Assembly
Bill No. 502–Committee on
Health and Human Services
March 24, 2003
____________
Referred to Committee on Commerce and Labor
SUMMARY—Requires certain policies of health insurance and health care plans to include coverage for certain medical treatment provided in clinical trial or study. (BDR 57‑1196)
FISCAL NOTE: Effect on Local Government: Yes.
Effect on the State: Yes.
~
EXPLANATION
– Matter in bolded italics is new; matter
between brackets [omitted material] is material to be omitted.
Green numbers along left margin indicate location on the printed bill (e.g., 5-15 indicates page 5, line 15).
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:
1-1 Section 1. Chapter 689A of NRS is hereby amended by
1-2 adding thereto a new section to read as follows:
1-3 1. A policy of health insurance must provide coverage for
1-4 medical treatment which a policyholder or subscriber receives as
1-5 part of a clinical trial or study if:
1-6 (a) The medical treatment is provided in a Phase II, Phase III
1-7 or Phase IV study or clinical trial for the treatment of cancer or
1-8 chronic fatigue syndrome;
1-9 (b) The clinical trial or study is approved by:
2-1 (1) An agency of the National Institutes of Health as set
2-2 forth in 42 U.S.C. § 281(b);
2-3 (2) A cooperative group;
2-4 (3) The Food and Drug Administration as an application
2-5 for a new investigational drug;
2-6 (4) The United States Department of Veterans Affairs; or
2-7 (5) The United States Department of Defense;
2-8 (c) The medical treatment is provided by a provider of health
2-9 care and thefacility and personnel have the experience and
2-10 training to provide the treatment in a capable manner;
2-11 (d) There is no medical treatment available which is
2-12 considered a more appropriate alternative medical treatment than
2-13 the medical treatment provided in the clinical trial or study;
2-14 (e) There is a reasonable expectation based on clinical data
2-15 that the medical treatment provided in the clinical trial or study
2-16 will be at least as effective as any other medical treatment;
2-17 (f) The clinical trial or study is conducted in this state; and
2-18 (g) The policyholder or subscriber has signed, before his
2-19 participation in the clinical trial or study, a statement of consent
2-20 indicating that he has been informed of, without limitation:
2-21 (1) The procedure to be undertaken;
2-22 (2) Alternative methods of treatment; and
2-23 (3) The risks associated with participation in the clinical
2-24 trial or study, including, without limitation, the general nature and
2-25 extent of such risks.
2-26 2. The coverage for medical treatment pursuant to this
2-27 section is required only to the extent that the medical treatment is
2-28 not otherwise provided in connection with the clinical trial or
2-29 study, and is limited to:
2-30 (a) Coverage for any drug or device that is approved for sale
2-31 by the Food and Drug Administration without regard to whether
2-32 the approved drug or device has been approved for use in the
2-33 medical treatment of the policyholder or subscriber.
2-34 (b) The cost of any reasonably necessary health care services
2-35 that are required as a result of the medical treatment provided in
2-36 the clinical trial or study or as a result of any complication arising
2-37 out of the medical treatment provided in the clinical trial or study,
2-38 to the extent that such health care services would otherwise be
2-39 covered under the policy of health insurance.
2-40 (c) The initial consultation to determine whether the
2-41 policyholder or subscriber is eligible to participate in the clinical
2-42 trial or study.
2-43 (d) Health care services required for the clinically appropriate
2-44 monitoring of the policyholder or subscriber during the clinical
2-45 trial or study.
3-1 The services provided pursuant to paragraphs (b) and (d) must be
3-2 covered only if the services are provided by a provider with whom
3-3 the insurer has contracted for such services. If the insurer has not
3-4 contracted for the provision of such services, the insurer shall pay
3-5 the provider the rate of reimbursement that is paid to other
3-6 providers with whom the insurer has contracted for similar
3-7 services and the provider shall accept that rate of reimbursement
3-8 as payment in full.
3-9 3. The coverage for medical treatment required by this
3-10 section does not include:
3-11 (a) Any portion of the clinical trial or study that is customarily
3-12 paid for by a government or a biotechnical, pharmaceutical or
3-13 medical industry.
3-14 (b) Coverage for a drug or device described in paragraph (a)
3-15 of subsection 2 which is paid for by the manufacturer, distributor
3-16 or provider of the drug or device.
3-17 (c) Health care services that are specifically excluded from
3-18 coverage under the policyholder’s or subscriber’s policy of health
3-19 insurance, regardless of whether such services are provided under
3-20 the clinical trial or study.
3-21 (d) Health care services that are customarily provided by the
3-22 sponsors of the clinical trial or study free of charge to the
3-23 participants in the trial or study.
3-24 (e) Extraneous expenses related to participation in the clinical
3-25 trial or study including, without limitation, travel, housing and
3-26 other expenses that a participant may incur.
3-27 (f) Any expenses incurred by a person who accompanies the
3-28 policyholder or subscriber during the clinical trial or study.
3-29 (g) Any item or service that is provided solely to satisfy a need
3-30 or desire for data collection or analysis that is not directly related
3-31 to the clinical management of the policyholder or subscriber.
3-32 (h) Any costs for the management of research relating to the
3-33 clinical trial or study.
3-34 4. An insurer who delivers or issues for delivery a policy of
3-35 health insurance specified in subsection 1, may require copies
3-36 of the approval or certification issued pursuant to paragraph (b) of
3-37 subsection 1, the statement of consent signed by the policyholder
3-38 or subscriber, protocols for the clinical trial or study and any other
3-39 materials related to the scope of the clinical trial or study relevant
3-40 to the coverage of medical treatment pursuant to this section.
3-41 5. An insurer who delivers or issues for delivery a policy
3-42 specified in subsection 1 shall:
3-43 (a) Include in the disclosure required pursuant to NRS
3-44 689A.390 notice to each policyholder and subscriber under the
3-45 policy of the availability of the benefits required by this section.
4-1 (b) Provide the coverage required by this section subject to the
4-2 same deductible, copayment, coinsurance and other such
4-3 conditions for coverage that are required under the policy.
4-4 6. A policy of health insurance subject to the provisions of
4-5 this chapter that is delivered, issued for delivery or renewed on or
4-6 after January 1, 2004, has the legal effect of including the
4-7 coverage required by this section, and any provision of the policy
4-8 that conflicts with this section is void.
