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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 882 Introduced in Senate (IS)]

112th CONGRESS
  1st Session
                                 S. 882

  To prevent misuse, overutilization, and trafficking of prescription 
   drugs by limiting access to such drugs for Medicare and Medicaid 
 beneficiaries who have been identified as high-risk prescription drug 
                                 users.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              May 4, 2011

 Mr. Brown of Ohio introduced the following bill; which was read twice 
                and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL

 
  To prevent misuse, overutilization, and trafficking of prescription 
   drugs by limiting access to such drugs for Medicare and Medicaid 
 beneficiaries who have been identified as high-risk prescription drug 
                                 users.

    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 ``Stop Trafficking of Pills Act'' or 
the ``STOP Act''.

SEC. 2. MEDICAID RESTRICTED RECIPIENT PROGRAM.

    (a) In General.--Title XIX of the Social Security Act (42 U.S.C. 
1396 et seq.) is amended--
            (1) in section 1902(a)--
                    (A) by striking ``and'' at the end of paragraph 
                (82);
                    (B) by striking the period at the end of paragraph 
                (83) and inserting ``; and''; and
                    (C) by inserting after paragraph (83) the following 
                new paragraph:
            ``(84) in accordance with section 1908B, provide for the 
        development and implementation of a restricted recipient 
        program for individuals identified as high-risk prescription 
        drug users.''; and
            (2) by inserting after section 1908A the following new 
        section:

