Category: Federal

PhRMA and Arkansas Seek Faster Court Ruling on State’s Novel 340B Contract Pharmacy Law

January 21, 2022 Tom Mirga, Editor at Large Views

PhRMA and the state of Arkansas have agreed on a plan that could lead the federal district court in Little Rock to rule sooner than now anticipated on the state’s law protecting 340B contract pharmacy arrangements.

The brand name drug industry and the state of Arkansas have agreed on a litigation plan that could lead to a quicker federal court decision than now anticipated on the state’s one-of-a-kind law protecting 340B contract pharmacy arrangements.

Pharmaceutical Research

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AHA Asks Congress to Attach 340B Hospital Protections to Must-Pass Spending Bill

January 21, 2022 Tom Mirga, Editor at Large Views

The House Appropriations Committee approved the Labor, Health and Human Services, Education and Related Agencies Appropriations Act on July 10.

The American Hospital Association (AHA) yesterday asked U.S. House and Senate party leaders to ensure that a must-pass spending bill next month protects hospitals from losing their 340B eligibility due to changes in patient and payer mix caused by the

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Three Drug Makers, Including Two with Contract Pharmacy Restrictions, Post 340B Refund Notices

January 21, 2022 Tom Mirga, Editor at Large Views

Bristol Myers Squibb, Novo Nordisk, and Ipsen Biopharmaceuticals notified 340B covered entities this week about refunds for charges above 340B ceiling prices.

Three drug manufacturers—including two that have imposed conditions on 340B contract pharmacy—posted public notices this week to 340B covered entities about refunds for charges above 340B ceiling prices.

Bristol Myers Squibb (BMS) and Novo Nordisk’s notices came to light yesterday

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Democrats Weigh Passing Build Back Better Act—Possibly Including Drug Pricing Reforms—in “Chunks”

January 21, 2022 Tom Mirga, Editor at Large Views

New CBO findings on brand drug price increases “drive home the urgent need to pass robust drug pricing reforms," U.S. Senate Finance Committee Chair Ron Wyden (D-Ore.) said this week.

U.S. Senate Finance Committee Chair Ron Wyden (D-Ore.) said this week that new Congressional Budget Office (CBO) findings on brand drug price increases “drive home the urgent need to pass robust drug pricing reforms.”

“The average net price for brand-name

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With Judge in Astra 340B Case About to Get Promotion, What Will Happen to the Highly Anticipated Case?

January 19, 2022 Tom Mirga, Editor at Large Views

The U.S. Senate could elevate Leonard Stark, the federal judge who has presided over AstraZeneca’s 340B contract pharmacy lawsuit, to a federal appeals court as soon as the end of this week.

Leonard Stark, the federal judge who presided over AstraZeneca’s 340B contract pharmacy lawsuit from its start last year, is on the verge of being elevated to a higher court, possibly by the end of this week. If that happens before

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“Pharma Bro” Who Drew Ire of 340B Providers and Drug Industry Alike Barred from Pharmaceutical Industry for Life

January 19, 2022 Ron Shinkman Views

A federal district judge imposed a lifetime ban against Martin Shkreli participating in the pharmaceutical industry and ordered him to pay $64.6 million to offset ill-gotten gains, stemming from his company's purchase of and huge price hike on the drug Daraprim.

A federal district judge on Friday held “pharma bro” Martin Shkreli liable for antitrust claims brought by the Federal Trade Commission (FTC) and seven states.

U.S. Senior District Judge Denise Cote of the Southern District of New York imposed a

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With Public Health Emergency Extended, 340B Flexibilities to Continue

January 19, 2022 Tom Mirga, Editor at Large Views

340B program flexibilities will continue for another 90 days under the latest extension of the COVID-19 national public health emergency.

340B program flexibilities will continue under the eighth 90-day extension of the COVID-19 national public health emergency (PHE) late last week.

U.S. Health and Human Services (HHS) Secretary Xavier Becerra renewed the PHE on Friday, Jan. 14.

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In Big Win for Pharmacy Groups, CMS Proposes Significant Changes to Medicare Part D Clawbacks

January 13, 2022 Ron Shinkman Views

CMS wants to change Medicare Part D rules to rein in PBMs' controversial practice of clawing back drug payments to pharmacies after point of sale.

The Centers for Medicare & Medicaid Services (CMS) yesterday proposed changing Medicare Part D rules to curb plan sponsors and pharmacy benefit managers’ skyrocketing use of direct and indirect renumeration fees (DIR)—PBMs’ controversial practice of clawing back drug payments to

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In a Big Relief for 340B Providers, Sen. Thune Will Run Again

January 11, 2022 Tom Mirga, Editor at Large Views

U.S. Sen. John Thune (S.D.), a staunch 340B provider ally and the Senate’s No. 2 Republican, announced over the weekend he will seek re-election in November.

340B providers are sighing relief after U.S. Sen. John Thune (S.D.), a staunch 340B provider ally and the Senate’s No. 2 Republican, announced over the weekend he will seek re-election in November.

Thune announced that he was running on

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N.Y. State and Va. Health Centers Ask Fed. Judge to Let their 340B-Related Antitrust Suit Against Drug Makers Go on

January 11, 2022 Tom Mirga, Editor at Large Views

New York state health center Mosaic Health and its co-plaintiff Central Virginia Health Services are opposing four insulin and diabetes drug manufacturers’ motion to dismiss their antitrust class action over the companies’ denials of 340B pricing when covered entities use contract pharmacies.

New York state and Virginia health centers on Friday asked a federal district judge to deny four insulin and diabetes drug manufacturers’ motion to dismiss the health centers’ antitrust class action over the companies’ denials of 340B pricing when covered

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