COMMITTEE SUBSTITUTE
FOR
H. B. 2675
(By Delegates Beane, Amores, Campbell,
Craig, Mahan, Michael and Webster
)
(Originating in the Committee on Finance)
[February 26, 2003]
A BILL to amend article fifteen, chapter thirty-three of the code
of West Virginia, one thousand nine hundred thirty-one, as
amended, by adding thereto a new section, designated section
four-h; to amend article sixteen of said chapter by adding
thereto a new section, designated section three-q; to amend
and reenact section four, article twenty-four of said chapter;
to amend and reenact section six, article twenty-five of said
chapter; to amend and reenact section twenty-four, article
twenty-five-a of said chapter; and to further amend said
chapter by adding thereto a new article, designated article
twenty-five-f, all relating to mandating insurance coverage
for certain clinical trials for ordinary costs of covered
services including definitions and applicable coverage.
Be it enacted by the Legislature of West Virginia:
That article fifteen, chapter thirty-three of the code of West
Virginia, one thousand nine hundred thirty-one, as amended, be
amended by adding thereto a new section, designated section four-h; that article sixteen of said chapter be amended by adding thereto
a new section, designated section three-q; that section four,
article twenty-four of said chapter be amended and reenacted; that
section six, article twenty-five of said chapter be amended and
reenacted; that section twenty-four, article twenty-five-a of said
chapter be amended and reenacted; and that said chapter be further
amended by adding thereto a new article, designated article twenty-
five-f, all to read as follows:
ARTICLE 15. ACCIDENT AND SICKNESS INSURANCE.
§33-15-4h. Coverage for patient cost of clinical trials.
The provisions relating to clinical trials established in
article twenty-five-f of this chapter shall apply to the insurance
regulated by this article.
ARTICLE 16. GROUP ACCIDENT AND SICKNESS INSURANCE.
§33-16-3q. Coverage for patient cost of clinical trials.
The provisions relating to clinical trials established in
article twenty-five-f of this chapter shall apply to the insurance
regulated by this article.
ARTICLE 24. HOSPITAL SERVICE CORPORATIONS, MEDICAL SERVICE
CORPORATIONS, DENTAL SERVICE CORPORATIONS AND
HEALTH SERVICE CORPORATIONS.
§33-24-4. Exemptions; applicability of insurance laws.
Every corporation defined in section two of this article is
hereby declared to be a scientific, nonprofit institution and
exempt from the payment of all property and other taxes. Every corporation, to the same extent the provisions are applicable to
insurers transacting similar kinds of insurance and not
inconsistent with the provisions of this article, shall be governed
by and be subject to the provisions as herein below indicated, of
the following articles of this chapter: Article two (insurance
commissioner), except that, under section nine of said article,
examinations shall be conducted at least once every four years;
article four (general provisions), except that section sixteen of
said article may not be applicable thereto; section twenty, article
five (borrowing by insurers); section thirty-four, article six (fee
for form and rate filing); article six-c (guaranteed loss ratio);
article seven (assets and liabilities); article eight-a (use of
clearing corporations and federal reserve book-entry system);
article eleven (unfair trade practices); article twelve (
agents,
brokers insurance producers and solicitors), except that the
agent's license fee shall be twenty-five dollars;
article twelve-c
(excess lines); section two-a, article fifteen (definitions);
section two-b, article fifteen (guaranteed issue); section two-d,
article fifteen (exception to guaranteed renewability); section
two-e, article fifteen (discontinuation of coverage); section
two-f, article fifteen (certification of creditable coverage);
section two-g, article fifteen (applicability); section four-e,
article fifteen (benefits for mothers and newborns); section
fourteen, article fifteen (individual accident and sickness
insurance); section sixteen, article fifteen (coverage of
children); section eighteen, article fifteen (equal treatment of state agency); section nineteen, article fifteen (coordination of
benefits with medicaid); article fifteen-a (long-term care
insurance); article fifteen-c (diabetes insurance); section three,
article sixteen (required policy provisions); section three-a,
article sixteen (mental health); section three-c, article sixteen
(group accident and sickness insurance); section three-d, article
sixteen (medicare supplement insurance); section three-f, article
sixteen (treatment of temporomandibular joint disorder and
craniomandibular disorder); section three-j, article sixteen
(benefits for mothers and newborns); section three-k, article
sixteen (preexisting condition exclusions); section three-l,
article sixteen (guaranteed renewability); section three-m, article
sixteen (creditable coverage); section three-n, article sixteen
(eligibility for enrollment); section eleven, article sixteen
