Section 1 Purpose
and Authority
This regulation is issued pursuant to the authority of the
Commissioner of the Department of Banking, Insurance, Securities and Health
Care Administration under
8 V.S.A. §
15 and 8 V.S.A. § 4088b to issue rules
and regulations requiring that health benefit plans provide coverage for
routine costs for patients who participate in approved cancer clinical
trials.
Section 2
Applicability and Scope
This rule applies to any health insurance policy or health
benefit plan in effect on March 1, 2002 and to any such plan offered, issued,
or renewed on or after March 1, 2002 in Vermont by a health insurer as defined
in
18 V.S.A. §
9402(7), and to cancer care
providers as defined in subsection
3(B) of
this regulation. This rule applies to the Vermont Agency of Human Services
through its Vermont Medicaid program in the same manner as insurers defined in
18 V.S.A. §
9402(7). The scope of this
rule is limited to the coverage of costs for routine patient care services for
patients who participate in approved cancer clinical trials as defined in
subsection
3(A) of
this regulation that are conducted under the auspices of cancer care providers
as defined in subsection
3(B) of
this regulation.
Section 3
Definitions
A. "Approved cancer clinical
trial" means an organized, systematic, scientific study of therapies, tests, or
other clinical interventions for purposes of treatment, palliation, or
prevention of cancer in human beings. The approved cancer clinical trial must
seek to answer a credible and specific medical or scientific question for the
purpose of advancing cancer care and:
1. is
conducted by a cancer care provider as defined in subsection
3(B) of
this regulation;
2. is conducted by
a facility and personnel capable of conducting such a trial by virtue of
experience, training and volume of patients treated to maintain
expertise;
3. enrolls only those
patients for whom there is no clearly superior, non-investigational treatment
alternative to the cancer clinical trial and the available clinical or
preclinical data provide a reasonable expectation that the treatment obtained
in the cancer clinical trial will be at least as effective as the
non-investigational alternative;
4.
is conducted only after obtaining fully informed, written consent from the
patient or the patient's legally authorized representative in a manner that is
consistent with current legal and ethical standards and requirements;
and
5. is conducted under the
auspices of a peer-reviewed protocol that has been approved by one of the
following entities:
a. one of the National
Institutes of Health ("NIH");
b. an
NIH-affiliated cooperative group that is a formal network of facilities that
collaborate on research projects and have an established NIH-approved peer
review program operating within the group;
c. the FDA in the form of an investigational
new drug application or exemption; or
d. the federal departments of Veterans
Affairs or Defense.
B. "Cancer care provider" means the
following: the Vermont Cancer Center at Fletcher Allen Health Care, the Norris
Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, and a Vermont
hospital and its affiliated, qualified Vermont cancer care providers
administering approved cancer clinical trials.
C. "Commissioner" means the commissioner of
the Vermont Department of Banking, Insurance, Securities and Health Care
Administration.
D. "Department"
means the Vermont Department of Banking, Insurance, Securities and Health Care
Administration.
E. "Division" means
the Division of Health Care Administration of the Department of Banking,
Insurance, Securities and Health Care Administration.
F. "Health benefit plan" means any health
insurance policy or health benefit plan offered by a health insurer as defined
in
18 V.S.A. §
9402(7).
G. "Health insurer" means any health
insurance company, nonprofit hospital and medical service corporation, managed
care organizations, and, to the extent permitted by federal law, any
administrator of an insured, self-insured, or publicly funded health care
benefit plan offered by public and private entities.
H. "Medically-necessary care" means health
care services including diagnostic testing, preventive services and aftercare
appropriate, in terms of type, amount, frequency, level, setting, and duration
to the member's diagnosis or condition. Medically-necessary care must be
consistent with generally accepted practice parameters as recognized by health
care providers in the same or similar general specialty as typically treat or
manage the diagnosis or condition, 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.
I. "Routine
patient care services" means those health care services for which a health
insurer subject to this regulation is otherwise responsible under the patient's
health benefit plan, including any medically necessary health care service that
is incurred as a result of the treatment being provided to the patient for the
purposes of the approved cancer clinical trial. Routine patient care services
include any physician service, diagnostic or laboratory test, hospitalization,
or other service provided to the patient during the course of treatment in the
approved cancer clinical trial for a condition or one of its complications or
for a complication of the treatment provided during the approved cancer
clinical trial which is consistent with the usual and customary standard of
care and would be covered even if the patient were not enrolled in an approved
cancer clinical trial. Routine patient care services do not include the
following items:
1. The costs of
investigational new drugs that have not been approved for market for any
indication by the U.S. Food and Drug Administration ("FDA") or the costs of any
drug being studied under an FDA-approved investigational new drug exemption for
the purpose of expanding the drug's labeled indications;
2. The costs of non-health care services that
may be required as a result of the treatment being provided for the purposes of
the approved cancer clinical trial;
3. The costs of services that are clearly
inconsistent with widely accepted and established regional or national
standards of care for a particular diagnosis and performed specifically to meet
the requirements of the approved cancer clinical trial;
4. the costs of any tests or services
performed specifically to meet the needs of the approved cancer clinical trial
protocol;
5. the costs of running
the approved cancer clinical trial and collecting and analyzing data;
6. the costs associated with managing the
research associated with the approved clinical trial;
7. costs for non-investigational treatments
or services that would not otherwise be covered under the patient's health
benefit plan; or
8. any product or
service paid for or supplied by the trial sponsor.
Section 4 Services Required to Be
Covered
All health insurance policies or health benefit plans in
effect on March 1, 2002 and all such plans offered, issued, or renewed on or
after March 1, 2002 in Vermont by a health insurer as defined in
18 V.S.A. §
9402(7) and this regulation
shall provide coverage for the costs of routine patient care services for
patients who participate in all four types of approved cancer clinical trials
(Phases I, II, III, and IV) that are conducted under the auspices of cancer
care providers. Such costs shall be covered in a manner that is otherwise
consistent with the terms of the patient's health benefit plan, the health
insurer's contract with the cancer care provider and applicable state and
federal law.
Section 5
Specific Responsibilities of Cancer Care Providers
A. Upon enrolling a patient into an approved
cancer clinical trial, the cancer care provider shall provide the patient's
health insurer(s) and the patient with information that clearly identifies what
services provided to the patient are being done solely to meet the needs of the
approved cancer clinical trial protocol, and thus are not the responsibility of
the health plan to cover and reimburse.
B. A copy of the document(s) evidencing the
fully informed, written consent of the patient or the patient's legally
authorized representative shall be made available to the patient's health
insurer upon request.
Section
6 Reporting Requirements
On or before July 1, 2004, the Office of Vermont Health
Access and the four health insurers with the largest number of covered lives in
Vermont on the effective date of this regulation shall submit to the Division
data and analysis pertaining to the financial impact of the clinical trial
pilot program required by
8 V.S.A. §
4088b on health care insurance premiums based
on specifications provided by the Division.
Section 7 Severability
If any provision of this regulation or the application
thereof to any person or circumstance is for any reason held to be invalid, the
remainder of the regulation and the application of such provisions to other
persons or circumstances shall not be affected thereby.
Section 8 Effective Date and Date of
Expiration
The effective date of this regulation is August 5,
2005.
Statutory Authority:
8 V.S.A.
§§
15 and
4088b,
especially 4088b (d)