Guarding against pseudoscience at Western University

As a member of the faculty at Western University, I was absolutely thrilled that last weekend’s Homecoming featured a panel discussion on the topic of pseudoscience. The panel consisted of: Dr. Jen Gunter, an obstetrician-gynecologist, Western alumnus, and prominent online voice for science-based medicine; Dr. Marina Salvadori, a local pediatric infectious disease specialist and passionate vaccine advocate; Mark Speechley, PhD and Dr. Saverio Stranges from the Department of Epidemiology and Biostatistics.

The talk was engaging, dealing with issues ranging from our society’s move away from appreciating the value of expertise, to vaccine denialism, to celebrity promotion of pseudoscientific products. My only quibble was with the short duration, as one hour was only a fraction of the time needed to tackle such a pressing topic, but hey, it’s Homecoming weekend, every minute is valuable.

So after a terrific talk, I waiting in line to greet Dr. Gunter (my Twitter buddy!) and Dr. Salvadori (who saved my cousin’s life in 2008, long story…) when, to my left, a fairly irritated man was needling Dr. Speechley with the demand that he “define pseudoscience for him”. Dr. Speechley politely explained that a definition could include beliefs and practices that appear scientific, but are not. The man was not satisfied, and repeatedly demanded a more specific definition. I couldn’t help but interject myself into the discussion, so I elaborated a bit further as to what a definition could entail. Again, he was not satisfied with our explanations. I sensed that he was clearly not interested in an actual discussion, but was rather trying to troll us into some ideological debate he wanted, so I asked him what he did for a living, to try and get a sense of where the heck he was coming from. He refused to answer. Giant red flag.

Before I had even a second to think of what to say next, he had moved on rapidly to explaining to us how he personally used homeopathy, and used it for all of his family, and who were we to tell him what works and doesn’t work.

There it was. The sacred cow. His love of homeopathy. Of course.

The rest of our conversation was a failed attempt at explaining to him that he and his family are free to pursue whatever treatments they desire, but he crosses a line when he attempts to convey to others that pseudoscientific treatments are based on any sound science. Oh, and I finally managed to get him to tell me what he did for a living. He’s an ENT surgeon. Frightening.

So where does that leave us? After an hour of kumbaya about science and fighting pseudoscience, this discussion brought me right back down to earth with the realization that pseudoscience is right in our midst on a daily basis, even promoted by those who we assume should know better.

There wasn’t any time for any questions to be taken from the audience, but here is the comment I wanted to deliver:

There was a lot of discussion during the talk about the role of health care professionals and the government in terms of education and policy around science, but we need to realize the important role that academic institutions like Western can play in terms of leadership in battling pseudoscience. Sadly, we have seen a proliferation of institutions in North America providing legitimization for pseudoscientific practices: UC Irvine accepting a $200 million gift to launch an “integrative health” institution, the fact that most American hospitals have a department dedicated to “integrative medicine”, and even the University of Toronto has its own “Centre for Integrative Medicine”. There is absolutely nothing from stopping Western from being the next university to fall prey to this trend. There has long been a course in the 4th year medicine curriculum about Complementary and Alternative Medicine, taught by “alternative practitioners”, with the students not provided with an ounce of scientific skepticism about these practices (as faculty, I provided an open lecture this year to any interested medical students, entitled “Scientific Skepticism in Medicine”). Western’s Departments of Health Sciences and Kinesiology have offered a course in “Integrative Health“, which….well just look at the syllabus. It’s horrifying.

To administrators who simply shrug and question what the magnitude of harm there could possibly be in allowing unscientific concepts to proliferate an institution, let me remind you of the institutional embarrassment that these individuals and concepts can bring to an institution. Do you think Yale was pleased at being referenced along Dr. Oz during his testimony before congress? Do you think the Cleveland Clinic had a few regrets about the fact the medical director of their Wellness Institute created an online firestorm after his blog that regurgitated anti-vaccine talking points? Do you think UBC is happy that two anti-vaccine researchers have made national headlines for having a paper retracted for the second time over accusations of fraudulent data?

There are consequences to allowing pseudoscience to flourish, because when there is the inevitable embarrassment, health professionals like myself will lay the blame at the feet of those in power who did not stand up for science.

Let’s be international leaders at Western, bucking the ongoing trend towards quackery, and setting a new standard for creating a health community dedicated to science-based medicine.

