Policy & Regulation: Page 2

Centene reaches $72M settlement with Illinois, Arkansas for alleged Medicaid overcharges

The two states allege Centene failed to disclose relevant discounts and inflated dispensing fees. The latest settlements come months after similar agreements were reached in Ohio and Mississippi.

By Samantha Liss • Oct. 01, 2021

Doctors slam surprise billing rule that details dispute resolution process

The interim final rule established that existing rates in a provider's geographic area will be a strong anchor for final payment decisions by arbitrators.

By Shannon Muchmore • Oct. 01, 2021

Explore the Trendline➔

Vertical integration and consolidation

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By Healthcare Dive staff

Merck says antiviral pill effective against COVID-19, lifting hopes for first oral drug

The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible."

By Ben Fidler • Oct. 01, 2021

AMA calls out shrinking payer competition amid rising antitrust interest in Washington

The study by the physician group is the latest salvo in a messaging war between provider and payer lobbies as they work to shift the blame for rapidly rising medical costs.

By Rebecca Pifer • Sept. 29, 2021

CMS defends proposal to nix MCIT pathway, but medtechs hold out hope

If the bid to repeal the breakthrough payment rule is finalized, the agency's CMO committed to an alternative pathway that evaluates devices for Medicare patients potentially via clinical trials, outcome registries and real-world data.

By Greg Slabodkin • Sept. 29, 2021

Top FDA official takes over vaccine office as agency weighs COVID-19 shots for children

Difficult vaccine decisions lie ahead. The agency could soon determine how to handle boosters for recipients of Moderna and Johnson & Johnson's shots.

By Ben Fidler • Sept. 29, 2021

Free insurance under COBRA for Americans without job-based coverage ends Thursday

Experts say there was huge demand for the six-month subsidy, with one estimate finding more than 16 million people lost their employer-sponsored health insurance during the pandemic.

By Rebecca Pifer • Sept. 29, 2021

Broadband investments can improve health, as long as insurers don't roll back telehealth coverage

Jason Resendez of Consumers for Quality Care argues it's time for insurers, policymakers and health systems to embrace telehealth as an integral part of the future of healthcare.

By Jason Resendez • Sept. 27, 2021

6 drug companies could face steep fines for violating 340B law

The ongoing refusal of Eli Lilly, AstraZeneca, Novartis, Novo Nordisk, Sanofi and United Therapeutics to offer discounts to safety-net providers through community pharmacy partnerships has been referred to OIG for enforcement.

By Rebecca Pifer • Sept. 24, 2021

FDA green lights booster dose of Pfizer vaccine for older, more vulnerable Americans

The authorization is more narrow than envisioned by the Biden administration last month, but still makes potentially millions of Americans eligible for a third Pfizer shot.

By Shoshana Dubnow • Sept. 23, 2021

CDC recommends Pfizer booster shots for many, overruling advisers on broad use

Though an agency panel voted against advising a third Pfizer vaccine dose for younger people in high-risk jobs like nursing or teaching, it was overriden by CDC Director Rochelle Walensky.

By Shoshana Dubnow , Ned Pagliarulo • UPDATED: Sept. 24, 2021 at 9:36 a.m.

State Medicaid officials face daunting fall season amid low vaccination rates, record enrollment

Telehealth and behavioral health service needs are also a challenge as the COVID-19 pandemic drags on and the Biden administration encourages more people to get on the rolls.

By Hailey Mensik • Sept. 23, 2021

OIG flags potential $5B overpaid to Medicare Advantage plans

The watchdog calls out 20 private insurers, which it does not name, and urges CMS to conduct greater oversight.

By Samantha Liss • Sept. 22, 2021

Second dose of J&J's coronavirus vaccine increases protection, company says

Long-awaited results from a Phase 3 study run by J&J could support use of a booster dose, although the drugmaker has not officially applied for FDA clearance yet.

By Shoshana Dubnow • Sept. 21, 2021

Pfizer says coronavirus vaccine is safe, spurs immune response in children

The results position Pfizer and BioNTech to seek clearance in children as young as 5 years old. But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators.

By Jonathan Gardner • Sept. 21, 2021

FDA advisers support booster dose of Pfizer vaccine in older or high-risk adults

In a back-and-forth meeting Friday, the committee opposed clearing a third shot widely for use in people older than 16, but agreed the benefits outweighed the risks for adults over 65 or those at risk of severe COVID-19.

By Shoshana Dubnow , Ned Pagliarulo • UPDATED: Sept. 17, 2021 at 6:56 p.m.

New data from Israel, Pfizer show potent effect from third coronavirus shot

The much-anticipated data arrived two days before an important FDA advisory meeting to discuss authorization of a booster dose for Pfizer's coronavirus vaccine.

By Jonathan Gardner • Sept. 16, 2021

FTC warns app makers fall under breach notification rule

The agency noted that a breach must be reported regardless of whether it was the result of malicious action. Any unauthorized access, including sharing information without consent, would trigger the rule.

By Shannon Muchmore • Sept. 16, 2021

FDA staff tight-lipped on booster shot views ahead of consequential meeting

In a briefing document released Wednesday, agency reviewers did not make a strong case either for or against the broad authorization of boosters for the general public.

By Shoshana Dubnow • Sept. 16, 2021

Providers balk at MIPS value program, Medicare rate in physician pay rule comments

While providers strongly support the telehealth coverage increases in the proposed rule, they asked the agency to go further by putting the services that are now going to be covered through the end of 2023 on the permanent list.

By Shannon Muchmore • Sept. 15, 2021

In rare move, DOJ intervenes in MA fraud case against data mining company

Defendants Independent Health, an MA payer, and its now defunct medical analytics subsidiary DxID denied all allegations of wrongdoing and said they planned to defend themselves "vigorously" in court.

By Rebecca Pifer • Sept. 15, 2021

CMS moves to scrap Medicare coverage of breakthrough devices due to clinical evidence concerns

AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts noted the reimbursement pathway could be resurrected in Cures 2.0 legislation.

By Nick Paul Taylor • Sept. 14, 2021

Biden pushes forward on Medicare price negotiation

But opposition from the drug industry and Republicans could make the Democrats' signature proposal an uphill battle.

By Jonathan Gardner • Sept. 13, 2021

Departing FDA officials, WHO leaders argue against broad rollout of COVID-19 booster shots

Marion Gruber and Philip Krause, two top FDA vaccine reviewers who are unexpectedly departing this fall, joined senior WHO officials in saying booster vaccine doses are not yet widely needed.

By Ned Pagliarulo • Sept. 13, 2021

HHS to release $25.5B in COVID-19 relief funding for providers

Some providers have been anxiously waiting on additional disbursements from the provider relief fund, especially for the period of the pandemic that saw the highest hospitalization rates.

By Samantha Liss • Sept. 13, 2021