This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives.
STORAGE NAME: h0967d.HCA
DATE: 4/12/2023
HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/HB 967 Medicaid Coverage of Continuous Glucose Monitors
SPONSOR(S): Healthcare Regulation Subcommittee, Bell
TIED BILLS: IDEN./SIM. BILLS: SB 988
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Healthcare Regulation Subcommittee 17 Y, 0 N, As CS Poche McElroy
2) Health Care Appropriations Subcommittee 13 Y, 0 N Smith Clark
3) Health & Human Services Committee
SUMMARY ANALYSIS
Diabetes occurs when blood glucose, also called blood sugar, is too high. Blood glucose is the body’s main
source of energy and comes mainly from one’s diet. Insulin, a hormone made by the pancreas, helps the
glucose in the blood get into the cells to be used for energy. Another hormone, glucagon, works with insulin to
control blood glucose levels. There are two primary types of diabetes- type 1 and type 2.
A continuous glucose monitor (CGM) automatically tracks blood glucose levels, allowing a person to see their
glucose level anytime at a glance. It can also review how glucose changes over a few hours or days to see
trends. Seeing glucose levels in real time can help a diabetic make more informed decisions throughout the
day about how to balance food, physical activity, and medicines.
CS/HB 967 requires the Agency for Health Care Administration (AHCA), subject to funding and any limitations
or directives in the General Appropriations Act (GAA), to cover CGMs under the Medicaid pharmacy benefit for
Medicaid recipients if:
The recipient has been diagnosed by his or her primary care physician, or another licensed health care
practitioner authorized to make such diagnosis, with Type 1 diabetes, Type 2 diabetes, gestational
diabetes, or any other type of diabetes that may be treated with insulin; and
A health care practitioner with the applicable prescribing authority has prescribed insulin to treat the
recipient's diabetes and a CGM to assist the recipient and practitioner in managing the recipient's
diabetes.
The bill requires AHCA to cover necessary repairs and replacement parts for the CGM.
The bill would have an indeterminate, but likely significant, negative fiscal impact on state government and no
fiscal impact on local government.
The bill provides an effective date of October 1, 2023. STORAGE NAME: h0967d.HCA PAGE: 2
DATE: 4/12/2023
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Diabetes
Diabetes occurs when blood glucose, also called blood sugar, is too high. Blood glucose is the body’s
main source of energy and comes mainly from one’s diet. Insulin, a hormone made by the pancreas,
helps the glucose in the blood get into the cells to be used for energy. Another hormone, glucagon,
works with insulin to control blood glucose levels. There are two primary types of diabetes- type 1 and
type 2.
Type 1 Diabetes
In most people with type 1 diabetes, the body’s immune system, which normally fights infection, attacks
and destroys the cells in the pancreas that make insulin.
1
As a result, the pancreas stops making
insulin. Without insulin, glucose cannot get into the cells and blood glucose rises above normal.
2
People with type 1 diabetes need to take insulin every day to stay alive.
Type 1 diabetes typically occurs in children and young adults, although it can appear at any age.
3
Having a parent or sibling with the disease may increase the chance of developing type 1 diabetes. In
the United States, about 5 percent of people with diabetes have type 1.
4
Symptoms of type 1 diabetes are serious and usually happen quickly, over a few days to weeks, and
can include:
Increased thirst and urination
Increased hunger
Blurred vision
Fatigue
Unexplained weight loss
5
Sometimes the first symptoms of type 1 diabetes are signs of a life-threatening condition called diabetic
ketoacidosis (DKA). The condition develops when the body cannot produce enough insulin.
6
Without
enough insulin, the body begins to break down fat as fuel.
7
This causes a buildup of acids in the
bloodstream called ketones; if left untreated, the buildup can lead to diabetic ketoacidosis.
