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

No comments: