Department of Health and Human Services October 7, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act'' (``revised draft guidance''). This revised draft guidance, when finalized, will describe how FDA intends to apply certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to human drug products compounded by State- licensed pharmacies that are not outsourcing facilities and distributed for use within a hospital or health system. First, it addresses the requirement that compounding be based on the receipt of a valid prescription order for an identified individual patient. Second, it addresses the provision concerning compounded drug products that are essentially copies of a commercially available drug product. This draft guidance revises the draft guidance issued in 2016 entitled, ``Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act'' (``draft guidance''). FDA is revising the draft guidance to address stakeholder feedback and provide further clarification on policies regarding hospital and health system compounding. This revised draft guidance is not final nor is it in effect at this time.

On behalf of the Interagency Autism Coordinating Committee (IACC), the National Institute of Mental Health (NIMH) Office of Autism Research Coordination (OARC) is seeking public comments to assist the IACC in identifying priorities for the 2021-2022 update of the IACC Strategic Plan for Autism Spectrum Disorder (ASD) as required by the Autism Collaboration, Accountability, Research, Education and Support (CARES) Act of 2019. The IACC is requesting public comments on research, services, and policy issues related to the seven topics addressed by the IACC Strategic Plan: Screening and Diagnosis, Biology, Risk Factors, Treatments and Interventions, Services, Lifespan Issues, and Infrastructure and Surveillance. The IACC is also requesting information on two additional issues related to autism described in two supplemental questions that are included in this Request for Public Comment.

This document sets forth interim final rules implementing certain provisions of the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021. These interim final rules implement provisions of the No Surprises Act that provide for a Federal independent dispute resolution (IDR) (Federal IDR) process to permit group health plans and health insurance issuers offering group or individual health insurance coverage and nonparticipating providers, facilities, and providers of air ambulance services to determine the out-of-network rate for items and services that are emergency services, nonemergency services furnished by nonparticipating providers at participating facilities, and air ambulance services furnished by nonparticipating providers of air ambulance services, under certain circumstances. The Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury (collectively, the Departments) are issuing these interim final rules with largely parallel provisions that apply to group health plans and health insurance issuers offering group or individual health insurance coverage and certified IDR entities, providers, facilities, and providers of air ambulance services. In addition to the interim final rules issued jointly by the Departments, this document also includes interim final rules issued by the Office of Personnel Management (OPM) to clarify how certain No Surprises Act provisions apply to health benefits plans offered by carriers under the Federal Employees Health Benefits (FEHB) Act. In addition to the interim final rules issued jointly by the Departments and OPM, this document includes interim final rules issued by HHS that address good faith estimates of health care items and services for uninsured or self-pay individuals and the associated patient-provider dispute resolution process. The HHS-only interim final rules apply to selected dispute resolution (SDR) entities, providers, facilities, and providers of air ambulance services.