I 

114TH CONGRESS 

1ST SESSION H. R. 2298 

To amend title XVIII of the Social Security Act to provide for programs 

to prevent prescription drug abuse under parts C and D of the Medicare 

program. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 13, 2015 

Mr. BILIRAKIS (for himself, Mr. BEN RAY LUJA ́N of New Mexico, and Mr. 

LONG) 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 amend title XVIII of the Social Security Act to provide 

for programs to prevent prescription drug abuse under 

parts C and D of the Medicare program. 

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 Patient Safe5 ty and Drug Abuse Prevention Act’’. 


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1 SEC. 2. PROGRAMS TO PREVENT PRESCRIPTION DRUG 

2 ABUSE UNDER MEDICARE PARTS C AND D. 

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–10(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 selected under 

21 subparagraph (D), and dispensed for such bene22 ficiary by a pharmacy selected under such sub23 paragraph. 

24 ‘‘(B) REQUIREMENT FOR NOTICES.— 

25 ‘‘(i) IN GENERAL.—A PDP sponsor 

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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. 

13 ‘‘(ii) INITIAL NOTICE.—An initial no14 tice described in this clause is a notice that 

15 provides to the beneficiary— 

16 ‘‘(I) notice that the PDP sponsor 

17 has identified the beneficiary as po18 tentially being an at-risk beneficiary 

19 for prescription drug abuse; 

20 ‘‘(II) information describing all 

21 State and Federal public health re22 sources that are designed to address 

23 prescription drug abuse to which the 

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1 tal health services and other coun2 seling services; 

3 ‘‘(III) notice of, and information 

4 about, the right of the beneficiary to 

5 appeal such identification under sub6 section (h) and the option of an auto7 matic escalation to external review; 

8 ‘‘(IV) a request for the bene9 ficiary to submit to the PDP sponsor 

10 preferences for which prescribers and 

11 pharmacies the beneficiary would pre12 fer the PDP sponsor to select under 

13 subparagraph (D) in the case that the 

14 beneficiary is identified as an at-risk 

15 beneficiary for prescription drug 

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

17 ‘‘(V) an explanation of the mean18 ing and consequences of the identi19 fication of the beneficiary as poten20 tially being an at-risk beneficiary for 

21 prescription drug abuse, including an 

22 explanation of the drug management 

23 program established by the PDP 

24 sponsor pursuant to subparagraph 

25 (A); 


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1 ‘‘(VI) clear instructions that ex2 plain how the beneficiary can contact 

3 the PDP sponsor in order to submit 

4 to the PDP sponsor the preferences 

5 described in subclause (IV) and any 

6 other communications relating to the 

7 drug management program for at-risk 

8 beneficiaries established by the PDP 

9 sponsor; and 

10 ‘‘(VII) contact information for 

11 other organizations that can provide 

12 the beneficiary with assistance regard13 ing such drug management program 

14 (similar to the information provided 

15 by the Secretary in other standardized 

16 notices provided to part D eligible in17 dividuals enrolled in prescription drug 

18 plans under this part). 

19 ‘‘(iii) SECOND NOTICE.—A second no20 tice described in this clause is a notice that 

21 provides to the beneficiary notice— 

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 is 

2 subject to the requirements of the 

3 drug management program for at-risk 

4 beneficiaries established by such PDP 

5 sponsor for such plan; 

6 ‘‘(III) of the prescriber and phar7 macy selected for such individual 

8 under subparagraph (D); 

9 ‘‘(IV) of, and information about, 

10 the beneficiary’s right to appeal such 

11 identification under subsection (h) 

12 and the option of an automatic esca13 lation to external review; 

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

15 the case that the beneficiary has not 

16 previously submitted to the PDP 

17 sponsor preferences for which pre18 scribers and pharmacies the bene19 ficiary would prefer the PDP sponsor 

20 select under subparagraph (D), sub21 mit such preferences to the PDP 

22 sponsor; and 

23 ‘‘(VI) that includes clear instruc24 tions that explain how the beneficiary 

25 can contact the PDP sponsor. 


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1 ‘‘(iv) TIMING OF NOTICES.— 

2 ‘‘(I) IN GENERAL.—Subject to 

3 subclause (II), a second notice de4 scribed in clause (iii) shall be provided 

5 to the beneficiary on a date that is 

6 not less than 60 days after an initial 

7 notice described in clause (ii) is pro8 vided to the beneficiary. 

