[Congressional Record (Bound Edition), Volume 162 (2016), Part 4]
[House]
[Pages 5699-5703]
[From the U.S. Government Publishing Office, www.gpo.gov]




              NURTURING AND SUPPORTING HEALTHY BABIES ACT

  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.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Kentucky (Mr. Guthrie) and the gentleman from Texas (Mr. Gene Green) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Kentucky.
  Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
  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.

[[Page 5700]]

  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.
  Mr. Speaker, I reserve the balance of my time.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I 
may consume.
  Mr. Speaker and Members, I rise to voice my support for H.R. 4978, 
the Nurturing and Supporting Healthy Babies Act.
  Nearly every community in every State has been impacted by heroin and 
opioid addiction. Tragically, newborns are the most vulnerable victims 
of this epidemic. It is estimated that every 25 minutes, a baby is born 
suffering from neonatal abstinence syndrome, or opioid withdrawal. 
According to a study by the New England Journal of Medicine, from 2004 
to 2013, the incidence of NAS has quadrupled.
  Neonatal abstinence syndrome, or NAS, arises from the exposure to 
opioids during pregnancy and impacts far too many of our Nation's 
newborns. Maternal exposure to opioids can be caused by both 
nonprescription and prescription medication, and the subsequent 
neonatal withdrawal can result in extended hospital stays and severe, 
heartbreaking symptoms.

                              {time}  1700

  NAS is associated with preterm births and low birth weight 
complications such as respiratory distress and seizures.
  H.R. 4978, the Nurturing and Supporting Healthy Babies Act, is an 
important part of our efforts to combat drug abuse. The legislation 
will expand our knowledge of care and treatment for babies with NAS. It 
will direct the GAO to identify the prevalence of NAS and the number of 
cases covered by Medicaid, the setting of care for these infants, and 
identify access barriers to treatment. H.R. 4978 will further our 
ability to meet this crisis head-on and provide America's children the 
healthy start they deserve.
  I want to thank the bill's sponsor, Representative Cheri Bustos, for 
her leadership in introducing this bill and urge my colleagues to 
support the Nurturing and Supporting Healthy Babies Act.
  Mr. Speaker, I reserve the balance of my time.
  Mr. GUTHRIE. Mr. Speaker, I yield 2 minutes to the gentleman from 
West Virginia (Mr. Jenkins), my friend and the sponsor of this 
legislation.
  Mr. JENKINS of West Virginia. Mr. Speaker, as you have just heard, 
every 25 minutes in this Nation a baby is born who was exposed to drugs 
during pregnancy. This is called neonatal abstinence syndrome, or NAS, 
and it is a devastating way to begin one's life.
  Today before the House is the Nurturing and Supporting Healthy Babies 
Act. I am proud to sponsor this bipartisan legislation that will expand 
our knowledge of care for babies born with NAS.
  Hearing the sounds of babies crying as they experience drug 
withdrawal is heartbreaking. We can only truly address this crisis by 
working together. For the past 5 years, I have worked tirelessly in my 
hometown of Huntington, West Virginia, to help those treating newborns 
with NAS and to help find new and innovative treatment methods.
  This firsthand experience highlighted the many challenges facing 
hospitals, doctors, nurses, and others seeking to treat these babies, 
and it has shown me the suffering these babies experience and just how 
much we need to help them. This bill will bring much-needed information 
on best practice models of care to our healthcare providers for the 
most vulnerable impacted by this drug crisis.
  Through this bill, we will also learn more about just how many 
newborns are suffering from withdrawal and more about the Federal 
obstacles to treating them. This bill will bring us closer to 
guaranteeing a healthy and happy start to life for every newborn.
  I thank the Energy and Commerce Committee's chairmen, Chairman Upton 
and Chairman Pitts, for their tireless work to find solutions to the 
drug crisis and to help NAS babies start their lives healthy and happy. 
I thank Congresswoman Cheri Bustos for joining me in cosponsoring this 
legislation.
  We are making progress. We must continue to strive for solutions to 
this tragic epidemic.
  Mr. GENE GREEN of Texas. Mr. Speaker, I yield 3 minutes to the 
gentlewoman from Illinois (Mrs. Bustos).
  Mrs. BUSTOS. Mr. Speaker, I thank Congressman Gene Green for yielding 
me time and for working with me to

