I 

115TH CONGRESS 

2D SESSION H. R. 5773 

To amend title XVIII of the Social Security Act to require Medicare prescription drug plans to establish drug management programs for at-risk 

beneficiaries, require electronic prior authorization for covered part D 

drugs, and to provide for other program integrity measures under parts 

C and D of the Medicare program. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 11, 2018 

Mr. ROSKAM (for himself, Ms. SEWELL of Alabama, Mr. KNIGHT, and Ms. 

SINEMA) 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 require 

Medicare prescription drug plans to establish drug management programs for at-risk beneficiaries, require electronic prior authorization for covered part D drugs, and 

to provide for other program integrity measures 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Preventing Addiction 

3 for Susceptible Seniors Act of 2018’’ or the ‘‘PASS Act 

4 of 2018’’. 

5 SEC. 2. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS 

6 UNDER MEDICARE TO ESTABLISH DRUG 

7 MANAGEMENT PROGRAMS FOR AT-RISK 

8 BENEFICIARIES. 

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

10 U.S.C. 1395w–104(c)) is amended— 

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

13 ‘‘(F) With respect to plan years beginning 

14 on or after January 1, 2021, a drug manage15 ment program for at-risk beneficiaries described 

16 in paragraph (5).’’; and 

17 (2) in paragraph (5)(A), by inserting ‘‘(and for 

18 plan years beginning on or after January 1, 2021, 

19 a PDP sponsor shall)’’ after ‘‘A PDP sponsor may’’. 

20 SEC. 3. ELECTRONIC PRIOR AUTHORIZATION FOR COV21 ERED PART D DRUGS. 

22 (a) INCLUSION IN ELECTRONIC PRESCRIPTION PRO23 GRAM.—Section 1860D–4(e)(2) of the Social Security Act 

24 (42 U.S.C. 1395w–104(e)(2)) is amended by adding at the 

25 end the following new subparagraph: 


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1 ‘‘(E) ELECTRONIC PRIOR AUTHORIZA2 TION.— 

3 ‘‘(i) IN GENERAL.—Not later than 

4 January 1, 2021, the program shall pro5 vide for the secure electronic transmittal 

6 of— 

7 ‘‘(I) a prior authorization request 

8 from the prescribing health care pro9 fessional for coverage of a covered 

10 part D drug for a part D eligible indi11 vidual enrolled in a part D plan (as 

12 defined in section 1860D–23(a)(5)) to 

13 the PDP sponsor or Medicare Advan14 tage organization offering such plan; 

15 and 

16 ‘‘(II) a response, in accordance 

17 with this subparagraph, from such 

18 PDP sponsor or Medicare Advantage 

19 organization, respectively, to such pro20 fessional. 

21 ‘‘(ii) ELECTRONIC TRANSMISSION.— 

22 ‘‘(I) EXCLUSIONS.—For purposes 

23 of this subparagraph, a facsimile, a 

24 proprietary payer portal that does not 

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1 retary, or an electronic form shall not 

2 be treated as an electronic trans3 mission described in clause (i). 

4 ‘‘(II) STANDARDS.—In order to 

5 be treated, for purposes of this sub6 paragraph, as an electronic trans7 mission described in clause (i), such 

8 transmission shall comply with tech9 nical standards adopted by the Sec10 retary in consultation with the Na11 tional Council for Prescription Drug 

12 Programs, other standard setting or13 ganizations determined appropriate by 

14 the Secretary, and stakeholders in15 cluding PDP sponsors, Medicare Ad16 vantage organizations, health care 

17 professionals, and health information 

18 technology software vendors.’’. 

19 (b) SENSE OF CONGRESS REGARDING ELECTRONIC

20 PRIOR AUTHORIZATION.—It is the sense of the Congress 

21 that— 

22 (1) there should be increased use of electronic 

23 prior authorizations for coverage of covered part D 

24 drugs for part D eligible individuals enrolled in pre25 scription drug plans under part D of title XVIII of 


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1 the Social Security Act and MA–PD plans under 

2 part C of such title to reduce access delays by re3 solving coverage issues before prescriptions for such 

4 drugs are transmitted; and 

5 (2) greater priority should be placed on increas6 ing the adoption of use of such electronic prior au7 thorizations among prescribers of such drugs, phar8 macies, PDP sponsors, and Medicare Advantage or9 ganizations. 

