(3) Procedures
for qualifying as a CHAMPUS-approved institutional provider.
General and special hospitals otherwise
meeting the qualifications outlined in paragraphs (b)(4) (i), (ii),
and (iii), of this section are not required to request CHAMPUS approval
formally.
(i) JCAH
accreditation status.
Each CHAMPUS fiscal intermediary
shall keep informed as to the current JCAH accreditation status
of all hospitals and skilled nursing facilities in its area; and
the provider’s status under Medicare, particularly with regard to
compliance with title VI of the Civil Rights Act of 1964 (42 U.S.C.
2000d(1)). The Director, OCHAMPUS, or a designee, shall specifically
approve all other authorized institutional providers providing services to
CHAMPUS beneficiaries. At the discretion of the Director, OCHAMPUS,
any facility that is certified and participating as a provider of
services under title XVIII of the Social Security Act (Medicare),
may be deemed to meet CHAMPUS requirements. The facility must be
providing a type and level of service that is authorized by this
part.
(ii) Required
to comply with criteria.
Facilities seeking CHAMPUS
approval will be expected to comply with appropriate criteria set
forth in paragraph (b)(4) of this section. They also are required
to complete and submit CHAMPUS Form 200, “Required Information,
Facility Determination Instructions,” and provide such additional information
as may be requested by OCHAMPUS. An onsite evaluation, either scheduled
or 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 the
facility and the appropriate CHAMPUS fiscal intermediary.
(iii) Notice
of peer review rights.
All health care facilities
subject to the DRG-based payment system shall provide CHAMPUS beneficiaries,
upon admission, with information about peer review including their
appeal rights. The notices shall be in a form specified by the Director,
OCHAMPUS.
(iv) Surveying
of facilities.
The surveying of newly established
institutional providers and the periodic resurveying of all authorized
institutional providers is a continuing process conducted by OCHAMPUS.
(v) Institutions
not in compliance with CHAMPUS standards.
If a determination
is made that an institution is not in compliance with one or more
of the standards applicable to its specific category of institution,
CHAMPUS shall take immediate steps to bring about compliance or
terminate the approval as an authorized institution in accordance with
Sec. 199.9(f)(2).
(vi) Participation
agreements required for some hospitals which are not Medicare-participating.
Notwithstanding the provisions
of this paragraph (B)(3), a hospital which is subject to the CHAMPUS
DRG-based payment system but which is not a Medicare-participating
hospital must request and sign an agreement with OCHAMPUS. By signing the
agreement, the hospital agrees to participate on all CHAMPUS inpatient
claims and accept the requirements for a participating provider
as contained in paragraph (a)(8) of Sec. 199.6. Failure to sign
such an agreement shall disqualify such hospital as a CHAMPUS-approved
institutional provider.
(4) Categories
of institutional providers.
The following categories of
institutional providers may be reimbursed by CHAMPUS for services
provided CHAMPUS beneficiaries subject to any and all definitions,
conditions, limitation, and exclusions specified or enumerated in
this part.
(i) Hospitals,
acute care, general and special.
An institution that provides
inpatient services, that also may provide outpatient services (including
clinical and ambulatory surgical services), and that:
(A) Is engaged primarily
in providing to inpatients, by or under the supervision of physicians,
diagnostic and therapeutic services for the medical or surgical
diagnosis and treatment of illness, injury, or bodily malfunction (including
maternity).
(B) Maintains
clinical records on all inpatients (and outpatients if the facility
operates an outpatient department or emergency room).
(C) Has bylaws in effect
with respect to its operations and medical staff.
(D) Has a requirement
that every patient be under the care of a physician.
(E) Provides 24-hour
nursing service rendered or supervised by a registered professional
nurse, and has a licensed practical nurse or registered professional
nurse on duty at all times.
(F) Has
in effect a hospital utilization review plan that is operational
and functioning.
(G) In
the case of an institution in a state in which state or applicable
local law provides for the licensing of hospitals, the hospital:
(1) Is licensed
pursuant to such law, or
(2) Is approved by the agency of such state
or locality responsible for licensing hospitals as meeting the standards
established for such licensing.
(H) Has in effect an
operating plan and budget.
(I) Is
accredited by the JCAH or meets such other requirements as the Secretary
of Health and Human Services, the Secretary of Transportation, or
the Secretary of Defense finds necessary in the interest of the
health and safety of patients who are admitted to and furnished
services in the institution.
Note to paragraph (b)(4)(i)(I): For
the duration of Medicare’s “Hospitals Without Walls” initiative
for the coronavirus disease 2019 (COVID-19) outbreak, any entity
that temporarily enrolls with Medicare as a hospital may be temporarily
exempt from certain institutional requirements for acute care hospitals
under TRICARE. To the extent practicable, the Director, Defense
Health Agency (DHA), will adopt by administrative policy any process requirement
related to Medicare’s Hospitals Without Walls initiative.
(ii) Organ
transplant centers.
To obtain TRICARE approval
as an organ transplant center, the center must be a Medicare approved
transplant center or meet the criteria as established by the Executive
Director, TMA, or a designee.
(iii) Organ
transplant consortia.
TRICARE shall approve individual
pediatric organ transplant centers that meet the criteria established
by the Executive Director, TMA, or a designee.
(iv) Hospitals,
psychiatric.
A psychiatric hospital is an
institution which is engaged primarily in providing services to
inpatients for the diagnosis and treatment of mental disorders.
(A)
There
are two major categories of psychiatric hospitals:
(1) The private
psychiatric hospital category includes both proprietary and the
not-for-profit nongovernmental institutions.
(2) The second
category is those psychiatric hospitals that are controlled, financed,
and operated by departments or agencies of the local, state, or
Federal Government and always are operated on a not-for-profit basis.
(B) In
order 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 accredited
under an accrediting organization approved by the Director, in order
for their services to be cost-shared under CHAMPUS. In the case
of those psychiatric hospitals that are not accredited because they
have not been in operation a sufficient period of time to be eligible
to request an accreditation survey, the Director, or a designee,
may grant temporary approval if the hospital is certified and participating
under Title XVIII of the Social Security Act (Medicare, Part A).
This temporary approval expires 12 months from the date on which
the psychiatric hospital first becomes eligible to request an accreditation
survey by an accrediting organization approved by the Director.
(C)
Factors
to be considered in determining whether CHAMPUS will cost-share
care provided in a psychiatric hospital include, but are not limited
to, the following considerations:
(1) Is the prognosis of the patient such that
care provided will lead to resolution or remission of the mental illness
to the degree that the patient is of no danger to others, can perform
routine daily activities, and can be expected to function reasonably
outside the inpatient setting?
(2) Can the services
being provided be provided more economically in another facility
or on an outpatient basis?
(3) Are
the charges reasonable?
(4) Is
the care primarily custodial or domiciliary? (Custodial or domiciliary
care of the permanently mentally ill or retarded is not a benefit
under the Basic Program.)
(D) Although psychiatric
hospitals are accredited under an accrediting organization approved
by Director, their medical records must be maintained in accordance
with accrediting organization’s current standards manual, along with
the requirements set forth in Sec. 199.7(b)(3). The hospital is
responsible for assuring that patient services and all treatment
are accurately documented and completed in a timely manner.
(v) Long
Term Care Hospital (LTCH).
LTCHs must meet all the criteria
for 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 considered
an authorized LTCH under the TRICARE program.
(A) In
order for the services of LTCHs to be covered, the hospitals must
comply with the provisions outlined in paragraph (b)(4)(i) of this
section. In addition, in order for services provided by such hospitals
to be covered by TRICARE, they must be primarily for the treatment
of the presenting illness.
