Lifestar, Chartwell Announce Refunds for Q4 2022 340B Overcharges

340B refund notices
HRSA recently posted notices on its website of refunds for 340B overcharges from two generic drug manufacturers.

Generic drug manufacturers Lifestar Pharma and Chartwell Pharmaceuticals may owe refunds to 340B covered entities for overcharges on drugs purchased from the companies in the fourth quarter of 2022, according to recent notices posted on the U.S. Health Resources and

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HRSA Says COVID Flexibility About Dispensing 340B Drugs in Unregistered Hospital Offsite Locations Will End Thursday

COVID-19 flexibility
HRSA has reversed course and will end a 340B COVID-19 flexibility that it previously said was permanent that lets hospitals under certain conditions start using 340B drugs at offsite outpatient locations sooner than HRSA would normally allow.

The U.S. Health Resources and Services Administration said late Friday that when the COVID-19 public health emergency ends on Thursday, so too will a nearly three-year-old policy clarification that lets hospitals under certain conditions dispense 340B drugs at offsite outpatient

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340B COVID-19 Flexibilities Will End May 11 as Public Health Emergency Expires

HRSA
340B program flexibilities allowed under the COVID-19 public health emergency will expire May 11, HRSA said Monday.

Certain flexibilities to the 340B program allowed under the COVID-19 public health emergency will expire May 11 alongside the PHE, the U.S. Health Resources and Services Administration announced Monday.

The update, which HRSA posted prominently on the Office of Pharmacy

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Astellas Notifies 340B Entities for Second Time in 2023 About a Change in Drug’s NDC

Cresemba
Astellas says for 340B replenishment, the new and old NDCs of Cresemba’s 372mg intravenous formulation are interchangable.

Drug maker Astellas will let 340B covered entities count accumulations of an injectable form of its antifungal drug Cresemba under its old National Drug Code toward replenishment of equal quantities under the product’s corresponding new NDC, provided the entities use

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340B Recertification for CDC Grantees Starts May 8

Recertification
Annual 340B recertification for CDC grantees will be May 8 through June 5.

This year’s annual 340B recertification period for U.S. Centers for Disease Prevention and Control grantees—Title X family planning, sexually transmitted disease, and tuberculosis clinics—will be May 8 through June 5, the U.S. Health Resources and Services Administration said Tuesday.

Recertification

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In Surprise Move, Pennsylvania Wants 340B Modifiers on Medicaid Managed Care Drugs

Pennsylvania
Pennsylvania 340B covered entities say they were blindsided by the state's disclosure last week that it wants drug claims billed to Medicaid managed care organizations to include a modifier showing if the prescription was filled with a 340B-purchased drug.

Pennsylvania health centers are upset about what they say was the state Medicaid office’s disclosure without warning last week that, starting July 1, it wants drug claims billed to Medicaid managed care organizations to include a modifier showing if the

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Feds Pass on Asking Full Appeals Court to Reconsider Adverse 340B Contract Pharmacy Ruling and Vacate Enforcement Letters to Three Manufacturers

Third Circuit Court
The federal government opted not to ask a federal appeals court to reconsider its opinion upholding three drug makers' restrictions on 340B pricing when their drugs are shipped to be dispensed by contract pharmacies.

The federal government yesterday decided not to ask all 14 judges on the U.S. Third Circuit Court of Appeals in Philadelphia to review a three-judge panel’s unanimous January opinion upholding AstraZeneca, Novo Nordisk, and Sanofi’s restrictions on 340B pricing when

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Lilly Asks Covered Entity to Promptly Repay “Duplicate 340B/Medicaid Discounts”

Lilly
Eli Lilly is conducting government approved 340B provider audits that for the first time look for certain Medicaid health plan duplicate discounts.

Drug manufacturer Eli Lilly asked a 340B covered entity last week to promptly repay it for “duplicate 340B/Medicaid discounts” and evaluate all Lilly prescriptions that it or its contract pharmacies dispensed for the last three years.

Consultants and attorneys with

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HHS OIG and HRSA Are Mum About 340B Manufacturer Civil Monetary Penalties and Violation Notices

screenshot of HRSA correspondence to stakeholders web page
HRSA and OIG have no comment on the status of drug manufacturer civil monetary penalties and violation letters stemming from denials of 340B pricing to covered entities that use contract pharmacies.

The U.S. Department of Health and Human Services Office of Inspector General said yesterday it has no comment on the status of referrals from the U.S. Health Resources and Services Administration to fine eight drug manufacturers for failing to offer

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HRSA Allows Immediate 340B Enrollment in Mississippi Due to Tornadoes

Tornado damage
Health care providers in Mississippi can enroll in 340B immediately under program flexibilities granted in response to March 24 tornadoes that killed 21.

Health care providers in Mississippi eligible to participate in the 340B program may do so immediately, rather than having to wait for the next normal quarterly registration period July 1-15, federal health officials said yesterday.

Strong tornadoes struck the state

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