National All Schedules Prescription Electronic Reporting Act of 2005

Bill: 109-hr-1132
Sponsor: Rep. Whitfield, Ed [R-KY-1]
Introduced: 2005-03-03 in the House
Policy area: Health
Subjects: Access to health care
Civil Rights and Liberties, Minority Issues
Clinical trials
Communication in medicine
Congress
Congressional reporting requirements
Crime and Law Enforcement
Data banks
Drug abuse
Drug abuse prevention
Drug law enforcement
Drug traffic
Drugs
Economics and Public Finance
Electronic data interchange
Electronic government information
Government Operations and Politics
Government paperwork
Governmental investigations
Grants-in-aid
Health information systems
Identification devices
Law
Licenses
Medical personnel
Medical records
Medical research
Medical statistics
Medication abuse
Pain
Pharmacies
Pharmacists
Physicians
Right of privacy
Science, Technology, Communications
Standards
State laws

Summary:
action_date: 2005-03-03
text: 
National All Schedules Prescription Electronic Reporting Act of 2005 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to award one-year grants to each approved State to establish or improve a State controlled substance monitoring program. Requires the Secretary to develop minimum standards for States to ensure security of information collected and to recommend penalties for the provision or use of information in violation of applicable laws or regulations.
 
Requires each approved State to: (1) require dispensers to report to the State within one week of each dispensing of a controlled substance to an ultimate user or research subject; and (2) establish and maintain an electronic searchable database containing the information reported. Allows a State to provide information from the database in response to certain requests by practitioners, law enforcement, narcotics control, licensure, disciplinary, or program authorities, the controlled substance monitoring program of another State, and agents of the Department of Health and Human Services (HHS), State Medicaid programs, State health departments, or the Drug Enforcement Administration (DEA).
 
Requires the Secretary to: (1) specify a uniform electronic format for the reporting, sharing, and provision of information under this Act; (2) give preference to approved States in awarding any grants related to drug abuse; and (3) study and report to Congress on such programs, including on interoperability between programs, the feasibility of a real-time electronic controlled substance monitoring program, privacy protections, and technological alternatives to centralized data storage.

action_date: 2005-07-27
text: 
National All Schedules Prescription Electronic Reporting Act of 2005 - (Sec. 3) Amends the Public Health Service Act to require the Secretary of Health and Human Services to award grants to establish a controlled substance monitoring program in each state or to improve existing state programs. Sets forth a formula for determining grant amounts, which includes a ratio of pharmacies in a state to the number of pharmacies in all states.
 
Requires the Secretary to establish minimum requirements for criteria to be used by states for information security, uniform electronic formats for reporting information, database access and accuracy, and the use and disclosure of information.
 
Requires a state to submit a grant application that includes: (1) an agreement to adopt health information interoperability standards; (2) penalties for the unauthorized use and disclosure of information; (3) information that demonstrates that the state has enacted legislation or regulations permitting the implementation of such a monitoring program and the imposition of penalties; and (4) a description of the manner by which interoperability will be achieved with a program in a bordering state. Provides for the return of grant funds if a state ceases implementation or improvement of its program.
 
Requires an approved state to: (1) require a dispenser to report within one week of each dispensing of a controlled substance to an ultimate user; (2) report information in an electronic format specified by the Secretary; (3) establish and maintain a searchable electronic database; and (4) take security measures to protect database integrity. Allows the Secretary to make certain exceptions to the reporting requirements.
 
Allows a state to disclose information from the database and summary statistics in response to certain requests by: (1) medical practitioners; (2) law enforcement, narcotics control, licensure, disciplinary, or program authorities; (3) the controlled substance monitoring program of another state; and (4) agents of the Department of Health and Human Services (HHS), state Medicaid programs, state health departments, or the Drug Enforcement Agency (DEA).
 
Requires an approved state to establish a program to notify practitioners and dispensers of information that will help identify and prevent the unlawful diversion or misuse of controlled substances. Allows a state to notify the appropriate authorities if information in the database indicates such diversion or abuse.
 
Directs the Secretary to specify a uniform electronic format for the reporting, sharing, and disclosure of information.
 
Requires the Secretary to: (1) determine whether the implementation of such monitoring programs has had a substantial negative impact on patient access to treatment or enrollment in research or clinical trials; and (2) identify additional appropriate categories of exclusion from reporting to the extent that there has been such a negative impact.
 
