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; 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:

1-7       (1) Is provided in a Phase I, Phase II, Phase III or Phase

1-8  IV study or clinical trial for the prevention, early detection and

1-9  treatment of cancer; or

1-10          (2) Is provided in a Phase I, Phase II, Phase III or Phase

1-11  IV clinical trial for any other condition which is life-threatening;

1-12      (b) The clinical trial or study is approved by:

1-13          (1) An agency of the National Institutes of Health as set

1-14  forth in 42 U.S.C. § 281(b);

1-15          (2) A cooperative group;


2-1       (3) The Food and Drug Administration as an application

2-2  for a new investigational drug;

2-3       (4) The United States Department of Veterans Affairs;

2-4       (5) The United States Department of Defense; or

2-5       (6) A review board of a medical facility or other

2-6  organization which has a multiple project assurance contract

2-7  approved by the Office for Human Research Protections of the

2-8  United States Department of Health and Human Services;

2-9  (c) The medical treatment is provided by a provider of health

2-10  care;

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; and

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      2.  The coverage for medical treatment required by this

2-18  section includes, without limitation:

2-19      (a) Coverage for any drug or device that is approved for sale

2-20  by the Food and Drug Administration without regard to whether

2-21  the approved drug or device has been approved for use in the

2-22  medical treatment of the policyholder or subscriber.

2-23      (b) The cost of any medically necessary health care that is

2-24  required as a result of the medical treatment provided in the

2-25  clinical trial or study.

2-26      3.  The coverage for medical treatment required by this

2-27  section does not include:

2-28      (a) Coverage for a drug or device described in paragraph (a)

2-29  of subsection 2 which is paid for by the manufacturer, distributor

2-30  or provider of the drug or device.

2-31      (b) Any costs for the management of the research relating to

2-32  the clinical trial or study.

2-33      (c) The cost of an investigational drug or device.

2-34      4.  An insurer who delivers or issues for delivery a policy

2-35  specified in subsection 1 shall:

2-36      (a) Include in the disclosure required pursuant to NRS

2-37  689A.390 notice to each policyholder and subscriber under the

2-38  policy of the availability of the benefits required by this section.

2-39      (b) Provide the coverage required by this section subject to the

2-40  same deductible, copayment, coinsurance and other such

2-41  conditions for coverage that are required under the policy.

2-42      5.  A policy of health insurance subject to the provisions of

2-43  this chapter that is delivered, issued for delivery or renewed on or

2-44  after October 1, 2003, has the legal effect of including the


3-1  coverage required by this section, and any provision of the policy

3-2  that conflicts with this section is void.

3-3  6.  As used in this section:

3-4  (a) “Cooperative group” means a network of facilities that

3-5  collaborate on research projects and has established a peer review

3-6  program approved by the National Institutes of Health. The term

3-7  includes:

3-8       (1) The Clinical Trials Cooperative Group Program;

3-9       (2) The Adult Aids Clinical Trials Group;

3-10          (3) The Community Clinical Oncology Program; and

3-11          (4) The Community Programs for Clinical Research on

3-12  AIDS.

3-13      (b) “Provider of health care” means any physician, hospital or

3-14  other person who is licensed or otherwise authorized in this state

3-15  to furnish any health care service.

3-16      Sec. 2.  NRS 689A.0404 is hereby amended to read as follows:

3-17      689A.0404  Except as otherwise provided in section 1 of this

3-18  act:

3-19      1.  No policy of health insurance that provides coverage for a

3-20  drug approved by the Food and Drug Administration for use in the

3-21  treatment of an illness, disease or other medical condition may be

3-22  delivered or issued for delivery in this state unless the policy

3-23  includes coverage for any other use of the drug for the treatment of

3-24  cancer , if that use is:

3-25      (a) Specified in the most recent edition of or supplement to:

3-26          (1) The United States Pharmacopoeia Drug Information; or

3-27          (2) The American Hospital Formulary Service Drug

3-28  Information; or

3-29      (b) Supported by at least two articles reporting the results of

3-30  scientific studies that are published in scientific or medical journals,

3-31  as defined in 21 C.F.R. § 99.3.

3-32      2.  The coverage required pursuant to this section:

3-33      (a) Includes coverage for any medical services necessary to

3-34  administer the drug to the insured.

