DIABETES TECHNOLOGY & THERAPEUTICS Volume 17, Number 2, 2015 ª Mary Ann Liebert, Inc. DOI: 10.1089/dia.2015.0005
EDITORIAL
Diabetes Care Entering 2015: Ineffective Ranting Irl B. Hirsch, MD
I rant, therefore I am. —Dennis Miller
M
y annual rant about processes and cost has now entered its third iteration.1,2 One would hope that after 2 years of ranting our situation would have stabilized or even improved, but after assessing our position in both practice and academia, my unfortunate conclusion is we are moving in the wrong direction. I base that observation on the number of endocrinologists who have retired long before their clinical acumen has declined, yet the hassles of seeing patients has been overwhelming in terms of the cost both in dollars and to their happiness. So as part of my annual ritualistic whine, let’s look at my last clinic of 2014. My first patient is an 80-year-old woman who developed type 1 diabetes at the age of 14 years. She was born in Austria, and prior to developing her diabetes her family escaped Nazi persecution and fled to the United States. She managed her diabetes as well as she could with the tools available in the middle part of the last century, and in 1964 she completed her only pregnancy with a healthy baby. Over the years she managed her diabetes with urine testing and unpurified insulins until the technology improved in the 1980s. She has had no microvascular complications, but at the age of 80 suffers from profound hypoglycemia unawareness. With much counseling from both me and her family, she has loosened her control and enjoys a good quality of life, particularly spending time with her grandchildren. Although this sounds like a wonderful story, there is a problem. At my institution, we are all ‘‘graded’’ for our patients with diabetes for hemoglobin A1c (HbA1c), lowdensity lipoprotein (LDL)-cholesterol, and blood pressure. Physician performance measures have become an important component of medical practice in the United States, yet there are still important questions that require resolution.3 Nevertheless, I am now ‘‘accountable’’ for these three measures, no different than my colleagues in cardiology, nephrology, or primary care. Our scores are currently hidden from the public, but eventually they will be transparent to all, and starting this year reimbursement will be tied as part of our entry into one of many accountable care organizations (ACOs).
One conclusion is that by having these three metrics for each patient, I will work harder to ensure my patients have guideline-consistent levels of HbA1c, LDL-cholesterol, and blood pressure. My problem with this thought is that this assumes that without these formal performance measures, I would otherwise not be as attentive to the health of my patient. I am now being told our previous incentives (not to mention the Hippocratic Oath) were not sufficient, and now we need to be graded, independent of the patient population, to meet these standards. Ironically, this is despite a clear recommendation about individualization of targets based on the patient’s specific situation.4 So, what does this have to do with my 80-year-old patient with diabetes for 66 years? Well, despite how well she is doing, I flunked. Her HbA1c was 9.1%, her LDL-cholesterol was 125 mg/dL (she ran out of her statin), and her blood pressure was 144/90 mm Hg. I received three ‘‘dings’’ as she (or I) failed each of the three graded performance measures. She escaped the Nazis but not the current ACO mentality of the practice of diabetes. A 40-year-old man with newly diagnosed type 2 diabetes is treated the same as my 80-year-old woman with type 1 diabetes. What did I do? First, I refilled the statin. Her potassium is borderline high on an angiotensin-converting enzyme inhibitor, diuretic, and calcium channel blocker, and I don’t want to add a fourth drug (yet). I’m having her daughter check her blood pressures, but I still got hit with the blood pressure ding, despite, to my knowledge, there being no randomized trials in octogenarians with type 1 diabetes on blood pressure control. But what did I do about the HbA1c? I congratulated her for not having another episode of severe hypoglycemia. But unfortunately, these performance measures have actually changed the way I practice medicine, and not for the better. On this same clinic day I had a patient with type 1 diabetes and polycythemia vera receiving regular plebotomies. His HbA1c always reads low and does not reflect his glycemic history. The same is true for a 52-year-old woman with end-stage renal disease receiving epoetin alfa and a 32year-old man with cystic fibrosis–related diabetes with cirrhosis and splenomegaly. For all three of these patients, HbA1c does not reflect glycemia, and normally I wouldn’t
University of Washington Medical Center-Roosevelt, Seattle, Washington.
69
70
measure it. But for these patients, not only did I waste the system’s resources to measure it, I knew this would help offset the dings I received earlier in the day for my 80-yearold lady. What’s more frightening is I’m teaching the fellows, residents, and students how to strategize to keep the dings at a minimum, knowing full well it is not possible to be ‘‘dingless in Seattle.’’ In no way am I proud about how I now need to practice diabetes. Still, it is about survival. Perhaps more frustrating than practicing ‘‘cookie-cutter’’ diabetes as a specialist is that, like many colleagues around the country, we have entered the new world of electronic medical records (EMRs). To be clear, we are not new to the EMR. In fact, our institution’s first of three EMRs was the first Web-based system and was implemented in 1994.5 However, it is safe to say our newest product has not resulted in improved medical management as was originally advertised. Although I appreciate the importance of ‘‘meaningful use’’ and appropriate medication reconciliation, as much as I try I can’t understand why taking minutes instead of seconds to write a prescription or order a lab test is ‘‘progress.’’ I also am amazed at how many of my primary care colleagues (not necessarily at my institution) are so overwhelmed they actually click that the medications are reviewed and correct when they are definitely not. ‘‘Cutting corners’’ is a necessity given the added workload of our progress. I see this as a major safety concern downstream, especially in emergency departments and operating rooms. But perhaps I’m the only one ranting about this problem. My last patient is a woman I’ve been following for over 20 years. She has had type 1 diabetes for 45 years and participated in the JDRF Continuous Glucose Monitoring (CGM) Study.6 Like most, she has suffered her share of severe hypoglycemia, even before we realized how common it is with her duration of diabetes.7 Obtaining a CGM device for her was not easy. Hours of effort were spent among my staff, the patient, and me with the insurance company. But in the end, we were able to obtain for her her CGM device, which she uses with an insulin pump. But then a horrible thing happened in 2014: she celebrated her 65th birthday. Although this may not have been expected when she developed her diabetes, this is now common; we have a new population of ‘‘geriatric’’ type 1 diabetes patients for whom, as a population, we have little experience let alone research to guide us. But what is clear to her, her family, and me is she benefited greatly from her CGM device. Taking this tool away from her is her punishment for living successfully with type 1 diabetes for 45 years. Unfortunately, neither she nor her family members can afford the cost of a CGM device, let alone the ongoing costs for the sensors themselves. My appeals to Medicare in the past have been unsuccessful because we don’t have a clinical trial with CGM specifically with this population, although it is clear hypoglycemia is more debilitating in the elderly.8 My frustration is not just this one patient—not at all. It is the thousands of patients exactly like this woman who can’t benefit from our technological advances. Although this may seem like a mega-whine by a spoiled academic clinician to those in other countries who have minimal if any access to CGM, why, just why, do we continue to spend millions of dollars from federal and foundation funding for a closed-loop artificial pancreas when it seems to most of us a commercial version would only be accessible to the wealthy children of the CEOs of insurance companies?
HIRSCH
And as we enter 2015, no rant would be complete without a mention of the incredible increased burden of bureaucracy and administrative hassles to see patients with diabetes. Several years ago our group engaged in an assessment about the time it took to see patients with diabetes that could not be reimbursed. Part of the assessment was for pre-authorizations for noncovered or poorly reimbursed items, including medications, devices, and glucose test strips for patients requiring insulin. At the time, each one took an average of 12 min, which I thought was much too short given the actual time we seem to spend explaining to payers why patients with diabetes required everything from glucose test strips to insulin analogs for type 1 patients on an insulin pump. Of course, why the pharmaceutical industry even bothers to launch new products in our poorly covered part of the country is beyond me. In fact, two new insulin pumps actually have not been formally launched in Washington State owing to the reimbursement pressures. Although one could argue (for the record, not me) we don’t need glucagon-like peptide-1 analogs or sodium-glucose cotransporter-2 inhibitors, the saga of the pricing of insulin is only worse than a year ago.2 As we enter 2015 the ‘‘cheapest’’ vial of insulin glargine in Seattle, WA, is $399, whereas in Denver, CO, it is north of $400 (with a coupon!).9 This topic will gain much attention this year, including at this year’s American Diabetes Association’s Scientific Session in June. The reasons for this continued increase in price are complex, but these high costs are not well known by many physicians. What is clear is many patients with insurance can’t afford copayments. Contracting by payers has resulted in eliminating the choice of which insulin to use, and traditional marketing of insulin products to both healthcare providers and directly to patients is no longer relevant. The cheaper human insulin alternatives are a good choice for many patients with type 2 diabetes, but even a vial of NPH insulin is usually about $120 per vial, although one can find it cheaper at certain pharmacies.9 I think my greatest concern as we are halfway through this decade is the physicians in training won’t be ranting, as our current status is their status quo. On the other hand, although many of our colleagues are retiring early because of how distasteful this has all become, the greatest irony is the major single reason why more physicians don’t retire early is to maintain their health insurance. As an endocrinologist, I can honestly conclude the system has us by the gonads. I am hopeful that there won’t be as much to rant about at the beginning of 2016. Unfortunately, there is so much in 2015 there wasn’t space to address the Sunshine Act and board recertification requirements. Still, we have to continue to remind ourselves what our world looked liked 94 years ago when Banting and Best injected that first pancreatic extract in Marjorie the dog. Still, it is a guess, just a guess, that Dr. Banting and Mr. Best did not require a pre-authorization or peer-to-peer consult to inject the first extract into Leonard Thomson, the first human to receive insulin. Otherwise we’d still be waiting for the appeal to go through. References
1. Hirsch IB: Healthcare reform in diabetes: more ranting about a broken healthcare system. Diabetes Technol Ther 2013; 15:212–213. 2. Hirsch IB: Diabetes care entering 2014: more ranting. Diabetes Technol Ther 2014;16:iii–iv.
