II 

114TH CONGRESS 

1ST SESSION S. 1431 

To provide for increased Federal oversight of prescription opioid treatment 

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

IN THE SENATE OF THE UNITED STATES 

MAY 21, 2015 

Mr. MANCHIN (for himself, Mr. KING, and Mrs. CAPITO) introduced the 

following bill; which was read twice and referred to the Committee on Finance 

A BILL 

To provide for increased Federal oversight of prescription 

opioid treatment and assistance to States in reducing 

opioid abuse, 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 ‘‘Prescription Drug 

5 Abuse Prevention and Treatment Act of 2015’’. 

6 SEC. 2. CONSUMER EDUCATION CAMPAIGN. 

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

8 (42 U.S.C. 290aa et seq.) is amended by adding at the 

9 end the following: 


emcdonald on DSK67QTVN1PROD with BILLS
2 

•S 1431 IS

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

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

3 grants to States and nonprofit entities for the purpose of 

4 conducting culturally sensitive consumer education about 

5 opioid abuse, including methadone abuse. Such education 

6 shall include information on the dangers of opioid abuse, 

7 how to prevent opioid abuse including through safe dis8 posal of prescription medications and other safety pre9 cautions, and detection of early warning signs of addic10 tion. 

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

12 under subsection (a), an entity shall— 

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

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

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

16 information as the Administrator may require. 

17 ‘‘(c) PRIORITY.—In awarding grants under this sec18 tion, the Administrator shall give priority to applicants 

19 that are States or communities with a high incidence of 

20 abuse of methadone and other opioids, and opioid-related 

21 deaths. 

22 ‘‘(d) EVALUATIONS.—The Administrator shall de23 velop a process to evaluate the effectiveness of activities 

24 carried out by grantees under this section at reducing 

25 abuse of methadone and other opioids. 


emcdonald on DSK67QTVN1PROD with BILLS
3 

•S 1431 IS

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

2 is authorized to be appropriated to carry out this section 

3 $15,000,000 for each of fiscal years 2016 through 2020.’’. 

4 SEC. 3. PRACTITIONER EDUCATION. 

5 (a) EDUCATION REQUIREMENTS.— 

6 (1) REGISTRATION CONSIDERATION.—Section 

7 303(f) of the Controlled Substances Act (21 U.S.C. 

8 823(f)) is amended by inserting after paragraph (5) 

9 the following: 

10 ‘‘(6) The applicant’s compliance with the train11 ing requirements described in subsection (g)(3) dur12 ing any previous period in which the applicant has 

13 been subject to such training requirements.’’. 

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

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

16 is amended by adding at the end the following: 

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

18 dispense methadone or other opioids, a practitioner de19 scribed in paragraph (1) shall comply with the 12-hour 

20 training requirement of subparagraph (B) at least once 

21 during each 3-year period. 

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

23 is that the practitioner has completed not less than 12 

24 hours of training (through classroom situations, seminars 


emcdonald on DSK67QTVN1PROD with BILLS
4 

•S 1431 IS

1 at professional society meetings, electronic communica2 tions, or otherwise) with respect to— 

3 ‘‘(i) the treatment and management of opioid4 dependent patients; 

5 ‘‘(ii) pain management treatment guidelines; 

6 and 

7 ‘‘(iii) early detection of opioid addiction, includ8 ing through such methods as Screening, Brief Inter9 vention, and Referral to Treatment (SBIRT), 

10 that is provided by the American Society of Addiction 

11 Medicine, the American Academy of Addiction Psychiatry, 

12 the American Medical Association, the American Osteo13 pathic Association, the American Psychiatric Association, 

14 the American Academy of Pain Management, the Amer15 ican Pain Society, the American Academy of Pain Medi16 cine, the American Board of Pain Medicine, the American 

17 Society of Interventional Pain Physicians, or any other or18 ganization that the Secretary determines is appropriate 

19 for purposes of this subparagraph.’’. 

20 (b) REQUIREMENTS FOR PARTICIPATION IN OPIOID

21 TREATMENT PROGRAMS.—Effective July 1, 2016, a phy22 sician practicing in an opioid treatment program shall 

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

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


emcdonald on DSK67QTVN1PROD with BILLS
5 

•S 1431 IS

1 with respect to required minimum training at least once 

2 during each 3-year period. 

