H.R.1132 - National All Schedules Prescription Electronic Reporting Act of 2005109th Congress (2005-2006)
|Sponsor:||Rep. Whitfield, Ed [R-KY-1] (Introduced 03/03/2005)|
|Committees:||House - Energy and Commerce|
|Committee Reports:||H. Rept. 109-191|
|Latest Action:||08/11/2005 Became Public Law No: 109-60. (TXT | PDF) (All Actions)|
This bill has the status Became Law
Here are the steps for Status of Legislation:
- Passed House
- Passed Senate
- To President
- Became Law
Summary: H.R.1132 — 109th Congress (2005-2006)All Bill Information (Except Text)
Public Law No: 109-60 (08/11/2005)
(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.