Current through Register Vol. 49, No. 9, September, 2024
Section 1.
Purpose
The purpose of this Regulation is to implement and coordinate
compliance with the Arkansas diabetes self-management benefits mandated for
inclusion in insurance and HMO policies and contracts under the provisions of
Arkansas Act 1249 of 1997, effective August 1, 1997, codified at Ark. Code Ann.
§§
23-79-601,
et seq.
Section 2.
Authority
This Rule is issued pursuant to the authority vested in the
Commissioner under Ark. Code Ann. §§
23-61-108 and
25-15-203,
Act 1249 of 1997, and other applicable provisions of Arkansas law as
amended.
Section 3.
Applicability and Scope
A.
APPLICATION.
(1) This Rule shail apply to
every disability (health) insurer, hospital or medical service corporation,
health maintenance organization ("HMO"), and fraternal benefit society licensed
by the Arkansas Insurance Commissioner ("Commissioner"). This Rule applies to
group and individual policies or contracts issued on an expense-incurred,
service, or pre-paid risk-sharing basis by authorized licensees of the
Insurance Commissioner. This Rule shall be applicable to any health insurance
policy which is delivered, issued, issued for delivery, renewed, extended, or
modified in this State on and after the effective date of this Rule as adopted
by the Commissioner.
(2) This Rule
shall be applicable to a disability policy, or a health insurance policy
providing coverage or benefits to an Arkansas resident as expressly defined in
accordance with Act 1249 of 1997, in A.C.A. §
23-79-601(3),
whether the health care insurer or other entity which provides the coverage is
located within or outside the State of Arkansas or not; and the policy shall be
deemed to be delivered in this State within the meaning of Act 1249 of
1997.
B. EXCLUSIONS.
This Regulation shall not apply to disability income, specified disease,
Medicare Supplement, hospital indemnity, limited benefit or accident-only
policies. This Rule shail not apply to Champus supplement, long term care
plans, short-term renewable individual health insurance (disability) policies
which expire after six (6) months, medical payments under homeowner or
automobile insurance policies, or to workers' compensation or employers'
liability insurance policies or contracts.
Section 4.
Effective Date
The effective date of this Rule is May 14, 1998, upon signature
of the Commissioner and statutory filing.
Section 5.
Definitions
As used in this Rule:
A.
COMMISSIONER means the Arkansas insurance Commissioner.
B. DEPARTMENT means the Arkansas insurance
Department.
C. DIABETES means and
shall include Type 1, Type 2, or Gestational Diabetes, Diabetes Insipidus, and
other specific types, and means diabetes mellitus, a common chronic, serious
systemic disorder of energy metabolism which includes a heterogeneous group of
metabolic disorders which can be characterized by an elevated blood glucose
level. The terms diabetes and diabetes mellitus are considered synonymous and
defined to include persons using insulin, persons not using insulin,
individuals with elevated blood glucose levels induced by pregnancy, or persons
with other medical conditions or medical therapies which wholly or partially
consist of elevated blood glucose levels.
D. DIABETES EDUCATOR or HEALTH CARE PROVIDER
means only an individual, licensed by one of the following Arkansas State
Boards, who has completed such Arkansas State Board's educational program that
is in compliance with the National Standards for Diabetes Serf-Management
Educational Programs as developed by the American Diabetes Association, and
only those duly certified to instruct in diabetes self-management, including
but not limited to:
1. The Arkansas State
Medical Board;
2. The Arkansas
Board of Podiatric Medicine;
3. The
Arkansas State Board of Optometry;
4. The Arkansas State Board of
Pharmacy;
5. The Arkansas State
Board of Nursing;
6. The Arkansas
State Board of Physical Therapy;
7.
The Arkansas Dietetics Licensing Board; and
8. Other Arkansas State licensing agencies,
boards or commissions for medical professionals.
E. DIABETES SELF-MANAGEMENT TRAINING means
instruction in an inpatient or outpatient setting, including medical nutrition
therapy,, relating to diet, caloric intake and diabetes management but
excluding programs the primary purposes of which are weight reduction. The
training is to enable diabetic patients to understand the diabetic management
process and daily management of diabetic therapy as a method of avoiding
frequent hospitalizations and complications when the instruction is provided in
accordance with a program in compliance with the National Standards for
Diabetes Self-Management Education Program developed by the American Diabetes
Association.
F. HEALTH CARE INSURER
under A.C.A. §
23-79-601
means any insurance company, fraternal benefit society, hospital and/or medical
services corporation, or health maintenance organization issuing or delivering
a health (disability) insurance policy subject to the Arkansas Insurance Code,
codified as Ark. Code Ann. §§
23-60-101, et
seq., or its successor laws; and in particular, the provisions of Ark. Code
Ann. §§
23-74-101,
et seq., as to fraternal benefit societies; and provisions of Ark. Code Ann.