3-35      (b) Does not include coverage for any:

3-36          (1) Experimental drug used for the treatment of cancer if that

3-37  drug has not been approved by the Food and Drug Administration;

3-38  or

3-39          (2) Use of a drug that is contraindicated by the Food and

3-40  Drug Administration.

3-41      3.  A policy of health insurance subject to the provisions of this

3-42  chapter that is delivered, issued for delivery or renewed on or after

3-43  October 1, 1999, has the legal effect of including the coverage

3-44  required by this section, and any provision of the policy that

3-45  conflicts with the provisions of this section is void.


4-1  Sec. 3.  NRS 689A.330 is hereby amended to read as follows:

4-2  689A.330  If any policy is issued by a domestic insurer for

4-3  delivery to a person residing in another state, and if the insurance

4-4  commissioner or corresponding public officer of that other state has

4-5  informed the Commissioner that the policy is not subject to approval

4-6  or disapproval by that officer, the Commissioner may by ruling

4-7  require that the policy meet the standards set forth in NRS 689A.030

4-8  to 689A.320, inclusive[.] , and section 1 of this act.

4-9  Sec. 4.  Chapter 689B of NRS is hereby amended by adding

4-10  thereto a new section to read as follows:

4-11      1.  A policy of group health insurance must provide coverage

4-12  for medical treatment which a person insured under the group

4-13  policy receives as part of a clinical trial or study if:

4-14      (a) The medical treatment:

4-15          (1) Is provided in a Phase I, Phase II, Phase III or Phase

4-16  IV study or clinical trial for the prevention, early detection and

4-17  treatment of cancer; or

4-18          (2) Is provided in a Phase I, Phase II, Phase III or Phase

4-19  IV clinical trial for any other condition which is life-threatening;

4-20      (b) The clinical trial or study is approved by:

4-21          (1) An agency of the National Institutes of Health as set

4-22  forth in 42 U.S.C. § 281(b);

4-23          (2) A cooperative group;

4-24          (3) The Food and Drug Administration as an application

4-25  for a new investigational drug;

4-26          (4) The United States Department of Veterans Affairs;

4-27          (5) The United States Department of Defense; or

4-28          (6) A review board of a medical facility or other

4-29  organization which has a multiple project assurance contract

4-30  approved by the Office for Human Research Protections of the

4-31  United States Department of Health and Human Services;

4-32      (c) The medical treatment is provided by a provider of health

4-33  care;

4-34      (d) There is no medical treatment available which is

4-35  considered a more appropriate alternative medical treatment than

4-36  the medical treatment provided in the clinical trial or study; and

4-37      (e) There is a reasonable expectation based on clinical data

4-38  that the medical treatment provided in the clinical trial or study

4-39  will be at least as effective as any other medical treatment.

4-40      2.  The coverage for medical treatment required by this

4-41  section includes, without limitation:

4-42      (a) Coverage for any drug or device that is approved for sale

4-43  by the Food and Drug Administration without regard to whether

4-44  the approved drug or device has been approved for use in the

4-45  medical treatment of the insured person.


5-1  (b) The cost of any medically necessary health care that is

5-2  required as a result of the medical treatment provided in the

5-3  clinical trial or study.

5-4  3.  The coverage for medical treatment required by this

5-5  section does not include:

5-6  (a) Coverage for a drug or device described in paragraph (a)

5-7  of subsection 2 which is paid for by the manufacturer, distributor

5-8  or provider of the drug or device.

5-9  (b) Any costs for the management of the research relating to

5-10  the clinical trial or study.

5-11      (c) The cost of an investigational drug or device.

5-12      4.  An insurer who delivers or issues for delivery a policy of

5-13  group health insurance specified in subsection 1 shall:

5-14      (a) Include in the disclosure required pursuant to NRS

5-15  689B.027 notice to each group policyholder of the availability of

5-16  the benefits required by this section.

5-17      (b) Provide the coverage required by this section subject to the

5-18  same deductible, copayment, coinsurance and other such

5-19  conditions for coverage that are required under the policy.

5-20      5.  A policy of group health insurance subject to the

5-21  provisions of this chapter that is delivered, issued for delivery or

5-22  renewed on or after October 1, 2003, has the legal effect of

5-23  including the coverage required by this section, and any provision

5-24  of the policy that conflicts with this section is void.

