ASSEMBLY ACTION Initial and Date |SENATE ACTION Initial and Date
Adopted Lost | Adopted Lost
Concurred In Not |Concurred In Not
Receded Not | Receded Not
Amend section 1, page 1, by deleting lines 6 through 11 and inserting:
“(a) The medical treatment is provided in a Phase II, Phase III or Phase IV study or clinical trial for the treatment of cancer;”.
Amend section 1, page 2, line 3, after “Affairs;” by inserting “or”.
Amend section 1, page 2, line 4, by deleting “or”.
Amend section 1, page 2, by deleting lines 5 through 8.
Amend section 1, page 2, line 10, by deleting “care;” and inserting:
“care and thefacility and personnel have the experience and training to provide the treatment in a capable manner;”.
Amend section 1, page 2, line 13, by deleting “and”.
Amend section 1, page 2, line 16, by deleting “treatment.” and inserting:
“treatment;
(f) The clinical trial or study is conducted in this state; and
(g) The policyholder or subscriber has signed, before his participation in the clinical trial or study, a statement of consent indicating that he has been informed of, without limitation:
(1) The procedure to be undertaken;
(2) Alternative methods of treatment; and
(3) The risks associated with participation in the clinical trial or study, including, without limitation, the general nature and extent of such risks.”.
Amend section 1, page 2, by deleting lines 23 through 33 and inserting:
“(b) The cost of any reasonably necessary health care services that are required as a result of the medical treatment provided in the clinical trial or study or as a result of any complication arising out of the medical treatment provided in the clinical trial or study, to the extent that such health care services would otherwise be covered under the policy of health insurance.
(c) The initial consultation to determine whether the policyholder or subscriber is eligible to participate in the clinical trial or study.
(d) Health care services required for the clinically appropriate monitoring of the policyholder or subscriber during the clinical trial or study.
3. The coverage for medical treatment required by this section does not include:
(a) Any portion of the clinical trial or study that is customarily paid for by a government or a biotechnical, pharmaceutical or medical industry.
(b) Coverage for a drug or device described in paragraph (a) of subsection 2 which is paid for by the manufacturer, distributor or provider of the drug or device.
(c) Health care services that are specifically excluded from coverage under the policyholder’s or subscriber’s policy of health insurance, regardless of whether such services are provided under the clinical trial or study.
(d) Health care services that are customarily provided by the sponsors of the clinical trial or study free of charge to the participants in the trial or study.
(e) Extraneous expenses related to participation in the clinical trial or study including, without limitation, travel, housing and other expenses that a participant may incur.
(f) Any expenses incurred by a person who accompanies the policyholder or subscriber during the clinical trial or study.
(g) Any item or service that is provided solely to satisfy a need or desire for data collection or analysis that is not directly related to the clinical management of the policyholder or subscriber.
4. An insurer who delivers or issues for delivery a policy of health insurance specified in subsection 1, may require copies of the approval or certification issued pursuant to paragraph (b) of subsection 1, the statement of consent signed by the policyholder or subscriber, protocols for the clinical trial or study and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment pursuant to this section.”.
Amend section 1, page 2, line 34, by deleting “4.”and inserting“5.”.
Amend section 1, page 2, line 42, by deleting “5.” and inserting “6.”.
Amend section 1, page 2, line 44, by deleting:
“October 1, 2003,” and inserting:
“January 1, 2004,”.
Amend section 1, page 3, line 3, by deleting “6.” and inserting:
“7. An insurer who delivers or issues for delivery a policy specified in subsection 1 is immune from liability for:
(a) Any injury to a policyholder or subscriber caused by:
(1) Any medical treatment provided to the policyholder or subscriber in connection with his participation in a clinical trial or study described in this section; or
(2) An act or omission by a provider of health care who provides medical treatment or supervises the provision of medical treatment to the policyholder or subscriber in connection with his participation in a clinical trial or study described in this section.
(b) Any adverse or unanticipated outcome arising out of a policyholder’s or subscriber’s participation in a clinical trial or study described in this section.
8.”.
Amend section 1, page 3, by deleting lines 8 through 15 and inserting:
“(1) The Clinical Trials Cooperative Group Program; and
(2) The Community Clinical Oncology Program.
