Source: https://www.law.cornell.edu/uscode/text/42/280g%E2%80%933
Timestamp: 2019-04-22 17:04:44+00:00

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to maintain an existing State-controlled substance monitoring program.
In making payments under a grant under paragraph (1) for a fiscal year, the Secretary shall allocate to each State with an application approved under this section an amount that equals 1.0 percent of the amount appropriated to carry out this section for that fiscal year.
In making payments under a grant under paragraph (1) for a fiscal year, the Secretary shall allocate to each State with an application approved under this section an additional amount which bears the same ratio to the amount appropriated to carry out this section for that fiscal year and remaining after amounts are made available under subparagraph (A) as the number of pharmacies of the State bears to the number of pharmacies of all States with applications approved under this section (as determined by the Secretary), except that the Secretary may adjust the amount allocated to a State under this subparagraph after taking into consideration the budget cost estimate for the State’s controlled substance monitoring program.
Grants awarded under this section shall be obligated in the year in which funds are allotted.
The Secretary shall maintain and, as appropriate, supplement or revise (after publishing proposed additions and revisions in the Federal Register and receiving public comments thereon) minimum requirements for criteria to be used by States for purposes of clauses (ii), (v), (vi), and (vii) of subsection (c)(1)(A).
information, where applicable, on how the controlled substance monitoring program jointly works with the applicant’s respective State substance abuse agency to ensure information collected and maintained by the controlled substance monitoring program is used to inform the provision of clinically appropriate substance use disorder services to individuals in need.
As part of an application under paragraph (1), the Secretary shall require a State to demonstrate that the State has enacted legislation or regulations to permit the implementation of the Statecontrolled substance monitoring program and the imposition of appropriate penalties for the unauthorized use and disclosure of information maintained in such program.
If a State that submits an application under this subsection geographically borders another State that is operating a controlled substance monitoring program under subsection (a)(1) on the date of submission of such application, and such applicant State has not achieved interoperability for purposes of information sharing between its monitoring program and the monitoring program of such border State, such applicant State shall, as part of the plan under paragraph (1)(B)(iii), describe the manner in which the applicant State will achieve interoperability between the monitoring programs of such States and include timelines for full implementation of such interoperability. The State shall also describe the manner in which it will achieve interoperability between its monitoring program and health information technology systems, as allowable under State law, and include timelines for the implementation of such interoperability.
The Secretary shall monitor State efforts to achieve interoperability, as described in subparagraph (A).
If a State submits an application in accordance with this subsection, the Secretary shall approve such application.
If the Secretary withdraws approval of a State’s application under this section, or the State chooses to cease to establish, improve, or maintain a controlled substance monitoring program under this section, a funding agreement for the receipt of a grant under this section is that the State will return to the Secretary an amount which bears the same ratio to the overall grant as the remaining time period for expending the grant funds bears to the overall time period for expending the grant (as specified by the Secretary at the time of the grant). The Secretary shall redistribute any funds that are so returned among the remaining grantees under this section in accordance with the formula described in subsection (a)(2)(B).
The State shall require dispensers to report to such State each dispensing in the State of a controlled substance to an ultimate user not later than 1 week after the date of such dispensing.
the administration or dispensing of a controlled substance in accordance with any other exclusion identified by the Secretary for purposes of this paragraph.
Drug Enforcement Administration Registration Number (or other identifying number used in lieu of such Registration Number) of the dispenser.
Drug Enforcement Administration Registration Number (or other identifying number used in lieu of such Registration Number) and name of the practitioner who prescribed the drug.
Name, address, and telephone number of the ultimate user or such contact information of the ultimate user as the Secretary determines appropriate.
Identification of the drug by a national drug code number.
Such other information as may be required by State law to be reported under this subsection.
The State shall require dispensers to report information under this section in accordance with the electronic format specified by the Secretary under subsection (i), except that the State may waive the requirement of such format with respect to an individual dispenser that is unable to submit such information by electronic means.
The State shall report on interoperability with the controlled substance monitoring program of Federal agencies, where appropriate, interoperability with health information technology systems such as electronic health records, health information exchanges, and e-prescribing, where appropriate, and whether or not the State provides automatic, up-to-date, or daily information about a patient when a practitioner (or the designee of a practitioner, where permitted) requests information about such patient.
The State shall establish and maintain an electronic database containing the information reported to the State under subsection (d).
The database must be searchable by any field or combination of fields.