[[Page 5701]]

find better treatment for babies born with neonatal abstinence 
syndrome, also known as NAS.
  Mr. Speaker, every 25 minutes, as we have heard, every 25 minutes in 
America, another baby is born addicted to heroin or other deadly 
opioids. It results from their mother's struggle with addiction.
  As the heroin epidemic sweeps our towns and our cities throughout the 
United States and impacts far too many families, many of the most 
overlooked victims have been the most vulnerable among us. It is heart-
wrenching and it is terrible that an innocent newborn, trembling, 
crying uncontrollably, clenching her small fists, and gasping for air, 
again, is born every 25 minutes.
  These are just a few of the symptoms babies face when they are born 
addicted to opioids, and nothing from my perspective as a mother and as 
a grandmother could be more demanding of our immediate attention. That 
is why I joined Congressman Evan Jenkins from West Virginia to 
introduce the Nurturing and Supporting Healthy Babies Act.
  This bipartisan legislation will improve care for babies born with 
neonatal abstinence syndrome. It will expand our knowledge of care for 
NAS babies, including its prevalence in the United States. It will also 
examine access to care for NAS babies under the State Medicaid programs 
and direct the Government Accountability Office to identify any Federal 
obstacles to care for NAS babies.
  In short, this legislation will do a top-to-bottom review to make 
sure we are doing everything we can to help babies born with addiction 
and withdrawal.
  Mr. Speaker, we must do our part to help all children reach their 
full potential.
  Mr. GUTHRIE. Mr. Speaker, I yield 2 minutes to the gentleman from 
Florida (Mr. Bilirakis), my friend and colleague from the Committee on 
Energy and Commerce.
  Mr. BILIRAKIS. Mr. Speaker, I rise in support of H.R. 4978, the 
Nurturing and Supporting Healthy Babies Act. This bill will help our 
most vulnerable Americans.
  H.R. 4978 will require the GAO to study and report on the prevalence 
of neonatal abstinence syndrome to help determine the size and scope of 
this prescription drug problem and its impact on newborns.
  Neonatal abstinence syndrome refers to a group of conditions that 
occur when a child is born addicted to narcotics and is going through 
withdrawal. This, unfortunately, affects my district in Florida and all 
over the country.
  I visited babies in the hospital. In 2013, during a drug summit in 
Pasco County, health officials discussed the growing problem of babies 
born addicted to prescription drugs. Pinellas County, my home county, 
at that time ranked first in the State for babies born addicted. We 
must do all we can to help those struggling infants and their families.
  This bill also includes two provisions I have worked on to reform 
Medicaid payments for abuse deterrent formulations and fight fraud in 
Medicare and Medicaid. Currently, Medicaid does not sufficiently cover 
abuse deterrent formulations for generic drugs. During a hearing, I 
spoke to Secretary Burwell about this problem, and she expressed to me 
the need for a legislative fix to this payment issue. This bill 
provides a solution and helps prevent drug abuse within Medicaid.
  This bill also includes a provision to protect the predictive 
analytic algorithm which identifies and prevents the payment of 
improper claims in Medicare. These tools, designed to prevent fraud, 
need to be protected from being disclosed to bad actors.
  Back in 2013, I introduced legislation to protect these predictive 
analytic algorithms from the Freedom of Information Act disclosure, and 
H.R. 4978 includes this important legislation.
  This legislation will help protect our newborns and all those facing 
prescription drug abuse and addiction.
  Mr. Speaker, again, I thank Representative Jenkins and the Energy and 
Commerce Committee, and I urge my colleagues to support H.R. 4978.
  Mr. GENE GREEN of Texas. Mr. Speaker, I reserve the balance of my 
time.
  Mr. GUTHRIE. Mr. Speaker, I yield 2 minutes to the gentleman from 
Kentucky (Mr. Barr), my good friend and fellow Kentuckian.
  Mr. BARR. Mr. Speaker, I thank my colleague from Kentucky (Mr. 
Guthrie) for his leadership on this issue, and I want to thank my 
colleague from West Virginia (Mr. Jenkins) for his leadership on this 
important legislation.
  Mr. Speaker, I rise today to encourage my colleagues to support his 
bill, H.R. 4978, the NAS Healthy Babies Act, which seeks to increase 
our understanding of neonatal abstinence syndrome and would help 
further strengthen best practices for treating this dangerous but 
preventable condition.
  According to the National Institute on Drug Abuse, there has been a 
dramatic increase in maternal opioid use; and as a tragic result, a 
baby is born suffering from neonatal abstinence syndrome, or NAS, every 
25 minutes in the United States.
  To help address this public health challenge, this legislation 
contains language drafted in coordination with my constituent, 
University of Kentucky pediatrician, Dr. Henrietta Bada-Ellzey, and 
members of the Sixth Congressional District Drug Abuse Task Force. 
Specifically, this provision would mandate a study which would gain 
critical data about the specific treatment options given to newborns 
with NAS during and after their hospital stay and identify treatment 
outcomes. This vital information would help lead pediatricians to 
provide improved care for the most vulnerable in our society.
  I would like to thank the leader's office and the Energy and Commerce 
Committee staff for giving me an opportunity to include this important 
recommendation from the Sixth Congressional District Drug Abuse Task 
Force in this legislation. The opioid heroin crisis in America impacts 
every congressional district, and my district is not immune. So I am 
proud that the people's House is taking up a series of important 
measures to combat this scourge in our society, and I can't think of 
any more important measure than dealing with these innocent victims of 
NAS.


