(a)
General.
The CHAMPUS
Basic Program is essentially a supplemental program to the Uniformed Services
direct medical care system. The Basic Program is similar to private
insurance programs, and is designed to provide financial assistance
to CHAMPUS beneficiaries for certain prescribed medical care obtained
from civilian sources.
(1)
(i) (i) Scope of benefits.
Subject to all
applicable definitions, conditions, limitations, or exclusions specified
in this part, the CHAMPUS Basic Program will pay for medically or
psychologically necessary services and supplies required in the
diagnosis and treatment of illness or injury, including maternity care
and well-baby care. Benefits include specified medical services
and supplies provided to eligible beneficiaries from authorized
civilian sources such as hospitals, other authorized institutional providers,
physicians, other authorized individual professional providers,
and professional ambulance service, prescription drugs, authorized
medical supplies, and rental or purchase of durable medical equipment.
(ii) Impact
of TRICARE program.
The basic program benefits set forth in this
section are applicable to the basic CHAMPUS program. In areas in
which the TRICARE program is implemented, certain provisions of
Sec. 199.17 will apply instead of the provisions of this section.
In those areas, the provisions of Sec. 199.17 will take precedence
over any provisions of this section with which they conflict.
(2) Persons
eligible for Basic Program benefits.
Persons eligible to receive
the Basic Program benefits are set forth in Sec. 199.3 of this part.
Any person determined to be an eligible CHAMPUS beneficiary is eligible
for Basic Program benefits.
(3) Authority
to act for CHAMPUS.
The authority to make benefit determinations
and authorize the disbursement of funds under CHAMPUS is restricted
to the Director, OCHAMPUS; designated OCHAMPUS staff; Director,
OCHAMPUSEUR; or CHAMPUS fiscal intermediaries. No other persons
or agents (such as physicians, staff members of hospitals, or CHAMPUS
health benefits advisors) have such authority.
(4) Status
of patient controlling for purposes of cost-sharing.
Benefits for
covered services and supplies described in this section will be
extended either on an inpatient or outpatient cost-sharing basis
in accordance with the status of the patient at the time the covered
services and supplies were provided, unless otherwise specifically
designated (such as for ambulance service or maternity care). For
cost-sharing provisions, refer to paragraph (f) of this section.
(5) Right to
information.
As
a condition precedent to the provision of benefits hereunder, OCHAMPUS
or its CHAMPUS fiscal intermediaries shall be entitled to receive
information from a physician or hospital or other person, institution,
or organization (including a local, state, or U.S. Government agency)
providing services or supplies to the beneficiary for which claims
or requests for approval for benefits are submitted. Such information
and records may relate to the attendance, testing, monitoring, or
examination or diagnosis of, or treatment rendered, or services
and supplies furnished to a beneficiary, and shall be necessary
for the accurate and efficient administration of CHAMPUS benefits.
Before a determination will be made on a request for preauthorization
or claim of benefits, a beneficiary or sponsor must provide particular
additional information relevant to the requested determination,
when necessary. The recipient of such information shall in every
case hold such records confidential except when:
(i) Disclosure
of such information is authorized specifically by the beneficiary;
(ii) Disclosure
is necessary to permit authorized governmental officials to investigate
and prosecute criminal actions, or
(iii)
Disclosure
is authorized or required specifically under the terms of the Privacy
Act or Freedom of Information Act (refer to Sec. 199.1(m) of this
part).
For the purposes of determining the
applicability of and implementing the provisions of Secs. 199.8, 199.11,
and 199.12, or any provision of similar purpose of any other medical
benefits coverage or entitlement, OCHAMPUS or CHAMPUS fiscal intermediaries
may release, without consent or notice to any beneficiary or sponsor,
to any person, organization, government agency, provider, or other
entity any information with respect to any beneficiary when such
release constitutes a routine use published in the Federal Register
in accordance with DoD 5400.11–R (Privacy Act (5 U.S.C. 552a)).
Before a person’s claim of benefits will be adjudicated, the person
must furnish to CHAMPUS information that reasonably may be expected
to be in his or her possession and that is necessary to make the
benefit determination. Failure to provide the requested information
may result in denial of the claim.
(6) Physical
examinations.
The
Director, OCHAMPUS, or a designee, may require a beneficiary to submit
to one or more medical (including psychiatric) examinations to determine
the beneficiary’s entitlement to benefits for which application
has been made or for otherwise authorized medically necessary services
and supplies required in the diagnosis or treatment of an illness
or injury (including maternity and well-baby care). When a medical
examination has been requested, CHAMPUS will withhold payment of
any pending claims or preauthorization requests on that particular
beneficiary. If the beneficiary refuses to agree to the requested
medical examination, or unless prevented by a medical reason acceptable
to OCHAMPUS, the examination is not performed within 90 days of
initial request, all pending claims for services and supplies will
be denied. A denial of payments for services or supplies provided
before (and related to) the request for a physical examination is
not subject to reconsideration. The medical examination and required
beneficiary travel related to performing the requested medical examination
will be at the expense of CHAMPUS. The medical examination may be performed
by a physician in a Uniformed Services medical facility or by an
appropriate civilian physician, as determined and selected by the
Director, OCHAMPUS, or a designee who is responsible for making
such arrangements as are necessary, including necessary travel arrangements.
(7) Claims
filing deadline.
For all services provided on or after January
1, 1993, to be considered for benefits, all claims submitted for
benefits must, except as provided in Sec. 199.7, be filed with the appropriate
CHAMPUS contractor no later than one year after the services are
provided. Unless the requirement is waived, failure to file a claim
within this deadline waives all rights to benefits for such services
or supplies.
(8) Double coverage and third party recoveries.
CHAMPUS claims
involving double coverage or the possibility that the United States
can recover all or a part of its expenses from a third party, are specifically
subject to the provisions of Sec. 199.8 or Sec. 199.12 of this part
as appropriate.
(9) Nonavailability
Statements within a 40-mile catchment area.
Unless required by action
of the Assistant Secretary of Defense for Health Affairs (ASD(HA))
under this paragraph (a)(9), nonavailability statements are not
required. If they are required by ASD(HA) action, in some geographic
locations, CHAMPUS beneficiaries not enrolled in TRICARE Prime may
be required to obtain a nonavailability statement from a military
medical treatment facility in order to receive specifically identified
health care services from a civilian provider. If the required care
cannot be provided through the Uniformed Service facility, the hospital
commander, or a designee, will issue a Nonavailability Statement
(NAS) (DD Form 1251). Failure to secure such a statement may waive
the beneficiary’s rights to benefits under CHAMPUS/TRICARE.
(i) With
the exception of maternity services, the ASD(HA) may require an
NAS prior to TRICARE cost-sharing for additional services from civilian
sources if such services are to be provided to a beneficiary who
lives within a 40-mile catchment area of an MTF where such services
are available and the ASD(HA):
(A) Demonstrates that
significant costs would be avoided by performing specific procedures
at the affected MTF or MTFs; or
(B) Determines that
a specific procedure must be provided at the affected MTF or MTFs
to ensure the proficiency levels of the practitioners at the MTF
or MTFs; or
(C) Determines that
the lack of NAS data would significantly interfere with TRICARE
contract administration; and
(D) Provides
notification of the ASD(HA)’s intent to require an NAS under this
authority to covered beneficiaries who receive care at the MTF or
MTFs that will be affected by the decision to require an NAS under
this authority; and
(E) Provides
at least 60-day notification to the Committees on Armed Services
of the House of Representatives and the Senate of the ASD(HA)’s
intent to require an NAS under this authority, the reason for the
NAS requirement, and the date that an NAS will be required.
(ii) Rules
in effect at the time civilian medical care is provided apply. The
applicable rules and regulations regarding Nonavailability Statements
in effect at the time the civilian care is rendered apply in determining
whether a NAS is required.
(iii)
The
Director, TMA is responsible for issuing the procedural rules and
regulations regarding Nonavailability Statements. Such rules and
regulations should address:
(A) When and for what
services a NAS is required. However, a NAS may not be required for
services otherwise available at an MTF located within a 40-mile
radius of the beneficiary’s residence when another insurance plan
or program provides the beneficiary’s primary coverage for the services.
This requirement for an NAS does not apply to beneficiaries enrolled
in TRICARE Prime, even when those beneficiaries use the point-of-service
option under Sec. 199.17(n)(3) of this part; and
(B) When
and how notifications will be made to a beneficiary who is not enrolled
in TRICARE Prime as to whether or not he or she resides in a geographic
area that requires obtaining a NAS; and
(C) What
information relating to claims submissions, including the documentation,
if any, that is required to document that a valid NAS was issued.
However, when documentation of a NAS is required, then that documentation
shall be valid for the adjudication of CHAMPUS claims for all related
care otherwise authorized by this part which is received from a
civilian source while the beneficiary resided within the Uniformed
Service facility catchment area which issued the NAS.
(iv) In
the case of any service subject to a NAS requirement under this
paragraph (a)(9) and also subject to a preadmission (or other pre-service)
authorization requirement under Sec. 199.4 or Sec. 199.15 of this
part, the administrative processes for the NAS and pre-service authorization
may be combined.
(10) [Reserved]
(11) Quality
and Utilization Review Peer Review Organization program.
All benefits
under the CHAMPUS program are subject to review under the CHAMPUS
Quality and Utilization Review Peer Review Organization program
pursuant to Sec 199.15.
(12) [Reserved]
(13) Implementing
instructions.
The
Director, OCHAMPUS shall issue policies, procedures, instructions, guidelines,
standards and/or criteria to implement this section.
(14) Confidentiality
of substance use disorder treatment.
Release of any patient identifying
information, including that required to adjudicate a claim, must
comply with the provisions of section 543 of the Public Health Service
Act, as amended, (42 U.S.C. 290dd-2), and implementing regulations
at 42 CFR part 2, which governs the release of medical and other
information from the records of patients undergoing treatment of
substance use disorder. If the patient refuses to authorize the
release of medical records which are, in the opinion of the Director,
Defense Health Agency, or a designee, necessary to determine benefits
on a claim for treatment of substance use disorder, the claim will
be denied.
(e)
Special
benefit information--
(1) General.
There are certain
circumstances, conditions, or limitations that impact the extension
of benefits and that require special emphasis and explanation. This
paragraph (e) sets forth those benefits and limitations recognized
to be in this category. The benefits and limitations herein described
also are subject to all applicable definitions, conditions, limitations,
exceptions, and exclusions as set forth in this or other sections
of this part, except as otherwise may be provided specifically in
this paragraph (e).
(2) Abortion.
The statute
under which CHAMPUS operates prohibits payment for abortions with
one single exception--where the life of the mother would be endangered
if the fetus were carried to term. Covered abortion services are
limited to medical services and supplies only. Physician certification
is required attesting that the abortion was performed because the
mother’s life would be endangered if the fetus were carried to term.
Abortions performed for suspected or confirmed fetal abnormality
(e.g., anencephalic) or for mental health reasons (e.g., threatened
suicide) do not fall within the exceptions permitted within the
language of the statute and are not authorized for payment under
CHAMPUS.
Note: Covered abortion services are limited
to medical services or supplies only for the single circumstance
outlined above and do not include abortion counseling or referral
fees. Payment is not allowed for any services involving preparation
for, or normal follow up to, a noncovered abortion. The Director,
OCHAMPUS, or a designee, shall issue guidelines describing the policy
on abortion.
(3) Family planning.
The scope of
the CHAMPUS family planning benefit is as follows:
(i) Birth
control (such as contraception)--
(A) Benefits provided.
Benefits are available for
services and supplies related to preventing conception, including
the following:
(1) Surgical
inserting, removal, or replacement of intrauterine devices.
(2) Measurement for, and purchase of, contraceptive
diaphragms (and later remeasurement and replacement).
