Friday, March 28, 2014

Progress in Healthcare Evolution... or Not? Part 2: PCMH

In my last post I described a series of studies, surveys, posts & papers that were highly critical of current healthcare reforms in three areas: 1) design of EHRs & their “meaningful use”, 2) the Patient-Centered Medical Home model & 3) health information exchange (HIE) & accountable care organizations (ACOs). EHRs were criticized as being poorly designed & not aligned with provider workflows for patient interaction. Meaningful Use was criticized as not being focused on capabilities that facilitate the Triple Aim, but rather at maintaining a very low level of incremental progress towards the productive use of HIT. A recent paper evaluating the PCMH model found little evidence that this new set of organizational & treatment processes either improved clinical outcomes or reduced per patient cost. Finally, a court case in Idaho calls into question the whole basis for the formation of ACOs as potentially a violation of anti-trust laws. That last post focused on meaningful use & made a number of recommendations that I believe might go a long way to re-aligning this massive federal program with patient & provider needs. In this post, I’ll focus on PCMH, what the recent criticisms have been, how valid (I think) they are & what might be done to ameliorate these concerns.

The National Committee for Quality Assurance first published criteria for PCMH recognition in 2008, & they have published two modifications of these criteria since then – one in 2011 & one just this month (3/2014). The 2014 criteria are focused on creating a system of patient-centered care with the following goals[1]:
  • Improved patient experience
  • Reduced clinician burnout
  • Reduced hospitalization rates
  • Reduced ER visits
  • Increased savings per patient
  • Higher quality of care, &
  • Reduced cost of care.

The 2014 criteria added &/or modified criteria in the following areas:
  •  More emphasis on team-based care
  • Care management focus on high-need populations
  • Alignment of quality improvement activities with the “triple aim”, &
  • Sustained transformation.

There are currently 34,500 clinicians at 6800 sites recognized for the 2008 or 2011 PCMH criteria.
The 2014 criteria are organized into six areas: patient-centered access, team-based care, population health management, care management & support, care coordination & care transitions & performance measurement & quality improvement. There has been a good deal of evolution in both the focus & the details of these criteria since 2008 – I’ll return to that in a bit…

As I’ve already stated, a group of researchers from The RAND Corporation, Brigham and Woman’s Hospital (Boston, MA), the University of Pennsylvania Medical School (Philadelphia, PA) & the Wharton School Healthcare Program published a paper in JAMA that looked at the performance of certified PCMH organizations over a three-year period[2]. This study found almost no improvement in outcomes, as measured by quality measures, & no reduction in costs as a result of operating as a PCMH. As always, the devil is in the details[3]… so what did they actually look at? & what did they actually say?

The pilot study was done between 1 June 2008 & 31 May 2011. 32 primary care practices (small to medium size) were surveyed with 64,243 patients treated. All practices were located in southeastern Pennsylvania & all were NCQA PCMH certified. A similar number of non-certified practices were selected by the State to act as controls with 55,959 patients treated during this time period. The practices were compared on 11 standardized quality (NCQA HEDIS claims-based) measures[4]. Utilization was calculated based on hospitalization rates, ED visits & ambulatory care encounters including care-sensitive encounters. Costs were calculated adjusted for local market factors. Comparisons were done at the beginning & end of the pilot period.

A statistically significant difference was found for only one of the 11 quality measures at the end of the pilot period. This was nephropathy screening in diabetes (adjusted performance of 82.7% vs 71.7% by year 3, P < .001). No difference was found in either utilization or cost of care. Essentially hospitalizations, ED visits & ambulatory encounters were essentially the same in both pilot & comparison sites for pre-intervention & Year 3 numbers. There was no significant difference in cost between the pilot (PCMH) sites & the comparison sites during the study period, but costs rose in both cases from pre-intervention through Year 3. The study authors summarized as follows: “a multi-payer medical home pilot, in which participating practices adopted new structural capabilities and received NCQA certification (recognition), was associated with limited improvements in quality and was not associated with reductions in utilization of hospital, emergency department, or ambulatory care services or total costs over 3 years. These findings suggest that medical home interventions may need further refinement.” 

