US Coverage of Medically Necessary Foods and Formulas Resources in United States

US Coverage of Medically Necessary Foods and Formulas Resources

At least 36 state legislatures have enacted bills to provide some insurance coverage of medically necessary foods and formula to treat disorders identified through newborn screening. Of those states, 17 state laws specifically mention medical foods and formula in the statute. Eight states refer to formula only, and five states refer to food only in the text of the statute. However, states that refer to either food or formula only may be covering both depending on how the statutes on interpreted in insurance regulations. Five of the 36 state statutes pertain to access to medical foods and formula through the state. One state, Oklahoma, adopted a resolution encouraging coverage of medical foods and formula. The District of Columbia also provides treatment for disorders identified through newborn screening to the indigent. State requirements for coverage may have caps or age limits. Please read the descriptions of the statutes below for details.

The list of statutes below reflects what is required by state law and does not address the activities that many state health departments are engaging in to help provide access to medical foods and formula.

JURISDICTION	CITATION	SUMMARY
Alabama		No statute found.
Alaska	AS § 21.42.380	Health insurers must provide for the formulas necessary for the treatment of phenylketonuria (PKU). Some insurers may be excluded. Health insurers providing coverage may impose reasonable contract limitations but may not refuse coverage based on a preexisting condition of PKU or require that an individual covered under the plan pay a higher deductible or copayment for the cost of treating PKU than for the cost of treating another condition or illness.
Arizona	A.R.S. §§ 20-826; 20-1057; 20-1342; 20-1402; 20-2327	Any hospital or medical service corporation, insurance company, or health benefits plan that includes prescription drug benefits must provide coverage for modified low protein foods and formula to treat inherited metabolic disorders and diseases screened for under the newborn screening program. Coverage must include at least 50% of the cost of low protein modified foods and formula and may be limited to maximum annual benefit of $5000.
Arkansas	A.C.A. §23-79-701 et seq.	A tax credit of up to $2,400 per year per child for expenses for the purchase of medically necessary medical foods and low protein modified food products is allowed to individuals or to families with a dependent child or children with PKU, galactosemia, organic acidemias, and disorders of amino acid metabolism. All health plans must provide at a minimum coverage for medical food or low protein modified food products, or other specialty products or formulas for the treatment of PKU, galactosemia, organic acidemias, and disorders of amino acid metabolism if prescribed and administered under the direction of a physician and the cost exceeds the amount of the income tax credit allowed. The amount may be subject to deductibles, copayment, coinsurance or cost-sharing. If coverage is denied, then the health department must reimburse providers up to $1000 for services provided.
California	Health & Safety Code §1374.56, Insurance Code § 10123.89	Every health care service plan contract must cover treatment for PKU, including medically necessary formulas and special food products that are part of a diet prescribed by a licensed physician and managed by a health care professional in consultation with a physician who specializes in the treatment of metabolic disease and who participates in or is authorized by the plan. Coverage is required to the extent that the cost of the necessary formulas and special food products exceeds the cost of a normal diet.
Colorado	C.R.S.A. s 10-16-104	Coverage for inherited enzymatic disorders caused by single gene defects involved in the metabolism of amino, organic, and fatty acids must include, but not be limited to, the following diagnosed conditions: PKU; maternal PKU; maple syrup urine disease; tyrosinemia; homocystinuria; histidinemia; urea cycle disorders; hyperlysinemia; glutaric acidemias; methylmalonic acidemia; and propionic acidemia. Covered care and treatment of such conditions must include medically necessary, prescribed medical foods and formulas. PKU coverage is required only to age 21 except that the maximum age to receive benefits for PKU for women who are of child-bearing age is thirty-five years of age. Required coverage only applies to insurance plans that include a pharmacy benefit. A carrier can impose deductibles, coinsurance, or other cost-sharing methods.
Connecticut	C.G.S.A. §§19a-59a; 38a-492c; 38a-518c	The health department may purchase prescribed special infant formula and medical foods directly, if appropriations are available. Any individual or group insurance policy providing coverage for basic hospital expenses, medical-surgical expenses, major medical expenses, accident-only expenses, and hospital/medical service contract plans must provide coverage for amino acid modified preparations and low protein modified food products prescribed for therapeutic treatment of inherited metabolic disesases and cystic fibrosis. Specialized formula must be covered through age eight, coverage must be available on the same basis as outpatient prescription drugs.
Delaware	Delaware Code 18 §§3355, 3571	Health insurance contracts and group and blanket health insurance must provide family member coverage for medical formulas and foods, low protein modified formulas, and modified food products for the treatment of inherited metabolic diseases, if the medical formulas and foods or low protein modified formulas and food products are prescribed as medically necessary administered under the direction of a physician.

