I 

114TH CONGRESS 

2D SESSION H. R. 4697 

To provide for increased Federal oversight of prescription opioid treatment 

and assistance to States in reducing opioid addiction, diversion, and deaths. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 3, 2016 

Ms. ESTY (for herself, Mr. COSTELLO of Pennsylvania, and Mr. KNIGHT) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and 

Means and 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 provide for increased Federal oversight of prescription 

opioid treatment and assistance to States in reducing 

opioid addiction, diversion, and deaths. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prevent Drug Addic5 tion Act of 2016’’. 


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1 SEC. 2. CONSUMER EDUCATION CAMPAIGN. 

2 Part A of title V of the Public Health Service Act 

3 (42 U.S.C. 290aa et seq.) is amended by adding at the 

4 end the following: 

5 ‘‘SEC. 506C. CONSUMER EDUCATION CAMPAIGN. 

6 ‘‘(a) IN GENERAL.—The Administrator shall award 

7 grants to States and nonprofit entities for the purpose of 

8 conducting culturally sensitive consumer education about 

9 opioid addiction, including methadone addiction. Such 

10 education shall include information on the dangers of 

11 opioid addiction, how to prevent opioid addiction including 

12 through safe disposal of prescription medications and 

13 other safety precautions, and detection of early warning 

14 signs of addiction. 

15 ‘‘(b) ELIGIBILITY.—To be eligible to receive a grant 

16 under subsection (a), an entity shall— 

17 ‘‘(1) be a State or nonprofit entity; and 

18 ‘‘(2) submit to the Administrator an application 

19 at such time, in such manner, and containing such 

20 information as the Administrator may require. 

21 ‘‘(c) PRIORITY.—In awarding grants under this sec22 tion, the Administrator shall give priority to applicants 

23 that are States or communities with a high incidence of 

24 addiction to methadone and other opioids, and opioid-re25 lated deaths. 


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1 ‘‘(d) EVALUATIONS.—The Administrator shall de2 velop a process to evaluate the effectiveness of activities 

3 carried out by grantees under this section at reducing ad4 diction to methadone and other opioids. 

5 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 

6 is authorized to be appropriated to carry out this section 

7 $15,000,000 for each of fiscal years 2017 through 2021.’’. 

8 SEC. 3. PRACTITIONER EDUCATION. 

9 (a) EDUCATION REQUIREMENTS.— 

10 (1) REGISTRATION CONSIDERATION.—Section 

11 303(f) of the Controlled Substances Act (21 U.S.C. 

12 823(f)) is amended by inserting after paragraph (5) 

13 the following: 

14 ‘‘(6) The applicant’s compliance with the train15 ing requirements described in subsection (g)(3) dur16 ing any previous period in which the applicant has 

17 been subject to such training requirements.’’. 

18 (2) TRAINING REQUIREMENTS.—Section 303(g) 

19 of the Controlled Substances Act (21 U.S.C. 823(g)) 

20 is amended by adding at the end the following: 

21 ‘‘(3)(A) To be registered to prescribe or otherwise 

22 dispense methadone or other opioids, a practitioner de23 scribed in paragraph (1) shall comply with the 12-hour 

24 training requirement of subparagraph (B) at least once 

25 during each 3-year period. 


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1 ‘‘(B) The training requirement of this subparagraph 

2 is that the practitioner has completed not less than 12 

3 hours of training (through classroom situations, seminars 

4 at professional society meetings, electronic communica5 tions, or otherwise) with respect to— 

6 ‘‘(i) the treatment and management of opioid7 dependent patients; 

8 ‘‘(ii) pain management treatment guidelines; 

9 and 

10 ‘‘(iii) early detection of opioid addiction, includ11 ing through such methods as Screening, Brief Inter12 vention, and Referral to Treatment (SBIRT), 

13 that is provided by the American Society of Addiction 

14 Medicine, the American Academy of Addiction Psychiatry, 

15 the American Medical Association, the American Osteo16 pathic Association, the American Psychiatric Association, 

17 the American Academy of Pain Management, the Amer18 ican Pain Society, the American Academy of Pain Medi19 cine, the American Board of Pain Medicine, the American 

20 Society of Interventional Pain Physicians, or any other or21 ganization that the Secretary determines is appropriate 

22 for purposes of this subparagraph.’’. 

23 (b) REQUIREMENTS FOR PARTICIPATION IN OPIOID

24 TREATMENT PROGRAMS.—Effective July 1, 2017, a phy25 sician practicing in an opioid treatment program shall 


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1 comply with the requirements of section 303(g)(3) of the 

2 Controlled Substances Act (as added by subsection (a)) 

3 with respect to required minimum training at least once 

4 during each 3-year period. 

