Category: Breaking

Breaking News

Two of Three Appeals Court Judges Question Government’s Stance That Drug Companies May Not Impose Conditions on 340B Sales

In Breaking, Federal, JudicialNovember 15, 20221080 Views

Two judges on a three-judge federal appeals court panel in Philadelphia today questioned whether the 340B statute forbids drug manufacturers from imposing distribution conditions on offers of 340B pricing.

Two judges on a three-judge federal appeals court panel this morning challenged a federal government lawyer’s stance that federal law forbids drug manufacturers from limiting how their drugs may be distributed when they offer to sell the drugs

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CMS Says It Will Announce Sometime Next Year How it Will Repay 340B Hospitals for Five Years of Illegal Drug Reimbursement Cuts

In Breaking, Federal, Judicial, RegulatoryNovember 1, 2022872 Views

Tom Mirga

CMS said late this afternoon it will put off until next year its decision on how it will comply with a U.S. Supreme Court decision striking down five years of drug reimbursement cuts for 340B hospitals.

The U.S. Centers for Medicare & Medicaid Services said late this afternoon that it will address how it will remedy five years of illegal Medicare Part B underpayments to hospitals for 340B purchased drugs “in future rulemaking,” rather

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Appeals Court Questions Yet Again if it Has Jurisdiction Over Lilly’s 340B Contract Pharmacy Case

In Breaking, Federal, JudicialOctober 31, 2022830 Views

Tom Mirga

Federal appeals court Judge Frank Easterbrook is pictured during an appearance on C-SPAN in 2013. Easterbrook during a court hearing today questioned whether a closely watched 340B contract pharmacy case was ripe for appellate review.

A federal appeals court judge in Chicago expressed doubt during a hearing this morning that the court can review a lower court decision in drug manufacturer Eli Lilly’s 340B contract pharmacy lawsuit.

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In Key Hearing, Appeals Court Panel Seems to Lean in Favor of Some Drug Manufacturer Conditions on 340B Pricing

In Breaking, Federal, JudicialOctober 24, 20221175 Views

Tom Mirga

A federal appeals court in Washington, D.C., heard arguments this morning in Novartis and United Therapeutics' consolidated 340B contract pharmacy cases.

Two of three judges on a federal appeals court panel strongly indicated this morning that they reject the federal government’s position that nothing in the 340B statute gives drug manufacturers the right to put any conditions on offers

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HRSA Refers Merck to HHS Inspector General Over its 340B Contract Pharmacy Policy

In Breaking, Federal, Pharma Industry, RegulatoryOctober 21, 2022833 Views

Tom Mirga

Merck did not immediately comment on the governnment's referral yesterday to the HHS Inspector General for possible imposition of civil fines over the company's 340B contract pharmacy restrictions.

The U.S. Health Resources and Services Administration yesterday referred drug manufacturer Merck to the Department of Health and Human Services Office of Inspector General for possible imposition of civil fines over Merck’s 340B contract pharmacy restrictions.

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Effort Launched to Create 340C—a Separate Drug Discount Program for Health Centers and Possibly Other Entities

In Breaking, Federal, Legislative, Regulatory, Trade AssociationOctober 14, 20222068 Views

Tom Mirga

National health center group Advocates for Community Health is urging Congress to create a new federal drug discount program named 340C open to health centers, rural hospitals, and federal grantees.

A national community health center association founded last year is launching a campaign to urge Congress to create a separate drug discount program called 340C open to health centers and perhaps rural hospitals and federal grantees.

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Exclusive: HHS OIG Declines to Penalize Drug Manufacturers at This Time Over 340B Contract Pharmacy Restrictions

In Breaking, Federal, Pharma IndustrySeptember 30, 20222460 Views

Ted Slafsky

The U.S. HHS Office of Inspector General has put off a decision on penalizing drug manufacturers that have placed restrictions on access to 340B discounts in the contract pharmacy setting, 340B Report has learned.

The U.S Department of Health and Human Services Office of Inspector General (HHS OIG) has informed a bipartisan group of House lawmakers that the enforcement agency does not plan to impose civil monetary penalties against the drug makers that have

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National Association of Community Health Centers Calls On Congress “To Move Urgently” To Tackle 340B Contract Pharmacy Impasse “Before It’s Too Late”

In Breaking, Federal, Judicial, Legislative, Pharma IndustrySeptember 28, 20221159 Views

Laura Gilcrest and Ted Slafsky

After the government’s Administrative Dispute Resolution panel dismissed its complaint against drug manufacturers, NACHC is calling for Congress to take urgent action to address the contract pharmacy impasse.

Sparked by the dismissal of its complaint against Astra Zeneca and Sanofi by the government’s Administrative Dispute Resolution Panel (ADR), the National Association of Community Health Centers say “they cannot wait any longer for a solution,” to the two-year standoff

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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

In Breaking, RegulatoryJuly 15, 20221170 Views

Tom Mirga

CMS announced late today that they are reversing significant Medicare cuts to 340B hospitals.

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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In Important Ruling, Federal Appeals Court Says Health Center May Challenge 340B Patient Definition’s Legality

In Breaking, Federal, JudicialJuly 1, 20221555 Views

Tom Mirga

A federal appeals court says South Carolina health center Genesis Healthcare has the right to challenge the 340B patient definition's legality in a lower federal court.

A federal appeals court ruled unanimously this morning that a South Carolina health center has the right to challenge the legality of the government’s 340B patient definition in a lower federal court.

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