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

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

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

6 any successor regulation). 

7 (d) FUNDING.—The Drug Enforcement Administra8 tion shall fund the enforcement of the requirements speci9 fied in section 303(g)(3) of the Controlled Substances Act 

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

11 of the licensing fees paid by controlled substance pre12 scribers under the Controlled Substances Act (21 U.S.C. 

13 801 et seq.). 

14 SEC. 4. OPERATION OF OPIOID TREATMENT PROGRAMS. 

15 Section 303 of the Controlled Substances Act (21 

16 U.S.C. 823) is amended by adding at the end the fol17 lowing: 

18 ‘‘(i)(1) An opioid treatment program that is reg19 istered under this section, and that closes for business on 

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

21 holiday, shall comply with the requirements of this sub22 section. 

23 ‘‘(2) The program shall make acceptable arrange24 ments for each patient who is restricted, by Federal regu25 lation or guideline or by the determination of the program 


emcdonald on DSK67QTVN1PROD with BILLS
6 

•S 1431 IS

1 medical director, from having a take home dose of a con2 trolled substance related to the treatment involved, to re3 ceive a dose of that substance under appropriate super4 vision during the closure. 

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

6 Mental Health Services Administration shall issue a notice 

7 that references regulations on acceptable arrangements 

8 under this subsection, or shall promulgate regulations on 

9 such acceptable arrangements.’’. 

10 SEC. 5. MORTALITY REPORTING. 

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

12 (42 U.S.C. 290aa et seq.), as amended by section 3, is 

13 further amended by adding at the end the following: 

14 ‘‘SEC. 506D. MORTALITY REPORTING. 

15 ‘‘(a) MODEL OPIOID TREATMENT PROGRAM MOR16 TALITY REPORT.— 

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

18 2016, the Secretary, acting through the Adminis19 trator, shall require that a Model Opioid Treatment 

20 Program Mortality Report be completed and sub21 mitted to the Administrator for each individual who 

22 dies while receiving treatment in an opioid treatment 

23 program. 

24 ‘‘(2) REQUIREMENT OF STATES THAT RECEIVE

25 FUNDING FOR THE CONTROLLED SUBSTANCE MONIVerDate Sep 11 2014 04:08 May 29, 2015 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1431.IS S1431

emcdonald on DSK67QTVN1PROD with BILLS
7 

•S 1431 IS

1 TORING PROGRAM.—As a condition for receiving 

2 funds under section 399O, each State shall require 

3 that any individual who signs a death certificate 

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

5 deceased, or where such drug is otherwise associated 

6 with the death, report such death to the Adminis7 trator by submitting a Model Opioid Treatment Pro8 gram Mortality Report described in paragraph (3). 

9 Such report shall be submitted to the Administrator 

10 on or before the later of— 

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

12 death certificate; or 

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

14 on which the necessary postmortem and toxi15 cology reports become available to such indi16 vidual, as required by the Secretary. 

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

18 consultation with State and local medical examiners, 

19 prescribing physicians, hospitals, and any other or20 ganization that the Administrator determines appro21 priate, shall develop a Model Opioid Treatment Pro22 gram Mortality Report to be used under paragraphs 

23 (1) and (2). 

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


emcdonald on DSK67QTVN1PROD with BILLS
8 

•S 1431 IS

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

2 2016, the Administrator shall establish and imple3 ment, through the National Center for Health Sta4 tistics, a National Opioid Death Registry (referred 

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

6 opioid-related deaths and information related to such 

7 deaths. 

8 ‘‘(2) CONSULTATION.—In establishing the uni9 form reporting criteria for the Registry, the Director 

10 of the Centers for Disease Control and Prevention 

11 shall consult with the Administrator, State and local 

12 medical examiners, prescribing physicians, hospitals, 

13 and any other organization that the Director deter14 mines is appropriate for purposes of this subsection. 

