Category: Regulatory

Arkansas Can Enforce 340B Contract Pharmacy Law, State Attorney Tells Appeals Court

September 12, 2023 William Newton, Associate Editor/Senior Writer Views

Arkansas Insurance Department office sign

The Arkansas Insurance Department will imminently enforce a state 340B contract pharmacy law following a key federal appeals court decision.

An attorney for the state of Arkansas recently told a federal appeals court that the state will enforce its 340B [...]

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HRSA Allows Immediate 340B Enrollment in Florida Due to Hurricane

September 8, 2023 Rich Daly, Editor in Chief Views

HRSA updated 340B enrollment eligibility guidelines in Florida in response to a public health emergency for Hurricane Idalia.

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

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As CMS Extends Comment Period on 340B Repayments, Hospitals Urge Changes

September 6, 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.

While federal regulators recently extended the comment period on a proposed lump sum repayment plan for hospitals Illegally underpaid for [...]

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HRSA Again Selects Bizzell Group to Audit 340B Covered Entities

August 31, 2023 Tom Mirga, Editor at Large Views

Dr. Anton Bizzell is president and CEO of The Bizzell Group, which recently signed a contract with HRSA to continue auditing 340B covered entities.

The Health Resources and Services Administration (HRSA) has awarded a $25.3 million, five-year contract to The Bizzell Group to audit [...]

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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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