Meaningful Use: The Final Rule

Meaningful use was given its final definition yesterday, in the meaningful use final rule released by HHS.  Secretary Sebelius, CMS Adminsitrator Berwick, ONC chief Blumenthal and the two Reginas spoke — U.S. Surgeon General Regina Benjamin, and Regina Holliday, whose late husband's last days were complicated by the failure of health care facilities to release and share health records.  Berwick, in his first full day on the job as CMS Adminstrator, waxed rhapsodic about the pleasures of practicing as a pediatrician at Harvard Community Health Plan using its pioneering electronic health record system.  (Years later, I am still a patient at Harvard Vanguard Medical Associates, which used to be part of HCHP, and I am still spoiled by the EHR system there.)  Blumenthal and Benjamin also spoke about how and why they came to use EHRs in their clinical practices, and why they wouldn't have it any other way.  (The rule will be published in the Federal Register July 28.)

Also released was the proposed permanent EHR certification rule.  (Last month, the federales released a temporary version of the EHR certification rule, so that there would be standards in place for providers seeking HITECH Act incentive payments for 2011 meaningful use of certified EHRs.)  Taken together with the draft regulations updating HIPAA privacy, security and enforcement rules under the HITECH Act announced last week, these rules outline the future of health care IT in this country.

Not surprisingly, after receiving over 2,000 comments on the draft definition of meaningful use released over six months ago, the feds revised the rule considerably, loosening the definitions of Stage 1 Objectives (i.e., the criteria by which 2011 compliance and eligibility for the full incentive payments will be judged), among other things.

The HHS fact sheet (available on the relatively new CMS EHR Incentive Programs web page) describes some of the key components of the rule as follows:  

• For Stage 1, CMS’s proposed rule called on physicians and other eligible professionals ("EPs") to meet 25 objectives (23 for hospitals) in reporting their meaningful use of EHRs. The final rule divides the objectives into a “core” group of required objectives and a “menu set” of procedures from which providers can choose.  This “two track” approach ensures that the most basic elements of meaningful EHR use will be met by all providers qualifying for incentive payments, while at the same time allowing latitude in other areas to reflect providers’ varying needs and their individual paths to full EHR use.
• In line with recommendations of the Health Information Technology Policy Committee, the final rule includes the objective of providing patient-specific educational resources for both EPs and eligible hospitals and the objective of recording advance directives for eligible hospitals.
• With respect to defining hospital-based physicians, the final rule conforms to the Continuing Extension Act of 2010. That law addressed provider concerns about hospital-based providers in ambulatory settings being unable to qualify for incentive payments by defining a hospital-based EP as performing substantially all of his or her services in an inpatient hospital setting or emergency room only.
• The rule makes final a proposed rule definition that would make individual payments to eligible hospitals identified by their individual CMS Certification Number.  The final rule retains the proposed definition of an eligible hospital because that is most consistent with policy precedents in how Medicare has historically applied the statutory definition of a ”subsection (d)” hospital under other hospital payment regulations.
• Under Medicaid, the final rule includes critical access hospitals (CAHs) in the definition of acute care hospital for the purpose of incentive program eligibility.
• The final rule’s economic analysis estimates that incentive payments under Medicare and Medicaid EHR programs for 2011 through 2019 will range from $9.7 billion to $27.4 billion.

Not only did the government go the "Chinese menu" route in allowing providers to customize the standard set that will be applicable to them; it also made the standards much less stringent (e.g. threshhold of 40% e-prescribing vs. 75% in the draft rule; though one must wonder whether this is mere window dressing, as an EP with an e-Rx system in place would not be likely to use it for anything less than 100% of patients).  That's not to say that qualifying for the incentives will be a breeze, though some naysayers are criticizing the feds for that reason.  On the other hand, there are plenty of voices out there decrying the difficulty providers will face in trying to qualify for the full incentive payments in the time remaining.  Finally, there are those who still question the value of this whole exercise, seeing it as a Recovery Act handout for the EHR vendors more than anything else, wondering when and where the clinical benefits will materialize.

The EHR vendors that are guaranteeing compliance with meaningful use are now in overdrive, working on the interim certification for their products, and looking to sign up providers now that the meaningful use rules have been finalized.  Hospitals and EPs that are not already in the midst of implementation may be hard-pressed to achieve meaningful use of a certified EHR before the first deadline in 2011.  Most will be able to pull it off by 2015, when the incentives for EHR adoption switch over to penalties for failure to get wired

.  (The cynics among us may see a future legislative deferral of the penalty provisions, just as we have been getting used to regular last-minute deferrals of SGR formula-driven physician reimbursement cuts.)  Some vendors are offering advances against incentive payments, in addition to compliance guarantees (see, e.g., GE's healthymagination program).

The FDA did not insert itself into the final rulemaking process, as some had hoped or expected.  The FDA has asserted jurisdiction over EHRs as "devices" and the regulated community would sure as heck like to know sooner, rather than later, just what the FDA has in mind for regulating EHRs (no pre-market approval, methinks). 

Finally, the criteria established and to be met are not ends in themselves, but a means to a further end: the improvement of quality while reducing cost — two legs of the proverbial three-legged stool.  (The third leg, access, may be improved through other aspects of the Obama administration's health reform initiatives.)   As the meaningful use rule and the revised HIPAA rules come together in seeking to promote a migration of health data to a near-universal online, interoperable state, some e-patients and patient advocates will measure the success of the implementation by its satisfaction of the Declaration of Health Data Rights.  Let's hope that the deferral of PHR-EHR connection requirements don't sidetrack the patient empowerment side of this rule.

There are many, many other issues dealt with and implicated in the more than 800 pages of the final rule, and many other commentators writing about them.  I invite you to peruse the rule and some of the other materials linked to in this post, and to offer your thoughts on the rule and its implications below.

For further reading:

The Stage 1 Meaningful Use objectives and associated measures, broken out by "core" and "menu" set are found in Table 2, beginning on page 221 of the final rule PDF released yesterday.

A helpful side-by-side comparison of final vs. proposed rule Stage 1 objectives and measures may be found at Keith Boone's blog (together with an analysis of the certification rule).

Another helpful meaningful use summary (courtesy of the federales) is available via the New England Journal of Medicine.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting