Assembly Bill No.
502–Committee on
Health and Human Services
CHAPTER..........
AN ACT relating to insurance; requiring certain policies of insurance and health plans to provide coverage for certain medical treatment provided in a clinical trial or study; providing immunity from liability for insurers, medical services corporations, health maintenance organizations and managed care organizations for injury and other adverse outcomes occurring in connection with treatment provided in a clinical trial or study for which coverage is required to be provided; and providing other matters properly relating thereto.
THE PEOPLE OF THE STATE OF NEVADA, REPRESENTED IN
SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS:
Section 1. Chapter 689A of NRS is hereby amended by
adding thereto a new section to read as follows:
1. A policy of health insurance must provide coverage for
medical treatment which a policyholder or subscriber receives as
part of a clinical trial or study if:
(a) The medical treatment is provided in a Phase II, Phase III
or Phase IV study or clinical trial for the treatment of cancer or
chronic fatigue syndrome;
(b) The clinical trial or study is approved by:
(1) An agency of the National Institutes of Health as set
forth in 42 U.S.C. § 281(b);
(2) A cooperative group;
(3) The Food and Drug Administration as an application
for a new investigational drug;
(4) The United States Department of Veterans Affairs; or
(5) The United States Department of Defense;
(c) The medical treatment is provided by a provider of health
care and thefacility and personnel have the experience and
training to provide the treatment in a capable manner;
(d) There is no medical treatment available which is
considered a more appropriate alternative medical treatment than
the medical treatment provided in the clinical trial or study;
(e) There is a reasonable expectation based on clinical data
that the medical treatment provided in the clinical trial or study
will be at least as effective as any other medical treatment;
(f) The clinical trial or study is conducted in this state; and
(g) The policyholder or subscriber has signed, before his
participation in the clinical trial or study, a statement of consent
indicating that he has been informed of, without limitation:
(1) The procedure to be undertaken;
(2) Alternative methods of treatment; and
(3) The risks associated with participation in the clinical
trial or study, including, without limitation, the general nature and
extent of such risks.
2. Except as otherwise provided in subsection 3, the coverage
for medical treatment required by this section is limited to:
(a) Coverage for any drug or device that is approved for sale
by the Food and Drug Administration without regard to whether
the approved drug or device has been approved for use in the
medical treatment of the policyholder or subscriber.
(b) The cost of any reasonably necessary health care services
that are required as a result of the medical treatment provided in
the clinical trial or study or as a result of any complication arising
out of the medical treatment provided in the clinical trial or study,
to the extent that such health care services would otherwise be
covered under the policy of health insurance.
(c) The initial consultation to determine whether the
policyholder or subscriber is eligible to participate in the clinical
trial or study.
(d) Health care services required for the clinically appropriate
monitoring of the policyholder or subscriber during the clinical
trial or study.
Except as otherwise provided in section 9 of Assembly Bill No. 320
of this session, the services provided pursuant to paragraphs (b)
and (d) must be covered only if the services are provided by a
provider with whom the insurer has contracted for such services.
If the insurer has not contracted for the provision of such services,
the insurer shall pay the provider the rate of reimbursement that is
paid to other providers with whom the insurer has contracted for
similar services and the provider shall accept that rate of
reimbursement as payment in full.
3. Particular medical treatment described in subsection 2 and
provided to a policyholder or subscriber is not required to be
covered pursuant to this section if that particular medical
treatment is provided by the sponsor of the clinical trial or study
free of charge to the policyholder or subscriber.
4. The coverage for medical treatment required by this
section does not include:
(a) Any portion of the clinical trial or study that is customarily
paid for by a government or a biotechnical, pharmaceutical or
medical industry.
(b) Coverage for a drug or device described in paragraph (a)
of subsection 2 which is paid for by the manufacturer, distributor
or provider of the drug or device.
(c) Health care services that are specifically excluded from
coverage under the policyholder’s or subscriber’s policy of health
insurance, regardless of whether such services are provided under
the clinical trial or study.
(d) Health care services that are customarily provided by the
sponsors of the clinical trial or study free of charge to the
participants in the trial or study.
(e) Extraneous expenses related to participation in the clinical
trial or study including, without limitation, travel, housing and
other expenses that a participant may incur.
(f) Any expenses incurred by a person who accompanies the
policyholder or subscriber during the clinical trial or study.
(g) Any item or service that is provided solely to satisfy a need
or desire for data collection or analysis that is not directly related
to the clinical management of the policyholder or subscriber.
(h) Any costs for the management of research relating to the
clinical trial or study.
5. An insurer who delivers or issues for delivery a policy of
health insurance specified in subsection 1, may require copies
of the approval or certification issued pursuant to paragraph (b) of
subsection 1, the statement of consent signed by the policyholder
or subscriber, protocols for the clinical trial or study and any other
materials related to the scope of the clinical trial or study relevant
to the coverage of medical treatment pursuant to this section.
6. An insurer who delivers or issues for delivery a policy
specified in subsection 1 shall:
(a) Include in the disclosure required pursuant to NRS
689A.390 notice to each policyholder and subscriber under the
policy of the availability of the benefits required by this section.
(b) Provide the coverage required by this section subject to the
same deductible, copayment, coinsurance and other such
conditions for coverage that are required under the policy.
