HHS’s Latest Regulatory Agenda Is Silent on 340B, but Program Rulemaking Is Possible

HHS's latest semi-annual regulatory agenda is mum on 340B, but that doesn't mean there is nothing 340B-related in the pipeline. | Shutterstock

The U.S. Health and Human Services Department (HHS) yesterday released the spring edition of its twice-annual public inventory of forthcoming regulatory actions. Although it was silent about the 340B program, 340B stakeholders shouldn’t breathe a sigh of relief yet.

Just

Read More »

AHA Asks Becerra to Waive a 340B Hospital Eligibility Requirement During COVID-19 Emergency

HHS Secretary Xavier Becerra told a House committee today "We are on this one" in reference to drug companies denying 340B pricing on their products.

The American Hospital Association (AHA) yesterday asked U.S. Health and Human Services (HHS) Secretary Xavier Becerra to temporarily waive 340B program eligibility criteria for hospitals at risk of losing their 340B eligibility due to changes in payer mix caused by

Read More »

Breaking News

For-Profit Hospitals Make Major Pitch for Keeping Medicare’s 340B Hospital Cuts

United Therapeutics says that, starting May 13, entities must upload their 340B contract pharmacy claims data to its vendor 340B ESP twice monthly to "be eligible to place Bill To / Ship To replenishment orders for United Therapeutics products dispensed through a contract pharmacy.”

The association for U.S. for-profit hospitals submitted a brief to the U.S. Supreme Court and released a study today arguing against reversing the nearly 30 percent cut in what Medicare pays many public and private nonprofit hospitals for physician-administered, 340B-purchased

Read More »

340B Entities Keeping Watch on Bills to Create State Drug Affordability Boards

The Colorado General Assembly is one of nine state legislatures considering bills to create state drug affordability boards.

Nine states are considering legislation to create boards to review prescription drug prices and intervene to lower them if drugs become too expensive or if their prices spike. Although the bills’ implications for the 340B program have not been fully

Read More »

Q2 340B Registration Period Starts April 1

A screen capture from HRSA's user guide for providers wishing to register to participate in the 340B program.

The second of four opportunities this year for covered entities to register themselves, their sites, and their contract pharmacies in the 340B program starts this Thursday, April 1 and ends on Thursday, April 15. New registrants can begin buying discounted

Read More »

Origin Biosciences Posts Limited Distribution Notice on 340B Program Site

The maker of Nulibry, a new, first-of-its-kind drug whose supply is limited, notified providers about how they can buy it at its 340B price.

The manufacturer of Nulibry, a recently approved, first-of-its-kind injectable treatment for a very rare, often fatal genetic disorder that typically appears soon after birth, has posted details about the limited distribution network for the drug on the U.S.

Read More »

HRSA Takes Step Forward on 340B Dispute Resolution Petitions

HRSA this week notified 340B covered entities that it had finished reviewing their administrative dispute resolution petitions for completeness, and determined that they were complete. | Shutterstock

The federal government on Tuesday declared 340B administrative dispute resolution (ADR) petitions by covered entities against drug manufacturers AstraZeneca, Eli Lilly, and Sanofi to be “complete,” a sign that claims against two of the three companies—AstraZeneca and Sanofi—are ready for

Read More »

Health Centers Get Reprieve as 340B Insulin Pricing Rule Delayed Again

HHS has for the second time delayed the effective date of a Trump administration rule to require health centers to provide insulin and injectable epinephrine to low-income patients at the price the centers pay for those drugs under the 340B program. The new date is July 20. | Shutterstock

The U.S. Health and Human Services Department (HHS) announced late this morning that it will delay, from this coming Monday, March 22 until July 20, the effective date of a Trump administration rule to require health centers to provide insulin

Read More »

Opposition to Express Scripts’ 340B Claims ID Requirement Grows

U.S. Rep. Abigail Spanberger (D-Va.) said her successful amendment today to a spending bill sends big pharma the message "Stop hiking drug prices on consumers and discriminating against our 340B providers and pharmacies."

Correction, Tuesday March 16, 4:00 p.m. EDT—Earlier today, we reported that during a March 16 webinar, advisers to 340B covered entities said that U.S. Rep. Abigail Spanberger (D-Va.) had written to pharmacy benefit manager Express Scripts (ESI) about its new

Read More »

FQHCs Fiercely Oppose Trump’s 340B Insulin Pricing Rule in New Round of Comments

HRSA received 200 comments on the Biden administration's proposal to delay until July 20 the effective date of a controversial rule on how much health centers can charge low-income patients for insulin and injectable epinephrine.

Federally qualified health centers and their trade groups are adamantly opposed to implementing a Trump administration rule to require health centers to provide insulin and injectable epinephrine to low-income patients at the price the centers pay for those drugs under

Read More »
Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
×

*Sign up for news summaries and alerts from 340B Report

Site Footer Live