IIB 114th CONGRESS 2d Session H. R. 4978 IN THE SENATE OF THE UNITED STATES May 12, 2016 Received; read twice and referred to the Committee on Finance AN ACT To require the Government Accountability Office to submit to Congress a report on neonatal abstinence syndrome (NAS) in the United States and its treatment under Medicaid, and for other purposes.

1. Short title This Act may be cited as the Nurturing And Supporting Healthy Babies Act or as the NAS Healthy Babies Act . 2. GAO report on neonatal abstinence syndrome (NAS) (a) In general Not later than 1 year after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Finance and the Committee on Health, Education, Labor and Pensions of the Senate a report on neonatal abstinence syndrome (in this section referred to as NAS ) in the United States. (b) Information To be included in report Such report shall include information on the following: (1) The prevalence of NAS in the United States, including the proportion of children born in the United States with NAS who are eligible for medical assistance under State Medicaid programs under title XIX of the Social Security Act at birth and the costs associated with NAS through such programs. (2) The services for which coverage is available under State Medicaid programs for treatment of infants with NAS. (3) The settings (including inpatient, outpatient, hospital-based, and other settings) for the treatment of infants with NAS and the reimbursement methodologies and costs associated with such treatment in such settings. (4) The prevalence of utilization of various care settings under State Medicaid programs for treatment of infants with NAS and any Federal barriers to treating such infants under such programs, particularly in non-hospital-based settings. (5) What is known about best practices for treating infants with NAS. (c) Recommendations Such report also shall include such recommendations as the Comptroller General determines appropriate for improvements that will ensure access to treatment for infants with NAS under State Medicaid programs. 3. Excluding abuse-deterrent formulations of prescription drugs from the Medicaid additional rebate requirement for new formulations of prescription drugs (a) In general The last sentence of section 1927(c)(2)(C) of the Social Security Act ( 42 U.S.C. 1396r–8(c)(2)(C) ) is amended by inserting before the period at the end the following: , but does not include an abuse-deterrent formulation of the drug (as determined by the Secretary), regardless of whether such abuse-deterrent formulation is an extended release formulation . (b) Effective date The amendment made by subsection (a) shall apply to drugs that are paid for by a State in calendar quarters beginning on or after the date of the enactment of this Act. 4. Limiting disclosure of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse (a) In general Title XI of the Social Security Act is amended by inserting after section 1128J ( 42 U.S.C. 1320a–7k ) the following new section: 1128K. Disclosure of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse (a) Reference to predictive modeling technologies requirements For provisions relating to the use of predictive modeling and other analytics technologies to identify and prevent waste, fraud, and abuse with respect to the Medicare program under title XVIII, the Medicaid program under title XIX, and the Children’s Health Insurance Program under title XXI, see section 4241 of the Small Business Jobs Act of 2010 ( 42 U.S.C. 1320a–7m ). (b) Limiting disclosure of predictive modeling technologies In implementing such provisions under such section 4241 with respect to covered algorithms (as defined in subsection (c)), the following shall apply: (1) Nonapplication of FOIA The covered algorithms used or developed for purposes of such section (including by the Secretary or a State (or an entity operating under a contract with a State)) shall be exempt from disclosure under section 552(b)(3) of title 5, United States Code. (2) Limitation with respect to use and disclosure of information by State agencies (A) In general A State agency may not use or disclose covered algorithms used or developed for purposes of such section except for purposes of administering the State plan (or a waiver of the plan) under the Medicaid program under title XIX or the State child health plan (or a waiver of the plan) under the Children’s Health Insurance Program under title XXI, including by enabling an entity operating under a contract with a State to assist the State to identify or prevent waste, fraud, and abuse with respect to such programs. (B) Information security A State agency shall have in effect data security and control policies that the Secretary finds adequate to ensure the security of covered algorithms used or developed for purposes of such section 4241 and to ensure that access to such information is restricted to authorized persons for purposes of authorized uses and disclosures described in subparagraph (A). (C) Procedural requirements State agencies to which information is disclosed pursuant to such section 4241 shall adhere to uniform procedures established by the Secretary. (c) Covered algorithm defined In this section, the term covered algorithm — (1) means a predictive modeling or other analytics technology, as used for purposes of section 4241(a) of the Small Business Jobs Act of 2010 (42 U.S.C. 1320a–7m(a)) to identify and prevent waste, fraud, and abuse with respect to the Medicare program under title XVIII, the Medicaid program under title XIX, and the Children’s Health Insurance Program under title XXI; and (2) includes the mathematical expressions utilized in the application of such technology and the means by which such technology is developed. . (b) Conforming amendments (1) Medicaid State plan requirement Section 1902(a) of the Social Security Act ( 42 U.S.C. 1396a(a) ) is amended— (A) in paragraph (80), by striking and at the end; (B) in paragraph (81), by striking the period at the end and inserting ; and ; and (C) by inserting after paragraph (81) the following new paragraph: (82) provide that the State agency responsible for administering the State plan under this title provides assurances to the Secretary that the State agency is in compliance with subparagraphs (A), (B), and (C) of section 1128K(b)(2). . (2) State child health plan requirement Section 2102(a)(7) of the Social Security Act ( 42 U.S.C. 1397bb(a)(7) ) is amended— (A) in subparagraph (A), by striking , and at the end and inserting a semicolon; (B) in subparagraph (B), by striking the period at the end and inserting ; and ; and (C) by adding at the end the following new subparagraph: (C) to ensure that the State agency involved is in compliance with subparagraphs (A), (B), and (C) of section 1128K(b)(2). . 5. Medicaid Improvement Fund Section 1941(b)(1) of the Social Security Act ( 42 U.S.C. 1396w–1(b)(1) ) is amended to read as follows: (1) In general There shall be available to the Fund, for expenditures from the Fund for fiscal year 2021 and thereafter, $5,000,000. .

Passed the House of Representatives May 11, 2016. Karen L. Haas, Clerk