November 29, 2007

Recommendations from Electronic Health Records Workgroup to AHIC, as revised:

BACKGROUND

The Institute of Medicine (IOM) characterized high quality care as being safe, effective, efficient, timely, patient centric, and equitable. Numerous studies have demonstrated that e-prescribing systems can support these aims by providing ready and immediate access to information in a number of ways: information about allergies and possible drug/drug interactions improves safety; correct dosing improves both safety and effectiveness; generic medications and other less costly alternatives improve cost effectiveness in medication management.

In spite of these benefits, e-prescribing has not been widely adopted by the delivery system, particularly by physicians and other clinicians who provide Part B services. Recent advances in standards and e-prescribing regulation show that there is growing opportunity to move decisively in support of widespread adoption of e-prescribing among physicians and other clinicians.

RECOMMENDATIONS:

Recommendation 1.0: The Secretary of Health and Human Services should seek authority from Congress to mandate e-prescribing, pursuant to standards defined by the Medicare Modernization Act (MMA) for e-prescribing ¹. This authority should be specific to e-prescribing and not extend to other health care processes.

The EHR Workgroup also recognized that the e-prescribing standards are not yet complete, safety issues are not completely explored, physician and clinician e-prescribing must be supported by e-prescribing capability among pharmacies, and that mechanisms must be in place to assure that e-prescribing systems meet specified criteria and standards.

Recommendation 2.0: Prior to exercising authority to mandate e-prescribing, the following requirements should be met:

2.1: Flexibility must be maintained, since mandated e-prescribing may not be applicable to all patients, all prescriptions, and all circumstances.

2.2: With appropriate Congressional authority, all pharmacies and pharmacy benefit managers must participate in such mandatory e-prescribing.

Discussion: At present, 30% of outpatient pharmacies are not enabled for e-prescribing. Requirements for e-prescribing by physicians and other clinicians will be most effective if accompanied by similar requirements for all pharmacies, including retail, mail, specialty, and long term care. At this time, however, pharmacies are not considered Part B providers and their participation in e-prescribing programs under the MMA is considered voluntary. Possible options include: a) The Centers for Medicare and Medicaid Services’ (CMS) contracts with Pharmacy Drug Plans and Medicare Advantage Plans include language mandating e-prescribing in the pharmacies with which they, in turn, contract; (b) Congressional Action.

2.3: All prescriptions must be electronically transmissible to the pharmacy of the patient’s choice.

Discussion: Studies suggest that 11% of prescriptions are for controlled substances, but current Drug Enforcement Administration (DEA) regulation precludes e-prescribing for some controlled substances and some states have specific regulation on use of paper prescriptions in triplicate form for certain controlled substances. This situation imposes administrative burden on prescribers to maintain dual systems for medication management: paper-based as well as electronic records. Moreover, it perpetuates the potential for lapses in the security of controlled substances associated with paper-based prescriptions. Renewed efforts are underway in the DEA to enable e-prescribing of controlled substances, and the National Governor’s Association (NGA), through a contract with the Office of the National Coordinator for Health Information Technology (ONC), is addressing the variances in state based regulations with respect to e-prescribing. Both situations have yet to come to fruition but must be resolved prior to any mandate for e-prescribing. The DEA and the NGA should report quarterly to the Community on progress in this area.

2.4: The Certification Commission for Healthcare Information Technology (CCHIT) should develop a certification process for e-prescribing systems that are: (i) interoperable with certified EHRs; (ii) include clinical decision supports to improve safety, efficacy, and efficiency; and (iii) can be extended to integrate with fully functional EHR systems, thus assuring that the e-prescribing investment is a step towards adoption of certified EHRs.

Discussion: EHRs certified in 2008 by the CCHIT will include interoperable e-prescribing capabilities with clinical decision supports and would fulfill these requirements for e-prescribing. EHRs certified before 2008 must be required to come into compliance with these 2008 e-prescribing requirements before e-prescribing becomes mandatory. Current free standing, non-interoperable e-prescribing systems cannot take advantage of the full set of clinical information necessary to provide patient specific decision support and will likely become replaced investments as the importance of the criteria for interoperability, extensibility, and patient safety features are recognized.

2.5: With the appropriate Congressional authority, CMS should develop and institute incentives for both physician/clinician and pharmacy adoption of certified EHRs and/or certified e-prescribing systems early in 2008 before authority to mandate e-prescribing can be granted and exercised.

Discussion: These incentives should reflect the return on investment (ROI) that accrues to various benefactors from e-prescribing and recognize that 50% of prescriptions are written by 15% of physicians.

2.6: Continue the successful pilot work undertaken by CMS to make ready important emerging standards, and supplement that work to address sustainability issues such as practice workflow, usability, clinical decision support, and safety surveillance.

2.7: Pursuant to Patient Safety legislation of 2005, the Agency for Healthcare Research and Quality (AHRQ) should designate Patient Safety Organizations to monitor and address possible patient issues that may arise as a result of e-prescribing, and patient safety criteria should be included in an e-prescribing certification process.

Discussion: In order to assure that e-prescribing systems do not decrease patient safety, the CCHIT certification process should include criteria designed to assess and certify the safety of e-prescribing systems, based on a description of hazards, how those hazards are eliminated or controlled, and a justification that the safety of the system is adequate as designed.

 

¹ The definition of e-prescribing includes both the description in Regulation 42 CFR 423.159, and recognition of the goals of patient safety, efficacy, and efficiency:

E-prescribing means transmission using electronic media, of prescription or prescription-related information between a prescriber, dispenser, pharmacy benefit manager, or health plan, either directly or through an intermediary, including an e-prescribing network. E-prescribing includes, but is not limited to, two-way transmissions between the point of care and the dispenser.

Prescription-related information means information regarding eligibility for drug benefits, medication history, or related health or drug information for Part D eligible individuals.

The goal of e-prescribing is to provide safer care, more effective care with better outcomes, and more cost efficient health care through the provision and transmission of appropriate electronic health information at the point of care