There have been many responses to this article, but I’ll look at two of them before getting to my own opinion. These two are the response of the NCQA, the organization that publishes the PCMH criteria & provides the recognition process, & the Patient-Centered Primary Care Collaborative (PCPCC), an advocacy group focused on healthcare transformation through the promotion of PCMH.

The NCQA responded to the JAMA article on 26 February 2014[5]. They made several points as follows:
  • The Pennsylvania Chronic Care Initiative (PACCI) lacked two common features of current PCMH pilot programs: cost reduction incentives and a high proportion of Level 3 medical homes.
  • The study was done based on the 2008 PCMH criteria.

They also stated 17 studies showing improvement in quality, cost reduction, patient experience, continuity & other dimensions that the criteria are focused on. In addition they singled out the Vermont Blueprint for Health Program[6] that was having success with the PCMH model during the period of the JAMA study. I’ll comment on this response shortly.

The PCPCC report provided a more nuanced response[7]. They point out that “recognition as a PCMH is not necessarily synonymous with being one”. They also state that PCMH, as all healthcare reforms, must be informed by & facilitate the move away from “volume-driven fee-for-service payment model to one driven by value”[8]. In their response they cite four additional points:
  • PCPPC’s annual report[9] meta-analyzed most of the existing peer-reviewed & industry-funded reports on PCMH & found outcome improvement & cost reduction in 60% of the cases.
  • There were no financial incentives to control costs as part of the criteria.
  • There was a very low response rate from the comparison (non-PCMH) group, 24% as opposed to 91% response rate in the pilot (PCMH) group.
  • There was no stratification of patients, so it is not known what percentage of the covered population was dealing with multiple chronic diseases & associated comorbidities.

OK – so where does this leave us. In my opinion, the criticism that the study was based on the 2008 criteria is at best moot as the study started in 2008 – when there was only one set of criteria - & ended in 2011 when very few organizations had been recognized based on the new criteria. It would not be possible to do the analysis based on a set of criteria that had not yet been adopted…

It is true that the Vermont Health Blueprint Program includes 138 organizations recognized as Patient-Centered Medical Homes (as of January 2014), but it is not known how these organizations contributed to the acknowledged success of the program. One important point that is pointed out in the Vermont Blueprint for Health Annual Report 2014[10] is that the PCMH criteria, regardless of the effectiveness in meeting the NCQA’s goals, provided an invaluable framework for organizing a clinical practice to emphasize care continuity & care transition.

With respect to cost incentives for costs controls, this is a more complicated issue. The 2014 PCMH criteria do not contain any requirements specifically for cost control, nor did any other version of the criteria. However, it seems that NCQA intends for cost control to be a core part of the PCMH model. Their own literature cites: increased savings per patient & reduced cost of care as general goals. The intent of coordinated care, which is the clinical goal of PCMH, is to provide a treatment environment where improved outcomes & cost control are realized through the medical home model. If being recognized for demonstrating compliance with all of the model’s criteria does not result in some form of cost reduction & savings per patient (or improvement in quality or clinical outcome), then perhaps as the study points out “the medical home intervention may need further refinement”.

This is exactly the point that the PCPCC made, that compliance with the PCMH criteria does not make a practice a patient-centered medical home in the larger context of moving closer to achieving the triple aim. There is no question that many studies since 2010 have found a variety of improvements in quality & cost reduction. Healthcare organizations have had several more years since the end of the JAMA study to work on the adoption & effective operation of these criteria & the triple aim is being moved forward. As PCPCC additionally pointed out, the JAMA study is a snapshot in time, & must be seen as such. Time moves on & so has organizations’ ability to implement PCMH.

The additional points that the PCPCC report makes: low response rate for non-PCMH organizations & the lack of stratification (classification) of patients are both valid criticisms & should be taken into account in our interpretation of the JAMA study.

