To facilitate the development of recommendations on interoperability standards to inform and facilitate the exchange of prescription information across State lines.
What it does: Adds Subtitle D--Interstate Drug Monitoring Efficiency and Data Sharing SECTION 1141. SHORT TITLE at the end of title XIWhat it changes
1 change to S. 3187 · shown in the bill's text
Adds Subtitle D--Interstate Drug Monitoring Efficiency and Data Sharing SECTION 1141. SHORT TITLE at the end of title XI
Adds a sectionIn S. 3187 · Placed on Calendar Senate
"(b) Financial Interest.--In this section, the term 'financial interest' means a financial interest under section 208(a) of title 18, United States Code.".
Inserted: Subtitle D--Interstate Drug Monitoring Efficiency and Data Sharing SECTION 1141. SHORT TITLE.
Inserted: This subtitle may be cited as the "Interstate Drug Monitoring Efficiency and Data Sharing Act of 2012" or the "ID MEDS Act".
Inserted: SEC. 1142. NATIONAL INTEROPERABILITY STANDARDS.
Inserted: (a) In General.--Not later than 1 year after the date of enactment of this Act, the Attorney General shall establish national interoperability standards to facilitate the exchange of prescription information across State lines by States receiving grant funds under--
Inserted: (1) the Harold Rogers Prescription Drug Monitoring Program established under the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2002 (Public Law 107 77; 115 Stat. 748); and
Inserted: (2) the Controlled Substance Monitoring Program established under section 399O of the Public Health Service Act (42 U.S.C. 280g 3).
Inserted: (b) Requirements.--The Attorney General, in consultation with the Secretary of Health and Human Services, shall ensure that the national interoperability standards established under subsection (a)--
Inserted: (1) implement open standards that are freely available, without cost and without restriction, in order to promote broad implementation;
Inserted: (2) provide for the use of exchange intermediaries, or hubs, as necessary to facilitate interstate interoperability by accommodating State-to-hub and direct State-to-State communication;
Inserted: (3) support transmissions that are fully secured as required, using industry standard methods of encryption, to ensure that Protected Health Information and Personally Identifiable Information (PHI and PII) are not compromised at any point during such transmission; and
Inserted: (4) employ access control methodologies to share protected information solely in accordance with State laws and regulations.
Inserted: SEC. 1143. STATE RECIPIENT REQUIREMENTS.
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Inserted: (a) Harold Rogers Prescription Drug Monitoring Program.--
Inserted: (1) In general.--Not later than 1 year after the date on which the Attorney General establishes national interoperability standards under section 1142(a), a recipient of a grant under the Harold Rogers Prescription Drug Monitoring Program established under the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2002 (Public Law 107 77; 115 Stat. 748) shall ensure that the databases of the State comply with such national interoperability standards.
Inserted: (2) Use of enhancement grant funds.--A recipient of an enhancement grant under the Harold Rogers Prescription Drug Monitoring Program established under the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2002 (Public Law 107 77; 115 Stat. 748) may use enhancement grant funds to standardize the technology architecture used by the recipient to comply with the national interoperability standards established under section 1142(a).
Inserted: (b) Controlled Substance Monitoring Program.--Section 399O(e) of the Public Health Service Act (42 U.S.C. 280g 3(e)) is amended by adding at the end the following:
Inserted: "(5) Not later than 1 year after the date on which the Attorney General establishes national interoperability standards under section 1142(a) of the ID MEDS Act, the State shall ensure that the database complies with such national interoperability standards.".
Inserted: SEC. 1144. REPORT.
Inserted: (a) In General.--Not later than 1 year after the date of enactment of this Act, the Attorney General, in consultation with the Secretary of Health and Human Services, shall submit to the Committee on the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives a report on enhancing the interoperability of State prescription monitoring programs with other technologies and databases used for detecting and reducing fraud, diversion, and abuse of prescription drugs.
Inserted: (b) Contents.--The report required under subsection (a) shall include--
Inserted: (1) a discussion of the feasibility of making State prescription monitoring programs interoperable with other relevant technologies and databases, including--
Inserted: (A) electronic prescribing systems;
Inserted: (B) databases operated by the Drug Enforcement Agency;
Inserted: (C) electronic health records; and
Inserted: (D) pre-payment fraud-detecting analytics technologies;
Inserted: (2) an assessment of legal, technical, fiscal, privacy, or security challenges that have an impact on interoperability;
Inserted: (3) a discussion of how State prescription monitoring programs could increase the production and distribution of unsolicited reports to prescribers and dispensers of prescription drugs, law enforcement officials, and health professional licensing agencies, including the enhancement of such reporting through interoperability with other States and relevant technology and databases; and
Inserted: (4) any recommendations for addressing challenges that impact interoperability of State prescription monitoring programs in order to reduce fraud, diversion, and abuse of prescription drugs.
