Short title

This Act may be cited as the

Medical Foods Equity Act of 2011

Findings

Congress finds the following: (1)Newborns are screened for inborn errors of metabolism, but treatment for such conditions is not uniformly covered by insurance. (2)Each year approximately 2,550 children in the United States are diagnosed with an inborn error of metabolism disorder, requiring foods modified to be void of the nutrient or nutrients the child’s body is incapable of processing, or requiring supplementation with vitamins or amino acids. (3)More than 35 States have passed laws to at least partially address the inequity in coverage for medically necessary foods, critical treatment for such disorders. (4)The cost associated with providing medically necessary foods presents a large financial burden for many families. (5)There is no current cure for inborn errors of metabolism disorders and treatment is necessary during the entire lifespan of the individual.

Coverage in Federal health programs of medically necessary food and food modified to be low protein

(a)

Coverage under the Medicare program

(1)

Coverage of medically necessary food under the original medicare fee-for-service program

(A)

In general

Section 1861(s)(2) of the Social Security Act (42 U.S.C. 1395x(s)(2)) is amended— (i)in subparagraph (EE), by striking and at the end; (ii)in subparagraph (FF), by inserting and at the end; and (iii)by adding at the end the following new subparagraph:

(GG)medically necessary food (as defined in subsection (iii)) and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food;

(B)

Definition

Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended by adding at the end the following new subsection:

(iii)(1)The term medically necessary food— (A)means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation; and (B)includes nutritionally modified counterparts of traditional foods and other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally. (2)For purposes of paragraph (1), the term enterally refers to consumption or administration through the gastrointestinal tract, whether orally or by tube.

(C)

Payment

Section 1833(a)(1) of the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended— (i)by striking and before (Z); and (ii)by inserting before the semicolon at the end the following: “, and (AA) with respect to medically necessary food and pharmacological doses of vitamins and amino acids under section 1861(s)(2)(GG), the amounts paid shall be 80 percent of the lesser of the actual charge for the services or 85 percent of the amount determined under the fee schedule established under section 1848(b) for the same services if furnished by a physician”. (2)

Inclusion of pharmacological doses of vitamins and amino acids as a covered part D drug

(A)

In general

Section 1860D–2(e)(1) of the Social Security Act (42 U.S.C. 1395w–102(e)(1)) is amended— (i)in subparagraph (A), by striking or at the end; (ii)in subparagraph (B), by striking the comma at the end and inserting ; or; and (iii)by inserting after subparagraph (B) the following new subparagraph:

(C)pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider,

(B)

Effective date

The amendments made by subparagraph (A) shall apply to plan years beginning on or after the date that is 6 months after date of enactment of this Act. (b)

Coverage under the Medicaid program

(1)

In general

Section 1905 of the Social Security Act (42 U.S.C. 1396d) is amended— (A)in subsection (a)— (i)in paragraph (12), by inserting including pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider, after prescribed drugs,; (ii)in paragraph (28), by striking and at the end; (iii)in paragraph (29), by striking the comma at the end and inserting ; and; and (iv)by inserting after paragraph (29) the following new paragraph:

(30)medically necessary food (as defined in subsection (ee)) and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food,

; and

(B)by adding at the end the following new subsection:

(ee)

Medically necessary food defined

(1)

In general

For purposes of subsection (a)(30), the term medically necessary food— (A)means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation; and (B)includes nutritionally modified counterparts of traditional foods and other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally. (2)

Enterally

For purposes of paragraph (1), the term enterally refers to consumption or administration through the gastrointestinal tract, whether orally or by tube.

(2)

Exception to rebate exclusion

Section 1927(d)(2)(E) of the Social Security Act (42 U.S.C. 1396r–8(d)(2)(E)) is amended by inserting , pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider, after prenatal vitamins. (3)

Conforming amendment

Section 1902(a)(10)(A) of the Social Security Act (42 U.S.C. 1396a(a)(10)(A)) is amended, in the matter preceding clause (i), by striking and (28) and inserting (28), and (30). (4)

Exception to effective date if state legislation required

In the case of a State plan for medical assistance under title XIX of the Social Security Act which the Secretary of Health and Human Services (referred to in this Act as the Secretary) determines requires State legislation (other than legislation appropriating funds) in order for the plan to meet the additional requirement imposed by the amendments made by this subsection, the State plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of such session shall be deemed to be a separate regular session of the State legislature. (c)

Coverage under CHIP

(1)

In general

(A)

Medically necessary food

Section 2103(c) of the Social Security Act (42 U.S.C. 1397cc(c)) is amended by adding at the end the following:

(9)

Medically necessary food

(A)

In general

The child health assistance provided to a targeted low-income child under the plan shall include coverage of medically necessary food and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food. (B)

Definitions

In this paragraph— (i)the term medically necessary food— (I)means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation; and (II)includes nutritionally modified counterparts of traditional foods and other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally; and (ii)the term enterally refers to consumption or administration through the gastrointestinal tract, whether orally or by tube.

