3.0 Policy
3.1 Medically
necessary food and medical equipment and supplies necessary to administer
such food are covered by TRICARE when prescribed for dietary management
of a covered disease or condition. Medically necessary food includes
specialized formulas, a Low Protein Modified Food (LPMF) product
or an amino acid preparation product. Medically necessary food and
medical equipment and supplies may be covered when it is:
3.1.1 Furnished pursuant
to the prescription of a TRICARE authorized individual professional provider
as described in
32 CFR 199.6 (e.g.,
physician, certified Nurse Practitioner (NP), or a certified Physician
Assistant (PA), etc.) acting within the provider’s scope of license/certificate
of practice for the dietary management of a covered disease or condition
as listed in
paragraph 3.2; and
3.1.2 A specifically formulated and processed
product (as opposed to a naturally occurring foodstuff used in its
natural state) for the partial or exclusive feeding of an individual
by means of oral intake, or enteral feeding by tube, or parenteral
feeding by IV, or intraperitoneal administration; and
3.1.3 Intended for
the dietary management of an individual who, because of therapeutic
or chronic medical needs, has limited or impaired capacity to ingest,
digest, absorb, or metabolize ordinary foodstuffs or certain nutrients,
or who has other special medically determined nutrient requirements,
the dietary management of which cannot be achieved by the modification
of the normal diet alone; and
3.1.4 Intended to be used under medical supervision,
which may include in a home setting; and
3.1.5 Intended only for an individual receiving
active and ongoing medical supervision under which the individual
requires medical care on a recurring basis for, among other things,
instructions on the use of the food.
3.2 Covered disease or conditions include:
• Inborn Errors
of Metabolism (IEM);
• Medical conditions
of malabsorption;
• Pathologies
of the alimentary tract or the gastrointestinal tract; and,
• A neurological
or physiological condition.
3.3
Medically
Necessary Vitamins And Minerals
Medically necessary
vitamins and minerals, including prenatal vitamins for prenatal
care (also see
Section 9.1), are covered when used for the
management of a covered disease or condition, as listed in
paragraph 3.2,
pursuant to a prescription or order of a TRICARE authorized individual professional
provider acting within the provider’s scope of license/certificate
of practice as described in
32 CFR 199.6.
3.4 Specialized
Formulas
3.4.1 Specialized
formulas, to include amino acid based formulas, when covered as
medically necessary food under
paragraph 3.1, are listed in the “Enteral
Nutrition Product Classification List.” The list
at:
https://www.health.mil/rates.
3.4.2 Specialized
formulas included on the Enteral Nutrition
Product Classification List are covered for enteral and oral consumption.
3.5 Low Protein
Modified Foods (LPMFs)
3.5.1 LPMFs,
when covered as medically necessary foods under
paragraph 3.1, are those food products
that have been modified to be low in protein for use by individuals
who have been diagnosed with IEM (e.g., phenylketonuria (PKU), or
maple syrup urine disease), and are not typically readily available
in grocery stores. LPMFs are primary to the management of IEM, as
they help those diagnosed with the condition, avoid organ damage,
grow properly, and maintain or improve health status. LPMFs may
be covered pursuant to a prescription, when medically necessary
and appropriate for the treatment of IEM.
3.5.2 Contractor Responsibilities - LPMFs
3.5.2.1 The contractor
shall preauthorize all prescribed LPMFs and ensure the LPMFs are
medically necessary and appropriate medical care for the treatment
of IEM.
3.5.2.2 If
preauthorization is not obtained and the contractor finds the LPMFs
is medically necessary and appropriate and the care otherwise meets
the requirements of this policy, the payment reduction provision
of the TRICARE Reimbursement Manual (TRM),
Chapter 1, Section 28 applies.
3.5.2.3 If preauthorization
is not obtained by the beneficiary and the beneficiary purchases
LPMF directly from a vendor, and all policy criteria are met, the
appropriate out of network cost-share shall apply.
