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 25th.
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: http://www.leginfo.ca.gov/yourleg.html

KEY Priority: Communicate with members of the Assembly Health
Committee who will hear AB 447 on April 25th. 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
http://ahea.assembly.ca.gov/. 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 942849, Sacramento, CA 94249-0002; (916) 319-2002
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.
(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 emails. 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 Email with your personal message of support for AB 447.
LETTER FORMAT
Salutations to Legislators:
“The Honorable (First and last name),
State Capitol
Sacramento, CA 95814
“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 25th. 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.
(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.
 California Childerens’ Services now provides access to CGM, both stand-alone
and integrated CGM with an insulin pump. If CCS is covering, shouldn’t MediCal?!
 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.
###
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.
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 2008 359:1464–1476
2 JDRF CGM Study Group, Diabetes Care 32:2047–2049, 2009
3 Golden et. al. Comparative Effectiveness Review No. 57. AHRQ Publication No. 12-EHC036-EF. July 2012
4 Endocrine Practice Vol 16 No. 5 September/October 2010
5 Diabetes Care, Volume 36, Supplement 1, January 2013, p S17
6 J Clin Endocrinol Metab, October, 2011, 96 (10): 2968–2979
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:

1
Using CGM can significantly improve diabetes control and decrease the frequency of high
and low blood glucose when used regularly.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; 359:1464-1476.


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 injections4.
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
percent5.
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: 10.2337/dc09-0889
3
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;32:2047-2049.
4
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;363:311-320.
5
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: 977-986.
6
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)2730-2732.
7
Centers for Disease Control and Prevention. National diabetes fact sheet: general information and national estimates on diabetes
in the United States, 2007. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and
Prevention, 2008.
8
American Association of Clinical Endocrinologists CGM Task Force. Consensus Statement: Continuous Glucose Monitoring.
Endocrine Practice. Sept/Oct 2010; Vol 16, No 5, pp 730 – 744.
The American Diabetes Association Standards of Care 9 and the Endocrine Society CGM
Practice Guidelines10 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 productivity11.

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 control12.
 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 year13.
 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 $450-810 million. By the 25 year mark, these savings to Medicare would
reach the $5.9 – 10.4 billion for T1D14.

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.17
9
Diabetes Care Volume 37, Supplement 1, January 2014: S21-S22, S26.
Journal of Clinical Endocrinology & Metabolism, October 2011, 96(1)):2968-2979.
10
11
Economic Costs of Diabetes in the U.S. in 2012, American Diabetes Association.
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):559-564.
13
Ahern MM, Hendryx M. Avoidable hospitalizations for diabetes: comorbidity risks. Dis Manag 2007;10(6):347-355.
14
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):1822-9.
15
Heaton A, Martin S, Brelje T. The economic effect of hypoglycemia in a health plan. Manag Care Interface 2003;16(7):23-27.
16
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):673-680.
17
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):665-671
12