§§
23-75-101,
et seq., as to hospital or medical service corporations; and the provisions of
Ark. Code Ann. §
23-76-101, et
seq. as to health maintenance organizations.
G. HEALTH INSURANCE POLICY means a group or
individual disability insurance policy, contract or plan which provides medical
coverage on an expense-incurred, service, or prepaid risk-sharing basis issued
by authorized stock and mutual insurers, authorized fraternal benefit
societies, authorized hospital or medical service corporations, and authorized
health maintenance organizations.
Section 6.
Coverage Mandated;
Limitations
A. Pursuant to Section 2
of Act 1249 of 1997, every individual and group health insurance policy as
defined in this Rule shall include coverage for one (1) per lifetime training
program per insured for diabetes self-management training, when medically
necessary. Training which is compensable under the policy may include one (1)
or more than one (1) visit from the physician or health care provider. The
diabetes self-management training which is compensable under the policy shall
include additional training sessions offered by the health care provider, as
prescribed by a physician, on grounds of medical necessity and when the
diabetic patient's condition changes or worsens upon a determination by that
physician that it is a significant change in the diabetic patient's
condition.
B. Any training for
diabetes self-management shall only be covered in the health care policy when
medically necessary as determined by a physician, and only if it is provided by
an appropriately licensed health care provider credentiaied as required by Act
1249 of 1997 and defined in Subsection (D) of Section 5 above. As to additional
requirements, the physician for the diabetic patient must be licensed under
Ark. Code Ann. §§
17-95-201,
et seq. The diabetes educator shall only provide diabetes self-management
training within his or her scope of practice after having demonstrated
expertise in diabetes care and treatment. The physician or diabetes educator
shall only provide such training after having completed an education training
program required by his or her licensing board when such program is in
compliance with the National Standards for Diabetes Self-Management Education
Program, developed by the American Diabetes Association. For the patient's
training to be compensable under the health care policy, the physician must
issue a written prescription ordering the training for the patient and/or the
patient's parent, spouse or legal guardian. For compensable coverage, the
training must be successfully completed by the diabetic patient and parent,
spouse or legal guardian; the health care provider must certify such successful
completion; and shall provide such written certification to the referring
physician and health care insurer providing the coverage.
A health care insurer is not required to pay benefits unless and
until the health care provider provides certification that the insured
individual has successfully completed the diabetes self-management training.
Additionally and to facilitate the payment of benefits due under this Rule,
health care insurers shall routinely obtain from all appropriate Arkansas State
Licensing Boards a list of licensed or certified health care professionals who
have demonstrated expertise in diabetes care and treatment and have completed
the educational program in compliance with the ADA program required by that
Arkansas State Licensing Board.
C. The coverage required under this Rule and
Act 1249 of 1997 shall be consistent with other benefits provided in the health
insurance policy and subject to all policy limitations, applicable deductibles;
coinsurance; other patient cost-sharing amounts or out-of pocket limits; as
well as referral, prior authorization or other utilization review requirements
or processes.
D. The provisions of
Act 1249 of 1997 and this Rule do not prohibit health care insurers from
selectively negotiating contracts with qualified providers of diabetes
self-management training programs, to the extent such contracts are not
inconsistent with this Rule.
E. The
health care insurers may legitimately exclude from coverage diabetes
self-management training, diabetes equipment, supplies and related services
which are not medically necessary for the treatment of Type 1, Type 2 or
gestational diabetes or other types; provided that such determinations are made
by the patient's licensed physician(s); and provided that such determinations
are consistent with Act 1249 of 1997 and this Rule, as well as other applicable
laws and rules and regulations; and provided that such determinations are not
at variance with generally accepted standards of the medical profession.
Nothing in this Rule shall be deemed to exclude or prohibit review and final
determination of a claim on appeal as provided by the applicable health
insurance policy or plan, after initial coverage determination on medical
necessity is made by a licensed physician as required by this Rule.
Section 7.
Standards for
Diabetes Self-Management Training
The diabetes education process for self-management training shall
include the following standards:
(1)
Needs Assessment. The health care provider shall conduct an
individualized educational needs assessment with the participation of the
patient, family, legal guardian, or support systems to be used in the
development of the educational plan and interventions. The educational needs
assessment shall include, but not be limited to, the following:
(A) Health history;
(B) Medical history;
(C) Previous use of medication;
(D) Diet history;
(E) Current mental health status;
(F) Use of health care delivery
systems;
(G) Life-style practices
such as occupation, education, financial status, social and cultural and
religious practices, health beliefs and attitudes or preventive
behaviors;
(H) Physical and
psychological factors including age, mobility, visual acuity, manual dexterity,
alertness, attention span, and ability to concentrate;
(I) Barriers to learning such as education,
literacy level, perceived learning needs, motivation to learn, and
attitude;
(J) Family and social
support; and
(K) Previous diabetes
education, including actual knowledge and skills.