5 (c) DEFINITION.—In this section, the term ‘‘opioid 

6 treatment program’’ has the meaning given such term in 

7 section 8.2 of title 42, Code of Federal Regulations (or 

8 any successor regulation). 

9 (d) FUNDING.—The Drug Enforcement Administra10 tion shall fund the enforcement of the requirements speci11 fied in section 303(g)(3) of the Controlled Substances Act 

12 (as added by subsection (a)) through the use of a portion 

13 of the licensing fees paid by controlled substance pre14 scribers under the Controlled Substances Act (21 U.S.C. 

15 801 et seq.). 

16 SEC. 4. OPERATION OF OPIOID TREATMENT PROGRAMS. 

17 Section 303 of the Controlled Substances Act (21 

18 U.S.C. 823) is amended by adding at the end the fol19 lowing: 

20 ‘‘(i)(1) An opioid treatment program that is reg21 istered under this section, and that closes for business on 

22 any weekday or weekend day, including a Federal or State 

23 holiday, shall comply with the requirements of this sub24 section. 


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1 ‘‘(2) The program shall make acceptable arrange2 ments for each patient who is restricted, by Federal regu3 lation or guideline or by the determination of the program 

4 medical director, from having a take-home dose of a con5 trolled substance related to the treatment involved, to re6 ceive a dose of that substance under appropriate super7 vision during the closure. 

8 ‘‘(3) The Administrator of the Substance Abuse and 

9 Mental Health Services Administration shall issue a notice 

10 that references regulations on acceptable arrangements 

11 under this subsection, or shall promulgate regulations on 

12 such acceptable arrangements.’’. 

13 SEC. 5. MORTALITY REPORTING. 

14 Part A of title V of the Public Health Service Act 

15 (42 U.S.C. 290aa et seq.), as amended by section 3, is 

16 further amended by adding at the end the following: 

17 ‘‘SEC. 506D. MORTALITY REPORTING. 

18 ‘‘(a) MODEL OPIOID TREATMENT PROGRAM MOR19 TALITY REPORT.— 

20 ‘‘(1) IN GENERAL.—Not later than July 1, 

21 2017, the Secretary, acting through the Adminis22 trator, shall require that a Model Opioid Treatment 

23 Program Mortality Report be completed and sub24 mitted to the Administrator for each individual who 


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1 dies while receiving treatment in an opioid treatment 

2 program. 

3 ‘‘(2) REQUIREMENT OF STATES THAT RECEIVE

4 FUNDING FOR THE CONTROLLED SUBSTANCE MONI5 TORING PROGRAM.—As a condition for receiving 

6 funds under section 399O, each State shall require 

7 that any individual who signs a death certificate 

8 where an opioid drug is detected in the body of the 

9 deceased, or where such drug is otherwise associated 

10 with the death, report such death to the Adminis11 trator by submitting a Model Opioid Treatment Pro12 gram Mortality Report described in paragraph (3). 

13 Such report shall be submitted to the Administrator 

14 on or before the later of— 

15 ‘‘(A) 90 days after the date of signing the 

16 death certificate; or 

17 ‘‘(B) as soon as practicable after the date 

18 on which the necessary postmortem and toxi19 cology reports become available to such indi20 vidual, as required by the Secretary. 

21 ‘‘(3) DEVELOPMENT.—The Administrator, in 

22 consultation with State and local medical examiners, 

23 prescribing physicians, hospitals, and any other or24 ganization that the Administrator determines appro25 priate, shall develop a Model Opioid Treatment ProVerDate Sep 11 2014 18:14 Mar 04, 2016 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4697.IH H4697

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1 gram Mortality Report to be used under paragraphs 

2 (1) and (2). 

3 ‘‘(b) NATIONAL OPIOID DEATH REGISTRY.— 

4 ‘‘(1) IN GENERAL.—Not later than July 1, 

5 2017, the Administrator shall establish and imple6 ment, through the National Center for Health Sta7 tistics, a National Opioid Death Registry (referred 

8 to in this subsection as the ‘Registry’) to track 

9 opioid-related deaths and information related to such 

10 deaths. 

11 ‘‘(2) CONSULTATION.—In establishing the uni12 form reporting criteria for the Registry, the Director 

13 of the Centers for Disease Control and Prevention 

14 shall consult with the Administrator, State and local 

15 medical examiners, prescribing physicians, hospitals, 

16 and any other organization that the Director deter17 mines is appropriate for purposes of this subsection. 

