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(3) Patient records review. The RTC shall implement a process, including monthly reviews of a representative sample of patient records, to determine the completeness and accuracy of the patient records and the timeliness and pertinence of record entries, particularly with regard to regular recording of progress/non-progress in treatment.

(4) Drug utilization review. The RTC shall implement a comprehensive process for the monitoring and evaluating of the prophylactic, therapeutic, and empiric use of drugs to assure that medications

provided appropriately, safely, and effectively.

(5) Risk management. The RTC shall implement a comprehensive risk management program, fully coordinated with other aspects of the quality assurance and quality improvement program, to prevent and control risks to patients and staff and costs associated with clinical aspects of patient care and safety.

(6) Infection control. The RTC shall implement a comprehensive system for the surveillance, prevention, control, and reporting of infections acquired or brought into the facility.

(7) Safety. The RTC shall implement an effective program to assure a safe environment for patients, staff, and visitors, including an incident report system, a continuous safety surveillance system, and an active multidisciplinary safety committee.

(8) Facility evaluation. The RTC annually evaluates accomplishment of the goals and objectives of each clinical program and service of the RTC and reports findings and recommendations to the governing body.

(E) Participation agreement requirements. In addition to other requirements set forth in paragraph (b)(4)(vii), of this section in order for the services of an RTC to be authorized, the RTC shall have entered into a Participation Agreement with OCHAMPUS. The period of a participation agreement shall be specified in the agreement, and will generally be for not more than five years. Participation agreements entered into prior April 6, 1995 must be renewed not later than October 1, 1995. In addition to review of a facility's application and supporting documentation, an on-site inspection

by

OCHAMPUS authorized personnel may be required prior to signing a Participation Agreement. Retroactive approval is not given. In addition, the Participation Agreement shall include provisions that the RTC shall, at a minimum:

(1) Render residential treatment center impatient services to eligible CHAMPUS beneficiaries in need of such services, in accordance with the participation agreement and CHAMPUS regulation;

(2) Accept payment for its services based upon the methodology provided in $199.14(f) or such other method as determined by the Director, OCHAMPUS;

(3) Accept the CHAMPUS all-inclusive per diem rate as payment in full and collect from the CHAMPUS beneficiary or the family of the CHAMPUS beneficiary only those amounts that represent the beneficiary's liability, as defined in § 199.4, and charges for services and supplies that are not a benefit of CHAMPUS;

(4) Make all reasonable efforts acceptable to the Director, OCHAMPUS, to collect those amounts, which represents the beneficiary's liability, defined in $199.4;

(5) Comply with the provisions of $199.8, and submit claims first to all health insurance coverage to which the beneficiary is entitled that is primary to CHAMPUS;

(6) Submit claims for services provided to CHAMPUS beneficiaries at least 30 days (except to the extent a delay is necessitated by efforts to first collect from other health insurance). If claims are not submitted at least every 30 days, the RTC agrees not to bill the beneficiary or the beneficiary's family for

any amounts disallowed by CHAMPUS;

(7) Certify that:

(i) It is and will remain in compliance with the provisions of paragraph (b)(4)(vii) of this section establishing standards for Residential Treatment Centers;

(ii) It has conducted a self assessment of the facility's compliance with the CHAMPUS Standards for Residential Treatment Centers Serving Children and Adolescents with Mental Disorders, as issued by the Director,

as

OCHAMPUS and notified the Director, (iv) Conducting on-site inspections of OCHAMPUS of any matter regarding the facilities of the RTC and interwhich the facility is not in compliance viewing employees, members of the with such standards; and

staff, contractors, board members, vol(iii) It will maintain compliance with unteers, and patients, as required; the CHAMPUS Standards for Residen- (V) Audits conducted by the United tial Treatment Centers Serving Chil- States General Accounting Office. dren and Adolescents with Mental Dis- (F) Other requirements applicable to orders, as issued by the Director, RTCs. OCHAMPUS, except for any such (1) Even though an RTC may qualify standards regarding which the facility

as a CHAMPUS-authorized provider notifies the Director, OCHAMPUS that

and may have entered into a participait is not in compliance.

