Life Science Compliance Update

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27 posts from April 2011

April 29, 2011

A Federal Unsales Force?: “Academic Detailing” On Medical Treatments And The Oversight Imperative

Academic Detailing 3 
Advances in medicine, science, and health care happen at revolutionary pace.  Unlike legal principles, which can take decades to change, progress in science and medicine frequently happen every day and sometimes overnight.  The rapid pace of medical advancement is beneficial to patients and Americans for a number of reasons.  Progress in medicine and health care often leads to new jobs, both directly and indirectly.  It leads to healthier patients, more accurate diagnosis, and better treatments.  However, with the promise of new medical progress also come challenges.

The biggest challenge facing today’s health care practitioners is staying up to date and trained in the newest medical treatments, technologies, and devices.  This requires a thorough understanding of new clinical trial data and information provided by the Food and Drug Administration (FDA).  Such knowledge must be constantly and consistently reinforced through continuing medical education (CME) and other resources such as commercial speakers, consulting, journals, and “detailing.” Detailing refers to the information physicians and other health care professionals routinely receive from visits by drug and medical device company representatives.

Interestingly however, over the past three decades, a practice known as "academic detailing" (or "counter-detailing") has developed and been embraced by some health insurers and state governments to address rising health care costs.  As a recent article from the Washington Legal Foundation (WLF) explained, “independent academic detailers (typically clinicians, nurses, or pharmacists) meet with health care professionals and share information and educational tools about treatment options which are, according to the detailers' research, as effective as those advanced by company salespeople, and available at a lower cost.”

The article, written by Dr. Joshua D. Lenchus, Assistant Professor of Clinical Medicine at the University of Miami Miller School of Medicine, noted that the U.S. government is currently working to implement academic detailing on a national level.  While “programs which enhance medical professionals' knowledge should certainly be welcome by all who work in and benefit from America's health care system,” the article noted concerns “with regards to the government regulatory oversight of such academic detailing.” 

Medical product industry detailers must comply with state and federal rules, as well as voluntary industry codes, with regards to their contact with physicians.  However, no such standards presently exist for federally-funded academic detailers to ensure transparency, impartiality, and quality in the information and provider interactions.

Academic Detailing Evolution and Adoption. 

Dr. Jerry Avorn of Harvard Medical School is acknowledged as the godfather of academic detailing.  In a 1983 New England Journal of Medicine article, he and Steven Soumerai described a randomized, controlled trial of clinical pharmacists visiting physicians' offices with the aim of reducing the excessive use of specific drug groups.  The article relates that these visits led to a fourteen percent decrease in prescribing the drugs.  The authors concluded that "academically-based ‘detailing' may represent a useful and cost-effective way to improve the quality of drug-therapy decisions and reduce unnecessary expenditures.” 

The concept of academic detailing attracted insurers like Kaiser Permanente, who has used it for over 2 decades.  In addition, Pennsylvania, Vermont, and South Carolina have created academic detailing programs.  Pennsylvania's Independent Drug Information Service (IDIS), initiated in 2005, has been cited as a model and noted as a success by the Pew Prescription Project for generating cost savings from decreases in "inappropriate prescribing" that offset program expenses.  In fact, the state's Department of Aging has been paying Dr. Avorn’s foundation $1 million a year for three years to compile data on doctors who have at least 25 patients who receive state assistance to pay for their drug treatments, and who treat such ailments as chronic pain, hypertension, gastrointestinal symptoms, and high cholesterol.

Emergence at the Federal Level. 

While the federal government was largely uninvolved in academic detailing, the American Recovery and Reinvestment Act (ARRA) included $1.1 billion for the Department of Health and Human Services (HHS) for the purpose of conducting "comparative effectiveness" research. $300 million of the ARRA appropriation was directed to lay the groundwork for a broader HHS-led academic detailing program. 

Additionally, the Patient Protection and Affordable Care Act (PPACA) signed into law in March 2010 further solidified the government-funded comparative effectiveness research by creating the Patient Centered Outcomes and Research Institute (PCORI). 

Consequently, “in April 2010, AHRQ put out a solicitation for contractors to support an "Academic Detailing Initiative" with the overall goal of "contract[ing] with an organization to conduct activities related to Academic Detailing.”  On September 28, AHRQ awarded an $11.7 million, three-year contract to Total Therapeutic Management, a physician and patient education company, to integrate the agency's comparative effectiveness tools through on-site visits with clinicians, nurses, health plan formularies, and professionals. 