18 ‘‘(3) REQUIREMENTS.—The registry shall be 

19 designed as a uniform reporting system for opioid20 related deaths and shall require the reporting of in21 formation with respect to such deaths, including— 

22 ‘‘(A) the particular drug formulation used 

23 at the time of death; 

24 ‘‘(B) the dosage level; 


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1 ‘‘(C) a description of the circumstances 

2 surrounding the death in relation to the rec3 ommended dosage involved; 

4 ‘‘(D) a disclosure of whether the medica5 tion involved can be traced back to a physi6 cian’s prescription; 

7 ‘‘(E) a disclosure of whether the individual 

8 was in an opioid treatment program at the time 

9 of death; 

10 ‘‘(F) the age and sex of the individual; and 

11 ‘‘(G) other nonpersonal information such 

12 as that included in filed National Association of 

13 Medical Examiners Pediatric Toxicology Reg14 istry case reports as required under the privacy 

15 standard for the de-identification of health in16 formation pursuant to the regulations contained 

17 in part 164 of title 45, Code of Federal Regula18 tions. 

19 ‘‘(4) AUTHORIZATION.—There is authorized to 

20 be appropriated $5,000,000 for each of fiscal years 

21 2017 through 2021 to carry out this subsection. 

22 ‘‘(c) REPORT ON REGISTRY INFORMATION.—Not 

23 later than the January 1 of the first fiscal year beginning 

24 2 years after the date of enactment of this section, and 

25 each January 1 thereafter, the Director of the Centers for 


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1 Disease Control and Prevention shall submit to the Sec2 retary a report, based on information contained in the 

3 Registry described in subsection (b), concerning the num4 ber of methadone-related deaths in the United States for 

5 the year for which the report is submitted.’’. 

6 SEC. 6. DEVELOPMENT OF PRESCRIPTION DRUG ADDIC7 TION PREVENTION AND TREATMENT QUAL8 ITY MEASURES ACROSS EACH RELEVANT 

9 PROVIDER SETTING. 

10 Subpart I of part D of title IX of the Public Health 

11 Service Act (42 U.S.C. 299b–31 et seq.) is amended by 

12 adding at the end the following: 

13 ‘‘SEC. 932. DEVELOPMENT OF PRESCRIPTION DRUG ADDIC14 TION PREVENTION AND TREATMENT QUAL15 ITY MEASURES ACROSS EACH RELEVANT 

16 PROVIDER SETTING. 

17 ‘‘(a) IN GENERAL.—The Secretary, acting through 

18 the Director of the Agency for Healthcare Research and 

19 Quality and in consultation with the Director of the Cen20 ters for Disease Control and Prevention, the Adminis21 trator of the Substance Abuse and Mental Health Services 

22 Administration, and the Director of the Centers for Medi23 care & Medicaid Services, shall require the development 

24 and application of specific prescription drug addiction preVerDate Sep 11 2014 18:14 Mar 04, 2016 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4697.IH H4697

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1 vention and treatment quality measures for each relevant 

2 health care provider setting, as identified by the Director. 

3 ‘‘(b) DISSEMINATION.—Not later than April 1, 2017, 

4 the Secretary shall disseminate the quality measure re5 quirements developed under subsection (a) to all affected 

6 providers. 

7 ‘‘(c) TYPES OF MEASURES.—Quality measures devel8 oped under this section may be structure-oriented (such 

9 as the required presence of a hospital-based treatment 

10 program), process-oriented (such as requiring patients to 

11 be informed of the addictive qualities of the medication 

12 being prescribed), or outcome-oriented (such as assessing 

13 family satisfaction with care).’’. 

14 SEC. 7. PROGRAMS TO PREVENT PRESCRIPTION DRUG AD15 DICTION UNDER MEDICARE PART D. 

16 (a) DRUG MANAGEMENT PROGRAM FOR AT-RISK

17 BENEFICIARIES.— 

18 (1) IN GENERAL.—Section 1860D–4(c) of the 

19 Social Security Act (42 U.S.C. 1395w–10(c)) is 

20 amended by adding at the end the following: 

21 ‘‘(4) DRUG MANAGEMENT PROGRAM FOR AT22 RISK BENEFICIARIES.— 

23 ‘‘(A) AUTHORITY TO ESTABLISH.—A PDP 

24 sponsor may establish a drug management pro25 gram for at-risk beneficiaries under which, subVerDate Sep 11 2014 18:14 Mar 04, 2016 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4697.IH H4697

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1 ject to subparagraph (B), the PDP sponsor 

2 may, in the case of an at-risk beneficiary for 

3 prescription drug addiction who is an enrollee 

4 in a prescription drug plan of such PDP spon5 sor, limit such beneficiary’s access to coverage 

6 for addictive drugs under such plan to addictive 

7 drugs that are prescribed for such beneficiary 

8 by a prescriber selected under subparagraph 

9 (D), and dispensed for such beneficiary by a 

10 pharmacy selected under such subparagraph. 

