Title 32 National Defense
Civilian Health And Medical Program Of The Uniformed Services (CHAMPUS)
Part 199.6
TRICARE-Authorized Providers
Revision:C-18, April 4, 2023
Rule:Final Rule/FR Vol 88, No 64
(a) General.
This section sets forth generalpolicies and procedures that are the basis for the CHAMPUS cost-sharingof medical services and supplies provided by institutions, individuals,or other types of providers. Providers seeking payment from theFederal Government through programs such as CHAMPUS have a dutyto familiarize themselves with, and comply with, the program requirements.
(1) Listingof provider does not guarantee payment of benefits.
The fact that a type of provideris listed in this section is not to be construed to mean that CHAMPUSwill automatically pay a claim for services or supplies providedby such a provider. The provider who actually furnishes the service(s)must, in fact, meet all licensing and other requirements establishedby this part to be an authorized provider; the provider must notbe the subject of sanction under Sec. 199.9; and, cost-sharing ofthe services must not otherwise be prohibited by this part. In addition,the patient must in fact be an eligible beneficiary and the servicesor supplies billed must be authorized and medically necessary, regardlessof the standing of the provider.
(2) Outsidethe United States or emergency situations within the United States.
Outside the United States orwithin the United States and Puerto Rico in emergency situations,the Director, OCHAMPUS, or a designee, after review of the facts,may provide payment to or on behalf of a beneficiary who receivesotherwise covered services or supplies from a provider of servicethat does not meet the standards described in this part.
Note:Only the Secretary of Defense,the Secretary of Health and Human Services, or the Secretary of Transportation,or their designees, may authorize (in emergency situations) paymentto civilian facilities in the United States that are not in compliancewith title VI of the Civil Rights Act of 1964. For the purpose ofthe Civil Rights Act only, the United States includes the 50 states,the District of Columbia, Puerto Rico, Virgin Islands, AmericanSamoa, Guam, Wake Island, Canal Zone, and the territories and possessionsof the United States.
(3) DualCompensation/Conflict of Interest.
Title5, United States Code, section 5536 prohibits medical personnel whoare active duty Uniformed Service members or civilian employeesof the Government from receiving additional Government compensationabove their normal pay and allowances for medical care furnished.In addition, Uniformed Service members and civilian employees ofthe Government are generally prohibited by law and agency regulationsand policies from participating in apparent or actual conflict ofinterest situations in which a potential for personal gain existsor in which there is an appearance of impropriety or incompatibilitywith the performance of their official duties or responsibilities.The Departments of Defense, Health and Human Services, and Transportationhave a responsibility, when disbursing appropriated funds in thepayment of CHAMPUS benefits, to ensure that the laws and regulationsare not violated. Therefore, active duty Uniformed Service members(including a reserve member while on active duty and civilian employeesof the United States Government shall not be authorized to be CHAMPUSproviders. While individual employees of the Government may be ableto demonstrate that the furnishing of care to CHAMPUS beneficiariesmay not be incompatible with their official duties and responsibilities,the processing of millions of CHAMPUS claims each year does notenable Program administrators to efficiently review the status ofthe provider on each claim to ensure that no conflict of interestor dual compensation situation exists. The problem is further complicatedgiven the numerous interagency agreements (for example, resourcesharing arrangements between the Department of Defense and the Veterans Administrationin the provision of health care) and other unique arrangements whichexist at individual treatment facilities around the country. Whilean individual provider may be prevented from being an authorizedCHAMPUS provider even though no conflict of interest or dual compensationsituation exists, it is essential for CHAMPUS to have an easilyadministered, uniform rule which will ensure compliance with theexisting laws and regulations. Therefore, a provider who is an activeduty Uniformed Service member or civilian employee of the Government shallnot be an authorized CHAMPUS provider. In addition, a provider shallcertify on each CHAMPUS claim that he/she is not an active dutyUniformed Service member or civilian employee of the Government.
(4) [Reserved]
(5) Utilizationreview and quality assurance.
Providers approved as authorizedCHAMPUS providers have certain obligations to provide services andsupplies under CHAMPUS which are (i) furnished at the appropriatelevel and only when and to the extent medically necessary underthe criteria of this part; (ii) of a quality that meets professionallyrecognized standards of health care; and, (iii) supported by adequatemedical documentation as may be reasonably required under this partby the Director, OCHAMPUS, or designee, to evidence the medicalnecessity and quality of services furnished, as well as the appropriatenessof the level of care. Therefore, the authorization of CHAMPUS benefitsis contingent upon the services and supplies furnished by any providerbeing subject to pre-payment or post-payment utilization and qualityassurance review under professionally recognized standards, norms,and criteria, as well as any standards or criteria issued by theDirector, OCHAMPUS, or a designee, pursuant to this part. (Referto Secs. 199.4, 199.5, and 199.7 of this part.)
(6) Exclusionof beneficiary liability.
In connection with certainutilization review, quality assurance and preauthorization requirementsof section 199.4 of this part, providers may not hold patients liablefor payment for certain services for which CHAMPUS payment is disallowed.With respect to such services, providers may not seek payment fromthe patient or the patient’s family. Any such effort to seek paymentis a basis for termination of the provider’s authorized status.
(7) Providerrequired.
In order to be considered forbenefits, all services and supplies shall be rendered by, prescribedby, or furnished at the direction of, or on the order of a CHAMPUS-authorizedprovider practicing within the scope of his or her license.
(8) Participatingproviders.
A CHAMPUS-authorized provideris a participating provider, as defined in Sec. 199.2 under thefollowing circ*mstances:
(i) Mandatoryparticipation.
(A) An institutionalprovider in Sec. 199.6(b), in order to be an authorized provider underTRICARE, must be a participating provider for all claims.
(B) ASNF or a HHA, in order to be an authorized provider under TRICARE,must enter into a participation agreement with TRICARE for all claims.
(C) Corporateservices providers authorized as CHAMPUS providers under the provisionsof paragraph (f) of this section must enter into a participationagreement as provided by the Director, OCHAMPUS, or designee.
(ii) Voluntaryparticipation--
(A) Totalclaims participation: The participating provider program.
A CHAMPUS-authorized providerthat is not required to participate by this part may become a participatingprovider by entering into an agreement or memorandum of understanding(MOU) with the Director, OCHAMPUS, or designee, which includes,but is not limited to, the provisions of paragraph (a)(13) of thissection. The Director, OCHAMPUS, or designee, may include in a participatingprovider agreement/MOU provisions that establish between CHAMPUS anda class, category, type, or specific provider, uniform proceduresand conditions which encourage provider participation while improvingbeneficiary access to benefits and contributing to CHAMPUS efficiency.Such provisions shall be otherwise allowed by this part or by DoDDirective or DoD Instruction specifically pertaining to CHAMPUSclaims participation. Participating provider program provisionsmay be incorporated into an agreement/MOU to establish a specificCHAMPUS-provider relationship, such as a preferred provider arrangement.
(B) Claim-specificparticipation.
A CHAMPUS-authorized providerthat is not required to participate and that has not entered intoa participation agreement pursuant to paragraph (a)(8)(ii)(A) ofthis section may elect to be a participating provider on a claim-by-claimbasis by indicating “accept assignment” on each claim form for which participationis elected.
(iii) Claim-by-claimparticipation.
Individual providers that arenot participating providers pursuant to paragraph (a)(8)(ii) ofthis section may elect to participate on a claim-by-claim basis.They may do so by signing the appropriate space on the claims formand submitting it to the appropriate TRICARE contractor on behalfof the beneficiary.
(9) Limitationto authorized institutional provider designation.
Authorized institutional providerstatus granted to a specific institutional provider applicant doesnot extend to any institution-affiliated provider, as defined inSec. 199.2, of that specific applicant.
(10) Authorizedprovider.
A hospital or institutionalprovider, physician, or other individual professional provider, orother provider of services or supplies specifically authorized inthis chapter to provide benefits under CHAMPUS. In addition, tobe an authorized CHAMPUS provider, any hospital which is a CHAMPUSparticipating provider under paragraph (a)(7) of this section, shallbe a participating provider for all care, services, or suppliesfurnished to an active duty member of the uniformed services forwhich the active duty member is entitled under 10 U.S.C. 1074(c). Asa participating provider for active duty members, the CHAMPUS authorizedhospital shall provide such care, services, and supplies in accordancewith the payment rules of Sec. 199.16 of this part. The failureof any CHAMPUS participating hospital to be a participating providerfor any active duty member subjects the hospital to terminationof the hospital’s status as a CHAMPUS authorized provider for failureto meet the qualifications established by this part.
(11) Balancebilling limits.
(i) In general.
Individual providers includingproviders salaried or under contract by an institutional providerand other providers who are not participating providers may notbalance bill a beneficiary an amount that exceeds the applicablebalance billing limit. The balance billing limit shall be the samepercentage as the Medicare limiting charge percentage for nonparticipatingpractitioners and suppliers.
(ii) Waiver.
The balance billing limit maybe waived by the Director, OCHAMPUS on a case-by-case basis if requestedby a CHAMPUS beneficiary. A decision by the Director, OCHAMPUS towaive or not waive the limit in any particular case is not subjectto the appeal and hearing procedures of Sec. 199.10.
(iii) Compliance.
Failure to comply with thebalance billing limit shall be considered abuse and/or fraud and groundsof exclusion or suspension of the provider under Sec. 199.9.
(12) Medicalrecords.
CHAMPUS-authorized providerorganizations and individuals providing clinical services shallmaintain adequate clinical records to substantiate that specificcare was actually furnished, was medically necessary, and appropriate,and identify(ies) the individual(s) who provided the care. Thisapplies whether the care is inpatient or outpatient. The minimumrequirements for medical record documentation are set forth by allof the following:
(i) Thecognizant state licensing authority;
(ii) TheJoint Commission on Accreditation of Healthcare Organizations, orthe appropriate Qualified Accreditation Organization as definedin Sec. 199.2;
(iii) Standardsof practice established by national medical organizations; and
(iv) This part.
(13) Participationagreements.
A participation agreement otherwiserequired by this part shall include, in part, all of the followingprovisions requiring that the provider shall:
(i) Not charge a beneficiaryfor the following:
(A) Servicesfor which the provider is entitled to payment from CHAMPUS;
(B) Servicesfor which the beneficiary would be entitled to have CHAMPUS paymentmade had the provider complied with certain procedural requirements.
(C) Servicesnot medically necessary and appropriate for the clinical managementof the presenting illness, injury, disorder or maternity;
(D) Services for whicha beneficiary would be entitled to payment but for a reduction ordenial in payment as a result of quality review; and
(E) Servicesrendered during a period in which the provider was not in compliancewith one or more conditions of authorization;
(ii) Complywith the applicable provisions of this part and related CHAMPUSadministrative policy;
(iii) Acceptthe CHAMPUS determined allowable payment combined with the cost-share,deductible, and other health insurance amounts payable by, or onbehalf of, the beneficiary, as full payment for CHAMPUS allowed services;
(iv) Collectfrom the CHAMPUS beneficiary those amounts that the beneficiaryhas a liability to pay for the CHAMPUS deductible and cost-share;
(v) Permit access bythe Director, OCHAMPUS, or designee, to the clinical record of anyCHAMPUS beneficiary, to the financial and organizational recordsof the provider, and to reports of evaluations and inspections conducted bystate, private agencies or organizations;
(vi) Provide the Director,OCHAMPUS, or designee, prompt written notification of the provider’semployment of an individual who, at any time during the twelve monthspreceding such employment, was employed in a managerial, accounting,auditing, or similar capacity by an agency or organization whichis responsible, directly or indirectly for decisions regarding Departmentof Defense payments to the provider;
(vii) Cooperate fullywith a designated utilization and clinical quality management organizationwhich has a contract with the Department of Defense for the geographicarea in which the provider renders services;
(viii) Obtain writtenauthorization before rendering designated services or items forwhich CHAMPUS cost-share may be expected;
(ix) Maintain clinicaland other records related to individuals for whom CHAMPUS paymentwas made for services rendered by the provider, or otherwise underarrangement, for a period of 60 months from the date of service;
(x) Maintaincontemporaneous clinical records that substantiate the clinicalrationale for each course of treatment, periodic evaluation of theefficacy of treatment, and the outcome at completion or discontinuationof treatment;
(xi) ReferCHAMPUS beneficiaries only to providers with which the referringprovider does not have an economic interest, as defined in Sec.199.2; and
(xii) Limitservices furnished under arrangement to those for which receiptof payment by the CHAMPUS authorized provider discharges the paymentliability of the beneficiary.
(14) Implementinginstructions.
The Director, OCHAMPUS, ora designee, shall issue CHAMPUS policies, instructions, procedures,and guidelines, as may be necessary to implement the intent of thissection.
(15) Exclusion.
Regardless of any provisionin this section, a provider who is suspended, excluded, or terminated underSec. 199.9 of this part is specifically excluded as an authorizedCHAMPUS provider.
(b) Institutionalproviders--
(1) General.
Institutional providers arethose providers who bill for services in the name of an organizationalentity (such as hospital and skilled nursing facility), rather thanin the name of a person. The term “institutional provider” doesnot include professional corporations or associations qualifyingas a domestic corporation under Sec. 301.7701-5 of the InternalRevenue Service Regulations nor does it include other corporationsthat provide principally professional services. Institutional providersmay provide medical services and supplies on either an inpatientor outpatient basis.
(i) Preauthorization.
Preauthorization may be requiredby the Director, OCHAMPUS for any health care service for whichpayment is sought under CHAMPUS. (See Secs. 199.4 and 199.15 forfurther information on preauthorization requirements.)
(ii) Billingpractices.
(A) Each institutionalbilling, including those institutions subject to the CHAMPUS DRG-based reimbursem*ntmethod or a CHAMPUS-determined all-inclusive rate reimbursem*ntmethod, must be itemized fully and sufficiently descriptive forthe CHAMPUS to make a determination of benefits.
(B) Institutionalclaims subject to the CHAMPUS DRG-based reimbursem*nt method ora CHAMPUS-determined all-inclusive rate reimbursem*nt method, maybe submitted only after the beneficiary has been discharged or transferredfrom the institutional provider’s facility or program.
(C) Institutionalclaims for Residential Treatment Centers and all other institutionalproviders, except those listed in (B) above, should be submittedto the appropriate CHAMPUS fiscal intermediary at least every 30days.
(2) Nondiscriminationpolicy.