DIABETES CARE ENTERING 2015
3. McGlynn EA, Schneider EC, Kerr EA: Reimagining quality measurement. N Engl J Med 2014;371:2150–2153. 4. American Diabetes Association: Glycemic targets. Diabetes Care 2015;38(Suppl 1):S33–S40. 5. Goldberg HI, Tarczy-Hornoch P, Stephens K, et al.: Internet access to patients’ records. Lancet 1998;351;1811. 6. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group: Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 2008;359:1464–1478. 7. Weinstock RS, Xing D, Maahs DM, et al.: Severe hypoglycemia and diabetic ketoacidosis in adults with type 1 diabetes: results from the T1D Exchange Clinic Registry. J Clin Endocrinol Metab 2013;98:3411–3419.
71
8. Lipska KJ, Ross JS, Wang Y, et al.: National trends in U.S. hospital admissions for hyperglycemia and hypoglycemia among Medicare beneficiaries, 1999–2011. JAMA Intern Med 2014;174:1116–1124. 9. www.goodrx.com (accessed January 1, 2015).
Address correspondence to: Irl B. Hirsch, MD University of Washington Medical Center-Roosevelt 4245 Roosevelt Way NE, 3rd Floor Seattle, WA 98105 E-mail: [email protected]
EDITORIAL
Diabetes Care Entering 2015: Ineffective Ranting Irl B. Hirsch, MD
I rant, therefore I am. —Dennis Miller
M
y annual rant about processes and cost has now entered its third iteration.1,2 One would hope that after 2 years of ranting our situation would have stabilized or even improved, but after assessing our position in both practice and academia, my unfortunate conclusion is we are moving in the wrong direction. I base that observation on the number of endocrinologists who have retired long before their clinical acumen has declined, yet the hassles of seeing patients has been overwhelming in terms of the cost both in dollars and to their happiness. So as part of my annual ritualistic whine, let’s look at my last clinic of 2014. My first patient is an 80-year-old woman who developed type 1 diabetes at the age of 14 years. She was born in Austria, and prior to developing her diabetes her family escaped Nazi persecution and fled to the United States. She managed her diabetes as well as she could with the tools available in the middle part of the last century, and in 1964 she completed her only pregnancy with a healthy baby. Over the years she managed her diabetes with urine testing and unpurified insulins until the technology improved in the 1980s. She has had no microvascular complications, but at the age of 80 suffers from profound hypoglycemia unawareness. With much counseling from both me and her family, she has loosened her control and enjoys a good quality of life, particularly spending time with her grandchildren. Although this sounds like a wonderful story, there is a problem. At my institution, we are all ‘‘graded’’ for our patients with diabetes for hemoglobin A1c (HbA1c), lowdensity lipoprotein (LDL)-cholesterol, and blood pressure. Physician performance measures have become an important component of medical practice in the United States, yet there are still important questions that require resolution.3 Nevertheless, I am now ‘‘accountable’’ for these three measures, no different than my colleagues in cardiology, nephrology, or primary care. Our scores are currently hidden from the public, but eventually they will be transparent to all, and starting this year reimbursement will be tied as part of our entry into one of many accountable care organizations (ACOs).
