The public-comment period has ended for the first batch of proposed final federal standards for electronic prescribing, and now the government will ready the guidelines with an eye toward developing a list of "foundation standards" by the January 2006 launch of the Medicare Part D prescription drug program.
The Jan. 1 deadline is not mandated by the Medicare Modernization Act of 2003, which did direct the CMS to undertake development of e-prescribing standards, says Karen Trudel, deputy director of the CMS' Office of HIPAA Standards. But the goal remains to have the e-Rx standards in place by year-end, she says.
The 60-day comment period ended April 5 and yielded about 100 submissions, Trudel says. Most are in hand, some of them "voluminous," in excess of 50 pages, she says. A few others are expected to pass through the government registration process and reach the CMS in the next couple of days, she said last week.
A joint effort led by senior reviewers from the CMS will review all the filings and deliver a draft of the final standards, Trudel says.
The Medical Group Management Association was one of several industry groups that weighed in, filing a generally supportive 14-page memorandum that included several "yes, but" caveats.
In a letter from MGMA President and Chief Executive Officer William Jessee to CMS Administrator Mark McClellan, the MGMA contends that the benefits of e-prescribing compared with its costs are "simply not evident." He called on the CMS to "establish a quantifiable return on investment through survey research and a comprehensive cost-benefit analysis for all sizes of physician practices."
The letter also called for federal tax credits, tax-sheltered technology savings accounts and forgivable federal loans for medically underserved areas to provide incentives for physicians investing in healthcare information technology.
The MGMA congratulated the CMS for proposing a safe harbor from the Stark self-referral laws in its interim final regulations, but also called for relief from federal antikickback laws. Both restrictions have limited the potential of hospitals to provide technology subsidies or extend their electronic medical-record systems to affiliated physicians.
The MGMA warned that "patients are more concerned than ever about maintaining the security and privacy of their health information" and called on the CMS to "maintain ... HIPAA standards as part of its core operating features."
The association, which counts 19,500 members from medical groups with a total of about 240,000 physicians, called on the CMS to help expand the reach of its e-prescribing initiative beyond the Medicare drug benefit, including the development of educational materials to assist stakeholders in adopting the program.
Meanwhile, the Healthcare Information and Management Systems Society, a trade group for healthcare IT vendors and users, also submitted comments. The 11-page response also calls for pilot projects as well as Stark and antikickback safe harbors that would assuage the fears of hospital leaders regarding extension of their IT systems to affiliated physicians.
HIMSS asked the CMS to avail itself of the interoperability testing and standards implementation work under way by Integrating the Healthcare Enterprise, a collaborative effort of HIMSS, the Radiological Society of North America and the American College of Cardiology.
H. Stephen Lieber, president and CEO of HIMSS, says it doesn't appear that the federal government will soon offer direct incentives to IT adoption, but finding a middle ground on Stark and antikickback laws is another means of IT support. Hospitals "are put in the position of saying to small group practices, `Sorry, I can't help you' or `Here's the price,' and it's not any less than they could find with anyone else," he says.
Federal law provides some latitude in setting up communitywide e-prescribing initiatives, but it is hardly clear and, as a consequence, "There is a very significant hesitancy trying to test the limits of that because you don't want to get on the wrong side of the interpretation," Lieber says.
He says it would be helpful if the U.S. attorney general or HHS' inspector general's office would provide guidance to providers on legally establishing such IT relationships.
"When you have a situation where your small physician practices are strapped for capital, we have to start asking the question: How can we alleviate this?" Lieber says.