(B) Custodial
or domiciliary care is not coverable under TRICARE, even if rendered
in an otherwise authorized LTCH.
(C) The controlling
factor in determining whether a beneficiary’s stay in a LTCH is
coverable by TRICARE is the level of professional care, supervision,
and skilled nursing care that the beneficiary requires, in addition
to the diagnosis, type of condition, or degree of functional limitations.
The type and level of medical services required or rendered is controlling
for purposes of extending TRICARE benefits; not the type of provider
or condition of the beneficiary.
(vi) Skilled
nursing facility.
A skilled nursing facility
is an institution (or a distinct part of an institution) that is engaged
primarily in providing to inpatients medically necessary skilled
nursing care, which is other than a nursing home or intermediate
facility, and which:
(A) Has
policies that are developed with the advice of (and with provisions
for review on a periodic basis by) a group of professionals, including
one or more physicians and one or more registered nurses, to govern
the skilled nursing care and related medical services it provides.
(B) Has
a physician, a registered nurse, or a medical staff responsible
for the execution of such policies.
(C) Has
a requirement that the medical care of each patient must be under
the supervision of a physician, and provides for having a physician
available to furnish necessary medical care in case of an emergency.
(D) Maintains clinical
records on all patients.
(E) Provides
24-hour skilled nursing service that is sufficient to meet nursing
needs in accordance with the policies developed as provided in paragraph
(b)(4)(iv)(A) of this section, and has at least one registered professional nurse
employed full-time.
(F) Provides
appropriate methods and procedures for the dispensing and administering
of drugs and biologicals.
(G) Has
in effect a utilization review plan that is operational and functioning.
(H) In the case of
an institution in a state in which state or applicable local law
provides for the licensing of this type facility, the institution:
(1) Is licensed
pursuant to such law, or
(2) Is approved by the agency of such state
or locality responsible for licensing such institutions as meeting
the standards established for such licensing.
(I) Has in effect an
operating plan and budget.
(J) Meets
such provisions of the most current edition of the Life Safety Code
as are
applicable to nursing facilities; except that if the Secretary of
Health and Human Services has waived, for such periods, as deemed appropriate,
specific provisions of such code which, if rigidly applied, would
result in unreasonable hardship upon a nursing facility.
(K) Is an authorized
provider under the Medicare program, and meets the requirements
of 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 certified
by Medicaid, it will be considered to meet the Medicare certification
requirement in order to be an authorized provider under TRICARE.
(vii) Residential
treatment centers.
This paragraph (b)(4)(vii)
establishes the definition of and eligibility standards and requirements
for residential treatment centers (RTCs).
(A) Organization
and administration--
(1) Definition.
A Residential Treatment Center
(RTC) is a facility or a distinct part of a facility that provides
to beneficiaries under 21 years of age a medically supervised, interdisciplinary program
of mental health treatment. An RTC is appropriate for patients whose
predominant symptom presentation is essentially stabilized, although
not resolved, and who have persistent dysfunction in major life
areas. Residential treatment may be complemented by family therapy
and case management for community based resources. Discharge planning
should support transitional care for the patient and family, to
include resources available in the geographic area where the patient
will be residing. The extent and pervasiveness of the patient’s
problems require a protected and highly structured therapeutic environment.
Residential treatment is differentiated from:
(i) Acute psychiatric
care, which requires medical treatment and 24-hour availability
of a full range of diagnostic and therapeutic services to establish
and implement an effective plan of care which will reverse life-threatening and/or
severely incapacitating symptoms;
(ii) Partial
hospitalization, which provides a less than 24-hour-per-day, seven-day-per-week
treatment program for patients who continue to exhibit psychiatric
problems but can function with support in some of the major life areas;
(iii) A group
home, which is a professionally directed living arrangement with
the availability of psychiatric consultation and treatment for patients
with significant family dysfunction and/or chronic but stable psychiatric disturbances;
(iv) Therapeutic
school, which is an educational program supplemented by psychological
and psychiatric services;
(v) Facilities that treat patients with a
primary diagnosis of substance use disorder; and
(vi) Facilities
providing care for patients with a primary diagnosis of mental retardation
or developmental disability.
(2) Eligibility.
(i) In order
to qualify as a TRICARE authorized provider, every RTC must meet
the minimum basic standards set forth in paragraphs (b)(4)(vii)(A)
through (C) of this section, and as well as such additional elaborative criteria
and standards as the Director determines are necessary to implement
the basic standards.
(ii) To qualify as a TRICARE authorized provider,
the facility is required to be licensed and operate in substantial compliance
with state and federal regulations.
(iii) The facility
is currently accredited by an accrediting organization approved
by the Director.
(iv) The facility has a written participation
agreement with OCHAMPUS. The RTC is not a CHAMPUS-authorized provider
and CHAMPUS benefits are not paid for services provided until the
date upon which a participation agreement is signed by the Director.
(B) Participation
agreement requirements.
In addition to other requirements
set forth in this paragraph (b)(4)(vii), for the services of an
RTC to be authorized, the RTC shall have entered into a Participation
Agreement with OCHAMPUS. The period of a participation agreement
shall be specified in the agreement, and will generally be for not
more than five years. In addition to review of a facility’s application
and supporting documentation, an on-site inspection by OCHAMPUS
authorized personnel may be required prior to signing a Participation
Agreement. Retroactive approval is not given. In addition, the Participation
Agreement shall include provisions that the RTC shall, at a minimum:
(1) Render residential
treatment center inpatient services to eligible CHAMPUS beneficiaries
in need of such services, in accordance with the participation agreement
and CHAMPUS regulation;
(2) Accept payment for its services based
upon the methodology provided in Sec. 199.14(f) or such other method
as determined by the Director;
(3) Accept
the CHAMPUS all-inclusive per diem rate as payment in full and collect
from the CHAMPUS beneficiary or the family of the CHAMPUS beneficiary
only those amounts that represent the beneficiary’s liability, as
defined in Sec. 199.4, and charges for services and supplies that
are not a benefit of CHAMPUS;
(4) Make all
reasonable efforts acceptable to the Director, to collect those
amounts, which represents 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 which
the beneficiary is entitled that is primary to CHAMPUS;
(6) Submit claims
for services provided to CHAMPUS beneficiaries at least every 30
days (except to the extent a delay is necessitated by efforts to
first collect from other health insurance). If claims are not submitted
at least every 30 days, the RTC agrees not to bill the beneficiary
or the beneficiary’s family for any amounts disallowed by CHAMPUS;
(7) Certify that:
(i) It is and
will remain in compliance with the TRICARE standards and provisions
of paragraph (b)(4)(vii) of this section establishing standards
for Residential Treatment Centers; and
(ii) It will
maintain compliance with the CHAMPUS Standards for Residential Treatment
Centers Serving Children and Adolescents with Mental Disorders,
as issued by the Director, except for any such standards regarding
which the facility notifies the Director that it is not in compliance.