(3) Prescription
contraceptives.
(4) Surgical
sterilization (either male or female).
(B) Exclusions.
The family planning
benefit does not include the following:
(1) Prophylactics (condoms).
(2) Spermicidal foams, jellies, and sprays
not requiring a prescription.
(3) Services
and supplies related to noncoital reproductive technologies, including
but not limited to artificial insemination (including any costs
related to donors or semen banks), in-vitro fertilization and gamete
intrafallopian transfer.
(4) Reversal
of a surgical sterilization procedure (male or female).
(ii) Genetic testing.
Genetic testing
essentially is preventive rather than related to active medical treatment
of an illness or injury. However, under the family planning benefit,
genetic testing is covered when performed in certain high risk situations.
For the purpose of CHAMPUS, genetic testing includes to detect developmental
abnormalities as well as purely genetic defects.
(A) Benefits provided.
Benefits may
be extended for genetic testing performed on a pregnant beneficiary
under the following prescribed circumstances. The tests must be
appropriate to the specific risk situation and must meet one of
the following criteria:
(1) The mother-to-be
is 35 years old or older; or
(2) The mother-
or father-to-be has had a previous child born with a congenital
abnormality; or
(3) Either the
mother- or father-to-be has a family history of congenital abnormalities;
or
(4) The mother-to-be contracted rubella during
the first trimester of the pregnancy; or
(5) Such other specific situations as may
be determined by the Director, OCHAMPUS, or a designee, to fall
within the intent of paragraph (e)(3)(ii) of this section.
(B) Exclusions.
It is emphasized
that routine or demand genetic testing is not covered. Further, genetic
testing does not include the following:
(1) Tests performed to establish paternity
of a child.
(2) Tests to
determine the sex of an unborn child.
(4) [Reserved)
(5) Transplants.
(i) Organ transplants.
Basic Program
benefits are available for otherwise covered services or supplies
in connection with an organ transplant procedure, provided such
transplant procedure is in accordance with accepted professional
medical standards and is not considered unproven.
(A) General.
(1) Benefits may be allowed for medically
necessary services and supplies related to an organ transplant for:
(i) Evaluation of potential candidate’s suitability
for an organ transplant, whether or not the patient is ultimately
accepted as a candidate for transplant.
(ii) Pre- and post-transplant inpatient hospital
and outpatient services.
(iii) Pre- and
post-operative services of the transplant team.
(iv) Blood and blood products.
(v) FDA approved immunosuppression drugs to
include off-label uses when determined to be medically necessary
for the treatment of the condition for which it is administered,
according to accepted standards of medical practice.
(vi) Complications of the transplant procedure,
including inpatient care, management of infection and rejection
episodes.
(vii) Periodic
evaluation and assessment of the successfully transplanted patient.
(viii) The donor acquisition team, including
the costs of transportation to the location of the donor organ and
transportation of the team and the donated organ to the location
of the transplant center.
(ix) The maintenance
of the viability of the donor organ after all existing legal requirements
for excision of the donor organ have been met.
(2) TRICARE benefits are payable for recipient
costs when the recipient of the transplant is a CHAMPUS beneficiary,
whether or not the donor is a CHAMPUS beneficiary.
(3) Donor costs are payable when:
(i) Both the donor and recipient are CHAMPUS
beneficiaries.
(ii) The donor
is a CHAMPUS beneficiary but the recipient is not.
(iii) The donor is the sponsor and the recipient
is a CHAMPUS beneficiary. (In such an event, donor costs are paid
as a part of the beneficiary and recipient costs.)
(iv) The donor is neither a CHAMPUS beneficiary
nor a sponsor, if the recipient is a CHAMPUS beneficiary. (Again,
in such an event, donor costs are paid as a part of the beneficiary
and recipient costs.)
(4) If the donor
is not a CHAMPUS beneficiary, TRICARE benefits for donor costs are
limited to those directly related to the transplant procedure itself
and do not include any medical care costs related to other treatment
of the donor, including complications.
(5) TRICARE benefits will not be allowed for
transportation of an organ donor.
(B) [Reserved]
(ii) Stem cell
transplants.
TRICARE
benefits are payable for beneficiaries whose conditions are considered
appropriate for stem cell transplant according to guidelines adopted
by the Executive Director, TMA, or a designee.
(6) Eyeglasses,
spectacles, contact lenses, or other optical devices.
Eyeglasses,
spectacles, contact lenses, or other optical devices are excluded
under the Basic Program except under very limited and specific circumstances.
(i) Exception
to general exclusion.
Benefits for glasses and lenses may be extended
only in connection with the following specified eye conditions and
circumstances:
(A) Eyeglasses or lenses
that perform the function of the human lens, lost as a result of
intraocular surgery or ocular injury or congenital absence.
Note: Notwithstanding the general requirement for U.S.
Food and Drug Administration approval of any surgical implant set
forth in paragraph (d)(3)(vii) of this section, intraocular lenses
are authorized under CHAMPUS if they are either approved for marketing
by FDA or are subject to an investigational device exemption.
(B) “Pinhole”
glasses prescribed for use after surgery for detached retina.
(C) Lenses
prescribed as “treatment” instead of surgery for the following conditions:
(1) Contract lenses used for treatment of
infantile glaucoma.
(2) Corneal or
scleral lenses prescribed in connection with treatment of keratoconus.
(3) Scleral lenses prescribed to retain moisture
when normal tearing is not present or is inadequate.
(4) Corneal or scleral lenses prescribed to
reduce a corneal irregularity other than astigmatism.
(ii) Limitations.
The specified
benefits are limited further to one set of lenses related to one
of the qualifying eye conditions set forth in paragraph (e)(6)(i)
of this section. If there is a prescription change requiring a new
set of lenses (but still related to the qualifying eye condition),
benefits may be extended for a second set of lenses, subject to
specific medical review.
(7) [Reserved]
(8) Cosmetic,
reconstructive, or plastic surgery.
For the purposes of CHAMPUS,
cosmetic, reconstructive, or plastic surgery is surgery that can
be expected primarily to improve physical appearance or that is
performed primarily for psychological purposes or that restores
form, but does not correct or improve materially a bodily function.
Note: If a surgical procedure primarily restores function,
whether or not there is also a concomitant improvement in physical
appearance, the surgical procedure does not fall within the provisions
set forth in this paragraph (e)(8).
(i) Limited
benefits under CHAMPUS.
Benefits under the Basic Program generally
are not available for cosmetic, reconstructive, or plastic surgery.
However, under certain limited circumstances, benefits for otherwise
covered services and supplies may be provided in connection with
cosmetic, reconstructive, or plastic surgery as follows:
(A) Correction
of a congenital anomaly; or
(B) Restoration of
body form following an accidental injury; or
(C) Revision
of disfiguring and extensive scars resulting from neoplastic surgery.
(D) Reconstructive
breast surgery following a medically necessary mastectomy performed
for the treatment of carcinoma, severe fibrocystic disease, other
nonmalignant tumors or traumatic injuries.
(E)
Penile
implants and testicular prostheses for conditions resulting from
organic origins (i.e., trauma, radical surgery, disease process,
for correction of congenital anomaly, etc.). Also, penile implants
for organic impotency.
Note: Organic impotence
is defined as that which can be reasonably expected to occur following certain
diseases, surgical procedures, trauma, injury, or congenital malformation.
Impotence does not become organic because of psychological or psychiatric
reasons.
(F) Generally, benefits
are limited to those cosmetic, reconstructive, or plastic surgery
procedures performed no later than December 31 of the year following
the year in which the related accidental injury or surgical trauma
occurred, except for authorized postmastectomy breast reconstruction
for which there is no time limitation between mastectomy and reconstruction.
Also, special consideration for exception will be given to cases
involving children who may require a growth period.
(ii) General exclusions.
(A) For
purposes of CHAMPUS, dental congenital anomalies such as absent tooth
buds or malocclusion specifically are excluded.
(B) Cosmetic,
reconstructive, or plastic surgery procedures performed primarily
for psychological reasons or as a result of the aging process also
are excluded.
(C) Procedures performed
for elective correction of minor dermatological blemishes and marks
or minor anatomical anomalies also are excluded.
(D) Any
procedures related to sex gender changes, except as provided in
paragraph (g)(29) of this section, are excluded.
(iii) Noncovered
surgery, all related services and supplies excluded.
When it is determined
that a cosmetic, reconstructive, or plastic surgery procedure does
not qualify for CHAMPUS benefits, all related services and supplies
are excluded, including any institutional costs.
(iv) Example
of noncovered cosmetic, reconstructive, or plastic surgery procedures.
The following
is a partial list of cosmetic, reconstructive, or plastic surgery
procedures that do not qualify for benefits under CHAMPUS. This
list is for example purposes only and is not to be construed as
being all-inclusive.
(A) Any
procedure performed for personal reasons to improve the appearance
of an obvious feature or part of the body that would be considered
by an average observer to be normal and acceptable for the patient’s
age or ethnic or racial background.
(B) Cosmetic, reconstructive,
or plastic surgical procedures that are justified primarily on the
basis of a psychological or psychiatric need.
(C) Augmentation
mammoplasties.
Augmentation
mammoplasties, except for breast reconstruction following a covered
mastectomy and those specifically authorized in paragraph (e)(8)(i)
of this section.
(D) Face
lifts and other procedures related to the aging process.
(E) Reduction
mammoplasties.
Reduction mammoplasties (unless there is medical
documentation of intractable pain, not amenable to other forms of
treatment, resulting from large, pendulous breasts or unless performed
as an integral part of an authorized breast reconstruction procedure
under paragraph (e)(8)(i) of this section, including reduction of
the collateral breast for purposes of ensuring breast symmetry)
(F) Panniculectomy;
body sculpture procedures.
(G) Repair of sagging
eyelids (without demonstrated and medically documented significant impairment
of vision).
(H) Rhinoplasties
(without evidence of accidental injury occurring within the previous
6 months that resulted in significant obstruction of breathing).
(I) Chemical
peeling for facial wrinkles.
(J) Dermabrasion of
the face.
(K) Elective correction
of minor dermatological blemishes and marks or minor anatomical
anomalies.
(L) Revision of scars
resulting from surgery or a disease process, except disfiguring
and extensive scars resulting from neoplastic surgery.
(M) Removal
of tattoos.
(N) Hair transplants.
(O) Electrolysis.
(P) [Reserved]
(Q) Penile
implant procedure for psychological impotency or as related to sex
gender changes, as prohibited by section 1079 of title 10, United
States Code.
(R) Insertion of prosthetic
testicles as related to sex gender changes, as prohibited by section
1079 of title 10, United States Code.
(9) Care
related to non-covered initial surgery or treatment.
(i) Benefits
are available for otherwise covered services and supplies required
in the treatment of complications resulting from a non-covered incident
of treatment (such as nonadjunctive dental care or cosmetic surgery)
but only if the later complication represents a separate medical
condition such as a systemic infection, cardiac arrest, and acute
drug reaction. Benefits may not be extended for any later care or
a procedure related to the complication that essentially is similar
to the initial non-covered care. Examples of complications similar to
the initial episode of care (and thus not covered) would be repair
of facial scarring resulting from dermabrasion for acne.
(ii) Benefits
are available for otherwise covered services and supplies required
in the treatment of complications (unfortunate sequelae) and any
necessary follow-on care resulting from a non-covered incident of
treatment provided in an MTF, when the initial non-covered service
has been authorized by the MTF Commander and the MTF is unable to
provide the necessary treatment of the complications or required
follow-on care, according to the guidelines adopted by the Director,
DHA, or a designee.
