Source: http://www.regulations.gov/?_escaped_fragment_=documentDetail;D=CMS-2014-0064-0002
Timestamp: 2016-08-31 06:18:57
Document Index: 321303338

Matched Legal Cases: ['art 495', 'art 495', 'art 170', 'art 495', 'art 170', '§ 170', 'art 495']

Skip Navigation HomeHelpResourcesContact Us Advanced Search Start of Main Content Medicare and Medicaid Programs; Modifications, Revisions: Medicare and Medicaid Electronic Health Record Incentive Programs for 2014; Health Information Technology This Proposed Rule document was issued by the Centers for Medicare Medicaid Services (CMS) For related information, Open Docket Folder Show agency attachment(s) DEPARTMENT OF HEALTH AND HUMAN SERVICES
[CMS-0052-P]
RIN 0991-AB97
AgencyCenters for Medicare & Medicaid Services (CMS), and Office of the National Coordinator for Health Information Technology (ONC), HHS.
SummaryThis proposed rule would change the meaningful use stage timeline and the definition of certified electronic health record technology (CEHRT). It would also change the requirements for the reporting of clinical quality measures for 2014.
DatesTo be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on July 21, 2014.
AddressesIn commenting, please refer to file code CMS-0052-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health andHuman Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For Further Information ContactElizabeth Holland, (410) 786-1309.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.I. BackgroundA. Statutory Basis for the Medicare and Medicaid EHR Incentive ProgramsThe American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) amended Titles XVIII and XIX of the Social Security Act (the Act) to authorize incentive payments to eligible professionals (EPs), eligible hospitals, critical access hospitals (CAHs), and Medicare Advantage (MA) organizations to promote the adoption and meaningful use of certified electronic health record (EHR) technology. Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act provide the statutory basis for the Medicare incentive payments made to meaningful EHR users. These statutory provisions govern EPs, MA organizations (for certain qualifying EPs and hospitals that meaningfully use certified EHR technology (CEHRT), subsection (d) hospitals, and CAHs, respectively. Sections 1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also establish downward payment adjustments, beginning with calendar or fiscal year 2015, for EPs, MA organizations, subsection (d) hospitals, and CAHs that are not meaningful users of CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for Medicaid incentive payments.B. Considerations in Defining Meaningful Use and CEHRTIn sections 1848(o)(2)(A) and 1886(n)(3)(A) of the Act, the Congress identified the broad goal of expanding the use of EHRs through the concept of meaningful use. Section 1903(t)(6)(C) of the Act also requires that Medicaid providers adopt, implement, upgrade, or meaningfully use CEHRT if they are to receive incentives under Title XIX of the Act. CEHRT used in a meaningful way is one piece of the broader health information technology (HIT) infrastructure needed to reform the health care system and improve health care quality, efficiency, and patient safety. This vision of reforming the health care system and improving health care quality, efficiency, and patient safety should inform the definition of meaningful use.
On September 4, 2012, we published in theFederal Register(77 FR 53968 through 54162) a final rule titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 2,” that established, among other final policies, the timeline for the stages of meaningful use through 2021 and the EHR reporting periods in 2014, as shown in Table 1 (77 FR 53973 through 53975).
