Title: Preventing Addiction for Susceptible Seniors Act of 2018
Policy area: Health

Summary:
Preventing Addiction for Susceptible Seniors Act of 2018 or the PASS Act of 2018
This bill alters several requirements under the Medicare prescription drug benefit. Specifically, the bill: (1) requires prescription drug plan sponsors to establish drug management programs for at-risk beneficiaries; (2) requires electronic prescription programs to enable the secure transmittal of prior authorization requests for covered drugs; and (3) establishes individuals who are identified as at-risk beneficiaries for prescription drug abuse as qualifying participants in medication therapy management programs.
The bill also requires the Centers for Medicare & Medicaid Services (CMS) to establish a secure online portal to allow: (1) data sharing among the CMS, Medicare prescription drug benefit plans, and Medicare Advantage (MA) plans; and (2) referrals by such plans of substantiated fraud, waste, or abuse in order to initiate or assist investigations by contracted entities under the Medicare Integrity Program.
The CMS must also: (1) identify outlier prescribers of opioids under Medicare prescription drug benefit plans and MA plans, based on specialty and geographic area; and (2) annually notify such prescribers of their status and provide them with resources on proper prescribing methods.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5773 Introduced in House (IH)]

<DOC>






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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Preventing Addiction for Susceptible 
Seniors Act of 2018'' or the ``PASS Act of 2018''.

SEC. 2. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS UNDER MEDICARE TO 
              ESTABLISH DRUG MANAGEMENT PROGRAMS FOR AT-RISK 
              BENEFICIARIES.

    Section 1860D-4(c) of the Social Security Act (42 U.S.C. 1395w-
104(c)) is amended--
            (1) in paragraph (1), by inserting after subparagraph (E) 
        the following new subparagraph:
                    ``(F) With respect to plan years beginning on or 
                after January 1, 2021, a drug management program for 
                at-risk beneficiaries described in paragraph (5).''; 
                and
            (2) in paragraph (5)(A), by inserting ``(and for plan years 
        beginning on or after January 1, 2021, a PDP sponsor shall)'' 
        after ``A PDP sponsor may''.

SEC. 3. ELECTRONIC PRIOR AUTHORIZATION FOR COVERED PART D DRUGS.

    (a) Inclusion in Electronic Prescription Program.--Section 1860D-
4(e)(2) of the Social Security Act (42 U.S.C. 1395w-104(e)(2)) is 
amended by adding at the end the following new subparagraph:
                    ``(E) Electronic prior authorization.--
                            ``(i) In general.--Not later than January 
                        1, 2021, the program shall provide for the 
                        secure electronic transmittal of--
                                    ``(I) a prior authorization request 
                                from the prescribing health care 
                                professional for coverage of a covered 
                                part D drug for a part D eligible 
                                individual enrolled in a part D plan 
                                (as defined in section 1860D-23(a)(5)) 
                                to the PDP sponsor or Medicare 
                                Advantage organization offering such 
                                plan; and
                                    ``(II) a response, in accordance 
                                with this subparagraph, from such PDP 
                                sponsor or Medicare Advantage 
                                organization, respectively, to such 
                                professional.
                            ``(ii) Electronic transmission.--
                                    ``(I) Exclusions.--For purposes of 
                                this subparagraph, a facsimile, a 
                                proprietary payer portal that does not 
                                meet standards specified by the 
                                Secretary, or an electronic form shall 
                                not be treated as an electronic 
                                transmission described in clause (i).
                                    ``(II) Standards.--In order to be 
                                treated, for purposes of this 
                                subparagraph, as an electronic 
                                transmission described in clause (i), 
                                such transmission shall comply with 
                                technical standards adopted by the 
                                Secretary in consultation with the 
                                National Council for Prescription Drug 
                                Programs, other standard setting 
                                organizations determined appropriate by 
                                the Secretary, and stakeholders 
                                including PDP sponsors, Medicare 
                                Advantage organizations, health care 
                                professionals, and health information 
                                technology software vendors.''.
    (b) Sense of Congress Regarding Electronic Prior Authorization.--It 
is the sense of the Congress that--
            (1) there should be increased use of electronic prior 
        authorizations for coverage of covered part D drugs for part D 
        eligible individuals enrolled in prescription drug plans under 
        part D of title XVIII of the Social Security Act and MA-PD 
        plans under part C of such title to reduce access delays by 
        resolving coverage issues before prescriptions for such drugs 
        are transmitted; and
            (2) greater priority should be placed on increasing the 
        adoption of use of such electronic prior authorizations among 
        prescribers of such drugs, pharmacies, PDP sponsors, and 
        Medicare Advantage organizations.

SEC. 4. PROGRAM INTEGRITY TRANSPARENCY MEASURES UNDER MEDICARE PARTS C 
              AND D.

