Section 1. Definitions.
(1) "Adverse determination" is defined by KRS 304.17A-600(1).
(2) "Assign" or
"assignment" means selection of an independent review entity by an insurer, and
acceptance of a request to conduct an external review by an independent review
entity.
(3) "Authorized person" is
defined by KRS 304.17A-600(2).
(4)
"Commissioner" is defined by KRS 304.1-050(1).
(5) "Coverage denial" is defined by KRS 304.17A-617(1)(c).
(6) "Covered
person" means:
(a) A covered person as defined
by KRS 304.17A-600(4); and
(b) As
used in:
1. Sections 2 and 3 of this
administrative regulation, insureds subject to a step therapy protocol
established by an insurer, health plan, pharmacy benefit manager, or private
review agent subject to KRS 304.17A-163; and
2. Section 5(2)(b) of this administrative
regulation, insureds seeking an external review under KRS 304.17A-163;
(7) "Department" is defined by KRS 304.1-050(2).
(8) "External review"
is defined by KRS 304.17A-600(5).
(9) "Financial hardship" means the:
(a) Gross income of the covered person is
below 200 percent of the federal poverty level based upon family size as shown
by a federal income tax return for the previous year; or
(b) Covered person's participation in one (1)
of the following programs:
1. National
Prescription Drug Patient Assistance;
2. Kentucky Transitional Assistance Program
(K-TAP);
3. Kentucky Medical
Assistance Program; or
4.
Unemployment Insurance.
(10) "Health care provider" or "provider" is
defined by
KRS 304.17A-005(23) and includes pharmacy as required by
806 KAR 17:580.
(11) "Independent review
entity" is defined by KRS 304.17A-600(7).
(12) "Insurer" means:
(a) An insurer as defined by KRS 304.17A-600(8); and
(b) Insurers,
health plans, pharmacy benefit managers, and private review agents subject to
KRS 304.17A-163.
(13)
"Reviewer" means an individual selected by the independent review entity to
conduct an external review and make a recommended decision to the independent
review entity.
(14) "Step therapy
exception" is defined by KRS 304.17A-163(1)(f).
(15) "Step therapy protocol" is defined by
KRS 304.17A-163(1)(g).
Section 3.
Requirements of an Independent Review Entity. An independent review entity
shall:
(1) Accept a request for assignment
unless:
(a) A conflict of interest
exists;
(b) Confidentiality issues
exist; or
(c) Due to circumstances
beyond the control of the independent review entity, an appropriate reviewer
becomes unavailable;
(2)
Upon receipt of a request for assignment from an insurer determine if a
condition of subsection (1)(a) through (c) of this section exists;
(3) Within twenty-four (24) hours of receipt
of a request for assignment:
(a) Immediately
provide verbal notification, followed by written notification to the insurer
and department of the rejection of an assignment if a condition of subsection
(1)(a) through (c) of this section exists; or
(b) Provide written notification to an
insurer and the department via DOI.UtilizationReview@ky.gov of the acceptance
of an assignment; and
(4)
Maintain a written record of:
(a) Whether the
external review relates to an adverse determination or coverage denial, which
requires resolution of a medical issue, or a step therapy exception internal
appeal denial;
(b) The specific
question or issue, as identified by the independent review entity, to be
resolved by the external review; and
(c) Whether the external review is expedited
or nonexpedited;
(5) For
each external review, obtain and maintain a signed statement of a reviewer that
the reviewer has no conflict of interest;
(6) Not limit the basis of an external review
decision to the standards, criteria, and clinical rationale used by the insurer
to make its decision pursuant to KRS 304.17A-625(1), (2), and (7);
(7) Have a reviewer with expertise in:
(a) Health insurance benefits and contracts,
who shall serve as a reviewer with a healthcare professional reviewer, in an
external review of a coverage denial, which requires the resolution of a
medical issue, or step therapy exception internal appeal denial, in accordance
with KRS 304.17A-617(3)(d); and
(b)
Health care, who shall:
1. Conduct an
external review of a step therapy exception internal appeal denial, or an
adverse determination or a coverage denial, which requires resolution of a
medical issue, in accordance with the requirements of KRS 304.17A-623;
and
2. Meet the following
requirements:
a. Hold active licensure in a
