Meaningful Use and its Evolution

What is Meaningful Use?

Meaningful Use is the use of certified EHR technology in a meaningful manner (for instance, electronic prescribing); ensuring that the certified EHR technology is connected in a manner that provides for the electronic exchange of health information to improve the quality of care. The provider must use the certified EHR technology and submit information on quality of care and other measures to the Secretary of Health & Human Services (HHS).

Background - American Recovery and Reinvestment Act (ARRA) of 2009

The American Recovery and Reinvestment Act (ARRA) of 2009 was primarily intended to help the country recover from the Great Recession of 2008.  However, it also contained measures aimed at providing investments in health and science technology, among others. As part of ARRA, the Health Information Technology for Economic and Clinical Health Act (HITECH) had a major impact on healthcare as it pushed for the nationwide adoption and “meaningful use” of electronic health records (EHRs).

Meaningful Use and Health Outcomes

According to the Centers for Disease Control (CDC), the concept of “meaningful” use or MU is anchored on five health outcomes pillars.  These are:

  1. Improving quality, safety, efficiency, and reducing health disparities
  2. Engage patients and families in their health
  3. Improve care coordination
  4. Improve population and public health
  5. Ensure adequate privacy and security protection for personal health information

The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator (ONC) for Health IT have been leading MU’s phased implementation, which occurred in stages. 

The ONC has noted on its website that the Advancing Care Information category (which in 2018 was renamed Promoting Interoperability or PI) within the Merit-Based Incentive Payment System or MIPS supplants meaningful use.  However, it would still be extremely useful to have a familiarity with the background and evolution of MU to better understand what’s coming in the future.

Meaningful Use Stages

According to the CDC’s MU website, “in order to encourage widespread EHR adoption, promote innovation and to avoid imposing excessive burden on healthcare providers, meaningful use was showcased as a phased approach, which is divided into three stages.”

This incremental implementation began with data capture and sharing in 2011 and moved up to advanced clinical processes in 2013 and then included improved outcomes in 2015.

Meaningful Use Stage 1

For Meaningful Use Stage 1, the 15 core objectives for Eligible Professionals (EPs) were:

  1. Use CPOE for medication orders directly entered by any licensed healthcare professional who can enter orders into the medical record per state, local and professional guidelines.
  2. Implement drug-drug and drug-allergy checks.
  3. Maintain an up-to-date problem of current and active diagnoses
  4. Maintain active medication list
  5. Maintain active medication allergy list
  6. Generate and transmit permissible prescriptions electronically (eRx).
  7. Record patient demographics: sex, preferred language, race, ethnicity, and date of birth.
  8. Record vital signs and chart changes in the following: height, weight, blood pressure, body mass index (BMI), growth charts for children.
  9. Record smoking status for patients 13 years old or older.
  10. On request, provide patients with an electronic copy of their health information (including diagnostics test results, problem list, medication lists, medication allergies).
  11. Provide clinical summaries for patients for each office visit.
  12. Implement capability to exchange key clinical information among providers and patient authorized entities electronically.
  13. Implement one clinical decision support rule along with the ability to track compliance with the rule.
  14. Implement systems to protect privacy and security of patient data in EHR
  15. Report clinical quality measures to CMS (or, for EPs seeking the Medicaid incentive payment, the States).

The 10 Menu Set Objectives for EPs, which they must report at least 5 of, were:

  1. Generate lists of patients by specific conditions to use for quality improvement, reduction of disparities, research, and outreach.
  2. Send reminders to patients per patient preference for preventive/follow-up care. (Patient preference refers to the patient's choice of delivery method between internet based delivery or delivery not requiring internet access.)
  3. Incorporate clinical lab-test results into EHR as structured data.
  4. Implement drug-formulary checks
  5. Provide patients with timely electronic access to their health information (including lab results, problem list, medication lists, allergies) within 4 business days of the information being available to the EP either through the receipt of final lab results or a patient interaction that updates the EP's knowledge of the patient's health. (Electronic access may be provided by a number of secure electronic methods like PHR, patient portal, CD, USB drive).
  6. User certified EHR technology to identify patient-specific education resources and provide those resources to the patient if appropriate.
  7. The EP who receives a patient from another setting of care or provider of care or believes an encounter is relevant should perform medication reconciliation.
  8. The EP who transitions their patient to another setting of care or provider of care or refers their patient to another provider of care should provide summary of care record for each transition of care or referral (*).
  9. Capability to submit electronic data to immunization registries or Immunization Information Systems and actual submission in accordance with applicable law and practice (*).
  10. Capability to submit electronic syndromic surveillance data to public health agencies and actual transmission according to applicable law and practice (*).

