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Year-End Package

PAYGO, Physician Fee Relief Expected, But Year-End Bill Still In Flux

Lobbyists expect Congress will likely waive the effects of upcoming PAYGO cuts on Medicare as part of the year-end package, but much of the rest of what could be a large legislative deal is still in flux -- including the extent to which the physician fee cuts will be mitigated and how much money lawmakers will dedicate to the health care industry overall.

CBO Estimates W&M Mental Health Provisions Cost $1.8 Billion

Latest Pandemic News

HHS: PRF Money Reprioritized For Boosters As Congress Didn’t Act

Ranking House Energy & Commerce Committee Republican Cathy McMorris Rodgers (WA) and Rep. Tom Cole (R-OK) slammed the administration for taking $475 million from the Provider Relief Fund to pay for a six-week COVID-19 vaccine booster campaign, but HHS told Inside Health Policy Congress forced the administration's hand, as it hasn’t given the administration enough COVID-19 funding to work with.

CMS Concerned About Low COVID-19 Booster Rates In Nursing Homes

WH Urges COVID Booster Uptake As CDC Data Reinforce Protection

HHS Report Touts Long COVID Plan, But CMS Vague On Medicare Spike

WTO Members Discuss Expansion Of TRIPS Waiver

Former FDAer; COVID Shows Fast Authorizations Work, But Better Surveillance Needed

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After finding numerous home and community-based services programs are not meeting regulatory requirements in the run-up to CMS’ hard compliance deadline, the agency last Wednesday (Nov. 16) gave the sector a final warning ahead of an impending Dec. 1 cutoff for providers to submit corrective action plans.

Medical experts and consumer advocates are at odds over how best to combat antimicrobial resistance and the debate has intensified as Congress gears up for its year-end legislative push that some hope includes passage of a key antibiotic funding bill that aims to spur development of new antibiotics.

Four anti-abortion medical groups filed suit against FDA, alleging the agency more than 20 years ago illegally approved medication abortion, which comprises mifepristone and misoprostol, in violation of pediatric research law and the agency’s accelerated approval pathway, and the groups are urging a U.S. district court in Texas to force FDA to withdraw approval of the brand and generic versions, marking a first-of-its-kind lawsuit challenging FDA’s approval of the abortion pill.

FDA chief Robert Califf and Oncology Center of Excellence head Richard Pazdur are worried about clinical trials being moved outside of the United States, and the agency is looking to do something about it, including by simplifying the clinical trial process.

Rare disease advocacy groups hope the new Congress will prioritize investment in the development of rare disease treatments by passing bills that restore and reinforce seven-year exclusivity for drugs being developed for specific rare conditions, require regular reporting to improve the approval process of orphan drug designation and ensure patient input is counted throughout the development process.

Other World Trade Organization members are doing more than the United States to protect U.S. intellectual property in pushing back against an effort to expand certain IP-related flexibilities to COVID-19 tests and treatments, a senior House Republican charged days before international talks were set to resume Tuesday (Nov. 22).

Pittsburgh-based Highmark Health tells Inside TeleHealth it hopes its new policy to cover prescription digital therapeutics (PDTs) will pave the way for insurers to offer the interventions more broadly.

CMS innovation center chief Liz Fowler said the agency could consider mandatory demonstrations after the health sector has recovered from the COVID-19 pandemic, but this isn’t the time for the center to move on such demos.

Congress will likely include in its year-end package a House-passed bill that would reauthorize more than 30 programs to treat and prevent mental health and substance use disorders as well as a provision to ensure incarcerated youth are screened for Medicaid eligibility prior to release, sources familiar with the issue told Inside Health Policy.