4-9 7. An insurer who delivers or issues for delivery a policy
4-10 specified in subsection 1 is immune from liability for:
4-11 (a) Any injury to a policyholder or subscriber caused by:
4-12 (1) Any medical treatment provided to the policyholder or
4-13 subscriber in connection with his participation in a clinical trial or
4-14 study described in this section; or
4-15 (2) An act or omission by a provider of health care who
4-16 provides medical treatment or supervises the provision of medical
4-17 treatment to the policyholder or subscriber in connection with his
4-18 participation in a clinical trial or study described in this section.
4-19 (b) Any adverse or unanticipated outcome arising out of a
4-20 policyholder’s or subscriber’s participation in a clinical trial or
4-21 study described in this section.
4-22 8. As used in this section:
4-23 (a) “Cooperative group” means a network of facilities that
4-24 collaborate on research projects and has established a peer review
4-25 program approved by the National Institutes of Health. The term
4-26 includes:
4-27 (1) The Clinical Trials Cooperative Group Program; and
4-28 (2) The Community Clinical Oncology Program.
4-29 (b) “Provider of health care” means:
4-30 (1) A hospital; or
4-31 (2) A person licensed pursuant to chapter 630, 631 or 633
4-32 of NRS.
4-33 Sec. 2. NRS 689A.0404 is hereby amended to read as follows:
4-34 689A.0404 Except as otherwise provided in section 1 of this
4-35 act:
4-36 1. No policy of health insurance that provides coverage for a
4-37 drug approved by the Food and Drug Administration for use in the
4-38 treatment of an illness, disease or other medical condition may be
4-39 delivered or issued for delivery in this state unless the policy
4-40 includes coverage for any other use of the drug for the treatment of
4-41 cancer , if that use is:
4-42 (a) Specified in the most recent edition of or supplement to:
4-43 (1) The United States Pharmacopoeia Drug Information; or
4-44 (2) The American Hospital Formulary Service Drug
4-45 Information; or
5-1 (b) Supported by at least two articles reporting the results of
5-2 scientific studies that are published in scientific or medical journals,
5-3 as defined in 21 C.F.R. § 99.3.
5-4 2. The coverage required pursuant to this section:
5-5 (a) Includes coverage for any medical services necessary to
5-6 administer the drug to the insured.
5-7 (b) Does not include coverage for any:
5-8 (1) Experimental drug used for the treatment of cancer if that
5-9 drug has not been approved by the Food and Drug Administration;
5-10 or
5-11 (2) Use of a drug that is contraindicated by the Food and
5-12 Drug Administration.
5-13 3. A policy of health insurance subject to the provisions of this
5-14 chapter that is delivered, issued for delivery or renewed on or after
5-15 October 1, 1999, has the legal effect of including the coverage
5-16 required by this section, and any provision of the policy that
5-17 conflicts with the provisions of this section is void.
5-18 Sec. 3. NRS 689A.330 is hereby amended to read as follows:
5-19 689A.330 If any policy is issued by a domestic insurer for
5-20 delivery to a person residing in another state, and if the insurance
5-21 commissioner or corresponding public officer of that other state has
5-22 informed the Commissioner that the policy is not subject to approval
5-23 or disapproval by that officer, the Commissioner may by ruling
5-24 require that the policy meet the standards set forth in NRS 689A.030
5-25 to 689A.320, inclusive[.] , and section 1 of this act.
5-26 Sec. 4. Chapter 689B of NRS is hereby amended by adding
5-27 thereto a new section to read as follows:
5-28 1. A policy of group health insurance must provide coverage
5-29 for medical treatment which a person insured under the group
5-30 policy receives as part of a clinical trial or study if:
5-31 (a) The medical treatment is provided in a Phase II, Phase III
5-32 or Phase IV study or clinical trial for the treatment of cancer or
5-33 chronic fatigue syndrome;
5-34 (b) The clinical trial or study is approved by:
5-35 (1) An agency of the National Institutes of Health as set
5-36 forth in 42 U.S.C. § 281(b);
5-37 (2) A cooperative group;
5-38 (3) The Food and Drug Administration as an application
5-39 for a new investigational drug;
5-40 (4) The United States Department of Veterans Affairs; or
5-41 (5) The United States Department of Defense;
5-42 (c) The medical treatment is provided by a provider of health
5-43 care and thefacility and personnel have the experience and
5-44 training to provide the treatment in a capable manner;
6-1 (d) There is no medical treatment available which is
6-2 considered a more appropriate alternative medical treatment than
6-3 the medical treatment provided in the clinical trial or study;
6-4 (e) There is a reasonable expectation based on clinical data
6-5 that the medical treatment provided in the clinical trial or study
6-6 will be at least as effective as any other medical treatment;
6-7 (f) The clinical trial or study is conducted in this state; and
6-8 (g) The insured has signed, before his participation in the
6-9 clinical trial or study, a statement of consent indicating that he has
6-10 been informed of, without limitation:
6-11 (1) The procedure to be undertaken;
6-12 (2) Alternative methods of treatment; and
6-13 (3) The risks associated with participation in the clinical
6-14 trial or study, including, without limitation, the general nature and
6-15 extent of such risks.
6-16 2. The coverage for medical treatment pursuant to this
6-17 section is required only to the extent that the medical treatment is
6-18 not otherwise provided in connection with the clinical trial or
6-19 study, and is limited to:
6-20 (a) Coverage for any drug or device that is approved for sale
6-21 by the Food and Drug Administration without regard to whether
6-22 the approved drug or device has been approved for use in the
6-23 medical treatment of the insured person.
6-24 (b) The cost of any reasonably necessary health care services
6-25 that are required as a result of the medical treatment provided in
6-26 the clinical trial or study or as a result of any complication arising
6-27 out of the medical treatment provided in the clinical trial or study,
6-28 to the extent that such health care services would otherwise be
6-29 covered under the policy of group health insurance.
6-30 (c) The initial consultation to determine whether the insured is
6-31 eligible to participate in the clinical trial or study.
6-32 (d) Health care services required for the clinically appropriate
6-33 monitoring of the insured during the clinical trial or study.
