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 edition of the Week in Review contains major updates on various regulatory actions along with reports and studies recently released.
For a full update on coronavirus actions, visit the Coronavirus Flash Update, here.
I. Regulations, Notices, & Guidance
- On March 6, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule entitled, Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-facilitated Exchanges, and Health Care Providers. The final rule is intended to move the health care ecosystem in the direction of interoperability, and to signal our commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813 to improve the quality and accessibility of information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reported burdens on affected health care providers and payers.
- On March 20, 2020, the Department of Health and Human Services (HHS) issued a notice entitled, Solicitation for Public Comments on Section 209 of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act. The Office of the Assistant Secretary for Health in HHS seeks public comment regarding Section 209 of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPA). Congress passed PAHPA in June 2019 and Section 209 states that HHS shall submit to Congress a report containing recommendations related to maintaining an adequate national blood supply. The legislation poses four specific questions regarding the adequacy of the national blood supply. HHS welcomes any public feedback related to how these questions should be addressed and/or potential solutions. The set of questions is included in the link.
- On March 20, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency. The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this notice and the guidance as compounders) for the duration of the public health emergency declared by the HHS Secretary on January 31, 2020. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
- On March 20, 2020, the FDA issued a notice entitled, Process for Making Available Guidance Documents Related to Coronavirus Disease 2019. The FDA is announcing the process for making available FDA guidance related to the coronavirus disease 2019 public health emergency. The FDA believes that this process will allow the Agency to rapidly disseminate essential agency recommendations and policies related to COVID-19 to industry, FDA staff, and other stakeholders.
- On March 20, 2020, the HHS published a rule entitled, Control of Communicable Diseases; Foreign Quarantine: Suspension of Introduction of Persons into United States from Designated Foreign Countries or Places for Public Health Purposes. This interim final rule provides a procedure for the Centers for Disease Control and Prevention (CDC) to suspend the introduction of persons from designated countries or places, if required, in the interest of public health.
- On March 20, 2020, the HHS published a notification of order entitled, Order Suspending Introduction of Persons from a Country Where a Communicable Disease Exists. This document is to inform the public that the CDC has issued an order suspending the introduction of persons into the United States.
Event Notice
- April 15, 2020: the National Institutes of Health (NIH) announced a Committee meeting of the National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Resource-Related Research Projects.
- April 16, 2020: the FDA announced a public meeting entitled, Scientific and Ethical Considerations for the Inclusions of Pregnant Women in Clinical Trials. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
II. Congressional Hearings
U.S. Senate
- No health care-related hearings this week.
House of Representatives
- No health care-related hearings this week.
III. Reports, Studies, & Analyses
- On March 20, 2020, the Congressional Budget Office (CBO) issued a report entitled, Baseline Budget Projections as of March 6, 2020. The document provides the CBO’s spring 2020 baseline budget projections and explains how they differ from the projections published earlier this year.
IV. Other Health Policy News
- On March 18, 2020, H.R. 6201, the Families First Coronavirus Response Act was singed into law.
Click here to view the members of our Health Care Legislative & Public Policy team.