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.
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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
Latest News
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.
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Surprise Billing Roundup
Insurers Tout Surprise Bill Protections; CMS Ups IDR Entity Fees Due To Volume
Insurers, employers and consumer advocates this week filed briefs in court supporting the administration’s final rule on the No Surprise Act’s arbitration process, which has been used significantly more than expected, according to recent data from CMS.
Abortion Policy Roundup
Anti-Abortion Activists Push Tighter Restrictions; AMA Strengthens Physician, Resident Protections; GA, KY Abortion Bans Come Under Fire
Anti-abortion activists are pushing state legislators to play offense in seeking more restrictive reproductive health goals, including restrictions on contraception and in vitro fertilization.
Focus On PHE Unwinding
Medicaid Directors Ask Congress For Certainty On PHE Requirements
Medicaid directors say uncertainty on the public health emergency’s end date is no longer tenable, and they are retooling their campaign that had focused on the Biden administration to now ask congressional leadership to set in statute the date that Medicaid renewals will begin, phase out the enhanced federal Medicaid matching funds over 12 months and prohibit CMS from changing Medicaid eligibility rules during the redetermination period.
Demand For Certainty On PHE’s End Continues After Latest Extension
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