Tom Mirga

Federal Judge Accepts Drug Company Filings in 340B Patient Definition Case

In Judicial, ProvidersAugust 29, 2023364 Views

Genesis Health Care defended its interpretation of the 340B statute in a filing to the U.S. District Court for the District of South Carolina.

A federal district judge has allowed five major drugmakers to file friend-of-the-court briefs in a lawsuit over patient eligibility to [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Share of Retail Pharmacies that Contract with ‘Core’ 340B Safety-Net Facilities Fell Over Time, Study Finds

In Pharma Industry, Providers, Research/ReportsAugust 17, 2023246 Views

Tom Mirga

There has been a decline in the share of retail pharmacies that contract with 340B "core safety-net facilities," according to a JAMA Health Forum study.

The proportion of retail contract pharmacies in the 340B program that contract exclusively with “core safety-net” facilities fell from 95% [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

HHS Asks Court to Deny Injunction Against Medicare Drug Price Negotiations

In Judicial, Pharma Industry, RegulatoryAugust 17, 2023137 Views

Tom Mirga

HHS asked the U.S. District Court in Dayton, Ohio to deny a preliminary injunction that would prevent Medicare drug price negotiations.

The U.S. Department of Health and Human Services (HHS) asked a federal court to deny a preliminary injunction sought by [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Pfizer Changes Costly Cardiac Drugs’ Access Rules for 340B Providers

In Pharma Industry, ProvidersAugust 17, 2023618 Views

Tom Mirga

Pfizer has limited multiple 340B-eligible drugs to direct purchase after a tornado damaged one of the drug maker's manufacturing facilities.

Drug manufacturer Pfizer is changing how healthcare providers access 340B pricing on two expensive, related heart medicines, effective Nov. 1, [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

HRSA Allows Immediate 340B Enrollment in Hawaii Due to Wildfires

In Providers, RegulatoryAugust 17, 2023281 Views

Tom Mirga

HRSA is allowing eligible covered entities in Hawaii to enroll in the 340B program immediately rather than having to wait for the next quarterly registration period.

Eligible covered entities in Hawaii may enroll in the 340B program immediately rather than having to wait for the next [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

GSK Giving 340B Entities Refunds Again for Asthma Medicine Purchases

In Pharma Industry, ProvidersAugust 15, 2023113 Views

Tom Mirga

GSK is sending 340B covered entities refunds for overcharges of its asthma treatment Nucala.

GlaxoSmithKline is sending 340B covered entities refunds for overcharges totaling $100 or more for purchases of two dosage forms of [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Let For-Profit Hospitals Into 340B, Trade Association Tells Senators

In Federal, Providers, Trade AssociationAugust 10, 2023298 Views

Tom Mirga

The Federation of American Hospitals has asked six U.S. senators to let for-profit hospitals join the 340B program.

Congress should let for-profit hospitals into the 340B drug pricing program as “a long overdue evolutionary step” that will advance [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Five Major Drug Makers Oppose Health Center’s Legal Challenge to 340B Patient Definition

In Genesis, Judicial, Pharma IndustryAugust 8, 20231207 Views

Tom Mirga

AbbVie, BMS, Lilly, and Merck jointly asked a federal district court to dismiss a health center’s challenge to the 340B patient definition. Drug maker Janssen asked the same separately.

Drug makers AbbVie, Bristol Myers Squibb, Janssen, Lilly, and Merck asked a federal district court in South Carolina on Friday [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Senate Appropriators Urge HRSA to Penalize Drug Makers That Impose 340B Contract Pharmacy Conditions

In GeneralAugust 3, 2023398 Views

Tom Mirga

The Democratic-controlled U.S. Senate Appropriations Committee urged HRSA to penalize drug manufacturers over 340B contract pharmacy restrictions.

Federal health care officials should use fines and “any available measures” to punish drug makers that deny 340B pricing for [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

HRSA Tells Federal Court it Still Stands by its 340B Patient Definition in Closely Watched Case

In Judicial, RegulatoryAugust 1, 2023576 Views

Tom Mirga

HRSA says it stands by its patient definition in Genesis' federal lawsuit seeking a far broader definition.

The U.S. Health Resources and Services Administration (HRSA) still stands by its 340B program patient definition, the agency said in [...]

Please Login or Become a Paid Subscriber to View this Content

If you are already a

…

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Please Login or Become a Paid Subscriber to View this Content

If you are already a

Site Footer