# Medicaid Program; Inpatient Psychiatric Services for Individuals Under Age 21; Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A94-28318 ## Record - **Collection:** Federal Register - **Document type:** Uncategorized Document - **Published:** November 17, 1994 ## Text SUMMARY: This proposed rule would amend our regulations to establish psychiatric residential treatment facilities as a new category of Medicaid facility, and establish standards that these facilities would have to meet; and specify that psychiatric units of general hospitals may be used for acute psychiatric care for individuals under age 21. It also would improve the regulatory implementation of the statutory requirements for State development of a comprehensive mental health program and coordination of various State authorities concerned with provision of mental health and related services. In addition, this proposed rule would ensure that representatives from agencies providing services to an individual develop and manage a coordinated plan of care whenever feasible. This rule would implement section 4755(a) of the Omnibus Budget Reconciliation Act of 1990 (Public Law 101-508). DATES: Written comments will be considered if we receive them at the appropriate address, as provided below, and must be received no later than 5:00 p.m. on January 17, 1995. ADDRESSES: Mail written comments (one original and two copies) to the following address: Health Care Financing Administration, Department of Health and Human Services, Attention: MB-60-P, P.O. Box 7518, Baltimore, Maryland 21207- 0518. If you prefer, you may deliver your written comments (one original and two copies) to one of the following addresses: Room 309-G, Hubert H. Humphrey Building, 200 Independence Ave., SW., Washington, DC or Room 132, East High Rise Building, 6325 Security Boulevard, Baltimore, Maryland. Due to staffing and resource limitations, we cannot accept comments by facsimile (FAX) transmissions. In commenting, please refer to file code MB-60-P. Written comments received timely will be available for public inspection as they are received, beginning approximately three weeks after publication of this document, in Room 309-G of the Department's offices at 200 Independence Ave., SW., Washington, DC on Monday through Friday of each week from 8:30 a.m. to 5:00 p.m. (phone: 690-7890). If you wish to submit written comments on the information collection requirements contained in this proposed rule, you may submit written comments to: Laura Oliven, HCFA Desk Officer, Office of Information and Regulatory Affairs, Room 3001, New Executive Office Building, Washington, D.C. 20503. FOR FURTHER INFORMATION CONTACT: Winona Hocutt, (410) 966-4625. SUPPLEMENTARY INFORMATION: I. Background Medicaid is the Federally assisted State program authorized under title XIX of the Social Security Act (the Act) to provide funding for medical care provided to certain needy aged, blind and disabled persons, families with dependent children, and low-income pregnant women and children. Each State determines the scope of its program, within limitations and guidelines established by the law and the implementing regulations at 42 CFR chapter IV, subchapter C. Each State submits a State plan that, when approved by HCFA, provides the basis for granting Federal funds to cover part of the expenditures incurred by the State for medical assistance and the administration of the program. Section 1902(a) of the Act specifies the eligibility requirements that individuals must meet in order to receive Medicaid. Other sections of the Act describe the eligibility groups in detail and specify limitations on what may be paid for as ``medical assistance.'' II. Statutory and Regulatory History--Inpatient Psychiatric Hospital Services Benefit for Individuals Under Age 21 The Social Security Amendments of 1972 (Public Law 92-603) amended the Medicaid statute to, among other things, allow States the option of covering inpatient psychiatric hospital services for individuals under age 21. In this preamble, we will refer to inpatient psychiatric hospital services for individuals under age 21 as the ``psychiatric\21 benefit.'' Originally the statute required that the psychiatric\21 benefit be provided by psychiatric hospitals that were accredited by the Joint Commission on Accreditation of Hospitals. This organization is now called the Joint Commission on Accreditation of Healthcare Organizations. We will refer to this organization as the ``Joint Commission.'' In 1976 the Social and Rehabilitation Service, one of the agencies that later merged to form HCFA, published final regulations in the 45 CFR part 249 implementing the psychiatric\21 benefit. These regulations allowed the coverage of this benefit in psychiatric facilities that were accredited by the Joint Commission. The term ``psychiatric facility'' was used rather than the statutory term ``psychiatric hospital'' because the Joint Commission had modified its accrediting practices to encompass a broader range of settings providing psychiatric services. Since the statute at that time required Joint Commission accreditation, HCFA desired to keep its requirements consistent with Joint Commission practices. In 1981 HCFA received comments from the Joint Commission expressing concern about HCFA's regulatory requirement for Joint Commission accreditation. The Joint Commission indicated that this Federal requirement was in conflict with Joint Commission policy that facilities should seek accreditation voluntarily. In response, HCFA noted that the regulatory requirement for Joint Commission accreditation could not be removed because it was required by statute. In 1984, the Congress amended section 1905(h) of the Act, removing the requirement for Joint Commission accreditation and adding the requirement that providers of the psychiatric\21 benefit meet the definition of a ``psychiatric hospital'' under the Medicare program as specified in section 1861(f) of the Act (section 2340 of the Deficit Reduction Act of 1984 (Public Law 98-369)). Despite this statutory change, based on our understanding of Congressional intent, we did not remove the requirement for Joint Commission accreditation from HCFA regulations, which are in subpart D of 42 CFR part 441. Our reliance on Joint Commission accreditation was the only basis for coverage of the psychiatric\21 benefit in psychiatric facilities other than psychiatric hospitals. Our decision to retain the regulatory requirement for Joint Commission accreditation was based on the fact that, in enacting the 1984 amendment, the Congress gave no indication that it intended to narrow the psychiatric\21 benefit or alter HCFA policy that had been in effect since 1976. On November 5, 1990, the Omnibus Budget Reconciliation Act of 1990 (OBRA '90), Public Law 101-508, was enacted. Consistent with HCFA's interpretation reflected in 42 CFR 441 et seq., section 4755 of OBRA '90 amended section 1905(h) of the Act to specify that the psychiatric\21 benefit can be provided in psychiatric hospitals that meet the definition of that term in section 1861(f) of the Act ``or in another inpatient setting that the Secretary has specified in regulations.'' This amendment, which was effective as if it had been enacted earlier as part of the Deficit Reduction Act of 1984, affirmed and effectively ratified preexisting HCFA policy as articulated in subpart D of 42 CFR part 441, which interpreted sections 1905(a)(16) and 1905(h) of the Act as not being limited solely to psychiatric hospital settings. OBRA '90, therefore, provides authority for HCFA to specify inpatient settings in addition to the psychiatric hospital setting for the psychiatric\21 benefit without continuing to require that providers obtain Joint Commission accreditation. III. Related Provisions Under section 1905(a) of the Act, Medicaid payment is generally not available for any services provided to individuals under age 65 who are patients in ``institutions for mental diseases'' (IMDs). This statutory preclusion of Medicaid payment is commonly known as the ``IMD exclusion.'' The term ``IMD'', as defined in section 1905(i) of the Act, includes hospitals, nursing facilities, or other institutions of more than 16 beds that are primarily engaged in providing diagnosis, treatment, or care of persons with mental diseases, including medical attention, nursing care, and related services. The psychiatric\21 benefit, at section 1905(a)(16) of the Act, is the only statutory exception to the IMD exclusion. The psychiatric\21 benefit is optional, and it is currently covered under 41 State plans. The psychiatric\21 benefit must, however, be provided in all States to those individuals who are determined during the course of an Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) screen to need this type of inpatient psychiatric care. Under the EPSDT provisions at section 1905(r)(5) of the Act, as amended by section 6403 of the Omnibus Budget Reconciliation Act of 1989, Public Law 101-239, States must provide any service listed in section 1905(a) of the Act that is needed to correct or ameliorate defects and physical and mental conditions discovered by EPSDT screening services, whether or not the service is covered under the State plan. While some inpatient psychiatric services can be provided in the psychiatric units of general hospitals as ``inpatient hospital services'' under section 1905(a)(1) of the Act, the services provided under the psychiatric\21 benefit, and which meet the regulatory requirements in subpart D of part 441, must also be available for children and adolescents who are determined to need these services as a result of an EPSDT screen. Because of the section 1905(r)(5) requirement, even States that do not elect to include the optional psychiatric\21 benefit in their State plans must be aware of its provisions so that inpatient psychiatric services can be provided to EPSDT-eligible individuals who are determined to require them. Under current law, Medicaid payment for psychiatric services can be available under a variety of services and settings listed in section 1905(a) of the Act. Optional inpatient psychiatric services are available for individuals age 65 or over in IMDs which are inpatient hospitals or nursing facilities (section 1905(a)(14) of the Act). Payment is available for medically necessary inpatient psychiatric services provided to Medicaid recipients of all ages in general hospitals, since such hospitals are typically not IMDs. Outpatient psychiatric services can be covered in the outpatient hospital setting or under the optional clinic or rehabilitative services benefits (see sections 1905(a)(2)(A), 1905(a)(9) and 1905(a)(13) of the Act). Finally, the physicians' service benefit under section 1905(a)(5)(A) of the Act can include psychiatrists' services. Under section 1905(a) of the Act, Medicaid payment is available for case management services, as defined in section 1915(g)(2) of the Act, which can be used to coordinate needed mental health services. Case management services assist individuals in gaining access to needed medical, social, educational, and other services. Moreover, under section 1915(g)(1), such case management services may be targeted to chronically mentally ill persons. Although coverage of case management services is generally optional for States, the case management services under section 1905(a)(19) must be provided under the EPSDT authority cited above if the need for these services is discovered during an EPSDT screen (see section 1905 (r)(5)). Section 4722 of OBRA '90 amended section 1905(a) of the Act to provide that no service shall be excluded from the definition of ``medical assistance'' solely because it is provided as a treatment service for alcoholism or drug dependency. (Under the International Classification of Diseases, which HCFA relies on for classification purposes, alcoholism and chemical dependency are classified as mental disorders.) This provision does not override the IMD exclusion, nor does it require a State to include chemical dependency treatment under any other optional benefit unless it chooses to do so. Since the Medicaid statute was enacted in 1965, it has required that all State agencies involved with mental health care coordinate their activities. Specifically, section 1902(a)(20)(A) of the Act requires that the State Medicaid agency, in a State offering the optional IMD benefit under section 1905(a)(14), have agreements or other arrangements with other State authorities concerned with mental diseases. These include arrangements for joint planning and development of alternate methods of care, and arrangements providing assurance of immediate readmittance to institutions, where needed, for individuals under alternate plans of care. The IMD services authorized under