7. A policy of health insurance subject to the provisions of
this chapter that is delivered, issued for delivery or renewed on or
after January 1, 2004, has the legal effect of including the
coverage required by this section, and any provision of the policy
that conflicts with this section is void.
8. An insurer who delivers or issues for delivery a policy
specified in subsection 1 is immune from liability for:
(a) Any injury to a policyholder or subscriber caused by:
(1) Any medical treatment provided to the policyholder or
subscriber in connection with his participation in a clinical trial or
study described in this section; or
(2) An act or omission by a provider of health care who
provides medical treatment or supervises the provision of medical
treatment to the policyholder or subscriber in connection with his
participation in a clinical trial or study described in this section.
(b) Any adverse or unanticipated outcome arising out of a
policyholder’s or subscriber’s participation in a clinical trial or
study described in this section.
9. As used in this section:
(a) “Cooperative group” means a network of facilities that
collaborate on research projects and has established a peer review
program approved by the National Institutes of Health. The term
includes:
(1) The Clinical Trials Cooperative Group Program; and
(2) The Community Clinical Oncology Program.
(b) “Provider of health care” means:
(1) A hospital; or
(2) A person licensed pursuant to chapter 630, 631 or 633
of NRS.
Sec. 2. NRS 689A.0404 is hereby amended to read as follows:
689A.0404 Except as otherwise provided in section 1 of this
act:
1. No policy of health insurance that provides coverage for a
drug approved by the Food and Drug Administration for use in the
treatment of an illness, disease or other medical condition may be
delivered or issued for delivery in this state unless the policy
includes coverage for any other use of the drug for the treatment of
cancer , if that use is:
(a) Specified in the most recent edition of or supplement to:
(1) The United States Pharmacopoeia Drug Information; or
(2) The American Hospital Formulary Service Drug
Information; or
(b) Supported by at least two articles reporting the results of
scientific studies that are published in scientific or medical journals,
as defined in 21 C.F.R. § 99.3.
2. The coverage required pursuant to this section:
(a) Includes coverage for any medical services necessary to
administer the drug to the insured.
(b) Does not include coverage for any:
(1) Experimental drug used for the treatment of cancer if that
drug has not been approved by the Food and Drug Administration;
or
(2) Use of a drug that is contraindicated by the Food and
Drug Administration.
3. A policy of health insurance subject to the provisions of this
chapter that is delivered, issued for delivery or renewed on or after
October 1, 1999, has the legal effect of including the coverage
required by this section, and any provision of the policy that
conflicts with the provisions of this section is void.
Sec. 3. NRS 689A.330 is hereby amended to read as follows:
689A.330 If any policy is issued by a domestic insurer for
delivery to a person residing in another state, and if the insurance
commissioner or corresponding public officer of that other state has
informed the Commissioner that the policy is not subject to approval
or disapproval by that officer, the Commissioner may by ruling
require that the policy meet the standards set forth in NRS 689A.030
to 689A.320, inclusive[.] , and section 1 of this act.
Sec. 4. Chapter 689B of NRS is hereby amended by adding
thereto a new section to read as follows:
1. A policy of group health insurance must provide coverage
for medical treatment which a person insured under the group
policy receives as part of a clinical trial or study if:
(a) The medical treatment is provided in a Phase II, Phase III
or Phase IV study or clinical trial for the treatment of cancer or
chronic fatigue syndrome;
(b) The clinical trial or study is approved by:
(1) An agency of the National Institutes of Health as set
forth in 42 U.S.C. § 281(b);
(2) A cooperative group;
(3) The Food and Drug Administration as an application
for a new investigational drug;
(4) The United States Department of Veterans Affairs; or
(5) The United States Department of Defense;
(c) The medical treatment is provided by a provider of health
care and thefacility and personnel have the experience and
training to provide the treatment in a capable manner;
(d) There is no medical treatment available which is
considered a more appropriate alternative medical treatment than
the medical treatment provided in the clinical trial or study;
(e) There is a reasonable expectation based on clinical data
that the medical treatment provided in the clinical trial or study
will be at least as effective as any other medical treatment;
(f) The clinical trial or study is conducted in this state; and
(g) The insured has signed, before his participation in the
clinical trial or study, a statement of consent indicating that he has
been informed of, without limitation:
(1) The procedure to be undertaken;
(2) Alternative methods of treatment; and
(3) The risks associated with participation in the clinical
trial or study, including, without limitation, the general nature and
extent of such risks.
2. Except as otherwise provided in subsection 3, the coverage
for medical treatment required by this section is limited to:
(a) Coverage for any drug or device that is approved for sale
by the Food and Drug Administration without regard to whether
the approved drug or device has been approved for use in the
medical treatment of the insured person.
(b) The cost of any reasonably necessary health care services
that are required as a result of the medical treatment provided in
the clinical trial or study or as a result of any complication arising
out of the medical treatment provided in the clinical trial or study,
to the extent that such health care services would otherwise be
covered under the policy of group health insurance.
(c) The initial consultation to determine whether the insured is
eligible to participate in the clinical trial or study.
(d) Health care services required for the clinically appropriate
monitoring of the insured during the clinical trial or study.
Except as otherwise provided in section 13 of Assembly Bill No.
320 of this session, the services provided pursuant to paragraphs
(b) and (d) must be covered only if the services are provided by a
provider with whom the insurer has contracted for such services.
