July 7, 2014 COMMENTS CMS-2014-0064-0002 Date Posted: May 27, 2014 RIN: 0938-AS30 CFR: 42 CFR Part 495 Federal Register Number: 2014-11944 Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record Incentive Programs for 2014; and Health Information Technology: Revisions to the Certified EHR Technology Definition To Whom It May Concern: California Health Information Partnership and Services Organization (CalHIPSO) appreciates the opportunity to comment on the CMS Proposed Modifications to the Medicare and Medicaid Electronic Health Record Incentive Program. CalHIPSO, as the largest Regional Extension Center (REC), has worked with over 5,000 providers, assisting them in achieving Stage 1 Meaningful Use and earning EHR incentive payments. Our work continues with over 1,500 providers who have yet to meet their first year of Stage 1 Meaningful use while continuing to guide all of our members on the path towards successful Stage 2 Meaningful Use attestations. Our comments on the proposed modification reflect both the successes and challenges that our member physicians, nurse practitioners, certified nurse midwives, physician assistants and hospitals have encountered in meeting the requirements of Stage 1 Meaningful Use and those that they have encountered while preparing for Stage 2. Statement of Support CalHIPSO is supportive of the increased flexibility that CMS and the ONC have attempted to make available in the May 2014 Notice of Proposed Rule Making referenced above. Key Points of Concern 1. 2. 3. 4. Timing of this rule making Alignment of policy, EHR capabilities, and NLR/SLR attestation capabilities The exclusion of modifications affecting the 2015 program year Maintaining MU momentum 1231 I Street, Suite 400, Sacramento, CA 95814 | 510.302.3364 | www.CalHIPSO.org Page 2 of 11 SUMMARY The comments in this document reflect the practical application of nearly five years assisting more than 5,000 clinicians to adopt electronic health technology and achieve Meaningful Use. A summary of comments is followed by a descriptive analysis of each point. CalHIPSO’s partners, member clinicians and other interested parties have permission to use the comments included in this document in their entirety or in part for their own submission. Acronyms NPRM – Notice of Proposed Rule Making RM – Rule Making MU – Meaningful Use EP – Eligible Professional SLR – State Level Registry CQMs – Clinical Quality Measures AIU – Adopt Implement Upgrade CEHRT – Certified Electronic Health Record Technology EHR – Electronic Health Record SUBMISSION INSTRUCTIONS The comment period for the Notice of Proposed Rule-Making (NPRM) on “Medicare and Medicaid Programs; Modifications, Revisions: Medicare and Medicaid Electronic Health Record Incentive Programs for 2014; Health Information Technology” is open. More info: http://www.regulations.gov/#!documentDetail;D=CMS-2014-0064-0002 Your comment can be submitted anonymously. The comment field allows up to 5000 characters. There is an option to upload files. There is a 3 page guide available that provides tips on how to submit effective comments: http://www.regulations.gov/docs/Tips_For_Submitting_Effective_Comments.pdf http://www.regulations.gov/#!submitComment;D=CMS-2014-0064-0002 Page 3 of 11 SUMMARY OF COMMENTS Comment No. & Link to detail Comment 1 CalHIPSO is in agreement that the pace of 2014 EHR certification awards and upgrades has constrained the number of EPs and EHs able to attest for program year 2014. 2 Flexibility should be granted to all providers, and not be conditional on attesting to being “not fully implemented.” 3 This Final Rule should not add administrative burden by requiring EPs or their administrative staff to have to document “not fully implemented.” 4 CalHIPSO is in agreement that “fully implemented” be a loosely defined term. 5 Final Rule must clarify that any continuous 90 day reporting period (Medicaid) or any 2014 calendar quarter (Medicare) be accepted, regardless of effective date. 6 The Final Rule should provide clarification that EPs do not have to be “on” 2014 CEHRT to attest to 2014 AIU, rather demonstrating a contractual obligation to upgrade or install 2014 CERHT on or before 12/31/2014 will suffice. 7 The Final Rule should include guidance on 2014 Public Health reporting, delving specifically into the timing of the Stage 1 tests that will be accepted. 8, 9 The proposed rule offers MU flexibility that State Level Registries and/or EHR vendors may not be able to accommodate. 10 It is suggested that the Final Rule reverse the Stage 1 requirement of having to meet the Stage 2 Patient Electronic Access measure. 11 Provide clarification around wording that states edition of CEHRT dictates stage of Meaningful Use. 12 Provide clarification that defines what is meant by “combination of 2011 and 2014 Edition CEHRT”. 