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services being provided, and the basis for charges and claims against the United States for services provided CHAMPUS beneficiaries;

(iii) Examining reports of evaluations and inspections conducted by federal, state and local government, and private agencies and organizations;

(iv) Conducting on-site inspections of the facilities of the PHP and interreviewing employees, members of the staff, contractors, board members, volunteers, and patients, as required;

(v) Audits conducted by the United States General Account Office.

(F) Other requirements applicable to PHPs. (1) Even though a PHP may qualify

CHAMPUS-authorized provider and may have entered into a participation agreement with CHAMPUS, payment by CHAMPUS for particular services provided is contingent upon the PHP also meeting all conditions set forth in section 199.4 of this part.

(2) The PHP shall provide patient services to CHAMPUS beneficiaries in the same manner it provides inpatient services to all other patients. The PHP may not discriminate against CHAMPUS beneficiaries in any manner, including admission practices, placement in special or separate wings or rooms, or provisions of special or limited treatment.

(3) The PHP shall assure that all certifications and information provided to the Director, OCHAMPUS incident to the process of obtaining and retaining authorized provider status is accurate and that is has no material errors or omissions. In the case of any misrepresentations, whether by inaccurate information being provided or material facts withheld, authorized provider status will be denied or terminated, and the PHP will be ineligible for consideration for authorized provider status for a two year period.

(xiii) Hospice programs. Hospice programs must be Medicare approved and meet all Medicare conditions of participation (42 CFR part 418) in relation to CHAMPUS patients in order to receive payment under the CHAMPUS program. A hospice program may be found to be out of compliance with a particular Medicare condition of participation and still participate in the

CHAMPUS as long as the hospice is allowed continued participation in Medicare while the condition of noncompliance is being corrected. The hospice program can be either a public agency or private organization (or a subdivision thereof) which:

(A) Is primarily engaged in providing the care and services described under $199.4(e)(19) and makes such services available on a 24-hour basis.

(B) Provides bereavement counseling for the immediate family or terminally ill individuals.

(C) Provides for such care and services in individuals' homes, on an outpatient basis, and on a short-term inpatient basis, directly or under arrangements made by the hospice program, except that the agency or organization must:

(1) Ensure that substantially all the core services are routinely provided directly by hospice employees.

(2) Maintain professional management responsibility for all services which are not directly furnished to the patient, regardless of the location or facility in which the services are rendered.

(3) Provide assurances that the aggregate number of days of inpatient care provided in any 12-month period does not exceed 20 percent of the aggregate number of days of hospice care during the same period.

(4) Have an interdisciplinary group composed of the following personnel who provide the care and services described under $199.4(e)(19) and who establish the policies governing the provision of such care/services:

(i) A physician;
(ii) A registered professional nurse;
(iii) A social worker; and
(iv) A pastoral or other counselor.

(5) Maintain central clinical records on all patients.

(6) Utilize volunteers.

(7) The hospice and all hospice employees must be licensed in accordance with applicable Federal, State and local laws and regulations.

(8) The hospice must enter into an agreement with CHAMPUS in order to be qualified to participate and to be eligible for payment under the program. In this agreement the hospice and CHAMPUS agree that the hospice will:

or

(i) Not charge the beneficiary or any other person for items or services for which the beneficiary is entitled to have payment made under the CHAMPUS hospice benefit.

(ii) Be allowed to charge the beneficiary for items or services requested by the beneficiary in addition to those that are covered under the CHAMPUS hospice benefit.

(9) Meet such other requirements as the Secretary of Defense may find necessary in the interest of the health and safety of the individuals who are provided care and services by such agency or organization.

(xiv) Substance use disorder rehabilitation facilities. Paragraph (b)(4)(xiv) of this section establishes standards and requirements for substance use order rehabilitation facilities (SUDRF). This includes both inpatient rehabilitation centers for the treatment of substance use disorders and partial hospitalization centers for the treatment of substance use disorders.

(A) Organization and administration.