10 SEC. 4. PROGRAM INTEGRITY TRANSPARENCY MEASURES 

11 UNDER MEDICARE PARTS C AND D. 

12 (a) IN GENERAL.—Section 1859 of the Social Secu13 rity Act (42 U.S.C. 1395w–28) is amended by adding at 

14 the end the following new subsection: 

15 ‘‘(i) PROGRAM INTEGRITY TRANSPARENCY MEAS16 URES.— 

17 ‘‘(1) PROGRAM INTEGRITY PORTAL.— 

18 ‘‘(A) IN GENERAL.—Not later than two 

19 years after the date of the enactment of this 

20 subsection, the Secretary shall, after consulta21 tion with stakeholders, establish a secure Inter22 net website portal (or other successor tech23 nology) that would allow a secure path for com24 munication between the Secretary, MA plans 

25 under this part, prescription drug plans under 


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1 part D, and an eligible entity with a contract 

2 under section 1893 (such as a Medicare drug 

3 integrity contractor or an entity responsible for 

4 carrying out program integrity activities under 

5 this part and part D) for the purpose of ena6 bling through such portal (or other successor 

7 technology)— 

8 ‘‘(i) the referral by such plans of sub9 stantiated fraud, waste, and abuse for ini10 tiating or assisting investigations con11 ducted by the eligible entity; and 

12 ‘‘(ii) data sharing among such MA 

13 plans, prescription drug plans, and the 

14 Secretary. 

15 ‘‘(B) REQUIRED USES OF PORTAL.—The 

16 Secretary shall disseminate the following infor17 mation to MA plans under this part and pre18 scription drug plans under part D through the 

19 secure Internet website portal (or other suc20 cessor technology) established under subpara21 graph (A): 

22 ‘‘(i) Providers of services and sup23 pliers that have been referred pursuant to 

24 subparagraph (A)(i) during the previous 

25 12-month period. 


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1 ‘‘(ii) Providers of services and sup2 pliers who are the subject of an active ex3 clusion under section 1128 or who are sub4 ject to a suspension of payment under this 

5 title pursuant to section 1862(o) or other6 wise. 

7 ‘‘(iii) Providers of services and sup8 pliers who are the subject of an active rev9 ocation of participation under this title, in10 cluding for not satisfying conditions of par11 ticipation. 

12 ‘‘(iv) In the case of such a plan that 

13 makes a referral under subparagraph 

14 (A)(i) through the portal (or other suc15 cessor technology) with respect to activities 

16 of substantiated fraud, waste, or abuse of 

17 a provider of services or supplier, if such 

18 provider or supplier has been the subject of 

19 an administrative action under this title or 

20 title XI with respect to similar activities, a 

21 notification to such plan of such action so 

22 taken. 

23 ‘‘(C) RULEMAKING.—For purposes of this 

24 paragraph, the Secretary shall, through rule25 making, specify what constitutes substantiated 


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1 fraud, waste, and abuse, using guidance such as 

2 what is provided in the Medicare Program In3 tegrity Manual 4.7.1. In carrying out this sub4 section, a fraud hotline tip (as defined by the 

5 Secretary) without further evidence shall not be 

6 treated as sufficient evidence for substantiated 

7 fraud, waste, or abuse. 

