eMRB InfoAlert: Highlights and Takeaways from CMS and ONC Final Rules

Moving forward with the new regulations released by CMS and ONC on October 6, 2015

In the recently published final rules most affecting the Medicare and Medicaid EHR Incentive Programs, CMS and ONC have continued on a course to support advanced use of health IT to improve outcomes for patients.  The final regulations make significant changes to current requirements by easing the reporting burden for providers, supporting interoperability, and improving patient outcomes.  That is the message from CMS (CMS Fact Sheet), and moving forward with that direction, it is now “our” turn to begin the ongoing analysis, interpretation and implementation of the rules.

What follows is a summary of the final rules formulated from recent CMS and ONC publications as well as Encore’s initial review.  We also provide links to the legislation and other sources.  Focus of this communication is on the Modified Stage 2 portion of the CMS final rule as requirements for 2015, 2016 and 2017 are presumed finalized.  However, we also summarize the Meaningful Use (MU) Stage 3 portion of the rule which includes a 60 day comment period; and the ONC 2015 Edition final rule, which from the provider perspective, is not required until 2018, or 2017 for the early adopters of Stage 3.

What final rules?

On October 6, 2015, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released two final rules.  The CMS final rule with comment period is for the Medicare and Medicaid Electronic Health Records (EHRs) Incentive Program; the ONC final rule is for 2015 Edition Health IT Certification Criteria (2015 Edition).  We reference the CMS final rule in two parts, Modified Stage 2 and MU Stage 3, and begin with the biggest changes impacting the few weeks that remain in 2015.

Most Significant Impacts to 2015

The most significant provision in the Modified Stage 2 portion of the CMS final rule is the reporting requirement.  CMS finalized a consecutive 90 day reporting period for MU in 2015.  That eases the reporting burden for providers in 2015; however, it still requires the ability to accommodate the modifications to the measure objectives and reporting requirements that were finalized.  Also significant for hospitals, the CMS rule aligns the EHR reporting period with the calendar year (CY) for all providers starting in 2015; hospitals will no longer be reporting based on a fiscal year (FY) calendar.  That brings us to alignment with other quality reporting programs such as the Hospital Inpatient Quality Reporting (IQR) program, and therefore, eases another reporting burden.  Another impact in 2015 are the measures deemed by CMS as topped out, duplicative, and redundant.  There are 11 measures for eligible professionals (EPs) and 12 for eligible hospitals (EHs) that no longer need to be reported and of those that remain, some have changes.  To compensate for some of the changes, especially for providers slated to demonstrate Stage 1 in 2015, CMS has provided an option that allows providers to claim an ‘alternate exclusion’ relieving them of the reporting requirement in 2015 and, in some cases, 2016.  By adding this option, for example, an EH that is scheduled to demonstrate Stage 1 in 2015 could claim an alternate exclusion option for 7 of the 14 Modified Stage 2 measures, and that would ease their reporting burden by half.

Take away:  There is a lot to understand, and quickly, to determine the impacts and adjustments for reporting in 2015.  For example, there are new public health reporting requirements for Stage 1 hospitals and claiming an exclusion could be a challenging task.  Although, in response to inquiries about the public health reporting objective in 2015, on 10/21, CMS published a new FAQ12985, which identifies alternate exclusions for the public health reporting objective in 2015.

CMS Final Rule - Modified Stage 2

The Modified Stage 2 portion of the final rule is finalized and it covers requirements for the EHR Incentive Program in 2015, 2016 and 2017.

Highlights of Modified Stage 2

• Changes reporting period in 2015 to “any” consecutive 90 days:
  • Eligible hospitals any 90 days from October 1, 2014 to December 31, 2015
  • Eligible professionals any 90 days from January 1, 2015 to December 31, 2015

• Changes reporting period from fiscal year to calendar year for eligible hospitals
• Creates a single definition for Stage 1 and Stage 2 participants called “Modified Stage 2”
  • Eliminates core and menu concept
  • Better aligns objectives with Stage 3 definitions
  • Removes measures that are topped out, redundant and duplicative

• Objectives for 2015 through 2017 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 (CAHs) including one public health reporting objective, down from 20 total objectives in prior stages

• All providers must attest to objectives and measures using EHR technology certified to the 2014 Edition for reporting years 2015, 2016 and 2017, if reporting Modified Stage 2 (2015 Edition must be used if reporting Stage 3 in 2017 which is optional)
• For an EHR reporting period in 2015, all Medicare providers must attest by February 29, 2016
• Despite the change to a 90-day EHR reporting period in 2015, providers will not be able to attest to meaningful use for an EHR reporting period in 2015 prior to January 4, 2016
• CQM reporting for both eligible professionals and eligible hospitals/critical access hospitals (CAHs) remains as previously finalized

CMS Final Rule with Comment Period - MU Stage 3

The MU Stage 3 timeframe begins in 2018 and it is for this portion of the final rule that CMS is seeking comments through a 60-day comment period.  CMS is seeking comments on Stage 3 measures, objectives and reporting periods.  The comment period also supports the transition to the Merit-Based Incentive Payment System (MIPS) established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) as it sunsets the meaningful use payment adjustment for eligible professionals at the end of CY 2018 when MIPS is incorporated beginning in CY 2019.