District of Columbia	DC ST § 7-838	If a newborn’s parents are indigent and the child’s residence is in DC, the government of DC pays any costs for follow-up testing and treatment. The Mayor shall define “indigency” and may establish a sliding scale of partial payment by the DC government based on the parents’ reasonable ability to pay some of the costs.
Florida	F.S.A. §§627.42395, 383.14	Health insurers must make available to the policyholder, for an appropriate additional premium, coverage for medically necessary prescription and nonprescription enteral formulas for the treatment of inherited diseases of amino acid, organic acid, carbohydrate, or fat metabolism as well as malabsorption originating from congenital defects present at birth or acquired during the neonatal period. Coverage for inherited diseases of amino acids and organic acids shall include modified low protein food products modified in an amount not to exceed $2,500 annually for any insured individual, through the age of 24. The statute applies to any person or family notwithstanding the existence of any preexisting condition. The health department must supply necessary dietary treatment products where practicable for diagnosed cases of PKU and other metabolic diseases for as long as medically indicated when the products are not otherwise available and provide nutrition education and supplemental foods to those families eligible for the Special Supplemental Nutrition Program for Women, Infants, and Children.
Georgia		No statute found.
Hawaii	§346-67, 431:10A-120, 432:1-609	Public assistance recipients are allowed coverage for prescribed, medically necessary medical foods and low-protein modified food products consumed or administered enterally under the supervision of a licensed physician for the treatment of an inborn error of metabolism. Each policy of accident and sickness insurance and all individual and group hospital and medical service plan contracts and medical service corporation contracts also must provide similar coverage. Insurers and all health maintenance organizations (HMOs) and prepaid health plans with which the department executes risk contracts for the provision of medical care to eligible public assistance recipients must provide notice to their members regarding the coverage required by this section.
Idaho		No statute found.
Illinois	410 ILCS 240/2	`The health department must supply the necessary treatment product where practicable for diagnosed cases for as long as medically indicated, when the product is not available through other State agencies.`

Indiana	IC §§16-41-17-10, 27-8-24.1 et seq, 27-13-7-18	The health department must administer a centralized program that provides follow-up, diagnosis, management, and family counseling and support, including equipment, supplies, formula, and other materials, for all infants and individuals identified as having a disorder screening for through the newborn screening program. Accident and sickness insurance policies and group health maintenance organization contracts must provide coverage for medically necessary, prescribed medical food defined as formula intended for the dietary treatment of a disease or condition for which nutritional requirements are established by medical evaluation; and formulated to be consumed or administered enterally under the direction of a physician.
Iowa		No statute found.
Kansas	K.S.A. s 65-180	If the medically necessary foods for diagnosed cases must be purchased, the purchaser shall be reimbursed for costs incurred up to $1,500 per year per diagnosed child age 18 or younger. For a purchaser to be eligible for reimbursement, the income of the person(s) who has legal responsibility for the diagnosed child shall not exceed 300% of the poverty level.
Kentucky	K.R.S. §205.560, 213.141, 304.17A-145	The scope of medical care that the Cabinet for Health and Family Services undertakes to pay may include prescribed amino acid modified preparations and low-protein modified food products for the treatment of certain inherited metabolic diseases administered under the direction of a physician. Fees for birth certificates help support the program. A health benefit plan that provides coverage for a newly born child must include the necessary care and treatment of medically diagnosed inherited metabolic diseases. A health benefit plan that provides prescription drug coverage must provide that coverage for amino acid modified preparations and low-protein modified food products prescribed and administered under the direction of a physician for the treatment of inherited metabolic diseases. Coverage under this subsection may be subject, for each plan year, to a cap of $25,000 for medical formulas and a separate cap for each plan year of $4,000 on low protein modified foods, subject to annual inflation adjustments.

