Statute: SB 299

• > Weblink: http://www.wvlegislature.gov/Bill_Status/bills_text.cfm?billdoc=SB299%20ORG.htm&yr=2018&sesstype=RS&i=299
• > Requires insurance coverage up to the age of 20, for certain medical foods for amino acid-based formulas for certain diagnosed conditions including eosinophilic disorders.

Language of representative statute, WV Code § 33-25A-8p, which provides:
(a) A policy, plan, or contract that is issued or renewed on or after January 1, 2019, and that is subject to this section, shall provide coverage, through the age of 20, for amino acid-based formula for the treatment of severe protein-allergic conditions or impaired absorption of nutrients caused by disorders affecting the absorptive surface, function, length, and motility of the gastrointestinal tract. This includes the following conditions, if diagnosed as related to the disorder by a physician licensed to practice in this state pursuant to either §30-3-1 et seq. or §30-14-1 et seq. of this code:

(1) Immunoglobulin E and Nonimmunoglobulin E-medicated allergies to multiple food proteins;
(2) Severe food protein-induced enterocolitis syndrome;
(3) Eosinophilic disorders as evidenced by the results of a biopsy; and
(4) Impaired absorption of nutrients caused by disorders affecting the absorptive surface, function, length and motility of the gastrointestinal tract (short bowel).

(b) The coverage required by paragraph (A) of this subdivision shall include medical foods for home use for which a physician has issued a prescription and has declared them to be medically necessary, regardless of methodology of delivery.

(c) For purposes of this subdivision, “medically necessary foods” or “medical foods” shall mean prescription amino acid-based elemental formulas obtained through a pharmacy: Provided, That these foods are specifically designated and manufactured for the treatment of severe allergic conditions or short bowel.

(d) The provisions of this subdivision shall not apply to persons diagnosed with cystic fibrosis or persons with an intolerance for lactose or soy.

Statute: SHB 2153

• > Weblink: https://apps.leg.wa.gov/billinfo/summary.aspx?bill=2153&year=2013#history
• > Any health plan issued or renewed after December 31, 2015, must cover medically necessary elemental formula for eosinophilic gastrointestinal associated disorders, with any cost sharing applied to the out-of-pocket maximum set forth in the plan.

Language of SHB 2153:
Section 1

(1) Each health benefit plan offered to public employees and their covered dependents under this chapter that is not subject to chapter 48.43 RCW and that is issued or renewed after December 31, 2015, must offer benefits or coverage for medically necessary elemental formula, regardless of delivery method, when a licensed physician or other health care provider with prescriptive authority:

(a) Diagnoses a patient with an eosinophilic gastrointestinal associated disorder; and
(b) Orders and supervises the use of the elemental formula.

(2) Nothing in this section prohibits a health benefit plan from requiring prior authorization or imposing other appropriate utilization controls in approving coverage for medically necessary elemental formula.

Section 2

(1) Each health benefit plan issued or renewed after December 31, 2015, must offer benefits or coverage for medically necessary elemental formula, regardless of delivery method, when a licensed physician or other health care provider with prescriptive authority:

(a) Diagnoses a patient with an eosinophilic gastrointestinal associated disorder; and
(b) Orders and supervises the use of the elemental formula.

(2) Nothing in this section prohibits a health benefit plan from requiring prior authorization or imposing other appropriate utilization controls in approving coverage for medically necessary elemental formula.

Statute: Tx. Ins. Code § 1377.051

• > Weblink: https://www.statutes.legis.state.tx.us/Docs/IN/htm/IN.1377.htm
• > Requires insurance coverage for amino acid-based elemental formulas for treatment of eosinophilic disorders.

Language of Statute:
Coverage for Certain Amino Acid Based Elemental Formulas.

a) A health benefit plan must provide coverage as provided by this chapter for amino acid‑based elemental formulas, regardless of the formula delivery method, that are used for the diagnosis and treatment of:

(1) immunoglobulin E and non‑immunoglobulin E mediated allergies to multiple food proteins;
(2) severe food protein‑induced enterocolitis syndrome;
(3) eosinophilic disorders, as evidenced by the results of a biopsy; and
(4) impaired absorption of nutrients caused by disorders affecting the absorptive surface, functional length, and motility of the gastrointestinal tract.

(b) Subject to Subsection (c), the coverage required under Subsection (a) is required if the treating physician has issued a written order stating that the amino acid‑based elemental formula is medically necessary for the treatment of an enrollee who is diagnosed with a disease or disorder listed in Subsection (a). The coverage must include coverage of any medically necessary services associated with the administration of the formula.

(c) A health benefit plan must provide the coverage described by Subsection (a) on a basis no less favorable than the basis on which prescription drugs and other medications and related services are covered by the plan, and to the same extent that the plan provides coverage for drugs that are available only on the orders of a physician.

No applicable statute. However, several insurance plans have agreed to reimburse families for amino acid based formula.

