Minor corrections, clarifying changes, and a minor policy change--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations to make minor corrections and clarifying changes to the NRC's 10 CFR Part 20, "Standards for Protection Against Radiation." The final rule is also intended to conform other regulations with the Commission's 1991 revised radiation protection requirements. In addition, the final rule includes a minor policy change that raises the monitoring criteria for minors from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) in a year and for declared pregnant women from 0.05 rem (0.5 mSv) to 0.1 rem (1 mSv) during their pregnancies. The 0.1 rem (1 mSv) in a year deep dose equivalent monitoring criterion is consistent with the public dose limit and represents a quantity more consistent with the measurement sensitivity of individual personnel dosimetry. Licensees are still required to ensure that the occupational dose limit of 0.5 rem (5 mSv) in a year is not exceeded for minors, that the dose limit of 0.5 rem (5 mSv) to an embryo/fetus due to occupational exposure of a declared pregnant woman is not exceeded during the course of the pregnancy, and that sufficient effort is made to ensure that substantial variations above a uniform monthly exposure rate for a declared pregnant woman are avoided. These changes to the threshold for monitoring exposures to radiation and radioactive material to demonstrate compliance with the limits do not change the occupational dose limits for minors or declared pregnant workers.     

Quality management program and misadministrations; NRC override of OMB disapproval of NRC information collection request--Nuclear Regulatory Commission. Final rule

The Commission has voted to override the Office of Management and Budget (OMB) disapproval of the information collection requirements imposed in the final rule entitled "Quality Management Program and Misadministrations" (July 25, 1991; 56 FR 34104). As part of this final rule, the Commission is amending its regulations to reflect OMB's assignment of a new control number to these information collection requirements. The Commission reevaluated the need for this final rule and the information collection requirements it contains. The Commission continues to believe that its requirements for written quality management programs and misadministration reports, if complied with, have a reasonable likelihood of decreasing misadministrations (e.g., wrong dose or wrong patient) with a small incremental cost to licensees. Without the reporting and recordkeeping requirements, it would not be possible to implement and enforce these regulations effectively.     

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.     

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.     

Medical administration of radiation and radioactive materials--NRC. Final rule

The Nuclear Regulatory Commission is amending its regulations to clarify that the medical administration of radiation or radioactive materials to any individual, even an individual not supposed to receive a medical administration, is regulated by the NRC's provisions governing the medical use of byproduct material rather than by the dose limits in the NRC's regulations concerning standards for protection against radiation. The rule does not represent a change in policy, but is necessary to indicate clearly that this is the NRC's policy and to clarify the relationship of NRC's regulations.     

Recordkeeping and reporting under Title VII and the ADA--EEOC. Final rule

This final rule is based on two separate Notices of Proposed Rulemaking (NPRM) published on February 13, 1989 (54 FR 6551), and March 5, 1991 (56 FR 9185). This final rule amends 29 CFR part 1602, EEOC's regulations on Recordkeeping and Reporting under title VII of the Civil Rights Act of 1964 (title VII), to add recordkeeping requirements under the Americans with Disabilities Act of 1990 (ADA). It increases the records retention period required in part 1602 for title VII and the ADA from 6 months to one year. The Commission also is adding a new subpart R to part 1602, 29 CFR 1602.56, that will clarify that the Commission has the authority to investigate persons to determine whether they comply with the reporting or recordkeeping requirements of part 1602. In addition, the Commission is making several minor changes to sections 1602.7 and 1602.10. The Commission also is deleting section 1602.14(b) of its title VII recordkeeping regulations, which provides that the section 1602 recordkeeping requirements do not apply to temporary or seasonal positions. Information regarding such employees now must be reported on Standard Form 100 on September 30 of each year, in the same fashion as information regarding permanent employees is reported. Similarly, the Commission is deleting sections 1627.3(b) and 1627.4(a)(2) of the Age Discrimination in Employment Act recordkeeping regulations, which provide for a 90-day retention period for temporary positions, and is clarifying the mandatory nature of such recordkeeping. The Commission is not issuing a final rule on proposed section 1602.57 at this time.     