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

16 designed as a uniform reporting system for opioid17 related deaths and shall require the reporting of in18 formation with respect to such deaths, including— 

19 ‘‘(A) the particular drug formulation used 

20 at the time of death; 

21 ‘‘(B) the dosage level; 

22 ‘‘(C) a description of the circumstances 

23 surrounding the death in relation to the rec24 ommended dosage involved; 


emcdonald on DSK67QTVN1PROD with BILLS
9 

•S 1431 IS

1 ‘‘(D) a disclosure of whether the medica2 tion involved can be traced back to a physi3 cian’s prescription; 

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

5 was in an opioid treatment program at the time 

6 of death; 

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

8 ‘‘(G) other non-personal information such 

9 as that included in filed National Association of 

10 Medical Examiners Pediatric Toxicology Reg11 istry case reports as required under the privacy 

12 standard for the de-identification of health in13 formation pursuant to the regulations contained 

14 in part 164 of title 45, Code of Federal Regula15 tions. 

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

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

18 2016 through 2020 to carry out this subsection. 

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

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

21 2 years after the date of enactment of this section, and 

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

23 Disease Control and Prevention shall submit to the Sec24 retary a report, based on information contained in the 

25 Registry described in subsection (b), concerning the numVerDate Sep 11 2014 04:08 May 29, 2015 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1431.IS S1431

emcdonald on DSK67QTVN1PROD with BILLS
10 

•S 1431 IS

1 ber of methadone-related deaths in the United States for 

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

3 SEC. 6. DEVELOPMENT OF PRESCRIPTION DRUG ABUSE 

4 PREVENTION AND TREATMENT QUALITY 

5 MEASURES ACROSS EACH RELEVANT PRO6 VIDER SETTING. 

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

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

9 adding at the end the following: 

10 ‘‘SEC. 932. DEVELOPMENT OF PRESCRIPTION DRUG ABUSE 

11 PREVENTION AND TREATMENT QUALITY 

12 MEASURES ACROSS EACH RELEVANT PRO13 VIDER SETTING. 

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

15 the Director of the Agency for Healthcare Research and 

16 Quality and in consultation with the Director of the Cen17 ters for Disease Control and Prevention, the Adminis18 trator of the Substance Abuse and Mental Health Services 

19 Administration, and the Director of the Centers for Medi20 care & Medicaid Services, shall require the development 

21 and application of specific prescription drug abuse preven22 tion and treatment quality measures for each relevant 

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

24 ‘‘(b) DISSEMINATION.—Not later than April 1, 2016, 

25 the Secretary shall disseminate the quality measure reVerDate Sep 11 2014 04:08 May 29, 2015 Jkt 049200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1431.IS S1431

emcdonald on DSK67QTVN1PROD with BILLS
11 

•S 1431 IS

1 quirements developed under subsection (a) to all affected 

2 providers. 

3 ‘‘(c) TYPES OF MEASURES.—Quality measures devel4 oped under this section may be structure-oriented (such 

5 as the required presence of a hospital-based treatment 

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

7 be informed of the addictive qualities of the medication 

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

9 family satisfaction with care).’’. 

10 SEC. 7. PROGRAMS TO PREVENT PRESCRIPTION DRUG 

11 ABUSE UNDER MEDICARE PART D. 

12 (a) DRUG MANAGEMENT PROGRAM FOR AT-RISK

13 BENEFICIARIES.— 

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

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

16 amended by adding at the end the following: 

17 ‘‘(4) DRUG MANAGEMENT PROGRAM FOR AT18 RISK BENEFICIARIES.— 

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

20 sponsor may establish a drug management pro21 gram for at-risk beneficiaries under which, sub22 ject to subparagraph (B), the PDP sponsor 

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

24 prescription drug abuse who is an enrollee in a 

25 prescription drug plan of such PDP sponsor, 


emcdonald on DSK67QTVN1PROD with BILLS
12 

•S 1431 IS

1 limit such beneficiary’s access to coverage for 

2 frequently abused drugs under such plan to fre3 quently abused drugs that are prescribed for 

4 such beneficiary by a prescriber selected under 

5 subparagraph (D), and dispensed for such bene6 ficiary by a pharmacy selected under such sub7 paragraph. 