Original wording
At the end of title XI, add the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
SA 2145. Mr. PORTMAN submitted an amendment intended to be proposed by him to the bill S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes; which was ordered to lie on the table; as follows:
At the end of title XI, add the following:
Subtitle D--Interstate Drug Monitoring Efficiency and Data Sharing SECTION 1141. SHORT TITLE.
This subtitle may be cited as the “Interstate Drug Monitoring Efficiency and Data Sharing Act of 2012” or the “ID MEDS Act”.
SEC. 1142. NATIONAL INTEROPERABILITY STANDARDS.
(a) In General.--Not later than 1 year after the date of enactment of this Act, the Attorney General shall establish national interoperability standards to facilitate the exchange of prescription information across State lines by States receiving grant funds under--
(1) the Harold Rogers Prescription Drug Monitoring Program established under the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2002 (Public Law 107 77; 115 Stat. 748); and
(2) the Controlled Substance Monitoring Program established under section 399O of the Public Health Service Act (42 U.S.C. 280g 3).
(b) Requirements.--The Attorney General, in consultation with the Secretary of Health and Human Services, shall ensure that the national interoperability standards established under subsection (a)--
(1) implement open standards that are freely available, without cost and without restriction, in order to promote broad implementation;
(2) provide for the use of exchange intermediaries, or hubs, as necessary to facilitate interstate interoperability by accommodating State-to-hub and direct State-to-State communication;
(3) support transmissions that are fully secured as required, using industry standard methods of encryption, to ensure that Protected Health Information and Personally Identifiable Information (PHI and PII) are not compromised at any point during such transmission; and
(4) employ access control methodologies to share protected information solely in accordance with State laws and regulations.
SEC. 1143. STATE RECIPIENT REQUIREMENTS.
(a) Harold Rogers Prescription Drug Monitoring Program.--
(1) In general.--Not later than 1 year after the date on which the Attorney General establishes national interoperability standards under section 1142(a), a recipient of a grant under the Harold Rogers Prescription Drug Monitoring Program established under the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2002 (Public Law 107 77; 115 Stat. 748) shall ensure that the databases of the State comply with such national interoperability standards.
(2) Use of enhancement grant funds.--A recipient of an enhancement grant under the Harold Rogers Prescription Drug Monitoring Program established under the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 2002 (Public Law 107 77; 115 Stat. 748) may use enhancement grant funds to standardize the technology architecture used by the recipient to comply with the national interoperability standards established under section 1142(a).
(b) Controlled Substance Monitoring Program.--Section 399O(e) of the Public Health Service Act (42 U.S.C. 280g 3(e)) is amended by adding at the end the following:
“(5) Not later than 1 year after the date on which the Attorney General establishes national interoperability standards under section 1142(a) of the ID MEDS Act, the State shall ensure that the database complies with such national interoperability standards.”.
SEC. 1144. REPORT.
(a) In General.--Not later than 1 year after the date of enactment of this Act, the Attorney General, in consultation with the Secretary of Health and Human Services, shall submit to the Committee on the Judiciary of the Senate and the Committee on the Judiciary of the House of Representatives a report on enhancing the interoperability of State prescription monitoring programs with other technologies and databases used for detecting and reducing fraud, diversion, and abuse of prescription drugs.
(b) Contents.--The report required under subsection (a) shall include--
(1) a discussion of the feasibility of making State prescription monitoring programs interoperable with other relevant technologies and databases, including--
(A) electronic prescribing systems;
(B) databases operated by the Drug Enforcement Agency;
(C) electronic health records; and
(D) pre-payment fraud-detecting analytics technologies;
(2) an assessment of legal, technical, fiscal, privacy, or security challenges that have an impact on interoperability;
(3) a discussion of how State prescription monitoring programs could increase the production and distribution of unsolicited reports to prescribers and dispensers of prescription drugs, law enforcement officials, and health professional licensing agencies, including the enhancement of such reporting through interoperability with other States and relevant technology and databases; and
(4) any recommendations for addressing challenges that impact interoperability of State prescription monitoring programs in order to reduce fraud, diversion, and abuse of prescription drugs.
Legislative Activity
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Senate amendment agreed to: Amendment SA 2145 as modified agreed to in Senate by Unanimous Consent.
May 24, 2012
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Senate amendment agreed to: Amendment SA 2145 as modified agreed to in Senate by Unanimous Consent.
May 24, 2012
Senate amendment proposed (on the floor): Amendment SA 2145 proposed by Senator Harkin for Senator Portman.(consideration: CR S3555-3557)
May 24, 2012
Amendment SA 2145 proposed by Senator Harkin for Senator Portman. (consideration: CR S3555-3557) To facilitate the development of recommendations on interoperability standards to inform and facilitate the exchange of prescription information across State lines.
May 24, 2012
Amendment SA 2145 as modified agreed to in Senate by Unanimous Consent.
May 24, 2012
Senate amendment submitted
May 22, 2012