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Executive Summary

REP. STARK's ELECTRONIC TRACING BILL WILL BE PROPOSED AS 10- STATE PILOT project soon after the House returns from Easter recess on April 28. House Ways & Means/Health subcommittee Chairman Stark (D-Calif.) will introduce legislation directing HHS to provide funding for up to 10 states to implement or improve computerized programs to trace prescribing of Schedule II-IV substances. The measure would allot up to $20 mil. in FY 1993 Public Health Service funds for the demonstrations plus allow imposition of fees for certain registrants under the Controlled Substances Act. Rep. Brewster (D-Okla.), a pharmacist before joining Congress, is expected to cosponsor the measure. States participating in the program would be required to set up a central repository for data on scheduled substances -- specifically, the prescriber's DEA number; the pharmacy's National Association of Boards of Pharmacy number; a unique indentifier patient number, coded to ensure confidentiality; patient birth date; drug National Drug Code, quantity and dosage units; patient's home state, and the physician medical specialty. The specialty identification is seen as a way to avoid audits of physicians who may be appropriately writing large numbers of scripts for controlled substances, for example, oncologists providing pain medications. Listing the home state of the patient is intended to help spot instances of patients who go to neighboring states to obtain additional quantities of a controlled substance, while the birth date is intended to identify possible misuse of drugs by certain age groups. Stark has been working on the bill for more than a year and the measure has gone through a number of evolutions. For example, the bill is now both optional to states and based on electronic tracing. Earlier in the process, Stark had considered mandatory and triplicate paper prescription approaches. When he introduces the bill on the House floor, Stark is expected to note an April 1 letter from DuPont Merck describing its experience with Oklahoma's electronic tracing program. With the Oklahoma program, there was little decrease in overall prescribing, in "contrast to a significant drop in prescribing for our products that we have experienced when a multiple copy prescription program has been implemented." This trend suggested a large effect on even legitimate prescribing, the letter says. It adds that the Oklahoma program appears to have resulted in identifying individuals who are "doctor shoppers" for controlled drugs. In addition, Stark appears to be depicting electronic tracing as part of a broader quality of care effort rather than a policing action against drug diversion. Stark has begun to position the bill as an extension of drug utilization review programs, and also is linking the initiative to current activities on medical outcomes research and practice parameters. For example, the draft lists four purposes for which states may use the demonstration funds: developing and implementing electronic prescription accountability programs; supplementing the establishment of the state's Medicaid electronic claims management system; providing for a transition from paper multiple copy Rx programs (now in place in 10 states); and supplementing the "implementation of guidelines developed by the Agency for Health Care Policy Research and accepted drug utilization review principles for the purposes of improving patient care and physician prescribing practices." ACHPR has issued guidelines on the management of post- operative pain and on urinary incontinence, and several more guidelines are due out this year ("The Pink Sheet" March 30, p. 11). Stark's use of the term "practice parameters" may reflect his efforts to work with organized medicine in developing an acceptable bill; that is the American Medical Association's preferred term for guidelines based on medical outcomes research. The draft bill also would require participating states to set up two boards, a Prescription Accountability and Patient Care Improvement Board and a Practice Parameter Advisory Panel. Regarding the Medicaid tie-in, the Stark measure, if enacted any time soon, could dovetail with federal Medicaid requirements to establish state DUR programs. The phase-in of those requirements will begin in 1993. Under the draft legislation, HHS would make awards after considering each state applicant's problems with diversion and illegal or inappropriate prescribing, the number of residents addicted to controlled substances and the "undertreatment of specialized medical needs." In states chosen for the demonstrations, controlled substances may not be dispensed unless reported to the central repository, generally via computer systems. Pharmacies without "reasonable access to electronic submission equipment" may submit the information within 14 days. Other provisions would require states to take several steps to protect patient confidentiality data. Among these, patient identifiers generally would be purged from central repository records after two years.

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