The items with asterisk (*) in both sets are public health objectives.  EPs must select at least one of them to report on. Additionally, EPs needed to complete 6 Clinical Quality Measures (CQI).

For Medicaid, states were given flexibility to revise meaningful use after seeking approval from CMS.

Meaningful Use Stage 2

For Stage 2, the 17 Core Objectives for EPs were:

  1. Use CPOE for more than 60% of medication, 30% of laboratory, and 30% of radiology
  2. E-Rx for more than 50%
  3. Record demographics for more than 80%
  4. Record vital signs for more than 80%
  5. Record smoking status for more than 80%
  6. Implement 5 clinical decision support interventions + drug/drug and drug/allergy
  7. Incorporate lab results for more than 55%
  8. Generate patient list by specific condition
  9. Use EHR to identify and provide reminders for preventive/follow-up care for more than 10% of patients with two or more office visits in the last 2 years
  10. Provide online access to health information for more than 50% with more than 5% actually accessing
  11. Provide office visit summaries for more than 50% of office visits
  12. Use EHR to identify and provide education resources more than 10%
  13. More than 5% of patients send secure messages to their EP
  14. Medication reconciliation at more than 50% of transitions of care
  15. Provide summary of care document for more than 50% of transitions of care and referrals with 10% sent electronically and at least one sent to a recipient with a different EHR vendor or successfully testing with CMS test EHR
  16. Successful ongoing transmission of immunization data
  17. Conduct or review security analysis and incorporate in risk management process

The 6 Menu Objectives for EPs were:

  1. Submit electronic syndromic surveillance data to public health agencies
  2. Record electronic notes in patient records
  3. Imaging results accessible through CEHRT
  4. Record patient family health history
  5. Identify and report cancer cases to a State cancer registry
  6. Identify and report specific cases to a specialized registry (other than a cancer registry)
In essence, Stage 2 and modified Stage 2 of Meaningful Use broadened and augmented on the Stage 1 criteria and added an emphasis on advancing clinical processes.  According to the CMS Promoting Interoperability website, Stage 2 criteria encouraged the use of CEHRT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible.

Meaningful Use Stage 3

In October 2015, CMS released a final rule that established Stage 3 in 2017 and beyond, which focuses on using CEHRT to improve health outcomes. In addition, this rule modified Stage 2 to ease reporting requirements and align with other CMS programs.

To meet its commitment to promoting and prioritizing interoperability of health care data, CMS renamed the EHR Incentive Programs to the Promoting Interoperability Programs in April 2018. This change moved the programs beyond the existing requirements of meaningful use to a new phase of EHR measurement with an increased focus on interoperability and improving patient access to health information.

MACRA, MIPS and Meaningful Use

The Medicare and CHIP Reauthorization Act of (MACRA) 2015 established the Quality Payment Program (QPP).  The Merit-based Incentive Payment System (MIPS) is one of two ways that eligible professionals and hospitals can participate in QPP.

Effect of MACRA on Meaningful Use

The Medicare EHR Incentive Program, aka Meaningful Use, was transitioned to become one of the four components of the new MIPS.  MIPS consolidates three fee-for-service programs – the Physician Quality Reporting System (PQRS), the Value-Based Payment Modifier Program (VBM) and the Medicare Electronic Health Records (EHR) Incentive Program which has been renamed as the Promoting Interoperability category in 2018 – into one fee-for-value program.

                              Image Source: https://www.healthit.gov/topic/meaningful-use-and-macra/meaningful-use

With the MACRA Promoting Interoperability category came a stronger push for interoperability.  Participants must report the required measures under each of the four objectives below, or claim exclusions if applicable:

  1. ePrescribing,
  2. Health Information Exchange
  3. Provider to Patient Exchange
  4. Public Health and Clinical Data Exchange

As noted, these objectives are similar to the requirements for the Meaningful Use program. 

“Significant Overhaul” of Meaningful Use

In her speech at the HIMSS19 Global Conference, CMS Administrator Seema Verma shared a strong message about the changes in the Meaningful Use program.  According to Administrator Verma, “Last year, we finalized a significant overhaul of the Meaningful Use programs. In fact, the changes were so significant it warranted a name change. In our new Promoting Interoperability Programs, clinicians and hospitals are no longer incentivized or penalized based on just using an EHR. We eliminated thresholds and removed check-the-box measures in favor of scoring based on performance and results around interoperability and giving patients their data. We meant what we said about putting patients at the center of the system; nearly half of a hospital or clinician’s score in these programs is now based solely on sharing data with patients.”

The U.S. government’s journal, The Federal Register, echoes that message: “In April 2018, (CMS) renamed the EHR Incentive Programs and the MIPS Advancing Care Information performance category to the Promoting Interoperability (PI) Programs and Promoting Interoperability performance category, respectively (83 FR 41635). This refocusing and rebranding of the initiatives is just one part of the CMS strategic shift in focus to advancing health IT and interoperability.”

