Monthly Archives: August 2015

What my patients need to know about the government imposed clawbacks

Over the next few months, Ontario doctors are going to be subject to severe clawbacks from the Ontario government, and I want my patients to know exactly what will be happening, and why we’ve gotten to this point.

As most of you know, the Ontario government and Ontario doctors failed to come to a funding agreement in January 2015. Rather than opt for a fair binding arbitration process, the government proceeded to unilaterally impose a 3.15% cut to all doctor services (on top of the 2.5% cut from 2012), and most concerning, to set an arbitrary global cap on total compensation to doctors.

For those who don’t understand how physicians are compensated, here’s a Coles Notes version. Some doctors are paid fee-for-service based on a fee schedule set out by the government. Do a specific service, get paid a specific amount. Simple. Some doctors get paid based on the number of patients on their roster that they are responsible for. Again, the government has agreed on a specific amount to pay them per patient. Simple. Depending on the patients seen, or the roster size, the government pays doctors once a month the owed amount. Simple again.

But here is what the government has decided to impose on doctors. They have decided to cut all of the individual visit fees by a set percentage, as well as setting a cap on total billings by all doctors. If total billings by doctors province-wide go above this arbitrary upper limit, the province will clawback that money from all doctors. Remember those monthly payments? For a few months this winter, each doctor may literally be paid ZERO dollars. Staff and expenses will still need to be paid, and I’ll show up to work every day to care for you for free, and I will pay for all of this out of pocket.

Let that sink in for a second. The government has set specific fees that they pay physicians for certain tasks or responsibilities. But if demand from patients over the next year (aging population, immigrants, outbreaks, etc.) exceeds the cap, then the province will not pay for that extra care. Patient demand for care is largely out of the control of physicians, yet the government is dictating that any demand above their arbitrary cap won’t be paid for. Physicians will continue to see patients, and not be paid for it.

There is no maximum clawback. 5%? 10%? With an aging population requiring more care than ever before, we can’t possibly fathom how high demand may go. If the government decides that they want to fund more surgeries, or new clinics, or new nursing homes, or any new program, total physician billings will increase, and they won’t have to pay a penny more than the cap they have set. More physicians providing more services, and far less pie to share.

This letter isn’t meant to earn your sympathy, because I know many of you are struggling financially, and doctors are still well paid. But we are asking the government for a fair process. They refuse to let an independent 3rd party decide on fair compensation through arbitration, choosing to instead impose their own cuts. Any other profession would go on strike, but doctors realize how much our patients need us, and we would never go on strike (nor are we allowed to by our regulatory college).

If the government continues to make these severe cuts, the only recourse doctors will have will be to retire, or to leave the province. Specialists will leave for other provinces or retire. Many already have since the negotiations fell apart in January. Family doctors will leave the province, since other provinces need family doctors just as much as Ontario does, and seem to value them more. Alberta’s doctors agreed to a seven-year deal in 2013. Manitoba’s doctors agreed to a four-year deal in 2015. Saskatchewan agreed to a four-year deal just last month worth a two-per-cent increase per year over four years. Even Quebec has come to an agreement with its general practitioners. In the past few months, doctors across the country have seen the negotiations playing out in Ontario, and Ontario has developed a reputation as a province that has a poor relationship with doctors. No other province has unilaterally imposed cuts and changes on its doctors. Very few doctors will come here for the foreseeable future. Waiting lists will continue to grow, and fewer patients will have family doctors.

We aren’t asking for raises. We only want the government to agree to a binding arbitration process, and let a 3rd party decide on a fair outcome. Please contact your MPP to let them know your feelings on this issue. We can’t afford to lose more Ontario doctors because of the stubbornness of one government.

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Ontario MDs ask for binding dispute mechanism: Government responds with silence, clawbacks, and lies

Back in January when I started my blog, one of my first articles was a product of my frustration with Ontario Health Minister Eric Hoskins, and what I felt was the deceptive and dishonest spin he was putting on the failed negotiations between the government and Ontario’s physicians. Eight months later, physicians are still without a contract with significant clawbacks looming this winter, and intentionally misleading comments from the Ministry of Health have once again drawn my ire.