8
Some
symptoms of DKA include:
Breath that smells fruity
Dry or flushed skin
Nausea or vomiting
Stomach pain
Trouble breathing
Trouble paying attention or feeling confused
9
1
U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Type
1 Diabetes, available at https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/type-1-diabetes/ (last visited on April 5, 2023).
2
Id.
3
Id.
4
Centers for Disease Control and Prevention, National diabetes statistics report, 2017, available at www.cdc.gov/diabetes/pdfs/data/statistics/national-
diabetes-statistics-report.pdf (last visited April 5, 2023).
5
Supra note 1.
6
Mayo Clinic, Patient Care & Health Information, Disease & Conditions, Diabetic Ketoacidosis, available at https://www.mayoclinic.org/diseases-
conditions/diabetic-ketoacidosis/symptoms-causes/syc-20371551 (last visited on April 5, 2023).
7
Id.
8
Id.
9
Id. STORAGE NAME: h0967d.HCA PAGE: 3
DATE: 4/12/2023
Type 1 diabetics must take insulin because the body no longer makes it on its own. Different types of
insulin start to work at different speeds, and the effects of each last a different length of time. Insulin
can be taken in several ways; common options include a needle and syringe, insulin pen, or insulin
pump.
10
Some people who have trouble reaching their blood glucose targets with insulin alone also might need
to take another type of diabetes medicine that works with insulin, such as pramlintide. Pramlintide,
given by injection, helps keep blood glucose levels from going too high after eating.
11
Few people with
type 1 diabetes take pramlintide, however. Another diabetes medicine, metformin, may help decrease
the amount of insulin necessary.
12
Researchers are also studying other diabetes pills that people with
type 1 diabetes might take along with insulin.
Hypoglycemia, or low blood sugar, can occur if insulin is taken, but the dose does not account for food
eaten or physical activity.
13
Over time, high blood glucose leads to problems such as:
Heart disease
Stroke
Kidney disease
Eye problems
Dental disease
Nerve damage
Foot problems
Depression
Sleep apnea
14
Type 2 Diabetes
Type 2 diabetes, the most common type of diabetes, occurs when blood glucose is too high.
15
In type 2
diabetes, the body does not make enough insulin or does not use insulin well enough. Too much
glucose then stays in the blood, and not enough reaches the cells.
Type 2 diabetes can develop at any age, even during childhood.
16
However, type 2 diabetes occurs
most often in middle-aged and older people.
17
A person is more likely to develop type 2 diabetes if he
or she is aged 45 or older, has a family history of diabetes, or is overweight or has obesity.
18
Diabetes
is more common in people who are African American, Hispanic/Latino, American Indian, Asian
American, or Pacific Islander.
19
Physical inactivity and certain health problems such as high blood pressure affects a person’s chances
of developing type 2 diabetes. A person is also more likely to develop type 2 diabetes if they have
prediabetes or had gestational diabetes when they were pregnant.
20
Symptoms of type 2 diabetes
include:
Increased thirst and urination
Increased hunger
10
Supra note 1.
11
Id.
12
Id.
13
Id.
14
Id.
15
U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Type
2 Diabetes, https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/type-2-diabetes (last visited on April 5, 2023).
16
Id.
17
Id.
18
Id.
19
Id.
20
Id. STORAGE NAME: h0967d.HCA PAGE: 4
DATE: 4/12/2023
Feeling tired
Blurred vision
Numbness or tingling in the feet or hands
Sores that do not heal
Unexplained weight loss
21
Symptoms of type 2 diabetes often develop slowly, usually over the course of several years, and can
be so mild as to not be noticed. Many people have no symptoms. Some people do not find out they
have the disease until they have diabetes-related health problems, such as blurred vision or heart
disease.
22
Type 2 diabetes is caused by several factors, including:
Overweight and obesity
Not being physically active
Insulin resistance
Genes
23
If not managed, diabetes can lead to problems such as:
Heart disease and stroke
Nerve damage
Kidney disease
Foot problems
Eye disease
Gum disease and other dental problems
Sexual and bladder problems
24
Many people with type 2 diabetes also have nonalcoholic fatty liver disease, a disease in which fat
appears inside the liver that can, over time, affect liver function and cause liver injury.
