[Congressional Record Volume 164, Number 97 (Tuesday, June 12, 2018)]
[House]
[Pages H5061-H5063]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ABUSE DETERRENT ACCESS ACT OF 2018
Mr. WALDEN. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 5582) to direct the Secretary of Health and Human Services
to conduct a study and submit a report on barriers to accessing abuse-
deterrent opioid formulations for individuals enrolled in a plan under
part C or D of the Medicare program, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows
H.R. 5582
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 at the ``Abuse Deterrent Access Act
of 2018''.
SEC. 2. STUDY ON ABUSE-DETERRENT OPIOID FORMULATIONS ACCESS
BARRIERS UNDER MEDICARE.
(a) In General.--Not later than one year after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall conduct a study and submit to Congress a
report on the adequacy of access to abuse-deterrent opioid
formulations for individuals with chronic pain enrolled in an
MA-PD plan under part C of title XVIII of the Social Security
Act or a prescription drug plan under part D of such title of
such Act, taking into account any barriers preventing such
individuals from accessing such formulations under such MA-PD
or part D plans, such as cost-sharing tiers, fail-first
requirements, the price of such formulations, and prior
authorization requirements.
(b) Definition of Abuse-deterrent Opioid Formulation.--In
this section, the term ``abuse-deterrent opioid formulation''
means an opioid that is a prodrug or that has certain abuse-
deterrent properties, such as physical or chemical barriers,
agonist or antagonist combinations, aversion properties,
delivery system mechanisms, or other features designed to
prevent abuse of such opioid.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Oregon (Mr. Walden) and the gentleman from New Jersey (Mr. Pallone)
each will control 20 minutes.
The Chair recognizes the gentleman from Oregon.
General Leave
Mr. WALDEN. Mr. Speaker, I ask unanimous consent that all Members may
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 Oregon?
There was no objection.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I want to commend Mr. Carter, Mr. Loebsack, and Mr.
Reed,
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bipartisan Members working together on legislation to develop the
bipartisan bill.
This Medicare program provides healthcare coverage to more than 58
million of our citizens. Serving the over-age-65 population, Medicare
accounts for a large share of total opioid prescriptions, as you might
imagine. While many Medicare beneficiaries with serious and very real
pain-related conditions are being properly prescribed opioids, we have
to be mindful of the potential dangers of diversion and misuse of these
very prescriptions.
There is no silver bullet in stopping the opioid crisis in this
country, but this legislation before us now will study one potential
tool for slowing misuse and diversion of opioids prescribed to the
chronic care population. Abuse-deterrent formulations have proven to
the Food and Drug Administration that they are harder to abuse because
of certain properties they contain.
While no abuse-deterrent formulation is 100 percent resistant to
abuse, I think we need to know what policies may be in place that would
limit patient access to these drugs for when they are the right option.
I believe this bill is important to inform future discussions on
these technologies, and I urge my colleagues to vote ``yes'' and pass
H.R. 5582.
I know Mr. Carter, again, our resident pharmacist, has been very
active in this effort.
House of Representatives,
Committee on Energy and Commerce,
Washington, DC, June 7, 2018.
Hon. Kevin Brady,
Chairman, Committee on Ways and Means,
Washington, DC.
Dear Chairman Brady: On May 9 and 17, 2018, the Committee
on Energy and Commerce ordered favorably reported over 50
bills to address the opioid epidemic facing communities
across our nation. Several of the bills were also referred to
the Committee on Ways and Means.
I ask that the Committee on Ways and Means not insist on
its referral of the following bills so that they may be
scheduled for consideration by the Majority Leader:
H.R. 1925, At-Risk Youth Medicaid Protection Act of 2017;
H.R. 3331, To amend title XI of the Social Security Act to
promote testing of incentive payments for behavioral health
providers for adoption and use of certified electronic health
record technology;
H.R. 3528, Every Prescription Conveyed Securely Act;
H.R. 4841, Standardizing Electronic Prior Authorization for
Safe Prescribing Act of 2018;
H.R. 5582, Abuse Deterrent Access Act of 2018;
H.R. 5590, Opioid Addiction Action Plan Act;
H.R. 5603, Access to Telehealth Services for Opioid Use
Disorder;
H.R. 5605, Advancing High Quality Treatment for Opioid Use
Disorders in Medicare Act;
H.R. 5675, To amend title XVIII of the Social Security Act
to require prescription drug plan sponsors under the Medicare
program to establish drug management programs for at-risk
beneficiaries;
H.R. 5684, Protecting Seniors from Opioid Abuse Act;
H.R. 5685, Medicare Opioid Safety Education Act;
H.R. 5686, Medicare Clear Health Options in Care for
Enrollees (CHOICE) Act; o H.R. 5715, Strengthening
Partnerships to Prevent Opioid Abuse Act;
H.R. 5715, Strengthening Partnerships to Prevent Opioid
Abuse Act;
H.R. 5716, Commit to Opioid Medical Prescriber
Accountability and Safety for Seniors (COMPASS) Act;
H.R. 5796, Responsible Education Achieves Care and Healthy
Outcomes for Users' Treatment (REACH OUT) Act of 2018;
H.R. 5798, Opioid Screening and Chronic Pain Management
Alternatives for Seniors Act;
H.R. 5804, Post-Surgical Injections as an Opioid
Alternative Act; and
H.R. 5809, Postoperative Opioid Prevention Act of 2018.
This concession in no way affects your jurisdiction over
the subject matter of these bills, and it will not serve as
precedent for future referrals. In addition, should a
conference on the bills be necessary, I would support your
request to have the Committee on Ways and Means on the
conference committee. Finally, I would be pleased to include
this letter and your response in the bill reports and the
Congressional Record.
