to decades of injuries, deaths and, in the end, products forced off the market.”

The authors take issue with the fact that the drugs are approved specifically for obesity, with “no proof the drugs improve the main health concern posed by obesity: heart attacks and other cardiovascular problems.” The article also focuses on a number of potential risks associated with previous diet therapies--such as pancreatic cancer--that should have made FDA reconsider whether to approve these new drugs. 

The article suggests that the risks inherent in the five diet drug products outweigh the benefits, though the article glosses over any benefits associated with weight-loss, and lumps all five drugs together when discussing risks. To bolster this risk/reward analysis, the authors then turn to drug company expenditures that they suggest forced FDA's hand. 

"Diet drug companies spent $60 million since 2010 amid push to win FDA approval for new products"

In a connected article, MedPage Today and the Milwaukee Sentinel put together an outline of the money that drug companies spent promoting their diet drugs. "The latest diet drug push was propelled with a fusion of public health, private enterprise and politics — and plenty of drug company money," note the authors.

The article indicates that the seven companies connected to the new drugs spent:

  • $51 million lobbying the FDA and Congress on a host of issues, including obesity.
  • At least $4 million since 2013 on sponsorships of medical societies that encouraged use of drugs to treat obesity.
  • At least $5 million on travel, food and speaking fees paid directly to physicians. The number is likely much higher, but publicly-reported data covers just the last five months of 2013.

The authors reveal that they used the Open Payments database to gather the information on physician payments. "According to the federal Open Payments database, the manufacturers of Belviq spent at least $4.1 million on travel, food and speaking fees to doctors on behalf of the drug in the last five months of 2013, [and] Qsymia makers spent $1 million in that same period." the article states. "The publicly-available data only covers that period, which is before the other three drugs were approved."

In addition, the article hones in on particular recipients involved in the Endocrine Society's clinical practice guidelines, which recommend certain drugs for treating obesity as a disease. For example, the authors state that guideline author Caroline Apovian "is listed in the disclosure section of the society's obesity guidelines as having a 'significant financial interest or leadership position' in four obesity drug companies: Eisai, Vivus, Orexigen and Takeda." The authors used Open Payments data to show that she received at least $31,000 in travel, food and speaking fees from diet drug-makers in the last five months of 2013. Three other members of the group that issued the Endocrine Society guidelines received at least $50,000 combined from diet drug-makers for the same type of work during that time period, according to the Open Payments website, note the authors.

"Apovian has leadership positions with two different organizations that get funding from diet drug companies," including being chairwoman of the Endocrine Society and a board member of the Obesity Society, states the article.

When asked about the payments, Apovian said because of her expertise in the field, she is often sought out by drug-makers to serve on scientific advisory boards, which compensate her for her time and expenses. "Despite the growing problem of obesity in this country," Apovian said, "there are still very few qualified experts in the field today."

The authors also uncovered via Open Payments that one of the guidelines panel members had not disclosed his payments. 


As this article shows, when journalists have a government database to point to that shows physician payments, they are more emboldened to make claims about drug efficacy. While the MedPage today article is one of the first in-depth stories to rely heavily on Open Payments, the article could signify a new trend, especially as data from 2014 comes out in the next few months. 


May 22, 2015

Medco Will Pay $7.9 Million to Resolve Kickback Allegations Related To Formulary Placement; Follows Astra Zeneca’s $7.9 Million Payout Earlier This Year


Medco Health Solutions Inc., a wholly-owned subsidiary of the pharmacy benefit manager Express Scripts Holding Company, has agreed to pay $7.9 million to settle allegations that it engaged in a kickback scheme in violation of the False Claims Act, the Justice Department announced on Wednesday.  Medco provides pharmacy benefit management (PBM) services to clients who receive subsidies under the Medicare Retiree Drug Subsidy program.

PBMs such as Medco act as intermediaries between pharmaceutical manufacturers and third-party payers to administer a plan’s prescription drug benefits. PBMs use the purchasing power of their healthcare plan clients to negotiate lower prices for prescription drugs from pharmaceutical manufacturers. These manufacturers have an incentive to offer discounts to PBMs if that means the company’s drug will be featured on the PBM’s formulary of preferred medicine. 

Here, though, the government alleges that Medco solicited remuneration from AstraZeneca in exchange for identifying Nexium as the “sole and exclusive” proton pump inhibitor on Medco’s drug formulary list.  The United States alleged that Medco received some or all of the remuneration from AstraZeneca in the form of reduced prices on other AstraZeneca drugs, including Prilosec, Toprol XL and Plendil.  The United States contended that this kickback arrangement between Medco and AstraZeneca violated the Federal Anti-Kickback statute, and thereby caused the submission of false or fraudulent claims for Nexium to the Retiree Drug Subsidy Program. 

In January 2015, the United States and AstraZeneca reached a $7.9 million settlement to resolve kickback allegations arising out of the same conduct. This case is examined in our free sample issue of our new publication, Life Science Compliance Update.

The allegations implicating AstraZeneca and Medco were initially made in a whistleblower lawsuit filed in 2010 by two high ranking former AstraZeneca employees--Paul DiMattia, a former executive director of commercial operations, and F. Folger Tuggle, who had been a managed markets account director in charge of the Medco account. The two relators split $1,422,000 from the AstraZeneca settlement, and DOJ notes that they will be entitled to a further share from the Medco settlement as well.

“We will continue to pursue pharmacy benefit managers that enter into kickback arrangements with pharmaceutical manufacturers,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division.  “Hidden financial agreements between drug manufacturers and pharmacy benefit managers can improperly influence which drugs are available to patients and the price paid for drugs.”

“Pharmacy benefit managers that seek or accept kickbacks will be held accountable for their improper conduct,” echoed Special Agent in Charge Nick DiGiulio of the U.S. Department of Health and Human Services-Office of Inspector General (HHS-OIG).  “We will continue to crack down on kickback arrangements, which can undermine drug choices for patients and corrode the public’s trust in the health care system.”

It will be important to follow the government’s interest in pharmacy benefit manager negotiations with drugmakers, as the line between permissible discounts and illegal kickbacks still seems blurry, even after a number of settlements. 


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