OMA/MOH Negotiations: Part Deux

My last blog post raised a few very specific ideas within primary care that I hope to see addressed in the upcoming negotiations between the OMA and the Ministry of Health.

While I love practical minutiae, I think it’s also important to step back and address some of the larger issues of how primary care is organized and funded.

First it is vital to clearly delineate the accountabilities within the system, which are currently blurred to the point of being non-existent. From a funding standpoint (for care deemed clinically necessary, third party care excluded), there should only be two lines of accountability, one between the insurer (government) and policy holders (patients), and the other between the insurer and care providers (physicians). Patients should not be financially accountable to physicians, nor vice versa, and their relationship should be strictly clinical. I’ll explain later why this is important.

Patients in Ontario (and Canada, for that matter), generally do not fully understand the fact that their taxes are paying into a health insurance policy, and that like any insurance policy, there are benefits, expectations, and restrictions to the type of care that their insurance covers. I don’t blame patients for this. The fault for this lack of clarity lies with the insurer (government), who is understandably fearful of the political ramifications of being seen to “restrict” care by enforcing any semblance of limitation on “insured care”. Second opinions, two visits for the same issue in one day, anything goes!  But can you imagine Anthem or Aetna in the US demonstrating this type of ambiguity with what their  policies cover? Tax payers don’t want to pay more taxes to cover increasing costs, so we need to have open discussions around what is medically necessary and appropriate. Clear answers are needed to the question of what does the insurer guarantee to patients, and what expectations are there of patients. Physician organizations can and should be engaged to provide their objective expertise to guide what should be covered by a provincial insurer, but the reason that there can be no physician-patient financial accountability is that physician recommendations and behaviour may be seen as being influenced by financial motives.

And the provider-physician accountability? Not as clear as you would expect. Should be pretty simple, too. Agree to a framework of what is covered by the insurer, what the expectations are of physicians, and compensate appropriately for the insured care that is provided. But rather than having a strict framework guide physician activity, we often have physician entrepreneurs stretching the boundaries of what the current loose framework intended. House calls for non-disabled patients, specialist clinics that bring stable patients back repeatedly for routine follow-up with expensive imaging tests, and niche clinics opening up for any new market that they identify (eg. “biochemistry nutrition clinics”, “functional medicine clinics”, “cannabinoid medicine clinics”, etc.). With many of these clinics, the horse is coming before the cart. The physicians have a OHIP billing number, and it’s essentially a blank cheque to bill the government for any semi-clinical interaction with patients, until the CPSO or the ministry deems the clinic’s practices egregious enough to intervene (which is rare).

So where am I going with this? I have a fairly radical plan for how primary care funding could be re-organized.

First we need to address the issue of the “access bonus” for those in a FHO model with negation for family physician billings outside of their FHO. The initial rationale for the concept was innovative: use the outside billings as a surrogate marker for the degree of access FHO physicians are providing. With better access, patients should be seeking care elsewhere less frequently. Unfortunately, it has proven to be a poor surrogate in many areas of the province, including areas without a walk-in clinic (ER visits don’t contribute to negation, physicians get their total access bonus regardless of actual access) and the GTA where commuting patients will seek convenient care at a walk-in rather than attending the after-hours clinic their FHO is providing (FHO provides the access, still gets negated). But apart from the inequality of the system, this mechanism is fundamentally flawed because it violates one of the principles of accountability I raised earlier. Lines of financial accountability should not exist between patients and physicians. In the case of the access bonus, it has strained many physician-patient relationships as physicians have often clumsily attempted to educate patients about what the access bonus/negation issue entails, while the patient hears “You are costing me money by seeking health care”.  This is not healthy for these relationships. We need a new system.

Here we go.

First, take the FHO/FHG/FNH models and replace them with two capitation “tracks” that family physicians can decide between for their practice. Track 1 would see 80% of their income from capitation fee, with a 20% fee-for-service shadow billing for patient encounters. Track 2 would see a 60/40 split. Depending on which Track a physician chooses, they would be locked in for 3 year periods (the math involved in switching between tracks more frequently would be a nightmare). Capitation figures would be adjusted based on a formula of patient complexity, the data of which would be taken from the accurate EMR coding of patient problems (with agreed-upon standards of what makes a patient eligible to be given a certain diagnosis/problem).