AHRQ awarded four other contracts that day for the Academic Detailing Initiative: one for $18 million to Ogilvy Public Relations to create a publicity center, as well as another to the firm for $8.6 million to create regional dissemination centers; a $4 million continuing education award to Prime Education; and a $2.4 million contract to IMPAQ International “to evaluate the impact of the other four contracts.”

Standards and Restrictions on Industry Detailing. 

As the article notes, the “Federal Food, Drug, and Cosmetic Act, its amendments, and scores of FDA regulations, guidance documents, and policies govern medical product companies' outreach and promotional efforts to health care providers and the public.”  For example, all promotional materials distributed by companies must undergo a rigorous FDA review process.  Information must be accurate and fair regarding the products' risks and benefits.  Omissions of material facts, including risk information in advertising or promotional materials, can result in criminal sanctions. 

As a result, FDA closely monitors all communications between care providers and company representatives, including audio conferences, pamphlets handed out at professional meetings, mailings to physicians, and advertisements in medical journals.  Federal regulators and prosecutors have focused especially strict enforcement on perceived promotion of "off-label" uses of drugs and devices, extracting billions of dollars in the settlement of such cases in recent years. 

However, other than generalized references in the AHRQ contract solicitation that "Communication to these target audiences must be consistent with FDA policies,” no specific standards have been publicly announced to which federally-funded academic detailers must conform. An absence of such rules “lies in stark contrast with the extensive state and federal controls placed on how pharmaceutical, medical device and other health product businesses can conduct outreach and education.”

The Oversight Imperative for Academic Detailing. 

When the lack of specific oversight for government-funded academic detailers was noted by an industry spokesperson, Dr. Avorn "defended his team's information as being above reproach" and retorted that such criticism was "ridiculous, offensive, self-serving, and ill-informed.”  However, “one should not assume that educational activities and materials are inherently impartial, accurate, and balanced simply because they are being presented and funded by academics and government, rather than industry.”

In fact, Dr. Lenchus pointed out that, “Dr. Avorn himself owns and operates a for-profit academic detailing company, an obvious business and financial interest in his ensuring that academic detailing is above reproach.”

Discussion

While health care practitioners should be “conscious of the cost of drugs and medical devices, their primary duty is to provide each patient with the care best suited to them, individually.”  Ideas such as comparative effectiveness research and academic detailing came in response to “intense political and fiscal pressure to reduce health care costs,” not improve the health and outcomes of patients.

Consequently, “with the attendant impetus to reduce costs, what safeguards will be in place to ensure that academic detailers are not exceedingly influenced by those pressures?”  In other words, what is to stop an academic detailer from telling your doctor not to prescribe a treatment because in the end it will save the government money first, and make you “healthy” second?

Will governmental academic detailers receive compensation in a pay-for-performance model, that is, bonuses based on how much they saved?  Also, will specific doctors or those in certain practice areas be targeted based largely on those doctors' or the practice area's patterns of prescribing newer or more expensive treatments?  Who will make those determinations and how?  Will the same restrictions that apply to industry detailers apply to academic detailers?

Dr. Lenchus noted that, “accounts of Pennsylvania's IDIS program report that counter-detailers offer free copies of Dr. Avorn's book, allow visited physicians to take a quiz and receive continuing-medical-education credits, and occasionally provide lunch.”  As a result, he asked, “who will police their activities and investigate and prosecute flagrant disregard of the same rules that govern industry detailers? Also, will there be consequences if medical professionals choose not to meet with federally-funded detailers? Will such meetings be mandated for physicians who wish to care for patients receiving Medicare?”

Conclusion

In the end, Dr. Lenchus recognized the need to develop clearer standards and oversight for academic detailing equal to the rules enforced on industry. Specifically, Dr. Lenchus pointed to a bill introduced in 2009 by Senator Kohl, The Independent Drug Education and Outreach Act.  The bill, on which Congress never took action, specifically:

-       Defines types of entities are eligible to receive a federal detailing program grant;

-       Includes quality of educational materials among criteria for contract award; and

-       Requires that the HHS director review and approve all educational materials, and that such materials be updated and reviewed again every two years. 

The bill also specifies that preference for federally-funded detailer visits be given to those medical professionals with a high percentage of Medicare and Medicaid patients.  Finally, it requires HHS to promulgate regulations aimed at preventing conflicts of interest and ensuring the accuracy of the educational materials. Such legislation, according to Dr. Lenchus, must address:

-       Whether studies and other materials academic detailers provide be peer reviewed and/or evaluated by federal health authorities 

-       If materials offer clear and balanced risk and benefit information 

-       What level of expertise and training must an academic detailer have 

-       Whether academic detailers can discuss off-label use of drugs/devices

Ultimately, Dr. Lenchus recognized that, “policy-makers must address these issues to ensure that medical professionals, and in turn their patients, are confident in the accuracy and reliability of the academic detailing initiative and the information it disseminates.”  Accordingly, he noted that “further elaboration is needed on the general statement in the AHRQ solicitation that federal detailing contractors must comply with FDA policies.”

