An Alternative Proposal For Certification

John HalamkaSome have suggested that my comments over the past few months about the Meaningful Use program, MACRA/MIPS, and Certification imply that we should just give up – throw out the baby with the bath water.

That’s not what I’ve written.

Here’s a clarification.

I believe MACRA/MIPS is the right trajectory – create a set of desirable policy outcomes, then enable clinicians to choose technology, quality measures, and process improvements that are relevant to their practice.

Although the current MACRA formula is overly complex, it’s the right idea and I’m confident that CMS will revise the notice of proposed rulemaking appropriately.   My metric for MACRA’s success is simple – can a clinician keep three goals in mind while seeing a patient and be rewarded if successful i.e.:

1. Ensure care is delivered in the most appropriate location in the community (urgent care, home care, rural hospital)

2. Focus on wellness/prevention

3. Avoid redundant and unnecessary testing, medications, and procedures

My issue is that MACRA currently “inherits” the flawed 2015 Certification Rule that is a kitchen sink of immature standards and a black hole for developers.   Overly zealous regulatory ambition resulted in a Rule that has basically stopped industry innovation for 24-36 months since it has listed every use case for every purpose including those unrelated to Meaningful Use and MACRA.

For vendors, every “OR” means an “AND” – developers must implement everything in the Rule because some stakeholder will demand every transaction in the regulation.   There was little curation in the Rule and most of the HIT Standards Committee recommendations to limit scope were ignored.

Here’s my recommendation for the path forward.   When the MACRA/MIPS rule is finalized it needs to reduce or eliminate dependency on the 2015 Certification Rule.  I realize that is highly unlikely because the Obama administration is drawing to a close and as of June 2016, there was not enough time for clearance processes to consider any major changes in regulations.   However, the entire HIT ecosystem is begging CMS to realize that the 2015 Certification Rule is mostly burden without benefit  – it paralyzes the industry for years without increasing inoperability.   Maybe subregulatory guidance can help diminish the role of the 2015 Certification Rule in MACRA/MIPS if regulatory change is impossible.

I’ve said this many times before, but here it is again for clarity.   There are 3 kinds of interoperability – push, pull and view.

To push data from one place to another you need a directory of endpoints (could be a provider, patient, payer, quality registry, or clinical trial database), a means (technical or policy) to trust those endpoints, and  a transmission standard to send data to an endpoint.    The right approach is to use a FHIR-based query/response for endpoint addresses, a private industry enabler for trust (such as DirectTrust, Surescripts, Commonwell etc) and a RESTful approach to push data from point to point, although the Direct protocol will suffice, given the regulatory and political history of the past 5 years.   Remember, Direct was a political compromise.  REST was always the desired technical solution.

To pull data from one place to another you need a master patient index/record locator service, a consent registry, and a query/response transaction for the data.    The right approach is to use a FHIR query/response for the master patient index/record locator service, and a FHIR query/response to request the records.   Consent can be handled in policy, technology or both.

To view data from one EHR in another EHR you need a means to identify the patient (probabilistic matching based on name/gender/data of birth or a national healthcare identifier).   You need shared authentication and authorization of trust such as OAUTH2/OpenID and a means of calling a remote viewer using a URL (a RESTful approach)

If I were King for a day, I would require certification of only 5 things

a.  Use of OAUTH2/OpenID to demonstrate an organization is a trusted exchange partner

b.  Use of a FHIR-based query to request the electronic endpoint address for a push transaction.

c.  Use of  a RESTful approach to push data to an endpoint

d.  Use of a FHIR-based query to request an enumeration of a patient’s record locations

e.  Use of a FHIR-based query to exchange the actual record (a common data set of key elements using the best available vocabulary standards)

We should limit certification to production testing of an EHR’s ability to do those 5 things.  The result would be seamless interoperability controlled by providers and patients, empowered by the vendors.

Developers would then return their programming resources to innovation and meeting their customer needs.

If Brexit taught us anything, it’s that over regulation leads to a demand for relief.

Pythagoras’ Theorem has 24 words

Archimedes’ Principle has 67 words

The Ten Commandments has 179 words

The US Declaration of Independence has 1300 words

The EU regulation on the sale of cabbages has 26,911 words.

As a comparison, the 2015 Certification Rule document has 166,733 words.

As I’ve said in an earlier post, we need to step back and ask what we’ve done to ourselves.  We can be thoughtful and incremental about addressing regulatory zeal and we should start by eliminating the concept of Certification as it exists, replacing it with only 5 criteria that are easy to understand and measure.

