HRSA Alerts Six Pharmaceutical Manufacturers of Referral to OIG for 340B Statute Violations
On September 22, 2021, the Health Resources and Services Administration (HRSA) sent several letters to drug manufacturer alerting them that their refusal to comply with 340B Statute has been referred to the HHS Office of the Inspector General (OIG) in accordance with the 340B Ceiling Price and Civil Monetary Penalties Final Rule (PDF – 405 KB). This decision follows the administration’s May 17 letters that directed the drug manufacturers, who are not in compliance with their obligation to sell covered outpatient drugs to covered entities via contract pharmacy arrangements, to submit a plan to come into compliance with the law. The manufacturers refused to comply and did not provide their plans.
HRSA’s decision follows February’s Health and Human Services (HHS) Secretary’s Tribal Advisory Committee meeting where Tribal leaders raised concerns regarding several drug manufactures that are limiting or denying access to 340B discounts through contract pharmacies, which are used by Tribal and Urban health programs, as well as outside the Indian health system.
The letters and additional information can be found on HRSA’s 340B program integrity page.
Why is this important to UIOs?:
The 340B Drug Pricing Program is especially vital for health care providers of AI/AN individuals. The 340B program enables covered entities, including UIOs, to purchase outpatient drugs at discounted rates. The program has enabled health care providers to better care for the most vulnerable and underserved communities. It is an important program for organizations with limited resources, like UIOs, that can utilize the savings from reduced prescription drug costs to provide more services to their patients or expand the services they offer.