Medical Device Daily Washington Editor

WASHINGTON — As part of the Department of Health and Human Services' (HHS) push toward a national system of electronic health records, the department recently issued proposed regulations on electronic prescriptions — termed “e-prescribing“ — for Medicare.

e-prescribing enables a physician to transmit a prescription electronically to the patient's choice of pharmacy. It also enables physicians and pharmacies to obtain from drug plans information about the patient's eligibility and medication history.

The proposed rules were released seven months ahead of the deadline set by the Medicare Modernization Act (MMA) and would take effect with the prescriptions drug benefit taking effect in January of 2006. The rules were made following recommendations by the HHS's National Committee on Vital and Health Statistics (NCVHS), a group made up of public- and private-sector industry and healthcare professionals, HHS said.

“These proposed e-prescription rules would set standards to help Medicare, physicians and pharmacies take advantage of new technology that can improve the health care of seniors and persons with disabilities,“ said HHS Secretary Mike Leavitt.

Mark McClellan, MD, administrator for the Centers for Medicare & Medicaid Services (CMS; Baltimore), said the Bush administration and the agency were “committed to widespread use of e-prescribing as quickly as possible.“

HHS said it believes that e-prescribing will improve patient safety and reduce avoidable healthcare costs by decreasing prescription errors due to hard-to-read physician handwriting and by automating the process of checking for drug interactions and allergies.

e-prescribing also is intended to ensure that patients and health professionals have the best and latest medical information at hand when they make important decisions about choosing medicines, and enabling beneficiaries to get the most benefits at the lowest cost, according to HHS.

The proposed e-prescribing regulations would create standards for transactions between prescribers and dispensers for new prescriptions, prescription refill request and response, prescription change request and response, prescription cancellation request and response, and related messaging and administrative transactions.

Regulations also would cover eligibility and benefits inquiries and responses between drug prescribers and prescription drug plans, in addition to eligibility and benefits inquiries and responses between dispensers and Medicare Part D sponsors.

HHS is proposing that additional electronic information can be used in conjunction with these “foundation“ standards, to provide more support for using drugs safely and effectively.

“This kind of public-private collaboration is the most effective way for Medicare to help lead the way to an effective electronic healthcare system,“ McClellan said. “We're going to take further collaborative steps to enhance our support for e-prescribing as quickly as possible.“

NCVHS was empowered by the MMA to develop recommendations for uniform standards for e-prescribing to promote patient safety and quality healthcare. From March to September 2004, NCVHS said it received testimony from 65 witnesses and other industry experts, including all stakeholder groups identified in the MMA, as well as e-prescribing networks, demonstration projects, software developers and consumer advocacy organizations.

Additional standards will be tested through a pilot project and recommended for adoption in a final rule to be issued no later than April 2008. Participation by physicians in e-prescribing will be optional, but the establishment of standards and steps to encourage the adoption of effective e-prescribing programs will make e-prescribing more attractive, HHS said.

The MMA calls for a pilot project to test e-prescribing standards for when there is no adequate industry experience before their adoption by CMS. The agency will solicit applications from physicians, physician groups, hospitals, prescription drug plan sponsors, Medicare Advantage or-ganizations and pharmacies.

The department hopes that these standards could provide for transmission of medical history, alerts to adverse drug interactions, and suggestions for lower-cost, therapeutically equivalent alternative medications.

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