11 ‘‘(B) REQUIREMENT FOR NOTICES.— 

12 ‘‘(i) IN GENERAL.—A PDP sponsor 

13 may not limit the access of an at-risk ben14 eficiary for prescription drug addiction to 

15 coverage for addictive drugs under a pre16 scription drug plan until such sponsor— 

17 ‘‘(I) provides to the beneficiary 

18 an initial notice described in clause 

19 (ii) and a second notice described in 

20 clause (iii); and 

21 ‘‘(II) verifies with the providers 

22 of the beneficiary that the beneficiary 

23 is an at-risk beneficiary for prescrip24 tion drug addiction. 


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1 ‘‘(ii) INITIAL NOTICE.—An initial no2 tice described in this clause is a notice that 

3 provides to the beneficiary— 

4 ‘‘(I) notice that the PDP sponsor 

5 has identified the beneficiary as po6 tentially being an at-risk beneficiary 

7 for prescription drug addiction; 

8 ‘‘(II) information describing all 

9 State and Federal public health re10 sources that are designed to address 

11 prescription drug addiction to which 

12 the beneficiary has access, including 

13 mental health services and other coun14 seling services; 

15 ‘‘(III) notice of, and information 

16 about, the right of the beneficiary to 

17 appeal such identification under sub18 section (h) and the option of an auto19 matic escalation to external review; 

20 ‘‘(IV) a request for the bene21 ficiary to submit to the PDP sponsor 

22 preferences for which prescribers and 

23 pharmacies the beneficiary would pre24 fer the PDP sponsor to select under 

25 subparagraph (D) in the case that the 


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1 beneficiary is identified as an at-risk 

2 beneficiary for prescription drug ad3 diction as described in clause (iii)(I); 

4 ‘‘(V) an explanation of the mean5 ing and consequences of the identi6 fication of the beneficiary as poten7 tially being an at-risk beneficiary for 

8 prescription drug addiction, including 

9 an explanation of the drug manage10 ment program established by the PDP 

11 sponsor pursuant to subparagraph 

12 (A); 

13 ‘‘(VI) clear instructions that ex14 plain how the beneficiary can contact 

15 the PDP sponsor in order to submit 

16 to the PDP sponsor the preferences 

17 described in subclause (IV) and any 

18 other communications relating to the 

19 drug management program for at-risk 

20 beneficiaries established by the PDP 

21 sponsor; and 

22 ‘‘(VII) contact information for 

23 other organizations that can provide 

24 the beneficiary with assistance regard25 ing such drug management program 


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1 (similar to the information provided 

2 by the Secretary in other standardized 

3 notices provided to part D eligible in4 dividuals enrolled in prescription drug 

5 plans under this part). 

6 ‘‘(iii) SECOND NOTICE.—A second no7 tice described in this clause is a notice that 

8 provides to the beneficiary notice— 

9 ‘‘(I) that the PDP sponsor has 

10 identified the beneficiary as an at-risk 

11 beneficiary for prescription drug ad12 diction; 

13 ‘‘(II) that such beneficiary is 

14 subject to the requirements of the 

15 drug management program for at-risk 

16 beneficiaries established by such PDP 

17 sponsor for such plan; 

18 ‘‘(III) of the prescriber and phar19 macy selected for such individual 

20 under subparagraph (D); 

21 ‘‘(IV) of, and information about, 

22 the beneficiary’s right to appeal such 

23 identification under subsection (h) 

24 and the option of an automatic esca25 lation to external review; 


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1 ‘‘(V) that the beneficiary can, in 

2 the case that the beneficiary has not 

3 previously submitted to the PDP 

4 sponsor preferences for which pre5 scribers and pharmacies the bene6 ficiary would prefer the PDP sponsor 

7 select under subparagraph (D), sub8 mit such preferences to the PDP 

9 sponsor; and 

10 ‘‘(VI) that includes clear instruc11 tions that explain how the beneficiary 

12 can contact the PDP sponsor. 

13 ‘‘(iv) TIMING OF NOTICES.— 

14 ‘‘(I) IN GENERAL.—Subject to 

15 subclause (II), a second notice de16 scribed in clause (iii) shall be provided 

17 to the beneficiary on a date that is 

18 not less than 60 days after an initial 

19 notice described in clause (ii) is pro20 vided to the beneficiary. 