Highlights of MU Stage 3

• Stage 3 will be optional in 2017 and required in 2018
  • Participants can report “any” 90 day reporting period in 2017 to allow more time to implement 2015 edition of Certified EHR Technology (CEHRT)

• Starting in 2018, all participants will report on the same definition of Meaningful Use at the Stage 3 level regardless of their prior participation
• The reporting period for Stage 3 is 365 days
• Actions to meet measures must be electronic – paper-based methods will not suffice (e.g., summary of care and patient education)
• 2015 Edition of CEHRT required for Stage 3 reporting
• CQMs can be reported by attestation through 2017, electronic submission is required starting in 2018
• Standard definition for Stage 3 consists of 8 objectives with multiple measures below each
  • Objectives for Stage 3 are percentage-based measures, wherever possible
  • Flexibility in some objectives to allow for 2 of the 3 measures to meet threshold for the objectives
  • No concept of core and menu set objectives
  • Objectives are the same for EPs and EHs/CAHs

• 60 day comment period will likely yield additional changes to this legislation

ONC Final Rule - 2015 Edition

The ONC final rule finalizes a new edition of certification criteria (2015 Edition) for Electronic Health Records (EHRs) and health information technology, and a new 2015 Edition Base EHR definition.  It also modifies the ONC Health IT Certification Program to make it open and accessible to more types of health IT and health IT that supports various care and practice settings.  The ONC 2015 Edition final rule covers the technology requirements that providers need to support objectives and measures associated with the EHR Incentive Program as well as other programs such as CMS’ chronic care management services or The Joint Commission for performance measurement initiative.

Highlights of the ONC Final Rule

The 2015 Edition final rule is moving health IT beyond the EHR Incentive Program (MU).  It creates a framework for the ongoing harmonization among multiple programs.  It expands Health IT certification beyond inpatient and ambulatory to other settings including Health Information Exchanges (HIEs), behavioral health, long-term and post-acute care and pediatrics.  In addition, ONC has broadened and changed definitions.  It replaced use of EHR and EHR technology with health IT; it changed the ONC HIT Certification Program name to ONC Health IT Certification Program; and it changed the Common MU Data Set name to Common Clinical Data Set.  A theme of moving away from using the term meaningful use.

The 2015 Edition final rule is focused on establishment of an interoperable nationwide health information infrastructure as proposed, but with an additional focus on reducing health IT developer and provider burden as compared to the proposed rule.

The final rule adopts a Base EHR definition specific to the 2015 Edition, which focuses on the functionalities all users of certified Health IT should possess and the minimum functionalities required by the Health Information Technology for Economic and Clinical Health (HITECH) Act remain in the Base EHR Definition.  It also provides that requirements can be met using a combination of certified Health IT Modules.

The Certified EHR Technology (CEHRT) definition has been removed from the ONC final rule, and now resides within the CMS EHR Incentive Programs Stage 3 and Modifications final rule.

The 2015 Edition adopted 60 of the 74 certification criteria that were proposed.  Compared to the 2014 Edition, there are 16 unchanged, 25 revised, and 19 new criteria.

ONC is in process of developing additional materials that will be available on their website in the next few weeks, including the test procedures.

Information Sources

• CMS Final Rule with Comment Period: Medicare and Medicaid Programs: Electronic Health Record Incentive Program — Stage 3 and Modifications to Meaningful Use in 2015 through 2017.  Pre-publication version filed on 10/6/2015; scheduled to be published in Federal Register on 10/16/2015.
• ONC Final Rule: 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications.  Pre-publication version filed on 10/6/2015; scheduled to be published in Federal Register on 10/16/2015.
• CMS Fact Sheet:  EHR Incentive Programs in 2015 and Beyond
• CMS EHR Incentive Program Website: 2015 Program Requirements
• CMS FAQ: FAQ12985, Alternate Exclusions for the Public Health Reporting Objective in 2015
• ONC 10/7/2015 Webinar:  2015 Edition Final Rule Improvements to the ONC Health IT Certification Program and the 2015 Edition Health IT Certification Criteria