13 Separate requirements between Core & Menu and CQMs. The Final Rule should allow for different reporting periods and program year requirements for Core & Menu and CQMs. 14, 15 Reporting periods for all EPs should be any continuous 90 days. 16 Clarify in Final Rule that changes pertain to both Medicare and Medicaid EHR Incentive Program participants. As presently drafted, the proposed rule is not clear in regards to Medicaid program participants. 17 Clearly explain the progression of Meaningful Use stages. 18 CMS should remove the constraints EPs suffer if they work at multiple locations. 19 CalHIPSO agrees with the extension of Stage 2 and the delay of Stage 3. 20, 21 Add clarifications to the Final Rule around CQM requirements for meeting MU in 2014. Page 4 of 11 DETAILED COMMENTS CalHIPSO is in agreement that the pace of 2014 EHR certification awards and upgrades has constrained the number of EPs and EHs able to attest for program year 2014. 1. The backlog of 2014 EHR certification awards, along with the updating, installation and implementation of the 2014 version, has already significantly constrained the number of EPs and EHs able to attest for Program Year 2014, Stage 1 or Stage 2. According to a CMS report to ONC’s Health IT Policy Committee on May 6th, only 224 EPs had attested to MU in 2014 and, of those, only six were attestations to Stage 2; only four EHs had attested to Stage 2. Flexibility should be granted to all providers, and not be conditional on attesting to being “not fully implemented.” 2. CalHIPSO is concerned that this proposed rule only offers flexibility to providers who are not able to fully implement 2014 Edition CERHT for a full reporting period in 2014. While definitely constrained by vendor rollout of the 2014 Edition, this exclusivity seems to reward those who were not proactive in planning their 2014 CEHRT upgrade. To be fair, the flexibility proposed with this rule’s modifications should be applicable to all EPs and EHs. The Final Rule should not add administrative burden by requiring EPs or their administrative staff to have to document “not fully implemented.” 3. Providers who choose to exercise the flexibility provided by these proposed modifications will have to attest that they were not able to fully implement 2014 Edition CEHRT. This choice should be afforded to all EPs and should not carry with it an administrative burden, to the EPs or to their organizations’ staff, to have to justify or document “not fully implemented.” CalHIPSO is in agreement that “fully implemented” be a loosely defined term. 4. The apparent approach taken in the notice to loosely define “fully implemented,” keeping it intentionally vague, is beneficial. However, the proposed rule does provide some helpful guidelines for providers: a. Required software patches b. Installation schedules c. Deployment of new processes d. Workflow investments e. Staff training Page 5 of 11 Final Rule must clarify that any continuous 90 day reporting period (Medicaid) or any 2014 calendar quarter (Medicare) be accepted, regardless of effective date. 5. “Look Back”. The Propose Rule is not clear whether any continuous 90 day reporting will be allowed in 2014. Clarification is suggested to allow any continuous 90 days in 2014, even if the 90 day reporting period is prior to the effective date of the Final Rule. For example, while the rule may not be finalized until September 2014, an EP should be allowed to use a reporting period of 01/31/14 thru 03/31/14. An example for a Medicaid EP, an EP should be permitted to report using May 15, 2014 through August 12, 2014, a consecutive 90 day reporting period that is not tied to a calendar quarter. The Final Rule should provide clarification that EPs do not have to be “on” 2014 CEHRT to attest to 2014 AIU, rather demonstrating a contractual obligation to upgrade or install 2014 CERHT on or before 12/31/2014 will suffice. 6. 2014 Adopt Implement Upgrade (“AIU”). The Proposed Rule takes a positive approach to encouraging forward momentum of the adoption of certified electronic health records in its requirement that qualification for 2014 Program Year AIU requires 2014 CEHRT. Defining the requirement to provide, at the very least, a financial obligation to adopt, implement, or upgrade to 2014 CEHRT for 2014’s program year is wise and recommended. An EP might be scheduled to install or upgrade to 2014 CEHRT November 1st, 2014 and should be permitted to submit an AIU attestation prior to that install or upgrade. The Final Rule should include guidance on 2014 Public Health reporting, delving specifically into the timing of the Stage 1 tests that will be accepted. 7. 