[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2298 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2298

To amend title XVIII of the Social Security Act to provide for programs 
to prevent prescription drug abuse under parts C and D of the Medicare 
                                program.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 13, 2015

 Mr. Bilirakis (for himself, Mr. Ben Ray Lujan of New Mexico, and Mr. 
    Long) introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   Ways and Means, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to provide for programs 
to prevent prescription drug abuse under parts C and D of the Medicare 
                                program.

    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 Patient Safety and Drug 
Abuse Prevention Act''.

SEC. 2. PROGRAMS TO PREVENT PRESCRIPTION DRUG ABUSE UNDER MEDICARE 
              PARTS C AND D.

    (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-10(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 selected under subparagraph 
                (D), and dispensed for such beneficiary by a pharmacy 
                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.
                            ``(ii) Initial notice.--An initial 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 describing all 
                                State and Federal public health 
                                resources that are designed to address 
                                prescription drug abuse to which the 
                                beneficiary has access, including 
                                mental health services and other 
                                counseling services;
                                    ``(III) notice of, and information 
                                about, the right of the beneficiary to 
                                appeal such identification under 
                                subsection (h) and the option of an 
                                automatic escalation to external 
                                review;
                                    ``(IV) 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);
                                    ``(V) 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);
                                    ``(VI) 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; and
                                    ``(VII) contact information for 
                                other organizations that can provide 
                                the beneficiary with assistance 
                                regarding such drug management program 
                                (similar to the information provided by 
                                the Secretary in other standardized 
                                notices provided to part D eligible 
                                individuals enrolled in prescription 
                                drug plans under this part).
                            ``(iii) Second notice.--A second 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 is 
                                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 beneficiary's right to appeal such 
                                identification under subsection (h) and 
                                the option of an automatic escalation 
                                to external review;
                                    ``(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.
                            ``(iv) Timing of notices.--
                                    ``(I) In general.--Subject to 
                                subclause (II), a second notice 
                                described in clause (iii) shall be 
                                provided to the beneficiary on a date 
                                that is not less than 60 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.
                    ``(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 the 
                                use of clinical guidelines developed by 
                                the Secretary in consultation with PDP 
                                sponsors and other stakeholders 
                                described in subsection (f)(2)(A); 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 the prescription drug 
                                plan in which such individual was most 
                                recently 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) an individual who receives 
                                hospice care under this title; or
                                    ``(II) an individual, such as an 
                                individual who is a resident of a long-
                                term care facility, who the Secretary 
                                elects to treat as an exempted 
                                individual for purposes of clause (i).
                    ``(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)(IV) and 
                        (iii)(V) of subparagraph (B), select--
                                    ``(I) one or more individuals who 
                                are authorized to prescribe frequently 
                                abused drugs (referred to in this 
                                paragraph as `prescribers') who may 
                                write prescriptions for such drugs for 
                                such beneficiary; and
                                    ``(II) one or more pharmacies that 
                                may dispense such drugs to such 
                                beneficiary.
                            ``(ii) Reasonable access.--In making the 
                        selection under this subparagraph, a PDP 
                        sponsor shall ensure that the beneficiary 
                        continues to have reasonable access to drugs 
                        described in subparagraph (G), taking into 
                        account geographic location, beneficiary 
                        preference, impact on cost-sharing, and 
                        reasonable travel time.
                            ``(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 without regard to 
                                the preferences of the beneficiary 
                                described in subclause (I).
                            ``(iv) Confirmation.--Before selecting a 
                        prescriber or pharmacy under this subparagraph, 
                        a PDP sponsor must request and receive 
                        confirmation from the prescriber or pharmacy 
                        acknowledging and accepting that the 
                        beneficiary involved is in the drug management 
                        program for at-risk beneficiaries.
                    ``(E) Terminations and 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 
                reconsideration and appeal under subsection (h) and the 
                option of an automatic escalation to external review to 
                the extent provided by the Secretary.
                    ``(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 a controlled substance that the Secretary 
                determines to be frequently abused or diverted.
                    ``(H) Data disclosure.--In the case of an 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, such PDP sponsor shall 
                disclose data, including any necessary individually 
                identifiable health information, in a form and manner 
