The laws included in this section are meant as models for state legislatures that wish to improve their state’s environment.

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The laws included in this section are meant as models for state legislatures that wish to improve their state’s environment for women with ovarian cancer. The Alliance is available to assist legislators who wish to implement similar legislation in their states.

CONTENTS

I. Direct Access to Gynecologists
II. Standing Referral to Specialists
III. Second Opinion
IV. Caps on Copayments
V. Coverage of Medically Accurate Diagnostic Tools
VI. Education/Awareness: State Cancer Plans
VII. Genetic Discrimination
VIII. License Plate Model
IX. Tax Check Off
X. Off Label Prescription
XI. Required Coverage of Routine Cost of Care Clinical Trials
XII. Awareness Legislation

I. DIRECT ACCESS TO GYNECOLOGISTS

TITLE 27 Insurance

CHAPTER 49 Obstetricians and Gynecologists as Primary Care Physician

Code of Ala. § 27-49-4 (2011)

§ 27-49-4. Generally.

(a) Each health benefit plan which is issued, delivered, issued for delivery, or renewed in this state on or after October 1, 1996, shall allow obstetricians and gynecologists as primary care physicians. This subsection shall not be construed to require an individual obstetrician or gynecologist to accept primary care physician status if the obstetrician or gynecologist does not wish to be designated as a primary care physician, nor to interfere with the credentialing and other selection criteria usually applied by a health benefit plan with respect to other physicians within its network.

(b) For women not using an obstetrician or gynecologist as their primary care physician, no health benefit plan which is issued, delivered, issued for delivery, or renewed in this state on or after October 1, 1996, shall require as a condition to the coverage of the services of a participating obstetrician or a participating gynecologist that an enrollee, subscriber, or insured first obtain a referral from another primary care physician, it being the intent of this subsection that a woman shall at all times have direct access to the services of a participating obstetrician or a participating gynecologist, or both, under any health benefit plan; provided, however, that the service covered by this subsection shall be limited to those services defined by the published recommendations of the Accreditation Council For Graduate Medical Education for training as an obstetrician or gynecologist, including, but not limited to, diagnosis, treatment, and referral.

HISTORY: Acts 1996, No. 96-671.

II. STANDING REFERRAL TO SPECIALISTS

Annotated Code of Maryland

INSURANCE

TITLE 15. HEALTH INSURANCE

SUBTITLE 8. REQUIRED HEALTH INSURANCE BENEFITS

Md. INSURANCE Code Ann. § 15-830 (2011)

§ 15-830. Referrals to specialists

(b) Procedure for standing referrals. –

(1) Each carrier that does not allow direct access to specialists shall establish and implement a procedure by which a member may receive a standing referral to a specialist in accordance with this subsection.

(2) The procedure shall provide for a standing referral to a specialist if:

(i) the primary care physician of the member determines, in consultation with the specialist, that the member needs continuing care from the specialist;

(ii) the member has a condition or disease that:

1. is life threatening, degenerative, chronic, or disabling; and

2. requires specialized medical care; and

(iii) the specialist:

1. has expertise in treating the life-threatening, degenerative, chronic, or disabling disease or condition; and

2. is part of the carrier’s provider panel.

(3) Except as provided in subsection (c) of this section, a standing referral shall be made in accordance with a written treatment plan for a covered service developed by:

(i) the primary care physician;

(ii) the specialist; and

(iii) the member.

(4) A treatment plan may:

(i) limit the number of visits to the specialist;

(ii) limit the period of time in which visits to the specialist are authorized; and

(iii) require the specialist to communicate regularly with the primary care physician regarding the treatment and health status of the member.

(5) The procedure by which a member may receive a standing referral to a specialist may not include a requirement that a member see a provider in addition to the primary care physician before the standing referral is granted.

(c) Standing referral for pregnancy. –

(1) Notwithstanding any other provision of this section, a member who is pregnant shall receive a standing referral to an obstetrician in accordance with this subsection.

(2) After the member who is pregnant receives a standing referral to an obstetrician, the obstetrician is responsible for the primary management of the member’s pregnancy, including the issuance of referrals in accordance with the carrier’s policies and procedures, through the postpartum period.

(3) A written treatment plan may not be required when a standing referral is to an obstetrician under this subsection.

(d) Referrals to nonpanel specialists. –

(1) Each carrier shall establish and implement a procedure by which a member may request a referral to a specialist or nonphysician specialist who is not part of the carrier’s provider panel in accordance with this subsection.

(2) The procedure shall provide for a referral to a specialist or nonphysician specialist who is not part of the carrier’s provider panel if:

(i) the member is diagnosed with a condition or disease that requires specialized health care services or medical care; and

(ii) 1. the carrier does not have in its provider panel a specialist or nonphysician specialist with the professional training and expertise to treat or provide health care services for the condition or disease; or

2. the carrier cannot provide reasonable access to a specialist or nonphysician specialist with the professional training and expertise to treat or provide health care services for the condition or disease without unreasonable delay or travel.

(e) Calculation of deductibles, copayments and coinsurance. — For purposes of calculating any deductible, copayment amount, or coinsurance payable by the member, a carrier shall treat services received in accordance with subsection (d) of this section as if the service was provided by a provider on the carrier’s provider panel.

(f) Adverse decision. — A decision by a carrier not to provide access to or coverage of treatment or health care services by a specialist or nonphysician specialist in accordance with this section constitutes an adverse decision as defined under Subtitle 10A of this title if the decision is based on a finding that the proposed service is not medically necessary, appropriate, or efficient.

(g) Copy of procedures filed with Commissioner. — Each carrier shall file with the Commissioner a copy of each of the procedures required under this section.

HISTORY: 1999, ch. 120, § 1; 2000, ch. 359; 2006, ch. 597; 2007, chs. 141, 142.

NOTES: EFFECT OF AMENDMENTS. –Chapter 597, Acts 2006, effective June 1, 2006, rewrote (a)(4); and added (d)(2)(ii)2. and (e) and made related changes.

Chapters 141 and 142, Acts 2007, effective October 1, 2007, made identical changes. Each added (a)(4) and redesignated accordingly; added “or nonphysician specialist” and “or provide health care services for” throughout (d) and (f); added “health care services or” or variant in (d)(2)(i) and (f).

EDITOR’S NOTE. –Section 2, ch. 597, Acts 2006, provides that “(a) On or before January 1, 2007, the Maryland Insurance Administration, in consultation with the Department of Health and Mental Hygiene’s Office of Health Care Quality and other interested and affected parties, shall adopt regulations to implement the provisions of § 15-112(b)(1)(i)1 of the Insurance Article, as enacted by Section 1 of this Act, with respect to insurers, nonprofit health service plans, and dental plan organizations.