Next, when a patient is rostered to a family physician, within a 30km radius of their provider they are only insured to see their provider group. If a patient chooses to seek care at a walk-in or other family physician within that 30km radius, it would not be an OHIP-insured service, while outside of that radius it would be insured (on vacation, visiting family, work, etc.). There would have to be point-of-care OHIP validation available in real-time for walk-in providers to determine whether the patient visit would be insured or would be patient-pay. For those without valid OHIP cards who present for care, there would also have to be a live ministry-run system available for dealing with issues of coverage during all clinic hours.

If a patient repeatedly is seeking care outside of their provider network/radius, it is the INSURER (the province) that then can de-roster the patient and make that patient a “fee-for-service patient” (that is, each service covered by OHIP is paid as fee-for-service, not covered by capitation rates). The ministry would then be incentivized to attempt to find the patient a primary care group that is closer to the patient’s geographic area, as the province does like the relative cost-certainy that capitation models bring.

For physicians in these new capitation “tracks”, there would be NO cap on fee-for-service billings provided to patients who have been excluded from capitation by the ministry, as the fact that they are “fee-for-service patients” is out of their hands (there is currently a cap on these billings for capitated physicians).

There would also be no further clawback on access bonus payments. The payments would all be made in full to all physicians, but with strict accountability for after-hours clinic availability (7 days a week, 3 hours/d), and adequate patient access for new-onset complaints (3rd next available appointment within 24 hours). For those in rural areas, providing scheduled after-hours care through emergency departments would be allowable if negotiated directly with the LHIN. If physicians are found not to be meeting the access requirements, there would be a tiered warning system, with repeated violations ultimately resulting in termination of their capitation contract, reverting the physician to an exclusively fee-for-service model. Some physicians may see these requirements as oppressive, but if we are going to create a model whereby payments are essentially guaranteed and patients are restricted from seeking care elsewhere, we must provide them with impeccable access to our services.

(There would also have to continue to be a significant financial advantage for physicians to be in a capitation “track” model over a fee-for-service model to provide the incentive to stay within the organized capitation system.)

Patients themselves can opt to be “fee-for-service patients” within a practice and the province, but then would not be guaranteed the provisions of access to after-hours clinics or the 24-hour clinic appointment guarantee.

So there’s my preliminary framework. Lots of work still to be done (and I’m sure exceptions and situations I haven’t considered), but I hope we can start moving our system forward with some new innovations, because the current blurred lines of accountability are frustrating both patients, physicians, and the government.

AAA screening in older males: Should we?

Last week, a Danish group made headlines with their Lancet study showing that “Triple-screening” older men for abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD), and hypertension reduced 5-year mortality by 7%.

This was seen as validating the current Canadian guidelines that call for all males 65-75 years old to undergo a one-time ultrasound to rule out a AAA, in addition to women with risk factors (smoking history, family history of AAA, or cerebrovascular disease).

So, is it time to move forward with a formal population-based screening program? Let me provide some food for thought using some of my own practice data.

In the Danish study, 21% of the subjects were active smokers at baseline. In my practice 10 of 154 (6.5%) men 65-75yo are smokers (3 of the 10 smokers smoke only cigars or pipes infrequently, and 3 men in the cohort have no smoking data available). We know that smoking is the strongest risk factor for development of AAA, as current smokers are 7.6 times more likely to have an AAA than nonsmokers, and even ex-smokers are 3.0 times more likely to have an AAA than nonsmokers. Screening a population where smoking is less prevalent will provide far less of a mortality benefit than was seen in the Danish population, with a larger number needed to screen.

In response to the Canadian guidelines, I have made an effort in my practice to increase AAA screening rates over the past few years, with 113 of 157 (72.0%) men 65-75yo completing an ultrasound screen. Of the 113, only 2 have a AAA, which is significantly lower than the 3.3% AAA rate seen in the Danish study. Lower smoking rates overall likely translating to the lower rate of AAA.

Looking at all age groups, 14 of my patients have a current or past AAA (7 men, 7 women). 10 of the 14 are former smokers, and none are current smokers. 12 of the 14 are over the age of 75.

The number needed to screen for men >65yo to prevent one AAA related mortality is 769, but this includes both smokers and non-smokers which are likely inflating the numbers. If we are going to implement a program, let’s start with the high-yield groups of smokers/ex-smokers first where we know we will see a see the biggest benefit.

