[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,

[[Page H5062]]

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.

                          ____________________