While public health epidemics worsen, a “Treatment Model” that has no support in research, practice theory, or standards of practice for behavioral health, “Primary Care Behavioral Health” (PCBH) is being pushed into Oregon medical settings by managed care organizations using their control of public healthcare funds.

Remarkably, it is a Columbia Pacific managed healthcare (CCO) employee tasked with forcing the fictional model into clinic practices privately acknowledging the lack of research support and that there is professional consensus for an alternative approach (below).

Worse, business- and medical-model driven Columbia Pacific CCO and its employees, working through a consortium of managed care and medical industry interests, CCO Oregon, has continued to leverage public funds to install the fictional model after twice being provided independent analyses of the lack of any research base for beneficial patient outcomes, and predicted harm.

The primary site of contact and identification for vulnerable Oregonians who have been overprescribed opioid medications, or otherwise are at risk due to problem opioid use, other substance use and mental health problems like depression, anxiety, and chronic PTSD, are primary care clinics (PCC), where behavioral health services have traditionally not been available on site. An important current trend is to provide “integrated” BH services (functioning as part of team care with medical staff) at those sites to identify need and effectively provide substance use and mental health services within PCCs, because the large majority of patients seen in PCC and referred for those services elsewhere will never follow through and access effective care.

In the NW U.S. and the rural Oregon region where public health funds are controlled by Care Oregon, Columbia Pacific, and GOBHI, this fictional (never having been supported by a research base) and invalidated treatment “model” Primary Care Behavioral Health (PCBH) for integrated care has been and continues to be implemented and pressured for use in medical clinics by Columbia Pacific and Care Oregon, despite the complete lack of a body of appropriate research to support the “model” and by its being invalidated by longstanding research (copy of analysis of relevant research provided to Columbia Pacific by request here).

As recently summarized:
“People who review the PCBH outcome research, including proponents of the model, agree that PCBH uptake has occurred on a foundation of limited effectiveness and efficacy research, especially patient-oriented clinical outcomes findings.” (emphasis added).

That’s a misleading, overly-positive account, because in fact, there are no RCTs (randomized controlled trials – the standard in research for confident conclusions about the experiment), let alone a body of RCTs, to support the practices described in PCBH. Its radical departure from standards of practice and EBP for the fields of Behavioral Health and Substance Use practice predict harm to patients and would require clinicians to practice unethically and illegally (analysis provided to Columbia Pacific by request here).

The model absurdly dictates the provision of, for example, 3 or 4 20-minute sessions, occurring about once each month, as “treatment” for an opioid use disorder, as well as for mental health disorders in general. Dr. Safina Koreishi, Medical Director of Columbia Pacific CCO, in a clinical staff meeting stated her understanding that this type of practice indeed does constitute “treatment” for substance use disorders and other mental health conditions.

These absurdly and grossly substandard practices appeal to payers (insurance companies) who, like Care Oregon and Columbia Pacific, use threat of withholding of public funds to attempt to coerce implementation. In our region, CO/CP staff have been made aware of the lack of validity of PCBH and continue efforts to mandate its implementation.

Made aware not once but twice.

As Columbia Pacific Innovation Specialist Andrew Huff acknowledges (request email string here):

evidence or no, [emphasis added] PCBH (uncredited) and some of its aspects are now baked into our medical home standards in Oregon. Seems the consensus for integration evidence is actually around the collaborative care model (CCM) . . .”

Mr. Huff adds:

“Nonetheless, I think that your points also highlight some questions about
• What is the role of innovation in healthcare
• What is the role of evidence in innovation?”

An “innovation specialist” for Columbia Pacific, Mr. Huff and CP leverage allocation of public funds to coerce compliance with the invalidated PCBH model, despite his acknowledgment that PCBH is not supported by evidence and that there is “consensus” against this invalidated model compared to alternatives. In the face of an opioid crisis with a mounting mortality count, he seems to ask whether health care practices should require an evidence base . . . “What is the role of evidence in innovation?”