section 1905(a)(14) currently are provided by 45 States. Section 1902(a)(20)(B) of the Act contains additional requirements regarding IMD benefits for individuals age 65 or older. Among other provisions, this section requires that the Medicaid State plan provide for an individual plan for each patient who may be in need of institutional care to ensure that any ``institutional care provided to him is in his best interests, including, to that end, assurances that there will be initial and periodic review of his medical and other needs.'' In addition, the State plan must include assurances that each patient will be given appropriate treatment within the institution, and that each patient will have a periodic assessment of the need for continued treatment in the institution. Section 1902(a)(20)(C) of the Act further requires States that offer the IMD benefit to provide for development of alternate plans of care, making maximum utilization of available resources, for recipients age 65 or older who would otherwise need institutional care, including appropriate medical treatment and other aid or assistance. This section also requires that States develop the methods of administration necessary to ensure that these responsibilities of the State agency for these recipients are effectively carried out. Section 1902(a)(21) of the Act requires that these States show that they are making satisfactory progress toward developing and implementing a comprehensive mental health program, including provision for utilization of community mental health centers and other alternatives to care in public IMDs. (The State's comprehensive mental health services plan, which a State has prepared in accordance with section 1912 of the Public Health Service Act, can serve as a basis for this process). These statutory requirements were designed to ensure that the mental health services covered by Medicaid are coordinated with all related services provided by other State authorities and that appropriate alternatives to institutional care are available. These requirements are implemented in our regulations at 42 CFR 441.106, which provides, among other things, that if a State plan includes services in public institutions for mental diseases, the State must implement a comprehensive mental health program which covers all ages. In this way, we make clear that a comprehensive program must include services for individuals under age 21 and over age 64 who are possible candidates for Medicaid coverage of inpatient psychiatric care as well as services for individuals age 22 through 64 who do not have a Medicaid benefit for inpatient psychiatric care. IV. General Goal of Proposed Regulatory Revisions We are preparing the proposed regulations under the authority provided by section 1905(h) of the Act, as amended by section 4755 of OBRA '90, to specify alternative inpatient settings in which inpatient psychiatric services may be covered for individuals under age 21. We also propose to update our rules for the psychiatric\21 benefit to take into account changes that have taken place in the provision of psychiatric services since the existing regulations were published, and to make implementation of the psychiatric\21 benefit consistent with related Medicaid benefits and other statutory provisions. In the process of developing these proposed regulations, we have consulted with several other Federal agencies, including the Civilian Health and Medical Programs of the Uniformed Services (CHAMPUS) and the National Institutes of Mental Health (NIMH), a number of States, and with a wide array of private organizations concerned with the provision of mental health services to children and adolescents. We propose to establish a policy which will improve coordination of the psychiatric\21 benefit with other services generally being provided to mentally ill children and adolescents, such as educational services, child welfare services, and juvenile justice services. Amid widespread concern that the services provided for mentally ill children and adolescents and their families are often overlapping, duplicative, and sometimes at cross-purposes because they have not been coordinated with each other, many States have begun to coordinate the activities of the State and local authorities involved with caring for mentally ill children and adolescents to ensure joint planning and joint provision of services. In many cases these efforts have been based on the NIMH's Child and Adolescent Service System Program. In addition, the Robert Wood Johnson Foundation has funded coordinated ``Mental Health Service Programs for Youth'' at 8 sites. It is especially critical that the possible need for inpatient services be considered in the context of all the services involved in a child's or adolescent's care because an unnecessary admission can put the individual at risk of a lifetime of public dependency. Inpatient admission also inevitably results in trauma and disruption of a child's normal support systems. Intensive services are increasingly available in the community to help resolve crisis situations. When inpatient admission is necessary, it is often needed because early intervention and treatment have been lacking. For this reason, fewer admissions to mental health facilities may be required when a comprehensive care system has been in place for a period of time. Coordinated programs are oriented toward the needs of children rather than being structured according to the requirements of various funding sources, and they result in a wider array of available services. Coordinated programs can lower overall costs because duplicative and unnecessary services can be eliminated, and optimal services can be made available. If the array of services available is uncoordinated, the patient runs the risk of an unnecessary admission because the alternative services that may have been more effective are not as readily available and the admission, therefore, occurs by default. Many studies have indicated that the most important factors in maintaining the beneficial effects of mental health treatment for children and adolescents are the availability and use of a wide range of post-treatment resources. Such resources include appropriate educational and vocational services and supportive services for the family members who will have ongoing responsibility for caring for the children. Many of these services are beyond the purview of the Medicaid program, but they are, nonetheless, vital to the mental health of Medicaid recipients and have direct bearing on future mental health service needs. These proposed regulations would support State coordination and planning efforts in this area (Sec. 441.106). Psychiatric Treatment Many professionals contend that psychiatric treatment should be available in a wide array of settings, including office visits, clinic services, home-based treatment programs, day treatment programs, partial hospitalization (day hospital), therapeutic foster care provided by trained ``parents,'' residential treatment facility services, and acute psychiatric hospital care. Mental health professionals generally agree that it is best for the individual for services to be provided in the least restrictive setting possible. In addition, it is usually cost effective to do so. ``Least restrictive setting'' generally means that needed care should be provided on an outpatient basis in the community where the individual lives, as opposed to in an inpatient setting. This principle has been codified in Part B of the Education of the Handicapped Act, Public Law 94-142 (20 U.S.C. 1400 et seq.). The Medicaid program has frequently been criticized for favoring institutional care over community-based care because the reimbursement rates are often viewed as being more adequate for inpatient care, and because eligibility may be more readily available for institutionalized individuals. As a result, institutional care may have been provided when it was not medically necessary, with possible detrimental effects on the patient, because alternative community care was not available. Various studies have estimated that from 39 to 95 percent of the psychiatric inpatient care provided is medically unnecessary. In fact, a wide array of outpatient mental health services can be funded under Medicaid, but for a variety of reasons these options have not been fully utilized by many States and outpatient providers. In recent years, however, many States have become concerned about dramatic increases in Medicaid expenditures for inpatient psychiatric care and have sought to assure that alternative care is available in the community. Many States have moved to increase funding for community services and instituted effective screening procedures for inpatient admissions. We are proposing revisions in Sec. 441.152, concerning certification of the need for inpatient care, that we believe will serve to support these efforts. These proposals are discussed in section V of this preamble. Inpatient Settings As discussed in Section II Statutory and Regulatory History of this preamble, existing regulations allow the provision of psychiatric inpatient care for individuals under age 21 in any psychiatric facility that is accredited by the Joint Commission and meets the other requirements in subpart D of 42 CFR part 441. The Joint Commission accredits a wide variety of health care organizations which may provide inpatient or outpatient services. Inpatient psychiatric services are currently being provided for individuals under age 21 in psychiatric hospitals in all but 7 States. Psychiatric hospitals must, under section 1905(h)(1)(A), meet the Medicare definition of ``psychiatric hospital'' contained in section 1861(f) of the Act. The regulatory requirements relating to psychiatric hospitals are specified in Sec. 482.60, Special provisions applying to psychiatric hospitals. In addition, 14 States provide inpatient psychiatric services for individuals under age 21 in psychiatric units in general hospitals. Three States cover the psychiatric\21 benefit in nursing facilities, and 19 States cover this benefit in facilities called ``residential treatment facilities.'' Although nursing facilities (NFs) are a recognized category of inpatient provider, we decided against designating NFs as an alternative setting for the psychiatric\21 benefit because NFs are primarily designed to provide geriatric nursing care and would not generally be appropriate for children and adolescents. In view of the fact that a number of States no longer use psychiatric hospitals to provide services to individuals under age 21 and a significant number of States now provide this inpatient benefit in psychiatric units of general hospitals, we propose to specify in the proposed regulations that States may use psychiatric units of general hospitals to provide acute psychiatric inpatient care under the psychiatric\21 benefit either instead of, or in addition to, psychiatric hospitals. We propose to revise existing regulations to establish a definition of the term ``psychiatric residential treatment facility'' (PRTF) and conditions of participation for this type of facility. A PRTF is a community-based facility that provides a less medically intensive program of treatment than a psychiatric hospital or a psychiatric unit of a general hospital. The proposed PRTF standards are based on existing standards for these facilities developed by CHAMPUS, the Joint Commission, and a number of States and other organizations. We have tried to structure the PRTF conditions of participation to ensure practical outcome- oriented benefit to patients, rather than establishing ``paper'' compliance with procedures and policies. We also would revise Sec. 441.152, which specifies the requirements for certification of the need for admission to all psychiatric\21 providers. These provisions are discussed in detail in section V of this preamble. Any State that chooses to offer the psychiatric\21 benefit would be required, at a minimum, to provide acute psychiatric care in a psychiatric hospital or a psychiatric unit of a general hospital. States would have the further option of also providing inpatient psychiatric services in the freestanding PRTF setting. If a State does not choose to include PRTF services as part of the psychiatric\21 benefit, it would not be required to certify freestanding PRTFs if it determines that medically necessary residential treatment services for EPSDT patients can be provided in a certified distinct part PRTF located in a general hospital or psychiatric hospital setting. PRTFs would provide a type of care that is distinctly different from the care provided by acute care facilities and therefore a PRTF that is affiliated with a participating psychiatric hospital or general hospital would need