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Senate Finance Mental Health Task Force Releases Workforce Reforms

The latest Senate Finance Committee discussion draft released on Thursday (Sept. 22) tackles mental health workforce shortages, who can seek Medicare reimbursement and burnout across all health care sectors, and Chair Ron Wyden (D-OR) said the committee plans to unveil the last two discussion drafts on crisis care and mental health care parity soon.

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FDA Must Craft Better EUA Test Policies For Emergencies, OIG Says

HHS’ Office of the Inspector General says FDA should rethink and revise its policies around granting emergency use authorization to tests during public health emergencies, and better prepare for future emergency test needs by expanding resources and information for developers about the EUA process, improving communication with laboratories to identify issues with testing, and helping develop a national testing strategy that goes beyond the EUA process.

House Report Details ‘Horrors’ Of For-Profit Nursing Home Conditions

HHS Again Pledges 60-Day Notice Of PHE End As GOP Seizes On Biden Remarks

Fauci: U.S. ‘Not Where We Need To Be,’ New COVID-19 Variants Coming

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Provider groups continue to challenge the Biden administration’s interpretation of the independent dispute resolution (IDR) process created under the surprise billing law: On Wednesday the Texas Medical Association, which had already won its case over the administration’s interim final rule in district court, filed another case in the same court claiming that the recently released final rule still goes beyond congressional intent and skews in favor of insurers because it asks arbiters to place more weight on the qualified payment amount (QPA) than other factors.

Members of the National Security Advisory Board for Biosecurity emphasized the importance of finding alternative methods to answer the same research questions without taking on the risks inherent in some kinds of experimentation involving pandemic-potential pathogens (PPPs) at the board’s meeting Wednesday (Sept. 21).

The Council for Responsible Nutrition claims FDA’s website overemphasizes the risks of taking supplements without sufficiently acknowledging the benefits and implies dietary supplements are not adequately regulated, and the group urges FDA to work with CRN to remedy the agency’s language to better educate consumers about the use of supplements.

Physician-led hospitals are pushing Congress to remove restrictions that hamper their expansion after a report they commissioned found hospitals that are owned or invested in by referring physicians performed better and offered more cost savings for Medicare than hospitals in general.

States, territories and tribes will receive $1.5 billion to address the opioid crisis by expanding access to 24/7 opioid treatment programs and removing barriers to medications that treat substance use disorder, the Biden administration announced Friday (Sept. 23) along with several other awards.

The House GOP laid out its “Commitment to America” agenda ahead of the November midterms and included saving and strengthening Medicare as one of its tenets -- while no details are included on what that might look like, some experts following the issue say the GOP could look to shore up Medicare Advantage rather than return to a push for premium support that has failed in the past.

FDA on Thursday (Sept. 22) announced it is exempting approved naloxone products, specifically those that are distributed to harm reduction programs, from certain drug tracking, tracing and distribution requirements during the opioid public health emergency in a bid to boost access to naloxone.

FDA has tapped Ohio State University to evaluate the agency’s response to the opioid crisis, and recommend actions the agency can take based on existing and potentially new authorities, FDA chief Robert Califf announced earlier this week, coming three weeks after Califf unveiled the agency’s overdose prevention framework.

Sens. Patty Murray (D-WA) and Richard Burr (R-NC) announced they have a deal for a “practically clean” reauthorization of FDA user fee programs that would be attached to a temporary government funding bill, but Senate Minority Leader Mitch McConnell (R-KY) wants to eliminate even the few policy riders the two negotiated, according to a McConnell spokesperson.

Diagnostic tests are essential to combating antimicrobial resistance (AMR), but developers face myriad challenges getting their tests through FDA, and the ones that do make it to market have to grapple with reimbursement issues, a panel of former FDA officials, academics and industry experts said during a Duke-Margolis webinar last week.

FDA on Wednesday (Sept. 21) published a draft guidance that explains how drug makers can obtain a so-called covered product authorization to access product samples of reference drugs that are subject to a risk mitigation strategy.

As the House Ways & Means Committee passed on Wednesday (Sept. 21) a couple bills meant to improve Medicare beneficiary access to mental health treatment, lawmakers and advocates are anxiously waiting to hear from congressional leadership whether any mental health provisions will be included in the continuing resolution or passed via another legislative vehicle before the year’s end.