Health care programs; fraud and abuse; amendments to OIG exclusion and CMP authorities resulting from Public Law 100-93-- Office of Inspector General, HHS. Final rule and clarification

This final rule clarifies the scope and purpose of the exclusion authority provisions originally set forth in final rulemaking published in the Federal Register on January 29, 1992 (57 FR 3298). That final rule implemented the OIG sanction and civil money penalty (CMP) provisions established through section 2 and other conforming amendments in the Medicare and Medicaid Patient and Program Protection Act of 1987, and other statutory authorities. This clarifying document modifies the final rule to give greater clarity to the original scope of the authorities contained in 42 CFR part 1001. In addition, this rule is providing further clarification to the discovery provision set forth in part 1005 of the regulations.     

Medicare program; coverage of epoetin (EPO) used by competent home dialysis patients--HCFA. Final rule

This final rule adopts as final the interim final rule that provided for Medicare coverage of EPO used by ESRD beneficiaries who dialyze at home and are competent to use the drug without medical or other supervision and established criteria for selection of patients that can be considered "competent" and for monitoring of the patients who are selected. It also makes minor changes in response to public comments on the interim rule. The interim rule was necessary to implement section 4201(d)(1) of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90). The purpose of the amendments is to facilitate use of EPO at home, while ensuring that such use of the drug is safe.     

Additional protections for children involved as subjects in research--Department of Health and Human Services. Final rule

The Department of Health and Human Services (Department or HHS)( is prescribing additional requirements for protection of children involved as subjects in research. These regulations adopt, with some changes, the recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) as were presented in the notice of proposed rulemaking (NPRM) 43 FR 31786 which preceded this final rule. Specifically, these regulations impose certain added responsibilities on Institutional Review Boards (IRBs) depending on the degree of risk involved in the research and the extent that the research is likely to be a benefit to the subject or relate to a subject's illness.     

Servicemembers' Group Life Insurance Traumatic Injury Protection Program--genitourinary losses. Final rule

The Department of Veterans Affairs (VA) is issuing this final rule that amends the regulations governing the Servicemembers' Group Life Insurance Traumatic Injury Protection (TSGLI) program by adding certain genitourinary (GU) system losses to the TSGLI Schedule of Losses and defining terms relevant to these new losses. This amendment is necessary to make qualifying GU losses a basis for paying TSGLI benefits to servicemembers with severe GU injuries. The intended effect is to expand the list of losses for which TSGLI payments can be made. This document adopts as a final rule, without change, the interim final rule published in the Federal Register on December 2, 2011.     

Medicare and Medicaid programs; requirements for long term care facilities; nursing services; posting of nurse staffing information. Final rule

In this rule, we finalize provisions specified in the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) that establish new data collection, posting, and recordkeeping requirements for skilled nursing facilities (SNFs) and nursing facilities (NFs). It requires that on a daily basis for each shift, SNFs and NFs must post nurse staffing data for the licensed and unlicensed staff directly responsible for resident care in the facility. Facility census information must also be posted. This final rule is also part of a broader communication outreach initiative by CMS to provide beneficiaries, their families, and the public with access to updated data and other information that can assist them in making healthcare decisions.     

Privacy Act; implementation. Office of Inspector General (OIG), HHS. Final rule

This final rule exempts the new system of records, the Healthcare Integrity and Protection Data Bank (HIPDB), from certain provisions of the Privacy Act (5 U.S.C. 552a). The establishment of the HIPDB is required by section 1128E of the Social Security Act (the Act), as added by section 221(a) of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Section 1128E of the Act directed the Secretary to establish a national health care fraud and abuse data collection program for the reporting and disclosing of certain final adverse actions taken against health care providers, suppliers or practitioners, and to maintain a data base of final adverse actions taken against health care providers, suppliers and practitioners. Regulations implementing the new HIPDB were published in the Federal Register on October 26, 1999 (64 FR 57740). The exemption being set forth in this rule applies to investigative materials compiled for law enforcement purposes.     