First payment yearStage of meaningful use20112012201320142015201620172018201920202021
2011111* 2233TBDTBDTBDTBD
201211* 2233TBDTBDTBDTBD
20131* 12233TBDTBDTBD
2014* 112233TBDTBD
EPs, eligible hospitals, and CAHs that attest to meaningful use for 2014 for their first year of Stage 2 or their second year of Stage 1 have a 3-month quarter EHR reporting period in CY 2014 (EPs) or FY 2014 (eligible hospitals and CAHs). For the Medicaid incentive payments for meaningful use, EPs have an EHR reporting period of any continuous 90-day period in CY 2014 as defined by the State Medicaid program, or, if the State so chooses, any 3-monthCY quarter in 2014. EPs, eligible hospitals, and CAHs that demonstrate meaningful use for the first time in 2014 have an EHR reporting period of any continuous 90-day period in CY 2014 or FY 2014, respectively.II. Provisions of the Proposed RegulationsA. Proposed Changes to Meaningful Use Stage Timeline and the Use of CEHRT1. Reporting in 2014We are revisiting some of the requirements for the Medicare and Medicaid EHR Incentive Programs for 2014. Many EHR vendors have indicated, through letters to CMS, public forums and listening sessions, survey data, and information related to the certification and testing process, that the amount of time available after the publication of the Stage 2 final rule in which to make the required coding changes to enable their EHR products to be certified to the 2014 Edition of EHR certification criteria was much too short. We understand, based on information gained from EHR technology developers and ONC-Authorized Certification Bodies on timing, backlogs, and the certification case load, many EHR products were certified later than anticipated, which has impacted the corresponding time available to providers—especially hospitals—to effectively deploy 2014 Edition CEHRT and to make the necessary patient safety, staff training, and workflow investments in order to be prepared to demonstrate meaningful use in 2014. The availability of 2014 Edition CEHRT is further limited by the large number of providers needing to upgrade to 2014 Edition CEHRT. By the end of February 2014, over 350,000 providers had received an EHR incentive payment for adopting, implementing, or upgrading, or for successfully demonstrating meaningful use using 2011 Edition CEHRT. All providers need 2014 Edition CEHRT to adopt, implement, or upgrade, or to successfully demonstrate meaningful use for Stage 1 or Stage 2 in 2014. Through letters to CMS, public forums, listening sessions, and public comment at CMS meetings, many provider associations have expressed concern that, although 2014 Edition CEHRT may be available for adoption, there is a backlog of many months for the updated version to be installed and implemented so that providers can successfully attest for 2014. We also understand that the delay in availability may limit a provider's ability to fully implement 2014 Edition CEHRT across the facility. For example, (1) a hospital may have different systems in multiple settings, which all require an update and integration or (2) a provider may have certain 2014 Edition CEHRT functionality that, once implemented in a live setting, requires software patches or workflow changes.
The three options for the use of CEHRT editions and the available Stage of meaningful use objectives and measures associated with each option are as follows:a. Using 2011 Edition CEHRT OnlyWe are proposing that all EPs, eligible hospitals, and CAHs that use only 2011 Edition CEHRT for their EHR reporting period in 2014 must meet the meaningful use objectives and associated measures for Stage 1 under 42 CFR 495.6 that were applicable for the 2013 payment year, regardless of their current stage of meaningful use. We note that in the Stage 2 final rule (77 FR 53975 through 53979), we finalized certain changes to the Stage 1 objectives and associated measures, and some of those changes were applicable beginning with 2013 while other changes were applicable beginning with 2014. For ease of reference, we will refer to the Stage 1 objectives and associated measures under 42 CFR 495.6 that were applicable for 2013 as the “2013 Stage 1 objectives and measures,” and we will refer to the Stage 1 objectives and associated measures under 42 CFR 495.6 that are applicable for 2014 as the “2014 Stage 1 objectives and measures.” Providers who choose this option must attest that they are unable to fully implement 2014 Edition CEHRT because of issues related to 2014 Edition CEHRT availability delays when they attest to the meaningful use objectives and measures.b. Using a Combination of 2011 and 2014 Edition CEHRTWe are proposing that all EPs, eligible hospitals, and CAHs using a combination of 2011 Edition CEHRT and 2014 Edition CEHRT for their EHR reporting period in 2014 may choose to meet the 2013 Stage 1 objectives and measures or the 2014 Stage 1 objectives and measures, or if they are scheduled to begin Stage 2 in 2014 under the timeline shown in Table 1, they may choose to meet the Stage 2 objectives and associated measures under 42 CFR495.6. Providers who choose this option must attest that they are unable to fully implement 2014 Edition CEHRT because of issues related to 2014 Edition CEHRT availability delays when they attest to the meaningful use objectives and measures.c. Using 2014 Edition CEHRT for 2014 Stage 1 Objectives and Measures in 2014 for Providers Scheduled To Begin Stage 2A provider's ability to fully implement all of the functionality of 2014 Edition CEHRT may be limited by the availability and timing of product installation, deployment of new processes and workflows, and employee training. This effect is compounded for providers in Stage 2 as some providers may not be able to fully implement all of the functions included in 2014 Edition CEHRT that are necessary to meet the Stage 2 objectives and measures in time to complete their EHR reporting period in 2014. Therefore, under our proposal, providers who are scheduled to begin Stage 2 for the 2014 EHR reporting period but are unable to fully implement all the functions of their 2014 Edition CEHRT required for Stage 2 objectives and measures due to delays in 2014 Edition CEHRT availability would have the option of using 2014 Edition CEHRT to attest to the 2014 Stage 1 objectives and measures for the 2014 EHR reporting period. Providers who are scheduled to begin Stage 2 in 2014 who choose this option must attest that they are unable to fully implement 2014 Edition CEHRT because of issues related to 2014 Edition CEHRT availability delays when they attest to the meaningful use objectives and measures.