to obtain separate PRTF certification in addition to its hospital certification. The setting(s) that a State chooses to use for the psychiatric\21 benefit would be indicated in its State plan. PRTFs would be certified in the same manner as other inpatient providers of Medicaid services. States may contract for specialized personnel to perform surveys if they wish to. Currently operating residential treatment facilities include a wide range of providers, from facilities that provide care similar to that provided in psychiatric hospitals to facilities that are more similar to group homes. In addition, many residential treatment facilities are part of multi-service mental health organizations which also provide a range of outpatient services. A number of States have developed or are in the process of developing licensure requirements for these facilities. Treatment in residential treatment facilities generally costs less per day than treatment in a psychiatric hospital, but because the length of stay in residential facilities is generally longer, treatment in a residential facility is not always less expensive for the total inpatient stay. Rates for residential treatment facility services now range from approximately $140 to $420 per day, including professional fees. Some States have developed managed care systems for mental health services and, in some cases, States have combined Medicaid funding for these mental health benefits with funding for related services administered by other agencies in the State. These arrangements tend to ensure that treatment programs are developed in response to the individual's service needs rather than being structured according to the funding criteria of various programs; we support these coordinated efforts. Under these programs, Medicaid is only billed for Medicaid covered services provided to Medicaid eligible individuals. In the course of developing these proposed regulations, several parties suggested that intensive outpatient services be included as a subcategory of services under the psychiatric\21 benefit in order to emphasize that outpatient services can often be substituted for inpatient care, with less traumatic impact on the patient. Although we support the goal of substituting outpatient services for inpatient services whenever possible, the statutory language of section 1905(h) of the Act authorizing this inpatient benefit does not provide latitude for including outpatient services; this benefit must be provided in ``a psychiatric hospital * * * or in another inpatient setting.'' We believe, however, that the system we have proposed for assessing the total needs of each child or adolescent will support the goal of assuring that outpatient services are used whenever this is a feasible alternative. It was also suggested that we consider allowing children and adolescents who do not require inpatient treatment of their mental conditions to enter residential facilities if they require residential placement to remove them from a problematic family setting. In this situation, it was suggested that Medicaid would fund the treatment services, and payment for the cost of room and board would come from other sources. While we recognize that this type of arrangement may be necessary in some circumstances, and we acknowledge that rehabilitative services can be provided in a wide variety of settings, we note that care provided under such an arrangement would not be provided in the context of the psychiatric\21 benefit, which is restricted by statute to individuals who require inpatient care for treatment of their mental condition (section 1905(h)(1)(B)). Accordingly, we have not incorporated this suggestion into the proposed regulations. V. Provisions of the Proposed Regulations A. Inpatient Mental Health Provisions We would establish a new Sec. 441.45, Mental health assessment and service plan, which implements section 1902(a)(26) of the Act. This section requires individual plans of care for psychiatric inpatients and periodic medical review in each psychiatric institution. The State would be required to ensure that a comprehensive assessment is made (Sec. 441.45(a)) and that an individual comprehensive services plan (Sec. 441.45(b)) is developed for each individual who has been determined to be at risk of requiring inpatient mental health treatment. We propose to extend this requirement to include not only eligible individuals currently receiving inpatient mental hospital services, but also certain eligible individuals who the State reasonably believes may imminently need such services, because we believe that such a requirement is a necessary safeguard to ensure proper utilization of inpatient services. We also believe that such a requirement will help to ensure continuity of care and appropriate service utilization for patients who have had intermittent inpatient mental hospital services. Furthermore, such a requirement is consistent with requirements for comprehensive assessments of medical status and needs under the early and periodic screening, diagnosis and treatment benefit available to individuals under the age of 21. A State must consider at risk of requiring inpatient mental health services at least those eligible individuals who are in the following categories: those who are applicants for inpatient mental health facilities, those determined to need inpatient mental health services on an EPSDT screen or preadmission screening and annual resident review (PASARR), and those discharged from an inpatient mental health facility, during the year following discharge. A State may include other groups of eligible individuals who it believes are at risk of needing inpatient treatment in the near future. For eligible individuals who have been identified based on an EPSDT screen or a PASARR, a State may adopt as its assessment or comprehensive service plan the results of these other reviews if those reviews are sufficient to meet the requirements specified in Sec. 441.45. Comprehensive mental health planning for a child or adolescent would typically involve representatives from the State mental health department, the child welfare authority, the educational/vocational services agency, the public health department, and in some cases the alcohol/drug treatment agency, and/or the juvenile justice system. The Medicaid agency would participate with these agencies in determining the proportionate share of funding responsibility for the services needed under the plan. The child or adolescent and the parents or guardians would also be involved in developing the services plan, and parents or guardians must also be involved in any treatment provided in order to ensure maximum long term benefit from the treatment. We would revise Sec. 441.106, Comprehensive mental health program, which implements the statutory requirement for a comprehensive mental health program, to reflect the statutory provisions more explicitly. The revision of this section, consistent with sections 1902 (a)(20) and (a)(21) of the Act, would require that each State's comprehensive mental health program involve all agencies in the State that serve mentally ill individuals. Medicaid's statutory authority for requiring a comprehensive mental health program applies to all States offering services for individuals age 65 and over in institutions for mental diseases (currently 46 States) and our regulations at Sec. 441.106 have long required that the comprehensive program cover all ages. Section 1912 of the Public Health Service Act includes a similar mental health planning provision and we would specify that any program developed as a result of that requirement would meet the Medicaid requirement. An annual progress report on the State's comprehensive mental health program is required under existing Sec. 441.106(c). We would move this requirement to Sec. 441.106(b), and modify it to specify that a comprehensive mental health services plan developed under section 1912 of the Public Health Service Act would satisfy the Medicaid reporting requirement. If a separate report is prepared, the interagency group involved in mental health planning would participate in the report preparation. The revision would also specify that the report must be submitted to the HCFA Regional Administrator within 3 months after the end of the fiscal year. In Sec. 441.151, General requirements, a new paragraph (c) would be added to require that services provided to an individual under the psychiatric\21 benefit must be compatible with the individual's comprehensive services plan developed as specified in Sec. 441.45(b) (discussed above). We also would delete the existing regulatory requirement for Joint Commission accreditation in Sec. 441.151(b). As discussed in section II of this preamble, this requirement was removed from the law in 1984 and the Joint Commission has indicated that it does not wish to have its accreditation mandated in HCFA regulations since accreditation is voluntary. We would require that psychiatric facilities meet either the psychiatric hospital requirements specified in existing Sec. 482.60 and proposed Sec. 483.202, or operate as an inpatient psychiatric unit in a general hospital that meets the requirements of existing subparts B and C of part 482 and proposed Sec. 483.202, or meet the psychiatric residential treatment facility conditions of participation that we are proposing in Secs. 483.210 through 483.224 of the new subpart F of part 483. To summarize, all providers of the psychiatric\21 benefit would be required to meet the condition of participation in Sec. 483.202 relating to active treatment and the inpatient plan of treatment, in addition to meeting the other regulatory requirements applicable to the particular setting. In addition to meeting the PRTF requirements specified in these proposed regulations, as determined by the survey process, a State could also require Joint Commission accreditation or accreditation by any other accrediting organization determined appropriate by the State if it wishes to. The regulations at 42 CFR 431.51(c)(2) allow States to establish reasonable standards relating to qualifications of providers. We emphasize that accreditation by an organization would not, however, be considered a substitute for meeting the regulatory requirements in the proposed new subpart F of part 483. Reliance on varied and changing accreditation requirements in the past has led to widespread confusion about the requirements providers must meet as Medicaid participants. We propose to modify the certification requirements in Sec. 441.152, Certification of need for services, by adding a requirement that the team or organization responsible for certifying the need for care must complete a comprehensive assessment as specified in Sec. 441.45(a) prior to determining whether inpatient care is necessary. In addition, we would require that the certification include the documented clinical evidence that serves as the basis for the certification. We wish to make it clear that certification of the need for inpatient care is not to be made unless inpatient care is medically necessary for treatment of the child or adolescent, as required by the statute. Section 1905(h)(1)(B) of the Act requires that ``physicians and other personnel qualified to make determinations with respect to mental health conditions and the treatment thereof'' certify the need for care which they have determined to be ``necessary on an inpatient basis and can reasonably be expected to improve the condition, by reason of which such services are necessary, to the extent that eventually such inpatient services will no longer be necessary.'' For this reason, we propose to delete the requirement in existing Sec. 441.152(a)(1) that the certification include a statement that the ambulatory care resources available in the community do not meet the treatment needs of the recipient. This ``availability of ambulatory care'' requirement was designed to supplement the certification of the medical necessity for inpatient care. However, we are concerned that this requirement may have been misinterpreted as forming a basis for certifying that inpatient care was needed when, in fact, it was not clinically required. Inpatient care may have been incorrectly certified to be necessary only because the community services that would have been sufficient and preferable for that individual were not available in his or her community. Given the above circumstances, the current reference to ambulatory services may have contributed to the inappropriately high incidence of unnecessary inpatient care. HCFA believes that if the need for inpatient care is certified on the basis that ambulatory care is unavailable, this action would undermine an important impetus to developing needed community services. The