Advisory committees; establishment and termination--FDA. Final rule

The Food and Drug Administration (FDA) is announcing the establishment by the Commissioner of Food and Drugs of the Medical Devices Advisory Committee and the termination of the existing devices panels. This document revises the agency's list of standing advisory committees to show these actions.     

Advisory committee; Risk Communication Advisory Committee; establishment. Final Rule

The Food and Drug Administration (FDA) is announcing the establishment of the Risk Communication Advisory Committee in the Office of Planning, Office of the Commissioner. This document adds the Risk Communication Advisory Committee to the agency's list of standing advisory committees.     

Advisory committee; Medical Imaging Drugs Advisory Committee; re-establishment

The Food and Drug Administration (FDA) is announcing the re-establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory committees in FDA's regulations.     

Work activity of persons working as members of advisory committees established under the Federal Advisory Committee Act (FACA). Final rule

We are revising our disability regulations under titles II and XVI of the Social Security Act to establish a new, special rule that affects individuals who are receiving payments or providing services as members or consultants of a committee, board, commission, council or similar group established under the Federal Advisory Committee Act (FACA). Under this special rule, we will not count any earnings an individual is receiving from serving as a member or consultant of a FACA advisory committee when we determine if the individual is engaging in substantial gainful activity under titles II and XVI of the Social Security Act (the Act). In addition, we will not evaluate any of the services the individual is providing as a member or consultant of the FACA advisory committee when determining if the individual has engaged in substantial gainful activity under titles II and XVI of the Act. Based on our experience with FACA advisory committees and the frequency and level of activity required by these committees, we believe that performance of activity on these committees does not demonstrate the ability to perform substantial gainful activity. We believe this to be consistent with Congress's view, as it has recognized in creating the Ticket to Work advisory committee, for example, that current disability beneficiaries should be considered for membership. This also will encourage individuals with disabilities to serve on FACA advisory committees, thereby providing the benefit of their unique perspective on policies and programs to the Federal Government.     

Respiratory protection; correction--OSHA. Final rule; correction

OSHA is correcting errors in the regulatory text of the Respiratory Protection final rule that appeared in the Federal Register on January 8, 1998 (63 FR 1152).     

Health maintenance organizations--PHS. Final rule; confirmation of interim rule

This document finalizes, without change, the interim rule published on January 12, 1983, that amends the Public Health Service regulations on Federal qualification of health maintence organizations (HMOs) to provide for greater flexibility for already existing prepaid health care delivery systems to become transitionally qualified HMOs.     

Medical devices; device tracking. Final rule

The Food and Drug Administration (FDA) is amending the medical device tracking regulation. FDA is making substantive changes to revise the scope of the regulation and add certain patient confidentiality requirements, and nonsubstantive changes to remove outdated references and simplify terminology. These revisions are made to conform the regulation to changes made in section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA), and to simplify certain requirements.     

Quality mammography standards; correction--FDA. Final rule; correction

The Food and Drug Administration (FDA) is correcting a document entitled "Quality Mammography Standards" that appeared in the Federal Register of October 28, 1997. The document was published with some inadvertent typographical errors and incorrect dates in the regulatory text. This document corrects those errors. FDA is also identifying with greater specificity those sections of the quality standards that will become effective October 28, 2002. For the convenience of the reader, FDA is republishing 21 CFR part 900 in its entirety with corrections.     

Medicare program; hospice care amendments. Final rule

This final rule revises existing regulations that govern coverage and payment for hospice care under the Medicare program. These revisions reflect the statutory changes required by the Balanced Budget Act of 1997 (BBA), the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), and the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA). Additionally, these revisions reflect current policy on the documentation needed to support a certification of terminal illness, admission to Medicare hospice, and a new requirement that allows for discharges from hospice for cause under very limited circumstances. This final rule does not address the requirement for hospice data collection, the changes to the limitation of liability rules, or the changes to the hospice conditions of participation that were included in the BBA. The intent of this final rule is to expand the hospice benefit periods, improve documentation requirements to support certification and recertification of terminal illness, provide guidance on hospice admission procedures, clarify hospice discharge procedures, update coverage and payment requirements, and address the changing needs of beneficiaries, suppliers, and the Medicare program.     

Medicare program; swing-bed program changes--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to hospital swing beds that was published on September 7, 1989 (54 FR 37270). The interim rule expanded the swing-bed program to encompass rural hospitals with 50 to 99 beds. It established requirements that approved swing-bed hospitals with more than 49 beds must meet. This rule establishes the interim rules as final regulations with changes. These changes are based on our review and consideration of the public comments.     

Medicare program; hospice wage index--HCFA. Final rule

This final rule establishes a methodology to update the wage index used to adjust Medicare payment rates for hospice care. It also includes the new wage index, to be effective October 1, 1997. The wage index is used to reflect local differences in wage levels. A new wage index is needed because the index currently applied is based on 1981 wage and employment data and has not been updated since 1983. The methodology is based on the recommendations of a negotiated rulemaking advisory committee comprised of persons who represent interests affected by the hospice rules.     