8 ‘‘(B) REQUIREMENT FOR NOTICES.— 

9 ‘‘(i) IN GENERAL.—A PDP sponsor 

10 may not limit the access of an at-risk ben11 eficiary for prescription drug abuse to cov12 erage for frequently abused drugs under a 

13 prescription drug plan until such spon14 sor— 

15 ‘‘(I) provides to the beneficiary 

16 an initial notice described in clause 

17 (ii) and a second notice described in 

18 clause (iii); and 

19 ‘‘(II) verifies with the providers 

20 of the beneficiary that the beneficiary 

21 is an at-risk beneficiary for prescrip22 tion drug abuse. 

23 ‘‘(ii) INITIAL NOTICE.—An initial no24 tice described in this clause is a notice that 

25 provides to the beneficiary— 


emcdonald on DSK67QTVN1PROD with BILLS
13 

•S 1431 IS

1 ‘‘(I) notice that the PDP sponsor 

2 has identified the beneficiary as po3 tentially being an at-risk beneficiary 

4 for prescription drug abuse; 

5 ‘‘(II) information describing all 

6 State and Federal public health re7 sources that are designed to address 

8 prescription drug abuse to which the 

9 beneficiary has access, including men10 tal health services and other coun11 seling services; 

12 ‘‘(III) notice of, and information 

13 about, the right of the beneficiary to 

14 appeal such identification under sub15 section (h) and the option of an auto16 matic escalation to external review; 

17 ‘‘(IV) a request for the bene18 ficiary to submit to the PDP sponsor 

19 preferences for which prescribers and 

20 pharmacies the beneficiary would pre21 fer the PDP sponsor to select under 

22 subparagraph (D) in the case that the 

23 beneficiary is identified as an at-risk 

24 beneficiary for prescription drug 

25 abuse as described in clause (iii)(I); 


emcdonald on DSK67QTVN1PROD with BILLS
14 

•S 1431 IS

1 ‘‘(V) an explanation of the mean2 ing and consequences of the identi3 fication of the beneficiary as poten4 tially being an at-risk beneficiary for 

5 prescription drug abuse, including an 

6 explanation of the drug management 

7 program established by the PDP 

8 sponsor pursuant to subparagraph 

9 (A); 

10 ‘‘(VI) clear instructions that ex11 plain how the beneficiary can contact 

12 the PDP sponsor in order to submit 

13 to the PDP sponsor the preferences 

14 described in subclause (IV) and any 

15 other communications relating to the 

16 drug management program for at-risk 

17 beneficiaries established by the PDP 

18 sponsor; and 

19 ‘‘(VII) contact information for 

20 other organizations that can provide 

21 the beneficiary with assistance regard22 ing such drug management program 

23 (similar to the information provided 

24 by the Secretary in other standardized 

25 notices provided to part D eligible inVerDate Sep 11 2014 04:08 May 29, 2015 Jkt 049200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S1431.IS S1431

emcdonald on DSK67QTVN1PROD with BILLS
15 

•S 1431 IS

1 dividuals enrolled in prescription drug 

2 plans under this part). 

3 ‘‘(iii) SECOND NOTICE.—A second no4 tice described in this clause is a notice that 

5 provides to the beneficiary notice— 

6 ‘‘(I) that the PDP sponsor has 

7 identified the beneficiary as an at-risk 

8 beneficiary for prescription drug 

9 abuse; 

10 ‘‘(II) that such beneficiary is 

11 subject to the requirements of the 

12 drug management program for at-risk 

13 beneficiaries established by such PDP 

14 sponsor for such plan; 

15 ‘‘(III) of the prescriber and phar16 macy selected for such individual 

17 under subparagraph (D); 

18 ‘‘(IV) of, and information about, 

19 the beneficiary’s right to appeal such 

20 identification under subsection (h) 

21 and the option of an automatic esca22 lation to external review; 

23 ‘‘(V) that the beneficiary can, in 

24 the case that the beneficiary has not 

25 previously submitted to the PDP 


emcdonald on DSK67QTVN1PROD with BILLS
16 

•S 1431 IS

1 sponsor preferences for which pre2 scribers and pharmacies the bene3 ficiary would prefer the PDP sponsor 

4 select under subparagraph (D), sub5 mit such preferences to the PDP 

6 sponsor; and 

7 ‘‘(VI) that includes clear instruc8 tions that explain how the beneficiary 

9 can contact the PDP sponsor. 