6-34 The services provided pursuant to paragraphs (b) and (d) must be
6-35 covered only if the services are provided by a provider with whom
6-36 the insurer has contracted for such services. If the insurer has not
6-37 contracted for the provision of such services, the insurer shall pay
6-38 the provider the rate of reimbursement that is paid to other
6-39 providers with whom the insurer has contracted for similar
6-40 services and the provider shall accept that rate of reimbursement
6-41 as payment in full.
6-42 3. The coverage for medical treatment required by this
6-43 section does not include:
7-1 (a) Any portion of the clinical trial or study that is customarily
7-2 paid for by a government or a biotechnical, pharmaceutical or
7-3 medical industry.
7-4 (b) Coverage for a drug or device described in paragraph (a)
7-5 of subsection 2 which is paid for by the manufacturer, distributor
7-6 or provider of the drug or device.
7-7 (c) Health care services that are specifically excluded from
7-8 coverage under the insured’s policy of group health insurance,
7-9 regardless of whether such services are provided under the clinical
7-10 trial or study.
7-11 (d) Health care services that are customarily provided by the
7-12 sponsors of the clinical trial or study free of charge to the
7-13 participants in the trial or study.
7-14 (e) Extraneous expenses related to participation in the clinical
7-15 trial or study including, without limitation, travel, housing and
7-16 other expenses that a participant may incur.
7-17 (f) Any expenses incurred by a person who accompanies the
7-18 insured during the clinical trial or study.
7-19 (g) Any item or service that is provided solely to satisfy a need
7-20 or desire for data collection or analysis that is not directly related
7-21 to the clinical management of the insured.
7-22 (h) Any costs for the management of research relating to the
7-23 clinical trial or study.
7-24 4. An insurer who delivers or issues for delivery a policy of
7-25 group health insurance specified in subsection 1, may require
7-26 copies of the approval or certification issued pursuant to
7-27 paragraph (b) of subsection 1, the statement of consent signed by
7-28 the insured, protocols for the clinical trial or study and any other
7-29 materials related to the scope of the clinical trial or study relevant
7-30 to the coverage of medical treatment pursuant to this section.
7-31 5. An insurer who delivers or issues for delivery a policy of
7-32 group health insurance specified in subsection 1 shall:
7-33 (a) Include in the disclosure required pursuant to NRS
7-34 689B.027 notice to each group policyholder of the availability of
7-35 the benefits required by this section.
7-36 (b) Provide the coverage required by this section subject to the
7-37 same deductible, copayment, coinsurance and other such
7-38 conditions for coverage that are required under the policy.
7-39 6. A policy of group health insurance subject to the
7-40 provisions of this chapter that is delivered, issued for delivery or
7-41 renewed on or after January 1, 2004, has the legal effect of
7-42 including the coverage required by this section, and any provision
7-43 of the policy that conflicts with this section is void.
8-1 7. An insurer who delivers or issues for delivery a policy of
8-2 group health insurance specified in subsection 1 is immune from
8-3 liability for:
8-4 (a) Any injury to the insured caused by:
8-5 (1) Any medical treatment provided to the insured in
8-6 connection with his participation in a clinical trial or study
8-7 described in this section; or
8-8 (2) An act or omission by a provider of health care who
8-9 provides medical treatment or supervises the provision of medical
8-10 treatment to the insured in connection with his participation in a
8-11 clinical trial or study described in this section.
8-12 (b) Any adverse or unanticipated outcome arising out of an
8-13 insured’s participation in a clinical trial or study described in this
8-14 section.
8-15 8. As used in this section:
8-16 (a) “Cooperative group” means a network of facilities that
8-17 collaborate on research projects and has established a peer review
8-18 program approved by the National Institutes of Health. The term
8-19 includes:
8-20 (1) The Clinical Trials Cooperative Group Program; and
8-21 (2) The Community Clinical Oncology Program.
8-22 (b) “Provider of health care” means:
8-23 (1) A hospital; or
8-24 (2) A person licensed pursuant to chapter 630, 631 or 633
8-25 of NRS.
8-26 Sec. 5. NRS 689B.0365 is hereby amended to read as follows:
8-27 689B.0365 Except as otherwise provided in section 4 of this
8-28 act:
8-29 1. No group policy of health insurance that provides coverage
8-30 for a drug approved by the Food and Drug Administration for use in
8-31 the treatment of an illness, disease or other medical condition may
8-32 be delivered or issued for delivery in this state unless the policy
8-33 includes coverage for any other use of the drug for the treatment of
8-34 cancer, if that use is:
8-35 (a) Specified in the most recent edition of or supplement to:
8-36 (1) The United States Pharmacopoeia Drug Information; or
8-37 (2) The American Hospital Formulary Service Drug
8-38 Information; or
8-39 (b) Supported by at least two articles reporting the results of
8-40 scientific studies that are published in scientific or medical journals,
8-41 as defined in 21 C.F.R. § 99.3.
8-42 2. The coverage required pursuant to this section:
8-43 (a) Includes coverage for any medical services necessary to
8-44 administer the drug to the employee or member of the insured
8-45 group.
9-1 (b) Does not include coverage for any:
9-2 (1) Experimental drug used for the treatment of cancer[,] if
9-3 that drug has not been approved by the Food and Drug
9-4 Administration; or
9-5 (2) Use of a drug that is contraindicated by the Food and
9-6 Drug Administration.
9-7 3. A policy subject to the provisions of this chapter that is
9-8 delivered, issued for delivery or renewed on or after October 1,
9-9 1999, has the legal effect of including the coverage required by this
9-10 section, and any provision of the policy that conflicts with the
9-11 provisions of this section is void.
