State Statutes and Regulations on Dietary Treatment of Disorders

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Alabama PKU, CH, GALT, CAH, hearing No provision No provision Statutes authorize board of AC §22‐20‐3 loss, hemoglobinopathy, BD, health to create regulations to AAC §40‐20‐10‐ CF, AAD, FAOD, OAD, and provide for treatment, .01 et seq. other heritable diseases including but not limited to advising dietary treatment. Regulations permit the health department to inform parents about department services, which may include treatment. Alaska PKU Necessary formula to treat PKU Health insurers except State reimburses enrolled AS §21..42.380 fraternal benefit societies providers for nutrition services 7 AAC 43.924 must cover formulas. given to Medicaid‐eligible 7 AAC 43.454 Reasonable contract patients under 21 and limitations allowed. pregnant women between 10 and 55 with metabolic disease. Arizona Insurance: metabolic Insurance: low protein foods & Hospital & medical service Children’s rehabilitative ARS §20‐826 disorders that are part of the formula necessary for lifetime corporations, health care services program provides ARS §20‐1057 newborn screening (NBS) and used under physician service organizations, nutrition to treat metabolic ARS §20‐1342 program; involve amino acid, orders to avoid serious disability insurers and disorders and services for CF, ARS §20‐1402 carbohydrate and fat impairment. i health benefit plans with including nutrition taken via ARS §20‐2327 metabolism; have standard State services: services exclude prescription drug benefits tube that supplies 50% of daily AAC R9‐7‐202 methods of diagnosis, lactose‐free nutrition for GALT, must cover at least 50% of caloric need or nutrition taken AAC R9‐7‐401 treatment and monitoring; & formula/milk products mixed cost of medical foods to without a tube that supplies AAC R9‐7‐410 require specially processed or with modified amino acid treat inherited metabolic 100% caloric need. treated medical foods formula, & low protein disorders up to $5,000 State services: AAD, BD, CF, nutrition annually. hemoglobinopathy, HCY, hypothyroidism, PKU, MSUD, OAD, storage disease and other conditions with similar treatment requirements.

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Arkansas Insurance and tax credit: PKU, Insurance and tax credit: If the cost of medical Statutes authorize health ACA §20‐15‐304 GALT, OAD, and AAD medical foods to treat a foods and low protein department to assist in ACA §23‐79‐701 State services: PKU, GALT, condition with recognized modified food products is treatment and care. For PKU et seq. and other metabolic nutritional requirements; low ≥$2,400 annually, and GALT, rules provide for AAR §17‐16‐07‐ conditions protein modified food products insurance company, formula and foods. For other 001 with ≤1 gram of protein per hospital medical service metabolic conditions, rules serving that are prescribed, corporation and HMO provide for nutritional therapy medically necessary foods policies must cover amino as recommended by taken under physician direction acid modified food consultants. Department State services for PKU & GALT: preparations, low protein reimburses providers ≤$1,000 formula and foods undefined modified foods, and other per person treated without State reimbursement to special dietary products insurance whose expenses providers: reimbursable and formulas. exceed $2,400. Tax credit treatment services undefined applies up to $2,400 annually per child for medical food & low protein modified food. California Insurance: PKU Insurance: formula, or Health care service plan GHPP provides inpatient, Health and Safety Genetically handicapped medically necessary, enteral contracts and disability outpatient, & home treatment §1374.56 persons program (GHPP): CF, product prescribed or ordered insurance plans must services to CCS clients under 21 17 CCR §2932 hemoglobinopathies, and for home use; special food cover treatment of PKU, with eligible conditions and 22 CCR §40675 certain metabolic disorders products prescribed or ordered including formula and GHPP clients over 21. Medi‐Cal 22 CCR §40715 California children services based on best practices & used special food products. coversl entera nutritional 22 CCR §41848, (CCS): inborn errors of in lieu of normal foods; foods supplements and replacements 41849 metabolism, CF and other modified to contain ≤1 gram of if used as a therapy to prevent 22 CCR §51313.3 lung disorders from protein per serving (not serious disability or death in metabolic & genetic defects naturally low in protein) patients with conditions that For Medi‐Cal: no conditions GHPP: treatment not defined preclude use of regular food. specified

