Health Care Financing Administration: adoption of the National Bureau of Standards fire safety evaluation system for health care facilities. Notice of comment period

The Department of Health, Education, and Welfare is proposing to extend use of the new Fire Safety Evaluation System (FSES) to all hospitals participating in the Medicare and Medicaid programs. We are seeking public comment on this proposal and on whether to apply the FSES to intermediate care and skilled nursing facilities. The Fire Safety Evaluation System (FSES) was designed by the National Bureau of Standards. It defines the combinations of widely accepted fire safety systems and structural arrangements which can be used by health care facilities to meet safety standards equal to or exceeding those in the Life Safety Code. The FSES provides a framework which guarantees that the high standards of fire safety necessary to protect patients will be met and which is flexible enough to allow for new advances in safety technology and practice. It is based on our experience, which clearly demonstrates that the Life Safety Code can be implemented more effectively and without waste if certain changes are made in the procedures for achieving these mandated levels of safety.     

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

This final rule amends the fire safety standards for hospitals, long-term care facilities, intermediate care facilities for the mentally retarded, ambulatory surgery centers, hospices that provide inpatient services, religious nonmedical health care institutions, critical access hospitals, and Programs of All-Inclusive Care for the Elderly facilities. Further, this final rule adopts the 2000 edition of the Life Safety Code and eliminates references in our regulations to all earlier editions.     

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.     

Final notice regarding section 602 of the Veterans Health Care Act of 1992 entity guidelines--PHS. Final notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must agree to charge a price that will not exceed the amount determined under a statutory formula. The purpose of this notice is to inform interested parties of final program guidelines regarding eligible covered entities.     

Medicare program; prospective payment system for home health agencies. Health Care Financing Administration (HCFA), HHS. Final rule

This final rule establishes requirements for the new prospective payment system for home health agencies as required by section 4603 of the Balanced Budget Act of 1997, as amended by section 5101 of the Omnibus Consolidated and Emergency Supplemental Appropriations Act for Fiscal Year 1999 and by sections 302, 305, and 306 of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999. The requirements include the implementation of a prospective payment system for home health agencies, consolidated billing requirements, and a number of other related changes. The prospective payment system described in this rule replaces the retrospective reasonable-cost-based system currently used by Medicare for the payment of home health services under Part A and Part B.     

Final notice regarding section 602 of the Veterans Health Care Act of 1992 duplicate discounts and rebates on drug purchases--HRSA. Final notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides discounts on covered outpatient drugs to eligible entities. Section 340B(a)(5)(A) provides that a drug purchase shall not be subject to both a discount under section 340B and a Medicaid rebate under section 1927 of the Social Security Act. The Department is directed to establish a mechanism to assure that covered entities comply with this prohibition. The purpose of this notice is to announce the final mechanism to prevent duplicate discounts and rebates. The proposed mechanism was announced in the Federal Register at 58 FR 27293 on May 7, 1993. A comment period of 30 days was established to allow public comment on the proposed mechanism. Two comments were received. Both comments concerned issues involving implementation of the mechanism and did not raise substantive issues concerning the mechanism itself; therefore, we will address both comments in the Effective Date section. The mechanism, in its final form, is adopted as proposed.     

Medicare and Medicaid programs; fire safety requirements for long term care facilities, automatic sprinkler systems. Final rule

This final rule requires all long term care facilities to be equipped with sprinkler systems by August 13, 2013. Additionally, this final rule requires affected facilities to maintain their automatic sprinkler systems once they are installed.     

Health Financing Research and Demonstration grants; availability of funds for grants--Health Care Financing Administration. General notice

This document announces additional priority subject areas for research and demonstration grants for fiscal year 1983, in addition to those included in the Federal Register on September 16, 1982 (47 FR 41090).     

Medicare program; recognition of the Community Health Accreditation Program, Inc. (CHAP) for hospices. Health Care Financing Administration (HCFA), HHS. Final notice

This notice recognizes the Community Health Accreditation Program, Inc. (CHAP) as a national accreditation organization for hospices that request participation in the Medicare program. We believe that accreditation of hospices by CHAP demonstrates that all Medicare hospice conditions of participation are met or exceeded. Thus, we grant deemed status to those hospices accredited by CHAP. The proposed notice included the application from the Joint Commission for Accreditation of Healthcare Organizations (JCAHO). We have separated the final notices to appropriately process each application and will issue a separate final notice containing the decision for JCAHO under HCFA-2039-FN.     

State child health; implementing regulations for the State Children's Health Insurance Program. Health Care Financing Administration (HCFA), HHS. Final rule

Section 4901 of the Balanced Budget Act of 1997 (BBA) amended the Social Security Act (the Act) by adding a new title XXI, the State Children's Health Insurance Program (SCHIP). Title XXI provides funds to States to enable them to initiate and expand the provision of child health assistance to uninsured, low-income children in an effective and efficient manner. To be eligible for funds under this program, States must submit a State plan, which must be approved by the Secretary. This final rule implements provisions related to SCHIP including State plan requirements and plan administration, coverage and benefits, eligibility and enrollment, enrollee financial responsibility, strategic planning, substitution of coverage, program integrity, certain allowable waivers, and applicant and enrollee protections. This final rule also implements the provisions of sections 4911 and 4912 of the BBA, which amended title XIX of the Act to expand State options for coverage of children under the Medicaid program. In addition, this final rule makes technical corrections to subparts B, and F of part 457.     

