II 

114TH CONGRESS 

1ST SESSION S. 1913 

To amend title XVIII of the Social Security Act to establish programs 

to prevent prescription drug abuse under the Medicare program, and 

for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JULY 30, 2015 

Mr. TOOMEY (for himself, Mr. BROWN, Mr. PORTMAN, and Mr. KAINE) introduced the following bill; which was read twice and referred to the Committee on Finance 

A BILL 

To amend title XVIII of the Social Security Act to establish 

programs to prevent prescription drug abuse under the 

Medicare program, 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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Stopping Medication 

5 Abuse and Protecting Seniors Act of 2015’’. 

6 SEC. 2. PROGRAMS TO PREVENT PRESCRIPTION DRUG 

7 ABUSE UNDER THE MEDICARE PROGRAM. 

8 (a) DRUG MANAGEMENT PROGRAM FOR AT-RISK

9 BENEFICIARIES.— 


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

2 Social Security Act (42 U.S.C. 1395w–104(c)) is 

3 amended by adding at the end the following: 

4 ‘‘(5) DRUG MANAGEMENT PROGRAM FOR AT5 RISK BENEFICIARIES.— 

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

7 sponsor may establish a drug management pro8 gram for at-risk beneficiaries under which, sub9 ject to subparagraph (B), the PDP sponsor 

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

11 prescription drug abuse who is an enrollee in a 

12 prescription drug plan of such PDP sponsor, 

13 limit such beneficiary’s access to coverage for 

14 frequently abused drugs under such plan to fre15 quently abused drugs that are prescribed for 

16 such beneficiary by a prescriber (or prescribers) 

17 selected under subparagraph (D), and dis18 pensed for such beneficiary by a pharmacy (or 

19 pharmacies) selected under such subparagraph. 

20 ‘‘(B) REQUIREMENT FOR NOTICES.— 

21 ‘‘(i) IN GENERAL.—A PDP sponsor 

22 may not limit the access of an at-risk ben23 eficiary for prescription drug abuse to cov24 erage for frequently abused drugs under a 


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1 prescription drug plan until such spon2 sor— 

3 ‘‘(I) provides to the beneficiary 

4 an initial notice described in clause 

5 (ii) and a second notice described in 

6 clause (iii); and 

7 ‘‘(II) verifies with the providers 

8 of the beneficiary that the beneficiary 

9 is an at-risk beneficiary for prescrip10 tion drug abuse, as described in sub11 paragraph (C)(iv). 

12 ‘‘(ii) INITIAL NOTICE.—An initial 

13 written notice described in this clause is a 

14 notice that provides to the beneficiary— 

15 ‘‘(I) notice that the PDP sponsor 

16 has identified the beneficiary as po17 tentially being an at-risk beneficiary 

18 for prescription drug abuse; 

19 ‘‘(II) information, when possible, 

20 describing State and Federal public 

21 health resources that are designed to 

22 address prescription drug abuse to 

23 which the beneficiary may have ac24 cess, including substance use disorder 

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1 ment services, mental health services, 

2 and other counseling services; 

3 ‘‘(III) a request for the bene4 ficiary to submit to the PDP sponsor 

5 preferences for which prescribers and 

6 pharmacies the beneficiary would pre7 fer the PDP sponsor to select under 

8 subparagraph (D) in the case that the 

9 beneficiary is identified as an at-risk 

10 beneficiary for prescription drug 

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

12 ‘‘(IV) an explanation of the 

13 meaning and consequences of the 

14 identification of the beneficiary as po15 tentially being an at-risk beneficiary 

16 for prescription drug abuse, including 

17 an explanation of the drug manage18 ment program established by the PDP 

19 sponsor pursuant to subparagraph 

20 (A); 

21 ‘‘(V) clear instructions that ex22 plain how the beneficiary can contact 

23 the PDP sponsor in order to submit 

24 to the PDP sponsor the preferences 

25 described in subclause (IV) and any 


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1 other communications relating to the 

2 drug management program for at-risk 

3 beneficiaries established by the PDP 

4 sponsor; 

5 ‘‘(VI) contact information for 

6 other organizations that can provide 

7 the beneficiary with information re8 garding drug management program 

9 for at-risk beneficiaries (similar to the 

10 information provided by the Secretary 

11 in other standardized notices to part 

12 D eligible individuals enrolled in pre13 scription drug plans under this part); 

14 and 

15 ‘‘(VII) notice that the beneficiary 

16 has a right to an appeal pursuant to 

17 subparagraph (E). 