3.5.2.4 LPMF
products are purchased from vendors who specialize in the distribution
of LPMFs. The contractor shall include providers of LPMFs in their
network as medical supply firm providers.
3.6 Ketogenic
Diet
3.6.1 Inpatient ketogenic diet is covered
when it is part of a medically necessary inpatient admission for
epilepsy. Services and supplies will be reimbursed under the Diagnosis
Related Group (DRG) payment methodology.
3.6.2 Outpatient services and supplies for ketogenic
diet are covered for the treatment of seizures that are refractory
to anti-seizure medication. Covered supplies are included on the
list maintained by Noridian Administrative Services and can be found
at:
https://www.health.mil/rates.
3.7 Medical Nutritional
Therapy/Medical Nutritional Counseling
3.7.1 Medical nutritional therapy/medical nutritional
counseling required in the administration and maintenance of TRICARE
covered medically necessary foods, to include low protein foods,
for those covered conditions listed in
paragraph 3.2, may be covered
when medically necessary and appropriate.
3.7.2 Medical nutritional therapy must be provided
by a TRICARE authorized individual professional provider described
in
32 CFR 199.6 (e.g.,
physician, nurse, nutritionist, or Registered Dietician (RD)). If
required by
32 CFR 199.6,
the authorized provider (e.g., a nutritionist or RD) must be licensed
by the state in which the care is provided and must be under the
supervision of a physician who is overseeing the episode of treatment
or the covered program of services.
3.8 Banked Donor
Milk (BDM)
3.8.1 Effective for dates of service on
or after January 1, 2019, BDM may be cost-shared as a medically
necessary food when all of the following conditions are met:
3.8.1.1 The infant has one or more of the
following conditions:
• Infant born at Very Low Birth Weight (VLBW)
(less than 1,500g) or lower (e.g., Extremely Low Birth Weight (ELBW)
infants, < 1,000g);
• Gastrointestinal
anomaly, metabolic/digestive disorder, or recovery from intestinal surgery
where digestive needs require additional support;
• Diagnosed Failure-to-Thrive
where other feeding options have been exhausted or are contraindicated;
• Formula intolerance
with either (1) documented feeding difficulty or (2) weight loss (where
other feeding options have been exhausted or are contraindicated);
• Infant hypoglycemia;
• Congenital heart
disease;
• Pre-or post-organ transplant; or
• Other serious
health conditions when the use of BDM is medically necessary and
will support the treatment and recovery of the infant.
3.8.1.2 And
own mother’s milk is contraindicated, unavailable due to medical
or psychological condition, or mother’s milk is available but is
insufficient in quantity or quality to meet the infant’s dietary
needs.
Note: If the birth
mother is unavailable due to the physical absence of the birth mother
in extraordinary circumstances (i.e., adoption, maternal death,
deployment of Active Duty Service Member (ADSM) mother), the own
mother’s milk is considered to be unavailable for the purposes of this
paragraph.
3.8.2 BDM must be prescribed by a TRICARE authorized
individual professional provider described in
32 CFR 199.6 (e.g., physician). As required
by
32 CFR 199.6,
the authorized provider must be licensed by the state in which the
care is provided and must be under the supervision of a physician (if
not a physician) who is overseeing the episode of treatment or the
covered program of services.
3.8.3 Coverage shall be extended for as
long as medically necessary, not to exceed 12 months of age.
3.8.4 BDM
must be procured through a HMBANA (Human Milk Banking Association
of North America) accredited milk bank, and delivered through a
TRICARE authorized provider (e.g., pediatrician or inpatient hospital,
or the supplier [HMBANA-accredited milk bank]).
Note: Currently HMBANA-accredited
milk banks only exist in the United States and Canada. Therefore,
BDM is not available overseas, except for Canada.
3.8.5 Coverage shall be limited to no
more than 35 ounces per day, per infant.