If the insurer has not contracted for the provision of such services,
the insurer shall pay the provider the rate of reimbursement that is
paid to other providers with whom the insurer has contracted for
similar services and the provider shall accept that rate of
reimbursement as payment in full.
3. Particular medical treatment described in subsection 2 and
provided to a person insured under the group policy is not
required to be covered pursuant to this section if that particular
medical treatment is provided by the sponsor of the clinical trial or
study free of charge to the person insured under the group policy.
4. The coverage for medical treatment required by this
section does not include:
(a) Any portion of the clinical trial or study that is customarily
paid for by a government or a biotechnical, pharmaceutical or
medical industry.
(b) Coverage for a drug or device described in paragraph (a)
of subsection 2 which is paid for by the manufacturer, distributor
or provider of the drug or device.
(c) Health care services that are specifically excluded from
coverage under the insured’s policy of group health insurance,
regardless of whether such services are provided under the clinical
trial or study.
(d) Health care services that are customarily provided by the
sponsors of the clinical trial or study free of charge to the
participants in the trial or study.
(e) Extraneous expenses related to participation in the clinical
trial or study including, without limitation, travel, housing and
other expenses that a participant may incur.
(f) Any expenses incurred by a person who accompanies the
insured during the clinical trial or study.
(g) Any item or service that is provided solely to satisfy a need
or desire for data collection or analysis that is not directly related
to the clinical management of the insured.
(h) Any costs for the management of research relating to the
clinical trial or study.
5. An insurer who delivers or issues for delivery a policy of
group health insurance specified in subsection 1, may require
copies of the approval or certification issued pursuant to
paragraph (b) of subsection 1, the statement of consent signed by
the insured, protocols for the clinical trial or study and any other
materials related to the scope of the clinical trial or study relevant
to the coverage of medical treatment pursuant to this section.
6. An insurer who delivers or issues for delivery a policy of
group health insurance specified in subsection 1 shall:
(a) Include in the disclosure required pursuant to NRS
689B.027 notice to each group policyholder of the availability of
the benefits required by this section.
(b) Provide the coverage required by this section subject to the
same deductible, copayment, coinsurance and other such
conditions for coverage that are required under the policy.
7. A policy of group health insurance subject to the
provisions of this chapter that is delivered, issued for delivery or
renewed on or after January 1, 2004, has the legal effect of
including the coverage required by this section, and any provision
of the policy that conflicts with this section is void.
8. An insurer who delivers or issues for delivery a policy of
group health insurance specified in subsection 1 is immune from
liability for:
(a) Any injury to the insured caused by:
(1) Any medical treatment provided to the insured in
connection with his participation in a clinical trial or study
described in this section; or
(2) An act or omission by a provider of health care who
provides medical treatment or supervises the provision of medical
treatment to the insured in connection with his participation in a
clinical trial or study described in this section.
(b) Any adverse or unanticipated outcome arising out of an
insured’s participation in a clinical trial or study described in this
section.
9. As used in this section:
(a) “Cooperative group” means a network of facilities that
collaborate on research projects and has established a peer review
program approved by the National Institutes of Health. The term
includes:
(1) The Clinical Trials Cooperative Group Program; and
(2) The Community Clinical Oncology Program.
(b) “Provider of health care” means:
(1) A hospital; or
(2) A person licensed pursuant to chapter 630, 631 or 633
of NRS.
Sec. 5. NRS 689B.0365 is hereby amended to read as follows:
689B.0365 Except as otherwise provided in section 4 of this
act:
1. No group policy of health insurance that provides coverage
for a drug approved by the Food and Drug Administration for use in
the treatment of an illness, disease or other medical condition may
be delivered or issued for delivery in this state unless the policy
includes coverage for any other use of the drug for the treatment of
cancer, if that use is:
(a) Specified in the most recent edition of or supplement to:
(1) The United States Pharmacopoeia Drug Information; or
(2) The American Hospital Formulary Service Drug
Information; or
(b) Supported by at least two articles reporting the results of
scientific studies that are published in scientific or medical journals,
as defined in 21 C.F.R. § 99.3.
2. The coverage required pursuant to this section:
(a) Includes coverage for any medical services necessary to
administer the drug to the employee or member of the insured
group.
(b) Does not include coverage for any:
(1) Experimental drug used for the treatment of cancer[,] if
that drug has not been approved by the Food and Drug
Administration; or
(2) Use of a drug that is contraindicated by the Food and
Drug Administration.
3. A policy subject to the provisions of this chapter that is
delivered, issued for delivery or renewed on or after October 1,
1999, has the legal effect of including the coverage required by this
section, and any provision of the policy that conflicts with the
provisions of this section is void.
