Current through Register Vol. 49, No. 9, September, 2024
RULES AND REGULATIONS
FOR
HEALTH MAINTENANCE ORGANIZATIONS
IN ARKANSAS
SECTION I.
AUTHORITY. The following Rules and Regulations for Health
Maintenance Organizations in Arkansas are duly adopted and promulgated by the
Arkansas Department of Health pursuant to the authority expressly conferred by
the laws of the State of Arkansas in Act 454 of 1975.
SECTION II
L PURPOSE. These
Rules and Regulations have been prepared for the purpose of establishing a
criterion for minimum standards for licensure and operation of Health
Maintenance Organizations in Arkansas that is consistent with current trends in
patient care practices. By necessity they are of a regulatory nature, but are
considered to be practical minimum design standards for these
entities/facilities. These standards are not static and are subject to periodic
revisions in the future as new knowledge and changes in patient care trends
become apparent. However, it is expected that Health Maintenance Organizations
will exceed these minimum requirements and that they will not be dependent upon
future revisions in these standards as a necessary prerequisite for improved
services. Health Maintenance Organizations have a strong moral responsibility
for providing a progressive preventive health program which assures that
adequate medical care is available and acceptable to all Enrollees.
These Rules and Regulations apply to certified Health
Maintenance Organizations, as well as to applicants for a Health Maintenance
Organization Certificate of Authority, and are promulgated to carry out Act 454
and to facilitate the full and uniform implementation, enforcement, and intent
of the Act.
These Rules and Regulations explain the requirements a Health
Maintenance Organization applicant must satisfy in order for the
Arkansas Department of Health to certify to the Arkansas Insurance
Department that the applicant's proposed plan of operation meets Arkansas
Department of Health requirements.
These Rules and Regulations are adopted in the best interest of
the public health, safety, and welfare. Compliance with these Rules and
Regulations in no way conveys assurance of the quality of patient care, but
rather provides the basic framework of capabilities required from which quality
patient care may evolve.
Persons in the process of developing a Health Maintenance
Organization shall periodically inform the Department of their developmental
activities and make use of Department technical advice and assistance.
SECTION III. DEFINITIONS. As used
in these Rules and Regulations, unless the content otherwise requires, the
words and terms defined in Section III inclusive, have the meanings ascribed to
them.
A. Act. Arkansas Act 454 of 1975, as
amended.
B.
Administrator.
The person responsible for the management of the Health Maintenance
Organization (HMO).
C. Case
Management. An activity which assists individuals in gaining and
coordinating access to necessary care and services appropriate to the needs of
the individual. It is the facilitation of health services including either
medical or ancillary health care resources for efficient and medically
appropriate ends for enrolled members. The activity is designed to achieve the
optimal patient outcome in the most cost-effective manner.
D.
Certificate of Authority. A
document issued by the Commissioner of the Arkansas Insurance Department
permitting one to establish, maintain, and operate an HMO.
E.
Commissioner. The
Commissioner of the Arkansas Insurance Department.
F.
Consumer. Solely for the
purpose of the composition of the Governing Body/Oversight Committee, is any
person other than a person (i)whose occupation involves, or before retirement
involved, the administration of health activities or the providing of Health
Care Services, (ii) who is, or ever was, employed by a health care facility as
a licensed Health Professional, or (iii) who has, or ever had, a direct,
substantial financial or managerial interest in the rendering of Health Care
Services other than the payment of a reasonable expense reimbursement or
compensation as a member of the board of an HMO.
G.
Credentials. Certificates,
diplomas, licenses, or other written documentation which establish proof of
training, education, and experience in a field of expertise.
H.
Department The Arkansas
Department of Health.
I.
Director. The Director of the Arkansas Department of
Health.
J.
Emergency Health
Care Services. Those Health Care Services which shall be available on a
twenty-four (24) hours per day, seven (7) days per week basis to evaluate and
treat medical conditions of a recent onset and severity, including, but not
limited to, severe pain that would lead a prudent lay person, possessing an
average knowledge of medicine and health, to believe that his or her condition,
sickness, or injury is of such a nature that failure to get immediate medical
care could result in (i) placing the patient's health in serious jeopardy;
(ii)serious impairment to bodily functions; or (iii) serious dysfunction of any
bodily organ or part.
K.
Enrollee. An individual who is contractually entitled to receive
covered Health Care Services from an HMO.
L.
Evidence of Coverage. Any
certificate, agreement, contract, identification card, or document issued to an
Enrollee setting out the coverage to which he/she is entitled.
M.
Health Care Plan. Any
arrangement whereby any person undertakes to provide, arrange for, pay for, or
reimburse any part of the cost of any Health Care Services, and at least part
of such arrangement consists of arranging for or the provision of Health Care
Services, as distinguished from mere indemnification against the cost of such
services, .on a prepaid basis through insurance or otherwise.
N.
Health Care Services. Any
services included in the furnishing to any individual of medical or dental
care, or hospitalization or incident to the furnishing of such care or
hospitalization, as well as the furnishing to any person of any and all other
services or goods for the purpose of preventing, alleviating, curing, or
healing human illness or injury.
O.
Health Maintenance Organization (HMO). Any person who undertakes
to provide or arrange for one or more Health Care Plans under the
Act.
P.
Health Professional.
Individuals engaged in the delivery of Health Care Services as are or
may be designated under U. S. Public Law 93-222, same being the Health
Maintenance Organization Act of 1973 or any amendment thereto or regulation
adopted thereunder.
Q.
Hospital. As defined in the currently certified Rules
and Regulations for Hospitals and Related Institutions in Arkansas
as promulgated by the Arkansas Department of Health.
R.