Ontario Osteoporosis Strategy Technical Report – My practice-level data/insight

The Ontario Osteoporosis Strategy recently released its technical report which I encourage all family physicians, endocrinologists and orthopaedic surgeons to read. The report takes data from ICES and CIHI and brings to light some interesting province-wide and LHIN-wide trends in osteoporosis screening.

The main takeaway for me from the report is that the current system is doing a generally poor job of screening patients for osteoporosis. Top level points include:

  • In 2014/15 only 13% of men and 28% of women aged 68-70 had received a BMD in the past 5 years

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  • In 2014/15, there was a three-fold difference between high and low rates for standardized BMD testing following a hip fracture (low of 11.9 in Erie St. Clair; high of 38.6 in Toronto Central)

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It goes without saying, but there is an awful lot of improvement when you look at that table. Many eligible patients not being screened at all, and many not receiving appropriate care post-fracture.

But before every LHIN jumps out of their seat wanting to improve this as a quality metric, we need to step back and practically evaluate which groups would truly benefit from screening.

The 2010 Canadian clinical practice guidelines recommend screening all individuals >= 65 years old (men and women) for osteoporosis. The Osteoporosis Self-Assessment Tool is a validated screen that is useful in determining which patients would warrant a BMD. The formula is Weight (kg) – Age (years), and if <10, increased risk of osteoporosis and BMD is warranted.

How do these two approaches to screening compare in a real-life setting? I looked at my practice-level data and will share the insights here.

In a practice of 2200 patients, 243 women >= 65yo were identified, 224 of whom have had at least one lifetime BMD (92%). 250 men >= 65yo were identified, 107 of whom have had at least one lifetime BMD (43%).

l went through my patient data and analyzed which patients have a calculated OST < 10 and would qualify for BMD screening, sorted by age cohort.

First, the men (11 patients were excluded because of no recorded weight):

65-69yo: 9/75 have an OST <10 (12%)

70-74yo: 24/61 (39%)

75-79yo: 23/37 (62%)

80-84yo: 26/31 (84%)

>=85yo: 31/31 (100%)

And the women (21 patients were excluded because of no recorded weight):

65-69yo: 34/52 have an OST <10 (65%)

70-74yo: 38/59 (64%)

75-79yo: 29/38 (76%)

80-84yo: 32/33 (97%)

>=85yo: 47/47 (100%)

In total, 45% of men >=65yo would qualify to be screened with BMD according to the OST, and 77% of women >=65yo would qualify.

Certainly looking at the male data, it appears that using the age 65 cut off is a very crude screen and may lead to over screening with BMD. But what about the most important outcome, which men actually required treatment for osteoporosis as a consequence of screening those >=65yo? (using Mayo Clinic resource as shared decision-making tool)

I identified 14 male patients in my practice who are currently being treatment for osteoporosis (either with bisphosphonate or denosumab): 10 patients >=65yo, 6 patients 50-64yo, and 1 patient <50yo. Interestingly, only one of the 14 patients was identified as having osteoporosis through the >=65yo screening program. The remainder were identified as requiring a BMD because of other risk factors:

– 5 with compression fractures (2 of whom have alcohol use disorder)

– 2 on prednisone

– 2 with rheumatoid arthritis

– 1 with Parkinson’s

– 2 with alcohol use disorder

– 1 with Prader-Wili

Out of 107 men >=65yo who received at least one lifetime BMD, only ONE patient lacking any other risk factors apart from age warranted (and agreed to) treatment for osteoporosis.

A few points to consider:

  • If we are going to target osteoporosis screening as a quality metric to improve, I think it behooves us to isolate screening in women >=65yo as the actionable, measurable metric, rather than including both men and women in the cohort. Screening all men >= 65yo will not be a cost-effective intervention, as it will not identify a significant number of men who will actually warrant treatment, and will instead result in many completely fruitless BMDs, at a cost of millions of dollars to the system. While likely not measurable as a widespread metric, the preferred approach to screening in men should be risk factor-based, with a particular focus on screening men with a history of corticosteroid use, alcohol use disorder, RA, those on aromatase inhibitors, and those with a previous fragility fracture (and screening men with chronic back pain with plain x-ray to rule out compression fracture).
  • The OST should be encouraged as the initial screening evaluation prior to BMD, and that it be highlighted to physicians that 100% screening compliance is not the suggested target in women >=65yo (only 77% were eligible according to OST in my patient population).
  • The technical report mentioned that of those on treatment for osteoporosis, 38% of individuals received a follow-up BMD within 2 years. While the report frames this as a proportion that should be increased, I would take the opposite approach to this data. Ordering a repeat BMD within the first 2 years of treatment for osteoporosis is rarely indicated as the results should not often change treatment. Any change in the BMD within 2 years of starting treatment is just as likely to be inherent variability in the test as compared to a meaningful change due to treatment. We should be targeting that 0% of patients receive a follow-up BMD within 2 years of starting treatment.