Sec. 6. Chapter 695B of NRS is hereby amended by adding
thereto a new section to read as follows:
1. A policy of health insurance issued by a medical services
corporation must provide coverage for medical treatment which a
person insured under the policy receives as part of a clinical trial
or study if:
(a) The medical treatment is provided in a Phase II, Phase III
or Phase IV study or clinical trial for the treatment of cancer or
chronic fatigue syndrome;
(b) The clinical trial or study is approved by:
(1) An agency of the National Institutes of Health as set
forth in 42 U.S.C. § 281(b);
(2) A cooperative group;
(3) The Food and Drug Administration as an application
for a new investigational drug;
(4) The United States Department of Veterans Affairs; or
(5) The United States Department of Defense;
(c) The medical treatment is provided by a provider of health
care and thefacility and personnel have the experience and
training to provide the treatment in a capable manner;
(d) There is no medical treatment available which is
considered a more appropriate alternative medical treatment than
the medical treatment provided in the clinical trial or study;
(e) There is a reasonable expectation based on clinical data
that the medical treatment provided in the clinical trial or study
will be at least as effective as any other medical treatment;
(f) The clinical trial or study is conducted in this state; and
(g) The insured has signed, before his participation in the
clinical trial or study, a statement of consent indicating that he has
been informed of, without limitation:
(1) The procedure to be undertaken;
(2) Alternative methods of treatment; and
(3) The risks associated with participation in the clinical
trial or study, including, without limitation, the general nature and
extent of such risks.
2. Except as otherwise provided in subsection 3, the coverage
for medical treatment required by this section is limited to:
(a) Coverage for any drug or device that is approved for sale
by the Food and Drug Administration without regard to whether
the approved drug or device has been approved for use in the
medical treatment of the insured person.
(b) The cost of any reasonably necessary health care services
that are required as a result of the medical treatment provided in
the clinical trial or study or as a result of any complication arising
out of the medical treatment provided in the clinical trial or study,
to the extent that such health care services would otherwise be
covered under the policy of health insurance.
(c) The initial consultation to determine whether the insured is
eligible to participate in the clinical trial or study.
(d) Health care services required for the clinically appropriate
monitoring of the insured during the clinical trial or study.
Except as otherwise provided in section 24 of Assembly Bill No.
320 of this session, the services provided pursuant to paragraphs
(b) and (d) must be covered only if the services are provided by a
provider with whom the medical services corporation has
contracted for such services. If the medical services corporation
has not contracted for the provision of such services, the medical
services corporation shall pay the provider the rate of
reimbursement that is paid to other providers with whom the
medical services corporation has contracted for similar services
and the provider shall accept that rate of reimbursement as
payment in full.
3. Particular medical treatment described in subsection 2 and
provided to a person insured under the policy is not required to be
covered pursuant to this section if that particular medical
treatment is provided by the sponsor of the clinical trial or study
free of charge to the person insured under the policy.
4. The coverage for medical treatment required by this
section does not include:
(a) Any portion of the clinical trial or study that is customarily
paid for by a government or a biotechnical, pharmaceutical or
medical industry.
(b) Coverage for a drug or device described in paragraph (a)
of subsection 2 which is paid for by the manufacturer, distributor
or provider of the drug or device.
(c) Health care services that are specifically excluded from
coverage under the insured’s policy of health insurance,
regardless of whether such services are provided under the clinical
trial or study.
(d) Health care services that are customarily provided by the
sponsors of the clinical trial or study free of charge to the
participants in the trial or study.
(e) Extraneous expenses related to participation in the clinical
trial or study including, without limitation, travel, housing and
other expenses that a participant may incur.
(f) Any expenses incurred by a person who accompanies the
insured during the trial or study.
(g) Any item or service that is provided solely to satisfy a need
or desire for data collection or analysis that is not directly related
to the clinical management of the insured.
(h) Any costs for the management of research relating to the
clinical trial or study.
5. A medical services corporation that delivers or issues for
delivery a policy of health insurance specified in subsection 1, may
require copies of the approval or certification issued pursuant to
paragraph (b) of subsection 1, the statement of consent signed by
the insured, protocols for the clinical trial or study and any other
materials related to the scope of the clinical trial or study relevant
to the coverage of medical treatment pursuant to this section.
6. A medical services corporation that delivers or issues for
delivery a policy of health insurance specified in subsection 1
shall:
(a) Include in the disclosure required pursuant to NRS
695B.172 notice to each person insured under the policy of the
availability of the benefits required by this section.
(b) Provide the coverage required by this section subject to the
same deductible, copayment, coinsurance and other such
conditions for coverage that are required under the policy.
7. A policy of health insurance subject to the provisions of
this chapter that is delivered, issued for delivery or renewed on or
after January 1, 2004, has the legal effect of including the
coverage required by this section, and any provision of the policy
that conflicts with this section is void.
8. A medical services corporation that delivers or issues for
delivery a policy of health insurance specified in subsection 1 is
immune from liability for:
(a) Any injury to the insured caused by:
(1) Any medical treatment provided to the insured in
connection with his participation in a clinical trial or study
described in this section; or
(2) An act or omission by a provider of health care who
provides medical treatment or supervises the provision of medical
treatment to the insured in connection with his participation in a
clinical trial or study described in this section.
(b) Any adverse or unanticipated outcome arising out of an
insured’s participation in a clinical trial or study described in this
section.
9. As used in this section:
(a) “Cooperative group” means a network of facilities that
collaborate on research projects and has established a peer review
program approved by the National Institutes of Health. The term
includes:
(1) The Clinical Trials Cooperative Group Program; and
(2) The Community Clinical Oncology Program.
(b) “Provider of health care” means:
(1) A hospital; or
(2) A person licensed pursuant to chapter 630, 631 and 633
of NRS.