Except as provided below, paymentmay not be made for inpatient or outpatient care provided and billedby an institutional provider found by the Federal Government topractice discrimination in the admission of patients to its serviceson the basis of race, color, or national origin. Reimbursem*nt maynot be made to a beneficiary who pays for care provided by sucha facility and submits a claim for reimbursem*nt. In the followingcirc*mstances, the Secretary of Defense, or a designee, may authorizepayment for care obtained in an ineligible facility:
(i) Emergency care.
Emergency inpatient or outpatientcare.
(ii) Carerendered before finding of a violation.
Care initiatedbefore a finding of a violation and which continues after such violationwhen it is determined that a change in the treatment facility wouldbe detrimental to the health of the patient, and the attending physicianso certifies.
(iii) Otherfacility not available.
Care provided in an ineligiblefacility because an eligible facility is not available within areasonable distance.
(3) Proceduresfor qualifying as a CHAMPUS-approved institutional provider.
General and special hospitals otherwisemeeting the qualifications outlined in paragraphs (b)(4) (i), (ii),and (iii), of this section are not required to request CHAMPUS approvalformally.
(i) JCAHaccreditation status.
Each CHAMPUS fiscal intermediaryshall keep informed as to the current JCAH accreditation statusof all hospitals and skilled nursing facilities in its area; andthe provider’s status under Medicare, particularly with regard tocompliance with title VI of the Civil Rights Act of 1964 (42 U.S.C.2000d(1)). The Director, OCHAMPUS, or a designee, shall specificallyapprove all other authorized institutional providers providing services toCHAMPUS beneficiaries. At the discretion of the Director, OCHAMPUS,any facility that is certified and participating as a provider ofservices under title XVIII of the Social Security Act (Medicare),may be deemed to meet CHAMPUS requirements. The facility must beproviding a type and level of service that is authorized by thispart.
(ii) Requiredto comply with criteria.
Facilities seeking CHAMPUSapproval will be expected to comply with appropriate criteria setforth in paragraph (b)(4) of this section. They also are requiredto complete and submit CHAMPUS Form 200, “Required Information,Facility Determination Instructions,” and provide such additional informationas may be requested by OCHAMPUS. An onsite evaluation, either scheduledor unscheduled, may be conducted at the discretion of the Director,OCHAMPUS, or a designee. The final determination regarding approval, reapproval,or disapproval of a facility will be provided in writing to thefacility and the appropriate CHAMPUS fiscal intermediary.
(iii) Noticeof peer review rights.
All health care facilitiessubject to the DRG-based payment system shall provide CHAMPUS beneficiaries,upon admission, with information about peer review including theirappeal rights. The notices shall be in a form specified by the Director,OCHAMPUS.
(iv) Surveyingof facilities.
The surveying of newly establishedinstitutional providers and the periodic resurveying of all authorizedinstitutional providers is a continuing process conducted by OCHAMPUS.
(v) Institutionsnot in compliance with CHAMPUS standards.
If a determinationis made that an institution is not in compliance with one or moreof the standards applicable to its specific category of institution,CHAMPUS shall take immediate steps to bring about compliance orterminate the approval as an authorized institution in accordance withSec. 199.9(f)(2).
(vi) Participationagreements required for some hospitals which are not Medicare-participating.
Notwithstanding the provisionsof this paragraph (B)(3), a hospital which is subject to the CHAMPUSDRG-based payment system but which is not a Medicare-participatinghospital must request and sign an agreement with OCHAMPUS. By signing theagreement, the hospital agrees to participate on all CHAMPUS inpatientclaims and accept the requirements for a participating provideras contained in paragraph (a)(8) of Sec. 199.6. Failure to signsuch an agreement shall disqualify such hospital as a CHAMPUS-approvedinstitutional provider.
(4) Categoriesof institutional providers.
The following categories ofinstitutional providers may be reimbursed by CHAMPUS for servicesprovided CHAMPUS beneficiaries subject to any and all definitions,conditions, limitation, and exclusions specified or enumerated inthis part.
(i) Hospitals,acute care, general and special.
An institution that providesinpatient services, that also may provide outpatient services (includingclinical and ambulatory surgical services), and that:
(A) Is engaged primarilyin providing to inpatients, by or under the supervision of physicians,diagnostic and therapeutic services for the medical or surgicaldiagnosis and treatment of illness, injury, or bodily malfunction (includingmaternity).
(B) Maintainsclinical records on all inpatients (and outpatients if the facilityoperates an outpatient department or emergency room).
(C) Has bylaws in effectwith respect to its operations and medical staff.
(D) Has a requirementthat every patient be under the care of a physician.
(E) Provides 24-hournursing service rendered or supervised by a registered professionalnurse, and has a licensed practical nurse or registered professionalnurse on duty at all times.
(F) Hasin effect a hospital utilization review plan that is operationaland functioning.
(G) Inthe case of an institution in a state in which state or applicablelocal law provides for the licensing of hospitals, the hospital:
(1) Is licensedpursuant to such law, or
(2) Is approved by the agency of such stateor locality responsible for licensing hospitals as meeting the standardsestablished for such licensing.
(H) Has in effect anoperating plan and budget.
(I) Isaccredited by the JCAH or meets such other requirements as the Secretaryof Health and Human Services, the Secretary of Transportation, orthe Secretary of Defense finds necessary in the interest of thehealth and safety of patients who are admitted to and furnishedservices in the institution.
Note to paragraph (b)(4)(i)(I): Forthe duration of Medicare’s “Hospitals Without Walls” initiativefor the coronavirus disease 2019 (COVID-19) outbreak, any entitythat temporarily enrolls with Medicare as a hospital may be temporarilyexempt from certain institutional requirements for acute care hospitalsunder TRICARE. To the extent practicable, the Director, DefenseHealth Agency (DHA), will adopt by administrative policy any process requirementrelated to Medicare’s Hospitals Without Walls initiative.
(ii) Organtransplant centers.
To obtain TRICARE approvalas an organ transplant center, the center must be a Medicare approvedtransplant center or meet the criteria as established by the ExecutiveDirector, TMA, or a designee.
(iii) Organtransplant consortia.
TRICARE shall approve individualpediatric organ transplant centers that meet the criteria establishedby the Executive Director, TMA, or a designee.
(iv) Hospitals,psychiatric.
A psychiatric hospital is aninstitution which is engaged primarily in providing services toinpatients for the diagnosis and treatment of mental disorders.
(A) Thereare two major categories of psychiatric hospitals:
(1) The privatepsychiatric hospital category includes both proprietary and thenot-for-profit nongovernmental institutions.
(2) The secondcategory is those psychiatric hospitals that are controlled, financed,and operated by departments or agencies of the local, state, orFederal Government and always are operated on a not-for-profit basis.
(B) Inorder for the services of a psychiatric hospital to be covered,the hospital shall comply with the provisions outlined in paragraph(b)(4)(i) of this section. All psychiatric hospitals shall be accreditedunder an accrediting organization approved by the Director, in orderfor their services to be cost-shared under CHAMPUS. In the caseof those psychiatric hospitals that are not accredited because theyhave not been in operation a sufficient period of time to be eligibleto request an accreditation survey, the Director, or a designee,may grant temporary approval if the hospital is certified and participatingunder Title XVIII of the Social Security Act (Medicare, Part A).This temporary approval expires 12 months from the date on whichthe psychiatric hospital first becomes eligible to request an accreditationsurvey by an accrediting organization approved by the Director.
(C) Factorsto be considered in determining whether CHAMPUS will cost-sharecare provided in a psychiatric hospital include, but are not limitedto, the following considerations:
(1) Is the prognosis of the patient such thatcare provided will lead to resolution or remission of the mental illnessto the degree that the patient is of no danger to others, can performroutine daily activities, and can be expected to function reasonablyoutside the inpatient setting?
(2) Can the servicesbeing provided be provided more economically in another facilityor on an outpatient basis?
(3) Arethe charges reasonable?
(4) Isthe care primarily custodial or domiciliary? (Custodial or domiciliarycare of the permanently mentally ill or retarded is not a benefitunder the Basic Program.)
(D) Although psychiatrichospitals are accredited under an accrediting organization approvedby Director, their medical records must be maintained in accordancewith accrediting organization’s current standards manual, along withthe requirements set forth in Sec. 199.7(b)(3). The hospital isresponsible for assuring that patient services and all treatmentare accurately documented and completed in a timely manner.
(v) LongTerm Care Hospital (LTCH).
LTCHs must meet all the criteriafor classification as an LTCH under 42 CFR part 412, subpart O,as well as all of the requirements of this part in order to be consideredan authorized LTCH under the TRICARE program.
(A) Inorder for the services of LTCHs to be covered, the hospitals mustcomply with the provisions outlined in paragraph (b)(4)(i) of thissection. In addition, in order for services provided by such hospitalsto be covered by TRICARE, they must be primarily for the treatmentof the presenting illness.
(B) Custodialor domiciliary care is not coverable under TRICARE, even if renderedin an otherwise authorized LTCH.
(C) The controllingfactor in determining whether a beneficiary’s stay in a LTCH iscoverable by TRICARE is the level of professional care, supervision,and skilled nursing care that the beneficiary requires, in additionto the diagnosis, type of condition, or degree of functional limitations.The type and level of medical services required or rendered is controllingfor purposes of extending TRICARE benefits; not the type of provideror condition of the beneficiary.
(vi) Skillednursing facility.
A skilled nursing facilityis an institution (or a distinct part of an institution) that is engagedprimarily in providing to inpatients medically necessary skillednursing care, which is other than a nursing home or intermediatefacility, and which:
(A) Haspolicies that are developed with the advice of (and with provisionsfor review on a periodic basis by) a group of professionals, includingone or more physicians and one or more registered nurses, to governthe skilled nursing care and related medical services it provides.
(B) Hasa physician, a registered nurse, or a medical staff responsiblefor the execution of such policies.
(C) Hasa requirement that the medical care of each patient must be underthe supervision of a physician, and provides for having a physicianavailable to furnish necessary medical care in case of an emergency.
(D) Maintains clinicalrecords on all patients.
(E) Provides24-hour skilled nursing service that is sufficient to meet nursingneeds in accordance with the policies developed as provided in paragraph(b)(4)(iv)(A) of this section, and has at least one registered professional nurseemployed full-time.
(F) Providesappropriate methods and procedures for the dispensing and administeringof drugs and biologicals.
(G) Hasin effect a utilization review plan that is operational and functioning.
(H) In the case ofan institution in a state in which state or applicable local lawprovides for the licensing of this type facility, the institution:
(1) Is licensedpursuant to such law, or
(2) Is approved by the agency of such stateor locality responsible for licensing such institutions as meetingthe standards established for such licensing.
(I) Has in effect anoperating plan and budget.
(J) Meetssuch provisions of the most current edition of the Life Safety Code1 as areapplicable to nursing facilities; except that if the Secretary ofHealth and Human Services has waived, for such periods, as deemed appropriate,specific provisions of such code which, if rigidly applied, wouldresult in unreasonable hardship upon a nursing facility.
(K) Is an authorizedprovider under the Medicare program, and meets the requirementsof Title 18 of the social Security Act, sections 1819(a), (b), (c),and (d) (42 U.S.C. 1395i-3(a)-(d)).
Note:If a pediatric SNF is certifiedby Medicaid, it will be considered to meet the Medicare certificationrequirement in order to be an authorized provider under TRICARE.
(vii) Residentialtreatment centers.
This paragraph (b)(4)(vii)establishes the definition of and eligibility standards and requirementsfor residential treatment centers (RTCs).
(A) Organizationand administration--
(1) Definition.
A Residential Treatment Center(RTC) is a facility or a distinct part of a facility that providesto beneficiaries under 21 years of age a medically supervised, interdisciplinary programof mental health treatment. An RTC is appropriate for patients whosepredominant symptom presentation is essentially stabilized, althoughnot resolved, and who have persistent dysfunction in major lifeareas. Residential treatment may be complemented by family therapyand case management for community based resources. Discharge planningshould support transitional care for the patient and family, toinclude resources available in the geographic area where the patientwill be residing. The extent and pervasiveness of the patient’sproblems require a protected and highly structured therapeutic environment.Residential treatment is differentiated from:
(i) Acute psychiatriccare, which requires medical treatment and 24-hour availabilityof a full range of diagnostic and therapeutic services to establishand implement an effective plan of care which will reverse life-threatening and/orseverely incapacitating symptoms;
(ii) Partialhospitalization, which provides a less than 24-hour-per-day, seven-day-per-weektreatment program for patients who continue to exhibit psychiatricproblems but can function with support in some of the major life areas;
(iii) A grouphome, which is a professionally directed living arrangement withthe availability of psychiatric consultation and treatment for patientswith significant family dysfunction and/or chronic but stable psychiatric disturbances;
(iv) Therapeuticschool, which is an educational program supplemented by psychologicaland psychiatric services;
(v) Facilities that treat patients with aprimary diagnosis of substance use disorder; and
(vi) Facilitiesproviding care for patients with a primary diagnosis of mental retardationor developmental disability.
(2) Eligibility.
(i) In orderto qualify as a TRICARE authorized provider, every RTC must meetthe minimum basic standards set forth in paragraphs (b)(4)(vii)(A)through (C) of this section, and as well as such additional elaborative criteriaand standards as the Director determines are necessary to implementthe basic standards.
(ii) To qualify as a TRICARE authorized provider,the facility is required to be licensed and operate in substantial compliancewith state and federal regulations.
(iii) The facilityis currently accredited by an accrediting organization approvedby the Director.
(iv) The facility has a written participationagreement with OCHAMPUS. The RTC is not a CHAMPUS-authorized providerand CHAMPUS benefits are not paid for services provided until thedate upon which a participation agreement is signed by the Director.
(B) Participationagreement requirements.