The State shall include reported information in the database in a manner consistent with criteria established by the Secretary, with appropriate safeguards for ensuring the accuracy and completeness of the database.
The State shall take appropriate security measures to protect the integrity of, and access to, the database.
the requested information is for the purpose of implementing the State’s controlled substance monitoring program under this section.
may, to the extent permitted under State law, notify the appropriate authorities responsible for carrying out drug diversion investigations if the State determines that information in the database maintained by the State under subsection (e) indicates an unlawful diversion or abuse of a controlled substance.
to prepare and submit the report to Congress required by subsection (k)(2).
A department, program, agency, or administration receiving nonidentifiable information under paragraph (1)(D) may make such information available to other entities for research purposes.
shall limit information provided in response to a request under subsection (f)(1)(D) to nonidentifiable information.
educate prescribers and dispensers on the benefits of the system.
The Secretary shall specify a uniform electronic format for the reporting, sharing, and disclosure of information under this section.
Nothing in this section shall be construed to restrict the ability of any authority, including any local, State, or Federal law enforcement, narcotics control, licensure, disciplinary, or program authority, to perform functions otherwise authorized by law.
Nothing in this section shall be construed as preempting any State law, except that no such law may relieve any person of a requirement otherwise applicable under this chapter.
Nothing in this section shall be construed as preempting any State from imposing any additional privacy protections.
Nothing in this section shall be construed to supersede any Federal privacy or confidentiality requirement, including the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191; 110 Stat. 2033) and section 290dd–2 of this title.
Nothing in this section shall be construed to create a Federal private cause of action.
patient enrollment in research or clinical trials in which, following the protocol that has been approved by the relevant institutional review board for the research or clinical trial, the patient has obtained a controlled substance from either the scientific investigator conducting such research or clinical trial or the agent thereof.
If the Secretary determines under subparagraph (A) that a substantial negative impact has been demonstrated with regard to one or more of the categories of patients described in such subparagraph, the Secretary shall identify additional appropriate categories of exclusion from reporting as authorized under subsection (d)(2)(C).
submit a report to the Congress on the results of the study.
A State may establish an advisory council to assist in the establishment, improvement, or maintenance of a controlled substance monitoring program under this section.
A State may not use amounts received under a grant under this section for the operations of an advisory council established under paragraph (1).
It is the sense of the Congress that, in establishing an advisory council under this subsection, a State should consult with appropriate professional boards and other interested parties.
The term “bona fide patient” means an individual who is a patient of the practitioner involved.
The term “controlled substance” means a drug that is included in schedule II, III, or IV of section 812(c) of title 21.
The term “dispense” means to deliver a controlled substance to an ultimate user by, or pursuant to the lawful order of, a practitioner, irrespective of whether the dispenser uses the Internet or other means to effect such delivery.
The term “dispenser” means a physician, pharmacist, or other person that dispenses a controlled substance to an ultimate user.
The term “interoperability” with respect to a State controlled substance monitoring program means the ability of the program to electronically share reported information, including each of the required report components described in subsection (d), with another State if the information concerns either the dispensing of a controlled substance to an ultimate user who resides in such other State, or the dispensing of a controlled substance prescribed by a practitioner whose principal place of business is located in such other State.
The term “nonidentifiable information” means information that does not identify a practitioner, dispenser, or an ultimate user and with respect to which there is no reasonable basis to believe that the information can be used to identify a practitioner, dispenser, or an ultimate user.
The term “practitioner” means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he or she practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.
The term “State” means each of the 50 States, the District of Columbia, and any commonwealth or territory of the United States.
The term “ultimate user” means a person who has obtained from a dispenser, and who possesses, a controlled substance for his or her own use, for the use of a member of his or her household, or for the use of an animal owned by him or her or by a member of his or her household.
To carry out this section, there are authorized to be appropriated, $10,000,000 for each of fiscal years 2017 through 2021.
Section 264(c) of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (j)(4), is section 264(c) of Pub. L. 104–191, which is set out as a note under section 1320d–2 of this title.
Another section 399O of act July 1, 1944, was renumbered section 399P and is classified to section 280g–4 of this title.
2016—Subsec. (a)(1). Pub. L. 114–198, § 109(b)(1)(A), inserted “, in consultation with the Administrator of the Substance Abuse and Mental Health Services Administration and Director of the Centers for Disease Control and Prevention,” after “the Secretary” in introductory provisions.
Subsec. (a)(1)(C). Pub. L. 114–198, § 109(b)(1)(B)–(D), added subpar. (C).
