FDA Pick Makary’s Conventional Background Could Clash With Some Of RFK Jr.’s Views

Surgeon and author Marty Makary, President-elect Donald Trump’s choice to head FDA, has a more conventional background than Trump’s picks for the top roles at HHS and CMS, which could set him up to clash with “Make American Healthy Again” priorities on some topics while sharing common ground on others, including his desire to reverse course on FDA’s current endorsement of universal and regular COVID-19 vaccination. Unlike Kennedy, Makary has called for FDA to speed up its product reviews, and...
Article Type: 
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/29/2024
FDA Volume: 
Vol. 30, No. 48
Author: 

CCIIO Touts 2.4M Transitions From Medicaid To Exchanges; CPI Says 900 Brokers Suspended

About 2.4 million people transitioned from Medicaid to an exchange plan after the restart of eligibility redeterminations, CMS’s exchange director Ellen Montz said during a stakeholders call Wednesday, where she touted a beefed-up relationship between the Center for Consumer Information and Insurance Oversight (CCIIO) and Medicaid and other achievements during her tenure as director of the CCIIO. Meanwhile, the Center for Program Integrity reported that 900 agents/brokers have been suspended from the marketplace over unauthorized plan enrollments and switches. “Last...
Article Type: 
Tags: 
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 11/28/2024
CMS Volume: 
Vol. 27, No. 48
Author: 

CMS Highlights 500K New Enrollments In First Snapshot Of OE 12

More than 496,000 new consumers selected an 2025 Affordable Care Act (ACA) plan through healthcare.gov or a state-based exchange since Nov. 1, and 2.5 million consumers returned to the marketplaces to pick a plan CMS says in its first snapshot of the 12th ACA open enrollment period out Friday (Nov. 22). The total 3.02 million enrollments fall far short of the 4.6 million that CMS reported in its first snapshot last year, but CMS expects to build on last year’s...
Article Type: 
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 11/28/2024
CMS Volume: 
Vol. 27, No. 48
Author: 

Bipartisan Bill Would Permanently Fund, Expand Medicare FLEX Program

The Medicare Rural Hospital Flexibility (FLEX) program, which gives states grants to support critical access hospitals, would be permanently reauthorized, expanded and made more flexible under a bipartisan, bicameral bill unveiled this week in recognition of Rural Health Day on Thursday (Nov. 21). The current FLEX program funding cycle ends in 2028, but the proposed Rural Hospital Flexibility Act of 2024 would grant the program permanent reauthorization for each fiscal year moving forward. The bill would expand eligibility for FLEX...
Article Type: 
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 11/28/2024
CMS Volume: 
Vol. 27, No. 48
Author: 

Dems Call For Final March-In Rights Framework Before Trump Takes Over

Democratic lawmakers are pressing the Biden administration to finalize a framework floated last year that would allow the government to use its rarely invoked march-in authority as a tool to lower the cost of expensive prescription drugs developed using U.S. taxpayer funding. President-elect Donald Trump issued an 11th-hour proposal before leaving his first term that prohibited use of march-in rights to license third parties to manufacture more affordable versions of drugs developed with federal funding. President Joe Biden quickly rescinded...
Article Type: 
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 11/25/2024
IDP Volume: 
Vol. 7, No. 48
Author: 

CDRH Pilot Program Aims To Speed Up Device Recall Notifications

FDA’s Center for Devices and Radiological Health (CDRH) is initiating a pilot program that aims to provide swifter communications about corrective actions taken in response to high-risk recalls, the agency said Thursday (Nov. 21). Those actions may include products being removed from the market, correction of products or updated instructions for product use. The pilot program will focus on high-risk devices in the areas of cardiovascular and gastrorenal medicine, general hospital devices, obstetrics and gynecology, and urology. It will provide...
Article Type: 
Tags: 
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/29/2024
FDA Volume: 
Vol. 30, No. 48
Author: 

FDA Digital Health Meeting Highlights Pre- And Post- Market Proposals for Generative AI Devices

FDA and digital health advisory committee (DHAC) members suggested a slew of generative artificial intelligence policies at their inaugural meeting this week, including new guidance for manufacturers on crafting post-market monitoring plans and calculating AI hallucinations along with requirements around stress testing AI, reporting AI errors to a centralized database and AI output watermarks. During the DHAC’s meeting on Wednesday and Thursday (Nov. 20-21), FDA officials also articulated unique challenges regulators see with generative AI-enabled devices, such as manufacturers struggling...
Article Type: 
Site Name: 
InsideHealthPolicy.com
Author: 

Amended PREVAIL Act Advances Out Of Senate Judiciary, But Updates Possible

The Senate Judiciary Committee on Thursday (Nov. 21) voted 11-10 to pass an amended version of S. 2220, the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act, that aims to update mechanisms used by the Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) to adjudicate patent validity without preventing patient advocacy groups or generic drug makers from challenging patents, but further revisions to the bill are possible. Several lawmakers who voted for the bill argued the...
Article Type: 
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 11/25/2024
IDP Volume: 
Vol. 7, No. 48
Author: 

Stakeholders Hope Hep C Bill Could Emerge As A Pay-For In The Lame Duck, Beyond

Updated Story A bill in the works that would create a subscription-style model for hepatitis C treatment for Medicaid patients, people who are uninsured, those in the prison and jail system and those on Native American reservations cared for by the Indian Health Service received a positive score from the Congressional Budget Office (CBO) and is being pushed as a payfor in a possible lame duck package or in broader health care legislation next Congress, sources tell...
Article Type: 
Tags: 
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/29/2024
FDA Volume: 
Vol. 30, No. 48
CMS Issue: 
Inside CMS - 11/28/2024
CMS Volume: 
Vol. 27, No. 48
Author: 

New Trump AG Choice, Pam Bondi, Led First Lawsuit To Overturn ACA

President-elect Donald Trump’s new pick for attorney general, Florida AG Pam Bondi, has a long record of suing the federal government to block expansion of health care programs, including leading the first lawsuit that aimed to overturn the Affordable Care Act (ACA), though the Supreme Court’s response to her efforts has been mixed. Trump announced Bondi as his pick for the position Thursday night (Nov. 21), after his first choice, former congressman Matt Gaetz, stepped aside. Bondi served as the...
Article Type: 
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 11/28/2024
CMS Volume: 
Vol. 27, No. 48
Author: 

Pages

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.