House Committee Releases Report With 340B Implications

The U.S. House Oversight and Reform Committee has issued a blistering report about drug industry pricing and business practices.

The U.S. House Oversight and Reform Committee issued a blistering report late last week accusing brand pharmaceutical manufacturers of systematically jacking up prices on their drugs in the United States.

Pharmaceutical Research and Manufacturers of America (PhRMA) called it a

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A Q&A with Two 340B Industry Experts About the Importance of Innovation and a Competitive Edge

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The word “innovation” gets tossed around so much these days that we almost forget its meaning—the introduction of new and different ideas for out-of-the-box problem solving that have meaningful impacts. Yet, innovation is different in every industry, and it’s essential in a field as complex as 340B.

To get a handle on it, we sat down with healthcare technology veteran Andrew Stevenson, VP of Product Strategy and Business Development, and 340B industry expert Christy Bryant, VP, Customer Service & Regulatory Affairs at Macro Helix, a third-party administrator that facilitates the 340B programs of more than 900 covered entities as well as hospital-owned and retail pharmacies. Responsible for supporting customer relationships, and driving the execution of critical innovation programs with Macro Helix’s customers, they have valuable insights to share for a 340B community faced with new challenges almost daily.

In a nutshell, what is Macro Helix? How do you help customers succeed with 340B?

Christy Bryant: We help healthcare entities maximize their 340B

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Calif. Health Centers Will Ask Court to Stop State Medicaid Change That Could Reduce 340B Savings Significantly

California health centers plan to seek a court order stopping the state from moving Medicaid managed care drug benefits to Medicaid fee for service on Jan. 1.

As California’s Medicaid program moves toward implementing a fee-for-service payment structure for drug coverage, one of the primary foes of the transition has returned to court to obtain a temporary restraining order.

The new Medi-Cal Rx program is intended to

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In What Is Believed to Be the First State Action, W.Va. Says Express Scripts’ 340B Claims ID Policy Violates State Law

West Virginia Insurance Commissioner Allan McVey ruled that Express Scripts’ controversial 340B claims identification and submission requirement violates state law.

Pharmaceutical benefit manager Express Scripts’ (ESI) controversial 340B claims identification and submission requirement violates West Virginia law, state Insurance Commissioner Allan McVey has ruled.

McVey on Dec. 8 adopted and approved a hearing examiner’s Nov. 17 finding that ESI’s

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Senate Finance Committee’s New Drug Pricing Text Includes a New 340B Provision

The U.S. Senate Finance Committee’s latest drug pricing legislation includes 340B language not seen before in earlier House and Senate versions.

The U.S. Senate Finance Committee’s latest drug pricing legislation includes language, not seen before in earlier House and Senate versions, about denying 340B covered entities’ access to government-negotiated lower prices on drugs covered under Medicare.

The committee released the

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Judge Grants Stay in Boehringer Ingelheim’s 340B Contract Pharmacy Lawsuit

A federal district judge has stayed Boehringer Ingelheim’s 340B contract pharmacy lawsuit.

A federal district judge in Washington, D.C., has paused Boehringer Ingelheim’s (BI) 340B contract pharmacy lawsuit while the federal government decides whether to appeal the same judge’s Nov. 5 joint ruling in Novartis and United Therapeutics’ (UT) contract pharmacy suits.

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Update: Lilly Comments on Forthcoming New 340B Dispute Resolution Rule

Drug manufacturer Lilly says it hopes the new 340B administrative dispute resolution regulation "addresses the serious shortcomings of the current rule.”

Drug manufacturer Lilly said this morning it looks forward to reviewing the Biden administration’s proposed new 340B administrative dispute resolution (ADR) regulation when it becomes available “and hope[s] that it addresses the serious shortcomings of the current rule.”

“As Lilly

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340B Covered Entities: Are You Ready for the Changes to Gilead’s Advancing Access Program?

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This strategy could save the 340B proceeds at your organization

Today, underinsured or uninsured patients who are undergoing treatment with a Gilead HIV treatment or preventative medication may be eligible to receive those medications at no cost through Gilead’s Advancing Access program. Under this program, covered entities are able to receive full 340B proceeds from these dispenses and can use these funds to support and expand critical community programs and outreach efforts.

As most Ryan White and STI grantee covered entities probably are aware, on January 1, 2022, Gilead will no longer reimburse pharmacies at full retail price under its Advancing Access program. This will eliminate nearly all the 340B proceeds you may be currently receiving under this program and could have a huge impact on your business and the

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News Alert: Biden Administration Plans to Scrap Existing 340B Dispute Resolution Rule and Publish New One Shortly

The Biden administration plans to withdraw its 340B administrative dispute resolution (ADR) regulation and replace it with an entirely new rule.

The Biden administration plans to replace its 340B administrative dispute resolution (ADR) regulation with an entirely new rule that “better aligns with the president’s priorities on drug pricing [and] better reflects the current state of the 340B program.”

The administration

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Drug Makers May Be Getting Orphan Drug Designations to Exploit 340B Orphan Drug Exclusion, HHS OIG Tells Congress

The 340B orphan drug exclusion may give drug makers a strong incentive to get an orphan designation for their drugs prescribed primarily for common diseases or conditions, a federal watchdog agency reminded Congress this month.

The ban on 340B pricing on orphan drugs for over 1,000 hospitals may give companies that make drugs used primarily for common diseases or conditions a strong financial incentive to get an orphan designation for those drugs, a federal watchdog

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