Category: Regulatory

HHS Announces First 10 Drugs Eligible for Medicare Price Negotiations

August 29, 2023 William Newton, Associate Editor/Senior Writer Views

CMS issued the final rule to implement a $9 billion lump sum payment to 340B hospitals for previous illegal cuts between 2018 and 2021.

The Department of Health and Human Services (HHS) today announced the first 10 prescription drugs eligible for Medicare price negotiations [...]

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From the Publisher & CEO: The Big Question on the Minds of Every 340B Stakeholder

August 24, 2023 Rich Daly, Editor in Chief Views

340B stakeholders are anticipating two major contract pharmacy judicial rulings, including one from the Court of Appeals for the District of Columbia.

Amid nationwide uncertainty over both the legality of the scope of the 340B contract pharmacy program and the legality of [...]

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Drug Maker Owes 340B Providers Repayment, HRSA Pending Audit Finds

August 22, 2023 Rich Daly, Editor in Chief Views

A HRSA fiscal year 2023 audit tentatively found that drug maker Nephron Pharmaceuticals owes 340B repayments to providers.

The first posted fiscal year 2023 audit of a drug maker tentatively found the company owes repayments to providers. The [...]

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340B Drugs Among Those at Tornado-Hit Facility Requiring Direct Purchase

August 22, 2023 Rich Daly, Editor in Chief Views

Pfizer has limited multiple 340B-eligible drugs to direct purchase after a tornado damaged one of the drug maker's manufacturing facilities.

Federal officials confirmed that 340B-eligible drugs are among the 12 medications pharmaceutical manufacturer Pfizer has limited to direct purchase after [...]

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Three Terminations, 10 Paybacks to Manufacturers in HRSA’s 2023 Pending Provider Audits

August 17, 2023 Rich Daly, Editor in Chief Views

HRSA audits found terminations were required for a 340B provider site and a contract pharmacy and that another provider owed repayments to drugmakers.

Three provider organizations may have contract pharmacies terminated from the 340B program and 10 providers would owe repayments to drug [...]

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HHS Asks Court to Deny Injunction Against Medicare Drug Price Negotiations

August 17, 2023 Tom Mirga, Editor at Large Views

HHS asked the U.S. District Court in Dayton, Ohio to deny a preliminary injunction that would prevent Medicare drug price negotiations.

The U.S. Department of Health and Human Services (HHS) asked a federal court to deny a preliminary injunction sought by [...]

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HRSA Allows Immediate 340B Enrollment in Hawaii Due to Wildfires

August 17, 2023 Tom Mirga, Editor at Large Views

HRSA is allowing eligible covered entities in Hawaii to enroll in the 340B program immediately rather than having to wait for the next quarterly registration period.

Eligible covered entities in Hawaii may enroll in the 340B program immediately rather than having to wait for the next [...]

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Enforceability of State Contract Pharmacy Laws Uncertain Amid Legal Challenges

August 10, 2023 William Newton, Associate Editor/Senior Writer Views

PhRMA has asked a federal district judge to block Louisiana's 340B contract pharmacy law, Act 358, which took effect Aug. 1.

While two drug manufacturers have recently relaxed or suspended their 340B contract pharmacy restrictions as a result of state laws [...]

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AHA Warns of “Legal Consequences” from Proposed Cuts to Fund 340B Lump Sum Payments

August 10, 2023 Rich Daly, Editor in Chief Views

AHA officials penned a Medical Economics op-ed on “the truth behind growth of the 340B prescription drug program.”

The lead plaintiff in the legal battle that resulted in Medicare proposing an unusual lump sum payback for hospitals’ lost [...]

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Medicare DSH Changes Will Cut 340B Access, Draw Legal Challenge, Say Attorneys

August 8, 2023 Rich Daly, Editor in Chief Views

CMS issued the final rule to implement a $9 billion lump sum payment to 340B hospitals for previous illegal cuts between 2018 and 2021.

Changes in the ways Medicare calculates hospitals’ shares of low-income patients that were finalized in a recent payment rule will [...]

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