Louisiana	LSA-RS §22:215.22, 22:2004.2, 22:3018.1	Health insurers that provide medical and surgical benefits must provide coverage, subject to applicable deductibles, coinsurance, and copayments, for medically necessary low protein food products for treatment of inherited metabolic obtained from a source approved by the health insurance issuer, provided coverage will not be denied if the health insurance issuer does not approve a source. Coverage provided shall not exceed eligible benefits of $200 per month, and the law does not apply to individually underwritten, guaranteed renewable limited benefit or short-term health insurance policies. Health maintenance organizations and self-insurers subject to state law must provide similar coverage.
Maine	24 §2320-D, 24-A §§2745-D, 2837-D, 4238	Individual and group nonprofit medical services plan policies and contracts, nonprofit health care plan policies and contracts, individual and group insurance policies and contracts (except accidental injury, specified disease, hospital indemnity, Medicare supplement, long-term care and other limited benefit health insurance policies and contracts), and health maintenance organization individual and group contracts must provide coverage for prescribed metabolic formula and special modified low-protein food products for a person with an inborn error of metabolism. The policies and contracts must reimburse for metabolic formula and up to $3,000 per year for special low protein food products.
Maryland	Health-General, s 19-705.5; Insurance, s 15-807	An HMO shall include as part of its benefit package coverage for medical for the treatment of inherited metabolic diseases if the medical foods are prescribed by and administered under a doctor. An insurance policy that is written on an expense-incurred basis and provides coverage for a family member of the insured shall include coverage for medical foods for the treatment of inherited metabolic diseases if the medical foods are prescribed by and administered under a doctor.
Massachusetts	M.G.L.A 32-A 17A, 176G §4D, 176B §4K, 176A §8L	Group HMO contracts, individual and group medical service agreements, individual or group hospital service plans, and the state plan for current and retired employees must provide coverage for medically necessary nonprescription enteral formulas ordered by a physician for the treatment of malabsorption caused by Crohn’s disease, ulcerative colitis, gastroesophageal reflux, gastrointestinal motility, chronic intestinal pseudo-obstruction, and inherited diseases of amino acids and organic acids. Coverage includes food products modified to be low protein in an amount not to exceed $2,500 annually for any insured individual.
Michigan		No statute found.
Minnesota	M.S.A. 62A.26, §256B.0625	Policies of accident and health insurance, HMO contracts, and health benefit certificates offered through a fraternal benefit society, and group subscriber contracts offered by nonprofit health service plan corporations must provide coverage for special dietary treatment for PKU when recommended by a physician. The statewide program of medical assistance for needy persons covers nutritional products needed for nutritional supplementation because solid food or nutrients cannot be properly absorbed by the body or needed for treatment of PKU, hyperlysinemia, maple syrup urine disease, a combined allergy to human milk, cow’s milk, and soy formula, or any other childhood or adult diseases, conditions, or disorders identified by the commissioner as requiring a similarly necessary nutritional product.
Mississippi		No statute found.
Missouri	V.A.M.S. 191.331, 376.1219	The state provides financial assistance for metabolic formula for babies with inherited diseases of amino acids and organic acids whose parents who meet income eligibility requirements. State assistance will be available to an applicant only after the applicant has shown that all benefits from third party payers have been exhausted.
Montana	MCA §33-22-131	Group or individual medical expense disability policies, certificates of insurance, and membership contracts must provide coverage for the treatment of inborn errors of metabolism that involve amino acid, carbohydrate, and fat metabolism and for which medically standard methods of diagnosis, treatment, and monitoring exist. Coverage must include expenses of diagnosing, monitoring, and controlling the disorders by nutritional and medical assessment, including clinical services, biochemical analysis, medical supplies, prescription drugs, corrective lenses for conditions related to the inborn error of metabolism, nutritional management, and medical foods used to compensate for the metabolic abnormality and to maintain adequate nutritional status.
Nebraska	NRS §71-520	The health department must establish a program to provide food supplements and treatment services to individuals suffering metabolic diseases detected through the newborn screening program. To defray the costs of the program, the department may prescribe and assess a scale of fees for the food supplements. The maximum prescribed fee for food supplements must be no more than the actual cost of providing such supplements. No fees may be charged for formula, and up to $2,000 of pharmaceutically manufactured food supplements is available to an individual without fees each year.

