Healthcare Week in Review March 29, 2019

Alston & Bird Healthcare Week in Review, March 29, 2019

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 March 27, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability. This guidance is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. This guidance finalizes the draft guidance issued on February 28, 2013.
  • On March 28, 2019, the FDA issued guidance entitled, Review and Update of Device Establishment Inspection Processes and Standards; Draft Guidance for Industry; Availability. FDA is issuing this draft guidance document to comply with changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA), which requires that FDA review and update, as needed, the processes and standards applicable to inspections (other than for-cause) of domestic and foreign medical device establishments in place as of August 18, 2017. This draft guidance describes how FDA will implement uniform inspection processes and standards. The draft guidance also describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments. This draft guidance is not final nor is it in effect at this time.
  • On March 28, 2019, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period entitled, Medicaid Program; Covered Outpatient Drug; Line Extension Definition; and Change to the Rebate Calculation for Line Extension Drugs. This interim final rule with comment period revises the regulatory text to accurately reflect the applicable statutory language describing the rebate calculation for line extension drugs, which was revised by the Bipartisan Budget Act (BBA) of 2018. In addition, CMS is issuing a final rule which responds to comments on the definition and identification of line extension drugs for which CMS requested additional comments in the Covered Outpatient Drugs final rule with comment period published in the February 1, 2016 Federal Register.
  • On March 29, 2019, CMS issued a proposed rule entitled, Basic Health Program; Federal Funding Methodology for Program Years 2019 and 2020. This document proposes the methodology and data sources necessary to determine federal payment amounts to be made in program years 2019 and 2020 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges. Prior to the final notice being published, Basic Health Program (BHP) payments will be made using the methodology described in the Final Administrative Order published on August 24, 2018. Payments for 2019 will be conformed to the finalized 2019 payment methodology through reconciliation.
Event Notices   
  • April 2-3, 2019: The Health Resources and Service Administration (HRSA) announced a meeting of the National Advisory Council on the National Health Service Corps (NHSC). No agenda has been posted but the Council is expected to make recommendations on the NHSC.
  • 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.

II. Congressional Legislation & Committee Action

U.S. Senate   House of Representatives

III. Reports, Studies, & Analyses

IV. Other Health Policy News

  • On March 26, 2019, a Quinnipiac University poll found that voters were split on a single-payer health care system. Approximately 45 percent thought it was a bad idea whereas 43 percent thought it was a good idea.
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