[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4876 Introduced in House (IH)]

<DOC>






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.

    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 ``Medicare Prescription Drug Abuse 
Prevention Act of 2016''.

SEC. 2. PROGRAMS TO PREVENT PRESCRIPTION DRUG ABUSE UNDER THE MEDICARE 
              PROGRAM.

    (a) Drug Management Program for At-Risk Beneficiaries.--
            (1) In general.--Section 1860D-4(c) of the Social Security 
        Act (42 U.S.C. 1395w-104(c)) is amended by adding at the end 
        the following:
            ``(5) Drug management program for at-risk beneficiaries.--
                    ``(A) Authority to establish.--A PDP sponsor may 
                establish a drug management program for at-risk 
                beneficiaries under which, subject to subparagraph (B), 
                the PDP sponsor may, in the case of an at-risk 
                beneficiary for prescription drug abuse who is an 
                enrollee in a prescription drug plan of such PDP 
                sponsor, limit such beneficiary's access to coverage 
                for frequently abused drugs under such plan to 
                frequently abused drugs that are prescribed for such 
                beneficiary by a prescriber (or prescribers) selected 
                under subparagraph (D), and dispensed for such 
                beneficiary by a pharmacy (or pharmacies) selected 
                under such subparagraph.
                    ``(B) Requirement for notices.--
                            ``(i) In general.--A PDP sponsor may not 
                        limit the access of an at-risk beneficiary for 
                        prescription drug abuse to coverage for 
                        frequently abused drugs under a prescription 
                        drug plan until such sponsor--
                                    ``(I) provides to the beneficiary 
                                an initial notice described in clause 
                                (ii) and a second notice described in 
                                clause (iii); and
                                    ``(II) verifies with the providers 
                                of the beneficiary that the beneficiary 
                                is an at-risk beneficiary for 
                                prescription drug abuse, as described 
                                in subparagraph (C)(iv).
                            ``(ii) Initial notice.--An initial written 
                        notice described in this clause is a notice 
                        that provides to the beneficiary--
                                    ``(I) notice that the PDP sponsor 
                                has identified the beneficiary as 
                                potentially being an at-risk 
                                beneficiary for prescription drug 
                                abuse;
                                    ``(II) information, when possible, 
                                describing State and Federal public 
                                health resources that are designed to 
                                address prescription drug abuse to 
                                which the beneficiary may have access, 
                                including substance use disorder 
                                treatment services, addiction treatment 
                                services, mental health services, and 
                                other counseling services;
                                    ``(III) a request for the 
                                beneficiary to submit to the PDP 
                                sponsor preferences for which 
                                prescribers and pharmacies the 
                                beneficiary would prefer the PDP 
                                sponsor to select under subparagraph 
                                (D) in the case that the beneficiary is 
                                identified as an at-risk beneficiary 
                                for prescription drug abuse as 
                                described in clause (iii)(I);
                                    ``(IV) an explanation of the 
                                meaning and consequences of the 
                                identification of the beneficiary as 
                                potentially being an at-risk 
                                beneficiary for prescription drug 
                                abuse, including an explanation of the 
                                drug management program established by 
                                the PDP sponsor pursuant to 
                                subparagraph (A);
                                    ``(V) clear instructions that 
                                explain how the beneficiary can contact 
                                the PDP sponsor in order to submit to 
                                the PDP sponsor the preferences 
                                described in subclause (IV) and any 
                                other communications relating to the 
                                drug management program for at-risk 
                                beneficiaries established by the PDP 
                                sponsor;
                                    ``(VI) contact information for 
                                other organizations that can provide 
                                the beneficiary with information 
                                regarding drug management program for 
                                at-risk beneficiaries (similar to the 
                                information provided by the Secretary 
                                in other standardized notices to part D 
                                eligible individuals enrolled in 
                                prescription drug plans under this 
                                part); and
                                    ``(VII) notice that the beneficiary 
                                has a right to an appeal pursuant to 
                                subparagraph (E).