First, a quick summary on where we are currently at. In 2012, the OMA and the Ministry agreed to a Representation Rights Agreement that outlined how future negotiations would proceed. In January 2015, following a Negotiation and Facilitation phase, and the Conciliation phase, the OMA rejected the Ministry’s final proposal calling for steep cuts to physician compensation. As all phases of the negotiation had been fulfilled, the Ministry saw it appropriate to unilaterally impose cuts to all physician fees, as well as impose a global clawback on all physician payments above an arbitrary budget that they had set (See here for a explanation of the absurdity of this clawback mechanism). Perhaps the OMA was naïve in 2012 to enter into an agreement with the Ministry that would allow the Ministry to unilaterally impose deep cuts to physicians, but I suspect the OMA felt that they had a trusting and productive relationship with the Ministry. At the OMA annual meeting in May, it was unanimously agreed upon that the OMA would demand a binding dispute mechanism from the Ministry. To anyone with a modicum of decency, this would be the only fair way to resolve this stalemate, to allow a neutral third party to determine a fair contract moving forward. It is now August, the Ministry has not accepted a binding dispute mechanism, and this matter has been referred to a special committee of the bilateral Physician Services Committee for consideration. Sadly, the Ministry is intentionally slow playing this issue, and in the meantime is putting the health care of millions of Ontarians in jeopardy.

So what has me so upset? First, the Ministry has still given physicians no details on when exactly the global clawbacks will be occurring. Late in 2015? Early 2016? When have we gone over their arbitrary cap? Ontario physicians essentially have a dark cloud of clawbacks hanging over our heads (in addition to the already 5+% cut on every fee since 2012), with the prospect of multiple months of zero income while our expenses still need to be paid.

Instead of working towards a resolution, and instead of attempting to repair their relationship with physicians, the Ministry has continued to parrot the same falsehoods that they have used since January. Yesterday on Twitter, Ontario government press secretary Shae Greenfield gave us a glimpse into how the Ministry will continue to confuse the public through the fall and winter months.

A few of his tweets…

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It is clear what the OMA is stating. The government has put a limit on what they will pay for. It’s a global budget. This is not in dispute. But here Mr. Greenfield ramps up the doublespeak. Yes, of course doctors technically have no limit on the number of services we can provide. I could see a MILLION patients in 2015! No limits! How is that relevant at all to the fact that the government is only paying for a fixed budget, regardless of patient demand or need?

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Adding 700 physicians a year is easy when you’re going to make other physicians pay for it. With their plan, they could add thousands of physicians, with the same overall cap, and physicians would be subsidizing their colleagues. They truly don’t see how this is a recipe for disaster. (I’m going to save my criticism of their residency cuts for another day).

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At this point I was about to spontaneously combust from frustration. This was a clever phrasing that someone in the Ministry hatched, to declare that physicians will “be compensated for every service they provide”. Being compensated one dollar for an appendectomy would satisfy their intentionally deceiving criteria here. He repeated this exact refrain at least half a dozen times. I won’t bore you with the repetition.

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(Hitting my head against the wall….)

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Solid data….that hasn’t been shared with physicians or the public for 8 months now. His claims of transparency interested me, that maybe we would finally get some specific details about the clawbacks…

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Again, if they laid out their plan for clawbacks, where is it? What is he talking about?

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Alas, finally we get to the Ministry’s favourite talking point, Justice Winkler. The final phase of the negotiations ended with Reconciliation, led by Justice Winkler. In any attempted explanation of their imposed unilateral cuts, the government has fallen back on the explanation that “we’re only implementing what Justice Winkler recommended”. Which is comically untrue.

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Mr. Greenfield actually linked to Justice Winkler’s report as support for his argument. Here’s the report. Find me where Justice Winkler endorses any concept of clawbacks beyond an arbitrary global cap, or find me where he outlines in detail a “reconciliation process”. It’s not there.

It is true that Justice Winkler asked the OMA to accept the Ministry’s offer, but here is the actual Ministry offer that was provided in the report:

The Ministry sought to address the outstanding gap between the Parties by responding in two areas: savings and the cost of practice – both in the third year. The Ministry tabled its final position (the “Ministry’s Proposal”) on the last day of the Conciliation. The proposal was for a three-year term. It provided for savings in the amount agreed upon by the Parties in years one and two. Importantly, in the third year, the Ministry conceded its position for a further savings of $32.7 million. Moreover, it offered a one-time lump-sum contribution in year three to physicians’ cost of practice in the amount of $117 million (1% of the PSB). The Ministry included in its proposal the agreed upon Task Force and the Minister’s Roundtable.

No mention of a reconciliation process, no mention of a fixed global budget from which clawbacks would be imposed. Also, falling back on the opinion of a conciliator is inappropriate, as his responsibility as conciliator was to bring the parties close to an agreement, not to serve a final judgement. Having an arbitrator decide on an appropriate contract would be the best solution, but the government is currently resisting this.