Sec. 7. NRS 695B.1908 is hereby amended to read as follows:
695B.1908 Except as otherwise provided in section 6 of this
act:
1. No contract for hospital or medical services that provides
coverage for a drug approved by the Food and Drug Administration
for use in the treatment of an illness, disease or other medical
condition may be delivered or issued for delivery in this state unless
the contract includes coverage for any other use of the drug for the
treatment of cancer, if that use is:
(a) Specified in the most recent edition of or supplement to:
(1) The United States Pharmacopoeia Drug Information; or
(2) The American Hospital Formulary Service Drug
Information; or
(b) Supported by at least two articles reporting the results of
scientific studies that are published in scientific or medical journals,
as defined in 21 C.F.R. § 99.3.
2. The coverage required pursuant to this section:
(a) Includes coverage for any medical services necessary to
administer the drug to a person covered under the contract.
(b) Does not include coverage for any:
(1) Experimental drug used for the treatment of cancer[,] if
that drug has not been approved by the Food and Drug
Administration; or
(2) Use of a drug that is contraindicated by the Food and
Drug Administration.
3. A contract for hospital or medical services subject to the
provisions of this chapter that is delivered, issued for delivery or
renewed on or after October 1, 1999, has the legal effect of
including the coverage required by this section, and any provision of
the contract that conflicts with the provisions of this section is void.
Sec. 8. Chapter 695C of NRS is hereby amended by adding
thereto a new section to read as follows:
1. Except as otherwise provided in NRS 695C.050, a health
care plan issued by a health maintenance organization must
provide coverage for medical treatment which an enrollee receives
as part of a clinical trial or study if:
(a) The medical treatment is provided in a Phase II, Phase III
or Phase IV study or clinical trial for the treatment of cancer or
chronic fatigue syndrome;
(b) The clinical trial or study is approved by:
(1) An agency of the National Institutes of Health as set
forth in 42 U.S.C. § 281(b);
(2) A cooperative group;
(3) The Food and Drug Administration as an application
for a new investigational drug;
(4) The United States Department of Veterans Affairs; or
(5) The United States Department of Defense;
(c) The medical treatment is provided by a provider of health
care and the facility and personnel have the experience and
training to provide the treatment in a capable manner;
(d) There is no medical treatment available which is
considered a more appropriate alternative medical treatment than
the medical treatment provided in the clinical trial or study;
(e) There is a reasonable expectation based on clinical data
that the medical treatment provided in the clinical trial or study
will be at least as effective as any other medical treatment;
(f) The clinical trial or study is conducted in this state; and
(g) The enrollee has signed, before his participation in the
clinical trial or study, a statement of consent indicating that he has
been informed of, without limitation:
(1) The procedure to be undertaken;
(2) Alternative methods of treatment; and
(3) The risks associated with participation in the clinical
trial or study, including, without limitation, the general nature and
extent of such risks.
2. Except as otherwise provided in subsection 3, the coverage
for medical treatment required by this section is limited to:
(a) Coverage for any drug or device that is approved for sale
by the Food and Drug Administration without regard to whether
the approved drug or device has been approved for use in the
medical treatment of the enrollee.
(b) The cost of any reasonably necessary health care services
that are required as a result of the medical treatment provided in
the clinical trial or study or as a result of any complication arising
out of the medical treatment provided in the clinical trial or study,
to the extent that such health care services would otherwise be
covered under the health care plan.
(c) The initial consultation to determine whether the enrollee
is eligible to participate in the clinical trial or study.
(d) Health care services required for the clinically appropriate
monitoring of the enrollee during the clinical trial or study.
Except as otherwise provided in section 27 of Assembly Bill No.
320 of this session, the services provided pursuant to paragraphs
(b) and (d) must be covered only if the services are provided by a
provider with whom the health maintenance organization has
contracted for such services. If the health maintenance
organization has not contracted for the provision of such services,
the health maintenance organization shall pay the provider the
rate of reimbursement that is paid to other providers with whom
the health maintenance organization has contracted for similar
services and the provider shall accept that rate of reimbursement
as payment in full.
3. Particular medical treatment described in subsection 2 and
provided to an enrollee is not required to be covered pursuant to
this section if that particular medical treatment is provided by the
sponsor of the clinical trial or study free of charge to the enrollee.
4. The coverage for medical treatment required by this
section does not include:
(a) Any portion of the clinical trial or study that is customarily
paid for by a government or a biotechnical, pharmaceutical or
medical industry.
(b) Coverage for a drug or device described in paragraph (a)
of subsection 2 which is paid for by the manufacturer, distributor
or provider of the drug or device.
(c) Health care services that are specifically excluded from
coverage under the enrollee’s health care plan, regardless of
whether such services are provided under the clinical trial or
study.
(d) Health care services that are customarily provided by the
sponsors of the clinical trial or study free of charge to the
participants in the trial or study.
(e) Extraneous expenses related to participation in the clinical
trial or study including, without limitation, travel, housing and
other expenses that a participant may incur.
(f) Any expenses incurred by a person who accompanies the
enrollee during the clinical trial or study.
(g) Any item or service that is provided solely to satisfy a need
or desire for data collection or analysis that is not directly related
to the clinical management of the enrollee.
(h) Any costs for the management of research relating to the
clinical trial or study.