(8) Designate
an individual who will act as liaison for CHAMPUS inquiries. The
RTC shall inform OCHAMPUS in writing of the designated individual;
(9) Furnish OCHAMPUS,
as requested by OCHAMPUS, with cost data certified by an independent
accounting firm or other agency as authorized by the Director, OCHAMPUS;
(10) Comply with
all requirements of this section applicable to institutional providers
generally concerning accreditation requirements, preauthorization,
concurrent care review, claims processing, beneficiary liability, double
coverage, utilization and quality review, and other matters;
(11) Grant the
Director, or designee, the right to conduct quality assurance audits
or accounting audits with full access to patients and records (including
records 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) Examination
of fiscal and all other records of the RTC which would confirm compliance
with the participation agreement and designation as a TRICARE authorized
RTC;
(ii) Conducting
such audits of RTC records including clinical, financial, and census
records, as may be necessary to determine the nature of the services
being provided, and the basis for charges and claims against the
United States for services provided CHAMPUS beneficiaries;
(iii) Examining
reports of evaluations and inspections conducted by federal, state
and local government, and private agencies and organizations;
(iv) Conducting
on-site inspections of the facilities of the RTC and interviewing
employees, members of the staff, contractors, board members, volunteers,
and patients, as required;
(v) Audits conducted
by the United States Government Accountability Office.
(C) Other
requirements applicable to RTCs.
(1) Even though an RTC may qualify as a TRICARE
authorized provider and may have entered into a participation agreement
with CHAMPUS, payment by CHAMPUS for particular services provided
is contingent upon the RTC also meeting all conditions set forth
in Sec. 199.4 especially all requirements of Sec. 199.4(b)(4).
(2) The RTC shall
provide inpatient services to CHAMPUS beneficiaries in the same
manner it provides inpatient services to all other patients. The
RTC may not discriminate against CHAMPUS beneficiaries in any manner, including
admission practices, placement in special or separate wings or rooms,
or provisions of special or limited treatment.
(3) The
RTC shall assure that all certifications and information provided
to the Director, incident to the process of obtaining and retaining
authorized provider status is accurate and that it has no material
errors or omissions. In the case of any misrepresentations, whether
by inaccurate information being provided or material facts withheld, authorized
status will be denied or terminated, and the RTC will be ineligible
for consideration for authorized provider status for a two year
period.
(viii) Christian
Science sanatoriums.
The services obtained in Christian
Science sanatoriums are covered by CHAMPUS as inpatient care. To
qualify 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 facilities
operated by student health departments of colleges and universities
to provide inpatient or outpatient care to enrolled students. Charges
for care provided by such facilities will not be cost-shared by
CHAMPUS if the student would not be charged in the absence of CHAMPUS,
or if student is covered by a mandatory student health insurance
plan, in which enrollment is required as a part of the student’s
school registration and the charges by the college or university
include a premium for the student health insurance coverage. CHAMPUS
will cost-share only if enrollment in the student health program
or health insurance plan is voluntary.
Note: An infirmary in a boarding
school also may qualify under this provision, subject to review
and approval by the Director, OCHAMPUS or a designee.
(x) Other
special institution providers.
(A) General.
(1) Care
provided by certain special institutional providers (on either an
inpatient or outpatient basis), may be cost-shared by CHAMPUS under
specified circumstances and only if the provider is specifically
identified in paragraph (b)(4)(x) of this section.
(i) The course
of treatment is prescribed by a doctor of medicine or osteopathy.
(ii) The patient
is under the supervision of a physician during the entire course
of the inpatient admission or the outpatient treatment.
(iii) The type
and level of care and service rendered by the institution are otherwise
authorized by this part.
(iv) The facility meets all licensing or other
certification requirements that are extant in the jurisdiction in
which the facility is located geographically.
(v) Is other
than a nursing home, intermediate care facility, home for the aged,
halfway house, or other similar institution.
(vi) Is accredited
by the JCAH or other CHAMPUS-approved accreditation organization,
if an appropriate accreditation program for the given type of facility
is available. As future accreditation programs are developed to cover
emerging specialized treatment programs, such accreditation will
be a prerequisite to coverage by CHAMPUS for services provided by
such facilities.
(2) To ensure
that CHAMPUS beneficiaries are provided quality care at a reasonable
cost when treated by a special institutional provider, the Director,
OCHAMPUS may:
(i) Require prior
approval of all admissions to special institutional providers.
(ii) Set appropriate
standards for special institutional providers in addition to or
in the absence of JCAHO accreditation.
(iii) Monitor
facility operations and treatment programs on a continuing basis
and conduct onsite inspections on a scheduled and unscheduled basis.
(iv) Negotiate
agreements of participation.
(v) Terminate
approval of a case when it is ascertained that a departure from
the facts upon which the admission was based originally has occurred.
(vi) Declare
a special institutional provider not eligible for CHAMPUS payment
if that facility has been found to have engaged in fraudulent or
deceptive practices.
(3) In
general, the following disclaimers apply to treatment by special
institutional providers:
(i) Just because one period or episode of
treatment by a facility has been covered by CHAMPUS may not be construed
to mean that later episodes of care by the same or similar facility
will be covered automatically.
(ii) The fact
that one case has been authorized for treatment by a specific facility
or similar type of facility may not be construed to mean that similar
cases or later periods of treatment will be extended CHAMPUS benefits automatically.
(B) Types of providers.
The following is a list of
facilities that have been designated specifically as special institutional
providers.
(1) Ambulatory
surgical centers (ASC). ASCs
must meet all criteria for classification as an Ambulatory Surgical Center
under 42 CFR part 416, as well as all of the requirements of this
part, in order to be considered an authorized ASC under the TRICARE
program. Care provided by an authorized TRICARE ASC may be cost-shared
under the following circumstances:
(i) A
childbirth procedure provided by a CHAMPUS-approved ASC shall not
be cost-shared by CHAMPUS unless the surgical center is also a CHAMPUS-approved
birthing center institutional provider as established by the birthing
center provider certification requirement of this part, and then
reimbursement of covered maternity care and childbirth services
shall be subject to Sec. 199.14(e).
(ii) ASCs
must demonstrate they have a valid participation agreement with
Medicare, except as provided under paragraph (b)(4)(x)(B)(1)(i) of
this section. In addition, in order to be considered an authorized
TRICARE provider, ASCs must accept the requirements for a participating
provider under paragraph (a)(13) of this section and must also enter
into a participation agreement with TRICARE which includes a specific
“hold harmless” provision under which the facility will agree not
to bill the patient for services not on the Medicare ASC procedures
list unless, the patient is advised in writing that the non-listed
procedure is not covered by TRICARE and the patient agrees, in advance
in writing, to be financially liable for the non-covered procedure.
(iii) ASCs
that do not have an agreement with Medicare due to the nature of
the patients they treat (e.g., pediatric patients) shall be accredited
by the Joint Commission, the Accreditation Association for Ambulatory
Health Care, Inc. (AAAHC), or such other accreditation as authorized
by the Director, DHA and published in the implementing instructions.
Additionally, these facilities must enter into participation agreements
with TRICARE, including the hold harmless provisions under paragraph
(b)(4)(x)(B)(1)(ii) of this section, and accept the requirements
for a participating provider under paragraph (a)(13) of this section
in order to be an authorized TRICARE provider.
(2) [Reserved]
(xi) Birthing centers.
A birthing center is a freestanding
or institution-affiliated outpatient maternity care program which
principally provides a planned course of outpatient prenatal care
and outpatient childbirth service limited to low-risk pregnancies;
excludes care for high-risk pregnancies; limits childbirth to the
use of natural childbirth procedures; and provides immediate newborn
care.
(A) Certification
requirements.
A birthing center which meets
the following criteria may be designated as an authorized CHAMPUS
institutional provider:
(1) The
predominant type of service and level of care rendered by the center
is otherwise authorized by this part.
(2) The center
is licensed to operate as a birthing center where such license is
available, or is specifically licensed as a type of ambulatory health
care facility where birthing center specific license is not available,
and meets all applicable licensing or certification requirements
that are extant in the state, county, municipality, or other political jurisdiction
in which the center is located.