• > Avera Health Plans HealthPartners: https://www.healthpartners.com/public/coverage-criteria/policy.html?contentid=AENTRY_045923
• > Medica: https://www.medica.com/-/media/documents/provider/coverage-policies/amino-acid-formulas-cp.pdf?la=en 
• > South Dakota State Employee Health PlanWellmark BlueCross BlueShield:  https://www.wellmark.com/Provider/MedPoliciesAndAuthorizations/MedicalPolicies/policies/
  Amino_Acid_Based_Elemental_Formula.aspx

The terms of plans vary. Check with your insurance company with specific coverage questions.

Rhode Island Gen. Laws 1956, § 27‑18‑70

• > Weblink: http://webserver.rilin.state.ri.us/Statutes/TITLE27/27-18/27-18-70.HTM
• > Requires insurance coverage for medically necessary enteral formula for the treatment of malabsorption caused by Crohn’s disease, ulcerative colitis, gastroesophageal reflux, chronic intestinal pseudo‑obstruction, and inherited diseases of amino acids and organic acids.

Language of Statute, Rhode Island Gen.Laws 1956, § 27‑18‑70(a):
Every individual or group health insurance contract, or every individual or group hospital or medical expense insurance policy, plan, or group policy delivered, issued for delivery, or renewed in this state on or after January 1, 2009, shall provide coverage for nonprescription enteral formulas for home use for which a physician has issued a written order and which are medically necessary for the treatment of malabsorption caused by Crohn’s disease, ulcerative colitis, gastroesophageal reflux, chronic intestinal pseudo‑obstruction, and inherited diseases of amino acids and organic acids.

Coverage for inherited diseases of amino acids and organic acids shall include food products modified to be low protein. Provided, however, that coverage shall not exceed an amount of two thousand five hundred dollars ($2,500) per covered member per year.

(b) Benefit plans offered by an insurer may impose a copayment and/or deductibles for the benefits mandated by this section, however, in no instance shall the copayment or deductible amount be greater than the copayment or deductible amount imposed for prescription enteral formulas or nutritional aids. Benefits for services under this chapter shall be reimbursed in accordance with the respective principles and mechanisms of reimbursement for each insurer, hospital, or medical service corporation, or health maintenance organization. Reimbursement shall be provided according to the respective principles and policies of the accident and sickness insurer. Nothing contained in this section precludes the accident and sickness insurer from conducting managed care, medical necessity, or utilization review.

(c) This section shall not apply to insurance coverage providing benefits for:

(1) hospital confinement indemnity;
(2) disability income;
(3) accident only;
(4) long‑term care;
(5) Medicare supplement;
(6) limited benefit health;
(7) specified disease indemnity;
(8) sickness or bodily injury or death by accident or both; and
(9) other limited benefit policies.

Legislation: House Bill 1436

• > Weblink: https://www.legis.state.pa.us/cfdocs/legis/PN/Public/btCheck.cfm?txtType=HTM&sessYr=2013&sessInd=0&billBody=H&billTyp=B&billNbr=1436&pn=4244
• > Requires insurance coverage for medically necessary elemental formula administered orally or enterally for food protein allergies, food protein-induced enterocolitis syndrome, eosinophilic disorders and short-bowel syndrome.

Pertinent Language of HB 1436:
Amino acid-based elemental medical formula.

Except as provided in section 7, any health insurance policy which is delivered, issued for delivery, renewed, extended or modified in this Commonwealth by any health care insurer shall provide that the health insurance benefits applicable under the policy include coverage for infants and children for the USUAL AND CUSTOMARY cost of amino acid-based elemental medical formula ORDERED by a physician AS MEDICALLY NECESSARY and administered orally or enterally for food protein allergies, food protein-induced enterocolitis syndrome, eosinophilic disorders and short-bowel syndrome. AN AMINO ACID-BASED ELEMENTAL FORMULA COVERED UNDER THIS SECTION IS A FORMULA MADE OF 100% FREE AMINO ACIDS AS THE PROTEIN SOURCE.

Statutes: Or. Rev. Stat. § 743A.070

• > Weblink: https://law.justia.com/codes/oregon/2011/vol16/743a/743a-070
• > Requires insurance coverage for enteral formula medically necessary for the treatment of severe intestinal malabsorption.

Language of Statute:– Or. Rev. Stat. § 743A.070:
Nonprescription enteral formula for home use.

(1) All policies providing health insurance, as defined in ORS 731.162, except those policies whose coverage is limited to expenses from accidents or specific diseases that are unrelated to the coverage required by this section, shall include coverage for a nonprescription elemental enteral formula for home use, 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.

(2) The coverage required by subsection (1) of this section may be made subject to provisions of the policy that apply to other benefits under the policy including, but not limited to, provisions related to deductibles and coinsurance. Deductibles and coinsurance for elemental enteral formulas shall be no greater than those for any other treatment for the condition under the policy.

(3) This section is exempt from ORS 743A.001.