                             General Leave

  Mr. GUTHRIE. Mr. Speaker, I ask unanimous consent that all Members 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials in the Record on the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Kentucky?
  There was no objection.
  Mr. GUTHRIE. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
Missouri (Mrs. Wagner), my good friend.
  Mrs. WAGNER. I thank the gentleman for yielding.
  Mr. Speaker, I rise today in support of the Nurturing and Supporting 
Healthy Babies Act, which will improve care for babies who are so sadly 
suffering from exposure to opioids while in their mother's womb.
  Hospital usage for opioid overuse in Missouri increased 137 percent 
between 2005 and 2014, with the highest rates being in the St. Louis 
region. We must do everything we can to combat this epidemic from all 
angles.
  Mr. Speaker, it is absolutely heartbreaking to stand in front of you 
knowing that in the United States an opioid-dependent baby is born 
every 20 minutes, immediately suffering from withdrawal: trembling, 
crying inconsolably, and clenching their tiny muscles as they gasp for 
breath.
  My principal mission as a Member of this Chamber is to provide a 
voice to the voiceless, and it is our duty to defend the most 
vulnerable. Ensuring babies have access to care and allowing them to 
recover from these horrible physical and emotional circumstances is not 
only common sense, but, Mr. Speaker, it is simply the right thing to 
do.
  Mr. Speaker, I urge the passage of H.R. 4978, and I thank 
Representative Evan Jenkins for introducing this legislation.

[[Page 5702]]


  Mr. GUTHRIE. Mr. Speaker, I yield 2 minutes to the gentleman from 
Georgia (Mr. Carter), my good friend.
  Mr. CARTER of Georgia. I thank the gentleman from Kentucky for 
yielding and for his work on this most important subject, as well as 
the gentleman from West Virginia.
  Mr. Speaker, I rise today in support of H.R. 4978, the NAS Healthy 
Babies Act because newborn infants deserve every opportunity to live a 
happy and healthy life.
  H.R. 4978 requires the Government Accountability Office to compile a 
report on the amount of babies born each year with NAS, Medicaid 
insurance coverage for families that have an NAS baby, and Federal 
obstacles for children who seek treatments for NAS. With this new 
information, we can increase our understanding of NAS and our ability 
to provide care for babies born with NAS. This new understanding is 
vital, considering the number of newborns with NAS has increased with 
the rise in the number of Americans addicted to opioids.
  As a lifelong pharmacist, I believe we should take every step 
possible to fight the addiction crisis in America, and the protection 
of our children should be our top priority. I encourage all of my 
colleagues to support this measure.
  Mr. GUTHRIE. Mr. Speaker, I yield such time as he may consume to the 
gentleman from Maine (Mr. Poliquin).
  Mr. POLIQUIN. Mr. Speaker, it cannot be said enough that every 25 
minutes in this great country, there is a baby born addicted to drugs. 
Last year alone, 1,000 of those babies were born in the great State of 
Maine.
  Now, 80 percent of these addicted infants are covered by Medicaid and 
treated at local hospitals, but our hospitals are overwhelmed. They are 
not equipped to provide the specialized care that these babies 
desperately need to recover from the drugs in their tiny bodies. I am 
very proud to serve as an original cosponsor of the Nurturing and 
Supporting Healthy Babies Act.

