I 

114TH CONGRESS 

2D SESSION H. R. 4876 

To authorize the establishment of programs to prevent prescription drug 

abuse under the Medicare program, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 23, 2016 

Mr. MEEHAN (for himself and Mr. NEAL) introduced the following bill; which 

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

to the Committee on Ways and Means, 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 authorize the establishment of 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 ‘‘Medicare Prescription 

5 Drug Abuse Prevention Act of 2016’’. 


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1 SEC. 2. PROGRAMS TO PREVENT PRESCRIPTION DRUG 

2 ABUSE UNDER THE MEDICARE PROGRAM. 

3 (a) DRUG MANAGEMENT PROGRAM FOR AT-RISK

4 BENEFICIARIES.— 

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

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

7 amended by adding at the end the following: 

8 ‘‘(5) DRUG MANAGEMENT PROGRAM FOR AT9 RISK BENEFICIARIES.— 

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

11 sponsor may establish a drug management pro12 gram for at-risk beneficiaries under which, sub13 ject to subparagraph (B), the PDP sponsor 

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

15 prescription drug abuse who is an enrollee in a 

16 prescription drug plan of such PDP sponsor, 

17 limit such beneficiary’s access to coverage for 

18 frequently abused drugs under such plan to fre19 quently abused drugs that are prescribed for 

20 such beneficiary by a prescriber (or prescribers) 

21 selected under subparagraph (D), and dis22 pensed for such beneficiary by a pharmacy (or 

23 pharmacies) selected under such subparagraph. 

24 ‘‘(B) REQUIREMENT FOR NOTICES.— 

25 ‘‘(i) IN GENERAL.—A PDP sponsor 

26 may not limit the access of an at-risk benVerDate Sep 11 2014 00:56 Mar 25, 2016 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4876.IH H4876

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1 eficiary for prescription drug abuse to cov2 erage for frequently abused drugs under a 

3 prescription drug plan until such spon4 sor— 

5 ‘‘(I) provides to the beneficiary 

6 an initial notice described in clause 

7 (ii) and a second notice described in 

8 clause (iii); and 

9 ‘‘(II) verifies with the providers 

10 of the beneficiary that the beneficiary 

11 is an at-risk beneficiary for prescrip12 tion drug abuse, as described in sub13 paragraph (C)(iv). 

14 ‘‘(ii) INITIAL NOTICE.—An initial 

15 written notice described in this clause is a 

16 notice that provides to the beneficiary— 

17 ‘‘(I) notice that the PDP sponsor 

18 has identified the beneficiary as po19 tentially being an at-risk beneficiary 

20 for prescription drug abuse; 

21 ‘‘(II) information, when possible, 

22 describing State and Federal public 

23 health resources that are designed to 

24 address prescription drug abuse to 

25 which the beneficiary may have acVerDate Sep 11 2014 00:56 Mar 25, 2016 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4876.IH H4876

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1 cess, including substance use disorder 

2 treatment services, addiction treat3 ment services, mental health services, 

4 and other counseling services; 

5 ‘‘(III) a request for the bene6 ficiary to submit to the PDP sponsor 

7 preferences for which prescribers and 

8 pharmacies the beneficiary would pre9 fer the PDP sponsor to select under 

10 subparagraph (D) in the case that the 

11 beneficiary is identified as an at-risk 

12 beneficiary for prescription drug 

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

14 ‘‘(IV) an explanation of the 

15 meaning and consequences of the 

16 identification of the beneficiary as po17 tentially being an at-risk beneficiary 

18 for prescription drug abuse, including 

19 an explanation of the drug manage20 ment program established by the PDP 

21 sponsor pursuant to subparagraph 

22 (A); 

23 ‘‘(V) clear instructions that ex24 plain how the beneficiary can contact 

25 the PDP sponsor in order to submit 


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1 to the PDP sponsor the preferences 

2 described in subclause (IV) and any 

3 other communications relating to the 

4 drug management program for at-risk 

5 beneficiaries established by the PDP 

6 sponsor; 

7 ‘‘(VI) contact information for 

8 other organizations that can provide 

9 the beneficiary with information re10 garding drug management program 

11 for at-risk beneficiaries (similar to the 

12 information provided by the Secretary 

13 in other standardized notices to part 

14 D eligible individuals enrolled in pre15 scription drug plans under this part); 

16 and 

17 ‘‘(VII) notice that the beneficiary 

18 has a right to an appeal pursuant to 

19 subparagraph (E). 