9 ‘‘(II) EXCEPTION.—In the case 

10 that the PDP sponsor, in conjunction 

11 with the Secretary, determines that 

12 concerns identified through rule13 making by the Secretary regarding 

14 the health or safety of the beneficiary 

15 or regarding significant drug diversion 

16 activities require the PDP sponsor to 

17 provide a second notice described in 

18 clause (iii) to the beneficiary on a 

19 date that is earlier than the date de20 scribed in subclause (II), the PDP 

21 sponsor may provide such second no22 tice on such earlier date. 

23 ‘‘(C) AT-RISK BENEFICIARY FOR PRE24 SCRIPTION DRUG ABUSE.— 


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1 ‘‘(i) IN GENERAL.—For purposes of 

2 this paragraph, the term ‘at-risk bene3 ficiary for prescription drug abuse’ means 

4 a part D eligible individual who is not an 

5 exempted individual described in clause (ii) 

6 and— 

7 ‘‘(I) who is identified through the 

8 use of clinical guidelines developed by 

9 the Secretary in consultation with 

10 PDP sponsors and other stakeholders 

11 described in subsection (f)(2)(A); or 

12 ‘‘(II) with respect to whom the 

13 PDP sponsor of a prescription drug 

14 plan, upon enrolling such individual in 

15 such plan, received notice from the 

16 Secretary that such individual was 

17 identified under this paragraph to be 

18 an at-risk beneficiary for prescription 

19 drug abuse under the prescription 

20 drug plan in which such individual 

21 was most recently previously enrolled 

22 and such identification has not been 

23 terminated under subparagraph (F). 

24 ‘‘(ii) EXEMPTED INDIVIDUAL DE25 SCRIBED.—An exempted individual deVerDate Sep 11 2014 06:04 May 15, 2015 Jkt 049200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H2298.IH H2298

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1 scribed in this clause is an individual 

2 who— 

3 ‘‘(I) an individual who receives 

4 hospice care under this title; or 

5 ‘‘(II) an individual, such as an 

6 individual who is a resident of a long7 term care facility, who the Secretary 

8 elects to treat as an exempted indi9 vidual for purposes of clause (i). 

10 ‘‘(D) SELECTION OF PRESCRIBERS.— 

11 ‘‘(i) IN GENERAL.—With respect to 

12 each at-risk beneficiary for prescription 

13 drug abuse enrolled in a prescription drug 

14 plan offered by such sponsor, a PDP spon15 sor shall, based on the preferences sub16 mitted to the PDP sponsor by the bene17 ficiary pursuant to clauses (ii)(IV) and 

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

19 ‘‘(I) one or more individuals who 

20 are authorized to prescribe frequently 

21 abused drugs (referred to in this 

22 paragraph as ‘prescribers’) who may 

23 write prescriptions for such drugs for 

24 such beneficiary; and 


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1 ‘‘(II) one or more pharmacies 

2 that may dispense such drugs to such 

3 beneficiary. 

4 ‘‘(ii) REASONABLE ACCESS.—In mak5 ing the selection under this subparagraph, 

6 a PDP sponsor shall ensure that the bene7 ficiary continues to have reasonable access 

8 to drugs described in subparagraph (G), 

9 taking into account geographic location, 

10 beneficiary preference, impact on cost11 sharing, and reasonable travel time. 

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 without re16 gard to the preferences of the bene17 ficiary described in subclause (I). 

18 ‘‘(iv) CONFIRMATION.—Before select19 ing a prescriber or pharmacy under this 

20 subparagraph, a PDP sponsor must re21 quest and receive confirmation from the 

22 prescriber or pharmacy acknowledging and 

23 accepting that the beneficiary involved is in 

24 the drug management program for at-risk 

25 beneficiaries. 


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

2 identification of an individual as an at-risk ben3 eficiary for prescription drug abuse under this 

4 paragraph, a coverage determination made 

5 under a drug management program for at-risk 

6 beneficiaries, and the selection of a prescriber 

7 or pharmacy under subparagraph (D) with re8 spect to such individual shall be subject to re9 consideration and appeal under subsection (h) 

10 and the option of an automatic escalation to ex11 ternal review to the extent provided by the Sec12 retary. 

