HHS issues proposed omnibus 340b guidance

August 27, 2015

Blog Post

On August 27, 2015, the Department of Health and Human Services (HHS) issued long-awaited proposed omnibus guidance for covered entities enrolled in the 340B Federal Drug Pricing Program, which allows certain safety-net providers to obtain discounted drugs. The guidance will be published in the August 28 edition of the Federal Register, and includes a revised definition of who qualifies as a patient for purposes of the program.

The guidance is intended to assist 340B covered entities and drug manufacturers in complying with program regulations. It will be finalized by HHS after consideration of public comments, which are due October 27.

McDonald Hopkins LLC is currently analyzing the implications of this guidance. A more substantive discussion of the proposed guidance will be provided in coming days.

Over the past 24 months, the U.S. Department of Health and Human Services Office for Civil Rights has brought notable enforcement efforts against several non-profit covered entities and business associates, resulting in instances of six and seven-figure penalties against providers across the county for incidents involving breaches of protected health information.

A new amendment to New York state law, which would have required all healthcare providers to obtain separate consents from patients for treatment and payment is on hold until further guidance is released, according to the New York Department of Health.

On November 1, 2024, the Centers for Medicare & Medicaid Services issued the Medicare Physician Fee Schedule 2025 final rule, which establishes new advanced primary care management billing codes that will expand opportunities for physician practices, federally qualified health centers, rural health clinics and other health care providers to get paid for services provided by clinical staff under the direction of a physician, nurse practitioner or physician assistant beginning January 1, 2025.

HHS issues proposed omnibus 340b guidance

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