House Energy and Commerce to Hold Hearing on Drug Pricing Legislation
Senate
Senators Thune and Carper Reintroduce Bill on Chronic Disease Management
Administration
Biden Administration to Divert Raw Materials for COVID-19 Vaccine and Provide Other Supplies to India
CDC Issues New Guidance for Vaccinated Americans
FDA Panel Votes to Keep Tecentriq on the Market
FDA to Propose Menthol Ban in Next Year
HHS Will Distribute $1 Billion for Community Health Centers
HHS Removes Some Prescribing Barriers for Buprenorphine
Final Rules
CMS Extends Comprehensive Joint Replacement Model Demonstration for Three Years
Proposed Rules
CMS Issues Proposed Rule on Payment Rates and Policies for Inpatient and Long-Term Hospitals
Examining Our COVID-19 Response: Using Lessons Learned to Address Mental Health and Substance Use Disorders”
10:00 a.m.
Senate Appropriations Committee Subcommittee on the Interior, Environment, and Related Agencies Hearing:
“Addressing Health Disparities in Indian Country: Review of the Indian Health Service’s COVID Response and Future Needs”
10:00 a.m.
Senate Appropriations Committee Subcommittee on Military Construction, Veterans Affairs, and Related Agencies Hearing:
“VA Telehealth Program: Leveraging Recent Investments to Build Future Capacity”
3:00 p.m.
May 4
House Energy and Commerce Committee Hearing: “
To Discuss the Reintroduction of the Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3)”
House
House Republicans Introduce Drug Pricing Legislation
House Passes Eight Health Care Bills
House Members Divided on Fentanyl Analogue Scheduling
Rep. Kevin Brady to Retire
Senate
Bipartisan Bill Would Require Cost-Free Breast Cancer Diagnostic Tests
Senators Ask HHS Secretary Becerra to Enforce Hospital Price Transparency Rule
Administration
HHS Secretary Becerra Approves Illinois Waiver for One-Year Postpartum Coverage
HHS to Roll Back Title X “Gag Rule”
HHS Secretary Becerra Confirms That Department Will Have Feedback Process on Surprise Billing
CMS Extends 2022 Deadline for Primary Care First Demonstration
Consumers First Coalition Recommends CMS Undertake Medicare Reforms
IRS Suspends Requirement That Taxpayers Repay Advanced Premium Tax Credits
FDA Details Plan for Remote Facility Inspections
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 proposed FY 2022 payment updates for inpatient psychiatric and rehabilitation facilities, hospice, and skilled nursing facilities. Read more about the updates and other news below.
I. Regulations, Notices & Guidance
On April 5, 2021, the Food and Drug Administration (FDA) issued guidance entitled,
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic Questions and Answers Guidance for Industry. FDA is issuing this guidance to provide general recommendations to prospective applicants and applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions in the form of