state of the United States;
b. Have
recent experience or familiarity with current body of knowledge and applicable
specialty or subspecialty practice;
c. Have at least five (5) years of experience
in the specialty or subspecialty of the external review; and
d. Hold current board certification by:
(i) The American Board of Medical Specialties
if the reviewer is a medical doctor;
(ii) The American Osteopathic Association if
the reviewer is a doctor of osteopathic medicine;
(iii) The American Board of Podiatric Surgery
if the reviewer is a doctor of podiatric medicine; or
(iv) Other recognized health professional
board pursuant to KRS 304.17A-627;
(8) Establish criteria in
accordance with
KRS 304.17A-627 for:
(a)
Selection of a qualified reviewer, including the initial verification and
reverification every three (3) years of credentials of the reviewer;
(b) Ensuring that an appropriate:
1. Reviewer performs the external review;
and
2. Number of reviewers are used
for the external review; and
(c) Ensuring that at least one (1) reviewer
qualified in each medical specialty and subspecialty is available for external
review;
(d) Provide a listing of
the reviewers to the department including each reviewer's name, date of
licensure, license number and specialty, including any subspecialty in
accordance with KRS 304.17A-627(5) and (6);
(9) Have a medical director or clinical
director with professional postresidency experience in direct patient care who
shall:
(a) Hold a current license to practice
medicine in a state of the United States;
(b) Provide guidance for the medical aspects
of the external review process; and
(c) Oversee the medical aspects of the:
1. Quality management program; and
2. Reviewer credentialing program;
(10) Establish and
implement criteria for determination of the need for a time extension pursuant
to KRS 304.17A-623(12) and (13);
(11) Provide written notification of a
decision as required by
KRS 304.17A-625(6), which shall include the:
(a) Title, professional license number, state
of licensure and specialty or subspecialty certifications, if any, of the
reviewer;
(b) Date the decision was
rendered; and
(c) A statement that:
1. The decision shall be final and binding on
the insurer; and
2. If dissatisfied
with the decision, a comment, question, or complaint may be submitted in
writing to the department;
(12) Within two (2) business days of
rendering a decision, provide written notification of the decision to the:
(a) Covered person or authorized person,
treating provider, and insurer; and
(b) Department via email at
DOI.UtilizationReview@ky.gov by:
1. Copying
the department on the written notification to the covered person; and
2. Completing an External Review Decision
Notification Form, HIPMC-IRE-3;
(13) Establish written policies and
procedures for maintenance and the confidential treatment of external review
records in accordance with
KRS 304.17A-623(9),
806 KAR 3:210, and
806 KAR 3:230;
(14) Maintain a written
record of an external review for a minimum of five (5) years in accordance with
806 KAR 2:070, which shall include, as applicable:
(a) All documentation relating to the
external review pursuant to KRS 304.17A-625(1)(a);
(b) The independent review entity's decision
regarding each issue identified in the external review request;
(c) The name, credentials, and specialty or
subspecialty of the reviewer;
(d)
Medical records and information considered during the review;
(e) References to any medical literature,
research data, or national clinical criteria upon which the independent review
entity's decision was based;
(f) A
copy of the covered person's health benefit plan;
(g) A copy of the adverse determination or
coverage denial, which requires resolution of a medical issue, or the step
therapy exception internal appeal denial, and the internal appeal decision;
and
(h) A copy of all
correspondence and communication between the independent review entity,
reviewer, and any other person regarding the external review, including a copy
of the final external review decision letter;
(15) Provide toll-free telephone access that:
(a) Operates at a minimum from 9 a.m. until 5
p.m. of each business day in each time zone if the services under review are in
dispute; and
(b) Allows for:
1. Receiving after-hours requests for
external review; and
2. Acting upon
expedited external review requests in accordance with KRS 304.17A-623(12);
(16) If an external review function, or any