(b) “Provider of health care” means:
(1) A hospital; or
(2) A person licensed pursuant to chapter 630, 631 or 633 of NRS.”.
Amend sec. 4, page 4, by deleting lines 14 through 19 and inserting:
“(a) The medical treatment is provided in a Phase II, Phase III or Phase IV study or clinical trial for the treatment of cancer;”.
Amend sec. 4, page 4, line 26, after “Affairs;” by inserting “or”.
Amend sec. 4, page 4, line 27, by deleting “or”.
Amend sec. 4, page 4, by deleting lines 28 through 31.
Amend sec. 4, page 4, line 33, by deleting “care;” and inserting:
“care and thefacility and personnel have the experience and training to provide the treatment in a capable manner;”.
Amend sec. 4, page 4, line 36, by deleting “and”.
Amend sec. 4, page 4, line 39, by deleting “treatment.” and inserting:
“treatment;
(f) The clinical trial or study is conducted in this state; and
(g) The insured has signed, before his participation in the clinical trial or study, a statement of consent indicating that he has been informed of, without limitation:
(1) The procedure to be undertaken;
(2) Alternative methods of treatment; and
(3) The risks associated with participation in the clinical trial or study, including, without limitation, the general nature and extent of such risks.”.
Amend sec. 4, page 5, by deleting lines 1 through 11 and inserting:
“(b) The cost of any reasonably necessary health care services that are required as a result of the medical treatment provided in the clinical trial or study or as a result of any complication arising out of the medical treatment provided in the clinical trial or study, to the extent that such health care services would otherwise be covered under the policy of group health insurance.
(c) The initial consultation to determine whether the insured is eligible to participate in the clinical trial or study.
(d) Health care services required for the clinically appropriate monitoring of the insured during the clinical trial or study.
3. The coverage for medical treatment required by this section does not include:
(a) Any portion of the clinical trial or study that is customarily paid for by a government or a biotechnical, pharmaceutical or medical industry.
(b) Coverage for a drug or device described in paragraph (a) of subsection 2 which is paid for by the manufacturer, distributor or provider of the drug or device.
(c) Health care services that are specifically excluded from coverage under the insured’s policy of group health insurance, regardless of whether such services are provided under the clinical trial or study.
(d) Health care services that are customarily provided by the sponsors of the clinical trial or study free of charge to the participants in the trial or study.
(e) Extraneous expenses related to participation in the clinical trial or study including, without limitation, travel, housing and other expenses that a participant may incur.
(f) Any expenses incurred by a person who accompanies the insured during the clinical trial or study.
(g) Any item or service that is provided solely to satisfy a need or desire for data collection or analysis that is not directly related to the clinical management of the insured.
4. An insurer who delivers or issues for delivery a policy of group health insurance specified in subsection 1, may require copies of the approval or certification issued pursuant to paragraph (b) of subsection 1, the statement of consent signed by the insured, protocols for the clinical trial or study and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment pursuant to this section.”.
Amend sec. 4, page 5, line 12, by deleting “4.” and inserting “5.”.
Amend sec. 4, page 5, line 20, by deleting “5.” and inserting “6.”.
Amend sec. 4, page 5, line 22, by deleting:
“October 1, 2003,” and inserting:
“January 1, 2004,”.
Amend sec. 4, page 5, line 25, by deleting “6.” and inserting:
“7. An insurer who delivers or issues for delivery a policy of group health insurance specified in subsection 1 is immune from liability for:
(a) Any injury to the insured caused by:
(1) Any medical treatment provided to the insured in connection with his participation in a clinical trial or study described in this section; or
(2) An act or omission by a provider of health care who provides medical treatment or supervises the provision of medical treatment to the insured in connection with his participation in a clinical trial or study described in this section.
(b) Any adverse or unanticipated outcome arising out of an insured’s participation in a clinical trial or study described in this section.
8.”.
Amend sec. 4, page 5, by deleting lines 30 through 37 and inserting:
“(1) The Clinical Trials Cooperative Group Program; and
(2) The Community Clinical Oncology Program.
(b) “Provider of health care” means:
(1) A hospital; or
(2) A person licensed pursuant to chapter 630, 631 or 633 of NRS.”.
Amend sec. 6, page 6, by deleting lines 31 through 36 and inserting:
“(a) The medical treatment is provided in a Phase II, Phase III or Phase IV study or clinical trial for the treatment of cancer;”.