In addition to other requirementsset forth in this paragraph (b)(4)(vii), for the services of anRTC to be authorized, the RTC shall have entered into a ParticipationAgreement with OCHAMPUS. The period of a participation agreementshall be specified in the agreement, and will generally be for notmore than five years. In addition to review of a facility’s applicationand supporting documentation, an on-site inspection by OCHAMPUSauthorized personnel may be required prior to signing a ParticipationAgreement. Retroactive approval is not given. In addition, the ParticipationAgreement shall include provisions that the RTC shall, at a minimum:
(1) Render residentialtreatment center inpatient services to eligible CHAMPUS beneficiariesin need of such services, in accordance with the participation agreementand CHAMPUS regulation;
(2) Accept payment for its services basedupon the methodology provided in Sec. 199.14(f) or such other methodas determined by the Director;
(3) Acceptthe CHAMPUS all-inclusive per diem rate as payment in full and collectfrom the CHAMPUS beneficiary or the family of the CHAMPUS beneficiaryonly those amounts that represent the beneficiary’s liability, asdefined in Sec. 199.4, and charges for services and supplies thatare not a benefit of CHAMPUS;
(4) Make allreasonable efforts acceptable to the Director, to collect thoseamounts, which represents the beneficiary’s liability, as definedin Sec. 199.4;
(5) Comply with the provisions of Sec. 199.8,and submit claims first to all health insurance coverage to whichthe beneficiary is entitled that is primary to CHAMPUS;
(6) Submit claimsfor services provided to CHAMPUS beneficiaries at least every 30days (except to the extent a delay is necessitated by efforts tofirst collect from other health insurance). If claims are not submittedat least every 30 days, the RTC agrees not to bill the beneficiaryor the beneficiary’s family for any amounts disallowed by CHAMPUS;
(7) Certify that:
(i) It is andwill remain in compliance with the TRICARE standards and provisionsof paragraph (b)(4)(vii) of this section establishing standardsfor Residential Treatment Centers; and
(ii) It willmaintain compliance with the CHAMPUS Standards for Residential TreatmentCenters Serving Children and Adolescents with Mental Disorders,as issued by the Director, except for any such standards regardingwhich the facility notifies the Director that it is not in compliance.
(8) Designatean individual who will act as liaison for CHAMPUS inquiries. TheRTC shall inform OCHAMPUS in writing of the designated individual;
(9) Furnish OCHAMPUS,as requested by OCHAMPUS, with cost data certified by an independentaccounting firm or other agency as authorized by the Director, OCHAMPUS;
(10) Comply withall requirements of this section applicable to institutional providersgenerally concerning accreditation requirements, preauthorization,concurrent care review, claims processing, beneficiary liability, doublecoverage, utilization and quality review, and other matters;
(11) Grant theDirector, or designee, the right to conduct quality assurance auditsor accounting audits with full access to patients and records (includingrecords relating to patients who are not CHAMPUS beneficiaries)to determine the quality and cost-effectiveness of care rendered.The audits may be conducted on a scheduled or unscheduled (unannounced)basis. This right to audit/review includes, but is not limited to:
(i) Examinationof fiscal and all other records of the RTC which would confirm compliancewith the participation agreement and designation as a TRICARE authorizedRTC;
(ii) Conductingsuch audits of RTC records including clinical, financial, and censusrecords, as may be necessary to determine the nature of the servicesbeing provided, and the basis for charges and claims against theUnited States for services provided CHAMPUS beneficiaries;
(iii) Examiningreports of evaluations and inspections conducted by federal, stateand local government, and private agencies and organizations;
(iv) Conductingon-site inspections of the facilities of the RTC and interviewingemployees, members of the staff, contractors, board members, volunteers,and patients, as required;
(v) Audits conductedby the United States Government Accountability Office.
(C) Otherrequirements applicable to RTCs.
(1) Even though an RTC may qualify as a TRICAREauthorized provider and may have entered into a participation agreementwith CHAMPUS, payment by CHAMPUS for particular services providedis contingent upon the RTC also meeting all conditions set forthin Sec. 199.4 especially all requirements of Sec. 199.4(b)(4).
(2) The RTC shallprovide inpatient services to CHAMPUS beneficiaries in the samemanner it provides inpatient services to all other patients. TheRTC may not discriminate against CHAMPUS beneficiaries in any manner, includingadmission practices, placement in special or separate wings or rooms,or provisions of special or limited treatment.
(3) TheRTC shall assure that all certifications and information providedto the Director, incident to the process of obtaining and retainingauthorized provider status is accurate and that it has no materialerrors or omissions. In the case of any misrepresentations, whetherby inaccurate information being provided or material facts withheld, authorizedstatus will be denied or terminated, and the RTC will be ineligiblefor consideration for authorized provider status for a two yearperiod.
(viii) ChristianScience sanatoriums.
The services obtained in ChristianScience sanatoriums are covered by CHAMPUS as inpatient care. Toqualify for coverage, the sanatorium either must be operated by,or be listed and certified by the First Church of Christ, Scientist.
(ix) Infirmaries.
Infirmaries are facilitiesoperated by student health departments of colleges and universitiesto provide inpatient or outpatient care to enrolled students. Chargesfor care provided by such facilities will not be cost-shared byCHAMPUS if the student would not be charged in the absence of CHAMPUS,or if student is covered by a mandatory student health insuranceplan, in which enrollment is required as a part of the student’sschool registration and the charges by the college or universityinclude a premium for the student health insurance coverage. CHAMPUSwill cost-share only if enrollment in the student health programor health insurance plan is voluntary.
Note:An infirmary in a boardingschool also may qualify under this provision, subject to reviewand approval by the Director, OCHAMPUS or a designee.
(x) Otherspecial institution providers.
(A) General.
(1) Careprovided by certain special institutional providers (on either aninpatient or outpatient basis), may be cost-shared by CHAMPUS underspecified circ*mstances and only if the provider is specificallyidentified in paragraph (b)(4)(x) of this section.
(i) The courseof treatment is prescribed by a doctor of medicine or osteopathy.
(ii) The patientis under the supervision of a physician during the entire courseof the inpatient admission or the outpatient treatment.
(iii) The typeand level of care and service rendered by the institution are otherwiseauthorized by this part.
(iv) The facility meets all licensing or othercertification requirements that are extant in the jurisdiction inwhich the facility is located geographically.
(v) Is otherthan a nursing home, intermediate care facility, home for the aged,halfway house, or other similar institution.
(vi) Is accreditedby the JCAH or other CHAMPUS-approved accreditation organization,if an appropriate accreditation program for the given type of facilityis available. As future accreditation programs are developed to coveremerging specialized treatment programs, such accreditation willbe a prerequisite to coverage by CHAMPUS for services provided bysuch facilities.
(2) To ensurethat CHAMPUS beneficiaries are provided quality care at a reasonablecost when treated by a special institutional provider, the Director,OCHAMPUS may:
(i) Require priorapproval of all admissions to special institutional providers.
(ii) Set appropriatestandards for special institutional providers in addition to orin the absence of JCAHO accreditation.
(iii) Monitorfacility operations and treatment programs on a continuing basisand conduct onsite inspections on a scheduled and unscheduled basis.
(iv) Negotiateagreements of participation.
(v) Terminateapproval of a case when it is ascertained that a departure fromthe facts upon which the admission was based originally has occurred.
(vi) Declarea special institutional provider not eligible for CHAMPUS paymentif that facility has been found to have engaged in fraudulent ordeceptive practices.
(3) Ingeneral, the following disclaimers apply to treatment by specialinstitutional providers:
(i) Just because one period or episode oftreatment by a facility has been covered by CHAMPUS may not be construedto mean that later episodes of care by the same or similar facilitywill be covered automatically.
(ii) The factthat one case has been authorized for treatment by a specific facilityor similar type of facility may not be construed to mean that similarcases or later periods of treatment will be extended CHAMPUS benefits automatically.
(B) Types of providers.
The following is a list offacilities that have been designated specifically as special institutionalproviders.
(1) Ambulatorysurgical centers (ASC).
ASCsmust meet all criteria for classification as an Ambulatory Surgical Centerunder 42 CFR part 416, as well as all of the requirements of thispart, in order to be considered an authorized ASC under the TRICAREprogram. Care provided by an authorized TRICARE ASC may be cost-sharedunder the following circ*mstances:
(i) Achildbirth procedure provided by a CHAMPUS-approved ASC shall notbe cost-shared by CHAMPUS unless the surgical center is also a CHAMPUS-approvedbirthing center institutional provider as established by the birthingcenter provider certification requirement of this part, and thenreimbursem*nt of covered maternity care and childbirth servicesshall be subject to Sec. 199.14(e).
(ii) ASCsmust demonstrate they have a valid participation agreement withMedicare, except as provided under paragraph (b)(4)(x)(B)(1)(i) ofthis section. In addition, in order to be considered an authorizedTRICARE provider, ASCs must accept the requirements for a participatingprovider under paragraph (a)(13) of this section and must also enterinto a participation agreement with TRICARE which includes a specific“hold harmless” provision under which the facility will agree notto bill the patient for services not on the Medicare ASC procedureslist unless, the patient is advised in writing that the non-listedprocedure is not covered by TRICARE and the patient agrees, in advancein writing, to be financially liable for the non-covered procedure.
(iii) ASCsthat do not have an agreement with Medicare due to the nature ofthe patients they treat (e.g., pediatric patients) shall be accreditedby the Joint Commission, the Accreditation Association for AmbulatoryHealth Care, Inc. (AAAHC), or such other accreditation as authorizedby the Director, DHA and published in the implementing instructions.Additionally, these facilities must enter into participation agreementswith TRICARE, including the hold harmless provisions under paragraph(b)(4)(x)(B)(1)(ii) of this section, and accept the requirementsfor a participating provider under paragraph (a)(13) of this sectionin order to be an authorized TRICARE provider.
(2) [Reserved]
(xi) Birthing centers.
A birthing center is a freestandingor institution-affiliated outpatient maternity care program whichprincipally provides a planned course of outpatient prenatal careand outpatient childbirth service limited to low-risk pregnancies;excludes care for high-risk pregnancies; limits childbirth to theuse of natural childbirth procedures; and provides immediate newborncare.
(A) Certificationrequirements.
A birthing center which meetsthe following criteria may be designated as an authorized CHAMPUSinstitutional provider:
(1) Thepredominant type of service and level of care rendered by the centeris otherwise authorized by this part.
(2) The centeris licensed to operate as a birthing center where such license isavailable, or is specifically licensed as a type of ambulatory healthcare facility where birthing center specific license is not available,and meets all applicable licensing or certification requirementsthat are extant in the state, county, municipality, or other political jurisdictionin which the center is located.
(3) Thecenter is accredited by a nationally recognized accreditation organizationwhose standards and procedures have been determined to be acceptableby the Director, OCHAMPUS, or a designee.
(4) Thecenter complies with the CHAMPUS birthing center standards set forthin this part.
(5) The center has entered into a participationagreement with OCHAMPUS in which the center agrees, in part, to:
(i) Participatein CHAMPUS and accept payment for maternity services based uponthe reimbursem*nt methodology for birthing centers;
(ii) Collectfrom the CHAMPUS beneficiary only those amounts that represent thebeneficiary’s liability under the participation agreement and thereimbursem*nt methodology for birthing centers, and the amountsfor services and supplies that are not a benefit of the CHAMPUS;
(iii) Permitaccess by the Director, OCHAMPUS, or a designee, to the clinicalrecord of any CHAMPUS beneficiary, to the financial and organizationalrecords of the center, and to reports of evaluations and inspectionsconducted by state or private agencies or organizations;
(iv) Submit claimsfirst to all health benefit and insurance plans primary to the CHAMPUSto which the beneficiary is entitled and to comply with the doublecoverage provisions of this part;
(v) Notify CHAMPUSin writing within 7 days of the emergency transport of any CHAMPUSbeneficiary from the center to an acute care hospital or of thedeath of any CHAMPUS beneficiary in the center.
(6) A birthingcenter shall not be a CHAMPUS-authorized institutional providerand CHAMPUS benefits shall not be paid for any service providedby a birthing center before the date the participation agreementis signed by the Director, OCHAMPUS, or a designee.
(B) CHAMPUSbirthing center standards.
(1) Environment:
The center has a safe and sanitaryenvironment, properly constructed, equipped, and maintained to protecthealth and safety and meets the applicable provisions of the “LifeSafety Code” of the National Fire Protection Association.
(2) Policiesand procedures:
The center has written administrative,fiscal, personnel and clinical policies and procedures which collectivelypromote the provision of high-quality maternity care and childbirthservices in an orderly, effective, and safe physical and organizationalenvironment.
(3) Informed consent:
Each CHAMPUS beneficiary admittedto the center will be informed in writing at the time of admissionof the nature and scope of the center’s program and of the possiblerisks associated with maternity care and childbirth in the center.
(4) Beneficiarycare:
Each woman admitted will becared for by or under the direct supervision of a specific physicianor a specific certified nurse-midwife who is otherwise eligibleas a CHAMPUS individual professional provider.
(5) Medicaldirection:
The center has written memorandaof understanding (MOU) for routine consultation and emergency carewith an obstetrician-gynecologist who is certified or is eligiblefor certification by the American Board of Obstetrics and Gynecologyor the American Osteopathic Board of Obstetrics and Gynecology andwith a pediatrician who is certified or eligible for certificationby the American Board of Pediatrics or by the American OsteopathicBoard of Pediatrics, each of whom have admitting privileges to atleast one backup hospital. In lieu of a required MOU, the centermay employ a physician with the required qualifications. Each MOUmust be renewed annually.
(6) Admissionand emergency care criteria and procedures.
The centerhas written clinical criteria and administrative procedures, whichare reviewed and approved annually by a physician related to thecenter as required by paragraph (b)(4)(xi)(B)(5) above,for the exclusion of a woman with a high-risk pregnancy from center careand for management of maternal and neonatal emergencies.
(7) Emergencytreatment.
The center has a written memorandumof understanding (MOU) with at least one backup hospital which documentsthat the hospital will accept and treat any woman or newborn transferredfrom the center who is in need of emergency obstetrical or neonatalmedical care. In lieu of this MOU with a hospital, a birthing centermay have an MOU with a physician, who otherwise meets the requirementsas a CHAMPUS individual professional provider, and who has admittingprivileges to a backup hospital capable of providing care for criticalmaternal and neonatal patients as demonstrated by a letter fromthat hospital certifying the scope and expected duration of theadmitting privileges granted by the hospital to the physician. TheMOU must be reviewed annually.
(8) Emergencymedical transportation.
The center has a written memorandumof understanding (MOU) with at least one ambulance service whichdocuments that the ambulance service is routinely staffed by qualified personnelwho are capable of the management of critical maternal and neonatalpatients during transport and which specifies the estimated transporttime to each backup hospital with which the center has arrangedfor emergency treatment as required in paragraph (b)(4)(xi)(B)(7) above.Each MOU must be renewed annually.
(9) Professionalstaff.
The center’s professional staffis legally and professionally qualified for the performance of theirprofessional responsibilities.
(10) Medicalrecords.
The center maintains full andcomplete written documentation of the services rendered to eachwoman admitted and each newborn delivered. A copy of the informedconsent document required by paragraph (b)(4)(xi)(B)(3),above, which contains the original signature of the CHAMPUS beneficiary,signed and dated at the time of admission, must be maintained inthe medical record of each CHAMPUS beneficiary admitted.