If you were scheduled to demonstrate:You would be able to attest for Meaningful Use:Using 2011 Edition CEHRT to do:Using 2011 & 2014 Edition CEHRT to do:Using 2014 Edition CEHRT to do:
Stage 1 in 20142013 Stage 1 objectives and measures *2013 Stage 1 objectives and measures *2014 Stage 1 objectives and measures
-OR- 2014 Stage 1 objectives and measures * Stage 2 in 20142013 Stage 1 objectives and measures *2013 Stage 1 objectives and measures *2014 Stage 1 objectives and measures *
2014 Stage 1 objectives and measures *Stage 2 objectives and measures *
-OR- Stage 2 objectives and measures * The following are example scenarios under our proposal.
Example A: An EP initiated participation in the Medicare EHR Incentive Program in 2011. The EP successfully demonstrated meaningful use and received incentive payments for 2011, 2012, and 2013. Based on the timeline in the Stage 2 final rule, the EP is required to use 2014 Edition CEHRT and demonstrate Stage 2 of meaningful use in 2014. Under our proposal, this EP who is scheduled to begin Stage 2 in 2014 would have the following options: Attest to the Stage 2 objectives and measures of meaningful use using 2014 Edition CEHRT in 2014 as scheduled.
Attest to the 2013 Stage 1 objectives and measures using 2011 Edition CEHRT or a combination of 2011 and 2014 Edition CEHRT in 2014 if they are unable to fully implement 2014 Edition CEHRT due to delays in 2014 Edition CEHRT availability. Clinical quality measures must be submitted through attestation if attesting to the 2013 Stage 1 objectives and measures as discussed below in section B of this proposal. Example B: An EP initiated participation in the Medicare EHR Incentive Program in 2013. The EP successfully demonstrated meaningful use and received an incentive payment for 2013. Based on the timeline in the Stage 2 final rule, the EP is required to use 2014 Edition CEHRT and demonstrate Stage 1 of meaningful use in 2014. Under our proposal, this EP would have one of the following options: Attest using 2014 Edition CEHRT to the 2014 Stage 1 objectives and measures of meaningful use in 2014 as scheduled.
Attest using 2011 Edition CEHRT or a combination of 2011 and 2014 Edition CEHRT and meet the 2013 Stage 1objectives and measures of meaningful use in 2014 if they are unable to fully implement 2014 Edition CEHRT due to delays in 2014 Edition CEHRT availability. Clinical quality measures must be submitted through attestation if attesting to the 2013 Stage 1 objectives and measures as discussed in section II.B. of this proposed rule.2. Extension of Stage 2Under the current timeline shown in Table 1, an EP, eligible hospital or CAH that first became a meaningful user in 2011 or 2012 would be required to begin Stage 3 on January 1, 2016 (the first day of CY 2016 for EPs) or October 1, 2015 (the first day of FY 2016 for eligible hospitals or CAHs), respectively. However, because we intend to analyze the meaningful use Stage 2 data to inform our development of the criteria for Stage 3 of meaningful use, we are proposing a 1-year extension of Stage 2 for those providers as is reflected in Table 3. We are proposing that Stage 3 would begin in CY 2017 for EPs and FY 2017 for eligible hospitals and CAHs that first became meaningful users in 2011 or 2012. The goal of this proposed change is two-fold: First, to allow CMS and ONC to focus efforts on the successful implementation of the enhanced patient engagement, interoperability, and health information exchange requirements in Stage 2; and second, to utilize data from Stage 2 participation to inform policy decisions for Stage 3.
2011111* 1 or 22233TBDTBDTBD
201211* 1 or 22233TBDTBDTBD
We invite public comment on our proposals.B. Clinical Quality Measure Submission in 2014In 2014, as part of the definition of “meaningful EHR user” under 42 CFR 495.4, all providers are required to select and report on clinical quality measures (CQMs) from the relevant sets adopted in the Stage 2 final rule (77 FR 54069 through 54075, and 77 FR 54081 through 54089 and further specified as noted in the December 7, 2012 interim final rule with comment period (77 FR 72985) and published on the CMS eCQM Library [http://cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/eCQM_Library.html], regardless of their stage of meaningful use or year of participation in the EHR Incentive Program. We are proposing the following changes for reporting on clinical quality measures in 2014 for EPs, eligible hospitals, and CAHs for the Medicare and Medicaid EHR Incentive Programs. The method of CQM submission under this proposal would depend on the edition of CEHRT a provider uses to record, calculate, and report its clinical quality measures for the selected EHR reporting period in 2014.
