Healthcare Authority Newsletter - October 2025 #2

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News Briefs


Amid Shutdown, Telehealth Coverage Flexibilities Expired

Lawmakers missed a deadline to extend telehealth flexibilities in Medicare, disrupting virtual care reimbursement and access for beneficiaries across the country. Without a spending plan, the telehealth coverage flexibilities lapsed on Oct. 1.

(Source: Healthcare Dive, 2025-10-01)

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New Drug, Device Applications on Hold Amid Shutdown

With a government shutdown now in effect, the U.S. FDA -- already shaken up by head count reductions earlier this year -- has sought to keep many of its functions running for the foreseeable future. But the shutdown, which at least one former senator predicts could drag on for a month or more, will still have very real consequences for biopharma companies that don't yet have an application in with the regulator, experts warned.

(Source: Fierce Pharma, 2025-10-01)

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Despite Shutdown, CMS Says No Surprise Arbitration Continues

Arbitration of surprise billing disputes between insurers and providers will continue despite the government shutdown, the CMS said. Parties that disagree over how much an out-of-network claim should be reimbursed can still submit disputes via the federal independent dispute resolution portal, and arbiters will continue to process disputes, according to the agency.

(Source: Healthcare Dive, 2025-10-06)

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FDA Seeks Public Feedback on Measuring AI-Enable Medical Devices

The Food and Drug Administration is requesting public comment to get feedback on current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real world. This includes strategies for identifying and managing performance drift, such as detecting changes in input and output.

(Source: Healthcare Finance News, 2025-10-06)

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New H-1B Visa Fees Could Severely Impact Physician Shortage

Major medical groups are urging the Trump administration to exempt foreign healthcare workers from new H1-B visa application fees, saying the steep charge will exacerbate a clinician shortage and hit rural and underserved areas particularly hard. The Trump administration proclamation titled "Restriction on Entry of Certain Nonimmigrant Workers" took effect Sept. 21, imposing a $100,000 fee on every new H-1B visa petition.

(Source: FierceHealthcare, 2025-09-30)

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Hospitals Finding EHR Cyberthreats Can Come From Within

Data breaches in hospitals don't always come from malicious remote cybercriminals. Insider threats from fellow clinicians down the hall can also jeopardize the security of protected health information in EHRs, with a tactic known as EHR snooping. EHR snooping occurs when a healthcare worker inappropriately accesses patient records unrelated to their job function.

(Source: TechTarget, 2025-09-30)

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Nursing Homes to Feel Impact of New Reporting Requirements

Federal definitions of nursing home falls and related injuries, and how they must be reported, are changing. The changes threaten to compromise providers' compliance and reimbursement efforts -- even with no new risk to patients.

(Source: McKnight's Long-Term Care News, 2025-09-30)

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Spending, Prices Rising as Physician Consolidation Increases

Physician consolidation has accelerated over the past decade, resulting in increased spending and prices, according to a new Government Accountability Office report. At least 47 percent of physicians were employed by or affiliated with hospitals in 2024, compared to under 30 percent in 2012, according to a study by the American Medical Association cited by GAO. Private equity firms owned an estimated 6.5 percent of physicians, and corporate entity employment rose from 15 percent in 2019 to 23 percent in 2024, various studies revealed.

(Source: HealthLeaders Media, 2025-10-03)

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Hospitals Say 340B Program Comes with Heavy Administrative Burden

The federal agency overseeing the controversial 340B Rebate Model Pilot Program has "vastly underestimated" how much time and money hospitals obligated to participate will spend on reporting burdens, the American Hospital Association wrote in a letter. The one-year test run -- largely supported by drugmakers and denounced by hospitals -- is set to kick off Jan. 1, with the Health Resources and Services Administration set to announce manufacturers' approved application and rebate plans by Oct. 15.

(Source: FierceHealthcare, 2025-10-02)

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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