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).