13 ‘‘(F) TERMINATION OF IDENTIFICATION.— 

14 ‘‘(i) IN GENERAL.—The Secretary 

15 shall develop standards for the termination 

16 of identification of an individual as an at17 risk beneficiary for prescription drug abuse 

18 under this paragraph. Under such stand19 ards such identification shall terminate as 

20 of the earlier of— 

21 ‘‘(I) the date the individual dem22 onstrates that the individual is no 

23 longer likely, in the absence of the re24 strictions under this paragraph, to be 

25 an at-risk beneficiary for prescription 


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1 drug abuse described in subparagraph 

2 (C)(i); or 

3 ‘‘(II) the end of such maximum 

4 period of identification as the Sec5 retary may specify. 

6 ‘‘(ii) RULE OF CONSTRUCTION.— 

7 Nothing in clause (i) shall be construed as 

8 preventing a plan from identifying an indi9 vidual as an at-risk beneficiary for pre10 scription drug abuse under subparagraph 

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

12 of additional information on drug use oc13 curring after the date of notice of such ter14 mination. 

15 ‘‘(G) FREQUENTLY ABUSED DRUG.—For 

16 purposes of this subsection, the term ‘frequently 

17 abused drug’ means a drug that is a controlled 

18 substance that the Secretary determines to be 

19 frequently abused or diverted. 

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

21 an at-risk beneficiary for prescription drug 

22 abuse whose access to coverage for frequently 

23 abused drugs under a prescription drug plan 

24 has been limited by a PDP sponsor under this 

25 paragraph, such PDP sponsor shall disclose 


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1 data, including any necessary individually iden2 tifiable health information, in a form and man3 ner specified by the Secretary, about the deci4 sion to impose such limitations and the limita5 tions imposed by the sponsor under this part. 

6 ‘‘(I) 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 by medicare administra13 tive contractors through the improper pay14 ment outreach and education program de15 scribed in section 1874A(h); and 

16 ‘‘(ii) through current education efforts 

17 (such as State health insurance assistance 

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

19 of section 119 of the Medicare Improve20 ments for Patients and Providers Act of 

21 2008 (42 U.S.C. 1395b–3 note)) and ma22 terials directed toward such enrollees. 

23 ‘‘(J) APPLICATION UNDER MA–PD

24 PLANS.—Pursuant to section 1860D–21(c)(1), 

25 the provisions of this paragraph apply under 


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1 part D to MA organizations offering MA–PD 

2 plans to MA eligible individuals in the same 

3 manner as such provisions apply under this 

4 part to a PDP sponsor offering a prescription 

5 drug plan to a part D eligible individual.’’. 

6 (2) INFORMATION FOR CONSUMERS.—Section 

7 1860D–4(a)(1)(B) of the Social Security Act (42 

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

9 at the end the following: 

10 ‘‘(v) The drug management program 

11 for at-risk beneficiaries under subsection 

12 (c)(5).’’. 

13 (b) UTILIZATION MANAGEMENT PROGRAMS.—Sec14 tion 1860D–4(c) of the Social Security Act (42 U.S.C. 

15 1395w–104(c)), as amended by subsection (a)(1), is fur16 ther amended— 

17 (1) in paragraph (1), by inserting after sub18 paragraph (D) the following new subparagraph: 

19 ‘‘(E) A utilization management tool to pre20 vent drug abuse (as described in paragraph 

21 (6)(A)).’’; and 

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

23 paragraph: 

24 ‘‘(6) UTILIZATION MANAGEMENT TOOL TO PRE25 VENT DRUG ABUSE.— 


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

2 this paragraph is any of the following: 

3 ‘‘(i) A utilization tool designed to pre4 vent the abuse of frequently abused drugs 

5 by individuals and to prevent the diversion 

6 of such drugs at pharmacies. 

7 ‘‘(ii) Retrospective utilization review 

8 to identify— 

9 ‘‘(I) individuals that receive fre10 quently abused drugs at a frequency 

11 or in amounts that are not clinically 

12 appropriate; and 

13 ‘‘(II) providers of services or sup14 pliers that may facilitate the abuse or 

15 diversion of frequently abused drugs 

16 by beneficiaries. 

