Category: Federal

Tennessee Health System Strikes Back Against DOJ Claims It Paid for Referrals to Boost 340B Revenue

May 24, 2022 Tom Mirga, Editor at Large Views

Methodist University Hospital, Methodist Le Bonheur Healthcare building

Methodist Le Bonheur Healthcare disputes U.S. Justice Department claims that the health system's agreements under the system’s affiliation with a private oncology practice were “a fiction” perpetuated partially to let the system “realize profits from the 340B program.”

A Tennessee health system last week denied U.S. Justice Department (DOJ) allegations that agreements under the system’s seven-year affiliation with a private oncology practice were “a fiction” perpetuated partially to let the system “realize profits from the 340B program.”

Methodist

Provider Groups File Appellate Briefs in Key 340B Contract Pharmacy Cases

May 19, 2022 Tom Mirga, Editor at Large Views

US court of appeals for the DC circuit courtroom interior

Groups representing health centers, HIV/AIDS clinics, and hospitals filed briefs in key 340B contract pharmacy cases in federal appeals courts in Washington, D.C., and Philadelphia.

Groups representing health centers, HIV/AIDS clinics, and hospitals asked federal appeals courts in Philadelphia and Washington, D.C., this week to hold that drug manufacturers must give covered entities 340B discounts on drugs when entities use contract pharmacies to fill prescriptions

U.S. Uninsured Rate Dipped Slightly in 2021 to 9.2% but Rates for Hispanics and Blacks Remain High

May 19, 2022 Tom Mirga, Editor at Large Views

bar chart showing percentage of U.S. population uninsured and insured by age group

The U.S. uninsured rate fell slightly in 2021 to 9.2%, down from 9.7% in 2020, new data from the National Center for Health Statistics (NCHS) show.

The U.S. uninsured rate fell slightly in 2021 to 9.2% (about 30 million people), down from 9.7% (about 31.6 million people) in 2020, the National Center for Health Statistics (NCHS) reports.

NCHS released this and related health insurance coverage findings earlier

25 States Say Drug Companies’ 340B Contract Pharmacy Actions Are Illegal and Harm Public Health

May 17, 2022 Tom Mirga, Editor at Large Views

excerpt of amicus brief for 340B drug pricing program

An excerpt from one of the two friend of the court briefs that 25 states filed in pivotal 340B contract pharmacy litigation in federal appeals courts.

Yesterday, 340B Report broke the news that a group of 25 states from blue bastions such as Connecticut and Maryland to red states such as Arkansas and Mississippi weighed in favor of the federal government’s effort to punish drug manufacturer

HRSA Announces 340B Enrollment Flexibilities in Fire-Ravished New Mexico

May 17, 2022 Tom Mirga, Editor at Large Views

flames and smoke over mountains in New Mexico

HRSA has announced 340B program enrollment flexibilities in New Mexico, which is coping with the biggest wildfire in state history.

The U.S. Health Resources and Services Administration (HRSA) yesterday announced 340B program enrollment flexibilities in New Mexico due to the declaration of a public health emergency in the state.

Wildfires in northern New Mexico that began in early April have

25 States File Joint Briefs Backing HHS and HRSA in 340B Contract Pharmacy Cases

May 16, 2022 Tom Mirga, Editor at Large Views

Connecticut Attorney General William Tong (D) led the coalition of states backing the federal government in 340B contract pharmacy cases before federal appeals courts.

Twenty-five states are backing the federal government in litigation before two federal appeals courts over drug manufacturers’ denials of 340B pricing when covered entities use contract pharmacies.

A bipartisan group of state attorneys general filed friend of the court briefs this

Mallinckrodt Is the Third Drug Company This Month to Announce Refunds for 340B Overcharges

May 12, 2022 Tom Mirga, Editor at Large Views

Mallinckrodt's SpecGx subsidiary is providing refunds for 340B overcharges on 22 NDCs for purchases from Q3 2019 through Q2 2020.

Drug manufacturer Mallinckrodt’s SpecGx generic pharmaceutical subsidiary is providing refunds for 340B overcharges on 22 NDCs for purchases from Q3 2019 through Q2 2020.

This is the third time this month that a drug manufacturer has announced 340B refunds for

340B Providers Lose their Biggest GOP Ally in U.S. House

May 12, 2022 Tom Mirga and Ted Slafsky, Editor at Large Views

U.S. Rep. David McKinley (R-WA) gestures during hearing

U.S. Rep. David McKinley (R-W.Va.) lost his GOP primary election this week. It's a huge blow for 340B entities that have relied on his help in Congress for years.

In a major blow to the 340B provider community, U.S. Rep. David McKinley, the leading voice for the 340B program in the House Republican caucus, was defeated Tuesday in the West Virginia Republican primary. McKinley will remain in office until

Letting Pharma Put Strings on 340B is Letting Fox Guard Henhouse, Feds Tell Appeals Courts

May 10, 2022 Tom Mirga, Editor at Large Views

Department of Justice sign on a building facade

The DOJ told federal appeals courts in Philadelphia and Washington, D.C., that HHS was right to tell drug manufacturers their conditions on 340B contract pharmacy are illegal and must end.

Letting drug manufacturers put conditions on 340B drug discounts “would be akin to letting the fox guard the henhouse,” the U.S. Justice Department (DOJ) told federal appeals courts in Philadelphia and Washington, D.C., last night in a pair of filings

Amgen and GSK Announce Refunds for 340B Overcharges – May 22

May 10, 2022 Tom Mirga, Editor at Large Views

Amgen is providing refunds for 340B overcharges for four NDCs of its top-selling drug Enbrel during 2016 and 2017.

Drug manufacturer Amgen is providing refunds for overcharges during varying periods over three years on some of its top selling drugs including Enbrel ($4.8 billion in U.S. sales in 2020), Neulasta ($2 billion), Kyprolis ($710 million), Aranesp ($629 million), Epogen

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