Amend sec. 6, page 6, line 43, after “Affairs;” by inserting “or”.
Amend sec. 6, page 6, line 44, by deleting “or”.
Amend sec. 6, page 7, by deleting lines 1 through 4.
Amend sec. 6, page 7, line 6, by deleting “care;” and inserting:
“care and thefacility and personnel have the experience and training to provide the treatment in a capable manner;”.
Amend sec. 6, page 7, line 9, by deleting “and”.
Amend sec. 6, page 7, line 12, by deleting “treatment.” and inserting:
“treatment;
(f) The clinical trial or study is conducted in this state; and
(g) The insured has signed, before his participation in the clinical trial or study, a statement of consent indicating that he has been informed of, without limitation:
(1) The procedure to be undertaken;
(2) Alternative methods of treatment; and
(3) The risks associated with participation in the clinical trial or study, including, without limitation, the general nature and extent of such risks.”.
Amend sec. 6, page 7, by deleting lines 19 through 29 and inserting:
“(b) The cost of any reasonably necessary health care services that are required as a result of the medical treatment provided in the clinical trial or study or as a result of any complication arising out of the medical treatment provided in the clinical trial or study, to the extent that such health care services would otherwise be covered under the policy of health insurance.
(c) The initial consultation to determine whether the insured is eligible to participate in the clinical trial or study.
(d) Health care services required for the clinically appropriate monitoring of the insured during the clinical trial or study.
3. The coverage for medical treatment required by this section does not include:
(a) Any portion of the clinical trial or study that is customarily paid for by a government or a biotechnical, pharmaceutical or medical industry.
(b) Coverage for a drug or device described in paragraph (a) of subsection 2 which is paid for by the manufacturer, distributor or provider of the drug or device.
(c) Health care services that are specifically excluded from coverage under the insured’s policy of health insurance, regardless of whether such services are provided under the clinical trial or study.
(d) Health care services that are customarily provided by the sponsors of the clinical trial or study free of charge to the participants in the trial or study.
(e) Extraneous expenses related to participation in the clinical trial or study including, without limitation, travel, housing and other expenses that a participant may incur.
(f) Any expenses incurred by a person who accompanies the insured during the trial or study.
(g) Any item or service that is provided solely to satisfy a need or desire for data collection or analysis that is not directly related to the clinical management of the insured.
4. A medical services corporation that delivers or issues for delivery a policy of health insurance specified in subsection 1, may require copies of the approval or certification issued pursuant to paragraph (b) of subsection 1, the statement of consent signed by the insured, protocols for the clinical trial or study and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment pursuant to this section.”.
Amend sec. 6, page 7, line 30, by deleting “4.” and inserting “5.”.
Amend sec. 6, page 7, line 39, by deleting “5.” and inserting “6.”.
Amend sec. 6, page 7, line 41, by deleting:
“October 1, 2003,” and inserting:
“January 1, 2004,”.
Amend sec. 6, page 7, line 44, by deleting “6.” and inserting:
“7. A medical services corporation that delivers or issues for delivery a policy of health insurance specified in subsection 1 is immune from liability for:
(a) Any injury to the insured caused by:
(1) Any medical treatment provided to the insured in connection with his participation in a clinical trial or study described in this section; or
(2) An act or omission by a provider of health care who provides medical treatment or supervises the provision of medical treatment to the insured in connection with his participation in a clinical trial or study described in this section.
(b) Any adverse or unanticipated outcome arising out of an insured’s participation in a clinical trial or study described in this section.
8.”.
Amend sec. 6, page 8, by deleting lines 5 through 12 and inserting:
“(1) The Clinical Trials Cooperative Group Program; and
(2) The Community Clinical Oncology Program.
(b) “Provider of health care” means:
(1) A hospital; or
(2) A person licensed pursuant to chapter 630, 631 and 633 of NRS.”.
Amend sec. 8, page 9, by deleting lines 6 through 11 and inserting:
“(a) The medical treatment is provided in a Phase II, Phase III or Phase IV study or clinical trial for the treatment of cancer;”.
Amend sec. 8, page 9, line 18, after “Affairs;” by inserting “or”.
Amend sec. 8, page 9, line 19, by deleting “or”.