18 ‘‘(iii) SECOND NOTICE.—A second 

19 written notice described in this clause is a 

20 notice that provides to the beneficiary no21 tice— 

22 ‘‘(I) that the PDP sponsor has 

23 identified the beneficiary as an at-risk 

24 beneficiary for prescription drug 

25 abuse; 


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1 ‘‘(II) that such beneficiary has 

2 been sent, or informed of, such identi3 fication in the initial notice and is 

4 now subject to the requirements of the 

5 drug management program for at-risk 

6 beneficiaries established by such PDP 

7 sponsor for such plan; 

8 ‘‘(III) of the prescriber and phar9 macy selected for such individual 

10 under subparagraph (D); 

11 ‘‘(IV) of, and information about, 

12 the right of the beneficiary to a recon13 sideration and an appeal under sub14 section (h) of such identification and 

15 the prescribers and pharmacies se16 lected; 

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

18 the case that the beneficiary has not 

19 previously submitted to the PDP 

20 sponsor preferences for which pre21 scribers and pharmacies the bene22 ficiary would prefer the PDP sponsor 

23 select under subparagraph (D), sub24 mit such preferences to the PDP 

25 sponsor; and 


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1 ‘‘(VI) that includes clear instruc2 tions that explain how the beneficiary 

3 can contact the PDP sponsor in order 

4 to submit to the PDP sponsor the 

5 preferences described in subclause 

6 (V). 

7 ‘‘(iv) TIMING OF NOTICES.— 

8 ‘‘(I) IN GENERAL.—Subject to 

9 subclause (II), a second written notice 

10 described in clause (iii) shall be pro11 vided to the beneficiary on a date that 

12 is not less than 30 days after an ini13 tial notice described in clause (ii) is 

14 provided to the beneficiary. 

15 ‘‘(II) EXCEPTION.—In the case 

16 that the PDP sponsor, in conjunction 

17 with the Secretary, determines that 

18 concerns identified through rule19 making by the Secretary regarding 

20 the health or safety of the beneficiary 

21 or regarding significant drug diversion 

22 activities require the PDP sponsor to 

23 provide a second notice described in 

24 clause (iii) to the beneficiary on a 

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1 scribed in subclause (II), the PDP 

2 sponsor may provide such second no3 tice on such earlier date. 

4 ‘‘(III) FORM OF NOTICE.—The 

5 written notices under clauses (ii) and 

6 (iii) shall be in a format determined 

7 appropriate by the Secretary, taking 

8 into account beneficiary preferences. 

9 ‘‘(C) AT-RISK BENEFICIARY FOR PRE10 SCRIPTION DRUG ABUSE.— 

11 ‘‘(i) IN GENERAL.—For purposes of 

12 this paragraph, the term ‘at-risk bene13 ficiary for prescription drug abuse’ means 

14 a part D eligible individual who is not an 

15 exempted individual described in clause (ii) 

16 and— 

17 ‘‘(I) who is identified through cri18 teria developed by the Secretary in 

19 consultation with PDP sponsors and 

20 other stakeholders described in sub21 section section 2(g)(2)(A) of the Stop22 ping Medication Abuse and Protecting 

23 Seniors Act of 2015 based on clinical 

24 factors indicating misuse or abuse of 

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1 paragraph (G), including dosage, 

2 quantity, duration of use, number of 

3 prescribers, and number of phar4 macies used to obtain such drug; or 

5 ‘‘(II) with respect to whom the 

6 PDP sponsor of a prescription drug 

7 plan, upon enrolling such individual in 

8 such plan, received notice from the 

9 Secretary that such individual was 

10 identified under this paragraph to be 

11 an at-risk beneficiary for prescription 

12 drug abuse under a prescription drug 

13 plan in which such individual was pre14 viously enrolled and such identifica15 tion has not been terminated under 

16 subparagraph (F). 

17 ‘‘(ii) EXEMPTED INDIVIDUAL DE18 SCRIBED.—An exempted individual de19 scribed in this clause is an individual 

20 who— 

21 ‘‘(I) receives hospice care under 

22 this title; 

23 ‘‘(II) resides in a long-term care 

24 facility, a facility described in section 


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1 1905(d), or other facility under con2 tract with a single pharmacy; or 

3 ‘‘(III) the Secretary elects to 

4 treat as an exempted individual for 

5 purposes of clause (i). 

6 ‘‘(iii) PROGRAM SIZE.—The Secretary 

7 shall establish policies, including the cri8 teria developed under clause (i)(I) and the 

9 exemptions under clause (ii)(III), to ensure 

10 that the population of enrollees in a drug 

11 management program for at-risk bene12 ficiaries operated by a prescription drug 

13 plan can be effectively managed by such 

14 plans. 

15 ‘‘(iv) CLINICAL CONTACT.—With re16 spect to each at-risk beneficiary for pre17 scription drug abuse enrolled in a prescrip18 tion drug plan offered by a PDP sponsor, 

19 the PDP sponsor shall contact the bene20 ficiary’s physicians regarding whether pre21 scribed medications are appropriate for 

22 such beneficiary’s medical conditions. 

23 ‘‘(D) SELECTION OF PRESCRIBERS.— 

24 ‘‘(i) IN GENERAL.—With respect to 

25 each at-risk beneficiary for prescription 


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1 drug abuse enrolled in a prescription drug 

2 plan offered by such sponsor, a PDP spon3 sor shall, based on the preferences sub4 mitted to the PDP sponsor by the bene5 ficiary pursuant to clauses (ii)(III) and 

6 (iii)(V) of subparagraph (B) if applicable, 

7 select— 

8 ‘‘(I) one, or, if the PDP sponsor 

9 reasonably determines it necessary to 

10 provide the beneficiary with reason11 able access under clause (ii), more 

12 than one, individual who is authorized 

13 to prescribe frequently abused drugs 

14 (referred to in this paragraph as a 

15 ‘prescriber’) who may write prescrip16 tions for such drugs for such bene17 ficiary; and 

18 ‘‘(II) one, or, if the PDP sponsor 

19 reasonably determines it necessary to 

20 provide the beneficiary with reason21 able access under clause (ii), more 

22 than one, pharmacy that may dis23 pense such drugs to such beneficiary. 

24 ‘‘(ii) REASONABLE ACCESS.—In mak25 ing the selection under this subparagraph, 


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1 a PDP sponsor shall ensure, taking into 

2 account geographic location, beneficiary 

3 preference, impact on cost-sharing, and 

4 reasonable travel time, that the beneficiary 

5 continues to have reasonable access to 

6 drugs described in subparagraph (G), in7 cluding— 

8 ‘‘(I) for individuals with multiple 

9 residences; and 

10 ‘‘(II) in the case of natural disas11 ters and similar emergency situations. 

12 ‘‘(iii) BENEFICIARY PREFERENCES.— 

13 ‘‘(I) IN GENERAL.—If an at-risk 

14 beneficiary for prescription drug 

15 abuse submits preferences for which 

16 in-network prescribers and pharmacies 

17 the beneficiary would prefer the PDP 

18 sponsor select in response to a notice 

19 under subparagraph (B), the PDP 

20 sponsor shall— 

21 ‘‘(aa) review such pref22 erences; 

23 ‘‘(bb) select or change the 

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1 macy for the beneficiary based on 

2 such preferences; and 

3 ‘‘(cc) inform the beneficiary 

4 of such selection or change of se5 lection. 