portion of this function, is delegated or subcontracted to another person or
organization, submit to the department:
(a)
Policies and procedures relating to oversight activities to ensure compliance
with requirements of an independent review entity as established in KRS 304.17A-623 and 304.17A-625, and this section; and
(b) A copy of the delegation or subcontract
agreement;
(17) Establish
and maintain a written quality assurance program in accordance with
KRS 304.17A-627(7), which shall be made available to the public upon request and
shall include a written plan, which addresses:
(a) Scope and objectives;
(b) Program organization;
(c) Monitoring and oversight mechanisms;
and
(d) Evaluation and
organizational improvement of external review activities, including:
1. Objectives and approaches used in the
monitoring and evaluation of external review activities, including the
systematic evaluation of complaints for patterns and trends;
2. The implementation of an action plan to
improve or correct an identified problem; and
3. The procedures to communicate the results
of an action plan to its employees and reviewers, as applicable;
(18) Submit a copy of
any change to information provided on the Application for Certification of an
Independent Review Entity, HIPMC-IRE-1, in writing to the department for
approval. A change shall not become effective until approved by the
commissioner;
(19) Submit a new
application for certification if requested by the department following
notification of a material change in the application information as required by
KRS 304.17A-627(2);
(20) Establish
a fee structure, to be available upon request, for each type or level of
external review, including at a minimum, a fee for:
(a) A completed external review of:
1. A coverage denial, which requires
resolution of a medical issue, or step therapy exception internal appeal
denial; and
2. An adverse
determination; and
(b) An
incomplete external review;
(21) Immediately terminate an external review
and provide notice by telephone, followed by a written notification to the
department and, if appropriate, the insurer requesting the external review if:
(a) A conflict of interest or confidentiality
issue is discovered at any time during the external review process;
(b) A reversal of a coverage denial, step
therapy exception internal appeal denial, or adverse determination is received
in writing from the insurer; or
(c)
The independent review entity or a reviewer becomes unavailable for reasons
beyond the control of the independent review entity, including acts of God,
natural disasters, epidemics, strikes or other labor disruptions, war, civil
disturbances, riots, or complete or partial disruptions of
facilities;
(22) If more
than one (1) reviewer is utilized in making a decision:
(a) Render an overall decision based upon the
majority decision of the reviewers; or
(b) If the reviewers are evenly split as to
whether the recommended or requested health care service or treatment shall be
covered, request an additional reviewer to make a binding majority
decision;
(23) Implement
a written policy and procedure for each aspect of an external review process,
including:
(a) Processing of the request for
assignment of an external review from an insurer;
(b) Receipt and maintenance of medical
records and information from insurer;
(c) Ensuring access to appropriate qualified
reviewers pursuant to subsection (8) of this section;
(d) Ensuring the credentialing, selection,
and notification of a reviewer who performs an external review;
(e) Rendering a timely decision and issuing
notification of the decision;
(f)
Ongoing monitoring and evaluation of the performance of a reviewer;
(g) Monitoring and oversight of a delegated
external review function, if any;
(h) Billing and collection of fees for
external review, including:
1. Filing fee of
the covered person; and
2. Cost of
external review for the insurer;
(i) Collecting and reporting data;
(j) Termination of external review;
and
(k) Response to a request for
information relating to a complaint filed with the department; and
(24)
(a) Conduct annually, a program for training
reviewers, which:
1. Provides information
relating to the requirements of the Kentucky Independent External Review
Program; and
2. Describes the
policies and procedures of the independent review entity, as applicable;
and
(b) Provide a written
record of the training to the department, upon request.