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Colorado Insurance: inherited Insurance: medically necessary Group and individual Under the Colorado Children’s CRS §10‐16‐104 enzymatic disorders caused foods prescribed by health insurance policies Basic Health Plan, eligible 10 CCR 2505‐3 by single gene defects participating provider, with pharmacy benefits children under 19 and involved in metabolism of including metabolic formula & must cover medical foods. pregnant women may receive amino, organic and fatty its modular counterparts to Deductibles, coinsurance formula for metabolic acids, including but not treat disorders; formulated to or other cost‐sharing disorders limited to PKU, maternal PKU, be deficient in one or more methods may apply. PKU maple syrup urine disease nutrients; taken via tube or benefits are required (MSUD), TYR, HCY, orally at home; available from through 21 years of age histidinemia, urea cycle participating pharmacy; and for men and women disorders, hyperlysinemia, excluding formulas to treat CF through age 35. glutaric acidemias, MMA and and lactose‐intolerance propionic acidemia State services: formula not State svcs: metabolic disorder defined Connecticut Insurance: CF, PKU and other Insurance: low protein Individual and group Statute authorizes health CGSA §19a‐55, metabolic diseases, modified foods formulated to health insurance policies department to include cost of 59a hypothyroidism, GALT, SCD, have ≤1 gram protein per must cover prescribed treatment in setting fees and CGSA §38a‐492c MSUD, HCY, BD, CAH and serving and amino acid amino acid modified allows department to purchase CGSA §38a‐518c other inborn errors of modified food preparations preparations and low special infant formula, amino metabolism as prescribed by prescribed to treat inherited protein modified food acid modified preparations, the health department metabolic disease with doctor products on same basis as and low protein modified food State services: conditions supervision; medically outpatient prescription products directly and without a listed for insurance except CF necessary specialized formula drugs. purchase order. for children up to age eight exempt from FDA labeling and intended for dietary management of disease under physician supervision For state services: same as above except formula not defined

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Delaware Insurance: PKU and other Insurance: prescribed low Under family member Statute declares intent to DC §16‐201 inherited metabolic diseases protein modified formula or coverage, health provide treatment. Under DC §18‐3355 caused by an inherited food formulated to have ≤1 insurance contracts and regulations, specialty formula DC §18‐3571 abnormality of biochemistry, gram of protein per serving group and blanket health fund allows the health DAC §16‐4103 including any diseases for (not naturally low in protein) insurance policies must department to cover costs of which the state screens and recognized medical provide coverage for specialty formula to treat newborns formulas or food to treat prescribed medical inherited metabolic disease State services: inherited inherited metabolic disease formulas and foods, low not covered by insurance. metabolic disorders defined used under doctor supervision protein modified formulas Eligible women of child bearing same as above and consumed enterally and modified food age and children receive aid State services: medically products. based on fee schedule less the necessary, prescribed specialty cost of normal infant formula formula or milk product or soy based milk products. substitution to treat inherited metabolic disorders used under doctor supervision District of GALT, HCY, hypothyroidism, Reimbursable treatment costs No provision Legislation recognizes intent to Columbia MSUD, PKU, and sickle not defined provide appropriate treatment DCA §7‐838 hemoglobinopathy and other and requires the District to metabolic disorders partially pay for treatment on a identified by the committee sliding scale if an infant’s of metabolic disorders parents are indigent. Florida Insurance: inherited fat, Insurance: prescription and Health insurance must State supplies necessary FS §383.13 carbohydrate, amino & nonprescription enteral cover enteral formulas to dietary treatment for PKU and FS §627.42395 organic acid metabolism formulas for home use treat certain inherited other metabolic diseases as diseases or malabsorption as prescribed by a physician; for diseases and up to $2,500 medically indicated if not a result of congenital or AAD and OAD, low protein annually for low protein otherwise available and neonatal defects modified foods modified foods to treat supplemental foods to eligible State services: PKU and other State services: dietary AAD and OAD until age families under WIC. metabolic diseases treatment not defined 24ii

