DIABETES ADVOCATES TAKE ACTION!

Transcription

1 DIABETES ADVOCATES TAKE ACTION! TELL CALIFORNIA STATE LEGISLATORS TO SUPPORT AB 447 MEDI-CAL COVERAGE OF CONTINUOUS GLUCOSE MONITORING (CGM) THERAPY FOR HIGH RISK DIABETICS This toolkit provides instructions and information you need to advocate for Continuous Glucose Monitoring (CGM) devices for high risk diabetics in California s Medi-Cal program. CGM is proven technology for patients who are unable to adequately control their blood glucose levels using finger-stick tests and are in jeopardy of incurring lifethreatening complications. AB 447 would authorize Medi-Cal to cover CGM as medically necessary and end the disparity in access compared to all major private health plans in California that offer CGM. The bill is scheduled to be heard by the Assembly Health Committee on April 25 th. What s Included: Instructions on how to get in touch with your Sacramento legislators Key message points you may include in your letter or communication A summary of clinical and economic value studies of CGM HOW TO CONTACT YOUR STATE LEGISLATOR & BE AN EFFECTIVE ADVOCATE Communicate with your state assemblymember and senator. If you don t know who your state legislators are, you can find them at this website by typing in your address: KEY Priority: Communicate with members of the Assembly Health Committee who will hear AB 447 on April 25 th. They will decide if the bill can move forward and be considered by the Assembly Appropriations Committee. Here s a link to the Health Committee Members From here you can retrieve their contact information. Be sure to write to their Capitol Address. Please contact the Chairman, Jim Wood: Assemblyman Jim Wood Room 6005, The Capitol P.O. Box , Sacramento, CA ; (916) Ways to Communicate: Office Visit: Scheduling a meeting with your state legislator in their home district office. Personal visits are the most effective way to convey your passion about the benefits of CGM to your legislator.

2 (Communicating with Legislators Con t.) Personal Letters: Send a personalized letters on your letterhead that describes your experience (clinician, patient, caregiver) with diabetes, its debilitating and costly complications, and the benefits of CGM. Personal letters have far more impact than s. You can also scan and send a letter electronically or fax it. Do Not Send Form Letters! The talking points and sample letter provide examples of messaging for you, but please do not copy and paste into your letter. Speak from your experience with diabetes. Last Resort Send an with your personal message of support for AB 447. Salutations to Legislators: The Honorable (First and last name), State Capitol Sacramento, CA LETTER FORMAT Dear Assemblymember (last name); or Dear Senator (last name): Sample Introduction and Talking Points I m contacting you to urge your support for AB 447, legislation scheduled to be considered by the Assembly Health Committee on April 25 th. AB 447 would give highrisk diabetic patients on Medi-Cal the same access to the potentially life-saving benefits of Continuous Glucose Monitoring (CGM) devices as patients enjoy in every major commercial health plan. PLEASE DESCRIBE YOUR EXPERIENCE AND THE BENEFITS YOU VE SEEN WITH CGM OVER FINGERSTICK TESTS ALONE OF BLOOD GLUCOSE INTEGRATED WITH AN INSULIN PUMP OR STAND-ALONE CGM. AS A CLINICIAN, PATIENT OR CAREGIVER IN IMPROVING DIABETES MANAGEMENT AND OUTCOMES. DESCRIBE SERIOUS COMPLICATIONS WITHOUT CGM AND HOW PATIENT HEALTH IMPROVED WITH CGM. REAL-LIFE EXAMPLES ARE POWERFUL IN COMMUNICATING CGM S BENEFITS. IF YOU ARE A MEDI-CAL PATIENT, CLINICIAN OR CAREGIVER AND HAVE SUFFERED FROM A LACK OF CGM, OR AN INTEGRATED CGM/INSULIN PUMP SYSTEM, PLEASE DESCRIBE HOW IT HAS NEGATIVELY AFFECTED YOUR HEALTH AND QUALITY OF LIFE.