Certainly there is tremendous room for improvement in how we are systematically screening for osteoporosis in Ontario, especially in those who have already experienced a fragility fracture and in women >=65yo. We must, however, also ensure that any widespread quality improvement efforts must be rational in who it targets and careful to avoid over screening in extremely low-risk populations, such as men who lack any risk factors other than age.

OMA/MOH Negotiations: A few suggestions for primary care

With a binding arbitration mechanism finally in place, negotiations between the OMA and the MOH are set to commence in the next month. Sections and districts are being consulted for their priorities in negotiations with the objective of developing a cohesive mandate.

While there will be broad consensus on many high-level issues that stretch across multiple specialties (appropriate funding of system growth, funding to improve physician staffing in under-service remote areas, etc), I want to get a bit more granular to raise some fairly narrow issues that are specific to primary care.

(Disclaimer: I don’t consider these to be anywhere near the most important issues to primary care, but simply a few issues where I think we can see some innovation.)

  1. Fix FHO oversight, and open them back up to all family physicians in all regions

Restricting FHO entry to those in under-serviced areas may have initially seemed like wise policy that would drive physicians to those areas, but instead has resulted in multiple unintended consequences. We have a two-tiered system within primary care of those in a capitation model and those who are stuck in a fee-for-service model which the ministry themselves has decried as antiquated. The difference between the two models is far more than one of finances: it potentially changes the manner in which care is delivered, where capitation incentivizes the physician to innovate, providing alternative methods of care delivery (phone, telemedicine, staff delegation) and removing the incentive to initiate potentially unnecessary visits. When we are dealing with fundamental principles of care delivery, this simply cannot be determined and restricted based strictly on geography. If it’s a good model, it’s a good model in North Bay, it’s a good model in Niagara Falls. But here’s the caveat: we need to fix what is currently happening in some FHOs. FHOs are contracted to provide a minimum number of after-hours clinics, and a small group simply aren’t meeting their obligations, partly answering why we haven’t seen much of an improvement in access despite large investments into FHOs. (I note a “small group”, because I know that the majority of FHO docs who are meeting their responsibilities bristle at any mention that some docs aren’t. If you are doing your mandatory clinics, you are completely exempt from this criticism). Part of the issue is that the ministry hasn’t enforced the requirements, but this can be easily remedied. Start enforcing the rules, and mandate that FHOs transparently advertise their after-hours clinics availability (websites, phone, push e-mails). I won’t comment on specific measures of access during office hours for new or urgent issues, but I think we’re well overdue to see some consistency around this issue across the province.

2. Revising the K030 and Q040 for diabetes management

Family physicians bill a K030 as a visit code for diabetes visits (max 4 per year), and are eligible to bill a Q040 code ($60) once per year “if the physician has rendered a minimum of three K030 services for the same patient in the same 12 month period to which the Q040 service applies”.

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Makes sense in theory to improve quality of care, but a few unintended consequences. If a patient comes in for assessment of a unrelated intercurrent illness where diabetes was not reviewed but a physical exam was completed, the physician is essentially forced to bring back the patient for a “diabetic visit” which can just as easily be done over the phone or by other telemedicine means. This leads to unnecessary visits and often inconveniences patients who are stable.

Proposal: Change the K030 into a Q030 tracking code, which can be billed either through provision of in-person or virtual care of all of the features of the Diabetes management Incentive at each visit (except the foot examination and neurologic examination, which should only be required once a year). Three Q030 codes in a 12-month period to be eligible for the Q040 code, which should be increased to the $125 range (matching CHF Q050 code) to properly incentivize physicians to do more virtual care and to properly remunerate the requirements of diabetes care.