2014 Public Health Reporting (Stage 1 Menu set, Stage 2 both Core and Menu set measures) The proposed rule does not address how an EP would report on public health reporting. The capabilities and requirements of every local health department in the country must be taken into account. The timing and the condition that it is site specific, not EP specific, are critical points of challenge in meeting these measures. If an EP elects to attest in 2014 per the Stage 1 2013 definition, when would their immunization registry test need to have been completed? In CY 2013? Or, in 2014, between January 1, 2014 and the last day of their reporting period? Or, anytime in 2014? Scenario to consider: NPRM finalized late September 2014 EP elects to report on Stage 1 2013 definition Reporting period to be used April 1, 2014 – June 30, 2014 Immunization test conducted August 1, 2014 Can this EP successfully attest to the Immunization Menu Measure? Page 6 of 11 The proposed rule offers MU flexibility that State Level Registries and/or EHR vendors may not be able to accommodate. 8. State Level Registry (SLR) Using California as an example, as of July 2014, EPs do not have access to the SLR to submit 2014 Medicaid MU attestations. This is due to the development challenges of having 2013 rules’ programming available through the attestation period ending April 30, 2014, and the requirement to have 2014 rules in production (and tested) before 2014 attestations can be submitted. It is anticipated that the platforms needed to meet the flexibility of the proposed rule would not be available in the next 12 months. If CMS is confident they can meet the programming needs to support this notice, it is suggested that all Medicaid EPs be able to submit 2014 MU attestations in the NLR instead of their respective SLR. 9. EHR Vendors There are serious concerns about EHR capability to export MU data to meet this rule making’s various options. Users of EHRs have faced challenges extracting MU data from their EHRs over the past few years. Some field examples: Can only run dashboards on a monthly basis, starting on the first day of a month (while an EP should be able to attest to any 90 continuous day period, such as July 15th – October 12th). Since January 1, 2014, some organizations do not have access to run CQMs for any period in 2014 without having upgraded to 2014 CEHRT. Once upgraded to 2014 CEHRT, yet far from being fully implemented, an organization can no longer run Stage 1 2013 Definition MU dashboard reports. Addressing the issues – Scenario: Organization upgrades to 2014 CEHRT August 2014 Organization can easily attest to not being fully implemented (their project plan is to upgrade August 2014 and be ready for full use by January 1, 2015). All of this Organization’s EPs will attest to MU Stage 1 2013 definition per the NPRM’s flexibility Organization’s EHR is incapable of running a 2013 MU dashboard with a 2014 90 day reporting period after the August 2014 upgrade Organization’s EHR is able to generate only 2014 CQMs; prior to the August 2014 upgrade, a CQM report would not generate One Possible Outcome and Timeline: The Organization runs MU dashboard reports (Core and Menu) for 90 days in 2014 prior to August 2014 upgrade; such as April 1, 2014 – June 30, 2014 Because this Organization has not upgraded to 2014 CEHRT, their EHR does not allow them to run CQMs (2013 or 2014) Page 7 of 11 Organization must be wary of the Public Health measures. It is suggested to work on 2014 public health measures in summer 2014 Organization upgrades to 2014 CEHRT August 2014 Organization runs 2014 CQMs as soon as possible after the upgrade If allowed per the NPRM, EPs with this Organization can attest as follows: o Stage 1 2013 Definition Core and Menu o Core and Menu April 1, 2014 – June 30, 2014 reporting period (for simplification, keeping to a calendar quarter though a vast majority of CA MU attestations are under the Medicaid EHR Incentive Program and are not constrained to reporting to a calendar quarter) o 2014 CQMs September 1, 2014 – November 30, 2014 Organization can use the CQM report to complete attestation for either 2011-2013 rules (3 Core/Alt and 3 Additional) or 2014 rules (9 CQMs from at least 3 domains) o December 2014 Medicaid attestation submitted via the NLR because SLR NPRM attestations not available It is suggested that the Final Rule reverse the Stage 1 requirement of having to meet the Stage 2 Patient Electronic Access measure. 