5-25      6.  As used in this section:

5-26      (a) “Cooperative group” means a network of facilities that

5-27  collaborate on research projects and has established a peer review

5-28  program approved by the National Institutes of Health. The term

5-29  includes:

5-30          (1) The Clinical Trials Cooperative Group Program;

5-31          (2) The Adult Aids Clinical Trials Group;

5-32          (3) The Community Clinical Oncology Program; and

5-33          (4) The Community Programs for Clinical Research on

5-34  AIDS.

5-35      (b) “Provider of health care” means any physician, hospital or

5-36  other person who is licensed or otherwise authorized in this state

5-37  to furnish any health care service.

5-38      Sec. 5.  NRS 689B.0365 is hereby amended to read as follows:

5-39      689B.0365  Except as otherwise provided in section 4 of this

5-40  act:

5-41      1.  No group policy of health insurance that provides coverage

5-42  for a drug approved by the Food and Drug Administration for use in

5-43  the treatment of an illness, disease or other medical condition may

5-44  be delivered or issued for delivery in this state unless the policy


6-1  includes coverage for any other use of the drug for the treatment of

6-2  cancer, if that use is:

6-3  (a) Specified in the most recent edition of or supplement to:

6-4       (1) The United States Pharmacopoeia Drug Information; or

6-5       (2) The American Hospital Formulary Service Drug

6-6  Information; or

6-7  (b) Supported by at least two articles reporting the results of

6-8  scientific studies that are published in scientific or medical journals,

6-9  as defined in 21 C.F.R. § 99.3.

6-10      2.  The coverage required pursuant to this section:

6-11      (a) Includes coverage for any medical services necessary to

6-12  administer the drug to the employee or member of the insured

6-13  group.

6-14      (b) Does not include coverage for any:

6-15          (1) Experimental drug used for the treatment of cancer[,] if

6-16  that drug has not been approved by the Food and Drug

6-17  Administration; or

6-18          (2) Use of a drug that is contraindicated by the Food and

6-19  Drug Administration.

6-20      3.  A policy subject to the provisions of this chapter that is

6-21  delivered, issued for delivery or renewed on or after October 1,

6-22  1999, has the legal effect of including the coverage required by this

6-23  section, and any provision of the policy that conflicts with the

6-24  provisions of this section is void.

6-25      Sec. 6.  Chapter 695B of NRS is hereby amended by adding

6-26  thereto a new section to read as follows:

6-27      1.  A policy of health insurance issued by a medical services

6-28  corporation must provide coverage for medical treatment which a

6-29  person insured under the policy receives as part of a clinical trial

6-30  or study if:

6-31      (a) The medical treatment:

6-32          (1) Is provided in a Phase I, Phase II, Phase III or Phase

6-33  IV study or clinical trial for the prevention, early detection and

6-34  treatment of cancer; or

6-35          (2) Is provided in a Phase I, Phase II, Phase III or Phase

6-36  IV clinical trial for any other condition which is life-threatening;

6-37      (b) The clinical trial or study is approved by:

6-38          (1) An agency of the National Institutes of Health as set

6-39  forth in 42 U.S.C. § 281(b);

6-40          (2) A cooperative group;

6-41          (3) The Food and Drug Administration as an application

6-42  for a new investigational drug;

6-43          (4) The United States Department of Veterans Affairs;

6-44          (5) The United States Department of Defense; or


7-1       (6) A review board of a medical facility or other

7-2  organization which has a multiple project assurance contract

7-3  approved by the Office for Human Research Protections of the

7-4  United States Department of Health and Human Services;

7-5  (c) The medical treatment is provided by a provider of health

7-6  care;

7-7  (d) There is no medical treatment available which is

7-8  considered a more appropriate alternative medical treatment than

7-9  the medical treatment provided in the clinical trial or study; and

7-10      (e) There is a reasonable expectation based on clinical data

7-11  that the medical treatment provided in the clinical trial or study

7-12  will be at least as effective as any other medical treatment.

7-13      2.  The coverage for medical treatment required by this

7-14  section includes, without limitation:

7-15      (a) Coverage for any drug or device that is approved for sale

7-16  by the Food and Drug Administration without regard to whether

7-17  the approved drug or device has been approved for use in the

7-18  medical treatment of the insured person.

