Year-by-Year and Objective-by-Objective Summary and Analysis of Final Rule with and Stage 3 Meaningful Use Guidance and 2015 CEHRT Rule

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1 Year-by-Year and Objective-by-Objective Summary and Analysis of Final Rule with and Stage 3 Meaningful Use Guidance and 2015 CEHRT Rule On October 16, the Centers for Medicare and Medicaid Services ( CMS ) published in the Federal Register a final rule with comment period ( Final Rule ) implementing changes to the Meaningful Use incentive and payment adjustment program relating to the use of electronic health records by hospitals and eligible professionals. (80 Federal Register 62,761-62,955.) The Final Rule combined two separate rules that were proposed on March 30 the Stage 3 Rule and on April 9 the Modifications Rule. On October 16, CMS also issued a final rule (the 2015 CEHRT Rule ) implementing the 2015 edition of the criteria for certified electronic health record technology ( CEHRT ). (80 Federal Register 62,601-62,759.) Both rules were released in pre-published form on October 6, Effective Dates The Final Rule is effective as of December 15, 2015, 60 days after the October 16, 2015 publication in the Federal Register. The 2015 CEHRT Rule is effective as of January 14, 2015, 90 days after the same publication date. (It is not exactly clear why the two rules had different effective dates.) The Final Rule applies to meaningful use attestation and compliance for calendar year Solicitation of Comments The Final Rule invited comments on certain provisions of the Final Rule applicable in 2017 or later. Comments are due by December 15, Comments were invited on the EHR reporting period for 2017 as well as Stage 3 criteria for 2018 and beyond. Summary of Major Changes Neither the Final Rule nor the 2015 CEHRT Rule made major changes from the rules that were proposed in March and April, but they did make significant changes to the Meaningful Use program beginning immediately. Among the significant changes contained in the Final Rule: Calendar Year Reporting for Hospitals For hospitals, the EHR reporting period changed from the federal fiscal year, which would have been September 30, 2015 for the current year, to the calendar year, meaning hospitals can use the period between October 1, 2014 through December 31, 2015 for their 2015 Meaningful Use attestation year v1 Bricker & Eckler LLP Page 1

2 90-Day Reporting Periods for 2015 For hospitals and eligible professionals ( EPs ), the 2015 reporting period can be any consecutive 90-day period instead of the full year, regardless of the current stage of meaningful use. For hospitals, the reporting period does not need to be a calendar year quarter. Stage 1 Basically Eliminated Except for some exclusions for hospitals and EPs that otherwise would have been eligible for Stage 1, all Meaningful Users will need to satisfy requirements under modified Stage 2 beginning in Option and Incentive to Start Stage 3 in 2017 Providers have the option of starting Stage 3 compliance in 2017 and, if they do so, they have the option (and incentive) to choose a 90-day reporting period. If they wait until 2018 to start Stage 3, the reporting period must be a full calendar year of compliance. Name Changes, But Transitions of Care Still Present what used to be called or referred to as Summary of Care or Transitions of Care is now called Health Information Exchange but that is not referring to organizations that are set up as health information exchanges. (Confused yet?) Menu and Core Concepts Removed; Fewer Objectives? Effective in 2015, there will no longer be core objectives required of all Meaningful Users and a menu of objectives of which Meaningful Users must satisfy some but not all objectives. Instead, there will simply be Objectives and corresponding Measures for each Objective. In theory, there are fewer Objectives. However, the requirements of two or more Objectives often exist under one Objective now, so the overall number of requirements may not be reduced in reality. In addition, with some of the Stage 3 Objectives, there are options to meet two of three possible threshold measures, even though the attesting provider is still required to attest to all three measures. Payment Adjustment Processes Modified The length of the reporting period, the deadlines for attesting and the timing of the payment adjustment year were modified in the Final Rule, mostly to align with the other changes to reporting periods discussed above. The following providers may use continuous 90-day reporting periods to avoid a payment adjustment: all participants attesting during 2015; providers attesting for the first time during any year between 2015 and 2017; providers attesting to Stage 3 in 2017; and providers attesting for the first time under the Medicaid program in For those first time attesters, the deadline for attestations is October 1 to avoid a payment adjustment in the next year following that October 1 (e.g., attest by October 1, 2016 to avoid 2017 payment adjustment), and February 28/29 to avoid a payment adjustment in the second year following the meaningful use year (e.g., attest by February 29, 2016 as to 2015 meaningful use to avoid a payment adjustment in 2017). A first time attester in 2015 can actually avoid a payment adjustment in both 2016 and 2017 by attesting by February 29, All second year or later participants must use a full calendar year reporting to avoid a payment adjustment in the second calendar year following the year of meaningful use (e.g., attest by February 29, 2016 as to 2015 meaningful use to avoid a 2017 payment adjustment) v1 Bricker & Eckler LLP Page 2