Inpatient Medical Care, Shall
include, but not be limited to medical and surgical care received in a hospital
or skilled nursing environment.
S.
Limited Benefit HMO. An HMO that elects to provide or arrange for
the provision of one (1) Health Care Service (e.g. dental, mental health,
vision, etc.) to its Enrollees. The limited benefit shall be the only type of
benefit offered to Enrollees under its Health Care Plan. An HMO certified in
this category shall comply with all applicable provisions of these Rules and
Regulations.
T.
Medical
Director. A physician (M.D. or D.O.) licensed to practice in the State
of Arkansas. The Medical Director shall provide medical direction of the HMO's
health care activities and consultation for and medical supervision of the
medical staff of a Staff Model HMO.
U.
Outpatient Services. Those
covered services which may be rendered in, but are not limited to, clinics,
home health services, hospices, kidney dialysis centers, private offices,
pharmacies, and hospital-based outpatient services, as a minimum, and may also
include, but are not limited to outpatient surgery centers and radiation
therapy centers.
V.
Peer
Review. A review of the decisions and actions by one's peers within the
organizational structure of the HMO.
W.
Person. Any natural or
artificial person including, but not limited to individuals, partnerships,
associations, trusts, or corporations.
X.
Pharmacy. A facility which
possesses the appropriate permit from the Arkansas State Board of
Pharmacy.
Y.
Physical Plant.
The physical building, equipment, and fixtures of a Staff Model HMO. It
shall include, but not be limited to environment, electrical services, plumbing
services, water supply and disposal, infection control, and waste
disposal.
Z.
Preventive
Health Services. Services designed to maintain an individual in optimum
health and to prevent unnecessary injury, illness, or disability.
AA
Primary Care Physician. A
physician who supervises, coordinates, and provides initial and basic care to
Enrollees; initiates their referral for specialty care; and maintains the
continuity of patient care. The care of episodic illness alone does not
constitute the role of a Primary Care Physician.
BB. Private Review Agency. Any entity
certified by the Department under Act 537 of 1989 performing utilization review
that is either affiliated with, under contract with, or acting on behalf of an
Arkansas business entity or a third party that provides or administers .
hospital and medical benefits to citizens of Arkansas including an HMO or any
entity offering health insurance policies, contracts, or benefits in this State
including a health insurer, non-profit health service plan, health insurance
organization, preferred Provider organization, or managed care
organization.
CC. Provider. Any
person who is licensed in this State to furnish Health Care Services as a
Health Professional.
DD.
Quality Assurance Systems. The planned and systematic management
actions which assure the consistent rendering of high quality Health Care
Services through the use of monitoring techniques.
EE. Retrospective Review. A mechanism to
review medical necessity and appropriateness of medical services through
compilation and analysis of data after medical care is rendered which includes,
but is not limited to the comparison of Provider practice patterns with
parameters established by the utilization review committee, recommendations of
changes in Provider practice patterns based on analysis and review, and
analyzation of care to Enrollees.
FF. Service Area. The geographic area as
defined by county boundaries authorized by the Certificate of
Authority.
GG.
Staff Model
HMO. An HMO that provides any of its Health Care Services through
physicians and other Health Professionals who work in centralized health
centers as salaried or paid employees (staff) of the HMO and where the Health
Care Service is provided at a health center owned or leased by the HMO. It
shall include a described Physical Plant.
HH.
Utilization Review
Plan. A system for the formal assessment of medical necessity,
efficiency, and/or appropriateness of Health Care Services and treatment plans
on a prospective, concurrent, or retrospective basis.
SECTION IV. LICENSURE. No person shall
perform any of the services or procedures or sell or dispense any goods or
devices in the field of the healing arts for which a license is required under
the laws of the State of Arkansas unless such person holds a valid license
authorizing him or her to perform said procedures or render such services or
dispense such good or devices. A valid license is a license from Arkansas or
from the state where the services are provided. Except for ambulatory care
facilities not required to be licensed by the State of Arkansas, the HMO shall
utilize only health care facilities that hold a valid license or are certified
as a Provider or supplier for Medicare, Medicaid, or CLIA (Clinical Laboratory
Improvement Amendments of 198S).
SECTION
V. GENERAL REQUIREMENTS
A. The
HMO shall provide and/or arrange for the provision of Health Care Services
which assure theEnroIlees adequate medical care which is available, accessible,
and continuous in accordance with the Enrollee's Plan. Assurances of
availability, accessibility, and continuity shall demonstrate the following:
1. Health Care Services for which Enrollees
have contracted shall be provided or arranged for by the HMO;
2. Facilities and personnel, both
professional and non-professional, adequate (within generally accepted norms)
to make these Health Care Services available to Enrollees can and shall be
secured and maintained;
3. These
Health Care Services shall be provided at hours convenient to and adequate to
meet the needs of Enrollees, including provision or arrangement for 24-hour
emergency service. The average waiting time for appointments or to receive
services shall be reasonable;
4.
The location of facilities and proximity shall enhance accessibility of service
to the reasonably anticipated Enrollees, including aged and persons with
disabilities;
5. Owned facilities
and/or leased facilities of a Staff Model HMO shall not present architectural
barriers to the aged or to persons with disabilities;
6. For initial Staff Model HMO applicants,
plans and resources, both current and reasonably anticipated, drawings and
specifications (if applicable), and other materials shall be required, in
addition to other requirements of these Rules and Regulations;
7. Continuity of service to Enrollees shall
be enhanced by provision of a means for ensuring that Enrollees receive the
proper level and type of care and that the provision of services is coordinated
both within and outside the HMO.
