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Midterm Politics

GOP Requests Explicit Congressional Authority For Upcoming HHS Rules

Ahead of a midterm election in which Republicans could regain control of Congress, House Republicans signaled they want to limit the Biden administration’s ability to set department policies with a letter that demands HHS and other agencies explain the “specific Congressional authority” for all upcoming rulemakings, citing a recent Supreme Court ruling to buttress their claims the Biden administration overstepped its authority on certain COVID-19 vaccine and testing mandates.

Biden Increases Focus On Medicare Ahead Of November Midterms

Latest Pandemic News

CMS Will Extend Remote Work Flexibilities For Lab Staff Past End Of PHE

FDA on Tuesday (Sept. 27) announced it will only review a “small subset” of emergency use authorization requests for COVID-19 tests, and the agency is encouraging COVID-19 test developers to pursue traditional premarket review through the de novo or 510(k) pathways.

FDA To Review Fewer COVID Test EUAs, Focus On Premarket Reviews

HHS Makes 60K Replacement Doses Of Bebtelovimab Available For Uninsured

CDC Says Health Care Facilities Can Drop Universal Masking In Some Counties

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Latest News

Advocates are increasingly optimistic mental health reforms will make it into a year-end package after the House passed legislation Thursday (Sept. 29) that would support behavioral health in schools.

Key House lawmakers on Friday (Sept. 30) pledged to keep working with the Senate to pass FDA reforms in a year-end legislative package, coming as both chambers passed a stop-gap bill to fund the government through Dec. 16.

A minimum staffing ratio for the nursing home sector is a good policy in a vacuum, but likely would require more dollars in the system, Congress’ Medicare payment advisers said this week.

HHS' eventual unwinding of the public health emergency could cause over 4.6 million Latines to lose Medicaid coverage, over 60% of whom could still be eligible for Medicaid, CMS officials and health policy experts said during the agency’s most recent (Sept. 28) webinar on the PHE unwinding.

CMS on Thursday (Sept. 29) announced Medicare Advantage premiums are set to drop to an average of $18 a month for 2023, down about 8% from 2022, and the agency estimates 31.8 million people will sign up for an MA plan for 2023 as Medicare open enrollment starts Oct. 15.

FDA on Thursday (Sept. 29) approved Amylyx Pharmaceuticals’ high-profile amyotrophic lateral sclerosis drug Relyvrio, which FDA and the company say could potentially meet an unmet need in ALS treatment, even though questions have been raised about the drug’s efficacy.

The Senate on Thursday (Sept. 29) passed by unanimous consent a bipartisan bill that would eliminate requirements that experimental drugs first be tested on animals.

FDA and the Veterans Health Administration on Wednesday (Sept. 28) announced they will collaborate to develop and disseminate new tools to test the safety and effectiveness of medical devices and emerging technologies, with an initial focus on interoperable systems that can help advance automation, telemedicine and personalized health care.

FDA’s warning that certain insulin pumps are vulnerable to cyberattacks, potentially allowing hackers to prevent insulin delivery or change patients’ dosages, marks the first FDA cybersecurity alert for a medical device since a new guidance on the topic was issued in April, and comes as the FBI identifies medical devices vulnerabilities as a growing concern.

A federal district court on Wednesday (Sept. 28) directed Medicare to immediately begin paying hospitals in full for 340B drugs after the U.S. Supreme Court in July overturned a nearly 30% pay cut for Part B drugs obtained through the 340B discount program.