3 Which CEHRT Criteria Apply By finalizing the 2015 certification criteria for EHR technology, providers will now have to decide when to convert from the currently-required 2014 Edition CEHRT criteria to the 2015 Edition CEHRT criteria. For 2015, the 2014 Edition CEHRT criteria are required. For 2016 and 2017, providers have the option to choose either the 2014 Edition criteria or the 2015 Edition criteria, or some combination of both criteria. For 2018 and beyond, the 2015 Edition criteria are required. Elimination of any paper-based formats for Stage 3 No Stage 3 Objectives will allow compliance through the use of paper-based formats as some Stage 2 Objectives allow (e.g., Stage 2 clinical summary objective). Year-by-year Summary As a result of the changes made in the Final Rule and the 2015 CEHRT Rule, the following applies to hospitals and EPs for 2015: Calendar year reporting for everyone. This means that hospitals 2015 Meaningful Use reporting period runs from October 1, 2014 through December 31, It also means that incentive payments will arrive around three months later than if attestations were done in late Any continuous 90-day period during calendar year 2015 (or, for hospitals, the 15-month period beginning October 1, 2014) may be used as the EHR reporting period. This does not have to be a calendar quarter. Attestations are due by February 29, Attestations are not expected to be available or accepted until January 4, If 2015 is the first year of Meaningful Use attestation, then: o the attesting provider must meet the modified Stage 2 requirements, though the provider can take advantage of certain exclusions that apply to providers that would otherwise be in Stage 1; and o successful attestation by February 29, 2016 would avoid a payment adjustment in 2016 and If 2015 is not the first year of Meaningful Use attestation, then: o the attesting provider must meet the modified Stage 2 requirements. If the provider could have attested to Stage 1 in 2015 prior to the Final Rule, the provider may qualify for certain exclusions that apply to providers that would otherwise be in Stage 1; and v1 Bricker & Eckler LLP Page 3

4 o successful attestation by February 29, 2016 would avoid a payment adjustment in The 2014 Edition Criteria for CEHRT apply. As a result of the changes made in the Final Rule and the 2015 CEHRT Rule, the following applies to hospitals and EPs for 2016: Full calendar year reporting periods for everyone, EXCEPT first time meaningful use attesting providers may use any continuous 90-day reporting period. Attestations are due by February 28, For providers that would have otherwise been eligible for Stage 1 in 2016, most of the Stage 1 exclusions are no longer applicable. However, if a provider does not possess the requisite CEHRT modules for the lab and radiology measures under the CPOE Objective (Objective 3 under Stage 2) or the electronic prescribing Objective (Objective 4 under Stage 2), an exclusion is available. If 2016 is the first year of Meaningful Use attestation, then: o Successful attestation by October 1, 2016 would avoid a payment adjustment in 2017 and 2018; and o Successful attestation by February 28, 2017 would avoid a payment adjustment in If 2016 is not the first year of Meaningful Use attestation, then successful attestation by February 28, 2017 would avoid a payment adjustment in Providers have the option of using CEHRT technology certified under either the 2014 Edition Criteria or the just-finalized 2015 Edition Criteria. As a result of the changes made in the Final Rule and the 2015 CEHRT Rule, the following applies to hospitals and EPs for 2017: Full calendar year reporting for everyone, EXCEPT for providers attesting for Medicaid for the first time, in which case any continuous 90-day period may be used. Also, providers attesting to Stage 3 in 2017 may use a 90-day continuous reporting period. Successful attestation for Stage 3 in 2017 would avoid a payment adjustment in v1 Bricker & Eckler LLP Page 4

