I 

115TH CONGRESS 

1ST SESSION H. R. 4482 

To deter opioid abuse and addiction, to establish additional registration requirements for prescribers of opioids, to encourage the development of 

abuse-deterrent formulations, to require a study and report on policy 

changes that may have contributed to the opioid epidemic, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 29, 2017 

Mr. MEADOWS (for himself and Mr. RENACCI) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To deter opioid abuse and addiction, to establish additional 

registration requirements for prescribers of opioids, to 

encourage the development of abuse-deterrent formulations, to require a study and report on policy changes 

that may have contributed to the opioid epidemic, and 

for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Opioid Abuse Deter3 rence, Research, and Recovery Act of 2017’’. 

4 SEC. 2. REGISTRATION REQUIREMENTS FOR PRESCRIBERS. 

5 Section 303 of the Controlled Substances Act (21 

6 U.S.C. 823) is amended by adding at the end the fol7 lowing: 

8 ‘‘(k)(1) The Attorney General shall not register, or 

9 renew the registration of, a practitioner under subsection 

10 (f) who is licensed under State law to prescribe controlled 

11 substances in schedule II or III, unless the practitioner 

12 submits to the Attorney General, for each such registra13 tion or renewal request, a certification that the practi14 tioner, during the applicable registration period, except as 

15 provided in paragraph (2), will not prescribe any schedule 

16 II or III opioid for the initial treatment of acute pain in 

17 an amount in excess of the lesser of— 

18 ‘‘(A) a 7-day supply (for which no refill is avail19 able); or 

20 ‘‘(B) an opioid prescription limit established 

21 under the law of the State where the prescribing oc22 curs. 

23 ‘‘(2) The certification required by paragraph (1) shall 

24 not prohibit a practitioner from— 

25 ‘‘(A) prescribing, for the treatment of an opioid 

26 use disorder, a schedule II or III opioid that is apVerDate Sep 11 2014 04:08 Nov 30, 2017 Jkt 079200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4482.IH H4482

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1 proved by the Food and Drug Administration for 

2 such treatment; 

3 ‘‘(B) prescribing, for immediate, post-operative 

4 pain relief, a schedule II or III opioid; or 

5 ‘‘(C) prescribing a schedule II or III opioid in 

6 an amount in excess of a 7-day supply if the practi7 tioner— 

8 ‘‘(i) provides a specific reason for exceed9 ing the 7-day limit that is in accordance with 

10 a clear medical standard of care whose imple11 mentation necessarily exceeds such limit; 

12 ‘‘(ii) documents such reason and medical 

13 standard of care in the patient’s medical record; 

14 and 

15 ‘‘(iii) consults the applicable State’s elec16 tronic health record system or prescription drug 

17 monitoring program. 

18 ‘‘(3) In this subsection, the term ‘acute pain’— 

19 ‘‘(A) means pain with abrupt onset and caused 

20 by an injury or other process that is diagnostically 

21 determined to have minimal risk of escalating in in22 tensity; and 

23 ‘‘(B) does not include— 

24 ‘‘(i) chronic pain; 


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1 ‘‘(ii) pain being treated as part of cancer 

2 care; 

3 ‘‘(iii) hospice or other end-of-life care; or 

4 ‘‘(iv) pain being treated as part of pallia5 tive care.’’. 

6 SEC. 3. ENCOURAGING DEVELOPMENT OF ABUSE-DETER7 RENT FORMULATIONS. 

8 The Commissioner of Food and Drugs shall continue 

9 to work with stakeholders to encourage the development 

10 of opioid formulations with abuse-deterrent properties. 

11 SEC. 4. GAO STUDY AND REPORT ON POLICY CHANGES 

12 THAT MAY HAVE CONTRIBUTED TO THE 

13 OPIOID EPIDEMIC. 

14 Not later than 2 years after the date of enactment 

15 of this Act, the Comptroller General of the United States 

16 shall complete a study and submit a report to Congress 

17 on health care policy changes that may have contributed 

18 to the increase in opioid overdoses and deaths during the 

19 10 years preceding the date of enactment of this Act. Such 

20 study shall include— 

21 (1) a review of health care-related legislative, 

22 administrative, and judicial decisions by officers and 

23 employees of the Federal Government that have af24 fected access to pain management strategies with an 

25 emphasis on pharmaceuticals; 


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1 (2) an analysis of what is known about the 

2 costs and benefits, whether financial or non-finan3 cial, of reversing or revising such decisions individ4 ually or in combination, including whether the rever5 sals or revisions would be expected to achieve a re6 duction in abuse of, addiction to, overdose on, and 

7 death from opioids; 

8 (3) an analysis of the differences among State9 based prescription drug monitoring programs, in10 cluding an analysis of what is known about the ef11 fects of such differences on monitoring for abuse of, 

12 addiction to, overdose on, and death from opioids; 

13 (4) an analysis of what is known about positive 

14 and negative impacts that prescribing limitations, 

15 both State and Federal, have on patient medical out16 comes, including for chronic pain patients; and 

17 (5) an analysis of what is known about the 

18 costs to payers of using abuse-deterrent formulations 

19 of opioid pain medications, compared to opioid pain 

20 medications without abuse-deterrent features. 

21 SEC. 5. STUDY ON FEASIBILITY OF REPLACING STATUTORY 

22 LIMITS WITH CLINICAL GUIDELINES ON 

23 OPIOID PRESCRIBING. 

24 The Commissioner of Food and Drugs shall— 

25 (1) conduct a study on the feasibility of— 


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1 (A) replacing the prescribing limits in sec2 tion 303(k)(1) of the Controlled Substances 

3 Act, as added by section 2 of this Act, with evi4 dence-based clinical guidelines to inform opioid 

5 selection, dosage, duration, follow up, and dis6 continuation, including guidelines on the first 

7 opioid prescription for patients for an acute 

8 pain diagnosis to ensure that no greater quan9 tity than needed is prescribed for the expected 

10 duration of pain severe enough to require 

11 opioids; and 

12 (B) the incorporation into routine medical 

13 visits of evidence-based screening tools for the 

14 misuse of opioids and other controlled sub15 stances; and 

16 (2) not later than the date that is 2 years after 

17 the date of enactment of this Act, submit to the 

18 Congress, and post on the public website of the Food 

19 and Drug Administration, a report on the results of 

20 such study. 

Æ 


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