Category: Regulatory

Genesis Ruling Could Expand 340B-Eligible Prescriptions, Say Some Attorneys

November 7, 2023 Views

Kyle Vasquez, an attorney for Polsinelli, said the Genesis ruling was "limited in reach" but could create obstacles for other HRSA enforcement activity.

A recent ruling by a federal district judge in South Carolina potentially could expand 340B-eligible prescriptions, say some provider advisers. [...]

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Hospitals Urge CMS to Reconsider Future Cuts in 340B Lump Sum Final Rule

November 7, 2023 Views

Tom Kraus, a vice president of the American Society of Health-System Pharmacists, said he was "deeply concerned" with future cuts in CMS' 340B lump sum final rule.

Hospital advocates praised the recent Medicare final rule implementing a $9 billion lump sum payment to 340B hospitals but worried [...]

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HRSA, Hospital Settle Lawsuit Over Termination from 340B

November 7, 2023 Views

The hospital Insight Chicago and federal regulators have agreed to dismiss a case before a federal district court over the hospital's 340B eligibility.

A federal district judge in Illinois has dismissed a Chicago hospital’s apparently successful lawsuit challenging its termination from the 340B [...]

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Senate Finance Committee Republicans Oppose CMS Plan to Redefine Medicaid Best Price

November 7, 2023 Views

A group of Republicans on the Senate Finance Committee have called on CMS to withdraw its plan to rewrite the definition of Medicaid best price.

A group of Senate Republicans recently urged federal regulators to withdraw a plan to change the definition of a drug’s [...]

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Medicare to Continue ASP Plus 6% for 340B Drugs in 2024

November 3, 2023 Views

In response to the ongoing Change Healthcare cyberattack, CMS will direct contractors to provide some accelerated payments to hospitals.

Medicare Part B will continue to pay hospitals for 340B drugs at the rate of average sales price (ASP) plus [...]

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CMS Finalizes 340B Lump Sum Payment, Retains Offsetting Cuts Starting in 2026

November 2, 2023 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.

Medicare issued a final rule today to implement a $9 billion lump sum payment to 340B hospitals and to cut [...]

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Health Systems Sue to Reverse Elimination of Hospital Registration Waiver

November 2, 2023 Views

A hospital association asked the U.S. District Court of the District of Columbia to side with more than 40 health systems that sued federal regulators over a hospital registration policy change.

Forty-four health systems and hospitals sued federal healthcare agencies over their recent decision to end a 340B COVID-related registration flexibility [...]

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340B Hospital Registration Waiver Withdrawal Could Draw Legal Challenge

October 31, 2023 Views

Dept. of Health and Human Services building and signage

Hospital advocates said HRSA's recent decision to end a 340B program waiver for hospitals could draw legal challenges.

The recent end of a 340B program waiver for hospitals is wrong, hurts hospitals and their patients, and is bound [...]

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HRSA To End Waiver for Some Offsite 340B Hospital Locations, Provides Grace Period

October 26, 2023 Views

HRSA confirmed it will end a pandemic-era waiver program that allowed 340B drug use in certain offsite hospital locations.

The Health Resources and Services Administration (HRSA) confirmed today it is ending a 340B program waiver issued early in the [...]

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Biocon Announces New NDC for its Lantus Biosimilar

October 26, 2023 Views

Biocon has added a new national drug code for its insulin biosimilar, the drugmaker recently notified 340B providers.

Indian biopharmaceutical manufacturer Biocon Biologics has notified 340B covered entities about a new national drug code (NDC) for insulin glargine-yfgn, [...]

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Category: Regulatory

Genesis Ruling Could Expand 340B-Eligible Prescriptions, Say Some Attorneys

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Hospitals Urge CMS to Reconsider Future Cuts in 340B Lump Sum Final Rule

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HRSA, Hospital Settle Lawsuit Over Termination from 340B

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Senate Finance Committee Republicans Oppose CMS Plan to Redefine Medicaid Best Price

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Medicare to Continue ASP Plus 6% for 340B Drugs in 2024

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CMS Finalizes 340B Lump Sum Payment, Retains Offsetting Cuts Starting in 2026

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Health Systems Sue to Reverse Elimination of Hospital Registration Waiver

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340B Hospital Registration Waiver Withdrawal Could Draw Legal Challenge

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HRSA To End Waiver for Some Offsite 340B Hospital Locations, Provides Grace Period

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Biocon Announces New NDC for its Lantus Biosimilar

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