    (a) In General.--Section 1859 of the Social Security Act (42 U.S.C. 
1395w-28) is amended by adding at the end the following new subsection:
    ``(i) Program Integrity Transparency Measures.--
            ``(1) Program integrity portal.--
                    ``(A) In general.--Not later than two years after 
                the date of the enactment of this subsection, the 
                Secretary shall, after consultation with stakeholders, 
                establish a secure Internet website portal (or other 
                successor technology) that would allow a secure path 
                for communication between the Secretary, MA plans under 
                this part, prescription drug plans under part D, and an 
                eligible entity with a contract under section 1893 
                (such as a Medicare drug integrity contractor or an 
                entity responsible for carrying out program integrity 
                activities under this part and part D) for the purpose 
                of enabling through such portal (or other successor 
                technology)--
                            ``(i) the referral by such plans of 
                        substantiated fraud, waste, and abuse for 
                        initiating or assisting investigations 
                        conducted by the eligible entity; and
                            ``(ii) data sharing among such MA plans, 
                        prescription drug plans, and the Secretary.
                    ``(B) Required uses of portal.--The Secretary shall 
                disseminate the following information to MA plans under 
                this part and prescription drug plans under part D 
                through the secure Internet website portal (or other 
                successor technology) established under subparagraph 
                (A):
                            ``(i) Providers of services and suppliers 
                        that have been referred pursuant to 
                        subparagraph (A)(i) during the previous 12-
                        month period.
                            ``(ii) Providers of services and suppliers 
                        who are the subject of an active exclusion 
                        under section 1128 or who are subject to a 
                        suspension of payment under this title pursuant 
                        to section 1862(o) or otherwise.
                            ``(iii) Providers of services and suppliers 
                        who are the subject of an active revocation of 
                        participation under this title, including for 
                        not satisfying conditions of participation.
                            ``(iv) In the case of such a plan that 
                        makes a referral under subparagraph (A)(i) 
                        through the portal (or other successor 
                        technology) with respect to activities of 
                        substantiated fraud, waste, or abuse of a 
                        provider of services or supplier, if such 
                        provider or supplier has been the subject of an 
                        administrative action under this title or title 
                        XI with respect to similar activities, a 
                        notification to such plan of such action so 
                        taken.
                    ``(C) Rulemaking.--For purposes of this paragraph, 
                the Secretary shall, through rulemaking, specify what 
                constitutes substantiated fraud, waste, and abuse, 
                using guidance such as what is provided in the Medicare 
                Program Integrity Manual 4.7.1. In carrying out this 
                subsection, a fraud hotline tip (as defined by the 
                Secretary) without further evidence shall not be 
                treated as sufficient evidence for substantiated fraud, 
                waste, or abuse.
                    ``(D) HIPAA compliant information only.--For 
                purposes of this subsection, communications may only 
                occur if the communications are permitted under the 
                Federal regulations (concerning the privacy of 
                individually identifiable health information) 
                promulgated under section 264(c) of the Health 
                Insurance Portability and Accountability Act of 1996.
            ``(2) Quarterly reports.--Beginning two years after the 
        date of enactment of this subsection, the Secretary shall make 
        available to MA plans under this part and prescription drug 
        plans under part D in a timely manner (but no less frequently 
        than quarterly) and using information submitted to an entity 
        described in paragraph (1) through the portal (or other 
        successor technology) described in such paragraph or pursuant 
        to section 1893, information on fraud, waste, and abuse schemes 
        and trends in identifying suspicious activity. Information 
        included in each such report shall--
                    ``(A) include administrative actions, pertinent 
                information related to opioid overprescribing, and 
                other data determined appropriate by the Secretary in 
                consultation with stakeholders; and
                    ``(B) be anonymized information submitted by plans 
                without identifying the source of such information.
            ``(3) Clarification.--Nothing in this subsection shall be 
        construed as precluding or otherwise affecting referrals 
        described in subparagraph (A) that may otherwise be made to law 
        enforcement entities or to the Secretary.''.
    (b) Contract Requirement To Communicate Plan Corrective Actions 
Against Opioid Over-Prescribers.--Section 1857(e)(4)(C) of the Social 
Security Act (42 U.S.C. 1395w-27(e)(4)(C)) is amended by adding at the 
end the following new paragraph:
            ``(5) Communicating plan corrective actions against opioids 
        over-prescribers.--
                    ``(A) In general.--Beginning with plan years 
                beginning on or after January 1, 2021, a contract under 
                this section with an MA organization shall require the 
                organization to submit to the Secretary, through the 
                process established under subparagraph (B), information 
                on the investigations and other actions taken by such 
                plans related to providers of services who prescribe a 
                high volume of opioids.
                    ``(B) Process.--Not later than January 1, 2021, the 
                Secretary shall, in consultation with stakeholders, 
                establish a process under which MA plans and 
                prescription drug plans shall submit to the Secretary 
                information described in subparagraph (A).
                    ``(C) Regulations.--For purposes of this paragraph, 
                including as applied under section 1860D-12(b)(3)(D), 
                the Secretary shall, pursuant to rulemaking--
                            ``(i) specify a definition for the term 
                        `high volume of opioids' and a method for 
                        determining if a provider of services 
                        prescribes such a high volume; and
                            ``(ii) establish the process described in 
                        subparagraph (B) and the types of information 
                        that shall be submitted through such 
                        process.''.
    (c) Reference Under Part D to Program Integrity Transparency 
Measures.--Section 1860D-4 of the Social Security Act (42 U.S.C. 1395w-
104) is amended by adding at the end the following new subsection:
    ``(m) Program Integrity Transparency Measures.--For program 
integrity transparency measures applied with respect to prescription 
drug plan and MA plans, see section 1859(i).''.

