Alston & Bird Health Care Week in Review - August 2021 #1

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare 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, CMS issued its FY 2022 final rule updating Medicare’s Hospital Inpatient Prospective Payment System. Read more about this regulation and other news below.


I. Regulations, Notices & Guidance

  • On August 2, 2021, the Food and Drug Administration (FDA) issued guidance entitled, Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act. This guidance is extending the comment period for the notice of availability entitled “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability” that appeared in the Federal Register of June 4, 2021.
  • On August 3, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program. This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from CMS’s continuing experience with these systems for FY 2022 and to implement certain recent legislation. The final rule also updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2022. It also finalizes a May 10, 2021 interim final rule with comment period regarding rural reclassification through the Medicare Geographic Classification Review Board (MGCRB). The final rule also implements changes and updates for the Medicare Promoting Interoperability, Hospital Value-Based Purchasing, Hospital Readmissions Reduction, Hospital Inpatient Quality Reporting, Hospital Acquired Condition Reduction, the PPS-Exempt Cancer Hospital Reporting, and the Long-Term Care Hospital Quality Reporting programs. It also finalizes provisions that alleviate a longstanding problem related to claiming Medicare bad debt and provide a participation opportunity for eligible accountable care organizations (ACOs).
  • On August 3, 2021, the Department of Health and Human Services (HHS) issued a notice entitled, Eighth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19. This amendment is pursuant to section 319F–3 of the Public Health Service Act to clarify and expand the authority for certain Qualified Persons authorized to prescribe, dispense, and administer covered countermeasures under section VI of this Declaration.
  • On August 4, 2021, the FDA issued a notice entitled, Authorizations of Emergency Use of Certain Biological Products During the COVID-19 Pandemic. The notice issues two Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for biological products for use during the COVID-19 pandemic. FDA has issued one Authorization for a biological product as requested by GlaxoSmithKline LLC and one Authorization for a biological product as requested by Genentech, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized products.
  • On August 4, 2021, the FDA issued guidance entitled, Remanufacturing of Medical Devices. This guidance extends the comment period for the notice of availability that appeared in the Federal Register of June 24, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled “Remanufacturing of Medical Devices.”
  • On August 6, 2021, the FDA issued a notice entitled, Extension of the Period Before the Food and Drug Administration Intends to Begin Enforcing the Statutory 5 Percent Limit on Out of State Distribution of Compounded Human Drug Products. This notice extends the period for States to decide whether to sign the final standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S. Food and Drug Administration” (final standard MOU) before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the final standard MOU. FDA is extending the period, which was scheduled to end on October 27, 2021, to October 27, 2022.
  • On August 6, 2021, the FDA issued guidance entitled, Development and Submission of Near Infrared Analytical Procedures. This guidance provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products. The recommendations apply to new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs for small molecule drugs. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files.
  • On August 6, 2021, the FDA issued guidance entitled, Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials. Recent approvals of several drug products for patients with nonmetastatic castration-resistant prostate cancer have been supported by randomized clinical trials demonstrating improvements in metastasis-free survival. This guidance intends to inform potential future applicants regarding the Agency’s expectations for collection, analysis, and reporting of data pertaining to metastasis-free survival.
  • On August 6, 2021, the CMS issued a proposed rule entitled, Most Favored Nation Model. This proposed rule proposes to rescind the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020, Federal Register.

