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)) 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 (US) 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 calendar days.
3.8.8 Subsequent prescriptions shall
describe the quantity and frequency of the required BDM, and must
be renewed every 30 calendar 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 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. When reimbursement
is made in accordance with the TRM,
Chapters
3 and
5, especially
when the state prevailing or billed rate is used.
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).
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).