  ``restricted recipient program for high-risk prescription drug users

    ``Sec. 1908B  (a) Identification of High-Risk Prescription Drug 
Users.--
            ``(1) In general.--Subject to paragraph (2), the State 
        shall establish and implement a program, subject to approval by 
        the Secretary, to--
                    ``(A) identify any prescription drug that--
                            ``(i) may be dispensed on the prescription 
                        of a physician to an individual eligible to 
                        receive medical assistance under the State 
                        Medicaid program; and
                            ``(ii) presents a high risk of misuse or 
                        overutilization, as determined by the State;
                    ``(B) establish a dosage level for each 
                prescription drug identified under subparagraph (A) 
                that would be deemed excessive in the absence of 
                evidence of medical necessity;
                    ``(C) using a percentile-based method or other such 
                form of statistical analysis, identify individuals 
                (referred to in this section as `individuals identified 
                as high-risk prescription drug users') who are eligible 
                for medical assistance under the State Medicaid program 
                and--
                            ``(i) are receiving a prescription drug 
                        that has been identified under subparagraph (A) 
                        at a dosage level that has been determined to 
                        be excessive pursuant to subparagraph (B); or
                            ``(ii) are determined by the State, 
                        pursuant to the procedure established under 
                        paragraph (3), to have been convicted of a 
                        drug-related offense; and
                    ``(D) ensure that individuals identified as high-
                risk prescription drug users pursuant to subparagraph 
                (C) are assigned to the restricted recipient program 
                described in subsection (b).
            ``(2) Case review.--For purposes of paragraph (1), the 
        State shall establish and implement procedures to ensure that 
        an individual who has been identified as a high-risk 
        prescription drug user and is subject to the requirements under 
        the restricted recipient program--
                    ``(A) is provided with reasonable notice regarding 
                their assignment to the program and a description of 
                the requirements under such program;
                    ``(B) is permitted to file an appeal with the State 
                agency and receive a hearing thereon to review whether 
                the individual has been properly identified as a high-
                risk prescription drug user;
                    ``(C) for purposes of subsection (b)(1), is 
                permitted to file a claim with the State agency in 
                order to seek reassignment to a different physician or 
                pharmacist; and
                    ``(D) has reasonable access to any prescription 
                drug that is medically necessary and required to be 
                dispensed on an emergency basis.
            ``(3) Drug-related offenses.--For purposes of paragraph 
        (1)(C)(ii), the State shall establish and implement procedures 
        to determine whether an individual, at the time of enrollment 
        or re-enrollment in the State Medicaid program, has been 
        convicted (under Federal or State law) of any offense which is 
        classified as a felony by the law of the jurisdiction involved 
        and which has as an element the unlawful possession, 
        manufacture, distribution, or dispensing of a prescription drug 
        (including opioids and similar pain-management prescription 
        drugs).
    ``(b) Restricted Recipient Program.--
            ``(1) Medicaid lock-in program.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                State shall establish and implement a program (referred 
                to in this section as the `Medicaid Lock-in Program') 
                to ensure that any individual identified as a high-risk 
                prescription drug user is--
                            ``(i) assigned to a single and exclusive 
                        physician (as defined in section 1861(r)) for 
                        purposes of receiving any medical assistance 
                        that is related to a prescription drug; and
                            ``(ii) assigned to a single and exclusive 
                        pharmacy for purposes of receiving any 
                        prescription drug that has been prescribed by a 
                        physician described in clause (i).
            ``(2) Medicaid prescription drug restriction program.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                State, in conjunction with the Secretary, shall 
                establish and implement a program to ensure that the 
                claims processing system for the State does not permit 
                a prescription drug to be dispensed by a provider to an 
                individual identified as a high-risk prescription drug 
                user if the same prescription drug has been dispensed 
                to such individual within the previous 20 days.
                    ``(B) Exceptions.--
                            ``(i) Increased dosage.--For purposes of 
                        subparagraph (A), the restrictions described in 
                        such subparagraph shall not apply to an 
                        individual identified as a high-risk 
                        prescription drug user--
                                    ``(I) if the current prescription 
                                is for an increased dosage of the 
                                prescription drug and has been issued 
                                by the same physician that issued the 
                                previous prescription; or
                                    ``(II) in such other circumstances 
                                as determined by the Secretary.
                            ``(ii) Procedural development.--The State, 
                        in conjunction with the Secretary, shall 
                        develop adequate procedures to ensure that 
                        prescriptions described in clause (i) are not 
                        affected by the restrictions described in 
                        subparagraph (A) and are permitted to be 
                        dispensed by a provider to an individual 
                        identified as a high-risk prescription drug 
                        user.
    ``(c) Existing State Programs.--
            ``(1) In general.--Subject to paragraphs (2) and (3), as 
        well as any procedures as are determined appropriate by the 
        Secretary, a restricted recipient program that has been 
        established by a State prior to the date of enactment of the 
        Stop Trafficking of Pills Act may be reviewed and certified by 
        the Secretary as being in accordance with the requirements 
        under this section for purposes of section 1902(a)(84).
            ``(2) Program improvement.--For purposes of paragraph (1), 
        if the Secretary does not certify an existing State restricted 
        recipient program as being in accordance with the requirements 
        under this section, the Secretary shall identify any necessary 
        enhancements or additional developments that are required in 
        order for such program to be deemed in accordance with such 
        requirements.
            ``(3) Drug-related offenses.--For purposes of paragraph 
        (1), an existing State restricted recipient program shall be 
        required to include procedures described in subsection (a)(3) 
        for the identification and inclusion of individuals convicted 
        of a drug-related offense.
    ``(d) Administrative Expenses.--Subject to such requirements as are 
determined appropriate by the Secretary, for purposes of section 
1903(a)(7), any amounts expended by the State to develop and implement 
a restricted recipient program for individuals identified as high-risk 
prescription drug users under this section, including any necessary 
enhancements or additional developments identified under subsection 
(c)(2), shall be considered amounts expended as necessary for the 
proper and efficient administration of the State Medicaid plan.
    ``(e) Definitions.--For purposes of this section:
            ``(1) State medicaid program.--The term `State Medicaid 
        program' means the State program for medical assistance 
        provided under a State plan under this title, including any 
        waiver approved with respect to such State plan.
            ``(2) Prescription drug.--The term `prescription drug' 
        means a drug subject to section 503(b)(1) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)).''.
    (b) Withholding of Payment.--Section 1903(i) of the Social Security 
Act (42 U.S.C. 1396b(i)), as amended by section 2001(a)(2)(B) of the 
Patient Protection and Affordable Care Act (Public Law 111-148), is 
amended--
            (1) in paragraph (25), by striking ``or'' at the end;
            (2) in paragraph (26), by striking the period and inserting 
        ``; or''; and
            (3) by adding at the end the following new paragraph:
            ``(27) with respect to amounts expended for medical 
        assistance for any prescription drug dispensed to an individual 
        identified as a high-risk prescription drug user (as described 
        in section 1908B(a)(1)(C)), unless the requirements under 
        section 1908B are met.''.

