Two of three judges on a federal appeals court panel strongly indicated this morning that they reject the federal government’s position that nothing in the 340B statute gives drug manufacturers the right to put any conditions on offers of 340B
…Category: Breaking
The U.S. Health Resources and Services Administration yesterday referred drug manufacturer Merck to the Department of Health and Human Services Office of Inspector General for possible imposition of civil fines over Merck’s 340B contract pharmacy restrictions.
Public Health Services Lt.
…Breaking News
Effort Launched to Create 340C—a Separate Drug Discount Program for Health Centers and Possibly Other Entities
A national community health center association founded last year is launching a campaign to urge Congress to create a separate drug discount program called 340C open to health centers and perhaps rural hospitals and federal grantees.
According to a description
…Breaking News
Exclusive: HHS OIG Declines to Penalize Drug Manufacturers at This Time Over 340B Contract Pharmacy Restrictions
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) has informed a bipartisan group of House lawmakers that the enforcement agency does not plan to impose civil monetary penalties against the drug makers that have
…Sparked by the dismissal of its complaint against Astra Zeneca and Sanofi by the government’s Administrative Dispute Resolution Panel (ADR), the National Association of Community Health Centers say “they cannot wait any longer for a solution,” to the two-year standoff
…The U.S. Centers for Medicare and Medicaid Services “fully anticipate[s]” applying a Medicare Part B reimbursement rate next year of average sales price ASP plus 6% to drugs and biologicals purchased through the 340B program, CMS announced late this afternoon.
…Breaking News
In Important Ruling, Federal Appeals Court Says Health Center May Challenge 340B Patient Definition’s Legality
A federal appeals court ruled unanimously this morning that a South Carolina health center has the right to challenge the legality of the government’s 340B patient definition in a lower federal court. The case ultimately could have profound implications for
…Bausch Health this afternoon became the 18th drug manufacturer to impose conditions on 340B pricing when covered entities use contract pharmacies. The restrictions apply to all entities; there is no exemption for federal grantees.
According to Bausch’s announcement, effective Aug.
…Breaking News
U.S. Supreme Court Strikes Down Medicare Part B Drug Payment Cuts for 340B Hospitals in 2018 and 2019
UPDATE, June 15, 2022, 12:45 p.m. EDT—The U.S. Centers for Medicare & Medicaid Services said, “We are aware and reviewing the decision.”
The U.S. Supreme Court ruled unanimously this morning that the federal government unlawfully slashed Medicare Part
…Breaking News
HRSA Sends Merck 340B Contract Pharmacy Cease and Desist Letter, Agency’s First in Seven Months
The federal government told drug manufacturer Merck today its conditions on 340B pricing when hospitals and health centers use contract pharmacies are illegal and must stop, or the company could face penalties of up to $6,323 per each instance of
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