9-12 Sec. 6. Chapter 695B of NRS is hereby amended by adding
9-13 thereto a new section to read as follows:
9-14 1. A policy of health insurance issued by a medical services
9-15 corporation must provide coverage for medical treatment which a
9-16 person insured under the policy receives as part of a clinical trial
9-17 or study if:
9-18 (a) The medical treatment is provided in a Phase II, Phase III
9-19 or Phase IV study or clinical trial for the treatment of cancer or
9-20 chronic fatigue syndrome;
9-21 (b) The clinical trial or study is approved by:
9-22 (1) An agency of the National Institutes of Health as set
9-23 forth in 42 U.S.C. § 281(b);
9-24 (2) A cooperative group;
9-25 (3) The Food and Drug Administration as an application
9-26 for a new investigational drug;
9-27 (4) The United States Department of Veterans Affairs; or
9-28 (5) The United States Department of Defense;
9-29 (c) The medical treatment is provided by a provider of health
9-30 care and thefacility and personnel have the experience and
9-31 training to provide the treatment in a capable manner;
9-32 (d) There is no medical treatment available which is
9-33 considered a more appropriate alternative medical treatment than
9-34 the medical treatment provided in the clinical trial or study;
9-35 (e) There is a reasonable expectation based on clinical data
9-36 that the medical treatment provided in the clinical trial or study
9-37 will be at least as effective as any other medical treatment;
9-38 (f) The clinical trial or study is conducted in this state; and
9-39 (g) The insured has signed, before his participation in the
9-40 clinical trial or study, a statement of consent indicating that he has
9-41 been informed of, without limitation:
9-42 (1) The procedure to be undertaken;
9-43 (2) Alternative methods of treatment; and
10-1 (3) The risks associated with participation in the clinical
10-2 trial or study, including, without limitation, the general nature and
10-3 extent of such risks.
10-4 2. The coverage for medical treatment pursuant to this
10-5 section is required only to the extent that the medical treatment is
10-6 not otherwise provided in connection with the clinical trial or
10-7 study, and is limited to:
10-8 (a) Coverage for any drug or device that is approved for sale
10-9 by the Food and Drug Administration without regard to whether
10-10 the approved drug or device has been approved for use in the
10-11 medical treatment of the insured person.
10-12 (b) The cost of any reasonably necessary health care services
10-13 that are required as a result of the medical treatment provided in
10-14 the clinical trial or study or as a result of any complication arising
10-15 out of the medical treatment provided in the clinical trial or study,
10-16 to the extent that such health care services would otherwise be
10-17 covered under the policy of health insurance.
10-18 (c) The initial consultation to determine whether the insured is
10-19 eligible to participate in the clinical trial or study.
10-20 (d) Health care services required for the clinically appropriate
10-21 monitoring of the insured during the clinical trial or study.
10-22 The services provided pursuant to paragraphs (b) and (d) must be
10-23 covered only if the services are provided by a provider with whom
10-24 the medical services corporation has contracted for such services.
10-25 If the medical services corporation has not contracted for the
10-26 provision of such services, the medical services corporation shall
10-27 pay the provider the rate of reimbursement that is paid to other
10-28 providers with whom the medical services corporation has
10-29 contracted for similar services and the provider shall accept that
10-30 rate of reimbursement as payment in full.
10-31 3. The coverage for medical treatment required by this
10-32 section does not include:
10-33 (a) Any portion of the clinical trial or study that is customarily
10-34 paid for by a government or a biotechnical, pharmaceutical or
10-35 medical industry.
10-36 (b) Coverage for a drug or device described in paragraph (a)
10-37 of subsection 2 which is paid for by the manufacturer, distributor
10-38 or provider of the drug or device.
10-39 (c) Health care services that are specifically excluded from
10-40 coverage under the insured’s policy of health insurance,
10-41 regardless of whether such services are provided under the clinical
10-42 trial or study.
10-43 (d) Health care services that are customarily provided by the
10-44 sponsors of the clinical trial or study free of charge to the
10-45 participants in the trial or study.
11-1 (e) Extraneous expenses related to participation in the clinical
11-2 trial or study including, without limitation, travel, housing and
11-3 other expenses that a participant may incur.
11-4 (f) Any expenses incurred by a person who accompanies the
11-5 insured during the trial or study.
11-6 (g) Any item or service that is provided solely to satisfy a need
11-7 or desire for data collection or analysis that is not directly related
11-8 to the clinical management of the insured.
11-9 (h) Any costs for the management of research relating to the
11-10 clinical trial or study.
11-11 4. A medical services corporation that delivers or issues for
11-12 delivery a policy of health insurance specified in subsection 1, may
11-13 require copies of the approval or certification issued pursuant to
11-14 paragraph (b) of subsection 1, the statement of consent signed by
11-15 the insured, protocols for the clinical trial or study and any other
11-16 materials related to the scope of the clinical trial or study relevant
11-17 to the coverage of medical treatment pursuant to this section.
11-18 5. A medical services corporation that delivers or issues for
11-19 delivery a policy of health insurance specified in subsection 1
11-20 shall:
11-21 (a) Include in the disclosure required pursuant to NRS
11-22 695B.172 notice to each person insured under the policy of the
11-23 availability of the benefits required by this section.
11-24 (b) Provide the coverage required by this section subject to the
11-25 same deductible, copayment, coinsurance and other such
11-26 conditions for coverage that are required under the policy.
11-27 6. A policy of health insurance subject to the provisions of
11-28 this chapter that is delivered, issued for delivery or renewed on or
11-29 after January 1, 2004, has the legal effect of including the
11-30 coverage required by this section, and any provision of the policy
11-31 that conflicts with this section is void.
11-32 7. A medical services corporation that delivers or issues for
11-33 delivery a policy of health insurance specified in subsection 1 is
11-34 immune from liability for:
11-35 (a) Any injury to the insured caused by:
11-36 (1) Any medical treatment provided to the insured in
11-37 connection with his participation in a clinical trial or study
11-38 described in this section; or
11-39 (2) An act or omission by a provider of health care who
11-40 provides medical treatment or supervises the provision of medical
11-41 treatment to the insured in connection with his participation in a
11-42 clinical trial or study described in this section.
11-43 (b) Any adverse or unanticipated outcome arising out of an
11-44 insured’s participation in a clinical trial or study described in this
11-45 section.
12-1 8. As used in this section:
12-2 (a) “Cooperative group” means a network of facilities that
12-3 collaborate on research projects and has established a peer review
12-4 program approved by the National Institutes of Health. The term
12-5 includes:
12-6 (1) The Clinical Trials Cooperative Group Program; and
12-7 (2) The Community Clinical Oncology Program.
12-8 (b) “Provider of health care” means:
12-9 (1) A hospital; or
12-10 (2) A person licensed pursuant to chapter 630, 631 and 633
12-11 of NRS.
