1. Short title This Act may be cited as the Patient Access to Medical Foods Act . 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. . 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