20 ‘‘(iii) SECOND NOTICE.—A second 

21 written notice described in this clause is a 

22 notice that provides to the beneficiary no23 tice— 

24 ‘‘(I) that the PDP sponsor has 

25 identified the beneficiary as an at-risk 


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1 beneficiary for prescription drug 

2 abuse; 

3 ‘‘(II) that such beneficiary has 

4 been sent, or informed of, such identi5 fication in the initial notice and is 

6 now subject to the requirements of the 

7 drug management program for at8 risk beneficiaries established by such 

9 PDP sponsor for such plan; 

10 ‘‘(III) of the prescriber and phar11 macy selected for such individual 

12 under subparagraph (D); 

13 ‘‘(IV) of, and information about, 

14 the right of the beneficiary to a recon15 sideration and an appeal under sub16 section (h) of such identification and 

17 the prescribers and pharmacies se18 lected; 

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

20 the case that the beneficiary has not 

21 previously submitted to the PDP 

22 sponsor preferences for which pre23 scribers and pharmacies the bene24 ficiary would prefer the PDP sponsor 

25 select under subparagraph (D), subVerDate Sep 11 2014 00:56 Mar 25, 2016 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4876.IH H4876

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1 mit such preferences to the PDP 

2 sponsor; and 

3 ‘‘(VI) that includes clear instruc4 tions that explain how the beneficiary 

5 can contact the PDP sponsor in order 

6 to submit to the PDP sponsor the 

7 preferences described in subclause 

8 (V). 

9 ‘‘(iv) TIMING OF NOTICES.— 

10 ‘‘(I) IN GENERAL.—Subject to 

11 subclause (II), a second written notice 

12 described in clause (iii) shall be pro13 vided to the beneficiary on a date that 

14 is not less than 30 days after an ini15 tial notice described in clause (ii) is 

16 provided to the beneficiary. 

17 ‘‘(II) EXCEPTION.—In the case 

18 that the PDP sponsor, in conjunction 

19 with the Secretary, determines that 

20 concerns identified through rule21 making by the Secretary regarding 

22 the health or safety of the beneficiary 

23 or regarding significant drug diversion 

24 activities require the PDP sponsor to 

25 provide a second notice described in 


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1 clause (iii) to the beneficiary on a 

2 date that is earlier than the date de3 scribed in subclause (II), the PDP 

4 sponsor may provide such second no5 tice on such earlier date. 

6 ‘‘(III) FORM OF NOTICE.—The 

7 written notices under clauses (ii) and 

8 (iii) shall be in a format determined 

9 appropriate by the Secretary, taking 

10 into account beneficiary preferences. 

11 ‘‘(C) AT-RISK BENEFICIARY FOR PRE12 SCRIPTION DRUG ABUSE.— 

13 ‘‘(i) IN GENERAL.—For purposes of 

14 this paragraph, the term ‘at-risk bene15 ficiary for prescription drug abuse’ means 

16 a part D eligible individual who is not an 

17 exempted individual described in clause (ii) 

18 and— 

19 ‘‘(I) who is identified through cri20 teria developed by the Secretary in 

21 consultation with PDP sponsors and 

22 other stakeholders described in section 

23 2(g)(2)(A) of the Medicare Prescrip24 tion Drug Abuse Prevention Act of 

25 2016 based on clinical factors indiVerDate Sep 11 2014 00:56 Mar 25, 2016 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4876.IH H4876

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1 cating misuse or abuse of prescription 

2 drugs described in subparagraph (G), 

3 including dosage, quantity, duration 

4 of use, number of and reasonable ac5 cess to prescribers, and number of 

6 and reasonable access to pharmacies 

7 used to obtain such drug; or 

8 ‘‘(II) with respect to whom the 

9 PDP sponsor of a prescription drug 

10 plan, upon enrolling such individual in 

11 such plan, received notice from the 

12 Secretary that such individual was 

13 identified under this paragraph to be 

14 an at- risk beneficiary for prescription 

15 drug abuse under a prescription drug 

16 plan in which such individual was pre17 viously enrolled and such identifica18 tion has not been terminated under 

19 subparagraph (F). 

