White House Press Notice Criticized For Potential Hatch Act Violation

A White House notice blaming Democrats for its press office staffing shortages and delayed responses to reporters is drawing scrutiny from ethics experts for potentially violating the Hatch Act by injecting partisan politics into official government communications, after agencies including HHS also posted partisan shutdown messages on their websites.

Tags: 
HHS
CDC
NIH
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 10/17/2025
FDA Volume: 
Vol. 31, No. 42

CBO Says Diagnostics Would Spike Bipartisan Breakthrough Device Coverage Bill’s Cost

SAN DIEGO -- The Congressional Budget Office (CBO) reportedly has estimated that adding diagnostics to a bipartisan bill expediting Medicare coverage for FDA-designated and authorized breakthrough devices would balloon the legislation’s cost by at least threefold.

Site Name: 
InsideHealthPolicy.com
Author: 
Christian Robles

Manufacturers Discuss Lessons Learned From First TCET NCDs

SAN DIEGO -- The first medical device manufacturers to receive national coverage determinations (NCDs) through a Medicare coverage pathway known as Transitional Coverage for Emerging Technologies (TCET) reported a positive experience working with CMS, but saw challenges, including communicating new coverage policies with hospitals and Medicare Advantage plans.

Site Name: 
InsideHealthPolicy.com
Author: 
Christian Robles

Study Finds Poor Evidence For Many FDA Breakthrough Devices

A study examining the products approved through FDA’s breakthrough devices program found FDA usually did not require postmarket studies for devices approved through the pathway even when they relied on surrogate endpoints or lacked statistical testing, raising questions about whether the program is meeting its objectives.

Site Name: 
InsideHealthPolicy.com
Author: 
Jessica Karins

Judge Lets Admin Pause Suit Over Limits To Short-Term Plans Until Mid-2026

A federal district judge in Texas this week granted the government’s request to pause a challenge to the Biden administration’s short-term plan rule through summer 2026 -- at which time Trump administration intends to issue a new draft rule that will likely allow short-term plans to last beyond the three-month limit in the Biden-era regulation.

Tags: 
ACA
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 10/16/2025
CMS Volume: 
Vol. 28, No. 42
Author: 
Amy Lotven

HHS Workers Included In Shutdown RIF, Details Of Layoffs Unclear

The Trump administration is firing HHS employees across multiple divisions as part of the new massive reductions in force it announced Friday (Oct. 10) in response to the government shutdown, but it hasn’t disclosed specifically which HHS workers are affected.

Tags: 
shutdown
appropriations
personnel
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 10/17/2025
FDA Volume: 
Vol. 31, No. 42
CMS Issue: 
Inside CMS - 10/16/2025
CMS Volume: 
Vol. 28, No. 42
Author: 
Jessica Karins

Sen. Susan Collins (R-ME)

Sen. Patty Murray (D-WA)

American Federation Of Government Employees

American Lung Association


ACIP Childhood Vaccine Work Group To Examine Aluminum Adjuvants, Coadministration

CDC’s Advisory Committee on Immunization Practices is starting up a new work group that will revisit the childhood and adolescent vaccination schedules and consider anti-vaccine talking points such as whether aluminum adjuvants are harmful and whether coadministration of vaccines increases risks of adverse events.

Tags: 
Vaccines
adcomms
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 10/17/2025
FDA Volume: 
Vol. 31, No. 42
Author: 
Jessica Karins

Oz: CMS ‘Loaded, Ready To Go’ With AI Tools To Monitor MA Plans If They Don’t Voluntarily Reform

CMS Administrator Mehmet Oz said that the Trump administration is offering Medicare Advantage (MA) insurers a limited window to voluntarily address concerns about rising costs, warning that federal regulators are now equipped with sophisticated artificial intelligence (AI) systems to track plan behavior and are prepared to act if industry-led reforms fall short.

Tags: 
AI
MA
RADV
trump
fraud
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 10/16/2025
CMS Volume: 
Vol. 28, No. 42
Author: 
Jalen Brown

Appeals Court Takes Up Whether Iowa’s PBM Law Rightfully Bans Copay Accumulators

The hot-button issue of whether states can bypass ERISA and pass laws requiring pharmacy benefit managers to count copay assistance towards patients’ deductibles and out-of-pocket costs is before the Eighth Circuit appeals court, with a national HIV patient advocacy group weighing in to defend Iowa’s copay accumulator ban after it was largely upheld by a lower court.

Tags: 
drug-reimbursement
Site Name: 
InsideHealthPolicy.com
CMS Issue: 
Inside CMS - 10/16/2025
CMS Volume: 
Vol. 28, No. 42
Author: 
Luke Zarzecki

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