In short, in the midst of mounting opioid and substance use crises, Oregon CCOs managing public health funds have “baked in” to their use of those funds to coerce clinical compliance, a fictional, invalidated “model” that: 1) is described by its authors as a “radical” departure from standards of practice; 2) has no evidence base (not a single supporting RCT); and 3) is invalidated, with predicted harm to patients, by decades of research establishing requirements for effective practice and outcomes in behavioral health (below).

“People who review the PCBH outcome research, including proponents of the model, agree that PCBH uptake has occurred on a foundation of limited effectiveness and efficacy research, especially patient-oriented clinical outcomes findings.” (emphasis added)

          – Mauksch, Peek & Fogarty. 2017. Family, Systems & Health. 35: 251–256.

evidence or no, [emphasis added] PCBH (uncredited) and some of its aspects are now baked into our medical home standards in Oregon.  Seems the consensus for integration evidence is actually around the collaborative care model (CCM)  . . .”

         – Andrew Huff, Columbia Pacific CCO Innovation Specialist

The example of PCBH points to something troubling. Columbia Pacific staff responsible for clinical practice guidance acknowledged privately that the adopted clinical models are not supported by research as valid, at the same time that those models and practices are being promoted and directed for use by the insurance company and funded with public healthcare money. Is PCBH a fluke, an exception in otherwise clinically-sound, ethical and legal use of pubic healthcare funds by Managed Care in Oregon ?

How are public funds being used by managed care to guide effective approaches for tobacco cessation, given the lethal connections to pain and opioid use, as well as the diabetes epidemic?

Columbia Pacific CCO provided clinical trainings to medical clinics and staff to disseminate “best practice” clinical practices for tobacco cessation, provided by CCO “experts”.

I’m personally and/or professionally acquainted with each of the insurance company staff members represented here as “experts” and placed in a position to determine best practices for a life-threatening substance use problem, in this case tobacco use.

None of the four insurance company employees have credentialing, formal training, or expertise in areas critically required to determine “best practices” in this area:

  • Training and background in research methods and design to analyze, vet and interpret the relevant research
  • Nature of substance use disorders and experience in EBP treatment program development
  • Comorbid underlying mental health conditions and their effective treatment
  • Placing in context research findings based on direct practice clinical experience providing EBP therapies to substance dependent patients

That is, none of the insurance company employees has competence in the areas required for this task, let alone expertise.

I was glad to support use by the CCO of a clinical tool I developed at our clinic comparing treatment options for tobacco use disorder (TUD) for use by patients, and I provided by email updated information on relevant research to behavioral health colleagues and to CCO staff preparing and providing the clinical trainings.

Columbia Pacific’s lead clinician replied to my material by email (email exchange available by request here), indicating that the CCO group disseminating “best practice” clinical practices to area clinics had not reviewed the research prior to validating, promoting and recommending continued use of nicotine replacement therapy (NRT = gum, patches for nicotine replacement) for tobacco use – could not have reviewed the research or would have been aware of emerging best evidence pointing to no benefit from NRT, see highlighted research summary.

Effects for positive outcomes with NRT have always been small for example “number needed to treat” NNT to provide one positive outcome, in this study NNT = 29 = 97% failure rate:

http://www.bmj.com/content/338/bmj.b1024

Newer research and meta-analysis point to no tobacco cessation benefit (no difference in cessation rates compared to no treatment) from NRT:

http://www.jclinepi.com/article/S0895-4356(16)30184-6/fulltext

http://www.jclinepi.com/article/S0895-4356(16)30075-0/fulltext

http://tobaccocontrol.bmj.com/content/early/2012/01/03/tobaccocontrol-2011-050129.short

Herd, N., Borland, R. and Hyland, A. (2009), Predictors of smoking relapse by duration of abstinence: findings from the International Tobacco Control (ITC) Four Country Survey. Addiction, 104: 2088–2099

If the designated experts had reviewed current evidence related to effective treatment of tobacco use, they would also have become aware of the body of research that establishes that urges per se to use substances, specifically tobacco, do not predict return to problem use (“relapse”), instead other factors do (e.g. Herd, Borland and Hyland, 2009, cited above). The assumed (and invalidated) effectiveness of medications and NRT for quitting tobacco use is based on the assumption – false – that urges to smoke are a primary trigger and cause of relapse.

