Section
1.4 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)
"Blueprint for Health" means the state's plan for chronic care infrastructure,
prevention of chronic conditions, and chronic care management program, and
includes an integrated approach to patient self- management, community
development, health care system and professional practice change, and
information technology initiatives.
(C) "Case management" means a coordinated set
of activities conducted to support the member and his/her health care provider
in managing serious, complicated, protracted or other health
conditions.
(D) "Chronic care"
means health services provided by a health care professional for an established
clinical condition that is expected to last a year or more and that requires
ongoing clinical management attempting to restore the individual to highest
function, minimize the negative effects of the condition, and prevent
complications related to chronic conditions. Examples of conditions that are or
may be considered chronic include diabetes, hypertension, cardiovascular
disease, cancer, asthma, pulmonary disease, substance abuse, mental illness,
spinal cord injury, and hyperlipidemia.
(E) "Chronic care management" means a system
of coordinated health care interventions and communications for individuals
with chronic conditions, including significant patient self-care efforts;
systemic supports for the physician and patient relationship; and a plan of
care emphasizing prevention of complications utilizing evidence-based practice
guidelines, patient empowerment strategies, and evaluation of clinical,
humanistic, and economic outcomes on an ongoing basis with the goal of
improving overall health.
(F)
"Clinical peer" means a health care provider in a specialty that typically
provides the procedure or treatment, or diagnoses or manages the medical
condition under review and who holds a non-restricted license in a state of the
United States. A general internist or family practitioner who does not
typically provide the procedure or treatment, or does not typically diagnose or
manage the medical condition does not meet the definition of clinical peer, nor
does a Pharm D meet the definition of clinical peer, but a. Pharm D could serve
on the first level grievance panel of reviewers and assist a clinical peer
during the first level grievance procedures.
(G) "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.
(H) "Commissioner" means
the commissioner of the Vermont Department of Financial Regulation or his or
her designee.
(I) "Concurrent
review" means utilization review conducted during a member's stay in a hospital
or other facility, or other ongoing course of treatment.
(J) "Confidentiality code" means the
confidentiality code adopted by the Department of Financial Regulation on
December 1, 1993 and any subsequent revisions.
(K) "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.
(L) "Credentialing
verification" or "credentialing reverification" means the process of obtaining
and verifying information about a health care provider and evaluating that
health care provider relative to the managed care organization's standards when
that health care provider applies to become or remain a contracted provider
with the managed care organization.
(M) "Delegate" means an entity to which a
managed care organization gives authority to carry out certain functions that
the managed care organization would otherwise perform, or the act of giving
authority to carry out certain functions to another entity.
(N) "Department" means the Department of
Financial Regulation.
(O)
"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.
(P) "Dose restriction"
means imposing a restriction on the number of doses of prescription drug that
will be covered during a specific time period.
"Dose restriction" does not include a restriction on the
number of doses when the prescription drug that is subject to the restriction
cannot be supplied by or has been withdrawn from the market by the drug's
manufacturer.
(Q) "Emergency
medical condition" means a medical condition manifesting itself by acute
symptoms of sufficient severity (including severe pain) so that a prudent
layperson, who possesses an average knowledge of health and medicine, could
reasonably expect the absence of immediate medical attention to result in a
condition described in clause (i), (ii), or (iii) of section 1867(e)(l)(A) of
the Social Security Act (
42 U.S.C.
1395 dd(e)(l)(A)). (In that provision of the
Social Security Act, clause (i) refers to placing the health of the individual
(or, with respect to a pregnant woman, the health of the woman or her unborn
child) in serious jeopardy; clause (ii) refers to serious impairment to bodily
functions; and clause (iii) refers to serious dysfunction of any bodily organ
or part.
