[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4697 Introduced in House (IH)]

<DOC>






114th CONGRESS
  2d Session
                                H. R. 4697

   To provide for increased Federal oversight of prescription opioid 
   treatment and assistance to States in reducing opioid addiction, 
                         diversion, and deaths.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 3, 2016

 Ms. Esty (for herself, Mr. Costello of Pennsylvania, and Mr. Knight) 
 introduced the following bill; which was referred to the Committee on 
  Energy and Commerce, and in addition to the Committees on Ways and 
Means and the Judiciary, 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 provide for increased Federal oversight of prescription opioid 
   treatment and assistance to States in reducing opioid addiction, 
                         diversion, and deaths.

    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 ``Prevent Drug Addiction Act of 
2016''.

SEC. 2. CONSUMER EDUCATION CAMPAIGN.

    Part A of title V of the Public Health Service Act (42 U.S.C. 290aa 
et seq.) is amended by adding at the end the following:

``SEC. 506C. CONSUMER EDUCATION CAMPAIGN.

    ``(a) In General.--The Administrator shall award grants to States 
and nonprofit entities for the purpose of conducting culturally 
sensitive consumer education about opioid addiction, including 
methadone addiction. Such education shall include information on the 
dangers of opioid addiction, how to prevent opioid addiction including 
through safe disposal of prescription medications and other safety 
precautions, and detection of early warning signs of addiction.
    ``(b) Eligibility.--To be eligible to receive a grant under 
subsection (a), an entity shall--
            ``(1) be a State or nonprofit entity; and
            ``(2) submit to the Administrator an application at such 
        time, in such manner, and containing such information as the 
        Administrator may require.
    ``(c) Priority.--In awarding grants under this section, the 
Administrator shall give priority to applicants that are States or 
communities with a high incidence of addiction to methadone and other 
opioids, and opioid-related deaths.
    ``(d) Evaluations.--The Administrator shall develop a process to 
evaluate the effectiveness of activities carried out by grantees under 
this section at reducing addiction to methadone and other opioids.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $15,000,000 for each of fiscal 
years 2017 through 2021.''.

SEC. 3. PRACTITIONER EDUCATION.

    (a) Education Requirements.--
            (1) Registration consideration.--Section 303(f) of the 
        Controlled Substances Act (21 U.S.C. 823(f)) is amended by 
        inserting after paragraph (5) the following:
            ``(6) The applicant's compliance with the training 
        requirements described in subsection (g)(3) during any previous 
        period in which the applicant has been subject to such training 
        requirements.''.
            (2) Training requirements.--Section 303(g) of the 
        Controlled Substances Act (21 U.S.C. 823(g)) is amended by 
        adding at the end the following:
    ``(3)(A) To be registered to prescribe or otherwise dispense 
methadone or other opioids, a practitioner described in paragraph (1) 
shall comply with the 12-hour training requirement of subparagraph (B) 
at least once during each 3-year period.
    ``(B) The training requirement of this subparagraph is that the 
practitioner has completed not less than 12 hours of training (through 
classroom situations, seminars at professional society meetings, 
electronic communications, or otherwise) with respect to--
            ``(i) the treatment and management of opioid-dependent 
        patients;
            ``(ii) pain management treatment guidelines; and
            ``(iii) early detection of opioid addiction, including 
        through such methods as Screening, Brief Intervention, and 
        Referral to Treatment (SBIRT),
that is provided by the American Society of Addiction Medicine, the 
American Academy of Addiction Psychiatry, the American Medical 
Association, the American Osteopathic Association, the American 
Psychiatric Association, the American Academy of Pain Management, the 
American Pain Society, the American Academy of Pain Medicine, the 
American Board of Pain Medicine, the American Society of Interventional 
Pain Physicians, or any other organization that the Secretary 
determines is appropriate for purposes of this subparagraph.''.
    (b) Requirements for Participation in Opioid Treatment Programs.--
Effective July 1, 2017, a physician practicing in an opioid treatment 
program shall comply with the requirements of section 303(g)(3) of the 
Controlled Substances Act (as added by subsection (a)) with respect to 
required minimum training at least once during each 3-year period.
    (c) Definition.--In this section, the term ``opioid treatment 
program'' has the meaning given such term in section 8.2 of title 42, 
Code of Federal Regulations (or any successor regulation).
    (d) Funding.--The Drug Enforcement Administration shall fund the 
enforcement of the requirements specified in section 303(g)(3) of the 
Controlled Substances Act (as added by subsection (a)) through the use 
of a portion of the licensing fees paid by controlled substance 
prescribers under the Controlled Substances Act (21 U.S.C. 801 et 
seq.).