proposed certification statement would have to indicate which category of inpatient services are needed, i.e., acute psychiatric services or PRTF services. The State Medicaid agency needs to ensure that the teams that develop the individual comprehensive services plans and assess the need for inpatient care are prepared to confer informally on a timely basis so that decisions concerning possible inpatient admissions can be made in times of crisis. Special procedures would be established for emergency admissions under the psychiatric\21 benefit to psychiatric hospitals or inpatient units of general hospitals, as specified in Sec. 441.152(c). Continued coordination and case management are vital in assuring that needed educational/vocational services are available in the community since these services are often critical in forestalling the need for repeated inpatient mental health treatment. If a Medicaid eligible patient requires an emergency admission to a psychiatric hospital or psychiatric inpatient unit of a general hospital, we would require that hospital staff assess the patient's condition and certify the need for inpatient care and then initiate appropriate treatment as soon as possible following admission. If an individual does not apply for Medicaid until after admission, the assessment and certification of the need for inpatient care would be made by hospital or facility staff within 7 days following the application for Medicaid. The formal inpatient plan of treatment developed in accordance with proposed Sec. 483.202(b) would have to be implemented within 7 days following admission or application for Medicaid if the individual remains in the hospital that long. The inpatient plan would need to be compatible with the individual's comprehensive services plan developed as specified in Sec. 441.45(b). No emergency admissions would be allowed for psychiatric residential treatment facilities (PRTFs). PRTFs provide less medically intensive and less extensive services than psychiatric hospitals or psychiatric units of general hospitals and are not generally equipped or staffed to deal with acute situations; if an acute situation arises during a PRTF stay, the patient would generally need to be transferred to an acute care facility. We would revise Sec. 441.153, Team certifying need for services, concerning the team that makes the certification that inpatient care is necessary, by deleting the requirement that different types of teams make the certification depending on when the individual becomes eligible for Medicaid. We instead propose that, whenever possible, the certification would be made by a team composed of representatives of the agencies providing services to the individual in order to ensure that these services are coordinated and that all possible alternatives to inpatient care are considered. The stress placed on interdisciplinary planning in this regulation is based on the premise that inpatient psychiatric services should be used only when medically necessary, and that those who are responsible for provision of all services to mentally ill individuals will arrange services in the individual's best interest, and arrange for services in the community whenever possible. When inpatient psychiatric care is provided, the stay should be as brief as possible, and focused on improving the individual's condition as quickly as possible to the point that he or she can be maintained with community-based services. Although it may be difficult to arrange for the necessary interagency coordination in States that have not already developed a coordinated approach, it is counterproductive to provide services in a fragmented manner that does not recognize the total service needs of the child or adolescent. Even when a State is not able to utilize interagency teams for certification of the need for inpatient care upon the effective date of this regulation, we expect that all States will move toward improving coordination of interrelated services. If inpatient psychiatric care is determined to be necessary, an interdisciplinary approach would also ensure that all service providers are aware of the need to arrange for or to accommodate service delivery in the new setting. The school system, for example, will need to arrange for or coordinate the provision of educational services in the inpatient setting. We would not require that team members meet in person to discuss cases if they find it more convenient to communicate via a teleconference or other means. We would retain the regulatory requirement for physician participation in the certification process (Sec. 441.153(c)(1)), consistent with section 1905(h) of the Act, which requires that the team certifying the need for care include a physician. The physician may be a representative of one of the service agencies. The team members must generally be independent, i.e., they may not be employees of the inpatient facility being considered for admission of the individual. If the inpatient facility is a public facility, an individual who is employed by the governmental component responsible for administration of the inpatient facility would not be considered independent. If inpatient care is required on an emergency basis, however, or the individual applied for Medicaid after admission, certification may be made by employees of the inpatient facility. In some States, it may not currently be feasible to use service agency representatives to form the review team. HCFA plans to provide guidance on this issue in the State Medicaid Manual. In such circumstances, the State would need to arrange for another type of review group. The State could establish its own review teams or contract with an independent review organization to determine whether admissions are necessary. An organization's team would need to meet any State registration requirements and would have to have physician participation in the determination of the necessity of inpatient psychiatric services, as required by statute. These teams or organizations would also be required to be aware of and consider the total service needs of each individual (Sec. 441.153). The rules in Secs. 441.154 and 441.155 concerning ``active treatment'' and ``plan of care'' would be revised and incorporated into the rules concerning conditions of participation at Sec. 483.202. We believe that it is important to incorporate these critical requirements into a condition of participation so that they will be subject to survey procedures. These requirements are discussed in a later section of this preamble. Section 441.156, Team developing individual plan of care, would be deleted. The process for developing the inpatient plan of treatment would be specified in Sec. 483.202(b), Active treatment program. A new Sec. 441.158, Care settings, would be added to describe the settings to be used for providing this inpatient benefit. One setting is a psychiatric hospital, the setting that has been authorized under the statute since the psychiatric\21 benefit was first established. We would specify psychiatric units in general hospitals as a second setting that States can use to provide acute care. Acute psychiatric care could be provided in either of these settings when the need for such care is certified as specified in Sec. 441.152. These settings would be used when an individual has an episode for which acute care is required, and when it is determined that this most restrictive type of care is necessary to stabilize the patient's acute condition. A third possible setting for the psychiatric\21 benefit would be a PRTF. The PRTF would be a new category of institutional provider under the Medicaid program and would be limited to the provision of the psychiatric\21 benefit under section 1905(a)(16) of the Act. PRTFs would provide care when an individual does not require acute care, but does require supervision and active treatment on a 24-hour inpatient basis to attain a level of functioning that allows subsequent treatment in a less restrictive setting. The PRTF setting is being specified as a new category of Medicaid provider in order to establish an alternative inpatient setting which provides care more similar to community-based care than the care provided in psychiatric hospitals or general hospitals. To ensure that PRTFs are community-oriented, we propose to require that these facilities coordinate their educational activities with school curricula in their communities (Sec. 483.212(a)(3)). In developing this proposed rule we considered the possibility of limiting the size of facilities to 30 or fewer beds in order to enable the facilities to be more appropriate in a community setting, but we are not including a proposed limit in the proposed rule. We nevertheless welcome comments and suggestions on this subject. The certification of need process for PRTF care is described in Sec. 441.152 (a) and (b). We are proposing to establish the requirements for PRTFs in Secs. 483.210 through 483.224 of the regulations in subpart F of part 483. The PRTF would be an additional optional setting for States that choose to provide this inpatient benefit. States that do not include PRTFs as providers under the psychiatric\21 benefit would still have to provide this type of care when determined to be necessary by an EPSDT screen. If such a State does not have freestanding PRTFs, a section of a general hospital or psychiatric hospital that has been certified as a PRTF can provide these residential services. Any State that elects to provide the psychiatric\21 benefit would be required, at a minimum, to provide these services in a psychiatric hospital or in a psychiatric unit in a general hospital and to have PRTF services available at least when required under EPSDT. The maintenance of effort provision in section 1905(h)(2) of the Act is implemented in Sec. 441.180 of the regulations. The Medicaid statute provides that a State's maintenance of effort computation, which would demonstrate that the State continues to provide the same level of funding for these services that it did before it began to receive FFP, is to be based on data from 1971, the year before this provision was enacted. We recognize that the statute is obsolete in this regard and we have requested a technical amendment to update this provision, but the current regulatory maintenance of effort requirement must remain in effect until a statutory amendment is enacted. It is not necessary, however, for States that currently offer the psychiatric\21 benefit to again demonstrate maintenance of effort if they wish to modify the State plan option to include PRTFs and/or hospital psychiatric units as providers of the psychiatric\21 benefit. We would add a new Sec. 441.160, Payment, that would specify the condition of payment for the psychiatric\21 benefit. For payment purposes, we propose to add PRTF services to the long-term care facility services definition in Sec. 447.251(c). In addition, we propose to apply the payment principles specified in Sec. 447.250 (a) through (c) to all providers of the psychiatric\21 benefit. B. Requirements for Participation for Facilities We propose to establish standards in subpart F of part 483 for all facilities and units that wish to participate in Medicaid as providers of the psychiatric\21 benefit. The proposed requirements relating to active treatment and the inpatient plan of treatment would apply to psychiatric hospitals and psychiatric units in general hospitals that provide the psychiatric\21 benefit, as well as to PRTFs. In Sec. 483.202, Active treatment program, we propose to require that the facility provide treatment designed to enable the individual to achieve sufficient stability to progress to outpatient care, and to attain the objectives specified in the inpatient plan of treatment that would be required in Sec. 483.202(b). Section 483.202(b), Inpatient plan of treatment, would require that an interdisciplinary team, which includes a facility staff physician and at least one other professional staff person, develop the inpatient plan of treatment which specifies the interventions to be provided for the individual. We would require that the inpatient treatment plan include specific measurable treatment objectives and timeframes for meeting these objectives. In addition, we would require that inpatient mental health services be coordinated with any other services being provided under the individual's comprehensive services plan. The interval for review of inpatient care by the review team in acute care psychiatric\21 providers would be set at 7 days after admission and every 7 days thereafter. In a PRTF, reviews would be required every 7 days in the initial month of stay; after the first month, reviews would be required at monthly intervals. We do not believe that longer periods should