(R) "Emergency services"
means, with respect to an emergency medical condition:
1. A medical screening examination (as
required under section 1867 of the Social Security Act,
42 U.S.C.
1395 dd) that is within the capability of the
emergency department of a hospital, including ancillary services routinely
available to the emergency department to evaluate such emergency medical
condition, and
2. Such further
medical examination and treatment, to the extent they are within the
capabilities of the staff and facilities available at the hospital, as are
required under section 1867 of the Social Security Act (
42 U.S.C.
1395 dd) to stabilize the patient.
(S) "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 Financial
Regulation and, if requested by the Department, to an organization designated
by the Department under Section 1.6(D). The Department may also, at its
discretion, permit documents to be filed electronically.
(T) "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.
(U) "Gynecological
health care services" means preventive and routine reproductive health and
gynecological care, including annual screening, counseling, and treatment of
gynecological disorders and diseases in accordance with the most current
published recommendations of the American College of Obstetricians and
Gynecologists.
(V) "Gynecological
health care provider" means a health care provider or health care facility that
is primarily engaged in providing gynecological health care services.
(W) "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.
(X)
"Health care facility" means all institutions, whether public or private,
proprietary or nonprofit, which offer diagnosis, treatment, inpatient or
ambulatory care to two or more unrelated persons, and the buildings in. which
those services are offered. The term shall not apply to any facility operated
by religious groups relying solely on spiritual means through prayer or
healing, but includes all institutions included in
18 V.S.A. §
9432, except health maintenance
organizations.
(Y) "Health care
provider" or "provider" means a person, partnership or corporation, other than
a facility or institution, licensed or certified or authorized by law to
provide professional health care services to an individual during that
individual's health care, treatment or confinement.
(Z) "Health care services" or "services"
means services for the diagnosis, prevention, treatment, cure or relief of a
health condition, illness, injury or disease.
(AA) "Health insurer" means any health
insurance company, nonprofit hospital and 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.
(BB) "Independent accreditation organization"
means an organization recognized by the Department as qualified to review some
or all of a managed care organization's quality management and consumer
protection activities according to the criteria established in this
rule.
(CC) "Independent external
review" means a review of a health care decision, by an independent review
organization pursuant to
8
V.S.A. §
4089f, as applicable and as may
be amended.
(DD) "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.
(EE) "Managed 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.
(FF) "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 managed care organization with responsibility for overseeing all
clinical activities of the health benefit plan, or his or her
designee.
(GG) "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.
(HH) "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.
(II) "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.
(JJ) "Mental health care
provider" means any person, corporation, facility or institution certified or
licensed by this state to provide mental health care or substance abuse
services, including but not limited to a physician, a nurse with recognized
psychiatric specialties, hospital or other health care facility, psychologist,
clinical social worker, mental health counselor, alcohol or drug abuse
counselor.
(KK) "Mental health
condition" means any condition or disorder involving mental illness or alcohol
or substance abuse that falls under any of the diagnostic categories listed in
the mental disorders section of the international classification of disease, as
periodically revised.
(LL) "Mental
health professional" means any person, certified or licensed by this state to
provide mental health care services, including but not limited to a physician,
a nurse with recognized psychiatric specialties, psychologist, clinical social
worker, mental health counselor, alcohol or drug abuse counselor.
(MM) "Peer review committee" means a
committee as defined in
26 V.S.A. §
1441, and for purposes of this rule includes
any quality management, credentialing or other similar committee established by
a managed care organization pursuant to
18 V.S.A. §
9414(c)(l) and this
rule.
(NN) "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.
(OO) "Pharmaceutical benefit management
program" ("PBMP") means any mechanisms or procedures used to manage
prescription drug benefits, including but not limited to formularies, dose
restrictions, prior or other authorization requirements, step therapy and/or
substitution requirements.
(PP)
"Post-service Review" means review of any claim for a benefit that is not a
pre-service or concurrent review claim as defined by this rule.
(QQ) "Pre-service Review" means review of any
claim for a benefit with respect to which the terms of coverage condition
receipt of the benefit, in whole or in part, on approval of the benefit in
advance of obtaining health care.
(RR) "Primary care provider" means a health
care provider who, within that provider's scope of practice as defined under
the relevant state licensing law, provides primary care services, and who is
designated as a primary care provider by a managed care organization.