tion agreement with CHAMPUS, pay(8) Designate an individual who will

ment by CHAMPUS for particular seryact as liaison for CHAMPUS inquiries.

ices provided is contingent upon the The RTC shall inform OCHAMPUS in

RTC also meeting all conditions set writing of the designated individual;

forth in $199.4 especially all require(9) Furnish OCHAMPUS, as requested

ments of paragraph (b)(4) of that secby OCHAMPUS, with cost data cer

tion. tified by an independent accounting

(2) The RTC shall provide inpatient firm or other agency as authorized by

services to CHAMPUS beneficiaries in the Director, OCHAMPUS;

the same manner it provides inpatient (10) Comply with all requirements of

services to all other patients. The RTC this section applicable to institutional

may not discriminate against providers generally concerning

CHAMPUS beneficiaries in any manpreauthorization, concurrent care re

ner, including admission practices, view, claims processing, beneficiary li

placement in special or separate wings ability, double coverage, utilization and quality review and other matters;

or rooms, or provisions of special or

limited treatment. (11) Grant the Director, OCHAMPUS,

(3) The RTC shall assure that all ceror designee, the right to conduct qual

tifications and information provided to ity assurance audits or accounting audits with full access to patients and

the Director, OCHAMPUS incident to records (including records relating to

the process of obtaining and retaining patients who are not CHAMPUS bene

authorized provider status is accurate ficiaries) to determine the quality and

and that it has no material errors or cost-effectiveness of care rendered. The

omissions. In the case of any misrepreaudits may be conducted on a sched

sentations, whether by inaccurate inuled unscheduled (unannounced)

formation being provided or material basis. This right to audit/review in

facts withheld, authorized status will cludes, but is not limited to:

be denied or terminated, and the RTC (i) Examination of fiscal and all other

will be ineligible for consideration for records of the RTC which would con

authorized provider status for a two firm compliance with the participation

year period. agreement and designation as an au

(viii) Christian Science sanatoriums. thorized CHAMPUS RTC provider;

The services obtained in Christian (ii) Conducting such audits of RTC

Science sanatoriums are covered by records including clinical, financial,

CHAMPUS as inpatient care. To qualand census records, as may be nec- ify for coverage, the sanatorium either essary to determine the nature of the must be operated by, or be listed and services being provided, and the basis certified by the First Church of Christ, for charges and claims against the Scientist. United States for services provided (ix) Infirmaries. Infirmaries are faciliCHAMPUS beneficiaries;

ties operated by student health depart(iii) Examining reports of evaluations ments of colleges and universities to and inspections conducted by federal, provide inpatient or outpatient care to state and local government, and pri- enrolled students. Charges for care provate agencies and organizations;

vided by such facilities will not be

or

cost-shared by CHAMPUS if the student would not be charged in the absence of CHAMPUS, or if student is covered by a mandatory student health insurance plan, in which enrollment is required as a part of the student's school registration and the charges by the college or university include a premium for the student health insurance coverage. CHAMPUS will cost-share only if enrollment in the student health program or health insurance plan is voluntary.

NOTE: An infirmary in a boarding school also may qualify under this provision, subject to review and approval by the Director, OCHAMPUS or a designee.

(x) Other special institution providers. (A) General. (1) Care provided by certain special institutional providers (on either an inpatient or outpatient basis), may be cost-shared by CHAMPUS under specified circumstances and only if the provider is specifically identified in paragraph (b)(4)(x) of this section.

(i) The course of treatment is prescribed by a doctor of medicine or osteopathy.

(ii) The patient is under the supervision of a physician during the entire course of the inpatient admission or the outpatient treatment.

(iii) The type and level of care and service rendered by the institution are otherwise authorized by this part.

(iv) The facility meets all licensing or other certification requirements that are extant in the jurisdiction in which the facility is located geographically.

(v) Is other than a nursing home, intermediate care facility, home for the aged, halfway house, or other similar institution.

(vi) Is accredited by the JCAH or other CHAMPUS-approved accreditation organization, if an appropriate accreditation program for the given type of facility is available. As future accreditation programs are developed to cover emerging specialized treatment programs, such accreditation will be a prerequisite to coverage by CHAMPUS for services provided by such facilities.

