Delay Stage 3 Meaningful Use Regs, Physicians Say

January 30, 2013

Organized medicine is urging the Obama administration to postpone drafting its stage 3 requirements for earning a bonus in its incentive program for electronic health record (EHR) systems until it studies how the stage 1 criteria have worked — or not worked — in physician offices.

"The stage 1 criteria were theory-based," said Jason Mitchell, MD, director of the Center for Health Information Technology at the American Academy of Family Physicians (AAFP). "Stage 3 needs to be evidence-based."

What the AAFP and other medical societies are saying amounts to a minor regulatory revolt in the world of EHRs. It all started on November 26, 2012, in the fine print of the Federal Register. There, the Department of Health and Human Services (HHS) solicited comments on its very tentative proposals for stage 3 standards for meaningful use of EHRs — meaningful as in improving and streamlining patient care. After all, HHS does not to reward physicians for merely buying the equipment. The proposals originated with an advisory committee of the HHS Office of the National Coordinator for Health Information Technology.

Right now, physicians must meet stage 1 meaningful use requirements such as transmitting prescriptions electronically and recording demographic information as structured data if they want to earn a 6-figure bonus under Medicare or Medicaid. Tougher stage 2 requirements, issued in their final form in August 2012, take effect in 2014 for physicians who aced stage 1 for at least 2 years beforehand.

In 2016, stage 3 criteria are supposed to kick in for physicians who satisfied stage 2 in both 2014 and 2015, but organized medicine wants to stretch out that timetable. In response to the government's request for feedback last fall, the AAFP, the American Medical Association (AMA), and other medical societies wrote letters urging HHS to delay issuing the next set of requirements. After all, most physicians have yet to register in the program or receive a payment in the stage 1 phase.

"It makes no sense to add stages and requirements to a program when even savvy EHR users and specialists are having difficulty meeting the Stage 1 measures," wrote AMA Executive Vice President James Madara, MD. "An external, independent evaluation is necessary to improve and inform the future of the program."

The AAFP's Dr. Mitchell told Medscape Medical News that HHS needs to examine some of the assumptions that went into the stage 1 criteria.

"Is computerized order entry of drugs, labs, and tests improving safety or efficiency?" he said. "Is it making a difference in terms of outcomes? Are we decreasing the duplication of tests?"

On top of that, no one knows how the stage 2 requirements will affect physician practices, say the medical societies. Regulators should not develop stage 3 until they first assess how stage 2 plays out, wrote William Zoghbi, MD, the president of the American College of Cardiology. Otherwise, physicians will face new regulations that "seek to change behavior rapidly without respect for the potential consequences," Dr. Zoghbi said.

If nothing else, delaying stage 3 will give physicians more time to catch up with stage 1 and stage 2 requirements, added AAFP board chairman Glen Stream, MD, in his group's letter to HHS. The AAFP recommends putting off stage 3 at least until 2017, citing the precedent of HHS moving the effective date of stage 2 from 2013 to 2014.

Not Enough Emphasis on Patient Outcomes

One big gripe among physicians is that stage 3 meaningful use, similar to in stages 1 and 2, emphasizes EHR functions and processes at the expense of "measuring and demonstrating improvements in patient health outcomes," as Michael Zaroukian, MD, PhD, put it in a letter on behalf of the American College of Physicians (ACP). As a result, physicians focus too much on performing and documenting tasks "that conflict with our sense of what is truly needed for quality, safety, and value."

In some instances, stage 3 merely raises a performance threshold for a medical chore. For example, under stage 2, a physician must send a reminder about preventive or follow-up care to more than 10% of his or her patients who have had 2 or more office visits within the previous 24 months. The reminder can be in any form the patient chooses — letter, telephone call, or electronic message. The meaningful use angle here is that the EHR can easily spit out a list of patients needing the reminder. A proposed stage 3 version boosts the performance threshold to 20% of patients who have had an office visit within the previous 24 months.

Another proposed stage 3 requirement increases the number of clinical decision support (CDS) interventions — one example is an automatic check for drug interactions — that a physician must deploy. Stage 2 called for 5 CDS interventions, and stage 3 makes it 15. Medical societies told HHS that with CDS, more is not necessarily better, particularly if new interventions are untested for efficacy and safety. Many physicians complain that poorly designed CDS produces "alert fatigue," causing them to sometimes ignore warnings on the computer screen or turn them off.

Other proposed stage 3 requirements, such as recording progress notes for 30% of office visits within 4 calendar days, strike physicians as overly prescriptive. Stage 2 also stipulated a 30% performance threshold, but not a deadline. "Imposing such deadlines could be viewed as the federal government attempting to dictate the practice of medicine," Dr. Madara of the AMA wrote.

The ACP's Dr. Zaroukian, who chairs his society's medical informatics committee, recommended that regulators avoid imposing "specific practice activities" on physicians and instead encourage them to experiment with EHR use "most appropriate to their patients, their specialty, and their practice setting." He urged HHS to introduce new measures for EHR functions only after testing them for effectiveness, user-friendliness, and the like.

Organized medicine also wants relief from a Medicare pay cut of 1% that takes effect in 2015 for physicians who are not meaningful users of EHRs. To avoid the penalty, physicians must demonstrate that they either satisfied stage 1 criteria in 2013 or did so for the first time in 2014.

Dr. Madara objected to the "100-percent pass rate" approach that subjects a physician to the penalty if he or she falls short of just a single measure by 1%. He proposed that the EHR incentive program borrow a page from Medicare's e-prescribing program: Reduce the number of requirements a physician has to meet to avoid the penalty, as opposed to earning a bonus.

The AAFP advocates either delaying the meaningful use penalty or eliminating it altogether.

"Pipe Dream" of Interoperability?

Another reason for HHS to slow down in its march toward stage 3 meaningful use, says organized medicine, is the need to first build the digital infrastructure that will permit EHR systems to freely exchange patient data with each other as well as hospitals, laboratories, and pharmacies as the incentive program requires.

This kind of interoperability will begin to figure into stage 2 and then intensify in stage 3. Under one proposed stage 3 requirement, when a physician hands off a patient to another care setting or provider, he or she must electronically transmit a summary-of-care record at least 30% of the time compared with 10% under stage 2.

All that is fine in theory, wrote the AMA's Dr. Madara, but where are the health information exchanges that connect everyone's computer systems and lets them talk to each other?

"If physicians...are unable to securely, accurately and effectively exchange health data about their patients, the promise that health IT [information technology] holds for enabling high quality and efficient care will be just a pipe dream," Dr. Madara wrote.

In his letter to HHS, Dr. Zoghbi said the American College of Cardiology is "disquieted by the increasing number of objectives that require the sharing of data between EHRs and lab or radiology sources." Many labs and imaging providers have not implemented the technology to make this data sharing possible, he said, and whether they become true digital partners is beyond the control of physicians.

"There are significant gaps that must be filled in before [a] nationwide health IT network can exist," he wrote. "The [advisory] committee must accept the reality that only so much pressure can be placed on physicians and hospitals to force change. Instead...pressure must be exerted on other actors, such as laboratories, imaging centers, and EHR vendors to encourage the adoption of health IT."

If the Obama administration disregards the call of organized medicine to delay the development of stage 3 criteria, the next step in the process would be a full-blown set of proposed regulations that CMS would publish in the Federal Register. Medical societies and other interested parties would have several months to comment on the regulations before CMS issues a final version.