3. Complete overhaul of the preventive care bonus program

With all of the innovation taking place in primary care in the province, somehow we are still stuck with the same five metrics for nearly a decade now (influenza vaccination, childhood immunizations, colorectal cancer screening, cervical cancer screening, and mammograms). Kiran et al showed in 2014 that in Ontario, “pay-for-performance scheme was associated with little or no improvement in screening rates despite substantial expenditure”. Total bonus payout can be as high as $12,800. Surely we can use that money to actually improve some areas of care. (Disclaimer: I have a compliant practice population and regularly hit all of my maximum targets. Any alteration may actually impact me negatively. But let’s tinker with it anyways.). Here are some ideas:

  • Take a small portion of the existing bonus money and leave it to reward the existing five metrics, but change the measured outcome from “test or treatment completed” to “test or treatment was offered to patient” and implement a tracking code for each. Make the threshold 95% compliance to obtain the bonus. Childhood immunizations discussions must occur in person, the other 4 interventions can be done virtually (batch email, snail mail, phone, etc). This will enable informed, patient-centred decision making, and will eliminate the tension between physicians and patients when patients refuse an intervention that may affect the physician’s income. If the bonuses for these metrics are completely eliminated, I do fear that we may see a significant decline in screening and immunization rates, as many patients complete these interventions because of their relationship with the primary care physicians (and would not be as compliant if Cancer Care Ontario or public health departments were the only bodies encouraging the interventions).
  • Develop an advance care planning framework (workbook, custom form, etc.), and establish bonus money thresholds for percentage of patients 65+ years of age for whom the established framework has been either completed or offered (for patients who refuse to engage in discussion). Codes should be established for both the visit where this discussion occurs, as well as making the bonus sufficiently generous given the large number of patients this initiative will encompass.
  • Dedicate the majority of incentive money towards EMR maturity programs, specifically a focus on rewarding data integrity and standardization over a 3-year period. Identify priorities (linking problem lists to ICD-codes according to defined algorithms, appropriately labelling data elements including lab results, imaging, immunizations, vitals, etc). There are massive disparities across the province in how effectively and consistently physicians are entering their data, and an incentive program would reward physicians who have 1) invested in an electronic medical record and 2) are interested in working towards maximizing the potential of their EMR to improve quality of care in their practices. Future agreements can focus on specific renumeration for participation in quality improvement initiatives using their high-quality data.

4. Tighten up house call restrictions

We have seen some entrepreneurs in the GTA create companies that offer the convenience of physician house calls. While of course I support the availability of house calls to all Ontarians, some of these programs risk putting simple patient convenience ahead of continuity of care, as well as markedly increasing health care costs with otherwise mobile patients costing the system 3-7 times the cost of a regular office visit. A few simple suggestions:

  • Strict enforcement that house calls are only available to patients who are physically disabled and unable to attend an office visit in person. Lack of adequate transportation and convenience (e.g. parent with febrile child would not qualify). This must be clearly advertised by these companies, the patient’s disability must be clearly documented for auditing purposes, and patients who do not qualify should be able to pay out of pocket for the total cost of these convenience house calls.
  • For patients requesting house calls who are rostered to a physician group, any house call physician outside of that group must 1) have prior consent to see the patient or 2) make an attempt to contact the on-call physician of that group to ensure that they are not able or willing to see the patient.

5. Change the billing framework for “physicals” and “Periodic health examinations”

In the last agreement, for patients without a chronic disease, any “checkup” or “physical” would become known as a “Periodic Health Visit”, code K130/131/132 to be billed at $50.00. (For those without chronic disease, this was a marked reduction from the A003, a general assessment, billed at $77.20 (pre-unilateral action)).

Here’s my radical suggestion, in keeping with the Choosing Wisely campaign: Change the K130/131/132 to a Periodic Health Review, billed at $30 once per 12 months, which can be done either in-person (in conjunction with a visit code) or virtually. The review will simply include a questionnaire including all of the history-taking components of the Preventive Care Checklist, with no required physical examination component. Patients can either monitor their own BP and weight to be recorded in the EMR, or they can stop into the office to have this measured (recording these vitals once yearly would be required to bill the K130/131/132). A003 will still be able to be billed for patients for a physical for follow-up of a cancer diagnosis or other life-threatening illness requiring a head-to-toe exam (eg. CKD patients should have a focus physical exam at regular appointments, and thus do not require an annual A003). If patients who do not meet the criteria request any hands-on annual physical examination, this should be not OHIP covered, and available to patients at OMA rates.

 

 

Crazy ideas, I know. We’ll see what happens with the negotiating parties.

Cheaper PPI options: An EMR QI exercise

Back in December 2016, I was doing some work around proton pump inhibitor (PPI) costs in Ontario and did some digging into my EMR data to see what savings could be found.