8 ‘‘(D) HIPAA COMPLIANT INFORMATION

9 ONLY.—For purposes of this subsection, com10 munications may only occur if the communica11 tions are permitted under the Federal regula12 tions (concerning the privacy of individually 

13 identifiable health information) promulgated 

14 under section 264(c) of the Health Insurance 

15 Portability and Accountability Act of 1996. 

16 ‘‘(2) QUARTERLY REPORTS.—Beginning two 

17 years after the date of enactment of this subsection, 

18 the Secretary shall make available to MA plans 

19 under this part and prescription drug plans under 

20 part D in a timely manner (but no less frequently 

21 than quarterly) and using information submitted to 

22 an entity described in paragraph (1) through the 

23 portal (or other successor technology) described in 

24 such paragraph or pursuant to section 1893, infor25 mation on fraud, waste, and abuse schemes and 


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1 trends in identifying suspicious activity. Information 

2 included in each such report shall— 

3 ‘‘(A) include administrative actions, perti4 nent information related to opioid overpre5 scribing, and other data determined appropriate 

6 by the Secretary in consultation with stake7 holders; and 

8 ‘‘(B) be anonymized information submitted 

9 by plans without identifying the source of such 

10 information. 

11 ‘‘(3) CLARIFICATION.—Nothing in this sub12 section shall be construed as precluding or otherwise 

13 affecting referrals described in subparagraph (A) 

14 that may otherwise be made to law enforcement en15 tities or to the Secretary.’’. 

16 (b) CONTRACT REQUIREMENT TO COMMUNICATE

17 PLAN CORRECTIVE ACTIONS AGAINST OPIOID OVER-PRE18 SCRIBERS.—Section 1857(e)(4)(C) of the Social Security 

19 Act (42 U.S.C. 1395w–27(e)(4)(C)) is amended by adding 

20 at the end the following new paragraph: 

21 ‘‘(5) COMMUNICATING PLAN CORRECTIVE AC22 TIONS AGAINST OPIOIDS OVER-PRESCRIBERS.— 

23 ‘‘(A) IN GENERAL.—Beginning with plan 

24 years beginning on or after January 1, 2021, a 

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1 zation shall require the organization to submit 

2 to the Secretary, through the process estab3 lished under subparagraph (B), information on 

4 the investigations and other actions taken by 

5 such plans related to providers of services who 

6 prescribe a high volume of opioids. 

7 ‘‘(B) PROCESS.—Not later than January 

8 1, 2021, the Secretary shall, in consultation 

9 with stakeholders, establish a process under 

10 which MA plans and prescription drug plans 

11 shall submit to the Secretary information de12 scribed in subparagraph (A). 

13 ‘‘(C) REGULATIONS.—For purposes of this 

14 paragraph, including as applied under section 

15 1860D–12(b)(3)(D), the Secretary shall, pursu16 ant to rulemaking— 

17 ‘‘(i) specify a definition for the term 

18 ‘high volume of opioids’ and a method for 

19 determining if a provider of services pre20 scribes such a high volume; and 

21 ‘‘(ii) establish the process described in 

22 subparagraph (B) and the types of infor23 mation that shall be submitted through 

24 such process.’’. 


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1 (c) REFERENCE UNDER PART D TO PROGRAM IN2 TEGRITY TRANSPARENCY MEASURES.—Section 1860D–4 

3 of the Social Security Act (42 U.S.C. 1395w–104) is 

4 amended by adding at the end the following new sub5 section: 

6 ‘‘(m) PROGRAM INTEGRITY TRANSPARENCY MEAS7 URES.—For program integrity transparency measures ap8 plied with respect to prescription drug plan and MA plans, 

9 see section 1859(i).’’. 

10 SEC. 5. EXPANDING ELIGIBILITY FOR MEDICATION THER11 APY MANAGEMENT PROGRAMS UNDER PART 

12 D. 

13 Section 1860D–4(c)(2)(A)(ii) of the Social Security 

14 Act (42 U.S.C. 1395w–104(c)(2)(A)(ii)) is amended— 

15 (1) by redesignating subclauses (I) through 

16 (III) as items (aa) through (cc), respectively, and 

17 adjusting the margins accordingly; 

18 (2) by striking ‘‘are part D eligible individuals 

19 who—’’ and inserting ‘‘are the following: 

20 ‘‘(I) Part D eligible individuals 

21 who—’’; and 

22 (3) by adding at the end the following new sub23 clause: 

24 ‘‘(II) Beginning January 1, 

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1 scription drug abuse (as defined in 

2 paragraph (5)(C)).’’. 