Current and Proposed Health IT Legislation supporting the Promoting Interoperability program

21st Century Cures Act

This law, signed by Congress in 2016, aims to “accelerate the discovery, development, and delivery of 21st century cures, and for other purposes.”  The Office of the National Coordinator (ONC) of Health IT has been given the responsibility of “implementing those parts of Title IV, delivery, related to advancing interoperability, prohibiting information blocking, and enhancing the usability, accessibility, and privacy and security of health IT.“

The law includes definitions for “interoperability” and “information blocking”.  Title IV also includes provisions for leveraging electronic health records to improve patient care and empowering patients and improving patient access to their electronic health information.

Proposed Rule CMS-9115-P on Interoperability and Patient Access for Medicare and Medicaid

The proposed CMS-9115-P, submitted in March 2019, states that it “is intended to move the health care ecosystem in the direction of interoperability, and to signal our commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813 to improve access to, and the quality of, information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected plans, health care providers, or payers.”

It further notes that this proposed rule is the “first phase of proposed policies centrally focused on advancing interoperability and patient access to health information using the authority available to (CMS).”

Additionally, this proposed rule includes initiatives that support Executive Order 13813 (Promoting Healthcare Choice and Competition Across the United States), such as:

  1. Enabling electronic access of their health information to patients “without special effort”.
  2. Including policies that “prevent health care providers from inappropriately restricting the flow of information to other health care providers and payers.
  3. Make enrollee electronic health information held by payers “available through an application programming interface (API)” so that “the information becomes easily accessible to the enrollee, and that the data flows seamlessly with the enrollee as they change providers, plans, and issuers”.

Other laws that support Promoting Interoperability

In section 106(b) of MACRA, Congress declared it a national objective to achieve widespread exchange of health information through interoperable certified EHR technology nationwide by December 31, 2018.

In 2018, CMS began participating in the Da Vinci project, a private-sector initiative led by Health Level 7 (HL7), a standards development organization. For one of the use cases under this project—called “Coverage Requirements and Documentation Rules Discovery”—the Da Vinci project developed a draft Fast Healthcare Interoperability Resources (FHIR) standard during the summer and fall of 2018.

CMS also proposes to revise the conditions of participation for hospitals (including short-term acute care hospitals, long-term care hospitals (LTCHs), rehabilitation hospitals, psychiatric hospitals, children's hospitals, and cancer hospitals) and CAHs to “require that these entities send patient event notifications to another health care facility or to another community provider.”

Conclusion

  1. While Meaningful Use is not dead, it has been significantly transformed into the Promoting Interoperability program under MIPS.
  2. As strongly communicated by CMS Administrator Verma, the US government is advocating not only the use EHRs, but the ability of providers and payers to demonstrate interoperability and giving patients easier and greater access to all of their healthcare data.
  3. Current and future legislation have been and are being put in place to support this push. CMS has even considered updating the Hospital Conditions of Participation (CoP) to establish interoperability.
  4. In addition to current and proposed legislation, healthcare practitioners and payers have also been notified to expect CMS to introduce a proposal for establishing “interoperability activities” in the FY 2020 IPPS/LTCH PPS rulemaking in conjunction with other updates to the Promoting Interoperability Program.
  5. Healthcare is now on its steady march towards greater ease of information flow of patient data, while still protecting its privacy and security. Payers, providers, and vendors alike have been put on notice that “information blocking” will have undesired consequences.  Meaningful Use has come a very long way indeed, and there is no more looking back.

Resources:

  1. CMS Meaningful Use and MACRA webpage: https://www.healthit.gov/topic/meaningful-use-and-macra/meaningful-use-and-macra
  2. Summary of 2018 MACRA Final Rule: https://www.macratoolkit.com/2017/11/09/summary-of-2018-macra-final-rule/
  3. Read the complete Proposed Rule CMS-9115-P on Interoperability and Patient Access for Medicare and Medicaid: https://www.federalregister.gov/documents/2019/03/04/2019-02200/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-interoperability-and
  4. 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program: https://www.regulations.gov/document?D=HHS-ONC-2019-0002-0001
  5. Download the Health Information Exchange Fact Sheet: https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Downloads/HealthInformationExchange_Stage3Medicare.pdf
  6. Full Text of CMS Administrator Seema Verma’s Remarks at HIMSS19: https://www.cms.gov/newsroom/press-releases/speech-remarks-administrator-seema-verma-2019-himss-conference
  7. List of 2015 Certified EHR Technologies: https://www.healthit.gov/topic/federal-incentive-programs/MACRA/MIPS/advancing-care-information-reporting