Author: Tom Mirga

Pedley Provides 340B Update but Avoids Contract Pharmacy Controversy

In Federal, RegulatoryJuly 22, 2021268 Views

Due to litigation, 340B program director Rear Adm. Krista Pedley could say little about the drug discount program during yesterday’s 340B Coalition virtual summer conference.

Rear Adm. Krista Pedley, Director of the U.S. Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs, gave a brief update on the 340B program during yesterday’s 340B Coalition virtual summer conference. She explained that “due to current litigation …

House GOP Starts Crafting Health Care Bills in Anticipation of Retaking Majority

In Federal, LegislativeJuly 22, 2021121 Views

Tom Mirga

U.S. Rep. Brett Guthrie (R-Ky.) is a co-leader of the House GOP's Healthy Future Task Force. He is also the ranking GOP member on the House committee overseeing 340B.

The top Republicans on two U.S. House health subcommittees are leading a party effort to “craft legislative proposals that Republicans can advance after retaking the majority” in the November 2022 midterm elections. It is not known whether the group will …

340B Program Flexibilities to Continue As COVID-19 Emergency Extended

In Federal, RegulatoryJuly 22, 202130 Views

Tom Mirga

HHS Secretary Xavier Becerra this week extended the COVID-19 public health emergency until mid-October.

U.S. Health and Human Services (HHS) Secretary Xavier Becerra on Monday extended the COVID-19 national public health emergency (PHE) for another 90 days, to Oct. 17. The move extends 340B program flexibilities implemented during the pandemic’s early days.

…

Biden Administration’s Proposal to Retain 340B Hospital Drug Payment Cuts Draws More Fire

In Federal, RegulatoryJuly 20, 2021414 Views

Tom Mirga

Groups whose members include 340B hospitals yesterday slammed CMS for proposing to continue deep drug payment cuts to 340B hospitals.

Several groups whose members or clients include 340B hospitals yesterday slammed the Biden administration’s decision to continue the Trump administration’s huge cut in Medicare Part B reimbursement for hospitals’ 340B purchased drugs. The American Hospital Association (AHA) has not, so …

One-Fourth of 340B DSH Hospitals at Risk of Losing Eligibility Due to Pandemic, Analysis Finds

In Federal, RegulatoryJuly 20, 2021327 Views

Tom Mirga

Many hospitals reduced inpatient admissions during the COVID-19 pandemic. 340B hospitals now fear that this could cause them to lose their eligibility for 340B drug discounts due to changes in patient mix.

Roughly one out of four 340B disproportionate share (DSH) hospitals could lose their eligibility for 340B drug discounts due to COVID-19 pandemic-related changes in patient mix, an analysis of hospital Medicare cost reports for 2019 and 2020 shows. About one …

Help Wanted Ads Suggest HRSA Reorganization Is in Gear

In Federal, RegulatoryJuly 20, 2021185 Views

Tom Mirga

Recent HRSA job postings suggest that a reorganization announced in late January is finally in motion.

There are signs that the U.S. Health Resources and Services Administration (HRSA) reorganization announced in late January is finally in motion. It is still unknown, though, if the 340B program is moving to a new home in the HRSA administrator’s …

Judge Consolidates Arguments in Two 340B Contract Pharmacy Lawsuits

In Federal, JudicialJuly 20, 2021151 Views

Tom Mirga

A federal district judge will hold a joint hearing in October on drug makers’ Novartis and United Therapeutics’ 340B contract pharmacy lawsuits.

A federal district judge will hold a joint hearing in October on drug makers’ Novartis and United Therapeutics’ (UT) lawsuits challenging the government’s findings in May that the two companies’ 340B contract pharmacy policies are unlawful.

…

United Therapeutics Fleshes Out its 340B Contract Pharmacy Legal Arguments

In Federal, JudicialJuly 20, 2021146 Views

Tom Mirga

United Therapeutics told a judge on Friday that the government’s position that the company's 340B contract pharmacies are illegal “contravenes the plain text” of the 340B statute.

The government’s position that United Therapeutics’ (UT) restrictions on 340B contract pharmacies are illegal “contravenes the plain text” of the 340B statute, the drug company told a federal district judge on Friday.

Please Login or Become

…

In Surprise Move, Biden Administration Proposes Keeping Trump’s Nearly 30% Cut in 340B Hospitals’ Drug Reimbursement

In Breaking, Federal, RegulatoryJuly 19, 2021801 Views

Tom Mirga

The U.S. Centers for Medicare & Medicaid Services (CMS) said today it proposes to continue a nearly 30% reduction in Medicare Part B reimbursement for hospitals’ 340B-purchased drugs.

The Biden administration said today it proposes to continue a nearly 30% reduction in Medicare Part B reimbursement for hospitals’ 340B-purchased drugs.

The Trump administration implemented the payment reduction in January 2018. Hospital groups say it costs affected 340B hospitals

…

Key Congressional Committee Urges HRSA to Fine Drug Makers Over 340B Contract Pharmacy Denials

In Federal, LegislativeJuly 15, 2021492 Views

Tom Mirga

U.S. House appropriators are encouraging HRSA to use fines and "any available measures" to hold drug manufacturers accountable for withholding 340B drug discounts.

The U.S. House Appropriations Committee is pleased with the U.S. Health Resources and Services Administration (HRSA) for challenging six drug makers’ denials of 340B pricing when covered entities use contract pharmacies, the committee said in a report released yesterday. It …