Subject:
Medical Nutritional Therapy for Inherited Metabolic Disease
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Medical nutritional therapy pertains to the use of medical foods and food products for therapeutic purposes. The phrase "medical food" is defined by statute as a food that is intended for the dietary treatment of a disease or condition for which nutritional requirements are established by medical evaluation and is formulated to be consumed or administered enterally under direction of a physician.
The phrase "low protein modified food product" is defined by statute as a food product that is specially formulated to have less than one gram of protein per serving and is intended to be used under the direction of a physician for the dietary treatment of an inherited metabolic disease. Foods that are considered low protein modified food products include, but are not limited to, cookies, bread, pasta, cheeses, soups and desserts that have been modified to reduce the protein content of the food and thereby, meet the statutory definition of a low protein modified food product. It does NOT include a natural food that is naturally low in protein.
Policy:
[INFORMATIONAL NOTE: Please refer to a separate policy on Nutritional Support (Policy #066) in the Treatment Section which also includes information on the New Jersey Infant Formula Mandate.
In addition, please note that this policy specifically addresses the eligibility of "medical foods" and "low protein modified food products" under the New Jersey Inherited Metabolic Disease Mandate. The mandate actually requires a more comprehensive coverage for "expenses incurred in the therapeutic treatment of inherited metabolic disease", and not just for medical foods and low protein modified food products. Eligibility of other nutritional therapeutic items are defined under policy statement #2 in this policy.
NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)
1. Foods and food products must meet all of the following criteria to be eligible for reimbursement:
A. must be used under the direction of a physician for the nutritional therapeutic management of these congenital diseases or conditions:
- Hypothyroidism ( Currently, there is no recognized "medical food" or "low protein modified food product" for this condition.)
- Galactosemia
- Phenylketonuria
- Sickle cell anemia and other hemoglobinopathies (as designated by the Commissioner)
- Maple syrup urine disease
- Congenital adrenal hyperplasia
- Cystic fibrosis
- Biotinidase deficiency
- Medium chain acyl-CoA dehydrogenase (MCAD) deficiency
- Short chain acyl-CoA dehydrogenase (SCAD) deficiency
- Long chain acyl-CoA dehydrogenase (LCAD) deficiency
- Very long chain acyl-CoA dehydrogenase (VLCAD) deficiency
- Citrullinemia
- Argininosuccinic acidemia
B. must be a "medical food" or "low protein modified food product" based on the above-referenced definition.
Please note that even if a member is diagnosed with an inherited metabolic disease, a food or food product which either (a) does not fall under the statutory definition of "medical food" or "low protein modified food product", or (b) is not specifically formulated as a dietary treatment of the inherited metabolic disease for which it is being given but is merely supplying calories and nutrients, is NOT eligible for reimbursement under the mandate.
Examples of eligible medical foods and low protein modified food products include, but are not limited to, the following:
| ANALOG MSUD | ANALOG XMET | ANALOG XP | ANALOG XPHEN |
| ANALOG XLEU | ANALOG XLYS, TRY | CALCILO XD | CYCLINEX-1 |
| CYCLINEX-2 | GLUTAREX-1 | GLUTAREX-2 | HIST 1 |
| HIST 2 | HOM 1 | HOM 2 | HOMINEX-1 |
| HOMINEX-2 | I-VALEX-1 | I-VALEX-2 | KETONEX-1 |
| KETONEX-2 | LOFENALAC | LYS 1 | LYS 2 |
| MAXAMAID MSUD | MAXAMAID XLEU | MAXAMAID XP | METHIONAID |
| MSUD 1 | MSUD 2 | MSUD AID | MSUD MAXAMAID |
| MSUD MAXAMUM | MSUD ANALOG | MSUD DIET | OS 1 |
| OS 2 | PHENEX-1 | PHENEX-2 | PHENYL-FREE |
| PKU 1 | PKU 2 | PKU 3 | PKU AID |
| PREGESTIMIL | PORTAGEN | PRODUCT 3200 AB | PRODUCT 3200K |
| PRODUCT 3232A | PRODUCT 80056 | PRO-PHREE | PROPIMEX-1 |
| PROPIMEX-2 | PROVIMIN | RCF | RCF SOY PROTEIN FORMULA |
| TYR 1 | TYR 2 | TYROMEX-1 | TYREX-2 |
| UCD 1 | UCD 2 | XLEU ANALOG | XLYS, TRY ANALOG |
| XMET ANALOG | XP ANALOG | XP ANALOG POWDER | XPHEN, TYR ANALOG |
| XPTM ANALOG | XLEU MAXAMAID | XLYS, TRY MAXAMAID | XLYS, TRY MAXAMUM |
| XMET MAXAMAID | XMET MAXAMUM | XMTVI MAXAMAID | XMTVI MAXAMUM |
| XP MAXAMAID | XP MAXAMUM | XPHEN, TYR MAXAMAID |  |
2. Other nutritional therapeutic items (including those that do not require prescription by a physician, i.e., in Phenylketonuria, phenylalanine-free or low protein baking mix, flour, and pasta) are considered eligible when used under the direction of a physician for the specific nutritional or dietary needs caused by an inherited metabolic disease.