(coverage of children); section thirteen, article sixteen (equal
treatment of state agency); section fourteen, article sixteen
(coordination of benefits with medicaid); section sixteen, article
sixteen (diabetes insurance); article sixteen-a (group health
insurance conversion);
article sixteen-c (small employer group
policies); article sixteen-d (marketing and rate practices for
small employers);
article twenty-five-f (coverage for patient cost
of clinical trials; article twenty-six-a (West Virginia life and
health insurance guaranty association act), after the first day of
October, one thousand nine hundred ninety-one; article twenty-seven
(insurance holding company systems); article twenty-eight
(individual accident and sickness insurance minimum standards); article thirty-three (annual audited financial report); article
thirty-four (administrative supervision); article thirty-four-a
(standards and commissioner's authority for companies considered to
be in hazardous financial condition); article thirty-five (criminal
sanctions for failure to report impairment); article thirty-seven
(managing general agents); and article forty-one (privileges and
immunity) and no other provision of this chapter may apply to these
corporations unless specifically made applicable by the provisions
of this article. If, however, the corporation is converted into a
corporation organized for a pecuniary profit or if it transacts
business without having obtained a license as required by section
five of this article, it shall thereupon forfeit its right to these
exemptions.
ARTICLE 25. HEALTH CARE CORPORATIONS.
§33-25-6. Supervision and regulation by insurance commissioner;
exemption from insurance laws.
Corporations organized under this article are subject to
supervision and regulation of the insurance commissioner. The
corporations organized under this article, to the same extent these
provisions are applicable to insurers transacting similar kinds of
insurance and not inconsistent with the provisions of this article,
shall be governed by and be subject to the provisions as
hereinbelow indicated of the following articles of this chapter:
Article four (general provisions), except that section sixteen of
said article shall not be applicable thereto; article six-c (guaranteed loss ratio); article seven (assets and liabilities);
article eight (investments); article ten (rehabilitation and
liquidation); section two-a, article fifteen (definitions); section
two-b, article fifteen (guaranteed issue); section two-d, article
fifteen (exception to guaranteed renewability); section two-e,
article fifteen (discontinuation of coverage); section two-f,
article fifteen (certification of creditable coverage); section
two-g, article fifteen (applicability); section four-e, article
fifteen (benefits for mothers and newborns); section fourteen,
article fifteen (individual accident and sickness insurance);
section sixteen, article fifteen (coverage of children); section
eighteen, article fifteen (equal treatment of state agency);
section nineteen, article fifteen (coordination of benefits with
medicaid); article fifteen-c (diabetes insurance); section three,
article sixteen (required policy provisions); section three-a,
article sixteen (mental health); section three-j, article sixteen
(benefits for mothers and newborns); section three-k, article
sixteen (preexisting condition exclusions); section three-l,
article sixteen (guaranteed renewability); section three-m, article
sixteen (creditable coverage); section three-n, article sixteen
(eligibility for enrollment); section eleven, article sixteen
(coverage of children); section thirteen, article sixteen (equal
treatment of state agency); section fourteen, article sixteen
(coordination of benefits with medicaid); section sixteen, article
sixteen (diabetes insurance); article sixteen-a (group health
insurance conversion); article sixteen-c (small employer group policies); article sixteen-d (marketing and rate practices for
small employers);
article twenty-five-f (coverage for patient cost
of clinical trials; article twenty-six-a (West Virginia life and
health insurance guaranty association act); article twenty-seven
(insurance holding company systems); article thirty-three (annual
audited financial report); article thirty-four-a (standards and
commissioner's authority for companies deemed to be in hazardous
financial condition); article thirty-five (criminal sanctions for
failure to report impairment); article thirty-seven (managing
general agents); and article forty-one (privileges and immunity));
and no other provision of this chapter may apply to these
corporations unless specifically made applicable by the provisions
of this article.
ARTICLE 25A. HEALTH MAINTENANCE ORGANIZATION ACT.
§33-25A-24. Scope of provisions; applicability of other laws.
(a) Except as otherwise provided in this article, provisions
of the insurance laws and provisions of hospital or medical service
corporation laws are not applicable to any health maintenance
organization granted a certificate of authority under this article.