elapse before the treatment modalities being used are assessed for their effectiveness. Any necessary changes should be made as soon as possible in order to make certain that discharge occurs at the earliest possible time. C. PRTF Conditions of Participation In developing the proposed requirements for PRTFs, we have tried to allow flexibility for providers whenever possible, and to avoid requiring specific documentation of administrative procedures. We recognize that policies and procedures relating to such matters as personnel and admissions are generally necessary but we believe that facilities that can meet the requirements specified in this proposed rule can develop these administrative procedures without additional Federal requirements. We have made an effort to minimize the imposition of any paperwork burdens. Facilities meeting all the requirements in subpart F of part 483 would be qualified as PRTFs to provide the psychiatric\21 benefit. We would require that facilities protect and promote the rights of each resident, as specified in Sec. 483.211, Resident rights. We would require that these providers meet applicable licensure laws in States that have established licensure requirements for this type of facility. This requirement would be specified in Sec. 483.212(a)(1), Licensure and other laws. Because it is important that the children and adolescents in the facility maintain their educational development while they are in the facility, we would require in Sec. 483.212(a)(2) that the facility coordinate its educational activities with school curricula in the community. We would specify at Sec. 483.212(a)(3) that providers would be expected to meet the regulations issued by the Department of Health and Human Services relating to nondiscrimination, protection of human subjects, and fraud and abuse, as specified in 45 CFR parts 46, 80, and 84 and 42 CFR part 455. The disclosure of ownership and control requirements in section 1126 of the Act would be applicable to these providers. The requirements for provider agreements under section 1902(a)(27) of the Act would also be applicable. We would also require that PRTFs have a governing body which would appoint an administrator to be responsible for the general management of the facility. These requirements would be specified in Sec. 483.212(b), Administrative structure. There would be a general requirement relating to competence, academic credentials, and administrative experience. We invite comments on whether these requirements should be more specific, and if so, what the requirements should be. We propose to require that the facility designate a clinical director who is at least board-eligible in psychiatry and has experience in child and adolescent mental health. The clinical director would be responsible for the implementation of each resident's inpatient treatment plan and for the coordination of all medical/ psychiatric care in the facility. We would require that all facilities have written procedures to use for all potential emergencies, such as fire, severe weather, and missing residents (proposed Sec. 483.218(b)). New employees would be trained in these procedures and all staff would participate in review drills. The facility would be required to have written transfer agreements with one or more hospitals which assure that a resident can be transferred to an appropriate setting in a timely manner when transfer is necessary for more intensive psychiatric care or for medical treatment (proposed Sec. 483.220(a)). Necessary information relating to the resident's care would be exchanged at the time of transfer. The facility would also be required to have an effective program for infection control (proposed Sec. 483.218(c)). Each resident's dignity would be respected and facilities would be precluded in Sec. 483.216, Facility practices and resident behavior, from imposing any physical restraints or administering any psychoactive drugs for purposes of discipline or convenience. All forms of abuse would be forbidden, including verbal, mental, sexual, and physical abuse. Any grouping of residents would be planned to protect the safety and promote the treatment of all group members. The facility would be required to report any alleged abuses to the administrator or to other officials in accordance with State law. Facilities would have to retain evidence of a thorough investigation. Concerning staff qualifications, we would require in Sec. 483.214(b) that the facility employ the professional, administrative and support staff necessary to implement the inpatient plans of treatment and to carry out the applicable regulatory requirements. Professional staff could include qualified psychiatrists and other physicians, clinical psychologists, psychiatric nurses, social workers, substance abuse specialists, other health professionals and ancillary staff. We would require that all staff be competent and that professional staff be appropriately licensed, certified, or registered when this is required under State law. We would further require that professional staff not be under sanctions imposed for infractions as specified in sections 1156, 1128, or 1892 of the Act. Services provided by nonemployees would be subject to a written agreement that specifies the facility's and contractor's responsibilities. We invite comments as to whether this section should contain more specific requirements concerning personnel qualifications. We would require that responsible direct care staff be on duty and awake on a 24-hour basis to take prompt action in case of injury, illness, fire, or other emergency in a facility housing residents who are aggressive, assaultive, or security risks (Sec. 483.214(a)). The facility would be required to maintain clinical records on each resident and retain the records for at least 5 years or any period of time required by State law. The material in the records would remain confidential except under specified circumstances (Sec. 483.212(d)). We would also require that facilities disclose ownership and control in accordance with Sec. 455.104 (Sec. 483.212(c)). A facility would also have to notify the Medicaid agency within 5 days if there is a change in the facility's ownership or administrator or clinical director. A facility would be required to maintain a quality assurance program which monitors care provided in the facility and to cooperate with an authorized program of independent medical evaluation, including evaluation of each resident's need for facility care (proposed Sec. 483.212(e)). PRTFs would be one type of psychiatric facility, and would therefore be subject to the ``inspection of care'' provisions specified in subpart I of 42 CFR part 456. Section 483.218, Safety provisions, contains the provisions we propose to ensure general resident safety. We propose to require that PRTFs meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (Sec. 483.218(a)). If these code provisions would result in unreasonable hardship upon facilities classified for health care occupancy only, they could be waived by the State survey agency, but only if the waiver does not adversely affect the health and safety of residents or staff. Refuse, including any toxic wastes generated in the facility, would have to be disposed of in accordance with applicable Federal, State, and local laws (Sec. 483.218(d)). PRTFs would be required in Sec. 483.222, Dietary services, to provide dietary services that ensure that each resident receives a diet that meets the daily nutritional needs of the resident. If a qualified dietitian is not employed on a full time basis, the facility would be required to designate a person to serve as the director of food service. The regulation would require menu planning, and sanitary food storage, preparation, and distribution methods. We would require that facilities provide sufficient space in the dining and program areas to enable staff to provide the services specified in each resident's inpatient plan of treatment (Sec. 483.224(a)). Residents' bedrooms would be required to accommodate no more than four residents, and to measure at least 80 square feet per resident in multiple resident bedrooms and at least 100 square feet in single resident rooms (Sec. 483.224(b)). Variations in these accommodation and size requirements could be allowed in individual cases when a physician providing direct care documents that the variations are required by special needs of residents and will not adversely affect residents' health and safety. Bedrooms would have to have direct access to a corridor and to have at least one window. Appropriate beds, bedding and furniture, and accessible closet space would be required. Each resident room would need to be equipped with or located near toilet and bathing facilities. Dining and activities rooms would have to be well lighted and ventilated, with nonsmoking areas identified if smoking is allowed in the facility. It is possible that, in the future, State and Federal laws may prohibit smoking in these facilities. The facility would have to ensure that there is a sanitary and orderly interior, including clean bath and bed linens. The facility would be required to establish procedures to ensure that water is available to essential areas when there is a loss of normal water supply. Comfortable temperature and sound levels would have to be maintained, and adequate ventilation would be required. The facility would have to maintain an effective pest control program. We believe that our proposed facility standards are reasonable and adequate for residential treatment facilities. We welcome comments and recommendations for modifications of these proposed requirements from the general public and especially from those who have had experience in providing these services and from residents and families of residents. D. Technical Revision General provisions relating to Medicaid services are included in 42 CFR part 440. Section 440.160, Inpatient psychiatric services for individuals under age 21, currently contains an abbreviated definition of the psychiatric\21 benefit. This abbreviated definition has caused confusion because it does not make it clear that this benefit must always be provided in a psychiatric facility. Therefore, we propose to revise the definition in this section to list the three possible settings and to cross refer to the detailed requirements in subpart D of part 441 and subpart F of part 483. VI. Collection of Information Regulations at Sec. 441.152 contain collection of information requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). The information collection requirements concern resident information. The respondents who will provide the information include physicians and medical personnel. Public reporting burden for this collection of information is estimated to be 30 minutes per respondent. A notice will be published in the Federal Register when approval is obtained. Organizations and individuals desiring to submit comments on the information collection and recordkeeping requirements should direct them to the OMB official whose name appears in the ADDRESSES section of this preamble. VII. Response to Public Comments Because of the large number of items of correspondence we normally receive on a proposed rule, we are unable to acknowledge or respond to them individually. However, we will consider all comments that we receive by the date and time specified in the ``DATES'' section of this preamble to the final rule. VIII. Regulatory Impact Statement We generally prepare a regulatory flexibility analysis that is consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 through 612), unless the Secretary certifies that a proposed regulation would not have a significant economic impact on a substantial number of small entities. For purposes of the RFA, psychiatric residential treatment facilities and psychiatric hospitals are considered to be small entities. Individuals and States are not included in the definition of small entity. In addition, section 1102(b) of the Act requires the Secretary to prepare a regulatory impact analysis for any final rule that may have a significant impact on the operations of a substantial number of small rural hospitals. Such analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital with fewer than 50 beds located outside a Metropolitan Statistical area. There are various aspects of this proposed regulation that might have some cost or saving, but the net impact of all of them appears to be negligible. The establishment of the psychiatric residential treatment facility as a new category of Medicaid facility for the purposes of inpatient psychiatric care has varying impacts. On one hand, daily charges at such facilities are projected to be lower than at psychiatric hospitals. On the other