Expanded phase out provisions of intermediate care facilities for the mentally retarded (ICFs/MR) correction plans--Health Care Financing Administration. Final rule

This regulation authorizes Intermediate Care Facilities For the Mentally Retarded (ICFs/MR) to negotiate revisions to their 1977 correction plans for Life Safety Code, living, dining, and therapy area deficiencies under certain circumstances. Under this regulation, HCFA is authorized to approve revised correction plans when facilities have completed at least 25 percent of their original plans and agree to phase out an increased number of beds in previously certified units not already scheduled for phase out under existing correction plans. The timetable for the phase out and the actual number of beds to be phased out will be negotiated with target figures established for each six-month period of the plan. The total time for the plan cannot exceed five years from the effective date of this rule. Facilities are still required to meet the July 18, 1982 deadline for those items in existing plans which include construction or renovation of units that will remain in use after the phase out is completed. The intent of this regulation is to stimulate an overall reduction in the number of certified beds in large residential facilities. We hope that it will forestall further expenditures of capital funds for renovation of existing facilities or construction of new units where an expanded phase out of units is feasible.     

Notice regarding section 602 of the Veterans Health Care Act of 1992--rebate option--HRSA. Final notice

Section 602 of Pub. L. 102-585, the "Veterans Health Care Act of 1992", enacted section 340B of the Public Health Service (PHS) Act, "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of HHS in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed that amount determined under a statutory formula. The purpose of this notice is to inform interested parties of the final guidelines recognizing a rebate option for State AIDS Drug Assistance Programs (ADAPs) receiving funds under Title XXVI of the PHS Act as an optional alternate means of accessing section 340B discount pricing.     

Medicare program; payment for nursing and allied health education. Health Care Financing Administration (HCFA), HHS. Final rule

This final rule sets forth in regulations Medicare policy for the payment of costs of approved nursing and allied health education programs. In addition, the rule clarifies the payment methodology for certified registered nurse anesthetist education programs. In general, the final rule clarifies and restates payment policies previously established in the Provider Reimbursement Manual and other documents, but never specifically addressed in regulations. The final rule carries out a directive made in the Omnibus Budget Reconciliation Act of 1989 and addresses changes required by the Omnibus Budget Reconciliation Act of 1990.     

Medicare program; recognition of the Community Health Accreditation Program standards for home care organizations--HCFA. Final notice

This final notice recognizes accreditation by the Community Health Accreditation Program (CHAP), a subsidiary of the National League for Nursing (NLN), for home health agencies (HHAs) that wish to participate in the Medicare Program. As a result of this recognition, HHAs accredited by CHAP are deemed to meet the Medicare conditions of participation for HHAs to the extent described in this notice. This final notice sets forth certain specific requirements with which CHAP must comply to maintain Medicare recognition of its HHA accreditation program.     

Medicare program; prospective payment system and consolidated billing for skilled nursing facilities. Department of Health and Human Services (HHS), Health Care Financing Administration (HCFA). Final rule

This final rule responds to comments submitted by the public on our May 12, 1998 interim final rule, that implemented provisions in section 4432 of the Balanced Budget Act of 1997 regarding Medicare payment for skilled nursing facility services. This legislation established a prospective payment system, a consolidated billing provision, and a number of related changes.     

Medicaid program; Medicaid managed care. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period amends the Medicaid regulations to implement provisions of the Balanced Budget Act of 1997 (BBA) that allow the States greater flexibility by permitting them to amend their State plan to require certain categories of Medicaid beneficiaries to enroll in managed care entities without obtaining waivers if beneficiary choice is provided; establish new beneficiary protections in areas such as quality assurance, grievance rights, and coverage of emergency services; eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs, such as the enrollment composition requirement, the right to disenroll without cause at any time, and the prohibition against enrollee cost-sharing. In addition, this final rule expands on regulatory beneficiary protections provided to enrollees of prepaid health plans (PHPs) by requiring that PHPs comply with specified BBA requirements that would not otherwise apply to PHPs.     

Notice regarding Section 602 of the Veterans Health Care Act of 1992; new drug pricing--PHS. Final notice

Section 602 of Public Law 102-585, the "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act ("PHS Act"), "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. The purpose of this notice is to inform interested parties of final guidelines regarding new drug pricing.     

Pharmaceutical Reimbursement Board; final maximum allowable cost (MAC) determinations for certain drug products--Health Care Financing Administration. Final notice

The Pharmaceutical Reimbursement Board announces the suspension of the maximum allowable cost (MAC) limit on erythromycin stearate, oral tablets, 500 mg, effective November 17, 1982. The limit for this drug product was published in the Federal Register on December 11, 1978 (43 FR 57972) and became effective on January 25, 1979. This suspension of the MAC limit on erythromycin stearate, oral tablets, 500 mg, is based on general price increases by manufacturers that have occurred in the marketplace and the Board's concern that this drug product may no longer be widely and consistently available at the established MAC limit. The Pharmaceutical Reimbursement Board may reinstitute procedures to establish a new MAC limit on this drug product in the future.     

Medicare and Medicaid programs; fire safety requirements for certain health care facilities; amendment. Interim final rule with comment period

This interim final rule with comment period adopts the substance of the April 15, 2004 temporary 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 will allow certain health care facilities to place alcohol-based hand rub dispensers in egress corridors under specified conditions. This interim final rule with comment period also requires that nursing facilities install smoke detectors in resident rooms and public areas if they do not have a sprinkler system installed throughout the facility or a hard-wired smoke detection system in those areas.     

Medicare program; removal of the requirements for the cardiac pacemaker registry. Health Care Financing Administration, HHS. Final rule

This final rule eliminates all requirements and references regarding the Cardiac Pacemaker Registry (the Registry) in our regulations. It conforms to the Food and Drug Adminstration's (FDA) recent final rule that required any physician and any provider of services who requests or receives Medicare payment for the implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the Registry. We used the information to administer Medicare payment for these devices. This rule implements an Act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress to eliminate duplicative and unnecessary reporting.