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8 replies »

  1. I realize the zealous desire for a tool that works to promote better care for individuals. But, tools just sit and rust without clear thinking users. I just was consulted by an 84 year old with a metastatic, non-treatable cancer who has had 2 CT scans, a MRI, a PET scan and now after 4 weeks of testing, a call for a more “up to date” CT scan. The patient is now at 90 pounds from a 4 month ago 120 pounds. I just was consulted by a woman with a very unusual biology breast cancer who is being asked to be treated like a whole bunch of women not like her in a “waste bucket” averaged out, population approached oncology onslaught. If any of us think that better EHR tools are going to help us learn to help these patients, we are lost. Maybe we should figure out first how we are to revive a profession of servants who can accurately quote information to patients and not flog them with EHR readable data?

  2. Brexit teaches us that over regulation leads to a demand for relief

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  3. Oh yeah… I forgot…. reparations to physicians… and patients 🙂

  4. If I were Queen (of health care) for 25 minutes, I would write an executive order to shut down ONC and everything that it spawned since 2004.
    Then I would repeal MACRA and replace it with a (modest) fixed pay increase in physician fees, to be financed by immediate elimination of facility fees.
    Then I would write another executive order to cut funding to all CMS physician harassment initiatives, and use the money to pay for a yuge study to evaluate outcomes/cost/satisfaction by practice size (and whether PCPs admit their own patients or not) and let the chips fall where they may.
    And when my 25 minutes get to the final countdown 9 8 7 6 5 4 3 2 1……… Medicare for All.

  5. I agree with Dr Z. I too am an advocate for no federal certification of EHRs. They have only made a huge mess of a process. They made a policy market that has squashed innovation and piled on clerical work to the already burdened provider. I also think that the FHIR standard is immature and that is yet another reason that we do not need a lock into that from a certification standard. Let the market work. Innovation would return. The standards would evolve within a competitive marketplace, not a policy market. I also feel that CMS should DEFINITELY PROVE that their asking of providers to count numerators and denominators and attesting and clicking (Quality, ACI/MU, CPIA) actually improves care, reduces cost, improves efficiency, reduces burden…exceedingly unlikely on all fronts as PQRS/MU has been nothing short of a 5 year disaster.
    I also think that Dr John H also meant what he said, that “its time to get out of the profession”, if we stay on our current path. I feel received major political pressure to backtrack on those statements. I feel he sees his colleagues being abused daily by these complex regulations and penalties, and that this has severely damaged the medical profession, leaving providers desperate, demoralized and burned out. He has try to wiggle out of that, but that is just DC putting the pressure on him. We all see that Dr John H, standup for your feelings.

  6. John,

    I believe we agree that:
    1) Healthcare needs to be less expensive, as the current system is fiscally unsustainable.
    2) Healthcare quality must improve and EHRs must contain the tools necessary to promote serial improvement. The current incarnation of EHR’s is far too restrictive as they do not allow the average physician to do “data mining.”
    3) We should promote patient engagement as a means to achieve #1 and #2, however I’m not yet convinced that patient engagement is going result in an improvement in quality nor reduce healthcare costs.
    4) We need to promote health information exchange. Here too I am not yet convinced that this will effect the desired end, but I maintain an open mind on the issue and think it is a reasonable objective.
    5) Federal policy towards healthcare delivery and health information technology needs to promote “innovation” if we hope to achieve the above four objectives.
    I would also add
    6) Federal rules/regulation should be “evidence based” (before the rules are implemented) as healthcare is immensely complicated and the risk of adverse un-intended consequences needs to be minimized.

    I agree with your suggestion that all EHRs should be able to perform the 5 tasks you thoughtfully specified. I also agree that the Federal Government should provide a test site which EHRs can use to prove they meet those “standards.” However, I do not think the Federal Government needs to “Certify” EHRs. This has proven to be a disaster for HIT innovation and the practice of medicine, and leaving these regulations on the books opens the door for future problem. Given the current HIT market conditions, I fully believe the market will force (most) vendors to implement your suggested/Federally suggested features. While there will be a few institutions/providers who choose to use an EHR which does not include the suggested features, that will effect a small minority of the total patient population; and there may be good reasons those institutions/providers choose to use an EHR that does not have those features.

    My resolution asking that the MMS actively work to end MU, MACRA and Certified EHRs (https://thehealthcareblog.com/blog/2016/07/02/how-to-end-macra-meaningful-use-and-onc-certified-ehrs-programsmandates/#comment-856357) is not an attempt to stymie the process of achieving better/less expensive health care. I am committed to that goal. My resolution is an attempt to correct the HIT trajectory so as to ensure we are ultimately successfully in achieving those ends.

    I believe we both want to get to the same destination, although we may be choosing slightly different paths to reach that destination.