(iii) Benefits
are available for otherwise covered services and supplies required
in the treatment of complications (unfortunate sequelae) and any
necessary follow-on care resulting from a non-covered incident of
treatment provided in the private sector pursuant to a properly
granted waiver under Sec. 199.16(f). The Director, DHA, or designee,
shall issue guidelines for implementing this provision.
(10) Dental.
TRICARE/CHAMPUS
does not include a dental benefit. However, in connection with dental
treatment for patients with developmental, mental, or physical disabilities
or for pediatric patients age 5 or under, only institutional and
anesthesia services may be provided as a benefit.
(i) Adjunctive
dental care: Limited.
Adjunctive dental care is limited to those
services and supplies provided under the following conditions:
(A) Dental
care which is medically necessary in the treatment of an otherwise
covered medical (not dental) condition, is an integral part of the
treatment of such medical condition and is essential to the control
of the primary medical condition. The following is a list of conditions
for which CHAMPUS benefits are payable under this provision:
(1) Intraoral abscesses which extend beyond
the dental alveolus.
(2) Extraoral
abscesses.
(3) Cellulitis
and osteitis which is clearly exacerbating and directly affecting
a medical condition currently under treatment.
(4) Removal of teeth and tooth fragments in
order to treat and repair facial trauma resulting from an accidental
injury.
(5) Myofacial
Pain Dysfunction Syndrome.
(6) Total or
complete ankyloglossia.
(7) Adjunctive
dental and orthodontic support for cleft palate.
(8) The prosthetic replacement of either the
maxilla or the mandible due to the reduction of body tissues associated
with traumatic injury (e.g., impact, gun shot wound), in addition
to services related to treating neoplasms or iatrogenic dental trauma.
Note: The test of whether dental trauma is covered is
whether the trauma is solely dental trauma. Dental trauma, in order
to be covered, must be related to, and an integral part of medical
trauma; or a result of medically necessary treatment of an injury
or disease.
(B) Dental care required
in preparation for medical treatment of a disease or disorder or
required as the result of dental trauma caused by the medically
necessary treatment of an injury or disease (iatrogenic).
(1) Necessary dental care including prophylaxis
and extractions when performed in preparation for or as a result
of in-line radiation therapy for oral or facial cancer.
(2) Treatment of gingival hyperplasia, with
or without periodontal disease, as a direct result of prolonged
therapy with Dilantin (diphenylhydantoin) or related compounds.
(C) Dental
care is limited to the above and similar conditions specifically
prescribed by the Director, OCHAMPUS, as meeting the requirements
for coverage under the provisions of this section.
(ii) General exclusions.
(A) Dental
care which is routine, preventative, restorative, prosthodontic, periodontic
or emergency does not qualify as adjunctive dental care for the
purposes of CHAMPUS except when performed in preparation for or
as a result of dental trauma caused by medically necessary treatment
of an injury or disease.
(B) The adding or modifying
of bridgework and dentures.
(C) Orthodontia, except
when directly related to and an integral part of the medical or
surgical correction of a cleft palate or when required in preparation
for, or as a result of, trauma to the teeth and supporting structures
caused by medically necessary treatment of an injury or disease.
(iii) Preauthorization
required.
In
order to be covered, adjunctive dental care requires preauthorization
from the Director, TRICARE Management Activity, or a designee, in
accordance with paragraph (a)(12) of this section. When adjunctive
dental care involves a medical (not dental) emergency (such as facial
injuries resulting from an accident), the requirement for preauthorization
is waived. Such waiver, however, is limited to the essential adjunctive
dental care related to the medical condition requiring the immediate
emergency treatment. A complete explanation, with supporting medical
documentation, must be submitted with claims for emergency adjunctive
dental care.
(iv) Covered
oral surgery.
Notwithstanding
the above limitations on dental care, there are certain oral surgical
procedures that are performed by both physicians and dentists, and
that are essentially medical rather than dental care. For the purposes
of CHAMPUS, the following procedures, whether performed by a physician
or dentist, are considered to be in this category and benefits may
be extended for otherwise covered services and supplies without
preauthorization:
(A) Excision
of tumors and cysts of the jaws, cheeks, lips, tongue, and roof
and floor of the mouth, when such conditions require a pathological
(histological) examination.
(B) Surgical procedures
required to correct accidental injuries of the jaws, cheeks, lips,
tongue, and roof and floor of the mouth.
(C) Treatment
of oral or facial cancer.
(D) Treatment
of fractures of facial bones.
(E) External (extra-oral)
incision and drainage of cellulitis.
(F) Surgery of accessory
sinuses, salivary glands, or ducts.
(G) Reduction of dislocations
and the excision of the temporomandibular joints, when surgery is
a necessary part of the reduction.
(H) Any
oral surgical procedure that falls within the cosmetic, reconstructive,
or plastic surgery definition is subject to the limitations and
requirements set forth in paragraph (e)(8) of this section.
Note: Extraction of unerupted or partially erupted,
malposed or impacted teeth, with or without the attached follicular
or development tissues, is not a covered oral surgery procedure
except when the care is indicated in preparation for medical treatment
of a disease or disorder or required as a result of dental trauma
caused by the necessary medical treatment of an injury or illness.
Surgical preparation of the mouth for dentures is not covered by
CHAMPUS.
(v) Inpatient
hospital stay in connection with non-adjunctive, noncovered dental
care.
Institutional benefits
specified in paragraph (b) of this section may be extended for inpatient
hospital stays related to noncovered, nonadjunctive dental care
when such inpatient stay is medically necessary to safeguard the
life of the patient from the effects of dentistry because of the
existence of a specific and serious nondental organic impairment
currently under active treatment. (Hemophilia is an example of a condition
that could be considered a serious nondental impairment.) Preauthorization
by the Director, OCHAMPUS, or a designee, is required for such inpatient
stays to be covered in the same manner as required for adjunctive
dental care described in paragraph (e)(10)(iii) of this section.
Regardless of whether or not the preauthorization request for the
hospital admission is approved and thus qualifies for institutional
benefits, the professional service related to the nonadjunctive
dental care is not covered.
(vi) Anesthesia
and institutional costs for dental care for children and certain
other patients.
Institutional benefits specified in paragraph
(b) of this section may be extended for hospital and in-out surgery
settings related to noncovered, nonadjunctive dental care when such
outpatient care or inpatient stay is in conjunction with dental
treatment for patients with developmental, mental, or physical disabilities
or for pediatric patients age 5 or under. For these patients, anesthesia
services will be limited to the administration of general anesthesia
only. Patients with developmental, mental, or physical disabilities
are those patients with conditions that prohibit dental treatment
in a safe and effective manner. Therefore, it is medically or psychologically
necessary for these patients to require general anesthesia for dental
treatment. Patients with physical disabilities include those patients having
disabilities as defined in Sec. 199.2 as a serious physical disability.
Preauthorization by the Director, TRICARE Management Activity, or
a designee, is required for such outpatient care or inpatient stays
to be covered in the same manner as required for adjunctive dental
care described in paragraph (e)(10)(iii) of this section. Regardless
of whether or not the preauthorization request for outpatient care or
hospital admission is approved and thus qualifies for institutional
benefits, the professional service related to the nonadjunctive
dental care is not covered, with the exception of coverage for anesthesia services.
(11) Drug abuse.
Under the Basic
Program, benefits may be extended for medically necessary prescription
drugs required in the treatment of an illness or injury or in connection
with maternity care (refer to paragraph (d) of this section). However,
TRICARE benefits cannot be authorized to support or maintain an
existing or potential drug abuse situation whether or not the drugs
(under other circumstances) are eligible for benefit consideration
and whether or not obtained by legal means. Drugs, including the
substitution of a therapeutic drug with addictive potential for
a drug of addiction, prescribed to beneficiaries undergoing medically
supervised treatment for a substance use disorder as authorized
under paragraphs (b) and (c) of this section are not considered
to be in support of, or to maintain, an existing or potential drug
abuse situation and are allowed. The Director may prescribe appropriate
policies to implement this prescription drug benefit for those undergoing
medically supervised treatment for a substance use disorder.
(i) Limitations
on who can prescribe drugs.
CHAMPUS benefits are not available for any
drugs prescribed by a member of the beneficiary’s family or by a
nonfamily member residing in the same household with the beneficiary
or sponsor.
(ii) [Reserved].
(iii) Kinds
of prescription drugs that are monitored carefully by CHAMPUS for
possible abuse situations--
(A) Narcotics.
Examples are Morphine and Demerol.
(B) Nonnarcotic analgesics.
Examples are
Talwin and Darvon.
(C) Tranquilizers.
Examples are Valium, Librium,
and Meprobamate.
(D) Barbiturates.
Examples are
Seconal and Nembuttal.
(E) Nonbarbituate
hypnotics.
Examples
are Doriden and Chloral Hydrate.
(F) Stimulants.
Examples are
amphetamines.
(iv) CHAMPUS
fiscal intermediary responsibilities.
CHAMPUS fiscal intermediaries
are responsible for implementing utilization control and quality
assurance procedures designed to identify possible drug abuse situations.
The CHAMPUS fiscal intermediary is directed to screen all drug claims
for potential overutilization and irrational prescribing of drugs,
and to subject any such cases to extensive review to establish the
necessity for the drugs and their appropriateness on the basis of
diagnosis or definitive symptoms.
(A) When a possible
drug abuse situation is identified, all claims for drugs for that
specific beneficiary or provider will be suspended pending the results
of a review.
(B) If the review determines
that a drug abuse situation does in fact exist, all drug claims
held in suspense will be denied.
(C) If the record indicates
previously paid drug benefits, the prior claims for that beneficiary
or provider will be reopened and the circumstances involved reviewed
to determine whether or not drug abuse also existed at the time
the earlier claims were adjudicated. If drug abuse is later ascertained, benefit
payments made previously will be considered to have been extended
in error and the amounts so paid recouped.
(D) Inpatient
stays primarily for the purpose of obtaining drugs and any other
services and supplies related to drug abuse also are excluded.
(v) Unethical or
illegal provider practices related to drugs.
Any such investigation into
a possible drug abuse that uncovers unethical or illegal drug dispensing
practices on the part of an institution, a pharmacy, or physician
will be referred to the professional or investigative agency having
jurisdiction. CHAMPUS fiscal intermediaries are directed to withhold
payment of all CHAMPUS claims for services and supplies rendered
by a provider under active investigation for possible unethical
or illegal drug dispensing activities.
(vi) Detoxification.
The above monitoring
and control of drug abuse situations shall in no way be construed
to deny otherwise covered medical services and supplies related
to drug detoxification (including newborn, addicted infants) when
medical supervision is required.
(12) [Reserved]
(13) Domiciliary
care.
The
statute under which CHAMPUS operates also specifically excludes domiciliary
care (refer to Sec. 199.2 of this part for the definition of “Domiciliary
Care”).
(i) Examples
of domiciliary care situations.
The following are examples of domiciliary
care for which CHAMPUS benefits are not payable.
(A) Home care is
not available.
Institutionalization
primarily because parents work, or extension of a hospital stay
beyond what is medically necessary because the patient lives alone,
are examples of domiciliary care provided because there is no other
family member or other person available in the home.
(B) Home care is
not suitable.
Institutionalization
of a child because a parent (or parents) is unable to provide a
safe and nurturing environment due to a mental or substance use
disorder, or because someone in the home has a contagious disease,
are examples of why domiciliary care is being provided because the
home setting is unsuitable.
(C) Family
unwilling to care for a person in the home.
A child who is difficult to
manage may be placed in an institution, not because institutional
care is medically necessary, but because the family does not want
to handle him or her in the home. Such institutionalization would
represent domiciliary care, that is, the family being unwilling
to assume responsibility for the child.
(ii) Benefits
available in connection with a domiciliary care case.