                            ``(iii) Second notice.--A second written 
                        notice described in this clause is a notice 
                        that provides to the beneficiary notice--
                                    ``(I) that the PDP sponsor has 
                                identified the beneficiary as an at-
                                risk beneficiary for prescription drug 
                                abuse;
                                    ``(II) that such beneficiary has 
                                been sent, or informed of, such 
                                identification in the initial notice 
                                and is now subject to the requirements 
                                of the drug management program for at- 
                                risk beneficiaries established by such 
                                PDP sponsor for such plan;
                                    ``(III) of the prescriber and 
                                pharmacy selected for such individual 
                                under subparagraph (D);
                                    ``(IV) of, and information about, 
                                the right of the beneficiary to a 
                                reconsideration and an appeal under 
                                subsection (h) of such identification 
                                and the prescribers and pharmacies 
                                selected;
                                    ``(V) that the beneficiary can, in 
                                the case that the beneficiary has not 
                                previously submitted to the PDP sponsor 
                                preferences for which prescribers and 
                                pharmacies the beneficiary would prefer 
                                the PDP sponsor select under 
                                subparagraph (D), submit such 
                                preferences to the PDP sponsor; and
                                    ``(VI) that includes clear 
                                instructions that explain how the 
                                beneficiary can contact the PDP sponsor 
                                in order to submit to the PDP sponsor 
                                the preferences described in subclause 
                                (V).
                            ``(iv) Timing of notices.--
                                    ``(I) In general.--Subject to 
                                subclause (II), a second written notice 
                                described in clause (iii) shall be 
                                provided to the beneficiary on a date 
                                that is not less than 30 days after an 
                                initial notice described in clause (ii) 
                                is provided to the beneficiary.
                                    ``(II) Exception.--In the case that 
                                the PDP sponsor, in conjunction with 
                                the Secretary, determines that concerns 
                                identified through rulemaking by the 
                                Secretary regarding the health or 
                                safety of the beneficiary or regarding 
                                significant drug diversion activities 
                                require the PDP sponsor to provide a 
                                second notice described in clause (iii) 
                                to the beneficiary on a date that is 
                                earlier than the date described in 
                                subclause (II), the PDP sponsor may 
                                provide such second notice on such 
                                earlier date.
                                    ``(III) Form of notice.--The 
                                written notices under clauses (ii) and 
                                (iii) shall be in a format determined 
                                appropriate by the Secretary, taking 
                                into account beneficiary preferences.
                    ``(C) At-risk beneficiary for prescription drug 
                abuse.--
                            ``(i) In general.--For purposes of this 
                        paragraph, the term `at-risk beneficiary for 
                        prescription drug abuse' means a part D 
                        eligible individual who is not an exempted 
                        individual described in clause (ii) and--
                                    ``(I) who is identified through 
                                criteria developed by the Secretary in 
                                consultation with PDP sponsors and 
                                other stakeholders described in section 
                                2(g)(2)(A) of the Medicare Prescription 
                                Drug Abuse Prevention Act of 2016 based 
                                on clinical factors indicating misuse 
                                or abuse of prescription drugs 
                                described in subparagraph (G), 
                                including dosage, quantity, duration of 
                                use, number of and reasonable access to 
                                prescribers, and number of and 
                                reasonable access to pharmacies used to 
                                obtain such drug; or
                                    ``(II) with respect to whom the PDP 
                                sponsor of a prescription drug plan, 
                                upon enrolling such individual in such 
                                plan, received notice from the 
                                Secretary that such individual was 
                                identified under this paragraph to be 
                                an at- risk beneficiary for 
                                prescription drug abuse under a 
                                prescription drug plan in which such 
                                individual was previously enrolled and 
                                such identification has not been 
                                terminated under subparagraph (F).