(11) Qualityassurance.
The center has an organizedprogram for quality assurance which includes, but is not limitedto, written procedures for regularly scheduled evaluation of eachtype of service provided, of each mother or newborn transferredto a hospital, and of each death within the facility.
(12) Governanceand administration.
The center has a governingbody legally responsible for overall operation and maintenance ofthe center and a full-time employee who has authority and responsibilityfor the day-to-day operation of the center.
(xii) Psychiatricand substance use disorder partial hospitalization programs.
This paragraph (b)(4)(xii)establishes the definition of and eligibility standards and requirementsfor psychiatric and substance use disorder partial hospitalizationprograms.
(A) Organizationand administration--
(1) Definition.
Partial hospitalization isdefined as a time-limited, ambulatory, active treatment programthat offers therapeutically intensive, coordinated, and structuredclinical services within a stable therapeutic milieu. Partial hospitalizationprograms serve patients who exhibit psychiatric symptoms, disturbancesof conduct, and decompensating conditions affecting mental health.Partial hospitalization is appropriate for those whose psychiatricand addiction-related symptoms or concomitant physical and emotional/behavioralproblems can be managed outside the hospital for defined periodsof time with support in one or more of the major life areas. A partialhospitalization program for the treatment of substance use disordersis an addiction-focused service that provides active treatment tochildren and adolescents, or adults aged 18 and over.
(2) Eligibility.
(i) To qualifyas a TRICARE authorized provider, every partial hospitalizationprogram must meet minimum basic standards set forth in paragraphs(b)(4)(xii)(A) through (D) of this section, as well as such additional elaborativecriteria and standards as the Director determines are necessaryto implement the basic standards. Each partial hospitalization programmust be either a distinct part of an otherwise-authorized institutionalprovider or a free-standing program. Approval of a hospital by TRICAREis sufficient for its partial hospitalization program to be an authorizedTRICARE provider. Such hospital-based partial hospitalization programsare not required to be separately authorized by TRICARE.
(ii) To be approvedas a TRICARE authorized provider, the facility is required to belicensed and operate in substantial compliance with state and federalregulations.
(iii) The facility is required to be currentlyaccredited by an accrediting organization approved by the Director. EachPHP authorized to treat substance use disorder must be accreditedto provide the level of required treatment by an accreditation bodyapproved by the Director.
(iv) The facility is required to have a writtenparticipation agreement with OCHAMPUS. The PHP is not a CHAMPUS-authorizedprovider and CHAMPUS benefits are not paid for services provideduntil the date upon which a participation agreement is signed bythe Director.
(B) Participationagreement requirements.
In addition to other requirementsset forth in this paragraph (b)(4)(xii), in order for the servicesof a PHP to be authorized, the PHP shall have entered into a ParticipationAgreement with OCHAMPUS. A single consolidated participation agreementis acceptable for all units of the TRICARE authorized facility grantedthat all programs meet the requirements of this part. The periodof a Participation Agreement shall be specified in the agreement,and will generally be for not more than five years. The PHP shallnot be considered to be a CHAMPUS authorized provider and CHAMPUSpayments shall not be made for services provided by the PHP untilthe date the participation agreement is signed by the Director.In addition to review of a facility’s application and supportingdocumentation, an on-site inspection by OCHAMPUS authorized personnelmay be required prior to signing a participation agreement. TheParticipation Agreement shall include at least the following requirements:
(1) Render partialhospitalization program services to eligible CHAMPUS beneficiariesin need of such services, in accordance with the participation agreementand CHAMPUS regulation.
(2) Accept payment for its services basedupon the methodology provided in Sec. 199.14, or such other method asdetermined by the Director;
(3) Acceptthe CHAMPUS all-inclusive per diem rate as payment in full and collectfrom the CHAMPUS beneficiary or the family of the CHAMPUS beneficiaryonly those amounts that represent the beneficiary’s liability, asdefined in Sec. 199.4, and charges for services and supplies thatare not a benefit of CHAMPUS;
(4) Make allreasonable efforts acceptable to the Director to collect those amounts,which represent the beneficiary’s liability, as defined in Sec.199.4;
(5) Comply with the provisions of Sec. 199.8,and submit claims first to all health insurance coverage to whichthe beneficiary is entitled that is primary to CHAMPUS;
(6) Submit claimsfor services provided to CHAMPUS beneficiaries at least every 30days (except to the extent a delay is necessitated by efforts tofirst collect from other health insurance). If claims are not submittedat least every 30 days, the PHP agrees not to bill the beneficiaryor the beneficiary’s family for any amounts disallowed by CHAMPUS;
(7) Certify that:
(i) It is andwill remain in compliance with the TRICARE standards and provisionsof paragraph (b)(4)(xii) of this section establishing standardsfor psychiatric and substance use disorder partial hospitalizationprograms; and
(ii) It will maintain compliance with the CHAMPUSStandards for Psychiatric Substance Use Disorder Partial HospitalizationPrograms, as issued by the Director, except for any such standardsregarding which the facility notifies the Director, or designee,that it is not in compliance.
(8) Designatean individual who will act as liaison for CHAMPUS inquiries. ThePHP shall inform the Director, or designee, in writing of the designatedindividual;
(9) Furnish OCHAMPUS, as requested by OCHAMPUS,with cost data certified by an independent accounting firm or otheragency as authorized by the Director;
(10) Comply withall requirements of this section applicable to institutional providersgenerally concerning accreditation requirements, preauthorization,concurrent care review, claims processing, beneficiary liability, doublecoverage, utilization and quality review, and other matters;
(11) Grant theDirector, or designee, the right to conduct quality assurance auditsor accounting audits with full access to patients and records (includingrecords relating to patients who are not CHAMPUS beneficiaries)to determine the quality and cost-effectiveness of care rendered.The audits may be conducted on a scheduled or unscheduled (unannounced)basis. This right to audit/review includes, but is not limited to:
(i) Examinationof fiscal and all other records of the PHP which would confirm compliancewith the participation agreement and designation as a TRICARE authorizedPHP provider;
(ii) Conducting such audits of PHP recordsincluding clinical, financial, and census records, as may be necessary todetermine the nature of the services being provided, and the basisfor charges and claims against the United States for services providedCHAMPUS beneficiaries;
(iii) Examining reports of evaluations and inspectionsconducted by federal, state and local government, and private agenciesand organizations;
(iv) Conducting on-site inspections of thefacilities of the PHP and interviewing employees, members of thestaff, contractors, board members, volunteers, and patients, asrequired;
(v) Audits conducted by the United StatesGeneral Account Office.
(C) Otherrequirements applicable to PHPs.
(1) Even though a PHP may qualify as a TRICAREauthorized provider and may have entered into a participation agreementwith CHAMPUS, payment by CHAMPUS for particular services providedis contingent upon the PHP also meeting all conditions set forthin Sec. 199.4.
(2) The PHP may not discriminate against CHAMPUSbeneficiaries in any manner, including admission practices, placementin special or separate wings or rooms, or provisions of specialor limited treatment.
(3) ThePHP shall assure that all certifications and information providedto the Director incident to the process of obtaining and retainingauthorized provider status is accurate and that is has no materialerrors or omissions. In the case of any misrepresentations, whetherby inaccurate information being provided or material facts withheld, authorizedprovider status will be denied or terminated, and the PHP will beineligible for consideration for authorized provider status fora two year period.
(xiii) Hospice programs.
Hospice programs must be Medicareapproved and meet all Medicare conditions of participation (42 CFRpart 418) in relation to CHAMPUS patients in order to receive paymentunder the CHAMPUS program. A hospice program may be found to beout of compliance with a particular Medicare condition of participationand still participate in the CHAMPUS as long as the hospice is allowedcontinued participation in Medicare while the condition of noncomplianceis being corrected. The hospice program can be either a public agencyor private organization (or a subdivision thereof) which:
(A) Isprimarily engaged in providing the care and services described underSec. 199.4(e)(19) and makes such services available on a 24-hourbasis.
(B) Providesbereavement counseling for the immediate family or terminally illindividuals.
(C) Providesfor such care and services in individuals’ homes, on an outpatientbasis, and on a short-term inpatient basis, directly or under arrangementsmade by the hospice program, except that the agency or organizationmust:
(1) Ensure thatsubstantially all the core services are routinely provided directlyby hospice employees.
(2) Maintain professional management responsibilityfor all services which are not directly furnished to the patient,regardless of the location or facility in which the services arerendered.
(3) Provideassurances that the aggregate number of days of inpatient care providedin any 12-month period does not exceed 20 percent of the aggregatenumber of days of hospice care during the same period.
(4) Havean interdisciplinary group composed of the following personnel whoprovide the care and services described under Sec. 199.4(e)(19)and who establish the policies governing the provision of such care/services:
(i) A physician;
(ii) A registeredprofessional nurse;
(iii) A social worker; and
(iv) A pastoralor other counselor.
(5) Maintaincentral clinical records on all patients.
(6) Utilize volunteers.
(7) The hospiceand all hospice employees must be licensed in accordance with applicableFederal, State and local laws and regulations.
(8) The hospicemust enter into an agreement with CHAMPUS in order to be qualifiedto participate and to be eligible for payment under the program.In this agreement the hospice and CHAMPUS agree that the hospicewill:
(i) Not chargethe beneficiary or any other person for items or services for whichthe beneficiary is entitled to have payment made under the CHAMPUShospice benefit.
(ii) Be allowed to charge the beneficiary foritems or services requested by the beneficiary in addition to those thatare covered under the CHAMPUS hospice benefit.
(9) Meet suchother requirements as the Secretary of Defense may find necessaryin the interest of the health and safety of the individuals whoare provided care and services by such agency or organization.
(xiv) Substanceuse disorder rehabilitation facilities.
This paragraph(b)(4)(xiv) establishes the definition of eligibility standardsand requirements for residential substance use disorder rehabilitationfacilities (SUDRF).
(A) Organizationand administration--
(1) Definition.
A SUDRF is a residential orrehabilitation facility, or distinct part of a facility, that providesmedically monitored, interdisciplinary addiction-focused treatmentto beneficiaries who have psychoactive substance use disorders.Qualified health care professionals provide 24-hour, seven-day-per-week,assessment, treatment, and evaluation. A SUDRF is appropriate forpatients whose addiction-related symptoms, or concomitant physicaland emotional/behavioral problems reflect persistent dysfunctionin several major life areas. Residential or inpatient rehabilitationis differentiated from:
(i) Acute psychoactive substance use treatmentand from treatment of acute biomedical/emotional/behavioral problems;which problems are either life-threatening and/or severely incapacitatingand often occur within the context of a discrete episode of addiction-relatedbiomedical or psychiatric dysfunction;
(ii) A partialhospitalization center, which serves patients who exhibit emotional/behavioraldysfunction but who can function in the community for defined periodsof time with support in one or more of the major life areas;
(iii) A grouphome, sober-living environment, halfway house, or three-quarterway house;
(iv) Therapeutic schools, which are educationalprograms supplemented by addiction-focused services;
(v) Facilitiesthat treat patients with primary psychiatric diagnoses other thanpsychoactive substance use or dependence; and
(vi) Facilitiesthat care for patients with the primary diagnosis of mental retardationor developmental disability.
(2) Eligibility.
(i) In orderto become a TRICARE authorized provider, every SUDRF must meet minimumbasic standards set forth in paragraphs (b)(4)(xiv)(A) through (C)of this section, as well as such additional elaborative criteriaand standards as the Director determines are necessary to implementthe basic standards.
(ii) To be approved as a TRICARE authorizedprovider, the SUDRF is required to be licensed and operate in substantialcompliance with state and federal regulations.
(iii) The SUDRFis currently accredited by an accrediting organization approvedby the Director. Each SUDRF must be accredited to provide the levelof required treatment by an accreditation body approved by the Director.
(iv) The SUDRFhas a written participation agreement with OCHAMPUS. The SUDRF isnot considered a TRICARE authorized provider, and CHAMPUS benefitsare not paid for services provided until the date upon which a participationagreement is signed by the Director.
(B) Participationagreement requirements.
In addition to other requirementsset forth in this paragraph (b)(4)(xiv), in order for the servicesof an inpatient rehabilitation center for the treatment of substanceuse disorders to be authorized, the center shall have entered intoa Participation Agreement with OCHAMPUS. A single consolidated participationagreement is acceptable for all units of the TRICARE authorizedfacility. The period of a Participation Agreement shall be specifiedin the agreement, and will generally be for not more than five years.The SUDRF shall not be considered to be a CHAMPUS authorized providerand CHAMPUS payments shall not be made for services provided bythe SUDRF until the date the participation agreement is signed bythe Director. In addition to review of the SUDRF’s application andsupporting documentation, an on-site visit by OCHAMPUS representativesmay be part of the authorization process. The Participation Agreementshall include at least the following requirements:
(1) Render applicableservices to eligible CHAMPUS beneficiaries in need of such services,in accordance with the participation agreement and CHAMPUS regulation;
(2) Accept paymentfor its services based upon the methodology provided in Sec. 199.14,or such other method as determined by the Director;
(3) Acceptthe CHAMPUS-determined rate as payment in full and collect fromthe CHAMPUS beneficiary or the family of the CHAMPUS beneficiaryonly those amounts that represent the beneficiary’s liability, asdefined in Sec. 199.4, and charges for services and supplies thatare not a benefit of CHAMPUS;
(4) Make allreasonable efforts acceptable to the Director to collect those amountswhich represent the beneficiary’s liability, as defined in Sec.199.4;
(5) Comply with the provisions of Sec. 199.8,and submit claims first to all health insurance coverage to whichthe beneficiary is entitled that is primary to CHAMPUS;
(6) Furnish OCHAMPUSwith cost data, as requested by OCHAMPUS, certified to by an independentaccounting firm or other agency as authorized by the Director;
(7) Certify that:
(i) It is andwill remain in compliance with the provisions of paragraph (b)(4)(xiv)of the section establishing standards for substance use disorderrehabilitation facilities; and
(ii) It has conducteda self-assessment of the facility’s compliance with the CHAMPUSStandards for Substance Use Disorder Rehabilitation Facilities,as issued by the Director and notified the Director of any matterregarding which the facility is not in compliance with such standards;and
(iii) It willmaintain compliance with the CHAMPUS Standards for Substance UseDisorder Rehabilitation Facilities, as issued by the Director, exceptfor any such standards regarding which the facility notifies theDirector that it is not in compliance.