7-19      (b) The cost of any medically necessary health care that is

7-20  required as a result of the medical treatment provided in the

7-21  clinical trial or study.

7-22      3.  The coverage for medical treatment required by this

7-23  section does not include:

7-24      (a) Coverage for a drug or device described in paragraph (a)

7-25  of subsection 2 which is paid for by the manufacturer, distributor

7-26  or provider of the drug or device.

7-27      (b) Any costs for the management of the research relating to

7-28  the clinical trial or study.

7-29      (c) The cost of an investigational drug or device.

7-30      4.  A medical services corporation that delivers or issues for

7-31  delivery a policy of health insurance specified in subsection 1

7-32  shall:

7-33      (a) Include in the disclosure required pursuant to NRS

7-34  695B.172 notice to each person insured under the policy of the

7-35  availability of 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      5.  A policy of health insurance subject to the provisions of

7-40  this chapter that is delivered, issued for delivery or renewed on or

7-41  after October 1, 2003, has the legal effect of including the

7-42  coverage required by this section, and any provision of the policy

7-43  that conflicts with this section is void.

7-44      6.  As used in this section:


8-1  (a) “Cooperative group” means a network of facilities that

8-2  collaborate on research projects and has established a peer review

8-3  program approved by the National Institutes of Health. The term

8-4  includes:

8-5       (1) The Clinical Trials Cooperative Group Program;

8-6       (2) The Adult Aids Clinical Trials Group;

8-7       (3) The Community Clinical Oncology Program; and

8-8       (4) The Community Programs for Clinical Research on

8-9  AIDS.

8-10      (b) “Provider of health care” means any physician, hospital or

8-11  other person who is licensed or otherwise authorized in this state

8-12  to furnish any health care service.

8-13      Sec. 7.  NRS 695B.1908 is hereby amended to read as follows:

8-14      695B.1908  Except as otherwise provided in section 6 of this

8-15  act:

8-16      1.  No contract for hospital or medical services that provides

8-17  coverage for a drug approved by the Food and Drug Administration

8-18  for use in the treatment of an illness, disease or other medical

8-19  condition may be delivered or issued for delivery in this state unless

8-20  the contract includes coverage for any other use of the drug for the

8-21  treatment of cancer, if that use is:

8-22      (a) Specified in the most recent edition of or supplement to:

8-23          (1) The United States Pharmacopoeia Drug Information; or

8-24          (2) The American Hospital Formulary Service Drug

8-25  Information; or

8-26      (b) Supported by at least two articles reporting the results of

8-27  scientific studies that are published in scientific or medical journals,

8-28  as defined in 21 C.F.R. § 99.3.

8-29      2.  The coverage required pursuant to this section:

8-30      (a) Includes coverage for any medical services necessary to

8-31  administer the drug to a person covered under the contract.

8-32      (b) Does not include coverage for any:

8-33          (1) Experimental drug used for the treatment of cancer[,] if

8-34  that drug has not been approved by the Food and Drug

8-35  Administration; or

8-36          (2) Use of a drug that is contraindicated by the Food and

8-37  Drug Administration.

8-38      3.  A contract for hospital or medical services subject to the

8-39  provisions of this chapter that is delivered, issued for delivery or

8-40  renewed on or after October 1, 1999, has the legal effect of

8-41  including the coverage required by this section, and any provision of

8-42  the contract that conflicts with the provisions of this section is void.

 

 


9-1  Sec. 8.  Chapter 695C of NRS is hereby amended by adding

9-2  thereto a new section to read as follows:

9-3  1.  A health care plan issued by a health maintenance

9-4  organization must provide coverage for medical treatment which

9-5  an enrollee receives as part of a clinical trial or study if:

9-6  (a) The medical treatment:

9-7       (1) Is provided in a Phase I, Phase II, Phase III or Phase

9-8  IV study or clinical trial for the prevention, early detection and

9-9  treatment of cancer; or

9-10          (2) Is provided in a Phase I, Phase II, Phase III or Phase

9-11  IV clinical trial for any other condition which is life-threatening;

9-12      (b) The clinical trial or study is approved by:

9-13          (1) An agency of the National Institutes of Health as set

9-14  forth in 42 U.S.C. § 281(b);

9-15          (2) A cooperative group;