B. There shall be a progressive preventive
health program which shall be developed according to the prevailing health
factors predominant in the Enrollee population. This program shall include, but
not be limited to health evaluation, education, and immunization. The program
shall be designed to prevent illness and disease and to improve the general
health of the HMO Enrollees.
SECTION
VI.
ISSUANCE OF CERTIFICATE OF AUTHORITY.
A. Upon receipt of an application for
issuance of a Certificate of Authority, the Commissioner .shall transmit,
copies of the application and accompanying documents to the Director. The
Director shall determine whether the applicant meets the
requirements with respect to Health Care Services to be furnished for receipt
of a Certificate of Authority.
B. If the Director determines that the HMO
does not meet such requirements, he shall specify in what respects it is
deficient. A request shall be sent in writing to the applicant stating
specifically what information is needed. A copy of the request shall be sent to
the Commissioner. However, the Director shall not certify to the Commissioner
that such requirements are not met unless the proposed HMO has been given the
opportunity to comment on the proposed findings of the deficiency or to furnish
the required information. If requested by the proposed HMO, the Director shall
hold a hearing on the finding of deficiency.
C. These requirements shall also apply to
applications and/or requests for amendments to the Certificate of Authority of
an operational HMO.
SECTION
VII.
CONTENT OF APPLICATION FOR CERTIFICATE OF
AUTHORITY.
A. No person shall operate
an HMO without first obtaining a Certificate of Authority from the
Commissioner.
B. In addition to the
requirements of the Commissioner, an application for a Certificate of Authority
shall include, at a minimum:
1. Copies of the
basic organizational documents such as certificates of incorporation, bylaws,
rules, articles of association, partnership agreement, trust agreement, or
other applicable documents and agreements relating to the conduct of the
internal affairs of the applicant and all amendments thereto;
2. A list of the names and addresses and
official positions of the members of the board of directors, officers,
controlling persons, owners, or partners, the Medical Director, and the
Administrator of the proposed HMO;
3. A curriculum vita and/or resume of the
Administrator and the Medical Director,
4. A detailed description of the proposed
HMO's potential ability to assure both the availability and accessibility of
adequate personnel and facilities to serve Enrollees in a manner enhancing
availability, accessibility, and continuity;
5. A description of the service area of the
proposed HMO (geographic boundaries and demographic data);
6. Information regarding proposed
administrative site locations and hours of operation;
7. Listing of Providers who have signed
contracts and/or letters of intent to contract;
8. A list of Health Care Services to be
provided or arranged for by the HMO;
9. A copy of the applicant's proposed form of
evidence of coverage to be issued to Enrollees, setting forth the HMO's
contractual obligation to provide and/or arrange for the provision of Health
Care Services;
10. A form of the
applicant's Provider contracts;
11.
A detailed description of the applicant's program for Preventive Health
Services;
12. A detailed
description of the applicant's proposed grievance resolution system whereby the
complaints of the Enrollees may be acted upon promptly and in a reasonable
manner,
13. A detailed description
of the applicant's ongoing quality assurance/improvement program;
14. A detailed description of the applicant's
capability to collect and analyze necessary data relating to the utilization of
Health Care Services;
15. Job
descriptions for the Administrator, Medical Director, and senior
personnel;
16. A procedure for the
referral of Enrollees to nonparticipating Providers, when not otherwise
available or appropriate under the circumstances;
17. A copy of the written procedures for
provision and payment of Emergency Health Care Services;
18. A detailed description of how medical
records will be maintained for administrative purposes within the
HMO;
19. For a Staff Model HMO, an
organizational chart demonstrating the delegation of authority and control of
the Health Care Services delivery system, from the highest authority to the
physician, with support documentation exhibiting all personnel at each-level of
authority have requisite expertise for their particular area of
authority;
20. For a Staff Model
HMO, a statement of the number and qualifications of all support staff employed
directly by the HMO (i.e. registered nurses, practical nurses, mid-level
practitioners, medical social service personnel, medical records personnel,
pharmacists, physical therapists, speech pathologists, physicians,
etc.);
21. Any other pertinent
information, as designated by the Director, and as required by other sections
of these Rules and Regulations.
SECTION VIII
ORGANIZATION.
A. The Health Maintenance Organization shall
be organized in a manner which demonstrates that it has
theIegal,,quaIifications,.authority, and ability to assure that Health Care
Services will be provided. For covered services, the HMO shall provide and/or
arrange for the provision of:
1. Emergency
Health Care Services;
2. Inpatient
Hospital and medical-surgical care;
3. Outpatient services;
4. Preventive Health Services and health
education services.
These services are provided for the purposes of preventing,
alleviating, curing, or healing human illness or injury.
B. Those persons legally
responsible for the operation of the HMO shall provide the following:
1. A copy of the agreement, contract, or
policy which the HMO proposes to issue to Enrollees which describes the scope
of Health Care Services it renders, as permitted by law, to Enrollees either
directly by a Provider staff or through arrangement with other,
2. The names of all Providers (giving their
license number), business address, specialty where applicable (board
certification or eligibility), and medical or Hospital staff privileges at
Hospitals used, or by which the HMO has a contractual arrangement, and the
maintenance of a listing of this information;
3. The appointment of a fiill-time
Administrator,
4. The appointment
of a Medical Director. The position may be either full-time or part-time in
accordance with the demands of the office. The Medical Director may serve as
the chief of the medical staff of a StaffModel HMO. A Staff Model HMO shall
formulate medical staff bylaws, rules, regulations, or other appropriate means
to include provisions for the delivery of Health Care Services by physicians
and Providers, licensed or duly authorized to practice in the State of
Arkansas. Other Providers, as required, to support the medical staff shall be
available in order to assure that the Enrollee receives Health Care Services
with continuity and without unreasonable periods of delay;
5. An ongoing quality assurance/improvement
program;
6. Assurance that files
are maintained to include current contracts for all participating physicians
and Providers;
C. Those
persons legally responsible for the overall operation of the HMO shall have
responsibilities which include, but are not limited to:
1. Adoption and enforcement of all policies
governing the HMO's management of Health Care Services delivery, quality
assurance/improvement, and utilization review programs including at least
annual meetings for the purpose of evaluation and improvement of the Health
Care Services of the HMO and to react to recommendations and/or findings of the
quality assurance/improvement committee. Records, as well as minutes of
meetings shall be maintained;
2.