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Georgia Genetic conditions such as Therapy is not defined. No provision. Health department may use GC §31‐12‐6 PKU, GALT, HCY, MSUD, state or federal funds, if hypothyroidism, CAH, and available, including Maternal other inherited metabolic and and Child Health Services Block genetic disorders Grant, to provide therapy. Hawaii Insurance & public assistance: Insurance & public assistance: Accident and sickness The state provides coverage to HRS §346‐67 inborn error of metabolism medical foods taken enterally insurance, employer public assistance recipients for HRS §431:10A‐ caused by inherited abnormal under doctor supervision to group health policies, and medical foods and low‐protein 120 biochemistry characterized by manage conditions with individual and group modified food products to HRS §432:1‐609 congenital or neonatal onset recognized nutritional hospital and medical treat inborn errors of metabolic defect of amino requirements; prescribed, service plans must cover metabolism. acid, organic acid, medically necessary low medical foods and low carbohydrate or fat protein modified foods protein modified food formulated to have ≤1 gram products to treat inborn protein per serving to treat an errors of metabolism. inborn error of metabolism Idaho Local health agencies: PKU Local health agencies: No provision Local health agencies IC §39‐910 and other preventable treatment not defined responsible for treatment and IDAPA §16.03.09 diseases Medicaid: oral or tube fed cure of infants. Medicaid Basic Medicaid: conditions that nutritional products medically Plan covers nutritional prevent use of traditional necessary to meet the patient’s products for eligible persons. foods alone caloric needs Illinois Statutes: amino & organic Statutes and regulations: No provision Statutes require the health 410 ILCS 240/2 acid metabolism disorders, medically necessary, department to, as indicated, IAC §661.50 including PKU, and FAOs prescribed treatment formulas supply otherwise unavailable For regulations: same as formulas for some disorders & above and additionally lists nutrition services. Regulations hyperphenylalaninemia provide for formula to treat some conditions.

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Indiana Insurance: inherited Insurance: medical foods Accident and sickness Statute creates a NBS program IC §16‐41‐17‐10 metabolic diseases caused by prescribed to a covered insurance policies must that provides support for all IC §27‐28‐24.1 inborn errors of amino or individual to treat inherited cover medically necessary infants and individuals IC §27‐13‐7‐18 organic acids or urea cycle metabolic disease medical foods. identified as having a disorder. metabolism and treatable by State services: family support, dietary restriction of one or including equipment, supplies, more amino acids formula and other materials State services: PKU, hypothyroidism, hemoglobinopathies, including sickle cell anemia, GALT, MSUD, HCY, inborn errors of metabolism identified by the health department that result in mental retardation, CAH, BD and disorders detected by tandem mass spectrometry (MS/MS)iii Iowa University of Iowa services: University of Iowa services: No provision NBS refers diagnosed infants to IC §641‐ Inherited diseases of amino special medical formula not University of Iowa special 4.3(136A) acid and organic acids. defined medical formula program. IAC §441‐78.1 Medical assistance: metabolic Medical assistance: daily Client payments, sliding fee or digestive disorder medically necessary enteral scales, donations and nutrition therapy, if unable to screening fee (last resort only) obtain any nutritional value support purchase of formula. from usual foods in any form Medical assistance provides and must avoid certain foods; enteral nutrition therapy and oral nutrition products if oral nutrition products if they unable to obtain sufficient provide ≥51% of daily calories nutrients from usual foods to eligible persons.

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Kansas Statute: CH, GALT, PKU, Statute: treatment products No provision Statutes allow health KSA §65‐180 MSUD and other genetic and food treatment products department to provide KAR 28‐4‐514 diseases being screened not defined necessary treatment products under the NBS program Regulations: Medically as indicated if funding available Regulations: MSUD and PKU necessary food treatment and no other resource exists. product specially formulated to Regulations state program have ≤1 gram protein per reimburses families for serving (not naturally low in percentage of cost as follows: protein), used under the  100% if 300% less than direction of a physician to treat poverty level inherited metabolic disease;  50% if 301‐500% of necessary treatment product poverty level or medical protein source used  25% if 501‐700% of under the direction of a poverty level physician to treat specific  0 if over 701% of metabolic diseases to prevent, poverty level delay or reduce medical Program may purchase or complications reimburse purchasers of treatment products up to $1,500 per year for children 18 and under whose families are ≤300% poverty level.

