Alston & Bird Healthcare Week in Review, April 13, 2018

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news.

I. Regulations, Notices, & Guidance

• On April 10, 2018, the Department of Health and Human Services (HHS) issued a final rule entitled, Patient Protection and Affordable Care Act: Benefit and Payment Parameters for 2019.  This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally-facilitated Exchanges and State Exchanges on the Federal platform. It finalizes changes that provide additional flexibility to States to apply the definition of essential health benefits (EHB) to their markets, enhance the role of States regarding the certification of qualified health plans (QHPs); and provide States with additional flexibility in the operation and establishment of Exchanges, including the Small Business Health Options Program (SHOP) Exchanges. It includes changes to standards related to Exchanges; the required functions of the SHOPs; actuarial value for stand-alone dental plans; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions; and other related topics.
• On April 11, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Expansion of the Abbreviated 510(k) Program; Demonstrating Substantial Equivalence Through Performance Criteria. This draft guidance provides FDA's rational on expanding the abbreviated 510(k) program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. The intent of the draft guidance is to describe an optional program for certain well understood device types, where a submitter could demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific, submitter-identified predicate device as part of a demonstration of substantial equivalence. This draft guidance is not final nor is it in effect at this time.
• On April 13, 2018, the FDA issued a guidance entitled, Highly Concentrated Caffeine in Dietary Supplements. The FDA considers some dietary supplements that consist of only highly concentrated caffeine to be adulterated. The FDA is issuing this document to provide guidance to firms that manufacture, market, or distribute dietary supplement products that contain pure or highly concentrated caffeine, or are considering doing such actions. This guidance should help such parties determine whether their products are or would be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help them understand how to reduce the likelihood that their products will be considered adulterated.

Event Notices

• April 16, 2018: The FDA announced a public meeting entitled, Evaluating Inclusion and Exclusion Criteria in Clinical Trials. The purpose of the meeting is to bring together stakeholders to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.
• April 17, 2018: The FDA announced a public meeting entitled, Patient-Focused Drug Development in Opioid Use Disorder. The purpose of the meeting is to obtain patients’ perspectives on treatment approaches for opioid use disorder. The meeting is part of FDA’s ongoing work aimed at reducing the impact of opioid abuse and addiction.
• April 16-18, 2018: the HRSA announced a public meeting of the National Advisory Committee on Rural Health and Human Services. During the meeting the Committee will examine the issues of Assessing and Mitigating the Effect of Adverse Childhood Experiences and Health Insurance Markets in Rural Areas; conduct site visits to the Adirondack Health Institute in Glens Falls, New York and St. Vincent de Paul Catholic Church in Cobleskill, New York, to visit the Head Start Program; and summarize key findings and develop a work plan for the next quarter.
• April 19, 2018: The FDA announced a public meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The Committee provides advice and recommendations to FDA on regulatory issues. The Committee will discuss new drug application 210365, cannabidiol oral solution, sponsored by GW pharmaceuticals, for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
• April 23, 2018: The FDA announced a public meeting of the Arthritis Advisory Committee. The committee will discuss the new drug application for baricitinib tablets submitted by Eli Lilly for the treatment of rheumatoid arthritis.
• April 23, 2018: The FDA announced a meeting of the Science Board to the Food and Drug Administration. The Science Board will hear a report from the Center for Biologics Evaluation and Research Program Subcommittee; hear about FDA’s Patient Affairs Initiative; and discuss how the FDA can leverage its existing tools and authorities.
• April 24-25, 2018: The FDA announced a joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss the findings of a recent study and interpret the study to better understand the safety risks of a number of NSAIDs.
• May 3, 2018: The FDA announced a public meeting of the Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee. The general function of the committees is to provide advice and recommendations for the FDA on regulatory issues.
• May 3, 2018: The HHS announced a public meeting of the National Vaccine Advisory Committee.  The public meeting will be dedicated to the deliberation of various recommendations to the Director of the National Vaccine Program.
• May 9, 2018: The FDA announced a public workshop entitled, Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation. The purpose of the public workshop is to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity when approving a product with a tissue agnostic indication.
• May 14-16, 2018: The Center for Medicare and Medicaid Services (CMS) announced the public meetings on the Healthcare Common Procedure Coding System (HCPCS) for 2018. The public meetings will cover CMS’ preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments.
• May 22, 2018: The FDA announced a public meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss the new drug application for buprenorphine sublingual spray that would treat moderate-to-severe acute pain.
• May 24, 2018: The FDA announced a public workshop entitled, FY 2018 Generic Drug Regulatory Science Initiatives. The purpose of the workshop is to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on the initiatives.
• June 25, 2018: The CMS announced the Annual Laboratory Public Meeting. The meeting will gather public input on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HSPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule for calendar year 2019.
• June 25-26, 2018: The FDA announced a public symposium to discuss scientific topics related to the regulation of biologics and to highlight science conducted at the Center for Biologics Evaluation and Research. The symposium will include presentations by experts from academic institutions, government agencies, and research institutions.

