Category: Federal

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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Judge Denies Calif. 340B Health Centers’ Motion to Halt State Medicaid Drug Payment Change

January 11, 2022 Ron Shinkman Views

California health centers say they will continue to fight against the transfer of state Medicaid managed care drug coverage to Medicaid fee for service, despite being denied a temporary restraining order against the change.

A federal judge in Sacramento, Calif., late yesterday declined to stop California Medicaid’s transfer of managed care drug coverage to Medicaid fee for service that took effect on Jan. 1. Health centers enrolled in the 340B drug pricing program pledged

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Appeals Court Signals it Might Send Lilly’s 340B Lawsuit Back to Lower Court

January 6, 2022 Tom Mirga Editor at Large Views

A federal circuit court has suspended Lilly’s 340B contract pharmacy lawsuit on technical grounds and might send it back to a lower court.

A federal circuit court on Tuesday halted drug manufacturer Lilly and the federal government’s appeals of a district judge’s late October ruling in Lilly’s 340B contract pharmacy lawsuit, on technical grounds. It’s the second time the case has run into

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Judge in AstraZeneca’s 340B Case, on Verge of Big Promotion, Gives Parties Just Two Days for a Status Report

January 6, 2022 Tom Mirga Editor at Large Views

The judge in AstraZeneca’s 340B contract pharmacy lawsuit, who could be elevated soon to a federal appeals court, indicated this week that his decision in the case is still in progress.

The judge in AstraZeneca’s 340B contract pharmacy lawsuit yesterday ordered both sides to file a joint status report by no later than Friday—a sign, lawyers say, that his decision in the case is still in progress.

U.S. District Judge Leonard

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Carole Johnson Takes Charge of HRSA and the 340B Program

January 6, 2022 Tom Mirga Editor at Large Views

Carole Johnson's tenure as HRSA administrator officially began this week Tuesday.

The U.S. Health Resources and Services Administration (HRSA), the agency that runs the 340B drug pricing program, has a permanent leader again for the first time in almost a year.

Carole Johnson started in her position as HRSA administrator on

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California Asks Judge to Reject 340B Community Health Centers’ Request to Stop Medicaid Drug Payment Change

January 6, 2022 Ron Shinkman Views

California's state health department asked a judge yesterday to reject 340B community health centers' request to halt a major state Medicaid drug reimbursement change that began on Jan. 1.

Federally qualified health clinics in California have no right to sue to stop a major state Medicaid drug reimbursement change that began on Jan. 1., the state Department of Health Care Services (DHCS) argued in a legal brief filed Wednesday.

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Drug Makers Want to Halt 340B Dispute Resolution Proceedings, Citing Lawsuits and Forthcoming Rule

January 4, 2022 Tom Mirga Editor at Large Views

AstraZeneca and Sanofi have asked 340B administrative dispute resolution panels to pause covered entities’ ADR proceedings against them.

Drug manufacturers AstraZeneca and Sanofi have asked 340B administrative dispute resolution panels to pause covered entities’ ADR proceedings against them until all 340B-related federal court litigation is finished and until after the government finalizes its forthcoming new 340B ADR regulation.

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