Month: August 2022

With Just a Month to Go, HRSA Releases First FY 2022 Manufacturer 340B Audit Result

In Federal, RegulatoryAugust 30, 2022628 Views

Unichem Pharmaceuticals USA must repay 340B covered entities for overcharges found during an FY 2022 340B program compliance audit.

Generic drug manufacturer Unichem Pharmaceuticals USA must repay 340B covered entities for overcharges found during a 340B program compliance audit, the U.S. Health Resources and Services Administration (HRSA) said yesterday.

HRSA has been auditing five drug manufacturers per

…

Advocates Urge Feds to Allow Distressed Rural Hospitals to Remain 340B Eligible

In Federal, RegulatoryAugust 30, 2022217 Views

Tom Mirga

Financially distressed critical access hospitals should be allowed to keep their 340B drug discounts if they opt under a new federal law to downgrade into emergency hospitals to remain solvent, rural health advocates told CMS in comments on proposed rules to implement the law.

Congress and the White House should let financially distressed critical access hospitals keep their 340B drug discounts if they opt under a new law to downgrade into emergency hospitals to remain solvent, rural health advocates told federal health

…

Financial Outlook Deteriorating for Nonprofit Hospitals in 2022 and Beyond, Credit Rating Agency Says

In Research/ReportsAugust 30, 2022245 Views

Sarah True

Mass General Brigham is among the nonprofit health systems that have reported significant financial pressure this year.

In its mid-year report released this month, Fitch Ratings predicts a “deteriorating” outlook for nonprofit hospitals and health systems through the remainder of 2022 and into 2023. This is primarily driven by the “macro headwinds” of high labor

…

Key Takeaways from New Medicare Law and 340B Implications

In Federal, LegislativeAugust 30, 2022446 Views

Tom Mirga

President Biden signs law while legislators watch at the White House

President Biden signed the Inflation Reduction Act into law on Aug. 16.

The landmark prescription drug pricing legislation that President Joe Biden signed this month is a mixed bag for 340B stakeholders, 340B Health Publisher and CEO Ted Slafsky says in his latest column for Omnicell.

Biden signed the Inflation

…

340B INDUSTRY LEADER SPOTLIGHT

Ivy Espendez, Director, 340B Compliance & Audit, Sentry Data Systems, now the Craneware Group

In Industry Leader Spotlight, Sponsored ContentAugust 30, 2022575 Views

Diane Slafsky

Q: Where did you grow up?

San Juan, Puerto Rico

Q: Where did you go to college?

Queens College in New York

Q: What are your favorites?

Food:

…

Exclusive: HRSA Hasn’t Posted a Limited Distribution Plan Notice to 340B Entities in Almost a Year. No One Outside of the Agency Knows Why.

In Federal, RegulatoryAugust 25, 2022958 Views

Tom Mirga

chart depicts limited distribution plan notices by HRSA in years from 2015 to 2022

HRSA has published no drug manufacturer limited distribution plan notices to 340B covered entities since mid-September 2021.

Last September, the U.S. Health Resources and Services Administration (HRSA) published a drug manufacturers’ notice to 340B covered entities that it was limiting distribution of a medicine that alleviates a side effect of HIV/AIDS treatment.

It was the

…

Judge Orders HHS to Respond to Ruling Letting Health Center Challenge 340B Patient Definition

In Federal, JudicialAugust 25, 2022529 Views

Tom Mirga

Genesis health care pharmacy workers wearing face masks

A federal appeals court gave South Carolina-based Genesis Health Care another chance to challenge the legality of the 340B drug pricing program's patient definition.

A federal district judge on Tuesday gave federal health officials a Sept. 22 deadline to respond to a higher court’s ruling last month that a South Carolina health center has the right to challenge the legality of the

…

House GOP Lawmaker Reintroduces Bill to Collect and Report 340B Hospital Data

In Federal, LegislativeAugust 25, 2022321 Views

Tom Mirga

U.S. Rep. Bruce Westerman (R-Ark.) has reintroduced a bill that would create new reporting requirements for 340B disproportionate share (DSH), children’s, and free-standing cancer hospitals and their child sites.

U.S. Rep. Bruce Westerman (R-Ark.) has reintroduced a comprehensive health care bill he sponsored during the last session of Congress that would create new reporting requirements for 340B disproportionate share (DSH), children’s, and free-standing cancer hospitals and their

…

Sixth Group of 340B Hospitals Sues HHS Over Medicare Drug Payment Cuts

In Federal, JudicialAugust 25, 2022246 Views

Laura Gilcrest

New Orleans-based Ochsner Medical Center and six other 340B hospitals have sued in federal court to force HHS to immediately remedy illegal Medicare Part B drug payment cuts in place since 2018.

Correction, Friday, Aug. 26, 2022, 3:00 p.m. EDT—The original version of this article mistakenly said the hospital plaintiffs’ complaint stated that HHS improperly based 2020 and 2021 Medicare Part B drug payment cuts for 340B hospitals on a

…