Should the beneficiary
receive otherwise covered medical services or supplies while also
being in a domiciliary care situation, CHAMPUS benefits are payable
for those medical services or supplies, or both, in the same manner
as though the beneficiary resided in his or her own home. Such benefits
would be cost-shared as though rendered to an outpatient.
(iii) General exclusion.
Domiciliary
care is institutionalization essentially to provide a substitute home--not
because it is medically necessary for the beneficiary to be in the
institution (although there may be conditions present that have
contributed to the fact that domiciliary care is being rendered). CHAMPUS
benefits are not payable for any costs or charges related to the
provision of domiciliary care. While a substitute home or assistance
may be necessary for the beneficiary, domiciliary care does not represent
the kind of care for which CHAMPUS benefits can be provided.
(14) CT scanning--
(i) Approved
CT scan services.
Benefits may be extended for medically necessary
CT scans of the head or other anatomical regions of the body when
all of the following conditions are met:
(A) The
patient is referred for the diagnostic procedure by a physician.
(B) The
CT scan procedure is consistent with the preliminary diagnosis or
symptoms.
(C) Other noninvasive
and less costly means of diagnosis have been attempted or are not appropriate.
(D) The
CT scan equipment is licensed or registered by the appropriate state
agency responsible for licensing or registering medical equipment
that emits ionizing radiation.
(E) The CT scan equipment
is operated under the general supervision and direction of a physician.
(F) The
results of the CT scan diagnostic procedure are interpreted by a
physician.
(ii) Review
guidelines and criteria.
The Director, OCHAMPUS, or a designee, will
issue specific guidelines and criteria for CHAMPUS coverage of medically
necessary head and body part CT scans.
(15) Morbid obesity.
The TRICARE
morbid obesity benefit is limited to those bariatric surgical procedures
for which the safety and efficacy has been proven comparable or
superior to conventional therapies and is consistent with the generally
accepted norms for medical practice in the United States medical
community. (See the definition of reliable evidence in Sec. 199.2
of this part for the procedures used in determining if a medical
treatment or procedure is unproven.)
(i) Conditions for coverage.
(A) Payment for bariatric
surgical procedures is determined by the requirements specified
in paragraph (g)(15) of this section, and as defined in Sec. 199.2(b)
of this part.
(B) Covered bariatric
surgical procedures are payable only when the patient has completed
growth (18 years of age or documentation of completion of bone growth)
and has met one of the following selection criteria:
(1) The patient has a BMI that is equal to
or exceeds 40 kg/m2 and has previously been unsuccessful with medical
treatment for obesity.
(2) The patient
has a BMI of 35 to 39.9 kg/m2, has at least one high-risk co-morbid
condition associated with morbid obesity, and has previously been
unsuccessful with medical treatment for obesity.
Note: The Director, TMA, shall issue guidelines for
review of the specific high-risk co-morbid conditions, exacerbated
or caused by obesity based on the Reliable Evidence Standard as
defined in Sec. 199.2 of this part.
(ii) Treatment
of complications.
(A) Payment may be extended for repeat bariatric
surgery when medically necessary to correct or treat complications
from the initial covered bariatric surgery (a takedown). For instance,
the surgeon in many cases will do a gastric bypass or gastroplasty
to help the patient avoid regaining the weight that was lost. In
this situation, payment is authorized even though the patient’s
condition technically may not meet the definition of morbid obesity
because of the weight that was already lost following the initial
surgery.
(B) Payment is authorized
for otherwise covered medical services and supplies directly related
to complications of obesity when such services and supplies are
an integral and necessary part of the course of treatment that was
aggravated by the obesity.
(iii) Exclusions.
CHAMPUS payment
may not be extended for weight control services, weight control/loss
programs, dietary regimens and supplements, appetite suppressants
and other medications; food or food supplements, exercise and exercise
programs, or other programs and equipment that are primarily intended
to control weight or for the purpose of weight reduction, regardless
of the existence of co-morbid conditions.
(16) Maternity care.
(i) Benefit.
The CHAMPUS
Basic Program may share the cost of medically necessary services
and supplies associated with maternity care which are not otherwise
excluded by this part.
(ii) Cost-share.
Maternity care
cost-share shall be determined as follows:
(A) Inpatient
cost-share formula applies to maternity care ending in childbirth
in, or on the way to, a hospital inpatient childbirth unit, and
for maternity care ending in a non-birth outcome not otherwise excluded
by this part.
(B) Ambulatory surgery
cost-share formula applies to maternity care ending in childbirth
in, or on the way to, a birthing center to which the beneficiary
is admitted and from which the beneficiary has received prenatal
care, or a hospital-based outpatient birthing room.
(C) Outpatient
cost-share formula applies to maternity care which terminates in
a planned childbirth at home.
(D) Otherwise covered
medical services and supplies directly related to “Complications
of pregnancy,” as defined in Sec. 199.2 of this part, will be cost-shared
on the same basis as the related maternity care for a period not
to exceed 42 days following termination of the pregnancy and thereafter
cost-shared on the basis of the inpatient or outpatient status of
the beneficiary when medically necessary services and supplies are
received.
(17) Biofeedback
Therapy.
Biofeedback
therapy is a technique by which a person is taught to exercise control
over a physiologic process occurring within the body. By using modern
biomedical instruments the patient learns how a specific physiologic
system within his body operates and how to modify the performance
of this particular system.
(i) Benefits Provided.
CHAMPUS benefits are payable
for services and supplies in connection with electrothermal, electromyograph
and electrodermal biofeedback therapy when there is documentation
that the patient has undergone an appropriate medical evaluation,
that their present condition is not responding to or no longer responds
to other forms of conventional treatment, and only when provided
as treatment for the following conditions:
(A) Adjunctive
treatment for Raynaud’s Syndrome.
(B) Adjunctive treatment
for muscle re-education of specific muscle groups or for treating pathological
muscle abnormalities of spasticity, or incapacitating muscle spasm
or weakness.
(ii) Limitations.
Payable benefits
include initial intake evaluation. Treatment following the initial intake
evaluation is limited to a maximum of 20 inpatient and outpatient
biofeedback treatments per calendar year.
(iii) Exclusions.
Benefits are
excluded for biofeedback therapy for the treatment of ordinary muscle tension
states or for psychosomatic conditions. Benefits are also excluded
for the rental or purchase of biofeedback equipment.
(iv) Provider
Requirements.
A
provider of biofeedback therapy must be a CHAMPUS-authorized provider.
(Refer to Sec. 199.6, “Authorized Providers). If biofeedback treatment
is provided by other than a physician, the patient must be referred
by a physician.
(v) Implementation Guidelines.
The Director of OCHAMPUS shall
issue guidelines as are necessary to implement the provision of
this paragraph.
(18) Cardiac
rehabilitation.
Cardiac rehabilitation is the process by which
individuals are restored to their optimal physical, medical, and
psychological status, after a cardiac event. Cardiac rehabilitation
is often divided into three phases. Phase I begins during inpatient
hospitalization and is managed by the patient’s personal physician.
Phase II is a medically supervised outpatient program which begins following
discharge. Phase III is a lifetime maintenance program emphasizing
continuation of physical fitness with periodic follow up. Each phase
includes an exercise component, patient education, and risk factor
modification. There may be considerable variation in program components,
intensity, and duration.
(i) Benefits Provided.
CHAMPUS benefits
are available on an inpatient or outpatient basis for services and
supplies provided in connection with a cardiac rehabilitation program
when ordered by a physician and provided as treatment for patients
who have experienced the following cardiac events within the preceding
twelve (12) months:
(A) Myocardial Infarction.
(B) Coronary
Artery Bypass Graft.
(C) Coronary Angioplasty.
(D) Percutaneous
Transluminal Coronary Angioplasty
(E) Chronic Stable
Angina (see limitations below).
(F) Heart valve surgery.
(G) Heart
or Heart-lung Transplantation.
(ii) Limitations.
Payable benefits
include separate allowance for the initial evaluation and testing. Outpatient
treatment following the initial intake evaluation and testing is
limited to a maximum of thirty-six (36) sessions per cardiac event,
usually provided 3 sessions per week for twelve (12) weeks. Patients
diagnosed with chronic stable angina are limited to one treatment
episode (36 sessions) in a calendar year.
(iii) Exclusions.
Phase III cardiac
rehabilitation lifetime maintenance programs performed at home or in
medically unsupervised settings are not covered.
(iv) Providers.
A provider of
cardiac rehabilitation services must be a TRICARE authorized hospital (see
Sec. 199.6 (b)(4)(i)) or a freestanding cardiac rehabilitation facility
that meets the requirements of Sec. 199.6 (f). All cardiac rehabilitation
services must be ordered by a physician.
(v) Payment.
Payment for
outpatient treatment will be based on an all inclusive allowable
charge per session. Inpatient treatment will be paid based upon
the reimbursement system in place for the hospital where the services
are rendered.
(vi) Implementation
Guidelines.
The
Director of OCHAMPUS shall issue guidelines as are necessary to implement
the provisions of this paragraph.
(19) Hospice care.
Hospice care
is a program which provides an integrated set of services and supplies designed
to care for the terminally ill. This type of care emphasizes palliative
care and supportive services, such as pain control and home care,
rather than cure-oriented services provided in institutions that
are otherwise the primary focus under CHAMPUS. The benefit provides
coverage for a humane and sensible approach to care during the last
days of life for some terminally ill patients.
(i) Benefit coverage.
CHAMPUS beneficiaries
who are terminally ill (that is, a life expectancy of six months
or less if the disease runs its normal course) will be eligible
for the following services and supplies in lieu of most other CHAMPUS
benefits:
(A) Physician services.
(B) Nursing
care provided by or under the supervision of a registered professional
nurse.
(C) Medical social services provided by a social
worker who has at least a bachelor’s degree from a school accredited
or approved by the Council on Social Work Education, and who is
working under the direction of a physician. Medical social services
include, but are not limited to the following:
(1) Assessment of social and emotional factors
related to the beneficiary’s illness, need for care, response to
treatment, and adjustment to care.
(2) Assessment of the relationship of the
beneficiary’s medical and nursing requirements to the individual’s
home situation, financial resources, and availability of community
resources.
(3) Appropriate
action to obtain available community resources to assist in resolving
the beneficiary’s problem.
(4) Counseling
services that are required by the beneficiary.
(D) Counseling
services provided to the terminally ill individual and the family
member or other persons caring for the individual at home. Counseling,
including dietary counseling, may be provided both for the purpose
of training the individual’s family or other care-giver to provide
care, and for the purpose of helping the individual and those caring
for him or her to adjust to the individual’s approaching death.
Bereavement counseling, which consists of counseling services provided
to the individual’s family after the individual’s death, is a required
hospice service but it is not reimbursable.
(E) Home
health aide services furnished by qualified aides and homemaker
services. Home health aides may provide personal care services.
Aides also may perform household services to maintain a safe and
sanitary environment in areas of the home used by the patient. Examples
of such services are changing the bed or light cleaning and laundering
essential to the comfort and cleanliness of the patient. Aide services
must be provided under the general supervision of a registered nurse. Homemaker
services may include assistance in personal care, maintenance of
a safe and healthy environment, and services to enable the individual
to carry out the plan of care. Qualifications for home health aides
can be found in 42 CFR 484.36.
(F) Medical appliances
and supplies, including drugs and biologicals. Only drugs that are
used primarily for the relief of pain and symptom control related
to the individual’s terminal illness are covered. Appliances may
include covered durable medical equipment, as well as other self-help
and personal comfort items related to the palliation or management
of the patient’s condition while he or she is under hospice care.
Equipment is provided by the hospice for use in the beneficiary’s
home while he or she is under hospice care. Medical supplies include
those that are part of the written plan of care. Medical appliances
and supplies are included within the hospice all-inclusive rates.