Statute: Md. Code, Insurance § 15-843

• > Weblink– https://law.justia.com/codes/maryland/2013/article-gin/section-15-843/
• > Requires insurance coverage for eosinophilic disorders

Language of Statute: § 15‑843. Coverage for amino‑acid based formulas:
(a) This section applies to:

(1) insurers and nonprofit health service plans that provide hospital, medical, or surgical benefits to individuals or groups on an expense‑incurred basis under health insurance policies that are issued or delivered in the State; and

(2) health maintenance organizations that provide hospital, medical, and surgical benefits to individuals or groups under contracts that are issued or delivered in the State.

(b)(1) Subject to paragraph (2) of this subsection, a policy or plan subject to this section shall include, under the family member coverage, coverage for amino acid‑based elemental formula, regardless of delivery method, for the diagnosis and treatment of:

(I) Immunoglobulin E and non‑Immunoglobulin E mediated allergies to multiple food proteins;
(ii) severe food protein induced enterocolitis syndrome;
(iii) eosinophilic disorders, as evidenced by the results of a biopsy; and
(iv) impaired absorption of nutrients caused by disorders affecting the absorptive surface, functional length, and motility of the gastrointestinal tract.

(2) Subject to paragraph (3) of this subsection, the coverage required under paragraph (1) of this subsection is required if the ordering physician has issued a written order stating that the amino acid‑based elemental formula is medically necessary for the treatment of a disease or disorder listed in paragraph (1) of this subsection.

(3) In accordance with Subtitle 10A of this title, a private review agent, acting on behalf of an insurer, nonprofit health service plan, or health maintenance organization, may review the ordering physician’s determination of the medical necessity of the amino acid‑based elemental formula for the treatment of a disease or disorder listed in paragraph (1) of this subsection.

Bill: 16 RS SB 193/GA

• > Weblink: https://apps.legislature.ky.gov/LRCSiteSessionSearch/dtSearch/
• > Mandates that health benefit plans with prescription drug coverage provide coverage for amino acid-based elemental formulas for insureds with a medical diagnosis of an eosinophilic disorder. Further, mandates that insurance policies for state employees and their dependents provide coverage for amino acid-based formulas for insureds with eosinophilic disorders. In addition, the bill requires that the state provide payment for amino acid-based formulas where the affected person has a medical diagnosis of an eosinophilic disorder and does not have coverage under any public or private health benefit plan for amino acid-based formulas.

Pertinent Language of Bill 16 RS SB 193/GA:
Section 1. KRS 205.560 is amended to read as follows:
The scope of medical care for which the Cabinet for Health and Family Services undertakes to pay shall be designated and limited by regulations promulgated by the cabinet, pursuant to the provisions in this section. . . . . The selection of another class or other classes of medical care shall be recommended by the council to the secretary for health and family services after taking into consideration, among other things, the amount of federal and state funds available, the most essential needs of recipients, and the meeting of such need on a basis insuring the greatest amount of medical care as defined in KRS 205.510 consonant with the funds available, including but not limited to the following categories, except where the aid is for the purpose of obtaining an abortion:

(c) Drugs, nursing care, medical supplies, and services during the time when a recipient is not in a hospital but is under treatment and on the prescription of a physician, dentist, or podiatrist. For purposes of this paragraph, drugs shall include products for the treatment of inborn errors of metabolism or genetic, gastrointestinal, and food allergic conditions, consisting of therapeutic food, formulas, supplements, amino acid-based elemental formula, or low-protein modified food products that are medically indicated for therapeutic treatment and are administered under the direction of a physician, and include but are not limited to the following conditions:

24. Food protein allergies;
25. Food protein-induced enterocolitis syndrome;
26. Eosinophilic disorders; and
27. Short-bowel syndrome;

Section 2. KRS 213.141 is amended to read as follows:
The cabinet shall prescribe by administrative regulation pursuant to KRS Chapter 13A a fee not to exceed ten dollars ($10) to be paid for a certified copy of a record of a birth:

(b) One dollar ($1) of which shall be used by the Division of Maternal and Child Health to pay for therapeutic food, formulas, supplements, amino acid-based elemental formula, or low-protein modified foods for all inborn errors of metabolism and genetic conditions if:

1. The therapeutic food, formulas, supplements, amino acid-based elemental formula, or low-protein modified food products are medically indicated for the therapeutic treatment of inborn errors of metabolism or genetic conditions and are administered under the direction of a physician; and

2. The affected person’s therapeutic food, formulas, supplements, amino acid-based elemental formula, or low-protein foods are not covered under any public or private health benefit plan.

Section 3. KRS 304.17A-258 is amended to read as follows:
(1) For purposes of this section:

(a) “Therapeutic food, formulas, and supplements” means products intended for the dietary treatment of inborn errors of metabolism or genetic conditions, including eosinophilic disorders, food protein allergies, food protein-induced enterocolitis syndrome, and short bowel disorders, under the direction of a physician and includes amino acid-based elemental formula; [and]

(b) “Low-protein modified food” means a product formulated to have less than one (1) gram of protein per serving and intended for the dietary treatment of inborn errors of metabolism or genetic conditions under the direction of a physician; and

(c) “Amino acid-based elemental formula” means a product intended for the diagnosis and dietary treatment of eosinophilic disorders, food protein allergies, food protein-induced enterocolitis, and short-bowel syndrome under the direction of a physician.