3 SEC. 6. MEDICARE NOTIFICATIONS TO OUTLIER PRE4 SCRIBERS OF OPIOIDS. 

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

6 U.S.C. 1395w–104(c)(4)) is amended by adding at the end 

7 the following new paragraph: 

8 ‘‘(D) OUTLIER PRESCRIBER NOTIFICA9 TION.— 

10 ‘‘(i) NOTIFICATION.—Beginning not 

11 later than two years after the date of the 

12 enactment of this subparagraph, the Sec13 retary shall, in the case of a prescriber 

14 identified by the Secretary under clause 

15 (ii) to be an outlier prescriber of opioids, 

16 provide, subject to clause (iv), an annual 

17 notification to such prescriber that such 

18 prescriber has been so identified and that 

19 includes resources on proper prescribing 

20 methods and other information specified in 

21 accordance with clause (iii). 

22 ‘‘(ii) IDENTIFICATION OF OUTLIER

23 PRESCRIBERS OF OPIOIDS.— 

24 ‘‘(I) IN GENERAL.—The Sec25 retary shall, subject to subclause (III), 


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1 using the valid prescriber National 

2 Provider Identifiers included pursuant 

3 to subparagraph (A) on claims for 

4 covered part D drugs for part D eligi5 ble individuals enrolled in prescription 

6 drug plans under this part or MA–PD 

7 plans under part C and based on the 

8 threshold established under subclause 

9 (II), conduct an analysis to identify 

10 prescribers that are outlier opioid pre11 scribers for a period specified by the 

12 Secretary. 

13 ‘‘(II) ESTABLISHMENT OF

14 THRESHOLD.—For purposes of sub15 clause (I) and subject to subclause 

16 (III), the Secretary shall, after con17 sultation with stakeholders, establish 

18 a threshold, based on prescriber spe19 cialty and geographic area, for identi20 fying whether a prescriber in a spe21 cialty and geographic area is an 

22 outlier prescriber of opioids as com23 pared to other prescribers of opioids 

24 within such specialty and area. 


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1 ‘‘(III) EXCLUSIONS.—The Sec2 retary may exclude the following indi3 viduals and prescribers from the anal4 ysis under this clause: 

5 ‘‘(aa) Individuals receiving 

6 hospice services. 

7 ‘‘(bb) Individuals with a 

8 cancer diagnosis. 

9 ‘‘(cc) Prescribers who are 

10 the subject of an investigation by 

11 the Centers for Medicare & Med12 icaid Services or the Office of In13 spector General of the Depart14 ment of Health and Human 

15 Services. 

16 ‘‘(iii) CONTENTS OF NOTIFICATION.— 

17 The Secretary shall, based on input from 

18 stakeholders, specify the resources and 

19 other information to be included in notifi20 cations provided under clause (i). 

21 ‘‘(iv) MODIFICATIONS AND EXPAN22 SIONS.— 

23 ‘‘(I) FREQUENCY.—Beginning 5 

24 years after the date of the enactment 

25 of this subparagraph, the Secretary 


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1 may change the frequency of the noti2 fications described in clause (i) based 

3 on stakeholder input. 

4 ‘‘(II) EXPANSION TO OTHER

5 PRESCRIPTIONS.—The Secretary may 

6 expand notifications under this sub7 paragraph to include identifications 

8 and notifications with respect to con9 current prescriptions of covered Part 

10 D drugs used in combination with 

11 opioids that are considered to have 

12 adverse side effects when so used in 

13 such combination, as determined by 

14 the Secretary. 

15 ‘‘(v) OPIOIDS DEFINED.—For pur16 poses of this subparagraph, the term 

17 ‘opioids’ has such meaning as specified by 

18 the Secretary through program instruction 

19 or otherwise.’’. 

Æ 


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