                            ``(ii) Exempted individual described.--An 
                        exempted individual described in this clause is 
                        an individual who--
                                    ``(I) receives hospice care under 
                                this title;
                                    ``(II) resides in a long-term care 
                                facility, a facility described in 
                                section 1905(d), or other facility 
                                under contract with a single pharmacy; 
                                or
                                    ``(III) the Secretary elects to 
                                treat as an exempted individual for 
                                purposes of clause (i).
                            ``(iii) Program size.--The Secretary shall 
                        establish policies, including the criteria 
                        developed under clause (i)(I) and the 
                        exemptions under clause (ii)(III), to ensure 
                        that the population of enrollees in a drug 
                        management program for at-risk beneficiaries 
                        operated by a prescription drug plan can be 
                        effectively managed by such plans.
                            ``(iv) Clinical contact.--With respect to 
                        each at-risk beneficiary for prescription drug 
                        abuse enrolled in a prescription drug plan 
                        offered by a PDP sponsor, the PDP sponsor shall 
                        contact the beneficiary's providers who have 
                        prescribed frequently abused drugs regarding 
                        whether prescribed medications are appropriate 
                        for such beneficiary's medical conditions.
                    ``(D) Selection of prescribers.--
                            ``(i) In general.--With respect to each at-
                        risk beneficiary for prescription drug abuse 
                        enrolled in a prescription drug plan offered by 
                        such sponsor, a PDP sponsor shall, based on the 
                        preferences submitted to the PDP sponsor by the 
                        beneficiary pursuant to clauses (ii)(III) and 
                        (iii)(V) of subparagraph (B) if applicable, 
                        select--
                                    ``(I) one, or, if the PDP sponsor 
                                reasonably determines it necessary to 
                                provide the beneficiary with reasonable 
                                access under clause (ii), more than 
                                one, individual who is authorized to 
                                prescribe frequently abused drugs 
                                (referred to in this paragraph as a 
                                `prescriber') who may write 
                                prescriptions for such drugs for such 
                                beneficiary; and
                                    ``(II) one, or, if the PDP sponsor 
                                reasonably determines it necessary to 
                                provide the beneficiary with reasonable 
                                access under clause (ii), more than 
                                one, pharmacy that may dispense such 
                                drugs to such beneficiary.
                            ``(ii) Reasonable access.--In making the 
                        selection under this subparagraph, a PDP 
                        sponsor shall ensure, taking into account 
                        geographic location, beneficiary preference, 
                        impact on cost-sharing, and reasonable travel 
                        time, that the beneficiary continues to have 
                        reasonable access to drugs described in 
                        subparagraph (G), including--
                                    ``(I) for individuals with multiple 
                                residences; and
                                    ``(II) in the case of natural 
                                disasters and similar emergency 
                                situations.
                            ``(iii) Beneficiary preferences.--
                                    ``(I) In general.--If an at-risk 
                                beneficiary for prescription drug abuse 
                                submits preferences for which in-
                                network prescribers and pharmacies the 
                                beneficiary would prefer the PDP 
                                sponsor select in response to a notice 
                                under subparagraph (B), the PDP sponsor 
                                shall--
                                            ``(aa) review such 
                                        preferences;
                                            ``(bb) select or change the 
                                        selection of a prescriber or 
                                        pharmacy for the beneficiary 
                                        based on such preferences; and
                                            ``(cc) inform the 
                                        beneficiary of such selection 
                                        or change of selection.
                                    ``(II) Exception.--In the case that 
                                the PDP sponsor determines that a 
                                change to the selection of a prescriber 
                                or pharmacy under item (bb) by the PDP 
                                sponsor is contributing or would 
                                contribute to prescription drug abuse 
                                or drug diversion by the beneficiary, 
                                the PDP sponsor may change the 
                                selection of a prescriber or pharmacy 
                                for the beneficiary. If the PDP sponsor 
                                changes the selection pursuant to the 
                                preceding sentence, the PDP sponsor 
                                shall provide the beneficiary with--
                                            ``(aa) at least 30 days 
                                        written notice of the change of 
                                        selection; and
                                            ``(bb) a rationale for the 
                                        change.