You’ve been patient (sorry about that) so here is my opinion about this study, PCMH & recognition/certification in general. First, this is the way research works… As a researcher, I do not particularly like it, but that’s the way it is. What way is that, you ask? The pilot study was completed in May 2011 & the paper was in all probability finished by the end of the year & submitted to JAMA. It was published, after (probably several rounds of) peer review in February 2014 – at least two years after submission. There are other ways of doing this; most of my work these days is published as blog posts, MIT working papers or in web-based journals. In this way, people can read the work days to weeks after it is completed, but if you want to publish in a well-respected peer reviewed journal like JAMA or Health Affairs, it will take time between when you finish the work & when it is generally available. One recommendation is for researchers working in fast evolving fields (like all of them in healthcare) to use alternative publishing methods, even if it means not publishing in the big journals. If we had read this study in October 2011, we would have reacted differently to it.

Second, I agree that there are both structural (low response from non-PCMH participants, lack of patient stratification…) & interpretive issues () with the study, but the bigger issue for me is the dichotomy that is surfaced by the study results & the PCPCC report’s reaction to them. If it is in fact the case that a healthcare organization can demonstrate compliance with the NCQA PCMH criteria, even at the highest level (Level 3) & not show measurable improvements in the higher level goals of the program, then something is at least misaligned with the criteria & the goals & possibly much worse than misaligned. How would we determine this? & What would we do about it? Here are some suggestions:
  •  If per patient savings & overall reduction in cost are actual goals of the program, make them explicit in the criteria. We can expect costs to be reduced if we do certain things (like care coordination), but unless we provide specific criteria & measurements to indicate this, we may not ever achieve it.
  • Actuallydevelop criteria for any goals that are important enough to be called out in the program description.
  • If we are serious about quality measures, & I’m assuming that NCQA is serious about HEDIS, then assessment of performance against these measures needs to be taken seriously. It may well be that a lower percentage of the PCMH recognized organizations in the study were Level 3, & that many other assumptions about this analysis were not ideal but the data are the data. Our opinion of the study structure & assumptions can inform how we view the results, but it does not change the results.
  •  It seems to me that the core of PCMH is the focus on team-based care to provide continuity of care & effective care transitions, & that this focus leads to the assumption that better care coordination will lead to better clinical outcomes & reductions in per patient costs. The PCMH criteria define a view of operational care co-ordination, & we additionally assume that they will lead to these goals because of reduction of redundancy in tests, prescriptions & treatment as well as a broader set of expertise, advised by the patient, in providing care. If this is true, then we should be able to show at least a correlation between the adherence to PCMH criteria & results showing higher performance on quality measures, better outcomes, & cost savings. It appears as if this is the case in post-2011 studies, but we need to look closely at all these results to make sure that there is such a direct connection. If there is not, or if the connection is weak, then we do need to re-evaluate whether the PCMH criteria actually promote productive care coordination. This is, in fact, the goal – not PCMH recognition.

I have not looked in detail at PCPCC’s meta-analysis of post-2010 studies, but I will do that in the next weeks - & I will write about what I see in their analysis. For now, let’s say that the JAMA paper should be a wake-up call, not to indicate that the PCMH model is ineffective, but to ensure that we continue to evaluate whether it is effective & to also explore other means of facilitating care co-ordination.

Next up is another look at HIEs & ACOs, from the perspective of these current criticisms & the Idaho court decision.




[1] 2014 Patient-Centered Medical Home Recognition. http://www.ncqa.org/Portals/0/Newsroom/2014/PCMH%202014%20Press%20Preview%20FINAL%20Slides.pdf. 10 March 2014. Accessed 15 March 2014.
[2] [2] Friedberg, M.W. et al. 2014. Association Between Participation in a Multipayer Medical Home Intervention & Changes on Quality, Utilization & Costs of Care. JAMA. 311(8):815-825. Accessed on 15 March 2014.
[3] Ludwig Mies van der Rohe, Gustav Flaubert & many others…
[4] http://www.ncqa.org/HEDISQualityMeasurement.aspx
[5] http://www.ncqa.org/Newsroom/Statements/NCQARespondstoJAMAStudy22014.aspx
[6] http://hcr.vermont.gov/sites/hcr/files/pdfs/VTBlueprintforHealthAnnualReport2013.pdf
[7] http://www.pcpcc.org/2014/02/26/pcpcc-leadership-responds-jama-article-medical-home-pilot-study
[8] see my last post on meaningful use – qualifying for meaningful use does not necessarily mean a provider is using HIT in a meaningful way, especially as long as the criteria are still based on a volume-driven fee-for-service model.
[9] http://www.pcpcc.org/resource/medical-homes-impact-cost-quality
[10] http://hcr.vermont.gov/sites/hcr/files/pdfs/VTBlueprintforHealthAnnualReport2013.pdf