5 If 2017 is the first year of Meaningful Use attestation, then: o Successful attestation by October 1, 2017 would avoid a payment adjustment in 2018 and 2019; and o Successful attestation by February 28, 2018 would avoid a payment adjustment in If 2017 is not the first year of Meaningful Use attestation, then successful attestation by February 28, 2018 would avoid a payment adjustment in Providers have the option of using CEHRT technology certified under either the 2014 Edition Criteria or the just-finalized 2015 Edition Criteria. As a result of the changes made in the Final Rule and the 2015 CEHRT Rule, the following applies to hospitals and EPs for 2018: Full calendar year reporting for everyone, EXCEPT for providers attesting for Medicaid for the first time, in which case any continuous 90-day period may be used. Successful attestation by February 28, 2019 would avoid a payment adjustment in Providers must use the just-finalized 2015 Edition Criteria. Objective-by-Objective Summary The Final Rule included a chart summarizing all of the Objectives and Measures and exclusions for hospitals and for EPs for This is located at 80 Federal Register 62,826-62,829 and is attached at the end of this summary. The following chart organizes the Objectives in a slightly different way showing the Objectives and how each is referenced depending on whether it applies to the modified Stage 2 standards available between 2015 and 2017 and the Stage 3 requirements for the same Objective, with a summary and analysis of some of the notable changes or rationale expressed by CMS in the commentary accompanying the Final Rule v1 Bricker & Eckler LLP Page 5

6 Protect Patient Health Information Affirmed that provider must conduct or Mod. Stage 2 = Objective 1 review a security risk analysis (SRA) for Stage 3 = Objective 1 each EHR reporting period and noted that SRA can be conducted outside the EHR reporting period if the period is less than one year, but analysis/review must be conducted within the same calendar year as the EHR reporting period. If provider attests prior to the end of the calendar year, it must be conducted prior to the date of attestation. Noted that an organization may conduct one security risk analysis or review which is applicable to all EPs if within the same calendar year and prior to any EP attestation. Stage 3 Maintained previously finalized Stage 2 objective on protecting ephi. Explained that the MU requirement for SRA is narrower than what is required to satisfy HIPAA in that the MU measure is limited to annually conducting or reviewing an SRA related to ephi created by or maintained in CEHRT. Under HIPAA, the SRA must assess the potential risk and vulnerabilities of all ephi including ephi in all forms of electronic media (hard drives, floppy disks, CDs, DVDs, others). Confirmed that EPs and hospitals must conduct the SRA upon installation of CEHRT or upon upgrade to a new Edition and then must review the SRA and make updates as necessary and at least once per EHR reporting period. Noted that the analysis and review must be completed in the same calendar year as the EHR reporting period either before or during the EHR reporting period; or, if it occurs after the EHR reporting period, it must occur before the provider attests or before the end of the calendar year, whichever date comes first v1 Bricker & Eckler LLP Page 6

7 Clinical Decision Support Declined to establish an exclusion for the Mod. Stage 2 = Objective 2 first measure (implement five CDS) based Stage 3 = Objective 3 upon specialty. Continued to include the use of drug-drug and drug-allergy interaction checks. Clarified that exclusion language fewer than 100 (medication orders, office visits, etc.) means fewer than 100 during the EHR reporting period. Stage 3 Emphasized the broad definition of CDS including computerized alerts and reminder, clinical guidelines, conditionspecific order sets, documentation templates, focused patient data reports and summaries, and contextually relevant reference information. Commented that providers who are not able to identify CQMs that apply to their scope of practice or patient population may implement CDS interventions that they believe are related to high-priority health conditions relevant to their patient population which will be effective in improving the quality, safety, or efficiency of patient care. Clarified that the implementation of five CDS interventions is a minimum and that the same interventions do not have to be implemented for the entire EHR reporting period as long as the threshold of five is maintained for the duration of the EHR reporting period. Noted that the definition of enabled means the provider is actively using the function for the duration of the EHR reporting period at the relevant point in care (rather than just having the functionality available) v1 Bricker & Eckler LLP Page 7

8 Computerized Provider Order Maintained the position that the provider Entry inputting the CPOE must have at least a Mod. Stage 2 = Objective 3 certain level of medical training in order Stage 3 = Objective 4 to execute the related CDS for a CPOE order entry. Deferred to the provider sdetermination of the proper credentialing, training, and duties of the staff member entering the orders as long as they fit within the proscribed guidelines. Maintained the position that scribes are not included as staff who may enter orders for purposes of CPOE; noted that policy is not specific to job title but rather to appropriate medical training, knowledge and experience. Noted that a circumstance involving telehealth or remote communication may be included in the numerator as long as the order entry otherwise meets the requirements of the objective and measures. Continued to allow providers to exclude orders that are predetermined for a given set of patient characteristics or for a given procedure for the calculation of CPOE numerators and denominators. Clarified that multiple tests ordered at the same time count individually if they fall under a different order code. Finalized an alternate exclusion in 2016 to Stage 3 Declined to increase the threshold for CPOE of medical orders which results in all three measures having the same threshold (60%) Continued stance that a layperson is not qualified to perform order entry and that the order must be entered by a qualified individual. Deferred to the provider s discretion to determine the appropriateness of the credentialing of staff to ensure that any staff entering orders have the clinical training and knowledge required to enter orders for CPOE. Maintained that CPOE should be used the first time the order becomes part of the patient s medical record and before any action can be taken on the order. Expanded third measure from radiology orders to diagnostic imaging orders and increased the thresholds for the measures v1 Bricker & Eckler LLP Page 8