(8) Designatean individual who will act as liaison for CHAMPUS inquiries. TheSUDRF shall inform OCHAMPUS in writing of the designated individual;
(9) Furnish OCHAMPUS,as requested by OCHAMPUS, with cost data certified by an independentaccounting firm or other agency as authorized by the Director;
(10) Complywith all requirements of this section applicable to institutionalproviders generally concerning accreditation requirements, preauthorization,concurrent care review, claims processing, beneficiary liability, doublecoverage, utilization and quality review, and other matters;
(11) Grant theDirector, or designee, the right to conduct quality assurance auditsor accounting audits with full access to patients and records (includingrecords relating to patients who are not CHAMPUS beneficiaries)to determine the quality and cost effectiveness of care rendered.The audits may be conducted on a scheduled or unscheduled (unannounced)basis. This right to audit/review included, but is not limited to:
(i) Examinationof fiscal and all other records of the center which would confirmcompliance with the participation agreement and designation as anauthorized TRICARE provider;
(ii) Conductingsuch audits of center records including clinical, financial, andcensus records, as may be necessary to determine the nature of theservices being provided, and the basis for charges and claims againstthe United States for services provided CHAMPUS beneficiaries;
(iii) Examiningreports of evaluations and inspection conducted by federal, stateand local government, and private agencies and organizations;
(iv) Conductingon-site inspections of the facilities of the SUDRF and interviewingemployees, members of the staff, contractors, board members, volunteers,and patients, as required.
(v) Audits conductedby the United States Government Accountability Office.
(C) Otherrequirements applicable to substance use disorder rehabilitationfacilities.
(1) Even thougha SUDRF may qualify as a TRICARE authorized provider and may haveentered into a participation agreement with CHAMPUS, payment byCHAMPUS for particular services provided is contingent upon theSUDRF also meeting all conditions set forth in Sec. 199.4.
(2) The centershall provide inpatient services to CHAMPUS beneficiaries in thesame manner it provides services to all other patients. The centermay not discriminate against CHAMPUS beneficiaries in any manner,including admission practices, placement in special or separatewings or rooms, or provisions of special or limited treatment.
(3) Thesubstance use disorder facility shall assure that all certificationsand information provided to the Director, incident to the processof obtaining and retaining authorized provider status, is accurateand that it has no material errors or omissions. In the case ofany misrepresentations, whether by inaccurate information beingprovided or material facts withheld, authorized provider statuswill be denied or terminated, and the facility will be ineligiblefor consideration for authorized provider status for a two yearperiod.
(xv) Homehealth agencies (HHAs).
HHAs must be Medicare approvedand meet all Medicare conditions of participation under sections1861(o) and 1891 of the Social Security Act (42 U.S.C. 1395x(o)and 1395bbb) and 42 CFR part 484 in relation to TRICARE beneficiariesin order to receive payment under the TRICARE program. An HHA maybe found to be out of compliance with a particular Medicare conditionof participation and still participate in the TRICARE program aslong as the HHA is allowed continued participation in Medicare whilethe condition of noncompliance is being corrected. An HHA is a publicor private organization, or a subdivision of such an agency or organization,that meets the following requirements:
(A) Engaged in providingskilled nursing services and other therapeutic services, such asphysical therapy, speech-language pathology services, or occupationaltherapy, medical services, and home health aide services.
(1) Makes availablepart-time or intermittent skilled nursing services and at leastone other therapeutic service on a visiting basis in place of residenceused as a patient’s home.
(2) Furnishes at least one of the qualifyingservices directly through agency employees, but may furnish the secondqualifying service and additional services under arrangement withanother HHA or organization.
(B) Policiesestablished by a professional group associated with the agency ororganization (including at least one physician and one registerednurse) to govern the services and provides for supervision of suchservices by a physician or a registered nurse.
(C) Maintainsclinical records for all patients.
(D) Licensed in accordancewith State and local law or is approved by the State or local licensingagency as meeting the licensing standards, where applicable.
(E) Entersinto an agreement with TRICARE in order to participate and to beeligible for payment under the program. In this agreement the HHAand TRICARE agree that the HHA will:
(1) Not charge the beneficiary or any otherperson for items or services for which the beneficiary is entitledto have payment under the TRICARE HHA prospective payment system.
(2) Be allowedto charge the beneficiary for items or services requested by thebeneficiary in addition to those that are covered under the TRICAREHHA prospective payment system.
(F) Abideby the following consolidated billing requirements:
(1) The HHA mustsubmit all TRICARE claims for all home health services, excludingdurable medical equipment (DME), while the beneficiary is underthe home health plan without regard to whether or not the item orservice was furnished by the HHA, by others under arrangement withthe HHA, or under any other contracting or consulting arrangement.
(2) Separatepayment will be made for DME items and services provided under thehome health benefit which are under the DME fee schedule. DME isexcluded from the consolidated billing requirements.
(3) Homehealth services included in consolidated billing are:
(i) Part-timeor intermittent skilled nursing;
(ii) Part-timeor intermittent home health aide services;
(iii) Physicaltherapy, occupational therapy and speech-language pathology;
(iv) Medicalsocial services;
(v) Routine and non-routine medical supplies;
(vi) A coveredosteoporosis drug (not paid under PPS rate) but excluding otherdrugs and biologicals;
(vii) Medical services provided by an internor resident-in-training of a hospital, under an approved teaching programof the hospital in the case of an HHA that is affiliated or undercommon control of a hospital;
(viii) Servicesat hospitals, SNFs or rehabilitation centers when they involve equipmenttoo cumbersome to bring home.
(G) Meet such otherrequirements as the Secretary of Health and Human Services and/orSecretary of Defense may find necessary in the interest of the healthand safety of the individuals who are provided care and servicesby such agency or organization.
(xvi) Critical Access Hospitals(CAHs).
CAHs must meet all conditionsof participation under 42 CFR 485.601 through 485.645 in relationto TRICARE beneficiaries in order to receive payment under the TRICAREprogram. If a CAH provides inpatient psychiatric services or inpatientrehabilitation services in a distinct part unit, the distinct partunit must meet the conditions of participation in 42 CFR 485.647,with the exception of being paid under the inpatient prospectivepayment system for psychiatric facilities as specified in 42 CFR412.1(a)(2) or the inpatient prospective payment system for rehabilitationhospitals or rehabilitation units as specified in 42 CFR 412.1(a)(3). Uponimplementation of TRICARE’s IRF PPS in Sec. 199.14(a)(10), if aCAH provides inpatient rehabilitation services in a distinct partunit, the distinct part unit shall be paid under TRICARE’s IRF PPS.
(xvii) Solecommunity hospitals (SCHs).
SCHs must meet all the criteriafor classification as an SCH under 42 CFR 412.92, in order to beconsidered an SCH under the TRICARE program.
(xviii) Intensiveoutpatient programs.
This paragraph (b)(4)(xviii)establishes standards and requirements for intensive outpatienttreatment programs for psychiatric and substance use disorder.
(A) Organizationand administration--
(1) Definition.
Intensive outpatient treatment(IOP) programs are defined in Sec. 199.2. IOP services consist ofa comprehensive and complimentary schedule of recognized treatment approachesthat may include day, evening, night, and weekend services consistingof individual and group counseling or therapy, and family counselingor therapy as clinically indicated for children and adolescents,or adults aged 18 and over, and may include case management to linkpatients and their families with community based support systems.
(2) Eligibility.
(i) In orderto qualify as a TRICARE authorized provider, every intensive outpatientprogram must meet the minimum basic standards set forth in paragraphs(b)(4)(xviii)(A) through (C) of this section, as well as additionalelaborative criteria and standards as the Director determines arenecessary to implement the basic standards. Each intensive outpatientprogram must be either a distinct part of an otherwise-authorized institutionalprovider or a free-standing psychiatric or substance use disorderintensive outpatient program. Approval of a hospital by TRICAREis sufficient for its IOP to be an authorized TRICARE provider.Such hospital-based intensive outpatient programs are not requiredto be separately authorized by TRICARE.
(ii) To qualifyas a TRICARE authorized provider, the IOP is required to be licensedand operate in substantial compliance with state and federal regulations.
(iii) The IOPis currently accredited by an accrediting organization approvedby the Director. Each IOP authorized to treat substance use disordermust be accredited to provide the level of required treatment byan accreditation body approved by the Director.
(iv) The facilityhas a written participation agreement with TRICARE. The IOP is notconsidered a TRICARE authorized provider and TRICARE benefits arenot paid for services provided until the date upon which a participationagreement is signed by the Director.
(B) Participationagreement requirements.
In addition to other requirementsset forth in paragraph (b)(4)(xii) of this section, in order forthe services of an IOP to be authorized, the IOP shall have enteredinto a Participation Agreement with TRICARE. A single consolidatedparticipation agreement is acceptable for all units of the TRICARE authorizedfacility granted that all programs meet the requirements of thispart. The period of a Participation Agreement shall be specifiedin the agreement, and will generally be for not more than five years.In addition to review of a facility’s application and supportingdocumentation, an on-site inspection by DHA authorized personnelmay be required prior to signing a participation agreement. TheParticipation Agreement shall include at least the following requirements:
(1) Render intensiveoutpatient program services to eligible TRICARE beneficiaries inneed of such services, in accordance with the participation agreementand TRICARE regulation.
(2) Accept payment for its services basedupon the methodology provided in Sec. 199.14, or such other method asdetermined by the Director;
(3) Collectfrom the TRICARE beneficiary or the family of the TRICARE beneficiaryonly those amounts that represent the beneficiary’s liability, asdefined in Sec. 199.4, and charges for services and supplies thatare not a benefit of TRICARE;
(4) Make allreasonable efforts acceptable to the Director to collect those amounts,which represent the beneficiary’s liability, as defined in Sec.199.4;
(5) Comply with the provisions of Sec. 199.8,and submit claims first to all health insurance coverage to whichthe beneficiary is entitled that is primary to TRICARE;
(6) Submit claimsfor services provided to TRICARE beneficiaries at least every 30days (except to the extent a delay is necessitated by efforts tofirst collect from other health insurance). If claims are not submittedat least every 30 days, the IOP agrees not to bill the beneficiaryor the beneficiary’s family for any amounts disallowed by TRICARE;
(7) Free-standingintensive outpatient programs shall certify that:
(i) It is andwill remain in compliance with the provisions of paragraph (b)(4)(xii)of this section establishing standards for psychiatric and SUD IOPs;
(ii) It has conducteda self-assessment of the facility’s compliance with the CHAMPUSStandards for Intensive Outpatient Programs, as issued by the Director,and notified the Director of any matter regarding which the facility isnot in compliance with such standards; and
(iii) It willmaintain compliance with the TRICARE standards for IOPs, as issuedby the Director, except for any such standards regarding which thefacility notifies the Director, or a designee that it is not incompliance.
(8) Designate an individual who will act asliaison for TRICARE inquiries. The IOP shall inform TRICARE, ora designee in writing of the designated individual;
(9) Furnish OCHAMPUSwith cost data, as requested by OCHAMPUS, certified by an independentaccounting firm or other agency as authorized by the Director.
(10) Comply withall requirements of this section applicable to institutional providersgenerally concerning accreditation requirements, preauthorization,concurrent care review, claims processing, beneficiary liability, doublecoverage, utilization and quality review, and other matters;
(11) Grant theDirector, or designee, the right to conduct quality assurance auditsor accounting audits with full access to patients and records (includingrecords relating to patients who are not CHAMPUS beneficiaries)to determine the quality and cost effectiveness of care rendered.The audits may be conducted on a scheduled or unscheduled (unannounced)basis. This right to audit/review included, but is not limited to:
(i) Examinationof fiscal and all other records of the center which would confirmcompliance with the participation agreement and designation as anauthorized TRICARE provider;
(ii) Conductingsuch audits of center records including clinical, financial, andcensus records, as may be necessary to determine the nature of theservices being provided, and the basis for charges and claims againstthe United States for services provided CHAMPUS beneficiaries;
(iii) Examiningreports of evaluations and inspection conducted by federal, stateand local government, and private agencies and organizations;
(iv) Conductingon-site inspections of the facilities of the IOP and interviewingemployees, members of the staff, contractors, board members, volunteers,and patients, as required.
(v) Audits conductedby the United States Government Accountability Office.
(C) Otherrequirements applicable to Intensive Outpatient Programs (IOP).
(1) Even thoughan IOP may qualify as a TRICARE authorized provider and may haveentered into a participation agreement with CHAMPUS, payment by CHAMPUSfor particular services provided is contingent upon the IOP alsomeeting all conditions set forth in Sec. 199.4.
(2) The IOP maynot discriminate against CHAMPUS beneficiaries in any manner, includingadmission practices, placement in special or separate wings or rooms,or provisions of special or limited treatment.
(3) TheIOP shall assure that all certifications and information providedto the Director incident to the process of obtaining and retainingauthorized provider status is accurate and that is has no materialerrors or omissions. In the case of any misrepresentations, whetherby inaccurate information being provided or material facts withheld, authorizedprovider status will be denied or terminated, and the IOP will beineligible for consideration for authorized provider status fora two year period.
(xix) OpioidTreatment Programs (OTPs).
This paragraph (b)(4)(xix)establishes standards and requirements for Opioid Treatment Programs.
(A) Organizationand administration.
(1) Definition.
Opioid Treatment Programs (OTPs)are defined in Sec. 199.2. Opioid Treatment Programs (OTPs) areorganized, ambulatory, addiction treatment services for patientswith an opioid use disorder. OTPs have the capacity to provide dailydirect administration of medications without the prescribing ofmedications. Medication supplies for patients to take outside ofOTPs originate from within OTPs. OTPs offer medication assistedtreatment, patient-centered, recovery-oriented individualized treatmentthrough addiction counseling, mental health therapy, case management,and health education.
(2) Eligibility.
(i) Every free-standingOpioid Treatment Program must be accredited by an accrediting organizationrecognized by Director, under the current standards of an accreditingorganization, as well as meet additional elaborative criteria andstandards as the Director determines are necessary to implementthe basic standards. OTPs adhere to requirements of the Departmentof Health and Human Services’ 42 CFR part 8, the Substance Abuseand Mental Health Services Administration’s Center for SubstanceAbuse Treatment, and the Drug Enforcement Agency. OTPs must be eithera distinct part of an otherwise authorized institutional provideror a free-standing program. Approval of hospitals by TRICARE issufficient for their OTPs to be authorized TRICARE providers. Suchhospital-based OTPs, if certified under 42 CFR 8, are not requiredto be separately authorized by TRICARE.
