II 112th CONGRESS 1st Session S. 882 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.

1.

Short title

This Act may be cited as the Stop Trafficking of Pills Act or the STOP Act.

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:

1908B

Restricted Recipient Program for High-Risk Prescription Drug Users

(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. .

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:

1860D–44

Restricted Recipient Program for High-Risk Prescription Drug Users

(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.

.

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.