More importantly, Justice Winkler made it very clear that “without systemic changes to the health care system, the Parties seemed to be on a collision course so that a Physician Services Agreement , at some point in the future, may not be achievable.” To seek solutions for this problem. He made recommendations for a Task Force on the Future of Physician Services in Ontario (the “Task Force”) and the Minister’s Roundtable on Health System Transformation (the “Minister’s Roundtable”). Eight months later, and not a word from government about any progress on these committees. Absolutely no urgency whatsoever. And eventually if the committees are ever formed, they will provide a voluminous report that will likely collect dust.

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And there you have it. The Ministry is treating this like a game. A game that they feel they have already won, packed up, and gone home. They got the result they wanted, through whatever means necessary, and don’t care about the fact that years of relationships built between government and physicians have disintegrated. Relationships that have strengthened aspects of health care across the province.

I don’t expect much from our government, but I do expect honesty and a fair process. That is certainly not happening right now, and I hope that the public is getting a clear glimpse into how this government is treating physicians. Because years from now, when Ontarians are wondering where all of their physicians went, we can point to the government’s behaviour in 2015.

 

An idea to reduce the epidemic of opioid prescribing

Most physicians will agree that opioids continue to be overprescribed. Of course they have a useful therapeutic role in specific clinical situations, but they continue to be overprescribed in chronic non-cancer pain cases, while other modalities are underused.

Very few of us are innocent in this. But interestingly, we have no idea how our opioid-prescribing stacks up against other practitioners. Do we prescribe more than average? Less than average? Are our own prescribing rates increasing or decreasing?

Here’s what I propose. In Ontario, the Ministry of Health has set up a Narcotics Monitoring System (NMS), which “collects dispensing information for all prescriptions for monitored drugs dispensed for all Ontarians, regardless of whether the prescription is paid for under a publicly funded drug program, through private insurance or by cash”. This link provides some details into what data this program provides, and the benefits of such a program.

But while the NMS focuses mostly on the monitoring of dispensing, I would propose a plan that would use the data to affect prescribing patterns. Every 3 months, every primary care practitioner would be provided a personal report detailing their average oral morphine equivalents (OME) dispensed per patient rostered (total, and by generic drug). This would be similar in format to the Screening Activity Reports that we already receive for physician-specific cancer screening statistics.  The primary care practitioner would be provided with provincial and regional averages as well for comparison, in addition to how their rates have changed from previous reports. I understand from the above-linked report that a Narcotics Monitoring Working Group was set up a few years ago, and I wonder whether this would be a strategy they could look to adopt.

One important caveats to this idea: the physician-specific information can under no circumstances be made public, as this is an educational endeavour, not a shaming exercise. It can also not be used by the government for any payment-based incentives, as inappropriate attempts to wean or deny appropriate treatment may logically ensue.

I also understand that some physicians, because of their work with chronic pain populations, may end up at the upper end of the spectrum, but again this is a self-assessment tool, and certainly those physicians should evaluate their own prescribing patterns given their own practice context.

This would be meant to be a tool for physicians to identify privately how their prescribing compares to others, and for prescribers who are actively trying to prescribe fewer opioids (through fewer starts, more opioid tapers, etc.) to have an objective measure of the success of their efforts. Will it change the behaviour of the worst offenders? Maybe not, but prescribers having more information and insight into our own behaviour can only help our current epidemic. A program such as this would also need to be accompanied by comprehensive physician resources, such as Echo Ontario, which can give physicians the knowledge and skills to treat patients with pain appropriately and comprehensively, without immediately turning to opioids.

I look forward to your feedback in the comments, as well as details from other provinces as to whether a similar strategy may be feasible in your area.

 

An analysis of the COLOGIC test for colorectal cancer

I recently opened my office mail to find a direct-to-physician informational package from a local laboratory about COLOGIC (also known as CRC-446 or GTA-446). The brochure marketed this test as “A simple blood test to assess the risk of colorectal cancer for 50-75 year olds”. That’s certainly a big claim to make, and game-changing if true, so I decided to delve further into the evidence.

(Spoiler: it’s slick marketing and disappointing statistics, not a life safer. But read on to find out why.)