(3) The
center is accredited by a nationally recognized accreditation organization
whose standards and procedures have been determined to be acceptable
by the Director, OCHAMPUS, or a designee.
(4) The
center complies with the CHAMPUS birthing center standards set forth
in this part.
(5) The center has entered into a participation
agreement with OCHAMPUS in which the center agrees, in part, to:
(i) Participate
in CHAMPUS and accept payment for maternity services based upon
the reimbursement methodology for birthing centers;
(ii) Collect
from the CHAMPUS beneficiary only those amounts that represent the
beneficiary’s liability under the participation agreement and the
reimbursement methodology for birthing centers, and the amounts
for services and supplies that are not a benefit of the CHAMPUS;
(iii) Permit
access by the Director, OCHAMPUS, or a designee, to the clinical
record of any CHAMPUS beneficiary, to the financial and organizational
records of the center, and to reports of evaluations and inspections
conducted by state or private agencies or organizations;
(iv) Submit claims
first to all health benefit and insurance plans primary to the CHAMPUS
to which the beneficiary is entitled and to comply with the double
coverage provisions of this part;
(v) Notify CHAMPUS
in writing within 7 days of the emergency transport of any CHAMPUS
beneficiary from the center to an acute care hospital or of the
death of any CHAMPUS beneficiary in the center.
(6) A birthing
center shall not be a CHAMPUS-authorized institutional provider
and CHAMPUS benefits shall not be paid for any service provided
by a birthing center before the date the participation agreement
is signed by the Director, OCHAMPUS, or a designee.
(B) CHAMPUS
birthing center standards.
(1) Environment:
The center has a safe and sanitary
environment, properly constructed, equipped, and maintained to protect
health and safety and meets the applicable provisions of the “Life
Safety Code” of the National Fire Protection Association.
(2) Policies
and procedures:
The center has written administrative,
fiscal, personnel and clinical policies and procedures which collectively
promote the provision of high-quality maternity care and childbirth
services in an orderly, effective, and safe physical and organizational
environment.
(3) Informed consent:
Each CHAMPUS beneficiary admitted
to the center will be informed in writing at the time of admission
of the nature and scope of the center’s program and of the possible
risks associated with maternity care and childbirth in the center.
(4) Beneficiary
care:
Each woman admitted will be
cared for by or under the direct supervision of a specific physician
or a specific certified nurse-midwife who is otherwise eligible
as a CHAMPUS individual professional provider.
(5) Medical
direction:
The center has written memoranda
of understanding (MOU) for routine consultation and emergency care
with an obstetrician-gynecologist who is certified or is eligible
for certification by the American Board of Obstetrics and Gynecology
or the American Osteopathic Board of Obstetrics and Gynecology and
with a pediatrician who is certified or eligible for certification
by the American Board of Pediatrics or by the American Osteopathic
Board of Pediatrics, each of whom have admitting privileges to at
least one backup hospital. In lieu of a required MOU, the center
may employ a physician with the required qualifications. Each MOU
must be renewed annually.
(6) Admission
and emergency care criteria and procedures.
The center
has written clinical criteria and administrative procedures, which
are reviewed and approved annually by a physician related to the
center as required by paragraph (b)(4)(xi)(B)(5) above,
for the exclusion of a woman with a high-risk pregnancy from center care
and for management of maternal and neonatal emergencies.
(7) Emergency
treatment.
The center has a written memorandum
of understanding (MOU) with at least one backup hospital which documents
that the hospital will accept and treat any woman or newborn transferred
from the center who is in need of emergency obstetrical or neonatal
medical care. In lieu of this MOU with a hospital, a birthing center
may have an MOU with a physician, who otherwise meets the requirements
as a CHAMPUS individual professional provider, and who has admitting
privileges to a backup hospital capable of providing care for critical
maternal and neonatal patients as demonstrated by a letter from
that hospital certifying the scope and expected duration of the
admitting privileges granted by the hospital to the physician. The
MOU must be reviewed annually.
(8) Emergency
medical transportation.
The center has a written memorandum
of understanding (MOU) with at least one ambulance service which
documents that the ambulance service is routinely staffed by qualified personnel
who are capable of the management of critical maternal and neonatal
patients during transport and which specifies the estimated transport
time to each backup hospital with which the center has arranged
for emergency treatment as required in paragraph (b)(4)(xi)(B)(7) above.
Each MOU must be renewed annually.
(9) Professional
staff.
The center’s professional staff
is legally and professionally qualified for the performance of their
professional responsibilities.
(10) Medical
records.
The center maintains full and
complete written documentation of the services rendered to each
woman admitted and each newborn delivered. A copy of the informed
consent 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 in
the medical record of each CHAMPUS beneficiary admitted.
(11) Quality
assurance.
The center has an organized
program for quality assurance which includes, but is not limited
to, written procedures for regularly scheduled evaluation of each
type of service provided, of each mother or newborn transferred
to a hospital, and of each death within the facility.
(12) Governance
and administration.
The center has a governing
body legally responsible for overall operation and maintenance of
the center and a full-time employee who has authority and responsibility
for the day-to-day operation of the center.
(xii) Psychiatric
and substance use disorder partial hospitalization programs.
This paragraph (b)(4)(xii)
establishes the definition of and eligibility standards and requirements
for psychiatric and substance use disorder partial hospitalization
programs.
(A) Organization
and administration--
(1) Definition.
Partial hospitalization is
defined as a time-limited, ambulatory, active treatment program
that offers therapeutically intensive, coordinated, and structured
clinical services within a stable therapeutic milieu. Partial hospitalization
programs serve patients who exhibit psychiatric symptoms, disturbances
of conduct, and decompensating conditions affecting mental health.
Partial hospitalization is appropriate for those whose psychiatric
and addiction-related symptoms or concomitant physical and emotional/behavioral
problems can be managed outside the hospital for defined periods
of time with support in one or more of the major life areas. A partial
hospitalization program for the treatment of substance use disorders
is an addiction-focused service that provides active treatment to
children and adolescents, or adults aged 18 and over.
(2) Eligibility.
(i) To qualify
as a TRICARE authorized provider, every partial hospitalization
program must meet minimum basic standards set forth in paragraphs
(b)(4)(xii)(A) through (D) of this section, as well as such additional elaborative
criteria and standards as the Director determines are necessary
to implement the basic standards. Each partial hospitalization program
must be either a distinct part of an otherwise-authorized institutional
provider or a free-standing program. Approval of a hospital by TRICARE
is sufficient for its partial hospitalization program to be an authorized
TRICARE provider. Such hospital-based partial hospitalization programs
are not required to be separately authorized by TRICARE.
(ii) To be approved
as a TRICARE authorized provider, the facility is required to be
licensed and operate in substantial compliance with state and federal
regulations.
(iii) The facility is required to be currently
accredited by an accrediting organization approved by the Director. Each
PHP authorized to treat substance use disorder must be accredited
to provide the level of required treatment by an accreditation body
approved by the Director.
(iv) The facility is required to have a written
participation agreement with OCHAMPUS. The PHP is not a CHAMPUS-authorized
provider and CHAMPUS benefits are not paid for services provided
until the date upon which a participation agreement is signed by
the Director.
(B) Participation
agreement requirements.
In addition to other requirements
set forth in this paragraph (b)(4)(xii), in order for the services
of a PHP to be authorized, the PHP shall have entered into a Participation
Agreement with OCHAMPUS. A single consolidated participation agreement
is acceptable for all units of the TRICARE authorized facility granted
that all programs meet the requirements of this part. The period
of a Participation Agreement shall be specified in the agreement,
and will generally be for not more than five years. The PHP shall
not be considered to be a CHAMPUS authorized provider and CHAMPUS
payments shall not be made for services provided by the PHP until
the date the participation agreement is signed by the Director.