(2)
Education Plan. The health
care provider shall develop a written education plan in collaboration with the
patient, his parent, spouse or legal guardian from information obtained in the
needs assessment, including the following:
(A)
Desired patient outcomes;
(B)
Measurable, behaviorally-stated learner objectives; and
(C) Instructional methods.
(3)
Education
Intervention. The health care provider shall create an educational
setting conducive to learning with adequate resources for space, teaching and
audio-visual aids to facilitate the educational process. The health care
provider shall use a planned content outline. The content outline shall be
provided based on the needs assessment, and may include:
(A) Diabetes pathophysiology;
(B) Stress and psychological
adjustment;
(C) Family involvement
in disease management;
(D) Medical
nutrition therapy as defined by the American Diabetes Association;
(E) Exercise and physical activity;
(F) Medications and insulin
administration;
(G) Blood glucose
monitoring and use of results;
(H)
Diabetes management which is the relationship between nutrition, exercise,
medication, and blood glucose levels;
(I) Prevention, detection, and treatment of
acute complications;
(J)
Prevention, detection and treatment of chronic complications;
(K) Foot, skin and dental care;
(L) Behavior change strategies, goal setting
risk factor reduction, and problem solving;
(M) Benefits, risks, and management options
for improving glucose control;
(N)
Uses of health care systems and community resources; and
(O) Preconception care, pregnancy and
gestationa! diabetes.
(4) Evaluation of Learner
Outcomes. The health care provider shall review and evaluate the degree to
which the person with diabetes is able to demonstrate diabetes seif-management
skills as identified by behavioral objectives.
(5)
Plan for Follow-up for Continuing
Learning Needs. The health care provider shall review the educational
plan and recommend any additional educational interventions to meet continuing
learning needs.
(6)
Documentation. The health care provider shall maintain written
files and shall thereby completely and accurately document the educational
experiences provided, and communicate such to the referring
physician.
Section 8.
Equipment, Supplies and Appliances
Health insurance policies shall provide coverage in accordance
with Section 6(c), for the equipment, supplies and services listed in this
section prescribed by an insured's physician licensed under Ark. Code Ann.
§§
17-19-201, et
seq., which are medically necessary for the treatment of diabetes mellitus,
including and not limited to Type 1, Type 2, and gestational diabetes.
(1) Blood glucose monitors, which include all
commercially available blood glucose monitors designed for patient use and for
persons who have been diagnosed with diabetes;
(2) Blood glucose monitors for the legally
blind, which include all commercially available blood glucose monitors designed
for patient use with adaptive devices and for persons who are legally blind and
have been diagnosed with diabetes;
(3) Test strips for glucose monitors, which
include all test strips approved by the Federal Food and Drug Administration,
glucose control solutions, lancet devices, and lancets for monitoring glycemic
control;
(4) Visual reading and
urine testing strips, which include visual reading strips for glucose, urine
testing strips for ketones, or urine test strips for both glucose and ketones.
Urine test strips for glucose only are not acceptable as the sole method of
monitoring;
(5) Insulin, which
includes all commercially available insulin preparations including insulin
analog preparations available in either vial or cartridge;
(6) Injection aids, which include devices
used to assist with insulin injection;
(7) Syringes, which include insulin syringes,
pen-like insulin injection devices, pen needles for pen-like insulin injection
devices;
(8) Insulin pumps as
prescribed by the physician and appurtenances thereto, which include insulin
infusion pumps and supplies such as skin preparations, adhesive supplies,
infusion sets, cartridges, batteries and other disposable supplies needed to
maintain insulin pump therapy. These include durable and disposable devices
used to assist in the injection of insulin;
(9) Oral agents for controlling the blood
sugar level, which are prescription drugs;
(10) Podiatric appliances for prevention of
complications associated with diabetes, which include therapeutic molded or
depth-inlay shoes, replacement inserts, preventive devices, and shoe
modifications for prevention and treatment; and
(11) Glucagon Emergency Kits and injectable
glucagon.
Section 9.
Penalties
Health care insurers who fail to comply with the provisions of
this Rule shall be subject to investigations and administrative proceedings and
penalties for trade practice violations enumerated in Ark. Code Ann.
§§
23-66-201, and following, and
other applicable laws and rules.
Section
10.
Severability
Any section or provision of this Rule held by a court to be
invalid or unconstitutional will not affect the validity of any other section
or provision of this Rule.
RULE AND REGULATION 70 DIABETES SELF-MANAGEMENT ACT OF
1997
Section 1.
Purpose
The purpose of this Regulation is to implement and coordinate
compliance with the Arkansas diabetes self-management benefits mandated for
inclusion in insurance and HMO policies and contracts under the provisions of
Arkansas Act 1249 of 1997, effective August 1, 1997, codified at Ark. Code Ann.