25
Diabetes is also
linked to other health problems such as sleep apnea, depression, some types of cancer, and
dementia.
26
21
Id.
22
Id.
23
Id.
24
Id.
25
Johns Hopkins Medicine, Health, Conditions and Diseases, Nonalcoholic Fatty Liver Disease, available at
https://hopkinsmedicine.org/health/conditions-and-diseases/nonalcoholic-fatty-liver-disease (last visited on April 5, 2023).
26
Supra note 15. STORAGE NAME: h0967d.HCA PAGE: 5
DATE: 4/12/2023
The following chart shows the number of people in the U.S. with diabetes more than doubled from 1990
to 2019, increasing 115 percent.
27
The United States ranks fourth, globally, in the number of diabetes cases (32 million), behind China
(141 million), India (74 million), and Pakistan (33 million).
28
27
Center for the Advancement of Health, Diabetes Statistics: Facts & Latest Data in the US (2023 Update), available at https://cfah.org/diabetes-
statistics/ (last visited on April 5, 2023).
28
International Diabetes Federation, IDF Diabetes Atlas: 10
th
Edition, available at https://diabetesatlas.org/atlas/tenth-edition (last visited on April 5,
2023). STORAGE NAME: h0967d.HCA PAGE: 6
DATE: 4/12/2023
Diabetes is the eighth leading cause of death in the United States.
29
Below is a snapshot of diabetes
prevalence and health care costs in the U.S.
30
29
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Underlying Cause of Death, 2018-2021, Single Race
Results, January 17, 2023, available at https://w onder.cdc.gov/controller/datarequest/D158 (last visited on April 5, 2023).
30
Centers for Disease Control and Prevention, A Snapshot: Diabetes in the United States, available at
https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html (last visited on April 5, 2023). STORAGE NAME: h0967d.HCA PAGE: 7
DATE: 4/12/2023
The following map shows the number of diabetes deaths in the United States, by state.
31
While the
largest number of deaths are from California, with 11.4 percent of all diabetes deaths in the U.S., the
highest diabetes rates, by population and incidence, are West Virginia, Mississippi, and Arkansas.
32
Continuous Glucose Monitors
A continuous glucose monitor (CGM) automatically tracks blood glucose levels, allowing a person to
see their glucose level anytime at a glance.
33
It can also review how glucose changes over a few hours
or days to see trends. Seeing glucose levels in real time can help a diabetic make more informed
decisions throughout the day about how to balance food, physical activity, and medicines.
34
A CGM works through a tiny sensor inserted under the skin, usually on the belly or arm.
35
The sensor
measures the interstitial glucose level, which is the glucose found in the fluid between the cells.
36
The
sensor tests glucose every few minutes. A transmitter wirelessly sends the information to a monitor.
The monitor may be part of an insulin pump or a separate device, which can be carried in a pocket or
purse.
37
Some CGMs send information directly to a smartphone or tablet.
CGMs are always on and recording glucose levels, regardless of activity level.
38
Many CGMs have
special features that work with information from the glucose readings, such as:
An alarm can sound when the glucose level goes too low or too high.
A diabetic can track meals, physical activity, and medicines in a CGM device.
Data can be downloaded to a computer or smart device to more easily see glucose trends. Some
models can send information right away to a second person’s smartphone. For example, if a child’s
glucose drops dangerously low overnight, the CGM could be set to wake a parent in the next
room.
39
31
Supra note 27.
32
Id.
33
U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases,
Continuous Glucose Monitoring, available at https://www.niddk.nih.gov/health-information/diabetes/overview/managing-diabetes/continuous-glucose-
monitoring (last visited on April 5, 2023).
34
Id.
35
Id.
36
Id.
37
Id.
38
Id.