(1) Definition of inpatient rehabilitation center. An inpatient rehabilitation center is a facility, or distinct part of a facility, that provides medically monitored, interdisciplinary addiction-focused treatment to beneficiaries who have psychoactive substance use disorders. Qualified health care professionals provide 24-hour, seven-day-perweek, medically monitored assessment, treatment, and evaluation. An inpatient rehabilitation center is appropriate for patients whose addiction-related symptoms, or concomitant physical and emotional/behavioral problems reflect persistent dysfunction in several major life areas. Inpatient rehabilitation is differentiated from:

(i) Acute psychoactive substance use treatment and from treatment of acute biomedical/emotional behavioral problems; which problems are either lifethreatening and/or severely incapacitating and often occur within the context of a discrete episode of addictionrelated biomedical or psychiatric dysfunction;

(ii) A partial hospitalization center, which serves patients who exhibit emotional/behavioral dysfunction but who can function in the community for de

fined periods of time with support in one or more of the major life areas;

(iii) A group home, sober-living environment, halfway house, or three-quarter way house;

(iv) Therapeutic schools, which are educational programs supplemented by addiction-focused services;

(v) Facilities that treat patients with primary psychiatric diagnoses other than psychoactive substance use or dependence; and

(vi) Facilities that care for patients with the primary diagnosis of mental retardation developmental disability.

(2) Definition of partial hospitalization center for the treatment of substance use disorders. A partial hospitalization center for the treatment of substance use disorders is an addiction-focused service that provides active treatment to adolescents between the ages of 13 and 18 or adults aged 18 and over. Partial hospitalization is a generic term for day, evening, or weekend programs that treat patients with psychoactive substance use disorders according to a comprehensive, individualized, integrated schedule of care. A partial hospitalization center is organized, interdisciplinary, and medically monitored. Partial hospitalization is appropriate for those whose addiction-related symptoms or concomitant physical and emotional behavioral problems can be managed outside the hospital environment for defined periods of time with support in one or more of the major life areas.

(3) Eligibility.

(i) Every inpatient rehabilitation center and partial hospitalization center for the treatment of substance use disorders must be certified pursuant to CHAMPUS certification standards. Such standards shall incorporate the basic standards set forth in paragraphs (b)(4)(xiv) (A) through (D) of this section, and shall include such additional elaborative criteria and standards as the Director, OCHAMPUS determines are necessary to implement the basic standards.

(ii) To be eligible for CHAMPUS certification, the SUDRF is required to be licensed and fully operational (with a minimum patient census of the lesser

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of: six patients or 30 percent of bed capacity) for a period of at least six months and operate in substantial compliance with state and federal regulations.

(iii) The SUDRF is currently accredited by the Joint Commission on Accreditation of Healthcare Organizations under the Accreditation Manual for Mental Health, Chemical Dependency, and Mental Retardation Developmental Disabilities Services, or by the Commission on Accreditation of Rehabilitation Facilities as an alcoholism and other drug dependency rehabilitation program under the Standards Manual for Organizations Serving People with Disabilities, or other designated standards approved by the Director, OCHAMPUS.

(iv) The SUDRF has a written participation agreement with OCHAMPUS. On October 1, 1995, the SUDRF is not considered a CHAMPUSauthorized provider, and CHAMPUS benefits are not paid for services provided until the date upon which a participation agreement is signed by the Director, OCHAMPUS.

(4) Governing body.

(i) The SUDRF shall have a governing body which is responsible for the policies, bylaws, and activities of the facility. If the SUDRF is owned by a partnership or single owner, the partners or single owner are regarded as the governing body. The facility will provide an up-to-date list of names, addresses, telephone numbers and titles of the members of the governing body.

(ii) The governing body ensures appropriate and adequate services for all patients and oversees continuing development and improvement of care. Where business relationships exist between the governing body and facility, appropriate conflict-of-interest policies are in place.

(iii) Board members are fully informed about facility services and the governing body conducts annual reviews of its performance in meeting purposes, responsibilities, goals and objectives.