3 (See Talking Points on Next Page) TALKING POINTS PLEASE DO NOT USE VERBATIM. CGM, either as a stand-alone device or in combination with an insulin pump, helps guard against debilitating and costly complications for insulin-dependent patients who struggle to manage their blood glucose levels with periodic fingerstick (blood) tests alone. Finger-stick glucose tests reveal only a snapshot in time. Glucose levels may appear good, but during non-testing periods will fluctuate to dangerous highs and lows without the patients knowledge. CGM technology gives patients a constant readout and just as important, shows if levels are trending up or down. CGM allows patients to react to rising or falling glucose levels before they become life-threatening by adjusting their insulin levels through self-injection or insulin pump infusion. Numerous clinical studies prove that CGM and CGM-augmented insulin pumps can reduce or even eliminate costly short-term complications such as black-outs, seizure, coma or even death that occur when blood sugar levels get too low, called hypoglycemia. Treating hypoglycemia results in great costs to Medi-Cal and taxpayers in ambulance trips to the emergency room and hospitalizations. Black-outs can occur at anytime, including when driving a car, causing serious or deadly car accidents. Hypoglycemic events occur frequently while sleeping and can be especially dangerous. It also harms quality of life and workplace productivity as patients are fearful and are emotionally distressed at the prospect of an event. CGM-augmented insulin pumps and stand-alone CGM reduces longer-term health problems such as kidney failure, stroke, nerve and eye damage, amputation and many other costly complications. Every 1 percent drop in A1C levels (a 3 month average of glucose) can reduce complications by 40%, according to the CDC. Every major commercial health plan in California covers CGM, including Kaiser Permanente. They recognize the value of CGM in improving outcomes and lowering the total cost of treating this horrible disease.

4 California Childerens Services now provides access to CGM, both stand-alone and integrated CGM with an insulin pump. If CCS is covering, shouldn t Medi- Cal?! Medicaid programs in forty states recognize the value of CGM and provide access for high-risk diabetic patients. CGM can help narrow the wide gap in diabetes outcomes between poor and wealthier communities in California. The rate of diabetic amputations where Medi-Cal is the primary health provider is 10 times higher than wealthy communities, according to a 2015 UCLA study. Another UCLA study showed the rate of hospitalizations was higher for people with diabetes, and the cost of care was over $2,200 more per patient. Access to CGM for Medi-Cal patients will not break the budget only a small portion all diabetics will meet the strict clinical guidelines for CGM use. The investment in CGM will pay for itself many times over in reducing severe and far more costly complications. ###

5 Economic Value: CGM-Sensor Augmented Pumps Reduce or Eliminate Severe Hypoglycemic Events and Improve Overall Glucose Control Costly Complications are Reduced or Eliminated 2 out of 3 Type 1 diabetic patients do not achieve good glycemic control Up to 75% of high and low glucose episodes go undetected Diabetes Costs: Each one percent increase in A1C glucose increases risk of costly and severe complications by 40%, such as nerve damage, vision loss, kidney failure, stroke, amputation, etc. Newer technology, CGM-sensor augmented pumps (SAPs), pauses insulin delivery to stop glycemic sugar from going lower. SAPs also improve the overall control of glucose in the normal range. Patients fear hypoglycemia, especially overnight (nocturnal hypoglycemia). Blackouts, seizure, coma and death result from severe hypoglycemia: 1 of every 2 patients experience nocturnal hypoglycemia per night 10% of hypo events require medical assistance 25 events per 100 patient years result in coma or seizure. Type 2 Diabetics require emergency assistance for hypoglycemic events with the same frequency as Type 1, according to an American Diabetes Assoc. study A recent clinical trial showed that the newest iteration of SAP, the Medtronic 670G pump, achieved normal glucose level control with only 0 to 1 hypo events depending on the patient. Patients using SAP experience less than 1 serious hypo event per year vs. 6 without SAP Hospital Costs: One severe hypoglycemic event results in costs between $1,387 to $17,564 for admitted patients. Outpatient costs: Averaged $394 in study several years ago the costs are greater now. Ambulance service costs can range between $250 to $1,000 depending on insurance. Other treatment options do not provide a way to reduce severe hypoglycemia. References for data are available upon request.