(G) Physical
therapy, occupational therapy and speech-language pathology services
provided for purposes of symptom control or to enable the individual
to maintain activities of daily living and basic functional skills.
(H) Short-term
inpatient care provided in a Medicare participating hospice inpatient
unit, or a Medicare participating hospital, skilled nursing facility
(SNF) or, in the case of respite care, a Medicaid-certified nursing
facility that additionally meets the special hospice standards regarding
staffing and patient areas. Services provided in an inpatient setting
must conform to the written plan of care. Inpatient care may be
required for procedures necessary for pain control or acute or chronic
symptom management. Inpatient care may also be furnished to provide
respite for the individual’s family or other persons caring for
the individual at home. Respite care is the only type of inpatient
care that may be provided in a Medicaid-certified nursing facility.
The limitations on custodial care and personal comfort items applicable
to other CHAMPUS services are not applicable to hospice care.
(ii) Core services.
The hospice
must ensure that substantially all core services are routinely provided directly
by hospice employees; i.e., physician services, nursing care, medical
social services, and counseling for individuals and care givers.
Refer to paragraphs (e)(19)(i)(A), (e)(19)(i)(B), (e)(19)(i)(C),
and (e)(19)(i)(D) of this section.
(iii) Non-core
services.
While
non-core services (i.e., home health aide services, medical appliances and
supplies, drugs and biologicals, physical therapy, occupational
therapy, speech-language pathology and short-term inpatient care)
may be provided under arrangements with other agencies or organizations,
the hospice must maintain professional management of the patient
at all times and in all settings. Refer to paragraphs (e)(19)(i)(E),
(e)(19)(i)(F), (e)(19)(i)(G), and (e)(19)(i)(H) of this section.
(iv) Availability
of services.
The
hospice must make nursing services, physician services, and drugs and
biologicals routinely available on a 24-hour basis. All other covered
services must be made available on a 24-hour basis to the extent
necessary to meet the needs of individuals for care that is reasonable
and necessary for the palliation and management of the terminal
illness and related condition. These services must be provided in
a manner consistent with accepted standards of practice.
(v) Periods of care.
Hospice care
is divided into distinct periods of care. The periods of care that
may be elected by the terminally ill CHAMPUS beneficiary shall be
as the Director, TRICARE determines to be appropriate, but shall
not be less than those offered under Medicare’s Hospice Program.
(vi) Conditions
for coverage.
The
CHAMPUS beneficiary must meet the following conditions/criteria in
order to be eligible for the hospice benefits and services referenced
in paragraph (e)(19)(i) of this section.
(A)
There
must be written certification in the medical record that the CHAMPUS
beneficiary is terminally ill with a life expectancy of six months
or less if the terminal illness runs its normal course.
(1) Timing of
certification.
The
hospice must obtain written certification of terminal illness for
each of the election periods described in paragraph (e)(19(vi)(B)
of this section, even if a single election continues in effect for
two, three or four periods.
(i) Basic
requirement.
Except
as provided in paragraph (e)(19(vi)(A)(1)(ii) of
this section the hospice must obtain the written certification no
later than two calendar days after the period begins.
(ii) Exception.
For the initial
90-day period, if the hospice cannot obtain the written certifications within
two calendar days, it must obtain oral certifications within two
calendar days, and written certifications no later than eight calendar
days after the period begins.
(2) Sources of
certification.
Physician
certification is required for both initial and subsequent election periods.
(i) For the initial 90-day period, the hospice
must obtain written certification statements (and oral certification
statements if required under paragraph (e)(19(vi)(A)
(1)(ii) of
this section) from:
(A) The individual’s
attending physician if the individual has an attending physician;
and
(B) The medical director of the hospice or
the physician member of the hospice interdisciplinary group.
(ii) For subsequent periods, the only requirement
is certification by one of the physicians listed in paragraph (e)(19)(vi)(A)(2)(i)(B) of
this section.
(B) The terminally
ill beneficiary must elect to receive hospice care for each specified
period of time; i.e., the two 90-day periods, a subsequent 30-day
period, and a final period of unlimited duration. If the individual
is found to be mentally incompetent, his or her representative may
file the election statement. Representative means an individual
who has been authorized under State law to terminate medical care
or to elect or revoke the election of hospice care on behalf of
a terminally ill individual who is found to be mentally incompetent.
(1) The episodes of care must be used consecutively;
i.e., the two 90-day periods first, then the 30-day period, followed
by the final period. The periods of care may be elected separately
at different times.
(2) The initial
election will continue through subsequent election periods without
a break in care as long as the individual remains in the care of
the hospice and does not revoke the election.
(3) The effective date of the election may
begin on the first day of hospice care or any subsequent day of
care, but the effective date cannot be made prior to the date that
the election was made.
(4) The beneficiary
or representative may revoke a hospice election at any time, but
in doing so, the remaining days of that particular election period
are forfeited and standard CHAMPUS coverage resumes. To revoke the
hospice benefit, the beneficiary or representative must file a signed
statement of revocation with the hospice. The statement must provide
the date that the revocation is to be effective. An individual or
representative may not designate an effective date earlier than
the date that the revocation is made.
(5) If an election of hospice benefits has
been revoked, the individual, or his or her representative may at
any time file a hospice election for any period of time still available
to the individual, in accordance with Sec. 199.4(e)(19)(vi)(B).
(6) A CHAMPUS beneficiary may change, once
in each election period, the designation of the particular hospice
from which he or she elects to receive hospice care. To change the
designation of hospice programs the individual or representative
must file, with the hospice from which care has been received and
with the newly designated hospice, a statement that includes the
following information:
(i) The name
of the hospice from which the individual has received care and the
name of the hospice from which he or she plans to receive care.
(ii) The date the change is to be effective.
(7) Each hospice will design and print its
own election statement to include the following information:
(i) Identification of the particular hospice
that will provide care to the individual.
(ii) The individual’s or representative’s acknowledgment
that he or she has been given a full understanding of the palliative
rather than curative nature of hospice care, as it relates to the individual’s
terminal illness.
(iii) The individual’s
or representative’s acknowledgment that he or she understands that
certain other CHAMPUS services are waived by the election.
(iv) The effective date of the election.
(v) The signature of the individual or representative,
and the date signed.
(8) The hospice
must notify the CHAMPUS contractor of the initiation, change or
revocation of any election.
(C) The
beneficiary must waive all rights to other CHAMPUS payments for
the duration of the election period for:
(1) Care provided
by any hospice program other than the elected hospice unless provided
under arrangements made by the elected hospice; and
(2) Other CHAMPUS basic program services/benefits
related to the treatment of the terminal illness for which hospice
care was elected, or to a related condition, or that are equivalent
to hospice care, except for services provided by:
(i) The designated hospice;
(ii) Another hospice under arrangement made
by the designated hospice; or
(iii) An attending
physician who is not employed by or under contract with the hospice
program.
(3) Basic CHAMPUS
coverage will be reinstated upon revocation of the hospice election.
(D)
A
written plan of care must be established by a member of the basic
interdisciplinary group assessing the patient’s needs. This group
must have at least one physician, one registered professional nurse,
one social worker, and one pastoral or other counselor.
(1) In establishing the initial plan of care
the member of the basic interdisciplinary group who assesses the
patient’s needs must meet or call at least one other group member
before writing the initial plan of care.
(2) At least one of the persons involved in
developing the initial plan must be a nurse or physician.
(3) The plan must be established on the same
day as the assessment if the day of assessment is to be a covered
day of hospice care.
(4) The other
two members of the basic interdisciplinary group--the attending
physician and the medical director or physician designee--must review
the initial plan of care and provide their input to the process
of establishing the plan of care within two calendar days following
the day of assessment. A meeting of group members is not required
within this 2-day period. Input may be provided by telephone.
(5) Hospice services must be consistent with
the plan of care for coverage to be extended.
(6) The plan must be reviewed and updated,
at intervals specified in the plan, by the attending physician,
medical director or physician designee and interdisciplinary group.
These reviews must be documented in the medical records.
(7) The hospice must designate a registered
nurse to coordinate the implementation of the plan of care for each
patient.
(8) The plan
must include an assessment of the individual’s needs and identification
of the services, including the management of discomfort and symptom
relief. It must state in detail the scope and frequency of services
needed to meet the patient’s and family’s needs.
(E) Complete
medical records and all supporting documentation must be submitted
to the CHAMPUS contractor within 30 days of the date of its request.
If records are not received within the designated time frame, authorization
of the hospice benefit will be denied and any prior payments made
will be recouped. A denial issued for this reason is not an initial
determination under Sec. 199.10, and is not appealable.
(vii) Appeal
rights under hospice benefit.
A beneficiary or provider is entitled to appeal
rights for cases involving a denial of benefits in accordance with
the provisions of this part and Sec. 199.10.
(20) [Reserved]
(21) Home health
services.
Home
health services are covered when furnished by, or under arrangement
with, a home health agency (HHA) that participates in the TRICARE
program, and provides care on a visiting basis in the beneficiary’s
home. Covered HHA services are the same as those provided under
Medicare under section 1861(m) of the Social Security Act (42 U.S.C.
1395x(m)) and 42 CFR part 409, subpart E.
(i) Benefit coverage.
Coverage will
be extended for the following home health services subject to the
conditions of coverage prescribed in paragraph (e)(21)(ii) of this
section:
(A) Part-time or intermittent
skilled nursing care furnished by a registered nurse or a licensed practical
(vocational) nurse under the supervision of a registered nurse;
(B) Physical
therapy, speech-language pathology, and occupational therapy;
(C) Medical
social services under the direction of a physician;
(D) Part-time
or intermittent services of a home health aide who has successfully
completed a state-established or other training program that meets
the requirements of 42 CFR Part 484;
(E) Medical supplies,
a covered osteoporosis drug (as defined in the Social Security Act
1861(kk), but excluding other drugs and biologicals) and durable
medical equipment;
(F) Medical services
provided by an interim 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; and
(G) Services
at hospitals, SNFs or rehabilitation centers when they involve equipment
too cumbersome to bring to the home but not including transportation
of the individual in connection with any such item or service.
(ii) Conditions
for Coverage.
The
following conditions/criteria must be met in order to be eligible
for the HHA benefits and services referenced in paragraph (e)(21)(i)
of this section:
(A) The person for
whom the services are provided is an eligible TRICARE beneficiary.
(B) The
HHA that is providing the services to the beneficiary has in effect
a valid agreement to participate in the TRICARE program.
(C) Physician
certifies the need for home health services because the beneficiary
is homebound.
(D)
The
services are provided under a plan of care established and approved
by a physician.
(1) The plan of care must contain all pertinent
diagnoses, including the patient’s mental status, the types of services,
supplies, and equipment required, the frequency of visits to be
made, prognosis, rehabilitation potential, functional limitations,
activities permitted, nutritional requirements, all medications
and treatments, safety measures to protect against injury, instructions
for timely discharge or referral, and any additional items the HHA
or physician chooses to include.
(2) The orders
on the plan of care must specify the type of services to be provided
to the beneficiary, both with respect to the professional who will
provide them and the nature of the individual services, as well
as the frequency of the services.
(E) The
beneficiary must need skilled nursing care on an intermittent basis
or physical therapy or speech-language pathology services, or have
continued need for occupational therapy after the need for skilled
nursing care, physical therapy, or speech-language pathology services
has ceased.
(F) The beneficiary
must receive, and an HHA must provide, a patient-specific, comprehensive assessment
that:
(1) Accurately reflects the patient’s current
health status and includes information that may be used to demonstrate
the patient’s progress toward achievement of desired outcomes;
(2) Identifies the beneficiary’s continuing
need for home care and meets the beneficiary’s medical, nursing,
rehabilitative, social, and discharge planning needs.