21 ‘‘(II) EXCEPTION.—In the case 

22 that the PDP sponsor, in conjunction 

23 with the Secretary, determines that 

24 concerns identified through rule25 making by the Secretary regarding 


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1 the health or safety of the beneficiary 

2 or regarding significant drug diversion 

3 activities require the PDP sponsor to 

4 provide a second notice described in 

5 clause (iii) to the beneficiary on a 

6 date that is earlier than the date de7 scribed in subclause (II), the PDP 

8 sponsor may provide such second no9 tice on such earlier date. 

10 ‘‘(C) AT-RISK BENEFICIARY FOR PRE11 SCRIPTION DRUG ADDICTION.— 

12 ‘‘(i) IN GENERAL.—For purposes of 

13 this paragraph, the term ‘at-risk bene14 ficiary for prescription drug addiction’ 

15 means a part D eligible individual who is 

16 not an exempted individual described in 

17 clause (ii) and— 

18 ‘‘(I) who is identified through the 

19 use of guidelines developed by the 

20 Secretary in consultation with PDP 

21 sponsors and other stakeholders de22 scribed in section 10(f)(2)(A) of the 

23 Prevent Drug Addiction Act of 2016; 

24 or 


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1 ‘‘(II) with respect to whom the 

2 PDP sponsor of a prescription drug 

3 plan, upon enrolling such individual in 

4 such plan, received notice from the 

5 Secretary that such individual was 

6 identified under this paragraph to be 

7 an at-risk beneficiary for prescription 

8 drug addiction under the prescription 

9 drug plan in which such individual 

10 was most recently previously enrolled 

11 and such identification has not been 

12 terminated under subparagraph (F). 

13 ‘‘(ii) EXEMPTED INDIVIDUAL DE14 SCRIBED.—An exempted individual de15 scribed in this clause is an individual 

16 who— 

17 ‘‘(I) receives hospice care under 

18 this title; or 

19 ‘‘(II) the Secretary elects to treat 

20 as an exempted individual for pur21 poses of clause (i). 

22 ‘‘(D) SELECTION OF PRESCRIBERS.— 

23 ‘‘(i) IN GENERAL.—With respect to 

24 each at-risk beneficiary for prescription 

25 drug addiction enrolled in a prescription 


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1 drug plan offered by such sponsor, a PDP 

2 sponsor shall, based on the preferences 

3 submitted to the PDP sponsor by the ben4 eficiary pursuant to clauses (ii)(IV) and 

5 (iii)(V) of subparagraph (B), select— 

6 ‘‘(I) one or more individuals who 

7 are authorized to prescribe addictive 

8 drugs (referred to in this paragraph 

9 as ‘prescribers’) who may write pre10 scriptions for such drugs for such 

11 beneficiary; and 

12 ‘‘(II) one or more pharmacies 

13 that may dispense such drugs to such 

14 beneficiary. 

15 ‘‘(ii) REASONABLE ACCESS.—In mak16 ing the selection under this subparagraph, 

17 a PDP sponsor shall ensure that the bene18 ficiary continues to have reasonable access 

19 to drugs described in subparagraph (G), 

20 taking into account geographic location, 

21 beneficiary preference, affordability, and 

22 reasonable travel time. 

23 ‘‘(iii) BENEFICIARY PREFERENCES.— 

24 ‘‘(I) IN GENERAL.—If an at-risk 

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1 diction submits preferences for which 

2 in-network prescribers and pharmacies 

3 the beneficiary would prefer the PDP 

4 sponsor select in response to a notice 

5 under subparagraph (B), the PDP 

6 sponsor shall— 

7 ‘‘(aa) review such pref8 erences; 

9 ‘‘(bb) select or change the 

10 selection of a prescriber or phar11 macy for the beneficiary based on 

12 such preferences; and 

13 ‘‘(cc) inform the beneficiary 

14 of such selection or change of se15 lection. 

16 ‘‘(II) EXCEPTION.—In the case 

17 that the PDP sponsor determines that 

18 a change to the selection of a pre19 scriber or pharmacy under item (bb) 

20 by the PDP sponsor is contributing or 

21 would contribute to prescription drug 

22 addiction or drug diversion by the 

23 beneficiary, the PDP sponsor may 

24 change the selection of a prescriber or 

25 pharmacy for the beneficiary without 


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1 regard to the preferences of the bene2 ficiary described in subclause (I). 

3 ‘‘(iv) CONFIRMATION.—Before select4 ing a prescriber or pharmacy under this 

5 subparagraph, a PDP sponsor must re6 quest and receive confirmation from the 

7 prescriber or pharmacy acknowledging and 

8 accepting that the beneficiary involved is in 

9 the drug management program for at-risk 

10 beneficiaries. 