hand, lengths of stay seem to be longer, probably due to the less acute, more chronic nature of the conditions they are designed to treat. However, if we assume that some recipients are currently getting inappropriate care in more expensive settings merely because of Medicaid regulations, then this regulation may save some money. This assumption, though, is impossible to verify. Also, there currently are many facilities that are not psychiatric hospitals that are currently providing these services under existing Medicaid regulations. It is not clear if their costs are higher than the proposed residential treatment facilities. It is also unclear how many of them will be able to qualify under the new regulations, and what this will do to the supply of care and its cost. In any event, it does not appear that more eligible individuals will come into the program because of this regulation. Currently, there are approximately 42,000 recipients of services under this category. As for the implementation of requirements for comprehensive programs and coordination of State authorities concerned with provision of mental health services, as well as the requirements for coordinated plans of care, they will probably increase administrative costs somewhat, but will reduce program costs by ensuring that the most appropriate and efficient form of care is utilized. The magnitude of these costs and savings is difficult to determine but probably is negligible, given the number of recipients involved. For these reasons, we are not preparing analyses for either the RFA or section 1102(b) of the Act since we have determined, and the Secretary certifies, that this proposed rule would not result in a significant economic impact on a substantial number of small entities and would not have a significant impact on the operations of a substantial number of small rural hospitals. In accordance with the provisions of Executive Order 12866, this proposed regulation was not reviewed by the Office of Management and Budget. List of Subjects 42 CFR Part 440 Grant programs--health, Medicaid. 42 CFR Part 441 Family planning, Grant programs--health, Infants and children, Medicaid, Penalties, Reporting and recordkeeping requirements. 42 CFR Part 447 Standards for payment. 42 CFR Part 483 Requirements for States and long term care facilities. 42 CFR chapter IV would be amended as set forth below: PART 440--SERVICES: GENERAL PROVISIONS A. Part 440 is amended as follows: 1. The authority citation for part 440 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). 2. Section 440.160 is revised to read as follows: Sec. 440.160 Inpatient psychiatric services for individuals under age 21. ``Inpatient psychiatric services for individuals under age 21'' means services that-- (a) Meet the requirements in subpart D of part 441 of this subchapter; and (b) Are provided in facilities that meet the applicable requirements specified in subpart F of part 483 of this chapter. PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES B. Part 441 is amended as set forth below: 1. The authority citation for part 441 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). 2. A new Sec. 441.45 is added to read as follows: Sec. 441.45 Mental health assessment and service plan. (a) The State Medicaid agency must ensure that a comprehensive assessment is made of each eligible individual who is determined by a mental health professional to be at risk of requiring inpatient mental health services in the near future. (1) At a minimum, this group would include-- (i) Those who are applicants for inpatient mental health facility services; (ii) Those determined to need inpatient mental health services on the basis of an EPSDT screen or PASARR; and (iii) Those recently discharged from an inpatient mental health facility (within the past year). (2) A State may include other groups of eligible individuals who it believes are at risk of needing inpatient treatment in the near future. (3) The assessment must accurately identify the individual's functional abilities and needs, and must take into account the following information about the individual-- (i) Current diagnoses; (ii) Prior medical and psychiatric history, including immunization status; (iii) Emotional and behavioral functional status; (iv) Psychosocial status; (v) Sensory and physical impairments; (vi) Cognitive status; and (vii) Any current drug therapy. (4) The assessment must include a determination as to whether the individual needs active treatment as defined in Sec. 483.202 of this chapter. (b) For each eligible individual who is determined to be at risk of requiring inpatient mental health treatment, as specified in paragraph (a) of this section, the State Medicaid agency must ensure that an individual comprehensive services plan is developed, implemented, and managed on an ongoing basis by a team composed of representatives from all State/local agencies involved in providing care for that individual or responsible for ensuring that needed care is provided. (1) The individual must be included in the process of developing the comprehensive services plan. (2) If the individual is under age 18 or has been found by a court to be incompetent, his or her parents or legal guardian must also be involved. (3) The team must be able to confer informally on a timely basis to make decisions concerning possible inpatient admission in times of crisis. (c) The team that develops the comprehensive services plan must monitor the plan's implementation to ensure that all services are coordinated. 3. Section 441.106 is revised to read as follows: Sec. 441.106 Comprehensive mental health program. If the plan includes services for individuals age 65 and over in institutions for mental diseases, the State must have a comprehensive mental health program. (a) The program must cover all ages, and include joint monitoring, review and evaluation with State mental health, education, vocational rehabilitation, criminal justice and social service representatives, of the allocation and adequacy of mental health services within the State; (b) The State Medicaid agency must prepare an annual progress report, with participation by the other State agency representatives described in paragraph (a) of this section. (1) The State Medicaid agency must submit the annual progress report to the HCFA Regional Administrator within 3 months after the end of the fiscal year. (2) The annual progress report must include a plan for improvements to be made in the next year. (3) The requirement for an annual progress report may be satisfied by the development of a comprehensive mental health services plan which meets the requirements of section 1912 of the Public Health Service Act. A copy of the plan submitted to PHS must be submitted to the HCFA Regional Administrator. 4. The title of subpart D is revised to read as follows: Subpart D--Inpatient Psychiatric Services for Individuals Under Age 21 5. Section 441.150 is revised to read as follows: Sec. 441.150 Basis and purpose. This subpart specifies the applicable requirements if a State elects to provide inpatient psychiatric services to individuals under age 21, as authorized under sections 1905(a)(16) and 1905(h) of the Act. 6. Section 441.151 is revised to read as follows: Sec. 441.151 General requirements. Inpatient psychiatric services for individuals under age 21 must be-- (a) Provided under the direction of a physician who is at least board eligible in psychiatry and has experience in child/adolescent mental health; (b) Provided in one or more of the care settings specified in Sec. 441.158; (c) Provided in accordance with an individual comprehensive services plan required by Sec. 441.45(b); (d) Provided before the individual reaches age 21 or, if the individual was receiving the services immediately before the individual reached age 21, before the earlier of the following-- (1) The date the individual no longer requires the services; or (2) The date the individual reaches age 22; and (e) Certified in writing to be necessary in the setting in which it will be provided (or is being provided in emergency circumstances), in accordance with Sec. 441.152. 7. In Sec. 441.152, paragraphs (a) and (b) are revised, and new paragraphs (c) and (d) are added to read as follows: Sec. 441.152 Certification of need for services. (a) The team or organization specified in Sec. 441.153 must-- (1) Make the comprehensive assessment as required in Sec. 441.45(a) before determining whether inpatient services are necessary; and (2) If it is determined that inpatient benefits encompassed by this benefit are necessary, certify in writing before the individual is admitted that inpatient services are necessary for treatment of the individual's condition. The certification must specify whether hospital or psychiatric residential treatment facility services are required. (b) The written certification must include: (1) The clinical evidence that justifies the necessity for the specified level of inpatient care; and (2) The basis for determining that inpatient services will improve the condition to the extent that these services will no longer be necessary. (c) If an admission must be made to a psychiatric hospital or psychiatric unit of a hospital on an emergency basis because there is imminent danger that the individual will do harm to himself or herself or to another person, hospital staff must perform an assessment, a hospital physician must certify the need for acute inpatient psychiatric services, and the hospital must implement an initial treatment plan. Hospital staff must also establish and implement the inpatient treatment plan required in Sec. 483.202(b) of this chapter. (d) The procedures specified in paragraph (c) of this section will also be followed, within 7 days following the date of application, for individuals who do not apply for medical assistance before admission. 8. Section 441.153 is revised to read as follows: Sec. 441.153 Composition of certifying team or organization. (a) The team that certifies the need for inpatient psychiatric care as required under Sec. 441.152 (a) and (b) must-- (1) Include at least one physician who is at least board eligible in psychiatry and has experience in the diagnosis and treatment of mental illness in children or adolescents; (2) Except as indicated in paragraph (b) of this section, include a representative from each of the State and local agencies that are providing services directly or are responsible for ensuring that needed services are provided to the individual, such as educational/ vocational, social welfare, medical, psychiatric and juvenile justice services; and (3) Be composed of individuals who are not employed by the inpatient facility being considered, or by the agency component responsible for providing inpatient care, except as specified in Sec. 441.152 (c) and (d). (b) If an interagency team is not feasible, another team which includes a physician, established by the State or an independent review organization contracted by the State, may certify the need for inpatient services if the organization meets any registration requirements that the State may have for such organizations. This alternative team must be aware of the complete array of service needs of the individual. (c) The certifying team or organization must involve the resident and his or her parents or legal guardian in the determination process. Sec. 441.154 [Reserved] Sec. 441.155 [Reserved] Sec. 441.156 [Reserved] 9. Sections 441.154, 441.155 and 441.156 are removed and reserved. 10. New Secs. 441.158 and 441.160 are added under subpart D to read as follows: Sec. 441.158 Care settings. (a) Types of settings. Inpatient psychiatric services for individuals under age 21-- (1) Must be provided in a psychiatric hospital that meets the requirements of Secs. 482.60 and 483.202 of this chapter, or in a psychiatric unit of a hospital that meets the requirements in subparts B and C of part 482, and Sec. 483.202 of this chapter; and (2) At the option of the State, may also be provided in a psychiatric residential treatment facility that meets the requirements in subpart F of part 483 of this chapter. All States must provide psychiatric residential treatment facility care when it is required as a result of an EPSDT screen. (b) Limitations on provision of care. (1) Psychiatric hospital or unit. Inpatient services in a psychiatric hospital or a psychiatric unit of a hospital are provided for an individual who has a severe acute episode of a psychiatric disorder which requires medical supervision and treatment on a 24-hour-a-day basis. The services must include intensive individualized treatment to stabilize the acute condition so that the individual can be discharged as soon as possible to a less restrictive type of care. (2) Psychiatric residential treatment facility. Inpatient care in a psychiatric residential treatment facility may be provided when an individual does not require acute care but requires supervision and treatment on a 24- hour-a-day basis to attain a level of functioning that allows subsequent treatment on an outpatient basis. Sec. 441.160 Payment. Payment for inpatient psychiatric services for individuals under age 21 must be made in accordance with the principles specified in Sec. 447.250 (a) through (c) of this subchapter. PART 447--PAYMENT FOR SERVICES C. Part 447 is amended as follows: 1. The authority citation for part 447 continues to read as follows: Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 1302). 