39
Id. STORAGE NAME: h0967d.HCA PAGE: 8
DATE: 4/12/2023
Currently, one CGM model is approved for treatment decisions, the Dexcom G5 Mobile, which means
changes can be made to a diabetes care plan based on CGM results alone.
40
Twice a day, a diabetic may need to check the CGM itself by testing a drop of blood on a standard
glucose meter.
41
The glucose reading should be similar on both devices. The CGM sensor needs to be
changed every 3 to 7 days, depending on the model.
42
Most people who use CGMs have type 1 diabetes. Research is underway to learn how CGMs might
help people with type 2 diabetes.
43
CGMs are approved for use by adults and children with a doctor’s prescription. Some models may be
used for children as young as age 2. A physician may recommend a CGM if a person, including a child:
Is on intensive insulin therapy, also called tight blood sugar control.
Has hypoglycemia unawareness.
Often has high or low blood glucose.
44
Compared with a standard blood glucose meter, using a CGM system can better manage glucose
levels every day, lead to fewer low blood glucose emergencies, and require fewer finger sticks. On
average, CGMs cost between $1,000 and $1,400, but can cost thousands of dollars, depending on the
model and features, and usually require an annually battery change, costing another $500.
45
People with type 1 and type 2 diabetes who use a CGM have fewer instances of hypoglycemia and a
lower A1C.
46
There are three manufacturers of CGMs with models on the market: Medtronic, Libre, and Dexcom.
Florida Medicaid
Medicaid is the health care safety net for low-income Floridians. Medicaid is a partnership of the federal
and state governments established to provide coverage for health services for eligible persons. The
program is administered by the Agency for Health Care Administration (AHCA) and financed by federal
and state funds. AHCA delegates certain functions to other state agencies, including the Department of
Children and Families (DCF), which makes eligibility determinations.
The state uses a comprehensive managed care delivery model for primary and acute care services
provided to most Medicaid enrollees, the Statewide Medicaid Managed Care (SMMC) program.
47
The
SMMC program provides acute health care services through managed care plans contracted with
AHCA in the 11 regions across the state. Specialty plans are also available to serve distinct
populations, such as the Children’s Medical Services Network for children with special health care
needs, or those in the child welfare system. Medicaid recipients with HIV/AIDS, serious mental illness,
dual enrollment with Medicare, chronic obstructive pulmonary disease, congestive heart failure, or
cardiovascular disease may also select from specialized plans.
Medicaid Coverage for Continuous Glucose Monitors
Florida
40
Id.
41
Id.
42
Id.
43
Id.
44
Id.
45
CheckDiabetes, Continuous Glucose Monitoring System and Devices, Jan. 8, 2022, available at https://www.checkdiabetes.org/continuous-glucose-
monitoring-system-and-
devices/#:~:text=The%20cost%20of%20continuous%20glucose%20monitor%20varies%20depending,a%20battery%20usually%20cost%20around%20
%24400%20to%20%24500 (last visited on April 5, 2023).
46
American Diabetes Association, Get Involved–Advocacy Overview, Continuous Glucose Monitors (CGMs) – Everything You Need to Know, available
at https://diabetes.org/get-involved/advocacy/continuous-glucose-monitors (last visited on April 5, 2023).
47
S. 409.964, F.S. STORAGE NAME: h0967d.HCA PAGE: 9
DATE: 4/12/2023
Florida Medicaid fee-for-service (FFS) recipients acquire diabetic supplies from a durable medical
equipment (DME) provider.