Colorectal cancer (CRC) screening is a hot-button topic to begin with. Colorectal cancer is the 3rd most common cancer in Canada (excluding non-melanoma skin cancer), the 2nd leading cause of death from cancer in men, and the 3rd leading cause of death from cancer in women. The “early detection” drum has been beaten loudly for colorectal screening, with government organizations employing organized screening programs and frequent advertising including a recent popular ad featuring Canadian comic Neil Crone. Colorectal screening has been shown to be cost effective at less than $30,000 per additional life year gained. A Cochrane review showed a 16% reduction in colorectal mortality with fecal occult blood testing (FOBT), despite the high number needed to screen of 1,176 to prevent one death over 10 years (1). A single FOBT test in isolation has a sensitivity of <20%. Despite erroneous claims from many cancer agencies that the 6-item FOBT kit will increase its sensitivity by 3-fold to nearly 90%, many studies show that the sensitivity remains 24-35% for advanced colonic lesions (specificity around 94%, positive predictive value (PPV) 36-39%). Most disappointing is its poor negative predictive value (NPV) of 87-89% (2,3,4,5). Fecal immunochemical testing (FIT) has a higher sensitivity than FOBT, but is more expensive than FOBT and we don’t yet have evidence of a decrease in mortality compared to FOBT. Fecal DNA testing has an even higher sensitivity, with a similar specificity, but has yet to be widely adopted. Colonoscopy screening for all low-risk patients is not currently recommended (and not likely feasible).

So we are left looking for other highly sensitive, highly specific, and cost-effective means of detecting clinically significant colorectal cancers. This is the niche that the COLOGIC test is desperately trying to fill.

The promotional material describes COLOGIC as a means of “categorizing a patient’s risk of developing colorectal cancer based on their level of GTA-446”, which is a “human-specific, hydroxylated, polyunsaturated, ultra-long chain fatty acid that is pro-apoptotic, anti-proliferative, anti-inflammatory”. It hits all of the buzzwords, but let’s dig a bit deeper.

All of the published studies on the link between GTA-446 and colorectal cancer have been authored by Dr. Shawn Ritchie, a biochemist from Saskatchewan who is the Director of Biomarker Discovery and Validation for Phenomenome, the company that discovered and markets the COLOGIC test. This connection does not itself invalidate any of the data produced to date, but with any studies that have ties to industry, we cannot take their final written conclusions for face value. We must dig into the data.

The first study describing this particular fatty acid pattern and a link to colorectal cancer was published in the open access BMC Medicine in 2012 (6). Dr. Ritchie and his colleagues took the blood samples of 222 patients with colorectal cancer and 220 controls (from 3 larger population data sets), and using mass spectroscopy identified the top 50 metabolites whose patterns were most significant, and from this group identified 13 metabolites that were common between the 3 data sets, which were all hydroxylated polyunsaturated ultra long-chain fatty acids containing between 28 and 36 carbons. The process of identifying a culprit metabolite was not determined a priori, so this entire study was merely hypothesis-generating. Their hypothesis is that low levels of these fatty acids with 28 carbons (which they call CRC-446 or GTA-446, 446 being the molecular weight) represents a compromised ability to protect against accumulating chronic inflammation and abnormal cell growth, which ultimately leads to a pro-cancer environment. There has been no basic science research to back up this specific claim to date. Interestingly, in this study they state that this group of metabolites was not present in the tumor itself, nor was it associated with tumor burden (high rate of association in stage I cancer, less in higher stage cancers).

Their next study in open-access BMC Gastroenterology in 2010 looked at blood samples of patients with CRC pre-treatment, post-treatment, and controls (7). They found that GTA-446 levels did not change post-treatment, again showing that this test is not a marker of tumour burden. They also showed that GTA-446 levels increase with age in healthy patients, but are stably low in CRC patients. They then take a huge leap, and begin to make projections on how many colonoscopies would be saved if we used the GTA-446 test instead of FOBT or FIT testing. Two observational studies, no prospective trials, yet the lead author is making grand pronouncements about the future utility of the test.

Finally the most recent study by Dr. Ritchie’s group from 2013 in the International Journal of Cancer (8). They looked at serum samples and pathology data from 4,923 representative subjects undergoing colonoscopy and from 964 subjects from the general population. (The general population data was useless, since it showed that non-CRC patients have higher GTA-446 levels, which we already knew. They didn’t do a colonoscopy on this general population, so it doesn’t give us any relevant screening data). Of the 4,923 subjects, 98 were found to have colon cancer, of which 84 had a GTA-446 level below their threshold, which is a positive test (not clear whether this threshold was determined a priori). 2,352 of the 4,923 patients had a GTA-446 level below the threshold yet did not have CRC (see Table 3 below, add up the numerators in the lower half of the All column). This gives a sensitivity of 85%, a NPV of 99%, but a horrific specificity of 53% and PPV of 3.4%. Shockingly, they did not include a specificity calculation in their paper. Once again their conclusion declares the utility of GTA-446 in CRC screening, despite the obvious flaws.

