If the federal government mandates the use of your product or service, it's a good thing. A very good thing. A lucrative thing. In late January, HHS did nearly that for information technology vendors who sell electronic prescribing tools.
On Jan. 27, new HHS Secretary Mike Leavitt announced the release of a first set of proposed, final "foundation" standards for Medicare electronic prescribing.
The goal is to ready the $295 billion-a-year Medicare program for e-prescribing before rolling out the Part D prescription drug benefit in 2006 to an estimated 29 million participants.
The proposed electronic prescribing standards cover portions of the nitty-gritty of data transmission for new and refill e-prescriptions written by physicians and other providers, patient eligibility inquiries and responses. They include three standards already in use, two developed by the National Council for Prescription Drug Programs -- a private-sector, standard-setting organization specifically targeting prescription drugs -- and another developed by the Accredited Standards Committee X12, a broader industry standard-setting group.
The standards cover data moving between prescribers and pharmacies and between pharmacies and payers.
HHS also asked for public comment on standards for checking comportment of a prescription with a drug formulary and a patient's medication history. These standards have been submitted to the council by RxHub, a consortium formed by three pharmacy-benefit management companies.
This first group of Medicare standards were deemed "foundation standards" and put on a fast track for final approval because they are already being used within the healthcare industry outside the Medicare program and "adequate industry experience exists" with their use, according to the proposed rule.
The standards will pre-empt various state e-prescribing laws that conflict with the federal law. The public comment period on the standards began Feb. 4 and runs for 60 days. The goal for adoption of these first foundation standards is before Sept. 1 of this year with compliance required by Jan. 1, 2006.
The government action was generally well-received by industry experts, who see their impact extending beyond the Medicare program as the nation attempts to electrify the movement of more than 3.1 billion prescriptions written each year, and increase the numbers of e-prescribers well beyond the estimated 5% to 18% of total prescribers today.
The government estimates the adoption of these rules would spark a 10% annual increase in the number of e-prescribers over the next five years. It also cites a study by the Center for Information Technology Leadership which claims that e-prescribing would eliminate nearly 2.1 million adverse drug events each year.
"We definitely see that as a great step forward," says Laura Adams, executive director of the Rhode Island Quality Institute, which has 350 physicians participating in a statewide e-prescribing program. "The more we see standards promulgated the better."
Ken Kizer, M.D., is president and chief executive officer of the National Quality Forum, which recently endorsed 22 quality standards, including one on healthcare IT and another on patient safety, which both had prescription-drug safety as a key component. Since e-prescrib-ing is touted as one way to reduce adverse drug events, Kizer says there is "definitely a consistency" between improving quality and the federal standards initiative.
"Moving on e-prescribing is a good step forward," he says.
Medicare drug plan sponsors, including Medicare HMOs, must comply with final federal e-prescribing standards and support e-prescribing when those rules go into effect.
Physicians, other prescribers and pharmacists are not required to write or handle electronic prescriptions under these proposed rules, but if they do, they too must comply with e-prescribing guidelines once they are in place.
In the short run, that won't present a problem for physicians currently using e-prescribing systems, many of which are configured to run on handheld computers such as iPaqs and Palm Pilots. The proposed federal standards mirror what already has been developed by the private sector and are in use today, according to the CMS. Vendors of their systems will have to keep up with new standards as they are set, however.
Frank Rhie, M.D, is chief medical officer for Alteer Corp., the maker of a suite of electronic medical records and practice management software systems that includes an e-prescribing tool. Rhie says the new federal regulations are "a good sign" for a couple of reasons. One, they indicate the government is interested in moving forward with healthcare IT in general, and two, the new standards ensure that healthcare IT developers will work on interoperability as their products and the IT infrastructure develop in the future (See Fast Forward, p. 4).
"Obviously, interoperability is a big buzzword these days," Rhie says, but there remains a technology gap to accommodate direct interconnectivity on what Rhie calls "the last mile" of e-prescribing -- the connection between office-based physicians and neighborhood pharmacies.
Assisting in that effort is SureScripts, a not-for-profit corporation based in Alexandria, Va. SureScripts was founded in 2001 by the National Association of Chain Drug Stores and the National Community Pharmacists Association to promote e-prescribing.
Kevin Hutchinson, SureScripts' CEO, said 85% of the 55,000 U.S. pharmacies have SureScripts software installed. Well over a third of them have the SureScripts system turned on. Those pharmacies, which are concentrated in urban areas, handle roughly 50% of all prescriptions, he says. "I have to take my hat off to CMS for taking the time and making the effort and taking into account what the industry has been doing," Hutchinson says.
"It could have gone the other way. They could have tried to reinvent the wheel. It was nice to see them recognize the amount of progress the industry has made and take that into account. That doesn't always happen with government. I think they did a good thing," he says.
The proposed e-prescribing rules were mandated by the 2003 Medicare Modernization Act, which also created the Medicare drug benefit. The act directed the National Committee on Vital and Health Statistics to recommend to HHS e-prescribing standards for use in the ambulatory-care setting.
The law requires pilot testing of proposed "initial" standards for which industry experience is lacking but also provides an exception for proposed "final" standards, or those standards the HHS secretary deems to have gained widespread industry acceptance.
The MMA mandates that payers participating in the Medicare drug program be ready to receive e-prescriptions. Physicians and pharmacies are not required to use e-prescribing with Medicare patients, but if they do they must follow standards then in effect.
The law allows the secretary to push those accepted standards on an accelerated timetable in a proposed final rule, which he did with this first group.
In September 2004, the committee sent a 16-page letter to then-HHS Secretary Tommy Thompson, including recommendations for both foundation standards that could be fast-tracked and long-term recommendations of other standards that could require pilot testing.
Karen Trudel, acting director of the CMS Office of HIPAA Standards, says the committee is working on further recommendations, which are on the agenda of the committee's meeting March 3-4.
Final regulations for all e-prescribing standards under the MMA are not required until April 2008.
The goal for the rule-making, Trudel says, "is to put more information about eligibility, formulary choices and medication history in the hands of the physician at the point of care when he (or she) is writing the prescription."