“(b) In developing the regulations required under subsection (a) of this section, the Administration shall take into consideration the standards and procedures adopted by national accrediting organizations for preferred provider organizations and the laws of other states.

“(c) Each insurer, nonprofit health service plan, and dental plan organization offering preferred provider organization benefit plans in the State shall comply with the regulations on or before July 1, 2007.”

Section 3, ch. 597, Acts 2006, provides that “on or before January 1, 2008, the Maryland Insurance Administration shall:

“(1) study the feasibility and desirability of imposing on carriers a network standard for in-network hospital-based physician services; and

“(2) report on the findings and recommendations of its study, in accordance with § 2-1246 of the State Government Article, to the Senate Finance Committee and the House Health and Government Operations Committee.”

Section 2, chs. 141 and 142, Acts 2007, provides that “this Act shall apply to all policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or after October 1, 2007.”

III. SECOND OPINION

KENTUCKY REVISED STATUTES ANNOTATED

TITLE XXV Business and Financial Institutions

CHAPTER 304 Insurance Code

SUBTITLE 17A. Health Benefit Plans

Managed Care Plans

KRS § 304.17A-520 (2011)

304.17A-520. Enrollee choice of primary care providers.

(1) An enrollee shall have adequate choice among participating primary care providers in a managed care plan who are accessible and qualified.

(2) A managed care plan shall permit enrollees to choose their own primary care provider from a list of health care providers within the plan. This list shall be updated as health care providers are added or removed and shall include a sufficient number of primary care providers who are accepting new enrollees.

(3) Women shall be able to choose a qualified health care provider offered by a plan for the provision of covered care necessary to provide routine and preventive women’s health care services.

(4) An insurer shall provide a covered person with access to a consultation with a participating health care provider for a second opinion. Obtaining the second opinion shall not cost a covered person more than the covered person’s normal copay or coinsurance amounts.

IV. CAPS ON COPAYMENTS

INSURANCE

CHAPTER 62L SMALL EMPLOYER INSURANCE REFORM

Minn. Stat. § 62L.05 (2010)

62L.05 SMALL EMPLOYER PLAN BENEFITS

Subdivision 1. Two small employer plans.

Each health carrier in the small employer market must make available, on a guaranteed issue basis, to any small employer that satisfies the contribution and participation requirements of section 62L.03, subdivision 3, both of the small employer plans described in subdivisions 2 and 3. Under subdivisions 2 and 3, coinsurance and deductibles do not apply to child health supervision services and prenatal services, as defined by section 62A.047. The maximum out-of-pocket costs for covered services must be $3,000 per individual and $6,000 per family per year. The maximum lifetime benefit must be not less than $1,000,000.

Subd. 2. Deductible-type small employer plan.

The benefits of the deductible-type small employer plan offered by a health carrier must be equal to 80 percent of the charges, as specified in subdivision 10, for health care services, supplies, or other articles covered under the small employer plan, in excess of an annual deductible which must be $2,250 per individual and $4,500 per family.

Subd. 3. Co-payment-type small employer plan.

The benefits of the co-payment-type small employer plan offered by a health carrier must be equal to 80 percent of the charges, as specified in subdivision 10, for health care services, supplies, or other articles covered under the small employer plan, in excess of the following co-payments:

(1) $15 per outpatient visit, including visits to an urgent care center but not including visits to a hospital outpatient department or emergency room, or similar facility;

(2) $15 per visit for the services of a home health agency or private duty registered nurse;

(3) $50 per outpatient visit to a hospital outpatient department or emergency room, or similar facility; and

(4) $300 per inpatient admission to a hospital.

Subd. 4. Benefits.

The medical services and supplies listed in this subdivision are the benefits that must be covered by the small employer plans described in subdivisions 2 and 3. Benefits under this subdivision may be provided through the managed care procedures practiced by health carriers:

(1) inpatient and outpatient hospital services, excluding services provided for the diagnosis, care, or treatment of chemical dependency or a mental illness or condition, other than those conditions specified in clauses (10) and (11). The health care services required to be covered under this clause must also be covered if rendered in a nonhospital environment, on the same basis as coverage provided for those same treatments or services if rendered in a hospital, provided, however, that this sentence must not be interpreted as expanding the types or extent of services covered;

(2) physician, chiropractor, and nurse practitioner services for the diagnosis or treatment of illnesses, injuries, or conditions;

(3) diagnostic x-rays and laboratory tests;

(4) ground transportation provided by a licensed ambulance service to the nearest facility qualified to treat the condition, or as otherwise required by the health carrier;

(5) services of a home health agency if the services qualify as reimbursable services under Medicare;

(6) services of a private duty registered nurse if medically necessary, as determined by the health carrier;

(7) the rental or purchase, as appropriate, of durable medical equipment, other than eyeglasses and hearing aids, unless coverage is required under section 62Q.675;

(8) child health supervision services up to age 18, as defined in section 62A.047;

(9) maternity and prenatal care services, as defined in sections 62A.041 and 62A.047;

(10) inpatient hospital and outpatient services for the diagnosis and treatment of certain mental illnesses or conditions, as defined by the International Classification of Diseases-Clinical Modification (ICD-9-CM), seventh edition (1990) and as classified as ICD-9 codes 295 to 299; and

(11) 50 percent of eligible charges for prescription drugs, up to a separate annual maximum out-of-pocket expense of $1,000 per individual for prescription drugs, and 100 percent of eligible charges thereafter.

Subd. 4a. Alternative benefit plan.

In addition to the small employer benefit plans described in subdivisions 1 to 4, a health carrier may offer to a small employer a benefit plan that differs from those plans in the following respects:

(1) the plan may include different co-payments and deductibles; and

(2) the plan may offer coverage on a per diem, fixed indemnity, or nonexpense incurred basis.

Subd. 5. Plan variations.

(a) No health carrier shall offer to a small employer a health benefit plan that differs from the small employer plans described in subdivisions 1 to 4a, unless the health benefit plan complies with all provisions of chapters 62A, 62C, 62D, 62E, 62H, 62N, 62Q, and 64B that otherwise apply to the health carrier, except as expressly permitted by paragraph (b).

(b) As an exception to paragraph (a), a health benefit plan is deemed to be a small employer plan and to be in compliance with paragraph (a) if it differs from one of the two small employer plans described in subdivisions 1 to 4 only by providing benefits in addition to those described in subdivision 4, provided that the health benefit plan has an actuarial value that exceeds the actuarial value of the benefits described in subdivision 4 by no more than two percent. “Benefits in addition” means additional units of a benefit listed in subdivision 4 or one or more benefits not listed in subdivision 4.

Subd. 6. Choice products exception.

