Alston & Bird Healthcare Week in Review, June 15, 2018

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 June 12, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input. The FDA is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders. This guidance is the first of a series of four methodological guidance documents that FDA committed to develop to address in a stepwise manner on how to collect and submit information from patients and caregivers for medical product development and regulatory decision making.
• On June 12, 2018, the FDA issued guidance entitled, Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers. This guidance provides information for manufacturers, packers, and distributors and their representatives (collectively “firms”) of drugs and medical devices for humans, including those that are licensed as biological products, and animal drugs (collectively “medical products”), about how FDA evaluates their medical product communications that present information that is not contained in the FDA required labeling for the product but that may be consistent with the FDA-required labeling for the product. The Agency is issuing this guidance to explain FDA’s current thinking on commonly asked questions regarding such communications to provide clarity for firms. FDA is also announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
• On June 13, 2018, the FDA issued a final order entitled, Gastroenterology-Urology Devices; Classification of the Endoscopic Electrosurgical Clip Cutting System. The FDA is classifying the endoscopic electrosurgical clip cutting system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic electrosurgical clip cutting system’s classification. The FDA is taking this action because the FDA has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. The FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.

Event Notices

• June 20, 2018: HRSA announced a public meeting of the Council on Medical Education (COGME). During the meeting, COGME members will discuss strategic directions and issues related to physician workforce development and graduate medical education.        
• 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 1, 2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The CSAT NAC will discuss substance use disorder spending estimates and the opioid epidemic.
• 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

U.S. Senate

• On June 12, 2018, the Senate Health, Education, Labor and Pensions Committee held a hearing entitled, The Cost of Prescription Drugs: Examining the President’s Blueprint ‘American Patients First’ to Lower Drug Prices. The Department of Health and Human Services Secretary Alex Azar was the only witness present.
• On June 12, 2018, the Senate Finance Committee held a markup entitled, Open Executive Session to Consider an Original Bill Entitled Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018. The Committee reported the bill favorably to the Senate floor by a 27-0 vote.
• On June 14, 2018, the Senate Judiciary Committee held an executive business meeting to consider health-related legislation, including S. 2837 Preventing Drug Diversion Act of 2018 and S. 974 CREATES Act of 2017. Both bills were advanced to the Senate floor.

House of Representatives

• On June 15, 2018, House Energy and Commerce Oversight Subcommittee held a hearing entitled, State of the U.S. Public Health Biopreparedness: Responding to Biological Attacks, Pandemics, and Emerging Infectious Disease Outbreaks. Witnesses included: Dr. Rick Bright, Director, Biomedical Advanced Research and Development Authority; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Rear Admiral Denise Hinton, Chief Scientist, FDA; and Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention.

III. Reports, Studies, & Analyses

• On June 12, 2018, the Atlantic reported on health disparities among race in Baltimore City, MD. The report also focused on the social determinants of health and how they impact individuals’ overall health.

IV. Other Health Policy News

• On June 14, 2018, the American Academy of Actuaries issued a brief entitled, Drivers of 2019 Health Insurance Premium Changes. The brief found a number of factors driving premium changes, including the elimination of the individual mandate, the pending expanded availability of short-term limited duration plans and association health plans.