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In Big Win For 340B Hospitals, CMS Will Reverse Massive Drug Reimbursement Cut for 2023 and Seeks Input on Potential Remedies for Prior Years

340B provider groups strongly criticized the Centers for Medicare & Medicaid Services’ draft guidance for Medicare drug price negotiations.

The U.S. Centers for Medicare and Medicaid Services “fully anticipate[s]” applying a Medicare Part B reimbursement rate next year of average sales price ASP plus 6% to drugs and biologicals purchased through the 340B program, CMS announced late this afternoon.

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HHS Warns Pharmacies Not to Turn Away Women Requesting Abortion Medication

U.S. Dept. of Health and Human Services Office for Civil RIghts Guidance to Nation's Retail Pharmacies title page
HHS issued guidance to retail pharmacies about their legal duty to fill prescriptions for drugs that can end or prevent pregnancy.

The U.S. Department of Health and Human Services issued guidance to retail pharmacies yesterday about their “unique role … in ensuring access to comprehensive reproductive health care services”—including filling prescriptions for drugs that can end or prevent pregnancy.

Mifepristone and

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340B Hospital Annual Recertification Begins Aug. 27

A red Certified stamp
Annual recertification of 340B eligibility for hospitals starts Aug. 24 and ends Sept. 19.

Hospitals enrolled in the 340B program will have to recertify their eligibility for reduced 340B drug pricing this year between Aug. 24 and Sept. 19, the U.S. Health Resources and Services Administration says.

340B covered entities must annually recertify their

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100 Congressional Democrats Urge HHS to Use Existing Power to Lower Drug Prices

soldiers marching in formation on parade ground
Congressional Democrats want HHS to use march-in rights and other existing authority to lower drug prices.

The U.S. Department of Health and Human Services should swiftly use its existing statutory authority—including forcing drug patent owners to license their products to others—to lower drug prices, 100 Democratic members of Congress urged HHS Secretary Xavier Becerra late last

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Lilly Announces Fourth Round of Refunds for 340B Overcharges in 2019

Lilly wordmark building-mounted sign
Lilly for the fourth time this year has announced refunds for overcharges on 340B-purchased drugs during 2019.

For the fourth time this year, drug manufacturer Lilly has announced refunds for overcharges on 340B-purchased drugs during 2019.

The U.S. Health Resources and Services Administration (HRSA) posted the notice, dated May 27, on the Office of Pharmacy Affairs website

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As UCB Reviews HRSA’s 340B Enforcement Letter, Grassley Presses OIG for Answers

Sen. Chuck Grassley (R-IA) speaking in a meeting with hospital employees
U.S. Sen. Chuck Grassley (R-Iowa), after meeting with 340B hospital employees in his home state, tweeted that he needs answers about drug company 340B violations and actions HHS may take.

Drug manufacturer UCB says it is reviewing Monday’s letter from the U.S. Health Resources and Services Administration telling the company its restrictions on 340B pricing to covered entities that use contract pharmacies break federal law and must end immediately.

“At

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AHA Tells HHS It Wants Prompt Repayment for All Years Hospitals’ Medicare Drug Payments Have Been Cut

American Hospital Association seal on interior office wall
The American Hospital Association and other major hospital groups have placed multiple 340B program goals on their 2024 advocacy agendas.

The American Hospital Association wants to discuss with U.S. Health and Human Services Secretary Xavier Becerra how 340B hospitals should be promptly repaid “for all of the years (2018-2022) in which the Centers for Medicare & Medicaid Services (CMS) illegally

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Q3 340B Entity Registration Starts Tomorrow

Screenshot of HRSA Office of Pharmacy Affairs 340B registration page
The Q3 2022 registration period for healthcare providers, outpatient facilities, and contract pharmacies to participate in 340B begins July 1 and ends July 15.

The third quarterly period this year for 340B registration of new covered entities, outpatient facilities, and contract pharmacies will begin tomorrow, July 1, and end on Friday, July 15.

Eligible hospitals, health centers, clinics, and their child sites and contract

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HRSA Tells UCB its 340B Contract Pharmacy Policy Is Illegal

UCB exterior sign and building
Drugmaker UCB recently told 340B providers in Arkansas that it will exempt them from its contract pharmacy restrictions.

Federal healthcare officials told drug manufacturer UCB yesterday its restrictions on 340B pricing when covered entities use contract pharmacies are illegal and must stop or the company could face civil monetary penalties of up to $6,323.00 for each instance of

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White House Now Says This Is Target Month for New 340B ADR Rule, but Publication Date Remains a Mystery

screenshot of HRSA 340B Administrative Dispute Resolution page
The White House says this is the target month to release a long delayed proposed rule to replace the existing 340B ADR final rule. But it is unclear whether it will be delayed again.

The White House office that oversees issuance of federal healthcare regulations now says that this is the target month for releasing a long delayed proposed rule to replace 340B program dispute resolution regulations. But the administration has not given a

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