11 ‘‘(E) TERMINATIONS AND APPEALS.—The 

12 identification of an individual as an at-risk ben13 eficiary for prescription drug addiction under 

14 this paragraph, a coverage determination made 

15 under a drug management program for at-risk 

16 beneficiaries, and the selection of a prescriber 

17 or pharmacy under subparagraph (D) with re18 spect to such individual shall be subject to re19 consideration and appeal under subsection (h) 

20 and the option of an automatic escalation to ex21 ternal review to the extent provided by the Sec22 retary. 

23 ‘‘(F) TERMINATION OF IDENTIFICATION.— 

24 ‘‘(i) IN GENERAL.—The Secretary 

25 shall develop standards for the termination 


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1 of identification of an individual as an at2 risk beneficiary for prescription drug ad3 diction under this paragraph. Under such 

4 standards such identification shall termi5 nate as of the earlier of— 

6 ‘‘(I) the date the individual dem7 onstrates that the individual is no 

8 longer likely, in the absence of the re9 strictions under this paragraph, to be 

10 an at-risk beneficiary for prescription 

11 drug addiction described in subpara12 graph (C)(i); or 

13 ‘‘(II) the end of such maximum 

14 period of identification as the Sec15 retary may specify. 

16 ‘‘(ii) RULE OF CONSTRUCTION.— 

17 Nothing in clause (i) shall be construed as 

18 preventing a plan from identifying an indi19 vidual as an at-risk beneficiary for pre20 scription drug addiction under subpara21 graph (C)(i) after such termination on the 

22 basis of additional information on drug use 

23 occurring after the date of notice of such 

24 termination. 


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1 ‘‘(G) ADDICTIVE DRUG.—For purposes of 

2 this subsection, the term ‘addictive drug’ means 

3 a drug that is determined by the Secretary to 

4 be addictive or frequently diverted and that is— 

5 ‘‘(i) a Controlled Drug Substance in 

6 Schedule CII–CIV; 

7 ‘‘(ii) within the same class or category 

8 of drugs as a Controlled Drug Substance 

9 in Schedule CII–CIV; or 

10 ‘‘(iii) within another class or category 

11 of drugs that the Secretary determines, in 

12 consultation with the Inspector General of 

13 the Department of Health and Human 

14 Services, is at high risk for diversion or 

15 addiction. 

16 ‘‘(H) DATA DISCLOSURE.—In the case of 

17 an at-risk beneficiary for prescription drug ad18 diction whose access to coverage for addictive 

19 drugs under a prescription drug plan has been 

20 limited by a PDP sponsor under this para21 graph, such PDP sponsor shall disclose data, 

22 including any necessary individually identifiable 

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1 pose such limitations and the limitations im2 posed by the sponsor under this part. 

3 ‘‘(I) EDUCATION.—The Secretary shall 

4 provide education to enrollees in prescription 

5 drug plans of PDP sponsors and providers re6 garding the drug management program for at7 risk beneficiaries described in this paragraph, 

8 including education— 

9 ‘‘(i) provided by Medicare administra10 tive contractors through the improper pay11 ment outreach and education program de12 scribed in section 1874A(h); and 

13 ‘‘(ii) through current education efforts 

14 (such as State health insurance assistance 

15 programs described in subsection (a)(1)(A) 

16 of section 119 of the Medicare Improve17 ments for Patients and Providers Act of 

18 2008 (42 U.S.C. 1395b–3 note)) and ma19 terials directed toward such enrollees.’’. 

20 (2) INFORMATION FOR CONSUMERS.—Section 

21 1860D–4(a)(1)(B) of the Social Security Act (42 

22 U.S.C. 1395w–104(a)(1)(B)) is amended by adding 

23 at the end the following: 


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1 ‘‘(v) The drug management program 

2 for at-risk beneficiaries under subsection 

3 (c)(4).’’. 

4 (b) UTILIZATION MANAGEMENT PROGRAMS.—Sec5 tion 1860D–4(c) of the Social Security Act (42 U.S.C. 

6 1395w–104(c)), as amended by subsection (a), is amend7 ed— 

8 (1) in paragraph (1), by inserting after sub9 paragraph (D) the following new subparagraph: 

10 ‘‘(E) A utilization management tool to pre11 vent drug addiction (as described in paragraph 

12 (5)(A)).’’; and 

13 (2) by adding at the end the following new 

14 paragraph: 

15 ‘‘(5) UTILIZATION MANAGEMENT TOOL TO PRE16 VENT DRUG ADDICTION.— 

17 ‘‘(A) IN GENERAL.—A tool described in 

18 this paragraph is any of the following: 

19 ‘‘(i) A utilization tool designed to pre20 vent addiction to addictive drugs by indi21 viduals and to prevent the diversion of 

22 such drugs at pharmacies. 

