Health Care Week in Review: HHS Announced the Distribution of $49 Million to Organizations | Alston & Bird


Below is Alston & Bird’s Health Care Week in Review, which 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.

Week in Review Highlight of the Week:

This week, HHS announced the distribution of $49 million to organizations working to increase health care coverage for children, parents, expectant parents, and families. Read more about this action and other news below.

I. Regulations, Notices & Guidance

  • On July 18, 2022, the Centers for Medicare & Medicaid Services (CMS) issued guidance entitled, Failure to File and Reconcile (FTR) Operations Flexibilities for Plan Year 2023. This guidance relayed that the agency will continue to not act on data received from the Internal Revenue Service (IRS) for consumers who have failed to file tax returns and reconcile a previous year’s advance payments of the premium tax credit (APTC) and with the premium tax credit (PTC) for plan year 2023. The agency noted this flexibility was to account for the delay in processing income tax returns during the COVID-19 pandemic.
  • On July 20, 2022, the Food and Drug Administration (FDA) issued draft guidance entitled, Human Prescription Drug and Biological Products–Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers–“Dose Banding”. This guidance intends to assist applicants in incorporating dose banding information into drug labeling provided in a new drug application (NDA) submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a biologics license application (BLA) submitted under the Public Health Service Act (PHS Act), or a supplement to these applications. The guidance is specifically for applicants who propose to develop ready-to-use containers and seeks to incorporate dose banding information into the prescribing information of the proposed drug product based on dosing…