Authority to employ and terminate the Administrator and Medical
Director,
3. Adoption of the HMO's
procedures for maintenance and control of all books, records, and audits which
are related to its operation;
4.
Assurance that the HMO's Administrator is performing the duties of that
position;
5. Assurance that the
HMO's Medical Director is performing the duties of that position and in a
manner that results in operation of a quality assurance/improvement program
that is effective and otherwise in compliance with the requirements of these
Rules and Regulations;
6. Adoption
of policies and procedures regarding the delivery of Health Care Services to
Enrollees;
7. Provision of
reasonable access by the Medical Director; and
8. Assurance that the HMO complies with
applicable laws and regulations.
D. The HMO shall be organized to accomplish
its stated mission which shall include, as a minimum, provision of or arranging
for the provision of Health Care Services.
E. The HMO shall possess organizational and
administrative capacity to provide or arrange for the provision of Health Care
Services and the ability to monitor the provision of such services.
SECTION IX. GOVERNING BODY.
A. The governing body and/or oversight
committee of any HMO shall include at least one (1) physician, one (1) dentist,
one (1) pharmacist, and one (1) nurse, all of whom shall be... licensed in the
State of Arkansas; and one (1) Enrollee and one (1) Consumer. These members of
the governing body and/or oversight committee shall also be residents of the
State of Arkansas.
B. Such
governing body/oversight committee shall establish a mechanism to afford
Enrollees an opportunity to participate in matters of policy operation through
the establishment of advisory panels, by the use of advisory referenda on major
policy decisions, or through the use of other mechanisms approved by the
Director.
SECTION X.
FACILITIES AND ENVIRONMENT.
A.
Facilities owned and/or operated by the Health Maintenance
Organization.1. There shall be a
described Physical Plant for all such facilities.
2. There shall be sufficient equipment and
supplies for examination, diagnosis, and treatment in accordance with Enrollee
contracts.
3. There shall be a
listing which shall include the name and location of the facility or facilities
other than the main service location, if any, enumerating the services offered
at each facility location and the service hours, including evenings and
holidays. The lists shall be available to the Director and the
Enrollees.
4. Such facilities shall
comply with the applicable parts of the Physical Environment Section,
Outpatient Facilities, of the currently certified Rules
and Regulations for Hospitals and Related Institutions, as
promulgated by the Department.
5.
The Physical Plant shall comply with all applicable provisions of state and
local fire safety, plumbing, and building codes.
B.
Contracted Providers of Services.
If all or part of the HMO services are to be performed by contract with
Providers of service, the following shall apply:
1. All Providers of service shall be licensed
or registered according to applicable state and local laws;
2. All contracted services shall be clearly
identifiable.
Any major changes in the scope of services to be offered to
Enrollees shall be approved by the Director. Notification of changes shall be
forwarded to the Director at least one month in advance of their anticipated
implementation.
SECTION XI.
SERVICES. The
requirements of this Section are applicable to the categories of services
listed as available under the Health Care Plan. The HMO may wish to provide
such services directly or arrange for their provision according to the specific
requirements of the Plan. Outside resources with which a Staff Model HMO
contracts shall be approved by the Director.
A.
Emergency Health Care Services.
Policies and procedures shall be developed pertaining to Emergency
Health Care Services to include after-office-hour Provider services. Such
policies shall include the conditions for which an Enrollee should seek
immediate assistance prior to contacting the HMO, in order to minimize the time
for treatment in critical and/or urgent situations. All Enrollees shall have
access to an HMO staff or an HMO contracted physician licensed to practice in
the State of Arkansas. A physician shall be available at least by telephone on
a twenty-four (24) hour basis, seven (7) days a week to respond to urgent calls
from Enrollees. Emergency Health Care Services shall be available without
restrictions as to where the services are provided. Physicians and Providers of
care which employ triage nurses and/or mid-level practitioners to assess the
health care needs of Enrollees shall also have policies in effect which
describe the exact duties of the involved professionals.
B.
Primary Care Physician Services.
Policies and procedures shall be developed pertaining to Primary Care
Physician Services. There shall be a sufficient number of participating Primary
Care Physicians to meet the needs of the enrolled membership. Such policies
shall include requirements that an adequate number of Primary Care Physicians
have admitting privileges and/or a referral arrangement at one or more
participating Hospitals located within the HMO's Service Area to assure that
necessary admissions are made. Such policies shall also meet the above
requirements for the provision of Emergency Health Care Services and after hour
access. The method by which Enrollees may secure Health Care Services after
hours shall be clearly communicated in writing to Enrollees.
C.
Inpatient Hospital and Medical Care.
An agreement with at least one Hospital shall be obtained by the HMO to
assure immediate access to covered Hospital Health Care Services as needed. In
counties where there is no licensed Hospital, the Director will give
consideration to contracted facilities within the Service Area of the HMO to
meet requirements of availability, accessibility, and continuity. Inpatient
Hospital care shall be available and accessible twenty-four (24) hours a day,
seven (7) days a week within the HMO's defined geographical Service Area.
