By JACOB REIDER, MD

It may have been a quiet week in Lake Wobegon, but not in Washington DC.  Last week, we saw the introduction of two congressional bills here (SGR fix) and here (EHR interoperability) and two proposed rules from HHS (one from CMS and one from ONC) – all of which would have substantive impact on health care in the US, and the role of information technology in how health is optimized and care is delivered.  While the iron’s still hot, let’s take a 30,000-foot view at all of this.   I’ll follow up later in the week with a more detailed overview of the ONC and CMS proposed rules with a bit more of an editorial voice on the SGR fix and Burgess’ interoperability bill.

1. The first document to land – way back on March 10^th – was the bill from Representative Burgess.

Some context: he’s a physician.  He understands the physician perspective – and is – like many physicians – confused by the paradox that several years and $20B after the passage of HITECH – we don’t have plug-and-play interoperability between health IT systems yet.  He might be asking: “isn’t this what was supposed to happen by now?”  Compelled by his training as a physician and (as my wife would argue) a human with a Y chromosome, Rep Burgess sees a problem and wants to fix it – hence this legislation.  HHS didn’t fix this?  Industry didn’t fix it?  Well, then, let’s see if Congress can fix it!  What’s the approach?

1. The bill attempts to redefine interoperability as:

“open access”

“complete access”

and

“does not block access.”

1. The bill proposes to disband the Health It Policy Committee and the Health IT Standards Committee and create a new FACA – with its membership entirely managed by Congress – to guide HHS on the definition of interoperable health IT systems.
2. The bill proposes to impose penalties on those who fail to comply with the definition of interoperability, and requires providers and hospitals to attest that they do not block interoperability.  This one’s much more complicated than I think he understands.  Is “charging customers for the development and maintenance of an interface” the same as “blocking?”

My take:  Unfortunately, “access” and “interoperability” are different concepts, so much of this bill barks up a tree that likely won’t bear fruit.  There is already a very good definition of interoperability that has been adopted beyond health care:  The Institute of Electrical and Electronic Engineers (IEEE) provides the generally accepted definition of interoperability, at least from a technical perspective. It defines the term as “the ability of two or more systems or components to exchange information and to use the information that has been exchanged.”   They should use the existing definition (which is used by HHS and FCC) and avoid inventing a new one.  Finally, while HITPC and HITSC could be more effective, a replacement body of only congressional appointees would be much worse.  So while this bill is well-intentioned, it needs to dovetail better with the SGR fix and MIPS, with the new health IT certification model that ONC has proposed (see below) and with a view of health IT certification and interoperability that extends beyond the concept of the EHR and includes other systems and tools that care providers and patients of the 21^st century will need to collaborate, communicate and coordinate toward better health for all.

1. 2.     Next came the “SGR doc fix” – again from Rep Burgess.  We should view the SGR fix and the interoperability bill together.  I’ve plagiarized this summary – toward brevity and clarity:

The Sustainable Growth Rate (SGR) formula is a budget cap passed into law in 1997 to control physician spending.

• Since 2003, Congress has spent nearly $150 billion in 17 patches to avoid cuts imposed by SGR. The most recent patch will expire on March 31^st 2015.

• The legislation repeals the SGR and transitions Medicare away from a volume-based system towards one based on value.

• The legislation repeals the SGR and replaces it with a system focused on quality, value, and accountability.

Improves the existing fee-for-service system by rewarding value over volume and ensuring payment accuracy

• Consolidates existing quality programs into MIPS – the Merit-Based Incentive Payment System:

• The Physician Quality Reporting System (PQRS) that incentivizes professionals to report on quality of care measures;
• The Value-Based Modifier (VBM) that adjusts payment based on quality and resource use in a budget-neutral manner; and
• Meaningful use of EHRs (EHR MU) that entails meeting certain requirements in the use of certified EHR systems.

• Incentivizes care coordination efforts for patients with chronic care needs.

• Introduces physician-developed clinical care guidelines.

• Requires development of quality measures and ensures close collaboration with physicians and other stakeholders regarding the measures used in the performance program.

Incentivizes movement to alternative payment models (APMs)

• Provides a 5 percent bonus to providers who receive a significant portion of their revenue from an APM or patient centered medical home (PCMH).