April 28, 2011

ACCME March Board Meeting: Dialogue and Decisions

Board_meeting 
The Accreditation Council for Continuing Medical Education (ACCME) has released the executive summary of its Board of Directors meeting, held March 15 –16, 2011, at its Chicago offices.  According to the executive summary, the ACCME ratified 45 accreditation and reaccreditation decisions, including 10 providers (22%) that received Accreditation with Commendation, which confers a six-year term of accreditation. The list of accredited providers on the ACCME Web site will be updated in May 2011 to reflect the March 2011 accreditation decisions.

The ACCME has now completed accreditation reviews for 458 accredited providers using the 2006 Accreditation Criteria. In total, there are 691 ACCME-accredited providers and 1,466 providers accredited by ACCME Recognized Accreditors (state or territory medical societies that accredit local organizations offering CME).

There are two graphs in the executive summary; one shows overall compliance results for each criterion from November 2008 through March 2011, while a second graph shows compliance results for the March 2011 cohort.  The differences in the graphs show that compliance has significantly improved over the last few years.

Dialogue Session with Stakeholders

The executive summary also discus a strategic dialogue session held by the Board in March, with stakeholders to gather input about three areas:

  • The ACCME’s accreditation process;
  • The connections between the ACCME, accredited CME, and the emerging Maintenance of Licensure and Maintenance of Certification® programs; and
  • How to build on the ACCME's Bridge to Quality™ model to further enhance accredited CME's value.

The dialogue session built on the discussions held during the ACCME's December 2009 Roundtable, the work done by the ACCME Board of Directors' 2010 task forces, and the interactive forums the ACCME has convened with various stakeholder groups.  During this session, it was noted that “the needs of MOC are addressed by the ACCME accreditation requirements.” 

In addition, the summary of the session noted that the ACCME needs to increase enforcement of the Standards for Commercial Support: Standards to Ensure Independence in CME Activities to assure that CME is above reproach. Specifically, the summary stated that this effort needs to be supported by the member organizations, credit systems, providers, and physician learners.

Accordingly, it recommended that ACCME explore whether all noncompliance issues are the same and differentiate the egregiousness of violations. Additionally, the ACCME could use focused interventions to close compliance gaps.  Ultimately, it was noted that stakeholders are examining the next level of commercial support issues: are there direct financial relationships between physicians and industry that should preclude physicians' participation in CME?

Accreditation Decision-Making: Accreditation with Commendation; Nonaccreditation

During their March meeting, the Board clarified eligibility requirements for providers that seek a change in status from Accreditation to Accreditation with Commendation after receiving a noncompliant finding for an ACCME policy. To be eligible for a change in status, a provider must have been found compliant with Accreditation Criteria 1-15 and have no more than one noncompliant finding for relevant ACCME policies or one noncompliant finding for Criteria 16 – 22. Once the provider demonstrates that it has come into compliance through an accepted progress report, it will be eligible for a change in status.

The Board amended the policy concerning Nonaccreditation decisions. From now on, Nonaccreditation decisions will be effective immediately, unless the ACCME Board of Directors specifies otherwise. Previously, the policy stated that Nonaccreditation decisions became effective one year after the decision, except in egregious cases, when a shorter timeframe could be implemented. The Board made the modification to bring the policy in line with the ACCME’s current decision-making practices, and to strengthen the ACCME's oversight and accountability.

Reporting of In-Kind Commercial Support

The Board modified the requirement for reporting in-kind commercial support, in response to provider feedback. Since the early 1990s, the ACCME has required providers to quantify the dollar value of in-kind commercial support (for example, when a company loans a provider a device to use for teaching purposes). All commercial support, whether in-kind or cash, is aggregated and listed in one commercial support category in the ACCME annual reports. Providers told ACCME however, that it is not always possible to determine accurate, standardized estimates for the dollar value for in-kind support, and that information about the type of in-kind support would be more meaningful and valid.

With the Program and Activity Reporting System in place, ACCME said it can offer providers an easy method for reporting the type of in-kind support they receive. As a result, ACCME noted that the modification will increase transparency, enabling ACCME to produce more detailed trend data about commercial support. The ACCME will communicate the requirement modification and implementation timeframe to providers.