II. Congressional Legislation & Committee Action

U.S. Senate

• On April 11, 2018, the Senate Health, Education, Labor, and Pensions Committee held a hearing entitled, The Opioid Crisis Response Act of 2018. Witnesses present included: Jennifer Donahue, Esq., Child Abuse Investigation Coordinator, Delaware Office of the Child Advocate; Robert Morrison, Executive Director, National Association of State Alcohol and Drug Abuse Directors; and Jessica Hulsey Nickel, President and Chief Executive Officer, Addiction Policy.
• On April 11, 2018, the Senate Judiciary Committee Subcommittee on Crime and Terrorism held a hearing entitled, Defeating Fentanyl: Addressing the Deadliest Drugs Fueling the Opioid Crisis. Witnesses present included: Christina Nolan, United States Attorney, District of Vermont; Kemp Chester, Associate Director, National Heroin Coordination Group, Office of National Drug Control Policy; Kenneth Miller, Chief of Police, Greenville, South Carolina Police Department; Josiah Rich, MD, Professor of Medicine and Epidemiology Brown University, Director of the Center for Prisoner Health and Human Rights; Brian Brown, MD, Professor and Chair, Department of Emergency Medicine, University of Maryland School of Medicine.       

House of Representatives

• On April 11, 2018, the House Oversight and Government Reform Subcommittee on Healthcare, Benefits, and Administrative Rules held a hearing entitled, Local Responses and Resources to Curtail the Opioid Epidemic. Witnesses present included: Amy Haskins, Project Director, Jackson County Anti-Drug Coalition; Lisa Roberts, Coordinator, Scioto County Drug Action Team Alliance; Derek Siegle, Executive Director, Ohio High Intensity Drug Trafficking Area Program; Karen Ayala, Lead Staff, DuPage Heroin/Opioid Prevention and Education Task-force.
• On April 11-12, 2018 the House Energy and Commerce Subcommittee on Health held a legislative hearing entitled, Combating the Opioid Crisis: Improving the Ability of Medicare and Medicaid to Provide Care for Patients. The hearing lasted two days and covered 34 bills that would make changes to Medicare and Medicaid. Witnesses present included: Kimberly Brandt, Principal Deputy Administrator for Operations, Centers for Medicare and Medicaid Services; Michael Botticelli, Executive Director, Grayken Center for Addiction, Boston Medical Center; Toby Douglas, Chief Executive Officer, Centerstone; John Kravitz, Chief Information Officer, Geisinger Health System; Sam Srivastava, Chief Executive Officer, Magellan Health.
• On April 12, 2018, the House Committee on Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee hearing entitled, FY 2019 Budget Hearing - Investments in our Health Workforce and Rural Communities. Witnesses included: Tom Morris, Associate Administrator for Rural Health Policy, Health Resources and Services Administration; Luis Padilla, MD, Associate Administrator for Health Workforce, Health Resources and Services Administration.

III. Reports, Studies, & Analyses

• On April 13, 2018, the Government Accountability Office (GAO) issued a report entitled, Illicit Opioids: While Greater Attention Given to Combating Synthetic Opioids, Agencies Need to Better Assess their Efforts. This report examines, in part, how the U.S. government measures their performance in combating the opioid epidemic. The GAO found that U.S. agencies are not tracking strategic outcomes adequately and provided recommendations to the relevant agencies.

IV. Other Health Policy News

• On April 10, 2018, President Trump signed an executive order encouraging welfare reform, which may impact some health-related programs. The executive order can be accessed here.