Policy & Regulation

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.

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Labor

Amid a surge in COVID-19 cases, hospitals need nurses so desparetly they're offering massive sign-on bonuses and staffing firms say open positions for both temporary and permanent nursing roles are at all-time highs

By Healthcare Dive staff

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

Insurers to disclose relationships with brokers, agents in new CMS proposed rule

Other proposals would require air ambulances to disclose additional data to HHS and outline how CMS can enforce surprise billing protections if states fail to act.

By Rebecca Pifer • Sept. 13, 2021

Sponsored by Consensus Cloud Solutions

4 ways ADT event notifications improve payer performance

Our all-in-one real-time health event notification solution allows payers to work alongside providers to ensure that their members are on a path to better health outcomes that reduces waste and frustration.

By Bevey Miner, Health IT Strategy/CMO for Consensus • Sept. 13, 2021

Biden, industry groups mandate COVID-19 vaccines for most healthcare workers

CMS and the Centers for Disease Control and Prevention are requiring that all provider facilities that participate in the Medicare and Medicaid programs vaccinate their workers, according to a Thursday release. 

By Ron Shinkman • Sept. 10, 2021

Industry pushes for more time before surprise billing ban enforced

Payers and hospitals say with the COVID-19 pandemic ongoing and key elements still unreleased, it will be difficult to comply by Jan. 1. Key sticking points include arbitration and qualified payment amounts.

By Shannon Muchmore • Sept. 09, 2021

Moderna expands mRNA vaccine supply in deal with new biotech producer

The company had previously said it could make up to 3 billion vaccine doses in 2022, depending on how booster shots are authorized.

By Shoshana Dubnow • Sept. 09, 2021

Biden admin shells out $452M to boost state reinsurance programs

The funding is aimed at getting more individuals to enroll in insurance at a lower cost, swelling coverage as the COVID-19 pandemic continues, HHS Secretary Xavier Becerra said.

By Rebecca Pifer • Sept. 08, 2021

Feds sue UPMC, heart surgeon for billing multiple surgeries at same time

The False Claims Act litigation also accuses the health system of ignoring or minimizing complaints by employees and staff.

By Ron Shinkman • Sept. 07, 2021

Sponsored by Zelis

The low-down on the latest NSA Member ID and Advanced EOB Requirements

What you need to know about new NSA requirements for Member ID cards & AEOBs to reach compliance.

AHA presents Congress with laundry list of requests for budget reconciliation bill

The hospital lobby asked that some of the funding be used to address the ongoing labor shortage, shore up mental health services and address ongoing coverage gaps.

By Ron Shinkman • Sept. 03, 2021

Pfizer, Merck launch large new trials of oral COVID-19 drugs

Both companies are racing to prove their oral antivirals are effective as treatments for COVID-19. Key clinical results could come later this year.

By Kristin Jensen • Sept. 02, 2021

Medicare insolvency still expected by 2026, unchanged by COVID-19, trustees say

The forecast is a bit of a bright spot for the otherwise grim financial prospects of the program, as experts worried COVID-19 would result in the fund that finances Medicare Part A running out of money faster than previously expected.

By Rebecca Pifer • Sept. 01, 2021

Hospital lobby urges Congress to extend Medicare cut relief

The cuts, if they go through, will result in an estimated loss of $36 billion in funding in 2022 alone, the Federation of American Hospitals said.

By Rebecca Pifer • Sept. 01, 2021

Hospitals lose legal challenge over changes to DSH payments

A federal judge sided with HHS, pointing to a portion of the Medicare law that prohibits any administrative and judicial review of how the department arrived at its calculations.

By Samantha Liss • Sept. 01, 2021

Sutter to pay $90M in largest False Claims Act settlement against a health system for alleged MA fraud

The record payment comes on the heels of another massive settlement for the nonprofit, adding to the hit on its already stressed bottom line.

By Rebecca Pifer • Aug. 31, 2021