21st Century Cures Act

I’m in Washington today for the HIT Standards Committee and I will post the usual summary of the meeting this evening.  However, I wanted to post a morning preview of the opening comments I’ll make a the meeting.

We are in a time of great turmoil in healthcare IT policy making.   We have the CMS and ONC Notices of Proposed Rulemaking for Meaningful Use Stage 3, both of which need to be radically pared down.   We have the Burgess Bill which attempts to fix interoperability with the blunt instrument of legislation.  Most importantly we have the 21st Century Cures Act, which few want to publicly criticize.   I’m happy to serve as the lightening rod for this discussion, pointing out the assumptions that are unlikely to be helpful and most likely to be hurtful.

The interoperability language to be included in the 21st Century Cures Act would sunset the Health IT Standards Committee while a new “charter organization” would help define the standards of interoperability.

Under the latest language, which was revised over the weekend and yesterday, electronic records must meet those interoperability standards by Jan. 1, 2018 and face being decertified by Jan. 1, 2019 if they don’t.

The bill would also require EHR vendors to publish their application program interfaces. Vendors must also publish fees to “purchase, license, implement, maintain, upgrade, use or otherwise enable and support” their products.

There is no provision mentioning the sharing of substance abuse treatment records, which Rep. Tim Murphy said last week he was working to include. Congressional staffers said the version the House Energy and Commerce Committee marks up Wednesday may still be changed before a floor vote, which is expected sometime next month.

It does not make sense to officially sanction a “charter organization” and seed it with $10 million, creating yet another player in an already crowded field of groups working on interoperability.  I agree that coordinating the standards development organizations makes a lot of sense -- why not just direct ONC to create a permanent Task Force that reports to the HIT Standards Committee, and let ONC support it out of existing resources?

The drafts have other significant issues

“standards to measure interoperability” –  I have no idea what that means.  I suggest that ONC create and report outcome measures that require interoperability rather than trying to measure the process of interoperability.  With Meaningful Use Stage 2 we experienced the failure of process measures to truly measure interoperability - transitions of care sent from and to the same organizations, transitions of care sent to an outside organization then thrown away.

“information blocking” - I believe this concept is like the Loch Ness Monster, often described but rarely seen.   As written, the information blocking language will result in some vendors lobbying in new political forums (Federal Trade Commission and Inspector General) to investigate every instance where they are getting beaten in the market by other vendors.  The criteria are not objective and will be unenforceable except in the most egregious cases, which none of us have ever experienced.

“De-certification” makes no sense.  Every provider would have to be granted a hardship exemption, so what is the point of the decertification?

So, how do we accelerate interoperability?

1.  Make Meaningful Use and certification more manageable by narrowing its scope but tightening its enforcement.  Encourage and expand value-based purchasing initiatives and sunset Meaningful Use as quickly as possible. Meaningful Use/certification should be used to lay the foundation ecosystem, but value-based purchasing is what will transform health care.

2.  ONC should  focus/narrow the number of projects it is executing simultaneously

3.  The Role of ONC should be  certification, safety, alignment of Federal agencies, making available data to support nationwide interoperability (such as NPPES/PECOS data for provider directories), and creating transparency by disseminating market information.

4.   Aggressively clean up privacy/security heterogeneity.   We need to get alignment of state laws.  We need to remove barriers to patient identity management.  We need to get rid of arcane Federal laws such as CFR 42 Part 2.  This will require bold leadership and a significant effort.  It won’t lead to political career advancement, but interoperability will be enabled and it will improve outcomes for patients over the medium- to long-term.

5.    We need a full time leader at ONC once Karen DeSalvo is confirmed as Assistant Secretary of Health

Throughout my life, I have tried to be a neutral convener without an agenda.   I hope the industry realizes that my observations above are not meant to be emotional or dogmatic.   My only self-interest is to make a difference and prevent poor legislation and regulation from doing harm.