Quality management program and misadministrations--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending regulations governing therapeutic administrations of byproduct material and certain uses of radioactive sodium iodide to require implementation of a quality management program to provide high confidence that the byproduct material or radiation from byproduct material will be administered as directed by an authorized user physician. The Commission believes this performance-based amendment will result in enhanced patient safety in a cost-effective manner while allowing the flexibility necessary to minimize intrusion into medical judgments. This amendment also modifies the notification, reporting, and recordkeeping requirements related to the quality management program and misadministrations.     

Biomedical waste disposal--Nuclear Regulatory Commission. Final rule

The NRC is amending its regulations to permit licensees greater leeway in disposing of liquid scintillation media and animal carcasses containing tracer levels of hydrogen-3 (tritium) or carbon-14. These rule changes will primarily affect NRC licensed hospitals and medical research institutions. Most licensees presently dispose of these items by sending them to a radioactive waste burial ground or by obtaining special authorization from NRC for incineration or onsite burial. Under the new regulations, the licensee may dispose of specified concentrations of these materials without regard to their radioactivity. The NRC is also amending its regulations to raise the annual limits for disposal of hydrogen-3 and carbon-14 by release to the sanitary sewerage systems. The rule changes will conserve waste burial capacity that is already in short supply.     

Institutional Radiation Safety Committee--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations regarding hospitals licensed to use radioactive byproduct material for human applications. Currently, such a license requires that the hospital have a Medical Isotopes Committee to review clinical aspects of the use of radioactive materials within the hospital. The amendment requires instead a Radiation Safety Committee with a simplified membership that will focus on the radiation safety of workers and the general public. The rule change acknowledges the Food and Drug Administration's role in regulating the safety and effectiveness of radioactive drugs with respect to the patient. The membership of the new Radiation Safety Committee will include the hospital management and the nursing staff in decisions affecting radiation safety at the hospital and will be easier for smaller hospitals to recruit.     

Standards for protection against radiation--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is revising its standards for protection against ionizing radiation. This action is necessary to incorporate updated scientific information and to reflect changes in the basic philosophy of radiation protection. The revision conforms the Commission's regulations to the Presidential Radiation Protection Guidance to Federal Agencies for Occupational Exposure and to recommendations of national and international radiation protection organizations.     

Occupational exposure to bloodborne pathogens; approval of information collection requirements--OSHA. Final rule; approval of information collection requirements

On December 6, 1991, OSHA published a final standard governing occupational exposure to bloodborne pathogens (56 FR 64004). The standard is designed to eliminate or minimize occupational exposure to Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV) and other bloodborne pathogens. At that time OSHA submitted the information collection requirements to the Office of Management and Budget (OMB) for review under section 3504(h) of the Paperwork Reduction Act (PRA) of 1980. Public reporting burden for this collection of information was estimated to average five minutes per employer response to an OSHA compliance officer's request for access to the employer's records. OMB reviewed the collection of information requirements for occupational exposure to bloodborne pathogens in accordance with the PRA, 44 U.S.C. 3501 et seq., and 5 CFR part 1320. OMB approved all information requirements contained in 29 CFR 1910.1030 under OMB clearance number 1218-0180. The OMB clearance expires on February 28, 1995. This document will also amend the December 6, 1991 rule to properly display the OMB control number.     

Consideration of potassium iodide in emergency plans. Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending its emergency planning regulations governing the domestic licensing of production and utilization facilities. The final rule requires that consideration be given to including potassium iodide (KI) as a protective measure for the general public that would supplement sheltering and evacuation. KI would help prevent thyroid cancers in the unlikely event of a major release of radioactivity from a nuclear power plant. The final rule responds to petitions for rulemaking (PRM 50-63 and PRM 50-63A) submitted by Mr. Peter G. Crane concerning the use of KI in emergency plans.     

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 and Medicaid programs; approved information collection requirements--HCFA. Final rule with comment period

This final rule updates our display of approved control numbers for the collection of information that have been assigned to HCFA by the Office of Management and Budget (OMB). OMB regulations require each agency to include the approval numbers in the agency's rules.     

Revision of fee schedules; 100% fee recovery; clarification of size standards--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations concerning the payment of annual fees to clarify the provisions that identify the size standards used to determine whether an NRC licensee would qualify as a "small entity" under the Regulatory Flexibility Act for the purpose of paying a reduced annual fee. This clarification is necessary because the size standards presented in the regulations did not clearly indicate the complete range of size standards adopted by the NRC.     

Medicare and Medicaid programs; approved information collection requirements and HCFA's claims collection authority--HCFA. Final rule with comment period

This final rule updates our display of control numbers assigned by the Office of Management and Budget (OMB) to approved "collection of information" requirements contained in regulations governing the Medicare and Medicaid programs. In addition, it incorporates a technical change to our regulations to reflect increased agency authority under the Federal Claims Collection Act, 31 U.S.C. 3711 et seq. This rule is issued in accordance with OMB regulations concerning approved collections of information and to conform to changes made by Public Law 101-552.     

Medicare program; hospital inpatient value-based purchasing program. Final rule

This final rule implements a Hospital Inpatient Value-Based Purchasing program (Hospital VBP program or the program) under section 1886(o) of the Social Security Act (the Act), under which value-based incentive payments will be made in a fiscal year to hospitals that meet performance standards with respect to a performance period for the fiscal year involved. The program will apply to payments for discharges occurring on or after October 1, 2012, in accordance with section 1886(o) (as added by section 3001(a) of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act)). Scoring in the Hospital VBP program will be based on whether a hospital meets or exceeds the performance standards established with respect to the measures. By adopting this program, we will reward hospitals based on actual quality performance on measures, rather than simply reporting data for those measures.     

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.     

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.     

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.     

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.