Nurturing and Supporting Healthy Babies Act

Floor Speech

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Mr. GUTHRIE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 4978) 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, as amended.

The Clerk read the title of the bill.

The text of the bill is as follows: H.R. 4978

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 ``Nurturing And Supporting Healthy Babies Act'' or as the ``NAS Healthy Babies Act''. SEC. 2. GAO REPORT ON NEONATAL ABSTINENCE SYNDROME (NAS).

(a) In General.--Not later than one 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. SEC. 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. SEC. 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: ``SEC. 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).''. SEC. 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.''.

Mr. Speaker, I rise in support of H.R. 4978, the Nurturing and Supporting Healthy Babies Act, sponsored by Representative Evan Jenkins. This commonsense, bipartisan piece of legislation contains two important policies which will help strengthen our efforts to curb opioid abuse.

First, the bill requires the Government Accountability Office to carefully study ways to improve care for babies born with neonatal abstinence syndrome, NAS. NAS is a drug-withdrawal syndrome that most commonly occurs after an in-utero exposure to opioids that has, sadly, grown into prevalence in recent years.

As the New England Journal of Medicine noted last year, from 2000 through 2009, the incidence of neonatal abstinence syndrome in the United States nearly tripled, with several States reporting even larger recent increases.

That same study noted that, in 2013, the number of NICU hospital days nationwide attributed to the care of infants with NAS was six to seven times greater than it was in 2004.

So this bill will expand our knowledge of care of NAS babies by requiring GAO to study what is known about the prevalence of NAS in the United States, the number of NAS babies covered by Medicaid, the settings for care of NAS babies, and access to care for NAS babies under State Medicaid programs.

Based on the recommendation of Representative Andy Barr, the bill also directs GAO to identify what is known about best practices providing care for infants with NAS.

This comprehensive study, including the research focusing on best practices, can help us improve our efforts to provide care for some of the most vulnerable among us.

This bill takes a second important step to help combat opioid abuse by fixing an unintended consequence with the Medicaid drug rebate program that effectively discourages drug manufacturers from producing opioids that are harder to abuse.

Specifically, this second policy would exempt abuse-deterrent formulations of drugs from the definition of ``line extension'' for the purpose of calculating Medicaid rebates.

Abuse-deterrent formulations of drugs represent a critically important tool in the Federal policy toolbox. In its Opioids Action Plan, FDA said its goal is to ``expand access to abuse-deterrent formulations to discourage abuse.'' And in its ADF guidance to manufacturers, the agency said it ``considers the development of these products a high public health priority.''

This policy enjoys bipartisan support, and was introduced by Representative Bilirakis previously. This policy was also included in the President's FY 2017 budget, which noted that correcting the law would ``incentivize continued development of abuse-deterrent formulations.''

This policy can help save lives. Currently, more than 4 million Americans misuse or abuse prescription painkillers and more than 16,000 individuals die from prescription painkiller overdoses each year. This change will help ensure there is continued investment in important abuse-deterrent drug technologies to help reduce the number of patients who abuse opioid drugs.

Finally, to help offset the cost of the Medicaid drug rebate change, this bill includes a third policy that was introduced by Representative Bilirakis in the past, and recently was included in the President's 2017 budget.

It would protect from public disclosure the program integrity algorithms CMS uses to identify and predict waste, fraud, and abuse in Medicare, Medicaid, and CHIP.

Today the mathematical algorithms and predictive technologies that CMS uses in Medicare, Medicaid, and CHIP are vital to uncovering fraud, waste, and abuse.

However, if various aspects of these algorithms were to become publicly known, fraudsters could utilize the information to redirect their schemes to avoid detection.

This policy would simply prevent the disclosure of these anti-fraud tools from freedom of information-related laws while still allowing CMS and State Medicaid and CHIP programs to freely share algorithms and other predictive analytic tools. Doing so saves taxpayers money and offsets the cost of the rebate policy.

Mr. Speaker, this bill would enhance our knowledge about how to care for infants with NAS, encourage more abuse-deterrent formulations of drugs, and prevent powerful, anti-fraud tools from falling into the wrong hands.

I urge support for this commonsense, bipartisan piece of legislation.

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Mr. GUTHRIE. Mr. Speaker, I appreciate my friend from West Virginia and our colleague from Illinois for moving this forward.

I urge the passage of H.R. 4978, and I would like for my colleagues to vote for this.

I yield back the balance of my time.

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