Medicare and Medicaid programs: changes to the hospital and critical access hospital conditions of participation to ensure visitation rights for all patients. Final rule

This final rule will revise the Medicare conditions of participation for hospitals and critical access hospitals (CAHs) to provide visitation rights to Medicare and Medicaid patients. Specifically, Medicare- and Medicaid-participating hospitals and CAHs will be required to have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital or CAH may need to place on such rights as well as the reasons for the clinical restriction or limitation.     

Discontinuation of approval of modifications in notes, guaranteed under Title VI or VII of the Public Health Service Act, proposed to permit use of the notes as collateral for tax-exempt financings--PHS. Final rule

The Department of Health and Human Services (HHS) adds a new section to regulations for making and guaranteeing loans for construction and modernization of hospitals and medical facilities and to regulations for guaranteeing loans for the construction of teaching facilities for health professions personnel. Under these regulations HHS will not approve the modification of the terms of an existing loan guaranteed under Title VI or Title VII of the Public Health Service (PHS) Act if the modification would permit use of the guarantee (or guaranteed loan) as collateral for tax-exempt financing.     

Medicare program; prospective payment system for long-term care hospitals: annual payment rate updates and policy changes. Final rule

This final rule establishes the annual update of the payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). It also changes the annual period for which the rates are effective. The rates will be effective from July 1 to June 30 instead of from October 1 through September 30, establishing a "long-term care hospital rate year" (LTCH PPS rate year). We also change the publication schedule for these updates to allow for an effective date of July 1. The payment amounts and factors used to determine the updated Federal rates that are described in this final rule have been determined based on this revised LTCH PPS rate year. The annual update of the long-term care diagnosis-related groups (LTC-DRG) classifications and relative weights remains linked to the annual adjustments of the acute care hospital inpatient diagnosis-related group system, and will continue to be effective each October 1. The outlier threshold for July 1, 2003, through June 30, 2004, is also derived from the LTCH PPS rate year calculations. In addition, we are making an adjustment to the short-stay outlier policy for certain LTCHs and a policy change eliminating bed-number restrictions for pre-1997 LTCHs that have established satellite facilities and elect to be paid 100 percent of the Federal rate or when the LTCH is fully phased-in to 100 percent of the Federal prospective rate after the transition period.     

Medicare and Medicaid programs; hospital conditions of participation; provider agreements and supplier approval; extension of comment period--HCFA. Notice of extension of comment period for proposed rule

This document extends the comment period for a proposed rule that generally would revise the hospital conditions of participation under Medicare and Medicaid, published in the Federal Register (62 FR 66726) on December 19, 1997. The comment period is extended 60 days for all provisions except the proposed new requirements relating to interactions between hospitals and organ procurement organizations, which are extended for an additional 14 days.     

Public Health Service--health maintenance organization loans and loan guarantees for acquisition and construction of ambulatory health care facilities. Interim regulations

This notice sets forth the requirements for qualified health maintenance organizations (HMOs) to obtain loans or loan guarantees for the acquisition or construction of ambulatory health care facilities and the acquisition of equipment for those facilities. It also sets forth project requirements and procedures to be followed for repayment of the loan and in the event of a default. These rules implement Section 1305A of the Public Health Service Act, as amended.     

‘You May Kiss the Bride,But You May Not Open Your Mouth When You Do So’: Policies Concerning Sex,Marriage and Relationships in English Forensic Psychiatric Facilities

In 1996, the Royal College of Psychiatrists recommended that all psychiatric facilities in the UK develop policies concerning sexuality and sexual expression for persons contained in those facilities. This paper analyses the prevalence and content of such policies in English forensic psychiatric facilities. While the College recommends an individualised approach to sexual and emotional relationships, most hospitals in fact either prohibit or actively discourage such expression as a matter of policy. The paper considers the advantages and disadvantages of that approach. The paper also considers the legal issues surrounding these policies, and in particular the legal authority for governing the sexual and emotional expression of hospital residents and the relevant human rights implications.     

Medicare and Medicaid programs; hospital conditions of participation; provider agreements and supplier approval--HCFA. Proposed rule

This proposed rule would revise the requirements that hospitals must meet to participate in the Medicare and Medicaid programs. The revised requirements focus on patients care and the outcomes of that care, reflect a cross-functional view of patient treatment, encourage flexibility in meeting quality standards, and eliminate unnecessary procedural requirements. These changes are necessary to reflect advances in patient care delivery and quality assessment practices since the requirements were last revised in 1986. They are also an integral part of the Administration's efforts to achieve broad-based improvements in the quality of care furnished through Federal programs and in the measurement of that care, while at the same time reducing procedural burdens on providers. In addition, in an effort to increase the number of organ donations, we are proposing changes in the interaction between hospitals and organ procurement organizations. The proposed rule also would specify that HCFA may terminate the participation agreement of a hospital, skilled nursing facility, home health agency, or other provider if the provider refuses to allow access to its facilities, or examination of its operations or records, by or on behalf of HCFA, as necessary to verify that it is complying with the Medicare law and regulations and the terms of its provider agreement.     