20 ‘‘(ii) EXEMPTED INDIVIDUAL DE21 SCRIBED.—An exempted individual de22 scribed in this clause is an individual 

23 who— 

24 ‘‘(I) receives hospice care under 

25 this title; 


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1 ‘‘(II) resides in a long-term care 

2 facility, a facility described in section 

3 1905(d), or other facility under con4 tract with a single pharmacy; or 

5 ‘‘(III) the Secretary elects to 

6 treat as an exempted individual for 

7 purposes of clause (i). 

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

9 shall establish policies, including the cri10 teria developed under clause (i)(I) and the 

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

12 that the population of enrollees in a drug 

13 management program for at-risk bene14 ficiaries operated by a prescription drug 

15 plan can be effectively managed by such 

16 plans. 

17 ‘‘(iv) CLINICAL CONTACT.—With re18 spect to each at-risk beneficiary for pre19 scription drug abuse enrolled in a prescrip20 tion drug plan offered by a PDP sponsor, 

21 the PDP sponsor shall contact the bene22 ficiary’s providers who have prescribed fre23 quently abused drugs regarding whether 

24 prescribed medications are appropriate for 

25 such beneficiary’s medical conditions. 


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1 ‘‘(D) SELECTION OF PRESCRIBERS.— 

2 ‘‘(i) IN GENERAL.—With respect to 

3 each at-risk beneficiary for prescription 

4 drug abuse enrolled in a prescription drug 

5 plan offered by such sponsor, a PDP spon6 sor shall, based on the preferences sub7 mitted to the PDP sponsor by the bene8 ficiary pursuant to clauses (ii)(III) and 

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

10 select— 

11 ‘‘(I) one, or, if the PDP sponsor 

12 reasonably determines it necessary to 

13 provide the beneficiary with reason14 able access under clause (ii), more 

15 than one, individual who is authorized 

16 to prescribe frequently abused drugs 

17 (referred to in this paragraph as a 

18 ‘prescriber’) who may write prescrip19 tions for such drugs for such bene20 ficiary; and 

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

22 reasonably determines it necessary to 

23 provide the beneficiary with reason24 able access under clause (ii), more 


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1 than one, pharmacy that may dis2 pense such drugs to such beneficiary. 

3 ‘‘(ii) REASONABLE ACCESS.—In mak4 ing the selection under this subparagraph, 

5 a PDP sponsor shall ensure, taking into 

6 account geographic location, beneficiary 

7 preference, impact on cost-sharing, and 

8 reasonable travel time, that the beneficiary 

9 continues to have reasonable access to 

10 drugs described in subparagraph (G), in11 cluding— 

12 ‘‘(I) for individuals with multiple 

13 residences; and 

14 ‘‘(II) in the case of natural disas15 ters and similar emergency situations. 

16 ‘‘(iii) BENEFICIARY PREFERENCES.— 

17 ‘‘(I) IN GENERAL.—If an at-risk 

18 beneficiary for prescription drug 

19 abuse submits preferences for which 

20 in-network prescribers and pharmacies 

21 the beneficiary would prefer the PDP 

22 sponsor select in response to a notice 

23 under subparagraph (B), the PDP 

24 sponsor shall— 


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1 ‘‘(aa) review such pref2 erences; 

3 ‘‘(bb) select or change the 

4 selection of a prescriber or phar5 macy for the beneficiary based on 

6 such preferences; and 

7 ‘‘(cc) inform the beneficiary 

8 of such selection or change of se9 lection. 

10 ‘‘(II) EXCEPTION.—In the case 

11 that the PDP sponsor determines that 

12 a change to the selection of a pre13 scriber or pharmacy under item (bb) 

14 by the PDP sponsor is contributing or 

15 would contribute to prescription drug 

16 abuse or drug diversion by the bene17 ficiary, the PDP sponsor may change 

18 the selection of a prescriber or phar19 macy for the beneficiary. If the PDP 

20 sponsor changes the selection pursu21 ant to the preceding sentence, the 

22 PDP sponsor shall provide the bene23 ficiary with— 


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1 ‘‘(aa) at least 30 days writ2 ten notice of the change of selec3 tion; and 

4 ‘‘(bb) a rationale for the 

5 change. 