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Kentucky PKU/hyperphenylalaninemia, Insurance: amino acid modified Health benefit plan with Health department may KRS §205.560 TYR Type I, II and II, MSUD, A‐ preparations and low protein prescription drug benefits provide assistance for KRS §213.41 ketoacid dehydrogenase modified foods formulated to must cover amino acid treatment referred to as drugs KRS §304.17A‐ deficiency, Isovaleryl‐CoA have ≤1 gram protein per modified food when recipients are out of 139 dehydrogenase deficiency, 3‐ serving prescribed by and used preparations and low hospital and costs are not 806 KAR 17:150 methylcrotonyl‐CoA under the direction of a protein modified food covered by ac publi or private 806 KAR 17:500 carboxylase deficiency, 3‐ physician to treat inherited products. Plans may cap health benefit plan. Birth 902 KAR 4:035 methylglutaconyl‐CoA metabolic disease benefits at $25,000 record fees help to support 902 KAR 4:040 hydratase deficiency, 3‐ State services: drugs, including annually for medical cost of treatment. Regulations 907 KAR 1:479 hyrdoxy ‐3‐methylglutaryl‐CoA amino acid modified formulas and $4,000 state that WIC covers amino lyase deficiency, B‐ preparations and low protein annually for low protein acid modified preparation and ketothiolase deficiency, HCY, modified food products modified foods, subject to low protein modified food glutaric aciduria type I and II, prescribed by and used under inflation adjustments. products for eligible recipients lysinuric protein intolerance, direction of a physician to treat When filing rates with the and individuals without private non‐ketotic, hyperglycinemia, certain conditions insurance department, insurance and unable to use propionic academia, gyrate insurers must include the WIC, Medicaid or K‐CHIP may atrophy, hyperornithinemia, effects of this mandated qualify for assistance. The hyperammonemia, benefit such as health department reimburses homocitrullinuria syndrome, percentage cost and providers for actual cost plus carbamoyl phosphate actual dollars attributable 20% with proper synthetase deficiency, to the rates and the documentation. ornithine carbamoyl number of policyholders transferase deficiency, affected. citrullinemia, arginosuccinic aciduria, MMA & argininemia

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Louisiana Insurance: glutaric academia, Insurance: low protein HMOs, self‐insurers, Health department NBS LRS §22:246 isovaleric academia, MSUD, modified food products employee welfare benefit program and WIC provide LRS §22:469 MMA, PKU, propionic formulated to have ≤1 gram of plans, health, hospital or special formulas to treat inborn LRS §22:1035 acidemia, TYR, urea cycle protein per serving (not medical expense errors of metabolism if LR 48:6301 et defects naturally low in protein) used insurance, accident and guidelines regarding clinical seq. State services: PKU, CH, BD, under the direction of a sickness insurance must and dietary management LR 32:319 et seq. SCD, and GALT screening but physician to treat inherited cover low protein food services and administrative treatment provision refers to metabolic disease products subject to guidelines are followed. State PKU and other rare inborn State services: special formulas deductibles, coinsurance employee benefits provide for errors of metabolism not defined and copayments, and same benefits as private obtained from approved insurance coverage source as long as coverage requirements. will not otherwise be denied. Maximum benefit is $200 per month. Maine Insurance: inborn error of Insurance: special modified Individual and group No provision MRSA 24§2320‐D metabolism, or genetically food product, or food nonprofit medical service MRSA 24‐ determined biochemical formulated to reduce protein plans, nonprofit health A§§2745‐D, disorder in which enzyme content to ≤1 gram of protein care plans, individual and 2837‐D and 4238 defect produces a metabolic per serving (not naturally low group health insurance 02‐031 CMR block that may have in protein) and HMOs must pathogenic consequences at reimburse for metabolic birth or later formula and modified low protein food products. $3,000 annual cap applies to food products.