Medicare Coverage:
Medical Nutrition Therapy may be covered for individuals with a diagnosis of diabetes or renal disease when NCD 180.1 criteria is met. For additional information and eligibility, refer to National Coverage Determination (NCD) for Medical Nutrition Therapy (180.1). Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=65&ncdver=2&bc=AAAAgAAAAAAAAA%3d%3d&.
Per NCD 180.2, coverage of nutritional therapy under Medicare Part B requires that the patient must have a permanently inoperative internal body organ or function thereof. Therefore, enteral and parenteral nutritional therapy are normally not covered under Part B in situations involving temporary impairments. However, if the medical record, including the judgment of the attending physician, indicates that the impairment will be of long and indefinite duration, the test of permanence is considered met.
Enteral Nutrition
Per L33783, enteral nutrition is covered for a beneficiary who has (a) permanent non-function or disease of the structures that normally permit food to reach the small bowel or (b) disease of the small bowel which impairs digestion and absorption of an oral diet, either of which requires tube feedings to provide sufficient nutrients to maintain weight and strength commensurate with the beneficiary's overall health status. Enteral nutrition is covered when NCD 180.2, LCD L33783 and Article A52493 criteria are met.
Parenteral Nutrition
Parenteral Nutrition is covered under the prosthetic benefit when the beneficiary has a permanent impairment and NCD 180.2, LCD33798 and Article (A52515) criteria are met.
For additional information and eligibility refer to National Coverage Determination (NCD) for Enteral and Parenteral Nutritional Therapy (180.2), Local Coverage Determination (LCD): Parenteral Nutrition (L33798) and Local Coverage Article: Parenteral Nutrition - Policy Article (A52515).
National Coverage Determination (NCD) for Enteral and Parenteral Nutritional Therapy (180.2). Available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.
Local Coverage Determination (LCD): Enteral Nutrition (L33783) and Local Coverage Article: Enteral Nutrition - Policy Article (A52493). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=1&bc=AAgAAAAAAAAA&#aFinal.
Local Coverage Determination (LCD): Parenteral Nutrition (L33798) and Local Coverage Article: Parenteral Nutrition - Policy Article (A52515). Available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=1&bc=AAgAAAAAAAAA&#aFinal.
The services represented by HCPCS codes S9433, S9434, and S9435 are noncovered as they are Medicare Statutory exclusions.
For Medicare Advantage Products no more than one month’s supply of nutrients will be authorized at any one time.
Medicaid Coverage:
FIDE-SNP:
For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Medical Nutritional Therapy for Inherited Metabolic Disease
Dietary Treatment of Inherited Metabolic Disease
Foods and Food Products for Inherited Metabolic Disease
Inherited Metabolic Disease Foods, Food Products and Other Nutritional Items
Low Protein Modified Food Products for Inherited Metabolic Disease
Mandated Coverage for Foods and Food Products
Medical Foods for Inherited Metabolic Disease
Metabolic Disease Foods and Food Products
Nutritional Treatment of Inherited Metabolic Disease
References:
1. New Jersey State Mandate (P.L. 1997, c. 338) approved January 12, 1998, which mandates health benefits coverage for therapeutic treatment of inherited metabolic disease, including coverage for certain foods and food products.
2. New Jersey State Mandate (P.L. 1977, c. 321) which requires that every effort should be made to detect in newborn infants, hypothyroidism, galactosemia, phenylketonuria and other preventable biochemical disorders which may cause mental retardation or other permanent disabilities and to treat affected individuals.
3. Adopted amendments to N.J.A.C. 8:19-2.3 - Newborn Biochemical Screening.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
B4150
B4152
B4153
B4154
B4155
B4157
B4158
B4161
B4162
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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