Category: Federal

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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HRSA Invokes Contract Pharmacy Fight in Pitch for Comprehensive 340B Regulatory Power

March 29, 2022 Tom Mirga, Editor at Large Views

Department of Health and Human Service budget title page

HRSA yesterday told Congress in its budget request that it needed comprehensive regulatory authority over the 340B program to resolve the dispute over the 340B contract pharmacy program.

Congress needs to give the U.S. Health Resources and Services Administration (HRSA) comprehensive regulatory authority over the 340B program to resolve the dispute over the 340B contract pharmacy program, the Biden administration said yesterday in its proposed budget—although it did

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Arkansas Health Centers and Community Hospital Want Role in Challenging PhRMA’s Lawsuit Over State’s Novel 340B Contract Pharmacy Law

March 29, 2022 Tom Mirga, Editor at Large Views

Mid Delta Health Center is a member of Community Health Centers of Arkansas, which wants to intervene in PhRMA's lawsuit challenging the state's one-of-a-kind law protecting 340B contract pharmacy arrangements.

Arkansas health centers asked a federal court yesterday to let them intervene in the drug industry lawsuit challenging the state’s one-of-a-kind law protecting 340B contract pharmacy arrangements.

Community Health Centers of Arkansas (CHCA) filed the motion yesterday along with

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