(3) Incorporates the use of the current version
of the Outcome and Assessment Information Set (OASIS) items, using
the language and groupings of the OASIS items, as specified by the
Director, TRICARE Management Activity.
(G) TRICARE
is the appropriate payer.
(H) The
services for which payment is claimed are not otherwise excluded
from payment.
(I) Any other conditions
of coverage/participation that may be required under Medicare’s
HHA benefit; i.e., coverage guidelines as prescribed under Sections
1861(o) and 1891 of the Social Security Act (42 U.S.C. 1395x(o)
and 1395bbb), 42 CFR Part 409, Subpart E and 42 CFR Part 484.
(22) Pulmonary
rehabilitation.
TRICARE benefits are payable for beneficiaries
whose conditions are considered appropriate for pulmonary rehabilitation
according to guidelines adopted by the Executive Director, TMA,
or a designee.
(23) A
speech generating device (SGD)
as defined in Sec. 199.2 of this part is covered
as a voice prosthesis. The prosthesis provisions found in paragraph
(d)(3)(vii) of this section apply.
(24) A hearing aid,
but only for
a dependent of a member of the uniformed services on active duty and
only if the dependent has a profound hearing loss as defined in
Sec. 199.2 of this part. Medically necessary and appropriate services
and supplies, including hearing examinations, required in connection
with this hearing aid benefit are covered.
(25) Rehabilitation
therapy
as
defined in Sec. 199.2 of this part to improve, restore, or maintain function,
or to minimize or prevent deterioration of function, of a patient
when prescribed by a physician. The rehabilitation therapy must
be medically necessary and appropriate medical care, rendered by
an authorized provider, necessary to the establishment of a safe
and effective maintenance program in connection with a specific
medical condition, and must not be custodial care or otherwise excluded
from coverage.
(26) National
Institutes of Health clinical trials.
By law, the general prohibition
against CHAMPUS cost-sharing of unproven drugs, devices, and medical
treatments or procedures may be waived in connection with clinical
trials sponsored or approved by the National Institutes of Health
National Cancer Institute if it is determined that such a waiver
will promote access by covered beneficiaries to promising new treatments
and contribute to the development of such treatments. A waiver shall
only be exercised as authorized under this paragraph.
(i) Demonstration
waiver.
A
waiver may be granted through a demonstration project established
in accordance with Sec. 199.1(o) of this part.
(ii) Continuous waiver.
(A) General.
As a result
of a demonstration project under which a waiver has been granted
in connection with a National Institutes of Health National Cancer
Institute clinical trial, a determination may be made that it is
in the best interest of the government and CHAMPUS beneficiaries
to end the demonstration and continue to provide a waiver for CHAMPUS
cost-sharing of the specific clinical trial. Only those specified
clinical trials identified under paragraph (e)(26)(ii) of this section
have been authorized a continuous waiver under CHAMPUS.
(B) National Cancer
Institute (NCI) sponsored cancer prevention, screening, and early
detection clinical trials.
A continuous waiver under paragraph (e)(26)
of this regulation has been granted for CHAMPUS cost-sharing for
those CHAMPUS-eligible patients selected to participate in NCI sponsored
Phase II and Phase III studies for the prevention and treatment
of cancer. Additionally, Phase I studies may be approved on a case
by case basis when the requirements below are met.
(1) TRICARE will cost-share all medical care
and testing required to determine eligibility for an NCI-sponsored
trial, including the evaluation for eligibility at the institution
conducting the NCI-sponsored study. TRICARE will cost-share all
medical care required as a result of participation in NCI-sponsored studies.
This includes purchasing and administering all approved chemotherapy
agents (except for NCI-funded investigational drugs), all inpatient
and outpatient care, including diagnostic and laboratory services
not otherwise reimbursed under an NCI grant program if the following
conditions are met:
(i) The provider
seeking treatment for a CHAMPUS-eligible patient in an NCI approved
protocol has obtained pre-authorization for the proposed treatment
before initial evaluation; and,
(ii) Such treatments
are NCI sponsored Phase I, Phase II or Phase III protocols; and
(iii) The patient continues to meet entry criteria
for said protocol; and,
(iv) The institutional
and individual providers are CHAMPUS authorized providers; and,
(v) The requirements for Phase I protocols
in paragraph (e)(26)(ii)(B)(2) of this section
are met:
(2) Requirements
for Phase I protocols are:
(i) Standard
treatment has been or would be ineffective, does not exist, or there
is no superior non-investigational treatment alternative; and,
(ii) The available clinical or preclinical
data provide a reasonable expectation that the treatment will be
at least as effective as the non-investigational alternative; and,
(iii) The facility and personnel providing the
treatment are capable of doing so by virtue of their experience,
training, and volume of patients treated to maintain expertise;
and,
(iv) The referring
physician has concluded that the enrollee’s participation in such
a trial would be appropriate based upon the satisfaction of paragraphs
(e)(26)(ii)(B)(2)(i) through (iii) of
this section.
(3) TRICARE will
not provide reimbursement for care rendered in the National Institutes
of Health Clinical Center or costs associated with non-treatment
research activities associated with the clinical trials.
(4) Cost-shares and deductibles applicable
to CHAMPUS will also apply under the NCI-sponsored clinical trials.
(5) The Director, TRICARE (or designee), shall
issue procedures and guidelines establishing NCI-sponsorship of
clinical trials and the administrative process by which individual
patients apply for and receive cost-sharing under NCI-sponsored
cancer clinical trials.
(27) TRICARE
will cost share forensic examinations following a sexual assault
or domestic violence. The forensic examination includes a history
of the event and a complete physical and collection of forensic
evidence, and medical and psychological follow-up care. The examination
for sexual assault also includes, but is not limited to, a test
kit to retrieve forensic evidence, testing for pregnancy, testing for
sexually transmitted disease and HIV, and medical services and supplies
for prevention of sexually transmitted diseases, HIV, pregnancy,
and counseling services.
(28) Preventive care.
The following
preventive services are covered:
(i) Cervical, breast,
colon and prostate cancer screenings according to standards issued
by the Director, TRICARE Management Activity, based on guidelines
from the U.S. Department of Health and Human Services. The standards
may establish a specific schedule that includes frequency, age specifications,
and gender of the beneficiary, as appropriate.
(ii) Immunizations
as recommended by the Centers for Disease Control and Prevention
(CDC).
(iii) Well-child
visits for children under 6 years of age as described in paragraph
(c)(3)(xi) of this section.
(iv) Health
promotion and disease prevention visits (which may include all of
the services provided pursuant to Sec. 199.17(f)(2)) for beneficiaries
6 years of age or older may be provided in connection with immunizations
and cancer screening examinations authorized by paragraphs (e)(28)(i)
and (ii) of this section).
(v) Breastfeeding
support, supplies (including breast pumps and associated equipment),
and counseling.
(29) Physical
examinations.
In
addition to the health promotion and disease prevention visits authorized
in paragraph (e)(28)(iv) of this section, the following physical
examinations are specifically authorized:
(i) Physical
examinations for dependents of Active Duty military personnel who
are traveling outside the United States. The examination must be
required because of an Active Duty member’s assignment and the travel
is being performed under orders issued by a Uniformed Service. Any immunizations
required for a dependent of an Active Duty member to travel outside
of the United States is covered as a preventive service under paragraph
(e)(28) of this section.
(ii) Physical
examinations for beneficiaries ages 5-11 that are required for school
enrollment and that are provided on or after October 30, 2000.
(iii) Other
types of physical examinations not listed above are excluded including
routine, annual, or employment-requested physical examinations and
routine screening procedures that are not part of medically necessary
care or treatment or otherwise specifically authorized by statute.
(30) Smoking
cessation program.
The TRICARE smoking cessation program is a
behavioral modification program to assist eligible beneficiaries
who desire to quit smoking. The program consists of a pharmaceutical
benefit; smoking cessation counseling; access to a toll-free quit
line for non-medical assistance; and, access to print and internet
web-based tobacco cessation materials.
(i) Availability.
The TRICARE
smoking cessation program is available to all TRICARE beneficiaries who
reside in one of the 50 United States or the District of Columbia
who are not eligible for Medicare benefits authorized under Title
XVIII of the Social Security Act. In addition, pursuant to Sec.
199.17, if authorized by the Assistant Secretary of Defense (Health
Affairs), the TRICARE smoking cessation program may be implemented
in whole or in part in areas outside the 50 states and the District
of Columbia for active duty members and their dependents who are
enrolled in TRICARE Prime (overseas Prime beneficiaries). In such
cases, the Assistant Secretary of Defense (Health Affairs) may also authorize
modifications to the TRICARE smoking cessation program rules and
procedures as may be appropriate to the overseas area involved.
Notice of the use of this authority, not otherwise mentioned in
this paragraph (e)(30), shall be published in the Federal
Register.
(ii) Benefits.
There is no
requirement for an eligible beneficiary to be diagnosed with a smoking related
illness to access benefits under this program. The specific benefits
available under the TRICARE smoking cessation program are:
(A) Pharmaceutical
agents.
Products
available under this program are identified through the DoD Pharmacy
and Therapeutics Committee, consistent with the DoD Uniform Formulary
in Sec. 199.21. Smoking cessation pharmaceutical agents, including
FDA-approved over-the-counter (OTC) pharmaceutical agents, are available
through the TRICARE Mail Order Pharmacy (TMOP) or the MTF at no
cost to the beneficiary. Smoking cessation pharmaceuticals through
the TRICARE program will not be available at any retail pharmacies.
A prescription from a TRICARE-authorized provider is required to obtain
any pharmaceutical agent used for smoking cessation, including OTC
agents. For overseas Prime beneficiaries, pharmaceutical agents
may be provided either in the MTF or through the TMOP where such
facility or service is available.
(B) Face-to-face
smoking cessation counseling.
Both individual and group smoking cessation counseling
are covered. The number and mix of face-to-face counseling sessions
covered under this program shall be determined by the Director,
TMA; however, shall not exceed the limits established in paragraph
(e)(30)(iii) of this section. A TRICARE-authorized provider listed
in Sec. 199.6 must render all counseling sessions.
(C) Toll-free
quit line.
Access
to a non-medical toll-free quit line 7 days a week, 24 hours a day
will be available. The quit line will be staffed with smoking cessation
counselors trained to assess a beneficiary’s readiness to quit,
identify barriers to quitting, and provide specific suggested actions
and motivational counseling to enhance the chances of a successful
quit attempt. When appropriate, quit line counselors will refer
beneficiaries to a TRICARE-authorized provider for medical intervention.
The quit line may, at the discretion of the Director, TMA, include
the opportunity for the beneficiary to request individual follow-up
contact initiated by quit line personnel; however, the beneficiary
is not required to participate in the quit line initiated follow-up.
Printed educational materials on the effects of tobacco use will
be provided to the beneficiary upon request. This benefit may be
made available to overseas Prime beneficiaries should the ASD(HA)
exercise his authority to do so and provide appropriate notice in
the Federal Register.
(D) Web-based
resources.
Downloadable
educational materials on the effects of tobacco use will be available
through the internet or other electronic media. This service may
be made available to overseas Prime beneficiaries in all locations
where web based resources are available. There shall be no requirement
to create web based resources in any geographic area in order to
make this service available.
(g)
Exclusions
and limitations.
In addition to any definitions, requirements,
conditions, or limitations enumerated and described in other sections
of this part, the following specifically are excluded from the Basic
Program:
(1) Not
medically or psychologically necessary.
Services and supplies that
are not medically or psychologically necessary for the diagnosis
or treatment of a covered illness (including mental disorder, to
include substance use disorder) or injury, for the diagnosis and
treatment of pregnancy or well-baby care except as provided in the
following paragraph.
(2) Unnecessary
diagnostic tests.