(2) To ensure that CHAMPUS beneficiaries are provided quality care at a reasonable cost when treated by a special institutional provider, the Director, OCHAMPUS may:

(i) Require prior approval of all admissions to special institutional providers.

(ii) Set appropriate standards for special institutional providers in addition to or in the absence of JCAHO accreditation.

(iii) Monitor facility operations and treatment programs on a continuing basis and conduct onsite inspections on a scheduled and unscheduled basis.

(iv) Negotiate agreements of participation.

(v) Terminate approval of a case when it is ascertained that a departure from the facts upon which the admission was based originally has occurred.

(vi) Declare a special institutional provider not eligible for CHAMPUS payment if that facility has been found to have engaged in fraudulent or deceptive practices.

(3) In general, the following disclaimers apply to treatment by special institutional providers:

(i) Just because one period or episode of treatment by a facility has been covered by CHAMPUS may not be construed to mean that later episodes of care by the same or similar facility will be covered automatically.

(ii) The fact that one case has been authorized for treatment by a specific facility or similar type of facility may not be construed to mean that similar cases or later periods of treatment will be extended CHAMPUS benefits automatically.

(B) Types of providers. The following is a list of facilities that have been designated specifically as special institutional providers.

(1) Free-standing ambulatory surgical centers. Care provided by freestanding ambulatory surgical centers may be cost-shared by CHAMPUS under the following circumstances:

(i) The treatment is prescribed and supervised by a physician.

(ii) The type and level of care and services rendered by the center are otherwise authorized by this part.

(iii) The center meets all licensing or other certification requirements of the jurisdiction in which the facility is located.

(iv) The center is accredited by the JCAH, the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC), or such other standards as authorized

by the Director, OCHAMPUS.

(v) A childbirth procedure provided by a CHAMPUS-approved free-standing ambulatory surgical center shall not be cost-shared by the CHAMPUS unless the surgical center is also a CHAMPUS-approved birthing center institutional provider as established by the birthing center provider certification requirement of this Regulation.

(2)[Reserved]

(xi) Birthing centers. A birthing center is a freestanding or institution-affiliated outpatient maternity care program which principally provides a planned course of outpatient prenatal care and outpatient childbirth service limited to low-risk pregnancies; excludes care for high-risk pregnancies; limits childbirth to the use of natural childbirth procedures; and provides immediate newborn care.

(A) Certification requirements. A birthing center which meets the following criteria may be designated as an authorized CHAMPUS institutional provider:

(1) The predominant type of service and level of care rendered by the center is otherwise authorized by this part.

(2) The center is licensed to operate as a birthing center where such license is available, or is specifically licensed as a type of ambulatory health care facility where birthing center specific license is not available, and meets all applicable licensing or certification requirements that are extant in the state, county, municipality, or other political jurisdiction in which the center is located.

(3) The center is accredited by a nationally recognized accreditation organization whose standards and procedures have been determined to be acceptable by the Director, OCHAMPUS, or a designee.

(4) The center complies with the CHAMPUS birthing center standards set forth in this part.

(5) The center has entered into a participation agreement with OCHAMPUS in which the center agrees, in part, to:

(i) Participate in CHAMPUS and accept payment for maternity services based upon the reimbursement methodology for birthing centers;

(ii) Collect from the CHAMPUS beneficiary only those amounts that represent the beneficiary's liability under the participation agreement and the reimbursement methodology for birthing centers, and the amounts for services and supplies that are not a benefit of the CHAMPUS;

(iii) Permit access by the Director, OCHAMPUS, or a designee, to the clinical record of any CHAMPUS beneficiary, to the financial and organizational records of the center, and to reports of evaluations and inspections conducted by state or private agencies or organizations;

(iv) Submit claims first to all health benefit and insurance plans primary to the CHAMPUS to which the beneficiary is entitled and to comply with the double coverage provisions of this part;

(v) Notify CHAMPUS in writing within 7 days of the emergency transport of any CHAMPUS beneficiary from the center to an acute care hospital or of the death of any CHAMPUS beneficiary in the center.

(6) A birthing center shall not be a CHAMPUS-authorized institutional provider and CHAMPUS benefits shall not be paid for any service provided by a birthing center before the date the participation agreement is signed by the Director, OCHAMPUS, or a designee.