5. A health maintenance organization that delivers or issues
for delivery a health care plan specified in subsection 1, may
require copies of the approval or certification issued pursuant to
paragraph (b) of subsection 1, the statement of consent signed by
the enrollee, protocols for the clinical trial or study and any other
materials related to the scope of the clinical trial or study relevant
to the coverage of medical treatment pursuant to this section.
6. A health maintenance organization that delivers or issues
for delivery a health care plan specified in subsection 1 shall:
(a) Include in the disclosure required pursuant to NRS
695C.193 notice to each enrollee of the availability of the benefits
required by this section.
(b) Provide the coverage required by this section subject to the
same deductible, copayment, coinsurance and other such
conditions for coverage that are required under the plan.
7. A health care plan subject to the provisions of this chapter
that is delivered, issued for delivery or renewed on or after
January 1, 2004, has the legal effect of including the coverage
required by this section, and any provision of the plan that
conflicts with this section is void.
8. A health maintenance organization that delivers or issues
for delivery a health care plan specified in subsection 1 is immune
from liability for:
(a) Any injury to an enrollee caused by:
(1) Any medical treatment provided to the enrollee in
connection with his participation in a clinical trial or study
described in this section; or
(2) An act or omission by a provider of health care who
provides medical treatment or supervises the provision of medical
treatment to the enrollee in connection with his participation in a
clinical trial or study described in this section.
(b) Any adverse or unanticipated outcome arising out of an
enrollee’s participation in a clinical trial or study described in this
section.
9. As used in this section:
(a) “Cooperative group” means a network of facilities that
collaborate on research projects and has established a peer review
program approved by the National Institutes of Health. The term
includes:
(1) The Clinical Trials Cooperative Group Program; and
(2) The Community Clinical Oncology Program.
(b) “Provider of health care” means:
(1) A hospital; or
(2) A person licensed pursuant to chapter 630, 631 or 633
of NRS.
Sec. 9. NRS 695C.050 is hereby amended to read as follows:
695C.050 1. Except as otherwise provided in this chapter or
in specific provisions of this title, the provisions of this title are not
applicable to any health maintenance organization granted a
certificate of authority under this chapter. This provision does not
apply to an insurer licensed and regulated pursuant to this title
except with respect to its activities as a health maintenance
organization authorized and regulated pursuant to this chapter.
2. Solicitation of enrollees by a health maintenance
organization granted a certificate of authority, or its representatives,
must not be construed to violate any provision of law relating to
solicitation or advertising by practitioners of a healing art.
3. Any health maintenance organization authorized under this
chapter shall not be deemed to be practicing medicine and is exempt
from the provisions of chapter 630 of NRS.
4. The provisions of NRS 695C.110, 695C.170 to 695C.200,
inclusive, 695C.250 and 695C.265 and section 8 of this act do not
apply to a health maintenance organization that provides health care
services through managed care to recipients of Medicaid under the
state plan for Medicaid or insurance pursuant to the Children’s
Health Insurance Program pursuant to a contract with the Division
of Health Care Financing and Policy of the Department of Human
Resources. This subsection does not exempt a health maintenance
organization from any provision of this chapter for services
provided pursuant to any other contract.
5. The provisions of NRS 695C.1694 and 695C.1695 apply to
a health maintenance organization that provides health care services
through managed care to recipients of Medicaid under the state plan
for Medicaid.
Sec. 10. NRS 695C.1733 is hereby amended to read as
follows:
695C.1733 Except as otherwise provided in section 8 of this
act:
1. No evidence of coverage that provides coverage for a drug
approved by the Food and Drug Administration for use in the
treatment of an illness, disease or other medical condition may be
delivered or issued for delivery in this state unless the evidence of
coverage includes coverage for any other use of the drug for the
treatment of cancer, if that use is:
(a) Specified in the most recent edition of or supplement to:
(1) The United States Pharmacopoeia Drug Information; or
(2) The American Hospital Formulary Service Drug
Information; or
(b) Supported by at least two articles reporting the results of
scientific studies that are published in scientific or medical journals,
as defined in 21 C.F.R. § 99.3.
2. The coverage required pursuant to this section:
(a) Includes coverage for any medical services necessary to
administer the drug to the enrollee.
(b) Does not include coverage for any:
(1) Experimental drug used for the treatment of cancer[,] if
that drug has not been approved by the Food and Drug
Administration; or
(2) Use of a drug that is contraindicated by the Food and
Drug Administration.
3. Any evidence of coverage subject to the provisions of this
chapter that is delivered, issued for delivery or renewed on or after
October 1, 1999, has the legal effect of including the coverage
required by this section, and any provision of the evidence of
coverage that conflicts with the provisions of this section is void.