One conclusion is that by having these three metrics for each patient, I will work harder to ensure my patients have guideline-consistent levels of HbA1c, LDL-cholesterol, and blood pressure. My problem with this thought is that this assumes that without these formal performance measures, I would otherwise not be as attentive to the health of my patient. I am now being told our previous incentives (not to mention the Hippocratic Oath) were not sufficient, and now we need to be graded, independent of the patient population, to meet these standards. Ironically, this is despite a clear recommendation about individualization of targets based on the patient’s specific situation.4 So, what does this have to do with my 80-year-old patient with diabetes for 66 years? Well, despite how well she is doing, I flunked. Her HbA1c was 9.1%, her LDL-cholesterol was 125 mg/dL (she ran out of her statin), and her blood pressure was 144/90 mm Hg. I received three ‘‘dings’’ as she (or I) failed each of the three graded performance measures. She escaped the Nazis but not the current ACO mentality of the practice of diabetes. A 40-year-old man with newly diagnosed type 2 diabetes is treated the same as my 80-year-old woman with type 1 diabetes. What did I do? First, I refilled the statin. Her potassium is borderline high on an angiotensin-converting enzyme inhibitor, diuretic, and calcium channel blocker, and I don’t want to add a fourth drug (yet). I’m having her daughter check her blood pressures, but I still got hit with the blood pressure ding, despite, to my knowledge, there being no randomized trials in octogenarians with type 1 diabetes on blood pressure control. But what did I do about the HbA1c? I congratulated her for not having another episode of severe hypoglycemia. But unfortunately, these performance measures have actually changed the way I practice medicine, and not for the better. On this same clinic day I had a patient with type 1 diabetes and polycythemia vera receiving regular plebotomies. His HbA1c always reads low and does not reflect his glycemic history. The same is true for a 52-year-old woman with end-stage renal disease receiving epoetin alfa and a 32year-old man with cystic fibrosis–related diabetes with cirrhosis and splenomegaly. For all three of these patients, HbA1c does not reflect glycemia, and normally I wouldn’t
University of Washington Medical Center-Roosevelt, Seattle, Washington.
69
70
measure it. But for these patients, not only did I waste the system’s resources to measure it, I knew this would help offset the dings I received earlier in the day for my 80-yearold lady. What’s more frightening is I’m teaching the fellows, residents, and students how to strategize to keep the dings at a minimum, knowing full well it is not possible to be ‘‘dingless in Seattle.’’ In no way am I proud about how I now need to practice diabetes. Still, it is about survival. Perhaps more frustrating than practicing ‘‘cookie-cutter’’ diabetes as a specialist is that, like many colleagues around the country, we have entered the new world of electronic medical records (EMRs). To be clear, we are not new to the EMR. In fact, our institution’s first of three EMRs was the first Web-based system and was implemented in 1994.5 However, it is safe to say our newest product has not resulted in improved medical management as was originally advertised. Although I appreciate the importance of ‘‘meaningful use’’ and appropriate medication reconciliation, as much as I try I can’t understand why taking minutes instead of seconds to write a prescription or order a lab test is ‘‘progress.’’ I also am amazed at how many of my primary care colleagues (not necessarily at my institution) are so overwhelmed they actually click that the medications are reviewed and correct when they are definitely not. ‘‘Cutting corners’’ is a necessity given the added workload of our progress. I see this as a major safety concern downstream, especially in emergency departments and operating rooms. But perhaps I’m the only one ranting about this problem. My last patient is a woman I’ve been following for over 20 years. She has had type 1 diabetes for 45 years and participated in the JDRF Continuous Glucose Monitoring (CGM) Study.6 Like most, she has suffered her share of severe hypoglycemia, even before we realized how common it is with her duration of diabetes.7 Obtaining a CGM device for her was not easy. Hours of effort were spent among my staff, the patient, and me with the insurance company. But in the end, we were able to obtain for her her CGM device, which she uses with an insulin pump. But then a horrible thing happened in 2014: she celebrated her 65th birthday. Although this may not have been expected when she developed her diabetes, this is now common; we have a new population of ‘‘geriatric’’ type 1 diabetes patients for whom, as a population, we have little experience let alone research to guide us. But what is clear to her, her family, and me is she benefited greatly from her CGM device. Taking this tool away from her is her punishment for living successfully with type 1 diabetes for 45 years. Unfortunately, neither she nor her family members can afford the cost of a CGM device, let alone the ongoing costs for the sensors themselves. My appeals to Medicare in the past have been unsuccessful because we don’t have a clinical trial with CGM specifically with this population, although it is clear hypoglycemia is more debilitating in the elderly.8 My frustration is not just this one patient—not at all. It is the thousands of patients exactly like this woman who can’t benefit from our technological advances. Although this may seem like a mega-whine by a spoiled academic clinician to those in other countries who have minimal if any access to CGM, why, just why, do we continue to spend millions of dollars from federal and foundation funding for a closed-loop artificial pancreas when it seems to most of us a commercial version would only be accessible to the wealthy children of the CEOs of insurance companies?