17 ‘‘(iii) Consultation with the Con18 tractor described in subparagraph (B) to 

19 verify if an individual enrolling in a pre20 scription drug plan offered by a PDP 

21 sponsor has been previously identified by 

22 another PDP sponsor as an individual de23 scribed in clause (ii)(I). 

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1 nization offering an MA–PD plan) in a State 

2 shall submit to the Secretary and the Medicare 

3 drug integrity contractor with which the Sec4 retary has entered into a contract under section 

5 1893 with respect to such State a report, on a 

6 monthly basis, containing information on— 

7 ‘‘(i) any provider of services or sup8 plier described in subparagraph (A)(ii)(II) 

9 that is identified by such plan sponsor (or 

10 organization) during the 30-day period be11 fore such report is submitted; and 

12 ‘‘(ii) the name and prescription 

13 records of individuals described in para14 graph (5)(C).’’. 

15 (c) EXPANDING ACTIVITIES OF MEDICARE DRUG IN16 TEGRITY CONTRACTORS (MEDICS).— 

17 (1) IN GENERAL.—Section 1893 of the Social 

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

19 adding at the end the following new subsection: 

20 ‘‘(j) EXPANDING ACTIVITIES OF MEDICARE DRUG

21 INTEGRITY CONTRACTORS (MEDICS).— 

22 ‘‘(1) ACCESS TO INFORMATION.—Under con23 tracts entered into under this section with Medicare 

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1 tion and necessary medical records from entities 

2 such as pharmacies, prescription drug plans, MA– 

3 PD plans, and physicians with respect to an indi4 vidual in order for such contractors to provide infor5 mation relevant to the determination of whether 

6 such individual is an at-risk beneficiary for prescrip7 tion drug abuse, as defined in section 1860D– 

8 4(c)(5)(C). 

9 ‘‘(2) REQUIREMENT FOR ACKNOWLEDGMENT

10 OF REFERRALS.—If a PDP sponsor or MA organiza11 tion refers information to a contractor described in 

12 paragraph (1) in order for such contractor to assist 

13 in the determination described in such paragraph, 

14 the contractor shall— 

15 ‘‘(A) acknowledge to the sponsor or organi16 zation receipt of the referral; and 

17 ‘‘(B) in the case that any PDP sponsor or 

18 MA organization contacts the contractor re19 questing to know the determination by the con20 tractor of whether or not an individual has been 

21 determined to be an individual described such 

22 paragraph, shall inform such sponsor or organi23 zation of such determination on a date that is 

24 not later than 15 days after the date on which 


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1 the sponsor or organization contacts the con2 tractor. 

3 ‘‘(3) MAKING DATA AVAILABLE TO OTHER EN4 TITIES.— 

5 ‘‘(A) IN GENERAL.—For purposes of car6 rying out this subsection, subject to subpara7 graph (B), the Secretary shall authorize MED8 ICs to respond to requests for information from 

9 PDP sponsors and MA organizations, State 

10 prescription drug monitoring programs, and 

11 other entities delegated by such sponsors or or12 ganizations using available programs and sys13 tems in the effort to prevent fraud, waste, and 

14 abuse. 

15 ‘‘(B) HIPAA COMPLIANT INFORMATION

16 ONLY.—Information may only be disclosed by a 

17 MEDIC under subparagraph (A) if the disclo18 sure of such information is permitted under the 

19 Federal regulations (concerning the privacy of 

20 individually identifiable health information) pro21 mulgated under section 264(c) of the Health 

22 Insurance Portability and Accountability Act of 

23 1996 (42 U.S.C. 1320d–2 note).’’. 