Event Notices

  • August 30, 2021: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a virtual public meeting of its National Advisory Council. The meeting will include remarks and discussion with the new Assistant Secretary for Mental Health and Substance Use; updates on SAMHSA priorities; follow up on topics related to the previous SAMHSA NAC meeting; new grant opportunities and initiatives, and a council discussion on clinical trends and emerging national issues with SAMHSA NAC members.
  • August 31-September 1, 2021: The National Institutes of Health (NIH) announced a virtual public meeting of the National Institute of Arthritis and Musculoskeletal and Skin Diseases Advisory Council. The Council will discuss program policies and issues, as well as review and evaluate grant applications.
  • August 31-September 1, 2021: NIH announced a virtual public meeting of the National Heart, Lung, and Blood Advisory Council. The Council will discuss program policies and issues.
  • September 1, 2021: FDA announced a virtual public workshop entitled, Advancing the Development of Pediatric Therapeutics Complex Innovative Trial Design. The purpose of the public workshop is to discuss applications of complex and innovative trial designs in pediatric clinical trials.
  • September 9-10, 2021: NIH announced a virtual public meeting of the National Advisory Child Health and Human Development Council of the National Institute of Child Health & Human Development (NICHD). The meeting will include opening remarks, administrative matters, NICHD Director's Report, and other business of the Council, as well as to review and evaluate grant applications.
  • September 9-10, 2021: NIH announced a virtual public meeting of the Fogarty International Center Advisory Board. The Board will review and evaluate grant applications, as well as provide an update and discuss current and planned Fogarty International Center activities.
  • September 15, 2021: NIH announced a virtual public meeting of the National Advisory Council on Drug Abuse. The Council will review and evaluate grant applications, as well as hold presentations and discuss other business of the Council.
  • September 29, 2021: The Centers for Disease Control and Prevention (CDC) announced a virtual public meeting of the Advisory Board on Radiation and Worker Health (ABRWH), Subcommittee for Dose Reconstruction Reviews (SDRR), National Institute for Occupational Safety and Health (NIOSH). The agenda will include discussions on various dose reconstruction program quality management and assurance activities. If time permits, there may also be discussion on professional judgement in response to the April 12, 2021 SDRR report to the Advisory Board.
  • October 14, 2021: NIH announced a virtual public meeting of the Division of the National Toxicology Program (DNTP). The meeting will peer review the Draft NTP Developmental and Reproductive Toxicity Technical Reports on 2-hydroxy-4-methoxybenzophenone and 2-ethylhexyl p-methoxycinnamate.

II. Congressional Hearings

U.S. Senate

III. Reports, Studies & Analyses

  • On August 5, 2021, the Government Accountability Office (GAO) published a report entitled, COVID-19: HHS’s Collection of Hospital Capacity Data. In this report, GAO describes (1) HHS's implementation of HHS Protect hospital capacity reporting requirements and the challenges experienced by reporting entities; (2) HHS's and stakeholders' use of the data, if at all; and (3) lessons learned about ensuring the collection of quality hospital capacity data during a public health emergency.
  • On August 5, 2021, the Kaiser Family Foundation (KFF) published an issue brief entitled, Medicaid Authorities and Options to Address Social Determinants of Health (SDOH). This brief describes options and federal Medicaid authorities states may use to address enrollees’ social determinants of health and provides state examples, including initiatives launched in response to the COVID-19 pandemic. The focus of this brief is on state-driven Medicaid efforts to address social determinants for nonelderly enrollees who do not meet functional status or health need criteria for home and community-based services (HCBS) programs.
  • On August 6, 2021, the RAND Corporation published a research brief entitled, Black Americans Cite Low Vaccine Confidence, Mistrust, and Limited Access as Barriers to COVID-19 Vaccination. This study finds that Vaccine confidence has improved among Black Americans, but mistrust plays a role in holding down vaccination rates.

IV. Other Health Policy News

  • On August 4, 2021, HHS provided $90 million to help rural communities combat opioid use disorders (OUD) and other forms of substance use disorders (SUD), and to improve access to maternal and obstetrics care. HHS is distributing the funding through the Health Resources and Services Administration (HRSA) across four programs within the Rural Community Opioid Response Program. More information about the funding decision can be found here.
  • On August 4, 2021, HHS announced that the American Rescue Plan lowered health costs for millions of Americans ahead of the August 15 deadline to get covered on HealthCare.gov. HHS said CMS released new data that shows returning consumers can save, on average, 40% off of their monthly premiums because of enhanced tax credits in the American Rescue Plan (ARP), and save with significantly lowered out-of-pocket costs. More information about the CMS data can be found here.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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