The provisions of this article shall not apply to an insurer or
hospital or medical service corporation licensed and regulated
pursuant to the insurance laws or the hospital or medical service
corporation laws of this state except with respect to its health
maintenance corporation activities authorized and regulated
pursuant to this article. The provisions of this article may not
apply to an entity properly licensed by a reciprocal state to provide health care services to employer groups, where residents of
West Virginia are members of an employer group, and the employer
group contract is entered into in the reciprocal state. For
purposes of this subsection, a "reciprocal state" means a state
which physically borders West Virginia and which has subscriber or
enrollee hold harmless requirements substantially similar to those
set out in section seven-a of this article.
(b) Factually accurate advertising or solicitation regarding
the range of services provided, the premiums and copayments
charged, the sites of services and hours of operation and any other
quantifiable, nonprofessional aspects of its operation by a health
maintenance organization granted a certificate of authority, or its
representative may not be construed to violate any provision of law
relating to solicitation or advertising by health professions:
Provided, That nothing contained in this subsection shall be
construed as authorizing any solicitation or advertising which
identifies or refers to any individual provider or makes any
qualitative judgment concerning any provider.
(c) Any health maintenance organization authorized under this
article may not be considered to be practicing medicine and is
exempt from the provisions of chapter thirty of this code, relating
to the practice of medicine.
(d) The provisions of sections
twelve, fifteen and twenty,
article four (general provisions); section seventeen, article six
(noncomplying forms); section twenty, article five (borrowing by
insurers); article six-c (guaranteed loss ratio); article seven (assets and liabilities); article eight (investments); article
eight-a (use of clearing corporations and federal reserve
book-entry system); article nine (administration of deposits);
article twelve (
agents, brokers, insurance producer and solicitors
and excess line);
article twelve-c (excess lines); section
fourteen, article fifteen (individual accident and sickness
insurance); section sixteen, article fifteen (coverage of
children); section eighteen, article fifteen (equal treatment of
state agency); section nineteen, article fifteen (coordination of
benefits with medicaid); article fifteen-b (uniform health care
administration act); section three, article sixteen (required
policy provisions);
section three-a, article sixteen (same-mental
health); section three-f, article sixteen (treatment of
temporomandibular disorder and craniomandibular disorder); section
eleven, article sixteen (coverage of children); section thirteen,
article sixteen (equal treatment of state agency); section
fourteen, article sixteen (coordination of benefits with medicaid);
article sixteen-a (group health insurance conversion); article
sixteen-d (marketing and rate practices for small employers);
article twenty-five-c (health maintenance organization patient bill
of rights);
article twenty-five-f (coverage for patient cost of
clinical trials; article twenty-seven (insurance holding company
systems); article thirty-four-a (standards and commissioner's
authority for companies considered to be in hazardous financial
condition); article thirty-five (criminal sanctions for failure to
report impairment); article thirty-seven (managing general agents); article thirty-nine (disclosure of material transactions); article
forty-one (privileges and immunity); and article forty-two (women's
access to health care) shall be applicable to any health
maintenance organization granted a certificate of authority under
this article. In circumstances where the code provisions made
applicable to health maintenance organizations by this section
refer to the "insurer", the "corporation" or words of similar
import, the language shall be construed to include health
maintenance organizations.
(e) Any long-term care insurance policy delivered or issued
for delivery in this state by a health maintenance organization
shall comply with the provisions of article fifteen-a of this
chapter.
ARTICLE 25F. COVERAGE FOR PATIENT COST OF CLINICAL TRIALS.
§33-25F-1.
Definitions.
For purposes of this article:
(a)A "clinical trial" is a study that determines whether new
drugs, treatments or medical procedures are safe and effective on
humans. To determine the efficacy of experimental drugs,
treatments or procedures, a study is conducted in four phases
including the following:
Phase I: Research is conducted on a small group of volunteers
for the first time to evaluate its safety, determine a safe dosage
range and identify side effects.
Phase II: The experimental drug or treatment is given to or a
procedure is performed on a larger group of people to further measure its effectiveness and safety.
Phase III: Further research is conducted to confirm the
effectiveness of the drug, treatment or procedure, monitor the side
effects, compare commonly used treatments and collect information
on safe use.
Phase IV: After the drug, treatment or medical procedure is
marketed, investigators continue testing to determine the effects
on various populations and whether there are side effects
associated with long-term use.