(2) A health benefit plan that provides prescription drug coverage shall include in that coverage therapeutic food, formulas, supplements, and low-protein modified food products for the treatment of inborn errors of metabolism or genetic conditions if the therapeutic food, formulas, supplements, and low-protein modified food products are obtained for the therapeutic treatment of inborn errors of metabolism or genetic conditions under the direction of a physician. Coverage under this subsection may be subject, for each plan year, to a cap of twenty-five thousand dollars ($25,000) for therapeutic food, formulas, and supplements and a separate cap for each plan year of four thousand dollars ($4,000) on low-protein modified foods. Each cap shall be subject to annual inflation adjustments based on the consumer price index.

Section 4. KRS 18A.225 is amended as follows:
(16) Any policy provided to state employees or their dependents pursuant to this section shall provide coverage for obtaining amino acid-based elemental formula pursuant to Section 3 of this Act.

Statute: 215 ILCS 5/356z.10

• > Weblink: https://www.ilga.gov/legislation/ilcs/fulltext.asp?DocName=021500050K356z.10
• > Requires insurance coverage for amino acid based elemental formulas for treatment of eosinophilic disorders.

Language of Statute–215 ILCS 5/356z.10. Amino acid‑based elemental formulas:
A group or individual major medical accident and health insurance policy or managed care plan amended, delivered, issued, or renewed after the effective date of this amendatory Act of the 95th General Assembly must provide coverage and reimbursement for amino acid‑based elemental formulas, regardless of delivery method, for the diagnosis and treatment of (I) eosinophilic disorders and (ii) short bowel syndrome when the prescribing physician has issued a written order stating that the amino acid‑based elemental formula is medically necessary.

Statutes: ARS §§ 20-826.03, 20-1057-10, 20-1342.05, 20-1402.02, 20-2332

• > Weblink: https://www.azleg.gov/legtext/47leg/2r/bills/hb2364h.pdf
• > Requires insurance coverage for amino-acid based formula where insured has been diagnosed with eosinophilic gastrointestinal disorder.

Language of representative statute, Section 20-2332, which provides:
A. Any health benefit plan that is offered by an accountable health plan and that contains a prescription drug benefit shall cover amino acid‑based formula that is ordered by a physician or by a registered nurse practitioner if:

1. The insured has been diagnosed with an eosinophilic gastrointestinal disorder.

2. The insured is under the continuous supervision of a physician who is licensed pursuant to title 32, chapter 13 or 17 or a registered nurse practitioner who is licensed pursuant to title 32, chapter 15.

3. There is risk of a mental or physical impairment without the use of the formula.

B. An accountable health plan shall cover at least seventy‑five per cent of the cost of the formula. The accountable health plan may limit the maximum annual benefit for formula under this section to twenty thousand dollars.

Statute: New York Insurance Law §§ 3216, 3221, 4303, 4322

• > Weblink: https://assembly.state.ny.us/leg/?default_fld=&bn=A00490&term=2013&Summary=Y&Actions=Y&Text=Y
• > Requires coverage for enteral formulas whether administered orally or via feeding tube that are medically necessary.
• > This bill, known as “Hannah’s Law” was signed into law in 2013.

Language of Statute:
Every policy which provides coverage for prescription drugs shall include coverage for the cost of enteral formulas for home use, WHETHER ADMINISTERED ORALLY OR VIA TUBE FEEDING, for which a physician or other licensed health care provider legally authorized to prescribe under title eight of the education law has issued a written order. Such written order shall state that the enteral formula is clearly medically necessary and has been proven effective as a disease‑specific treatment regimen for those individuals who are or will become malnourished or suffer from disorders, which if left untreated, cause chronic physical disability, mental retardation or death.

Specific diseases for which enteral formulas have been proven effective shall include, but are not limited to, inherited diseases of amino acid or organic acid metabolism; Crohn’s Disease; gastroesophageal reflux with failure to thrive; disorders of gastrointestinal motility such as chronic intestinal pseudo‑obstruction; and multiple, severe food allergies which if left untreated will cause malnourishment, chronic physical disability, mental retardation or death. Enteral formulas which are medically necessary and taken under written order from a physician for the treatment of specific diseases shall be distinguished from nutritional supplements taken electively.

Coverage for certain inherited diseases of amino acid and organic acid metabolism shall include modified solid food products that are low protein or which contain modified protein which are medically necessary, and such coverage for such modified solid food products for any calendar year or for any continuous period of twelve months for any insured individual shall not exceed two thousand five hundred dollars.