Directs the Secretary to study and report to Congress on such monitoring programs, including: (1) state progress in implementing such programs; (2) the effect of such programs on inappropriate use, abuse, or diversion of controlled substances or on access to appropriate pain care; (3) interoperability of state programs; (4) the feasibility of implementing a real-time electronic controlled substance monitoring program; (5) privacy protections for program information; (6) the feasibility of implementing technological alternatives to centralized data storage; and (7) state penalties for unauthorized use and disclosure of program information.
 
Requires the Secretary to give preference to approved states in awarding any competitive grants related to drug abuse.
 
Allows a state to establish an advisory council to assist in the establishment, implementation, or improvement of such a monitoring program.
 
Authorizes appropriations.

action_date: 2005-07-29
text: 

(This measure has not been amended since it was passed by the House on July 27, 2005. The summary of that version is repeated here.)

 
National All Schedules Prescription Electronic Reporting Act of 2005 - (Sec. 3) Amends the Public Health Service Act to require the Secretary of Health and Human Services to award grants to establish a controlled substance monitoring program in each state or to improve existing state programs. Sets forth a formula for determining grant amounts, which includes a ratio of pharmacies in a state to the number of pharmacies in all states.
 
Requires the Secretary to establish minimum requirements for criteria to be used by states for information security, uniform electronic formats for reporting information, database access and accuracy, and the use and disclosure of information.
 
Requires a state to submit a grant application that includes: (1) an agreement to adopt health information interoperability standards; (2) penalties for the unauthorized use and disclosure of information; (3) information that demonstrates that the state has enacted legislation or regulations permitting the implementation of such a monitoring program and the imposition of penalties; and (4) a description of the manner by which interoperability will be achieved with a program in a bordering state. Provides for the return of grant funds if a state ceases implementation or improvement of its program.
 
Requires an approved state to: (1) require a dispenser to report within one week of each dispensing of a controlled substance to an ultimate user; (2) report information in an electronic format specified by the Secretary; (3) establish and maintain a searchable electronic database; and (4) take security measures to protect database integrity. Allows the Secretary to make certain exceptions to the reporting requirements.
 
Allows a state to disclose information from the database and summary statistics in response to certain requests by: (1) medical practitioners; (2) law enforcement, narcotics control, licensure, disciplinary, or program authorities; (3) the controlled substance monitoring program of another state; and (4) agents of the Department of Health and Human Services (HHS), state Medicaid programs, state health departments, or the Drug Enforcement Agency (DEA).
 
Requires an approved state to establish a program to notify practitioners and dispensers of information that will help identify and prevent the unlawful diversion or misuse of controlled substances. Allows a state to notify the appropriate authorities if information in the database indicates such diversion or abuse.
 
Directs the Secretary to specify a uniform electronic format for the reporting, sharing, and disclosure of information.
 
Requires the Secretary to: (1) determine whether the implementation of such monitoring programs has had a substantial negative impact on patient access to treatment or enrollment in research or clinical trials; and (2) identify additional appropriate categories of exclusion from reporting to the extent that there has been such a negative impact.
 
Directs the Secretary to study and report to Congress on such monitoring programs, including: (1) state progress in implementing such programs; (2) the effect of such programs on inappropriate use, abuse, or diversion of controlled substances or on access to appropriate pain care; (3) interoperability of state programs; (4) the feasibility of implementing a real-time electronic controlled substance monitoring program; (5) privacy protections for program information; (6) the feasibility of implementing technological alternatives to centralized data storage; and (7) state penalties for unauthorized use and disclosure of program information.
 
Requires the Secretary to give preference to approved states in awarding any competitive grants related to drug abuse.
 
Allows a state to establish an advisory council to assist in the establishment, implementation, or improvement of such a monitoring program.
 
Authorizes appropriations.

action_date: 2005-08-11
text: 

(This measure has not been amended since it was passed by the House on July 27, 2005. The summary of that version is repeated here.)

 
National All Schedules Prescription Electronic Reporting Act of 2005 - (Sec. 3) Amends the Public Health Service Act to require the Secretary of Health and Human Services to award grants to establish a controlled substance monitoring program in each state or to improve existing state programs. Sets forth a formula for determining grant amounts, which includes a ratio of pharmacies in a state to the number of pharmacies in all states.
 
Requires the Secretary to establish minimum requirements for criteria to be used by states for information security, uniform electronic formats for reporting information, database access and accuracy, and the use and disclosure of information.
 