                              {time}  1715

  I am thrilled that this bill, Mr. Speaker, is being considered today 
on the floor. I want to congratulate Congressman Evan Jenkins from West 
Virginia, a Republican, and I want to congratulate Congresswoman Bustos 
from Illinois, a Democrat, for their leadership on this issue. This is 
not a political issue, Mr. Speaker. This is about our kids. This is 
about our babies. This is about that generation.
  H.R. 4978 made sure that we get the information we need as to how 
hospitals and other medical facilities are currently treating these 
addicted babies, such that we can fill in the gap with Medicaid 
coverage.
  Mr. Speaker, every baby born into this world deserves our compassion 
and our care. This bill offers real hope for a healthy and a safe and a 
loving start for thousands of American babies born addicted to drugs.
  Let's all get together and get this done, Mr. Speaker. This is not a 
political issue. This is about our kids.
  Mr. GENE GREEN from Texas. Mr. Speaker, I yield back the balance of 
my time.
  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.
  Ms. JACKSON LEE. Mr. Speaker, I rise in support of H.R. 4978, the 
``Nurturing & Supporting Healthy Babies Act,'' approved by the Energy 
and Commerce Committee.
  In the past decade and a half, the growth in the number of physicians 
prescribing opioids to help patients deal with pain from surgeries, 
dental work and chronic conditions has resulted in an increasing number 
of patients becoming dependent on the powerful and highly addictive 
painkillers--with patients not only abusing the use of those 
painkillers but often turning to heroin once their opioid prescription 
ended.
  The Centers for Disease Control and Prevention reports that nearly 
259 million opioid prescriptions were written in 2012, more than enough 
for every adult in the United States.
  It is estimated that in 2013 nearly 4.5 million people in the United 
States without a valid medical need were using prescription 
painkillers.
  The Health and Human Services Department estimates that the number of 
unintentional overdose deaths from prescription painkillers almost 
quadrupled between 1999 and 2013 and that abuse of prescription opioids 
now kills nearly 30,000 Americans each year.
  Both states and the federal government have begun responding to this 
growing public health crisis, with many states moving to make anti-
overdose drugs more available and shield first-responders from 
liability in administering those drugs.
  President Obama, meanwhile, has updated prescribing guidelines to 
encourage doctors to be more cautious when prescribing opioid 
painkillers and to emphasize non-opioid therapies for certain 
conditions.
  Additionally, the Obama administration has awarded $94 million to 
community health centers to improve and expand the delivery of 
substance abuse services.
  In the president's FY 2017 budget the administration proposed $1.1 
billion to combat drug addiction and is also considering modifying 
certain rules to improve treatment.
  Our counterparts in the Senate, on March 10, 2016, passed S. 524, an 
antiopioid abuse bill that would authorize grants for opioid treatment 
services and first-responder training in using anti-overdose drug by a 
94-1 vote, as well as create a task force to review and update best 
practices for prescribing pain medication.
  S. 524 also mandates investigations into heroin distribution and 
unlawful distribution of prescription opioids, and requires the 
creation of a national drug awareness campaign that takes into account 
the association between prescription opioid abuse and heroin use.
  The science indicates that opioids can have particularly harrowing 
effects on infants whose mothers took the drugs during pregnancy, 
including medical issues stemming from drug withdrawal known as 
neonatal abstinence syndrome.
  Advocacy groups note that the incidence of neonatal abstinence 
syndrome almost tripled from 1.20 per 1,000 hospital births in 2000 to 
3.39 per 1,000 hospital births in 2009.
  In conjunction with H.R. 4978, the ``Nurturing & Supporting Healthy 
Babies Act,'' the Congressional Budget Office (CBO) has estimated that 
45 percent of births in the United States are now covered by the joint 
federal-state Medicaid program.
  This bill directs the Government Accountability Office (GAO) to 
report to Congress on neonatal abstinence syndrome among children 
covered by Medicaid, including any federal barriers to treating such 
infants.
  The GAO must also provide recommendations for improvements that will 
ensure access to treatment for infants with neonatal abstinence 
syndrome under state Medicaid programs.
  Additionally, the measure modifies Medicaid to provide incentives for 
the development of abuse-deterrent formulations of prescription drugs 
and to prevent disclosure of Medicaid anti-fraud algorithms.
  The bill requires that GAO's report identify the prevalence of 
neonatal abstinence syndrome in the United States, including the 
proportion of affected children who are eligible for Medicaid at birth 
and the costs associated with neonatal abstinence syndrome.
  GAO will also be required to examine Medicaid-eligible services that 
are available for treatment of infants with neonatal abstinence 
syndrome, settings for such treatment, related reimbursement 
methodologies and costs, and the utilization of various care settings 
under state Medicaid programs for such treatment.
  This GAO's report must be submitted to Congress within one year of 
the bill's enactment.
  Seeking to right the same wrongs as H.R. 4978, the ``Nurturing And 
Supporting Healthy Babies Act,'' I introduced the, ``Stop Infant 
Mortality and Recidivism Reduction Act of 2016,'' or the ``SIMARRA 
Act,'' which will help the Federal Bureau of Prisons to improve the 
effectiveness and efficiency of the Federal prison system for pregnant 
offenders, by establishing a pilot program of critical-stage, 
developmental nurseries in Federal prisons for children born to 
inmates.
  It is time that our nation recognizes a long-persistent need to break 
the cycle of generational, institutional incarceration amongst mothers 
serving time for non-violent crimes and the children they birth behind 
prison bars.
  H.R. 5130, the, ``SIMARRA Act of 2016,'' gives those infants born to 
incarcerated mothers a chance to succeed in life.
  ``SIMARRA'' is not merely yet another second chance program, 
demanding leniency from the criminal justice system.
  Instead, H.R. 5130 asks our national criminal justice system what it 
can do for those