10. Patient Electronic Access “View Download Transmit” (VDT) 2014 Stage 1 Core measure 11. Often referred to as the “portal measure”. It is recommended that CMS reverse the Stage 2 Final Rule requirement that brings part of a Stage 2 measure (Core Measure 7) into 2014 Stage 1 Core requirements. Many EPs would be able to continue on their 2nd year of Meaningful Use Stage 1 in 2014 without having to revert to Stage 1 2013 definitions or without having to “skip” MU attestation in 2014 for not having a portal or not having a portal that has been fully implemented. Reverting back to the former Stage 1 Core 12 “Electronic Copy of Health Information” upon request measure should be considered and included in this rule making. Provide clarification around wording that states edition of CEHRT dictates stage of Meaningful Use. 11. The notice includes a sentence, “The edition of certified EHR technology which is available to a provider dictates the stage and version of the meaningful use objectives and measures to which the provider will attest.” As it is currently stated in the Proposed Rule, this can be extremely confusing to a provider. For example, EPs most certainly can work at the same practice but be in different stages of MU, despite having the same EHR technology. This statement should be revised to reflect that “the edition of CEHRT which is available to a provider in addition to each individual EP’s prior MU participation dictates the stage . . .” Provide clarification that defines what is meant by “combination of 2011 and 2014 Edition CEHRT.” Page 8 of 11 12. It would assist providers to have CMS more clearly define what is meant by a “Combination of 2011 and 2014 Edition CEHRT.” As stated in the proposed rule, an EP’s CQM reporting could be greatly affected by the fact that they might use a combination of 2011 and 2014 CEHRT or whether their reporting period has X number of days on 2011 CEHRT and Y number of days on 2014 CEHRT. Separate requirements between Core & Menu and CQMs. The Final Rule should allow for different reporting periods and program year requirements for Core & Menu and CQMs. 13. CQMs have proven to be a challenging aspect of meeting Meaningful Use. A community health center recently shared their tale of having to exclude 6 EPs from their 2013 MU attestation applications because their EHR software allowed only one run of 90 day CQMs during any given year. These EPs had met every Core and Menu measure! It is suggested that the Final Rule include the flexibility to EPs to meet 2014 MU by allowing for the separation of CQMs from Core and Menu Measures. Example: If not fully implemented on 2014 CEHRT, an EP may attest to Stage 1 2013 definition for Core and Menu measures using a 2014 90 day reporting period. This same EP may report on 2014 CQMs because it is the only CQM data that they are able to extract from their not-fully-implemented-but-2014-certified EHR. Reporting periods for all EPs should be any continuous 90 days. 14. It is highly encouraged that CMS consider revising reporting periods in 2015. The proposed rule states that the new required start date for exclusive use of 2014 CEHRT is January 1, 2015. Due to the timing of this notice, it is not anticipated to have a Final Rule until the last quarter of 2014. This provides EPs and vendors very little time to be ready for a required full year reporting period commencing on January 1, 2015. It is also recommended that 2015 reporting periods be any continuous 90 day period for all EPs. To restrict Medicare EPs beyond their first year of meeting MU to a calendar quarter, and therefore afforded only 4 reporting period options while their colleagues in the Medicaid EHR program have 280, 90 day reporting period options, is simply not fair. Below is an excerpt from the Stage 2 Final Rule. The fact that quarter reporting is required for only certain providers counters the argument of preserving data validity. We need to encourage the adoption of EHRs and meaningful use for at least a decade before relying on year over year comparisons. Seat belt adoption took Americans 20 years. The full adoption of EHR technology, meaningful use and meaningful data will not be any speedier. https://www.federalregister.gov/articles/2012/09/04/2012-21050/medicare-andmedicaid-programs-electronic-health-record-incentive-program-stage-2 Page 9 of 11 In an effort to preserve some data validity with similar Medicare quality measurement programs, we are finalizing 3-month quarter EHR reporting periods in 2014 for certain providers that are beyond their first year of meaningful use, rather than any continuous 90-day period within the year as for first-time meaningful users. For more information on alignment with other programs, we refer readers to our discussion on clinical quality measures (see section II.B.1. of this final rule). 15. Progression through Stage 3 would be greatly enhanced if the final rule were to include that the first year of each stage (Stages 2 and 3) be a 90 day reporting period as opposed to a full year. The burden of advancing to a new stage coupled with 365 days reporting will see a decrease in successful MU attestations. Be proactive in 2014 to enhance meaningful use through 2020! Clarify in Final Rule that changes pertain to both Medicare and Medicaid EHR Incentive Program participants. As presently drafted, the proposed rule is not clear in regards to Medicaid program participants. 