                                    ``(III) Timing.--An at-risk 
                                beneficiary for prescription drug abuse 
                                may choose to express their prescriber 
                                and pharmacy preference and communicate 
                                such preference to their PDP sponsor at 
                                any date while enrolled in the program, 
                                including after a second notice under 
                                subparagraph (B)(iii) has been 
                                provided.
                            ``(iv) Confirmation.--Before selecting a 
                        prescriber or pharmacy under this subparagraph, 
                        a PDP sponsor must notify the prescriber and 
                        pharmacy that the beneficiary involved has been 
                        identified for inclusion in the drug management 
                        program for at-risk beneficiaries and that the 
                        prescriber and pharmacy has been selected as 
                        the beneficiary's designated prescriber and 
                        pharmacy.
                    ``(E) Appeals.--The identification of an individual 
                as an at-risk beneficiary for prescription drug abuse 
                under this paragraph, a coverage determination made 
                under a drug management program for at-risk 
                beneficiaries, and the selection of a prescriber or 
                pharmacy under subparagraph (D) with respect to such 
                individual shall be subject to an expedited 
                reconsideration and appeal pursuant to subsection (h).
                    ``(F) Termination of identification.--
                            ``(i) In general.--The Secretary shall 
                        develop standards for the termination of 
                        identification of an individual as an at-risk 
                        beneficiary for prescription drug abuse under 
                        this paragraph. Under such standards such 
                        identification shall terminate as of the 
                        earlier of--
                                    ``(I) the date the individual 
                                demonstrates that the individual is no 
                                longer likely, in the absence of the 
                                restrictions under this paragraph, to 
                                be an at-risk beneficiary for 
                                prescription drug abuse described in 
                                subparagraph (C)(i); or
                                    ``(II) the end of such maximum 
                                period of identification as the 
                                Secretary may specify.
                            ``(ii) Rule of construction.--Nothing in 
                        clause (i) shall be construed as preventing a 
                        plan from identifying an individual as an at-
                        risk beneficiary for prescription drug abuse 
                        under subparagraph (C)(i) after such 
                        termination on the basis of additional 
                        information on drug use occurring after the 
                        date of notice of such termination.
                    ``(G) Frequently abused drug.--For purposes of this 
                subsection, the term `frequently abused drug' means a 
                drug that is determined by the Secretary to be 
                frequently abused or diverted and that is--
                            ``(i) a Controlled Drug Substance in 
                        Schedule CII; or
                            ``(ii) within the same class or category of 
                        drugs as a Controlled Drug Substance in 
                        Schedule CII, as determined through notice and 
                        comment rulemaking.
                    ``(H) Data disclosure.--
                            ``(i) Data on decision to impose 
                        limitation.--In the case of an at-risk 
                        beneficiary for prescription drug abuse (or an 
                        individual who is a potentially at-risk 
                        beneficiary for prescription drug abuse) whose 
                        access to coverage for frequently abused drugs 
                        under a prescription drug plan has been limited 
                        by a PDP sponsor under this paragraph, the 
                        Secretary shall establish rules and procedures 
                        to require such PDP sponsor to disclose data, 
                        including necessary individually identifiable 
                        health information, about the decision to 
                        impose such limitations and the limitations 
                        imposed by the PDP sponsor under this part.
                            ``(ii) Data to reduce fraud, abuse, and 
                        waste.--The Secretary shall establish rules and 
                        procedures to require PDP sponsors operating a 
                        drug management program for at-risk 
                        beneficiaries under this paragraph to provide 
                        the Secretary with such data as the Secretary 
                        determines appropriate for purposes of 
                        identifying patterns of prescription drug 
                        utilization for plan enrollees that are outside 
                        normal patterns and that may indicate 
                        fraudulent, medically unnecessary, or unsafe 
                        use.