In addition to review of a facility’s application and supporting
documentation, an on-site inspection by OCHAMPUS authorized personnel
may be required prior to signing a participation agreement. The
Participation Agreement shall include at least the following requirements:
(1) Render partial
hospitalization program services to eligible CHAMPUS beneficiaries
in need of such services, in accordance with the participation agreement
and CHAMPUS regulation.
(2) Accept payment for its services based
upon the methodology provided in Sec. 199.14, or such other method as
determined by the Director;
(3) Accept
the CHAMPUS all-inclusive per diem rate as payment in full and collect
from the CHAMPUS beneficiary or the family of the CHAMPUS beneficiary
only those amounts that represent the beneficiary’s liability, as
defined in Sec. 199.4, and charges for services and supplies that
are not a benefit of CHAMPUS;
(4) Make all
reasonable 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 which
the beneficiary is entitled that is primary to CHAMPUS;
(6) Submit claims
for services provided to CHAMPUS beneficiaries at least every 30
days (except to the extent a delay is necessitated by efforts to
first collect from other health insurance). If claims are not submitted
at least every 30 days, the PHP agrees not to bill the beneficiary
or the beneficiary’s family for any amounts disallowed by CHAMPUS;
(7) Certify that:
(i) It is and
will remain in compliance with the TRICARE standards and provisions
of paragraph (b)(4)(xii) of this section establishing standards
for psychiatric and substance use disorder partial hospitalization
programs; and
(ii) It will maintain compliance with the CHAMPUS
Standards for Psychiatric Substance Use Disorder Partial Hospitalization
Programs, as issued by the Director, except for any such standards
regarding which the facility notifies the Director, or designee,
that it is not in compliance.
(8) Designate
an individual who will act as liaison for CHAMPUS inquiries. The
PHP shall inform the Director, or designee, in writing of the designated
individual;
(9) Furnish OCHAMPUS, as requested by OCHAMPUS,
with cost data certified by an independent accounting firm or other
agency as authorized by the Director;
(10) Comply with
all requirements of this section applicable to institutional providers
generally concerning accreditation requirements, preauthorization,
concurrent care review, claims processing, beneficiary liability, double
coverage, utilization and quality review, and other matters;
(11) Grant the
Director, or designee, the right to conduct quality assurance audits
or accounting audits with full access to patients and records (including
records 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) Examination
of fiscal and all other records of the PHP which would confirm compliance
with the participation agreement and designation as a TRICARE authorized
PHP provider;
(ii) Conducting such audits of PHP records
including clinical, financial, and census records, as may be necessary to
determine the nature of the services being provided, and the basis
for charges and claims against the United States for services provided
CHAMPUS beneficiaries;
(iii) Examining reports of evaluations and inspections
conducted by federal, state and local government, and private agencies
and organizations;
(iv) Conducting on-site inspections of the
facilities of the PHP and interviewing employees, members of the
staff, contractors, board members, volunteers, and patients, as
required;
(v) Audits conducted by the United States
General Account Office.
(C) Other
requirements applicable to PHPs.
(1) Even though a PHP may qualify as a TRICARE
authorized provider and may have entered into a participation agreement
with CHAMPUS, payment by CHAMPUS for particular services provided
is contingent upon the PHP also meeting all conditions set forth
in Sec. 199.4.
(2) The PHP may not discriminate against CHAMPUS
beneficiaries in any manner, including admission practices, placement
in special or separate wings or rooms, or provisions of special
or limited treatment.
(3) The
PHP shall assure that all certifications and information provided
to the Director incident to the process of obtaining and retaining
authorized provider status is accurate and that is has no material
errors or omissions. In the case of any misrepresentations, whether
by inaccurate information being provided or material facts withheld, authorized
provider status will be denied or terminated, and the PHP will be
ineligible for consideration for authorized provider status for
a two year period.
(xiii) Hospice programs.
Hospice programs must be Medicare
approved and meet all Medicare conditions of participation (42 CFR
part 418) in relation to CHAMPUS patients in order to receive payment
under the CHAMPUS program. A hospice program may be found to be
out of compliance with a particular Medicare condition of participation
and still participate in the CHAMPUS as long as the hospice is allowed
continued participation in Medicare while the condition of noncompliance
is being corrected. The hospice program can be either a public agency
or private organization (or a subdivision thereof) which:
(A) Is
primarily engaged in providing the care and services described under
Sec. 199.4(e)(19) and makes such services available on a 24-hour
basis.
(B) Provides
bereavement counseling for the immediate family or terminally ill
individuals.
(C)
Provides
for such care and services in individuals’ homes, on an outpatient
basis, and on a short-term inpatient basis, directly or under arrangements
made by the hospice program, except that the agency or organization
must:
(1) Ensure that
substantially all the core services are routinely provided directly
by hospice employees.
(2) Maintain professional management responsibility
for all services which are not directly furnished to the patient,
regardless of the location or facility in which the services are
rendered.
(3) Provide
assurances that the aggregate number of days of inpatient care provided
in any 12-month period does not exceed 20 percent of the aggregate
number of days of hospice care during the same period.
(4) Have
an interdisciplinary group composed of the following personnel who
provide the care and services described under Sec. 199.4(e)(19)
and who establish the policies governing the provision of such care/services:
(i) A physician;
(ii) A registered
professional nurse;
(iii) A social worker; and
(iv) A pastoral
or other counselor.
(5) Maintain
central clinical records on all patients.
(6) Utilize volunteers.
(7) The hospice
and all hospice employees must be licensed in accordance with applicable
Federal, State and local laws and regulations.
(8) The hospice
must enter into an agreement with CHAMPUS in order to be qualified
to participate and to be eligible for payment under the program.
In this agreement the hospice and CHAMPUS agree that the hospice
will:
(i) Not charge
the beneficiary or any other person for items or services for which
the beneficiary is entitled to have payment made under the CHAMPUS
hospice benefit.
(ii) Be allowed to charge the beneficiary for
items or services requested by the beneficiary in addition to those that
are covered under the CHAMPUS hospice benefit.
(9) Meet such
other requirements as the Secretary of Defense may find necessary
in the interest of the health and safety of the individuals who
are provided care and services by such agency or organization.
(xiv) Substance
use disorder rehabilitation facilities.
This paragraph
(b)(4)(xiv) establishes the definition of eligibility standards
and requirements for residential substance use disorder rehabilitation
facilities (SUDRF).
(A) Organization
and administration--
(1) Definition.
A SUDRF is a residential or
rehabilitation facility, or distinct part of a facility, that provides
medically monitored, interdisciplinary addiction-focused treatment
to beneficiaries who have psychoactive substance use disorders.
Qualified health care professionals provide 24-hour, seven-day-per-week,
assessment, treatment, and evaluation. A SUDRF is appropriate for
patients whose addiction-related symptoms, or concomitant physical
and emotional/behavioral problems reflect persistent dysfunction
in several major life areas. Residential or inpatient rehabilitation
is differentiated from:
(i) Acute psychoactive substance use treatment
and from treatment of acute biomedical/emotional/behavioral problems;
which problems are either life-threatening and/or severely incapacitating
and often occur within the context of a discrete episode of addiction-related
biomedical or psychiatric dysfunction;
(ii) A partial
hospitalization center, which serves patients who exhibit emotional/behavioral
dysfunction but who can function in the community for defined periods
of time with support in one or more of the major life areas;
(iii) A group
home, sober-living environment, halfway house, or three-quarter
way house;
(iv) Therapeutic schools, which are educational
programs supplemented by addiction-focused services;
(v) Facilities
that treat patients with primary psychiatric diagnoses other than
psychoactive substance use or dependence; and
(vi) Facilities
that care for patients with the primary diagnosis of mental retardation
or developmental disability.