24 (2) OIG STUDY AND REPORT ON EFFECTIVE25 NESS OF MEDICS.— 


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1 (A) STUDY.—The Inspector General of the 

2 Department of Health and Human Services 

3 shall conduct a study on the effectiveness of 

4 Medicare drug integrity contractors in identi5 fying combating, and preventing fraud under 

6 the Medicare program, including under the au7 thority provided under section 1893(j) of the 

8 Social Security Act, as added by paragraph (1). 

9 (B) REPORT.—Not later than 1 year after 

10 the date of the enactment of this Act, the In11 spector General shall submit to Congress a re12 port on the study conducted under subpara13 graph (A). Such report shall include such rec14 ommendations for improvements in the effec15 tiveness of such contractors as the Inspector 

16 General determines appropriate. 

17 (d) TREATMENT OF CERTAIN COMPLAINTS FOR PUR18 POSES OF QUALITY OR PERFORMANCE ASSESSMENT.— 

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

20 1395w–152) is amended by adding at the end the fol21 lowing new subsection: 

22 ‘‘(d) TREATMENT OF CERTAIN COMPLAINTS FOR

23 PURPOSES OF QUALITY OR PERFORMANCE ASSESS24 MENT.—In conducting a quality or performance assess25 ment of a PDP sponsor, the Secretary shall develop or 


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1 utilize existing screening methods for reviewing and con2 sidering complaints that are received from enrollees in a 

3 prescription drug plan offered by such PDP sponsor and 

4 that are complaints regarding the lack of access by the 

5 individual to prescription drugs due to a drug manage6 ment program for at-risk beneficiaries.’’. 

7 (e) SENSE OF CONGRESS REGARDING USE OF TECH8 NOLOGY TOOLS TO COMBAT FRAUD.—It is the sense of 

9 Congress that MA organizations and PDP sponsors 

10 should consider using e-prescribing and other health infor11 mation technology tools to support combating fraud under 

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

13 and D of the Medicare program. 

14 (f) EFFECTIVE DATE.— 

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

16 this section shall apply to prescription drug plans 

17 (and MA–PD plans) for plan years beginning more 

18 than 1 year after the date of the enactment of this 

19 Act. 

20 (2) STAKEHOLDER MEETINGS PRIOR TO EFFEC21 TIVE DATE.— 

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

23 1, 2016, the Secretary of Health and Human 

24 Services shall convene stakeholders, including 

25 individuals entitled to benefits under part A of 


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1 title XVIII of the Social Security Act or en2 rolled under part B of such title of such Act, 

3 advocacy groups representing such individuals, 

4 clinicians, plan sponsors, entities delegated by 

5 plan sponsors, and biopharmaceutical manufac6 turers for input regarding the topics described 

7 in subparagraph (B). 

8 (B) TOPICS DESCRIBED.—The topics de9 scribed in this subparagraph are the topics of— 

10 (i) the impact on cost-sharing and en11 suring accessibility to prescription drugs 

12 for enrollees in prescription drug plans of 

13 PDP sponsors, and enrollees in MA–PD 

14 plans, who are at-risk beneficiaries for pre15 scription drug abuse (as defined in sub16 paragraph (C) of paragraph (5) of section 

17 1860D–4(c) of the Social Security Act (42 

18 U.S.C. 1395w–104(c))); 

19 (ii) the use of an expedited appeals 

20 process under which such an enrollee may 

21 appeal an identification of such enrollee as 

22 an at-risk beneficiary for prescription drug 

23 abuse under such paragraph (similar to the 

24 processes established under the Medicare 

25 Advantage program under part C of title 


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1 XVIII of the Social Security Act that allow 

2 an automatic escalation to external review 

3 of claims submitted under such part); 

4 (iii) the types of enrollees that should 

5 be treated as exempted individuals, as de6 scribed in subparagraph (C)(ii) of such 

7 paragraph; 

8 (iv) the manner in which terms and 

9 definitions in such paragraph should be ap10 plied, such as the use of clinical appro11 priateness in determining whether an en12 rollee is an at-risk beneficiary for prescrip13 tion drug abuse as defined in subpara14 graph (C) of such paragraph; 

15 (v) the information to be included in 

16 the notices described in subparagraph (B) 

17 of such paragraph and the standardization 

18 of such notices; and 

19 (vi) with respect to a PDP sponsor 

20 (or Medicare Advantage organization) that 

21 establishes a drug management program 

22 for at-risk beneficiaries under such para23 graph, the responsibilities of such PDP 

24 sponsor (or organization) with respect to 

25 the implementation of such program. 


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1 (g) RULEMAKING.—The Secretary of Health and 

2 Human Services shall promulgate regulations based on the 

3 input gathered pursuant to subsection (f)(2)(A). 

Æ 


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