9 allow providers to elect to exclude from lab orders and radiology orders for an EHR reporting period in 2016 if they were previously scheduled to be in Stage 1 in Electronic Prescribing Changed the measure to remove the term Mod. Stage 2 = Objective 4 controlled substances from the Stage 3 = Objective 2 denominator; instead reads permissible prescription which supports the current policy for Stage 2 allowing but not requiring providers to include prescriptions for controlled substances in the measure. For EPs, clarified that providers may count a patient in the numerator where no formulary exists to conduct a query, and providers may also limit their effort to query a formulary to simply using the function available to them in their CEHRT with no further action required. If a query using the function of their CEHRT is not possible or shows no result, a provider is not required to conduct any further manual or paper-based action in order to complete the query, and the provider may count the prescription in the numerator. For hospitals, modified the measure language to remove the requirement for refill prescriptions and allow providers discretion over including or excluding Stage 3 Clarified that over the counter medications should be excluded from the definition of prescription. For EPs, lowered to 60% (from 80%) the percent of all permissible prescriptions that must be queried for a drug formulary and transmitted electronically using CEHRT. Noted that prescription includes authorization for refills of previously authorized drugs. Continued to allow providers the option to include or exclude controlled substances in the denominator where such medications can be electronically prescribed v1 Bricker & Eckler LLP Page 9

10 these prescriptions rather than requiring providers to exclude them. Health Information Exchange Updated the measure to require a provider Mod. Stage 2 = Objective 5 to create the summary of care using Stage 3 = Objective 7 CEHRT but not specifying the manner in (formerly known as Summary of which the summary of care record must be Care ) transmitted to allow flexibility. Maintained existing Stage 2 policies including requirements for the data elements included in the summary of care document. Requires providers to have ability to send all lab test results in the summary of care document, but allows providers to establish parameters for clinical relevance (i.e. to determine what information is relevant to include in the transition of care); providers must have ability to send all results if requested. Set percentage for measure at relatively low level of 10% (providers must electronically transmit a summary of care record to a receiving provider for more than 10% of transitions of care and referrals) due to concerns about lack of participation by EPs to whom referrals are made, such as specialists. Clarified transition of care is where the referring provider is under a different billing identity within the EHR Incentive Program than the receiving provider and Stage 3 Three measures, of which providers must only meet two but attest to all; percentages increased from Stage 2 s 10% to 50% of transitions of care initiated; other two measures require 40% of transitions of care received and 80% of new patient clinical information reconciliations. For transitions of care initiated (Measure 1), all summary of care records used to meet this objective must be populated with fields specified in the Common Clinical Data Set specified in the 2015 edition CEHRT criteria; providers can exercise discretion to determine which historical items are relevant to include in light of current clinical circumstances, but providers must have CEHRT functionality to include and send all labs or clinical notes, problem lists and the care plan within the summary of care document. Transitions of care to providers that share an EHR may be counted if they do so across all settings and for all such transitions and also providers must complete the required action for each measure (not merely share access to the EHR). Providers may count, but are not required v1 Bricker & Eckler LLP Page 10

11 where the providers do not share an EHR; if providers share an EHR, a transition of care referral may still count toward the measure if the referring provider creates a summary of care document using CEHRT and sends the summary document electronically; if a provider chooses to count such transitions it must do so for all patients. Stage 3 to count, patients who self-refer or selfselected a follow-up provider; providers must determine in what cases they will or will not include patient self-referrals and apply across all such referrals throughout the EHR reporting period and should seek to receive or retrieve a summary of care document from the other provider of care and reconcile clinical information once the provider is identified for measures 2 and 3. Clarified that the initiating provider in a referral must send a C-CDA document that the receiving provider would be capable of electronically incorporating as a C-CDA upon receipt; the sending provider cannot convert the file to a format the receiving provider could not electronically receive and incorporate as a C-CDA; for measure 1, a sending provider must have confirmation of receipt or that a query of the summary of care record occurred to count the action. Finalized exclusion for EPs who transfer a patient to another setting or refer a patient to another provider less than 100 times during the EHR reporting period v1 Bricker & Eckler LLP Page 11

