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BREAKING: HHS Withdraws 340B Contract Pharmacy Advisory Opinion, and Becerra Appoints 340B Dispute Resolution Board Members

HHS yesterday withdrew its ex-General Counsel Robert Charrow's legal advisory opinion that the 340B statute requires drug companies to offer 340B pricing when covered entities use contract pharmacies.

HHS Withdraws 340B Contract Pharmacy Advisory Opinion, Says May 17 Demand Letters Are Unaffected

The U.S. Health and Human Services Department (HHS) yesterday withdrew its December 2020 legal advisory opinion (AO) that the 340B statute unambiguously requires drug manufacturers to

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340B Entity Groups Accentuate Positives in 340B Contract Pharmacy Court Opinion

The 340B statute “is silent as to the role that contract pharmacies may play in connection with covered entities’ purchases of 340B drugs," a judge ruled Wednesday in a suit filed by AstraZeneca.

Groups representing 340B covered entities are emphasizing the positives in what they say was a federal judge’s otherwise disappointing opinion Wednesday on whether drug makers must offer 340B ceiling prices when covered entities use contract pharmacies.

The groups’ message is,

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Supreme Court Preserves ACA and, with it, the Health Care Reform Law’s 340B Provisions

340B hospital challenge to Medicare Part B reimbursement could reverse long-standing legal doctrine.

The U.S. Supreme Court ruled 7-2 this morning that Texas and a dozen other Republican-led states lacked standing to challenge the constitutionality of the Affordable Care Act.

In addition to expanding health insurance to 21 million Americans, the ACA included

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Congressman Asks Becerra to Commit to Pause 340B Hospitals’ DSH Percentage Requirement

Democratic Rep. Joe Morelle of New York (left) asked HHS Secretary Xavier Becerra (right) during a House Education and Labor Committee hearing yesterday if he would commit to temporarily waive an eligibility requirement for 340B hospitals during the COVID-19 pandemic.

A congressman from New York asked U.S. Health and Human Services Xavier Becerra during a hearing yesterday if he will use his existing authority to protect hospitals from losing eligibility for 340B drug discounts due to changes in patient mix

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BREAKING: Judge Hands HHS Major Setback in AstraZeneca’s 340B Contract Pharmacy Lawsuit

U.S. District Judge Leonard Stark today rejected HHS's conclusion that the 340B statute requires drug makers to offer 340B pricing when covered entities use contract pharmacies.

A federal district judge ruled today that the U.S. Health and Human Services Department’s (HHS) position that the 340B statute requires drug manufacturers that participate in the 340B program to offer discounts on drugs dispensed by contract pharmacies “is not

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Biden Administration Proposes to Rescind Trump’s 340B Health Center Insulin Rule

The Biden administration today moved to rescind the Trump administration final rule requiring health centers to pass along their 340B savings on insulin and epinephrine pens to low-income patients.

The Biden administration this morning formally announced plans to rescind the controversial Trump administration final rule requiring community health centers to pass along all 340B drug discount savings on insulin and injectable epinephrine to low-income patients, as a condition for

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MedPAC Recommends Part B Drug Payment Changes That Could Exacerbate Financial Strain for 340B Hospitals

The Medicare Payment Advisory Commission today made recommendations to Congress that some say would would amplify the effect of Part B drug payment cuts for 340B hospitals in place since 2018.

Congressional Medicare policy advisers today recommended Medicare Part B drug reimbursement changes that hospitals say would amplify the effect of Part B drug payment cuts for 340B hospitals in place since 2018.

The Medicare Payment Advisory Commission (MedPAC) made

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Health Centers and 340B Play Integral Role In Filling Gaps After Rural Hospital Closures, MedPAC Finds

Community health centers’ 340B savings have enabled some to maintain access to health care following rural hospital closures, congressional Medicare advisers say.

Federally qualified health centers in some rural communities have stepped up and maintained access to health care following rural hospital closures, advisers to Congress on Medicare reported today.

Health centers’ ability to generate income through the 340B program is one

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Two Closely Watched 340B Lawsuits Will Soon Get a New Judge

U.S. District Judge Ketanji Brown Jackson, the judge assigned to two closely watched 340B-related lawsuits, has been elevated to the U.S. Court of Appeals for the District of Columbia Circuit.

In a 53-44 vote, the U.S. Senate yesterday confirmed President Biden’s nomination of Ketanji Brown Jackson, the federal district judge who has been assigned to two closely watched 340B-related lawsuits, for a seat on the U.S. Court of Appeals for

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Rep. Porter Files Bill to Require Medicare Part B inflation-Based Rebates

U.S. Rep. Katie Porter's (D-Calif.) Freedom from Price Gouging Act would require drug manufacturers to pay a Medicare Part B rebate for certain drugs if the price of such drugs increases faster than inflation.

U.S. Rep. Katie Porter (D-Calif.), a California Democrat with a significant national profile, yesterday introduced legislation to require drug manufacturers to pay a Medicare Part B rebate for certain drugs if the price of such drugs increases faster than inflation.

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