(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,
and pursuant to an agreement between the Department of Defense and
the Department of Health and Human Services, the general prohibition
against CHAMPUS cost-sharing of unproven drugs, devices, and medical
treatments or procedures may be waived by the Secretary of Defense
in connection with clinical trials sponsored or approved by the
National Institutes of Health (NIH) or an NIH Institute or Center
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.
(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.
(iii) Public Health
Emergency Waiver.
(A) General.
During public health emergencies
(e.g., a national state of emergency declared by the President),
TRICARE may cover cost-sharing for TRICARE-eligible patients who participate
in Phase I, II, III, or IV trials that are sponsored by the NIH
or an NIH Institute for the purposes of treatment or prevention
of the pandemic or public health emergency.
(B) National Institute of Allergy and Infectious
Diseases (NIAID)-sponsored clinical trials for COVID-19.
For the duration of the President’s
national emergency regarding the COVID-19 outbreak, TRICARE will
cover cost-sharing for those TRICARE-eligible patients selected
to participate in NIAID-sponsored Phase I, II, III, and IV studies examining
the treatment or prevention of COVID-19 and its associated sequelae
(e.g., cardiac and pulmonary issues). TRICARE will continue to cover
cost-sharing for any eligible beneficiary enrolled in such a study
until the conclusion of that study, even if the national emergency
ends before the conclusion of the study.
(1) TRICARE will cost-share all medical care
(including associated health complications) and testing required
to determine eligibility for an NIAID-sponsored trial, including
the evaluation for eligibility at the institution conducting the NIAID-sponsored
study. TRICARE will cost-share all medical care required as a result
of participation in NIAID-sponsored studies. This includes purchasing
and administering all approved pharmaceutical agents (except for
NIAID-funded investigational drugs), all inpatient and outpatient
care, including diagnostic, laboratory, rehabilitation, and home health
services not otherwise reimbursed under an NIAID grant program if
the following conditions are met:
(i) Such treatments
are NIAID-sponsored Phase I, Phase II, Phase III, or Phase IV protocols;
(ii) The patient continues to meet entry criteria
for said protocol;
(iii) The institutional
and individual providers are TRICARE-authorized providers; and
(iv) The requirements for Phase I protocols
in paragraph (e)(26)(iii)(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;
(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;
(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)(iii)(B)(2)(i) through (iii) of this section.
(3) TRICARE will not provide reimbursement
for care rendered in the NIH Clinical Center or costs associated
with non-treatment research activities associated with the clinical
trials.
(4) Cost-shares
and deductibles applicable to TRICARE will also apply under the
NIAID-sponsored clinical trials.
(5) The Director, Defense Health Agency (or
designee), shall issue procedures and guidelines establishing NIAID-sponsorship
of clinical trials and the administrative process by which individual
patients apply for and receive cost-sharing under NIAID-sponsored
COVID-19 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. Exceptions:
(i) Medically
necessary and appropriate Telephonic office visits are covered as
authorized in paragraph (c)(1)(iii) of this section.
(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; 85 FR 68757, Oct
30, 2020; 85 FR 73196, Nov 17, 2020; 87 FR 33013,
Jun 1, 2022]