§§
23-79-601,
et seq.
Section 2.
Authority
This Rule is issued pursuant to the authority vested in the
Commissioner under Ark. Code Ann. §§
23-61-108 and
25-15-203,
Act 1249 of 1997, and other applicable provisions of Arkansas law as
amended.
Section 3.
Applicability and Scope
A.
APPLICATION.
(1) This Rule shall apply to
every disability (health) insurer, hospital or medical service corporation,
health maintenance organization ("HMO"), and fraternal benefit society licensed
by the Arkansas insurance Commissioner ("Commissioner"). This Rule applies to
group and individual policies or contracts issued on an expense-incurred,
service, or pre-paid risk-sharing basis by authorized licensees of the
Insurance Commissioner. This Rule shall be applicable to any health insurance
policy which is delivered, issued, issued for delivery, renewed, extended, or
modified in this State on and after the effective date of this Rule as adopted
by the Commissioner.
(2) This Rule
shall be applicable to a disability policy, or a health insurance policy
providing coverage or benefits to an Arkansas resident as expressly defined in
accordance with Act 1249 of 1997, in A.C.A. §
23-79-601(3),
whether the health care insurer or other entity which provides the coverage is
located within or outside the State of Arkansas or not; and the policy shall be
deemed to be delivered in this State within the meaning of Act 1249 of
1997.
B. EXCLUSIONS.
This Regulation shall not apply to disability income, specified disease,
Medicare Supplement, hospital indemnity, limited benefit or accident-only
policies. This Rule shall not apply to Champus supplement, long term care
plans, short-term nonrenewable individual health insurance (disability)
policies which expire after six (6) months, medical payments under homeowner or
automobile insurance policies, or to workers' compensation or employers'
liability insurance policies or contracts.
(M) Benefits, risks, and management options
for improving glucose control;
(N)
Uses of health care systems and community resources; and
(O) Preconception care, pregnancy and
gestational diabetes.
(4)
Evaluation of
Learner Outcomes. The health care provider shall review and evaluate the
degree to which the person with diabetes is able to demonstrate diabetes
self-management skills as identified by behavioral objectives.
(5)
Plan for Follow-up for Continuing
Learning Needs. The health care provider shall review the educational
plan and recommend any additional educational interventions to meet continuing
learning needs.
(6)
Documentation. The health care provider shall maintain written
files and shall thereby completely and accurately document the educational
experiences provided, and communicate such to the referring
physician.
Section 8.
Equipment, Supplies and
Appliances
Health insurance policies shall provide coverage in accordance
with Section 6(c), for the equipment, supplies and services listed in this
section prescribed by an insured's physician licensed under Ark. Code Ann.
§§ 17-49-95 -201, et seq., which are medically necessary for the
treatment of diabetes mellitus, including and not limited to Type 1, Type 2,
and gestational diabetes.
(1) Blood
glucose monitors, which include all commercially available blood glucose
monitors designed for patient use and for persons who have been diagnosed with
diabetes;
(2) Blood glucose
monitors for the legally blind, which include all commercially available blood
glucose monitors designed for patient use with adaptive devices and for persons
who are legally blind and have been diagnosed with diabetes;
(3) Test strips for glucose monitors, which
include all test strips approved by the Federal Food and Drug Administration,
glucose control solutions, lancet devices, and lancets for monitoring glycemic
control;
(4) Visual reading and
urine testing strips, which include visual reading strips for glucose, urine
testing strips for ketones, or urine test strips for both glucose and ketones.
Urine test strips for glucose only are not acceptable as the sole method of
monitoring;
(5) Insulin, which
includes all commercially available insulin preparations including insulin
analog preparations available in either vial or cartridge;
(6) Injection aids, which include devices
used to assist with insulin injection;
(7) Syringes, which include insulin syringes,
pen-like insulin injection devices, pen needles for pen-like insulin injection
devices;
(8) Insulin pumps as
prescribed by the physician and appurtenances thereto, which include insulin
infusion pumps and supplies such as skin preparations, adhesive supplies,
infusion sets, cartridges, batteries and other disposable supplies needed to
maintain insulin pump therapy. These include durable and disposable devices
used to assist in the injection of insulin;
(9) Oral agents for controlling the blood
sugar level, which are prescription drugs;
(10) Podiatric appliances for prevention of
complications associated with diabetes, which include therapeutic molded or
depth-inlay shoes, replacement inserts, preventive devices, and shoe
modifications for prevention and treatment; and
(11) Glucagon Emergency Kits and injectable
glucagon.
Section 9.
Penalties
Health care insurers who fail to comply with the provisions of
this Rule shall be subject to investigations and administrative proceedings and
penalties for trade practice violations enumerated in Ark. Code Ann.
§§
23-66-201, and following, and
other applicable laws and rules.