Nothing in subdivision 1 prohibits a health carrier from offering a small employer plan which provides for different benefit coverages based on whether the benefit is provided through a primary network of providers or through a secondary network of providers so long as the benefits provided in the primary network equal the benefit requirements of the small employer plan as described in this section. For purposes of products issued under this subdivision, out-of-pocket costs in the secondary network may exceed the out-of-pocket limits described in subdivision 1. A secondary network must not be used to provide “benefits in addition” as defined in subdivision 5, except in compliance with that subdivision.

Subd. 7. Benefit exclusions.

No medical, hospital, or other health care benefits, services, supplies, or articles not expressly specified in subdivision 4 are required to be included in a small employer plan. Nothing in subdivision 4 restricts the right of a health carrier to restrict coverage to those services, supplies, or articles which are medically necessary. Health carriers may exclude a benefit, service, supply, or article not expressly specified in subdivision 4 from a small employer plan.

Subd. 8. Continuation coverage.

Small employer plans must include the continuation of coverage provisions required by the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA), Public Law 99-272, as amended, and by state law.

Subd. 9. Dependent coverage.

Other state law and rules applicable to health plan coverage of newborn infants, dependent children who do not reside with the eligible employee, disabled children and dependents, and adopted children apply to a small employer plan. Health benefit plans that provide dependent coverage must define “dependent” no more restrictively than the definition provided in section 62L.02.

Subd. 10. Medical expense reimbursement.

Health carriers may reimburse or pay for medical services, supplies, or articles provided under a small employer plan in accordance with the health carrier’s provider contract requirements including, but not limited to, salaried arrangements, capitation, the payment of usual and customary charges, fee schedules, discounts from fee-for-service, per diems, diagnosis-related groups (DRGs), and other payment arrangements. Nothing in this chapter requires a health carrier to develop, implement, or change its provider contract requirements for a small employer plan. Coinsurance, deductibles, out-of-pocket maximums, and maximum lifetime benefits must be calculated and determined in accordance with each health carrier’s standard business practices.

Subd. 11. Plan design.

Notwithstanding any other law, regulation, or administrative interpretation to the contrary, health carriers may offer small employer plans through any provider arrangement, including, but not limited to, the use of open, closed, or limited provider networks. A health carrier may only use product and network designs currently allowed under existing statutory requirements. The provider networks offered by any health carrier may be specifically designed for the small employer market and may be modified at the carrier’s election so long as all otherwise applicable regulatory requirements are met. Health carriers may use professionally recognized provider standards of practice when they are available, and may use utilization management practices otherwise permitted by law, including, but not limited to, second surgical opinions, prior authorization, concurrent and retrospective review, referral authorizations, case management, and discharge planning. A health carrier may contract with groups of providers with respect to health care services or benefits, and may negotiate with providers regarding the level or method of reimbursement provided for services rendered under a small employer plan.

Subd. 12. Demonstration projects.

Nothing in this chapter prohibits a health maintenance organization from offering a demonstration project authorized under section 62D.30. The commissioner of health may approve a demonstration project which offers benefits that do not meet the requirements of a small employer plan if the commissioner finds that the requirements of section 62D.30 are otherwise met.

Subd. 13. Notice of plan availability.

Each health carrier in the small employer market must provide information to small employers regarding the availability of the plans described in subdivisions 2 and 3, and in section 62L.056. At a minimum, each health carrier must provide information describing the plans and their availability:

(1) displayed with other small employer product information on the health carrier’s public Web site; and

(2) delivered to each small employer currently insured by the health carrier at the time of the small employer’s renewal, at the same time and in the same manner as the small employer’s renewal information.

HISTORY: 1992 c 549 art 2 s 5; 1993 c 247 art 2 s 8; 1993 c 345 art 7 s 7-10; 1994 c 625 art 10 s 35-37; 1999 c 177 s 54; 1999 c 181 s 2,3; 2001 c 215 s 21,22; 1Sp2003 c 14 art 7 s 21; 2005 c 56 s 1; 2008 c 231 s 1; 2010 c 384 s 23

V. COVERAGE OF MEDICALLY ACCURATE DIAGNOSTIC TOOLS:

This bill was introduced to the California State Assembly Committee in 2008, but did not move forward through the legislative process.

BILL NUMBER: AB 1774AMENDED
BILL TEXT

AMENDED IN ASSEMBLY APRIL 22, 2008
AMENDED IN ASSEMBLY MARCH 5, 2008

INTRODUCED BY Assembly Members Lieber and De Leon
(Coauthors: Assembly Members Dymally, Evans, Fuentes, and Laird)
(Coauthor: Senator Cedillo)

JANUARY 14, 2008

An act to add Section 1367.655 to the Health and Safety Code, and to add Section 10123.182 to the Insurance Code, relating to health care coverage.

LEGISLATIVE COUNSEL’S DIGEST

AB 1774, as amended, Lieber. Health care coverage: gynecological cancer screening tests.

Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of the act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. Under existing law, a health care service plan and a health insurer are deemed to provide coverage for all generally medically accepted cancer screening tests.

This bill would specifically require that a health care service plan contract and a health insurance policy be deemed to provide coverage for any test necessary for the screening and diagnosis of gynecological cancers when ordered by a physician, nurse practitioner, or certified nurse midwife, as specified, and would require that this coverage be provided consistent with national professional standard guidelines.

Because the bill would specify an additional requirement for a health care service plan, the willful violation of which would be a crime, it would impose a state-mandated local program.

The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Vote: majority. Appropriation: no. Fiscal committee: yes.

State-mandated local program: yes.

THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

SECTION 1. Section 1367.655 is added to the Health and Safety Code, to read:

1367.655. Every individual or group health care service plan contract, except for a specialized health care service plan contract, that is issued, amended, or renewed, on or after January 1, 2009, shall be deemed to provide coverage for any test necessary for the screening and diagnosis of gynecological cancers when ordered by a physician, nurse practitioner, or certified nurse midwife in whose judgment the test would assist or facilitate the diagnosis of cancer.

Coverage provided pursuant to this section shall be provided consistent with national professional standard guidelines.

SEC. 2. Section 10123.182 is added to the Insurance Code, to read:

10123.182. (a) Every individual or group policy of health insurance that is issued, amended, or renewed, on or after January 1, 2009, shall be deemed to provide coverage for any test necessary for the screening and diagnosis of gynecological cancers when ordered by a physician, nurse practitioner, or certified nurse midwife in whose judgment the test would assist or facilitate the diagnosis of cancer. Coverage provided pursuant to this section shall be provided consistent with national professional standard guidelines.

(b) This section shall not apply to Medicare supplement, vision-only, dental-only, or CHAMPUS supplement insurance, or to hospital indemnity, accident-only, or specified disease insurance that does not pay benefits on a fixed-benefit, cash payment only basis.

SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.

