A Brief Summary of the CMS Meaningful Use Final Rule

I’ve been asked to summarize the  752 page CMS Meaningful Use  Final Rule.

Although it is a final rule, it has a 60 day comment period, so there is still is an opportunity to modify some of the criteria.   Between the Notice of Proposed Rulemaking and the publication of the CMS Final Rule, the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) passed to include sunsetting the Meaningful Use payment adjustment for professionals at the end of 2018.   Also, MACRA requires the establishment of a Merit-Based Incentive Payment System (MIPS) which would incorporate Meaningful Use.  The comment period will be used in an attempt to align the Meaningful Use program and the MIPS program.

The CMS Final Rule contains revisions to Meaningful Use Stage 2 such as reducing the reporting period for 2015 to 90 days and changing the patient/family engagement thresholds from 5% of patients to 1 (a single) patient.

The Stage 2 changes followed the recommendations of several professional societies.  Hopefully more clinicians and hospitals will now be able to cross the Meaningful Use Stage 2 finish line.

Stage 3 is more controversial and I will focus on that.  

Eligible Professionals (EPs) and Hospitals have 8 goals with optional participation in 2017 and required participation in 2018 to gain stimulus and avoid penalties.     The rule was released in October 2015 and since it is optional for 2017, vendors have only 1 year to make software changes and get certified.    That could be very difficult, especially for the application program interface (API) requirements described below.   Here are the goals:

1.  Protect Electronic Health Information - a security assessment must be done and a mitigation plan followed to reduce risks of privacy breach.   Appropriate encryption of data must be included in the plan.  This applies equally to EPs and hospitals.

2.  Electronic Prescribing - For EPs, electronic prescribing must be done for 60% of electronically prescribe-able medications.  Electronic prescribing of controlled substances is not required but can be counted.  For hospitals, electronic prescribing must be done for 25% of electronically prescribe-able discharge medications.

3   Clinical Decision Support -  five clinical decision support interventions related to four or more clinical quality measures as well as support for drug/drug and drug/allergy checking must be implemented.   This applies equally to EPs and hospitals.

4.   Computerized Provider Order Entry (CPOE) - 60% of labs, radiology, and medication orders must be done electronically.    This applies equally to EPs and hospitals.

5.  Patient Electronic Access - 80% of patients must be given access to View/Download/Transmit AND Application Program Interface (API) capabilities.  35% of patients must receive tailored educational resources electronically.  

 I suspect the API requirement may be among the most controversial aspects of the final rule.   I’m a strong supporter of the use of APIs as a means to enhance interoperability, such as we’ve proposed with the Argonaut Project .   However, at the moment, there are few patient facing applications that use APIs.   Maybe in the future, the problem of multiple PHRs will be addressed by moving patients from portals to apps that consolidate data from multiple EHRs i.e. the patient’s PCP, specialists, urgent care clinicians, and hospital care team.

6.  Coordination of Care through Patient Engagement - 10% of patients must access their record via a portal or application program interface.   25% of patients must receive or send a secure email. Information from non-clinical settings must be received for 5% of patients, which includes patient-generated data (weight/blood pressure/glucometer readings or Fitbit-like devices) or data from providers in non-clinical settings such as home health or physical therapists or behavior health.   This applies equally to EPs and hospitals.

I wonder if regulation is the best approach to accelerate the move to consumer-facing mobile apps and APIs for downloading of EHR data and uploading of patient generated data.   Meaningful Use Stage 2 attempted to use regulation to accelerate patient downloading/transmission of data.   There were few places to transmit consumer data and few compelling reasons for consumers to do it, so few tried.   Meaningful Use Stage 2 was revised to move the 5% view/download/transmit requirement to just one patient.   Regulation alone cannot change consumer behavior since APIs are not so much a technology but a market ecosystem to support the technology.  One of the lessons of Direct is that such challenges are profound and cannot be created overnight based on federal regulation.

A better driver would be a payment model  such as risk-based pay for outcomes approaches which incentivize patients and providers to collaboratively share data using novel applications.    I would advocate removing the API requirement from Meaningful use Stage 3 and moving it to the merit-based incentive programs (MIPS), enabling the marketplace to evolve innovative technologies after there is increased consumer and provider demand.

7.  Health Information Exchange - Transition of care summaries must be sent for 50% of all encounters.  Transition of care summaries must be incorporated for 40% of patients.    Transition of care summaries must be reconciled as structured data (problems/medications/allergies) for 80% of patients.

Unlike MU Stage 2, providers will now have to receive as well as send data.   Reconciling problems for 80% of patients will be quite challenging because of the different ways that providers maintain problem lists, which, unlike meds and allergies, has less to do with coding objective findings and more to do with documentation conventions and individual habits.

8.  Public Health and Clinical Data Registry Reporting - immunization submission, syndromic surveillance (urgent care only for EPs),  electronic case reporting, cancer registries or surveys, data registry reporting, reportable lab are required for EPs and Hospitals.    There will be exceptions offered for areas in which public health entities cannot receive these transmissions.

My general opinion of the rule is that
*The Stage 2 revisions that enable a 90 day reporting period and reduce some of the thresholds are good.
*The Stage 3 API requirement and patient generated healthcare data are better done in merit-based payment approaches rather than Meaningful Use regulation
*The collective burden of all the workflow changes required by three stages of Meaningful Use regulations will make it hard for clinicians to get through their day and spend time on direct patient care
*The public health reporting requirements will be hard to achieve in many locations due to the heterogeneity of local public health capabilities
*Many EPs and hospitals would welcome the end of Meaningful Use in favor of merit-based payment because at this point it is more effective and efficient for them to focus on achieving better outcomes for value-based care than being told exactly how they should get there.

I look forward to the comment period.