House Passes Drug Monitoring
Bill, Authorizes Grants for State Programs
Michael Scott, J.D., Director
Governmental and Legal Affairs
n
October 5, the House of Representatives passed,
by voice vote, H.R. 3015, the National All Schedules
Prescription Drug Reporting Act (NASPER), sponsored
by Representatives Charles Norwood (R-GA) and Frank
Pallone, Jr. (D-NJ). If enacted into law, the bill
would authorize federal grants totaling $95 million
through FY2010 to states agreeing to establish and
implement a program for monitoring of Schedule II,
III and IV controlled substances.
Action by the Senate in the 108th Congress authorizing
such grants is unlikely, but passage of H.R. 3015
by the House sets the stage for legislation being
sent to the president next year.
H.R. 3015 is an anti-drug abuse measure worked out
in the Energy and Commerce Committee as a compromise
between a bill that would have established a federal
monitoring program and one that would merely support
state monitoring programs. Although 21 states currently
maintain drug monitoring programs, the programs
differ significantly in their reach and effectiveness,
and no method currently exists for states to share
monitoring information.
Under the new House bill, states receiving a federal
grant must require dispensers of controlled substances
to the ultimate user to report such dispensing,
with certain exceptions, to the state monitoring
agency within one week in federally specified electronic
form. Exceptions to the reporting requirement include
direct administration of a controlled substance
to the body of an ultimate user and dispensing of
a limited quantity of drug needed for treatment
for 48 hours or less.
Reports to the monitoring agency must include the
Drug Enforcement Administration number of the dispenser
and prescriber of the drug, the name and address
of the patient, the name and quantity of the drug
dispensed and other information related to the prescription.
Upon receipt of a report showing prescribing by
a practitioner or for a patient located in another
state operating a federally supported monitoring
program, the receiving state agency must automatically
send the report to the other state.
States participating in the support program are
required to maintain an electronic database for
maintaining reported information with safeguards
to ensure accuracy and completeness of information
and to protect the integrity of and access to the
database. The bill authorizes the state agency to
provide information from the database to a practitioner
who certifies that the request is sought for purposes
of treating or evaluating a bona fide current patient;
information also is to be provided to a law enforcement
agency that certifies that the information is related
to a drug-abuse investigation, to certain federal
or state agencies engaged in research, or any agent
of another participating state agency seeking to
implement a monitoring program.
Various provisions are contained in the bill to
ensure the protection of patient privacy, except
to the extent necessary to carry out the purposes
of the bill. The bill also calls for a federal study
two years after enactment to determine progress
of the states in establishing a monitoring program,
analyze privacy protections in place in the state
programs and determine the feasibility of a real-time
controlled substances monitoring program.
Patient
Safety Bill Stalled at Recess
s of this writing in mid-October, it appears that
efforts have failed to find a mechanism for Congress
to pass an agreed patient safety reporting measure
even though both the Senate and House have passed
similar bills establishing a mechanism for the reporting
of adverse events on a confidential basis. Efforts
to persuade the House leadership simply to bring the
Senate bill to a vote in the House, originally thought
to provide a means of resolving the matter, appear
to have failed. Congress recessed on October 8 but
will return for a lame duck session in November. It
is possible, but not likely, that an agreed bill could
have been worked out and adopted by then.
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