Life Science Compliance Update

July 25, 2017

New Report Releases Strategies to Reduce Opioid Epidemic

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The National Academies of Sciences, Engineering, and Medicine recently released a report, requested by the United States Food and Drug Administration, that highlights what can be done to stop the opioid use disorder and other opioid-related harms without closing access to opioids for patients who need them.

The committee that conducted the study and wrote the report recommended actions the FDA, other federal agencies, state and local governments, and health-related organizations should take – which include promoting more cautious prescribing of opioids, expanding access to treatment for opioid use disorder, preventing more overdose deaths, weighing societal impacts in opioid-related regulatory decisions, and investing in research to better understand the nature of pain and develop non-addictive alternatives.

In more recent years, national initiatives to reduce opioid prescribing have modestly decreased the number of prescription opioids dispensed. Unfortunately, many people who otherwise would have been using prescription opioids have transitioned to heroin use. According to the report, the declining price of heroin, together with regulatory efforts designed to reduce harms associated with the use of prescription opioids – including the availability of abuse-deterrent formulations – may be contributing to increased heroin use.

One approach to addressing the opioid epidemic is to have a fundamental shift in the nation’s approach to prescribing practices and improve awareness of the risks and benefits of opioids. Therefore, the committee recommended education for both health professionals and the public. Such education should involve mandating pain-related education for all health professionals who provide care to people with pain, requiring and providing basic training in the treatment of opioid use disorder for health care providers, and training prescribers and pharmacists to recognize and counsel patients who are at risk for opioid use disorder or overdose.  In addition, the lack of attention paid to educating the public about the risks and benefits of prescription opioids needs to be addressed. The report called for an evaluation of the impact and cost of an education program that raises awareness among patients with pain and the public.

The committee stressed that restrictions on lawful access to prescription opioids could have other unintended effects, and any policy designed to curtail legal access to them will inevitably drive some people toward the illegal market. Therefore, a strategy for reducing lawful access to opioids should be coupled with an investment in treatment for the millions who have opioid use disorder. 

The committee recommended that states – with assistance from relevant federal agencies, particularly the Substance Abuse and Mental Health Services Administration – provide universal access to evidence-based treatment for opioid use disorder in a variety of settings, including hospitals, criminal justice settings, and substance-use treatment programs. The U.S. Department of Health and Human Services (HHS) and state health financing agencies should also remove impediments to full coverage of medications approved by the FDA for treatment of opioid use disorder.

Several other strategies that the committee recommended include:

  • the FDA should complete a review of the safety and effectiveness of all approved opioids;
  • states should convene a public-private partnership to implement drug take-back programs that allow drugs to be returned to any pharmacy on any day, rather than relying on occasional take-back events;
  • public and private payers, including insurance companies, should develop reimbursement models that support evidence-based and cost-effective comprehensive pain management, including both drug and non-drug treatments for pain;
  • HHS, in concert with state organizations, should conduct or sponsor research on how data from prescription drug monitoring programs can be better leveraged to track opioid prescribing and dispensing information; and
  • the National Institutes of Health, the Substance Abuse and Mental Health Services Administration, the U.S. Department of Veterans Affairs, and industry should invest in research that examines the nature of pain and opioid use disorder, as well as develop new non-addictive treatments for pain.

July 24, 2017

AAFP and ABFM Collaborate to Create Unified Credit Reporting Process

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Earlier this month, the American Academy of Family Physicians (AAFP) announced a collaboration with the American Board of Family Medicine (ABFM) to create a more seamless credit-reporting experience for family physicians. The new process will allow AAFP members to use the AAFP as a one-stop shop for all of their Continuing Medical Education (CME) credit reporting needs.

It is hoped that this new process will make it easier for providers to claim their credit for performance improvement CME activities with both the AAFP and the ABFM.

The AAFP – as one of the nation’s three CME accrediting bodies – will work with CME provider organizations that wish to have their CME activities (including performance improvement activities) certified for AAFP Prescribed and/or Elective credit. CME providers can seek approval for those activities through the AAFP Credit System.

The AAFP and ABFM are currently working together to allow CME providers to apply for AAFP Performance Improvement CME Credit and ABFM Certification Activity credit for their performance improvement activities through the AAFP Credit System using a single application process. Starting in October, CME providers who apply for dual credit using the new unified process will no longer have to pay an additional fee for ABFM Certification Activity credit approval.

In addition to meeting AAFP performance improvement activity requirements, to be eligible to receive Certification Activity credit from the ABFM, each performance improvement activity must comply with the ABFM's Industry Support Policy and meet the ABFM Requirements for Performance Improvement activities, and the provider must agree to periodic audits by the ABFM.

From the physician-learner's perspective, the unified process means that ABFM diplomates will have more performance improvement activities to choose from. In addition, when the physician reports CME credit for a dually approved performance improvement activity to the AAFP, the ABFM will automatically be notified that the performance improvement certification activity has been completed.

The AAFP was created as a national professional association to protect the rights of general practitioners, and is the oldest national CME accreditor. Each year, the AAFP produces over 100 CME activities, including the Family Medicine Experience, live events, as well as journal and online CME sessions that are designed for family physicians with input from members. AAFP also reviews more than 3,000 activities from about 1,300 different organizations for accreditation annually to ensure they meet the needs of family physicians.

LSCU SPECIAL FEATURE: Into the Nexus - Anti-Kickback Statute ("AKS") versus Value-Driven Health Care

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Part 1: An Uncertain Future in a Dynamic Landscape

Fans of Star Trek will remember the scene from the 1994 movie “Generations” in which Captains James T. Kirk and Jean-Luc Picard meet each other in The Nexus: the old versus the new. As the need to reform the healthcare system becomes ever more urgent, a new Nexus has developed between the old legal and regulatory framework (i.e., the Anti-Kickback Statute) and new ways of incentivizing the system to reward improved patient outcomes (i.e., Value Driven Health Care).

Health care is changing, including the way in which payments, compensation, and value policies and procedures are being implemented. As one recent article notes, these “changes are moving healthcare from a fee-for-service reimbursement model to a fee-for-value payment and care delivery model [including the] passage of the Patient Protection and Affordable Care Act of 2010 (ACA)."

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