Category: Federal

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

June 17, 2021 Tom Mirga, Editor at Large Views

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

June 17, 2021 Tom Mirga, Editor at Large Views

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

June 16, 2021 Tom Mirga, Editor at Large Views

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

June 15, 2021 Tom Mirga, Editor at Large Views

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

June 15, 2021 Tom Mirga, Editor at Large Views

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

June 15, 2021 Tom Mirga, Editor at Large Views

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

June 15, 2021 Tom Mirga, Editor at Large Views

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

June 15, 2021 Tom Mirga, Editor at Large Views

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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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 6

June 14, 2021 Tom Mirga, Editor at Large Views

Our six-part investigative series takes an in-depth look into a question often asked by 340B providers: Why can’t they access 340B pricing on one of Bristol Myers Squibb/Celgene’s most profitable drug products? We also delve into serious fraud allegations, Congressional oversight, and the possibility of a renewed focus on this contentious area under new leadership at the U.S. Health and Human Services Department. Throughout the series, we also provide BMS/Celgene's viewpoint, their justification for their drug pricing practices, limited distribution policies and why they believe they are following the law.

Part 6 of 6—What Happens Next For Revlimid, Pomalyst, Thalomid, and 340B?

As we described in Parts 2 and 3 of this series, in 2018, an ex-Celgene vice president responsible for the company’s 340B program compliance alleged in a whistleblower

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Bristol Myers Squibb/Celgene Myeloma Drugs: Patient-Safety or Profit Motive? Part 5

June 11, 2021 Tom Mirga, Editor at Large Views

Part 5 of 6—Revlimid “didn’t get any better…. You just got better at making money”

Last September, the Democratic-controlled U.S. House Oversight and Reform Committee released a 45-page report focused on Celgene and Bristol Myers Squibb’s (BMS’s) nearly two

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