Tuesday, March 25, 2014

Progress in Healthcare Reform or Not? - Part 1: Meaningful Use

Well, it’s Spring, 2014. Most of the dirty snowpiles are gone here in Boston & I’m hoping we’re done with Winter finally (although it’s supposed to snow tonight). It’s been a tough few months, though, for healthcare reform. Even with the debacle of the ACA website launch behind us & over 5 million people signed up for care under the act, there are still many issues & events that call into question some of the underpinnings of the reforms we are working toward. A non-inclusive list would consist of:
  • Idaho - The U.S. District Court (Idaho) found that the acquisition by St. Luke's Hospital System of the 40-provider primary care medical group, Saltzer Medical Practice, violated federal anti-trust law[1] since the combined organization would control over 80% of the primary care physicians in the area. The court acknowledged that the acquisition was done in order to improve the ability of St. Luke’s to provide primary care, & that it in all probability would improve primary care in the area, but that it was still illegal. If upheld, this has all sorts of implications for ACOs & other new forms of healthcare organization consolidation.
  • Black Book Survey - A new Black Book Survey[2] reported in Government Health IT found that 95% of payers, 83% of hospitals & 75% of providers thought that publicly funded HIEs had flawed business models & provided no meaningful connectivity. So much for public information exchange.
  • CCHIT's recent announcement that they are ceasing to do certification of EHRs.[3] Their new CEO cites the complexity of Stage 2 certification & the "vagaries" of ONC's Stage 3 timeline & content. Apparently their Board felt that there was no sustainable business model remaining in certification. If their assertions/assumptions are true, then Stage 2 & Stage 3 are in for a rough road.
  • IDC Health Report - IDC Health Insights has just released a report on 2014 healthcare IT trends.[4] It basically says that first generation (Stage 1 & 2) meaningful use of EHRs has "failed because even if providers qualify for Stage 2 MU, they still do not have the tools they need to actually improve outcomes & reduce costs. Specifically the report talks about EHRs (& MU) not realistically addressing: provider-to-provider connectivity (including eReferral), provider-to-patient connectivity, patient-to-patient connectivity, care management & transition, medication reconciliation, analytics for revenue & cost management etc. In short, EHRs must become an application & data platform to layer additional necessary capabilities on. To the extent that this is done successfully, HIT will continue to provide value. The report highlights many other areas including: use of private cloud, privacy & security, consolidation of healthcare organizations (see first bullet above), but the EHR "predictions" are most relevant to us for this purpose.

& finally: 
  • A study published in the Journal of the American Medical Association (JAMA)[5] looked at 32 NCQA PCMH certified primary care practices & found very limited improvement in quality (improvement in 1 of 11 quality measures assessed) & no significant change in utilization or cost of care over three years. The authors’ primary conclusion was: “These findings suggest that medical home interventions may need further refinement.”


OK – I’m ready to give up… not really. What should we make of this litany of issues, problems & unexpected results?

First, it’s important to understand how early we are in many of these reforms. The HITECH Act , Title VIII of the American Reinvestment & Recovery Act (Public Law 111-5) was published in February 2009. Supplementary payments from CMS for meaningful use of certified EHR technology began in 2011 & we are only at the beginning of the fourth year of such payments & just at the beginning of Stage 2 of meaningful use. The adoption curve for EHR technology is necessarily difficult, as it requires alignment of clinical practice with both new software technology & new workflows for provider-patient interaction. There are other important factors for why this adoption is difficult & they’ll be discussed shortly.