VI. EDUCATION/AWARENESS: STATE CANCER PLANS

New Jersey Comprehensive Cancer Control Plan, 2008-2012
CHAPTER 7
Gynecologic Cancer
Ovarian Cancer

Importance of Ovarian Cancer for Cancer Prevention and Control

Ovarian Cancer is the seventh leading cause of cancer (excluding cancers of the skin) and the fifth leading cause of cancer death among women in the U.S. It is estimated that 22,430 new cases of ovarian cancer will be diagnosed nationwide in 2007, and 15,280 women will die of the disease. Ovarian cancer is responsible for more deaths than any other gynecologic cancer. A woman has a 1.7% chance of developing ovarian cancer over her lifetime.1,63,64

While 93% of women diagnosed with ovarian cancer in the early, localized stage survive five years beyond diagnosis, less than 20% of cases are found early. Women diagnosed with regional- and distant-stage ovarian cancer have five-year relative survival rates of 68% and 30%, respectively.1,63

Factors that act to increase a woman’s risk of developing ovarian cancer include age, hereditary factors, a personal or family history of ovarian or breast cancer, nulliparity (bearing no children), physical inactivity, a diet high in animal fats and low in fruits and vegetables, and smoking.65–69 Research has shown that using oral contraceptive pills (OCP) reduces the risk of ovarian cancer.65,70

It is a myth that ovarian cancer is most often asymptomatic. Many women diagnosed with ovarian cancer recall experiencing symptoms of the disease several months before diagnosis. However, they were usually unaware that the symptoms could be associated with ovarian cancer.71 Symptoms of ovarian cancer may include enlargement of the abdomen; abdominal bloating or pain; abnormal vaginal bleeding (rarely); fatigue; change in bowel habits, digestive disturbances, or inability to eat normally; pelvic pain; constipation; back pain and urinary frequency or incontinence; and unexplained weight loss or gain. Symptoms are usually sudden and persist despite home treatment. However, often these symptoms are not recognized as cause for concern, and many patients and healthcare professionals attribute them to other conditions.69,72,73

There currently exists no effective screening mechanism to detect ovarian cancer. Contrary to what many women believe, the Pap test, which screens for cervical cancer, is not effective in detecting ovarian cancer. Because ovarian cancer often has no significant signs or symptoms until the later stages, it is difficult to diagnose the disease in its earliest stages when it is most treatable.

Ovarian Cancer in New Jersey

In this section we discuss the status of ovarian cancer in New Jersey, including incidence, mortality, prevalence, survival, and screening.

Incidence.
 In 2004, there were 677 cases of invasive ovarian cancer diagnosed in New Jersey. White women have consistently higher age-adjusted ovarian cancer incidence rates than do black or Hispanic women (13.9 versus 10.1 and 11.5 per 100,000, respectively, in 2004)18 (Figure 5). Between 1979 and 2003, ovarian cancer incidence rates declined more than 20% to just under 15 per 100,000 in 2003. †71 Despite this decline, however, New Jersey ovarian cancer incidence rates in 2003 (all races and ethnicities combined) was slightly higher than those of the U.S. as a whole (14.4 versus 13.0, respectively).18,74

† Part of the decreases in 2001 through 2003 are due to borderline ovarian cancer cases not being included because of a change in the coding rules between the second and third editions of the International Classification of Diseases for Oncology (ICD-O).

Mortality. In 2003, there were 512 ovarian cancer deaths in New Jersey. From 1979 through 2003, ovarian cancer mortality rates remained fairly stable, though slightly higher than the U.S. rate. The New Jersey mortality rate in 2003 was higher for white women than for black and Hispanic women (10.3 versus 7.6 and 4.9 per 100,000**, respectively) (Figure 6).21

Prevalence. Estimates indicate that on January 1, 2003, there were 6,059 or 0.1% of New Jersey women alive who had ever been diagnosed with ovarian cancer. As with other cancers, the prevalence of ovarian cancer increases with age and is highest in the 65+ age group (0.4%). The prevalence of ovarian cancer is twice as high in whites as in blacks (0.2% versus 0.1%, respectively).22

Survival
. The five-year relative survival rate for ovarian cancer diagnosed in New Jersey from 1994–1997 is 49.3%. This rate is higher than the U.S. rate of 44.6%. Disparities in survival exist between black and white women. In New Jersey, as in the U.S., black women have a lower survival rate than do white women (44.8% versus 49.6%, respectively).23

New Jersey specific survival data for ovarian cancer by stage are not available. However, as with other cancers, ovarian cancer survival rates are much higher for cancers diagnosed at the local stage than at the regional or distant stage. According to the American Cancer Society, when diagnosed at the local stage, the five-year relative survival rate is 94%.1 Similar to the U.S., only about 17% of ovarian cancers in New Jersey are diagnosed at the local stage.18 Survival rates also vary by age, with women younger than 65 being about twice as likely to survive five years following diagnosis than women 65 and older, 57% and 28%, respectively.1

Screening
. There are tests that can detect ovarian cancer, such as pelvic examination, transvaginal ultrasound, and CA-125 antigen. However, due to the high rate of false positives among average-risk women, current recommendations indicate transvaginal ultrasound and CA-125 only for those women at highest risk.

What Can Be Done about Ovarian Cancer in New Jersey?

Unfortunately, the majority of the risk factors associated with ovarian cancer (excluding smoking and nutrition and physical activity) are not modifiable, so little can be done to prevent the disease. While oral contraceptive pill use has been shown to protect against ovarian cancer in some women, there are other risks associated with OCP use.

However, women who are aware of their risk of developing ovarian cancer due to one or more risk factors may be more likely to notice early symptoms of the disease and seek medical care, leading to earlier diagnosis. Educating women and healthcare professionals about the risk factors and symptoms associated with ovarian cancer is currently the only means to decrease morbidity and mortality from the disease.

Goals, Objectives, and Strategies for Ovarian Cancer

In support of the Healthy New Jersey 2010 goals for ovarian cancer, the recommendations of the Gynecologic Cancer Workgroup are summarized below in the following focal areas:

  • Awareness and education
  • Research and surveillance

Awareness and Education

Over 75% of ovarian cancers are diagnosed in the regional or distant stages, when the chances for successful treatment and survival are diminished.63 Many women experience symptoms, even with early-stage disease.71 However, several factors stand in the way of early diagnosis. Healthcare providers and patients alike are often unaware of the signs and symptoms of the disease and commonly attribute them to other conditions.69,72,73 Delays in the diagnosis of ovarian cancer occur in the self-care and primary provider care phases of the diagnosis-seeking process.72,75 Both phases present opportunities to improve the early detection of ovarian cancer. The Gynecologic Cancer Workgroup is in agreement with the American College of Obstetricians and Gynecologists (ACOG), which recommends that, in order to increase the early diagnosis of ovarian cancers, both patients and clinicians must be educated about symptoms associated with ovarian cancer and must have a high index of suspicion of the disease in symptomatic women. ACOG also recommends that physicians perform a physical examination, including a pelvic examination, in evaluating symptomatic women.76 Referral to a gynecologic oncologist is an important step if suspicion is aroused by the pelvic exam, elevated CA-125, or abnormal ultrasound findings.