12-12 Sec. 7. NRS 695B.1908 is hereby amended to read as follows:
12-13 695B.1908 Except as otherwise provided in section 6 of this
12-14 act:
12-15 1. No contract for hospital or medical services that provides
12-16 coverage for a drug approved by the Food and Drug Administration
12-17 for use in the treatment of an illness, disease or other medical
12-18 condition may be delivered or issued for delivery in this state unless
12-19 the contract includes coverage for any other use of the drug for the
12-20 treatment of cancer, if that use is:
12-21 (a) Specified in the most recent edition of or supplement to:
12-22 (1) The United States Pharmacopoeia Drug Information; or
12-23 (2) The American Hospital Formulary Service Drug
12-24 Information; or
12-25 (b) Supported by at least two articles reporting the results of
12-26 scientific studies that are published in scientific or medical journals,
12-27 as defined in 21 C.F.R. § 99.3.
12-28 2. The coverage required pursuant to this section:
12-29 (a) Includes coverage for any medical services necessary to
12-30 administer the drug to a person covered under the contract.
12-31 (b) Does not include coverage for any:
12-32 (1) Experimental drug used for the treatment of cancer[,] if
12-33 that drug has not been approved by the Food and Drug
12-34 Administration; or
12-35 (2) Use of a drug that is contraindicated by the Food and
12-36 Drug Administration.
12-37 3. A contract for hospital or medical services subject to the
12-38 provisions of this chapter that is delivered, issued for delivery or
12-39 renewed on or after October 1, 1999, has the legal effect of
12-40 including the coverage required by this section, and any provision of
12-41 the contract that conflicts with the provisions of this section is void.
12-42 Sec. 8. Chapter 695C of NRS is hereby amended by adding
12-43 thereto a new section to read as follows:
12-44 1. Except as otherwise provided in NRS 695C.050, a health
12-45 care plan issued by a health maintenance organization must
13-1 provide coverage for medical treatment which an enrollee receives
13-2 as part of a clinical trial or study if:
13-3 (a) The medical treatment is provided in a Phase II, Phase III
13-4 or Phase IV study or clinical trial for the treatment of cancer or
13-5 chronic fatigue syndrome;
13-6 (b) The clinical trial or study is approved by:
13-7 (1) An agency of the National Institutes of Health as set
13-8 forth in 42 U.S.C. § 281(b);
13-9 (2) A cooperative group;
13-10 (3) The Food and Drug Administration as an application
13-11 for a new investigational drug;
13-12 (4) The United States Department of Veterans Affairs; or
13-13 (5) The United States Department of Defense;
13-14 (c) The medical treatment is provided by a provider of health
13-15 care and the facility and personnel have the experience and
13-16 training to provide the treatment in a capable manner;
13-17 (d) There is no medical treatment available which is
13-18 considered a more appropriate alternative medical treatment than
13-19 the medical treatment provided in the clinical trial or study;
13-20 (e) There is a reasonable expectation based on clinical data
13-21 that the medical treatment provided in the clinical trial or study
13-22 will be at least as effective as any other medical treatment;
13-23 (f) The clinical trial or study is conducted in this state; and
13-24 (g) The enrollee has signed, before his participation in the
13-25 clinical trial or study, a statement of consent indicating that he has
13-26 been informed of, without limitation:
13-27 (1) The procedure to be undertaken;
13-28 (2) Alternative methods of treatment; and
13-29 (3) The risks associated with participation in the clinical
13-30 trial or study, including, without limitation, the general nature and
13-31 extent of such risks.
13-32 2. The coverage for medical treatment pursuant to this
13-33 section is required only to the extent that the medical treatment is
13-34 not otherwise provided in connection with the clinical trial or
13-35 study, and is limited to:
13-36 (a) Coverage for any drug or device that is approved for sale
13-37 by the Food and Drug Administration without regard to whether
13-38 the approved drug or device has been approved for use in the
13-39 medical treatment of the enrollee.
13-40 (b) The cost of any reasonably necessary health care services
13-41 that are required as a result of the medical treatment provided in
13-42 the clinical trial or study or as a result of any complication arising
13-43 out of the medical treatment provided in the clinical trial or study,
13-44 to the extent that such health care services would otherwise be
13-45 covered under the health care plan.
14-1 (c) The initial consultation to determine whether the enrollee
14-2 is eligible to participate in the clinical trial or study.
14-3 (d) Health care services required for the clinically appropriate
14-4 monitoring of the enrollee during the clinical trial or study.
14-5 The services provided pursuant to paragraphs (b) and (d) must be
14-6 covered only if the services are provided by a provider with whom
14-7 the health maintenance organization has contracted for such
14-8 services. If the health maintenance organization has not
14-9 contracted for the provision of such services, the health
14-10 maintenance organization shall pay the provider the rate of
14-11 reimbursement that is paid to other providers with whom the
14-12 health maintenance organization has contracted for similar
14-13 services and the provider shall accept that rate of reimbursement
14-14 as payment in full.
14-15 3. The coverage for medical treatment required by this
14-16 section does not include:
14-17 (a) Any portion of the clinical trial or study that is customarily
14-18 paid for by a government or a biotechnical, pharmaceutical or
14-19 medical industry.
14-20 (b) Coverage for a drug or device described in paragraph (a)
14-21 of subsection 2 which is paid for by the manufacturer, distributor
14-22 or provider of the drug or device.
14-23 (c) Health care services that are specifically excluded from
14-24 coverage under the enrollee’s health care plan, regardless of
14-25 whether such services are provided under the clinical trial or
14-26 study.
14-27 (d) Health care services that are customarily provided by the
14-28 sponsors of the clinical trial or study free of charge to the
14-29 participants in the trial or study.
14-30 (e) Extraneous expenses related to participation in the clinical
14-31 trial or study including, without limitation, travel, housing and
14-32 other expenses that a participant may incur.
14-33 (f) Any expenses incurred by a person who accompanies the
14-34 enrollee during the clinical trial or study.
14-35 (g) Any item or service that is provided solely to satisfy a need
14-36 or desire for data collection or analysis that is not directly related
14-37 to the clinical management of the enrollee.
14-38 (h) Any costs for the management of research relating to the
14-39 clinical trial or study.
14-40 4. A health maintenance organization that delivers or issues
14-41 for delivery a health care plan specified in subsection 1, may
14-42 require copies of the approval or certification issued pursuant to
14-43 paragraph (b) of subsection 1, the statement of consent signed by
14-44 the enrollee, protocols for the clinical trial or study and any other
15-1 materials related to the scope of the clinical trial or study relevant
15-2 to the coverage of medical treatment pursuant to this section.