Intrastate Accreditation System

The Board adopted "The ACCME’s Recognition Process: Responsibilities of Maintenance of Recognition." The continuous Maintenance of Recognition approach improves the quality, value, and efficiency of the recognition process, and enables the ACCME and Recognized Accreditors to identify areas for improvement on an ongoing basis. To further support the intrastate accreditation system, the Board expanded the CRR from seven to nine members.

Elections

The Board elected Stuart L Abramson, MD, PhD, to serve on the Accreditation Review Committee.

Government Incentives and Life Science Research

Biotech 
In the midst of budget debates and continued concerns over the Affordable Care Act (ACA or health care reform), a number of House Representatives and U.S. Senators, stakeholders, and policymakers have begun to focus their efforts on ways to bring innovation in medical and scientific research back to the forefront of American health care policy.

For example, over the past several months, two pieces of legislation have been introduced to help America progress in the field of medicine and science, and to maintain our status as a world leader in healthcare.  First, the American Research and Competitiveness Act (H.R. 942), which has bipartisan support, would make a research-and-development tax credit a permanent part of the federal tax code. The tax credit would be extended to all “types of companies investing in research and development, not just med-tech concerns.” Such a credit holds significant promise for big med-tech companies because they “spend anywhere from 8 to 13% of their annual revenue on R&D—a crucial component in the development of new products.

Second, the Senate recently passed the “America Invents Act” (S. 23), a bill that would overhaul the U.S. patent system by changing it from a first-to-invent to a first-to-file system.  Additionally, the National Institutes of Health (NIH) will begin a new office that will focus on early stage drug development and research.

While these changes and others are being considered in Congress, there are still a number of questions and issues that must be addressed to ensure that the government and federal policies support continued research and development to find cures and treatments for diseases that cost Americans billions of dollars each year.  One of the problems America currently faces is that “life sciences companies have no alternative to re-investing in developing more drugs, biologics, and medical devices.”

A recent post from FDA Matters, explored the nature and need for incentives to conduct life sciences’ research.  As the article points out, “the government’s goal in incentivizing certain life sciences research is to stimulate activity that meets or resolves societal needs (e.g. drugs and devices for cancers, therapies for rare diseases, treatments for tropical diseases).  Idealistically, the incentives encourage vital, new activity without providing subsidies for research that would have occurred without incentives.”  However, “the reality is different.”

To explain how the current regulatory system in the U.S. fails to adequately incentivize life sciences’ research, the article identified three broad categories of public incentives for research:

Ordinary research incentives. These are the incentives available for all corporate-supported research. These include the research and development (R&D) tax credit, access to government technology transfer programs and patent protection. For most industries, and even most life sciences research, these seem sufficient to stimulate a high-level of research investment.

Upgraded incentives.  Ordinary research incentives are sometimes not enough to stimulate life science research that will benefit society. As a result, Congress has created a number of upgraded incentives for medical product development.

For example, Congress has provided partial patent term restoration for drug companies experiencing particularly long delays in receiving marketing approval. This has led to increased research investment (as well as boosting the generic drug market as part of the same legislation).  

Also, Congress created the Orphan Drug Act to provide incentives for research on drugs for rare diseases/small populations. This law incorporated a number of incentives, notably up to seven years market exclusivity for any new orphan indication on a drug.  

FDA also provides a number of upgraded incentives for particular types of research through its expanded access and accelerated approvals programs. User fee waivers granted to first products from new companies also stimulates research investment.  

Extraordinary incentives.   Congress may consider incentives designed to dramatically alter the normal risk/reward/certainty calculation that usually precedes research investments.  The only example the author could think of is in 2007, Congress enacted a program that awards a “priority review voucher” for successful development of a new treatment for a neglected tropical disease. Owning a voucher entitles a company to ask for a priority review (6 months) by FDA of an unrelated product that would otherwise be granted a normal review (10 months). Currently, Congress is looking at legislation (S. 606) that would extend this voucher program to developers of products to treat pediatric rare diseases.

Conclusion

Ultimately, “it is up to Congress to decide whether to encourage particular life sciences research beyond the ordinary incentives.”  It is important for Congress to create these incentives because they will stimulate substantial additional research….and the development of many new drugs that are particularly beneficial to society.  Without these incentives, pipelines for drug companies may remain empty, and patients will suffer.  Moreover, overly tight restrictions on program eligibility result in understimulatoin of needed research.  As a result, the article recommended that, “when creating incentives and, also, assessing their impact later, Congress needs to take the broad view of the societal good that can be achieved by upgraded and extraordinary incentives for research.” 

 

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