The National Committee for Quality Assurance (NCQA) first published criteria for Patient-Centered Medical Home qualification in 2008, & we are about to go to the third version (2011, 2014) of those criteria. Currently about 7000 primary care practices (10% of those in the U.S.) are recognized by NCQA as PCMHs, but that means that 90% are not.

Health information exchange organizations have been around well over a decade. They predate the Office of the National Coordinator (formed by Presidential Executive order in April 2004), the HITECH Act (February 2009) and were originally formed to provide economies of scale for costs and to improve clinical outcomes through data sharing. According to the eHI 2013 HIE Survey[6] there are about 315 HIEs in the country & half of those reporting were financially viable in 2013 (& so half are not). There were many other issues including technical (substantial difficulty of interoperability & data acquisition from multiple (EHR) sources) & organizational (lack of cooperation &/or data sharing among HIEs).

Finally, ACOs… The Patient Protection and Affordable Care Act (PPACA) requires, under Section 3022, that a Medicare Shared Savings Program (MSSP), be established which is intended to improve quality of care while containing costs. The program began in January 1, 2012. Groups of providers, healthcare organizations formed Accountable Care Organizations (ACOs) in order to qualify for payments or shared savings by managing and coordinating care for Medicare fee-for-service beneficiaries. We’ve had two years of experience with ACOs during which time the model has evolved as the issues associated with shared risk have become apparent. Accountable care (basically capitation) has become a focus of HIE evolution as the exchanges try to evolve to more sustainable business models – whether this is a more sustainable model, however, remains to be seen.

We’ve had between two & four years of experience with these reforms (meaningful use, HIE, ACO), & we know several things from many years of study & experience with technology adoption. Thing 1 – You can incent technology acquisition, but you cannot incent technology adoption; & Thing 2 – Technology adoption depends on the alignment of the new technology with both organizational culture & the work being done. Any substantial difference in either means that either the technology will not be adopted (used) or that it will be adopted (used) imperfectly. In any case, adoption will take much longer than anticipated or planned.  

I’ll look at meaningful use in this post & cover each of the other reforms in future posts… IDC Health Insights has issued two reports recently that are pretty damning of meaningful use as currently defined. The one I’ve already cited on HIT Provider Predictions for 2014 & a report on ambulatory EHR[7]. The first report controversially states that first generation EHR technology, & by extension the meaningful use effort associated with it, has failed. Current EHRs are not engineered for post-reform healthcare models. The levels of interoperability, connectivity, usability & usefulness they provide are just not effective enough for the expense they incur, both financial & in terms of the change required to use them. As long as EHR technology & the incentive programs associated with their adoption are based on billing & our current reimbursement system, the use of EHRs will be seen as a financial necessity, not as a clinical advantage. It needs to not only be seen as both, but to actually be both. The second report lists a set of issues with current EHRs for ambulatory practice (in the real world, the issues are not so different for hospital-based practices). These issues are focused around the loss of productivity after adopting an EHR. The survey found close to 60% of ambulatory providers were neutral to very dissatisfied with their EHR & the two biggest complaints were that it took substantially longer to document patient encounters (including the system inadequately representing provider notes), & that many fewer patients were able to be seen (because of the first issue). Additionally, providers complained about poor reliability & usability, inefficient (& ineffective) workflows, poor integration with mobile devices & a variety of other problems. IDC Research Director Judy Hannover stated (in the second report), "Despite achieving meaningful use, most office-based providers find themselves at lower productivity levels than before the implementation of EHR. Workflow, usability, productivity, and supplier quality issues continue to drive dissatisfaction and need to be addressed by suppliers and practices." 
To continue in this vein (did I actually say that), David Blumenthal, former National Coordinator of HIT (ONC, HHS) now President of the Commonwealth Fund gave an interview in The Atlantic (19 March 2014)[8] where he said, "there are substantial costs in setting up and using" health IT systems.” He added, "Until now, providers haven't recovered those costs, either in payment or increased satisfaction, or in any other way." Blumenthal went on to say  "The disincentive to adopt HIT is related to the brokenness of the health care market." He said,  “]f the medical market functioned like the car industry or the computer industry or the service industry, with true competition based on quality and price, providers would have adopted electronic records long ago." This insight that healthcare, for all of the talk about market incentives & market forces acting in it, is not really a market is important, & one that I’ll return to in another post.