X-ray, laboratory, and pathological services
and machine diagnostic tests not related to a specific illness or
injury or a definitive set of symptoms except for cancer screening mammography
and cancer screening papanicolaou (PAP) tests provided under the
terms and conditions contained in the guidelines adopted by the
Director, OCHAMPUS.
(3) Institutional
level of care.
Services
and supplies related to inpatient stays in hospitals or other authorized
institutions above the appropriate level required to provide necessary
medical care.
(4) Diagnostic admission.
Services and supplies related
to an inpatient admission primarily to perform diagnostic tests,
examinations, and procedures that could have been and are performed routinely
on an outpatient basis.
Note: If it is determined
that the diagnostic x-ray, laboratory, and pathological services
and machine tests performed during such admission were medically
necessary and would have been covered if performed on an outpatient
basis, CHAMPUS benefits may be extended for such diagnostic procedures only,
but cost-sharing will be computed as if performed on an outpatient
basis.
(5) Unnecessary
postpartum inpatient stay, mother or newborn.
Postpartum inpatient stay
of a mother for purposes of staying with the newborn infant (usually
primarily for the purpose of breast feeding the infant) when the
infant (but not the mother) requires the extended stay; or continued inpatient
stay of a newborn infant primarily for purposes of remaining with
the mother when the mother (but not the newborn infant) requires
extended postpartum inpatient stay.
(6) Therapeutic absences.
Therapeutic
absences from an inpatient facility, except when such absences are
specifically included in a treatment plan approved by the Director,
OCHAMPUS, or a designee. For cost-sharing provisions refer to Sec.
199.14, paragraph (f)(3).
(7) Custodial care.
Custodial care
as defined in Sec. 199.2.
(8) Domiciliary
care.
Domiciliary
care as defined in Sec. 199.2.
(9) Rest or rest
cures.
Inpatient
stays primarily for rest or rest cures.
(10) Amounts above
allowable costs or charges.
Costs of services and supplies to the extent
amounts billed are over the CHAMPUS determined allowable cost or
charge, as provided for in Sec. 199.14.
(11) No
legal obligation to pay, no charge would be made.
Services or
supplies for which the beneficiary or sponsor has no legal obligation
to pay; or for which no charge would be made if the beneficiary
or sponsor was not eligible under CHAMPUS; or whenever CHAMPUS is
a secondary payer for claims subject to the CHAMPUS DRG-based payment
system, amounts, when combined with the primary payment, which would
be in excess of charges (or the amount the provider is obligated
to accept as payment in full, if it is less than the charges).
(12) Furnished
without charge.
Services or supplies furnished without charge.
(13) Furnished
by local, state, or Federal Government.
Services and supplies paid
for, or eligible for payment, directly or indirectly by a local,
state, or Federal Government, except as provided under CHAMPUS,
or by government hospitals serving the general public, or medical
care provided by a Uniformed Service medical care facility, or benefits
provided under title XIX of the Social Security Act (Medicaid) (refer
to Sec. 199.8 of this part).
(14) Study, grant,
or research programs.
Services and supplies provided as a part of
or under a scientific or medical study, grant, or research program.
(15) Unproven
drugs, devices, and medical treatments or procedures.
By law, CHAMPUS
can only cost-share medically necessary supplies and services. Any
drug, device, or medical treatment or procedure, the safety and
efficacy of which have not been established, as described in this
paragraph (g)(15), is unproved and cannot be cost-shared by CHAMPUS
except as authorized under paragraph 199.4(e)(26) of this part.
(i) A
drug, device, or medical treatment or procedure is unproven:
(A)
If
the drug or device cannot be lawfully marketed without the approval
or clearance of the United States Food and Drug Administration (FDA)
and approval or clearance for marketing has not been given at the
time the drug or device is furnished to the patient.
Note to paragraph (g)(15)(i)(A): Although
the use of drugs and medicines not approved by the FDA for commercial
marketing, that is for use by humans, (even though permitted for
testing on humans) is excluded from coverage as unproven, drugs
grandfathered by the Federal Food, Drug and Cosmetic Act of 1938
may be covered by CHAMPUS as if FDA approved.
Certain cancer drugs, designated as Group C drugs
(approved and distributed by the National Cancer Institute) and
Treatment Investigational New Drugs (INDs), are not covered under
CHAMPUS because they are not approved for commercial marketing by
the FDA. However, medical care related to the use of Group C drugs
and Treatment INDs can be cost-shared under CHAMPUS when the patient’s
medical condition warrants their administration and the care is
provided in accordance with generally accepted standards of medical
practice. For the duration of the President’s national
emergency in response to the COVID-19 outbreak, TRICARE will cost-share
investigational drugs provided for the treatment of COVID-19 under
expanded access.
CHAMPUS
will consider coverage of off-label uses of drugs and devices that
meet the definition of Off-Label Use of a Drug or Device in Sec.
199.2(b). Approval for reimbursement of off-label uses requires review
for medical necessity and also requires demonstrations from medical
literature, national organizations, or technology assessment bodies
that the off-label use of the drug or device is safe, effective,
and in accordance with nationally accepted standards of practice
in the medical community.
(B) If a medical device
(as defined by 21 U.S.C. 321(h)) with an Investigational Device
Exemption (IDE) approved by the Food and Drug Administration is
categorized by the FDA as experimental/investigational (FDA Category
A).
Note: CHAMPUS will consider for coverage
a device with an FDA-approved IDE categorized by the FDA as non-experimental/investigational
(FDA Category B) for CHAMPUS beneficiaries participating in FDA approved
clinical trials. Coverage of any such Category B device is dependent
on its meeting all other requirements of the laws and rules governing
CHAMPUS and upon the beneficiary involved meeting the FDA-approved
IDE study protocols.
(C) Unless
reliable evidence shows that any medical treatment or procedure
has been the subject of well-controlled studies of clinically meaningful
endpoints, which have determined its maximum tolerated dose, its
toxicity, its safety, and its efficacy as compared with standard
means of treatment or diagnosis. (See the definition of reliable
evidence in Sec. 199.2 of this part for the procedures
used in determining if a medical treatment or procedure is unproven.)
(D) If
reliable evidence shows that the consensus among experts regarding
the medical treatment or procedure is that further studies or clinical
trials are necessary to determine its maximum tolerated doses, its
toxicity, its safety, or its effectiveness as compared with the
standard means of treatment or diagnosis (see the definition of
reliable evidence in Sec. 199.2 for the procedures used in determining
if a medical treatment or procedure is unproven).
(ii)
CHAMPUS
benefits for rare diseases are reviewed on a case-by-case basis
by the Director, Office of CHAMPUS, or a designee. In reviewing
the case, the Director, or a designee, may consult with any or all
of the following sources to determine if the proposed therapy is
considered safe and effective:
(A) Trials
published in refereed medical literature.
(B) Formal
technology assessments.
(C) National
medical policy organization positions.
(D) National
professional associations.
(E) National expert
opinion organizations.
(iii) Care excluded.
This exclusion
from benefits includes all services directly related to the unproven drug,
device, or medical treatment or procedure. However, CHAMPUS may
cover services or supplies when there is no logical or causal relationship
between the unproven drug, device or medical treatment or procedure
and the treatment at issue or where such a logical or causal relationship
cannot be established with a sufficient degree of certainty. This
CHAMPUS coverage is authorized in the following circumstances:
(A) Treatment
that is not related to the unproven drug, device or medical treatment
or procedure; e.g., medically necessary in the absence of the unproven
treatment.
(B) Treatment which
is necessary follow-up to the unproven drug, device or medical treatment
or procedure but which might have been necessary in the absence
of the unproven treatment.
(16) Immediate
family, household.
Services or supplies provided or prescribed
by a member of the beneficiary’s immediate family, or a person living
in the beneficiary’s or sponsor’s household.
(17) Double coverage.
Services and
supplies that are (or are eligible to be) payable under another medical
insurance or program, either private or governmental, such as coverage
through employment or Medicare (refer to Sec. 199.8 of this part).
(18) Nonavailability
Statement required.
Services and supplies provided under circumstances
or in geographic locations requiring a Nonavailability Statement
(DD Form 1251), when such a statement was not obtained.
(19) Preauthorization
required.
Services
or supplies which require preauthorization if preauthorization was
not obtained. Services and supplies which were not provided according
to the terms of the preauthorization. The Director, OCHAMPUS, or
a designee, may grant an exception to the requirement for preauthorization
if the services otherwise would be payable except for the failure
to obtain preauthorization.
(20) Psychoanalysis
or psychotherapy, part of education.
Psychoanalysis or psychotherapy
provided to a beneficiary or any member of the immediate family
that is credited towards earning a degree or furtherance of the
education or training of a beneficiary or sponsor, regardless of
diagnosis or symptoms that may be present.
(21) Runaways.
Inpatient stays
primarily to control or detain a runaway child, whether or not admission
is to an authorized institution.
(22) Services
or supplies ordered by a court or other government agency.
Services or
supplies, including inpatient stays, directed or agreed to by a
court or other governmental agency. However, those services and
supplies (including inpatient stays) that otherwise are medically
or psychologically necessary for the diagnosis or treatment of a
covered condition and that otherwise meet all CHAMPUS requirements for
coverage are not excluded.
(23) Work-related
(occupational) disease or injury.
Services and supplies required
as a result of occupational disease or injury for which any benefits
are payable under a worker’s compensation or similar law, whether
or not such benefits have been applied for or paid; except if benefits
provided under such laws are exhausted.
(24) Cosmetic,
reconstructive, or plastic surgery.
Services and supplies in connection
with cosmetic, reconstructive, or plastic surgery except as specifically
provided in paragraph (e)(8) of this section.
(25) Surgery, psychological
reasons.
Surgery
performed primarily for psychological reasons (such as psychogenic).
(26) Electrolysis.
(27) Dental care.
Dental care
or oral surgery, except as specifically provided in paragraph (e)(10)
of this section.
(28) Obesity,
weight reduction.
Service and supplies related “solely” to obesity
or weight reduction or weight control whether surgical or nonsurgical;
wiring of the jaw or any procedure of similar purpose, regardless
of the circumstances under which performed (except as provided in
paragraph (e)(15) of this section).
(29) Sex
gender changes.
Services and supplies related to sex gender
change, also referred to as sex reassignment surgery, as prohibited
by section 1079 of title 10, United States Code. This exclusion
does not apply to surgery and related medically necessary services
performed to correct sex gender confusion/intersex conditions (that
is, ambiguous genitalia) which has been documented to be present at
birth.
(30) Therapy
or counseling for sexual dysfunctions or sexual inadequacies.
Sex therapy,
sexual advice, sexual counseling, sex behavior modification, psychotherapy
for mental disorders involving sexual deviations (i.e., transvestic
fetishism), or other similar services, and any supplies provided
in connection with therapy for sexual dysfunctions or inadequacies.
(31) Corns,
calluses, and toenails.
Removal of corns or calluses or trimming of
toenails and other routine podiatry services, except those required
as a result of a diagnosed systemic medical disease affecting the
lower limbs, such as severe diabetes.
(32) Dyslexia.
(33) Surgical sterilization,
reversal.
Surgery
to reverse surgical sterilization procedures.
(34) Noncoital
reproductive procedures including artificial insemination, in-vitro
fertilization, gamete intrafallopian transfer and all other such
reproductive technologies.
Services and supplies related to artificial
insemination (including semen donors and semen banks), in-vitro
fertilization, gamete intrafallopian transfer and all other noncoital
reproductive technologies.
(35) Nonprescription
contraceptives.
(36) Tests
to determine paternity or sex of a child.
Diagnostic tests to establish
paternity of a child; or tests to determine sex of an unborn child.
(37) Preventive care.