SEC. 4. OPERATION OF OPIOID TREATMENT PROGRAMS.

    Section 303 of the Controlled Substances Act (21 U.S.C. 823) is 
amended by adding at the end the following:
    ``(i)(1) An opioid treatment program that is registered under this 
section, and that closes for business on any weekday or weekend day, 
including a Federal or State holiday, shall comply with the 
requirements of this subsection.
    ``(2) The program shall make acceptable arrangements for each 
patient who is restricted, by Federal regulation or guideline or by the 
determination of the program medical director, from having a take-home 
dose of a controlled substance related to the treatment involved, to 
receive a dose of that substance under appropriate supervision during 
the closure.
    ``(3) The Administrator of the Substance Abuse and Mental Health 
Services Administration shall issue a notice that references 
regulations on acceptable arrangements under this subsection, or shall 
promulgate regulations on such acceptable arrangements.''.

SEC. 5. MORTALITY REPORTING.

    Part A of title V of the Public Health Service Act (42 U.S.C. 290aa 
et seq.), as amended by section 3, is further amended by adding at the 
end the following:

``SEC. 506D. MORTALITY REPORTING.

    ``(a) Model Opioid Treatment Program Mortality Report.--
            ``(1) In general.--Not later than July 1, 2017, the 
        Secretary, acting through the Administrator, shall require that 
        a Model Opioid Treatment Program Mortality Report be completed 
        and submitted to the Administrator for each individual who dies 
        while receiving treatment in an opioid treatment program.
            ``(2) Requirement of states that receive funding for the 
        controlled substance monitoring program.--As a condition for 
        receiving funds under section 399O, each State shall require 
        that any individual who signs a death certificate where an 
        opioid drug is detected in the body of the deceased, or where 
        such drug is otherwise associated with the death, report such 
        death to the Administrator by submitting a Model Opioid 
        Treatment Program Mortality Report described in paragraph (3). 
        Such report shall be submitted to the Administrator on or 
        before the later of--
                    ``(A) 90 days after the date of signing the death 
                certificate; or
                    ``(B) as soon as practicable after the date on 
                which the necessary postmortem and toxicology reports 
                become available to such individual, as required by the 
                Secretary.
            ``(3) Development.--The Administrator, in consultation with 
        State and local medical examiners, prescribing physicians, 
        hospitals, and any other organization that the Administrator 
        determines appropriate, shall develop a Model Opioid Treatment 
        Program Mortality Report to be used under paragraphs (1) and 
        (2).
    ``(b) National Opioid Death Registry.--
            ``(1) In general.--Not later than July 1, 2017, the 
        Administrator shall establish and implement, through the 
        National Center for Health Statistics, a National Opioid Death 
        Registry (referred to in this subsection as the `Registry') to 
        track opioid-related deaths and information related to such 
        deaths.
            ``(2) Consultation.--In establishing the uniform reporting 
        criteria for the Registry, the Director of the Centers for 
        Disease Control and Prevention shall consult with the 
        Administrator, State and local medical examiners, prescribing 
        physicians, hospitals, and any other organization that the 
        Director determines is appropriate for purposes of this 
        subsection.
            ``(3) Requirements.--The registry shall be designed as a 
        uniform reporting system for opioid-related deaths and shall 
        require the reporting of information with respect to such 
        deaths, including--
                    ``(A) the particular drug formulation used at the 
                time of death;
                    ``(B) the dosage level;
                    ``(C) a description of the circumstances 
                surrounding the death in relation to the recommended 
                dosage involved;
                    ``(D) a disclosure of whether the medication 
                involved can be traced back to a physician's 
                prescription;
                    ``(E) a disclosure of whether the individual was in 
                an opioid treatment program at the time of death;
                    ``(F) the age and sex of the individual; and
                    ``(G) other nonpersonal information such as that 
                included in filed National Association of Medical 
                Examiners Pediatric Toxicology Registry case reports as 
                required under the privacy standard for the de-
                identification of health information pursuant to the 
                regulations contained in part 164 of title 45, Code of 
                Federal Regulations.
            ``(4) Authorization.--There is authorized to be 
        appropriated $5,000,000 for each of fiscal years 2017 through 
        2021 to carry out this subsection.
    ``(c) Report on Registry Information.--Not later than the January 1 
of the first fiscal year beginning 2 years after the date of enactment 
of this section, and each January 1 thereafter, the Director of the 
Centers for Disease Control and Prevention shall submit to the 
Secretary a report, based on information contained in the Registry 
described in subsection (b), concerning the number of methadone-related 
deaths in the United States for the year for which the report is 
submitted.''.