These disincentives combined with the fact that a bit greater than 50% of healthcare organizations are planning on replacing their current EHR vendor in the next 12 months clearly indicates that we have a long way to go to align EHR use with actual meaningful use. What could be done to facilitate this alignment? Here’s a list (non-inclusive & also to be returned to in future posts):
  • Nathan Myrvold, former CTO of Microsoft & (unfortunately) current patent troll, made the distinction between usability & usefulness. Regardless of how technically usable EHRs are (& they provably are not), this is not a major impediment to adoption, so long as they do something useful for their target audience. Once EHRs provide capabilities that providers find useful in their interactions with patients (& not just necessary for more effective billing), effective adoption will not be an issue.
  • Many other industries (as David Blumenthal points out) have struggled with the adoption of new technologies in the past 25 years. Two that I have worked in directly are automobile manufacturing (General Motors) & aerospace (Boeing, McDonnell Douglas). Each of these industries underwent very disruptive workflow & work process redesign during the 1980s-1990s as they adopted new information technologies. These re-engineering efforts led to increased productivity & lower costs – exactly the outcome (along with improved clinical outcomes) we want to see in healthcare. This work has not, for all the rhetoric of EHR adoption & meaningful use, been done in healthcare & it needs to be. Re-engineering of both the business & clinical work processes is necessary in order to be able to adopt & productively use new technology – otherwise you are just “paving the cowpath”
  •  Vendors must also revise & redesign EHR products based on usefulness & not primarily on meeting meaningful use criteria. Current products are neither really useful in a clinical sense nor meaningful in the sense of the Triple Aim. If CCHIT is right, & there is no sustainable business model in meaningful use certification, then vendors must reexamine the design, including both the user experience & the product functionality to ensure that their products facilitate the Triple Aim. Providers must insist on usefulness & alignment with redesigned workflow as features of future EHR products
  • HHS just released its 2014-2018 Strategic Plan[9]. It emphasizes Stage 2 & Stage 3 Meaningful Use as the primary HIT effort during this time. HHS & the ONC need to revisit this plan in the light of these, & other current opinions, issues & criticisms regarding EHR use & meaningful use. I recently heard both Marilyn Tavenner (Administrator, CMS) & Karen DeSalvo (National Coordinator for HIT, ONC) speak at the HIMSS14 conference. Both emphasized staying the course on meaningful use (although Dr. DeSalvo’s message was more nuanced). A re-exmination of this strategy is necessary if HIT, as envisioned by the relevant government agencies, is to provide real progress in improving clinical outcomes, improving population health & reducing per-patient costs.


PCMH is next, then HIE/ACO…





[1] http://www.ag.idaho.gov/consumerProtection/pendingActions/stLukes.html
[2] http://www.prweb.com/releases/2014/01/prweb11503131.htm
[3] http://www.cchit.org/press-releases/-/asset_publisher/l7V2/content/2014-01-29-business-transition?redirect=https%3a%2f%2fwww.cchit.org%2fpress-releases%3fp_p_id%3d101_INSTANCE_l7V2%26p_p_lifecycle%3d0%26p_p_state%3dnormal%26p_p_mode%3dview%26p_p_col_id%3dcolumn-2%26p_p_col_pos%3d1%26p_p_col_count%3d2
[4] U.S. Healthcare Provider IT 2014 Top 10 Predictions: IT Priorities for the Post-EHR Era http://www.idc.com/getdoc.jsp?containerId=HI244741, accessed February 20, 2014.
[5] Friedberg, M.W. et al. 2014. Association Between Participation in a Multipayer Medical Home Intervention & Changes on Quality, Utilization & Costs of Care. 311(8):815-825. Accessed on 15 March 2014.
[6] http://www.ehidc.org/resource-center/surveys
[7] Business Strategy: The current State of Ambulatory EHR Buyer Satisfaction. IDC Health Insights (Doc HI244027). November 2013.
[9] http://www.hhs.gov/strategic-plan/introduction.html