HR3015: The National All Schedules Prescription Electronic Reporting Act

The Issue :

Prescription medications are used very successfully to treat a variety of injuries, conditions and illnesses. Their high level of effectiveness can bring needed relief to people suffering from pain, anxiety or other various conditions. However, prescription drugs are also a common source of abuse. Prescription drug abuse is estimated by the Drug Abuse Warning Network to comprise almost a full third of drug abuse in the country and is on the rise. Statistics from the Center for Substance Abuse Prevention show:

• In 2000, 43% of drug overdoses in hospital emergency rooms were from misuse of prescription drugs.
• Over the past 15 years, the number of new abuses of prescription painkillers in those ages 12-25 has grown 5-fold to over 2 million in 2000.
• New misusers of prescribed tranquilizers increased 50% from 1999 to 2000 totaling over 1 million.

The Policy Approach :

In an effort to address the problem of prescription drug abuse, twenty-one states have implemented prescription drug monitoring programs. In a prescription drug monitoring program, dispensers (pharmacists) are required to provide a standard set of information to a state database when dispensing a controlled substance. Information typically includes DEA number of the dispenser and the practitioner, name and contact information for the patient, and information about the drug dispensed. The administrator of the state database can then alert appropriate authorities if data indicates possible abuse or diversion. The confidentiality of and access to the information is statutorily protected.

The strength of a monitoring program is that it allows a database administrator to detect if a specific individual is getting multiple prescriptions filled in multiple locations indicating possible prescription fraud. Further, it also allows the database administrator to detect if a specific practitioner has an extremely high volume of prescriptions of a specific drug or class of drugs also indicating possible prescription fraud. A monitoring program allows practitioners to query the database to determine if a patient has already obtained prescriptions for controlled substances.

While these programs have been effective, if a border state does not have a program, abusers can cross state lines to evade the monitoring program. This has been a particular problem for states like Kentucky that have numerous border states.

The Compromise :

Mr. Whitfield and Mr. Pallone (HR3015) and Mr. Norwood and Mr. Strickland (HR3870) have both introduced bills to increase the prevalence of prescription drug monitoring so that abusers are not able to evade the system by crossing state borders. The amendment in the nature of a substitute is a compromise of the two bills.

The amendment in the nature of a substitute provides for the Secretary of Health and Human Services to set up a formula grant to provide funding for the establishment and implementation of state monitoring programs. The intent of the amendment is to provide adequate funding to fully fund the state programs. To create an incentive for states to participate in the program, the Secretary shall give preference in awarding drug abuse grants to those states that establish prescription drug monitoring programs. Further, the amendment requires a report to Congress on the number of states that have established programs so Congress can determine if additional incentives are appropriate.

The amendment specifies the standards a state monitoring program must meet in order to qualify for federal funding. Dispensers are required to report dispensing of schedule II, III, and IV controlled substances to the state monitoring program within one week. The amendment also requires the Secretary report on the feasibility of moving to real-time disclosure.

The amendment specifies the standard set of information reported to a state database. Information to be reported includes DEA number of the dispenser and the practitioner, name and contact information for the patient, and information about the drug dispensed.

The amendment requires that states automatically share information if either the patient or the practitioner are from another state. Interoperability between state monitoring programs will eliminate the state border issue that plagues certain state programs today.

The amendment specifies conditions for the provision of information by a state monitoring program. A state may provide information from the database to a practitioner or pharmacist who certifies it is for the purpose of treating a bona fide patient. A state may provide information from the database to local, state or federal law enforcement agents that certify the request is related to an individual investigation of abuse. A state may provide de-identified information to an agent of the Department of Health and Human Services, a state Medicaid program, a state health department, or the DEA for research purposes.

The amendment requires the state monitoring program to limit the information provided to the minimum necessary to meet the request and applies the requirements under HIPAA to transfers of information under this bill unless it is preempted by the requirements of this bill.