Statutes: N.J. Stat. Ann. §§ 17:48‑6z, 17:48A‑7y, 17:48E‑35.24. 17B:26‑2.1v, 17B:27‑46.1z

• > Weblink for N.J. Stat. Ann. § 17:48-6z: https://lis.njleg.state.nj.us/nxt/gateway.dll?f=templates&fn=default.htm&vid=Publish:10.1048/Enu
• > Requires hospital service corporation, medical service corporation, group and individual health insurers to cover medically necessary non-standard infant formulas for infants diagnosed as having multiple food protein intolerance and the covered infant has not been responsive to trials of standard non‑cow milk‑based formulas, including soybean and goat milk.

Language of Representative Statute:
An individual health insurer which provides hospital or medical expense benefits for expenses incurred in the purchase of prescription drugs under a policy that is delivered, issued, executed or renewed in this State, or approved for issuance or renewal in this State by the Commissioner of Banking and Insurance on or after the effective date of this act, shall provide benefits under the policy for expenses incurred in the purchase of specialized non-standard infant formulas, when the covered infant’s physician has diagnosed the infant as having multiple food protein intolerance and has determined such formula to be medically necessary, and when the covered infant has not been responsive to trials of standard non-cow milk-based formulas, including soybean and goat milk. The coverage may be subject to utilization review, including periodic review, of the continued medical necessity of the specialized infant formula.

The benefits shall be provided to the same extent as for any other prescribed items under the policy.

This section shall apply to those policies in which the insurer has reserved the right to change the premium.

Statutes: N.H. Rev. Stat. Ann. § 415:6‑c, 415:18‑e, 420‑A:17, 420‑B:8‑ff

• > Weblink: https://www.lawserver.com/law/state/new-hampshire/nh-statutes/new_hampshire_revised_statutes_415_6-c
• > Requires coverage for formula for treatment of impaired absorption of nutrients caused by disorders affecting the absorptive surface, functional length, or motility of the gastrointestinal tract.

Language of Representative Statute: N.H. Rev. Stat. Ann. § 415:6‑c Coverage for Nonprescription Enteral Formulas:
I. Each insurer that issues or renews any individual policy of accident or health insurance providing benefits for medical or hospital expenses, shall provide to certificate holders of such insurance who are residents of this state, coverage for the provision of nonprescription enteral formulas for the treatment of impaired absorption of nutrients caused by disorders affecting the absorptive surface, functional length, or motility of the gastrointestinal tract. Such coverage shall be provided when the prescribing physician has issued a written order stating that the enteral formula is needed to sustain life, is medically necessary, and is the least restrictive and most cost effective means for meeting the needs of the patient.

II. Each insurer that issues or renews any individual policy of accident or health insurance providing benefits for medical or hospital expenses, shall provide to certificate holders of such insurance who are residents of this state, coverage for the provision of nonprescription enteral formulas and food products required for persons with inherited diseases of amino acids and organic acids. Such coverage shall be provided 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 shall, in addition to the enteral formula, include food products modified to be low protein in an amount not to exceed $1,800 annually for any insured individual.

III. The benefits included in this section shall 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.

Statute: M.G.L.A. 176B § 4K

• > Weblink– https://www.malegislature.gov/Laws/GeneralLaws/PartI/TitleXXII/Chapter176B/Section4K
• > Requires coverage for enteral formulas that are medically necessary for 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.

Language of Statute MGLA 176B § 4K:
Any subscription certificate under an individual or group medical service agreement that shall be delivered, issued or renewed in the commonwealth shall provide, as benefits to all individual subscribers and members within the commonwealth, all group members having a principal place of employment within the commonwealth and all persons included in section four C, coverage for nonprescription enteral formulas for home use for which a physician has issued a written order and which are medically necessary 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 for inherited diseases of amino acids and organic acids shall include food products modified to be low protein in an amount not to exceed $5,000 annually for any insured individual.

Statute: LB 254

• > Weblink: https://legiscan.com/NE/bill/LB254/2013
  https://dhhs.ne.gov/publichealth/Pages/ElementalFormulaReimbursementProgram.aspx
• >LB 254 directed the Nebraska Department of Health and Human Services to establish a state funded program that provided amino acid-based elemental formula for the diagnosis and treatment of certain digestive disorders. Nebraska formed the Elemental Formula Reimbursement Program. Under the program, Nebraska residents with the diagnosis of Immunoglobulin E and non-Immunoglobulin E mediated allergies to multiple food proteins, food-protein-induced enterocolitis syndrome, eosinophilic disorders, or impaired absorption of nutrients caused by disorders affecting the absorptive surface, functional length, and motility of the gastrointestinal tract that require medically necessary amino acid-based elemental formulas may receive reimbursement of up to fifty percent (50%) of out-of-pocket expenses for these formulas.
• >A maximum reimbursement of $12,000 is available in a twelve month period for out-of-pocket expenses incurred on or after July 1, 2014. There is an application and requirement of annual physician certification that elemental formula is medically necessary. Funds are distributed on a first-come, first-served basis with a cap $250,000 for each fiscal year through 2016.

