Section
3 Definitions
(A) "Adverse
benefit determination" means a denial, reduction, modification or termination
of, or a failure to provide or make payment (in whole or in part) for, a
benefit, including but not limited to:
1. a
denial, reduction, termination or failure to provide or make payment that is
based on a determination of a participant's or beneficiary's eligibility to
participate in a health benefit plan;
2. a denial, reduction, modification or
termination of, or a failure to provide or make payment (in whole or in part)
for, a benefit resulting from the application of any utilization review;
and
3. a failure to cover an item
or service for which benefits are otherwise provided because it is determined
to be experimental or investigational or not medically necessary or
appropriate.
(B)
"Clinical review criteria" means the written screening procedures, clinical
protocols, practice guidelines and utilization management and review guidelines
used by the managed care organization to determine the necessity and
appropriateness of health care services.
(C) "Commissioner" means the Commissioner of
Banking, Insurance, Securities and Health Care Administration or his or her
designee.
(D) "Concurrent review"
means utilization review conducted during a member's stay in a hospital or
other facility, or other ongoing course of treatment.
(E) "Contracted provider" means a provider
employed by, under contract or subcontract with, in a network, designated as
preferred or otherwise in an arrangement with a managed care organization for
the purpose of furnishing health care services to the members of the managed
care organization, regardless of the specific terms of or the terminology
applied by the managed care organization to its relationship with the
provider.
(F) "De-identified" means
there has been a redaction consistent with the requirements in federal privacy
rules promulgated pursuant to the Health Insurance Portability and
Accountability Act (HIPAA) such that the de-identified information does not
identify an individual and there is no reasonable basis to believe that the
information can be used to identify an individual.
(G) "Department" means the Department of
Banking, Insurance, Securities and Health Care Administration.
(H) "Discharge plan" means the plan that
results from the formal process for determining, before discharge from a health
care facility, the coordination and management of the care that a member will
receive following the discharge.
(I) "File", where used in the context of
information to be provided to the Department by a managed care organization,
means to file an original document by delivering it, and any copies as
requested by the Department, to the Department of Banking, Insurance,
Securities and Health Care Administration and, if requested by the Department,
to an organization designated by the Department under Section
6(D).
The Department may also, at its discretion, permit documents to be filed
electronically.
(J) "Grievance"
means a complaint submitted by or on behalf of a member regarding the:
1. Adverse benefit determination;
2. Availability, delivery or quality of
health care services;
3. Claims
payment, handling or reimbursement for health care services; or
4. Matters relating to the contractual
relationship between a member and a managed care organization or the health
insurer offering the health benefit plan.
(K) "Health benefit plan" means a policy,
contract, certificate or agreement entered into, offered or issued by a health
insurer to provide, deliver, arrange for, pay for, or reimburse any of the
costs of health care services.
(L)
"Health care services" or "services" means services for the diagnosis,
prevention, treatment, cure or relief of a health condition, illness, injury or
disease.
(M) "Health insurer" means
any health insurance company, nonprofit hospital service corporation and
nonprofit medical service corporation, managed care organization, and, to the
extent permitted under federal law, any administrator of an insured,
self-insured, or publicly funded health care benefit plan offered by public and
private entities.
(N) "License"
means a review agent's license granted by the Commissioner
(O) "Manage care organization" means any
financing mechanism or system that manages health care delivery for its members
or subscribers, including but not limited to health maintenance organizations,
preferred provider organizations, exclusive provider organizations and any
other health care delivery system or organization that manages health care
delivery for its members or subscribers, or that issues a health insurance
policy, plan, or subscriber contract which operates to manage health care
delivery. The term managed care organization includes a mental health review
agent as defined in
8 V.S.A. §
4089a, a health insurer as defined in
18 V.S.A. §
9402, a managed care organization as defined
in
18 V.S.A. §
9402, a delegate of a health insurer or
managed care organization, and any person or entity that meets the definition
of a managed care organization under law.
(P) "Manage health care delivery" means to
apply any design or mechanism to a health benefit plan to affect access to or
the quality, coordination or cost of the health care available to members under
the health benefit plan, including but not limited to the use of any form of
utilization management; pharmaceutical benefit management; networks, preferred
providers or any other restrictions or incentives for members to use certain
providers; and/or disease, care or case management.
(Q) "Medical or scientific evidence" means
the following sources:
1. Peer-reviewed
scientific studies published in or accepted for publication by medical journals
that meet nationally recognized requirements for scientific manuscripts and
that submit most of their published articles for review by experts who are not
part of the editorial staff.
2.