Educational programs must be targeted at women, emphasizing the importance of recognizing the early symptoms of ovarian cancer and the need for an annual pelvic exam. Women should also be educated about self-monitoring strategies for ovarian health as a strategy for reducing diagnosis delays during self-care.75

In addition, clinicians must be educated with state-of-the-science ovarian cancer health programs that emphasize recognition of early signs and symptoms and the risk of misdiagnosis.75

GOAL GY-8: To increase awareness of the early signs, symptoms, and risk factors associated with ovarian cancer

Objective GY-8.1

To obtain, or develop as needed, information for developing ovarian cancer public awareness initiatives.

Strategies

1.1 Partner with organizations and universities to obtain, or develop as needed, appropriate public education and awareness materials.

Objective GY-8.2

To collaborate with organizations to promote public awareness of ovarian cancer early signs, symptoms, and risk factors.

Strategies

2.1 Distribute public awareness and education materials at health fairs and other public events.

Objective GY-8.3

To educate health care professionals about the early signs and symptoms of ovarian cancer.

Strategies

3.1 Partner with organizations and universities to obtain, or develop as needed, appropriate professional education and awareness materials and messages.

3.2 Work with stakeholders to disseminate appropriate professional education and awareness materials and messages and encourage collaboration between primary care and gynecologic oncologists through CME offerings

Research and Surveillance

Currently, a number of research studies are ongoing into developing more effective screening and early diagnostic tests for ovarian cancer. Studies of new tumor markers are in progress, but it is not yet known whether these will be successful in detecting ovarian cancer tumors at earlier stages or in reducing mortality.71

Clinical trials are the major avenue for discovering, developing, and evaluating new therapies. However, only about 3% of all adult cancer patients participate in clinical trials. It is important to increase physician and patient awareness of, and participation in, clinical trials if we are to test new treatments more rapidly, find more effective treatments, and broaden the options available to patients.56

Research must be conducted to learn why New Jersey women do not participate in clinical trials. Then, solutions to the barriers must be addressed. The Gynecologic Cancer Workgroup suggests the following goal, objectives, and strategies as next steps.

GOAL GY-9:
 To ensure that New Jersey residents and physicians remain up-to-date on the most currently available ovarian cancer technologies and resources.

Objective GY-9.1

To monitor ongoing research regarding the possible efficacy of screening/detection methods for ovarian cancer and formulate and distribute recommendations as warranted by such research.

Strategies

1.1 Conduct periodic literature reviews to determine the state of the science in ovarian cancer screening/detection and to identify potentially promising new technologies.

1.2 Work with stakeholders to disseminate, as they become available, evidence-based advances in ovarian cancer screening/detection to health care providers through CME offerings for professionals and awareness campaigns for the public.

Objective GY-9.2

To monitor and disseminate current advances in ovarian cancer prevention and treatment.

Strategies

2.1 Conduct periodic literature reviews to determine the state of the science in ovarian cancer research and to identify potentially promising new technologies.

2.2 Work with stakeholders to disseminate, as they become available, evidence-based advances to health care providers through CME offerings.

2.3 Work with stakeholders to disseminate, as they become available, evidence-based advances to the public.

Objective GY-9.3

To monitor trends in ovarian cancer incidence, mortality, and survival.

Strategies

3.1 Request appropriate data, as needed, from the New Jersey State Cancer Registry and other applicable sources.

3.2 Work with stakeholders to disseminate, as they become available, evidence-based advances to health care providers through CME offerings.

3.3 Work with stakeholders to disseminate, as they become available, evidence-based advances to the public.

GOAL GY-10: To foster the development of and to improve awareness of clinical and translational research for ovarian cancer and increase participation in clinical research available in New Jersey and/or available to New Jersey residents.

Objective GY-10.1

To identify existing research being done for ovarian cancer available in New Jersey and/or available to New Jersey residents.

Strategies

1.1 Partner with the pharmaceutical industry and medical organizations to improve the number and breadth of current clinical trials for ovarian cancer in New Jersey.

1.2 Identify a department within the state that practitioners can use as a resource for identifying ovarian cancer clinical trials in New Jersey for which their patients are eligible.

Objective GY-10.2

To attract and encourage participation in new and existing clinical research in New Jersey and/or available to New Jersey residents, especially in screening and treatment measures in ovarian cancer.

Strategies

2.1 Partner with the pharmaceutical industry and medical organizations to improve the number and breadth of current clinical trials for ovarian cancer in New Jersey.

2.2 Collaborate with key associations/organizations to publicize ovarian cancer clinical trials in New Jersey.

VII. GENETIC DISCRIMINATION

COLORADO REVISED STATUTES

TITLE 10. INSURANCE
REGULATION OF INSURANCE COMPANIES
ARTICLE 3.REGULATION OF INSURANCE COMPANIES
PART 11. UNFAIR COMPETITION – DECEPTIVE PRACTICES

C.R.S. 10-3-1104.6 (2010)

10-3-1104.6. Genetic information – limitations on disclosure of information – liability – definitions – legislative declaration

(1) The general assembly hereby finds and determines that recent advances in genetic science have led to improvements in the diagnosis, treatment, and understanding of a significant number of human diseases. The general assembly further declares that:

(a) Genetic information is the unique property of the individual to whom the information pertains;

(b) Any information concerning an individual obtained through the use of genetic services may be subject to abuses if disclosed to unauthorized third parties without the willing consent of the individual to whom the information pertains;

(c) To protect individual privacy and to preserve individual autonomy with regard to the individual’s genetic information, it is appropriate to limit the use and availability of genetic information;

(d) The intent of this section is to prevent genetic information from being used to deny access to health care insurance or Medicare supplement insurance coverage.

(2) For the purposes of this section:

(a) “Entity” means any sickness and accident insurance company, health maintenance organization, nonprofit hospital, medical-surgical and health service corporation, or other entity that provides health care insurance or Medicare supplement insurance coverage and is subject to the jurisdiction of the commissioner of insurance.

(b) “Family member” means an individual who is related to another individual by blood, adoption, or marriage within the first, second, third, or fourth degree.

(c)

(I) “Genetic information” means information about an individual’s genetic test, the genetic tests of family members of the individual, and the manifestation of a disease or disorder in family members of the individual. “Genetic information” includes any request for, or receipt of, genetic services with respect to an individual, or participation by an individual or the family member of an individual in clinical research that includes genetic services.