Language of LB 254:
Sec. 3. The Department of Health and Human Services shall establish a program to provide amino acid-based elemental formulas for the diagnosis and treatment of Immunoglobulin E and non-Immunoglobulin E mediated allergies to multiple food proteins, food protein-induced enterocolitis syndrome, eosinophilic disorders, and impaired absorption of nutrients caused by disorders affecting the absorptive surface, functional length, and motility of the gastrointestinal tract, when the ordering physician has issued a written order stating that the amino acid-based elemental formula is medically necessary for the treatment of a disease or disorder. Up to fifty percent of the actual out-of-pocket cost, not to exceed twelve thousand dollars, for amino acid-based elemental formulas shall be available to an individual without fees each twelve-month period.

The department shall distribute funds on a first-come, first-served basis. Nothing in this section is deemed to be an entitlement. The maximum total General Fund expenditures per year for amino acid-based elemental formulas shall not exceed two hundred fifty thousand dollars each fiscal year in FY2014-15 and FY2015-16. The Department of Health and Human Services shall provide an electronic report on the program to the Legislature annually on or before December 15 of each year.

Sec. 4. There is hereby appropriated (1) $362,500 from the General Fund for FY2014-15 and (2) $725,000 from the General Fund for FY2015-16 to the Board of Regents of the University of Nebraska, for Program 781, to aid in carrying out the provisions of this legislative bill.

Sec. 5. There is hereby appropriated (1) $250,000 from the General Fund for FY2014-15 and (2) $250,000 from the General Fund for FY2015-16 to the Department of Health and Human Services, for Program 514, to aid in carrying out the provisions of this legislative bill. No expenditures for permanent and temporary salaries and per diems for state employees shall be made from funds appropriated in this section.

Sec. 6. There is hereby appropriated (1) $10,000 from the General Fund for FY2014-15 and (2) $10,000 from the General Fund for FY2015-16 to the Department of Health and Human Services, for Program 33, to aid in carrying out the provisions of this legislative bill. Total expenditures for permanent and temporary salaries and per diems from funds appropriated in this section shall not exceed $10,000 for FY2014-15 or $10,000 for FY2015-16.

Bill: SS SCS SB 354

• > Weblink: http://www.senate.mo.gov/15info/pdf-bill/tat/SB354.pdf
• > Requires the Department of Health to provide for coverage amino acid-based elemental formulas for children under 19 years old with medical diagnosis of  eosinophilic disorders.

Language of Bill SS SCS SB 354:
1. The department shall provide coverage, subject to state and federal appropriations, for the full cost of amino acid-based elemental formulas, meaning formulas made from single nonallergenic amino acids, for children under nineteen years of age with a medical diagnosis of immunoglobulin E and nonimmunoglobulin E mediated allergies to multiple food proteins, food protein-induced enterocolitis syndrome, eosinophilic disorders, and impaired absorption of nutrients caused by disorders affecting the absorptive surface, functional length, and motility of the gastrointestinal tract.

2. The department may promulgate rules and regulations to implement the provisions of this section. Any rule or portion of a rule, as that term is defined in section 536.010 that is created under the authority delegated in this section shall become effective only if it complies with and is subject to all of the provisions of chapter 536, and, if applicable, section 536.028. This section and chapter 536 are nonseverable and if any of the powers vested with the general assembly pursuant to chapter 536, to review, to delay the effective date, or to disapprove and annul a rule are subsequently held unconstitutional, then the grant of rulemaking authority and any rule proposed or adopted after August 28, 2015, shall be invalid and void.

No specific statute. However, there is an Insurer’s agreement. The insurers’ agreement reimburses families for amino acid‑based formula and is supported by the state’s six largest insurance plans:

• > BlueCross BlueShield of Minnesota/Blue Plus
• > HealthPartners
• > Medica
• > PreferredOne
• > Sanford Health Plan
• > First Plan of Minnesota: Conditions covered include milk protein allergies, allergic enterocolitis, eosinophilic esophagitis (EoE) and short bowel syndrome (SBS). Copays and terms differ depending on plan.

Statute: HB 1113

• > Weblink: https://www.flsenate.gov/Session/Bill/2019/01113

Requires the Requires the Division of State Group Insurance (DSGI) to provide to state employees participating in the State Group Insurance Program annual coverage of $20,000 per enrollee for medically necessary prescription and nonprescription enteral formula and amino-acid-based elemental formulas for home use, regardless of the method of delivery or intake, which have been ordered or prescribed by a physician.

Statutes: 24 A M.R.S.A. § 2764, 24-A M.R.S.A. § 2847-P, 24‑A M.R.S.A. § 4256

• > Weblink: http://www.mainelegislature.org/legis/statutes/24-A/title24-Asec2764.html
• > Requires insurance coverage for medically necessary amino acid-based elemental infant formula for children 2 years and under diagnosed with eosinophilic gastroenteritis, GERD, anaphalaxis, severe diarrhea or vomiting, and malabsorption.