(2) Eligibility.
(i) In order
to become a TRICARE authorized provider, every SUDRF must meet minimum
basic standards set forth in paragraphs (b)(4)(xiv)(A) through (C)
of this section, as well as such additional elaborative criteria
and standards as the Director determines are necessary to implement
the basic standards.
(ii) To be approved as a TRICARE authorized
provider, the SUDRF is required to be licensed and operate in substantial
compliance with state and federal regulations.
(iii) The SUDRF
is currently accredited by an accrediting organization approved
by the Director. Each SUDRF must be accredited to provide the level
of required treatment by an accreditation body approved by the Director.
(iv) The SUDRF
has a written participation agreement with OCHAMPUS. The SUDRF is
not considered a TRICARE authorized provider, and CHAMPUS benefits
are not paid for services provided until the date upon which a participation
agreement is signed by the Director.
(B) Participation
agreement requirements.
In addition to other requirements
set forth in this paragraph (b)(4)(xiv), in order for the services
of an inpatient rehabilitation center for the treatment of substance
use disorders to be authorized, the center shall have entered into
a Participation Agreement with OCHAMPUS. A single consolidated participation
agreement is acceptable for all units of the TRICARE authorized
facility. The period of a Participation Agreement shall be specified
in the agreement, and will generally be for not more than five years.
The SUDRF shall not be considered to be a CHAMPUS authorized provider
and CHAMPUS payments shall not be made for services provided by
the SUDRF until the date the participation agreement is signed by
the Director. In addition to review of the SUDRF’s application and
supporting documentation, an on-site visit by OCHAMPUS representatives
may be part of the authorization process. The Participation Agreement
shall include at least the following requirements:
(1) Render applicable
services to eligible CHAMPUS beneficiaries in need of such services,
in accordance with the participation agreement and CHAMPUS regulation;
(2) Accept payment
for its services based upon the methodology provided in Sec. 199.14,
or such other method as determined by the Director;
(3) Accept
the CHAMPUS-determined rate as payment in full and collect from
the CHAMPUS beneficiary or the family of the CHAMPUS beneficiary
only those amounts that represent the beneficiary’s liability, as
defined in Sec. 199.4, and charges for services and supplies that
are not a benefit of CHAMPUS;
(4) Make all
reasonable 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 which
the beneficiary is entitled that is primary to CHAMPUS;
(6) Furnish OCHAMPUS
with cost data, as requested by OCHAMPUS, certified to by an independent
accounting firm or other agency as authorized by the Director;
(7) Certify that:
(i) It is and
will remain in compliance with the provisions of paragraph (b)(4)(xiv)
of the section establishing standards for substance use disorder
rehabilitation facilities; and
(ii) It has conducted
a self-assessment of the facility’s compliance with the CHAMPUS
Standards for Substance Use Disorder Rehabilitation Facilities,
as issued by the Director and notified the Director of any matter
regarding which the facility is not in compliance with such standards;
and
(iii) It will
maintain compliance with the CHAMPUS Standards for Substance Use
Disorder Rehabilitation Facilities, as issued by the Director, except
for any such standards regarding which the facility notifies the
Director that it is not in compliance.
(8) Designate
an individual who will act as liaison for CHAMPUS inquiries. The
SUDRF shall inform OCHAMPUS in writing of the designated individual;
(9) Furnish OCHAMPUS,
as requested by OCHAMPUS, with cost data certified by an independent
accounting firm or other agency as authorized by the Director;
(10) Comply
with all requirements of this section applicable to institutional
providers generally concerning accreditation requirements, preauthorization,
concurrent care review, claims processing, beneficiary liability, double
coverage, utilization and quality review, and other matters;
(11) Grant the
Director, or designee, the right to conduct quality assurance audits
or accounting audits with full access to patients and records (including
records 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) Examination
of fiscal and all other records of the center which would confirm
compliance with the participation agreement and designation as an
authorized TRICARE provider;
(ii) Conducting
such audits of center records including clinical, financial, and
census records, as may be necessary to determine the nature of the
services being provided, and the basis for charges and claims against
the United States for services provided CHAMPUS beneficiaries;
(iii) Examining
reports of evaluations and inspection conducted by federal, state
and local government, and private agencies and organizations;
(iv) Conducting
on-site inspections of the facilities of the SUDRF and interviewing
employees, members of the staff, contractors, board members, volunteers,
and patients, as required.
(v) Audits conducted
by the United States Government Accountability Office.
(C) Other
requirements applicable to substance use disorder rehabilitation
facilities.
(1) Even though
a SUDRF may qualify as a TRICARE authorized provider and may have
entered into a participation agreement with CHAMPUS, payment by
CHAMPUS for particular services provided is contingent upon the
SUDRF also meeting all conditions set forth in Sec. 199.4.
(2) The center
shall provide inpatient services to CHAMPUS beneficiaries in the
same manner it provides services to all other patients. The center
may not discriminate against CHAMPUS beneficiaries in any manner,
including admission practices, placement in special or separate
wings or rooms, or provisions of special or limited treatment.
(3) The
substance use disorder facility shall assure that all certifications
and information provided to the Director, incident to the process
of obtaining and retaining authorized provider status, is accurate
and that it has no material errors or omissions. In the case of
any misrepresentations, whether by inaccurate information being
provided or material facts withheld, authorized provider status
will be denied or terminated, and the facility will be ineligible
for consideration for authorized provider status for a two year
period.
(xv) Home
health agencies (HHAs).
HHAs must be Medicare approved
and meet all Medicare conditions of participation under sections
1861(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 beneficiaries
in order to receive payment under the TRICARE program. An HHA may
be found to be out of compliance with a particular Medicare condition
of participation and still participate in the TRICARE program as
long as the HHA is allowed continued participation in Medicare while
the condition of noncompliance is being corrected. An HHA is a public
or private organization, or a subdivision of such an agency or organization,
that meets the following requirements:
(A) Engaged in providing
skilled nursing services and other therapeutic services, such as
physical therapy, speech-language pathology services, or occupational
therapy, medical services, and home health aide services.
(1) Makes available
part-time or intermittent skilled nursing services and at least
one other therapeutic service on a visiting basis in place of residence
used as a patient’s home.
(2) Furnishes at least one of the qualifying
services directly through agency employees, but may furnish the second
qualifying service and additional services under arrangement with
another HHA or organization.
(B) Policies
established by a professional group associated with the agency or
organization (including at least one physician and one registered
nurse) to govern the services and provides for supervision of such
services by a physician or a registered nurse.
(C) Maintains
clinical records for all patients.
(D) Licensed in accordance
with State and local law or is approved by the State or local licensing
agency as meeting the licensing standards, where applicable.
(E)
Enters
into an agreement with TRICARE in order to participate and to be
eligible for payment under the program. In this agreement the HHA
and TRICARE agree that the HHA will:
(1) Not charge the beneficiary or any other
person for items or services for which the beneficiary is entitled
to have payment under the TRICARE HHA prospective payment system.
(2) Be allowed
to charge the beneficiary for items or services requested by the
beneficiary in addition to those that are covered under the TRICARE
HHA prospective payment system.