Due to limitations in the Registration and Attestation System for the EHR Incentive Program and other CMS data systems, the reporting options and methods for CQMs for 2014 would depend upon the edition of CEHRT that a provider uses for its EHR reporting period in 2014. If a provider elects to use only 2011 Edition CEHRT for its EHR reporting period in 2014, the provider would be required to report CQMs by attestation as follows: EPs would report from the set of 44 measures and according to the reporting criteria finalized in the Stage 1 final rule (75 FR 44386 through 44411)—++Three core/alternate core;
++The reporting period would be any continuous 90 days within CY 2014 for EPs that are demonstrating meaningful use for the first time or a 3-month CY quarter for EPs that have previously demonstrated meaningful use. Eligible hospitals and CAHs would report all 15 measures finalized in the Stage 1 final rule (75 FR 44411 through 44422).
The reporting period would be any continuous 90 days within FY 2014 for hospitals that are demonstrating meaningful use for the first time or a 3-month FY quarter for hospitals that have previously demonstrated meaningful use.If a provider elects to use a combination of 2011 Edition and 2014 Edition CEHRT and chooses to attest to the 2013 Stage 1 objectives and measures for its EHR reporting period in 2014, the provider would be required to report CQMs by attestation using the same measure sets and reporting criteria outlined earlier for providers who elect to use only 2011 Edition CEHRT for their EHR reporting periods in 2014. Because of the differences in how CQMs are calculated and tested between the 2011 and the 2014 Editions of CEHRT, we are further proposing that a provider may attest to data for the CQMs derived exclusively from the 2011 Edition CEHRT for the portion of the reporting period in which 2011 Edition CEHRT was in place.
We invite public comment on our proposal.C. Revision to the CEHRT Definition for Additional Flexibility in 2014To support the CMS proposals to provide additional flexibility in the Medicare and Medicaid EHR Incentive Programs during 2014, ONC is proposing to make a minor, but necessary, corresponding revision to the CEHRT definition at 45 CFR 170.102.
Specifically, ONC is proposing to modify the CEHRT definition at 45 CFR 170.102 to replace the following “2013” with “2014” in the first sentence of paragraph (1).
“2014” with “2015” in the first sentence of paragraph (2).Overall, this proposed revision would make the first day of FY 2015 (for eligible hospitals and CAHs) and CY 2015 (for eligible professionals) the new required start date for exclusive use of 2014 Edition certified Complete EHRs and EHR Modules to meet the CEHRT definition.
We invite public comment on our proposals.III. Collection of Information RequirementsThis document does not impose any new information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements, as defined under the Paperwork Reduction Act of 1995 (5 CFR 1320). However, it does make reference to the currently approved information collection request associated with the Electronic Health Record Incentive Program. The information collection requirements for the program are currently approved under OMB control number 0938-1158 with an expiration date of April 30, 2015.IV. Response to CommentsBecause of the large number of public comments we normally receive onFederal Registerdocuments, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in theDATESsection of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.V. Regulatory Impact StatementWe have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately$141 million. This rule will have no consequential effect on State, local, or tribal governments or on the private sector.
List of Subjects42 CFR Part 495
For the reasons stated in the preamble of this proposed rule, the Centers for Medicare & Medicaid Services is proposing to amend 42 CFR Part 495 and the Department is proposing to amend 45 CFR Part 170 as set forth below:Title 42—Public HealthPart 495 Standards for the Electronic Health Record Technology Incentive Program
* * * * *Title 45—Public HealthPart 170 Health Information Technology Standards Implementation Specifications and Certification Criteria and Certification Programs for Health Information Technology
Authority42 U.S.C. 300jj-11; 42 U.S.C. 300jj-14; 5 U.S.C. 552.
4. In § 170.102, the definition of “Certified EHR Technology” is amended as follows:
[FR Doc. 2014-11944 Filed 5-20-14; 4:15 pm]BILLING CODE 4120-01-P
Attachments View All (0) View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed Jul 21 2014, at 11:59 PM ET ID: CMS-2014-0064-0002 Tracking Number: View original printed format: Document Information Date Posted: May 27, 2014RIN: 0938-AS30CFR: 42 CFR Part 495Federal Register Number: 2014-11944 Show More Details Submitter Information Comments1,139 Comments Received* See Attached View Comment See Attached View Comment Who are we?
o Visonex is an EHR Vendor providing solutions to the Dialysis Clinic who service the approximately 400,000 Medicare beneficiaries with ESRD.
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