Federal Health Officials with Significant 340B History Play Major Roles in CDC Revamp

Mary Wakefield, James Macrae headshots
Ex-HRSA Administrator Mary Wakefield and current HRSA Associate Administrator are playing pivotal roles in the U.S. Centers for Disease Control and Prevention overhaul.

Two federal health officials with long track records managing key aspects of the 340B program are playing pivotal roles in a major overhaul of the U.S. Centers for Disease Control and Prevention.

CDC Director Rochelle Walensky last month named Mary

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News Alert

Becerra Says Legislation Is Needed to Strengthen HHS Authority to Address 340B Contract Pharmacy Pricing Denials

Xavier Becerra speaking to the press
Congress needs to give HHS more more regulatory power and money if its wants the department to do more about drug companies that curtail the use of 340B drugs in contract pharmacies, HHS Secretary Xavier Becerra told House members in a Sept. 1 letter.

U.S. Health and Human Services Secretary Xavier Becerra told members of Congress on Thursday that his department is doing all it can with the tools it has to address drug manufacturers’ denials of 340B pricing involving contract pharmacies.

If lawmakers

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340B Report Exclusive: CMS May Owe 340B Hospitals More Money Than Anticipated

health care worker inserts IV into patient's arm
There have been various estimates of how much it will cost the U.S. government to remedy unlawful Medicare Part B drug payment cuts for 340B hospitals.

The potential cost to the U.S. government next year of remedying unlawful Medicare Part B drug payment cuts for 340B hospitals could be higher than federal Medicare officials think.

The U.S. Centers for Medicare & Medicaid Services in mid-July put

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340B Stakeholders Seek Clarity on HRSA Flexibilities as COVID-19 Public Health Emergency Winds Down

screenshot of HRSA COVID-19 resources web page
340B covered entities are wondering if 340B program COVID-19 flexibilities might become permanent 340B program features.

The U.S. Center for Medicare & Medicaid Services encouraged health care providers on its blog last month “to prepare for the end” of its COVID-19 waivers and flexibilities “as soon as possible and to begin moving forward to reestablishing previous

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GOP House Leaders Want Answers from Becerra on Implementation and Impact of Medicare Drug Price Negotiation

Screenshot of Reps. Kevin Brady, Cathy McMorris Rodgers, and Kevin McCarthy on C-SPAN
Ranking Republicans Kevin Brady (left) and Cathy McMorris Rodgers (center) of House Ways & Means and Energy & Commerce committees sent a letter to HHS foreshadowing intensified oversight if Republicans win back control of the House in November.

Top U.S. House Republicans sent U.S. Health and Human Services Secretary Xavier Becerra a letter on Monday asking 18 detailed questions about implementation and oversight of the Inflation Reduction Act’s (IRA) Medicare drug price negotiation provisions. Their interrogation foreshadows intensified

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340B INDUSTRY LEADER SPOTLIGHT

Kristin Fox-Smith, SVP, Visante

Kristin Fox-Smith
Kristin Fox-Smith, Visante, Inc.
Kristin Fox-Smith
Q: Where did you grow up?

Vancouver, WA and Sandy, UT

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

Unichem building mounted sign
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 year for

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

Save Our Hospital lawn sign
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 officials in

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

Mass General Hospital building entrance
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 costs and

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Key Takeaways from New Medicare Law and 340B Implications

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 Reduction Act on

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