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Now to the fun part. The marketing.

The national laboratory promoting this test included “Post-Market Results” in their marketing material. Of the 14,995 COLOGIC tests ordered on a private pay basis between October 2012 and October 2014, 2233 were positive, of which 419 underwent colonoscopy (it is not clear what happened to the rest). Of the 419, 12 were found to have carcinoma, for a positive predictive value of 2.86%. For comparison, even the lacklustre PSA test has a PPV of 25%.

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They break down the 12 carcinoma patients further:  8 had no previous FOBT, 1 had a previous positive FOBT, and 1 had a negative FOBT. They declare this as “92% of CRC cases detected by colonoscopy were missed by FOBT because the person did not perform the test (8 cases) or the test was a false negative (3 cases).” Intentionally misleading, and they are conflating issues of patient compliance with the quality of the COLOGIC test. Of course the COLOGIC is going to “pick up” cases missed by FOBT, since nearly half of all patients have a positive COLOGIC and will go on to colonoscopy!

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The data of the patients who were COLOGIC negative was incomplete, so no legitimate analysis can be done from this data.

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Here are some other amusing screenshots from their promotional material:

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Yes, patients would like to take a blood test rather than collect their stool. I’m surprised it’s not higher than 90%. That doesn’t change the effectiveness of the test.

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I’m not sure where they are getting these numbers from. They compare sensitivity and specificity to FOBT, which is misleading to start (should be compared to gold standard colonoscopy), but from my calculations their sensitivity and specificity calculations are incorrect. If anyone can see an error I’ve made, I’d be happy to look at things again.

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This is essentially arguing that having millions of patients do a COLOGIC test (and thus hundreds of thousands of colonoscopies) will save lives. It is saving lives just by virtue of increasing the number of colonoscopies, not by any positive attributes of the test.

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This is the laboratory version of the free drug sample. This card was provided in the package. Get the physician comfortable with ordering the test, and they are likely to order and recommend it more frequently. This test is not cheap, and for that money, we need to be able to justify the test’s value to the patient with the data available to us.

What’s the lesson in all of this? Apart from the lack of utility of the COLOGIC test specifically, clinicians need to be incredibly sceptical with new tests being marketed to them. Scott Gavura from Science-Based Medicine has a great article here about the allergy testing that is being heavily marketed by local laboratories. Take their marketing materials, and if you are considering ordering the test, you owe it to your patients to do at least a little bit of digging into the quality of the evidence being presented. Most of us don’t take all of the claims of pharmaceutical reps at face value, and it’s time we applied the same skepticism to the claims of local labs.

  1. Cochrane systematic review of colorectal cancer screening using the fecal occult blood test (hemoccult): an update. Am J Gastroenterol. 2008 Jun;103(6):1541-9.
  1. Collins, JF, et al., Accuracy fo screening for fecal occult flood on a single stool sample obtained by digital rectal examination:  a comparison with recommended sampling practice.  Ann Intern Med 2005; 142: 81-85
  1. Lieberman, DA, et al., One time screening for colorectal cancer with combined fecal occult-blood testing and examination of the distal colon.  N Engl J Med 2001; 345: 555-60
  1. Greenberg PD, et al., A prospective multicenter evaluation of new fecal occult blood tests in patients undergoing colonoscopy. Am J Gastroenterol 2000; 95:1331-8
  1. Mandel, JS, et al., Reducing mortality from colorectal cancer by screening for fecal occult blood.  Minnesota Colon Cancer Control Study. N Engl J Med 1993; 328: 1365-71
  1. Ritchie, S.A, Ahiahony, P.W.K, et al. Reduced levels of hydroxylated, polyunsaturated ultra long-chain fatty acids in the serum of colorectal cancer patients: implications for early screening and detection. BMC Med. 2010; 8: 13.
  2. Ritchie, S.A, Heath, D, et al. Reduction of novel circulating long-chain fatty acids in colorectal cancer patients is independent of tumor burden and correlates with age. BMC Gastroenterol. 2010 Nov 29;10:140.
  3. Ritchie, S.A, Tonita, J, et al. Low-serum GTA-446 anti-inflammatory fatty acid levels as a new risk factor for colon cancer. Int. J. Cancer. 2013, 132:355-362.