Amend sec. 8, page 9, by deleting lines 20 through 23.
Amend sec. 8, page 9, by deleting lines 24 and 25, and inserting:
“(c) The medical treatment is provided by:
(1) A provider of health care;
(2) If the health maintenance organization has a list of providers of health care given by the health maintenance organization, a provider of health care who is included on that list; and
(3) Facility and personnel who have the experience and training to provide the treatment in a capable manner;”.
Amend sec. 8, page 9, line 28, by deleting “and”.
Amend sec. 8, page 9, line 31, by deleting “treatment.” and inserting:
“treatment;
(f) The clinical trial or study is conducted in this state; and
(g) The enrollee has signed, before his participation in the clinical trial or study, a statement of consent indicating that he has been informed of, without limitation:
(1) The procedure to be undertaken;
(2) Alternative methods of treatment; and
(3) The risks associated with participation in the clinical trial or study, including, without limitation, the general nature and extent of such risks.”.
Amend sec. 8, pages 9 and 10, by deleting lines 38 through 45 on page 9 and lines 1 through 3 on page 10 and inserting:
“(b) The cost of any reasonably necessary health care services that are required as a result of the medical treatment provided in the clinical trial or study or as a result of any complication arising out of the medical treatment provided in the clinical trial or study, to the extent that such health care services would otherwise be covered under the health care plan.
(c) The initial consultation to determine whether the enrollee is eligible to participate in the clinical trial or study.
(d) Health care services required for the clinically appropriate monitoring of the enrollee during the clinical trial or study.
3. The coverage for medical treatment required by this section does not include:
(a) Any portion of the clinical trial or study that is customarily paid for by a government or a biotechnical, pharmaceutical or medical industry.
(b) Coverage for a drug or device described in paragraph (a) of subsection 2 which is paid for by the manufacturer, distributor or provider of the drug or device.
(c) Health care services that are specifically excluded from coverage under the enrollee’s health care plan, regardless of whether such services are provided under the clinical trial or study.
(d) Health care services that are customarily provided by the sponsors of the clinical trial or study free of charge to the participants in the trial or study.
(e) Extraneous expenses related to participation in the clinical trial or study including, without limitation, travel, housing and other expenses that a participant may incur.
(f) Any expenses incurred by a person who accompanies the enrollee during the clinical trial or study.
(g) Any item or service that is provided solely to satisfy a need or desire for data collection or analysis that is not directly related to the clinical management of the enrollee.
4. A health maintenance organization that delivers or issues for delivery a health care plan specified in subsection 1, may require copies of the approval or certification issued pursuant to paragraph (b) of subsection 1, the statement of consent signed by the enrollee, protocols for the clinical trial or study and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment pursuant to this section.”.
Amend sec. 8, page 10, line 4, by deleting “4.” and inserting “5.”.
Amend sec. 8, page 10, line 12, by deleting “5.” and inserting “6.”.
Amend sec. 8, page 10, line 14, by deleting:
“October 1, 2003,” and inserting:
“January 1, 2004,”.
Amend sec. 8, page 10, line 17, by deleting “6.” and inserting:
“7. A health maintenance organization that delivers or issues for delivery a health care plan specified in subsection 1 is immune from liability for:
(a) Any injury to an enrollee caused by:
(1) Any medical treatment provided to the enrollee in connection with his participation in a clinical trial or study described in this section; or
(2) An act or omission by a provider of health care who provides medical treatment or supervises the provision of medical treatment to the enrollee in connection with his participation in a clinical trial or study described in this section.
(b) Any adverse or unanticipated outcome arising out of an enrollee’s participation in a clinical trial or study described in this section.
8.”.
Amend sec. 8, page 10, by deleting lines 22 through 29 and inserting:
“(1) The Clinical Trials Cooperative Group Program; and
(2) The Community Clinical Oncology Program.
(b) “Provider of health care” means:
(1) A hospital; or
(2) A person licensed pursuant to chapter 630, 631 or 633 of NRS.”.
Amend sec. 12, page 13, by deleting lines 22 through 27 and inserting:
“(a) The medical treatment is provided in a Phase II, Phase III or Phase IV study or clinical trial for the treatment of cancer;”.
Amend sec. 12, page 13, line 34, after “Affairs;” by inserting “or”.
Amend sec. 12, page 13, line 35, by deleting “or”.