Sec. 11. NRS 695C.330 is hereby amended to read as follows:
695C.330 1. The Commissioner may suspend or revoke any
certificate of authority issued to a health maintenance organization
pursuant to the provisions of this chapter if he finds that any of the
following conditions exist:
(a) The health maintenance organization is operating
significantly in contravention of its basic organizational document,
its health care plan or in a manner contrary to that described in and
reasonably inferred from any other information submitted pursuant
to NRS 695C.060, 695C.070 and 695C.140, unless any amendments
to those submissions have been filed with and approved by the
Commissioner;
(b) The health maintenance organization issues evidence of
coverage or uses a schedule of charges for health care services
which do not comply with the requirements of NRS [695C.170]
695C.1694 to 695C.200, inclusive, [or 695C.1694, 695C.1695] or
695C.207[;] or section 8 of this act;
(c) The health care plan does not furnish comprehensive health
care services as provided for in NRS 695C.060;
(d) The State Board of Health certifies to the Commissioner that
the health maintenance organization:
(1) Does not meet the requirements of subsection 2 of NRS
695C.080; or
(2) Is unable to fulfill its obligations to furnish health care
services as required under its health care plan;
(e) The health maintenance organization is no longer financially
responsible and may reasonably be expected to be unable to meet its
obligations to enrollees or prospective enrollees;
(f) The health maintenance organization has failed to put into
effect a mechanism affording the enrollees an opportunity to
participate in matters relating to the content of programs pursuant to
NRS 695C.110;
(g) The health maintenance organization has failed to put into
effect the system for resolving complaints required by NRS
695C.260 in a manner reasonably to dispose of valid complaints;
(h) The health maintenance organization or any person on its
behalf has advertised or merchandised its services in an untrue,
misrepresentative, misleading, deceptive or unfair manner;
(i) The continued operation of the health maintenance
organization would be hazardous to its enrollees; or
(j) The health maintenance organization has otherwise failed to
comply substantially with the provisions of this chapter.
2. A certificate of authority must be suspended or revoked only
after compliance with the requirements of NRS 695C.340.
3. If the certificate of authority of a health maintenance
organization is suspended, the health maintenance organization shall
not, during the period of that suspension, enroll any additional
groups or new individual contracts, unless those groups or persons
were contracted for before the date of suspension.
4. If the certificate of authority of a health maintenance
organization is revoked, the organization shall proceed, immediately
following the effective date of the order of revocation, to wind up its
affairs and shall conduct no further business except as may be
essential to the orderly conclusion of the affairs of the organization.
It shall engage in no further advertising or solicitation of any kind.
The Commissioner may , by written order , permit such further
operation of the organization as he may find to be in the best interest
of enrollees to the end that enrollees are afforded the greatest
practical opportunity to obtain continuing coverage for health care.
Sec. 12. Chapter 695G of NRS is hereby amended by adding
thereto a new section to read as follows:
1. A health care plan issued by a managed care organization
must provide coverage for medical treatment which a person
insured under the plan receives as part of a clinical trial or study
if:
(a) The medical treatment is provided in a Phase II, Phase III
or Phase IV study or clinical trial for the treatment of cancer or
chronic fatigue syndrome;
(b) The clinical trial or study is approved by:
(1) An agency of the National Institutes of Health as set
forth in 42 U.S.C. § 281(b);
(2) A cooperative group;
(3) The Food and Drug Administration as an application
for a new investigational drug;
(4) The United States Department of Veterans Affairs; or
(5) The United States Department of Defense;
(c) The medical treatment is provided by a provider of health
care and the facility and personnel have the experience and
training to provide the treatment in a capable manner;
(d) There is no medical treatment available which is
considered a more appropriate alternative medical treatment than
the medical treatment provided in the clinical trial or study;
(e) There is a reasonable expectation based on clinical data
that the medical treatment provided in the clinical trial or study
will be at least as effective as any other medical treatment;
(f) The clinical trial or study is conducted in this state; and
(g) The insured has signed, before his participation in the
clinical trial or study, a statement of consent indicating that he has
been informed of, without limitation:
(1) The procedure to be undertaken;
(2) Alternative methods of treatment; and
(3) The risks associated with participation in the clinical
trial or study, including, without limitation, the general nature and
extent of such risks.
2. Except as otherwise provided in subsection 3, the coverage
for medical treatment required by this section is limited to:
(a) Coverage for any drug or device that is approved for sale
by the Food and Drug Administration without regard to whether
the approved drug or device has been approved for use in the
medical treatment of the insured.
(b) The cost of any reasonably necessary health care services
that are required as a result of the medical treatment provided in
the clinical trial or study or as a result of any complication arising
out of the medical treatment provided in the clinical trial or study,
to the extent that such health care services would otherwise be
covered under the health care plan.
(c) The initial consultation to determine whether the insured is
eligible to participate in the clinical trial or study.
(d) Health care services required for the clinically appropriate
monitoring of the insured during the clinical trial or study.
Except as otherwise provided in section 33 of Assembly Bill No.
320 of this session, the services provided pursuant to paragraphs
(b) and (d) must be covered only if the services are provided by a
provider with whom the managed care organization has
contracted for such services. If the managed care organization has
not contracted for the provision of such services, the managed
care organization shall pay the provider the rate of reimbursement
that is paid to other providers with whom the managed care
organization has contracted for similar services and the provider
shall accept that rate of reimbursement as payment in full.
3. Particular medical treatment described in subsection 2 and
provided to a person insured under the plan is not required to be
covered pursuant to this section if that particular medical
treatment is provided by the sponsor of the clinical trial or study
free of charge to the person insured under the plan.
4. The coverage for medical treatment required by this
section does not include:
(a) Any portion of the clinical trial or study that is customarily
paid for by a government or a biotechnical, pharmaceutical or
medical industry.
(b) Coverage for a drug or device described in paragraph (a)
of subsection 2 which is paid for by the manufacturer, distributor
or provider of the drug or device.
