Much of the health care community is still sifting through the 864-page final rule CMS released Tuesday describing how health care providers can demonstrate "meaningful use" of electronic health records to qualify for Medicare and Medicaid incentive payments under the 2009 federal stimulus package.
The long-awaited rule comes exactly six months after CMS published a Notice of Proposed Rulemaking on meaningful use. Federal officials received more than 2,000 comments on the proposed rule, often getting conflicting advice.
Some health provider groups -- such as the American Hospital Association and the American Medical Association -- argued that the proposed rules were unreachable for most health care providers and needed to be relaxed. On the other hand, consumer groups -- such as the National Partnership for Women & Families and AARP -- urged federal health officials to maintain the high bar of the proposed rule. Even lawmakers weighed in, offering recommendations on how to improve upon the proposal.
The final rule strikes somewhat of a compromise, and after initial review, most groups seem cautiously pleased with the outcome, but, as expected, not everyone's happy.
Federal Health Officials Announce Final Rule
At a news briefing announcing the release of the final rule, HHS Secretary Kathleen Sebelius said, "Electronic health records are the foundation of a high-performing, high-quality health care system." She added that when EHRs "are well designed and implemented correctly, they're a powerful force for reducing errors, lowering costs, raising the quality of care, and increasing doctor and patient satisfaction."
Sebelius and National Coordinator for Health IT David Blumenthal stressed that federal officials carefully weighed all of the input they received. Blumenthal said, "We have tried to listen to those comments," adding, "We very much want well-intended providers to be able to become meaningful users, so we want the objectives of meaningful use to be both ambitious but achievable."
Sebelius and Blumenthal were joined for the announcement by newly appointed CMS Administrator Donald Berwick and Surgeon General Regina Benjamin, who both discussed their personal experience using EHRs.
Berwick noted that "moving from legacy paper systems to modern information technology is a big change ... it's really a new culture, and you don't get there in one step." He added that the final rule "represents really, really good progress."
Changes in Final Rule
The proposed rule included a set of objectives -- 23 for hospitals and 25 for clinicians -- health care providers must meet to demonstrate meaningful use. In response to comments from some stakeholders that the "all-or-nothing" approach was too demanding and inflexible, CMS divided the objectives into two groups: a core set of objectives -- 14 measures for hospitals and 15 measures for physicians and "eligible providers" -- that must be met and a set of 10 additional tasks from which providers can choose any five to implement during Stage 1 of the federal incentive payment program.
In addition, CMS lowered the bar for achievement for certain objectives. To achieve the electronic prescribing objective, for example, physicians are required to transmit 40% of their prescriptions electronically, down from 75% in the proposed rule.
Other changes from the proposed rule include:
- Modifying the definition of hospital-based physicians to conform with the Continuing Extension Act of 2010 to allow hospital-based providers to qualify for meaningful use incentive payments;
- Including critical access hospitals in the definition of acute care hospital for the purpose of incentive program eligibility under Medicaid; and
- The addition of an objective for providing patient-specific educational resources for eligible providers and hospitals; and
- Adding an objective for recording advance directives for hospitals.
According to the economic analysis of the final rule, Medicaid and Medicare incentive payments under the program will range from $9.7 billion to $27.4 billion for 2011 through 2019.
In a New England Journal of Medicine article published on Tuesday, Blumenthal and Marilyn Tavenner, principal deputy administrator of CMS, write, "The meaningful use rule strikes a balance between acknowledging the urgency of adopting EHRs to improve our health care system and recognizing the challenges that adoption will pose to health care providers." They add, "Like an escalator, HITECH attempts to move the health system upward toward improved quality and effectiveness in health care. But the speed of ascent must be calibrated to reflect both the capability of providers who face a multitude of real-world challenges and the maturity of the technology itself."
Reaction
Jennifer Covich Bordenick -- CEO of the eHealth Initiative, which is still reviewing the rule -- said, "At a high level and from reviewing the summary documents and the New England Journal of Medicine article, it looks like many of the concerns that were raised during the comment period were addressed." She cited the reduction of the number of requirements and the addition of choice and flexibility as some of the important concessions.
Covich Bordenick predicted that consumer groups likely would "be very pleased" with the final rule, while some of the provider and hospital groups "are still going to say it's a little too aggressive."
Christine Bechtel -- vice president of the National Partnership for Women & Families, one of the groups that urged CMS to keep the final rule strong -- said she doesn't view the final rule a "relaxation." She said, "We view it as striking a good balance between ambitious and achievable."
Bechtel said, "We were really looking to make sure that the rule maintained the strong direction that it had, which was an orientation towards improving health and health care, and of course engaging patients and families and reducing health disparities. And, we think that they've hit the mark on that." She added, "Of course, there are things that we would have liked to see be required instead of optional, but there were a lot of things," such as patient education and advanced directives, "that were added back in that we're really happy with."
Carol Diamond, managing director of the Markle Foundation, said, "The final rule has added flexibility to encourage providers to participate in this critical effort to improve health, promote efficiency, drive innovation and protect privacy."
Sen. Tom Harkin (D-Iowa), chair of the Senate Health, Education, Labor and Pensions Committee, said the rule "draws on the best advancements across the full spectrum to improve Americans' health, increase safety and reduce health care costs -- all of which are critical steps to improve the quality and efficiency of patient care."
Chip Kahn, president and CEO of the Federation of American Hospitals, praised the rule for incorporating many of his organization's concerns. However, he said, "Congressional framers of HITECH clearly intended that its financial incentives flow to all qualifying hospitals. But under today's final rule, multiple hospitals under a single Medicare provider number will not receive the full allotment." Kahn also called on Congress to "expand the legislation's reach to include post-acute hospitals and care."
Rich Umbdenstock, president and CEO of the American Hospital Association, voiced similar concerns. He said that while the final rule includes "some important improvements," AHA "remains concerned that the requirements may be out of reach for many of America's hospitals."
Specifically, he said that "individual hospitals in multicampus settings are unfairly excluded from incentive payments" and that the rule's requirement for hospitals to immediately begin using computerized provider order entry is unrealistic.
Umbdenstock added that AHA is "concerned this rule may adversely impact rural hospitals and the patients they serve and exacerbate the digital divide in health care."
Reps. Sandy Levin (D-Mich.) and Pete Stark (D-Calif.) also raised concerns about the multicampus exclusion.
Some groups, including the American Medical Association, are still wading through the lengthy rule before issuing a formal response.
What's Next?
The House Ways and Means Health Subcommittee will hold a hearing on Tuesday to examine the new meaningful use rule.
Covich Bordenick said the release of the final rule is just "HHS setting the bar for us. Now it's really all about implementation so it's still going to be a really long, hot summer."
Bechtel said that HHS needs "to really monitor how it's going in the field and to monitor what requirements are being deferred." She added, "I would assume if providers find [the objectives] hard or untenable, they're going to defer them. So if we monitor what's being deferred, then we can know better how to target outreach and education and resources and support so that providers can succeed at doing those things."
Federal officials will release additional information on the Stage 2 and Stage 3 meaningful use requirements over the next few years.
Bechtel said that in future stages, she'd like "to see a shift in focus from institutional care to home- and community-based care." She also called for the use of "better quality measures that are really health IT-enabled and oriented toward both patient outcomes and health status" and for patient experience to be incorporated into meaningful use.