15-3 5. A health maintenance organization that delivers or issues
15-4 for delivery a health care plan specified in subsection 1 shall:
15-5 (a) Include in the disclosure required pursuant to NRS
15-6 695C.193 notice to each enrollee of the availability of the benefits
15-7 required by this section.
15-8 (b) Provide the coverage required by this section subject to the
15-9 same deductible, copayment, coinsurance and other such
15-10 conditions for coverage that are required under the plan.
15-11 6. A health care plan subject to the provisions of this chapter
15-12 that is delivered, issued for delivery or renewed on or after
15-13 January 1, 2004, has the legal effect of including the coverage
15-14 required by this section, and any provision of the plan that
15-15 conflicts with this section is void.
15-16 7. A health maintenance organization that delivers or issues
15-17 for delivery a health care plan specified in subsection 1 is immune
15-18 from liability for:
15-19 (a) Any injury to an enrollee caused by:
15-20 (1) Any medical treatment provided to the enrollee in
15-21 connection with his participation in a clinical trial or study
15-22 described in this section; or
15-23 (2) An act or omission by a provider of health care who
15-24 provides medical treatment or supervises the provision of medical
15-25 treatment to the enrollee in connection with his participation in a
15-26 clinical trial or study described in this section.
15-27 (b) Any adverse or unanticipated outcome arising out of an
15-28 enrollee’s participation in a clinical trial or study described in this
15-29 section.
15-30 8. As used in this section:
15-31 (a) “Cooperative group” means a network of facilities that
15-32 collaborate on research projects and has established a peer review
15-33 program approved by the National Institutes of Health. The term
15-34 includes:
15-35 (1) The Clinical Trials Cooperative Group Program; and
15-36 (2) The Community Clinical Oncology Program.
15-37 (b) “Provider of health care” means:
15-38 (1) A hospital; or
15-39 (2) A person licensed pursuant to chapter 630, 631 or 633
15-40 of NRS.
15-41 Sec. 9. NRS 695C.050 is hereby amended to read as follows:
15-42 695C.050 1. Except as otherwise provided in this chapter or
15-43 in specific provisions of this title, the provisions of this title are not
15-44 applicable to any health maintenance organization granted a
15-45 certificate of authority under this chapter. This provision does not
16-1 apply to an insurer licensed and regulated pursuant to this title
16-2 except with respect to its activities as a health maintenance
16-3 organization authorized and regulated pursuant to this chapter.
16-4 2. Solicitation of enrollees by a health maintenance
16-5 organization granted a certificate of authority, or its representatives,
16-6 must not be construed to violate any provision of law relating to
16-7 solicitation or advertising by practitioners of a healing art.
16-8 3. Any health maintenance organization authorized under this
16-9 chapter shall not be deemed to be practicing medicine and is exempt
16-10 from the provisions of chapter 630 of NRS.
16-11 4. The provisions of NRS 695C.110, 695C.170 to 695C.200,
16-12 inclusive, 695C.250 and 695C.265 and section 8 of this act do not
16-13 apply to a health maintenance organization that provides health care
16-14 services through managed care to recipients of Medicaid under the
16-15 state plan for Medicaid or insurance pursuant to the Children’s
16-16 Health Insurance Program pursuant to a contract with the Division
16-17 of Health Care Financing and Policy of the Department of Human
16-18 Resources. This subsection does not exempt a health maintenance
16-19 organization from any provision of this chapter for services
16-20 provided pursuant to any other contract.
16-21 5. The provisions of NRS 695C.1694 and 695C.1695 apply to
16-22 a health maintenance organization that provides health care services
16-23 through managed care to recipients of Medicaid under the state plan
16-24 for Medicaid.
16-25 Sec. 10. NRS 695C.1733 is hereby amended to read as
16-26 follows:
16-27 695C.1733 Except as otherwise provided in section 8 of this
16-28 act:
16-29 1. No evidence of coverage that provides coverage for a drug
16-30 approved by the Food and Drug Administration for use in the
16-31 treatment of an illness, disease or other medical condition may be
16-32 delivered or issued for delivery in this state unless the evidence of
16-33 coverage includes coverage for any other use of the drug for the
16-34 treatment of cancer, if that use is:
16-35 (a) Specified in the most recent edition of or supplement to:
16-36 (1) The United States Pharmacopoeia Drug Information; or
16-37 (2) The American Hospital Formulary Service Drug
16-38 Information; or
16-39 (b) Supported by at least two articles reporting the results of
16-40 scientific studies that are published in scientific or medical journals,
16-41 as defined in 21 C.F.R. § 99.3.
16-42 2. The coverage required pursuant to this section:
16-43 (a) Includes coverage for any medical services necessary to
16-44 administer the drug to the enrollee.
16-45 (b) Does not include coverage for any:
17-1 (1) Experimental drug used for the treatment of cancer[,] if
17-2 that drug has not been approved by the Food and Drug
17-3 Administration; or
17-4 (2) Use of a drug that is contraindicated by the Food and
17-5 Drug Administration.
17-6 3. Any evidence of coverage subject to the provisions of this
17-7 chapter that is delivered, issued for delivery or renewed on or after
17-8 October 1, 1999, has the legal effect of including the coverage
17-9 required by this section, and any provision of the evidence of
17-10 coverage that conflicts with the provisions of this section is void.