(SS) "Primary care services" include services
provided by providers specifically trained for and skilled in first-contact and
continuing care for persons with undiagnosed signs, symptoms or health
concerns, not limited by problem origin (biological, behavioral or social),
organ system or diagnosis. Primary care services include health promotion,
disease prevention, health maintenance, counseling, patient education, self-
management support, care planning and the diagnosis and treatment of acute and
chronic illnesses in a variety of health care settings.
(TT) "Primary verification" means
verification of a health professional's credentials based upon evidence
obtained from the issuing source of the credential.
(UU) "Provider Directory" means a
comprehensive list of all of the health care providers employed by, under
contract or subcontract with, in a network, designated as preferred or
otherwise in an arrangement with the managed care organization and available to
members or subscribers of a particular health benefit plan.
(VV) "Provider List" means a subset of the
provider directory created by the managed care organization to meet a
particular member's health care and geographic accessibility needs, usually
generated in response to a request from the member or the member's
representative.
(WW) "Quality
management program" means a set of procedures and activities designed to
safeguard or improve the quality of health care and the quality of the managed
care organization's service to members and providers by assessing the quality
of care or service, usually against a set of established standards, and taking
action to improve it.
(XX) "Quality
improvement" means the effort to improve the quality of health care services
and outcomes of treatment for members as well as the quality of the managed
care organization's service to members and providers. Opportunities to improve
care and service are found primarily by continual examination of, and continual
feedback and education about how services are provided and the results they
produce.
(YY) "Quality of care"
means the degree to which health care services for individuals and populations
increase the likelihood of desired health outcomes, decrease the probability of
undesired health outcomes, and are consistent with current professional
knowledge.
(ZZ) "Referral" means a
prior authorization from the managed care organization or contracted provider
that allows a member to have one or more appointments with a health care
provider for consultation, diagnosis, or treatment of a medical condition, to
be covered as a benefit under the member's health benefit plan
contract.
(AAA) "Relevant document,
record or other information" means, for the purposes of Section 3.3, that a
document, record or other information shall be considered relevant if such
document, record or other information was relied upon in making the benefit
determination or the determination of a grievance, or was submitted, considered
or generated in the course of making the benefit determination or the
determination of a grievance, without regard to whether such document, record
or other information was relied upon in making the benefit determination or the
determination of a grievance.
(BBB)
"Secondary verification" means verification of a health professional's
credentials based on evidence obtained by means other than direct contact with
the issuing source of the credential.
(CCC) "Service area" means the geographic
region in or for which a health benefit plan subject to Part 5 or 6 of this
rule is, consistent with applicable law, marketed, sold, intended by the issuer
and described in the policy and certificate as the region in which the travel
and waiting time standards in Section 5.1 of this rule are met and in which
certificate holders are expected to and are able to access all or most of the
covered benefits at the benefit level most advantageous to the member. That a
health benefit plan subject to Part 5 or 6 of this rule may be required to
authorize coverage for services for individual members in a location outside of
the service area at the benefit level most advantageous to the member does not
subject that location to the travel and waiting time requirements of this
rule.
(DDD) "Stabilize" means, with
respect to an emergency medical condition, the meaning given in section
1867(e)(3) of the Social Security Act (
42 U.S.C.
1395 dd(e)(3).
(EEE) "Step therapy" means a type of protocol
that specifies the sequence in which different prescription drugs are to be
tried for treating a specified medical condition.
(FFF) "Urgently-needed care" or "urgent care"
means those health care services that are necessary to treat a condition or
illness of an individual that if not provided promptly (within twenty-four
hours or a time frame consistent with the medical exigencies of the case)
presents a serious risk of harm.
(GGG) "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.
(HHH) "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.
(III) "Utilization review guidelines" mean
the normative standards and clinical review criteria for resource utilization
for various clinical conditions and medical services that are used by managed
care organizations in deciding whether to approve or deny health care
services.