Category: Federal

Lilly Providing Refunds for 340B Overcharges During Q3 2019

April 12, 2022 Tom Mirga, Editor at Large Views

Drug company Lilly is providing refunds for 340B overcharges on 14 NDCs during 3Q 2019.

Drug manufacturer Lilly is giving 340B covered entities refunds for overcharges on 14 NDCs during Q3 2019 after restating Medicaid average manufacturer prices and best prices “to account for lagged transactional data,” the company says on a notice on the

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340B Report Publisher and CEO Slafsky: 340B Contract Pharmacy Program Has Fractured Into 17 Pieces

April 12, 2022 Tom Mirga, Editor at Large Views

Drug manufacturers' 340B contract pharmacy actions have seemingly fractured the 340B program into pieces, 340B Publisher and CEO Ted Slafsky says.

“The 340B contract pharmacy program has seemingly fractured into 17 programs, one governed by the federal government and 16 others with their own standards determined by pharmaceutical manufacturers,” 340B Publisher and CEO Ted Slafsky observes in his latest column for

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While All Eyes are on 340B Contract Pharmacy Battle, Federal Appeals Court Hears Arguments in Key Case Challenging HRSA’s Patient Definition

April 7, 2022 Tom Mirga, Editor at Large Views

Genesis Health Care office sign and facility

A South Carolina health center's lawsuit, now before a federal appeals court, challenges one of of the 340B program's basic elements—the definition of a “patient” eligible to receive 340B drugs.

Part 1 of Two-Part Deep Dive into One of the Most Important and Contentious Areas of 340B Program

While much of the 340B community’s attention has been focused on the contract pharmacy suits winding through the federal court system, there

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340B Patient Definition Is at the Heart of Case Debated Before Federal Appeals Court

April 7, 2022 Tom Mirga, Editor at Large Views

A federal appeals court in Richmond, Va., heard arguments last month in a case involving the legality of the 340B program definition of "patient."

Part 2 of a Two-Part Series About One of the Most Important and Contentious Areas of the 340B Program. Read Part 1 here.

An attorney for a South Carolina health center asked a federal appeals court in Richmond, Va., last

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Influential 340B Lawmaker Upton Announces Retirement

April 7, 2022 Tom Mirga, Editor at Large Views

Rep. Fred Upton speaks at a House hearing

U.S. Rep. Fred Upton (R-Mich.), a former House Energy & Commerce Committee chair who 340B entities call a close ally, is retiring from Congress.

U.S. Rep. Fred Upton (R-Mich.), a former House Energy & Commerce Committee chair who 340B entities call a close ally, announced on Tuesday he will not seek another term in Congress.

“Even the best of stories has a last chapter,”

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Influential Drug Cost-Effectiveness Organization Endorses Partially Lifting 340B Orphan Drug Exclusion

April 7, 2022 Tom Mirga, Editor at Large Views

Policymakers should consider narrowing the 340B orphan drug exemption, ICER said today in a new report.

The exclusion of 340B pricing for some hospitals on drugs to treat orphan conditions and diseases could be partially eliminated to slow “the rapid growth in approved rare disease treatments” and “their cumulative affordability to the health system,” an influential

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House Passes Bill to Limit Insulin Co-Pays, but the Way Forward in Senate Is Unclear

April 5, 2022 Tom Mirga, Editor at Large Views

Senate Majority Leader Chuck Schumer (D-N.Y.) said last month "the Senate will vote on a bill to fix" the skyrocketing cost of insulin. The House last week passed a bill limiting cost-sharing for insulin.

The U.S. House passed a bill late last week limiting cost-sharing for insulin under private health insurance and Medicare Part D.

H.R. 6833 caps cost-sharing under private health insurance for a month’s supply of selected insulin products at $35 or

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CMS Projects that Drug Spending and Drug Prices Will Keep Rising Through 2030

March 31, 2022 Tom Mirga, Editor at Large Views

CMS predicts that U.S. retail prescription drug spending will grow 4.3% this year, with growth accelerating to 4.7% next year and to 5.1% in 2024.

Federal actuaries predict retail prescription drug spending in the United States will grow 4.3% this year, with growth accelerating to 4.7% next year and to 5.1% in 2024.

The Centers for Medicare & Medicaid Services (CMS) Office of the Actuary

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Next Month’s 340B Registration Period Overlaps with Deadline for Hospitals Seeking Reinstatement

March 31, 2022 Tom Mirga, Editor at Large Views

The Q2 2022 registration period for 340B overlaps with the April 14 deadline for hospitals that lost their 340B eligibility due to the COVID-19 public health emergency to file paperwork for reinstatement.

The next period for 340B registration of new covered entities, outpatient facilities, and contract pharmacies will begin tomorrow, April 1, and end on Friday, April 15.

Eligible hospitals, health centers, clinics, and their child sites and contract pharmacies registered during

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HRSA Refers Boehringer Ingelheim to HHS Inspector General over its 340B Contract Pharmacy Policy

March 29, 2022 Tom Mirga, Editor at Large Views

Boehringer Ingelheim exterior sign and building

HRSA has referred Boehringer Ingelheim to the HHS Inspector General for possible imposition of civil monetary penalties over BI's conditions on 340B pricing when hospitals use contract pharmacies.

The U.S. Health Resources and Services Administration (HRSA) today turned the screws tighter on Boehringer Ingelheim (BI) over its “continued failure to provide the 340B price to covered entities utilizing contract pharmacies.”

HRSA told BI in a March 29

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