Bill Summary
This legislation, titled the "Patient Access to Medical Foods Act," seeks to amend the Orphan Drug Act in regards to the definition of medical food. The Orphan Drug Act is a law that provides incentives for pharmaceutical companies to develop treatments for rare diseases. This amendment specifically aims to expand the definition of medical food to include products that are formulated to be consumed or administered enterally (through tube feeding or oral intake) and dispensed with a prescription from a licensed practitioner. It also includes a provision for a National Drug Code number for medical foods. Additionally, the legislation proposes that medically necessary food (defined in the bill as a medical food that is intended for the specific dietary management of a disease or condition or has been shown to provide clinical benefit) be covered under federal health programs and private health insurance programs. This includes coverage under Medicare, Medicaid, CHIP, TRICARE, and private health insurance plans. The effective date for these coverage requirements varies based on the program, with the earliest date being January 1, 2021.
Possible Impacts
1. The Patient Access to Medical Foods Act may impact individuals who rely on medical foods for the management of their specific medical conditions. By amending the definition of medical food under the Orphan Drug Act, this legislation may affect the availability and accessibility of certain medical foods for these individuals.
2. The amendments made to the Social Security Act through this bill may affect the coverage and payment for medically necessary foods under federal health programs such as Medicare, Medicaid, and CHIP. This could have financial implications for individuals who rely on these programs for their healthcare.
3. Private health insurance plans and group health plans may now be required to provide coverage for medically necessary foods under the Patient Access to Medical Foods Act. This could benefit individuals who have previously struggled to afford these specialized foods, but it could also lead to higher premiums for all individuals covered under these plans.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8138 Introduced in House (IH)]
<DOC>
116th CONGRESS
2d Session
H. R. 8138
To amend the Orphan Drug Act with respect to the definition of medical
food, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 1, 2020
Mr. Biggs introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
Ways and Means, and Armed Services, for a period to be subsequently
determined by the Speaker, in each case for consideration of such
provisions as fall within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend the Orphan Drug Act with respect to the definition of medical
food, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Patient Access to Medical Foods
Act''.
SEC. 2. DEFINITION OF MEDICAL FOOD FOR PURPOSES OF ORPHAN DRUG ACT.
(a) In General.--Section 5(b)(3) of the Orphan Drug Act (21 U.S.C.
360ee(b)(3)) is amended to read as follows:
``(3) The term `medical food' means a food which--
``(A) is formulated to be consumed or administered
enterally, including tube feeding and oral intake, and
dispensed upon a written prescription of a practitioner
licensed under the laws of the State in which such
practitioner practices to administer drugs; and
``(B)(i) is intended for the specific dietary
management of a disease or condition for which
distinctive nutritional requirements, including
conditions of inborn errors of metabolism, based on
recognized scientific principles, are established by
medical evaluation; or
``(ii) in the case of an individual for whom the
prescribing physician determines the individual has
failed on traditional therapies or determines
continuing the traditional therapy is inappropriate for
the patient due to comorbidities or severe side effects
that endanger the health of the individual--
``(I) has been shown to provide clinical
benefit in well-controlled peer-reviewed
clinical trials to patients with a disease or
condition specified in clause (i); and
``(II) is determined by the prescribing
physician to be a safer therapeutic option or
the only effective clinical option for the
individual.''.
(b) National Drug Code Number.--Section 5 of the Orphan Drug Act
(21 U.S.C. 360ee) is amended--
(1) by redesignating subsection (c) as subsection (d); and
(2) by inserting after subsection (b) the following:
``(c) National Drug Code Number.--Medical foods shall be eligible
for a National Drug Code number.''.
SEC. 3. COVERAGE OF MEDICALLY NECESSARY FOOD UNDER FEDERAL HEALTH
PROGRAMS AND PRIVATE HEALTH INSURANCE.
(a) Coverage Under Medicare Program.--
(1) Part b coverage.--
(A) In general.--Section 1861(s)(2) of the Social
Security Act (42 U.S.C. 1395x(s)(2)) is amended--
(i) in subparagraph (GG), by striking
``and'' at the end;
(ii) in subparagraph (HH), by striking the
period at the end and inserting ``; and''; and
(iii) by adding at the end the following
new subparagraph:
``(II) medically necessary food (as defined in subsection
(kkk));''.
(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:
``Medically Necessary Food
``(kkk) The term `medically necessary food' has the meaning given
the term `medical food' in section 5(b)(3) of the Orphan Drug Act (21
U.S.C. 360ee(b)(3)).''.
(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 ``(DD)'';
and
(ii) by inserting before the semicolon at
the end the following: ``, and (EE) with
respect to medically necessary food (as defined
in section 1861(kkk)), the amount paid shall be
an amount equal to 80 percent of the actual
charge for the services.''.
(D) Effective date.--The amendments made by this
paragraph shall apply to items and services furnished
on or after January 1, 2021.
(2) Coverage as 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 at the
end ``or'';
(ii) in subparagraph (B), by striking at
the end the comma and inserting ``; or''; and
(iii) by inserting after subparagraph (B)
the following new subparagraph:
``(C) a medically necessary food (as defined in
section 1861(kkk)),''.
(B) Effective date.--The amendments made by
subparagraph (A) shall apply with respect to plan years
beginning on or after January 1, 2021.
(b) Coverage Under Medicaid Program.--
(1) In general.--Section 1905(a) of the Social Security Act
(42 U.S.C. 1396d(a)) is amended--
(A) in paragraph (29), by striking ``and'' at the
end;
(B) by redesignating paragraph (30) as paragraph
(31); and
(C) by inserting after paragraph (29) the following
new paragraph:
``(30) medically necessary food (as defined in section
1861(kkk)); and''.
(2) Mandatory benefit.--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 (29)'' and
inserting ``(29), and (30)''.
(3) Effective date.--
(A) In general.--Subject to subparagraph (B), the
amendments made by this subsection shall apply with
respect to medical assistance furnished on or after
July 1, 2021.
(B) Exception 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 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.--Section 2103(c) of the Social Security Act
(42 U.S.C. 1397cc(c)) is amended by adding at the end the
following:
``(11) Medically necessary food.--The child health
assistance provided to a targeted low-income child shall
include coverage of medically necessary food (as defined in
section 1861(kkk)).''.
(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 (8)'' and inserting
``, (8), and (11)''.
(3) Effective date.--
(A) In general.--Subject to subparagraph (B), the
amendments made by this subsection shall apply with
respect to child health assistance furnished on or
after July 1, 2021.
(B) Exception if state legislation required.--In
the case of a State child health plan for child health
assistance under title XXI of the Social Security Act
which the Secretary of Health and Human Services
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 child
health 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.
(d) Coverage Under TRICARE.--Paragraph (2) of section 1077(h) of
title 10, United States Code, is amended to read as follows:
``(2) In this section, the term `medically necessary food' has the
meaning given the term `medical food' in section 5(b)(3) of the Orphan
Drug Act.''.
(e) Coverage Under Private Health Insurance.--
(1) In general.--Subpart II of part A of title XXVII of the
Public Health Service Act (42 U.S.C. 300gg-11 et seq.) is
amended by adding at the end the following:
``SEC. 2730. COVERAGE OF MEDICALLY NECESSARY FOOD.
``A group health plan and group or individual health insurance
coverage offered by a health insurance issuer shall provide coverage
for medically necessary food (as defined in section 1861(kkk) of the
Social Security Act).''.
(2) Effective date.--The amendment made by paragraph (1)
shall apply to plan years beginning on or after January 1,
2021.
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