Here was my Twitter thread about the topic.

In short, I identified 414 of my patients on a PPI, 314 (76%) of which were on rabeprazole or pantoprazole, the two cheapest options. I calculated the potential monetary savings by switching every patient in my practice who is on a more expensive PPI (esomeprazole, lansoprazole, omeprazole, dexlansoprazole) to generic rabeprazole; projected tally would be $22,340 over the course of a year. Not an insignificant sum.

It’s one thing to project a cost savings. But would it actually work?

I embarked on a very simple intervention in January 2017. Using my EMR (Telus PS Suite), I created a reminder that would place the note “Consider switch to cheaper PPI” on the chart of every patient on esomeprazole, lansoprazole, omeprazole, dexlansoprazole, or pantoprazole.

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That reminder would appear on their chart, and would prompt a discussion at their next appointment about a potential trial of rabeprazole.

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(I am intentionally omitting the issue of de-prescribing from this analysis, as de-pescribing PPIs has been another important undertaking in my practice, yet this analysis was strictly looking at looking at cost-saving from cheaper PPIs. The above reminder did prompt many instances of de-prescribing, but these were not as easily quantifiable retrospectively. In addition, I bristle at the idea of openly quantifying and applauding the cost savings from de-prescribing, as it would rightfully raise the question in patients’ eyes whether we are de-prescribing out of concern for their health, or simply to save money. This analysis looks at cost-savings from switching from one PPI to another, the goal of which is to produce no clinical negative change).

Of the patients who were engaged in a discussion, many were found not to be appropriate for a rabeprazole trial, either because of intolerance or lack of efficacy from previous trials of rabeprazole. Other patients were not open to a trial because of lack of interest in “rocking the boat” or because of an upcoming trip and concern about impacting travel insurance.

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28 patients (some private pay, some publicly-funded) who required ongoing PPI therapy (due to ongoing indication or due to previous failure with PPI wean) agreed to a rotation to rabeprazole as a trial. 7 patients described a clinical worsening of symptoms (most within the first two weeks), and requested to be put back onto their initial PPI (5 patients on lansoprazole, 1 on pantoprazole, and 1 on omeprazole).  21 patients saw no clinical change, and those 21 have been found to be stable at the 3-month mark post-rotation (11 on lansoprazole, 4 on omeprazole, 4 on esomeprazole, and 2 on pantoprazole).

The cost savings were as follows (using rabeprazole 20mg tablet, $0.24/pill):

  • Esomeprazole – $1.86 per pill ($1.62 savings/d, $591.30/yr per patient)
  • Omeprazole – $0.41 per pill ($0.14 savings/d, $51.10/yr per patient)
  • Lansoprazole – $0.50 per pill ($0.26 savings/d, $94.90/yr per patient)
  • Pantoprazole – $0.30 per pill ($0.06 savings/d, $21.90/yr per patient)

Total yearly savings from these 21 patients now stable on rabeprazole: $3657.30

A few things to take away from this:

  1. This was a ridiculously simple intervention, and took me virtually no time to create the reminder or to have those discussions with patients.
  2. This should be a wake-up call to the Ministry of Health on the importance of working with physicians on finding efficiencies in our system. Physicians know where these efficiencies are, so allow innovation and creativity, reward it appropriately, and we’ll find the money.
  3. It is critical that the first script for the rabeprazole be of short duration (I prescribed two weeks), otherwise 3 months of wasted pills for the 25% failure rate would have erased some of the cost savings.
  4. Most practices will likely see greater savings than I achieved in my practice, as I have been consciously working to prescribe exclusively rabeprazole for some time now. Even if you assume my prescribing rate to be on par with the Ontario average (2200 patients), extrapolating this out to Ontario’s population of 13.6 million, this simple intervention would amount to a provincial total of $22.6 million.
  5. Note that most of the savings were found in switching patients from esomeprazole. Please don’t use it unless you are absolutely handcuffed. It is insanely expensive compared to others in the class.

All of us have these opportunities in our practices for small interventions that we may actually find some element of satisfaction in evaluating, especially with the power of a well-functioning EMR behind us.

ACE-inhibitors/ARBs in diabetics: Evidence doesn’t support the CDA guidelines

As part of my work on a provincial committee, the issue came up recently regarding a quality metric evaluating proportion of all diabetic patients aged >55  who are being prescribed an ACE-inhibitor or ARB. When it was pointed out that the evidence supporting this specific metric is weak, the response was that this recommendation is part of the Canadian Diabetes Association Clinical Practice Guidelines, and that for a committee to go against an established guideline would be difficult.