6 Clinical Evidence, Clinical Guidelines, and Private Health Plans Support Use of a CGM Extensive clinical evidence shows use of a CGM improves diabetes outcomes. A JDRF-funded clinical trial, published in The New England Journal of Medicine(1) and Diabetes Care,(2) found adults using a CGM had improved glucose control (reduced A1c) and reduced rates of severe hypoglycemia. Many studies since the original trial have shown similar results. A 2012 review of the published literature conducted by the Agency for Healthcare Research and Quality found continuous glucose monitoring is superior to blood glucose monitoring.(3) It also found that insulin pumps with CGM functionality are superior to other available insulin delivery and glucose monitoring methods. Based on this clinical evidence, diabetes clinical guidelines by all leading diabetes professional societies recommend use of a CGM, including the American Association of Clinical Endocrinologists,(4) the American Diabetes Association, (5) and The Endocrine Society.(6) In addition, nearly all private health plans cover CGM devices, including Aetna, CIGNA, United Healthcare, Wellpoint, Kaiser, many Blue Cross and Blue Shield plans, and numerous regional plans. 1 JDRF CGM Study Group, N Engl J Med : JDRF CGM Study Group, Diabetes Care 32: , Golden et. al. Comparative Effectiveness Review No. 57. AHRQ Publication No. 12-EHC036-EF. July Endocrine Practice Vol 16 No. 5 September/October Diabetes Care, Volume 36, Supplement 1, January 2013, p S17 6 J Clin Endocrinol Metab, October, 2011, 96 (10):

7 Value of Continuous Glucose Monitoring Continuous glucose monitor (CGM) technology that detects and displays glucose levels every 5 minutes is a critical diabetes management tool for thousands of people with diabetes. Benefit of CGM Monitoring glucose levels throughout the day and night provides real-time information such as: o The direction a person s glucose levels are going and how fast they re changing o Early notification of oncoming lows and highs o Alerts that notify when sensor glucose levels are too low or too high, maximizing a person s time within the desired glucose range CGM provides a more complete picture for people with diabetes because it reveals high and low glucose levels that periodic fingerstick testing might miss. Trend graphs can help people recognize patterns and give insight to underlying causes of glucose fluctuations. Fingerstick Testing Limits Glucose Variability to Snapshots in Time CGM Reveals the Complete Picture to Optimize Glucose Management Practices Clinical Proof that CGM Improves Glucose Control An abundance of clinical studies demonstrate the benefits of CGM for people with diabetes. A few examples include: 1) The landmark JDRF CGM studies combine to provide the largest body of data on CGM use in children, adolescents, and adults. These studies show: Using CGM can significantly improve diabetes control and decrease the frequency of high and low blood glucose when used regularly. 1 1 The 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:

8 Regular use (at least six days per week) of CGM devices was the principal factor in achieving better diabetes control in every age group. 2 CGM use had long-term impact: people using CGM were able to sustain good diabetes control while actually lowering the incidence of hypoglycemia. 3 2) The longest and largest study of its kind, the STAR 3 Trial compared the efficacy an insulin pump integrated with CGM to multiple daily injections. The study found: Adults, children and adolescents can achieve better glucose control with an insulin pump integrated with CGM than with multiple daily injections 4. Patients on sensor-augmented insulin pump therapy demonstrated a reduction in mean A1C levels that was four times greater than the multiple daily injection group (0.8 percent study vs. 0.2 percent control (p<.001). Every percentage point drop in A1c blood test results (e.g., from 8.0 percent to 7.0 percent) can reduce the risk of microvascular complications (eye, kidney, and nerve diseases) by 40 percent 5. 3) The GuardControl Trial evaluated whether type 1 patients with poor glucose control could improve glucose control using CGM. The study revealed: A >1 percent A1C reduction in half the subjects and 2 percent in 26 percent of the subjects after three months of near daily CGM use. 6 A1C is a blood test used to measure average blood glucose levels over a three-month period Every percentage point drop in A1C can reduce the risk of microvascular complications (eye, kidney, and nerve diseases) by 40%. 7 Professional Society Support for CGM In 2010, the American Association of Clinical Endocrinologists (AACE) released a consensus statement on continuous glucose monitoring. After a comprehensive analysis, a panel of endocrinology experts shared the latest information and best practices for CGM in the consensus statement, which stated: CGM technology is not only novel, but it can improve the lives of patients who incorporate it into a comprehensive diabetes management plan. 8 The AACE statement recommends CGM particularly for children, adolescents and adults with frequent hypoglycemia or hypoglycemia unawareness, A1C levels over their target, large variability in glycemic levels, and the need to lower A1C levels without increasing hypoglycemic events, as well as for those who are pregnant or are planning to become pregnant. 2 Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Factors Predictive of Use and of Benefit from Continuous Glucose Monitoring in Type 1 Diabetes. Diabetes Care, 2009 DOI: /dc The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Sustained benefit of continuous glucose monitoring on HbA1c, glucose profiles, and hypoglycemia in adults with type 1 diabetes. Diabetes Care 2009;32: Bergenstal RM, Tamborlane WV, Ahmann A, et al; the STAR 3 Study Group. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010;363: The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: Deiss D, Bolinder J, Riveline JP, et al. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006;29:(12) Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes in the United States, Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, American Association of Clinical Endocrinologists CGM Task Force. Consensus Statement: Continuous Glucose Monitoring. Endocrine Practice. Sept/Oct 2010; Vol 16, No 5, pp