Absence and leave; sick leave. Final rule

The U.S. Office of Personnel Management is issuing final regulations on the use of sick leave and advanced sick leave for serious communicable diseases, including pandemic influenza when appropriate. We are also permitting employees to substitute up to 26 weeks of accrued or accumulated sick leave for unpaid Family and Medical Leave Act (FMLA) leave to care for a seriously injured or ill covered servicemember, as authorized under the National Defense Authorization Act for Fiscal Year 2008, including up to 30 days of advanced sick leave for this purpose. Finally, we are reorganizing the existing sick leave regulations to enhance reader understanding and administration of the program.     

Privacy Act; exempt record system--HHS. Final rule

The Office for Civil Rights of the Department of Health and Human Services maintains a system of records entitled "Complaint Files and Log. HHS/OC/OCR." The Department is exempting this system from certain provisions of the Privacy Act, 5 U.S.C. 552a. The exemption is authorized by subsection (k)(2) of the Privacy Act, which applies to investigative materials compiled for law enforcement purposes. The Office for Civil Rights (OCR) is authorized to gather information for civil and administrative law enforcement purposes pursuant to several statutes requiring nondiscrimination in programs or activities receiving Federal financial assistance. In order to maintain the integrity of the OCR investigative process and to assure that OCR will be able to obtain access to complete and accurate information, the Department is exempting this system, under subsection (k)(2), from the notification, access, correction and amendment provisions of the Privacy Act.     

Medicaid program; qualified family members--HCFA. Final rule

Under the Aid to Families with Dependent Children (AFDC) program, certain States may elect to limit the number of months of benefits provided to families who are eligible by reason of the unemployment of the principal wage earner. This final rule ensures that States that exercise this option continue to provide Medicaid to qualified family members beyond the time when AFDC ends solely because of the State's election of a time limit. This final rule conforms the regulations with sections 1902(a)(10)(A)(i)(V) and 1905(m) of the Social Security Act, as added by section 401(d) of the Family Support Act of 1988.     

Medicaid program; recovery audit contractors. Final rule

This final rule implements section 6411 of the Patient Protection and Affordable Care Act (the Affordable Care Act), and provides guidance to States related to Federal/State funding of State start-up, operation and maintenance costs of Medicaid Recovery Audit Contractors (Medicaid RACs) and the payment methodology for State payments to Medicaid RACs. This rule also directs States to assure that adequate appeal processes are in place for providers to dispute adverse determinations made by Medicaid RACs. Lastly, the rule directs States to coordinate with other contractors and entities auditing Medicaid providers and with State and Federal law enforcement agencies.     

Medicaid program; citizenship documentation requirements. Final rule

This final rule amends Medicaid regulations to implement the provision of the Deficit Reduction Act that requires States to obtain satisfactory documentary evidence of an applicant's or recipient's citizenship and identity in order to receive Federal financial participation. It also incorporates changes made to these requirements through section 405(c)(1)(A) of Division B of the Tax Relief and Health Care Act (TRHCA), Pub. L. 109-432, enacted December 20, 2006. This regulation provides States with guidance on the types of documentary evidence that may be accepted, including alternative forms of documentary evidence in addition to those described in the statute and the conditions under which this documentary evidence can be accepted to establish the applicant's citizenship.     

Updating fire safety standards. Final rule; affirmation

This document affirms as final, without changes, a provision included in a final rule with request for comments that amended the Department of Veterans Affairs (VA) regulations concerning community residential care facilities, contract facilities for certain outpatient and residential services, and State home facilities. That provision established a five-year period within which all covered buildings with nursing home facilities existing as of June 25, 2001, must conform to the automatic sprinkler requirement of the 2009 edition of the National Fire Protection Association (NFPA) 101. This rule helps ensure the safety of veterans in the affected facilities.     

Biological technical amendment--FDA. Final rule; technical amendment

The Food and Drug Administration (FDA) is amending the biologics regulations to make a minor, technical amendment. The pressure stated at which a sustained sterilization temperature is attained is incorrect. This document corrects that error.     

Medicare program; photocopying reimbursement methodology. Final rule

This final rule increases the rate of reimbursement for expenses incurred by prospective payment system PPS) hospitals for photocopying medical records requested by Quality Improvement Organizations (QIOs), formerly known as Utilization and Quality Control Peer Review Organizations (PROs). We are increasing the rate from 7 cents per page to 12 cents per page to reflect inflationary changes in the labor and supply cost components of the formula. This final rule also provides for the periodic review and adjustment of the per-page reimbursement rate to account for inflation and changes in technology. The methodology for calculating the per-page reimbursement rate will remain unchanged. We are also providing for the payment of the expenses of furnishing photocopies to QIOs, to other providers subject to a PPS (for example, skilled nursing facilities and home health agencies), in accordance with the rules established for reimbursing PPS hospitals for these expenses.