6 ‘‘(III) TIMING.—An at-risk bene7 ficiary for prescription drug abuse 

8 may choose to express their prescriber 

9 and pharmacy preference and commu10 nicate such preference to their PDP 

11 sponsor at any date while enrolled in 

12 the program, including after a second 

13 notice under subparagraph (B)(iii) 

14 has been provided. 

15 ‘‘(iv) CONFIRMATION.—Before select16 ing a prescriber or pharmacy under this 

17 subparagraph, a PDP sponsor must notify 

18 the prescriber and pharmacy that the bene19 ficiary involved has been identified for in20 clusion in the drug management program 

21 for at-risk beneficiaries and that the pre22 scriber and pharmacy has been selected as 

23 the beneficiary’s designated prescriber and 

24 pharmacy. 


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

2 individual as an at-risk beneficiary for prescrip3 tion drug abuse under this paragraph, a cov4 erage determination made under a drug man5 agement program for at-risk beneficiaries, and 

6 the selection of a prescriber or pharmacy under 

7 subparagraph (D) with respect to such indi8 vidual shall be subject to an expedited reconsid9 eration and appeal pursuant to subsection (h). 

10 ‘‘(F) TERMINATION OF IDENTIFICATION.— 

11 ‘‘(i) IN GENERAL.—The Secretary 

12 shall develop standards for the termination 

13 of identification of an individual as an at14 risk beneficiary for prescription drug abuse 

15 under this paragraph. Under such stand16 ards such identification shall terminate as 

17 of the earlier of— 

18 ‘‘(I) the date the individual dem19 onstrates that the individual is no 

20 longer likely, in the absence of the re21 strictions under this paragraph, to be 

22 an at-risk beneficiary for prescription 

23 drug abuse described in subparagraph 

24 (C)(i); or 


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1 ‘‘(II) the end of such maximum 

2 period of identification as the Sec3 retary may specify. 

4 ‘‘(ii) RULE OF CONSTRUCTION.— 

5 Nothing in clause (i) shall be construed as 

6 preventing a plan from identifying an indi7 vidual as an at-risk beneficiary for pre8 scription drug abuse under subparagraph 

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

10 of additional information on drug use oc11 curring after the date of notice of such ter12 mination. 

13 ‘‘(G) FREQUENTLY ABUSED DRUG.—For 

14 purposes of this subsection, the term ‘frequently 

15 abused drug’ means a drug that is determined 

16 by the Secretary to be frequently abused or di17 verted and that is— 

18 ‘‘(i) a Controlled Drug Substance in 

19 Schedule CII; or 

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

21 of drugs as a Controlled Drug Substance 

22 in Schedule CII, as determined through 

23 notice and comment rulemaking. 

24 ‘‘(H) DATA DISCLOSURE.— 


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1 ‘‘(i) DATA ON DECISION TO IMPOSE

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

3 beneficiary for prescription drug abuse (or 

4 an individual who is a potentially at-risk 

5 beneficiary for prescription drug abuse) 

6 whose access to coverage for frequently 

7 abused drugs under a prescription drug 

8 plan has been limited by a PDP sponsor 

9 under this paragraph, the Secretary shall 

10 establish rules and procedures to require 

11 such PDP sponsor to disclose data, includ12 ing necessary individually identifiable 

13 health information, about the decision to 

14 impose such limitations and the limitations 

15 imposed by the PDP sponsor under this 

16 part. 

17 ‘‘(ii) DATA TO REDUCE FRAUD, 

18 ABUSE, AND WASTE.—The Secretary shall 

19 establish rules and procedures to require 

20 PDP sponsors operating a drug manage21 ment program for at-risk beneficiaries 

22 under this paragraph to provide the Sec23 retary with such data as the Secretary de24 termines appropriate for purposes of iden25 tifying patterns of prescription drug utiliVerDate Sep 11 2014 00:56 Mar 25, 2016 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H4876.IH H4876

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1 zation for plan enrollees that are outside 

2 normal patterns and that may indicate 

3 fraudulent, medically unnecessary, or un4 safe use. 