9-16          (3) The Food and Drug Administration as an application

9-17  for a new investigational drug;

9-18          (4) The United States Department of Veterans Affairs;

9-19          (5) The United States Department of Defense; or

9-20          (6) A review board of a medical facility or other

9-21  organization which has a multiple project assurance contract

9-22  approved by the Office for Human Research Protections of the

9-23  United States Department of Health and Human Services;

9-24      (c) The medical treatment is provided by a provider of health

9-25  care;

9-26      (d) There is no medical treatment available which is

9-27  considered a more appropriate alternative medical treatment than

9-28  the medical treatment provided in the clinical trial or study; and

9-29      (e) There is a reasonable expectation based on clinical data

9-30  that the medical treatment provided in the clinical trial or study

9-31  will be at least as effective as any other medical treatment.

9-32      2.  The coverage for medical treatment required by this

9-33  section includes, without limitation:

9-34      (a) Coverage for any drug or device that is approved for sale

9-35  by the Food and Drug Administration without regard to whether

9-36  the approved drug or device has been approved for use in the

9-37  medical treatment of the enrollee.

9-38      (b) The cost of any medically necessary health care that is

9-39  required as a result of the medical treatment provided in the

9-40  clinical trial or study.

9-41      3.  The coverage for medical treatment required by this

9-42  section does not include:

9-43      (a) Coverage for a drug or device described in paragraph (a)

9-44  of subsection 2 which is paid for by the manufacturer, distributor

9-45  or provider of the drug or device.


10-1      (b) Any costs for the management of the research relating to

10-2  the clinical trial or study.

10-3      (c) The cost of an investigational drug or device.

10-4      4.  A health maintenance organization that delivers or issues

10-5  for delivery a health care plan specified in subsection 1 shall:

10-6      (a) Include in the disclosure required pursuant to NRS

10-7  695C.193 notice to each enrollee of the availability of the benefits

10-8  required by this section.

10-9      (b) Provide the coverage required by this section subject to the

10-10  same deductible, copayment, coinsurance and other such

10-11  conditions for coverage that are required under the plan.

10-12     5.  A health care plan subject to the provisions of this chapter

10-13  that is delivered, issued for delivery or renewed on or after

10-14  October 1, 2003, has the legal effect of including the coverage

10-15  required by this section, and any provision of the plan that

10-16  conflicts with this section is void.

10-17     6.  As used in this section:

10-18     (a) “Cooperative group” means a network of facilities that

10-19  collaborate on research projects and has established a peer review

10-20  program approved by the National Institutes of Health. The term

10-21  includes:

10-22         (1) The Clinical Trials Cooperative Group Program;

10-23         (2) The Adult Aids Clinical Trials Group;

10-24         (3) The Community Clinical Oncology Program; and

10-25         (4) The Community Programs for Clinical Research on

10-26  AIDS.

10-27     (b) “Provider of health care” means any physician, hospital or

10-28  other person who is licensed or otherwise authorized in this state

10-29  to furnish any health care service.

10-30     Sec. 9.  NRS 695C.050 is hereby amended to read as follows:

10-31     695C.050  1.  Except as otherwise provided in this chapter or

10-32  in specific provisions of this title, the provisions of this title are not

10-33  applicable to any health maintenance organization granted a

10-34  certificate of authority under this chapter. This provision does not

10-35  apply to an insurer licensed and regulated pursuant to this title

10-36  except with respect to its activities as a health maintenance

10-37  organization authorized and regulated pursuant to this chapter.

10-38     2.  Solicitation of enrollees by a health maintenance

10-39  organization granted a certificate of authority, or its representatives,

10-40  must not be construed to violate any provision of law relating to

10-41  solicitation or advertising by practitioners of a healing art.

10-42     3.  Any health maintenance organization authorized under this

10-43  chapter shall not be deemed to be practicing medicine and is exempt

10-44  from the provisions of chapter 630 of NRS.


11-1      4.  The provisions of NRS 695C.110, 695C.170 to 695C.200,

11-2  inclusive, 695C.250 and 695C.265 do not apply to a health

11-3  maintenance organization that provides health care services through

11-4  managed care to recipients of Medicaid under the state plan for

11-5  Medicaid or insurance pursuant to the Children’s Health Insurance

11-6  Program pursuant to a contract with the Division of Health Care

11-7  Financing and Policy of the Department of Human Resources. This

11-8  subsection does not exempt a health maintenance organization from

11-9  any provision of this chapter for services provided pursuant to any

11-10  other contract.