(F)
Abide
by the following consolidated billing requirements:
(1) The HHA must
submit all TRICARE claims for all home health services, excluding
durable medical equipment (DME), while the beneficiary is under
the home health plan without regard to whether or not the item or
service was furnished by the HHA, by others under arrangement with
the HHA, or under any other contracting or consulting arrangement.
(2) Separate
payment will be made for DME items and services provided under the
home health benefit which are under the DME fee schedule. DME is
excluded from the consolidated billing requirements.
(3) Home
health services included in consolidated billing are:
(i) Part-time
or intermittent skilled nursing;
(ii) Part-time
or intermittent home health aide services;
(iii) Physical
therapy, occupational therapy and speech-language pathology;
(iv) Medical
social services;
(v) Routine and non-routine medical supplies;
(vi) A covered
osteoporosis drug (not paid under PPS rate) but excluding other
drugs and biologicals;
(vii) Medical services provided by an intern
or resident-in-training of a hospital, under an approved teaching program
of the hospital in the case of an HHA that is affiliated or under
common control of a hospital;
(viii) Services
at hospitals, SNFs or rehabilitation centers when they involve equipment
too cumbersome to bring home.
(G) Meet such other
requirements as the Secretary of Health and Human Services and/or
Secretary of Defense may find necessary in the interest of the health
and safety of the individuals who are provided care and services
by such agency or organization.
(xvi) Critical Access Hospitals
(CAHs).
CAHs must meet all conditions
of participation under 42 CFR 485.601 through 485.645 in relation
to TRICARE beneficiaries in order to receive payment under the TRICARE
program. If a CAH provides inpatient psychiatric services or inpatient
rehabilitation services in a distinct part unit, the distinct part
unit must meet the conditions of participation in 42 CFR 485.647,
with the exception of being paid under the inpatient prospective
payment system for psychiatric facilities as specified in 42 CFR
412.1(a)(2) or the inpatient prospective payment system for rehabilitation
hospitals or rehabilitation units as specified in 42 CFR 412.1(a)(3). Upon
implementation of TRICARE’s IRF PPS in Sec. 199.14(a)(10), if a
CAH provides inpatient rehabilitation services in a distinct part
unit, the distinct part unit shall be paid under TRICARE’s IRF PPS.
(xvii) Sole
community hospitals (SCHs).
SCHs must meet all the criteria
for classification as an SCH under 42 CFR 412.92, in order to be
considered an SCH under the TRICARE program.
(xviii) Intensive
outpatient programs.
This paragraph (b)(4)(xviii)
establishes standards and requirements for intensive outpatient
treatment programs for psychiatric and substance use disorder.
(A) Organization
and administration--
(1) Definition.
Intensive outpatient treatment
(IOP) programs are defined in Sec. 199.2. IOP services consist of
a comprehensive and complimentary schedule of recognized treatment approaches
that may include day, evening, night, and weekend services consisting
of individual and group counseling or therapy, and family counseling
or therapy as clinically indicated for children and adolescents,
or adults aged 18 and over, and may include case management to link
patients and their families with community based support systems.
(2) Eligibility.
(i) In order
to qualify as a TRICARE authorized provider, every intensive outpatient
program must meet the minimum basic standards set forth in paragraphs
(b)(4)(xviii)(A) through (C) of this section, as well as additional
elaborative criteria and standards as the Director determines are
necessary to implement the basic standards. Each intensive outpatient
program must be either a distinct part of an otherwise-authorized institutional
provider or a free-standing psychiatric or substance use disorder
intensive outpatient program. Approval of a hospital by TRICARE
is sufficient for its IOP to be an authorized TRICARE provider.
Such hospital-based intensive outpatient programs are not required
to be separately authorized by TRICARE.
(ii) To qualify
as a TRICARE authorized provider, the IOP is required to be licensed
and operate in substantial compliance with state and federal regulations.
(iii) The IOP
is currently accredited by an accrediting organization approved
by the Director. Each IOP authorized to treat substance use disorder
must be accredited to provide the level of required treatment by
an accreditation body approved by the Director.
(iv) The facility
has a written participation agreement with TRICARE. The IOP is not
considered a TRICARE authorized provider and TRICARE benefits are
not paid for services provided until the date upon which a participation
agreement is signed by the Director.
(B) Participation
agreement requirements.
In addition to other requirements
set forth in paragraph (b)(4)(xii) of this section, in order for
the services of an IOP to be authorized, the IOP shall have entered
into a Participation Agreement with TRICARE. A single consolidated
participation agreement is acceptable for all units of the TRICARE authorized
facility granted that all programs meet the requirements of this
part. The period of a Participation Agreement shall be specified
in the agreement, and will generally be for not more than five years.
In addition to review of a facility’s application and supporting
documentation, an on-site inspection by DHA authorized personnel
may be required prior to signing a participation agreement. The
Participation Agreement shall include at least the following requirements:
(1) Render intensive
outpatient program services to eligible TRICARE beneficiaries in
need of such services, in accordance with the participation agreement
and TRICARE regulation.
(2) Accept payment for its services based
upon the methodology provided in Sec. 199.14, or such other method as
determined by the Director;
(3) Collect
from the TRICARE beneficiary or the family of the TRICARE beneficiary
only those amounts that represent the beneficiary’s liability, as
defined in Sec. 199.4, and charges for services and supplies that
are not a benefit of TRICARE;
(4) Make all
reasonable 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 which
the beneficiary is entitled that is primary to TRICARE;
(6) Submit claims
for services provided to TRICARE beneficiaries at least every 30
days (except to the extent a delay is necessitated by efforts to
first collect from other health insurance). If claims are not submitted
at least every 30 days, the IOP agrees not to bill the beneficiary
or the beneficiary’s family for any amounts disallowed by TRICARE;
(7) Free-standing
intensive outpatient programs shall certify that:
(i) It is and
will remain in compliance with the provisions of paragraph (b)(4)(xii)
of this section establishing standards for psychiatric and SUD IOPs;
(ii) It has conducted
a self-assessment of the facility’s compliance with the CHAMPUS
Standards for Intensive Outpatient Programs, as issued by the Director,
and notified the Director of any matter regarding which the facility is
not in compliance with such standards; and
(iii) It will
maintain compliance with the TRICARE standards for IOPs, as issued
by the Director, except for any such standards regarding which the
facility notifies the Director, or a designee that it is not in
compliance.
(8) Designate an individual who will act as
liaison for TRICARE inquiries. The IOP shall inform TRICARE, or
a designee in writing of the designated individual;
(9) Furnish OCHAMPUS
with cost data, as requested by OCHAMPUS, certified by an independent
accounting firm or other agency as authorized by the Director.
(10) Comply with
all requirements of this section applicable to institutional providers
generally concerning accreditation requirements, preauthorization,
concurrent care review, claims processing, beneficiary liability, double
coverage, utilization and quality review, and other matters;
(11) Grant the
Director, or designee, the right to conduct quality assurance audits
or accounting audits with full access to patients and records (including
records 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) Examination
of fiscal and all other records of the center which would confirm
compliance with the participation agreement and designation as an
authorized TRICARE provider;
(ii) Conducting
such audits of center records including clinical, financial, and
census records, as may be necessary to determine the nature of the
services being provided, and the basis for charges and claims against
the United States for services provided CHAMPUS beneficiaries;
(iii) Examining
reports of evaluations and inspection conducted by federal, state
and local government, and private agencies and organizations;
(iv) Conducting
on-site inspections of the facilities of the IOP and interviewing
employees, members of the staff, contractors, board members, volunteers,
and patients, as required.
