Life Science Compliance Update

February 23, 2018

New Limitations on Guidance Documents Expected to Have Heavy Effect on Industry

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The Trump Administration recently adopted new limits on the use of “guidance documents” issued by federal agencies. Various industries use the applicable guidance documents to better understand the government’s interpretation of laws, and as such, this may have a sweeping effect on industry compliance measures.

The revised policy piggybacks off of a previous memo issued by Attorney General Jeff Sessions that prohibited the Agency from issuing guidance documents that effectively bind the public without undergoing the notice-and-comment rulemaking process. This means that the DOJ was unable to issue guidance documents that effectively created rights or obligations that were binding on those outside of the Executive Branch, or to create binding standards by which the DOJ determines compliance with already existing statutory or regulatory requirements.

Under the revised policy, issued by Rachel L. Brand at the Department of Justice (DOJ), the Agency will not “use its enforcement authority to effectively convert agency guidance documents into binding rules.” Guidance documents are not permitted to “create binding requirements that do not already exist by statute or regulation.” Additionally, DOJ lawyers representing the government in court “may not use noncompliance with guidance documents as a basis for proving violations of applicable law,” a common tactic previously used.

The guidance documents may be used for “proper purposes” in cases, such as by using them to explain or paraphrase legal mandates from existing statutes or regulations, or to use evidence that a party read such a guidance document to help prove that the party had requisite knowledge of the mandate.

Brand goes on to note that the DOJ “should not treat a party’s noncompliance with an agency guidance document as presumptively or conclusively establishing that the party violated the applicable statute or regulation.” Just because a party does not comply with the agency guidance that expands upon a statutory or regulatory requirement does not mean that the party violated those underlying legal requirements – agency guidance documents are not permitted to create any additional legal obligations.

This policy applies to future actions brought by the DOJ and – wherever practicable – to any matters pending as of January 25, 2018.

As such, defense attorneys seem to be pleased with this change, saying that it gives them a tool to help fend off wrongdoing allegations against their clients.

Benjamin C. Mizer, a former DOJ official, said that the new policy “may significant affect cases involving the health care and life science industries” because the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) heavily rely on guidance documents in court proceedings and other allegations of wrongdoing.

Lindsey E. Gabrielson, a lawyer in the Boston office of Foley & Lardner, stated that the government will now “face serious hurdles” in enforcement actions based on violations of health care guidance documents. Barry L. Goldstein, a lawyer based in Oakland, California, referred to the shift as “extraordinary.”

February 22, 2018

Senate HELP Committee Holds Hearing on Opioids and the Impact on Families

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On February 8, 2018, the Senate Health, Education, Labor, and Pensions (HELP) committee held a hearing entitled “Impact of the Opioid Crisis on Children and Families,”  the fourth in a series of hearings on the opioid crisis. Committee members examined the various ways states are implementing adequate care for children impacted by drug abuse as set out by the Comprehensive Care Act (CARA).

Opening

During his opening statement, Committee Chairman Lamar Alexander spoke about legislation he helped to craft that allowed the National Institute of Health (NIH) more flexibility in funding opioid addiction research. He also noted that while additional legislation may be needed to ensure that newborns and children suffering from drug abuse receive adequate care, Congress had taken steps to protect these children through various legislative acts.

Ranking Member Patty Murray discussed the unrelenting need to respond to the opioid crisis with additional federal funding. She criticized the current Administration and stated that the child welfare system should be reoriented towards prevention services for families, in hopes that such a change of focus will decrease the number of children entering the foster care system due to loss of parental rights due to opioid addiction.

Committee Discussion

Child Welfare Funding

The Committee discussion seemed to have an emphasis on the growing number of children entering child welfare programs. The discussion touched upon ways to best to address mental health and drug education in schools, the growing strain on the foster care system, and the additional burden put on grandparents who act as primary care givers for children with parents with opioid addictions. 