Medicare program; prospective payment system for hospital outpatient services--HCFA. Proposed rule

As required by sections 4521, 4522, and 4523 of the Balanced Budget Act of 1997, this proposed rule would eliminate the formula-driven overpayment for certain outpatient hospital services, extend reductions in payment for costs of hospital outpatient services, and establish in regulations a prospective payment system for hospital outpatient services (and for Medicare Part B services furnished to inpatients who have no Part A coverage). The prospective payment system would simplify our current payment system and apply to all hospitals, including those that are excluded from the inpatient prospective payment system. The Balanced Budget Act provides for implementation of the prospective payment system effective January 1, 1999, but delays application of the system to cancer hospitals until January 1, 2000. The hospital outpatient prospective payment system would also apply to partial hospitalization services furnished by community mental health centers. Although the statutory effective date for the outpatient prospective payment system is January 1, 1999, implementation of the new system will have to be delayed because of year 2000 systems concerns. The demands on intermediary bill processing systems and HCFA internal systems to become compliant for the year 2000 preclude making the major systems changes that are required to implement the prospective payment system. The outpatient prospective payment system will be implemented for all hospitals and community mental health centers as soon as possible after January 1, 2000, and a notice of the anticipated implementation date will be published in the Federal Register at least 90 days in advance. This document also proposes new requirements for provider departments and provider-based entities. These proposed changes, as revised based on our consideration of public comments, will be effective 30 days after publication of a final rule. This proposed rule would also implement section 9343(c) of the Omnibus Budget Reconciliation Act of 1986, which prohibits Medicare payment for nonphysician services furnished to a hospital outpatient by a provider or supplier other than a hospital, unless the services are furnished under an arrangement with the hospital. This section also authorizes the Department of Health and Human Services' Office of Inspector General to impose a civil money penalty, not to exceed $10,000, against any individual or entity who knowingly and willfully presents a bill for nonphysician or other bundled services not provided directly or under such an arrangement. This proposed rule also addresses the requirements for designating certain entities as provider-based or as a department of a hospital.     

Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 1993 rates--HCFA. Final rule

We are revising the Medicare hospital inpatient prospective payment systems for operating costs and capital-related costs to implement necessary changes arising from our continuing experience with the systems. In addition, in the addendum to this final rule, we are describing changes in the amounts and factors necessary to determine prospective payment rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes will be applicable to discharges occurring on or after October 1, 1992. We are also setting forth rate-of-increase limits for hospitals and hospital units excluded from the prospective payment systems. Finally, we are changing and clarifying the criteria and procedures concerning the reclassification of hospitals by the Medicare Geographic Classification Review Board (MGCRB). These changes result from public comment and our analysis of hospital reclassifications for Federal fiscal year (FY) 1992.     

Requirements for the group health insurance market; non-federal governmental plans exempt from HIPAA Title I requirements. Final rule

This rule finalizes existing exemption election requirements that apply to self-funded non-Federal governmental plans. In it, we clarify the conditions under which plan sponsors may exempt these plans from most of the requirements of title XXVII of the PHS Act, and provide guidance on the procedures, limitations, and documentation associated with exemption elections. Finally, we revise the requirements to reinforce beneficiary protections for exemption elections.     

Medicare and Medicaid programs; hospital conditions of participation: quality assessment and performance improvement. Final rule

This final rule requires hospitals to develop and maintain a quality assessment and performance improvement (QAPI) program. In the December 19, 1997 Federal Register, we published a proposed rule to revise the hospitals conditions of participation (CoPs). The QAPI CoP was one of the conditions included in the proposed rule. We separated the QAPI CoP from the larger set of hospital CoPs so that it could be published in advance of the remaining CoPs to implement the Administration's initiatives regarding medical errors. QAPI focuses provider efforts on the actual care delivered to patients, the performance of the hospital as an organization, and the impact of treatment furnished by the hospital on the health status of its patients. Specifically, it is important to note that a QAPI is not designed to measure a hospital's quality, but rather a minimum requirement that the hospital systematically examine its quality and implement specific improvement projects on an ongoing basis. State agencies (SAs) during their surveys, review all aspects of a hospital's operations and this review provides a framework in which the SA can assess a hospital's QAPI program. In addition, the QAPI entails all activities required for measuring quality of care and maintaining it at acceptable levels. This typically includes; 1) Identifying and verifying quality-related problems and their underlying cause; 2) Designing and implementing corrective action activities to address deficiencies; 3) Following up to determine the degree of success of an intervention and to detect new problems and opportunities for improvement. Performance improvement activities aim to improve overall performance assuming that there is no permanent threshold for good performance. Under performance improvement framework, hospitals will continuously study and improve the processes of healthcare and delivery of service.     