3.8.6 Discontinuation of coverage for
BDM for ELBW/VLBW infants shall be considered on a case-by-case
basis. In general, this is considered to occur concluding the 36th
post-menstrual week for otherwise healthy infants; however, continuation
of coverage for BDM for healthy but ELBW/VLBW infants after 36 weeks
post-menses may be appropriate in certain cases upon medical review. Continuation
past 36 weeks post-menses may be covered when BDM is documented
as being medically necessary or appropriate and all other conditions
of coverage are met.
3.8.7 The initial prescription shall describe
the quantity and frequency of the required BDM, and shall only be
valid for 30 days.
3.8.8 Subsequent prescriptions shall describe
the quantity and frequency of the required BDM, and must be renewed
every 30 days.
3.8.9 In accordance with this section, prescriptions
for BDM require active medical management by the prescribing provider.
The contractor may require medical documentation demonstrating active medical
management, as well as documentation of medical necessity to validate
both the initial as well as ongoing prescriptions for BDM, and to
validate the frequency, quantity, and duration of treatment with
BDM.
3.8.10 BDM provided
during an inpatient stay shall be cost-shared the same as any other
medical supply provided during an inpatient stay.
3.8.11 BDM provided on an outpatient basis
shall be subject to the same copays and cost-sharing requirements
as other outpatient medical supplies.
4.0 Reimbursement
4.1 Medical
foods shall be reimbursed using the rate on the Durable Medical
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) fee schedule.
If there is no DMEPOS fee schedule rate, the allowable charge shall
be established in accordance with the TRM,
Chapter 1, Section 39;
Chapter 3, Section 1; and
Chapter 5, Sections 1 and
3, for BDM.
4.2 When reimbursement is made in accordance
with the TRM,
Chapters 3 and
5, especially when the state prevailing or
billed rate is used, the contractor shall ensure the provisions
of
32 CFR 199.9(b)(2),
(b)(7),
(c)(11) and
the TRICARE Operations Manual (TOM),
Chapter 13,
are followed to prevent fraud and abuse.
4.3 BDM shall be reimbursed in accordance
with TRM,
Chapter 1, Section 39. The beneficiary may be
required to pay out-of-pocket for BDM and submit a claim to the
contractor for reimbursement. Provisions are outlined in TOM,
Chapter 8, Section 1.
5.0 Exclusions
TRICARE
covered medically necessary food and vitamins do not include:
5.1 Food taken as
part of an overall diet designed to reduce the risk of a disease
or medical condition, or as weight-loss products, even if the food
is recommended by a physician or other health care professional.
5.2 Food marketed
as gluten-free for the management of celiac disease or non-celiac
gluten sensitivity.
5.3 Food marketed for the management of diabetes.
5.4 Vitamins or
mineral preparations, except as provided in
paragraph 3.3.
5.5 Nutritional
supplements administered in the absence of a covered disease or
a medical condition that is listed in
paragraph 3.2.
5.6 Megavitamin
psychiatric therapy, orthomolecular psychiatric therapy.
5.7 Items used primarily
for convenience or for features which exceed that which is medically necessary
(for example, prepackaged, liquid vs. powder, etc.).
5.8 Nutritional
products that are marketed for use for individuals without medical
conditions.
5.9 Naturally
occurring foodstuff used in its natural state, to include those
that are naturally low in protein. Excluded items are those not
intended to be used under the direction of a physician for the dietary
treatment of an inborn error of metabolism.
5.10 Healthcare Common
Procedure Coding System (HCPCS) code B4104 is an enteral formula additive.
The enteral formula codes include all nutrient components, including
vitamins, mineral and fiber. As a result B4104 is not separately
payable.
5.11 Specialized formulas, except those covered
in
paragraph 3.4.
5.12 BDM
from any milk bank not accredited by HMBANA.
5.13 Peer-to-peer
donation or sale of BDM.
5.14 More than 35 ounces of BDM per day, per
infant.
5.15 BDM for healthy, normal birth weight infants
(even if own mother’s milk is unavailable).
5.16 BDM
provided for convenience (e.g., to facilitate the mother’s return
to work).