Hospitals which provide services shall be currently licensed by the Arkansas
Department of Health.
D.
Outpatient Services. Ambulatory Outpatient Services shall be
provided. These services shall, as a minimum, include an ongoing preventive
health program.
E.
Diagnostic
Laboratory Services. Each HMO shall have available diagnostic laboratory
services commensurate with the needs of its Enrollees. Each laboratory shall
possess a current Clinical Laboratory Improvement Amendments of 1988 (CLIA)
certificate authorizing the performance of testing. The use of outside
reference laboratories and/or accredited laboratories shall meet this
requirement. All laboratory services shall meet the non-emergent, urgent, and
emergency needs of Enrollees. Reference laboratory specimen services shall be
convenient to Provider physicians through the strategic location of drawing
stations or through a courier service which is under the management of the
reference laboratory. Staff Model HMOs shall provide and/or arrange for the
provision of laboratory services in clinical chemistry, pathology,
microbiology, hematology, serology, and urinalysis.
F.
Diagnostic Imaging.
Diagnostic imaging services shall be available and accessible to all
Enrollees. Those procedures that require the injection/ingestion of radiopaque
chemicals shall be performed only underthe supervision of physicians qualified
to perform such procedures. Diagnostic imaging machines shall be registered and
inspected in accordance with Arkansas State law. Personnel who work with
imaging machines shall comply with State law regarding monitoring.
G.
Pharmacy Services. Pharmacy
services shall be available and accessible within the Service Area of the HMO
to Enrollees. Pharmacy services shall be offered directly by the HMO or
through- contracts with pharmacies licensed by the Arkansas State Board of
Pharmacy. The plan of pharmacy services provided by the HMO shall be under the
supervision of the Director of Pharmacy Services and shall assure quality of
and accessibility to pharmacy services. The plan shall include an acceptable
drug utilization review and claims processing system. If a Staff Model HMO has
a pharmacy department, a licensed pharmacist with a permit from the Arkansas
State Board of Pharmacy shall be employed to administer the pharmacy in
accordance with all State and Federal laws regarding drugs and drug control The
pharmacy director shall develop policies and procedures for administration of
the pharmacy department. There shall be a committee composed of physician(s),
pharmacist(s), and other professionals needed to regularly review the quality
of pharmacy services of the HMO.
1. The
committee shall be responsible for assuring that drug utilization review is
performed on a regular basis, but no less frequently than quarterly.
2. The committee shall assure that
contracting pharmacies maintain medication profiles on the Enrollees and
utilize such profiles to detect inappropriate medication use.
3. The committee shall make recommendations
on policies under which pharmacists provide pharmacy care to
Enrollees.
H.
Home
Health Care. If home health care is covered, it shall be available and
accessible within the Service Area of the HMO to Enrollees. This service may be
offered through home health agencies and their branches or sub-ofEces, which
are licensed by the State. Home health care may be provided directly by the HMO
or through contracts. Hospices shall be appropriately licensed.
I.
Nursing Home Care. If nursing
home care is covered, it shall be available and accessible within the Service
Area to the enrolled population by one or a combination of the following
facilities:
1. A skilled nursing home that is
licensed by the State and certified by Medicare or Medicaid or both;
2. A Hospital with swing-beds that is
licensed by the State and certified by Medicare;
3. A Hospital licensed by the State, a
distinct part of which is a skilled nursing facility. Nursing home care may be
provided by facilities owned and operated by the HMO or by contract.
J.
Other Services.
Other covered services shall be in accordance with those specified in
the Health Care Plan. If Health Care Services such as dental, podiatric,
nutrition/dietary, vision, hearing, speech, durable medical equipment, mental
health, drug dependency, chiropractic care, or others not listed are offered,
they shall be provided directly by the HMO or through contracts with Providers
or physicians who hold a valid license or are otherwise allowed to practice in
the State of Arkansas. Such services shall be of sufficient number and
locations and as approved by the Director to be readily available and
accessible to Enrollees. ............ .........
SECTION XII
PROFESSIONAL
STAFFING.
A. An HMO shall have
sufficient numbers of physicians and other Health Professionals, either as
employees or by contract, to adequately cover the health care needs of
Enrollees.
B. There shall be
established a credentials committee charged with the responsibility of
reviewing each physician and other Health Professionals, as established by the
policies and procedures of the HMO, to determine that the Health Professionals
are properly credentialed in Arkansas. This committee shall conduct reviews of
said personnel at intervals necessary to assure appropriate licensure and
certification.
C. In addition to
other requirements, the Medical Director of the HMO shall be involved in the
implementation of protocols for the credentials committee, protocols for
quality assurance, and programs for continuing education for Health
Professionals.
D. The HMO shall
define procedures for taking corrective action against any Provider whose
conduct is detrimental to public safety or the delivery of care, or disruptive
to the operation of the HMO.
SECTION
XIII.
MEDICAL RECORDS.
A. The HMO shall maintain or cause the
Provider to maintain an active record for each Enrollee who receives Health
Care Services. This record shall be kept current, complete, legible, and
available to the medical and administrative staff of the HMO and to the
Department's representatives. The HMO shall have policies and procedures, as
related to medical records, for the review of physicians and other Providers.
The policies and procedures shall address, at a minimum, the retention,
security, storage, confidentiality, transfer, release, and destruction of
medical record information.
B. Each
medical record shall contain sufficient information and data to support
diagnosis, plan of treatment, and other pertinent medical information such as
medical history, progress notes, and other related reports.
C. The HMO shall require that each entry be
indelibly added to the Enrollee's record, dated, and signed or initialed by the
person making the entry. The HMO shall require each Provider site to have a
means of identifying the name and professional title of the individual who
makes the entry.
