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 3, 2019, the Centers for Medicare & Medicaid Services (CMS) issued an extension of comment period on the proposed rule entitled, Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analyses and Acceptable Performance. The comment period for the proposed rule, which would end on April 5, 2019, is extended 60 days.
- On April 5, 2019, CMS issued a final rule entitled, Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021. This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Bipartisan Budget Act of 2018; improve quality and accessibility; clarify certain program integrity policies for MA, Part D, and cost plans and PACE organizations; reduce burden on providers, MA plans, and Part D sponsors through providing additional policy clarification; and implement other technical changes regarding quality improvement. This final rule will also revise the appeals and grievances requirements for certain Medicaid managed care and MA special needs plans for dual eligible individuals to implement certain provisions of the Bipartisan Budget Act of 2018.
- April 10, 2019: The FDA announced a public meeting entitled, Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards. The purpose of the meeting is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission systems’ past performance, future targets, emerging industry needs and technology initiatives.
- April 29, 2019: The FDA announced a public meeting entitled, Perspectives on the Impact of Rare Diseases: Bridging the Commonalities. The meeting is intended to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to asses commonalities that may help the FDA and medical product developers further understand and advance the development of treatments for rare diseases.
- 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.
II. Congressional Legislation & Committee Action
- On April 2, 2019, the Senate Committee on Aging held a hearing entitled, Alzheimer’s: New Directions in Biomedical Research and Caregiving. Witnesses present included: Mary Hartt, Family Caregiver; Clay Jacobs, Executive Director, Greater Pennsylvania Area Chapter of the Alzheimer’s Association; Sharon Fekrat, Professor of Ophthalmology and Associate Professor of Surgery, Duke School of Medicine; and Richard Hodes, Director, National Institute on Aging, NIH.
House of Representatives
- On April 2, 2019, the House Energy and Commerce Subcommittee on Oversight held a hearing entitled, Priced Out of a Lifesaving Drug: The Human Impact of Rising Insulin Costs. Witnesses present included: Dail DeVore, Patient Advocate; William Cefalu, Scientific Medical and Mission Officer, American Diabetes Association; Alvin Powers, Endocrine Society Representative, Vanderbilt Medical School; Kasia Lipska, Yale –New Haven Hospital, Yale Medical School; Christel Aprigliano, CEO, Diabetes Patient Advocacy Coalition; and Aaron Kowalski, Chief Mission Officer, JDRF.
- On April 2, 2019, the Education & Labor Subcommittee on Health, Employment, Labor, and Pensions held a hearing entitled, Examining Surprise Billing: Protecting Patients from Financial Pain. Witnesses present included: Christen Linke Young, Fellow, USC-Brookings Schaeffer Initiative on Health Policy; Ilyse Schuman, Senior Vice President, Health Policy at American Benefits Council; Frederick Isasi, Executive Director, Families USA; and Professor Jack Hoadley, Georgetown University.
- On April 3, 2019, the House Energy and Commerce Committee held a markup entitled, Markup of H.R. 1644, H.R. 1781, H.R. 938, H.R. 1520, H.R. 1503, H.R. 1499, H.R. 965, H.R. 1385, H.R. 1386, H.R. 987, H.R. 1010, H.R. 986, H.R. 1425, H.R. 9.
III. Reports, Studies, & Analyses
- On April 1, 2019, the Government Accountability Office (GAO) issued a report entitled, Behavioral Health: Research on Health Care Costs of Untreated Conditions is Limited. GAO was asked to describe what is known about adults with untreated behavioral health conditions and examined reasons why some adults with behavioral health conditions do not receive treatment for their condition, and what is known about health care costs associated with untreated conditions. The GAO found, among other things, that not treating behavioral health conditions can lead to other health care costs, such as the costs of emergency care for an overdose. However, research on such costs is limited and there is no generally accepted estimate of all the health care costs associated with untreated behavioral health conditions.
IV. Other Health Policy News
- On April 4 and 5, 2019, the Medicare Payment and Access Commission (MedPAC) held their April meeting. The agenda is available here.
- On April 1, 2019, Centers for Medicare & Medicaid Services (CMS) issued a letter entitled, Announcement of Calendar Year (CY) 2020 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. The announcement included the Calendar Year (CY) 2020 final policy and payment updates to the MA and Part D programs, among other policy initiatives.