10 ‘‘(iv) TIMING OF NOTICES.— 

11 ‘‘(I) IN GENERAL.—Subject to 

12 subclause (II), a second notice de13 scribed in clause (iii) shall be provided 

14 to the beneficiary on a date that is 

15 not less than 60 days after an initial 

16 notice described in clause (ii) is pro17 vided to the beneficiary. 

18 ‘‘(II) EXCEPTION.—In the case 

19 that the PDP sponsor, in conjunction 

20 with the Secretary, determines that 

21 concerns identified through rule22 making by the Secretary regarding 

23 the health or safety of the beneficiary 

24 or regarding significant drug diversion 

25 activities require the PDP sponsor to 


emcdonald on DSK67QTVN1PROD with BILLS
17 

•S 1431 IS

1 provide a second notice described in 

2 clause (iii) to the beneficiary on a 

3 date that is earlier than the date de4 scribed in subclause (II), the PDP 

5 sponsor may provide such second no6 tice on such earlier date. 

7 ‘‘(C) AT-RISK BENEFICIARY FOR PRE8 SCRIPTION DRUG ABUSE.— 

9 ‘‘(i) IN GENERAL.—For purposes of 

10 this paragraph, the term ‘at-risk bene11 ficiary for prescription drug abuse’ means 

12 a part D eligible individual who is not an 

13 exempted individual described in clause (ii) 

14 and— 

15 ‘‘(I) who is identified through the 

16 use of guidelines developed by the 

17 Secretary in consultation with PDP 

18 sponsors and other stakeholders de19 scribed in section 10(f)(2)(A) of the 

20 Prescription Drug Abuse Prevention 

21 and Treatment Act of 2015; or 

22 ‘‘(II) with respect to whom the 

23 PDP sponsor of a prescription drug 

24 plan, upon enrolling such individual in 

25 such plan, received notice from the 


emcdonald on DSK67QTVN1PROD with BILLS
18 

•S 1431 IS

1 Secretary that such individual was 

2 identified under this paragraph to be 

3 an at-risk beneficiary for prescription 

4 drug abuse under the prescription 

5 drug plan in which such individual 

6 was most recently previously enrolled 

7 and such identification has not been 

8 terminated under subparagraph (F). 

9 ‘‘(ii) EXEMPTED INDIVIDUAL DE10 SCRIBED.—An exempted individual de11 scribed in this clause is an individual 

12 who— 

13 ‘‘(I) receives hospice care under 

14 this title; or 

15 ‘‘(II) the Secretary elects to treat 

16 as an exempted individual for pur17 poses of clause (i). 

18 ‘‘(D) SELECTION OF PRESCRIBERS.— 

19 ‘‘(i) IN GENERAL.—With respect to 

20 each at-risk beneficiary for prescription 

21 drug abuse enrolled in a prescription drug 

22 plan offered by such sponsor, a PDP spon23 sor shall, based on the preferences sub24 mitted to the PDP sponsor by the beneVerDate Sep 11 2014 04:08 May 29, 2015 Jkt 049200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S1431.IS S1431

emcdonald on DSK67QTVN1PROD with BILLS
19 

•S 1431 IS

1 ficiary pursuant to clauses (ii)(IV) and 

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

3 ‘‘(I) one or more individuals who 

4 are authorized to prescribe frequently 

5 abused drugs (referred to in this 

6 paragraph as ‘prescribers’) who may 

7 write prescriptions for such drugs for 

8 such beneficiary; and 

9 ‘‘(II) one or more pharmacies 

10 that may dispense such drugs to such 

11 beneficiary. 

12 ‘‘(ii) REASONABLE ACCESS.—In mak13 ing the selection under this subparagraph, 

14 a PDP sponsor shall ensure that the bene15 ficiary continues to have reasonable access 

16 to drugs described in subparagraph (G), 

17 taking into account geographic location, 

18 beneficiary preference, affordability, and 

19 reasonable travel time. 

