General Publications June 8, 2018

Alston & Bird Healthcare Week in Review, June 8, 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 4, 2018, the Food and Drug Administration (FDA) issued a notice entitled, Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry; Availability. This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. The previous guidance for industry entitled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,” issued on November 18, 2015, has been withdrawn.
  • On June 6, 2018, the Department of Health and Human Services (HHS) issued a request for information entitled, Facilitation of Public-Private Dialogue to Increase Innovation and Investment in the Healthcare Sector. This request for information solicits public comment on a planned initiative of the Office of the Deputy Secretary of HHS to develop a workgroup to facilitate constructive, high-level dialogue between HHS leadership and those focused on innovating and investing in the healthcare industry. HHS seeks comment on how to structure a workgroup, or other form of interaction between the Department and such participants in the healthcare industry, in order to best support communication and understanding between these parties that will spur investment, increase competition, accelerate innovation, and allow capital investment in the healthcare sector to have a more significant impact on the health and wellbeing of Americans. HHS also seeks comment more broadly on opportunities for increased engagement and dialogue between HHS and those focused on innovating and investing in the healthcare industry.
  • On June 6, 2018, the FDA issued guidance entitled, Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for President's Emergency Plan for AIDS Relief. This draft guidance describes circumstances under which an applicant may be eligible for a barrier-to-innovation waiver for some new drug applications (NDAs) for fixed-combination versions and single-entity versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV).
  • On June 7, 2018, the Center for Medicare and Medicaid Services (CMS) issued a rule entitled, Changes to the Comprehensive Care for Joint Replacement Payment Model: Extreme and Uncontrollable Circumstances Policy for the Model. This final rule finalizes a policy that provides flexibility in the determination of episode spending for Comprehensive Care for Joint Replacement Payment Model (CJR) participant hospitals located in areas impacted by extreme and uncontrollable circumstances for performance years 3 through 5.

Event Notices

  • June 15, 2018: The Health Resources and Services Administration (HRSA) 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 20, 2018: HRSA announced a public meeting of the Council on Graduate 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 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

  • No health care-related hearings this week.

House of Representatives

  • On June 6, 2018, the House Ways and Means Committee held a hearing entitled, Lowering Costs and Expanding Access to Health Care through Consumer-Directed Health Plans. Witnesses present included, Roy Ramthun, President and Founder, HAS Consulting Services, LLC; Matt Eyles, President & CEO, America’s Health Insurance Plans; Jody Dietel, Chief Compliance Officer, WageWorks, Inc.; Sherry Glied, Dean, New York University, Robert Wagner Graduate School of Public Service.
  • On June 6, 2018, House Energy and Commerce Subcommittee on Health hearing entitled, Examining the Reauthorization of the Pandemic and All-Hazards Preparedness Act. Witnesses present included: Robert Kadlec, MD, Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS); Stephen Redd, MD, Rear Admiral, Director, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention (CDC); Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis, Food and Drug Administration (FDA); Umair Shah, MD, Executive Director, Harris County Public Health on behalf of the National Association of County and City Health Officials (NACCHO); M. Michelle Berrey, MD, President and Chief Executive Officer, Chimerix; Erik Decker, Chief Security and Privacy Officer, University of Chicago Medicine.
  • On June 6, 2018, the House Committee on Education and the Workforce held a hearing entitled, Examining the Policies and Priorities of the U.S. Department of Health and Human Services. HHS Secretary Alex Azar was the only witness present.

III. Reports, Studies, & Analyses

  • On June 8, 2018, the HHS Office of Inspector General (OIG) released a report entitled, Increases in Reimbursement for Brand-Name Drugs in Part D. The OIG drafted the report in response to recent congressional and media attention surrounding government reimbursement for prescription drugs. The OIG found that the total reimbursement for all brand-name drugs in Medicare Part D increased 77 percent from 2011 to 2015, despite a 17-percent decrease in the number of prescriptions.

IV. Other Health Policy News

  • On June 7, 2018, the Department of Justice (DOJ) announced that it will not defend the Affordable Care Act in ongoing litigation in Texas.
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