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Maryland Insurance: inherited Insurance: prescribed, HMOs, individual hospital Children’s medical services Health‐General metabolic disease caused by medically necessary low or major medical program specialized care §19‐705.5 an inherited abnormality, protein modified food products insurance policy, group or coordination services and Health‐General including diseases for which formulated to have ≤1 gram blanket health insurance activities to facilitate a §15‐807 the state screens newborns protein per servingt (no policy, and nonprofit treatment program may COMAR naturally low in protein) to health service plan must include formula and 10.11.03.04 treat metabolic disease under cover medical foods and medication to correct COMAR physician direction; medical low protein modified food metabolic errors. Medical 10.54.03.03 foods taken enterally under products. foods are authorized WIC COMAR physician direction to treat foods. 31.11.06.03 disease or condition for which COMAR medical evaluation shows 31.11.12.03 nutritional requirement Medical services program: metabolic errors not defined WIC: medical foods authorized for children and women with special dietary needs Massachusetts Insurance: PKU, TYR, HCY, Insurance: medically necessary, Blanket or general Civil service retirement MGL 32A§17A MSUD, propionic acidemia or prescribed medical formulas accident and sickness contributory group or blanket MGL 175§47C MMA, maternal PKU approved by health insurance, and non‐profit insurance covers enteral MGL 176A§8B,8L Private and civil service department; medically hospital, hospital and formulas and low protein MGL 176B§4C,4K insurance: inherited diseases necessary nonprescription medical service modified food products up to MGL 176G§4D of amino and organic acids enteral formulas for home use corporations must cover $2,500 annually. State has 105 CMR 270.001 State payment rates: ordered by a physician and medical formulas for established rates of payment 114.3 CMR 22 inherited disease of low protein modified foods infants, children and to be used by governmental metabolism, including Civil service insurance: enteral pregnant women with units in making payment to protein, fat, carbohydrate, formulas as defined above PKU and enteral formulas eligible providers for enteral vitamins, minerals and State payment rates: enteral and low protein modified formula. possibly fiber formula, nutritionally complete food products up to for special metabolic needs $2,500 annually.

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Michigan Specified metabolic disorders Special formula and treatment No provision Michigan medical services 2008 SB 1094 not listed in legislation not defined program determines (budget bill reimbursement policies for presented to treatment of children with Governor July 10) special health care needs (CSHCN). Appropriations allow provision of special formula for eligible clients with specified metabolic disorders as well as treatment for eligible patients with CF who are 21 or older. Minnesota Insurance: PKU Insurance: special dietary Accident and health State medical assistance for MSA §62A.26 State medical assistance: treatment not defined insurers, HMOs, fraternal needy persons covers MSA §256B.0625 PKU, hyperlysinemia, MSUD, State medical assistance: benefits societies and parenteral and enteral MAR 4615.0760 or any other childhood or medically necessary, nonprofit health service nutrition products for eligible MAR 9505.0325 adulthood disease, conditions prescribed parenteral and plan corporations must persons. Parenteral nutrition or disorders identified by the enteral nutritional products cover special dietary subject to limits similar to health commissioner needed because nutrients treatment for PKU per pharmacy services. State State health department: cannot be properly absorbed, doctor recommendation. health department regulations hemoglobinopathy, PKU, formulated to provide require arrangements for GALT, hypothyroidism and nourishment and affect medically indicated treatment, CAH nutritive and metabolic including referral to private processes of the body insurance, medical assistance, (disorders only specifically MinnesotaCare, and Services listed for enteral products) for Children with Disabilities. Mississippi No provision No provision No provision No provision

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Missouri Insurance: PKU and any other Insurance: low protein Expense‐incurred or Subject to appropriations, the MRS §191.331 et inherited disease of amino or modified foods specifically indemnity type health health department provides seq. organic acid formulated to contain ≤1 gram insurers, HMOs, group formula for children under five MRS §376.1219 State services: inherited protein per serving used under health self‐insurers and if all other sources have been diseases of amino and organic direction of physician to treat health care plans exhausted, to children acids inherited metabolic disease managed by health care between six and 18 if family State services: formula not delivery entities must income is ≤300% of poverty defined cover formula and low level, or to children between protein modified foods for six and 18 whose family is children under six up to ≥300% of poverty level on a $5,000 per year. sliding fee scale, and applicants Deductible, coinsurance above 18 based on income‐ or copayments may not based means test. exceed %50 of cost of food and formula. Montana Insurance: inborn errors of Insurance: medical foods to be Group and individual The handicapped children’s MCA §32‐22‐131 metabolism that involve taken enterally under physician medical expense disability services program provides ARM 37.57.110 amino acid, carbohydrate, supervision, distinct in one or insurance must cover medical foods benefits to and fat metabolism for which more nutrients present in treatment of inborn errors eligible children under 19 up to medical standards of natural food, used for medical of metabolism, including a maximum of $12,000 per diagnosis, monitoring and and nutritional management of clinical services, medical year. treatment exist patients with limited capacity supplies, prescription State services: metabolic to metabolize food or nutrients drugs, nutritional disorders not defined or who have specific nutrient management and medical needs essential for growth, foods. Durational limits, health and metabolic caps, deductibles, homeostasis. coinsurance and State services: medical foods to copayments may apply if treat a metabolic disorder, terms same as other including prescriptive illnesses. supplements