• Participants need to receive at least 25 percent of their Medicare revenue through an APM in 2018-2019. This threshold increases over time. The policy also incentivizes participation in private-payer APMs.

• Establishes a Technical Advisory Committee (TAC) to review and recommend physician-developed APMs based on criteria developed through an open comment process.

Expands the use of Medicare data for transparency and quality improvement

• Posts quality and utilization data on the Physician Compare website to enable patients to make more informed decisions about their care.

• Allows qualified entities (QEs) to provide analysis and underlying data to providers for purposes of quality improvement, subject to relevant privacy and security laws.

• Allows qualified clinical data registries to purchase claims data for purposes of quality improvement and patient safety.

My bottom line:  this legislation would fold Meaningful Use, PQRS and VBM into MIPS, and provide additional incentives for providers to participate in alternative payment models.

Missing (IMHO): 

• Recognition that quality measurement is only one side of the quality improvement coin, and reciprocal resources need to be allocated for the development and maintenance of standards (by ONC) and content (by AHRQ) for clinical decision support, in the same manner that CMMS maintains clinical quality measures.  We won’t get better quality without this.
• Specification that when information technology is used, all providers participating in MIPS (and not just MU) need certified health IT.  This will enhance the likelihood that products are safe, secure, usable, and interoperable.

1. 3.     Proposed rule for Stage 3 of the Meaningful Use Incentive Programs.

As I mention above – I’m not going to try to summarize this in depth just yet.  I’ve read it once.  It usually takes me a second read to make sure I’m not missing the nuances.  High-level summary:

This proposed rule simplifies the program for it’s final stage.

• This is stage infinity of the meaningful use incentive program.  Expect no substantive changes to follow.  Ever.  Call it “stage 3” – but there will be no 4,5 or 6.
• Reporting period.  No more “hospitals do this and EPs do that.  One reporting period for everyone.  Calendar year.  Yay.
• Full year reporting periods.  No more 90 day reporting.  (some exceptions for first-timers.)
• Phased-in timelines.  Stage 3/infinity begins in 2017, but CMS will allow attestation to Stages 1,2 or 3 in 2017.  Everyone needs to attest to Stage 3/infinity in 2018.
• Simplified Objectives and Measures – only 8 objectives, all tied to HHS Delivery System Reform Goals:

I’ll walk through each objective in my follow-up post later in the week.  A few elements deserve attention sooner than later:

• Objective 1 – Protect Patient Health Information.  There are new expectations for the implementation of technical, physical and administrative safeguards, and CMS has clarified that their expectations for a security risk assessment are narrower than those expected by HHS under HIPAA.  If you’re scratching your chin – so am I.  All covered entities will be required to meet the expectations of HIPAA.  Why wouldn’t CMS invoke (and align with) HIPAA?
• Objective 4 – CPOE.  No substantive change from Stage 2, but CMS clarifies the role of a “certified medical assistant” so that there is no ambiguity regarding who is permitted to enter orders on behalf of an EP.  I was initially confused by the use of an expanded term “diagnostic imaging orders” being included in CPOE while stating that the description of radiologic services (“any imaging service that uses electronic radiation”) as defined in Stage 2.  But a quick re-look at Stage 2 reminded me that:  “Electronic product radiation is defined at 21 CFR 1000.3 as: any ionizing or nonionizing electromagnetic or particulate radiation, or [a]ny sonic, infrasonic, or ultrasonicwave that is emitted from an electronicproduct as the result of the operation ofan electronic circuit in such product.’’  Phew!  I’m not sure the physicists will agree – but now I understand.  They should make this clearer in the Final Rule – rather than play regulatory scavenger hunt – sending us elsewhere for an explanation of a sentence.
• Objective 5 – Patient Electronic Access to Health Information.  This one’s a biggie.  Stage 2’s biggest hurdles have been in this domain, and I’ll discuss this in greater detail later in the week, but readers should pay close attention to this section and review the references to APIs.  The crux of this objective comes down to how much CMS trusts the market.  In the core proposal, an EP or EH must attest to 80 percent of patients’ ability to view, download or transmit OR have access to an API.  They also offer alternate proposals – with varying variants of AND/OR but my favorite (and I’ll argue that it should be YOUR favorite) is alternate C, which requires only that an API be present and enabled.  The inclusion of 80 percent of patients here is a bit odd – as one wouldn’t enable the API of a percentage of patients.  (if it’s on for one – it’s on for 100%.)  My assertion here is that the tethered portals are unnecessary and will disappear – causing a market explosion of web apps, smartphone apps, and other things (refrigerator apps?  Bathroom mirror apps?) that we’ve not even dreamed of.  By maintaining the requirement for VDT (OR/AND alternatives), CMS keeps the legacy tools in place unnecessarily, and constrains innovation.  Trusting that the market will respond (alternate C) would be fantastic.
• Objective 6 – Coordination of Care Through Patient Engagement.  Like Objective 5, this objective includes AND/OR language to allow for variants of VDT, secure messaging, and incorporation of patient generated health data.  I’ll discuss this objective in our next episode, but readers should note that there are now exclusions for providers who care for patients without broadband Internet service.  This anticipates the challenges of rural providers, but I think they’re still missing the cultural & socioeconomic barriers that may be present.

