115TH CONGRESS 

2D SESSION H. R. 5773 

AN ACT 

To amend title XVIII of the Social Security Act to 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. ELECTRONIC PRIOR AUTHORIZATION FOR COV6 ERED PART D DRUGS. 

7 (a) INCLUSION IN ELECTRONIC PRESCRIPTION PRO8 GRAM.—Section 1860D–4(e)(2) of the Social Security Act 

9 (42 U.S.C. 1395w–104(e)(2)) is amended by adding at the 

10 end the following new subparagraph: 

11 ‘‘(E) ELECTRONIC PRIOR AUTHORIZA12 TION.— 

13 ‘‘(i) IN GENERAL.—Not later than 

14 January 1, 2021, the program shall pro15 vide for the secure electronic transmission 

16 of— 

17 ‘‘(I) a prior authorization request 

18 from the prescribing health care pro19 fessional for coverage of a covered 

20 part D drug for a part D eligible indi21 vidual enrolled in a part D plan (as 

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

23 the PDP sponsor or Medicare Advan24 tage organization offering such plan; 

25 and 
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1 ‘‘(II) a response, in accordance 

2 with this subparagraph, from such 

3 PDP sponsor or Medicare Advantage 

4 organization, respectively, to such pro5 fessional. 

6 ‘‘(ii) ELECTRONIC TRANSMISSION.— 

7 ‘‘(I) EXCLUSIONS.—For purposes 

8 of this subparagraph, a facsimile, a 

9 proprietary payer portal that does not 

10 meet standards specified by the Sec11 retary, or an electronic form shall not 

12 be treated as an electronic trans13 mission described in clause (i). 

14 ‘‘(II) STANDARDS.—In order to 

15 be treated, for purposes of this sub16 paragraph, as an electronic trans17 mission described in clause (i), such 

18 transmission shall comply with tech19 nical standards adopted by the Sec20 retary in consultation with the Na21 tional Council for Prescription Drug 

22 Programs, other standard setting or23 ganizations determined appropriate by 

24 the Secretary, and stakeholders in25 cluding PDP sponsors, Medicare Ad-
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1 vantage organizations, health care 

2 professionals, and health information 

3 technology software vendors. 

4 ‘‘(III) APPLICATION.—Notwith5 standing any other provision of law, 

6 for purposes of this subparagraph, the 

7 Secretary may require the use of such 

8 standards adopted under subclause 

9 (II) in lieu of any other applicable 

10 standards for an electronic trans11 mission described in clause (i) for a 

12 covered part D drug for a part D eli13 gible individual.’’. 

14 (b) SENSE OF CONGRESS REGARDING ELECTRONIC

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

16 that— 

17 (1) there should be increased use of electronic 

18 prior authorizations for coverage of covered part D 

19 drugs for part D eligible individuals enrolled in pre20 scription drug plans under part D of title XVIII of 

21 the Social Security Act and MA–PD plans under 

22 part C of such title to reduce access delays by re23 solving coverage issues before prescriptions for such 

24 drugs are transmitted; and 
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1 (2) greater priority should be placed on increas2 ing the adoption of use of such electronic prior au3 thorizations among prescribers of such drugs, phar4 macies, PDP sponsors, and Medicare Advantage or5 ganizations. 

6 SEC. 3. PROGRAM INTEGRITY TRANSPARENCY MEASURES 

7 UNDER MEDICARE PARTS C AND D. 

8 (a) IN GENERAL.—Section 1859 of the Social Secu9 rity Act (42 U.S.C. 1395w–28) is amended by adding at 

10 the end the following new subsection: 

11 ‘‘(i) PROGRAM INTEGRITY TRANSPARENCY MEAS12 URES.— 

13 ‘‘(1) PROGRAM INTEGRITY PORTAL.— 

14 ‘‘(A) IN GENERAL.—Not later than 2 years 

15 after the date of the enactment of this sub16 section, the Secretary shall, after consultation 

17 with stakeholders, establish a secure Internet 

18 website portal (or other successor technology) 

19 that would allow a secure path for communica20 tion between the Secretary, MA plans under 

21 this part, prescription drug plans under part D, 

22 and an eligible entity with a contract under sec23 tion 1893 (such as a Medicare drug integrity 

24 contractor or an entity responsible for carrying 

25 out program integrity activities under this part 
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1 and part D) for the purpose of enabling 

2 through such portal (or other successor tech3 nology)— 

4 ‘‘(i) the referral by such plans of sub5 stantiated fraud, waste, and abuse for ini6 tiating or assisting investigations con7 ducted by the eligible entity; and 

8 ‘‘(ii) data sharing among such MA 

9 plans, prescription drug plans, and the 

10 Secretary. 

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

12 Secretary shall disseminate the following infor13 mation to MA plans under this part and pre14 scription drug plans under part D through the 

15 secure Internet website portal (or other suc16 cessor technology) established under subpara17 graph (A): 

18 ‘‘(i) Providers of services and sup19 pliers that have been referred pursuant to 

20 subparagraph (A)(i) during the previous 

21 12-month period. 