Except as stated
in paragraph (e)(28) of this section, preventive care, such as routine,
annual, or employment-requested physical examinations and routine
screening procedures.
(38) Chiropractors
and naturopaths.
Services of chiropractors and naturopaths
whether or not such services would be eligible for benefits if rendered
by an authorized provider.
(39) Counseling.
Educational,
vocational, non-medical nutritional counseling, counseling for socioeconomic
purposes, stress management, and/or lifestyle modification purposes,
except the following are not excluded:
(i) Services
provided by a certified marriage and family therapist, pastoral
or mental health counselor in the treatment of a mental disorder
as specifically provided in paragraph (c)(3)(ix) of this section
and in Sec. 199.6.
(ii) Diabetes
self-management training (DSMT) as specifically provided in paragraph
(d)(3)(ix) of this section.
(iii) Smoking cessation
counseling and education as specifically provided in paragraph (e)(30)
of this section.
(iv) Services provided
by alcoholism rehabilitation counselors only when rendered in a
CHAMPUS-authorized treatment setting and only when the cost of those
services is included in the facility’s CHAMPUS-determined allowable
cost rate.
(v) Medical nutritional
therapy (also referred to as medical nutritional counseling) required
in the administration of the medically necessary foods, services
and supplies authorized in paragraph (d)(3)(iii)(B) of this section,
medically necessary vitamins authorized in paragraph (d)(3)(vi)(D)
of this section, or when medically necessary for other authorized
covered services.
(40) Acupuncture.
Acupuncture,
whether used as a therapeutic agent or as an anesthetic.
(41) Hair
transplants, wigs/hair pieces/cranial prosthesis.
Note: In accordance with section 744 of the DoD Appropriation
Act for 1981 (Pub. L. 96–527), CHAMPUS coverage for wigs or hairpieces
is permitted effective December 15, 1980, under the conditions listed below.
Continued availability of benefits will depend on the language of
the annual DoD Appropriation Acts.
(i) Benefits provided.
Benefits may be extended,
in accordance with the CHAMPUS-determined allowable charge, for
one wig or hairpiece per beneficiary (lifetime maximum) when the
attending physician certifies that alopecia has resulted from treatment
of a malignant disease and the beneficiary certifies that a wig
or hairpiece has not been obtained previously through the U.S. Government (including
the Veterans Administration).
(ii) Exclusions.
The wig or hairpiece
benefit does not include coverage for the following:
(A) Alopecia
resulting from conditions other than treatment of malignant disease.
(B) Maintenance,
wig or hairpiece supplies, or replacement of the wig or hairpiece.
(C) Hair
transplants or any other surgical procedure involving the attachment
of hair or a wig or hairpiece to the scalp.
(D) Any
diagnostic or therapeutic method or supply intended to encourage
hair regrowth.
(42) Education
or training.
Self-help,
academic education or vocational training services and supplies, unless
the provisions of Sec. 199.4, paragraph (b)(1)(v) relating to general
or special education, apply.
(43) Exercise/relaxation/comfort/sporting
items or sporting devices.
Exercise equipment, to include items primarily
and customarily designed for use in sports or recreational activities,
spas, whirlpools, hot tubs, swimming pools health club memberships
or other such charges or items.
(44) Exercise.
General exercise
programs, even if recommended by a physician and regardless of whether
or not rendered by an authorized provider. In addition, passive
exercises and range of motion exercises also are excluded, except
when prescribed by a physician and rendered by a physical therapist
concurrent to, and as an integral part of, a comprehensive program
of physical therapy.
(45) [Reserved].
(46) Vision care.
Eye exercises
or visual training (orthoptics).
(47) Eye
and hearing examinations.
Eye and hearing examinations except as specifically
provided in paragraphs (c)(2)(xvi), (c)(3)(xi), and (e)(24) of this
section, or except when rendered in connection with medical or surgical
treatment of a covered illness or injury.
(48) Prosthetic devices.
Prostheses other
than those determined by the Director, OCHAMPUS to be necessary
because of significant conditions resulting from trauma, congenital
anomalies, or disease. All dental prostheses are excluded, except
for those specifically required in connection with otherwise covered
orthodontia directly related to the surgical correction of a cleft
palate anomaly.
(49) Orthopedic shoes.
Orthopedic shoes,
arch supports, shoe inserts, and other supportive devices for the
feet, including special-ordered, custom-made built-up shoes, or
regular shoes later built up.
(50) Eyeglasses.
Eyeglasses,
spectacles, contact lenses, or other optical devices, except as
specifically provided under paragraph (e)(6) of this section.
(51) Hearing aids.
Hearing aids
or other auditory sensory enhancing devices, except those allowed
in paragraph (e)(24) of this section.
(52) Telephone
services.
Services
or advice rendered by telephone are excluded, except that:
(i) Telephone services
(audio-only) are not excluded when otherwise covered TRICARE services
are provided to a beneficiary through this modality during the coronavirus
2019 (COVID-19) public health national emergency, if the services
are medically necessary and appropriate, and
(ii) A diagnostic or
monitoring procedure which incorporates electronic transmission
of data or remote detection and measurement of a condition, activity,
or function (biotelemetry) is not excluded when:
(A) The procedure without
electronic transmission of data or biotelemetry is otherwise an
explicit or derived benefit of this section;
(B) The addition of
electronic transmission of data or biotelemetry to the procedure
is found by the Director, CHAMPUS, or designee, to be medically
necessary and appropriate medical care which usually improves the
efficiency of the management of a clinical condition in defined
circumstances; and
(C) The
each data transmission or biotelemetry devices incorporated into
a procedure that is otherwise an explicit or derived benefit of
this section, has been classified by the U.S. Food and Drug Administration,
either separately or as a part of a system, for consistent use with
the defined circumstances in paragraph (g)(52)(ii) of this section.
(53) Air conditioners, humidifiers, dehumidifiers,
and purifiers.
(54) Elevators or
chair lifts.
(55) Alterations.
Alterations
to living spaces or permanent features attached thereto, even when necessary
to accommodate installation of covered durable medical equipment
or to facilitate entrance or exit.
(56) Clothing.
Items of clothing
or shoes, even if required by virtue of an allergy (such as cotton
fabric as against synthetic fabric and vegetable-dyed shoes).
(57) Food,
food substitutes.
Food, food substitutes, vitamins, or other
nutritional supplements, including those related to prenatal care,
except as authorized in paragraphs (d)(3)(iii)(B) and (d)(3)(vi)(D) of
this section.
(58) Enuretic.
Enuretic conditioning
programs, but enuretic alarms may be cost-shared when determined
to be medically necessary in the treatment of enuresis.
(59) Duplicate equipment.
As defined in
Sec. 199.2, duplicate equipment is excluded.
(60) Autopsy
and postmortem.
(61) Camping.
All camping
even though organized for a specific therapeutic purpose (such as diabetic
camp or a camp for emotionally disturbed children), and even though
offered as a part of an otherwise covered treatment plan or offered
through a CHAMPUS-approved facility.
(62) Housekeeper,
companion.
Housekeeping,
homemaker, or attendant services; sitter or companion.
(63) Noncovered condition/treatment,
unauthorized provider.
All services and supplies (including inpatient
institutional costs) related to a non-covered condition or treatment,
including any necessary follow-on care or the treatment of complications,
are excluded from coverage except as provided under paragraph (e)(9)
of this section. In addition, all services and supplies provided
by an unauthorized provider are excluded.
(64) Comfort
or convenience.
Personal, comfort, or convenience items such
as beauty and barber services, radio, television, and telephone.
(65) [Reserved]
(66) Megavitamin
psychiatric therapy, orthomolecular psychiatric therapy.
(67) Transportation.
All transportation
except by ambulance, as specifically provided under paragraph (d),
and except as authorized in paragraph (e)(5) of this section.
(68) Travel.
All travel even
though prescribed by a physician and even if its purpose is to obtain medical
care, except as specified in paragraph (a)(6) of this section in
connection with a CHAMPUS-required physical examination and as specified
in Sec. 199.17(n)(2)(vi).
(69) Institutions.
Services and
supplies provided by other than a hospital, unless the institution
has been approved specifically by OCHAMPUS. Nursing homes, intermediate
care facilities, halfway houses, homes for the aged, or institutions
of similar purpose are excluded from consideration as approved facilities
under the Basic Program.
Note: In order to
be approved under CHAMPUS, an institution must, in addition to meeting
CHAMPUS standards, provide a level of care for which CHAMPUS benefits
are payable.
(70) [Reserved]
(71) [Reserved]
(72) [Reserved]
(73) Economic
interest in connection with mental health admissions.
Inpatient mental
health services (including both acute care and RTC services) are
excluded for care received when a patient is referred to a provider
of such services by a physician (or other health care professional
with authority to admit) who has an economic interest in the facility
to which the patient is referred, unless a waiver is granted. Requests
for waiver shall be considered under the same procedure and based
on the same criteria as used for obtaining preadmission authorization
(or continued stay authorization for emergency admissions), with
the only additional requirement being that the economic interest
be disclosed as part of the request. This exclusion does not apply
to services under the Extended Care Health Option (ECHO) in Sec.
199.5 or provided as partial hospital care. If a situation arises
where a decision is made to exclude CHAMPUS payment solely on the
basis of the provider’s economic interest, the normal CHAMPUS appeals
process will be available.
(74) Not
specifically listed.
Services and supplies not specifically listed
as a benefit in this part. This exclusion is not intended to preclude
extending benefits for those services or supplies specifically determined
to be covered within the intent of this part by the Director, OCHAMPUS,
or a designee, even though not otherwise listed.
Note: The fact that a physician may prescribe, order,
recommend, or approve a service or supply does not, of itself, make
it medically necessary or make the charge an allowable expense,
even though it is not listed specifically as an exclusion.
[51 FR 24008, Jul 1, 1986; 67 FR 15725, Apr
3, 2002; 67 FR 18826, Apr 17, 2002; 67 FR 40602, Jun 13, 2002; 67
FR 42720, Jun 25, 2002; 67 FR 45311, Jul 9, 2002; 68 FR 44880, Jul
31, 2003; 68 FR 44883, Jul 31, 2003; 68 FR 65173, Nov 19, 2003;
69 FR 29229, May 21, 2004; 69 FR 44947, Jul 28, 2004; 69 FR 51564,
Aug 20, 2004; 69 FR 55359, Sep 14, 2004; 69 FR 60554, Oct 12, 2004;
70 FR 12802, Mar 16, 2005; 70 FR 61377, Oct 24, 2005; 71 FR 31944,
Jun 2, 2006; 71 FR 35390, Jun 20, 2006; 72 FR 54353, Sep 25, 2007;
73 FR 46809, Aug 12, 2008; 73 FR 74965, Dec 10, 2008; 74 FR 34696,
Jul 17, 2009; 75 FR 47459, Aug 6, 2010; 75 FR 47461, Aug 6, 2010;
75 FR 50882, Aug 18, 2010; 75 FR 2253, Jan 13, 2011; 76 FR 8297,
Feb 14, 2011; 76 FR 57642, Sep 16, 2011; 76 FR 80743, Dec 27, 2011;
76 FR 81370, Dec 28, 2011; 77 FR 38175, Jun 27, 2012; 77 FR 38178,
Jun 27, 2012; 78 FR 12952, Feb 26, 2013; 78 FR 13240, Feb 27, 2013;
78 FR 62430, Oct 22, 2013; 79 FR 41641, Jul 17, 2014; 79 FR 78707,
Dec 31, 2014; 79 FR 78712, Dec 31, 2014; 81 FR 27328, May 6, 2016;
81 FR 61086, Sep 2, 2016; 82 FR 45445, Sep 29, 2017; 85 FR 27927,
May 12, 2020; 85 FR 54923, Sep 3, 2020]