20 ‘‘(iii) BENEFICIARY PREFERENCES.— 

21 ‘‘(I) IN GENERAL.—If an at-risk 

22 beneficiary for prescription drug 

23 abuse submits preferences for which 

24 in-network prescribers and pharmacies 

25 the beneficiary would prefer the PDP 


emcdonald on DSK67QTVN1PROD with BILLS
20 

•S 1431 IS

1 sponsor select in response to a notice 

2 under subparagraph (B), the PDP 

3 sponsor shall— 

4 ‘‘(aa) review such pref5 erences; 

6 ‘‘(bb) select or change the 

7 selection of a prescriber or phar8 macy for the beneficiary based on 

9 such preferences; and 

10 ‘‘(cc) inform the beneficiary 

11 of such selection or change of se12 lection. 

13 ‘‘(II) EXCEPTION.—In the case 

14 that the PDP sponsor determines that 

15 a change to the selection of a pre16 scriber or pharmacy under item (bb) 

17 by the PDP sponsor is contributing or 

18 would contribute to prescription drug 

19 abuse or drug diversion by the bene20 ficiary, the PDP sponsor may change 

21 the selection of a prescriber or phar22 macy for the beneficiary without re23 gard to the preferences of the bene24 ficiary described in subclause (I). 


emcdonald on DSK67QTVN1PROD with BILLS
21 

•S 1431 IS

1 ‘‘(iv) CONFIRMATION.—Before select2 ing a prescriber or pharmacy under this 

3 subparagraph, a PDP sponsor must re4 quest and receive confirmation from the 

5 prescriber or pharmacy acknowledging and 

6 accepting that the beneficiary involved is in 

7 the drug management program for at-risk 

8 beneficiaries. 

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

10 identification of an individual as an at-risk ben11 eficiary for prescription drug abuse under this 

12 paragraph, a coverage determination made 

13 under a drug management program for at-risk 

14 beneficiaries, and the selection of a prescriber 

15 or pharmacy under subparagraph (D) with re16 spect to such individual shall be subject to re17 consideration and appeal under subsection (h) 

18 and the option of an automatic escalation to ex19 ternal review to the extent provided by the Sec20 retary. 

21 ‘‘(F) TERMINATION OF IDENTIFICATION.— 

22 ‘‘(i) IN GENERAL.—The Secretary 

23 shall develop standards for the termination 

24 of identification of an individual as an at25 risk beneficiary for prescription drug abuse 


emcdonald on DSK67QTVN1PROD with BILLS
22 

•S 1431 IS

1 under this paragraph. Under such stand2 ards such identification shall terminate as 

3 of the earlier of— 

4 ‘‘(I) the date the individual dem5 onstrates that the individual is no 

6 longer likely, in the absence of the re7 strictions under this paragraph, to be 

8 an at-risk beneficiary for prescription 

9 drug abuse described in subparagraph 

10 (C)(i); or 

11 ‘‘(II) the end of such maximum 

12 period of identification as the Sec13 retary may specify. 

14 ‘‘(ii) RULE OF CONSTRUCTION.— 

15 Nothing in clause (i) shall be construed as 

16 preventing a plan from identifying an indi17 vidual as an at-risk beneficiary for pre18 scription drug abuse under subparagraph 

19 (C)(i) after such termination on the basis 

20 of additional information on drug use oc21 curring after the date of notice of such ter22 mination. 

23 ‘‘(G) FREQUENTLY ABUSED DRUG.—For 

24 purposes of this subsection, the term ‘frequently 

25 abused drug’ means a drug that is determined 


emcdonald on DSK67QTVN1PROD with BILLS
23 

•S 1431 IS

1 by the Secretary to be frequently abused or di2 verted and that is— 

3 ‘‘(i) a Controlled Drug Substance in 

4 Schedule CII–CIV; 

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

6 of drugs as a Controlled Drug Substance 

7 in Schedule CII–CIV; or 

8 ‘‘(iii) within another class or category 

9 of drugs that the Secretary determines, in 

10 consultation with the Inspector General of 

11 the Department of Health and Human 

12 Services, is at high risk for diversion or 

13 abuse. 