22 ‘‘(ii) Providers of services and sup23 pliers who are the subject of an active ex24 clusion under section 1128 or who are sub25 ject to a suspension of payment under this 
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1 title pursuant to section 1862(o) or other2 wise. 

3 ‘‘(iii) Providers of services and sup4 pliers who are the subject of an active rev5 ocation of participation under this title, in6 cluding for not satisfying conditions of par7 ticipation. 

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

9 makes a referral under subparagraph 

10 (A)(i) through the portal (or other suc11 cessor technology) with respect to activities 

12 of substantiated fraud, waste, or abuse of 

13 a provider of services or supplier, if such 

14 provider or supplier has been the subject of 

15 an administrative action under this title or 

16 title XI with respect to similar activities, a 

17 notification to such plan of such action so 

18 taken. 

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

20 paragraph, the Secretary shall, through rule21 making, specify what constitutes substantiated 

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

23 what is provided in the Medicare Program In24 tegrity Manual 4.7.1. In carrying out this sub25 section, a fraud hotline tip (as defined by the 
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1 Secretary) without further evidence shall not be 

2 treated as sufficient evidence for substantiated 

3 fraud, waste, or abuse 

4 ‘‘(D) HIPAA COMPLIANT INFORMATION

5 ONLY.—For purposes of this subsection, com6 munications may only occur if the communica7 tions are permitted under the Federal regula8 tions (concerning the privacy of individually 

9 identifiable health information) promulgated 

10 under section 264(c) of the Health Insurance 

11 Portability and Accountability Act of 1996. 

12 ‘‘(2) QUARTERLY REPORTS.—Beginning 2 years 

13 after the date of enactment of this subsection, the 

14 Secretary shall make available to MA plans under 

15 this part and prescription drug plans under part D 

16 in a timely manner (but no less frequently than 

17 quarterly) and using information submitted to an 

18 entity described in paragraph (1) through the portal 

19 (or other successor technology) described in such 

20 paragraph or pursuant to section 1893, information 

21 on fraud, waste, and abuse schemes and trends in 

22 identifying suspicious activity. Information included 

23 in each such report shall— 

24 ‘‘(A) include administrative actions, perti25 nent information related to opioid overpre-
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1 scribing, and other data determined appropriate 

2 by the Secretary in consultation with stake3 holders; and 

4 ‘‘(B) be anonymized information submitted 

5 by plans without identifying the source of such 

6 information. 

7 ‘‘(3) CLARIFICATION.—Nothing in this sub8 section shall be construed as precluding or otherwise 

9 affecting referrals described in subparagraph (A) 

10 that may otherwise be made to law enforcement en11 tities or to the Secretary.’’. 

12 (b) CONTRACT REQUIREMENT TO COMMUNICATE

13 PLAN CORRECTIVE ACTIONS AGAINST OPIOID OVER-PRE14 SCRIBERS.—Section 1857(e) of the Social Security Act 

15 (42 U.S.C. 1395w–27(e)) is amended by adding at the end 

16 the following new paragraph: 

17 ‘‘(5) COMMUNICATING PLAN CORRECTIVE AC18 TIONS AGAINST OPIOIDS OVER-PRESCRIBERS.— 

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

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

21 contract under this section with an MA organi22 zation shall require the organization to submit 

23 to the Secretary, through the process estab24 lished under subparagraph (B), information on 

25 the investigations and other actions taken by 
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1 such plans related to providers of services who 

2 prescribe a high volume of opioids. 

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

4 1, 2021, the Secretary shall, in consultation 

5 with stakeholders, establish a process under 

6 which MA plans and prescription drug plans 

7 shall submit to the Secretary information de8 scribed in subparagraph (A). 

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

10 paragraph, including as applied under section 

11 1860D–12(b)(3)(D), the Secretary shall, pursu12 ant to rulemaking— 

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

14 ‘high volume of opioids’ and a method for 

15 determining if a provider of services pre16 scribes such a high volume; and 

17 ‘‘(ii) establish the process described in 

18 subparagraph (B) and the types of infor19 mation that shall be submitted through 

20 such process.’’. 

21 (c) REFERENCE UNDER PART D TO PROGRAM IN22 TEGRITY TRANSPARENCY MEASURES.—Section 1860D–4 

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

24 amended by adding at the end the following new sub25 section: 
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1 ‘‘(m) PROGRAM INTEGRITY TRANSPARENCY MEAS2 URES.—For program integrity transparency measures ap3 plied with respect to prescription drug plan and MA plans, 

4 see section 1859(i).’’. 