Subsec. (c)(1)(A)(iv). Pub. L. 114–198, § 109(b)(9), substituted “subsection (i)” for “subsection (h)”.
Subsec. (c)(1)(B). Pub. L. 114–198, § 109(b)(3)(A)(i), substituted “(a)(1)(B) or (a)(1)(C)” for “(a)(1)(B)” in introductory provisions.
Subsec. (c)(1)(B)(i). Pub. L. 114–198, § 109(b)(3)(A)(ii), substituted “program to be improved or maintained” for “program to be improved”.
Subsec. (c)(1)(B)(iii). Pub. L. 114–198, § 109(b)(3)(A)(iv), added cl. (iii). Former cl. (iii) redesignated (iv).
Subsec. (c)(1)(B)(iv). Pub. L. 114–198, § 109(b)(3)(A)(iii), (v), redesignated cl. (iii) as (iv) and substituted “and at least one health information technology system such as electronic health records, health information exchanges, or e-prescribing systems;” for “; and”. Former cl. (iv) redesignated (v).
Subsec. (c)(1)(B)(vi). Pub. L. 114–198, § 109(b)(3)(A)(vii), added cl. (vi).
Subsec. (c)(3). Pub. L. 114–198, § 109(b)(3)(B), designated existing provisions as subpar. (A) and inserted heading, inserted before period at end “and include timelines for full implementation of such interoperability. The State shall also describe the manner in which it will achieve interoperability between its monitoring program and health information technology systems, as allowable under State law, and include timelines for the implementation of such interoperability”, and added subpar. (B).
Subsec. (d). Pub. L. 114–198, § 109(b)(4)(A), in introductory provisions, substituted “In establishing, improving, or maintaining a controlled substance monitoring program under this section, a State shall comply, or with respect to a State that applies for a grant under subparagraph (B) or (C) of subsection (a)(1)” for “In implementing or improving a controlled substance monitoring program under this section, a State shall comply, or with respect to a State that applies for a grant under subsection (a)(1)(B)” and “public health or safety” for “public health”.
Subsec. (d)(4). Pub. L. 114–198, § 109(b)(9), substituted “subsection (i)” for “subsection (h)”.
Subsec. (d)(5). Pub. L. 114–198, § 109(b)(4)(B), added par. (5).
Subsecs. (e), (f)(1). Pub. L. 114–198, § 109(b)(5), substituted “establishing, improving, or maintaining” for “implementing or improving” in introductory provisions.
Subsec. (f)(1)(B). Pub. L. 114–198, § 109(b)(6)(A)(i), substituted “misuse of a controlled substance included in schedule II, III, or IV of section 812(c) of title 21” for “misuse of a schedule II, III, or IV substance”.
Subsec. (f)(1)(D). Pub. L. 114–198, § 109(b)(6)(A)(ii), inserted “a State substance abuse agency,” after “State health department,” and substituted “such department, program, agency, or administration” for “such department, program, or administration” in two places.
Subsec. (f)(3), (4). Pub. L. 114–198, § 109(b)(6)(B), added pars. (3) and (4).
Subsec. (g). Pub. L. 114–198, § 109(b)(5), substituted “establishing, improving, or maintaining” for “implementing or improving” in introductory provisions.
Subsecs. (h) to (j). Pub. L. 114–198, § 109(b)(8), (10), added subsec. (h) and redesignated former subsecs. (h) and (i) as (i) and (j), respectively. Former subsec. (j) redesignated (k).
Subsec. (k)(2)(A)(ii). Pub. L. 114–198, § 109(b)(11)(A), substituted “, established or strengthened initiatives to ensure linkages to substance use disorder services, or affected” for “or affected”.
Subsec. (k)(2)(A)(iii). Pub. L. 114–198, § 109(b)(11)(B), substituted “and between controlled substance monitoring programs and health information technology systems, including an assessment” for “including an assessment”.
Subsec. (l)(1). Pub. L. 114–198, § 109(b)(12), substituted “establishment, improvement, or maintenance” for “establishment, implementation, or improvement”.
Subsec. (m)(8). Pub. L. 114–198, § 109(b)(13), substituted “, the District of Columbia, and any commonwealth or territory of the United States” for “and the District of Columbia”.
Subsec. (n). Pub. L. 114–198, § 109(b)(14), amended subsec. (n) generally. Prior to amendment, subsec. (n) authorized appropriations for fiscal years 2006 to 2010.

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