Requires a state to submit a grant application that includes: (1) an agreement to adopt health information interoperability standards; (2) penalties for the unauthorized use and disclosure of information; (3) information that demonstrates that the state has enacted legislation or regulations permitting the implementation of such a monitoring program and the imposition of penalties; and (4) a description of the manner by which interoperability will be achieved with a program in a bordering state. Provides for the return of grant funds if a state ceases implementation or improvement of its program.
 
Requires an approved state to: (1) require a dispenser to report within one week of each dispensing of a controlled substance to an ultimate user; (2) report information in an electronic format specified by the Secretary; (3) establish and maintain a searchable electronic database; and (4) take security measures to protect database integrity. Allows the Secretary to make certain exceptions to the reporting requirements.
 
Allows a state to disclose information from the database and summary statistics in response to certain requests by: (1) medical practitioners; (2) law enforcement, narcotics control, licensure, disciplinary, or program authorities; (3) the controlled substance monitoring program of another state; and (4) agents of the Department of Health and Human Services (HHS), state Medicaid programs, state health departments, or the Drug Enforcement Agency (DEA).
 
Requires an approved state to establish a program to notify practitioners and dispensers of information that will help identify and prevent the unlawful diversion or misuse of controlled substances. Allows a state to notify the appropriate authorities if information in the database indicates such diversion or abuse.
 
Directs the Secretary to specify a uniform electronic format for the reporting, sharing, and disclosure of information.
 
Requires the Secretary to: (1) determine whether the implementation of such monitoring programs has had a substantial negative impact on patient access to treatment or enrollment in research or clinical trials; and (2) identify additional appropriate categories of exclusion from reporting to the extent that there has been such a negative impact.
 
Directs the Secretary to study and report to Congress on such monitoring programs, including: (1) state progress in implementing such programs; (2) the effect of such programs on inappropriate use, abuse, or diversion of controlled substances or on access to appropriate pain care; (3) interoperability of state programs; (4) the feasibility of implementing a real-time electronic controlled substance monitoring program; (5) privacy protections for program information; (6) the feasibility of implementing technological alternatives to centralized data storage; and (7) state penalties for unauthorized use and disclosure of program information.
 
Requires the Secretary to give preference to approved states in awarding any competitive grants related to drug abuse.
 
Allows a state to establish an advisory council to assist in the establishment, implementation, or improvement of such a monitoring program.
 
Authorizes appropriations.


Legislative actions:
action_date: 2005-08-11
text: Became Public Law No: 109-60.
action_date: 2005-08-11
text: Became Public Law No: 109-60.
action_date: 2005-08-11
text: Signed by President.
action_date: 2005-08-11
text: Signed by President.
action_date: 2005-08-04
text: Presented to President.
action_date: 2005-08-04
text: Presented to President.
action_date: 2005-08-02
text: Message on Senate action sent to the House.
action_date: 2005-07-29
text: Cleared for White House.
action_date: 2005-07-29
text: Passed Senate without amendment by Unanimous Consent. (consideration: CR S9584)
action_date: 2005-07-29
text: Passed/agreed to in Senate: Passed Senate without amendment by Unanimous Consent.(consideration: CR S9584)
action_date: 2005-07-28
text: Received in the Senate, read twice.
action_date: 2005-07-27
text: Motion to reconsider laid on the table Agreed to without objection. (consideration: CR S9584)
action_date: 2005-07-27
text: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H6681-6683)
action_date: 2005-07-27
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H6681-6683)
action_date: 2005-07-27
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 1132.
action_date: 2005-07-27
text: Considered under suspension of the rules. (consideration: CR H6681-6686)
action_date: 2005-07-27
text: Mr. Deal (GA) moved to suspend the rules and pass the bill, as amended.
action_date: 2005-07-27
text: Placed on the Union Calendar, Calendar No. 115.
action_date: 2005-07-27
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 109-191.
action_date: 2005-07-27
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 109-191.
action_date: 2005-07-20
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2005-07-20
text: Committee Consideration and Mark-up Session Held.
action_date: 2005-06-22
text: Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote.
action_date: 2005-06-22
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2005-03-22
text: Referred to the Subcommittee on Health.
action_date: 2005-03-03
text: Referred to the House Committee on Energy and Commerce.
action_date: 2005-03-03
text: Introduced in House
action_date: 2005-03-03
text: Introduced in House

Enacted as: number: 109-60