D. The medical
record for each Enrollee who has had a routine, scheduled appointment with one
of the HMO's Providers shall include basic information collected; as a minimum,
identification of the Enrollee, patient history, known past surgical
procedures, known past and current diagnoses and problems, and known allergies
and untoward reactions to drugs.
E.
The HMO shall require that the medical records for each Enrollee who receives
Health Care Services include the following information regarding each episode
of care:
1. Reason for the
encounter,
2. Evidence of the
Provider's assessment of the Enrollee's health problems;
3. Current diagnosis of the Enrollee,
including the results of any diagnostic testing;
4. Plan of treatment, including any therapies
and health education; and
5.
Medical history relevant to the current episode of care if not available as
Part D above.
F. The HMO
shall require each Provider site to document that all outcomes of ancillary
reports, such as laboratory tests and x-rays have been reviewed by the Provider
who requested the reports. The HMO shall require each Provider site to document
that follow-up actions have been taken regarding report results that are deemed
significant by the Provider who requested the report.
G. Arrangements shall be made for the sharing
of pertinent medical records among Providers participating in the HMO and for
maintenance by the HMO when needed for committee reviews. In all cases, the
confidentiality of the record shall be assured.
SECTION XIV. ENROLLEE RIGHTS.
A Health Maintenance Organization shall develop and adhere to
written policies and procedures informing Enrollees of at least the following
rights:
A. An Enrollee has the right
to timely and effective redress of grievances through a system established by
the HMO in a complaint/grievance program;
B. An Enrollee has the right to obtain
current information concerning a diagnosis, treatment, and prognosis from a
physician or other Provider in terms the Enrollee can be reasonably expected to
understand. When it is not advisable to give such information to the Enrollee,
this information shall be made available to an appropriate person on the
Enrollee's behalf;
C. An Enrollee
has the right to be given the name, professional title, and function of any
personnel providing Health Care Services to him/her;
D. An Enrollee has the right to give his/her
informed consent before the start of any surgical -procedure or
treatment;
E. An Enrollee has the
right to refuse any medications, treatment, or other procedure offered to
him/her by the HMO or its Providers to the extent provided by law and to be
informed by a physician of the medical consequences of the Enrollee's refusal
of any medications, treatments, or procedures;
F. An Enrollee has the right to obtain
Emergency Health Care Services without unnecessary delay,
G. An Enrollee has the right to have all
records pertaining to his/her medical care treated as confidential unless
disclosure is otherwise permitted by law,
H. An Enrollee has the right to information
in his/her medical records, consistent with state law. Nothing is these
regulations shall prohibit a Provider from charging for copies of the
information, also consistent with state law;
I. An Enrollee has the right to be advised if
a health care facility or any of the Providers participating in his/her care
propose to engage in or perform human experimentation or research affecting
his/her care or treatment. An Enrollee or legally responsible party on his/her
behalf may, at any time, refuse to participate or to continue in any
experimentation or research program to which he/she had previously given
informed consent;
J. An Enrollee
has the right to be informed of these rights listed in this Section;
and
K. No HMO may, in any event,
cancel or refuse to renew an Enrollee solely on the basis of the health of an
Enrollee.
SECTION XV.
STATISTICAL INFORMATION.
There shall be a procedure for the HMO to compile, develop,
evaluate, and report, as may be requested and in the form indicated by the
Director, statistics relating to the cost ofoperation, the pattern of
utilization of services, and the availability and accessibility of services.
Sufficient information shall be maintained to support continuity and adequate
quality of care to Enrollees.
A. Each
membership file shall include, as a minimum:
1. Name of the individual and if other than
the individual, also the name and address of the Enrollee;
2. Individual's identification
number,
3. Date of birth;
4. Sex;
5. Effective date;
6. Termination date and reason(s);
7. Date of most recent verification of
information; and
8. Such other
information as the Commissioner and Director may require.
B. Service area demographic characteristics
which include the age, sex, and the geographic residence of Enrollees, and the
number of Enrollees terminated during each one year period shall be available
to the Department;
C. The HMO shall
compile the number of medical services encounters, the number of Inpatient
Medical Care encounters, and the number of direct ambulatory encounters for
Enrollees for each one year period. The information shall be available to the
Department as may be requested, and in the form indicated by the Director.
1. Medical services shall mean those services
provided for the prevention, diagnosis, treatment, and rehabilitation of
physical illness by Health Professionals.
2. Direct ambulatory encounters shall mean
face-to-face contacts between patients not confined to a health care
institution and a Health Professional employed actively and directly by the
HMO, or by contract, who exercises independent judgment in the care and
provision of Health Care Services to the patient. The term "independent" is
used to distinguish between Health Professionals who assume major
responsibility for the care of individual Enrollees and all other personnel who
assist in providing that care.
D. Enrollee surveys and comments, as well as
other materials shall be made available to the Director;
E. Each HMO shall annually, on or before the
first day of March, file a report, verified by at least two principal officers
of the HMO, with the Commissioner, with a copy to the Director, covering the
previous calendar year. It shall include a summary of the statistical
information required. Interim reports may be required by the
Director.
SECTION XVI.
COMPLAINT/GRIEVANCE SYSTEM.
A.
Each HMO shall establish and maintain a complaint/grievance system approved by
the Commissioner, afterconsultation with the Director, to provide reasonable
procedures for the resolution of complaints and grievances initiated by
Enrollees concerning Health Care Services.
B. Each HMO shall provide a designated
position/title with a designated telephone number and address for receiving
oral and written complaints and inquiries concerning complaints and for
assisting the Enrollee.
