Department of Health and Human Services July 2, 2010 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, the U.S. Department of Health and Human Services' (HHS) Office of Consumer Information and Insurance Oversight (OCIIO) is proposing to establish a new system of records (SOR) titled ``Pre-Existing Condition Insurance Plan (PCIP),'' System No. 09-90-0275. Section 1101 of Title I of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) requires that the Secretary of Health and Human Services establish, either directly or through contracts with States and nonprofit private entities, a temporary high risk health insurance pool program to make health insurance coverage available at standard rates to uninsured individuals with pre-existing conditions. This program will continue until January 1, 2014, when American Health Benefit Exchanges established under sections 1311 and 1321 of the Affordable Care Act will be available for individuals to obtain health insurance coverage. HHS provided each State or its designated nonprofit entity the opportunity to contract with HHS to establish this program. However, to the extent that HHS does contract with a State to administer the program, HHS will make available a Pre-Existing Insurance Plan in such State under arrangements with the U.S. Office of Personnel Management, the U.S. Department of Agriculture's National Finance Center (NFC), and one or more nonprofit entities to serve as a third-party administrator (TPA) responsible for maintaining a network of health care providers and adjudicating claims for covered services.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.