Nevada	NRS §689A.0423, 689B.0353, 695B.1923, 695C.1723	Individual and group health insurance policies, contracts for hospital and medical services, and HMO’s must provide coverage for medically necessary enteral formulas and at least $2,500 per year for special food products prescribed or ordered by a physician for the treatment of inherited metabolic diseases characterized by deficient metabolism, or malabsorption originating from congenital defects or defects arising shortly after birth, of amino acid, organic acid, carbohydrate or fat. Coverage is required whether or not the condition existed when the policy was purchased.
New Hampshire	§415:6-c, 415:18-e, 420-A:17, 420-B:8-ff	Any individual, group or blanket policy of accident or health insurance, health service corporation and health maintenance organization providing benefits for medical or hospital expenses, must provide coverage for nonprescription enteral formulas and food products required for persons with inherited diseases of amino acids and organic acids when the prescribing physician has issued a written order stating that the enteral formula or food product is medically necessary and is the least restrictive and most cost effective means for meeting the needs of the patient. Coverage for inherited diseases of amino acids and organic acids must, in addition to the enteral formula, include food products modified to be low protein in an amount not to exceed $1,800 annually. Benefits must not be subject to any greater deductible than any other benefits provided by the insurer. The coinsurance required by the enrolled participant shall not exceed the amount allowed under the contract for the reasonable and customary charge for the service provided.
New Jersey	NJSA 52:14-17.29c	The State Health Benefits Commission shall provide benefits to each person covered under the State Health Benefits Program for the therapeutic treatment of inherited metabolic diseases, including the purchase of medical foods and low protein modified food products, when diagnosed and determined to be medically necessary by the covered person’s physician. The health care services must be provided to the same extent as for any other medical condition under the program.