11-11     5.  The provisions of NRS 695C.1694 and 695C.1695 and

11-12  section 8 of this act apply to a health maintenance organization that

11-13  provides health care services through managed care to recipients of

11-14  Medicaid under the state plan for Medicaid.

11-15     Sec. 10.  NRS 695C.1733 is hereby amended to read as

11-16  follows:

11-17     695C.1733  Except as otherwise provided in section 8 of this

11-18  act:

11-19     1.  No evidence of coverage that provides coverage for a drug

11-20  approved by the Food and Drug Administration for use in the

11-21  treatment of an illness, disease or other medical condition may be

11-22  delivered or issued for delivery in this state unless the evidence of

11-23  coverage includes coverage for any other use of the drug for the

11-24  treatment of cancer, if that use is:

11-25     (a) Specified in the most recent edition of or supplement to:

11-26         (1) The United States Pharmacopoeia Drug Information; or

11-27         (2) The American Hospital Formulary Service Drug

11-28  Information; or

11-29     (b) Supported by at least two articles reporting the results of

11-30  scientific studies that are published in scientific or medical journals,

11-31  as defined in 21 C.F.R. § 99.3.

11-32     2.  The coverage required pursuant to this section:

11-33     (a) Includes coverage for any medical services necessary to

11-34  administer the drug to the enrollee.

11-35     (b) Does not include coverage for any:

11-36         (1) Experimental drug used for the treatment of cancer[,] if

11-37  that drug has not been approved by the Food and Drug

11-38  Administration; or

11-39         (2) Use of a drug that is contraindicated by the Food and

11-40  Drug Administration.

11-41     3.  Any evidence of coverage subject to the provisions of this

11-42  chapter that is delivered, issued for delivery or renewed on or after

11-43  October 1, 1999, has the legal effect of including the coverage

11-44  required by this section, and any provision of the evidence of

11-45  coverage that conflicts with the provisions of this section is void.


12-1      Sec. 11.  NRS 695C.330 is hereby amended to read as follows:

12-2      695C.330  1.  The Commissioner may suspend or revoke any

12-3  certificate of authority issued to a health maintenance organization

12-4  pursuant to the provisions of this chapter if he finds that any of the

12-5  following conditions exist:

12-6      (a) The health maintenance organization is operating

12-7  significantly in contravention of its basic organizational document,

12-8  its health care plan or in a manner contrary to that described in and

12-9  reasonably inferred from any other information submitted pursuant

12-10  to NRS 695C.060, 695C.070 and 695C.140, unless any amendments

12-11  to those submissions have been filed with and approved by the

12-12  Commissioner;

12-13     (b) The health maintenance organization issues evidence of

12-14  coverage or uses a schedule of charges for health care services

12-15  which do not comply with the requirements of NRS [695C.170]

12-16  695C.1694 to 695C.200, inclusive, [or 695C.1694, 695C.1695] or

12-17  695C.207[;] or section 8 of this act;

12-18     (c) The health care plan does not furnish comprehensive health

12-19  care services as provided for in NRS 695C.060;

12-20     (d) The State Board of Health certifies to the Commissioner that

12-21  the health maintenance organization:

12-22         (1) Does not meet the requirements of subsection 2 of NRS

12-23  695C.080; or

12-24         (2) Is unable to fulfill its obligations to furnish health care

12-25  services as required under its health care plan;

12-26     (e) The health maintenance organization is no longer financially

12-27  responsible and may reasonably be expected to be unable to meet its

12-28  obligations to enrollees or prospective enrollees;

12-29     (f) The health maintenance organization has failed to put into

12-30  effect a mechanism affording the enrollees an opportunity to

12-31  participate in matters relating to the content of programs pursuant to

12-32  NRS 695C.110;

12-33     (g) The health maintenance organization has failed to put into

12-34  effect the system for resolving complaints required by NRS

12-35  695C.260 in a manner reasonably to dispose of valid complaints;

12-36     (h) The health maintenance organization or any person on its

12-37  behalf has advertised or merchandised its services in an untrue,

12-38  misrepresentative, misleading, deceptive or unfair manner;

12-39     (i) The continued operation of the health maintenance

12-40  organization would be hazardous to its enrollees; or

12-41     (j) The health maintenance organization has otherwise failed to

12-42  comply substantially with the provisions of this chapter.