1. Oral complaints
and inquiries regarding complaints shall be entered into a written or automated
record.
2. Enrollees with
complaints which are not resolved shall be informed of the written grievance
procedure. Any oral complaint which cannot be resolved informally shall be
presented in writing before it can be considered a formal grievance.
C. Each HMO shall have a written
grievance procedure for prompt and effective resolution of Enrollee grievances.
The grievance procedure shall include, as a minimum, assisting the Enrollee
with filing the grievance and the following elements:
1. There shall be an initial level of
investigation and review of any grievance;
2. The initial review shall provide the
opportunity for the Enrollee and any other party of interest to present data
pertinent to the grievance;
3. The
decision of the initial review shall be binding unless the Enrollee appeals the
decision in writing;
4. The
Enrollee shall be notified in writing of the decisions. If the outcome is
adverse to the Enrollee, the written notice shall include specific findings
related to the grievance, the reason(s) for denial, and the right of the
Enrollee to appeal to a second level.
D. An Enrollee shall have the right to appeal
a decision of the initial review to a second level review committee.
1. The second level of review shall be
conducted by a committee established by the HMO.
2. The second level review committee shall
have written procedures for investigating grievances and for utilizing informed
consultants to resolve grievances.
3. The Enrollee shall be notified in writing
of the decision of the second level review. If the outcome is adverse to the
Enrollee, the written notice shall include the specific findings Related to the
decision, the reason(s) for denial, and the right of the Enrollee to appeal the
decision of the second level review committee to the Commissioner or
Director.
E. The HMO
shall specify time limits for receipt and disposition of grievances at each
level of review. The time frame for each level shall not exceed thirty (30)
days unless the HMO provides documentation for justification of a longer time
frame.
F. The HMO shall include a
description of the complaint/grievance system in the Enrollee Evidence of
Coverage.
G. At any stage of the
grievance process, at the request of the Enrollee, the HMO may appoint a member
of its staf£ who has no direct involvement in the case, to assist the
Enrollee. An Enrollee presenting a grievance shall be specifically notified of
his/her right to have such a staff member appointed for assistance.
H. Each HMO shall submit to the Commissioner
and the Director an annual report which shall include:
1. A description of the procedures of such
grievance/appeals system;
2. The
total number of grievances/appeals handled through such grievance/appeals
system and a compilation of the causes underlying those filed;
3. For a StafFModel HMO, the number, amount,
and disposition of malpractice claims settled during the year by the HMO and
any of the Providers utilized by it;
4. A summary of the disposition of
grievances/appeals; (the copy to the Director shall also include a summary of
the processing times as an addendum), and
5. Any such other information as reasonably
required by the Commissioner or Director pursuant to these Rules and
Regulations.
I. The
Commissioner or Director may examine such grievance/appeals system subject to
limitations concerning medical records of Enroilees. J. The Director shall
investigate each complaint filed with the Department concerning Health Care
Services of an HMO or its Providers.
SECTION XVII
UTILIZATION
REVIEW.
A. Each HMO shall develop a
Utilization Review Plan that includes:
1. A
description of review standards and procedures to be used in evaluating
proposed, ongoing, or delivered hospital and outpatient medical
services;
2. The provisions by
which patients, physicians, or hospitals may seek reconsideration or appeal of
adverse decisions;
3. The type,
qualifications, and oversight of the personnel performing utilization review
and case management;
4. The
policies and procedures to insure that a utilization review representative is
reasonably accessible to patients and Providers five (5) days a week during
normal business hours in Arkansas;
5. The policies and procedures to insure that
all applicable state and federal laws to protect the confidentiality of
individual medical records are followed;
6. Compliance with all relevant provisions of
rules and regulations promulgated pursuant to Act 537 of 1989.
B. If a private review agent
performs the utilization review, that entity shall meet the requirements of Act
537 of 1989 and rules and regulations promulgated pursuant to same
Act.
SECTION XVIII.
QUALITY ASSURANCE/IMPROVEMENT SYSTEMS.
A. Each
HMO shall develop and implement a quality assurance/improvement (QA/I) program
.....subject to approval by_theDirector.. The program.shall include amethod
foranalyzing the outcomes of health care, peer review, the collection of health
care data, and appropriate recommendations for remedial action. It shall
include organizational arrangements and ongoing procedures for the
identification, evaluation, intervention, and follow-up of potential and actual
problems in health care administration and delivery to Enrollees.
B. The QA/I organizational arrangements and
ongoing procedures shall be fully described in written form, and a summary
provided to all members of the governing body, Providers, and staf£ and
made available, upon request, to Enrollees of the HMO. This written program
shall be clearly defined and transmitted to all individuals involved in the
QA/I program and shall include, but not be limited to, the following:
1. Provision for necessary staff to implement
the program and evaluate the effectiveness of the program;
2. Formation of a QA/I committee responsible
for QA/I activities and utilization review activities;
3. Requirements of responsibility for all
QA/I activities conducted by the HMO or for activities delegated to another
entity;
4. Accountability of the
committee to the Administrator and to the persons legally responsible for the
operation of the HMO including written and oral reports related to the
continuity and effectiveness of the program and any findings of the committee,
with recommended actions as needed to improve the program.
C. As a minimum, studies undertaken, results,
subsequent actions, and aggregate data on utilization and quality of services
rendered to Enrollees shall be compiled.
D. There shall be participation, supervised
by the Medical Director, of Providers and support staff appropriate to the
current QA/I studies.
E. Minutes or
records of the QA/I committee shall be maintained.
