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 May 7, 2018, the Food and Drug Administration (FDA) issued a guidance entitled, Menu Labeling: Guidance for Industry. The guidance addresses stakeholder concerns regarding the implementation of nutrition labeling required for foods sold in covered establishments, includes expanded and new examples of alternatives to aid in compliance, identifies places where FDA intend to be more flexible in its approach, and advises of FDA’s intent to exercise enforcement discretion regarding nutrient declaration for “calories from fat” as part of the additional written nutrition information. The guidance also includes many graphical depictions to convey FDA’s rational on various topics and to provide examples of options for implementation, and addresses calorie disclosure signage for self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods, when determining nutrition labeling for such foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer.
- On May 9, 2018, the Center for Medicare and Medicaid Services (CMS) issued an interim final rule entitled, Durable Medical Equipment Fee Schedule Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Rural Areas and Non-Contiguous Areas. This interim final rule with comment period makes technical amendments to the regulation to reflect the extension of the transition period from June 30, 2016 to December 31, 2016 that was mandated by the 21st Century Cures Act for phasing in fee schedule adjustments for certain durable medical equipment (DME) and enteral nutrition paid in areas not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). In addition, this interim final rule with comment period amends the regulation to resume the transition period’s blended fee schedule rates for items furnished in rural areas and non-contiguous areas (Alaska, Hawaii, and United States territories) not subject to the CBP from June 1, 2018 through December 31, 2018. This interim final rule with comment period also makes technical amendments to existing regulations for DMEPOS items and services to reflect the exclusion of infusion drugs used with DME from the DMEPOS CBP.
- On May 10, 2018, the FDA issued guidance entitled, Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address.” The FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. The FDA is issuing this guidance to provide the Agency’s current thinking on these questions and related issues regarding how to ensure that the compounding of drugs in an outsourcing facility occurs only in accordance with section 503B.
- On May 11, 2018, the FDA issued guidance entitled, Pediatric HIV Infection; Drug Development for Treatment. The FDA is announcing the availability of a draft guidance for industry entitled “Pediatric HIV Infection: Drug Development for Treatment.” This guidance provides general recommendations on the development of drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients (birth to younger than 17 years of age).
- 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 17, 2018: The FDA announced a public meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The VRBPAC will discuss approaches from demonstrating effectiveness in certain vaccines intended for use in pregnant women.
- 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.
- May 30, 2018: The HHS announced a meeting for the Pain Management Best Practices Inter-Agency Task Force (Task Force). The Task Force will identify, review, and determine whether there are gaps or inconsistencies between best practices for pain management, including for chronic and acute pain.
- 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.
- July 25, 2018: The CMS announced a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The meeting will focus on obtaining the MEDCAC’s appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements, trans-catheter aortic valve replacements and percutaneous coronary interventions for hospitals.
- 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.
- August 20, 2018: The CMS announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the HHS Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues.
II. Congressional Legislation & Committee Action
- On May 8, 2018, the Senate Special Committee on Aging held a hearing entitled, Insulin Access and Affordability: The Rising Cost of Treatment. Witnesses present, included William Cefalu, M.D., Chief Scientific, Medical, and Mission Officer, American Diabetes Association; Paul Grant, Father of Son with Type 1 Diabetes; Lois Ondik, Diabetes Patient; and Jeremey Greene, M.D., Ph.D., Elizabeth Treide and A. McGehee Professor of Medicine and the History of Medicine, and Interim Chair of the Department of the history of Medicine, Johns Hopkins University School of Medicine.
- On May 10, 2018, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies hearing entitled, Hearing to Review the FY 2019 Budget Request for U.S. Department of Health and Human Services. Department of Health and Human Services Secretary Alex Azar was the only witness present.
House of Representatives
- On May 8, 2018, the House Energy and Commerce Committee Oversight Subcommittee held a hearing entitled, Combating the Opioid Epidemic: Examining Concerns About Distribution and Diversion. Witnesses present, included Dr. Joseph Mastandrea, Chairman of the Board, Miami-Luken, Inc.; John Hammergren, Chairman, President and CEO, McKesson Corporation; George Barret, Executive Chairman of the Board, Cardinal Health, Inc.; Steven Collis, Chairman, President and CEO, AmerisourceBergen Corporation; and J. Christopher Smith, Former President and CEO, H.D. Smith Wholesale Drug Co.
- On May 8, 2018, the Energy and Commerce Subcommittee on Health hearing entitled, Improving the Coordination and Quality of Substance Use Disorder. Witnesses present included Representative Earl Blumenauer (D-OR); Dustin McKee, Director of Policy, National Alliance on Mental Illness of Ohio; Patty McCarthy Metcalf, Executive Director, Faces and Voices of Recovery; Jeremiah Gardner, Manager, Public Affairs and Advocacy, Hazelden Betty Ford Foundation; H. Westley Clark, MD, Public Health Program, Santa Clara University; Gerald DeLoss, Officer, Greensfedler, Hemker, and Gale, P.C..
- On May 8, 2018, the House Education and Workforce Committee Subcommittee on Oversight held a hearing entitled, The Opioid Epidemic: Implications for the Federal Employees’ Compensation Act. Witnesses present, included Dr. Scott Szymendera; Ramona Tanabe; Joe Paduba; and The Honorable Scott Dahl.
- On May 8, 2018, the House Judiciary Committee held a hearing entitled, Challenges and Solutions in the Opioid Abuse Crisis. Witnesses present, included Robert Patterson, Acting Director, Drug Enforcement Administration; Timothy Westlake, M.D.; J. Spencer Morgan, Commonwealth’s Attorney; Kristen Holman; Josiah Rich, M.D.
- On May 8, 2018, House Ways and Means Subcommittee on Health hearing entitled, The Current Status of and Quality in the Medicare Advantage (MA) Program. Witnesses present included Karoline Mortensen, Ph.D., Associate Professor, Health Sector Management & Policy, University of Miami Business School; Andrew Toy, Chief Technology Officer, Clover Health; Daphne Klausner, Senior Vice President, Senior Markets, Independence Blue Cross; and Jack Hoadley, Ph.D., Georgetown University Health Policy Institute.
- On May 9, 2018, the House Energy and Commerce Committee (Committee) held a markup entitled, Energy and Commerce Committee Vote on Opioids Legislation and H.R. 4606, H.R. 5174, H.R. 5175, H.R. 5239, and H.R. 5240. The Committee considered a range of opioid-related bills that amended the Controlled Substance Act, Public Health Service Act, Federal Food, Drug, and Cosmetic Act as well as the Medicare program. In total, the Committee reported 25 opioid-related bills to the House floor.
III. Reports, Studies, & Analyses
- On May 10, 2018, the Kaiser Family Foundation released a poll entitled, Preview of the Role of Health Care in the 2018 Midterm Campaigns. The survey found that health care is among the top issues voters want to hear their candidates talk about. The top issues chosen by voters are the economy (23 percent), health care (22 percent), and gun policy (22 percent).
IV. Other Health Policy News
- On May 11, 2018, the Trump administration released its plan to lower drug costs. The plan is available here.