2. Section 447.251 is amended by revising the definition of ``long- term care facility services'' to read as follows: Sec. 447.251 Definitions. * * * * * Long-term care facility services means intermediate care facility services for the mentally retarded (ICF/MR), nursing facility (NF) services, and psychiatric residential treatment facility (PRTF) services. * * * * * PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES E. Part 483 is amended as follows: 1. The authority citation for part 483 is revised to read as follows: Authority: Secs. 1102, 1819(a)-(f), 1905(c) and (d), and 1919(a)-(f) of the Social Security Act (42 U.S.C. 1302, 1395i-3(a)- (f), 1396d(c) and (d), and 1396r(a)-(f)). Subpart E--[Reserved] 2. Subpart E is removed and reserved. 3. A new subpart F containing Secs. 483.200 through 483.224 is added to read as follows: Subpart F--Conditions of Participation for Providers of Inpatient Psychiatric Services for Individuals Under Age 21 Sec. 483.200 Basis and scope of subpart F. 483.202 Condition of participation: Active treatment program. 483.204 Requirements for psychiatric hospitals. 483.205 Requirements for psychiatric units of hospitals. Conditions of Participation for Psychiatric Residential Treatment Facilities 483.210 General requirements for psychiatric residential treatment facilities. 483.212 Condition of participation: Administration. 483.214 Condition of participation: Facility staffing. 483.215 Condition of participation: Resident rights. 483.216 Condition of participation: Facility practices and resident behavior. 483.218 Condition of participation: Safety provisions. 483.220 Condition of participation: Health services. 483.222 Condition of participation: Dietary services. 483.224 Condition of participation: Space and equipment. Subpart F-- Conditions of Participation for Providers of Inpatient Psychiatric Services for Individuals Under Age 21 Sec. 483.200 Basis and scope of subpart F. (a) Basis. Section 1905(h) of the Act provides that the inpatient psychiatric services benefit for individuals under age 21 includes inpatient services which are provided in an institution (or distinct part thereof) which is a psychiatric hospital as defined in section 1861(f) or in another inpatient setting that the Secretary has specified in regulations. Section 1905(h) also specifies that a team of physicians and other personnel qualified to make determinations about mental health treatment must determine that inpatient care is necessary for the individual; and that these services must-- (1) Involve active treatment that meets standards which may be specified in regulations; and (2) Reasonably be expected to improve the individual's condition to the extent that inpatient psychiatric services will no longer be necessary. (b) Scope. This subpart contains the requirements that a facility must meet in order to qualify as a Medicaid provider of psychiatric inpatient services for individuals under age 21. These requirements serve as the basis for survey activities for the purpose of determining whether a facility meets the requirements for participation in Medicaid. All providers of this benefit must also meet the requirements in subpart D of part 441 of this chapter. Sec. 483.202 Condition of participation: Active treatment program. (a) Standard: Active treatment requirement. The inpatient provider must ensure that each individual receives a continuous program of individualized psychiatric treatment that is designed to enable the individual to achieve sufficient stability to progress to outpatient care, and to attain the treatment objectives specified in the inpatient plan of treatment specified in paragraph (b) of this section. These services must be consistent with implementation of the individual comprehensive services plan required in Sec. 441.45(b) of this chapter. (b) Standard: Inpatient plan of treatment. The inpatient provider must-- (1) Ensure that an interdisciplinary team, including a facility staff physician and at least one other professional staff person, reviews the assessment data collected as specified in Sec. 441.45(a) of this chapter, and updates the data as necessary. The team then immediately initiates appropriate treatment. (2) Ensure that within 7 days after admission, the team develops the inpatient plan of treatment for each institutionalized individual which specifies the interventions needed to improve the individual's psychiatric condition to the extent that inpatient care is no longer necessary. This general active treatment goal must be expressed in terms of specific measurable treatment objectives for the individual, and include the treatment modalities to be used and the target date by which the individual will achieve each objective. (3) Ensure that the plan includes an estimated discharge date and post-discharge plans which specify the coordination required with the family or guardian, and the school/vocational and community services needed to ensure continuity of care. (4) Ensure that the interdisciplinary team reviews inpatient progress at least every 7 days, starting from the date of admission, except that in PRTFs, after the first month, reviews must be done at least once a month. During a review, the team must determine whether-- (i) Inpatient services continue to be required; (ii) The stated objectives for attaining stabilization are being achieved; and (iii) Any changes are needed in the plan. (5) Ensure that the individual's assessment is updated and that the inpatient plan of treatment is revised as needed based on the results of the progress reviews specified in paragraph (b)(4) of this section. (6) Report results of the progress reviews to the team responsible for the individual's comprehensive services plan (as specified in Sec. 441.45(c) of this chapter) no later than the day following the review. (7) Provide that the development and review of the inpatient plan of treatment specified in this section satisfies the utilization control requirements for-- (i) Recertification under Secs. 456.60(b), 456.160(b), 456.260(b) and 456.360(b) of this chapter; and (ii) Establishment and periodic review of the plan of care under Secs. 456.80, 456.100, 456.200 and 456.300 of this chapter. Sec. 483.204 Requirements for psychiatric hospitals. A psychiatric hospital providing the psychiatric inpatient benefit for individuals under age 21 must meet the requirements specified in Secs. 482.60 of this chapter and 483.202. Sec. 483.205 Requirements for psychiatric units of hospitals. A psychiatric unit of a hospital providing the psychiatric inpatient benefit for individuals under age 21 must meet the requirements specified in Sec. 483.202. The hospital must meet the requirements specified in subparts B and C of part 482 of this chapter. Conditions of Participation for Psychiatric Residential Treatment Facilities Sec. 483.210 General requirements for psychiatric residential treatment facilities. A psychiatric residential treatment facility providing the psychiatric inpatient benefit for individuals under age 21 must meet the requirements specified in Sec. 483.202, and 483.212 through 483.224. Sec. 483.212 Condition of participation: Administration. (a) Standard: Licensure and other laws. (1) When State or local law requires licensure of this type of medical facility, the facility must be licensed. (2) The facility must coordinate its educational activities with school curricula in the community. (3) The facility must support and protect the fundamental human, civil, constitutional, and statutory rights of each patient, and must meet the applicable provisions of other HHS regulations, including but not limited to those pertaining to nondiscrimination on the basis of race, color, or national origin (as specified in 45 CFR part 80), nondiscrimination on the basis of handicap (as specified in 45 CFR part 84), protection of human subjects of research (as specified in 45 CFR part 46), and fraud and abuse (as specified in 42 CFR part 455). Although these regulations are not considered requirements under this part, violation may result in the termination or suspension of, or the refusal to grant or continue payment of Federal funds. (b) Standard: Administrative structure. (1) The facility must have a governing body, or designated person(s) functioning as a governing body, that is legally responsible for establishing and implementing policies regarding the management and operation of the facility. (2) The governing body must appoint an administrator who is responsible for the general management of the facility. The administrator must have appropriate academic credentials and administrative experience in psychiatric treatment settings for children and adolescents, and must be responsible for the fiscal and administrative aspects of facility management as necessary to support the facility's clinical program. (3) The facility must designate as clinical director a physician who is at least board-eligible in psychiatry and has experience in providing child and adolescent mental health services. The clinical director is responsible for the implementation of each resident's clinical plan of care and for the coordination of all medical/ psychiatric care in the facility. (c) Standard: Disclosure of ownership. The facility must comply with the disclosure requirements of Sec. 455.105 of this chapter. The facility must provide written notice to the State survey agency within 5 working days if a change occurs in-- (1) Persons with an ownership or control interest, as defined in Sec. 455.101 of this chapter; or (2) The facility's administrator or clinical director. (d) Standard: Clinical records. The facility must develop and maintain a separate clinical record on each resident in accordance with professional standards. Records must be complete, accurate, accessible and organized. (1) Clinical records must be retained for the period of time required by State law or 5 years from the date of discharge when there is no requirement in State law. (2) The facility must assure that the clinical record information is not lost, destroyed, or put to unauthorized use. (3) The facility must assure the confidentiality of all information contained in the resident's record, except when release is required by-- (i) Transfer to another health care institution; (ii) State and/or Federal law; (iii) Third party contract; or (iv) The resident. (4) The clinical record must contain information which identifies the resident, documents the comprehensive assessment, the inpatient plan of treatment, the services received, notes on progress toward the objectives in the inpatient plan of treatment and any revision of the plan of treatment made following review. (e) Standard: Quality assurance. The facility must develop and implement an ongoing quality assurance program to monitor and evaluate the quality of patient care, pursue opportunities to improve care, and correct identified problems. (f) Standard: Independent medical evaluation. A facility must cooperate with a medical evaluation and an inspection of care of residents in the facility, including evaluation of each resident's need for facility care when the evaluation has been authorized by State or Federal government. Sec. 483.214 Condition of participation: Facility staffing. The facility must have enough competent and appropriately qualified health care professional, administrative and support staff to provide active treatment through implementation of the inpatient plan of treatment for each resident and to carry out other facility requirements. The facility is responsible for assuring that all services are effective, timely, and meet the needs of residents. (a) Standard: Staffing status. (1) In a facility that houses residents who are aggressive, assaultive or security risks, responsible direct care staff must be on duty and awake on a 24-hour basis to take prompt action in case of injury, illness, fire or other emergency. (2) In a facility that does not house residents who are aggressive, assaultive or security risks, a responsible direct care staff person must be on duty on a 24-hour basis, but need not remain