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BREAKING: CMS Releases Final Meaningful Use Program Rules

October 6, 2015
by Rajiv Leventhal and David Raths
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Number of objectives scaled back some, but providers must be on board for Stage 3 by 2018

After weeks of speculation about when the meaningful use Stage 2 modifications and Stage 3 final rules would be published, the Centers for Medicare & Medicaid Services (CMS) released both rules together in a 752-page document late in the afternoon on Oct. 6.

The final rules, according to CMS, were designed to simplify requirements and add new flexibilities for providers to make electronic health information available when and where it matters most. The Stage 3 final rule also maintains the proposed patient engagement measures are ones that support a patient's access to their health information.

In recent weeks, calls for a Stage 3 delay have gotten louder, particularly from Sen.  Lamar Alexander (R-TN), Chairman of the Senate Health Education Labor and Pensions (HELP) Committee, which just completed its sixth meeting on electronic health records (EHRs). Nonetheless, Stage 3 will go on as planned. However, it should be noted that with the rules, CMS announced a 60-day public comment period to facilitate additional feedback about Stage 3 of the EHR Incentive Programs going forward, in particular with regards to the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) that requires the establishment of a Merit-based Incentive Payment System (MIPS) and consolidates certain aspects of a number of quality measurement and federal incentive programs for Medicare physicians and other providers into one more efficient framework.

In April, CMS issued a new proposed rule to align meaningful use Stage 1 and Stage 2 objectives and measures with the long-term proposals for Stage 3, with that proposal being released in March. Major healthcare advocacy groups questioned the logic of several Stage 3 proposals, most notably the requirement that would establish a single set of objectives and measure, tailored to eligible providers (EPs), eligible hospitals (EHs), and critical access hospitals (CAHs), by 2018. Industry stakeholders speculated that most providers wouldn’t be able to participate by 2018.

CMS, which said it receieved more than 2,500 comments on the proposed rules, did not change that mandate in its final rule—2018 is the effective Stage 3 date, regardless of a provider's prior participation in the EHR Incentive Program. CMS said that providers and states now have more time—27 months, until January 1, 2018—to comply with the new requirements and prepare for the next set of system improvements. According to CMS, commenters have said that 2017 is not a realistic start date, so it made the effective date 2018, making the program optional for providers in 2017.

What’s more, responding to industry pleading, CMS is allowing a 90-day reporting for all providers in 2015, extending the 90-day reporting period to new providers in 2016 and 2017, and to anyone choosing to adopt the 2018 measures a year early. CMS also says that it is giving developers more time to create the next advancements in technology that will be easier to use and more appropriate to new models of care and access to data by consumers. As such, CMS finalized fewer criteria and focused on interoperable exchange (e.g., inclusion of an improved common clinical data set for exchange and supporting API functionality.  By finalizing fewer criteria, developers will have additional time to develop innovations and create usability-focused EHRs, CMS said.

Additionally, for the EHR Incentive Programs in 2015 through 2017, major provisions include:

  • 10 objectives for eligible professionals including one public health reporting objective, down from 18 total objectives in prior stages.
  • 9 objectives for eligible hospitals and critical access hospitals including one public health reporting objective, down from 20 total objectives in prior stages.
  •  Clinical Quality Measures (CQM) reporting for both EPs and eligible hospitals/CAHs remains as previously finalized.

For Stage 3 of the EHR Incentive Programs in 2017 and subsequent years, major provisions include:

  •  8 objectives for eligible professionals, eligible hospitals, and CAHs:  In Stage 3, more than 60 percent of the proposed measures require interoperability, up from 33 percent in Stage 2.
  • Public health reporting with flexible options for measure selection.
  • CQM reporting aligned with the CMS quality reporting programs.
  •  Finalize the use of application program interfaces (APIs) that enable the development of new functionalities to build bridges across systems and provide increased data access. This will help patients have unprecedented access to their own health records, empowering individuals to make key health decisions.

Further, according to CMS, several commenters on the Stage 3 proposed rule believed that the proposals would be burdensome, more time-consuming, and do little to improve patient care. Some commenters attributed the increased burden to increased measure thresholds.  In response, CMS said that it recognizes clinical workflows and maintaining documentation may require modifications upon implementation of the requirements for Stage 3. It said, “However, the changes were proposed in response to stakeholder concerns and designed to reduce burdens associated with the number of program requirements, the multiple stages of program participation, and the timing of EHR reporting periods. Patient-focused care is very important to us, and we have proposed to maintain measures specific to patient engagement and that support a patient's access to their health information. The measures promote increased communication between providers and their patients, while placing focus on a patient's involvement in their care.”

In the release of the rules today CMS transitions to what the agency calls “a new and more responsive regulatory framework.” This new framework will be based on the landmark bipartisan legislation—MACRA—that requires the establishment of a Merit-based Incentive Payment System (MIPS) and consolidates certain aspects of a number of quality measurement and federal incentive programs for Medicare physicians and other providers into one more efficient framework. 

“We have a shared goal of electronic health records helping physicians, clinicians, and hospitals to deliver better care, smarter spending, and healthier people.  We eliminated unnecessary requirements, simplified and increased flexibility for those that remain, and focused on interoperability, information exchange, and patient engagement. By 2018, these rules move us beyond the staged approach of ‘meaningful use’ and focus on broader delivery system reform,”  Patrick Conway, M.D., CMS deputy administrator for innovation and quality and chief medical officer said in a statement. “Most importantly we are seeking additional public comments and plan for active engagement of stakeholders so we take time to get broad input on how to improve these programs over time.”

Along with meaningful use rules, CMS and the Office of the National Coordinator for Health IT (ONC) released the 2015 Edition Health IT Certification Criteria, which also highlights interoperability by adopting new and updated vocabulary and content standards for the structured recording and exchange of health information, including a common clinical data set composed primarily of data expressed using adopted standards; and rigorously testing an identified content exchange standard (Consolidated Clinical Document Architecture (C-CDA).

Healthcare Informatics will keep you updated on this story as it progresses and will get industry feedback in the coming days.

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