Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
I. Regulations, Notices, & Guidance
- On June 17, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals; Correction. This document corrects technical errors in the proposed rule that appeared in the May 3, 2019, issue of the Federal Register entitled “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals.”
- On June 17, 2019, CMS issued a proposed rule entitled, Medicare Program; Secure Electronic Prior Authorization for Medicare Part D. This rule proposes a new transaction standard for the Medicare Prescription Drug Benefit Program’s (Part D) e-prescribing program as required by the “Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act.” Under the SUPPORT for Patients and Communities Act, the Department of Health and Human Services (HHS) Secretary is required to adopt standards for Part D e-prescribing program to ensure secure electronic prior authorization request and response transmissions. If finalized, the proposals in this rule would amend the Part D e-prescribing regulations to require Part D plan sponsors’ support of version 2017071 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for use in electronic Prior Authorization (ePA) transactions with prescribers regarding Part D covered drugs to Part D-eligible individuals.
- On June 20, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework. The purpose of this guidance is to describe the benefit-risk framework the FDA uses in evaluating applications for opioid analgesic drugs. This guidance summarizes the information that should be included in a New Drug Application (NDA) for an opioid analgesic drug to facilitate the FDA’s benefit-risk assessment.
- On June 21, 2019, HHS issued a proposed rule entitled, Regulatory Agenda: Semiannual Regulatory Agenda. This document meets the requirements set forth in the Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 to issue a semiannual inventory of rulemaking actions under development throughout the Department, offering summarized information about forthcoming regulatory actions for public review.
Event Notices
- July 9, 2019: HHS announced a public meeting entitled, Presidential Advisory Council on HIV/AIDS. The Presidential Advisory Council on HIV/AIDS (PACHA) will be holding its 64th full Council meeting in Jackson, Mississippi. Members will hear a panel presentation regarding Ending the HIV Epidemic: A Plan for America and will discuss possible recommendations regarding programs, policies, and research to promote effective prevention, treatment, and cure of HIV disease and AIDS.
- September 17, 2019: The FDA announced a public hearing entitled, Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction. The hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain.
II. Congressional Legislation & Committee Action
U.S. Senate
- On June 18, 2019, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, Lower Health Care Costs Act. Witnesses present included: Sean Cavanaugh, Chief Administrative Officer, Aledade; Benedic N. Ippolito, Research Fellow, American Enterprise Institute; Elizabeth Mitchell, President and Chief Executive, Pacific Business Group on Health; Tom Nickels, Executive Vice President, American Hospital Association; Frederick Isasi, Executive Director, Families USA; and Marilyn Bartlett, Special Projects Coordinator for the Commissioner of Securities and Insurance, Office of the Montana State Auditor.
- On June 19, 2019, Senate Special Committee on Aging held a hearing entitled, The Complex Web of Prescription Drug Prices, Part III: Examining Agency Efforts to Further Competition and Increase Affordability. Witnesses present included: Demetrios Kouzoukas, Principal Deputy Administrator & Director of the Center for Medicare, CMS; Janet Woodcock, Director of the Center for Drug Evaluation and Research, FDA; and Vicki L. Robinson, Senior Counselor for Policy, HHS, Office of Inspector General (OIG).
House of Representatives
- On June 19, 2019, the House Committee on Oversight and Reform held hearing entitled, Medical Experts: Inadequate Federal Approach to Opioid Treatment and the Need to Expand Care. Witnesses present included: Dr. Susan R Bailey, President-elect, American Medical Association; Dr. Arthur C. Evans, CEO/Executive Vice President, American Psychological Association; Angela Gray BSN, RN, Nurse Director, Berkeley-Morgan County Board of Health, WV; Dr. Yngvild K. Olsen, Vice President, American Society of Addiction Medicine; Jean Ross RN, President, National Nurses United; and Dr. Nancy K. Young, Executive Director, Children and Family Futures.
- On June 20, 2019, the House Subcommittee on Government Operations held a hearing entitled, Ensuring Quality Health Care for Our Veterans. Witnesses present included: Ms. Tammy Czarnecki, Assistant Deputy Undersecretary for Health for Administrative Operations, Veterans Health Administration (VHA), on behalf of Department of Veterans Affairs (VA); Mr. Michael Heimall, Director, Veteran Affairs Medical Center (Washington, D.C.); and The Honorable Michael Missal, Inspector General, Office of Inspector General (OIG), on behalf of U.S. Department of Veterans Affairs.
III. Reports, Studies, & Analyses
- On June 20, 2019, the Kaiser Family Foundation issued a brief on a study entitled, An Examination of Surprise Medical Bills and Proposals to Protect Consumers from Them. The study used claims data from large employer plans to estimate the incidence of out-of-network charges associated with hospital stays and emergency visits that could result in a surprise bill. Researchers also examined state and federal policies aimed at addressing the incidence of surprise billing.
IV. Other Health Policy News
- On June 20, 2019, CMS issued renewed guidance to state Medicaid agencies that outlined the necessary assurances that states should make to ensure that program resources are reserved for those who meet eligibility requirements. The guidance is available here.