23 ‘‘(ii) Retrospective utilization review 

24 to identify— 


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1 ‘‘(I) individuals that receive ad2 dictive drugs at a frequency or in 

3 amounts that are not clinically appro4 priate; and 

5 ‘‘(II) providers of services or sup6 pliers that may facilitate the addiction 

7 to or diversion of addictive drugs by 

8 beneficiaries. 

9 ‘‘(iii) Consultation with the Con10 tractor described in subparagraph (B) to 

11 verify if an individual enrolling in a pre12 scription drug plan offered by a PDP 

13 sponsor has been previously identified by 

14 another PDP sponsor as an individual de15 scribed in clause (ii)(I). 

16 ‘‘(B) REPORTING.—A PDP sponsor offer17 ing a prescription drug plan in a State shall 

18 submit to the Secretary and the Medicare drug 

19 integrity contractor with which the Secretary 

20 has entered into a contract under section 1893 

21 with respect to such State a report, on a 

22 monthly basis, containing information on— 

23 ‘‘(i) any provider of services or sup24 plier described in subparagraph (A)(ii)(II) 

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1 ing the 30-day period before such report is 

2 submitted; and 

3 ‘‘(ii) the name and prescription 

4 records of individuals described in para5 graph (4)(C).’’. 

6 (c) EXPANDING ACTIVITIES OF MEDICARE DRUG IN7 TEGRITY CONTRACTORS (MEDICS).—Section 1893 of the 

8 Social Security Act (42 U.S.C. 1395ddd) is amended by 

9 adding at the end the following new subsection: 

10 ‘‘(j) EXPANDING ACTIVITIES OF MEDICARE DRUG

11 INTEGRITY CONTRACTORS (MEDICS).— 

12 ‘‘(1) ACCESS TO INFORMATION.—Under con13 tracts entered into under this section with Medicare 

14 drug integrity contractors, the Secretary shall au15 thorize such contractors to directly accept prescrip16 tion and necessary medical records from entities 

17 such as pharmacies, prescription drug plans, and 

18 physicians with respect to an individual in order for 

19 such contractors to provide information relevant to 

20 the determination of whether such individual is an 

21 at-risk beneficiary for prescription drug addiction, as 

22 defined in section 1860D–4(c)(4)(C). 

23 ‘‘(2) REQUIREMENT FOR ACKNOWLEDGMENT

24 OF REFERRALS.—If a PDP sponsor refers informa25 tion to a contractor described in paragraph (1) in 


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1 order for such contractor to assist in the determina2 tion described in such paragraph, the contractor 

3 shall— 

4 ‘‘(A) acknowledge to the PDP sponsor re5 ceipt of the referral; and 

6 ‘‘(B) in the case that any PDP sponsor 

7 contacts the contractor requesting to know the 

8 determination by the contractor of whether or 

9 not an individual has been determined to be an 

10 individual described such paragraph, shall in11 form such PDP sponsor of such determination 

12 on a date that is not later than 15 days after 

13 the date on which the PDP sponsor contacts 

14 the contractor. 

15 ‘‘(3) MAKING DATA AVAILABLE TO OTHER EN16 TITIES.— 

17 ‘‘(A) IN GENERAL.—For purposes of car18 rying out this subsection, subject to subpara19 graph (B), the Secretary shall authorize MED20 ICs to respond to requests for information from 

21 PDP sponsors, State prescription drug moni22 toring programs, and other entities delegated by 

23 PDP sponsors using available programs and 

24 systems in the effort to prevent fraud, waste, 

25 and abuse. 


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1 ‘‘(B) HIPAA COMPLIANT INFORMATION

2 ONLY.—Information may only be disclosed by a 

3 MEDIC under subparagraph (A) if the disclo4 sure of such information is permitted under the 

5 Federal regulations (concerning the privacy of 

6 individually identifiable health information) pro7 mulgated under section 264(c) of the Health 

8 Insurance Portability and Accountability Act of 

9 1996 (42 U.S.C. 1320d–2 note).’’. 

10 (d) TREATMENT OF CERTAIN COMPLAINTS FOR PUR11 POSES OF QUALITY OR PERFORMANCE ASSESSMENT.— 

12 Section 1860D–42 of the Social Security Act (42 U.S.C. 

13 1395w–152) is amended by adding at the end the fol14 lowing new subsection: 

15 ‘‘(d) TREATMENT OF CERTAIN COMPLAINTS FOR

16 PURPOSES OF QUALITY OR PERFORMANCE ASSESS17 MENT.—In conducting a quality or performance assess18 ment of a PDP sponsor, the Secretary shall develop or 

19 utilize existing screening methods for reviewing and con20 sidering complaints that are received from enrollees in a 

21 prescription drug plan offered by such PDP sponsor and 

22 that are complaints regarding the lack of access by the 

23 individual to prescription drugs due to a drug manage24 ment program for at-risk beneficiaries.’’. 

