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