(II) With regard to an individual who is pregnant, “genetic information” includes genetic information of the fetus carried by the pregnant individual. With regard to an individual or family member using reproductive technology, “genetic information” includes genetic information of any embryo legally held by an individual or family member.

(III) “Genetic information” does not include information about the sex or age of an individual.

(d) “Genetic services” means a genetic test, genetic counseling, which includes obtaining, interpreting, or assessing genetic information, or genetic education.

(e)

(I) “Genetic test” means any analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes.
(II) “Genetic test” does not include:

(A) An analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition that could reasonably be detected by a health care professional with appropriate training and expertise in the field of medicine involved; or

(B) An analysis of proteins or metabolites that does not detect genotypes, mutations, or chromosomal changes.

(I) Rules for, or determination of, eligibility for enrollment or continued eligibility in a policy or for benefits under the policy;
(II) The computation of premium or contribution amounts under the policy;
(III) The application of any preexisting condition exclusion under the policy; and
(IV) Other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits.

(3)

(a) Genetic information shall be confidential and privileged. Any release, for purposes other than diagnosis, treatment, or therapy, of genetic information that identifies the person tested with the test results released requires specific written consent by the person about whom the genetic information pertains or the parent or guardian of that person.

(b)

(I) Any entity that receives genetic information may not seek, use, or keep the information for any nontherapeutic purpose or for any underwriting purpose connected with the provision of health care insurance or Medicare supplement insurance coverage.
(II) If an entity obtains genetic information incidental to a request or requirement for, or purchase of, other information concerning an individual, the request or requirement for, or purchase of, such information shall not be considered a violation of this paragraph (b) if it is not in violation of paragraph (a) of this subsection (3).

(c)

(I) An entity shall not request or require an individual or family member of the individual to undergo a genetic test unless otherwise authorized by applicable state or federal law.

(II) Nothing in this paragraph (c) shall be construed to preclude an entity from obtaining and using the results of a genetic test in making a determination regarding payment, as defined in 45 CFR 164.501, as may be amended, and consistent with paragraphs (a) and (b) of this subsection (3).
(4) Notwithstanding the provisions of subsection (3) of this section, in the course of a criminal investigation or a criminal prosecution, and to the extent allowed under the federal or state constitution, any peace officer, district attorney, or assistant attorney general, or a designee thereof, may obtain genetic information regarding the identity of any individual who is the subject of the criminal investigation or prosecution for use exclusively in any criminal investigation or prosecution without the consent of the individual being tested.

(5) Notwithstanding the provisions of subsection (3) of this section, any research facility may use genetic information for scientific research purposes if the identity of any individual to whom the information pertains is not disclosed to any third party; except that the individual’s identity may be disclosed to the individual’s physician if the individual consents to the disclosure in writing.

(6) This section does not limit the authority of a court or any party to a parentage proceeding to use genetic information for purposes of determining parentage pursuant to section 13-25-126, C.R.S.

(7) This section does not limit the authority of a court or any party to a proceeding that is subject to the limitations of part 5 of article 64 of title 13, C.R.S., to use genetic information for purposes of determining the cause of damage or injury.

(8) This section does not limit the authority of the state board of parole to require any offender who is involved in a sexual assault to submit to blood tests and to retain the results of such tests on file as authorized under section 17-2-201 (5) (g), C.R.S.

(9) This section does not limit the authority granted the state department of public health and environment, the state board of health, or county, district, or municipal public health agencies pursuant to section 25-1-122, C.R.S.

(10) Any violation of this section is an unfair practice as defined in section 10-3-1104 (1), and is subject to the provisions of sections 10-3-1106 to 10-3-1113.

(11) Any individual who is injured by an entity’s violation of this section may recover in a court of competent jurisdiction the following remedies:

(a) Equitable relief, which may include a retroactive order, directing the entity to provide health insurance or Medicare supplement insurance coverage, whichever is appropriate, to the injured individual under the same terms and conditions as would have applied had the violation not occurred; and
(b) The greater of:
(I) An amount equal to any actual damages suffered by the individual as a result of the violation; or
(II) Ten thousand dollars per violation.
(12) The prevailing party in an action under this section may recover costs and reasonable attorney fees.

HISTORY: Source: L. 2009: Entire section added, (HB 09-1338), ch. 353, p. 1840, § 2, effective July 1. L. 2010: (9) amended, (HB 10-1422), ch. 419, p. 2066, § 14, effective August 11.

VIII. LICENSE PLATE

ILLINOIS COMPILED STATUTES ANNOTATED
CHAPTER 625. VEHICLES
ILLINOIS VEHICLE CODE
CHAPTER 3. CERTIFICATES OF TITLE AND REGISTRATION OF VEHICLES
ARTICLE VI. SPECIAL PLATES AND SPECIAL LICENSE PLATE STICKERS

625 ILCS 5/3-678 (2011)

Legislative Alert: LEXSEE 2011 Ill. ALS 409 — See section 5.

§ 625 ILCS 5/3-678. Ovarian Cancer Awareness license plates

Sec. 3-678. Ovarian Cancer Awareness license plates. (a) The Secretary, upon receipt of an application made in the form prescribed by the Secretary, may issue special registration plates designated as Ovarian Cancer Awareness license plates. The special plates issued under this Section shall be affixed only to passenger vehicles of the first division and motor vehicles of the second division weighing not more than 8,000 pounds. Plates issued under this Section shall expire according to the multi-year procedure established by Section 3-414.1 of this Code [625 ILCS 5/3-414.1].

(b) The design and color of the plates is wholly within the discretion of the Secretary. The Secretary may allow the plates to be issued as vanity or personalized plates under Section 3-405.1 of this Code [625 ILCS 5/3-405.1]. The Secretary shall prescribe stickers or decals as provided under Section 3-412 of this Code [625 ILCS 5/3-412].

(c) An applicant for the special plate shall be charged a $ 25 fee for original issuance in addition to the appropriate registration fee. Of this fee, $10 shall be deposited into the Ovarian Cancer Awareness Fund and $ 15 shall be deposited into the Secretary of State Special License Plate Fund, to be used by the Secretary to help defray the administrative processing costs.

For each registration renewal period, a $25 fee, in addition to the appropriate registration fee, shall be charged. Of this fee, $23 shall be deposited into the Ovarian Cancer Awareness Fund and $2 shall be deposited into the Secretary of State Special License Plate Fund.

(d) The Ovarian Cancer Awareness Fund is created as a special fund in the State treasury. All moneys in the Ovarian Cancer Awareness Fund shall be paid, subject to appropriation by the General Assembly and approval by the Secretary, as grants to the National Ovarian Cancer Coalition, Inc. for ovarian cancer research, education, screening, and treatment.