SEC. 5. EXPANDING ELIGIBILITY FOR MEDICATION THERAPY MANAGEMENT 
              PROGRAMS UNDER PART D.

    Section 1860D-4(c)(2)(A)(ii) of the Social Security Act (42 U.S.C. 
1395w-104(c)(2)(A)(ii)) is amended--
            (1) by redesignating subclauses (I) through (III) as items 
        (aa) through (cc), respectively, and adjusting the margins 
        accordingly;
            (2) by striking ``are part D eligible individuals who--'' 
        and inserting ``are the following:
                                    ``(I) Part D eligible individuals 
                                who--''; and
            (3) by adding at the end the following new subclause:
                                    ``(II) Beginning January 1, 2021, 
                                at-risk beneficiaries for prescription 
                                drug abuse (as defined in paragraph 
                                (5)(C)).''.

SEC. 6. MEDICARE NOTIFICATIONS TO OUTLIER PRESCRIBERS OF OPIOIDS.

    Section 1860D-4(c)(4) of the Social Security Act (42 U.S.C. 1395w-
104(c)(4)) is amended by adding at the end the following new paragraph:
                    ``(D) Outlier prescriber notification.--
                            ``(i) Notification.--Beginning not later 
                        than two years after the date of the enactment 
                        of this subparagraph, the Secretary shall, in 
                        the case of a prescriber identified by the 
                        Secretary under clause (ii) to be an outlier 
                        prescriber of opioids, provide, subject to 
                        clause (iv), an annual notification to such 
                        prescriber that such prescriber has been so 
                        identified and that includes resources on 
                        proper prescribing methods and other 
                        information specified in accordance with clause 
                        (iii).
                            ``(ii) Identification of outlier 
                        prescribers of opioids.--
                                    ``(I) In general.--The Secretary 
                                shall, subject to subclause (III), 
                                using the valid prescriber National 
                                Provider Identifiers included pursuant 
                                to subparagraph (A) on claims for 
                                covered part D drugs for part D 
                                eligible individuals enrolled in 
                                prescription drug plans under this part 
                                or MA-PD plans under part C and based 
                                on the threshold established under 
                                subclause (II), conduct an analysis to 
                                identify prescribers that are outlier 
                                opioid prescribers for a period 
                                specified by the Secretary.
                                    ``(II) Establishment of 
                                threshold.--For purposes of subclause 
                                (I) and subject to subclause (III), the 
                                Secretary shall, after consultation 
                                with stakeholders, establish a 
                                threshold, based on prescriber 
                                specialty and geographic area, for 
                                identifying whether a prescriber in a 
                                specialty and geographic area is an 
                                outlier prescriber of opioids as 
                                compared to other prescribers of 
                                opioids within such specialty and area.
                                    ``(III) Exclusions.--The Secretary 
                                may exclude the following individuals 
                                and prescribers from the analysis under 
                                this clause:
                                            ``(aa) Individuals 
                                        receiving hospice services.
                                            ``(bb) Individuals with a 
                                        cancer diagnosis.
                                            ``(cc) Prescribers who are 
                                        the subject of an investigation 
                                        by the Centers for Medicare & 
                                        Medicaid Services or the Office 
                                        of Inspector General of the 
                                        Department of Health and Human 
                                        Services.
                            ``(iii) Contents of notification.--The 
                        Secretary shall, based on input from 
                        stakeholders, specify the resources and other 
                        information to be included in notifications 
                        provided under clause (i).
                            ``(iv) Modifications and expansions.--
                                    ``(I) Frequency.--Beginning 5 years 
                                after the date of the enactment of this 
                                subparagraph, the Secretary may change 
                                the frequency of the notifications 
                                described in clause (i) based on 
                                stakeholder input.
                                    ``(II) Expansion to other 
                                prescriptions.--The Secretary may 
                                expand notifications under this 
                                subparagraph to include identifications 
                                and notifications with respect to 
                                concurrent prescriptions of covered 
                                Part D drugs used in combination with 
                                opioids that are considered to have 
                                adverse side effects when so used in 
                                such combination, as determined by the 
                                Secretary.
                            ``(v) Opioids defined.--For purposes of 
                        this subparagraph, the term `opioids' has such 
                        meaning as specified by the Secretary through 
                        program instruction or otherwise.''.
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