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Nebraska PKU, primary hypothyroidism, State services: No provision Health department provides NRS §71‐520 BD, GALT, pharmaceutically food supplement and hemoglobinopathies, MCAD, manufactured food treatment services to and other disease specified by supplements; treatment individuals with inherited the health department services not defined metabolic disease. No fee exists for formula, but scale of fees for food supplements, which are capped at $2,000 annually, may apply. Nevada Insurance: inherited Insurance: medically necessary Health insurance policies, State provides medical NRS §689A.0423 metabolic diseases enteral formulas for home use contracts for hospital and services, including dietary NRS §689B.0353 characterized by deficient or special food products medical service, and supplements to eligible NRS §695B.1923 metabolism or malabsorption formulated to have ≤1 gram of HMOs must cover enteral children under 19 with inborn NRS §695C.1723 caused by an inherited protein per serving (not formulas and special food errors of metabolism. NAC 442.685 abnormality of body naturally low in protein) products. Annual cap of NAC 442.782 et chemistry as a result of a prescribed or ordered by a $2,500 applies to food seq. congenital or neonatal defect physician to treat inherited only. of amino or organic acid, fat, metabolic diseases or carbohydrate State: services inborn errors of metabolism, including but not limited to aminoaciduria, BD, CF, GALT, glycogen storage disease, HCY, MSUD, PKU, TYR and those detected by the NBS program

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE New Hampshire Insurance: inherited diseases Insurance: medically necessary, Individual, group or No provision NHRS §415:6‐c of amino or organic acids nonprescription enteral blanket accident or health NHRS §415:18‐e formula or food products to insurance, health service NHRS §420‐A:17 treat inherited diseases corporations, and HMOs NHRS §420‐B:8‐ff ordered by a physician and the must provide coverage for least restrictive and most cost enteral formulas and food effective means for meeting products. Annual cap of patient needs $1,800 for food products. Normal deductibles and coinsurance may apply. New Jersey Insurance and state benefits: Insurance and state benefits: Individual or group State Health Benefits Program NJSA §§17:48A‐ inherited metabolic disease of low protein modified food medical or health service covers therapeutic treatment 7q, 17:48E‐35.16, abnormal body chemistry for product formulated to have ≤1 corporation, health of inherited metabolic 17B:26‐2.1o, which the state screens gram of protein per serving insurer, small employer diseases. 17B:27‐46.1r, newborns used under physician direction health benefits, and HMO §17B:27A‐7.4 & to treat inherited metabolic plans must cover 19.6, §26:2J‐4.17, disease; medical food to treat therapeutic treatment of §52:14‐17.29c disease of condition with metabolic disease on established nutritional needs same basis as other to be taken enterally under conditions. physician direction

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE New Mexico Insurance: genetic inborn Insurance: medical foods to be Individual and group Children’s medical services NMSA §59A‐22‐ errors of metabolism of taken enterally under physician health insurance policies, program provides treatment to 41.1 amino acid, fat and supervision and distinct in one health care plans, individuals under 21 at NMAC 7.30.3.1 et carbohydrate for which or more nutrients present in certificate of health increased risk of physical or seq. treatment standards exist natural food, used for the insurance, and managed developmental conditions, State services: CH, GALT, medical and nutritional care plans must cover adults with CF, and adults at hyperphenylalanemia, PKU, management of patients with treatment of genetic risk of having a child with BD, disorders of amino acid limited capacity to metabolize inborn errors of special needs. and carbohydrate transport ordinary food or certain metabolism, including and metabolism, lipidoses, nutrients in it or who have clinical services, medical , CAH, hypothyroidism, specific nutrient needs prescription drugs, hemoglobinopathies and essential for growth, health nutritional management other disorders and metabolic homeostasis. and medical foods. State services: treatment Durational limits, caps, services not defined deductibles, coinsurance and copayments may apply if terms same as other illnesses. New York PKU, branch‐chained Prescribed nutritional HMO in‐plan and out‐of‐ No provision Insurance Law ketonuria, GALT and HCY supplements (formulas) plan contracts must cover §4322 obtained from a participating nutritional supplements pharmacy to treat certain disorders. Normal deductibles and copayments may apply. North Carolina PKU, GALT, CH, CAH, SCD, and Medically necessary dietary No provision The NBS program provides NCGS §130A‐125 other hereditary and treatment products or treatment products or 10A NCAC 43H congenital disorders medications medications for identified .0314 children as indicated and when not otherwise available.