Senator Robert Casey cited the opioid crisis as both a human and economic problem as growing numbers of grandparents raise children of OUD suffering parents. Grandparents who raise these children save the country billions of dollars by keeping these children out of foster care but often deal with a lower quality of life under the added burden.

Senator Tim Scott asked how best to fiscally support children born with NAS through the first several years of their lives when they lack financial support from their parents. Dr. Stephen Patrick, an Assistant Professor of Pediatric Health at Vanderbilt University Health Center, believes that one way is for Congress to push for additional funding for early intervention services such as speech and occupational therapy in order to provide the greatest benefit to these children.

Senator Elizabeth Warren also mentioned the financial impact that parental overdose could have on a child. She suggested restoring survivor benefits granted to children through the Social Security Act through the age of twenty-two to help support full time students who “age out” of the foster care system.

Educating and Supporting Adolescents

Along the same lines, another topic that was discussed was how to educate and support adolescents to try to prevent another generation from coming under the grips of opioid addiction.

Becky Savage, the co-founder of the 525 Foundation, cited peer counseling groups and open dialogue drug education programs in schools as effective methods to reduce the stigma around opioid use and lower drug use rates in teens and adolescents, while Dr. Bell called for stronger efforts to make schools a “safe haven” for children in the community who may be at risk for drug abuse and addiction.

Senator Todd Young suggested a nationwide public awareness campaign that would be aimed at adolescent and high-school aged students in an attempt to educate them about OUDs and the potential for overdose.

Conclusion

In a moment of rare bipartisanship, Committee members came together to agree that additional funding was needed to address the opioid crisis and provide opioid use disorder (OUD) sufferers with adequate anti-addiction resources. The bipartisanship ended, however, Democrats specifically criticized recent budget cuts by the administration and recommended that additional federal funding should be directed towards Medicaid and other health care institutions that work to support the families of opioid users. 

February 21, 2018

ACCME Releases Report Highlighting 2017 Successes

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The Accreditation Council for Continuing Medical Education (ACCME) recently released a new report, Transforming Continuing Medical Education Together: 2017 Highlights from the Accreditation Council for Continuing Medical Education. The inaugural year-in-review report showcases the efforts of the ACCME and the continuing medical education (CME) community to leverage the power of education to respond to the changing healthcare environment. 

The report aims to celebrate the CME community’s initiatives to drive meaningful change for educators, clinicians, and ultimately patients, including: 

  • The Menu of Criteria for Accreditation with Commendation which represents the CME community’s vision of the future of education. From engaging with students, patients, and teams to tackling population and public health issues, CME providers that meet these criteria demonstrate the capacity of education to address healthcare challenges. 
  • Expanded opportunities for physicians to participate in education that counts for multiple requirements, thus reducing burdens and allowing clinicians more flexibility in choosing education that meets their needs, as a result of collaborations between accreditors, certifying boards, and educators. 
  • Freedom and flexibility in employing blended, new, and innovative approaches to education through the alignment of ACCME/American Medical Association requirements. 
  • Collaborations with other organizations, including the nursing and pharmacy accreditor colleagues to initiate a new IPCE credit mark that identifies education designed to improve team collaboration and patient care, helping to increase recognition for interprofessional continuing education (IPCE).
  • Increased engagement with healthcare leaders to promote the value of CME as a strategy to fulfil institutional and health system priorities.
  • Becoming a model of accreditation standards for other CME systems and providers around the world.

The report also describes the ACCME’s commitment to supporting the CME community. With its new annual meeting and online learning portal, as well as other educational offerings, the ACCME aims to build a community of practice that assists CME professionals in achieving their full potential. 

The ACCME published Transforming Continuing Medical Education Together as part of its efforts to build visibility for the CME community and communicate the value of accreditation and accredited CME.  

Graham McMahon, MD, MMSc, ACCME President and CEO said, “The CME community has much to be proud of. We look forward to continuing our work together, as we fulfill our shared aspiration to enhance education, drive improvements in clinician and team performance, and—most important—to optimize care for the patients we all serve.”  

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