Peer-reviewed literature, biomedical compendia and other medical literature
that meet the criteria of the National Institutes of Health's National Library
of Medicine for indexing in Excerpta Medica (EMBASE), Medline, and PubMed
Medline, and resources from the Cochrane Library, HSTAT, and the National
Guideline Clearinghouse.
3. Medical
journals recognized by the federal Secretary of Health and Human Services,
under Section 1861(t)(2) of the federal Social Security Act.
4. The following standard reference
compendia: the American Hospital Formulary Service-Drug Information (AHFS Drug
Information), the American Dental Association Accepted Dental Therapeutics and
Monograph Series on Dental Materials and Therapeutics, The United States
Pharmacopeia, The National Formulary and the USPDI.
5. Findings, studies or research conducted by
or under the auspices of federal government agencies and nationally recognized
federal research institutes, including the Agency for Health Care Research and
Quality, National Institutes of Health, National Cancer Institute, National
Academy of Sciences, Centers for Medicare and Medicaid Services, and any
national board recognized by the National Institutes of Health for the purpose
of evaluating the medical value of health services.
6. Peer-reviewed abstracts accepted for
presentation at major medical association meetings.
(R) "Medically necessary care" means health
care services, including diagnostic testing, preventive services and aftercare,
that are appropriate in terms of type, amount, frequency, level, setting, and
duration to the member's diagnosis or condition. Medically necessary care must
be informed by generally accepted medical or scientific evidence and consistent
with generally accepted practice parameters as recognized by health care
professions in the same specialties as typically provide the procedure or
treatment, or diagnose or manage the medical condition; must be informed by the
unique needs of each individual patient and each presenting situation; and
1. help restore or maintain the member's
health; or
2. prevent deterioration
of or palliate the member's condition; or
3. prevent the reasonably likely onset of a
health problem or detect an incipient problem.
(S) "Member" means any individual who has
entered into a contract with a health insurer or managed care organization for
the provision of health care services, or on whose behalf such an arrangement
has been made, as well as the individual's dependents covered by the
contract.
(T) "Mental health care
services" means acts of diagnosis, treatment, evaluation or advice or any other
acts permissible under the health care laws of Vermont, whether performed in an
outpatient or an institutional setting, and includes alcohol and drug abuse
treatment.
(U) "Person" means a
natural person, partnership, unincorporated association, corporation, limited
liability company, municipality, the state of Vermont or a department, agency
or subdivision of the state, or other legal entity.
(V) "Practicing mental health care provider"
means any person certified or licensed to provide mental health care services
and currently providing such services, including but not limited to a
physician, nurse with recognized psychiatric specialties, psychologist,
clinical social worker, mental health counselor, or alcohol or drug abuse
counselor.
(W) "Review agent" means
a person or entity performing service review activities who is either
affiliated with, under contract with, or acting on behalf of a business entity
in this state; or a third party who provides or administers mental health care
benefits to citizens of Vermont, who are members of health benefit plans
subject to the Department's jurisdiction, including a health insurer, nonprofit
health service plan, health insurance service organization, health maintenance
organization or preferred provider organization, including organizations that
rely upon primary care physicians to coordinate delivery of services.
(X) "Review agent medical director" means a
Vermont-licensed physician who is board-certified or board-eligible in his or
her field of specialty as determined by the American Board of Medical
Specialties (ABMS) or the American Osteopathic Association (AOA), and who is
charged by a mental health review agent with responsibility for overseeing all
clinical activities of the mental health review agent in Vermont, or his or her
designee.
(Y) "Service review"
means any system for reviewing the appropriate and efficient allocations of
mental health care services given or proposed to be given to a member or group
of members for the purpose of recommending or determining whether such services
should be reimbursed, covered or provided by an insurer, plan or other entity
or person and includes activities of utilization review and managed care, but
does not include professional peer review which does not affect reimbursement
for or provision of services.
(Z)
"Treating mental health care provider" means any person, corporation, facility
or institution certified or licensed to provide mental health care services
that is providing treatment to a member of a health benefit plan, including but
not limited to a physician, nurse with recognized psychiatric specialties,
hospital or other health care facility, psychologist, clinical social worker,
mental health counselor, alcohol or drug abuse counselor, employee or agent of
such provider acting in the course and scope of employment, or agency related
to mental health care services.
(AA) "Utilization management" means the set
of organizational functions and related policies, procedures, criteria,
standards, protocols and measures used by a managed care organization or
pharmaceutical benefit management program to ensure that it is appropriately
managing access to and the quality and cost of health care services, including
prescription drug benefits, provided to its members.
