Resources

Client Alerts, News Articles, Blog Posts, & Multimedia

Everything you need to know about BMD and the industry.

Another Drug Manufacturer Pursues Rebate Program as 340B Alternative

Client Alert

Some of the nation’s largest drug manufacturers are forging ahead to implement rebate programs for 340B drugs, even after the federal government has called these programs illegal.

In August 2024, Johnson & Johnson first announced its plan to implement a drug rebate program for 340B drugs whereby the manufacturer would charge buyers full price for drugs and offer a back-end rebate, instead of allowing safety net providers to purchase outpatient drugs at lower costs, as they have done since the program’s inception.

In response, the Health Resources and Services Administration (HRSA), the federal agency that oversees the 340B drug pricing program, deemed Johnson & Johnson’s rebate program illegal, prompting Johnson & Johnson to initially revoke the rebate plan. However, Johnson & Johnson had a change of heart and on November 12, 2024, filed a lawsuit to challenge HRSA’s decision.

Emboldened, other drug manufacturers have begun to implement drug rebate programs. On November 26, 2024, Bristol Myers Squibb filed a lawsuit against HRSA, asking the federal court to deem its rebate program legal and prevent U.S. Department of Health and Human Services from taking agency action to invalidated rebates.

While it is unclear how these federal courts will rule, these lawsuits signal a desire by drug makers to change how they offer 340B drug discounts to health care providers that operate using scarce federal resources, a move that could threaten the sustainability of safety net providers and the patients they serve.

If you have questions about these lawsuits, or the 340B program in general, please contact Member Daphne Kackloudis at dlkackloudis@bmdllc.com or Attorney Jordan Burdick at jaburdick@bmdllc.com.


CMS Requires Providers to Use an Updated Advance Beneficiary Notice (ABN) Form by May 12, 2026

CMS has released an updated Advance Beneficiary Notice of Noncoverage (ABN), Form CMS-R-131, that all providers and suppliers must begin using by May 12, 2026. The revised form includes clearer language and formatting updates intended to improve patient understanding and compliance.

CMS and Ohio Ramp Up Fraud Enforcement in Home Health and Hospice

CMS and Ohio have launched sweeping new fraud prevention initiatives targeting home health and hospice providers, signaling a period of heightened scrutiny for enrollment, billing, documentation, and EVV compliance. While aimed at combating fraud, these measures also create significant operational and due process risks for compliant agencies, making proactive compliance programs, auditing, and governance more important than ever.

MYTH BUSTER: Can a New Chiropractor Bill Under An Established Chiropractor’s NPI?

Many chiropractic practices mistakenly believe a newly hired chiropractor can bill under an established chiropractor’s NPI while waiting for credentialing approval. In most cases, this is not permitted. Claims should be submitted under the NPI of the chiropractor who actually rendered the service to avoid compliance risks, including potential False Claims Act exposure. This article outlines key billing rules, common exceptions, and practical compliance tips for chiropractic practices.

RNs and APRNs Take Note: Ohio Board of Nursing Mandates a New CE Reporting Period

Ohio’s Board of Nursing has updated the continuing education reporting period for RNs and APRNs. Beginning March 26, 2026, CE credits must be completed between July 1 and June 30 of odd-numbered years, replacing the previous November to October timeframe.

Ohio Med Spas: Peptide Do's and Do Not's

Recent guidance from the Ohio Board of Pharmacy outlines key compliance requirements for med spas using peptides. While some peptide drugs are FDA approved, others are not or cannot be compounded. Med spa operators should ensure they source medications from licensed suppliers, avoid non-approved or “research use only” products, and follow all compounding and storage regulations to maintain compliance and avoid enforcement actions.