12-43     2.  A certificate of authority must be suspended or revoked only

12-44  after compliance with the requirements of NRS 695C.340.


13-1      3.  If the certificate of authority of a health maintenance

13-2  organization is suspended, the health maintenance organization shall

13-3  not, during the period of that suspension, enroll any additional

13-4  groups or new individual contracts, unless those groups or persons

13-5  were contracted for before the date of suspension.

13-6      4.  If the certificate of authority of a health maintenance

13-7  organization is revoked, the organization shall proceed, immediately

13-8  following the effective date of the order of revocation, to wind up its

13-9  affairs and shall conduct no further business except as may be

13-10  essential to the orderly conclusion of the affairs of the organization.

13-11  It shall engage in no further advertising or solicitation of any kind.

13-12  The Commissioner may , by written order , permit such further

13-13  operation of the organization as he may find to be in the best interest

13-14  of enrollees to the end that enrollees are afforded the greatest

13-15  practical opportunity to obtain continuing coverage for health care.

13-16     Sec. 12.  Chapter 695G of NRS is hereby amended by adding

13-17  thereto a new section to read as follows:

13-18     1.  A health care plan issued by a managed care organization

13-19  must provide coverage for medical treatment which a person

13-20  insured under the plan receives as part of a clinical trial or study

13-21  if:

13-22     (a) The medical treatment:

13-23         (1) Is provided in a Phase I, Phase II, Phase III or Phase

13-24  IV study or clinical trial for the prevention, early detection and

13-25  treatment of cancer; or

13-26         (2) Is provided in a Phase I, Phase II, Phase III or Phase

13-27  IV clinical trial for any other condition which is life-threatening;

13-28     (b) The clinical trial or study is approved by:

13-29         (1) An agency of the National Institutes of Health as set

13-30  forth in 42 U.S.C. § 281(b);

13-31         (2) A cooperative group;

13-32         (3) The Food and Drug Administration as an application

13-33  for a new investigational drug;

13-34         (4) The United States Department of Veterans Affairs;

13-35         (5) The United States Department of Defense; or

13-36         (6) A review board of a medical facility or other

13-37  organization which has a multiple project assurance contract

13-38  approved by the Office for Human Research Protections of the

13-39  United States Department of Health and Human Services;

13-40     (c) The medical treatment is provided by a provider of health

13-41  care;

13-42     (d) There is no medical treatment available which is

13-43  considered a more appropriate alternative medical treatment than

13-44  the medical treatment provided in the clinical trial or study; and


14-1      (e) There is a reasonable expectation based on clinical data

14-2  that the medical treatment provided in the clinical trial or study

14-3  will be at least as effective as any other medical treatment.

14-4      2.  The coverage for medical treatment required by this

14-5  section includes, without limitation:

14-6      (a) Coverage for any drug or device that is approved for sale

14-7  by the Food and Drug Administration without regard to whether

14-8  the approved drug or device has been approved for use in the

14-9  medical treatment of the insured.

14-10     (b) The cost of any medically necessary health care that is

14-11  required as a result of the medical treatment provided in the

14-12  clinical trial or study.

14-13     3.  The coverage for medical treatment required by this

14-14  section does not include:

14-15     (a) Coverage for a drug or device described in paragraph (a)

14-16  of subsection 2 which is paid for by the manufacturer, distributor

14-17  or provider of the drug or device.

14-18     (b) Any costs for the management of the research relating to

14-19  the clinical trial or study.

14-20     (c) The cost of an investigational drug or device.

14-21     4.  A managed care organization that delivers or issues for

14-22  delivery a health care plan specified in subsection 1 shall:

14-23     (a) Include in the disclosure required pursuant to NRS

14-24  695C.193 notice to each person insured under the plan of the

14-25  availability of the benefits required by this section.

14-26     (b) Provide the coverage required by this section subject to the

14-27  same deductible, copayment, coinsurance and other such

14-28  conditions for coverage that are required under the plan.