(BB) "Utilization review" means a set of
formal techniques designed to monitor the use of, or evaluate the clinical
necessity, appropriateness, efficacy, or efficiency of, health care services,
procedures, or settings, including prescription drugs.
Section 6 License Application
(A) An application for an initial license as
a review agent shall include, in a form prescribed by the Commissioner:
1. the applicant's name, business address,
contact name, telephone and email address, business website address,
EIN;
2. the number of lives for
whom the applicant is obligated to provide service reviews in each of the
following categories:
a. the number of lives
proposed to be or currently covered by health benefit plans subject to the
Department's jurisdiction, and within each of those categories, the number of
lives that reside in Vermont and the number of lives that do not reside in
Vermont, if known;
b. the number of
Vermont lives proposed to be or currently covered by health benefit plans not
subject to the Department's jurisdiction;
c. the total number of lives nationwide for
which the review agent is responsible.
3. an organizational chart that identifies
all positions within the organization, including the location within the
organization of the position or positions responsible for supervising the
service review staff, and the licensed physicians responsible for reviewing
adverse benefit determinations prior to their issuance;
4. a list of officers and directors of the
review agent, the person or persons with responsibility for supervising the
service review staff and the names and license numbers of all physicians
responsible for reviewing adverse benefit determinations;
5. a statement explaining any changes in name
or acquisition of a majority equity interest by a single individual or entity
of the review agent at any time during the previous two calendar
years;
6. disclosure of all
instances during the past five years in which the review agent and review agent
medical director(s) have:
a. had a license,
permit, registration, accreditation or other certificate of authority denied,
revoked, suspended, limited, conditioned or otherwise sanctioned by a licensing
entity in any jurisdiction;
b. been
subject to a cease and desist letter or order, or enjoined, either temporarily
or permanently, in any judicial, administrative, regulatory, or disciplinary
action, from violating any federal or state laws, or law of another
country;
c. been subject to any
non-confidential business-related administrative, civil or criminal
investigations, regulatory actions, disciplinary actions, lawsuits,
arbitrations or other proceedings, except for any such actions initiated by the
Department.
Any such disclosures shall include a description of the
matter, including dates; how the matter was resolved, if not a confidential
settlement; and the subsequent history of the matter, including details of any
settlement, restrictions, conditions, limitations and
penalties.
7.
information about the professions, licensure type and status, qualifications,
compensation structure and number of personnel performing service review
activities. Information about compensation structure shall not include
information about salaries, but shall include information about any bonus or
incentive structures, not to include amounts;
8. documentation of any URAC, NCQA or other
accreditation, including level and duration of accreditation, and whether the
business office(s) location of the review agent responsible for Vermont service
reviews has specifically been accredited;
9. copies of all written policies, and
procedures, and adverse benefit determination letter templates, used for
initial service review, and grievance reviews, if applicable, or a detailed
explanation of how such notices to members are handled if not by the review
agent;
10. a list of the titles,
sources and a brief description of all clinical review criteria, including
those that are proprietary; any other resources used by service review staff,
including interpretive guidelines for use with the criteria; and an attestation
by the review agent medical director that the clinical review criteria:
a. are informed by generally accepted medical
or scientific evidence and consistent with generally accepted practice
parameters as recognized by health care professions in the same specialties as
typically provide the procedure or treatment, or diagnose or manage the
condition; and
b. have been
reviewed and updated at least annually, taking into account input from
practicing mental health care providers, including providers under contract
with the review agent, if any. This subsection shall not be construed to
require review agents to make modifications to nationally-recognized
guidelines. The Department reserves the right to review clinical review
criteria at any time;
11.
a detailed description of how the applicant will train and evaluate all service
review staff at least annually to ensure consistent and clinically appropriate
application of clinical review criteria and how it will assess accuracy and
inter-reviewer reliability;
12.
evidence of liability insurance coverage sufficient to ensure financial
responsibility in the event of a claim, settlement or judgment against the
review agent;
13. a description of
the applicant's business activities in the State of Vermont other than mental
health or substance abuse service review, if any, and evidence of registration
and/or licensure if required for those activities; and if the applicant is not
licensed as an insurer by the Department, an attestation that the applicant
does not engage in the business of insurance in Vermont;
14. any other information requested by the
Department; and
15. the license fee
required by law and any additional expenses incurred by the Department to
examine and investigate the application or amendment to the
application.
(B) The
review agent shall report any changes to the information described in Section
6A of this Rule and provided in its application or renewal applications to the
Department at least 30 days prior to the anticipated implementation of the
change and within 15 days of an unanticipated material change.