(b) "Cooperative group" means a formal network of facilities
that collaborate on research projects and have an established
NIH-approved peer review program operating within the group.
(c) "Cooperative group" includes:
(1) The national cancer institute clinical cooperative group;
(2) The national cancer institute community clinical oncology
program;
(3) The AIDS clinical trial group; and
(4) The community programs for clinical research in AIDS.
(d) "FDA means the federal food and drug administration.
(e) "Life-threatening condition" means that the member has a
terminal condition or illness that according to current diagnosis
has a high probability of death within two years, even with
treatment with an existing generally accepted treatment protocol.
(f) "Member" means a policyholder, subscriber, insured or
certificate holder or a covered dependent of a policyholder,
subscriber, insured or certificate holder.
(g) "Multiple project assurance contract" means a contract
between an institution and the federal department of health and
human services that defines the relationship of the institution to
the federal department of health and human services and sets out
the responsibilities of the institution and the procedures that
will be used by the institution to protect human subjects.
(h) "NIH" means the national institutes of health.
(i) "Patient cost" means the routine costs of a medically
necessary health care service that is incurred by a member as a
result of the treatment being provided pursuant to the protocols
of the clinical trial. Routine costs of a clinical trial include
all items or services that are otherwise generally available to
beneficiaries of the insurance policies. "Patient cost" does not
include:
(1) The cost of the investigational drug or device;
(2) The cost of nonhealth care services that a patient may be
required to receive as a result of the treatment being provided to
the member for purposes of the clinical trial;
(3) Services customarily provided by the research sponsor free
of charge for any participant in the trial
(4) Costs associated with managing the research associated
with the clinical trial, including but not limited to, services
furnished to satisfy data collection and analysis needs that are
not used in the direct clinical management of the participant; or
(5) Costs that would not be covered under the participant's
policy, plan, or contract for noninvestigational treatments.
(6) Adverse events during treatment are divided into those
that reflect the natural history of the disease, or its
progression, and those that are unique in the experimental
treatment. Costs for the former are the responsibility of the
payor, and costs for the later are the responsibility of the
sponsor. The sponsor shall hold harmless any payor for any losses
and injuries sustained by any member as a result of his or her
participation in the clinical trial.
§
33-25F-2.
Coverage applicable under this article.
(a) This section applies to:
(1) Insurers and nonprofit health service plans that provide
hospital, medical, surgical or pharmaceutical benefits to
individuals or groups on an expense-incurred basis under a health
insurance policy or contract issued or delivered in the state;
(2) Health maintenance organizations that provide hospital,
medical, surgical or pharmaceutical benefits to individuals or
groups under contracts that are issued or delivered in the state;
and
(3) Public employees insurance agency, the medicaid agency and
the children's health insurance program.
(b) This section does not apply to a policy, plan or contract
paid for under Title XVIII of the Social Security Act.
(c) A policy, plan or contract subject to this section shall
provide coverage for patient cost to a member in a clinical trial,
as a result of:
(1) Treatment provided for a life-threatening condition; or
(2) Prevention, early detection and treatment studies on
cancer.
(d) The coverage under subsection (c) of this section is
required if:
(1)(A) The treatment is being provided or the studies are
being conducted in a Phase I, Phase II, Phase III or Phase IV
clinical trial for cancer and has therapeutic intent; or
(B) The treatment is being provided in a Phase 1, Phase II,
Phase III or Phase IV clinical trial for any other life-threatening
condition and has therapeutic intent;
(2) The treatment is being provided in a clinical trial
approved by:
(A) One of the national institutes of health;
(B) An NIH cooperative group or an NIH center;
(C) The FDA in the form of an investigational new drug
application or investigational device exemption;
(D) The federal department of veterans affairs; and
(E) An institutional review board of an institution in the
state which has a multiple project assurance contract approved by
the office of protection from research risks of the national
institutes of health;
(3) The facility and personnel providing the treatment are
capable of doing so by virtue of their experience, training and
volume of patients treated to maintain expertise;
(4) There is no clearly superior, noninvestigational treatment
alternative;
(5) The available clinical or preclinical data provide a
reasonable expectation that the treatment will be more effective
than the noninvestigational treatment alternative;
(6) The treatment is provided in this state or, if out-of-
state, by approval of the payor;
(7) Reimbursement for treatment is subject to all coinsurance,
copayment and deductibles and is otherwise subject to all
restrictions and obligations of the health plan.
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