Category: Federal

340B Registration for Third Quarter of 2023 Will Run from July 1 to July 17

June 21, 2023 Tom Mirga, Editor at Large Views

Q3 2023 covered entity registration for the 340B program runs from July 1 to July 17, HRSA says.

The U.S. Health Resources and Services Administration has added two days to the next quarterly 340B registration period.

A HRSA spokesperson said Friday that Q3 registration for 340B covered entities, their child sites, and their contract pharmacies will begin July

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Six Democratic and Republican U.S. Senators Ask 340B Stakeholders for “Bipartisan Policy Solutions”

June 16, 2023 Tom Mirga, Editor at Large Views

A bipartisan group of six U.S. senators today sought 340B stakeholders' best advice on subjects including 340B contract pharmacy, duplicate discount prevention, accountability, and ensuring that program benefits accrue to covered entities and their patients.

Six Democratic and Republican U.S. senators this morning asked 340B drug pricing program stakeholders for input on “bipartisan policy solutions that would ensure the program has stability and oversight to continue to achieve its original intention of serving eligible patients.”

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Congressional Republicans Want to Know if 340B Plays a Role in Drug Shortages

June 15, 2023 Tom Mirga, Editor at Large Views

The GOP leaders of two congressional committees want public input on whether 340B program growth leads to drug shortages.

U.S. House Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.) and Senate Finance Committee ranking Republican Mike Crapo (Idaho) are soliciting public input on what’s driving the increase in drug shortages, including whether or not the 340B drug pricing

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First Merck, Now Chamber of Commerce Sues to Stop Medicare Drug Price Negotiation

June 15, 2023 Laura Gilcrest, Contributor Views

The U.S. Chamber of Commerce and local and state chambers have sued to stop Medicare from negotiating "maximum fair prices" on a small number of expensive single-source drugs.

The U.S. Chamber of Commerce and three state and local affiliates are asking a federal court to strike down the part of the Inflation Reduction Act that lets Medicare negotiate “maximum fair prices” (MFPs) for some expensive, single-source drugs, arguing

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Federal Court Hearing Next Week on California’s Medicaid Drug Benefit Transfer; Bill Introduced in N.J. with 340B Implications

June 13, 2023 Tom Mirga, Editor at Large Views

A federal district judge in Sacramento, Calif., is holding arguments next week in a lawsuit to reverse the state’s transfer of Medicaid managed care benefits to Medicaid fee for service.

A federal district judge in Sacramento, Calif., is holding oral arguments next week in a lawsuit aimed at reversing the state’s January 2022 transfer of Medicaid managed care benefits to Medicaid fee for service.

Meanwhile, a bill was introduced

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Protest Held at Indiana Congressman’s State Office Against His 340B Hospital Reporting Bill

June 8, 2023 Tom Mirga, Editor at Large Views

AIDS Healthcare Foundation advocates marched yesterday outside U.S. Rep. Larry Bucshon's (R-Ind.) Terre Haute, Ind., office to protest Bucshon's bill to impose reporting requirements on 340B hospitals and potentially other covered entities.

AIDS Healthcare Foundation staged a march yesterday outside U.S. Rep. Larry Bucshon’s (R-Ind.) Terre Haute office to protest his bill that would require 340B disproportionate share hospitals to report data about patients who get 340B drugs, spending on charity care,

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Merck Sues to Stop Medicare Drug Price Negotiation

June 8, 2023 Tom Mirga, Editor at Large Views

Merck has sued to stop the federal government from negotiating prices for certain high expenditure, single source Medicare Part B or Part D drugs

Federal Medicare drug price negotiation “is tantamount to extortion” and must be struck down as unconstitutional, drug manufacturer Merck told a federal district court yesterday.

Merck on Tuesday became the first drug maker to sue to stop the federal government

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CMS Creates New Group to Lead Medicaid Managed Care Policy

June 8, 2023 Tom Mirga, Editor at Large Views

CMS has created a new group within the CMS Center for Medicaid and CHIP Services to develop and manage federal Medicaid managed care policy.

The U.S. Centers for Medicare & Medicaid Services (CMS) said this week it has created a new unit within the CMS Center for Medicaid and CHIP Services (CMCS) to develop and manage federal Medicaid managed care policy.

CMS announced the

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HHS, HRSA Tell Judge They Don’t Know When They’ll Replace 340B Dispute Resolution Process

June 6, 2023 Tom Mirga, Editor at Large Views

HHS and HRSA recently told a federal district court they “are unable to predict” when they will finally replace HRSA’s 340B administrative dispute resolution proces.

The U.S. Department of Health and Human Services and the Health Resources and Services Administration “are unable to predict” when they will finally replace HRSA’s 340B administrative dispute resolution process, the government said in a recent legal filing.

The government

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HRSA Posts Four Manufacturer Notices to 340B Entities

June 6, 2023 Tom Mirga, Editor at Large Views

Lilly is providing refunds for 340B overcharges during Q1 2020 on Humalog and Trulicity.

The U.S. Health Resources and Services Administration yesterday posted notices of refunds for 340B overcharges from drug manufacturers Lilly, Novo Nordisk, and Neurocrine and a notice from Amneal about product NDC changes.

Lilly

Lilly’s May 30 notice covers purchases

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