(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, certain temporary hospitals and freestanding ambulatory
surgical centers (ASCs) that enroll with Medicare as hospitals may
be temporarily exempt from certain institutional requirements for
acute care hospitals in this paragraph 199.6(b)(4)(i), as determined
by the Director, Defense Health Agency (DHA), or designee, to ensure
access to acute inpatient care during the COVID-19 outbreak.
(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) Free-standing
ambulatory surgical centers.
Care provided by freestanding ambulatory surgical centers
may be cost-shared by CHAMPUS under the following circumstances:
(i) The treatment is prescribed and supervised
by a physician.
(ii) The type
and level of care and services rendered by the center are otherwise
authorized by this part.
(iii) The center
meets all licensing or other certification requirements of the jurisdiction
in which the facility is located.
(iv) The center
is accredited by the JCAH, the Accreditation Association for Ambulatory
Health Care, Inc. (AAAHC), or such other standards as authorized
by the Director, OCHAMPUS.
(v) A childbirth
procedure provided by a CHAMPUS-approved free-standing ambulatory
surgical center shall not be cost-shared by the CHAMPUS unless the
surgical center is also a CHAMPUS-approved birthing center institutional
provider as established by the birthing center provider certification
requirement of this Regulation.
(2) [Reserved]
(xi) Birthing centers.
A birthing center
is a freestanding or institution-affiliated outpatient maternity care
program which principally provides a planned course of outpatient
prenatal care and outpatient childbirth service limited to low-risk
pregnancies; excludes care for high-risk pregnancies; limits childbirth
to the use of natural childbirth procedures; and provides immediate
newborn care.
(A) Certification
requirements.
A
birthing center which meets the following criteria may be designated
as an authorized CHAMPUS institutional provider:
(1) The
predominant type of service and level of care rendered by the center
is otherwise authorized by this part.
(2) The center is licensed to operate as a
birthing center where such license is available, or is specifically
licensed as a type of ambulatory health care facility where birthing
center specific license is not available, and meets all applicable
licensing or certification requirements that are extant in the state,
county, municipality, or other political jurisdiction in which the
center is located.
(3) The
center is accredited by a nationally recognized accreditation organization
whose standards and procedures have been determined to be acceptable
by the Director, OCHAMPUS, or a designee.
(4) The
center complies with the CHAMPUS birthing center standards set forth
in this part.
(5) The center
has entered into a participation agreement with OCHAMPUS in which
the center agrees, in part, to:
(i) Participate
in CHAMPUS and accept payment for maternity services based upon
the reimbursement methodology for birthing centers;
(ii) Collect from the CHAMPUS beneficiary only
those amounts that represent the beneficiary’s liability under the
participation agreement and the reimbursement methodology for birthing
centers, and the amounts for services and supplies that are not
a benefit of the CHAMPUS;
(iii) Permit
access by the Director, OCHAMPUS, or a designee, to the clinical
record of any CHAMPUS beneficiary, to the financial and organizational
records of the center, and to reports of evaluations and inspections
conducted by state or private agencies or organizations;
(iv) Submit claims first to all health benefit
and insurance plans primary to the CHAMPUS to which the beneficiary
is entitled and to comply with the double coverage provisions of
this part;
(v) Notify CHAMPUS
in writing within 7 days of the emergency transport of any CHAMPUS beneficiary
from the center to an acute care hospital or of the death of any
CHAMPUS beneficiary in the center.
(6) A birthing center shall not be a CHAMPUS-authorized
institutional provider and CHAMPUS benefits shall not be paid for
any service provided by a birthing center before the date the participation agreement
is signed by the Director, OCHAMPUS, or a designee.
(B) CHAMPUS
birthing center standards.
(1) Environment:
The center has
a safe and sanitary environment, properly constructed, equipped,
and maintained to protect health and safety and meets the applicable
provisions of the “Life Safety Code” of the National Fire Protection
Association.
(2) Policies
and procedures:
The center has written administrative, fiscal,
personnel and clinical policies and procedures which collectively
promote the provision of high-quality maternity care and childbirth
services in an orderly, effective, and safe physical and organizational
environment.
(3) Informed consent:
Each CHAMPUS
beneficiary admitted to the center will be informed in writing at
the time of admission of the nature and scope of the center’s program
and of the possible risks associated with maternity care and childbirth
in the center.
(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) (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.