Thank you for your consideration of my request and for the
extraordinary cooperation shown by you and your staff over
matters of shared jurisdiction. I look forward to further
opportunities to work with you this Congress.
Sincerely,
Greg Walden,
Chairman.
____
House of Representatives,
Committee on Ways and Means,
Washington, DC, June 8, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce,
Washington, DC.
Dear Chairman Walden: Thank you for your letter concerning
several bills favorably reported out of the Committee on
Energy and Commerce to address the opioid epidemic and which
the Committee on Ways and Means was granted an additional
referral.
As a result of your having consulted with us on provisions
within these bills that fall within the Rule X jurisdiction
of the Committee on Ways and Means, I agree to waive formal
consideration of the following bills so that they may move
expeditiously to the floor:
H.R. 1925, At-Risk Youth Medicaid Protection Act of 2017;
H.R. 3331, To amend title XI of the Social Security Act to
promote testing of incentive payments for behavioral health
providers for adoption and use of certified electronic health
record technology;
H.R. 3528, Every Prescription Conveyed Securely Act;
H.R. 4841, Standardizing Electronic Prior Authorization for
Safe Prescribing Act of 2018;
H.R. 5582, Abuse Deterrent Access Act of 2018;
H.R. 5590, Opioid Addiction Action Plan Act;
H.R. 5603, Access to Telehealth Services for Opioid Use
Disorder;
H.R. 5605, Advancing High Quality Treatment for Opioid Use
Disorders in Medicare Act;
H.R. 5675, To amend title XVIII of the Social Security Act
to require prescription drug plan sponsors under the Medicare
program to establish drug management programs for at-risk
beneficiaries;
H.R. 5684, Protecting Seniors from Opioid Abuse Act;
H.R. 5685, Medicare Opioid Safety Education Act;
H.R. 5686, Medicare Clear Health Options in Care for
Enrollees (CHOICE) Act;
H.R. 5715, Strengthening Partnerships to Prevent Opioid
Abuse Act;
H.R. 5716, Commit to Opioid Medical Prescriber
Accountability and Safety for Seniors (COMPASS) Act;
H.R. 5796, Responsible Education Achieves Care and Healthy
Outcomes for Users' Treatment (REACH OUT) Act of 2018;
H.R. 5798, Opioid Screening and Chronic Pain Management
Alternatives for Seniors Act;
H.R. 5804, Post-Surgical Injections as an Opioid
Alternative Act; and
H.R. 5809, Postoperative Opioid Prevention Act of 2018.
The Committee on Ways and Means takes this action with the
mutual understanding that we do not waive any jurisdiction
over the subject matter contained in this or similar
legislation, and the Committee will be appropriately
consulted and involved as the bill or similar legislation
moves forward so that we may address any remaining issues
that fall within our jurisdiction. The Committee also
reserves the right to seek appointment of an appropriate
number of conferees to any House-Senate conference involving
this or similar legislation and requests your support for
such a request.
Finally, I would appreciate your commitment to include this
exchange of letters in the bill reports and the Congressional
Record.
Sincerely,
Kevin Brady,
Chairman.
Mr. WALDEN. Mr. Speaker, I yield such time as he may consume to the
gentleman from Georgia (Mr. Carter), an incredibly important member of
our committee.
Mr. CARTER of Georgia. Mr. Speaker, I thank the gentleman for
yielding.
Mr. Speaker, each year, approximately 4\1/2\ million Americans use
prescription pain medications for nonmedical purposes, contributing to
89 deaths per day. Of those who misuse prescription pain relievers, 53
percent reported obtaining them from friends or relatives.
Although past legislative efforts have encouraged innovation in
prescription drug regulation, law enforcement, and education, there are
still individuals who have severe, legitimate chronic pain and need
access to opioids.
Abuse-deterrent formulations, ADFs, represent a breakthrough
technology for these individuals that helps prevent the crushing, the
snorting, and the injection of painkillers. Currently, many
prescription drug plans present barriers to ADFs, including cost-
sharing tiers, fail-first requirements, pricing, and prior
authorization requirements, all limiting patient access to abuse-
deterrent formulations.
This legislation directs the Secretary of Health and Human Services
to conduct a study on barriers to accessing abuse-deterrent
formulations for chronic pain patients enrolled in Medicare. Solutions
to this public health crisis must balance the need to preserve access
to effective pain medications for legitimate patients living with pain
while minimizing the risk of
[[Page H5063]]
opioid misuse and abuse that occurs in our communities.
I am proud to introduce this legislation with my colleague across the
aisle, Representative Loebsack, and my Ways and Means colleague,
Representative Reed. I urge Members' support.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, this bill would require the Department of Health and
Human Services to conduct a study and submit to Congress a report on
the adequacy of access to abuse-deterrent opioid formulations for
individuals with chronic pain enrolled in Medicare Advantage or part D.
{time} 1715
While I am hesitant about the true impact abuse-deterrent
formulations can have in addressing this crisis, especially given that
these formulations can still lead to opioid dependance and misuse, I
also recognize that we must be utilizing every tool available to combat
this epidemic.
I am especially glad that this bill includes language to address the
price of abuse-deterrent formulations as well. It is critical, when
evaluating the adequacy of access, to also study the price of such drug
formulations, as cost is a critical component of access.
Mr. Speaker, I support the bill, and I urge my colleagues to support
the bill.
I yield back the balance of my time.
Mr. WALDEN. Mr. Speaker, I urge the same, and I yield back the
balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Oregon (Mr. Walden) that the House suspend the rules and
pass the bill, H.R. 5582, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
____________________