New Mexico	NMSA 59A-22-41.1	Individual and group health insurance policies, health care plans, certificates of health insurance and managed health care plans must provide coverage for the treatment of genetic inborn errors of metabolism that involve amino acid, carbohydrate and fat metabolism and for which medically standard methods of diagnosis, treatment and monitoring exist. Coverage must include expenses of diagnosing, monitoring and controlling disorders by nutritional and medical assessment, including clinical services, biochemical analysis, medical supplies, prescription drugs, corrective lenses for conditions related to the genetic inborn error of metabolism, nutritional management and special medical foods used in treatment to compensate for the metabolic abnormality and to maintain adequate nutritional status. Services required to be covered are subject to the terms and conditions of the applicable individual or group policy or plan that establishes durational limits, dollar limits, deductibles and co-payments as long as the terms are not less favorable than for physical illness generally.
New York	Insurance Law §4322	In-plan and out-of-plan benefits for the standardized individual enrolle direct payment contracts must include coverage for all health services which an enrolled population in a health maintenance organization might require in order to be maintained in good health, rendered without limitation as to time and cost, including prescription drugs, defined to include nutritional supplements (formulas) for the therapeutic treatment of PKU, branched-chain ketonuria, galactosemia and homocystinuria, obtained at a participating pharmacy under a prescription written by an in-plan or out-of-plan provider.
North Carolina	NCGS §130A-125	The health department’s newborn screening program must include the provision of necessary dietary treatment products or medications for identified children as medically indicated and when not otherwise available.
North Dakota	NDCC §26.1-36-09.7, §54-52.1-04.11	An insurance company, nonprofit health service corporation, or health maintenance organization must provide coverage for medically necessary medical foods and low-protein modified food products for the therapeutic treatment of an inherited metabolic disease. Coverage is not required in excess of $3,000 a year total for low-protein modified food products or medical food for an individual with an inherited metabolic disease of amino acid or organic acid. Medical benefits coverage for low-protein modified food products or medical food is not required for an individual to the extent those benefits are available to that individual under a state department of health or department of human services program.
Ohio		No statute found.
Oklahoma	2004 HCR 1044	This resolution urges health insurance companies that offer, issue, or renew a health benefit plan in the State of Oklahoma to include coverage for medical foods and food products for the treatment of PKU and other inherited metabolic diseases.
Oregon	ORS §743-729	Health insurance policies must include coverage for nonprescription elemental enteral formula if the formula is medically necessary for the treatment of severe intestinal malabsorption and a physician has issued a written order for the formula and the formula comprises the sole source, or an essential source, of nutrition. The coverage required may be subject to provisions of the policy that apply to other benefits under the policy such as deductibles and coinsurance. Deductibles and coinsurance for elemental enteral formulas must be no greater than those for any other treatment for the condition under the policy.
Pennsylvania	40 PS §3904 et seq.	Health insurance policies must provide coverage for the cost of nutritional supplements (formulas) as medically necessary for the therapeutic treatmentof PKU, branched-chain ketonuria, galactosemia and homocystinuria as administered under the direction of a physician. Benefits are subject to copayment and coinsurance to the extent that other medical services covered by the policy are subject to those provisions and are exempt from deductible or dollar limit provisions in a health insurance policy. The exemption must beexplicitly provided for in the policy. The law should not be construed to require a health insurance policy to include if the individual is employed outside theCommonwealth; and the individual’s employer maintains a health insurance policy for the individual as an employment benefit. The health and insurance departments must promulgate regulations to implement the law.
Rhode Island		No statute found.
South Carolina		No statute found.
South Dakota	SDCL §§58-17-62, 58-18-41, 58-38-23, 58-40-21, 58-41-98	Individual and group health insurance policies, service and indemnity type contracts, and health maintenance contracts, except for policies that provide coverage for specified disease or other limited benefit coverage, must offer coverage for testing, diagnosis, and treatment of PKU including dietary management, formulas, case management, intake and screening, assessment, comprehensive care planning, and service referral.

Tennessee	TCA §56-7-2505	Any individual, franchise, blanket or group health insurance policy, medical service plan, contract, hospital service corporation contract, hospital and medical service corporation contract, fraternal benefit society, or health maintenance organization that provides hospital expense and surgical expense insurance must provide coverage for licensed professional medical services under the supervision of a physician and those special dietary formulas which are medically necessary for the therapeutic treatment of PKU.
Texas	VTCA Insurance Code §1359.001 et seq.	A group health benefit plan must provide coverage for formulas necessary to treat PKU or a heritable disease. The group health benefit plan must provide the coverage to the same extent that the plan provides coverage for drugs that are available only on the orders of a physician.
Utah	Utah Code §31A-22-623	The insurance commissioner shall establish, by rule, minimum standards of coverage for dietary products used for the treatment of inborn errors of amino acid or urea cycle metabolism at levels consistent with the major medical benefit provided under an accident and health insurance policy.
Vermont	8 V.S.A. §4089e	An insurer must provide coverage for medically necessary foods for an inherited metabolic disease. Coverage for medically necessary foods for an inherited metabolic disease shall be at least $2,500.00 during any continuous period of twelve months for any insured individual.
Virginia		No statute found. (section repealed in 2005)
Washington	RCWA §§48.20.520 48.21.300 48.44.440, 48.46.510	Any individual or group disability insurance contract, health care services contract, and health maintenance organization that insures for hospital or medical expenses must provide coverage for the formulas necessary for the treatment of PKU.
West Virginia		No statute found.
Wisconsin		No statute found.
Wyoming		No statute found.