5 SEC. 4. EXPANDING ELIGIBILITY FOR MEDICATION THER6 APY MANAGEMENT PROGRAMS UNDER PART 

7 D. 

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

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

10 (1) by redesignating subclauses (I) through 

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

12 adjusting the margins accordingly; 

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

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

15 ‘‘(I) Part D eligible individuals 

16 who—’’; and 

17 (3) by adding at the end the following new sub18 clause: 

19 ‘‘(II) Beginning January 1, 

20 2021, at-risk beneficiaries for pre21 scription drug abuse (as defined in 

22 paragraph (5)(C)).’’. 
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1 SEC. 5. MEDICARE NOTIFICATIONS TO OUTLIER PRE2 SCRIBERS OF OPIOIDS. 

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

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

5 the following new subparagraph: 

6 ‘‘(D) OUTLIER PRESCRIBER NOTIFICA7 TION.— 

8 ‘‘(i) NOTIFICATION.—Beginning not 

9 later than 2 years after the date of the en10 actment of this subparagraph, the Sec11 retary shall, in the case of a prescriber 

12 identified by the Secretary under clause 

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

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

15 notification to such prescriber that such 

16 prescriber has been so identified and that 

17 includes resources on proper prescribing 

18 methods and other information specified in 

19 accordance with clause (iii). 

20 ‘‘(ii) IDENTIFICATION OF OUTLIER

21 PRESCRIBERS OF OPIOIDS.— 

22 ‘‘(I) IN GENERAL.—The Sec23 retary shall, subject to subclause (III), 

24 using the valid prescriber National 

25 Provider Identifiers included pursuant 

26 to subparagraph (A) on claims for 
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1 covered part D drugs for part D eligi2 ble individuals enrolled in prescription 

3 drug plans under this part or MA–PD 

4 plans under part C and based on the 

5 threshold established under subclause 

6 (II), conduct an analysis to identify 

7 prescribers that are outlier opioid pre8 scribers for a period specified by the 

9 Secretary. 

10 ‘‘(II) ESTABLISHMENT OF

11 THRESHOLD.—For purposes of sub12 clause (I) and subject to subclause 

13 (III), the Secretary shall, after con14 sultation with stakeholders, establish 

15 a threshold, based on prescriber spe16 cialty and geographic area, for identi17 fying whether a prescriber in a spe18 cialty and geographic area is an 

19 outlier prescriber of opioids as com20 pared to other prescribers of opioids 

21 within such specialty and area. 

22 ‘‘(III) EXCLUSIONS.—The Sec23 retary may exclude the following indi24 viduals and prescribers from the anal25 ysis under this clause: 
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1 ‘‘(aa) Individuals receiving 

2 hospice services. 

3 ‘‘(bb) Individuals with a 

4 cancer diagnosis. 

5 ‘‘(cc) Prescribers who are 

6 the subject of an investigation by 

7 the Centers for Medicare & Med8 icaid Services or the Office of In9 spector General of the Depart10 ment of Health and Human 

11 Services. 

12 ‘‘(iii) CONTENTS OF NOTIFICATION.— 

13 The Secretary shall, based on input from 

14 stakeholders, specify the resources and 

15 other information to be included in notifi16 cations provided under clause (i). 

17 ‘‘(iv) MODIFICATIONS AND EXPAN18 SIONS.— 

19 ‘‘(I) FREQUENCY.—Beginning 5 

20 years after the date of the enactment 

21 of this subparagraph, the Secretary 

22 may change the frequency of the noti23 fications described in clause (i) based 

24 on stakeholder input. 
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1 ‘‘(II) EXPANSION TO OTHER

2 PRESCRIPTIONS.—The Secretary may 

3 expand notifications under this sub4 paragraph to include identifications 

5 and notifications with respect to con6 current prescriptions of covered Part 

7 D drugs used in combination with 

8 opioids that are considered to have 

9 adverse side effects when so used in 

10 such combination, as determined by 

11 the Secretary. 

12 ‘‘(v) OPIOIDS DEFINED.—For pur13 poses of this subparagraph, the term 

14 ‘opioids’ has such meaning as specified by 

15 the Secretary through program instruction 

16 or otherwise.’’. 

17 SEC. 6. NO ADDITIONAL FUNDS AUTHORIZED. 

18 No additional funds are authorized to be appro19 priated to carry out the requirements of this Act and the 

20 amendments made by this Act. Such requirements shall 
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1 be carried out using amounts otherwise authorized to be 

2 appropriated. 

Passed the House of Representatives June 19, 2018. 

Attest: 

Clerk. 

115TH CONGRESS 

2D SESSION H. R. 5773 

AN ACT 

To amend title XVIII of the Social Security Act to 

Medicare program. integrity measures under parts C and D of the part D drugs and to provide for other program require electronic prior authorization for covered