48
DME providers are reimbursed according to a promulgated fee schedule
containing fixed payment amounts for all products falling under the same billable codes. Currently,
Florida Medicaid covers CGMs for recipients ages 0-20 years only; however, in managed care the
plans can be less restrictive, and some have already elected to cover CGMs for adults as an expanded
benefit, and/or to provide CGMs as a pharmacy benefit. The companies that cover diabetic supplies
under the pharmacy benefit include:
United
Aetna
Humana
Molina
Simply
Sunshine Health
Community Care Plan (CCP)
Florida Community Care (FCC)
AmeriHealth Caritas
Children’s Medical Services (CMS)
49
In 2021, Florida Medicaid spent nearly $40M on diabetic supplies for recipients, inclusive of
expenditures for the FFS delivery system and SMMC. Nearly half the expense was for diabetic test
strips, totaling $19M for SMMC diabetic enrollees and $500,000 for FFS recipients. Additional diabetic
supplies, such as sensors, transmitters, pumps, needles, lancets, CGMs, syringes, glucose meters and
alcohol swabs, accounted for the approximate $19M in SMMC diabetic enrollee expenses.
50
Other States
More than 20 state Medicaid procedures cover diabetic supplies for both Type 1 and Type 2 diabetes
through the pharmacy benefit and collect rebates.
51
Diabetic supplies in these arrangements include
CGMs, test strips, lancets, meters, transmitters, and sensors. The map below shows which states
provide coverage for diabetic supplies.
48
On March 30, 2023, AHCA issued a Florida Medicaid Health Care Alert advising all provider types that the Medicaid program w ill transfer diabetic
coverage from the DME benefit to the pharmacy benefit. In the coming months, AHCA w ill begin rulemaking to update necessary coverage policies;
amend the Florida Medicaid State Plan; and amend Statew ide Medicaid Managed Care plan contracts to reflect the change in policy. Agency for Health
Care Administration, Florida Medicaid, Florida Medicaid Health Care Alert, Florida Medicaid Transfer of Diabetic Supply Coverage from the Durable
Medical Equipment Benefit to the Pharmacy Benefit, March 30, 2023. Also, on March 2, 2023, the Centers for Medicare and Medicaid Services
announced that Medicare w ill cover CGMs for an expanded group of people w ith type 2 diabetes. Up until now , Medicare only covered CGMs for people
w ith type 2 diabetes w ho w ere on at least three shots of insulin per day. Beginning April 16, 2023, the expanded policy now includes people w ho are
taking any type of insulin as w ell as people w ith non-insulin-treated diabetes who have a history of recurrent level 2 hypoglycemia, or w ho have had at
least one level 3 hypoglycemic event. The diaTribe Foundation, Medicare to Expand CGM Coverage for People with Type 2 Diabetes, March 3, 2023,
available at https://diatribe.org/medicare-expands-cgm-continuous-glucose-monitor-coverage-type-2-
diabetes#:~:text=Medicare%20will%20begin%20covering%20continuous%20glucose%20monitors%20%28CGMs%29,coverage%20to%20more%2 0pe
ople%20w ith%20type%202%20diabetes (last visited on April 5, 2023).
49
Email from Patrick Steele, Legislative Affairs Director for AHCA, Re: HB 967 bill analysis, March 17, 2023, on file w ith the House Healthcare
Regulation Subcommittee.
50
Agency for Health Care Administration, 2023 Agency Legislative Bill Analysis – HB 967, February 22, 2023, pg. 3, on file w ith the House Healthcare
Regulation Subcommittee.
51
Id. STORAGE NAME: h0967d.HCA PAGE: 10
DATE: 4/12/2023
Effect of Proposed Changes
CS/HB 967 requires AHCA, subject to funding and any limitations or directives in the General
Appropriations Act (GAA), to cover CGMs under the Medicaid pharmacy benefit for Medicaid recipients
if:
The recipient has been diagnosed by his or her primary care physician, or another licensed
health care practitioner authorized to make such diagnosis, with Type 1 diabetes, Type 2
diabetes, gestational diabetes, or any other type of diabetes that may be treated with insulin;
and
A health care practitioner with the applicable prescribing authority has prescribed insulin to treat
the recipient's diabetes and a CGM to assist the recipient and practitioner in managing the
recipient's diabetes.
The bill requires AHCA to cover necessary repairs and replacement parts for the CGM.
