Medicare program; revision of the procedures for requesting exceptions to cost limits for skilled nursing facilities and elimination of reclassifications. Department of Health and Human Services (HHS), Health Care Financing Administration (HCFA). Final rule

This final rule revises the procedures for granting exceptions to the cost limits for skilled nursing facilities (SNFs) and retains the current procedures for exceptions to the cost limits for home health agencies (HHAs). It also removes the provision allowing reclassification for all providers.     

Medicare and Medicaid programs; advance directives--HCFA. Final rule

This final rule responds to public comments on the March 6, 1992 interim final rule with comment period that amended the Medicare and Medicaid regulations governing provider agreements and contracts to establish requirements for States, hospitals, nursing facilities, skilled nursing facilities, providers of home health care or personal care services, hospice programs and managed care plans concerning advance directives. An advance directive is a written instruction, such as a living will or durable power of attorney for health care, recognized under State law, relating to the provision of health care when an individual's condition makes him or her unable to express his or her wishes. The intent of the advance directives provisions is to enhance an adult individual's control over medical treatment decisions. This rule confirms the interim final rule with several minor changes based on our review and consideration of public comments.     

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); mental health services--DoD. Final rule

This final rule is to reform CHAMPUS quality of care standards and reimbursement methods for inpatient mental health services. The rule updates existing standards for residential treatment centers (RTCs) and establishes new standards for approval as CHAMPUS-authorized providers for substance use disorder rehabilitation facilities (SUDRFs) and partial hospitalization programs (PHPs); implements recommendations of the Comptroller General of the United States that DoD establish cost-based reimbursement methods for psychiatric hospitals and residential treatment facilities; adopts another Comptroller General recommendation that DoD remove the current incentive for the use of inpatient mental health care; and eliminates payments to residential treatment centers for days in which the patient is on a leave of absence.     

Medicare and Medicaid programs; advance directives--HCFA. Interim final rule with comment period

This interim final rule amends the Medicare and Medicaid regulations governing provider agreements and contracts to establish requirements for States, hospitals, nursing facilities, skilled nursing facilities, providers of home health care or personal care services, hospice programs and prepaid health plans concerning advance directives. An advance directive is a written instruction, such as a living will or durable power of attorney for health care, recognized under State law, relating to the provision of health care when an individual's condition makes him or her unable to express his or her wishes. The intent of these provisions is to enhance an individual's control over medical treatment decisions. This rule implements sections 4206 and 4751 of the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), Public Law 101-508.     

Medicaid program; use of restraint and seclusion in psychiatric residential treatment facilities providing psychiatric services to individuals under age 21. Health Care Financing Administration (HCFA), HHS. Interim final rule with comment period

This interim final rule with comment period establishes a definition of a "psychiatric residential treatment facility" that is not a hospital and that may furnish covered Medicaid inpatient psychiatric services for individuals under age 21. This rule also sets forth a Condition of Participation (CoP) that psychiatric residential treatment facilities that are not hospitals must meet to provide, or to continue to provide, the Medicaid inpatient psychiatric services benefit to individuals under age 21. Specifically, this rule establishes standards for the use of restraint or seclusion that psychiatric residential treatment facilities must have in place to protect the health and safety of residents. This CoP acknowledges a resident's right to be free from restraint or seclusion except in emergency safety situations. We are requiring psychiatric residential treatment facilities to notify a resident (and, in the case of a minor, his or her parent(s) or legal guardian(s)) of the facility's policy regarding the use of restraint or seclusion during an emergency safety situation that occurs while the resident is in the program. We believe these added requirements will protect residents against the inappropriate use of restraint or seclusion.     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities for FY 2009. Final rule

This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2009. It also discusses our ongoing analysis of nursing home staff time measurement data collected in the Staff Time and Resource Intensity Verification (STRIVE) project. Finally, this final rule makes technical corrections in the regulations text with respect to Medicare bad debt payments to SNFs and the reference to the definition of urban and rural as applied to SNFs.     

Medicare program; revision of the procedures for requesting exceptions to cost limits for skilled nursing facilities and elimination of reclassifications--HCFA. Proposed rule

This proposed rule would revise the procedures for granting exceptions to the cost limits for skilled nursing facilities (SNFs) and retain the current procedures for exceptions to the cost limits for home health agencies (HHAs). It also would remove the provision allowing reclassifications for all providers.     

Medicare program; optional payment system for low Medicare volume skilled nursing facilities--HCFA. Final rule

This final rule allows skilled nursing facilities (SNFs) that provide fewer than 1,500 days of care to Medicare beneficiaries in a cost reporting period to have the option of receiving prospectively determined payment rates in the following cost reporting period. The prospectively determined payment rates are based on components of SNF costs such as routine operating costs, capital-related costs, and a return on equity for proprietary facilities for routine services furnished before October 1, 1993. This rule also specifies that the return on equity provision for proprietary SNFs is eliminated for services furnished on or after October 1, 1993.     