Student health insurance coverage. Final rule

This final rule establishes requirements for student health insurance coverage under the Public Health Service (PHS) Act and the Patient Protection and Affordable Care Act (Affordable Care Act). The final rule defines "student health insurance coverage" as a type of individual health insurance coverage, and specifies that certain PHS Act requirements are inapplicable to this type of individual health insurance coverage. This final rule also amends the medical loss ratio and annual limits requirements for student health insurance coverage under the PHS Act.     

Medicare and Medicaid programs; programs of all-inclusive care for the elderly (PACE); program revisions. Final rule

This rule finalizes the interim final rule with comment period published in the Federal Register November 24, 1999 (64 FR 66234) and the interim final rule with comment period published in the Federal Register on October 1, 2002 (67 FR 61496). The November 1999 interim final rule implemented sections 4801 through 4803 of the Balanced Budget Act of 1997 (Pub. L. 105-33) and established requirements for Programs of All-inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs. The interim final rule with comment period published on October 1, 2002 (67 FR 61496) implemented section 903 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554).     

Medicare program; payment for customized wheelchairs--HCFA. Final rule

This final rule responds to comments we received on an interim final rule relating to payment for customized wheelchairs that was published on December 20, 1991 (56 FR 65995). The interim rule set forth the Secretary's criteria that a wheelchair must meet to be considered a customized item and allowed for a payment for the purchase of customized items based on the carrier's case-by-case determination. This rule establishes the interim rule as a final regulation with one change. The change is based on our review and consideration of the public comments. EFFECTIVE DATE: This final rule is effective on July 30, 1993.     

Medicare and Medicaid programs; fire safety requirements for certain health care facilities; amendment. Final rule

This final rule adopts the substance of the April 15, 2004 tentative interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub Solutions, an amendment to the 2000 edition of the Life Safety Code, published by the National Fire Protection Association (NFPA). This amendment allows certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This final rule also requires that nursing facilities at least install battery-operated single station smoke alarms in resident rooms and common areas if they are not fully sprinklered or they do not have system-based smoke detectors in those areas. Finally, this final rule confirms as final the provisions of the March 25, 2005 interim final rule with changes and responds to public comments on that rule.     

Medicare and state health care programs: fraud and abuse; amendments to OIG exclusion and CMP authorities resulting from the Medicare and Medicaid Patient and Program Protection Act--Office of Inspector General (OIG), HHS. Final rule

This document amends a technical error that appeared in the final rule, which amends the OIG exclusion and CMP authorities, published on January 29, 1992 designed to implement section 2 of the Medicare and Medicaid Patient and Program Protection Act, along with other conforming amendments. The final rule is designed to protect program beneficiaries from unfit health care practitioners, and otherwise improve the anti-fraud provisions of the Department's Medicare and State health care programs.     

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; home health prospective payment system rate update for calendar year 2011; changes in certification requirements for home health agencies and hospices. Final rule

This final rule sets forth an update to the Home Health Prospective Payment System (HH PPS) rates, including: the national standardized 60-day episode rates, the national per-visit rates, the nonroutine medical supply (NRS) conversion factors, and the low utilization payment amount (LUPA) add-on payment amounts, under the Medicare prospective payment system for HHAs effective January 1, 2011. This rule also updates the wage index used under the HH PPS and, in accordance with the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act), updates the HH PPS outlier policy. In addition, this rule revises the home health agency (HHA) capitalization requirements. This rule further adds clarifying language to the "skilled services" section. The rule finalizes a 3.79 percent reduction to rates for CY 2011 to account for changes in case-mix, which are unrelated to real changes in patient acuity. Finally, this rule incorporates new legislative requirements regarding face-to-face encounters with providers related to home health and hospice care.