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

15 an at-risk beneficiary for prescription drug 

16 abuse whose access to coverage for frequently 

17 abused drugs under a prescription drug plan 

18 has been limited by a PDP sponsor under this 

19 paragraph, such PDP sponsor shall disclose 

20 data, including any necessary individually iden21 tifiable health information, in a form and man22 ner specified by the Secretary, about the deci23 sion to impose such limitations and the limita24 tions imposed by the sponsor under this part. 


emcdonald on DSK67QTVN1PROD with BILLS
24 

•S 1431 IS

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

2 provide education to enrollees in prescription 

3 drug plans of PDP sponsors and providers re4 garding the drug management program for at5 risk beneficiaries described in this paragraph, 

6 including education— 

7 ‘‘(i) provided by Medicare administra8 tive contractors through the improper pay9 ment outreach and education program de10 scribed in section 1874A(h); and 

11 ‘‘(ii) through current education efforts 

12 (such as State health insurance assistance 

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

14 of section 119 of the Medicare Improve15 ments for Patients and Providers Act of 

16 2008 (42 U.S.C. 1395b–3 note)) and ma17 terials directed toward such enrollees.’’. 

18 (2) INFORMATION FOR CONSUMERS.—Section 

19 1860D–4(a)(1)(B) of the Social Security Act (42 

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

21 at the end the following: 

22 ‘‘(v) The drug management program 

23 for at-risk beneficiaries under subsection 

24 (c)(4).’’. 


emcdonald on DSK67QTVN1PROD with BILLS
25 

•S 1431 IS

1 (b) UTILIZATION MANAGEMENT PROGRAMS.—Sec2 tion 1860D–4(c) of the Social Security Act (42 U.S.C. 

3 1395w–104(c)), as amended by subsection (a), is amend4 ed— 

5 (1) in paragraph (1), by inserting after sub6 paragraph (D) the following new subparagraph: 

7 ‘‘(E) A utilization management tool to pre8 vent drug abuse (as described in paragraph 

9 (5)(A)).’’; and 

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

11 paragraph: 

12 ‘‘(5) UTILIZATION MANAGEMENT TOOL TO PRE13 VENT DRUG ABUSE.— 

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

15 this paragraph is any of the following: 

16 ‘‘(i) A utilization tool designed to pre17 vent the abuse of frequently abused drugs 

18 by individuals and to prevent the diversion 

19 of such drugs at pharmacies. 

20 ‘‘(ii) Retrospective utilization review 

21 to identify— 

22 ‘‘(I) individuals that receive fre23 quently abused drugs at a frequency 

24 or in amounts that are not clinically 

25 appropriate; and 


emcdonald on DSK67QTVN1PROD with BILLS
26 

•S 1431 IS

1 ‘‘(II) providers of services or sup2 pliers that may facilitate the abuse or 

3 diversion of frequently abused drugs 

4 by beneficiaries. 

5 ‘‘(iii) Consultation with the Con6 tractor described in subparagraph (B) to 

7 verify if an individual enrolling in a pre8 scription drug plan offered by a PDP 

9 sponsor has been previously identified by 

10 another PDP sponsor as an individual de11 scribed in clause (ii)(I). 

12 ‘‘(B) REPORTING.—A PDP sponsor offer13 ing a prescription drug plan in a State shall 

14 submit to the Secretary and the Medicare drug 

15 integrity contractor with which the Secretary 

16 has entered into a contract under section 1893 

17 with respect to such State a report, on a 

18 monthly basis, containing information on— 

19 ‘‘(i) any provider of services or sup20 plier described in subparagraph (A)(ii)(II) 

21 that is identified by such plan sponsor dur22 ing the 30-day period before such report is 

23 submitted; and 


emcdonald on DSK67QTVN1PROD with BILLS
27 

•S 1431 IS

1 ‘‘(ii) the name and prescription 

2 records of individuals described in para3 graph (4)(C).’’. 