14-29     5.  A health care plan subject to the provisions of this chapter

14-30  that is delivered, issued for delivery or renewed on or after

14-31  October 1, 2003, has the legal effect of including the coverage

14-32  required by this section, and any provision of the plan that

14-33  conflicts with this section is void.

14-34     6.  As used in this section:

14-35     (a) “Cooperative group” means a network of facilities that

14-36  collaborate on research projects and has established a peer review

14-37  program approved by the National Institutes of Health. The term

14-38  includes:

14-39         (1) The Clinical Trials Cooperative Group Program;

14-40         (2) The Adult Aids Clinical Trials Group;

14-41         (3) The Community Clinical Oncology Program; and

14-42         (4) The Community Programs for Clinical Research on

14-43  AIDS.


15-1      (b) “Provider of health care” means any physician, hospital or

15-2  other person who is licensed or otherwise authorized in this state

15-3  to furnish any health care service.

15-4      Sec. 13.  NRS 287.010 is hereby amended to read as follows:

15-5      287.010  1.  The governing body of any county, school

15-6  district, municipal corporation, political subdivision, public

15-7  corporation or other public agency of the State of Nevada may:

15-8      (a) Adopt and carry into effect a system of group life, accident

15-9  or health insurance, or any combination thereof, for the benefit of its

15-10  officers and employees, and the dependents of officers and

15-11  employees who elect to accept the insurance and who, where

15-12  necessary, have authorized the governing body to make deductions

15-13  from their compensation for the payment of premiums on the

15-14  insurance.

15-15     (b) Purchase group policies of life, accident or health insurance,

15-16  or any combination thereof, for the benefit of such officers and

15-17  employees, and the dependents of such officers and employees, as

15-18  have authorized the purchase, from insurance companies authorized

15-19  to transact the business of such insurance in the State of Nevada,

15-20  and, where necessary, deduct from the compensation of officers and

15-21  employees the premiums upon insurance and pay the deductions

15-22  upon the premiums.

15-23     (c) Provide group life, accident or health coverage through a

15-24  self-insurance reserve fund and, where necessary, deduct

15-25  contributions to the maintenance of the fund from the compensation

15-26  of officers and employees and pay the deductions into the fund. The

15-27  money accumulated for this purpose through deductions from

15-28  the compensation of officers and employees and contributions of the

15-29  governing body must be maintained as an internal service fund as

15-30  defined by NRS 354.543. The money must be deposited in a state or

15-31  national bank or credit union authorized to transact business in the

15-32  State of Nevada. Any independent administrator of a fund created

15-33  under this section is subject to the licensing requirements of chapter

15-34  683A of NRS, and must be a resident of this state. Any contract

15-35  with an independent administrator must be approved by the

15-36  Commissioner of Insurance as to the reasonableness of

15-37  administrative charges in relation to contributions collected and

15-38  benefits provided. The provisions of NRS 689B.030 to 689B.050,

15-39  inclusive, and 689B.575 and section 4 of this act apply to coverage

15-40  provided pursuant to this paragraph, except that the provisions of

15-41  NRS 689B.0359 do not apply to such coverage.

15-42     (d) Defray part or all of the cost of maintenance of a self-

15-43  insurance fund or of the premiums upon insurance. The money for

15-44  contributions must be budgeted for in accordance with the laws

15-45  governing the county, school district, municipal corporation,


16-1  political subdivision, public corporation or other public agency of

16-2  the State of Nevada.

16-3      2.  If a school district offers group insurance to its officers and

16-4  employees pursuant to this section, members of the board of trustees

16-5  of the school district must not be excluded from participating in the

16-6  group insurance. If the amount of the deductions from compensation

16-7  required to pay for the group insurance exceeds the compensation to

16-8  which a trustee is entitled, the difference must be paid by the trustee.

16-9      Sec. 14.  NRS 287.04335 is hereby amended to read as

16-10  follows:

16-11     287.04335  If the Board provides health insurance through a

16-12  plan of self-insurance, it shall comply with the provisions of section

16-13  12 of this act and NRS 689B.255, 695G.150, 695G.160, 695G.170

16-14  and 695G.200 to 695G.230, inclusive, in the same manner as an

16-15  insurer that is licensed pursuant to title 57 of NRS is required to

16-16  comply with those provisions.

 

16-17  H