(B)

Vitamins and amino acids

Section 2110(a)(6) of the Social Security Act (42 U.S.C. 1397jj(a)(6)) is amended by striking and biologicals and the administration of such drugs and biologicals, only if such drugs and biologicals and inserting , pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider, and biologicals, and the administration of such drugs, vitamins and amino acids, and biologicals, only if such drugs, vitamins and amino acids, and biologicals. (2)

Conforming amendment

Section 2103(a) of the Social Security Act (42 U.S.C. 1397cc(a)) is amended, in the matter preceding paragraph (1), by striking , and (7) and inserting , (7), and (9). (d)

Availability of medically necessary food, food modified To be low protein, and related items under the TRICARE program

Section 1077(a)(8) of title 10, United States Code, is amended by striking including and all that follows and inserting “including the following:

(A)Well-baby care that includes one screening of an infant for the level of lead in the blood of the infant. (B)Medically necessary food (as defined in section 1861(iii) of the Social Security Act) and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food. (C)Pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism and other conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children.

Coverage in the private insurance market of medically necessary food and food modified to be low protein

(a)

Group health plans

(1)

Amendments to ERISA

(A)

In general

Subpart B of part 7 of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et seq.) is amended by adding at the end the following:

716.

Coverage of medically necessary food and food modified to be low protein

(a)

Definition

In this section— (1)the term medically necessary food— (A)means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation; and (B)includes nutritionally modified counterparts of traditional foods and other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally; and (2)the term enterally refers to consumption or administration through the gastrointestinal tract, whether orally or by tube. (b)

Coverage

(1)

Medically necessary food and food modified to be low protein

A group health plan, or a health insurance issuer that provides health insurance coverage in connection with a group health plan, shall provide coverage for medically necessary food and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food. (2)

Vitamins and amino acids

A group health plan, or a health insurance issuer that provides health insurance coverage in connection with a group health plan, that provides prescription drug coverage shall provide coverage for pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider, to the same extent as other prescription drug coverage under such plan or coverage.

(B)

Conforming amendment

The table of contents in section 1 of such Act is amended by inserting after the item relating to section 714 the following new items:

Sec. 715. Additional market reforms.

Sec. 716. Coverage of medically necessary food and food modified to be low protein.

(2)

Amendments to the Public Health Service Act

Subpart 2 of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–4 et seq.) is amended by adding at the end the following new section:

2729.

Coverage of medically necessary food and food modified to be low protein

(a)

Definitions

In this section— (1)the term medically necessary food— (A)means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation, and (B)includes nutritionally modified counterparts of traditional foods and other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally; and (2)the term enterally refers to consumption or administration through the gastrointestinal tract, whether orally or by tube. (b)

Coverage

(1)

Medically necessary food and food modified to be low protein

Vitamins and amino acids

A group health plan, or a health insurance issuer that provides health insurance coverage in connection with a group health plan, that provides prescription drug coverage, shall provide coverage for pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children and as prescribed by a qualified medical provider, to the same extent as other prescription drug coverage under such plan or coverage.

(3)

Amendments to the Internal Revenue Code

(A)

In general

Subchapter B of chapter 100 of the Internal Revenue Code of 1986 (relating to other group health plan requirements) is amended by inserting after section 9813 the following new section:

9814.

Coverage of medically necessary food and food modified to be low protein

(a)

Definitions

Coverage

(1)

Medically necessary food and food modified to be low protein

A group health plan, or a health insurance issuer that provides health insurance coverage in connection with a group health plan, shall provide coverage for necessary medically necessary food and food modified to be low protein that is formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children, and the medical equipment and supplies necessary to administer such food. (2)

Vitamins and amino acids

(B)

Conforming amendment

The table of sections for subchapter B of chapter 100 of such Code is amended by inserting after the item relating to section 9813 the following new item:

Sec. 9814. Coverage of medically necessary food and food modified to be low protein.

(b)

Individual market

Subpart 2 of part B of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–51 et seq.) is amended by adding at the end the following new section:

2754.

Coverage of medically necessary food and food modified to be low protein

The provisions of section 2729 shall apply to health insurance coverage offered by a health insurance issuer in the individual market in the same manner as they apply to health insurance coverage offered by a health insurance issuer in connection with a group health plan in the small or large group market.

(c)

Amendment to PPACA

Section 1302(b)(1) of the Patient Protection and Affordable Care Act (42 U.S.C. 18022(b)(1)) is amended by adding at the end the following:

(K)Medically necessary food, as defined in section 2729 of the Public Health Service Act.

Effective date; determination of minimum yearly coverage

(a)

Effective date

The amendments made by sections 3 and 4 shall apply to plan years beginning after the date that is 180 days after the date of enactment of this Act. (b)

Determination by Secretary

(1)

In general

Prior to the date described under subsection (a), the Secretary of Health and Human Services (referred to in this Act as the Secretary) shall determine the minimum yearly coverage for all health insurance plans pursuant to the amendments made by this Act. Such minimum yearly coverage shall apply to an individual during any period when the individual is covered under the plan and for as long as deemed medically necessary. The Secretary may establish age-specific minimum levels of coverage and periodically update these levels based on a standard cost of living index, the actual cost of treatment, and other appropriate measures as determined by the Secretary. (2)

No preemption

The minimum yearly coverage determined by the Secretary under paragraph (1) shall not preempt any State standards that require a higher minimum yearly coverage level for the same services and benefits.