(ii) To qualifyas a TRICARE authorized provider, OTPs are required to be licensedand operate in substantial compliance with state and federal regulations.
(iii) OTPs havea written participation agreement with OCHAMPUS. OTPs are not considereda TRICARE authorized provider, and CHAMPUS benefits are not paidfor services provided until the date upon which a participationagreement is signed by the Director.
(B) Participationagreement requirements.
In addition to other requirementsset forth in this paragraph (b)(4)(xix), in order for the servicesof OTPs to be authorized, OTPs shall have entered into a ParticipationAgreement with TRICARE. A single consolidated participation agreementis acceptable for all units of a TRICARE authorized facility. Theperiod of a Participation Agreement shall be specified in the agreement,and will generally be for not more than five years. In additionto review of a facility’s application and supporting documentation,an on-site inspection by DHA authorized personnel may be requiredprior to signing a participation agreement. The Participation Agreementshall include at least the following requirements:
(1) Render servicesfrom OTPs to eligible TRICARE beneficiaries in need of such services,in accordance with the participation agreement and TRICARE regulation.
(2) Accept paymentfor its services based upon the methodology provided in Sec. 199.14,or such other method as determined by the Director;
(3) Collectfrom the TRICARE beneficiary or the family of the TRICARE beneficiaryonly those amounts that represent the beneficiary’s liability, asdefined in Sec. 199.4, and charges for services and supplies thatare not a benefit of TRICARE;
(4) Make allreasonable efforts acceptable to the Director to collect those amounts,which represent the beneficiary’s liability, as defined in Sec.199.4;
(5) Comply with the provisions of Sec. 199.8,and submit claims first to all health insurance coverage to whichthe beneficiary is entitled that is primary to TRICARE;
(6) Submit claimsfor services provided to TRICARE beneficiaries at least every 30days (except to the extent a delay is necessitated by efforts tofirst collect from other health insurance). If claims are not submittedat least every 30 days, OTPs agree not to bill the beneficiary orthe beneficiary’s family for any amounts disallowed by TRICARE;
(7) Free-standingopioid treatment programs shall certify that:
(i) It is andwill remain in compliance with the provisions of paragraph (b)(4)(xii)of this section establishing standards for opioid treatment programs;
(ii) It willmaintain compliance with the TRICARE standards for OTPs, as issuedby the Director, except for any such standards regarding which thefacility notifies the Director, or a designee, that it is not incompliance.
(8) Designate an individual who will act asliaison for TRICARE inquiries. OTPs shall inform TRICARE, or a designee, inwriting of the designated individual;
(9) Furnish TRICARE,or a designee, with cost data, as requested by TRICARE, certifiedby an independent accounting firm or other agency as authorizedby the Director;
(10) Comply with all requirements of this sectionapplicable to institutional providers generally concerning accreditationrequirements, claims processing, beneficiary liability, double coverage,utilization and quality review, and other matters;
(11) Grant theDirector, or designee, the right to conduct quality assurance auditsor accounting audits with full access to patients and records (includingrecords relating to patients who are not TRICARE beneficiaries)to determine the quality and cost effectiveness of care rendered.The audits may be conducted on a scheduled or unscheduled (unannounced)basis. This right to audit/review includes, but is not limited to:
(i) Examinationof fiscal and all other records of OTPs which would confirm compliancewith the participation agreement and designation as an authorizedTRICARE provider;
(ii) Conducting such audits of OTPs’ recordsincluding clinical, financial, and census records, as may be necessary todetermine the nature of the services being provided, and the basisfor charges and claims against the United States for services providedTRICARE beneficiaries;
(iii) Examining reports of evaluations and inspectionsconducted by federal, state and local government, and private agenciesand organizations.
(C) Otherrequirements applicable to OTPs.
(1) Even though OTPs may qualify as a TRICAREauthorized provider and may have entered into a participation agreementwith CHAMPUS, payment by CHAMPUS for particular services providedis contingent upon OTPs also meeting all conditions set forth inSec. 199.4.
(2) OTPs may not discriminate against CHAMPUSbeneficiaries in any manner, including admission practices or provisionsof special or limited treatment.
(3) OTPsshall assure that all certifications and information provided tothe Director incident to the process of obtaining and retainingauthorized provider status is accurate and that is has no materialerrors or omissions. In the case of any misrepresentations, whetherby inaccurate information being provided or material facts withheld, authorizedprovider status will be denied or terminated, and OTPs will be ineligiblefor consideration for authorized provider status for a two yearperiod.
(xx) Inpatient RehabilitationFacility (IRF).
IRFs must meet all the criteriafor classification as an IRF under 42 CFR part 412, subpart B, andmeet all applicable requirements established in this part in orderto be considered an authorized IRF under the TRICARE program.
(A) Inorder for the services of inpatient rehabilitation facilities tobe covered, the facility must comply with the provisions outlinedin paragraph (b)(4)(i) of this section. In addition, in order forservices provided by these facilities to be covered by TRICARE,they must be primarily for the treatment of the presenting illness.
(B) Custodialor domiciliary care is not coverable under TRICARE, even if renderedin an otherwise authorized inpatient rehabilitation facility.
(C) Thecontrolling factor in determining whether a beneficiary’s stay inan inpatient rehabilitation facility is coverable by TRICARE isthe level of professional care, supervision, and skilled nursingcare that the beneficiary requires, in addition to the diagnosis,type of condition, or degree of functional limitations. The typeand level of medical services required or rendered is controllingfor purposes of extending TRICARE benefits; not the type of provideror condition of the beneficiary.
(5) FreestandingEnd Stage Renal Disease (ESRD) facilities.
FreestandingESRD facilities must be Medicare certified and meet all Medicareconditions for coverage as provided in 42 CFR part 494, and be classifiedas freestanding ESRD facilities by Medicare, in order to be approvedas TRICARE-authorized institutional providers and receive paymentunder the TRICARE program. State licensing are not required in casesof a freestanding ESRD facility located in a State that does notlicense such facilities. Freestanding ESRD facilities are not hospital-affiliatednor hospital-based and are reimbursed based on the payment methodologyestablished in Sec. 199.14(c). Freestanding ESRD facilities renderoutpatient hemodialysis or peritoneal dialysis services in the ESRDfacility or in a patient’s home for the treatment of ESRD and acutekidney injury (AKI).
(c) Individualprofessional providers of care--
(1) General--
(i) Purpose.
This individual professionalprovider class is established to accommodate individuals who arerecognized by 10 U.S.C. 1079(a) as authorized to assess or diagnoseillness, injury, or bodily malfunction as a prerequisite for CHAMPUScost-share of otherwise allowable related preventive or treatmentservices or supplies, and to accommodate such other qualified individualswho the Director, OCHAMPUS, or designee, may authorize to renderotherwise allowable services essential to the efficient implementationof a plan-of-care established and managed by a 10 U.S.C. 1079(a)authorized professional.
(ii) Professionalcorporation affiliation or association membership permitted.
Paragraph (c) of this sectionapplies to those individual health care professionals who have formeda professional corporation or association pursuant to applicablestate laws. Such a professional corporation or association may fileclaims on behalf of a CHAMPUS-authorized individual professionalprovider and be the payee for any payment resulting from such claimswhen the CHAMPUS-authorized individual certifies to the Director,OCHAMPUS, or designee, in writing that the professional corporationor association is acting on the authorized individual’s behalf.
(iii) Scopeof practice limitation.
For CHAMPUS cost-sharing tobe authorized, otherwise allowable services provided by a CHAMPUS-authorizedindividual professional provider shall be within the scope of theindividual’s license as regulated by the applicable state practiceact of the state where the individual rendered the service to theCHAMPUS beneficiary or shall be within the scope of the test whichwas the basis for the individual’s qualifying certification.
(iv) Employeestatus exclusion.
An individual employed directly,or indirectly by contract, by an individual or entity to renderprofessional services otherwise allowable by this part is excludedfrom provider status as established by this paragraph (c) for theduration of each employment.
(v) Trainingstatus exclusion.
Individual health care professionalswho are allowed to render health care services only under directand ongoing supervision as training to be credited towards earninga clinical academic degree or other clinical credential requiredfor the individual to practice independently are excluded from providerstatus as established by this paragraph (c) for the duration ofsuch training.
(2) Conditionsof authorization--
(i) Professionallicense requirement.
The individual must be currentlylicensed to render professional health care services in each statein which the individual renders services to CHAMPUS beneficiaries.Such license is required when a specific state provides, but doesnot require, license for a specific category of individual professionalprovider. The license must be at full clinical practice level tomeet this requirement. A temporary license at the full clinicalpractice level is acceptable. During the period of national emergencyfor the global coronavirus 2019 (COVID-19) pandemic, a license isnot required in the United States for each state in which the providerpractices, so long as the provider holds an equivalent license inanother state, the state in which the provider is practicing permitssuch practice under its interstate licensing requirements or the statelicensing requirements have been preempted by Federal law, and theprovider is not affirmatively barred or restricted from practicingin any state. During the COVID-19 pandemic, providers overseas arenot required to be licensed in each nation in which the provideroperates, so long as the provider holds an equivalent license in anothernation, the host nation permits such practice under its licensingrequirements, and the provider is not on the Department of Healthand Human Services sanction list.
(ii) Professionalcertification requirement.
When a state does not licensea specific category of individual professional, certification bya Qualified Accreditation Organization, as defined in Sec. 199.2,is required. Certification must be at full clinical practice level.A temporary certification at the full clinical practice level is acceptable.
(iii) Education,training and experience requirement.
The Director,OCHAMPUS, or designee, may establish for each category or type ofprovider allowed by this paragraph (c) specific education, training,and experience requirements as necessary to promote the deliveryof services by fully qualified individuals.
(iv) Physicianreferral and supervision.
When physician referral andsupervision is a prerequisite for CHAMPUS cost-sharing of the servicesof a provider authorized under this paragraph (c), such referraland supervision means that the physicians must actually see thepatient to evaluate and diagnose the condition to be treated priorto referring the beneficiary to another provider and that the referringphysician provides ongoing oversight of the course of referral relatedtreatment throughout the period during which the beneficiary isbeing treated in response to the referral. Written contemporaneousdocumentation of the referring physician’s basis for referral and ongoingcommunication between the referring and treating provider regardingthe oversight of the treatment rendered as a result of the referralmust meet all requirements for medical records established by thispart. Referring physician supervision does not require physicallocation on the premises of the treating provider or at the siteof treatment.
(v) Subjectto section 1079(a) of title 10, U.S.C., chapter 55, a physicianor other health care practitioner who is eligible to receive reimbursem*ntfor services provided under Medicare (as defined in section 1086(d)(3)(C)of title 10 U.S.C., chapter 55) shall be considered approved toprovide medical care authorized under section 1079 and section 1086of title 10, U.S.C., chapter 55 unless the administering Secretarieshave information indicating Medicare, TRICARE, or other Federalhealth care program integrity violations by the physician or otherhealth care practitioner. Approval is limited to those classes ofprovider currently considered TRICARE authorized providers as outlinedin 32 CFR 199.6. Services and supplies rendered by those providerswho are not currently considered authorized providers shall be denied.
(3) Types of providers.
Subject to the standards ofparticipation provisions of this part, the following individual professionalproviders of medical care are authorized to provide services toCHAMPUS beneficiaries:
(i) Physicians.
(A) Doctors of Medicine(M.D.).
(B) Doctorsof Osteopathy (D.O.).
(ii) Dentists.
Except for covered oral surgeryas specified in Sec. 199.4(e) of this part, all otherwise covered servicesrendered by dentists require preauthorization.
(A) Doctorsof Dental Medicine (D.M.D.).
(B) Doctors of DentalSurgery (D.D.S.).
(iii) Otherallied health professionals.
The services of the followingindividual professional providers of care are coverable on a fee-for-servicebasis provided such services are otherwise authorized in this orother sections of this part.
(A) Clinicalpsychologist.
For purposes of CHAMPUS, aclinical psychologist is an individual who is licensed or certifiedby the state for the independent practice of psychology and:
(1) Possessesa doctoral degree in psychology from a regionally accredited university;and
(2) Has has 2years of supervised clinical experience in psychological healthservices of which at least 1 year is post-doctoral and 1 year (maybe the post-doctoral year) is in an organized psychological healthservice training program; or
(3) Asan alternative to paragraphs (c)(3)(iii)(A)(1) and (2) ofthis section is listed in the National Register of Health ServiceProviders in Psychology.
(B) Doctors of Optometry.
(C) Doctorsof Podiatric Medicine or Podiatrists.
(D) Certifiednurse midwives.
(1) A certified nurse midwife may providecovered care independent of physician referral and supervision,provided the nurse midwife is:
(i) Licensed, when required, by the locallicensing agency for the jurisdiction in which the care is provided;and
(ii) Certifiedby the American College of Nurse Midwives. To receive certification,a candidate must be a registered nurse who has completed successfullyan educational program approved by the American College of NurseMidwives, and passed the American College of Nurse Midwives NationalCertification Examination.
(2) The servicesof a registered nurse who is not a certified nurse midwife may beauthorized only when the patient has been referred for care by alicensed physician and a licensed physician provides continuingsupervision of the course of care. A lay midwife who is neithera certified nurse midwife nor a registered nurse is not a CHAMPUS-authorizedprovider, regardless of whether the services rendered may otherwisebe covered.
(E) Certifiednurse practitioner.
Within the scope of applicablelicensure or certification requirements, a certified nurse practitionermay provide covered care independent of physician referral and supervision,provided the nurse practitioner is:
(1) A licensed,registered nurse; and
(2) Specifically licensed or certified asa nurse practitioner by the state in which the care was provided,if the state offers such specific licensure or certification; or
(3) Certifiedas a nurse practitioner (certified nurse) by a professional organizationoffering certification in the speciality of practice, if the statedoes not offer specific licensure or certification for nurse practitioners.
(F) CertifiedClinical Social Worker.
A clinical social worker mayprovide covered services independent of physician referral and supervision,provided the clinical social worker:
(1) Is licensedor certified as a clinical social worker by the jurisdiction wherepracticing; or, if the jurisdiction does not provide for licensureor certification of clinical social workers, is certified by a nationalprofessional organization offering certification of clinical socialworkers; and
(2) Has at least a master’s degree in socialwork from a graduate school of social work accredited by the Council onSocial Work Education; and
(3) Hashad a minimum of 2 years or 3,000 hours of post-master’s degreesupervised clinical social work practice under the supervision ofa master’s level social worker in an appropriate clinical setting,as determined by the Director, OCHAMPUS, or a designee.