Amend sec. 12, page 13, by deleting lines 36 through 39.
Amend sec. 12, page 13, by deleting lines 40 and 41 and inserting:
(c) The medical treatment is provided by:
(1) A provider of health care;
(2) If the managed care organization has established a panel of providers of health care for the purpose of offering health care services pursuant this chapter or chapter 689A, 689B, 689C, 695A, 695B or 695C of NRS, a provider of health care who is included on the panel; and
(3) Facility and personnel who have the experience and training to provide the treatment in a capable manner;”.
Amend sec. 12, page 13, line 44, by deleting “and”.
Amend sec. 12, page 14, line 3, by deleting “treatment.” and inserting:
“treatment;
(f) The clinical trial or study is conducted in this state; and
(g) The insured has signed, before his participation in the clinical trial or study, a statement of consent indicating that he has been informed of, without limitation:
(1) The procedure to be undertaken;
(2) Alternative methods of treatment; and
(3) The risks associated with participation in the clinical trial or study, including, without limitation, the general nature and extent of such risks.”.
Amend sec. 12, page 14, by deleting lines 10 through 20 and inserting:
“(b) The cost of any reasonably necessary health care services that are required as a result of the medical treatment provided in the clinical trial or study or as a result of any complication arising out of the medical treatment provided in the clinical trial or study, to the extent that such health care services would otherwise be covered under the health care plan.
(c) The initial consultation to determine whether the insured is eligible to participate in the clinical trial or study.
(d) Health care services required for the clinically appropriate monitoring of the insured during the clinical trial or study.
3. The coverage for medical treatment required by this section does not include:
(a) Any portion of the clinical trial or study that is customarily paid for by a government or a biotechnical, pharmaceutical or medical industry.
(b) Coverage for a drug or device described in paragraph (a) of subsection 2 which is paid for by the manufacturer, distributor or provider of the drug or device.
(c) Health care services that are specifically excluded from coverage under the insured’s health care plan, regardless of whether such services are provided under the clinical trial or study.
(d) Health care services that are customarily provided by the sponsors of the clinical trial or study free of charge to the participants in the trial or study.
(e) Extraneous expenses related to participation in the clinical trial or study including, without limitation, travel, housing and other expenses that a participant may incur.
(f) Any expenses incurred by a person who accompanies the insured during the clinical trial or study.
(g) Any item or service that is provided solely to satisfy a need or desire for data collection or analysis that is not directly related to the clinical management of the insured.
4. A managed care organization that delivers or issues for delivery a health care plan specified in subsection 1, may require copies of the approval or certification issued pursuant to paragraph (b) of subsection 1, the statement of consent signed by the insured, protocols for the clinical trial or study and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment pursuant to this section.”.
Amend sec. 12, page 14, line 21, by deleting “4.” and inserting “5.”.
Amend sec. 12, page 14, line 29, by deleting “5.” and inserting “6.”.
Amend sec. 12, page 14, line 31, by deleting:
“October 1, 2003,” and inserting:
“January 1, 2004,”.
Amend sec. 12, page 14, line 34, by deleting “6.” and inserting:
“7. A managed care organization that delivers or issues for delivery a health care plan specified in subsection 1 is immune from liability for:
(a) Any injury to an insured caused by:
(1) Any medical treatment provided to the insured in connection with his participation in a clinical trial or study described in this section; or
(2) An act or omission by a provider of health care who provides medical treatment or supervises the provision of medical treatment to the insured in connection with his participation in a clinical trial or study described in this section.
(b) Any adverse or unanticipated outcome arising out of an insured’s participation in a clinical trial or study described in this section.
8.”.
Amend sec. 12, pages 14 and 15, by deleting lines 39 through 43 on page 14 and lines 1 through 3 on page 15 and inserting:
“(1) The Clinical Trials Cooperative Group Program; and
(2) The Community Clinical Oncology Program.
(b) “Provider of health care” means:
(1) A hospital; or
(2) A person licensed pursuant to chapter 630, 631 or 633 of NRS.”.
Amend the bill as a whole by adding a new section designated sec. 15, following sec. 14, to read as follows:
“Sec. 15. This act becomes effective on January 1, 2004.”.
Amend the title of the bill, third line, after “study;” by inserting:
“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;”.