SEC. 6. DEVELOPMENT OF PRESCRIPTION DRUG ADDICTION PREVENTION AND 
              TREATMENT QUALITY MEASURES ACROSS EACH RELEVANT PROVIDER 
              SETTING.

    Subpart I of part D of title IX of the Public Health Service Act 
(42 U.S.C. 299b-31 et seq.) is amended by adding at the end the 
following:

``SEC. 932. DEVELOPMENT OF PRESCRIPTION DRUG ADDICTION PREVENTION AND 
              TREATMENT QUALITY MEASURES ACROSS EACH RELEVANT PROVIDER 
              SETTING.

    ``(a) In General.--The Secretary, acting through the Director of 
the Agency for Healthcare Research and Quality and in consultation with 
the Director of the Centers for Disease Control and Prevention, the 
Administrator of the Substance Abuse and Mental Health Services 
Administration, and the Director of the Centers for Medicare & Medicaid 
Services, shall require the development and application of specific 
prescription drug addiction prevention and treatment quality measures 
for each relevant health care provider setting, as identified by the 
Director.
    ``(b) Dissemination.--Not later than April 1, 2017, the Secretary 
shall disseminate the quality measure requirements developed under 
subsection (a) to all affected providers.
    ``(c) Types of Measures.--Quality measures developed under this 
section may be structure-oriented (such as the required presence of a 
hospital-based treatment program), process-oriented (such as requiring 
patients to be informed of the addictive qualities of the medication 
being prescribed), or outcome-oriented (such as assessing family 
satisfaction with care).''.