5 ‘‘(I) SHARING OF INFORMATION FOR SUB6 SEQUENT PLAN ENROLLMENTS.—The Secretary 

7 shall establish procedures under which PDP 

8 sponsors who offer prescription drug plans shall 

9 share information with respect to individuals 

10 who are at-risk beneficiaries for prescription 

11 drug abuse (or individuals who are potentially 

12 at-risk beneficiaries for prescription drug 

13 abuse) and enrolled in a prescription drug plan 

14 and who subsequently disenroll from such plan 

15 and enroll in another prescription drug plan of16 fered by another PDP sponsor. 

17 ‘‘(J) PRIVACY ISSUES.—Prior to the imple18 mentation of the rules and procedures under 

19 this paragraph, the Secretary shall clarify pri20 vacy requirements, including requirements 

21 under the regulations promulgated pursuant to 

22 section 264(c) of the Health Insurance Port23 ability and Accountability Act of (42 U.S.C. 

24 1320d–2 note), related to the sharing of data 

25 under subparagraphs (H) and (I) by PDP 


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1 sponsors. Such clarification shall provide that 

2 the sharing of such data shall be considered to 

3 be protected health information in accordance 

4 with the requirements of the regulations pro5 mulgated pursuant to such section 264(c). 

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

7 provide education to enrollees in prescription 

8 drug plans of PDP sponsors and providers re9 garding the drug management program for at10 risk beneficiaries described in this paragraph, 

11 including education— 

12 ‘‘(i) provided through the improper 

13 payment outreach and education program 

14 described in section 1874A(h); and 

15 ‘‘(ii) through current education efforts 

16 (such as State health insurance assistance 

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

18 of section 119 of the Medicare Improve19 ments for Patients and Providers Act of 

20 2008 (42 U.S.C. 1395b–3 note)) and ma21 terials directed toward such enrollees. 

22 ‘‘(L) CMS COMPLIANCE REVIEW.—The 

23 Secretary shall ensure that existing plan spon24 sor compliance reviews and audit processes in25 clude the drug management programs for atVerDate Sep 11 2014 00:56 Mar 25, 2016 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\H4876.IH H4876

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1 risk beneficiaries under this paragraph, includ2 ing appeals processes under such programs.’’. 

3 (2) INFORMATION FOR CONSUMERS.—Section 

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

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

6 at the end the following: 

7 ‘‘(v) The drug management program 

8 for at-risk beneficiaries under subsection 

9 (c)(5).’’. 

10 (3) DUAL ELIGIBLES.—Section 1860D– 

11 1(b)(3)(D) of the Social Security Act (42 U.S.C. 

12 1395w–101(b)(3)(D)) is amended by inserting ‘‘, 

13 subject to such limits as the Secretary may establish 

14 for individuals identified pursuant to section D15 4(c)(5)’’ after ‘‘the Secretary’’. 

16 (b) UTILIZATION MANAGEMENT PROGRAMS.—Sec17 tion 1860D–4(c) of the Social Security Act (42 U.S.C. 

18 1395w–104(c)), as amended by subsection (a)(1), is 

19 amended— 

20 (1) in paragraph (1), by inserting after sub21 paragraph (D) the following new subparagraph: 

22 ‘‘(E) A utilization management tool to pre23 vent drug abuse (as described in paragraph 

24 (5)(A)).’’; and 


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

2 paragraph: 

3 ‘‘(6) UTILIZATION MANAGEMENT TOOL TO PRE4 VENT DRUG ABUSE.— 

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

6 this paragraph is any of the following: 

7 ‘‘(i) A utilization tool designed to pre8 vent the abuse of frequently abused drugs 

9 by individuals and to prevent the diversion 

10 of such drugs at pharmacies. 

11 ‘‘(ii) Retrospective utilization review 

12 to identify— 

13 ‘‘(I) individuals that receive fre14 quently abused drugs at a frequency 

15 or in amounts that are not clinically 

16 appropriate; and 

17 ‘‘(II) providers of services or sup18 pliers that may facilitate the abuse or 

19 diversion of frequently abused drugs 

20 by beneficiaries. 

