I. Regulations, Notices, & Guidance
- On May 21, 2018, the Center for Medicare and Medicaid Services (CMS) issued a notice entitled, Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year; Corrections. The document makes technical corrections in the final rule with comment period published in the Federal Register on November 16, 2017 entitled, Medicare Program: CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year.
- On May 21, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Bioanalytical Method Validation; Guidance for Industry; Availability. The final guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data.
- On May 21, 2018, the FDA issued guidance entitled, Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment; Guidance for Industry; Availability. This guidance provides recommendations to industry for establishing the clinical effectiveness of drugs for the treatment of acne vulgaris (acne). This guidance finalizes the draft guidance for industry entitled, Acne Vulgaris: Developing Drugs for Treatment, which was issued September 19, 2005.
- On May 22, 2018, the FDA issued guidance entitled, Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph. This draft guidance addresses FDA’s current thinking on the conduct of in vivo absorption trials for topical active ingredients that are under consideration for inclusion in an over-the-counter monograph.
- 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 15, 2018: The Health Resources and Services Administration announced a public meeting of the Advisory Commission on Childhood Vaccines. The meeting agenda includes updates from other government agencies, including the Department of Justice and the FDA.
- June 25, 2018: The Center for Medicare and Medicaid Services (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.
- 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.
- June 26, 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 new drug application for oxycodone extended-release capsules, submitted by Pain Therapeutics.
- July 9, 2018: The FDA announced a public meeting on “Patient-Focused Drug Development for Chronic Pain.” The meeting will provide patients with an opportunity to present FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments.
- 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.
- 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.
- On May 22, 2018, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, The Health Care Workforce: Addressing Shortages and Improving Care. Witnesses present included Kristen Goodell, M.D., F.A.A.F.P., Assistant Professor of Family Medicine, Assistant Dean for Admissions, Boston University; Julie Sanford, D.N.S., R.N., F.A.A.N., Director and Professor, School of Nursing, James Madison University; and Elizabeth Phelan, M.D., M.S., Director, Northwest Geriatrics Workforce Enhancement Center, Associate Professor of Medicine, Gerontology and Geriatric Medicine, University of Washington.
- On May 23, 2018, the Senate Aging Committee held a hearing entitled, Preventing and Treating Opioid Misuse Among Older Americans. Witnesses present included Gary Cantrell, Deputy Inspector General for Investigations, Office of the Inspector General at the Department of Health and Human Services; Charles Pattavina, M.D., FACEP, Medical Director and Chief of Emergency Medicine; William Stauffer, Executive Director, Pennsylvania Recovery Organization Alliance; Nicolas Terry, Professor of Law and Executive Director of the William and Christine Hall Center for Law and Health at Indiana University.
- On May 23, 2018, the Senate HELP Committee held an executive session entitled, 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018. The Committee advanced the bill to the Senate floor by a 22-1 vote.
- On May 24, 2018, the Senate Finance Committee held a hearing entitled, Rural Health Care in America: Challenges and Opportunities. Witnesses present included George H. Pink, Ph.D., Humana Distinguished Professor, Deputy Director, NC Rural Health Research Program, Sheps Center for Health Services Research, University of North Carolina at Chapel Hill (UNC Chapel Hill); Keith J. Mueller, Ph.D., Interim Dean, College Of Public Health, Gerhard Hartman Professor In Health Management And Policy, Director, RUPRI Center For Rural Health Policy Analysis (RUPRI), Chair, RUPRI Health Panel, University of Iowa; Konnie Martin, Chief Executive Officer (CEO), San Luis Valley Health; Susan K. Thompson, MS, BSN, RN, Senior Vice President Of Integration and Optimization, CEO, UnityPoint Accountable Care, UnityPoint Health; and Karen M. Murphy, Ph.D., RN, Executive Vice President, Chief Innovation Officer, and Founding Director Of Glenn Steele Institute Of Health Innovation, Geisinger.
- On May 24, 2018, the Senate Committee on the Judiciary held an executive business meeting to consider opioid-related legislation. The Committee reported S. 2645, Access to Increased Drug Disposal Act; 2535, Opioid Quota Reform Act; 2789, Substance Abuse Prevention Act; S. 207, Synthetic Abuse and Labeling of Toxic Substances Act; and S. 2838, Using Data to Prevent Opioid Diversion Act of 2018 to the Senate floor.
- On May 23, 2018, the Committee on House Energy and Commerce Health Subcommittee held a hearing entitled, Reauthorization of the Children’s Hospital Graduate Education Medical Education Program. Witnesses present included Dr. Gordon Schutze, Executive Vice Chairman, Department of Pediatrics, Texas Children’s Hospital and Dr. Susan Guralnick, Associate Dean for Graduate Medical Education, University of California Davis, Representing the American Academy of Pediatrics.
- On May 22, 2018, the Government Accountability Office (GAO) released a report entitled, Medicare: CMS Should Take Actions to Continue Prior Authorization Efforts to Reduce Spending. GAO was asked to examine CMS’s prior authorization programs by reviewing program data, CMS documentation, and federal internal control standards. The report recommends that CMS (1) subject accessories essential to the power wheelchairs in the permanent durable medical equipment, prosthetics, orthotics, and supplies (DEMPOS) program to prior authorization and (2) take steps to continue prior authorization.
- On May 22, 2018, Congress passed S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, which would allow terminally ill patients who have exhausted approved treatment options and are unable to participate in a clinical trial to try certain investigational drugs that have not been approved by the FDA. The President is expected to sign the bill into law next week.