17-11 Sec. 11. NRS 695C.330 is hereby amended to read as follows:
17-12 695C.330 1. The Commissioner may suspend or revoke any
17-13 certificate of authority issued to a health maintenance organization
17-14 pursuant to the provisions of this chapter if he finds that any of the
17-15 following conditions exist:
17-16 (a) The health maintenance organization is operating
17-17 significantly in contravention of its basic organizational document,
17-18 its health care plan or in a manner contrary to that described in and
17-19 reasonably inferred from any other information submitted pursuant
17-20 to NRS 695C.060, 695C.070 and 695C.140, unless any amendments
17-21 to those submissions have been filed with and approved by the
17-22 Commissioner;
17-23 (b) The health maintenance organization issues evidence of
17-24 coverage or uses a schedule of charges for health care services
17-25 which do not comply with the requirements of NRS [695C.170]
17-26 695C.1694 to 695C.200, inclusive, [or 695C.1694, 695C.1695] or
17-27 695C.207[;] or section 8 of this act;
17-28 (c) The health care plan does not furnish comprehensive health
17-29 care services as provided for in NRS 695C.060;
17-30 (d) The State Board of Health certifies to the Commissioner that
17-31 the health maintenance organization:
17-32 (1) Does not meet the requirements of subsection 2 of NRS
17-33 695C.080; or
17-34 (2) Is unable to fulfill its obligations to furnish health care
17-35 services as required under its health care plan;
17-36 (e) The health maintenance organization is no longer financially
17-37 responsible and may reasonably be expected to be unable to meet its
17-38 obligations to enrollees or prospective enrollees;
17-39 (f) The health maintenance organization has failed to put into
17-40 effect a mechanism affording the enrollees an opportunity to
17-41 participate in matters relating to the content of programs pursuant to
17-42 NRS 695C.110;
17-43 (g) The health maintenance organization has failed to put into
17-44 effect the system for resolving complaints required by NRS
17-45 695C.260 in a manner reasonably to dispose of valid complaints;
18-1 (h) The health maintenance organization or any person on its
18-2 behalf has advertised or merchandised its services in an untrue,
18-3 misrepresentative, misleading, deceptive or unfair manner;
18-4 (i) The continued operation of the health maintenance
18-5 organization would be hazardous to its enrollees; or
18-6 (j) The health maintenance organization has otherwise failed to
18-7 comply substantially with the provisions of this chapter.
18-8 2. A certificate of authority must be suspended or revoked only
18-9 after compliance with the requirements of NRS 695C.340.
18-10 3. If the certificate of authority of a health maintenance
18-11 organization is suspended, the health maintenance organization shall
18-12 not, during the period of that suspension, enroll any additional
18-13 groups or new individual contracts, unless those groups or persons
18-14 were contracted for before the date of suspension.
18-15 4. If the certificate of authority of a health maintenance
18-16 organization is revoked, the organization shall proceed, immediately
18-17 following the effective date of the order of revocation, to wind up its
18-18 affairs and shall conduct no further business except as may be
18-19 essential to the orderly conclusion of the affairs of the organization.
18-20 It shall engage in no further advertising or solicitation of any kind.
18-21 The Commissioner may , by written order , permit such further
18-22 operation of the organization as he may find to be in the best interest
18-23 of enrollees to the end that enrollees are afforded the greatest
18-24 practical opportunity to obtain continuing coverage for health care.
18-25 Sec. 12. Chapter 695G of NRS is hereby amended by adding
18-26 thereto a new section to read as follows:
18-27 1. A health care plan issued by a managed care organization
18-28 must provide coverage for medical treatment which a person
18-29 insured under the plan receives as part of a clinical trial or study
18-30 if:
18-31 (a) The medical treatment is provided in a Phase II, Phase III
18-32 or Phase IV study or clinical trial for the treatment of cancer or
18-33 chronic fatigue syndrome;
18-34 (b) The clinical trial or study is approved by:
18-35 (1) An agency of the National Institutes of Health as set
18-36 forth in 42 U.S.C. § 281(b);
18-37 (2) A cooperative group;
18-38 (3) The Food and Drug Administration as an application
18-39 for a new investigational drug;
18-40 (4) The United States Department of Veterans Affairs; or
18-41 (5) The United States Department of Defense;
18-42 (c) The medical treatment is provided by a provider of health
18-43 care and the facility and personnel have the experience and
18-44 training to provide the treatment in a capable manner;
19-1 (d) There is no medical treatment available which is
19-2 considered a more appropriate alternative medical treatment than
19-3 the medical treatment provided in the clinical trial or study;
19-4 (e) There is a reasonable expectation based on clinical data
19-5 that the medical treatment provided in the clinical trial or study
19-6 will be at least as effective as any other medical treatment;
19-7 (f) The clinical trial or study is conducted in this state; and
19-8 (g) The insured has signed, before his participation in the
19-9 clinical trial or study, a statement of consent indicating that he has
19-10 been informed of, without limitation:
19-11 (1) The procedure to be undertaken;
19-12 (2) Alternative methods of treatment; and
19-13 (3) The risks associated with participation in the clinical
19-14 trial or study, including, without limitation, the general nature and
19-15 extent of such risks.
19-16 2. The coverage for medical treatment pursuant to this
19-17 section is required only to the extent that the medical treatment is
19-18 not otherwise provided in connection with the clinical trial or
19-19 study, and is limited to:
19-20 (a) Coverage for any drug or device that is approved for sale
19-21 by the Food and Drug Administration without regard to whether
19-22 the approved drug or device has been approved for use in the
19-23 medical treatment of the insured.
19-24 (b) The cost of any reasonably necessary health care services
19-25 that are required as a result of the medical treatment provided in
19-26 the clinical trial or study or as a result of any complication arising
19-27 out of the medical treatment provided in the clinical trial or study,
19-28 to the extent that such health care services would otherwise be
19-29 covered under the health care plan.
19-30 (c) The initial consultation to determine whether the insured is
19-31 eligible to participate in the clinical trial or study.
19-32 (d) Health care services required for the clinically appropriate
19-33 monitoring of the insured during the clinical trial or study.
19-34 The services provided pursuant to paragraphs (b) and (d) must be
19-35 covered only if the services are provided by a provider with whom
19-36 the managed care organization has contracted for such services. If
19-37 the managed care organization has not contracted for the
19-38 provision of such services, the managed care organization shall
19-39 pay the provider the rate of reimbursement that is paid to other
19-40 providers with whom the managed care organization has
19-41 contracted for similar services and the provider shall accept that
19-42 rate of reimbursement as payment in full.
19-43 3. The coverage for medical treatment required by this
19-44 section does not include:
20-1 (a) Any portion of the clinical trial or study that is customarily
20-2 paid for by a government or a biotechnical, pharmaceutical or
20-3 medical industry.
20-4 (b) Coverage for a drug or device described in paragraph (a)
20-5 of subsection 2 which is paid for by the manufacturer, distributor
20-6 or provider of the drug or device.
20-7 (c) Health care services that are specifically excluded from
20-8 coverage under the insured’s health care plan, regardless of
20-9 whether such services are provided under the clinical trial or
20-10 study.
20-11 (d) Health care services that are customarily provided by the
20-12 sponsors of the clinical trial or study free of charge to the
20-13 participants in the trial or study.
