HRSA Posts Novartis Notice About 340B Refunds on a Top-Selling Drug—With Contract Pharmacy Strings Attached (Updated)

Novartis exempted Mississippi 340B providers from its contract pharmacy restrictions following a new state law.

UPDATE Tuesday, July 27, 2021, 1:45 p.m. Eastern—Drug manufacturer Novartis provided the following statement:

“Novartis recently notified the Health Resources and Services Administration (HRSA) that we inadvertently neglected to offer the 340B ceiling price to covered entity types added by

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For 340B Hospitals, Some Consolation in Otherwise Disappointing CMS Drug Reimbursement Rule

CMS proposes extending "pass-through" status for 24 drugs and three biosimilars in 2022—a move that would temporarily shield the medicines from the deep payment cut for 340B hospitals.

Hospitals groups were deeply disappointed last week with the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposal to continue a nearly 30% cut in Medicare Part B reimbursement for hospitals’ 340B purchased drugs in place since 2018.

Another provision

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Pedley Provides 340B Update but Avoids Contract Pharmacy Controversy

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 (OPA), gave a brief update on the 340B program during yesterday’s 340B Coalition virtual summer conference. She explained that “due to current

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

Rep. Brett Guthrie (R-Ky.) will run to chair the House E&C Committee next session--and is considered by some lobbyists as the favorite to win--if Republicans maintain control of the House.

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

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

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.

In

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With 340B Hospital Recertification Set to Begin Soon, HRSA To Host Webinar Aug. 11

Annual recertification of hospital eligibility for 340B drug discounts begins on Aug. 16.

The recertification period for hospitals to continue to participate in the 340B program begins in mid-August. The U.S. Health Resources Services Administration (HRSA) has scheduled an informational webinar on Wednesday, Aug. 11 at 1 p.m. Eastern time to discuss the

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

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

Several groups whose members include 340B hospitals yesterday slammed the Biden administration’s proposal to continue the Trump administration’s huge cut in Medicare Part B reimbursement for hospitals’ 340B purchased drugs.

The new administration yesterday announced its proposed plans for

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

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

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Help Wanted Ads Suggest HRSA Reorganization Is in Gear

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

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Judge Consolidates Arguments in Two 340B Contract Pharmacy Lawsuits

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.

In a short unpublished

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