(5) Chief executive officer. The chief executive officer, appointed by and subject to the direction of the governing body, shall assume overall administrative responsibility for the op

eration of the facility according to governing body policies. The chief executive officer shall have five years' administrative experience in the field of mental health or addictions. On October 1, 1997 the CEO shall possess a degree in business administration, public health, hospital administration, nursing, social work, or psychology, or meet similar educational requirements

prescribed by the Director, OCHAMPUS.

(6) Clinical Director. The clinical director, appointed by the governing body, shall be a qualified psychiatrist

doctoral level psychologist who meets applicable CHAMPUS requirements for individual professional providers and is licensed to practice in the state where the SUDRF is located. The clinical director shall possess requisite education and experience, including credentials applicable under state practice and licensing laws appropriate to the professional discipline. The clinical director shall satisfy at least one of the following requirements: certification by the American Society of Addiction Medicine; one year or 1,000 hours of experience in the treatment of psychoactive substance use disorders; or is a psychiatrist or doctoral level psychologist with experience in the treatment of substance use disorders. The clinical director shall be responsible for planning, development, implementation, and monitoring of all clinical activities.

(7) Medical director. The medical director, appointed by the governing body, shall be licensed to practice medicine in the state where the center is located and shall possess requisite education including graduation from an accredited school of medicine or osteopathy. The medical director shall satisfy at least one of the following requirements: certification by the American Society of Addiction Medicine; one year or 1,000 hours of experience in the treatment of psychoactive substance use disorders; or is a psychiatrist with experience in the treatment of substance use disorders. The medical director shall be responsible for the planning, development, implementation, and monitoring of all activities

relating to medical treatment of pa- agement of medical care is vested in a tients. If qualified, the Medical Direc- physician. tor may also serve as Clinical Director. (ii) The SUDRF shall establish and

(8) Medical or professional staff organi- follow written plans to assure adequate zation. The governing body shall estab- staff coverage during all hours of operlish a medical or professional staff or- ation of the center, including physician ganization to assure effective imple- availability and other professional mentation of clinical privileging, pro- staff coverage 24 hours per day, seven fessional conduct rules, and other ac- days per week for an inpatient rehabilitivities directly affecting patient care. tation center and during all hours of

(9) Personnel policies and records. The operation for a partial hospitalization SUDRF shall maintain written per- center. sonnel policies, updated job descrip- (2) Staff qualifications. Within the tions, personnel records to assure the scope of its programs and services, the selection of qualified personnel and SUDRF has a sufficient number of prosuccessful job performance of those fessional, administrative, and support personnel.

staff to address the medical and clin(10) Staff development. The SUDRF ical needs of patients and to coordinate shall provide appropriate training and the services provided. SUDRFs that development programs for administra- employ individuals with master's or tive, support, and direct care staff. doctoral level degrees in a mental

(11) Fiscal accountability. The SUDRF health discipline who do not meet the shall assure fiscal accountability to ap- licensure, certification and experience plicable government authorities and requirements for a qualified mental patients.

health provider but are actively work(12) Designated teaching facilities. Stu- ing toward licensure or certification, dents, residents, interns, or fellows may provide services within the DRG, providing direct clinical care are under provided the individual works under the supervision of a qualified staff the clinical supervision of a fully qualimember approved by an accredited uni- fied mental health provider employed versity or approved training program. by the SUDRF. The teaching program is approved by (3) Patient rights. the Director, OCHAMPUS.

(i) The SUDRF shall provide ade(13) Emergency reports and records. The quate protection for all patient rights, facility notifies OCHAMPUS of any se- safety, confidentiality, informed conrious occurrence involving CHAMPUS sent, grievances, and personal dignity. beneficiaries.

(ii) The SUDRF has a written policy (B) Treatment services.

regarding patient abuse and neglect. (1) Staff composition.