(c) Health care services that are specifically excluded from
coverage under the insured’s health care plan, regardless of
whether such services are provided under the clinical trial or
study.
(d) Health care services that are customarily provided by the
sponsors of the clinical trial or study free of charge to the
participants in the trial or study.
(e) Extraneous expenses related to participation in the clinical
trial or study including, without limitation, travel, housing and
other expenses that a participant may incur.
(f) Any expenses incurred by a person who accompanies the
insured during the clinical trial or study.
(g) Any item or service that is provided solely to satisfy a need
or desire for data collection or analysis that is not directly related
to the clinical management of the insured.
(h) Any costs for the management of research relating to the
clinical trial or study.
5. A managed care organization that delivers or issues for
delivery a health care plan specified in subsection 1, may require
copies of the approval or certification issued pursuant to
paragraph (b) of subsection 1, the statement of consent signed by
the insured, protocols for the clinical trial or study and any other
materials related to the scope of the clinical trial or study relevant
to the coverage of medical treatment pursuant to this section.
6. A managed care organization that delivers or issues for
delivery a health care plan specified in subsection 1 shall:
(a) Include in the disclosure required pursuant to NRS
695C.193 notice to each person insured under the plan of the
availability of the benefits required by this section.
(b) Provide the coverage required by this section subject to the
same deductible, copayment, coinsurance and other such
conditions for coverage that are required under the plan.
7. A health care plan subject to the provisions of this chapter
that is delivered, issued for delivery or renewed on or after
January 1, 2004, has the legal effect of including the coverage
required by this section, and any provision of the plan that
conflicts with this section is void.
8. A managed care organization that delivers or issues for
delivery a health care plan specified in subsection 1 is immune
from liability for:
(a) Any injury to an insured caused by:
(1) Any medical treatment provided to the insured in
connection with his participation in a clinical trial or study
described in this section; or
(2) An act or omission by a provider of health care who
provides medical treatment or supervises the provision of medical
treatment to the insured in connection with his participation in a
clinical trial or study described in this section.
(b) Any adverse or unanticipated outcome arising out of an
insured’s participation in a clinical trial or study described in this
section.
9. As used in this section:
(a) “Cooperative group” means a network of facilities that
collaborate on research projects and has established a peer review
program approved by the National Institutes of Health. The term
includes:
(1) The Clinical Trials Cooperative Group Program; and
(2) The Community Clinical Oncology Program.
(b) “Provider of health care” means:
(1) A hospital; or
(2) A person licensed pursuant to chapter 630, 631 or 633
of NRS.
Sec. 13. NRS 287.010 is hereby amended to read as follows:
287.010 1. The governing body of any county, school
district, municipal corporation, political subdivision, public
corporation or other public agency of the State of Nevada may:
(a) Adopt and carry into effect a system of group life, accident
or health insurance, or any combination thereof, for the benefit of its
officers and employees, and the dependents of officers and
employees who elect to accept the insurance and who, where
necessary, have authorized the governing body to make deductions
from their compensation for the payment of premiums on the
insurance.
(b) Purchase group policies of life, accident or health insurance,
or any combination thereof, for the benefit of such officers and
employees, and the dependents of such officers and employees, as
have authorized the purchase, from insurance companies authorized
to transact the business of such insurance in the State of Nevada,
and, where necessary, deduct from the compensation of officers and
employees the premiums upon insurance and pay the deductions
upon the premiums.
(c) Provide group life, accident or health coverage through a
self-insurance reserve fund and, where necessary, deduct
contributions to the maintenance of the fund from the compensation
of officers and employees and pay the deductions into the fund. The
money accumulated for this purpose through deductions from
the compensation of officers and employees and contributions of the
governing body must be maintained as an internal service fund as
defined by NRS 354.543. The money must be deposited in a state or
national bank or credit union authorized to transact business in the
State of Nevada. Any independent administrator of a fund created
under this section is subject to the licensing requirements of chapter
683A of NRS, and must be a resident of this state. Any contract
with an independent administrator must be approved by the
Commissioner of Insurance as to the reasonableness of
administrative charges in relation to contributions collected and
benefits provided. The provisions of NRS 689B.030 to 689B.050,
inclusive, and 689B.575 and section 4 of this act apply to coverage
provided pursuant to this paragraph, except that the provisions of
NRS 689B.0359 do not apply to such coverage.
(d) Defray part or all of the cost of maintenance of a self-
insurance fund or of the premiums upon insurance. The money for
contributions must be budgeted for in accordance with the laws
governing the county, school district, municipal corporation,
political subdivision, public corporation or other public agency of
the State of Nevada.
2. If a school district offers group insurance to its officers and
employees pursuant to this section, members of the board of trustees
of the school district must not be excluded from participating in the
group insurance. If the amount of the deductions from compensation
required to pay for the group insurance exceeds the compensation to
which a trustee is entitled, the difference must be paid by the trustee.
Sec. 14. NRS 287.04335 is hereby amended to read as
follows:
287.04335 If the Board provides health insurance through a
plan of self-insurance, it shall comply with the provisions of section
12 of this act and NRS 689B.255, 695G.150, 695G.160, 695G.170
and 695G.200 to 695G.230, inclusive, in the same manner as an
insurer that is licensed pursuant to title 57 of NRS is required to
comply with those provisions.
Sec. 15. This act becomes effective on January 1, 2004.
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