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE North Dakota Insurance and state services: Insurance and state services: Insurance companies, The human services and health NDCC §25‐17‐ PKU, MSUD medically necessary low nonprofit health services departments provide medical 00.1 et seq. protein modified food product corporations and HMOs food at no cost to males under NDCC §26.1‐36‐ formulated to have ≤I gram of must cover medical foods 22 and females under 45 and 09.7 protein per servingt (no and low protein modified offer sale at cost to those older NDCC §54‐52.1‐ naturally low in protein) and food products as part of with PKU orUD MS regardless 01 et seq. used under physician direction prescription drug of income. Low protein NDAC 75‐03‐35‐ to treat metabolic disease; coverage. Annual cap of modified foods are available to 01 et seq. medical food to treat disease $3,000 for low protein females under 45 and males or condition with established modified food products under 22. Human services nutritional needs to be taken and medical foods applies. department may seek enterally under physician reimbursement from other direction government programs. The public employees retirement board provides same coverage as required of private insurers. Ohio Genetic disease Treatment, habilitation and No provision The director of health ORCA §3701.502 rehabilitation not defined encourages and assists in the treatment of genetic diseases and provides for habilitation and rehabilitation. Oklahoma No provision No provision No provision No provision

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Oregon Inborn errors of metabolism For metabolic disorder, foods For metabolic disorder, No provision ORS §743A.070, that involve amino acid, formulated for enteral individual and group 743A.188 carbohydrate and fat consumption under physician health insurance policies metabolism for which supervision that are deficient must cover medical foods. medically standard methods in one or more nutrients for For malabsorption, health of diagnosis, treatment, and medical and nutritional insurance policies must monitoring exist, including management of patients with cover enteral formula. quantification of metabolites limited capacity to metabolize in blood, urine, or spinal fluid nutrients or have specific or enzyme or DNA nutrient requirements confirmation in tissues and necessary for growth, health severe intestinal and metabolic homeostasis. malabsorption For malabsorption, medically necessary nonprescription enteral formula for home use ordered by a physician that comprises the sole source or an essential source of nutrition Pennsylvania Insurance: PKU, branch‐ Insurance: medically necessary Health insurance policies The WIC Program provides 40 PS §3904 et chained ketonuria, GALT and nutritional supplements must cover nutritional allowable foods to eligible seq. HCY (formula) to treat certain supplements. Normal pregnant, breast‐feeding and 028 Pa. Code State services: nutritional risk, disorders administered under copayment and postpartum women and §1101.1 et seq. including conditions that physician direction coinsurance may apply. children until age 5 who are at predispose a person to WIC: allowable foods on the Benefits are exempt from nutritional risk because of nutritionally related medical WIC food list deductibles. medical problems. conditions