                    ``(I) Sharing of information for subsequent plan 
                enrollments.--The Secretary shall establish procedures 
                under which PDP sponsors who offer prescription drug 
                plans shall share information with respect to 
                individuals who are at-risk beneficiaries for 
                prescription drug abuse (or individuals who are 
                potentially at-risk beneficiaries for prescription drug 
                abuse) and enrolled in a prescription drug plan and who 
                subsequently disenroll from such plan and enroll in 
                another prescription drug plan offered by another PDP 
                sponsor.
                    ``(J) Privacy issues.--Prior to the implementation 
                of the rules and procedures under this paragraph, the 
                Secretary shall clarify privacy requirements, including 
                requirements under the regulations promulgated pursuant 
                to section 264(c) of the Health Insurance Portability 
                and Accountability Act of (42 U.S.C. 1320d-2 note), 
                related to the sharing of data under subparagraphs (H) 
                and (I) by PDP sponsors. Such clarification shall 
                provide that the sharing of such data shall be 
                considered to be protected health information in 
                accordance with the requirements of the regulations 
                promulgated pursuant to such section 264(c).
                    ``(K) Education.--The Secretary shall provide 
                education to enrollees in prescription drug plans of 
                PDP sponsors and providers regarding the drug 
                management program for at-risk beneficiaries described 
                in this paragraph, including education--
                            ``(i) provided through the improper payment 
                        outreach and education program described in 
                        section 1874A(h); and
                            ``(ii) through current education efforts 
                        (such as State health insurance assistance 
                        programs described in subsection (a)(1)(A) of 
                        section 119 of the Medicare Improvements for 
                        Patients and Providers Act of 2008 (42 U.S.C. 
                        1395b-3 note)) and materials directed toward 
                        such enrollees.
                    ``(L) CMS compliance review.--The Secretary shall 
                ensure that existing plan sponsor compliance reviews 
                and audit processes include the drug management 
                programs for at-risk beneficiaries under this 
                paragraph, including appeals processes under such 
                programs.''.
            (2) Information for consumers.--Section 1860D-4(a)(1)(B) of 
        the Social Security Act (42 U.S.C. 1395w-104(a)(1)(B)) is 
        amended by adding at the end the following:
                            ``(v) The drug management program for at-
                        risk beneficiaries under subsection (c)(5).''.
            (3) Dual eligibles.--Section 1860D-1(b)(3)(D) of the Social 
        Security Act (42 U.S.C. 1395w-101(b)(3)(D)) is amended by 
        inserting ``, subject to such limits as the Secretary may 
        establish for individuals identified pursuant to section D-
        4(c)(5)'' after ``the Secretary''.
    (b) Utilization Management Programs.--Section 1860D-4(c) of the 
Social Security Act (42 U.S.C. 1395w-104(c)), as amended by subsection 
(a)(1), is amended--
            (1) in paragraph (1), by inserting after subparagraph (D) 
        the following new subparagraph:
                    ``(E) A utilization management tool to prevent drug 
                abuse (as described in paragraph (5)(A)).''; and
            (2) by adding at the end the following new paragraph:
            ``(6) Utilization management tool to prevent drug abuse.--
                    ``(A) In general.--A tool described in this 
                paragraph is any of the following:
                            ``(i) A utilization tool designed to 
                        prevent the abuse of frequently abused drugs by 
                        individuals and to prevent the diversion of 
                        such drugs at pharmacies.
                            ``(ii) Retrospective utilization review to 
                        identify--
                                    ``(I) individuals that receive 
                                frequently abused drugs at a frequency 
                                or in amounts that are not clinically 
                                appropriate; and
                                    ``(II) providers of services or 
                                suppliers that may facilitate the abuse 
                                or diversion of frequently abused drugs 
                                by beneficiaries.