9 The American Diabetes Association Standards of Care 9 and the Endocrine Society CGM Practice Guidelines 10 also assert the value of CGM in improving health outcomes for people with diabetes. CGM Coverage Lags Behind Clinical Best Practice Currently, CGM coverage by private insurance is very strong around 90% of health plans cover CGM when certain medical criteria are met. However, a recent decision by Centers for Medicare & Medicaid Services (CMS) stated that CGM technology does not satisfy its definition of durable medical equipment. As a result, the decision automatically blocks access to CGM technology for people on Medicare and Medicaid. It is important to initiate efforts to reverse this decision and open up access to CGM technology for the Medicare and Medicaid beneficiaries who need it. Insulin pumps and continuous glucose monitors (CGM) can reduce long-term costs to the healthcare system. The American Diabetes Association estimates that in 2012 the US economy spent $245 billion on diabetes. $176 billion was spent on medical purposes, including emergency room, hospital and physician visits, therapies and pharmaceutical. $69 billion was attributed to indirect costs such as lost work days or reduced productivity 11. Good glucose control can reduce these long-term costs. A study of a large US health plan assessed that total diabetes-attributable costs were 20% lower in patients with good control compared with fair control, and 24% lower compared to those with poor control 12. A recent analysis of US hospital data shows that over a one-year time frame, short term diabetic complications and hospitalization for uncontrolled diabetes account for 6% of all diabetes hospitalization, resulting in a total cost of over 1.3 billion per year 13. A recent study by Winn et. al., found that intensive control of blood glucose levels in those with T1D would, at the ten year mark, result in estimated savings to Medicare in the range of $ million. By the 25 year mark, these savings to Medicare would reach the $ billion for T1D 14. Improving glucose control can also reduce the costs associated with short term diabetes complications that contribute to the economic burden. Hypoglycemia, also known as low blood sugar, is a common complicating factor affecting patients with diabetes. The costs associated with hypoglycemia can be substantial, with estimates ranging from $1,186 to $17,564 per severe episode. 15, 16 (US estimate) Hypoglycemia episodes can impact worker productivity. A recent study showed that 14.1% of people experiencing nocturnal hypoglycemia arrived to work late or missed a full day, with an average of 14.3 working hours missed per event Diabetes Care Volume 37, Supplement 1, January 2014: S21-S22, S Journal of Clinical Endocrinology & Metabolism, October 2011, 96(1)): Economic Costs of Diabetes in the U.S. in 2012, American Diabetes Association. 12 Shetty S, Secnik K, Oglesby AK. Relationship of glycemic control to total diabetes-related costs for managed care health plan members with type 2 diabetes. J Manag Care Pharm 2005;11(7): Ahern MM, Hendryx M. Avoidable hospitalizations for diabetes: comorbidity risks. Dis Manag 2007;10(6): O'grady MJ, John P, Winn A. Substantial Medicare savings may result if insurers cover 'artificial pancreas' sooner for diabetes patients. Health Aff (Millwood). 2012;31(8): Heaton A, Martin S, Brelje T. The economic effect of hypoglycemia in a health plan. Manag Care Interface 2003;16(7): Quilliam BJ, Simeone JC, Ozbay AB, Kogut SJ. The incidence and costs of hypoglycemia in type 2 diabetes. Am J Manag Care 2011;17(10): Brod M, Christensen T, Thomsen TL, Bushnell DM. The impact of non-severe hypoglycemic events on work productivity and diabetes management. Value Health 2011;14(5):