Department of Health and Human Services March 30, 2012 – Federal Register Recent Federal Regulation Documents

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA) to discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems. FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data. The meeting will be open to the public.

This notice announces our proposal to renew the Medicare Advantage ``deeming authority'' of the Utilization Review Accreditation Commission (URAC) for Health Maintenance Organizations and Preferred Provider Organizations for a term of 6 years. This new term of approval would begin May 26, 2012 and end May 25, 2018. This notice announces a 30-day period for public comments on the renewal of the application.

In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, the Health Resources and Services Administration (HRSA) is publishing a notice to alter the system of records for the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners, HHS/HRSA/BHPR. The System of Records Notice (SORN) 09-15-0054 was last published on October 1, 2010 (75 FR 60763). The Health Care Quality Improvement Act of 1986, as amended, title IV of Public Law 99-660 (42 U.S.C. 11101 et seq.) authorized the Secretary to establish a National Practitioner Data Bank (NPDB) to collect and release certain information relating to the professional competence and conduct of physicians, dentists, and other health care practitioners. By law, the information is releasable only to the specific entities described in the SORN. The law requires the maintenance of records such as medical malpractice payments, adverse licensure and clinical privilege actions, disciplinary actions taken by Boards of Medical Examiners, and professional review actions taken by entities against physicians, dentists, and other healthcare practitioners. Section 1921 of the Social Security Act, as amended, expands reporting to the NPDB to authorize maintenance of records of adverse licensure actions and negative actions or findings taken by a State licensing authority, peer review organization, or private accreditation entity against all health care practitioners or healthcare entities. The primary purpose of this alteration is to publish the Privacy Act exemptions that became necessary after implementation of Section 1921, which entitles law enforcement agencies to access NPDB information and which therefore requires a similar exemption from certain provisions of the Privacy Act that the Healthcare Integrity and Protection Data Bank (HIPDB) has for investigative materials. Because some of the records may be queried by law enforcement agencies for investigative purposes (i.e., as opposed to employment or other purposes), the system will be exempt from certain Privacy Act requirements to the extent necessary to avoid revealing law enforcement investigative interest and compromising law enforcement investigations. Another purpose of this alteration is to add a new routine use pertaining to system security, which is being added to other SORNs published by HHS.