Department of Health and Human Services September 20, 2010 – Federal Register Recent Federal Regulation Documents

Section 602 of Public Law 102-585, the ``Veterans Health Care Act of 1992'' enacted Section 340B of the Public Health Service Act (PHSA). Section 340B implements a drug pricing program by which manufacturers enter into an agreement to sell covered outpatient drugs to particular covered entities at a price not exceeding the amount determined under a statutory formula. Manufacturers are required by section 1927(a) of the Social Security Act to enter in agreements with the Secretary that comply with section 340B if they participate in the Medicaid Drug Rebate Program. Section 7102(a) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148) requires the Secretary of HHS to develop and issue regulations for the 340B Drug Pricing Program (340B Program) establishing standards for the imposition of sanctions in the form of civil monetary penalties for manufacturers that knowingly and intentionally overcharge a covered entity for a 340B drug. As HHS never has had civil monetary penalty authority that addresses manufacturing overcharging of the 340B Program, these regulations present a number of issues that have the potential to impact stakeholders. Accordingly, the Health Resources and Services Administration (HRSA) is issuing this advance notice of proposed rulemaking (ANPRM) to solicit public comment on multiple issues regarding the implementation of this requirement. These comments will be used to help draft a proposed rule that will be published in the Federal Register for public comments.

AHRQ has accepted a notification of voluntary relinquishment from the Florida Patient Safety Corporation of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b- 21b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.