[[Page 5703]]

young Americans born and relegated to a life of nearly impossible odds 
of survival.
  ``SIMARRA'' provides that first chance--a first chance for American 
infants--that many of their mothers, born themselves to mothers behind 
bars, never received.
  The bill excludes abuse-deterrent formulations of prescription drugs 
from Medicaid's additional rebate requirement for new prescription drug 
formulations, which is intended to encourage the development of these 
drugs by allowing drug companies to reduce the rebates they otherwise 
must pay to Medicaid.
  The measure also limits disclosure of predictive modeling and other 
analytics technologies that are used to identify and prevent waste, 
fraud and abuse in Medicaid, including by exempting covered program 
integrity algorithms from the Freedom of Information Act (FOIA) and 
requiring state Medicaid and Children's Health Insurance Program (CHIP) 
agencies to have adequate data security policies to ensure the security 
of covered algorithms.
  Finally, the measure makes $5 million available to the Medicaid 
Improvement Fund for expenditures for FY 2021 and beyond.
  CBO estimates that enacting H.R. 4978 would not, on net, change 
direct spending over the 2017-2026 period.
  While opponents argue that some provisions of the bill will increase 
direct spending by $80 million over that period, I point out that other 
provisions would decrease direct spending by the same amount balancing 
the total cost.
  Enacting the legislation would affect direct spending, rather than 
revenues.
  Under current law, pharmaceutical manufacturers are required to pay 
rebates to states for prescription drugs provided through Medicaid.
  The formula which determines rebate amounts in the Medicaid program 
has several components, with some components generating rebates that 
are paid to states and shared with the federal government, and others 
generating rebates that are paid to states and subsequently transferred 
in their entirety to the federal government.
  Abuse deterrent formulation, or ADF, is a new technology that is 
being implemented by the pharmaceutical industry to prevent the abuse 
of prescription pain medications.
  For example, some ADFs make it more difficult for an individual to 
crush, break, or dissolve a drug to inappropriately extract and use its 
active ingredient.
  Under the bill, the component of the rebate formula that would no 
longer apply to ADFs of brand-name drugs is one that is paid to states 
and transferred in full to the federal government.
  Therefore, states would not be directly affected by this section of 
the bill.
  CBO estimates that this section would increase federal Medicaid costs 
by about $75 million over the 2017-2026 period by reducing rebates.
  CBO anticipates that an increasing number of ADFs of brand name drugs 
will launch over time; therefore, the component of the rebate affected 
by H.R. 4978 would also grow over time.
  CBO estimates that enacting the legislation would not increase net 
direct spending or on-budget deficits by more than $5 billion in any of 
the four consecutive 10-year periods beginning in 2026.
  H.R. 4978 contains no intergovernmental or private-sector mandate as 
defined in UMRA and would impose no costs on state, local, or tribal 
governments.
  In sum, H.R. 4978, the ``Nurturing & Supporting Healthy Babies Act,'' 
is a valuable piece of legislation that I encourage my colleagues to 
support.
  Additionally, I urge my colleagues to join me in sponsoring and 
supporting all legislation targeting the improvement of care for the 
prevention of infant abuse and neglect, such as H.R. 5130, the, ``Stop 
Infant Mortality and Recidivism Reduction Act of 2016'' or the 
``SIMARRA Act.''
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Kentucky (Mr. Guthrie) that the House suspend the rules 
and pass the bill, H.R. 4978, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  The title of the bill was amended so as to read: ``A bill 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.''.
  A motion to reconsider was laid on the table.

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