F. The QA/I procedures shall include defined
methods for the identification and selection of clinical and administrative
problems. Input for problem identification shall come from multiple sources
including, but not limited to, medical chart reviews, Enrollee complaints,
utilization review, Enrollee assessment audits, and HMO services. Methods shall
be established by which potential problems are selected and scheduled for
further study.
G. Each HMO shall
document the manner by which it examines actual and potential problems in
health care administration and delivery.
H. The QA/I activities shall include the
development of recommendations that are timely and appropriate for problems
that are identified, and the HMO shall demonstrate an operational mechanism for
responding to those problems.
I.
There shall be evidence of adequate follow-up on recommendations and such
follow-up shall meet the standards of the currently approved QA/I plan of the
HMO. J. Review of quality of care shall not be limited to technical aspects of
care alone, but shall also include availability, accessibility, and continuity
of care provided to Enrollees. K. The QA/I program shall include written
guidelines which set forth the procedures for remedial actions when problems
related to quality of care are identified. The guidelines shall include:
1. A listing of the types of problems which
require remedial action;
2.
Specific remedial actions required, with time frames within which Providers of
health care must comply, withsuchremedial actions;
3. The procedures used to assess the
effectiveness of any remedial action;
4. Procedures utilized by the HMO if remedial
actions are not implemented as required, to include specific procedures for
terminating an affiliation with a physician or other health care
Provider.
L. All records
and minutes shall be available for review by Department
representatives.
SECTION
XIX. EXTERNAL QUALITY ASSURANCE/IMPROVEMENT ASSESSMENT.
A. "When the Department determines that
a.significant quality.problem exists that is not being addressed internally,
that HMO shall have an external QA/l assessment performed.
Such external assessment shall study the quality of care being provided to
Enrollees and the effectiveness of the QA/I program established by the HMO.
B. The assessment shall be
conducted by a person or persons hired by the HMO and not involved in the
operation or direction of the HMO or in the delivery of Health Care Services to
its Enrollees.
C. The person or
persons hired shall be an individual or organization with recognized experience
in the appraisal of medical practice and quality assurance in an HMO
setting.
D. The person or persons
hired shall be approved by the Director and shall report at frequent intervals
to Department representatives during the assessment period.
E. The person or persons hired shall issue a
written report of findings to the HMO's governing body. A copy of this report
shall be submitted to the Director within ten (10) business days of its receipt
by the HMO.
SECTION XX.
RECORDS MAINTENANCE.
A. Each
HMO shall maintain all of its books, records, files, procedures, minutes, and
any other, required documentation to support compliance with these Rules and
Regulations at, and under the control o£ its principal place of doing
business in Arkansas.
B. All such
records shall be maintained for a period corresponding to the time interval
between each onsite review of the quality of care of the HMO by the
Department.
SECTION XXI.
ONSITE QUALITY OF CARE REVIEWS.
A. The
Director shall conduct an examination concerning the quality and
appropriateness of covered Health CareServices provided and/or arranged for by
the HMO as oftenas is deemed necessary for the protection of the interests of
the citizens of this State and for the protection ofEnrollees of each HMO. The
examination shall not be less frequent than once every three (3) years. Such
examinations shall be subsequent to the issuance of a Certificate of
Authority.
B. The examination shall
be based on, but not limited to, the following:
1. The effectiveness of quality of care
monitoring;
2. A medical referral
system which is both available and accessible;
3. Continuing education programs to upgrade
the expertise of all professional and non-professional personnel; and
4. Other quality issues in relation to the
number ofEnrollees.
C.
Complaints concerning the quality of care shall be investigated by the
Department without prior notice to the HMO. Complaints determined to be
substantiated may require a full survey of the HMO, which shall be
unannounced.
D. Requirements
concerning a statement of deficiencies cited on surveys and complaint
investigations are as follows:
1. The
Department shall provide the HMO with a written statement of the survey
outcome;
2. If deficiencies are
cited, a written plan of correction shall be returned to the Department within
thirty (30) days of receipt of the written statement of deficiencies;
3. Deficiencies which represent an immediate
health and safety concern to Enrollees shall be corrected in a time frame that
is appropriate. A time frame will be established for each such deficiency, and
in no case shall exceed thirty (30) days from the date of receipt of the
written statement of deficiencies;
4. All other deficiencies shall be corrected
within sixty (60) days of receipt of the written statement of deficiencies.
Documentation for justification of a longer time frame shall be provided to the
Director.
E. The
Department may impose disciplinary action in the following instances:
1. The HMO fails to develop an acceptable
plan of correction for deficiencies within the time frame allowed;
2. The HMO fails to implement and complete
its plan of correction within the time frame approved by the
Department;
3. The HMO fails to
notify the Department of changes in operation that would affect previous
considerations for applications or amendments to the Certificate of
Authority,
4. The HMO fails to
provide the Department with required reports and other documents, as requested;
and
5. The HMO fails to pay fees or
other expenses required by these Rules and Regulations.
F. Each affected HMO shall receive written
notice of the Department's disciplinary action. A written response shall be
made to the Department within ten (10) calendar days of receipt of the notice.
The response may exercise the HMO's right of appeal of the Director's
disciplinary action.
G. Any charge
of noncompliance shall be removed after determination that the HMO has
corrected the deficiency(ies) which prompted the request for disciplinary
action.
SECTION XXII.
SEVERABILITY.
If any provision of these Rules and Regulations, or the
application thereof to any person or circumstances is held invalid, such
invalidity shall not affect other provisions or applications of these Rules and
Regulations which can give effect without the invalid provisions or
applications, and to this end the provisions hereto are declared to be
severable.
SECTION XXIII.
REPEAL.
All Regulations and parts of Rules and Regulations in conflict
herewith are hereby repealed.