Worse, provision of NRT and other medication-based interventions to patients trying to stop smoking, with no or clinically insignificant benefit, is associated with additional harm due to reinforcement of patient belief in the invalidated disease model of “addiction” (NRT provided by medical providers in medical settings and perceived as a medical treatment for addiction), because research establishes belief in the fictional disease model as a primary predictor of relapse.

Managed Healthcare’s ineffective misuse of public funds to treat tobacco use disorder is critically harmful because: 1) health care system and social costs of tobacco use eclipse those of opioids and illicit substances combined, and 2) tobacco use is directly related to the opioid crisis – evidenced as contributing to the cause of chronic pain conditions and to worsened perception of chronic pain
and increasing risk of continued or return to problem use of substances including opioids (acting as a “gateway drug” for opioids)

In that research context – of multiple evidenced links between tobacco use and worsened risk of development and effects of problem opioid use – the private acknowledgments (request the email string here) of Columbia Pacific CCO’s Clinical Coordinator importantly highlight the continued harms perpetuated by managed care and Oregon CCOs against vulnerable Oregonians and associated abuse of public funds. Those acknowledgments include that:

  • tobacco use disorder (TUD), like any substance use disorder, is not a “disease” or medical condition with effective or primary medical treatments
  • the required, indicated EBP interventions that predict success are (individual therapy) behavioral health (BH) treatments including Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT)NRT and
  • medications (bupropion, varenicline) are not significantly effective treatments, certainly not on their own.

Publicly and in contrast, Columbia Pacific CCO avoids reference to and recommendation of the effective, indicated EBP therapies for tobacco use, instead promoting and funding practices – visits to medical professionals, phone counseling, NRT, medications –that predict no clinically significant benefit for the life-threatening disorder, constituting apparent abuse of public funds and perpetuating public harm.

Worse, those private acknowledgments – specifically that the indicated, effective EBP treatments for smoking are Behavioral Health therapies, not medical or other interventions – point also to the false, deceptive, and harm-predicting promotion by Columbia Pacific of their employees as “experts” tasked with disseminating credible clinical practices for smoking cessation to health care professionals. These “experts” are individuals without credentialing, training, or research or practice experience in the area of EBP BH therapies for substance use disorders – presented by CP as “experts” but possessing neither expertise nor competence in those areas of healthcare practice.

The example of PCBH – like that of Columbia Pacific clinical practice experts tasked with understanding and distilling research to identify and promote effective EBP healthcare practices for tobacco use – points to something troubling. In both cases, Columbia Pacific staff responsible for clinical practice guidance acknowledged privately that the adopted clinical models are not supported by research as valid – at the same time that those models and practices are being promoted and directed for use by the insurance company and funded with public healthcare money.

In rural Oregon hard-hit by the opioid crisis, on every count, from all lines of evidence, the business-model managed healthcare system, allowing insurance companies to use control of public healthcare dollars to drive and determine clinical practices, is failing to support effective evidence-based practices for vulnerable Oregonians trapped in the opioid and substance use epidemics, failing egregiously.

 

Forging a new meaning for “Gold Standard”

Ten or twenty years ago, a gold standard in the healthcare industry supported and encouraged routine use of opioid pain medications for common chronic pain. Like PCBH (see addendum below), there was never any body of research to support that practice as safe and effective, and all lines of evidence pointed against it, pointed to predictable harm.

What could go wrong?

Now the medical industry and Managed Healthcare are forging ahead with an unvalidated medical fix for the medically-induced opioid crisis, the research base at best conflicting and less than validating, with a pattern of treatment outcome failures and unquestioning support from media promoting The “Gold Standard” for fixing the opioid crisis.  In practice, in clinics, use of buprenorphine (Suboxone) in Medication-Assisted Treatment, under medical model design and oversight, leaves out the Treatment part of MAT, with predictable outcome failures.

That’s two strikes, two high-lethality failures.

The publisher’s pitch for the second edition of the influential book laying out Primary Care Behavioral Health identifies another gold standard:

 

Behavioral Consultation and Primary Care

A Guide to Integrating Services

 

Authors: Robinson, Patricia J., Reiter, Jeffrey T.