6 ‘‘(II) EXCEPTION.—In the case 

7 that the PDP sponsor determines that 

8 a change to the selection of a pre9 scriber or pharmacy under item (bb) 

10 by the PDP sponsor is contributing or 

11 would contribute to prescription drug 

12 abuse or drug diversion by the bene13 ficiary, the PDP sponsor may change 

14 the selection of a prescriber or phar15 macy for the beneficiary. If the PDP 

16 sponsor changes the selection pursu17 ant to the preceding sentence, the 

18 PDP sponsor shall provide the bene19 ficiary with— 

20 ‘‘(aa) at least 30 days writ21 ten notice of the change of selec22 tion; and 

23 ‘‘(bb) a rationale for the 

24 change. 


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1 ‘‘(III) TIMING.—An at-risk bene2 ficiary for prescription drug abuse 

3 may choose to express their prescriber 

4 and pharmacy preference at any date 

5 while enrolled in the program, includ6 ing after a second notice under sub7 paragraph (B)(iii) has been provided. 

8 ‘‘(iv) CONFIRMATION.—Before select9 ing a prescriber or pharmacy under this 

10 subparagraph, a PDP sponsor must notify 

11 the prescriber and pharmacy that the bene12 ficiary involved has been identified for in13 clusion in the drug management program 

14 for at-risk beneficiaries and that the pre15 scriber and pharmacy has been selected as 

16 the beneficiary’s designated prescriber and 

17 pharmacy. 

18 ‘‘(E) APPEALS.—The identification of an 

19 individual as an at-risk beneficiary for prescrip20 tion drug abuse under this paragraph, a cov21 erage determination made under a drug man22 agement program for at-risk beneficiaries, and 

23 the selection of a prescriber or pharmacy under 

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1 vidual shall be subject to an expedited reconsid2 eration and appeal pursuant to subsection (h). 

3 ‘‘(F) TERMINATION OF IDENTIFICATION.— 

4 ‘‘(i) IN GENERAL.—The Secretary 

5 shall develop standards for the termination 

6 of identification of an individual as an at7 risk beneficiary for prescription drug abuse 

8 under this paragraph. Under such stand9 ards such identification shall terminate as 

10 of the earlier of— 

11 ‘‘(I) the date the individual dem12 onstrates that the individual is no 

13 longer likely, in the absence of the re14 strictions under this paragraph, to be 

15 an at-risk beneficiary for prescription 

16 drug abuse described in subparagraph 

17 (C)(i); or 

18 ‘‘(II) the end of such maximum 

19 period of identification as the Sec20 retary may specify. 

21 ‘‘(ii) RULE OF CONSTRUCTION.— 

22 Nothing in clause (i) shall be construed as 

23 preventing a plan from identifying an indi24 vidual as an at-risk beneficiary for pre25 scription drug abuse under subparagraph 


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

2 of additional information on drug use oc3 curring after the date of notice of such ter4 mination. 

5 ‘‘(G) FREQUENTLY ABUSED DRUG.—For 

6 purposes of this subsection, the term ‘frequently 

7 abused drug’ means a drug that is determined 

8 by the Secretary to be frequently abused or di9 verted and that is— 

10 ‘‘(i) a Controlled Drug Substance in 

11 Schedule CII; or 

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

13 of drugs as a Controlled Drug Substance 

14 in Schedule CII, as determined through 

15 notice and comment rulemaking. 

16 ‘‘(H) DATA DISCLOSURE.— 

17 ‘‘(i) DATA ON DECISION TO IMPOSE

18 LIMITATION.—In the case of an at-risk 

19 beneficiary for prescription drug abuse (or 

20 an individual who is a potentially at-risk 

21 beneficiary for prescription drug abuse) 

22 whose access to coverage for frequently 

23 abused drugs under a prescription drug 

24 plan has been limited by a PDP sponsor 

25 under this paragraph, the Secretary shall 


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1 establish rules and procedures to require 

2 such PDP sponsor to disclose data, includ3 ing necessary individually identifiable 

4 health information, about the decision to 

5 impose such limitations and the limitations 

6 imposed by the PDP sponsor under this 

7 part. 