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Texas Insurance: heritable disease Insurance: physician ordered Group health benefit CHCSN program serves eligible Insurance Code that may result in mental or medically necessary formulas plans issued by an insurer, individuals of any age. CSHCN §1359.001 et seq. physical retardation or death; CSHCN: prescribed nutritional HMOs, or group hospital provides nutritional services Health and Safety PKU services and products service corporations must and products for identified Code §33.031 et CSHCN statute: PKU, other excluding hyperalimentation cover formulas to treat metabolic disorders or other seq. heritable diseases, and total parenteral nutrition PKU and other heritable conditions. Medical food TAC Health hypothyroidism, or another as medically necessary diseases. Coverage must coverage is available to treat Services §38 disorder for which the state therapeutic agent for life and mirror prescription drug inborn metabolic disorders screens newborns health or when all or part of benefits. only. CSHCN regulations: metabolic nutritional intake is via tube; disorder, other medical approved medical foods to condition and inborn treat inborn metabolic metabolic disorders not listed disorders Utah Insurance: inborn errors of Insurance: dietary products, Accident and health No provision Utah Code §31A‐ amino acid or urea cycle including formulas and low insurers must cover 22‐623 metabolism caused by an protein modified foods, to dietary products as a UAC R590‐194 inherited abnormality of body treat inborn errors of major medical benefit. chemistry treatable by dietary metabolism used under restriction physician direction Vermont Insurance: inherited Insurance: low protein An insurer must cover The health department may 18 VSA §4089e metabolic disease caused by modified food products medically necessary accept children suffering from 18 VSA §115, an abnormality of body formulated to have ≤1 gram of medical foods. Coverage chronic diseases for treatment. 115a chemistry for which the state protein per serving and of low protein modified screens newborns medical food (amino acid food products also State services: chronic modified preparation) used required to at least $2,500 diseases such as CF under physician direction to annually. treat metabolic disease State services: treatment not defined

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Virginia Core panel of heritable Under physician direction, No provision Subject to available funding, 12 VAC 5‐71‐10 disorders and genetic disease metabolic formula (prescribed the health department assists et seq. consistent with nutritional substances eligible persons in obtaining recommendations of the formulated for internal dietary treatment. Financially American College of Medical consumption or administration eligible children under 21 and Genetics distinct in one or more adults at or below 300% nutrients from regular food poverty level receive used to treat limited capacity treatment at no cost. Children to metabolize ordinary food); and adults who do not meet medically necessary low financial eligibility may be able protein modified foods to purchase dietary products formulated to have ≤1 gram of from the department. protein per serving (not naturally low in protein); metabolic supplements (dietary/nutritional substances for nutritional management) Washington Insurance: PKU Insurance: formulas necessary Disability insurance The health department is RCW §48.20.520 State specialty clinics: to treat PKU contracts, contracts or authorized to include costs for RCW §48.21.300 hemoglobin diseases, PKU, State specialty clinics: agreements for health specialty clinics that provide RCW §48.44.440 CAH, CH, and other disorders treatment not defined care services must cover treatment services in the NBS RCW §48.46.510 for which the state screens treatment for PKU. fee. Individuals in state medical WAC 246‐650‐ newborns assistance plans are eligible to 991 receive oral or tube‐delivered WAC 388‐554‐ enteral nutrition products if 300 criteria met. West Virginia No provision No provision No provision No provision Wisconsin Metabolic disorders as Specially formulated nutritional State medical assistance HFS 107.09 described in the medical supplements and replacement program provides nutritional assistance provider products, including enteral and supplements and replacement handbooks and bulletins parenteral products products if eligible.

STATE STATUTES AND REGULATIONS ON DIETARY TREATMENT OF DISORDERS IDENTIFIED THROUGH NEWBORN SCREENING JURISDICTION DISORDERS NAMED TREATMENT DEFINITIONS PRIVATE INSURANCE STATE SERVICES AND AND CITATION REQUIREMENTS ASSISTANCE Wyoming Inborn errors of metabolism Medical foods necessary to No provision Children’s health insurance KidCare CHIP involving amino acid, treat inborn errors of program covers medical foods Rules §8 carbohydrate, and fat metabolism for eligible persons. metabolism with an accepted diagnosis and treatment

Abbreviations for disorders: Amino acid disorders AAD Fatty acid oxidation disorders FAOD Organic acid disorders OAD Biotinidase deficiency BD Galactosemia GALT Phenylketonuria PKU Congenital adrenal hyperplasia CAH Homocystiniuria HCY Sickle cell disease SCD Congenital hypothyroidism CH Medium‐chain acyl co‐a dehydrogenase MCAD Tyrosinemia TYR Cystic fibrosis CF Methylmalonic acidemia MMA i Modified low protein foods and formula are further defined. ii Additional appropriate premiums and pre‐existing condition exclusions may apply. iii Disorders detected by other technologies with equal or greater capabilities than MS/MS are included if approved by the health department. iv New statute requiring rule‐making enacted July 2008.

Developed by Johnson Policy Consulting, VA, July 2008, for the American College of Medical Genetics, and supported by a grant from HHS Health Resources and Services Administration (HRSA) U22MC03957‐05.