4 (c) EXPANDING ACTIVITIES OF MEDICARE DRUG IN5 TEGRITY CONTRACTORS (MEDICS).—Section 1893 of the 

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

7 adding at the end the following new subsection: 

8 ‘‘(j) EXPANDING ACTIVITIES OF MEDICARE DRUG

9 INTEGRITY CONTRACTORS (MEDICS).— 

10 ‘‘(1) ACCESS TO INFORMATION.—Under con11 tracts entered into under this section with Medicare 

12 drug integrity contractors, the Secretary shall au13 thorize such contractors to directly accept prescrip14 tion and necessary medical records from entities 

15 such as pharmacies, prescription drug plans, and 

16 physicians with respect to an individual in order for 

17 such contractors to provide information relevant to 

18 the determination of whether such individual is an 

19 at-risk beneficiary for prescription drug abuse, as 

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

21 ‘‘(2) REQUIREMENT FOR ACKNOWLEDGMENT

22 OF REFERRALS.—If a PDP sponsor refers informa23 tion to a contractor described in paragraph (1) in 

24 order for such contractor to assist in the determinaVerDate Sep 11 2014 04:08 May 29, 2015 Jkt 049200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\S1431.IS S1431

emcdonald on DSK67QTVN1PROD with BILLS
28 

•S 1431 IS

1 tion described in such paragraph, the contractor 

2 shall— 

3 ‘‘(A) acknowledge to the PDP sponsor re4 ceipt of the referral; and 

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

6 contacts the contractor requesting to know the 

7 determination by the contractor of whether or 

8 not an individual has been determined to be an 

9 individual described such paragraph, shall in10 form such PDP sponsor of such determination 

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

12 the date on which the PDP sponsor contacts 

13 the contractor. 

14 ‘‘(3) MAKING DATA AVAILABLE TO OTHER EN15 TITIES.— 

16 ‘‘(A) IN GENERAL.—For purposes of car17 rying out this subsection, subject to subpara18 graph (B), the Secretary shall authorize MED19 ICs to respond to requests for information from 

20 PDP sponsors, State prescription drug moni21 toring programs, and other entities delegated by 

22 PDP sponsors using available programs and 

23 systems in the effort to prevent fraud, waste, 

24 and abuse. 


emcdonald on DSK67QTVN1PROD with BILLS
29 

•S 1431 IS

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.— 


emcdonald on DSK67QTVN1PROD with BILLS
30 

•S 1431 IS

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 abuse drug man8 agement 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. 


emcdonald on DSK67QTVN1PROD with BILLS
31 

•S 1431 IS

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

2 2016, 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, 2017. 


emcdonald on DSK67QTVN1PROD with BILLS
32 

•S 1431 IS

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

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

4 1, 2016, 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 abuse (as defined in paragraph 

20 (4)(C) of section 1860D–4(c) of the Social 

21 Security Act (42 U.S.C. 1395w–10(c)), as 

22 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 


emcdonald on DSK67QTVN1PROD with BILLS
33 

•S 1431 IS

1 an at-risk beneficiary for prescription drug 

2 abuse under such paragraph (similar to the 

3 processes established under the Medicare 

4 Advantage program under part C of title 

5 XVIII of the Social Security Act that allow 

6 an automatic escalation to external review 

7 of claims submitted under such part); 

8 (iii) the types of enrollees that should 

9 be treated as exempted individuals, as de10 scribed in clause (ii) of such paragraph; 

11 (iv) the manner in which terms and 

12 definitions in paragraph (4) of such section 

13 1860D–4(c) should be applied, such as the 

14 use of clinical appropriateness in deter15 mining whether an enrollee is an at-risk 

16 beneficiary for prescription drug abuse as 

17 defined in subparagraph (C) of such para18 graph (4); 

19 (v) the information to be included in 

20 the notices described in subparagraph (B) 

21 of such section and the standardization of 

22 such notices; and 

23 (vi) with respect to a PDP sponsor 

24 that establishes a drug management pro25 gram for at-risk beneficiaries under such 


emcdonald on DSK67QTVN1PROD with BILLS
34 

•S 1431 IS

1 paragraph (4), the responsibilities of such 

2 PDP sponsor with respect to the imple3 mentation of such program. 

4 (C) RULEMAKING.—The Secretary shall 

5 promulgate regulations based on the input 

6 gathered pursuant to subparagraph (A). 

Æ 


emcdonald on DSK67QTVN1PROD with BILLS