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 2, 2019, the Food and Drug Administration (FDA) issued a notice entitled, List of Patient Preference-Sensitive Priorities. As part of FDA’s commitments for the reauthorization of the Medical Device User Fee Amendments of 2017 (MDUFA IV), the Center for Devices and Radiological Health (CDRH) committed to publish a list of priority areas where preference-sensitive data can inform regulatory decision making. FDA is also establishing a docket to solicit public input on this list of preference-sensitive areas that may impact the design and conduct of premarket medical device clinical studies, benefit-risk assessments, and postmarket evaluation.
- On May 2, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Reassignment of Medicaid Provider Claims. This final rule removes the regulatory text that allows a state to make Medicaid payments to third parties on behalf of an individual provider for benefits such as health insurance, skills training, and other benefits customary for employees. CMS has concluded that this provision is neither explicitly nor implicitly authorized by the statute, which identifies the only permissible exceptions to the rule that only a provider may receive Medicaid payments. As CMS noted in their prior rulemaking, section 1902(a)(32) of the Social Security Act (the Act) provides for a number of exceptions to the direct payment requirement, but it does not authorize the CMS to create new exceptions.
- On May 3, 2019, the FDA issued guidance entitled, Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment. The purpose of this draft guidance is to assist sponsors in the clinical development of stimulant drugs for treatment of attention deficit hyperactivity disorder in pediatric and adult patients. Specifically, the draft guidance addresses the FDA’s current recommendations regarding the development programs for methylphenidate and amphetamine products, as well as for novel products (i.e., new molecular entity stimulant drugs).
- On May 3, 2019, CMS issued a final rule entitled, Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures. This final rule revises the regulations setting forth the appeals process that Medicare beneficiaries, providers, and suppliers must follow in order to appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B or determinations for prescription drug coverage under Part D. These changes help to streamline the appeals process and reduce administrative burden on providers, suppliers, beneficiaries, and appeal adjudicators. These revisions, which include technical corrections, also help to ensure the regulations are clearly arranged and written to give stakeholders a better understanding of the appeals process.
- May 9 – 10, 2019: The FDA announced a meeting of the Pain Management Best Practices Inter-Agency Task Force. The Task Force will review clinical guidelines and identify gaps and/or inconsistencies for best practices for pain management.
- May 13, 2019: The FDA announced a public meeting entitled, The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products. The hearing is set to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.
- 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.
II. Congressional Legislation & Committee Action
- There were no health-related hearings this week.
House of Representatives
- On April 30, 2019, the House Rules Committee held a hearing entitled, Medicare for All. Witnesses present included: Mr. Ady Barkan, Founder, Be A Hero Organization and Amyotrophic Lateral Sclerosis (ALS) patient; Dr. Charles Blahous, J. Fish and Lillian F. Smith Chair and Senior Research Strategist, Mercatus Center; Dr. Dean Baker, Senior Economist, Center for Economic and Policy Research; Ms. Grace-Marie Turner, President, Galen Institute; Dr. Sara Collins, Vice President for Health Care Coverage and Access, The Commonwealth Fund; Dr. Doris Browne, Immediate Past-President, National Medical Association; and Dr. Farzon Nahvi, Emergency Room Physician.
- On April 30, 2019, the House Energy and Commerce Subcommittee on health held a hearing entitled, Prescription Drug Coverage in the Medicare Program. James Mathews, Ph.D., Executive Director at the Medicare Payment Advisory Commission was the only witness present.
- On April 30, 2019 the House Judiciary Committee held a markup entitled, R. 965, the “CREATES Act”; H.R. 2375, the “Preserve Access to Affordable Generics and Biosimilars Act”; H.R. 2374, the “Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act”; and H.R. 2376, the “Prescription Pricing.” The four bills considered were reported favorably by a voice vote.
- On April 30, 2019, the House Appropriations Subcommittee on Labor and Health and Human Services held a markup of the FY 2020 Labor-HHS-Education Funding Bill. The bill was advanced to the full Committee.
III. Reports, Studies, & Analyses
- On May 3, 2019, the Department of Health and Human Services Office of Inspector General (OIG) issued a report entitled, Medicaid Could Save Hundreds of Millions by Excluding Authorized Generic Drug Transactions to Secondary Manufacturers from Brand Name Drugs’ Average Manufacturer Price Calculations. The OIG’s objective was to determine the impact on Medicaid drug rebates from including authorized generic drug transactions in the brand name drugs’ average manufacturer Price (AMP) calculations. The OIG found that Medicaid received 46 percent less in rebates than it otherwise would have for nine brand name drugs that were reviewed, totaling $595 million for calendar year 2017.
IV. Other Health Policy News
- On May 2, 2019, the Congressional Budget Office (CBO) released its updated budget projections for 2019-2029. Along with the projections, CBO issued a supplemental document entitled, Incorporating the Effects of the Proposed Rule on Safe Harbors for Pharmaceutical Rebates in CBOS’s Budget Projections. CBO estimates that implementing the Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees proposed rule would increase federal spending by about $177 billion over the 2020–2029 period with Medicare spending increasing by about $170 billion and Medicaid spending increasing by about $7 billion.