HISTORY: Source: P.A. 95-552, § 10; 95-876, § 300.

IX. TAX CHECK OFF

DELAWARE CODE ANNOTATED

TITLE 30. STATE TAXES
PART II. INCOME, INHERITANCE AND ESTATE TAXES
CHAPTER 11. PERSONAL INCOME TAX
SUBCHAPTER IX. MISCELLANEOUS

30 Del. C. § 1192 (2011)

§ 1192. The Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation

(a) To honor and memorialize the lives of Cynthia Waterman and Sidney DeSmyter and all other women who have fought valiantly against the ravages of ovarian cancer, but lost, the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation is hereby established. Individuals who claim an overpayment of taxes may designate an amount to be deposited in the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation, and individuals who have an income tax liability may designate an amount to be paid to the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation, pursuant to subsections (b) and (c) of this section.

(b) An individual who claims an overpayment of taxes on an income tax return may designate that $ 1.00 or more be deducted from the refund that would otherwise be payable to the individual, and, instead, be paid to the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation. The Division of Revenue shall forward the designated amounts to the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation who, in turn, shall deposit them to the credit of the Delaware Ovarian Cancer Foundation Fund to be used for ovarian cancer research, with emphasis on early detection, education, and awareness.

(c) An individual who has an income tax liability may, in addition to the liability, include a donation of $ 1.00 or more to be paid to the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation. The Division of Revenue shall forward the designated amounts to the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation who, in turn, shall deposit them to the credit of the Delaware Ovarian Cancer Foundation Fund to be used for ovarian cancer research, with emphasis on early detection, education and awareness.

(d) The Division of Revenue shall provide a space on the Delaware income tax return form or schedule where an individual may voluntarily designate a contribution of an amount of $ 1.00 or more to the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation.

(e) An amount designated for the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation on the income tax return form must be deducted from the tax refund to which the individual is entitled, or an amount designated may be added to the individual’s payment of taxes due. In neither case may those amounts be included in the general revenue of the State.

(f) From time to time as determined by the Delaware State Clearinghouse Committee, the custodians of the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation shall submit a detailed report to members of the Committee of revenues, expenditures, and program measures for the fiscal period in question. The report must be descriptive in nature, as well as concise and informative. The Committee may cause any person employed by or associated with the Delaware Ovarian Cancer Foundation Fund at the Delaware Community Foundation to appear before the Committee and answer questions that the Committee may require.

HISTORY: 77 Del. Laws, c. 209, § 1.

X. OFF LABEL PRESCRIPTION

INDIANA STATUTES ANNOTATED

Title 27 Insurance
Article 8 Life, Accident and Health
Chapter 20 Reimbursement for Off Label Drug Treatment

Burns Ind. Code Ann. § 27-8-20-7 (2011)

27-8-20-7. When drug not approved by Food and Drug Administration may not be excluded from coverage.

An insurance policy or a health maintenance organization that provides coverage for drugs may not exclude coverage of a covered drug for a particular indication on the grounds that the drug has not been approved by the federal Food and Drug Administration for the particular indication if any of the following conditions are met:

(1) The drug is recognized for treatment of the indication in at least one (1) standard reference compendium.

(2) The drug is recommended for that particular type of cancer and found to be safe and effective in formal clinical studies, the results of which have been published in a peer reviewed professional medical journal published in the United States or Great Britain.

HISTORY: P.L.277-1993(ss), § 120; P.L.26-1994, § 20.

Title 27 Insurance
Article 8 Life, Accident and Health
Chapter 20 Reimbursement for Off Label Drug Treatment

Burns Ind. Code Ann. § 27-8-20-9 (2011)

27-8-20-9. Limitations of chapter.

This chapter does not do any of the following:

(1) Require coverage for any drug when the federal Food and Drug Administration has determined the drug’s use to be contraindicated.

(2) Require coverage for an experimental drug not approved for any indication by the federal Food and Drug Administration.

(3) Alter any other law limiting the coverage of drugs that have not been approved by the federal Food and Drug Administration.

XI. REQUIRED COVERAGE OF ROUTINE COST OF CARE CLINICAL TRIALS

NEVADA REVISED STATUTES ANNOTATED

TITLE 57. Insurance.
CHAPTER 689A. Individual Health Insurance.
Required Provisions
Nev. Rev. Stat. Ann. § 689A.04033 (2011)

689A.04033. Coverage for treatment received as part of clinical trial or study.

1. A policy of health insurance must provide coverage for medical treatment which a policyholder or subscriber receives as part of a clinical trial or study if:

(a) The medical treatment is provided in a Phase I, Phase II, Phase III or Phase IV study or clinical trial for the treatment of cancer or in a Phase II, Phase III or Phase IV study or clinical trial for the treatment of chronic fatigue syndrome;

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

(1) An agency of the National Institutes of Health as set forth in 42 U.S.C. § 281(b);

(2) A cooperative group;

(3) The Food and Drug Administration as an application for a new investigational drug;

(4) The United States Department of Veterans Affairs; or

(5) The United States Department of Defense;

(c) In the case of:
(1) A Phase I clinical trial or study for the treatment of cancer, the medical treatment is provided at a facility authorized to conduct Phase I clinical trials or studies for the treatment of cancer; or

(2) A Phase II, Phase III or Phase IV study or clinical trial for the treatment of cancer or chronic fatigue syndrome, the medical treatment is provided by a provider of health care and the facility and personnel for the clinical trial or study have the experience and training to provide the treatment in a capable manner;

(d) There is no medical treatment available which is considered a more appropriate alternative medical treatment than the medical treatment provided in the clinical trial or study;

(e) There is a reasonable expectation based on clinical data that the medical treatment provided in the clinical trial or study will be at least as effective as any other medical treatment;

(f) The clinical trial or study is conducted in this state; and

(g) The policyholder or subscriber has signed, before participating in the clinical trial or study, a statement of consent indicating that the policyholder or subscriber has been informed of, without limitation:

(1) The procedure to be undertaken;

(2) Alternative methods of treatment; and

(3) The risks associated with participation in the clinical trial or study, including, without limitation, the general nature and extent of such risks.

2. Except as otherwise provided in subsection 3, the coverage for medical treatment required by this section is limited to:

(a) Coverage for any drug or device that is approved for sale by the Food and Drug Administration without regard to whether the approved drug or device has been approved for use in the medical treatment of the policyholder or subscriber.

(b) The cost of any reasonably necessary health care services that are required as a result of the medical treatment provided in a Phase II, Phase III or Phase IV clinical trial or study or as a result of any complication arising out of the medical treatment provided in a Phase II, Phase III or Phase IV clinical trial or study, to the extent that such health care services would otherwise be covered under the policy of health insurance.

