[Congressional Record Volume 162, Number 74 (Wednesday, May 11, 2016)]
[House]
[Pages H2259-H2263]
From the Congressional Record Online through the 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
[[Page H2260]]
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.
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
[[Page H2261]]
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 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
[[Page H2262]]
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.
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.
[[Page H2263]]
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 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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