HIRSCH
And as we enter 2015, no rant would be complete without a mention of the incredible increased burden of bureaucracy and administrative hassles to see patients with diabetes. Several years ago our group engaged in an assessment about the time it took to see patients with diabetes that could not be reimbursed. Part of the assessment was for pre-authorizations for noncovered or poorly reimbursed items, including medications, devices, and glucose test strips for patients requiring insulin. At the time, each one took an average of 12 min, which I thought was much too short given the actual time we seem to spend explaining to payers why patients with diabetes required everything from glucose test strips to insulin analogs for type 1 patients on an insulin pump. Of course, why the pharmaceutical industry even bothers to launch new products in our poorly covered part of the country is beyond me. In fact, two new insulin pumps actually have not been formally launched in Washington State owing to the reimbursement pressures. Although one could argue (for the record, not me) we don’t need glucagon-like peptide-1 analogs or sodium-glucose cotransporter-2 inhibitors, the saga of the pricing of insulin is only worse than a year ago.2 As we enter 2015 the ‘‘cheapest’’ vial of insulin glargine in Seattle, WA, is $399, whereas in Denver, CO, it is north of $400 (with a coupon!).9 This topic will gain much attention this year, including at this year’s American Diabetes Association’s Scientific Session in June. The reasons for this continued increase in price are complex, but these high costs are not well known by many physicians. What is clear is many patients with insurance can’t afford copayments. Contracting by payers has resulted in eliminating the choice of which insulin to use, and traditional marketing of insulin products to both healthcare providers and directly to patients is no longer relevant. The cheaper human insulin alternatives are a good choice for many patients with type 2 diabetes, but even a vial of NPH insulin is usually about $120 per vial, although one can find it cheaper at certain pharmacies.9 I think my greatest concern as we are halfway through this decade is the physicians in training won’t be ranting, as our current status is their status quo. On the other hand, although many of our colleagues are retiring early because of how distasteful this has all become, the greatest irony is the major single reason why more physicians don’t retire early is to maintain their health insurance. As an endocrinologist, I can honestly conclude the system has us by the gonads. I am hopeful that there won’t be as much to rant about at the beginning of 2016. Unfortunately, there is so much in 2015 there wasn’t space to address the Sunshine Act and board recertification requirements. Still, we have to continue to remind ourselves what our world looked liked 94 years ago when Banting and Best injected that first pancreatic extract in Marjorie the dog. Still, it is a guess, just a guess, that Dr. Banting and Mr. Best did not require a pre-authorization or peer-to-peer consult to inject the first extract into Leonard Thomson, the first human to receive insulin. Otherwise we’d still be waiting for the appeal to go through. References
1. Hirsch IB: Healthcare reform in diabetes: more ranting about a broken healthcare system. Diabetes Technol Ther 2013; 15:212–213. 2. Hirsch IB: Diabetes care entering 2014: more ranting. Diabetes Technol Ther 2014;16:iii–iv.
DIABETES CARE ENTERING 2015
3. McGlynn EA, Schneider EC, Kerr EA: Reimagining quality measurement. N Engl J Med 2014;371:2150–2153. 4. American Diabetes Association: Glycemic targets. Diabetes Care 2015;38(Suppl 1):S33–S40. 5. Goldberg HI, Tarczy-Hornoch P, Stephens K, et al.: Internet access to patients’ records. Lancet 1998;351;1811. 6. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group: Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med 2008;359:1464–1478. 7. Weinstock RS, Xing D, Maahs DM, et al.: Severe hypoglycemia and diabetic ketoacidosis in adults with type 1 diabetes: results from the T1D Exchange Clinic Registry. J Clin Endocrinol Metab 2013;98:3411–3419.
71
8. Lipska KJ, Ross JS, Wang Y, et al.: National trends in U.S. hospital admissions for hyperglycemia and hypoglycemia among Medicare beneficiaries, 1999–2011. JAMA Intern Med 2014;174:1116–1124. 9. www.goodrx.com (accessed January 1, 2015).
Address correspondence to: Irl B. Hirsch, MD University of Washington Medical Center-Roosevelt 4245 Roosevelt Way NE, 3rd Floor Seattle, WA 98105 E-mail: [email protected]