• The Primary Care Behavioral Health (PCBH) model, as defined in the first edition, is on its way to becoming the gold standard for design and delivery of behavioral health services in primary care.

 

Strike three. But in the game they own, their batters are never out.

 

Addendum below: highlights of analysis of the research, standards of practice, and theory base for PCBH, prepared by me on request by Columbia Pacific CCO. Request a copy of the full analysis here at A Critical Discourse.

Andrew [Huff, of Columbia Pacific CCO],

Thanks for providing for review the compilation of summaries of published articles, “PCBH outcomes with quadruple aim”, source unknown, attached to this email. You indicated that these summaries have been offered by advocates of implementation of the PCBH approach to integrated behavioral health care (IBHC) as evidence of effectiveness, and you requested my evaluation and impressions, from my combined direct practice and research background and frame of reference.

. . . from the information provided in the summaries, representing studies spanning a period 1996 – 2015 and with 6 of the 19 published 2014 or 2015, it is clear that the corresponding studies do not provide relevant evaluation of or support for the PCBH approach, or any IBHC model, for a variety of reasons. The most generous thing we can say about the referenced studies is that due to overall design and other factors, they are not able to provide confidence in conclusions for the effectiveness of any model of IBHC, certainly not for the R&R 2016 PCBH approach.

. . .

Of the 19 summaries, one (1) was a RCT, providing a control – study # 19.

None of the other studies is of the type that could, even provided other requirements were met for internal and external validity (below), support confident conclusion of a causal relationship between the experimental treatment (intervention) and measured outcomes. They are generally “pre-, post-“ type studies.

At this time, there is not a research base to support use of the PCBH approach for any BH condition, let alone the range of MH conditions encountered in our clinics and for which patients want and need BH services.  . . .

The above are critical considerations for BH practitioners in IBHC settings because they raise important ethical constraints, constraints that do not arise when BH practitioners employ established EBP therapies in our field, under standards of practice for our field. Faced with referring patients with any diagnosed or diagnosable BH condition to outside services appears to place BH clinicians in potential violation of at least three core ethical mandates. . . .

While the lack of a research base ethically prohibits its implementation as a generalized BH intervention treatment approach for the range of BH conditions and needs presenting in integrated health homes, the PCBH approach is independently and sufficiently invalidated by the existing body of research that describes and establishes effectiveness for EBPs and standards of practice within the field of Behavioral Health. . . .

In short, the CMP [aka Common Factors Approach] model establishing, by decades of research, the features essential for patient benefit in generalized BH practice is antithetical to the prescriptions of PCBH and similar approaches as models of generalized BH intervention treatment approach for the range of BH conditions and needs presenting in integrated health homes . . .

Additionally, it is incumbent on BH professionals to be aware of and adhere to professional standards. Social workers, for example, are required to meet standards of practice in all settings including medical, those standards including requirement for provision of comprehensive psychosocial assessments and provision of services that are EBP or at minimum supported by research

Summary – Despite a decade of marketing, there is no research base (body of RCTs, with external validity) to support use of the PCBH approach described by R&R 2016 and promoted for integrated care settings in Oregon (for example by CCOs and by the Integrated Behavioral Health Alliance of Oregon) as a generalized BH intervention treatment approach for the range of BH conditions and needs presenting in integrated health homes including e.g. behavior change, resolving barriers to adoption of wellness behaviors, substance use disorders (SUD), chronic pain, major mental illness, and other mental health conditions impacting physical health in patients unable or unwilling to access MH services elsewhere.

Lack of such support was predictable on consideration of the prescriptions of the PCBH approach, which represent what can only be described as a radical departure from established EBPs and research-based standards of practice for BH.

It would not be exaggeration to note that the PCBH approach as prescribed in R&R 2016 is invalidated by essentially everything we know about effective and ethical practice in Behavioral Health. From frames of reference of research base, standards of practice, and ethical practice, PCBH as a generalized treatment approach for BH needs in health home settings has the same status as generalized use of opioid pain medications for chronic pain . . .

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