                specified by the Secretary, about the decision to 
                impose such limitations and the limitations imposed by 
                the sponsor under this part.
                    ``(I) 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 by medicare administrative 
                        contractors 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.
                    ``(J) Application under ma-pd plans.--Pursuant to 
                section 1860D-21(c)(1), the provisions of this 
                paragraph apply under part D to MA organizations 
                offering MA-PD plans to MA eligible individuals in the 
                same manner as such provisions apply under this part to 
                a PDP sponsor offering a prescription drug plan to a 
                part D eligible individual.''.
            (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).''.
    (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 further 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 (6)(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 (and an MA organization offering 
                an MA-PD 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 (or 
                        organization) 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) Expanding Activities of Medicare Drug Integrity Contractors 
(MEDICs).--
            (1) In general.--Section 1893 of the Social Security Act 
        (42 U.S.C. 1395ddd) is amended by adding at the end the 
        following new subsection:
    ``(j) Expanding Activities of Medicare Drug Integrity Contractors 
(MEDICs).--
            ``(1) Access to information.--Under contracts entered into 
        under this section with Medicare drug integrity contractors, 
        the Secretary shall authorize such contractors to directly 
        accept prescription and necessary medical records from entities 
        such as pharmacies, prescription drug plans, MA-PD plans, and 
        physicians with respect to an individual in order for such 
        contractors to provide information relevant to the 
        determination of whether such individual is an at-risk 
        beneficiary for prescription drug abuse, as defined in section 
        1860D-4(c)(5)(C).
            ``(2) Requirement for acknowledgment of referrals.--If a 
        PDP sponsor or MA organization refers information to a 
        contractor described in paragraph (1) in order for such 
        contractor to assist in the determination described in such 
        paragraph, the contractor shall--
                    ``(A) acknowledge to the sponsor or organization 
                receipt of the referral; and
                    ``(B) in the case that any PDP sponsor or MA 
                organization contacts the contractor requesting to know 
                the determination by the contractor of whether or not 
                an individual has been determined to be an individual 
                described such paragraph, shall inform such sponsor or 
                organization of such determination on a date that is 
                not later than 15 days after the date on which the 
                sponsor or organization contacts the contractor.
            ``(3) Making data available to other entities.--
                    ``(A) In general.--For purposes of carrying out 
                this subsection, subject to subparagraph (B), the 
                Secretary shall authorize MEDICs to respond to requests 
                for information from PDP sponsors and MA organizations, 
                State prescription drug monitoring programs, and other 
                entities delegated by such sponsors or organizations 
                using available programs and systems in the effort to 
                prevent fraud, waste, and abuse.
                    ``(B) HIPAA compliant information only.--
                Information may only be disclosed by a MEDIC under 
                subparagraph (A) if the disclosure of such information 
                is 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 (42 U.S.C. 1320d-2 note).''.
            (2) OIG study and report on effectiveness of medics.--
                    (A) Study.--The Inspector General of the Department 
                of Health and Human Services shall conduct a study on 
                the effectiveness of Medicare drug integrity 
                contractors in identifying combating, and preventing 
                fraud under the Medicare program, including under the 
                authority provided under section 1893(j) of the Social 
                Security Act, as added by paragraph (1).
                    (B) Report.--Not later than 1 year after the date 
                of the enactment of this Act, the Inspector General 
                shall submit to Congress a report on the study 
                conducted under subparagraph (A). Such report shall 
                include such recommendations for improvements in the 
                effectiveness of such contractors as the Inspector 
                General determines appropriate.
    (d) 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.''.
    (e) 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.
    (f) Effective Date.--
            (1) In general.--The amendments made by this section shall 
        apply to prescription drug plans (and MA-PD plans) for plan 
        years beginning more than 1 year after the date of the 
        enactment of this Act.
            (2) Stakeholder meetings prior to effective date.--
                    (A) In general.--Not later than January 1, 2016, 
                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, entities 
                delegated by plan sponsors, and biopharmaceutical 
                manufacturers for input regarding the topics described 
                in subparagraph (B).
                    (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, and enrollees in MA-PD plans, who are 
                        at-risk beneficiaries for prescription drug 
                        abuse (as defined in subparagraph (C) of 
                        paragraph (5) 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 that allow an automatic 
                        escalation to external review of claims 
                        submitted under such part);
                            (iii) the types of enrollees that should be 
                        treated as exempted individuals, as described 
                        in subparagraph (C)(ii) of such paragraph;
                            (iv) the manner in which terms and 
                        definitions in such paragraph 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;
                            (v) the information to be included in the 
                        notices described in subparagraph (B) of such 
                        paragraph and the standardization of such 
                        notices; and
                            (vi) with respect to a PDP sponsor (or 
                        Medicare Advantage organization) that 
                        establishes a drug management program for at-
                        risk beneficiaries under such paragraph, the 
                        responsibilities of such PDP sponsor (or 
                        organization) with respect to the 
                        implementation of such program.
    (g) Rulemaking.--The Secretary of Health and Human Services shall 
promulgate regulations based on the input gathered pursuant to 
subsection (f)(2)(A).
                                 <all>