(v) Audits conducted
by the United States Government Accountability Office.
(C) Other
requirements applicable to Intensive Outpatient Programs (IOP).
(1) Even though
an IOP may qualify as a TRICARE authorized provider and may have
entered into a participation agreement with CHAMPUS, payment by CHAMPUS
for particular services provided is contingent upon the IOP also
meeting all conditions set forth in Sec. 199.4.
(2) The IOP may
not discriminate against CHAMPUS beneficiaries in any manner, including
admission practices, placement in special or separate wings or rooms,
or provisions of special or limited treatment.
(3) The
IOP shall assure that all certifications and information provided
to the Director incident to the process of obtaining and retaining
authorized provider status is accurate and that is has no material
errors or omissions. In the case of any misrepresentations, whether
by inaccurate information being provided or material facts withheld, authorized
provider status will be denied or terminated, and the IOP will be
ineligible for consideration for authorized provider status for
a two year period.
(xix) Opioid
Treatment Programs (OTPs).
This paragraph (b)(4)(xix)
establishes standards and requirements for Opioid Treatment Programs.
(A) Organization
and administration.
(1) Definition.
Opioid Treatment Programs (OTPs)
are defined in Sec. 199.2. Opioid Treatment Programs (OTPs) are
organized, ambulatory, addiction treatment services for patients
with an opioid use disorder. OTPs have the capacity to provide daily
direct administration of medications without the prescribing of
medications. Medication supplies for patients to take outside of
OTPs originate from within OTPs. OTPs offer medication assisted
treatment, patient-centered, recovery-oriented individualized treatment
through addiction counseling, mental health therapy, case management,
and health education.
(2) Eligibility.
(i) Every free-standing
Opioid Treatment Program must be accredited by an accrediting organization
recognized by Director, under the current standards of an accrediting
organization, as well as meet additional elaborative criteria and
standards as the Director determines are necessary to implement
the basic standards. OTPs adhere to requirements of the Department
of Health and Human Services’ 42 CFR part 8, the Substance Abuse
and Mental Health Services Administration’s Center for Substance
Abuse Treatment, and the Drug Enforcement Agency. OTPs must be either
a distinct part of an otherwise authorized institutional provider
or a free-standing program. Approval of hospitals by TRICARE is
sufficient for their OTPs to be authorized TRICARE providers. Such
hospital-based OTPs, if certified under 42 CFR 8, are not required
to be separately authorized by TRICARE.
(ii) To qualify
as a TRICARE authorized provider, OTPs are required to be licensed
and operate in substantial compliance with state and federal regulations.
(iii) OTPs have
a written participation agreement with OCHAMPUS. OTPs are not considered
a TRICARE authorized provider, and CHAMPUS benefits are not paid
for services provided until the date upon which a participation
agreement is signed by the Director.
(B) Participation
agreement requirements.
In addition to other requirements
set forth in this paragraph (b)(4)(xix), in order for the services
of OTPs to be authorized, OTPs shall have entered into a Participation
Agreement with TRICARE. A single consolidated participation agreement
is acceptable for all units of a TRICARE authorized facility. The
period of a Participation Agreement shall be specified in the agreement,
and will generally be for not more than five years. In addition
to review of a facility’s application and supporting documentation,
an on-site inspection by DHA authorized personnel may be required
prior to signing a participation agreement. The Participation Agreement
shall include at least the following requirements:
(1) Render services
from OTPs to eligible TRICARE beneficiaries in need of such services,
in accordance with the participation agreement and TRICARE regulation.
(2) Accept payment
for its services based upon the methodology provided in Sec. 199.14,
or such other method as determined by the Director;
(3) Collect
from the TRICARE beneficiary or the family of the TRICARE beneficiary
only those amounts that represent the beneficiary’s liability, as
defined in Sec. 199.4, and charges for services and supplies that
are not a benefit of TRICARE;
(4) Make all
reasonable 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 which
the beneficiary is entitled that is primary to TRICARE;
(6) Submit claims
for services provided to TRICARE beneficiaries at least every 30
days (except to the extent a delay is necessitated by efforts to
first collect from other health insurance). If claims are not submitted
at least every 30 days, OTPs agree not to bill the beneficiary or
the beneficiary’s family for any amounts disallowed by TRICARE;
(7) Free-standing
opioid treatment programs shall certify that:
(i) It is and
will remain in compliance with the provisions of paragraph (b)(4)(xii)
of this section establishing standards for opioid treatment programs;
(ii) It will
maintain compliance with the TRICARE standards for OTPs, as issued
by the Director, except for any such standards regarding which the
facility notifies the Director, or a designee, that it is not in
compliance.
(8) Designate an individual who will act as
liaison for TRICARE inquiries. OTPs shall inform TRICARE, or a designee, in
writing of the designated individual;
(9) Furnish TRICARE,
or a designee, with cost data, as requested by TRICARE, certified
by an independent accounting firm or other agency as authorized
by the Director;
(10) Comply with all requirements of this section
applicable to institutional providers generally concerning accreditation
requirements, claims processing, beneficiary liability, double coverage,
utilization and quality review, and other matters;
(11) Grant the
Director, or designee, the right to conduct quality assurance audits
or accounting audits with full access to patients and records (including
records 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) Examination
of fiscal and all other records of OTPs which would confirm compliance
with the participation agreement and designation as an authorized
TRICARE provider;
(ii) Conducting such audits of OTPs’ records
including clinical, financial, and census records, as may be necessary to
determine the nature of the services being provided, and the basis
for charges and claims against the United States for services provided
TRICARE beneficiaries;
(iii) Examining reports of evaluations and inspections
conducted by federal, state and local government, and private agencies
and organizations.
(C) Other
requirements applicable to OTPs.
(1) Even though OTPs may qualify as a TRICARE
authorized provider and may have entered into a participation agreement
with CHAMPUS, payment by CHAMPUS for particular services provided
is contingent upon OTPs also meeting all conditions set forth in
Sec. 199.4.
(2) OTPs may not discriminate against CHAMPUS
beneficiaries in any manner, including admission practices or provisions
of special or limited treatment.
(3) OTPs
shall assure that all certifications and information provided to
the Director incident to the process of obtaining and retaining
authorized provider status is accurate and that is has no material
errors or omissions. In the case of any misrepresentations, whether
by inaccurate information being provided or material facts withheld, authorized
provider status will be denied or terminated, and OTPs will be ineligible
for consideration for authorized provider status for a two year
period.
(xx) Inpatient Rehabilitation
Facility (IRF).
IRFs must meet all the criteria
for classification as an IRF under 42 CFR part 412, subpart B, and
meet all applicable requirements established in this part in order
to be considered an authorized IRF under the TRICARE program.
(A) In
order for the services of inpatient rehabilitation facilities to
be covered, the facility must comply with the provisions outlined
in paragraph (b)(4)(i) of this section. In addition, in order for
services provided by these facilities to be covered by TRICARE,
they must be primarily for the treatment of the presenting illness.
(B) Custodial
or domiciliary care is not coverable under TRICARE, even if rendered
in an otherwise authorized inpatient rehabilitation facility.
(C) The
controlling factor in determining whether a beneficiary’s stay in
an inpatient rehabilitation facility is coverable by TRICARE is
the level of professional care, supervision, and skilled nursing
care that the beneficiary requires, in addition to the diagnosis,
type of condition, or degree of functional limitations. The type
and level of medical services required or rendered is controlling
for purposes of extending TRICARE benefits; not the type of provider
or condition of the beneficiary.