Per diem payments for the care provided to eligible veterans evacuated from a state home as a result of an emergency. Final rule

The Department of Veterans Affairs (VA) amends its regulations concerning per diem payments to States to permit continuation of such payments in some situations for veterans who have been evacuated from a State home as a result of an emergency. Per diem is the daily rate paid by VA to a State for providing a specified level of care to eligible veterans in a facility that is officially recognized and certified by VA. This final rule authorizes VA to continue to pay per diem when veterans for whom VA is paying per diem are evacuated as a result of an emergency from a State home to a facility that is not recognized by VA as a State home. The rule requires, in order for per diem payments to continue while the veteran is relocated due to an emergency, that an appropriate VA official determine whether an emergency exists and whether the facility to which veterans may be evacuated (evacuation facility) complies with certain minimum standards. The rule establishes the minimum standards that facilities to which veterans are evacuated must meet in order for States to continue receiving per diem for relocated veterans. These standards also apply to evacuation facilities when veterans are evacuated from contract nursing homes.     

Registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Final rule

The Food and Drug Administration (FDA) is issuing a final regulation that confirms the interim final rule entitled "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (68 FR 58894, October 10, 2003 (interim final rule) as corrected by a technical amendment (69 FR 29428, May 24, 2004), and responds to comments submitted in response to the request for comments in the interim final rule. This final rule affirms the interim final rule's requirement that domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States be registered with FDA by December 12, 2003. The interim final rule implemented the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires domestic and foreign facilities to be registered with FDA by December 12, 2003. This final rule does not make any changes to the regulatory requirements established by the interim final rule.     

Medicare program; electronic cost reporting for skilled nursing facilities and home health agencies--HCFA. Final rule

This final rule adds the requirement that, for cost reporting periods ending on or after February 1, 1997, most skilled nursing facilities and home health agencies must submit cost reports currently required under the Medicare regulations in a standardized electronic format. This rule also allows a delay or waiver of this requirement where implementation would result in financial hardship for a provider. The provisions of this rule allow for more accurate preparation and more efficient processing of cost reports.     

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.     

Medical devices; medical device, user facility, distributor, and manufacturer reporting, certification, and registration--FDA. Tentative final rule

The Food and Drug Administration (FDA) is issuing a tentative final rule to require that device user facilities and distributors, including importers, submit reports to FDA and to the manufacturers, of deaths, serious illnesses and serious injuries related to medical devices. FDA is authorized to issue regulations implementing reporting requirements for user facilities and distributors by certain provisions of the Safe Medical Devices Act of 1990 (the SMDA). This tentative final rule also amends existing reporting requirements for manufacturers to conform them with the proposed reporting requirements for user facilities and distributors, and requires distributors and manufacturers to report certain malfunctions that may cause a death, serious illness or serious injury. The tentative final rule also requires foreign manufacturers to be subject to the same reporting requirements as domestic manufacturers. FDA is designating this document a tentative final rule, although under the Administrative Procedure Act it is a proposed rule. Because of the statutory deadlines discussed below, this "tentative final rule" alerts the public not only to the agency's interest in receiving comments, but also to the need for device user facilities, distributors, and other affected persons to begin preparing for compliance.     

Medicare and Medicaid programs; conditions of participation: immunization standards for hospitals,long-term care facilities,and home health agencies. Final rule with comment period

The provisions of this final rule will remove the Federal barrier related to the requirement for a physician to order influenza and pneumococcal immunizations in Medicare and Medicaid participating hospitals, long-term care facilities, and home health agencies. This final rule will affect vaccine-preventable diseases and will help improve adult vaccination coverage rates. It will facilitate the delivery of appropriate vaccinations in a timely manner, increase the levels of vaccination coverage, and decrease the morbidity and mortality rate of influenza and pneumococcal diseases.     

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 program; home health prospective payment system rate update for calendar year 2007 and Deficit Reduction Act of 2005 changes to Medicare payment for oxygen equipment and capped rental durable medical equipment; final rule

This final rule sets forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health services. In addition, this final rule sets forth policy changes related to Medicare payment for certain durable medical equipment for the purpose of implementing sections 1834(a)(5) and 1834(a)(7) of the Social Security Act, as amended by section 5101 of the Deficit Reduction Act of 2005. This final rule also responds to public comments on the August 3, 2006, proposed rule that pertain to a number of issues including the requirement that home health payments are based on the reporting of specific quality data by home health agencies.     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities for FY 2008. Final rule

This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2008. In addition, this final rule revises and rebases the SNF market basket, and modifies the threshold for the adjustment to account for market basket forecast error. This final rule also responds to public comments submitted on the proposed rule and makes a technical correction in the regulations text.     

Medicare and Medicaid programs: reporting outcome and assessment information set data as part of the conditions of participation for home health agencies. Final rule

This final rule makes revisions in response to public comments received on the January 25, 1999 interim final rule with comment period (64 FR 3748). The interim final rule requires electronic reporting of data from the Outcome and Assessment Information Set as a Condition of Participation for home health agencies.     

Medicaid program; coverage of personal care services--HCFA. Final rule

This final rule specifies the revised requirements for Medicaid coverage of personal care services furnished in a home or other location as an optional benefit, effective for services furnished on or after October 1, 1994. In particular, this final rule specifies that personal care services may be furnished in a home or other location by any individual who is qualified to do so. This rule conforms the Medicaid regulations to the provisions of section 13601(a)(5) of the Omnibus Budget Reconciliation Act of 1993, which added section 1905(a)(24) to the Social Security Act. Additionally, we are making two minor changes to the Medicaid regulations concerning home health services.