Eli Lilly fires back against HHS order to repay providers for violating 340B

As California's Attorney General, HHS chief Xavier Becerra led a group of states pushing the agency to force drugmakers to comply with the controversial drug discount program late last year.

By Hailey Mensik , Rebecca Pifer Parduhn • Updated May 21, 2021

HHS asks Supreme Court to keep site-neutral payments in place

Hospitals and HHS have been wrangling about the issue since the federal agency moved to cut payments to hospital-owned outpatient sites in 2019.

By Ron Shinkman • May 17, 2021

CMS again delays breakthrough device payment rule in nod to skeptics

Medtech manufacturers pushed for the MCIT rule, but high-profile detractors like payer lobby America's Health Insurance Plans and doctor groups drove CMS to delay implementation, citing potential risks to Medicare beneficiaries.

By Nick Paul Taylor • May 17, 2021

Despite CMS rule, few hospitals post prices in a coherent fashion, study says

Among 25 common items and procedures posted by the 100 largest hospitals, far fewer than 20% of facilities had decipherable pricing for any single item, according to the research in JAMA Network Open.

By Ron Shinkman • May 14, 2021

Missouri Medicaid expansion hits snag, headed to court

Medicaid expansion in Missouri will now be decided by the courts as its legislature refused to allocate funds after voters approved expansion last year.

By Samantha Liss • Updated May 21, 2021

EU plans to impose additional regulations on medtech AI products, other 'high risk' systems

The proposed legal framework, which addresses potential artificial intelligence risks, seeks to regulate the technology and issue fines for noncompliance that could total billions of dollars, positioning Europe for a "leading" AI role globally.

By Nick Paul Taylor • May 13, 2021

Report calls for broader scope of practice for nurses, better support for equity, mental health

Demand for nurses will only grow post-pandemic, as will the rigors of the job, according to the paper published Tuesday from the National Academy of Medicine and Robert Wood Johnson Foundation.

By Hailey Mensik • May 12, 2021

CDC panel endorses Pfizer vaccine for 12- to 15-year-olds

The vote, which the CDC officially adopted hours after, gives a clear green light for states to begin vaccinating younger adolescents with the shot.

By Ned Pagliarulo • Updated May 13, 2021

FDA authorizes Pfizer's coronavirus vaccine for younger teens

The emergency clearance greatly expands the pool of people who can be vaccinated in the U.S. just as some states begin to report waning demand.

By Ned Pagliarulo • May 11, 2021

Billions of dollars remain in the provider relief fund. Hospital execs are left in the lurch waiting for relief.

"My greatest frustration is just the unknown," one Illinois hospital official said. "There seems to be a vacuum of information out there about how much is there, when would you expect it, how do you apply for it."

By Samantha Liss • May 11, 2021

TAVR readmission rates vary widely between hospitals for unknown reasons

Length of stay and discharge disposition only explained 15% of the inter-hospital variation. Researchers called for efforts to identify practices associated with low rates or readmission.

By Nick Paul Taylor • May 11, 2021

Providers supportive of push to overhaul HIPAA, but air serious concerns about data privacy, timing

"We urge OCR to reconsider implementing a massive change to patient privacy laws in the midst of this transition," AMA commented on the Trump-era rule.

By Rebecca Pifer Parduhn • May 10, 2021

Pharma erupts as Biden administration backs waiver of vaccine patent rights

The shift in U.S. policy might not undermine future research as the drug industry claims. Easing patent protections, though, isn't likely to translate to an immediate boost in vaccine supply.

By Jonathan Gardner , Ned Pagliarulo • May 7, 2021

ACA special enrollment period sign-ups surged in April

The Biden administration began the SEP primarily to help people who have lost coverage due to the COVID-19 pandemic and related economic fallout.

By Shannon Muchmore • May 7, 2021

Adagio, flush with cash, launches large study of next-gen COVID-19 antibody

The privately held biotech believes its drug might treat or prevent infections from existing variants and future coronavirus strains, which could make it a threat to marketed therapies from Regeneron and Eli Lilly.

By Kristin Jensen • May 5, 2021

State lawmakers mull out-of-state nurse licenses after pandemic rollbacks

Many tried to join the Nurse Licensure Compact before the pandemic, "but COVID was a kind of glaring example of how the compact could help," Rebecca Fotsch at the National Council of State Boards of Nursing said.

By Hailey Mensik • May 4, 2021

Full speed ahead on interoperability: Q&A with ONC head Micky Tripathi

In a wide-ranging interview, Tripathi addressed what the government can do to build on the regulations, noting further delays are unlikely and predicting industry will soon see further action on codifying disincentives for bad actors.

By Rebecca Pifer Parduhn • May 3, 2021

Kentucky must rebid Medicaid contracts again, judge rules

This ruling puts six insurers at risk of losing their lucrative contracts with the state. It's unclear when the state will rebid the work.

By Samantha Liss • April 30, 2021

CMS finalizes joint replacement pricing extension

Some analysts say the agency's initiative may evolve to put pricing pressure on orthopaedic devices. However, they contend companies can mitigate that threat by selling more products to customers.

By Nick Paul Taylor • April 30, 2021

FDA greenlights device to retrain muscles in stroke patients

The noninvasive brain-computer interface technology uses data from the uninjured side of a patient's brain to recover motor function in the affected arm and hand.

By Susan Kelly • April 29, 2021

In big win for hospitals, CMS pitches nixing mandate to submit some payer-negotiated rates

The proposed rule would also add 1,000 graduate medical education slots over the next five years, with a priority given to facilities in rural areas and with underserved patient populations.

By Shannon Muchmore , Samantha Liss • April 28, 2021

CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices

In light of the COVID-19 pandemic, the agency is proposing the payments to hospitals be extended beyond the typical timeframe for 14 products.

By Nick Paul Taylor • April 28, 2021

FDA, CDC support resuming use of J&J vaccine after advisory panel vote

While health officials have documented more cases of a rare blood clotting syndrome associated with J&J's vaccine, a CDC committee supported use of the shot with an added warning.

By Ned Pagliarulo , Ben Fidler • Updated April 23, 2021

Senate panel split on Brooks-LaSure nomination after Biden pulls Texas Medicaid waiver

Lawmakers voted along party lines on Biden's pick to lead CMS, with Republicans saying their dissent wasn't due to the nominee's qualifications but the administration's nixing a Trump-era waiver approval in Texas.

By Rebecca Pifer Parduhn • April 23, 2021

Science groups urge providers not to use certain COVID-19 test data for care decisions

The Association for Molecular Pathology and the Infectious Diseases Society of America say some results run the risk of being misinterpreted due to a lack of standardization across test methods.

By Susan Kelly • April 23, 2021