1. 4.     Finally – my favorite regulation: the 2015 Edition Health Information Technology Certification Criteria, 2015 Edition Base EHR Definition, and ONC Health IT Certification Program Modifications.

Yeh – even the title is a mouthful! Coming in at 431 pages (it’ll be fewer pages in the final Federal Register publication) this tome has some fascinating nuggets.  Headlines for today:

• There is no such thing as a “complete” EHR any longer.    There is “Base” EHR – as required by HITECH, but the concept of a “complete” one is now discarded.
• Certification is not just for EHRs.  The program explicitly changes to allow for the certification of products beyond the CMS EHR incentive programs.  So if a county department of public health wants to create a program to motivate nursing homes to report gonorrhea cases to their public health database using certified Health Information Technology – they are free to do so – and can invoke only the certification criterion that applies to their use case.  Certification is therefore best viewed as an opportunity for both ends of the market:  government/payers/employers and the developers of health Information technology products.
• The terms are changed.  Notice that throughout the proposed regulation, “EHR” and “CEHRT” are modified to “Base EHR” (where required by statue) and (more commonly) “Health Information Technology.”  “Vendors” are also no longer referenced – in favor of the preferred term: “developers of health information technology.”
• There are no “optional” or “required” criteria.  They are just criteria.  Developers should certify to the criteria that reflect market requirements of their customers.
• There are no “ambulatory” or “inpatient” criteria.  Criteria are agnostic to setting, and the goal is to enable developers who create solutions in markets such as behavioral health and long-term post-acute care to certify their products to criteria appropriate to their care delivery settings.
• There are enhanced expectations regarding the creation of a C-CDA document.
• There is a new criterion for an API – called “Application access to Common Clinical Data Set.”

Is your head spinning yet?  Mine sure is.  What’s your next step here?

• If you are hospital, provider, or someone who works with/for them, focus on the SGR fix first.  Time is very tight.  If there’s something that you see missing, or something that you think isn’t correct, contact congress and tell them so.  Really.  If you don’t do so – then don’t complain when things don’t go your way.   After you finish with SGR fix, focus on the Stage 3 (Stage ∞) proposed regulation.  You have 60 days to send in your comments.  Please send in your comments.  Again – no whining if you didn’t participate.
• If you are a technology company – focus on the Burgess bill first, and then the 2015 Edition document.  Remember the guiding principles I mentioned above.  There will be criteria that apply to you – and criteria that do not apply to you.  Don’t be intimidated by the length of the document or by the number of criteria.  It’s actually a simpler program now, with fewer confusing concepts (“Base EHR remains – but they couldn’t get rid of what’s in the HITECH act).
• Finally – think about how value based care can be enhanced by all of the above.   Decades of paying more for more volume has taught us all that the we’ll get volume of care rather than a healthier population with this model.   If you’ve been putting your head in the sand before – you can now see that both Congress and the Administration have put out formative proposals with a common thread:  fee-for-service is a sinking ship.  It’s time to get off soon, folks.  Are you ready?

Jacob Reider MD, FAAFP is the former Deputy National Coordinator at ONC and is now Founder & Chief Strategy Officer at Kyron, and physician-in-residence at Khosla Ventures.  His blog, docnotes.com, started in 1999 and is the longest-running medical  blog.