Note:Patients’ organic medical problemsmust receive appropriate concurrent management by a physician.
(G) Certifiedpsychiatric nurse specialist.
A certified psychiatric nursespecialist may provide covered care independent of physician referraland supervision. For purposes of CHAMPUS, a certified psychiatricnurse specialist is an individual who:
(1) Is a licensed,registered nurse; and
(2) Has at least a master’s degree in nursingfrom a regionally accredited institution with a specialization in psychiatricand mental health nursing; and
(3) Has had atleast 2 years of post-master’s degree practice in the field of psychiatricand mental health nursing, including an average of 8 hours of directpatient contact per week; or
(4) Islisted in a CHAMPUS-recognized, professionally sanctioned listingof clinical specialists in psychiatric and mental health nursing.
(H) Certifiedphysician assistant.
A physician assistant may providecare under general supervision of a physician (see Sec. 199.14(j)(1)(ix)of this part for limitations on reimbursem*nt). For purposes ofCHAMPUS, a physician assistant must meet the applicable state requirementsgoverning the qualifications of physician assistants and at leastone of the following conditions:
(1) Is currentlycertified by the National Commission on Certification of PhysicianAssistants to assist primary care physicians, or
(2) Has satisfactorilycompleted a program for preparing physician assistants that:
(i) Was at least1 academic year in length;
(ii) Consistedof supervised clinical practice and at least 4 months (in the aggregate)of classroom instruction directed toward preparing students to deliverhealth care; and
(iii) Was accredited by the American MedicalAssociation’s Committee on Allied Health Education and Accreditation;or
(3) Has satisfactorily completed a formaleducational program for preparing program physician assistants that doesnot meet the requirement of paragraph (c)(3)(iii)(H)(2) ofthis section and had been assisting primary care physicians fora minimum of 12 months during the 18-month period immediately precedingJanuary 1, 1987.
(I) AnesthesiologistAssistant.
An anesthesiologist assistantmay provide covered anesthesia services, if the anesthesiologistassistant:
(1) Works under the direct supervision ofan anesthesiologist who bills for the services and for each patient;
(i) The anesthesiologistperforms a pre-anesthetic examination and evaluation;
(ii) The anesthesiologistprescribes the anesthesia plan;
(iii) The anesthesiologistpersonally participates in the most demanding aspects of the anesthesiaplan including, if applicable, induction and emergence;
(iv) The anesthesiologistensures that any procedures in the anesthesia plan that he or shedoes not perform are performed by a qualified anesthesiologist assistant;
(v) The anesthesiologistmonitors the course of anesthesia administration at frequent intervals;
(vi) The anesthesiologistremains physically present and available for immediate personaldiagnosis and treatment of emergencies;
(vii) The anesthesiologistprovides indicated post-anesthesia care; and
(viii) The anesthesiologistperforms no other services while he or she supervises no more thanfour anesthesiologist assistants concurrently or a lesser numberif so limited by the state in which the procedure is performed.
(2) Is in compliancewith all applicable requirements of state law, including any licensurerequirements the state imposes on nonphysician anesthetists; and
(3) Is a graduateof a Master’s level anesthesiologist assistant educational programthat is established under the auspices of an accredited medicalschool and that:
(i) Is accredited by the Committee on AlliedHealth Education and Accreditation, or its successor organization; and
(ii) Includesapproximately two years of specialized basic science and clinicaleducation in anesthesia at a level that builds on a premedical undergraduatescience background.
(4) TheDirector, TMA, or a designee, shall issue TRICARE policies, instructions,procedures, guidelines, standards, and criteria as may be necessaryto implement the intent of this section.
(J) CertifiedRegistered Nurse Anesthetist (CRNA).
A certifiedregistered nurse anesthetist may provide covered care independentof physician referral and supervision as specified by state licensure.For purposes of CHAMPUS, a certified registered nurse anesthetistis an individual who:
(1) Is a licensed, registered nurse; and
(2) Is certifiedby the Council on Certification of Nurse Anesthetists, or its successororganization.
(K) Otherindividual paramedical providers.
(1) The services of the following individualprofessional providers of care to be considered for benefits ona fee-for-service basis may be provided only if the beneficiaryis referred by a physician for the treatment of a medically diagnosedcondition and a physician must also provide continuing and ongoingoversight and supervision of the program or episode of treatmentprovided by these individual paramedical providers.
(i) Licensedregistered nurses.
(ii) Audiologists.
(2) The servicesof the following individual paramedical providers of care to beconsidered for benefits on a fee-for-service basis may be providedonly if: The beneficiary is referred by a physician, certified physicianassistant, certified nurse practitioner, or podiatrist; and a physician,certified physician assistant, certified nurse practitioner, orpodiatrist must also provide continuing and ongoing oversight andsupervision of the program or episode of treatment provided by theseindividual paramedical providers.
(i) Licensedregistered physical therapist (PT), including a licensed or certifiedphysical therapist assistant (PTA) performing under the supervisionof a TRICARE-authorized PT. PTAs shall meet the qualifications specifiedby Medicare (42 CFR 484.115, or successor regulation) and the Director,DHA, shall issue policy adopting, to the extent practicable, Medicare’srequirements for PTA supervision.
(ii) Licensedregistered occupational therapist (OT), including a licensed orcertified occupational therapy assistant (OTA) performing underthe supervision of a TRICARE authorized OT. OTAs shall meet thequalifications specified by Medicare (42 CFR 484.115, or successorregulation) and the Director, DHA, shall issue policy adopting, tothe extent practicable, Medicare’s requirements for OTA supervision.
(3) Licensed registered speech therapists(speech pathologists). In order to be considered for benefits ona fee-for-service basis, the services of a licensed registered speechtherapist as an individual paramedical provider of care may be providedonly if: (1) The beneficiary is referred by a physician, a certifiedphysician assistant, or a certified nurse practitioner; and (2)a physician, a certified physician assistant, or a certified nursepractitioner must also provide continuing and ongoing oversightand supervision of the program or episode of treatment providedby these individual paramedical providers.
(L) Nutritionist.
A nutritionist must be licensedby the State in which the care is provided and must be under the supervisionof a physician who is overseeing the episode of treatment or thecovered program of services.
(M) Registereddietician.
A dietician may must be licensedby the State in which the care is provided and must be under thesupervision of a physician who is overseeing the episode of treatmentor the covered program of services.
(N) TRICAREcertified mental health counselor.
For thepurposes of CHAMPUS, a TRICARE certified mental health counselor(TCMHC) must be licensed for independent practice in mental healthcounseling by the jurisdiction where practicing. In jurisdictionswith two or more licenses allowing for differing scopes of independentpractice, the licensed mental health counselor may only practicewithin the scope of the license he or she possesses. In addition,a TCMHC must meet the requirements of either paragraph (c)(3)(iii)(N)(1)or the requirements of paragraph (c)(3)(iii)(N)(2) of this section.
(1) The requirementsof this paragraph are that the TCMHC:
(i) Must havepassed the National Clinical Mental Health Counselor Examination(NCMHCE) or its successor as determined by the Director, TMA; and
(ii) Must possessa master’s or higher-level degree from a mental health counselingprogram of education and training accredited by the Council forAccreditation of Counseling and Related Educational Programs (CACREP);and
(iii) Must havea minimum of two (2) years of post-master’s degree supervised mentalhealth counseling practice which includes a minimum of 3,000 hoursof supervised clinical practice and 100 hours of face-to-face supervision. Supervisionmust be provided by mental health counselors at the highest levelof state licensure, psychiatrists, clinical psychologists, certifiedclinical social workers, or certified psychiatric nurse specialistswho are licensed for independent practice in the jurisdiction wherepracticing and who are practicing within the scope of their licenses. Supervisedclinical practice must be received in a manner that is consistentwith the guidelines regarding knowledge, skills, and practice standardsfor supervision of the American Mental Health Counselors Association; and
(iv) Is licensedor certified for independent practice in mental health counselingby the jurisdiction where practicing (see paragraph (c)(2)(ii) ofthis section for more specific information).
(2) The requirementsof this paragraph are that the TCMHC, prior to January 1, 2017:
(i) Possess amaster’s or higher-level degree from a mental health counselingprogram of education and training accredited by CACREP and musthave passed the National Counselor Examination (NCE); or
(ii) Possessa master’s or higher-level degree from a mental health counselingprogram of education and training from either a CACREP or regionallyaccredited institution and have passed the NCMHCE; and
(iii) Must havea minimum of two (2) years of post-master’s degree supervised mentalhealth counseling practice which includes a minimum of 3,000 hoursof supervised clinical practice and 100 hours of face-to-face supervision. Supervisionmust be provided by mental health counselors at the highest levelof state licensure, psychiatrists, clinical psychologists, certifiedclinical social workers, or certified psychiatric nurse specialistswho are licensed for independent practice in the jurisdiction wherepracticing and who are practicing within the scope of their licenses. Supervisedclinical practice must be received in a manner that is consistentwith the guidelines regarding knowledge, skills, and practice standardsfor supervision of the American Mental Health Counselors Association; and
(iv) Is licensedor certified for independent practice in mental health counselingby the jurisdiction where practicing (see paragraph (c)(2)(ii) ofthis section for more specific information).
(3) The Director,TRICARE Management Activity may amend or modify existing or specifyadditional certification requirements as needed to accommodate futurepractice and licensing standards and to ensure that all TCMHCs continueto meet educational, licensing, and clinical training requirementsconsidered appropriate.
(iv) Extramedicalindividual providers.
Extramedical individual providersare those who do counseling or nonmedical therapy and whose trainingand therapeutic concepts are outside the medical field. The servicesof extramedical individual professionals are coverable followingthe CHAMPUS determined allowable charge methodology provided suchservices are otherwise authorized in this or other sections of theregulation.
(A) Certifiedmarriage and family therapists.
For the purposes of CHAMPUS,a certified marriage and family therapist is an individual who meetsthe following requirements:
(1) Recognizedgraduate professional education with the minimum of an earned master’sdegree from a regionally accredited educational institution in anappropriate behavioral science field, mental health discipline; and
(2) The followingexperience:
(i) Either 200hours of approved supervision in the practice of marriage and familycounseling, ordinarily to be completed in a 2- to 3-year period,of which at least 100 hours must be in individual supervision. Thissupervision will occur preferably with more than one supervisorand should include a continuous process of supervision with at leastthree cases; and
(ii) 1,000 hours of clinical experience inthe practice of marriage and family counseling under approved supervision,involving at least 50 different cases; or
(iii) 150 hoursof approved supervision in the practice of psychotherapy, ordinarilyto be completed in a 2- to 3-year period, of which at least 50 hoursmust be individual supervision; plus at least 50 hours of approvedindividual supervision in the practice of marriage and family counseling,ordinarily to be completed within a period of not less than 1 normore than 2 years; and
(iv) 750 hours of clinical experience in thepractice of psychotherapy under approved supervision involving at least30 cases; plus at least 250 hours of clinical practice in marriageand family counseling under approved supervision, involving at least20 cases; and
(3) Is licensed or certified to practice asa marriage and family therapist by the jurisdiction where practicing(see paragraph (c)(3)(iv)(D) of this section for more specific informationregarding licensure); and
(4) Agreesthat a patients’ organic medical problems must receive appropriateconcurrent management by a physician.
(5) Agrees toaccept the CHAMPUS determined allowable charge as payment in full,except for applicable deductibles and cost-shares, and hold CHAMPUSbeneficiaries harmless for noncovered care (i.e., may not bill a beneficiaryfor noncovered care, and may not balance bill a beneficiary foramounts above the allowable charge). The certified marriage andfamily therapist must enter into a participation agreement withthe Office of CHAMPUS within which the certified marriage and familytherapist agrees to all provisions specified above.
(6) As of theeffective date of termination, the certified marriage and familytherapist will no longer be recognized as an authorized providerunder CHAMPUS. Subsequent to termination, the certified marriageand family therapist may only be reinstated as an authorized CHAMPUSextramedical provider by entering into a new participation agreementas a certified marriage and family therapist.
(B) Pastoralcounselors.
For the purposes of CHAMPUS,a pastoral counselor is an individual who meets the following requirements:
(1) Recognizedgraduate professional education with the minimum of an earned master’sdegree from a regionally accredited educational institution in anappropriate behavioral science field, mental health discipline; and
(2) The followingexperience:
(i) Either 200hours of approved supervision in the practice of pastoral counseling,ordinarily to be completed in a 2- to 3-year period, of which atleast 100 hours must be in individual supervision. This supervisionwill occur preferably with more than one supervisor and should includea continuous process of supervision with at least three cases; and
(ii) 1,000 hoursof clinical experience in the practice of pastoral counseling underapproved supervision, involving at least 50 different cases; or
(iii) 150 hoursof approved supervision in the practice of psychotherapy, ordinarilyto be completed in a 2- to 3-year period, of which at least 50 hoursmust be individual supervision; plus at least 50 hours of approvedindividual supervision in the practice of pastoral counseling, ordinarilyto be completed within a period of not less than 1 nor more than2 years; and
(iv) 750 hours of clinical experience in thepractice of psychotherapy under approved supervision involving at least30 cases; plus at least 250 hours of clinical practice in pastoralcounseling under approved supervision, involving at least 20 cases;and
(3) Is licensed or certified to practice asa pastoral counselor by the jurisdiction where practicing (see paragraph (c)(3)(iv)(D)of this section for more specific information regarding licensure);and
(4) Theservices of a pastoral counselor meeting the above requirementsare coverable following the CHAMPUS determined allowable chargemethodology, under the following specified conditions:
(i) The CHAMPUSbeneficiary must be referred for therapy by a physician; and
(ii) A physicianis providing ongoing oversight and supervision of the therapy beingprovided; and
(iii) The pastoral counselor must certify oneach claim for reimbursem*nt that a written communication has been madeor will be made to the referring physician of the results of thetreatment. Such communication will be made at the end of the treatment,or more frequently, as required by the referring physician (referto Sec. 199.7).
(5) Because ofthe similarity of the requirements for licensure, certification,experience, and education, a pastoral counselor may elect to beauthorized under CHAMPUS as a certified marriage and family therapist,and as such, be subject to all previously defined criteria for thecertified marriage and family therapist category, to include acceptanceof the CHAMPUS determined allowable charge as payment in full, exceptfor applicable deductibles and cost-shares (i.e., balance billingof a beneficiary above the allowable charge is prohibited; may notbill beneficiary for noncovered care). The pastoral counselor mustalso agree to enter into the same participation agreement as a certifiedmarriage and family therapist with the Office of CHAMPUS withinwhich the pastoral counselor agrees to all provisions includinglicensure, national association membership and conditions upon termination,outlined above for certified marriage and family therapist.
