At 565 pages, the CMS proposed rule was the full tome, by far the greater of the two new and much anticipated federal rules released Dec. 30, 2009.
Both new rules add more flesh to the already beefy bones of the American Recovery and Reinvestment Act, also known as the federal stimulus law, which passed Congress in February 2009.
HHS Secretary Kathleen Sebelius delegated to the CMS, as overseer of the Medicare and Medicaid programs, the rule-writing task given her under the stimulus law that required certain rules for the EHR subsidy program to be released by Dec. 31, 2009.
The new CMS rule sets the calculations and timing of EHR subsidy payments.
More importantly, it spells out what participating hospitals, office-based physicians and certain other providers must do to qualify for EHR subsidies under the Medicare, Medicare Advantage and Medicaid programs and avoid—later on down the road—the “payment adjustments,” i.e., reimbursement cuts, Medicare providers would suffer if they fail to meet EHR adoption and use targets in a timely fashion.
Most critically—and controversially—the CMS rule also creates an official set of criteria providers must meet to achieve “meaningful use” of EHR systems.
Under the law, and thus by rule under all three CMS subsidy programs, EHR payments can only be made to those providers who use in a “meaningful manner” a “qualified” EHR that has been “certified” by an organization “recognized” by the ONC at HHS. The only exception to the ongoing “meaningful use” requirement is for eligible providers receiving initial EHR subsidy payments under the Medicaid program. These Medicaid providers don't have to demonstrate “meaningful use” in the first year, but do in subsequent years.
In a separate, but companion interim final rule also released Wednesday, the ONC set out in 136 pages the standards, implementation specifications and certification criteria for EHRs to be used under the federal incentive program.
Both the CMS and ONC rules are scheduled to be officially published in the
Federal Register on Jan. 13 when the clock starts on their 60-day public-comment periods.
CMS rulemakers expressed concern for striking the appropriate balance between providing a catalyst for healthcare reform and attacking a bridge too far in setting meaningful use requirements that are at once a stretch for providers and attainable by them. In summarizing this effort, they wrote:
“In defining meaningful use through the creation of criteria, we have balanced competing considerations of proposing a definition that best ensures reform of healthcare and improved healthcare quality, encourages widespread EHR adoption, promotes innovation, and avoids imposing excessive or unnecessary burdens on healthcare providers, while at the same time recognizing the short time frame” providers have under the law to begin using certified EHR technology.
Thus CMS drafters seek to establish a “phased approach” to criteria compliance, adopting, as they did throughout the rule, this and many other recommendations of the Health IT Policy Committee, a federal advisory committee set up under the stimulus law. The HIT Policy Committee and its work groups held multiple meetings discussing how to approach “meaningful use” and issued an initial set of formal meaningful use recommendations in June 2009 and a revised version last July.
CMS rulemakers were at pains to explain in their work released last week how they tried to mirror the HIT Policy Committee recommendations and when and why they, on occasion, deviated from those recommendations. The rulemakers also paid homage to other groups that contributed to their work, including the HIT Standards Committee, another advisory group created pursuant to the stimulus law, the National Committee on Vital and Health Statistics, which also held hearings and issued a report on meaningful use, and a consortium convened by the National Quality Forum, which guided the HIT Policy committee.
The CMS rule calls for creation of increasingly more stringent “stages” of meaningful use criteria, with the first of three stages covered by the new rule. The rule writers said they plan to address the two subsequent stages with rules to be issued again in 2011 to cover the payment years of 2012 and 2013, and reissued in 2013, to be applicable in 2014 and 2015.
CMS writers said, in summary: “The Stage 1 meaningful use criteria focuses on electronically capturing health information in a coded format; using that information to track key clinical conditions and communicating that information for care coordination purposes (whether that information is structured or unstructured, but in structured format whenever feasible); consistent with other provisions of Medicare and Medicaid law, implementing clinical decision support tools to facilitate disease and medication management; and reporting clinical quality measures and public health information.”
The stimulus law from which both new federal rules derive was a law produced in a hurry. Its healthcare IT provisions are scattered across its 785 pages in which there appear multiple, circular references. Many of those provisions were incorporated in a section often referenced by outsiders and even within the law itself as the Health Information Technology for Economic and Clinical Health Act, or HITECH Act. But HITECH is part of the stimulus law.
The law requires that the HHS secretary, through the federal rulemaking process, adopt no later than Dec. 31, 2009, “an initial set of standards, implementation specifications and certification criteria” that are needed for the electronic exchange of health information” for a variety of purposes listed in the law. Those uses and goals include segmenting data for privacy protection, improving the quality of care, coordination care, population health and reducing medical errors. These are incorporated in the ONC rule.
The law does not, however, impose a specific deadline for issuing “meaningful use” criteria. The practical matter is, however, that for the whole EHR subsidy program to work, government regulators must set “meaningful use” targets so providers will know what hoops they have to jump through and so EHR vendors will know what functionality their systems are going to need to meet certification requirements and the demands of the market.
Several organizations, including the American Hospital Association and the Medical Group Management Association,
have issued critical, first-blush analyses of the new federal rules. The AHA and MGMA, for example, concluded the government is being too aggressive in setting meaningful use targets.
Wes Rishel is a vice president and distinguished analyst for Gartner, a provider of market research for many forms of technology. Rishel agreed that certain meaningful use provisions might need to be dialed back a bit, but “I am saying that the overall position that this is a bridge too far, I think of it more as political positioning than a deep analysis.”
Rishel said the rules don't appear to tip the regulatory balance in favor of certain specific vendors at the expense of others, but will force some vendors to upgrade their systems if they expect to afford the functionality healthcare providers will need to meet their new meaningful use targets and get paid under the subsidy programs.
“I don't see anything in there that represents one vendor or a small group of vendors getting an edge,” Rishel said. “All of the vendors whose products don't do structured documentation or can't accept a certain number of codes, a coding system for the problem list, are going to say, ‘Oh, it's overkill.' ”
According to Rishel, the appropriate scope of testing and certifying EHRs has been debated ever since the not-for-profit Certification Commission for Health Information Technology was formed at the request of the ONC in 2004. But in the end, Rishel said, it's not about the vendors, or even the providers.
“The government isn't doing this to be nice to physicians,” Rishel said. “It's doing it to measure the quality of healthcare. Specific data elements must be measured. That's why it's worth money to the federal government to make it happen.”
Coming tomorrow: A look at the proposed new meaningful use criteriaWhat do you think? Write us with your comments at hitsdaily@modernhealthcare.com. Please include your name, title and hometown.
