National All Schedules Prescription Electronic Reporting Act of 2005

Bill: 109-s-518
Sponsor: Sen. Sessions, Jeff [R-AL]
Introduced: 2005-03-03 in the Senate
Policy area: Health
Subjects: Communication in medicine
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
Fines (Penalties)
Government Operations and Politics
Government paperwork
Governmental investigations
Grants-in-aid
Health information systems
Identification devices
Law
Licenses
Medical personnel
Medical records
Medical research
Medication abuse
Pharmacists
Physicians
Science, Technology, Communications
Standards

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 grants for terms of 18 months 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; 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; and (2) 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: 2005-07-29
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 amount, which includes a ratio of pharmacies in a state to the number of pharmacies in all states.
 
Requires the Secretary to identify 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 be approved for a grant, to: (1) submit a grant application that includes an agreement to adopt health information interoperability standards and penalties for the unauthorized use and disclosure of information; (2) have enacted legislation or regulations permitting the implementation of such a monitoring program and the imposition of appropriate penalties; and (3) describe how it will achieve interoperability with any existing 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) interoperability of state programs; (3) the feasibility of implementing a real-time electronic controlled substance monitoring program; (4) privacy protections for program information; (5) the feasibility of implementing technological alternatives to centralized data storage; and (6) state penalties for unauthorized use and disclosure of program information.
 
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: 2005-07-29
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 187.
action_date: 2005-07-29
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-117.
action_date: 2005-07-29
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Enzi with an amendment in the nature of a substitute. With written report No. 109-117.
action_date: 2005-05-25
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
action_date: 2005-03-03
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2005-03-03
text: Introduced in Senate