Language of Representative Statute 24-A M.R.S.A. § 2764:
All individual health insurance policies, contracts and certificates must provide coverage for amino acid‑based elemental infant formula for children 2 years of age and under in accordance with this section.

1. Determination of medical necessity. Coverage for amino acid‑based elemental infant formula must be provided when a licensed physician has submitted documentation that the amino acid‑based elemental infant formula is medically necessary health care as defined in section 4301‑A, subsection 10‑A, that the amino acid‑based elemental infant formula is the predominant source of nutritional intake at a rate of 50% or greater and that other commercial infant formulas, including cow milk‑based and soy milk‑based formulas have been tried and have failed or are contraindicated. A licensed physician may be required to confirm and document ongoing medical necessity at least annually.

2. Method of delivery. Coverage for amino acid‑based elemental infant formula must be provided without regard to the method of delivery of the formula.

3. Required diagnosis. Coverage for amino acid‑based elemental infant formula must be provided when a licensed physician has diagnosed and through medical evaluation has documented one of the following conditions:

A. Symptomatic allergic colitis or proctitis;
B. Laboratory‑ or biopsy‑proven allergic or eosinophilic gastroenteritis;
C. A history of anaphylaxis;
D. Gastroesophageal reflux disease that is nonresponsive to standard medical therapies;
E. Severe vomiting or diarrhea resulting in clinically significant dehydration requiring treatment by a medical provider;
F. Cystic fibrosis; or
G. Malabsorption of cow milk‑based or soy milk‑based infant formula.

4. Health savings accounts. Coverage for amino acid‑based elemental infant formula under a health insurance policy, contract or certificate issued in connection with a health savings account as authorized under Title XII of the federal Medicare Prescription Drug, Improvement, and Modernization Act of 2003 may be subject to the same deductible and out‑of‑pocket limits that apply to overall benefits under the policy, contract or certificate.

Statute: Connecticut General Statutes § 38a‑492c ‑ Coverage for low protein modified food products, amino acid modified preparations and specialized formulas

• > Weblink: https://www.cga.ct.gov/2012/rpt/2012-R-0304.htm
• > Requires insurance coverage for children up to the age of twelve for specialized formulas that are medically necessary for the treatment of a disease or condition and are administered under the direction of a physician.

Language of Statute– § 38a-492c:
(a) For purposes of this section:

(1) “Inherited metabolic disease” includes (A) a disease for which newborn screening is required under section 19a‑55; and (B) cystic fibrosis.

(2) “Low protein modified food product” means a product formulated to have less than one gram of protein per serving and intended for the dietary treatment of an inherited metabolic disease under the direction of a physician.

(3) “Amino acid modified preparation” means a product intended for the dietary treatment of an inherited metabolic disease under the direction of a physician.

(4) “Specialized formula” means a nutritional formula for children up to age twelve that is exempt from the general requirements for nutritional labeling under the statutory and regulatory guidelines of the federal Food and Drug Administration and is intended for use solely under medical supervision in the dietary management of specific diseases.

(b) Each individual health insurance policy providing coverage of the type specified in subdivisions (1), (2), (4), (6), (11) and (12) of section 38a‑469 delivered, issued for delivery or renewed in this state on or after October 1, 1997, shall provide coverage for amino acid modified preparations and low protein modified food products for the treatment of inherited metabolic diseases if the amino acid modified preparations or low protein modified food products are prescribed for the therapeutic treatment of inherited metabolic diseases and are administered under the direction of a physician.

(c) Each individual health insurance policy providing coverage of the type specified in subdivisions (1), (2), (4), (6), (11) and (12) of section 38a‑469 delivered, issued for delivery or renewed in this state on or after October 1, 2007, shall provide coverage for specialized formulas when such specialized formulas are medically necessary for the treatment of a disease or condition and are administered under the direction of a physician.

(d) Such policy shall provide coverage for such preparations, food products and formulas on the same basis as outpatient prescription drugs.

Statutes: SB 348

• > Weblink: https://legiscan.com/KS/text/SB348/id/1791821/Kansas-2017-SB348-Enrolled.pdf
• > Requires insurance coverage for state employees for amino acid-based formula for certain diagnosed conditions including eosinophilic disorders beginning January 1, 2019. Further, the state employees health care commission is required to submit a report by March 1, 2020, regarding the impact of mandated coverage for amino acid-based elemental formula and a recommendation whether coverage should continue. After receipt of the report, the legislature will consider whether to require coverage for amino acid-based elemental formula for other health individual or group plans.

Language of Senate Bill No. 348 provides:
(a) In the coverage for the next health plan coverage year commencing on January 1, 2019, the state employees health care com-mission shall provide for the coverage for amino acid-based elemental formula, regardless of delivery method, for the diagnosis or treatment of food protein-induced enterocolitis syndrome, eosinophilic disorders or short bowel syndrome, if prescribed by a prescriber, as defined by K.S.A. 65-1626, and amendments thereto, authorized by the pharmacy act of the state of Kansas and the applicable medical professional licensure entity in the state of Kansas.