                            ``(iii) Consultation with the contractor 
                        described in subparagraph (B) to verify if an 
                        individual enrolling in a prescription drug 
                        plan offered by a PDP sponsor has been 
                        previously identified by another PDP sponsor as 
                        an individual described in clause (ii)(I).
                    ``(B) Reporting.--A PDP sponsor offering a 
                prescription drug plan in a State shall submit to the 
                Secretary and the Medicare drug integrity contractor 
                with which the Secretary has entered into a contract 
                under section 1893 with respect to such State a report, 
                on a monthly basis, containing information on--
                            ``(i) any provider of services or supplier 
                        described in subparagraph (A)(ii)(II) that is 
                        identified by such plan sponsor during the 30-
                        day period before such report is submitted; and
                            ``(ii) the name and prescription records of 
                        individuals described in paragraph (5)(C).
                    ``(C) CMS compliance review.--The Secretary shall 
                ensure that plan sponsor annual compliance reviews and 
                program audits include a certification that utilization 
                management tools under this paragraph are in compliance 
                with the requirements for such tools.''.
    (c) Treatment of Certain Complaints for Purposes of Quality or 
Performance Assessment.--Section 1860D-42 of the Social Security Act 
(42 U.S.C. 1395w-152) is amended by adding at the end the following new 
subsection:
    ``(d) Treatment of Certain Complaints for Purposes of Quality or 
Performance Assessment.--In conducting a quality or performance 
assessment of a PDP sponsor, the Secretary shall develop or utilize 
existing screening methods for reviewing and considering complaints 
that are received from enrollees in a prescription drug plan offered by 
such PDP sponsor and that are complaints regarding the lack of access 
by the individual to prescription drugs due to a drug management 
program for at-risk beneficiaries.''.
    (d) Sense of Congress Regarding Use of Technology Tools To Combat 
Fraud.--It is the sense of Congress that MA organizations and PDP 
sponsors should consider using e-prescribing and other health 
information technology tools to support combating fraud under MA-PD 
plans and prescription drug plans under parts C and D of the Medicare 
program.
    (e) GAO Study and Report.--
            (1) Study.--The Comptroller General of the United States 
        shall conduct a study on the implementation of the amendments 
        made by this section, including the effectiveness of the at-
        risk beneficiaries for prescription drug abuse drug management 
        programs authorized by paragraph (5) of section 1860D-4(c) of 
        the Social Security Act (42 U.S.C. 1395w-104(c)), as added by 
        subsection (a)(1). Such study shall include an analysis of--
                    (A) the impediments, if any, that impair the 
                ability of individuals described in subparagraph (C) of 
                such section D-4(c)(5) to access clinically appropriate 
                levels of prescription drugs;
                    (B) the effectiveness of the reasonable access 
                protections under subparagraph (D)(ii) of such section 
                1860D-4(c)(5), including the impact on beneficiary 
                access and health;
                    (C) how best to define the term ``designated 
                pharmacy'', including whether the definition of such 
                term should include an entity that is comprised of a 
                number of locations that are under common ownership and 
                that electronically share a real-time, online database 
                and whether such a definition would help to protect and 
                improve beneficiary access;
                    (D) the types of--
                            (i) individuals who, in the implementation 
                        of such section, are determined to be 
                        individuals described in such subparagraph; and
                            (ii) prescribers and pharmacies that are 
                        selected under subparagraph (D) of such 
                        section;
                    (E) the extent of prescription drug abuse beyond 
                Controlled Drug Substances in Schedule CII in parts C 
                and D of the Medicare program; and
                    (F) other areas determined appropriate by the 
                Comptroller General.
            (2) Report.--Not later than July 1, 2019, the Comptroller 
        General of the United States shall submit to the appropriate 
        committees of jurisdiction of Congress a report on the study 
        conducted under paragraph (1), together with recommendations 
        for such legislation and administrative action as the 
        Comptroller General determines to be appropriate.