(iii) SUDRF marketing and adver(i) The SUDRF shall follow written tising meets professional standards. plans which assure that medical and (4) Behavioral management. When a clinical patient needs will be appro- SUDRF uses a behavioral management priately addressed during all hours of program, the center shall adhere to a operation by a sufficient number of comprehensive, written plan of behavfully qualified (including license, reg- ioral management, developed by the istration or certification requirements, clinical director and the medical or educational attainment, and profes- professional staff and approved by the sional experience) health care profes- governing body. It shall be based on sionals and support staff in the respec- positive reinforcement methods and, tive disciplines. Clinicians providing except for infrequent use of temporary individual, group and family therapy physical holds or time outs, does not meet CHAMPUS requirements as quali- include the use of restraint or seclufied mental health providers and oper- sion. Only trained and clinically priviate within the scope of their licenses. leged RNs or qualified mental health The ultimate authority for planning professionals may be responsible for development, implementation, and the implementation of seclusion and monitoring of all clinical activities is restraint in an emergency situation. vested in a psychiatrist or doctoral (5) Admission process. The SUDRF level clinical psychologist. The man- shall maintain written policies and

procedures to ensure that, prior to an admission, a determination is made, and approved pursuant to CHAMPUS preauthorization requirements, that the admission is medically and/or psychologically necessary and the program is appropriate to meet the patient's needs. Medical and/or psychological necessity determinations shall be rendered by qualified mental health professionals who meet CHAMPUS requirements for individual professional providers and who are permitted by law and by the facility to refer patients for admission.

(6) Assessment. The professional staff of the SUDRF shall provide a complete, multidisciplinary assessment of each patient which includes, but is not limited to, medical history, physical health, nursing needs, alcohol and drug history, emotional and behavioral factors, age-appropriate social circumstances, psychological condition, education status, and skills. Unless otherwise specified, all required clinical assessments are completed prior to development of the multidisciplinary treatment plan.

(7) Clinical formulation. A qualified mental health care professional of the SUDRF will complete a clinical formulation on all patients. The clinical formulation will be reviewed and approved by the responsible individual professional provider and will incorporate significant findings from each of the multidisciplinary assessments. It will provide the basis for development of an interdisciplinary treatment plan.

(8) Treatment planning. A qualified health care professional with admitting privileges shall be responsible for the development, supervision, implementation, and assessment of a written, individualized, and interdisciplinary plan of treatment, which shall be completed within 10 days of admission to an inpatient rehabilitation center or by the fifth day following admission to full day partial hospitalization center, and by the seventh day of treatment for half day partial hospitalization. The treatment plan shall include individual, measurable, and observable goals for incremental progress towards the treatment plan objectives and goals and discharge. A preliminary treatment plan is completed within 24

hours of admission and includes at least a physician's admission note and orders. The master treatment plan is regularly reviewed for effectiveness and revised when major changes occur in treatment.

(9) Discharge and transition planning. The SUDRF shall maintain a transition planning process to address adequately the anticipated needs of the patient prior to the time of discharge.

(10) Clinical documentation. Clinical records shall be maintained on each patient to plan care and treatment and provide ongoing evaluation of the patient's progress. All care is documented and each clinical record contains at least the following: demographic data, consent forms, pertinent legal documents, all treatment plans and patient assessments, consultation and laboratory reports, physician orders, progress notes, and a discharge summary. All documentation will adhere to applicable provisions of the JCAHO and requirements set forth in $199.7(b)(3). An appropriately qualified records administrator or technician will supervise and maintain the quality of the records. These requirements are in addition to other records requirements of this part, and provisions of the JCAHO Manual for Mental Health, Chemical Dependency, and Mental Retardation/ Developmental Disabilities Services.

(11) Progress notes. Timely and complete progress notes shall be maintained to document the course of treatment for the patient and family.

(12) Therapeutic services.

(i) Individual, group, and family psychotherapy and addiction counseling services are provided to all patients, consistent with each patient's treatment plan by qualified mental health providers.

(ii) A range of therapeutic activities, directed and staffed by qualified personnel, are offered to help patients meet the goals of the treatment plan.

(iii) Therapeutic educational services are provided or arranged that are appropriate to the patient's educational and therapeutic needs.

(13) Ancillary services. A full range of ancillary services is provided. Emergency services include policies and procedures for handling emergencies with

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