20-14 (e) Extraneous expenses related to participation in the clinical
20-15 trial or study including, without limitation, travel, housing and
20-16 other expenses that a participant may incur.
20-17 (f) Any expenses incurred by a person who accompanies the
20-18 insured during the clinical trial or study.
20-19 (g) Any item or service that is provided solely to satisfy a need
20-20 or desire for data collection or analysis that is not directly related
20-21 to the clinical management of the insured.
20-22 (h) Any costs for the management of research relating to the
20-23 clinical trial or study.
20-24 4. A managed care organization that delivers or issues for
20-25 delivery a health care plan specified in subsection 1, may require
20-26 copies of the approval or certification issued pursuant to
20-27 paragraph (b) of subsection 1, the statement of consent signed by
20-28 the insured, protocols for the clinical trial or study and any other
20-29 materials related to the scope of the clinical trial or study relevant
20-30 to the coverage of medical treatment pursuant to this section.
20-31 5. A managed care organization that delivers or issues for
20-32 delivery a health care plan specified in subsection 1 shall:
20-33 (a) Include in the disclosure required pursuant to NRS
20-34 695C.193 notice to each person insured under the plan of the
20-35 availability of the benefits required by this section.
20-36 (b) Provide the coverage required by this section subject to the
20-37 same deductible, copayment, coinsurance and other such
20-38 conditions for coverage that are required under the plan.
20-39 6. A health care plan subject to the provisions of this chapter
20-40 that is delivered, issued for delivery or renewed on or after
20-41 January 1, 2004, has the legal effect of including the coverage
20-42 required by this section, and any provision of the plan that
20-43 conflicts with this section is void.
21-1 7. A managed care organization that delivers or issues for
21-2 delivery a health care plan specified in subsection 1 is immune
21-3 from liability for:
21-4 (a) Any injury to an insured caused by:
21-5 (1) Any medical treatment provided to the insured in
21-6 connection with his participation in a clinical trial or study
21-7 described in this section; or
21-8 (2) An act or omission by a provider of health care who
21-9 provides medical treatment or supervises the provision of medical
21-10 treatment to the insured in connection with his participation in a
21-11 clinical trial or study described in this section.
21-12 (b) Any adverse or unanticipated outcome arising out of an
21-13 insured’s participation in a clinical trial or study described in this
21-14 section.
21-15 8. As used in this section:
21-16 (a) “Cooperative group” means a network of facilities that
21-17 collaborate on research projects and has established a peer review
21-18 program approved by the National Institutes of Health. The term
21-19 includes:
21-20 (1) The Clinical Trials Cooperative Group Program; and
21-21 (2) The Community Clinical Oncology Program.
21-22 (b) “Provider of health care” means:
21-23 (1) A hospital; or
21-24 (2) A person licensed pursuant to chapter 630, 631 or 633
21-25 of NRS.
21-26 Sec. 13. NRS 287.010 is hereby amended to read as follows:
21-27 287.010 1. The governing body of any county, school
21-28 district, municipal corporation, political subdivision, public
21-29 corporation or other public agency of the State of Nevada may:
21-30 (a) Adopt and carry into effect a system of group life, accident
21-31 or health insurance, or any combination thereof, for the benefit of its
21-32 officers and employees, and the dependents of officers and
21-33 employees who elect to accept the insurance and who, where
21-34 necessary, have authorized the governing body to make deductions
21-35 from their compensation for the payment of premiums on the
21-36 insurance.
21-37 (b) Purchase group policies of life, accident or health insurance,
21-38 or any combination thereof, for the benefit of such officers and
21-39 employees, and the dependents of such officers and employees, as
21-40 have authorized the purchase, from insurance companies authorized
21-41 to transact the business of such insurance in the State of Nevada,
21-42 and, where necessary, deduct from the compensation of officers and
21-43 employees the premiums upon insurance and pay the deductions
21-44 upon the premiums.
22-1 (c) Provide group life, accident or health coverage through a
22-2 self-insurance reserve fund and, where necessary, deduct
22-3 contributions to the maintenance of the fund from the compensation
22-4 of officers and employees and pay the deductions into the fund. The
22-5 money accumulated for this purpose through deductions from
22-6 the compensation of officers and employees and contributions of the
22-7 governing body must be maintained as an internal service fund as
22-8 defined by NRS 354.543. The money must be deposited in a state or
22-9 national bank or credit union authorized to transact business in the
22-10 State of Nevada. Any independent administrator of a fund created
22-11 under this section is subject to the licensing requirements of chapter
22-12 683A of NRS, and must be a resident of this state. Any contract
22-13 with an independent administrator must be approved by the
22-14 Commissioner of Insurance as to the reasonableness of
22-15 administrative charges in relation to contributions collected and
22-16 benefits provided. The provisions of NRS 689B.030 to 689B.050,
22-17 inclusive, and 689B.575 and section 4 of this act apply to coverage
22-18 provided pursuant to this paragraph, except that the provisions of
22-19 NRS 689B.0359 do not apply to such coverage.
22-20 (d) Defray part or all of the cost of maintenance of a self-
22-21 insurance fund or of the premiums upon insurance. The money for
22-22 contributions must be budgeted for in accordance with the laws
22-23 governing the county, school district, municipal corporation,
22-24 political subdivision, public corporation or other public agency of
22-25 the State of Nevada.
22-26 2. If a school district offers group insurance to its officers and
22-27 employees pursuant to this section, members of the board of trustees
22-28 of the school district must not be excluded from participating in the
22-29 group insurance. If the amount of the deductions from compensation
22-30 required to pay for the group insurance exceeds the compensation to
22-31 which a trustee is entitled, the difference must be paid by the trustee.
22-32 Sec. 14. NRS 287.04335 is hereby amended to read as
22-33 follows:
22-34 287.04335 If the Board provides health insurance through a
22-35 plan of self-insurance, it shall comply with the provisions of section
22-36 12 of this act and NRS 689B.255, 695G.150, 695G.160, 695G.170
22-37 and 695G.200 to 695G.230, inclusive, in the same manner as an
22-38 insurer that is licensed pursuant to title 57 of NRS is required to
22-39 comply with those provisions.
22-40 Sec. 15. This act becomes effective on January 1, 2004.
22-41 H