25 (e) GAO STUDIES AND REPORTS.— 


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1 (1) STUDIES.—The Comptroller General of the 

2 United States shall conduct a study on each of the 

3 following: 

4 (A) The implementation of the amend5 ments made by this section. 

6 (B) The effectiveness of the at-risk bene7 ficiaries for prescription drug addiction drug 

8 management programs authorized by section 

9 1860D–4(c)(4) of the Social Security Act (42 

10 U.S.C. 1395w–10(c)(4)), as added by sub11 section (a)(1), including an analysis of— 

12 (i) the impediments, if any, that im13 pair the ability of individuals described in 

14 subparagraph (C) of such section 1860D– 

15 4(c)(4) to access clinically appropriate lev16 els of prescription drugs; and 

17 (ii) the types of— 

18 (I) individuals who, in the imple19 mentation of such section, are deter20 mined to be individuals described in 

21 such subparagraph; and 

22 (II) prescribers and pharmacies 

23 that are selected under subparagraph 

24 (D) of such section. 


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1 (2) REPORTS.—Not later than January 1, 

2 2017, the Comptroller General of the United States 

3 shall begin work, with respect to each study de4 scribed in paragraph (1), on a report that describes 

5 the result of such study. Upon the completion of 

6 each such report, such Comptroller General shall 

7 submit the report to each of the committees de8 scribed in paragraph (3). 

9 (3) COMMITTEES DESCRIBED.—The committees 

10 described in this paragraph are the following: 

11 (A) The Committee on Ways and Means of 

12 the House of Representatives. 

13 (B) The Committee on Energy and Com14 merce of the House of Representatives. 

15 (C) The Committee on Finance of the Sen16 ate. 

17 (D) The Committee on Health, Education, 

18 Labor, and Pensions of the Senate. 

19 (E) The Special Committee on Aging of 

20 the Senate. 

21 (f) EFFECTIVE DATE.— 

22 (1) IN GENERAL.—The amendments made by 

23 this section shall apply to prescription drug plans for 

24 plan years beginning on or after January 1, 2018. 


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1 (2) STAKEHOLDER MEETINGS PRIOR TO EFFEC2 TIVE DATE.— 

3 (A) IN GENERAL.—Not later than January 

4 1, 2017, the Secretary shall convene stake5 holders, including individuals entitled to bene6 fits under part A of title XVIII of the Social 

7 Security Act or enrolled under part B of such 

8 title of such Act, advocacy groups representing 

9 such individuals, clinicians, plan sponsors, and 

10 entities delegated by plan sponsors, for input 

11 regarding the topics described in subparagraph 

12 (B). 

13 (B) TOPICS DESCRIBED.—The topics de14 scribed in this subparagraph are the topics of— 

15 (i) ensuring affordability and accessi16 bility to prescription drugs for enrollees in 

17 prescription drug plans of PDP sponsors 

18 who are at-risk beneficiaries for prescrip19 tion drug addiction (as defined in para20 graph (4)(C) of section 1860D–4(c) of the 

21 Social Security Act (42 U.S.C. 1395w– 

22 10(c)), as added by subsection (a)(1)); 

23 (ii) the use of an expedited appeals 

24 process under which such an enrollee may 

25 appeal an identification of such enrollee as 


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1 an at-risk beneficiary for prescription drug 

2 addiction under such paragraph (similar to 

3 the processes established under the Medi4 care Advantage program under part C of 

5 title XVIII of the Social Security Act that 

6 allow an automatic escalation to external 

7 review of claims submitted under such 

8 part); 

9 (iii) the types of enrollees that should 

10 be treated as exempted individuals, as de11 scribed in clause (ii) of such paragraph; 

12 (iv) the manner in which terms and 

13 definitions in paragraph (4) of such section 

14 1860D–4(c) should be applied, such as the 

15 use of clinical appropriateness in deter16 mining whether an enrollee is an at-risk 

17 beneficiary for prescription drug addiction 

18 as defined in subparagraph (C) of such 

19 paragraph (4); 

20 (v) the information to be included in 

21 the notices described in subparagraph (B) 

22 of such section and the standardization of 

23 such notices; and 

24 (vi) with respect to a PDP sponsor 

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1 gram for at-risk beneficiaries under such 

2 paragraph (4), the responsibilities of such 

3 PDP sponsor with respect to the imple4 mentation of such program. 

5 (C) RULEMAKING.—The Secretary shall 

6 promulgate regulations based on the input 

7 gathered pursuant to subparagraph (A). 

Æ 


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