In order to receive continuing coverage for the CGM, the Medicaid recipient, must get follow-up care,
in person or through telehealth, once every six months for the first 18 months he or she has the CGM
for the purpose of assessing the efficacy of using the CGM for treatment of their diabetes. After the first
18 months, such follow-up care must take place annually.
The bill directs AHCA to seek federal approval, if necessary, to implement the bill. Lastly, the bill directs
AHCA to include the rate impact of CGM coverage in the Medicaid medical managed assistance and
long-term care managed care programs’ rates that take effect on October 1, 2023.
The bill provides an effective date of October 1, 2023.
B. SECTION DIRECTORY:
Section 1: Creates s. 409.9063, F.S., relating to coverage of continuous glucose monitors for Medicaid
recipients.
Section 2: Creates an unnumbered section of law directing the Agency for Health Care Administration
to include the rate impact of the bill in the Medicaid managed medical assistance program
and long-term managed care program rates that take effect on October 1, 2023.
Section 3: Provides an effective date of October 1, 2023.
STORAGE NAME: h0967d.HCA PAGE: 11
DATE: 4/12/2023
II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT
A. FISCAL IMPACT ON STATE GOVERNMENT:
1. Revenues:
CGMs are currently reimbursed under a DME benefit contained in the SMMC plan. If
reimbursement were made under the pharmacy benefit, the state may receive rebates for diabetic
supplies, offsetting a portion of the cost to the Medicaid program.
2. Expenditures:
The Medicaid program in Florida currently does not cover CGMs for adults over the age of 20. In
federal fiscal year 2021-2022, 43,924 Medicaid recipients required diabetic supplies.
52
If five
percent of that eligible population were prescribed a CGM, the increase in expenditures for state
fiscal year 2023-2024 would be $13.1 million, with a $5.3 million impact to the General Revenue
Fund.
53
The chart below contains estimated fiscal impacts based on select percentages of the
eligible population being prescribed a CGM.
54
Participation
%
Number of
Potential
Recipient
Participation
Total Potential
Expense
Potential Impact to
General Revenue
1% 439 $ 2,630,521 $ 1,065,887
3% 1318 $ 7,891,562 $ 3,197,661
5% 2196 $ 13,152,603 $ 5,329,435
15% 6589 $ 39,457,808 $ 15,988,304
50% 21962 $ 131,526,026 $ 53,294,346
B. FISCAL IMPACT ON LOCAL GOVERNMENTS:
1. Revenues:
None.
2. Expenditures:
None.
C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR:
None.
D. FISCAL COMMENTS:
Future expenditures related to CGMs and potential revenues from drug rebates would be considered
by the Social Services Estimating Conference in the Medicaid Expenditures forecast.
III. COMMENTS
A. CONSTITUTIONAL ISSUES:
52
Agency for Health Care Administration, 2023 Agency Legislative Bill Analysis–HB 967, pg. 5 (Feb. 22, 2023), on file w ith the House Healthcare
Regulation Subcommittee.
53
Id.
54
Id. STORAGE NAME: h0967d.HCA PAGE: 12
DATE: 4/12/2023
1. Applicability of Municipality/County Mandates Provision:
Not applicable. The bill does not affect municipal or county governments.
2. Other:
None.
B. RULE-MAKING AUTHORITY:
AHCA has sufficient rulemaking authority to implement the provisions of the bill.
C. DRAFTING ISSUES OR OTHER COMMENTS:
None.
IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES
On April 3, 2023, the Healthcare Regulation Subcommittee adopted one amendment and reported the bill
favorable as a committee substitute. The amendment, for purposes of defining a continuous glucose
monitor, changed the length of time such a device is expected to stay in the skin and active from 10 days to
7 days, to incorporate the expected length of use of one CGM model manufactured by one of the three
manufacturers with models on the market.
The bill was reported favorably as amended. The analysis is drafted to the committee substitute as passed
by the Healthcare Regulation Subcommittee.