    (f) Report by Secretary.--
            (1) In general.--Not later than 12 months after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services shall submit to the appropriate committees of 
        jurisdiction of Congress a report on ways to improve upon the 
        appeals process for Medicare beneficiaries with respect to 
        prescription drug coverage under part D of title XVIII of the 
        Social Security Act. Such report shall include an analysis 
        comparing appeals processes under parts C and D of such title 
        XVIII.
            (2) Feedback.--In development of the report described in 
        paragraph (1), the Secretary of Health and Human Services shall 
        solicit feedback on the current appeals process from 
        stakeholders, such as beneficiaries, consumer advocates, plan 
        sponsors, pharmacy benefit managers, pharmacists, providers, 
        independent review entity evaluators, and pharmaceutical 
        manufacturers.
    (g) Effective Date.--
            (1) In general.--Except as provided in subsection (d)(2), 
        the amendments made by this section shall apply to prescription 
        drug plans for plan years beginning on or after January 1, 
        2018.
            (2) Stakeholder meetings prior to effective date.--
                    (A) In general.--Not later than January 1, 2017, 
                the Secretary of Health and Human Services shall 
                convene stakeholders, including individuals entitled to 
                benefits under part A of title XVIII of the Social 
                Security Act or enrolled under part B of such title of 
                such Act, advocacy groups representing such 
                individuals, clinicians, plan sponsors, pharmacists, 
                retail pharmacies, entities delegated by plan sponsors, 
                and biopharmaceutical manufacturers for input regarding 
                the topics described in subparagraph (B). The input 
                described in the preceding sentence shall be provided 
                to the Secretary in sufficient time in order for the 
                Secretary to take such input into account in 
                promulgating the regulations pursuant to subparagraph 
                (C).
                    (B) Topics described.--The topics described in this 
                subparagraph are the topics of--
                            (i) the impact on cost-sharing and ensuring 
                        accessibility to prescription drugs for 
                        enrollees in prescription drug plans of PDP 
                        sponsors who are at-risk beneficiaries for 
                        prescription drug abuse (as defined in 
                        paragraph (5)(C) of section 1860D-4(c) of the 
                        Social Security Act (42 U.S.C. 1395w-104(c)));
                            (ii) the use of an expedited appeals 
                        process under which such an enrollee may appeal 
                        an identification of such enrollee as an at-
                        risk beneficiary for prescription drug abuse 
                        under such paragraph (similar to the processes 
                        established under the Medicare Advantage 
                        program under part C of title XVIII of the 
                        Social Security Act);
                            (iii) the types of enrollees that should be 
                        treated as exempted individuals, as described 
                        in clause (ii) of such paragraph;
                            (iv) the manner in which terms and 
                        definitions in paragraph (5) of such section 
                        1860D-4(c) should be applied, such as the use 
                        of clinical appropriateness in determining 
                        whether an enrollee is an at-risk beneficiary 
                        for prescription drug abuse as defined in 
                        subparagraph (C) of such paragraph (5);
                            (v) the information to be included in the 
                        notices described in subparagraph (B) of such 
                        section and the standardization of such 
                        notices;
                            (vi) with respect to a PDP sponsor that 
                        establishes a drug management program for at-
                        risk beneficiaries under such paragraph (5), 
                        the responsibilities of such PDP sponsor with 
                        respect to the implementation of such program;
                            (vii) notices for plan enrollees at the 
                        point of sale that would explain why an at-risk 
                        beneficiary has been prohibited from receiving 
                        a prescription at a location outside of the 
                        designated pharmacy;
                            (viii) evidence-based prescribing 
                        guidelines for opiates; and
                            (ix) the sharing of claims data under parts 
                        A and B with PDP sponsors.
                    (C) Rulemaking.--The Secretary of Health and Human 
                Services shall, taking into account the input gathered 
                pursuant to subparagraph (A) and after providing notice 
                and an opportunity to comment, promulgate regulations 
                to carry out the provisions of, and amendments made by 
                subsections (a) and (b).
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