awake when residents are sleeping. (3) If any resident is present in the facility, a direct care staff person must be present. If all residents are away from the facility during the day, a staff member must be available by telephone. (b) Standard: Professional staff. Staff may include qualified psychiatrists and other physicians, clinical psychologists, psychiatric nurses, social workers, substance abuse specialists, and other health care professionals and ancillary staff. When licensure, certification, or registration is required under State law, professional staff must meet these requirements. Professional staff must not be under a sanction imposed in accordance with sections 1156, 1128, or 1892 of the Act. (c) Standard: Contracts. Any professional or other services that are furnished to facility residents by persons who are not employed by the facility must be furnished under a written contract that specifies the contractor's responsibilities. Sec. 483.215 Condition of participation: Resident rights. A facility must protect and promote the rights of each resident, with special consideration for residents who are emancipated and have no parent or legal guardian, including each of the following rights: (a) Access and visits. A resident has a right to see family members and legal guardians and to have visitors from outside the facility. (b) Consultation. The resident has the right to be consulted as much as possible about his or her treatment. (c) Complaints. The resident has the right to file complaints with the facility administrator or with State officials concerning facility conditions or treatment. (d) Independent examination. The resident has a right to have independent medical or psychological examination. (e) Discharge planning. A resident has a right to participate in his or her discharge planning. Sec. 483.216 Condition of participation: Facility practices and resident behavior. Each resident's care must be provided in a manner that promotes and maintains his or her dignity. (a) Standard: Restraints. The facility may not impose any physical restraints or administer any psychoactive drugs for purposes of discipline or convenience. No restraints may be used which are not required to treat the resident's psychiatric symptoms and specified in the inpatient plan of treatment. (b) Standard: Freedom from abuse. The resident has the right to be free from verbal, sexual, physical and mental abuse, corporal punishment and involuntary seclusion. The facility must develop written policies that prohibit mistreatment, neglect, or abuse of residents and ensure that the policies are implemented. (1) The facility must-- (i) Not use verbal, mental, sexual or physical abuse, corporal punishment, or involuntary seclusion; and (ii) Not employ or contract with individuals who have a prior employment or personal history of abusing, neglecting or mistreating individuals, or have been found guilty of any of these acts in a court of law. (2) The facility must not house residents who have aggressive tendencies, or may otherwise be dangerous, in close physical proximity with vulnerable residents who are prone to be victimized. Any resident grouping must be planned to protect the safety and promote the treatment of all members of the group. (3) The facility must ensure that all alleged violations involving mistreatment, neglect or abuse, including injuries of unknown source, are reported immediately to the administrator of the facility and to any other officials specified in State law. (4) The facility must have evidence that all alleged violations are thoroughly investigated, and must take appropriate action to prevent further abuse during the period of the investigation. (5) The results of all investigations must be reported to the administrator or to his or her designated representative and to other officials in accordance with State law within 5 working days of the report of the incident. If the alleged violation is verified, the administrator must take appropriate corrective action. (c) Standard: Drug therapy. The facility must not use drugs in doses that interfere with the resident's daily living activities. (1) When drugs are used for control of inappropriate behavior, they must be used only as an integral part of the resident's plan of care that is directed specifically toward the reduction of and eventual elimination of the behaviors for which the drugs are employed. (2) Drugs used for control of inappropriate behavior must not be used unless it is evident that the harmful effects of the behavior clearly outweigh the potentially harmful effects of the drugs. (d) Standard: Resident work. The facility must ensure that residents are not compelled to perform services for the facility. If a resident chooses to perform work for the facility, compensation for the services must be made at prevailing wage levels. Sec. 483.218 Condition of participation: Safety provisions. The facility must be designed, constructed, equipped, and maintained to protect the health and safety of the residents. If a circumstance develops that poses a significant threat to the health or safety of facility residents, the facility must address the problem immediately and promptly advise the State survey agency of the problem and the action taken to remove the threat. (a) Standard: Fire protection--(1) General. Except as provided in paragraph (a)(2) of this section, the facility must meet the applicable provisions of either the Health Care Occupancies Chapter or the Residential Board and Care Occupancies Chapter of the Life Safety Code (LSC) of the National Fire Protection Association, 1991 edition, which is incorporated herein by reference. (2) Exceptions. For facilities that meet the LSC definition of a health care occupancy, the State survey agency may waive, for a period considered appropriate, specific provisions of the LSC if-- (i) The waiver would not adversely affect the health and safety of the residents; and (ii) Rigid application of specific provisions would result in an unreasonable hardship for the facility. (b) Standard: Emergency procedures. The facility must develop and implement written procedures to meet all potential emergencies, such as fire, severe weather, and missing residents. The facility must train all new employees in emergency procedures and periodically review the procedures. All staff members must demonstrate ability to follow the procedures. Staff emergency procedure drills must be held at least quarterly on each shift. (c) Standard: Infection control. The facility must implement an infection control program which prevents, controls, and investigates the development and transmission of communicable disease and infection. This program must ensure that appropriate immunizations are done, according to State law. (1) When a resident needs isolation to prevent the spread of infection, the facility must isolate the resident and, if necessary, transfer the resident to a hospital for diagnostic testing. (2) The facility must prohibit employees with symptoms or signs of a communicable disease or infected skin lesions from direct contact with residents or their food if direct contact will transmit the disease. (3) Personnel must handle, store, process, and transport linens so as to prevent the spread of infection. (d) Standard: Waste disposal. The facility must dispose of garbage and refuse, including any toxic waste generated at the facility, in accordance with Federal, State and local laws. (e) Standard: Pest control. The facility must maintain an effective pest control program so that the facility is free of pests and rodents. (f) Standard: Systems. The facility must maintain all essential mechanical, electrical, and other equipment in safe operating condition. Sec. 483.220 Condition of Participation: Health services. (a) Standard: Hospital services. The facility must have a written transfer agreement in effect with one or more hospitals approved for participation under the Medicaid program that reasonably assures that-- (1) A resident will be transferred from the facility to the hospital and admitted in a timely manner when transfer is medically necessary for medical care or acute psychiatric care; and (2) Medical and other information needed for care of the resident will be exchanged between the institutions, including any information needed to determine whether appropriate care can be provided in a less restrictive setting. (b) Standard: Medical services. Medical and emergency dental services must be available to each resident 24 hours a day. Sec. 483.222 Condition of participation: Dietary services. Each resident must receive a nourishing, well-balanced diet that meets the daily nutritional needs of the resident. Each resident must receive a minimum of 3 meals daily. (a) Standard: Dietitian. The facility must employ a qualified dietitian on at least a part-time or consultant basis. If a qualified dietitian is not employed on a full-time basis, the facility must designate a person to serve as the director of food service. (b) Standard: Menus. Menus must be prepared in advance and must be followed. (c) Standard: Nutrition. Each resident receives food that conserves nutritive value, flavor and appearance; is palatable, attractive and at the proper temperature, and is of sufficient quantity. Substitute food of similar nutritive value must be offered to residents who refuse standard food service. (d) Standard: Food procedures. The facility must-- (1) Procure food from sources approved by Federal, State or local authorities; and (2) Store, prepare, distribute and serve food under sanitary conditions. Sec. 483.224 Condition of participation: Space and equipment. (a) Standard: Dining and program areas. The facility must provide sufficient space and equipment in dining and program areas to enable staff to provide residents with needed services as identified in each resident's plan of care. The facility must provide one or more rooms designated for resident dining and activities. These rooms must-- (1) Be well lighted; (2) Be well ventilated, with nonsmoking areas identified if smoking is allowed in the facility; (3) Be adequately furnished; and (4) Have adequate space to accommodate all activities. (b) Standard: Resident rooms. Resident rooms must be designed and equipped for the comfort, dignity and privacy of residents. (1) Bedrooms must-- (i) Accommodate no more than four residents; (ii) Measure at least 80 square feet per resident in multiple resident bedrooms and at least 100 square feet in single resident rooms; (iii) Have direct access to an exit corridor; and (iv) Have at least one window to the outside. If the bedroom is below grade level, the window must be usable as a second means of escape by the resident occupying the room. (2) The survey agency may grant a variance to the bedroom sizes specified in paragraph (b)(1) of this section in individual cases when a physician involved in direct patient care documents that the variations are required by special needs of residents and will not adversely affect the health and safety of residents. (3) The facility must provide each resident with-- (i) A separate bed of proper size and height in the resident's room; (ii) A clean and comfortable mattress and clean bedding appropriate to the weather and climate; and (iii) Functional furniture appropriate to the resident's needs, suitable storage space and individual closet space in the resident's bedroom with clothes racks and shelves accessible to the resident. (c) Standard: Toilet facilities. Each resident's room must be equipped with or located near toilet and bathing facilities. The facility must-- (1) Provide toilet and bathing facilities appropriate in number, size and design to meet the needs of the residents; and (2) Provide for individual privacy in toilets, bathtubs and showers. (d) Standard: Other environmental conditions. The facility must-- (1) Ensure a safe, clean, functional, comfortable and homelike environment for residents and staff, including clean bath and bed linens; (2) Establish procedures to ensure that water is available to essential areas when there is a loss of normal water supply; (3) Maintain comfortable temperature levels; (4) Maintain comfortable sound levels; and (5) Have adequate outside ventilation by means of windows or mechanical ventilation or a combination of the two. Subpart G--[Reserved] 4. Subpart G is reserved. Subpart H--[Reserved] 5. Subpart H is reserved. (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program) Dated: July 5, 1994. Bruce C. Vladeck, Administrator, Health Care Financing Administration. Dated: October 24, 1994. Donna E. Shalala, Secretary. [FR Doc. 94-28318 Filed 11-16-94; 8:45 am] BILLING CODE 4120-01-P --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-28318. Public record. Not legal advice.