(c) The cost of any routine health care services that would otherwise be covered under the policy of health insurance for a policyholder or subscriber participating in a Phase I clinical trial or study.

(d) The initial consultation to determine whether the policyholder or subscriber is eligible to participate in the clinical trial or study.

(e) Health care services required for the clinically appropriate monitoring of the policyholder or subscriber during a Phase II, Phase III or Phase IV clinical trial or study.

(f) Health care services which are required for the clinically appropriate monitoring of the policyholder or subscriber during a Phase I clinical trial or study and which are not directly related to the clinical trial or study.

Except as otherwise provided in NRS 689A.04036, the services provided pursuant to paragraphs (b), (c), (e) and (f) must be covered only if the services are provided by a provider with whom the insurer has contracted for such services. If the insurer has not contracted for the provision of such services, the insurer shall pay the provider the rate of reimbursement that is paid to other providers with whom the insurer has contracted for similar services and the provider shall accept that rate of reimbursement as payment in full.

3. Particular medical treatment described in subsection 2 and provided to a policyholder or subscriber is not required to be covered pursuant to this section if that particular medical treatment is provided by the sponsor of the clinical trial or study free of charge to the policyholder or subscriber.

4. The coverage for medical treatment required by this section does not include:

(a) Any portion of the clinical trial or study that is customarily paid for by a government or a biotechnical, pharmaceutical or medical industry.

(b) Coverage for a drug or device described in paragraph (a) of subsection 2 which is paid for by the manufacturer, distributor or provider of the drug or device.

(c) Health care services that are specifically excluded from coverage under the policyholder’s or subscriber’s policy of health insurance, regardless of whether such services are provided under the clinical trial or study.

(d) Health care services that are customarily provided by the sponsors of the clinical trial or study free of charge to the participants in the trial or study.

(e) Extraneous expenses related to participation in the clinical trial or study including, without limitation, travel, housing and other expenses that a participant may incur.

(f) Any expenses incurred by a person who accompanies the policyholder or subscriber during the clinical trial or study.

(g) Any item or service that is provided solely to satisfy a need or desire for data collection or analysis that is not directly related to the clinical management of the policyholder or subscriber.

(h) Any costs for the management of research relating to the clinical trial or study.

5. An insurer who delivers or issues for delivery a policy of health insurance specified in subsection 1 may require copies of the approval or certification issued pursuant to paragraph (b) of subsection 1, the statement of consent signed by the policyholder or subscriber, protocols for the clinical trial or study and any other materials related to the scope of the clinical trial or study relevant to the coverage of medical treatment pursuant to this section.

6. An insurer who delivers or issues for delivery a policy specified in subsection 1 shall:

(a) Include in the disclosure required pursuant to NRS 689A.390 notice to each policyholder and subscriber under the policy of the availability of the benefits required by this section.

(b) Provide the coverage required by this section subject to the same deductible, copayment, coinsurance and other such conditions for coverage that are required under the policy.

7. A policy of health insurance subject to the provisions of this chapter that is delivered, issued for delivery or renewed on or after January 1, 2006, has the legal effect of including the coverage required by this section, and any provision of the policy that conflicts with this section is void.

8. An insurer who delivers or issues for delivery a policy specified in subsection 1 is immune from liability for:

(a) Any injury to a policyholder or subscriber caused by:

(1) Any medical treatment provided to the policyholder or subscriber in connection with his or her 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 or her participation in a clinical trial or study described in this section.

(b) Any adverse or unanticipated outcome arising out of a policyholder’s or subscriber’s participation in a clinical trial or study described in this section.

9. As used in this section:

(a) “Cooperative group” means a network of facilities that collaborate on research projects and has established a peer review program approved by the National Institutes of Health. The term includes:

(1) The Clinical Trials Cooperative Group Program; and

(2) The Community Clinical Oncology Program.

(b) “Facility authorized to conduct Phase I clinical trials or studies for the treatment of cancer” means a facility or an affiliate of a facility that:

(1) Has in place a Phase I program which permits only selective participation in the program and which uses clear-cut criteria to determine eligibility for participation in the program;

(2) Operates a protocol review and monitoring system which conforms to the standards set forth in the Policies and Guidelines Relating to the Cancer-Center Support Grant published by the Cancer Centers Branch of the National Cancer Institute;

(3) Employs at least two researchers and at least one of those researchers receives funding from a federal grant;

(4) Employs at least three clinical investigators who have experience working in Phase I clinical trials or studies conducted at a facility designated as a comprehensive cancer center by the National Cancer Institute;

(5) Possesses specialized resources for use in Phase I clinical trials or studies, including, without limitation, equipment that facilitates research and analysis in proteomics, genomics and pharmacokinetics;

(6) Is capable of gathering, maintaining and reporting electronic data; and

(7) Is capable of responding to audits instituted by federal and state agencies.
(c) “Provider of health care” means:

(1) A hospital; or

(2) A person licensed pursuant to chapter 630, 631 or 633 of NRS.

HISTORY
: 2003, ch. 515, § 1, p. 3519; 2005, ch. 440, § 1, p. 2009.

NOTES: Effective date.
This section is effective January 1, 2006.

Effect of amendment.
The 2005 amendment, effective January 1, 2006, rewrote subsections 1 and 2; substituted “2006” for “2004” in subsection 7; and added paragraph 9(b), redesignating paragraphs accordingly.

XII. AWARENESS LEGISLATION

Florida Annotated Statutes

TITLE 29. PUBLIC HEALTH (Chs. 381-408)
CHAPTER 381. PUBLIC HEALTH: GENERAL PROVISIONS

Fla. Stat. § 381.9315 (2011)

§ 381.9315. Gynecologic and ovarian cancer education and awareness

(1) This section may be cited as the “Kelly Smith Gynecologic and Ovarian Cancer Education and Awareness Act.”

(2) The department shall encourage health care providers, including, but not limited to, hospitals, birthing facilities, county health departments, physicians, midwives, and nurses, to disseminate and display information about gynecologic cancers, including the signs and symptoms, risk factors, benefits of early detection through appropriate diagnostic testing, and treatment options.

(3) The department shall encourage women to discuss the risks of gynecologic cancers with their health care providers.

(4) The State Surgeon General shall make publicly available, by posting on the Internet website of the Department of Health, resources and an Internet website link to the federal Centers for Disease Control and Prevention website for gynecologic cancer information.

(5) The department is encouraged to seek any available grants from private or federal sources to promote gynecologic cancer awareness, including, but not limited to, early warning signs and risk factors associated with gynecologic cancers.

(6) The department is encouraged to collaborate with other agencies, organizations, and institutions to create a systematic approach to increasing public awareness regarding gynecologic cancers.