SEC. 3. MEDICARE RESTRICTED RECIPIENT PROGRAM.

    Part D of title XVIII of the Social Security Act (U.S.C. 1395w-101 
et seq.) is amended by adding at the end the following new section:

  ``restricted recipient program for high-risk prescription drug users

    ``Sec. 1860D-44  (a) Identification of High-Risk Prescription Drug 
Users.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall establish and implement a program to--
                    ``(A) identify any prescription drug that--
                            ``(i) may be dispensed on the prescription 
                        of a physician to an individual enrolled in a 
                        prescription drug plan under this part; and
                            ``(ii) presents a high risk of misuse or 
                        overutilization, as determined by the 
                        Secretary;
                    ``(B) establish a dosage level for each 
                prescription drug identified under subparagraph (A) 
                that would be deemed excessive in the absence of 
                evidence of medical necessity;
                    ``(C) using a percentile-based method or other such 
                form of statistical analysis, identify individuals 
                (referred to in this section as `individuals identified 
                as high-risk prescription drug users') who are enrolled 
                in a prescription drug plan under this part; and
                            ``(i) are receiving a prescription drug 
                        that has been identified under subparagraph (A) 
                        at a dosage level that has been determined to 
                        be excessive pursuant to subparagraph (B); or
                            ``(ii) are determined by the Secretary, 
                        pursuant to the procedure established under 
                        paragraph (3), to have been convicted of a 
                        drug-related offense; and
                    ``(D) ensure that individuals identified as high-
                risk prescription drug users pursuant to subparagraph 
                (C) are assigned to the restricted recipient program 
                described in subsection (b).
            ``(2) Case review.--For purposes of paragraph (1), the 
        Secretary shall establish and implement procedures to ensure 
        that an individual who has been identified as a high-risk 
        prescription drug user and is subject to the requirements under 
        the restricted recipient program--
                    ``(A) is provided with reasonable notice regarding 
                their assignment to the program and a description of 
                the requirements under such program;
                    ``(B) is permitted to file an appeal and receive a 
                hearing thereon to review whether the individual has 
                been properly identified as a high-risk prescription 
                drug user; and
                    ``(C) has reasonable access to any prescription 
                drug that is medically necessary and required to be 
                dispensed on an emergency basis.
            ``(3) Drug-related offense.--For purposes of paragraph 
        (1)(C)(ii), the Secretary shall establish and implement 
        procedures to determine whether an individual, at the time of 
        enrollment or re-enrollment in a prescription drug plan under 
        this part, has been convicted (under Federal or State law) of 
        any offense which is classified as a felony by the law of the 
        jurisdiction involved and which has as an element the unlawful 
        possession, manufacture, distribution, or dispensing of a 
        prescription drug (including opioids and similar prescription 
        pain-management drugs).
    ``(b) Prescription Drug Restriction Program.--The Secretary shall 
establish policies and procedures to ensure that the provisions 
described in section 1908B(b)(3) are applied to any individual 
identified, pursuant to subsection (a)(1), as a high-risk prescription 
drug user in a similar manner as such provisions are applied to such 
individuals for purposes of title XIX.''.

SEC. 4. EFFECTIVE DATE.

    (a) In General.--Except as provided in subsection (b), the 
amendments made by this section shall take effect 120 days after the 
date of enactment of this Act.
    (b) Extension of Effective Date for State Law Amendment.--In the 
case of a State plan under title XIX of the Social Security Act (42 
U.S.C. 1396 et seq.) which the Secretary determines requires State 
legislation in order for the plan to meet the additional requirements 
imposed by the amendments made by this section, the State plan shall 
not be regarded as failing to comply with the requirements of the 
amendments made by this section solely on the basis of its failure to 
meet such additional requirements before the first day of the first 
calendar quarter beginning after the close of the first regular session 
of the State legislature that begins after the date of the enactment of 
this Act. For purposes of the previous sentence, in the case of a State 
that has a 2-year legislative session, each year of the session is 
considered to be a separate regular session of the State legislature.
                                 <all>
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