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.
- Regulations, Notices, & Guidance
- On May 20, 2019, the Department of Health and Human Services (HHS) issued a final rule entitled, Protecting Statutory Conscience Rights in Health Care; Delegations of Authority. This final rule revises existing regulations to ensure vigorous enforcement of Federal conscience and anti-discrimination laws applicable to HHS, its programs, and recipients of HHS funds, and to delegate overall enforcement and compliance responsibility to the Department’s Office for Civil Rights (OCR). In addition, this final rule clarifies OCR’s authority to initiate compliance reviews, conduct investigations, supervise and coordinate compliance by HHS and its components, and use enforcement tools otherwise available in existing regulations to address violations and resolve complaints. In order to ensure that recipients of Federal financial assistance and other Department funds comply with their legal obligations, this final rule requires certain recipients to maintain records; cooperate with OCR’s investigations, reviews, or other proceedings; and submit written assurances and certifications of compliance to HHS.
- On May 23, 2019, the Food and Drug Administration (FDA) issued a notice entitled, Section 503A Bulks List Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability. The FDA is announcing the availability of a guidance for industry entitled "Section 503A Bulks List Final Rule Questions and Answers--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule establishing the list of bulk drug substances that can be used in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- June 11, 2019: The FDA announced a public meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The Committee will discuss clinical utility and safety concerns associated with the higher range of opioid analgesic dosing in the outpatient setting.
- June 21, 2019: HHS announced a public meeting entitled, ReImagine HHS: Accelerate Clinical Innovation, Public Hearing. HHS is interested in how to decrease the overall time for new medical products (drug, medical device, biologic) to go from discovery to widespread patient access and use while maintaining public health standards.
- July 2, 2019: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. The meeting will include panel presentations and discussions surrounding emerging antifungals, and provider challenges and educational solutions to influence antibiotic stewardship.
- On May 22, 2019, the Senate Committee on Aging held a hearing entitled, Aging and Disability in the 21st Century: How Technology Can Help Maintain Health and Quality of Life. Witnesses present included: Joseph Coughlin, Ph.D., Director, Massachusetts Institute of Technology AgeLAB; Cara McCarty, Curatorial Director, Cooper Hewitt Smithsonian Design Museum; Brenda Gallant, Executive Director, Maine Long-Term Care Ombudsman Program; and Robert Mecca, Executive Director, Life and Independence for Today.
- On May 21, 2019, the House Energy and Commerce Health Subcommittee held a hearing entitled, Improving Drug Transparency and Lowering Prices for American Consumers. Witnesses present included: Lisa Joldersma, Senior Vice President, Insurance and State Issues, Pharmaceutical Research and Manufacturers of America; Kristin Bass, Chief Policy and External Affairs Officer, Pharmaceutical Care Management Association; Madelaine Feldman, MD, President, Coalition of State Rheumatology Organizations, Alliance of Specialty Medicine; Frederick Isasi, Executive Director, Families USA; Mark Miller, PhD, Executive Vice President of Health Care, Arnold Ventures; and Douglas Holtz-Eakin, PhD, President, American Action Forum.
- On May 21, 2019, the House Ways and Means Committee held a hearing entitled, Protecting Patients from Surprise Medical Bills. Witnesses present included: Katie Porter, Congresswoman (D-CA); Cathy McMorris Rogers, Congresswoman (R-WA); Bobby Mukkamala, Board of Trustees, American Medical Association; Jeannette Thornton, Senior Vice President, America’s Health Insurance Plans; Tom Nickels, Executive Vice President, Government Relations and Public Policy, American Hospital Association; and James Gelfand, Senior Vice President, Health Policy, Employee Retirement Income Security Act Industry Committee.
- On May 22, 2019, the House Budget Committee held a hearing entitled, Key Design Components and Considerations for Establishing a Single-Payer Health Care System. Witnesses present included: Mark Hadley, Deputy Director, Congressional Budget Office; Jessica Banthin, Deputy Assistant Director for Health, Retirement, and Long-Term Analysis, Congressional Budget Office; Jeffrey Kling, Associate Director for Economic Analysis, Congressional Budget Office.
- On May 20, 2019, the Government Accountability Office (GAO) issued a report entitled, Prescription Opioids: Voluntary Drug Management Programs to Control Misuse. Medicare’s drug management program (DMP) identifies beneficiaries at risk of opioid misuse or abuse, and attempts to mitigate risk through the use of case management and coverage limitations. GAO interviewed plan sponsors to determine whether beneficiaries were receiving adequate care when participating in a plan that utilizes the DMP. GAO found that there was little concern that beneficiaries were not receiving appropriate clinical opioid doses. However, plan sponsors said that the DMP could be more successful if there was better communication among sponsors, opioid prescribers, and pharmacies.
- Other Health Policy News
- On May 23, 2019, the Senate Health, Education, Labor, and Pensions Committee leadership issued a draft bill entitled, Lower Health Care Costs Act of 2019. Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) are soliciting feedback on the bill until June 5, 2019. The announcement is available here.