Note:No dual status will be recognizedby the Office of CHAMPUS. Pastoral counselors must elect to becomeone of the categories of extramedical CHAMPUS provides specifiedabove. Once authorized as either a pastoral counselor, or a certifiedmarriage and family therapist, claims review and reimbursem*nt willbe in accordance with the criteria established for the elected providercategory.
(C) Supervisedmental health counselor.
For the purposes of TRICARE,a supervised mental health counselor is an individual who does notmeet the requirements of a TRICARE certified mental health counselorin paragraph (c)(3)(iii)(N) of this section, but meets all of thefollowing requirements and conditions of practice:
(1) Minimum ofa master’s degree in mental health counseling or allied mental healthfield from a regionally accredited institution; and
(2) Two yearsof post-masters experience which includes 3,000 hours of clinicalwork and 100 hours of face-to-face supervision; and
(3) Is licensedor certified to practice as a mental health counselor by the jurisdictionwhere practicing (see paragraph (c)(3)(iv)(D) of this section formore specific information); and
(4) Mayonly be reimbursed when:
(i) The TRICARE beneficiary is referred fortherapy by a physician; and
(ii) A physicianis providing ongoing oversight and supervision of the therapy beingprovided; and
(iii) The mental health counselor certifieson each claim for reimbursem*nt that a written communication has beenmade or will be made to the referring physician of the results ofthe treatment. Such communication will be made at the end of thetreatment, or more frequently, as required by the referring physician(refer to Sec. 199.7).
(D) The following additionalinformation applies to each of the above categories of extramedicalindividual providers:
(1) These providers must also be licensedor certified to practice as a certified marriage and family therapist, pastoralcounselor or mental health counselor by the jurisdiction where practicing.In jurisdictions that do not provide for licensure or certification,the provider must be certified by or eligible for full clinicalmembership in the appropriate national professional associationthat sets standards for the specific profession.
(2) Grace periodfor therapists or counselors in states where licensure/certificationis optional. CHAMPUS is providing a grace period for those therapistsor counselors who did not obtain optional licensure/certificationin their jurisdiction, not realizing it was a CHAMPUS requirementfor authorization. The exemption by state law for pastoral counselorsmay have misled this group into thinking licensure was not required.The same situation may have occurred with the other therapist orcounselor categories where licensure was either not mandated bythe state or was provided under a more general category such as“professional counselors.” This grace period pertains only to thelicensure/certification requirement, applies only to therapistsor counselors who are already approved as of October 29, 1990, andonly in those areas where the licensure/certification is optional.Any therapist or counselor who is not licensed/certified in thestate in which he/she is practicing by August 1, 1991, will be terminatedunder the provisions of Sec. 199.9. This grace period does not changeany of the other existing requirements which remain in effect. Duringthis grace period, membership or proof of eligibility for full clinical membershipin a recognized professional association is required for those therapistsor counselors who are not licensed or certified by the state. Thefollowing organizations are recognized for therapists or counselorsat the level indicated: Full clinical member of the American Associationof Marriage and Family Therapy; membership at the fellow or diplomatelevel of the American Association of Pastoral Counselors; and membershipin the National Academy of Certified Clinical Mental Health Counselors.Acceptable proof of eligibility for membership is a letter fromthe appropriate certifying organization. This opportunity for delayedcertification/licensure is limited to the counselor or therapistcategory only as the language in all of the other provider categorieshas been consistent and unmodified from the time each of the otherprovider categories were added. The grace period does not applyin those states where licensure is mandatory.
(E) ChristianScience practitioners and Christian Science nurses.
CHAMPUS cost-shares the servicesof Christian Science practitioners and nurses. In order to billas such, practitioners or nurses must be listed or be eligible for listingin the Christian Science Journal2 atthe time the service is provided.
(d) Other providers.
Certain medical supplies andservices of an ancillary or supplemental nature are coverable byCHAMPUS, subject to certain controls. This category of providerincludes the following:
(1) Independentlaboratory.
Laboratory services of independentlaboratories may be cost-shared if the laboratory is approved forparticipation under Medicare and certified by the Medicare Bureau,Health Care Financing Administration.
(2) Suppliersof portable x-ray services.
Such suppliers must meet theconditions of coverage of the Medicare program, set forth in theMedicare regulations, or the Medicaid program in that state in whichthe covered service is provided.
(3) Pharmacies.
Pharmacies must meet the applicablerequirements of state law in the state in which the pharmacy islocated. In addition to being subject to the policies and proceduresfor authorized providers established by this section, additionalpolicies and procedures may be established for authorized pharmacies underSec. 199.21 of this part implementing the Pharmacy Benefits Program.
(4) Ambulancecompanies.
Such companies must meet therequirements of state and local laws in the jurisdiction in whichthe ambulance firm is licensed.
(5) Medicalequipment firms, medical supply firms, and Durable Medical Equipment,Prosthetic, Orthotic, Supplies providers/suppliers.
Any firm, supplier, or providerthat is an authorized provider under Medicare or is otherwise designatedan authorized provider by the Director, TRICARE Management Activity.
(6) Mammographysuppliers.
Mammography services may becost-shared only if the supplier is certified by Medicare for participationas a mammography supplier, or is certified by the American Collegeof Radiology as having met its mammography supplier standards.
(e) ExtendedCare Health Option Providers.--
(1) General.
(i) Services and itemscost-shared through Sec. 199.5 must be rendered by a CHAMPUS-authorizedprovider.
(ii) AProgram for Persons with Disabilities (PFPWD) provider with TRICARE-authorizedstatus on the effective date for the Extended Care Health Option(ECHO) Program shall be deemed to be a TRICARE-authorized provider untilthe expiration of all outstanding PFPWD benefit authorizations forservices or items being rendered by the provider.
(2) ECHOprovider categories--
(i) ECHO inpatient care provider.
A provider of residential institutionalcare, which is otherwise an ECHO benefit, shall be:
(A) A not-for-profitentity or a public facility; and
(B) Locatedwithin a state; and
(C) Becertified as eligible for Medicaid payment in accordance with astate plan for medical assistance under Title XIX of the SocialSecurity Act (Medicaid) as a Medicaid Nursing Facility, or IntermediateCare Facility for the Mentally Retarded, or be a TRICARE-authorizedinstitutional provider as defined in paragraph (b) of this section,or be approved by a state educational agency as a training institution.
(ii) ECHOoutpatient care provider.
A provider of ECHO outpatient,ambulatory, or in-home services shall be:
(A) A TRICARE-authorizedprovider of services as defined in this section; or
(B) Anindividual, corporation, foundation, or public entity that predominantlyrenders services of a type uniquely allowable as an ECHO benefitand not otherwise allowable as a benefit of Sec. 199.4, that meetsall applicable licensing or other regulatory requirements of thestate, county, municipality, or other political jurisdiction inwhich the ECHO service is rendered, or in the absence of such licensingor regulatory requirements, as determined by the Director, TRICAREManagement Activity or designee.
(iii) ECHOvendor.
A provider of an allowableECHO item, such as supplies or equipment, shall be deemed to bea TRICARE-authorized vendor for the provision of the specific item,supply or equipment when the vendor supplies such information asthe Director, TRICARE Management Activity or designee determinesnecessary to adjudicate a specific claim.
(3) ECHOprovider exclusion or suspension.
A providerof ECHO services or items may be excluded or suspended for a patternof discrimination on the basis of disability. Such exclusion orsuspension shall be accomplished according to the provisions ofSec. 199.9.
(f) Corporateservices providers--
(1) General.
(i) Thiscorporate services provider class is established to accommodateindividuals who would meet the criteria for status as a CHAMPUSauthorized individual professional provider as established by paragraph(c) of this section but for the fact that they are employed directlyor contractually by a corporation or foundation that provides principallyprofessional services which are within the scope of the CHAMPUSbenefit. With authorization of freestanding end stage renal disease(ESRD) facilities as TRICARE institutional providers under paragraph(b)(4)(xxi) of this section, corporate service provider status willnot be authorized for the provision of ESRD services.
(ii) Payment for otherwiseallowable services may be made to a CHAMPUS-authorized corporateservices provider subject to the applicable requirements, exclusionsand limitations of this part.
(iii) The Director,OCHAMPUS, or designee, may create discrete types within any allowablecategory of provider established by this paragraph (f) to improvethe efficiency of CHAMPUS management.
(iv) TheDirector, OCHAMPUS, or designee, may require, as a condition ofauthorization, that a specific category or type of provider establishedby this paragraph (f):
(A) Maintaincertain accreditation in addition to or in lieu of the requirementof paragraph (f)(2)(v) of this section;
(B) Cooperate fullywith a designated utilization and clinical quality management organizationwhich has a contract with the Department of Defense for the geographicarea in which the provider does business;
(C) Renderservices for which direct or indirect payment is expected to bemade by CHAMPUS only after obtaining CHAMPUS written authorization;and
(D) Maintain Medicareapproval for payment when the Director, OCHAMPUS, or designee, determinesthat a category, or type, of provider established by this paragraph(f) is substantially comparable to a provider or supplier for whichMedicare has regulatory conditions of participation or conditionsof coverage.
(v) Otherwiseallowable services may be rendered at the authorized corporate servicesprovider’s place of business, or in the beneficiary’s home undersuch circ*mstances as the Director, OCHAMPUS, or designee, determinesto be necessary for the efficient delivery of such in-home services.
(vi) The Director,OCHAMPUS, or designee, may limit the term of a participation agreementfor any category or type of provider established by this paragraph(f).
(vii) Corporate servicesproviders shall be assigned to only one of the following allowablecategories based upon the predominate type of procedure renderedby the organization;
(A) Medicaltreatment procedures;
(B) Surgicaltreatment procedures;
(C) Maternitymanagement procedures;
(D) Rehabilitationand/or habilitation procedures; or
(E) Diagnostic technicalprocedures.
(viii) TheDirector, OCHAMPUS, or designee, shall determine the appropriateprocedural category of a qualified organization and may change thecategory based upon the provider’s CHAMPUS claim characteristics.The category determination of the Director, OCHAMPUS, designee,is conclusive and may not be appealed.
(2) Conditionsof authorization.
An applicant must meet thefollowing conditions to be eligible for authorization as a CHAMPUScorporate services provider:
(i) Be a corporationor a foundation, but not a professional corporation or professionalassociation; and
(ii) Beinstitution-affiliated or freestanding as defined in Sec. 199.2;and
(iii) Provide:
(A) Services and relatedsupplies of a type rendered by CHAMPUS individual professional providersor diagnostic technical services and related supplies of a typewhich requires direct patient contact and a technologist who is licensedby the state in which the procedure is rendered or who is certifiedby a Qualified Accreditation Organization as defined in Sec. 199.2;and
(B) A level of carewhich does not necessitate that the beneficiary be provided withon-site sleeping accommodations and food in conjunction with thedelivery of services; and
(iv) Complies withall applicable organizational and individual licensing or certificationrequirements that are extant in the state, county, municipality,or other political jurisdiction in which the provider renders services;and
(v) Be approved forMedicare payment when determined to be substantially comparableunder the provisions of paragraph (f)(1)(iv)(D) of this sectionor, when Medicare approved status is not required, be accreditedby a qualified accreditation organization, as defined in Sec. 199.2;and
(vi) Has entered intoa participation agreement approved by the Director, OCHAMPUS, ordesignee, which at least complies with the minimum participationagreement requirements of this section.
(3) Transferof participation agreement.
In order to provide continuityof care for beneficiaries when there is a change of provider ownership,the provider agreement is automatically assigned to the new owner,subject to all the terms and conditions under which the originalagreement was made.
(i) Themerger of the provider corporation or foundation into another corporationor foundation, or the consolidation of two or more corporationsor foundations resulting in the creation of a new corporation or foundation,constitutes a change of ownership.
(ii) Transfer of corporatestock or the merger of another corporation or foundation into theprovider corporation or foundation does not constitute change ofownership.
(iii) Thesurviving corporation or foundation shall notify the Director, OCHAMPUS,or designee, in writing of the change of ownership promptly afterthe effective date of the transfer or change in ownership.
(4) Pricingand payment methodology:
The pricing and payment ofprocedures rendered by a provider authorized under this paragraph(f) shall be limited to those methods for pricing and payment allowedby this part which the Director, OCHAMPUS, or designee, determinescontribute to the efficient management of CHAMPUS.
(5) Terminationof participation agreement.
A provider may terminate aparticipation agreement upon 45 days written notice to the Director,OCHAMPUS, or designee, and to the public.
[51 FR 24008, Jul 1, 1986;67 FR 40602, Jun 13, 2002; 67 FR 42720, Jun 25, 2002; 68 FR 65174,Nov 19, 2003; 69 FR 29229, May 21, 2004; 69 FR 44591, Jul 28, 2004;69 FR 51568, Aug 20, 2004; 69 FR 55359, Sep 14, 2004; 70 FR 61378, Oct24, 2005; 72 FR 63988, Nov 14, 2007; 74 FR 44755, Aug 31, 2009;74 FR 55777, Oct 29, 2009; 74 FR 65438, Dec 10, 2009; 75 FR 47460,Aug 6, 2010; 75 FR 50882, Aug 18, 2010; 76 FR 41065, Jul 13, 2011;76 FR 80743, Dec 27, 2011; 78 FR 48309, Aug 8, 2013; 79 FR 41641,Jul 17, 2014; 81 FR 61091, Sep 2, 2016; 81 FR 63695, Sep 16, 2016;82 FR 45447, Sep 29, 2017; 82 FR 61692, Dec 29, 2017; 85 FR 15066,Mar 17, 2020; 85 FR 27927, May 12, 2020; 85 FR 54923, Sep 3, 2020;85 FR 73196, Nov 17, 2020; 87 FR 33013, Jun 1, 2022; 88 FR 2001,Jan 12, 2023; 88 FR 19855, Apr 4, 2023]
Editorial Note: ForFederal Register citations affecting Sec. 199.6, see the List ofSections Affected, which appears in the Finding Aids section ofthe printed volume and on GPO Access.
1)
Compiledand published by the National Fire Protection Association, BatterymarchPark, Quincy, Massachusetts 02269.
2)
Copiesof this journal can be obtained through the Christian Science PublishingCompany, 1 Norway Street, Boston, MA 02115-3122 or the ChristianScience Publishing Society, P.O. Box 11369, Des Moines, IA 50340.