21 ‘‘(iii) Consultation with the contractor 

22 described in subparagraph (B) to verify if 

23 an individual enrolling in a prescription 

24 drug plan offered by a PDP sponsor has 

25 been previously identified by another PDP 


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1 sponsor as an individual described in 

2 clause (ii)(I). 

3 ‘‘(B) REPORTING.—A PDP sponsor offer4 ing a prescription drug plan in a State shall 

5 submit to the Secretary and the Medicare drug 

6 integrity contractor with which the Secretary 

7 has entered into a contract under section 1893 

8 with respect to such State a report, on a 

9 monthly basis, containing information on— 

10 ‘‘(i) any provider of services or sup11 plier described in subparagraph (A)(ii)(II) 

12 that is identified by such plan sponsor dur13 ing the 30-day period before such report is 

14 submitted; and 

15 ‘‘(ii) the name and prescription 

16 records of individuals described in para17 graph (5)(C). 

18 ‘‘(C) CMS COMPLIANCE REVIEW.—The 

19 Secretary shall ensure that plan sponsor annual 

20 compliance reviews and program audits include 

21 a certification that utilization management tools 

22 under this paragraph are in compliance with 

23 the requirements for such tools.’’. 

24 (c) TREATMENT OF CERTAIN COMPLAINTS FOR PUR25 POSES OF QUALITY OR PERFORMANCE ASSESSMENT.— 


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

2 1395w–152) is amended by adding at the end the fol3 lowing new subsection: 

4 ‘‘(d) TREATMENT OF CERTAIN COMPLAINTS FOR

5 PURPOSES OF QUALITY OR PERFORMANCE ASSESS6 MENT.—In conducting a quality or performance assess7 ment of a PDP sponsor, the Secretary shall develop or 

8 utilize existing screening methods for reviewing and con9 sidering complaints that are received from enrollees in a 

10 prescription drug plan offered by such PDP sponsor and 

11 that are complaints regarding the lack of access by the 

12 individual to prescription drugs due to a drug manage13 ment program for at-risk beneficiaries.’’. 

14 (d) SENSE OF CONGRESS REGARDING USE OF TECH15 NOLOGY TOOLS TO COMBAT FRAUD.—It is the sense of 

16 Congress that MA organizations and PDP sponsors 

17 should consider using e-prescribing and other health infor18 mation technology tools to support combating fraud under 

19 MA–PD plans and prescription drug plans under parts C 

20 and D of the Medicare program. 

21 (e) GAO STUDY AND REPORT.— 

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

23 United States shall conduct a study on the imple24 mentation of the amendments made by this section, 

25 including the effectiveness of the at-risk beneficiaries 


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1 for prescription drug abuse drug management pro2 grams authorized by paragraph (5) of section 

3 1860D–4(c) of the Social Security Act (42 U.S.C. 

4 1395w–104(c)), as added by subsection (a)(1). Such 

5 study shall include an analysis of— 

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

7 the ability of individuals described in subpara8 graph (C) of such section D–4(c)(5) to access 

9 clinically appropriate levels of prescription 

10 drugs; 

11 (B) the effectiveness of the reasonable ac12 cess protections under subparagraph (D)(ii) of 

13 such section 1860D–4(c)(5), including the im14 pact on beneficiary access and health; 

15 (C) how best to define the term ‘‘des16 ignated pharmacy’’, including whether the defi17 nition of such term should include an entity 

18 that is comprised of a number of locations that 

19 are under common ownership and that elec20 tronically share a real-time, online database and 

21 whether such a definition would help to protect 

22 and improve beneficiary access; 

23 (D) the types of— 

24 (i) individuals who, in the implemen25 tation of such section, are determined to be 


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1 individuals described in such subpara2 graph; and 

3 (ii) prescribers and pharmacies that 

4 are selected under subparagraph (D) of 

5 such section; 

6 (E) the extent of prescription drug abuse 

7 beyond Controlled Drug Substances in Schedule 

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

9 and 

10 (F) other areas determined appropriate by 

11 the Comptroller General. 