Medicare and Medicaid programs: changes affecting hospital and critical access hospital conditions of participation: telemedicine credentialing and privileging. Final rule

This final rule will revise the conditions of participation (CoPs) for both hospitals and critical access hospitals (CAHs). The final rule will implement a new credentialing and privileging process for physicians and practitioners providing telemedicine services. Currently, a hospital or CAH receiving telemedicine services must go through a burdensome credentialing and privileging process for each physician and practitioner who will be providing telemedicine services to its patients. This final rule will remove this undue hardship and financial burden.     

Uniform administrative requirements for grants and agreements with institutions of higher education, hospitals, other non-profit, and commercial organizations--Department of Commerce. Interim final rule

This interim final rule implements the revisions to the Office of Management and Budget (OMB) Circular A-110, "Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations" which was published in the Federal Register on November 29, 1993. The revised Circular was developed by an interagency task force for governmentwide use in a model rule format to facilitate regulatory adoption by executive departments and agencies. In the published revised Circular, OMB specified as "required action" that Federal agencies responsible for awarding and administering grants and other agreements to recipients described therein, shall adopt the language of the Circular unless other provisions are required by Federal statute or exceptions or deviations are approved by OMB. This interim final rule adopts the provisions of the Circular and its language to the maximum extent feasible. However, minor changes were made to update the procedures, clarify the language, and make the language apply specifically to the DoC and its operating units. No changes are intended to deviate from the substance of Circular A-110. The Circular covers both grants and cooperative agreements made by Federal agencies and subawards, unless sections of the Circular specifically exclude subrecipients from coverage. Consistent with guidance provided in the Circular, DoC will apply its provisions to grants and agreements with institutions of higher education, hospitals, other nonprofit, and commercial organizations. The provisions of the interim final rule will also apply to foreign governments, organizations under the jurisdiction of foreign governments, and international organizations when appropriate.     

Public mobile radio services; regulatory policies and procedures for the Domestic Public Land Mobile Radio Service--Federal Communications Commission. Final rule

Final policies and procedures concerning objective need showings are being adopted for applications requesting multiple new two-way channels and applications requesting additional channels for an existing system. The policies and procedures we had in the past were vague and did not provide applicants with sufficient information as to what was required in need showings before various types of applications could be granted. Thus, applicants requesting multiple new two-way frequencies or additional two-way channels for an existing system must show that the existing, projected or expected grade of service for the proposed facilities is .25 or greater, this will determine the number of new or additional channels granted.     

Special report on taxation. Prepare for impending legislation that could threaten your tax-exempt status!

With impending federal action, and the likelihood of "copycat" legislation at the state and local levels if a federal statue is adopted, nonprofit hospitals need to ensure that they will be in compliance if a mandatory charity care bill were to become law. Such facilities should take the initiative now, by clearly articulating their charity care policies and by describing their other undercompensated or uncompensated activities that are maintained in order to benefit their communities. They should also ensure that all of their activities that could be counted as charity care or community benefit are fully documented and quantified. Financial consultants and counsel may be helpful in this process. Exempt facilities also should, of course, closely monitor the progress of the bills discussed above. Most importantly, they should continue to test their charity care and community benefit statistics on a regular basis to determine if their facilities meet the thresholds specified in the bills as they proceed through Congress.     

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.     

Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 2006 rates. Final rule

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. We also are setting forth rate-of-increase limits as well as policy changes for hospitals and hospital units excluded from the IPPS that are paid in full or in part on a reasonable cost basis subject to these limits. These changes are applicable to discharges occurring on or after October 1, 2005, with one exception: The changes relating to submittal of hospital wage data by a campus or campuses of a multicampus hospital system (that is, the changes to Sec. 412.230(d)(2) of the regulations) are effective on August 12, 2005. Among the policy changes that we are making are changes relating to: The classification of cases to the diagnosis-related groups (DRGs); the long-term care (LTC)-DRGs and relative weights; the wage data, including the occupational mix data, used to compute the wage index; rebasing and revision of the hospital market basket; applications for new technologies and medical services add-on payments; policies governing postacute care transfers, payments to hospitals for the direct and indirect costs of graduate medical education, submission of hospital quality data, payment adjustment for low-volume hospitals, changes in the requirements for provider-based facilities; and changes in the requirements for critical access hospitals (CAHs).     

Revisions to the requirements applicable to blood, blood components and source plasma. Direct final rule

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.