16. It is recommended that CMS include in the Final Rule an additional example (over and above the notice’s Examples A & B) that showcases a Medicaid EP. As the notice stands, it is unclear that the flexibility being provided in the Proposed Rule will be extended to participants in both the Medicare and Medicaid EHR Incentive Programs. Clearly explain the progression of Meaningful Use stages. 17. It is recommended that this rule making clarify the progression of stages for an EP that elects to report to Stage 1 2013 Definition in 2014 wherein that EP had been scheduled to demonstrate Stage 2 in 2014. Does that EP move on to Stage 2 Year 2 in 2015 or Stage 2 Year 1 in 2015? Clearly stating “each EP must attest to two years at each stage before progressing to the next stage, if the next stage is available” would help. Timetable scenario - Medicaid EP: 2011 AIU Incentive 1 of 6 2012 MU Stage 1 Year 1 90 day reporting Incentive 2 of 6 2013 MU Stage 1 Year 2 365 day reporting Incentive 3 of 6 2014 MU Stage 1 Year 3 (per this rulemaking; would have been scheduled to achieve MU Stage 2 Year 1); 90 day reporting Incentive 4 of 6 2015 MU Stage 2 Year 1, 365 day reporting (365 days unless revised per this rulemaking) Incentive 5 of 6 2016 MU Stage 2 Year 2 Incentive 6 of 6 2017 MU Stage 3 Year 1 Not an incentive year Timetable scenario - Medicare EP: 2011 MU Stage 1 Year 1 90 day reporting Incentive 1 of 5 Page 10 of 11 2012 MU Stage 1 Year 2 365 day reporting Incentive 2 of 5 2013 MU Stage 1 Year 3 365 day reporting Incentive 3 of 5 2014 MU Stage 1 Year 4 90 day reporting Incentive 4 of 5 2015 MU Stage 2 Year 1 365 day reporting (365 days unless revised per this rulemaking) Incentive 5 of 5 2016 – No longer earning incentive – MU Stage 2 Year 2, 365 day reporting 2017 – No longer earning incentive – MU Stage 3 Year 1, 365 day reporting CMS should remove the constraints EPs suffer if they work at multiple locations. 18. If an EP works at a location that uses CEHRT, they should be able to demonstrate Meaningful Use per the encounters at that one site alone. This change would likely increase the number of Meaningful Users. To advance the number of meaningful users nationwide, removing all restrictions (applicable to all Stages and all Program Years) that an EP faces if working at multiple locations would benefit many. Multiple Location Scenario: One location is fully implemented on 2014 CEHRT. Other location is not fully implemented on 2014 CEHRT. How would this EP attest to MU in 2014? It is suggested that an EP in a situation like this should attest to MU using encounters from the location wherein they had the most encounters during a 90 day reporting period and that they report using MU data from only that location. CalHIPSO agrees with the extension of Stage 2 and the delay of Stage 3. 19. We agree with the extension of Stage 2 and delay of commencement of Stage 3 until 2017. This will encourage providers to continue with Meaningful Use and not be rushed to adopt new Stage 3 rules. Having a year or two at a particular stage without the burden of meeting the next stage will benefit all! Additionally, having data from Stage 2 will indeed help to inform policy decisions for Stage 3. Add clarifications to the Final Rule around CQM requirements for meeting MU in 2014. 20. The notice includes a section that outlines which CQM measures the EPs would report from if they use only 2011 EHR Edition CERHT. Clarification is needed on the use of the word “any.” As it reads, the CQM reporting period would not have to mirror that of the reporting period used to report on Core and Menu objectives. Per the notice: a. Three core/alternate core b. Three additional measures; and c. The reporting period would be any continuous 90 days within CY 2014 Page 11 of 11 21. The notice includes a section that outlines which CQM measures the EPs would report from if they use a combination of 2011 EHR Edition & 2014 CERHT. Clarification is needed on the phrase, “for the portion of the reporting period in which 2011 Edition CEHRT was in place.” As it reads, the CQM reporting period would not have to mirror that of the reporting period used to report on Core and Menu objectives and could be far less than 90 days. Example: a. 2011 CEHRT January 2014 b. Upgrade of some modules to 2014 CHERT Feb 2014 but not fully implemented c. MU and Core measures would be Jan 2014 – March 2014 but CQMs could be derived exclusively from the 2011 Edition, only 30 days Jan 2014 CalHIPSO appreciates the opportunity to comment on the Proposed Rule Making and we are available to answer any questions that arise from these comments. Please contact DeeAnne McCallin at deeanne@calhipso.org or (510) 302-3364 should you have any questions. Sincerely, DeeAnne McCallin REC Director, Meaningful Use cc: California Primary Care Association (CPCA) California Medical Association (CMA) California Association of Public Hospitals and Health Systems (CAPH) Local Extension Centers Office Health Information Technology, CA Department of Health Care Services CA State Level Registry - Xerox