12 Patient Specific Education Clarified that while patient-specific Mod. Stage 2 = Objective 6 education resources may be provided Stage 3 = not required outside of the EHR reporting period, this action must occur no earlier than the start of the same year as the EHR reporting period if the EHR reporting period is less than one full calendar year and no later than the date of attestation. Patient Electronic Access to Health Information Mod. Stage 2 = Objective 8 Stage 3 = Objective 5 Finalized measure 1,which requires that 50 percent of all unique patients seen by an EP, or who are discharged from a hospital inpatient ED during the EHR reporting period,are provided timely access to view online, download, and transmit to a third party their health information. Clarified that the measure requires patient access for each and every time new information is generated for the patient, regardless of when a patient is first enrolled or given electronic access to their record. For measure 2 in 2015 and 2016, at least one patient, and in 2017, more than 5% of patients during the EHR reporting period must view, download or transmit to a third party his or her health information during the EHR reporting period. Stage 3 NOT APPLICABLE Providers can give access using different forms of access and do not require a patient address; providers can meet the measure by providing the patient all of the necessary information to access their information, such as through a patient representative, or they can opt back in to participation using an address at any time. Timeframe for providing access to new information is 36 hours for hospitals and 4 business days for EPs. A patient who has multiple encounters during the EHR reporting period, or even in subsequent EHR reporting periods in future years, needs to have access to the information related to their care for each encounter. Patient actions must be taken during the same year as the EHR reporting period and no later than the date of attestation v1 Bricker & Eckler LLP Page 12

13 Coordination of Care Through Patient Engagement NOT APPLICABLE Mod. Stage 2 = Not required Stage 3 = Objective 6 Medication Reconciliation Mod. Stage 2 = Objective 7 Stage 3 = Not required Clarified that an electronic summary of care document is not required for medication reconciliation. Noted that reconciliation occurs with the Stage 3 For measure 1, 10% of all unique patients seen or discharged actively engage with the EHR by either (1) view, download, or transmit their information to a third party; (2) accessing their health record using API; or (3) a combination of (1) and (2). For measure 2, 5% in 2017, and 25% in 2018 and later, of all unique patients seen or discharged are sent a secure message using CEHRT or in response to a secure message sent by the patient. For measure 3, patient generated health data or data from a non-clinical setting must be incorporated into the CEHRT for more than 5% of all unique patients seen or discharged. For measure 3, the types of data that can be incorporated into the patient s medical record are broad (e.g., social service data, data generated by the patient, advance directives, medical device data, home health monitoring data, and fitness monitor data) and from varying sources (e.g., mobile applications for tracking health and nutrition, home health devices with tracking, patient-reported outcome data). NOT APPLICABLE v1 Bricker & Eckler LLP Page 13

14 transition or referral, not with the receipt of the summary of care document. Clarified that the denominator includes first encounters with a new patient and encounters with existing patients where a summary of care record (of any type) is provided to the receiving provider. Public Health and Clinical Data Three options for EPs: 1) immunization Registry Reporting registry reporting; 2) syndromic Mod. Stage 2 = Objective 10 surveillance reporting; or 3) specialized Stage 3 = Objective 8 registry reporting; Four options for hospitals: same 3 options as available to EPs plus electronic reportable lab result reporting. Providers need to register with a public health agency or clinical data registry only once and can register before the EHR reporting period begins, including from prior MU stages; they must register for each measure they intend to use to meet MU. Providers may report to more than one specialized registry and may count specialized registry reporting more than once to meet the required number of measures for the objective. Secure Electronic Messaging (EP only) Mod. Stage 2 = Objective 9 Stage 3 = not required Clarified that fully enabled means the function is fully installed, any security measures are fully enabled, and the function is readily available for patient use. Stage 3 Six options for providers: 1) immunization registry reporting; 2) syndromic surveillance reporting; 3) electronic case reporting; 4) public health registry reporting; 5) clinical data registry reporting; 6) electronic reportable laboratory results. EPs required to choose from measures 1-5 and to attest to any combination of two; and hospitals required to choose from measures 1-6 and required to attest to any combination of four. Providers may attest to measure 4 (public health registry) and measure 5 (clinical data registry) more than once. NOT APPLICABLE v1 Bricker & Eckler LLP Page 14

15 Finalized fully enabled for 2015, at least one patient for 2016, and a threshold of 5 percent for 2017 to build toward the Stage 3 threshold. Stage v1 Bricker & Eckler LLP Page 15

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