8 ‘‘(ii) DATA TO REDUCE FRAUD, 

9 ABUSE, AND WASTE.—The Secretary shall 

10 establish rules and procedures to require 

11 PDP sponsors operating a drug manage12 ment program for at-risk beneficiaries 

13 under this paragraph to provide the Sec14 retary with such data as the Secretary de15 termines appropriate for purposes of iden16 tifying patterns of prescription drug utili17 zation for plan enrollees that are outside 

18 normal patterns and that may indicate 

19 fraudulent, medically unnecessary, or un20 safe use. 

21 ‘‘(I) SHARING OF INFORMATION FOR SUB22 SEQUENT PLAN ENROLLMENTS.—The Secretary 

23 shall establish procedures under which PDP 

24 sponsors who offer prescription drug plans shall 

25 share information with respect to individuals 


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1 who are at-risk beneficiaries for prescription 

2 drug abuse (or individuals who are potentially 

3 at-risk beneficiaries for prescription drug 

4 abuse) and enrolled in a prescription drug plan 

5 and who subsequently disenroll from such plan 

6 and enroll in another prescription drug plan of7 fered by another PDP sponsor. 

8 ‘‘(J) PRIVACY ISSUES.—Prior to the imple9 mentation of the rules and procedures under 

10 this paragraph, the Secretary shall clarify pri11 vacy requirements, including requirements 

12 under the regulations promulgated pursuant to 

13 section 264(c) of the Health Insurance Port14 ability and Accountability Act of 1996 (42 

15 U.S.C. 1320d–2 note), related to the sharing of 

16 data under subparagraphs (H) and (I) by PDP 

17 sponsors. Such clarification shall provide that 

18 the sharing of such data shall be considered to 

19 be protected health information in accordance 

20 with the requirements of the regulations pro21 mulgated pursuant to such section 264(c). 

22 ‘‘(K) EDUCATION.—The Secretary shall 

23 provide education to enrollees in prescription 

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1 risk beneficiaries described in this paragraph, 

2 including education— 

3 ‘‘(i) provided through the improper 

4 payment outreach and education program 

5 described in section 1874A(h); and 

6 ‘‘(ii) through current education efforts 

7 (such as State health insurance assistance 

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

9 of section 119 of the Medicare Improve10 ments for Patients and Providers Act of 

11 2008 (42 U.S.C. 1395b–3 note)) and ma12 terials directed toward such enrollees. 

13 ‘‘(L) CMS COMPLIANCE REVIEW.—The 

14 Secretary shall ensure that existing plan spon15 sor compliance reviews and audit processes in16 clude the drug management programs for at17 risk beneficiaries under this paragraph, includ18 ing appeals processes under such programs.’’. 

19 (2) INFORMATION FOR CONSUMERS.—Section 

20 1860D–4(a)(1)(B) of the Social Security Act (42 

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

22 at the end the following: 

23 ‘‘(v) The drug management program 

24 for at-risk beneficiaries under subsection 

25 (c)(5).’’. 


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1 (3) DUAL ELIGIBLES.—Section 1860D– 

2 1(b)(3)(D) of the Social Security Act (42 U.S.C. 

3 1395w–101(b)(3)(D)) is amended by inserting ‘‘, 

4 subject to such limits as the Secretary may establish 

5 for individuals identified pursuant to section 

6 1860D–4(c)(5)’’ after ‘‘the Secretary’’. 

7 (b) UTILIZATION MANAGEMENT PROGRAMS.—Sec8 tion 1860D–4(c) of the Social Security Act (42 U.S.C. 

9 1395w–104(c)), as amended by subsection (a)(1), is 

10 amended— 

11 (1) in paragraph (1), by inserting after sub12 paragraph (D) the following new subparagraph: 

13 ‘‘(E) A utilization management tool to pre14 vent drug abuse (as described in paragraph 

15 (5)(A)).’’; and 

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

17 paragraph: 

18 ‘‘(6) UTILIZATION MANAGEMENT TOOL TO PRE19 VENT DRUG ABUSE.— 

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

21 this paragraph is any of the following: 

22 ‘‘(i) A utilization tool designed to pre23 vent the abuse of frequently abused drugs 

24 by individuals and to prevent the diversion 

25 of such drugs at pharmacies. 