SEC. 7. PROGRAMS TO PREVENT PRESCRIPTION DRUG ADDICTION UNDER MEDICARE 
              PART 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:
            ``(4) 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 addiction who is an 
                enrollee in a prescription drug plan of such PDP 
                sponsor, limit such beneficiary's access to coverage 
                for addictive drugs under such plan to addictive 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 addiction to coverage for 
                        addictive 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 addiction.
                            ``(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 
                                addiction;
                                    ``(II) information describing all 
                                State and Federal public health 
                                resources that are designed to address 
                                prescription drug addiction 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 addiction 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 addiction, 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 
                                addiction;
                                    ``(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 
                addiction.--
                            ``(i) In general.--For purposes of this 
                        paragraph, the term `at-risk beneficiary for 
                        prescription drug addiction' 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 guidelines developed by the 
                                Secretary in consultation with PDP 
                                sponsors and other stakeholders 
                                described in section 10(f)(2)(A) of the 
                                Prevent Drug Addiction Act of 2016; 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 addiction 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) receives hospice care under 
                                this title; or
                                    ``(II) 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 
                        addiction 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 addictive 
                                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, affordability, and reasonable 
                        travel time.
                            ``(iii) Beneficiary preferences.--
                                    ``(I) In general.--If an at-risk 
                                beneficiary for prescription drug 
                                addiction 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 
                                addiction 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 addiction 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 addiction 
                        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 addiction 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 
                        addiction 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) Addictive drug.--For purposes of this 
                subsection, the term `addictive drug' means a drug that 
                is determined by the Secretary to be addictive or 
                frequently diverted and that is--
                            ``(i) a Controlled Drug Substance in 
                        Schedule CII-CIV;
                            ``(ii) within the same class or category of 
                        drugs as a Controlled Drug Substance in 
                        Schedule CII-CIV; or
                            ``(iii) within another class or category of 
                        drugs that the Secretary determines, in 
                        consultation with the Inspector General of the 
                        Department of Health and Human Services, is at 
                        high risk for diversion or addiction.
                    ``(H) Data disclosure.--In the case of an at-risk 
                beneficiary for prescription drug addiction whose 
                access to coverage for addictive 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.''.
            (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)(4).''.
    (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), is amended--
            (1) in paragraph (1), by inserting after subparagraph (D) 
        the following new subparagraph:
                    ``(E) A utilization management tool to prevent drug 
                addiction (as described in paragraph (5)(A)).''; and
            (2) by adding at the end the following new paragraph:
            ``(5) Utilization management tool to prevent drug 
        addiction.--
                    ``(A) In general.--A tool described in this 
                paragraph is any of the following:
                            ``(i) A utilization tool designed to 
                        prevent addiction to addictive drugs by 
                        individuals and to prevent the diversion of 
                        such drugs at pharmacies.
                            ``(ii) Retrospective utilization review to 
                        identify--
                                    ``(I) individuals that receive 
                                addictive drugs at a frequency or in 
                                amounts that are not clinically 
                                appropriate; and
                                    ``(II) providers of services or 
                                suppliers that may facilitate the 
                                addiction to or diversion of addictive 
                                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 (4)(C).''.
    (c) Expanding Activities of Medicare Drug Integrity Contractors 
(MEDICs).--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, 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 
        addiction, as defined in section 1860D-4(c)(4)(C).
            ``(2) Requirement for acknowledgment of referrals.--If a 
        PDP sponsor 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 PDP sponsor receipt of the 
                referral; and
                    ``(B) in the case that any PDP sponsor 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 PDP sponsor of such 
                determination on a date that is not later than 15 days 
                after the date on which the PDP sponsor 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, State prescription 
                drug monitoring programs, and other entities delegated 
                by PDP sponsors 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).''.
    (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) GAO Studies and Reports.--
            (1) Studies.--The Comptroller General of the United States 
        shall conduct a study on each of the following:
                    (A) The implementation of the amendments made by 
                this section.
                    (B) The effectiveness of the at-risk beneficiaries 
                for prescription drug addiction drug management 
                programs authorized by section 1860D-4(c)(4) of the 
                Social Security Act (42 U.S.C. 1395w-10(c)(4)), as 
                added by subsection (a)(1), including an analysis of--
                            (i) the impediments, if any, that impair 
                        the ability of individuals described in 
                        subparagraph (C) of such section 1860D-4(c)(4) 
                        to access clinically appropriate levels of 
                        prescription drugs; and
                            (ii) 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.
            (2) Reports.--Not later than January 1, 2017, the 
        Comptroller General of the United States shall begin work, with 
        respect to each study described in paragraph (1), on a report 
        that describes the result of such study. Upon the completion of 
        each such report, such Comptroller General shall submit the 
        report to each of the committees described in paragraph (3).
            (3) Committees described.--The committees described in this 
        paragraph are the following:
                    (A) The Committee on Ways and Means of the House of 
                Representatives.
                    (B) The Committee on Energy and Commerce of the 
                House of Representatives.
                    (C) The Committee on Finance of the Senate.
                    (D) The Committee on Health, Education, Labor, and 
                Pensions of the Senate.
                    (E) The Special Committee on Aging of the Senate.
    (f) Effective Date.--
            (1) In general.--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 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, and entities delegated by plan sponsors, for 
                input regarding the topics described in subparagraph 
                (B).
                    (B) Topics described.--The topics described in this 
                subparagraph are the topics of--
                            (i) ensuring affordability and 
                        accessibility to prescription drugs for 
                        enrollees in prescription drug plans of PDP 
                        sponsors who are at-risk beneficiaries for 
                        prescription drug addiction (as defined in 
                        paragraph (4)(C) of section 1860D-4(c) of the 
                        Social Security Act (42 U.S.C. 1395w-10(c)), as 
                        added by subsection (a)(1));
                            (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 
                        addiction 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 clause (ii) of such paragraph;
                            (iv) the manner in which terms and 
                        definitions in paragraph (4) 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 addiction as defined in 
                        subparagraph (C) of such paragraph (4);
                            (v) the information to be included in the 
                        notices described in subparagraph (B) of such 
                        section and the standardization of such 
                        notices; and
                            (vi) with respect to a PDP sponsor that 
                        establishes a drug management program for at-
                        risk beneficiaries under such paragraph (4), 
                        the responsibilities of such PDP sponsor with 
                        respect to the implementation of such program.
                    (C) Rulemaking.--The Secretary shall promulgate 
                regulations based on the input gathered pursuant to 
                subparagraph (A).
                                 <all>