The full CDA Clinical Practice Guidelines were last updated in 2013 (partial updates in 2015, February 2016, and November 2016), including the section specific to vascular protection in people with diabetes. Here is the recommendation around ACE-inhibitors/ARBs:

ace

The efficacy for ACE-inhibitor/ARB use in established macrovascular disease was established back in 2000 with the HOPE trial. No argument there. Same with patients with diabetes and kidney disease (including microalbuminuria) from the RENAAL trial showing losartan improved proteinuria and renal outcomes.

I want to focus on the first half of point #2, where they recommend ACE-inhibitors for all patients 55 or older “with an additional risk factor”. From the HOPE definition, these risk factors would include hypertension, cigarette smoking, elevated total cholesterol levels, low HDL levels, or microalbuminuria.

Should ACE-inhibitors be the preferred treatment for hypertensive diabetics without cardiovascular or kidney disease? Not quite. The 2017 CHEP Guidelines reviewed the evidence and found that thiazide/thiazide-like diuretics and dihydropyridine CCBs would also be appropriate choices in this population (Section XII, Point #3). American guidelines from JNC 8 came to a similar conclusion (Recommendation #6). Here’s a systematic review from the BMJ from 2016 on the topic.

The most relevant question to me is, should patients with diabetes with no history of cardiovascular disease, no history of hypertension, and no end-organ damage, be prescribed an ACE-inhibitor? Simply on the basis of having hyperlipidemia or cigarette smoking?

The HOPE study population was a mix of patients with established cardiovascular disease and those who where 55 or older with one of the above mentioned risk factors. While a benefit was found to ACE-inhibition in the study population as a whole, here were the confidence intervals for those with and without cardiovascular disease:

ace2.png

As you can see, it is very difficult to make any conclusions about the “no cardiovascular disease” group. Point estimate around 0.8, but very wide confidence intervals. One could argue that the point estimate could be hypothesis-generating, but certainly no more than that in terms of guiding whether these patients should be all prescribed ACE-inhibitor/ARB therapy.

The guidelines also cite a “recent meta-analysis indicates that ACE inhibitors and ARBs reduce CVD events in normotensive individuals with and without diabetes” and “accordingly, the use of ACE inhibitors or ARBs for vascular protection with persons with diabetes ≥55 years or with any evidence of organ damage is recommended, even in the absence of hypertension”.

But hold on a second. What did this meta-analysis show? Or should I ask, what studies did this meta-analysis look at? 13 studies in total: 3 studies including only those with heart failure (SOLVD, SAVE, and TRACE), the RENAAL trial (patients with nephropathy), PROGRESS (patients with stroke or TIA), CAMELOT (those with angiographically documented CAD and elevated DBP), EUROPA (stable CAD patients), DIABHYCAR (patients with microalbuminuria), DREAM (dysglycemia, no frank diabetes), TRANSCEND (established atherosclerotic disease or end-organ damage), PROFESS (history of ischemic stroke), ACTIVE-I (history of atrial fibrillation), and the above-mentioned HOPE trial.

So the only study in this meta-analysis that included the patients from our relevant clinical question (diabetes with only hyperlipidemia or smoking as a risk factor) is the HOPE trial, which we already showed we cannot look to for a definite answer on this. None of the other trials cited by the CDA Guidelines looked at ACE-inhibitor/ARB use in our subset of patients.

Why is this relevant? In my practice alone, of 220 patients with diabetes, I have 40 patients who either smoker or have hyperlipidemia, and who have no history of cardiovascular disease, no microalbuminuria, and are not on an ACE-inhibitor/ARB for hypertension. The current guidelines suggest that all 40 of these patients should be on treatment, despite the evidence not supporting this claim. This is not a minor clinical issue. And to compound this problem, we have provincial and local organizations uneasy about contradicting these guidelines, and feeding data to physicians with the intent of altering prescribing rates.

I would suggest that the Canadian Diabetes Association Clinical Practice Guidelines Expert Committee re-evaluate their stance on the issue of ACE-inhibitor/ARB use in patients 55 and older with one additional risk factor (without macrovascular disease or end-organ damage) given the paucity of evidence supporting their current recommendation.