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1 ‘‘(ii) Retrospective utilization review 

2 to identify— 

3 ‘‘(I) individuals that receive fre4 quently abused drugs at a frequency 

5 or in amounts that are not clinically 

6 appropriate; and 

7 ‘‘(II) providers of services or sup8 pliers that may facilitate the abuse or 

9 diversion of frequently abused drugs 

10 by beneficiaries. 

11 ‘‘(iii) Consultation with the contractor 

12 described in subparagraph (B) to verify if 

13 an individual enrolling in a prescription 

14 drug plan offered by a PDP sponsor has 

15 been previously identified by another PDP 

16 sponsor as an individual described in 

17 clause (ii)(I). 

18 ‘‘(B) REPORTING.—A PDP sponsor offer19 ing a prescription drug plan in a State shall 

20 submit to the Secretary and the Medicare drug 

21 integrity contractor with which the Secretary 

22 has entered into a contract under section 1893 

23 with respect to such State a report, on a 

24 monthly basis, containing information on— 


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1 ‘‘(i) any provider of services or sup2 plier described in subparagraph (A)(ii)(II) 

3 that is identified by such plan sponsor dur4 ing the 30-day period before such report is 

5 submitted; and 

6 ‘‘(ii) the name and prescription 

7 records of individuals described in para8 graph (5)(C). 

9 ‘‘(C) CMS COMPLIANCE REVIEW.—The 

10 Secretary shall ensure that plan sponsor annual 

11 compliance reviews and program audits include 

12 a certification that utilization management tools 

13 under this paragraph are in compliance with 

14 the requirements for such tools.’’. 

15 (c) TREATMENT OF CERTAIN COMPLAINTS FOR PUR16 POSES OF QUALITY OR PERFORMANCE ASSESSMENT.— 

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

18 1395w–152) is amended by adding at the end the fol19 lowing new subsection: 

20 ‘‘(d) TREATMENT OF CERTAIN COMPLAINTS FOR

21 PURPOSES OF QUALITY OR PERFORMANCE ASSESS22 MENT.—In conducting a quality or performance assess23 ment of a PDP sponsor, the Secretary shall develop or 

24 utilize existing screening methods for reviewing and con25 sidering complaints that are received from enrollees in a 


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1 prescription drug plan offered by such PDP sponsor and 

2 that are complaints regarding the lack of access by the 

3 individual to prescription drugs due to a drug manage4 ment program for at-risk beneficiaries.’’. 

5 (d) SENSE OF CONGRESS REGARDING USE OF TECH6 NOLOGY TOOLS TO COMBAT FRAUD.—It is the sense of 

7 Congress that MA organizations and PDP sponsors 

8 should consider using e-prescribing and other health infor9 mation technology tools to support combating fraud under 

10 MA-PD plans and prescription drug plans under parts C 

11 and D of the Medicare Program. 

12 (e) GAO STUDY AND REPORT.— 

13 (1) STUDY.—The Comptroller General of the 

14 United States shall conduct a study on the imple15 mentation of the amendments made by this section, 

16 including the effectiveness of the at-risk beneficiaries 

17 for prescription drug abuse drug management pro18 grams authorized by section 1860D–4(c)(5) of the 

19 Social Security Act (42 U.S.C. 1395w–10(c)(5)), as 

20 added by subsection (a)(1). Such study shall include 

21 an analysis of— 

22 (A) the impediments, if any, that impair 

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1 cess clinically appropriate levels of prescription 

2 drugs; 

3 (B) the types of— 

4 (i) individuals who, in the implemen5 tation of such section, are determined to be 

6 individuals described in such subpara7 graph; and 

8 (ii) prescribers and pharmacies that 

9 are selected under subparagraph (D) of 

10 such section; 

11 (C) the extent of prescription drug abuse 

12 beyond Controlled Drug Substances in Schedule 

13 CII in parts C and D of the Medicare program; 

14 and 

15 (D) other areas determined appropriate by 

16 the Comptroller General. 