(B) CHAMPUS birthing center standards. (1) Environment: The center has a safe and sanitary environment, properly constructed, equipped, and maintained to protect health and safety and meets the applicable provisions of the "Life Safety Code" of the National Fire Protection Association.

(2) Policies and procedures: The center has written administrative, fiscal, personnel and clinical policies and procedures which collectively promote the provision of high-quality maternity care and childbirth services in an orderly, effective, and safe physical and organizational environment.

(3) Informed consent: Each CHAMPUS beneficiary admitted to the center will be informed in writing at the time of admission of the nature and scope of the center's program and of the possible risks associated with maternity care and childbirth in the center.

a

(4) Beneficiary care: Each woman ad- (8) Emergency medical transportation. mitted will be cared for by or under the The center has a written memorandum direct supervision of a specific physi- of understanding (MOU) with at least cian or a specific certified nurse-mid- one ambulance service which docuwife who is otherwise eligible as ments that the ambulance service is CHAMPUS individual professional pro- routinely staffed by qualified personnel vider.

who are capable of the management of (5) Medical direction: The center has critical maternal and neonatal patients written memoranda of understanding during transport and which specifies (MOU) for routine consultation and the estimated transport time to each emergency care with an obstetrician- backup hospital with which the center gynecologist who is certified or is eligi- has arranged for emergency treatment ble for certification by the American as required in paragraph (b)(4)(xi)(B)(7) Board of Obstetrics and Gynecology or above. Each MOU must be renewed anthe American Osteopathic Board of Ob- nually. stetrics and Gynecology and with a pe- (9) Professional staff. The center's prodiatrician who is certified or eligible fessional staff is legally and profesfor certification by the American sionally qualified for the performance Board of Pediatrics or by the American of their professional responsibilities. Osteopathic Board of Pediatrics, each (10) Medical records. The center mainof whom have admitting privileges to tains full and complete written docuat least one backup hospital. In lieu of mentation of the services rendered to a required MOU, the center may em- each woman admitted and each newploy a physician with the required born delivered. A copy of the informed qualifications. Each MOU must be re- consent document required by paranewed annually.

graph (b)(4)(xi)(B)(3), above, which con(6) Admission and emergency care cri- tains the original signature of the teria and procedures. The center has CHAMPUS beneficiary, signed and written clinical criteria and adminis- dated at the time of admission, must trative procedures, which are reviewed be maintained in the medical record of and approved annually by a physician each CHAMPUS beneficiary admitted. related to the center as required by (11) Quality assurance. The center has paragraph (b)(4)(xi)(B)(5) above, for the an organized program for quality asexclusion of a woman with a high-risk surance which includes, but is not limpregnancy from center care and for ited to, written procedures for regumanagement of maternal and neonatal larly scheduled evaluation of each type emergencies.

of service provided, of each mother or (7) Emergency treatment. The center newborn transferred to a hospital, and has a written memorandum of under- of each death within the facility. standing (MOU) with at least one (12) Governance and administration. backup hospital which documents that The center has a govening body legally the hospital will accept and treat any responsible for overall operation and woman or newborn transferred from maintenance of the center and a fullthe center who is in need of emergency time employee who has authority and obstetrical or neonatal medical care. responsibility for the day-to-day operIn lieu of this MOU with a hospital, a ation of the center. birthing center may have an MOU with (xii) Psychiatric partial hospitalization a physician, who otherwise meets the programs. Paragraph (b)(4)(xii) of this requirements as a CHAMPUS indi- section establishes standards and revidual professional provider, and who quirements for psychiatric partial hoshas admitting privileges to a backup pitalization programs. hospital capable of providing care for (A) Organization and administration. critical maternal and neonatal patients (1) Definition. Partial hospitalization as demonstrated by a letter from that is defined as a time-limited, ambulahospital certifying the scope and ex- tory, active treatment program that pected duration of the admitting privi- offers therapeutically intensive, leges granted by the hospital to the ordinated, and structured clinical servphysician. The MOU must be reviewed ices within a stable therapeutic milieu. annually.

Partial hospitalization programs serve

CO

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