(b) (1) Pursuant to the provisions of K.S.A. 40-2249a, and amendments thereto, on or before March 1, 2020, the state employees health care commission shall submit to the president of the senate and to the speaker of the house of representatives a report including the following information pertaining to the mandated coverage for amino acid-based elemental formula provided during the plan year commencing on January 1, 2019, and ending on December 31, 2019:

(A) The impact that the mandated coverage for amino acid-based elemental formula required by subsection (a) has had on the state health care benefits program;

(B) data on the utilization of coverage for amino acid-based elemental formula by covered individuals and the cost of providing such coverage for amino acid-based elemental formula; and

(C) a recommendation whether such mandated coverage for amino acid-based elemental formula should continue for the state health care benefits program or whether additional utilization and cost data is required.

(2) At the next legislative session following receipt of the report required in paragraph (1), the legislature may consider whether or not to require the coverage for amino acid-based elemental formula required by subsection (a) to be included in any individual 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 coverage for accident and health services and that is delivered, issued for delivery, amended or renewed in this state on or after July 1, 2021.

HOUSE BILL 16-1387 amending Col. Rev. Stat. Ann. § 10-16-104 (effective January 1, 2018)

• > Weblink: http://www.leg.state.co.us/clics/clics2016a/csl.nsf/fsbillcont3/7F7412B5357AA78987257F690058054C?Open&file=1387_enr.pdf
• > Mandates health insurance coverage for children for medically necessary, medical foods including elemental formulas ingested via tube or orally for which a physician who is a participating provider has issued a written, oral, or electronic prescription for treatment of inherited enzymatic disorders caused by single gene defects involved in the metabolism of amino, organic, and fatty acids as well as severe protein allergic conditions includes, without limitation, the following diagnosed conditions: phenylketonuria; maternal phenylketonuria; maple syrup urine disease; tyrosinemia; homocystinuria; histidinemia; urea cycle disorders; hyperlysinemia; glutaric acidemias; methylmalonic acidemia; propionic acidemia; immunoglobulin E and nonimmunoglobulin E-mediated allergies to multiple food proteins; severe food protein induced enterocolitis syndrome; eosinophilic disorders as evidenced by the results of a biopsy; and impaired absorption of nutrients caused by disorders affecting the absorptive surface, function, length, and motility of the gastrointestinal tract.

Pertinent Language of Bill – 16-1387 amending Col. Rev. Stat. Ann. § 10-16-104:
SECTION 1. In Colorado Revised Statutes, 10–16–104, amend (1)(c)(III)(A) and (1)(c)(III)(C) as follows:

10–16–104. Mandatory coverage provisions—definitions—rules. (1) Newborn children. (c)(III)(A) Coverage for inherited enzymatic disorders caused by single gene defects involved in the metabolism of amino, organic, and fatty acids shall include, but not be limited to as well as severe protein allergic conditions includes, without limitation, the following diagnosed conditions: Phenylketonuria; maternal phenylketonuria; maple syrup urine disease; tyrosinemia; homocystinuria; histidinemia; urea cycle disorders; hyperlysinemia; glutaric acidemias; methylmalonic acidemia; and propionic acidemia; immunoglobulin E and nonimmunoglobulin E-mediated allergies to multiple food proteins; severe food protein induced enterocolitis syndrome; eosinophilic disorders as evidenced by the results of a biopsy; and impaired absorption of nutrients caused by disorders affecting the absorptive surface, function, length, and motility of the gastrointestinal tract. Covered care and treatment of such conditions shall include, to the extent medically necessary, medical foods for home use for which a physician who is a participating provider has issued a written, oral, or electronic prescription.

(C) As used in this subparagraph (III), “medical foods” means prescription metabolic formulas and their modular counterparts and amino acid-based elemental formulas, obtained through a pharmacy, that are specifically designated and manufactured for the treatment of inherited enzymatic disorders caused by single gene defects involved in the metabolism of amino, organic, and fatty acids and for severe allergic conditions, if diagnosed by a board-certified allergist or board-certified gastroenterologist, for which medically standard methods of diagnosis, treatment, and monitoring exist. Such formulas are specifically processed or formulated to be deficient in one or more nutrients. and the formulas for severe food allergies contain only singular form elemental amino acids. The formulas are to be consumed or administered enterally either via tube or oral route under the direction of a physician who is a participating provider. This sub-subparagraph (C) shall not be construed to apply to cystic fibrosis patients or lactose- or soy-intolerant patients.

SECTION 2. Act subject to petition—effective date. This act takes effect January 1, 2018; except that, if a referendum petition is filed pursuant to section 1(3) of article V of the state constitution against this act or an item, section, or part of this act within the ninety-day period after final adjournment of the general assembly, then the act, item, section, or part will not take effect unless approved by the people at the general election to be held in November 2016 and, in such case, will take effect on January 1, 2018, or on the date of the official declaration of the vote thereon by the governor, whichever is later.

Approved June 1, 2016.