17 (2) REPORT.—Not later than July 1, 2019, the 

18 Comptroller General of the United States shall sub19 mit to the appropriate committees of jurisdiction of 

20 Congress a report on the study conducted under 

21 paragraph (1), together with recommendations for 

22 such legislation and administrative action as the 

23 Comptroller General determines to be appropriate. 

24 (f) REPORT BY SECRETARY.— 


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1 (1) IN GENERAL.—Not later than 12 months 

2 after the date of the enactment of this Act, the Sec3 retary of Health and Human Services shall submit 

4 to the appropriate committees of jurisdiction of Con5 gress a report on ways to improve upon the appeals 

6 process for Medicare beneficiaries with respect to 

7 prescription drug coverage under part D of title 

8 XVIII of the Social Security Act. Such report shall 

9 include an analysis comparing appeals processes 

10 under parts C and D of such title XVIII. 

11 (2) FEEDBACK.—In development of the report 

12 described in paragraph (1), the Secretary of Health 

13 and Human Services shall solicit feedback on the 

14 current appeals process from stakeholders, such as 

15 beneficiaries, consumer advocates, plan sponsors, 

16 pharmacy benefit managers, pharmacists, providers, 

17 independent review entity evaluators, and pharma18 ceutical manufacturers. 

19 (g) EFFECTIVE DATE.— 

20 (1) IN GENERAL.—Except as provided in sub21 section (d)(2), the amendments made by this section 

22 shall apply to prescription drug plans for plan years 

23 beginning on or after January 1, 2018. 

24 (2) STAKEHOLDER MEETINGS PRIOR TO EFFEC25 TIVE DATE.— 


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

2 1, 2017, the Secretary of Health and Human 

3 Services shall convene stakeholders, including 

4 individuals entitled to benefits under part A of 

5 title XVIII of the Social Security Act or en6 rolled under part B of such title of such Act, 

7 advocacy groups representing such individuals, 

8 clinicians, plan sponsors, pharmacists, retail 

9 pharmacies, entities delegated by plan sponsors, 

10 and biopharmaceutical manufacturers 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) the impact on cost-sharing and en16 suring accessibility to prescription drugs 

17 for enrollees in prescription drug plans of 

18 PDP sponsors who are at-risk beneficiaries 

19 for prescription drug abuse (as defined in 

20 paragraph (5)(C) of section 1860D–4(c) of 

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

22 10(c))); 

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 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); 

6 (iii) the types of enrollees that should 

7 be treated as exempted individuals, as de8 scribed in clause (ii) of such paragraph; 

9 (iv) the manner in which terms and 

10 definitions in paragraph (5) of such section 

11 1860D–4(c) should be applied, such as the 

12 use of clinical appropriateness in deter13 mining whether an enrollee is an at-risk 

14 beneficiary for prescription drug abuse as 

15 defined in subparagraph (C) of such para16 graph (5); 

17 (v) the information to be included in 

18 the notices described in subparagraph (B) 

19 of such section and the standardization of 

20 such notices; 

21 (vi) with respect to a PDP sponsor 

22 that establishes a drug management pro23 gram for at-risk beneficiaries under such 

24 paragraph (5), the responsibilities of such 


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1 PDP sponsor with respect to the imple2 mentation of such program; 

3 (vii) notices for plan enrollees at the 

4 point of sale that would explain why an at5 risk beneficiary has been prohibited from 

6 receiving a prescription at a location out7 side of the designated pharmacy; and 

8 (viii) evidence-based prescribing guide9 lines for opiates. 

10 (C) RULEMAKING.—The Secretary of 

11 Health and Human Services shall, taking into 

12 account the input gathered pursuant to sub13 paragraph (A) and after providing notice and 

14 an opportunity to comment, promulgate regula15 tions to carry out the provisions of, and amend16 ments made by subsections (a) and (b). 

Æ 


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