(C) A review agent shall apply annually for
license renewal on September 15 or an alternative date specified by the
Department. The renewal application shall include:
1. a completed renewal application in a form
prescribed by the Commissioner;
2.
disclosure of any changes in the information described in Section 6A of this
Rule that have occurred since the latter of the initial license application or
any renewal application, whether or not previously disclosed to the
Department;
3. a de-identified
summary of the information specified below for the prior calendar year, in the
format specified by the Department, that includes:
a. the number, results and a summary of all
service reviews, if applicable and whether benefits were denied or reduced,
including the number of members involved. The Department, in its sole
discretion, may waive the requirement in this sub-paragraph for review agents
that are subject to and in compliance with other rules that would require them
to file the identical information with the Department;
b. the number and results of any internal
grievances, if applicable, including the number of members involved;
and
c. a summary of reasons for the
internal grievances, if applicable.
4. current evidence of liability insurance
coverage sufficient to ensure financial responsibility in the event of a claim,
settlement or judgment against the review agent;
5. an updated attestation, verifying that:
a. the clinical review criteria and standards
have been reviewed within the last year, taking into account input from
practicing licensed mental health care providers, including providers under
contract with the review agent, if any. This subsection shall not be construed
to require managed care organizations to make modifications to
nationally-recognized guidelines based on input from practicing mental health
care providers;
b. the clinical
review criteria and standards and policy and procedure manuals have been
updated, if necessary, and remain informed by generally accepted medical and
scientific evidence and consistent with clinical practice parameters as
recognized by health care professions in the same specialties as typically
provide the procedure or treatment, or diagnose or manage the condition;
and
c. the training required by
subsection
6.A.14. of
this Rule was conducted within the last year, including a summary of the
evaluation of the service reviewer staff's consistency, accuracy and
inter-reviewer reliability;
6. current copies of adverse benefit
determination letter templates used for initial service reviews, first level
grievances and voluntary second level grievances;
7. any other information requested by the
Department; and
8. the license
renewal fee required by law, including any additional expenses incurred by the
Department to examine and investigate the application or amendment to the
application.
(D) The
Department may, in its discretion, designate another organization to review
initial license applications. Any such organization shall have a
confidentiality code acceptable to the Department, or shall be subject to the
Department's confidentiality code.
Section
9 Agreements
(A) A review agent
shall not agree with any business entity or third-party payor that the payment
to the review agent shall include an incentive or contingent fee arrangement
based on the reduction of medically necessary care for mental health
services.
(B) All agreements
between a review agent and a business entity or person regarding the review of
mental health care shall be in writing. If such entity or person is engaging in
activity that meets the definition of "service review" under this Rule, it must
be licensed under this Rule. In addition, any contracted business entity or
person to whom the review agent delegates activities must meet the requirements
of Section 1.3(F) of Department Rule H-2009-03.
(C) A review agent, that enters into a
contract with a health insurer for the purpose of administering the health
insurer's mental health benefits shall COOPERATE with the health insurer to
ensure that the portion of the health insurer's premium rate attributable to
the coverage of mental health benefits under Title
8 V.S.A.
§§
4062,
4513,
4584, or
5104
is not excessive, inadequate, unfairly discriminatory, unjust, unfair,
inequitable, misleading or contrary to the laws of this State prior to
implementation.
Premium rates submitted by a health insurer are subject to
Department review and approval at least 90 days prior to the first intended use
of that premium rate and shall include the following information obtained from
the contract currently in effect between the health insurer and the mental
health review agent as of the date the premium rate filing is submitted
regarding the premium rate component attributable to coverage for mental health
benefits administrated by a review agent:
1. the amount that the health insurer has
agreed to pay a review agent for administering mental health benefits;
and
2. an itemized detailed
description of the benefits and administrative services to be financed and/or
administered by the review agent or managed care organization;
3. the degree of insurance risk assumed by
the review agent;
4. the period of
time that the rates are designed to be effective;
5. the amount of the rate(s), variations by
benefit level (if any), and any other variations that are
contemplated;
6. for other than
capitation agreements, the components of the proposed rates, including the
expected claims cost, the cost of administration, the profit margin, and any
other component not otherwise identified;
7. any other relevant information requested
by the Department; and
8. a
statement signed by a member of the American Academy of Actuaries attesting
that the filing is consistent with actuarial standards of practice and meets
the requirements of the Code of Professional Conduct of the American Academy of
Actuaries.
(D) Nothing in
this section shall prohibit capitation arrangements for reimbursement of mental
health services.