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

13 Comptroller General of the United States shall sub14 mit to the appropriate committees of jurisdiction of 

15 Congress a report on the study conducted under 

16 paragraph (1), together with recommendations for 

17 such legislation and administrative action as the 

18 Comptroller General determines to be appropriate. 

19 (f) REPORT BY SECRETARY.— 

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

21 after the date of the enactment of this Act, the Sec22 retary of Health and Human Services shall submit 

23 to the appropriate committees of jurisdiction of Con24 gress a report on ways to improve upon the appeals 

25 process for Medicare beneficiaries with respect to 


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1 prescription drug coverage under part D of title 

2 XVIII of the Social Security Act. Such report shall 

3 include an analysis comparing appeals processes 

4 under parts C and D of such title XVIII. 

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

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

7 and Human Services shall solicit feedback on the 

8 current appeals process from stakeholders, such as 

9 beneficiaries, consumer advocates, plan sponsors, 

10 pharmacy benefit managers, pharmacists, providers, 

11 independent review entity evaluators, and pharma12 ceutical manufacturers. 

13 (g) EFFECTIVE DATE.— 

14 (1) IN GENERAL.—Except as provided in sub15 section (d)(2), the amendments made by this section 

16 shall apply to prescription drug plans for plan years 

17 beginning on or after January 1, 2018. 

18 (2) STAKEHOLDER MEETINGS PRIOR TO EFFEC19 TIVE DATE.— 

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

21 1, 2017, the Secretary of Health and Human 

22 Services shall convene stakeholders, including 

23 individuals entitled to benefits under part A of 

24 title XVIII of the Social Security Act or en25 rolled under part B of such title of such Act, 


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1 advocacy groups representing such individuals, 

2 clinicians, plan sponsors, pharmacists, retail 

3 pharmacies, entities delegated by plan sponsors, 

4 and biopharmaceutical manufacturers for input 

5 regarding the topics described in subparagraph 

6 (B). The input described in the preceding sen7 tence shall be provided to the Secretary in suffi8 cient time in order for the Secretary to take 

9 such input into account in promulgating the 

10 regulations pursuant to subparagraph (C). 

11 (B) TOPICS DESCRIBED.—The topics de12 scribed in this subparagraph are the topics of— 

13 (i) the impact on cost-sharing and en14 suring accessibility to prescription drugs 

15 for enrollees in prescription drug plans of 

16 PDP sponsors who are at-risk beneficiaries 

17 for prescription drug abuse (as defined in 

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

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

20 104(c))); 

21 (ii) the use of an expedited appeals 

22 process under which such an enrollee may 

23 appeal an identification of such enrollee as 

24 an at-risk beneficiary for prescription drug 

25 abuse under such paragraph (similar to the 


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•HR 4876 IH

1 processes established under the Medicare 

2 Advantage program under part C of title 

3 XVIII of the Social Security Act); 

4 (iii) the types of enrollees that should 

5 be treated as exempted individuals, as de6 scribed in clause (ii) of such paragraph; 

7 (iv) the manner in which terms and 

8 definitions in paragraph (5) of such section 

9 1860D–4(c) should be applied, such as the 

10 use of clinical appropriateness in deter11 mining whether an enrollee is an at-risk 

12 beneficiary for prescription drug abuse as 

13 defined in subparagraph (C) of such para14 graph (5); 

15 (v) the information to be included in 

16 the notices described in subparagraph (B) 

17 of such section and the standardization of 

18 such notices; 

19 (vi) with respect to a PDP sponsor 

20 that establishes a drug management pro21 gram for at-risk beneficiaries under such 

22 paragraph (5), the responsibilities of such 

23 PDP sponsor with respect to the imple24 mentation of such program; 


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•HR 4876 IH

1 (vii) notices for plan enrollees at the 

2 point of sale that would explain why an at3 risk beneficiary has been prohibited from 

4 receiving a prescription at a location out5 side of the designated pharmacy; 

6 (viii) evidence-based prescribing guide7 lines for opiates; and 

8 (ix) the sharing of claims data under 

9 parts A and B with PDP sponsors. 

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 


smartinez on DSK4TPTVN1PROD with BILLS