CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Senate Bill No. 70Introduced by Senator WienerJanuary 09, 2023 An act to amend Sections 1367.21 and 1367.22 of the Health and Safety Code, and to amend Section 10123.195 of, and to add Section 10123.190 to, the Insurance Code, relating to health care coverage. LEGISLATIVE COUNSEL'S DIGESTSB 70, as introduced, Wiener. Prescription drug coverage.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 provides for the regulation of health insurers by the Department of Insurance. Existing law generally authorizes a health care service plan or health insurer to use utilization review, under which a licensed physician or a licensed health care professional who is competent to evaluate specific clinical issues may approve, modify, delay, or deny requests for health care services based on medical necessity. Existing law prohibits a health care service plan contract that covers prescription drug benefits or a specified health insurance policy from limiting or excluding coverage for a drug on the basis that the drug is prescribed for a use that is different from the use for which it was approved by the federal Food and Drug Administration if specified conditions are met. Existing law also prohibits a health care service plan that covers prescription drug benefits from limiting or excluding coverage for a drug that was previously approved for coverage if an enrollee continues to be prescribed that drug, as specified.This bill would expand the above-described prohibitions to prohibit limiting or excluding coverage of a dose of a drug or dosage form, and would apply these prohibitions to a prescription drug that is prescribed for off-label use. The bill would prohibit a health care service plan contract from requiring additional cost sharing not already imposed for a drug that was previously approved for coverage. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program. The bill would also prohibit a disability insurer that covers prescription drug benefits from limiting or declining coverage for a drug or dose of a drug as prescribed if specified criteria are met.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.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 1367.21 of the Health and Safety Code is amended to read:1367.21. (a) No A health care service plan contract which that covers prescription drug benefits shall not be issued, amended, delivered, or renewed in this state if the plan limits or excludes coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, condition and the drug is medically necessary to treat that condition, and the drug is on the plan formulary. If the drug is not on the plan formulary, the participating subscribers request shall be considered pursuant to the process required by Section 1367.24. condition.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the participating prescriber to submit to the plan documentation supporting compliance with the requirements of subdivision (a), if requested by the plan.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug, subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the plan.(g) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(h) If a plan denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under Section 1370.4.(i) Health care service plan contracts for the delivery of Medi-Cal services under the Waxman-Duffy Prepaid Health Plan Act (Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code) are exempt from the requirements of this section.SEC. 2. Section 1367.22 of the Health and Safety Code is amended to read:1367.22. (a) A health care service plan contract, issued, amended, or renewed on or after July 1, 1999, that covers prescription drug benefits shall not limit or exclude coverage coverage, or require additional cost sharing not already imposed, for a drug drug, dose of a drug, or dosage form for an enrollee if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee and the plans prescribing provider continues to prescribe the drug for the medical condition, provided that the drug drug, dose of the drug, or dosage form is appropriately prescribed and is considered safe and effective for treating the enrollees medical condition. Nothing in this section shall This section does not preclude the prescribing provider from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to and does not prohibit generic drug substitutions as authorized by Section 4073 of the Business and Professions Code. For purposes of this section, a prescribing provider shall include a provider authorized to write a prescription, pursuant to subdivision (a) of Section 4059 of the Business and Professions Code, to treat a medical condition of an enrollee.(b) This section does not apply to coverage for any drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the federal Food and Drug Administration. Coverage for different-use drugs is subject to Section 1367.21.(c) (b) This section shall not be construed to restrict or impair the application of any other provision of this chapter, including, but not limited to, Section 1367, which includes among its requirements that plans furnish services in a manner providing continuity of care and demonstrate that medical decisions are rendered by qualified medical providers unhindered by fiscal and administrative management.(d) (c) This section does not prohibit a health care service plan from charging a subscriber or enrollee a copayment or a deductible for prescription drug benefits or from setting forth, by contract, limitations on maximum coverage of prescription drug benefits, provided that the copayments, deductibles, or limitations are reported to, and held unobjectionable by, the director and set forth to the subscriber or enrollee pursuant to the disclosure provisions of Section 1363.(d) This section applies to a prescription drug that is prescribed off-label in accordance with Section 1367.21.SEC. 3. Section 10123.190 is added to the Insurance Code, to read:10123.190. (a) (1) Notwithstanding Sections 10123.13, 10123.191, and 10123.201, or another section of this code to the contrary, a disability insurer that provides coverage for prescription drugs shall not limit or decline to cover a drug or dose of a drug as prescribed, or impose additional cost sharing for covering a drug as prescribed, if all the following apply:(A) An insured is undergoing a current course of treatment with the prescription drug for a covered medical condition or is seeking an authorization for continued coverage within a month of the date of expiration of the last prescription or refill.(B) The drug was previously covered by the insurer or the insureds prior private or public health care coverage for the insureds medical condition.(C) A prescribing provider prescribed the drug for the insureds medical condition, and the drug is appropriately prescribed and considered safe and effective under generally accepted standards of medical care for treating the insureds medical condition.(2) An insurer that verifies that a condition in paragraph (1) is satisfied shall not delay or deny coverage during the verification process, except if a drug is unsafe as prescribed. If a drug is unsafe as prescribed, an insurer shall notify the provider of its coverage determination, as provided by Section 10123.191. If an insurer determines that another condition in paragraph (1) is unsatisfied, it shall comply with Section 10123.13.(3) This subdivision does not do any of the following:(A) Preclude a provider from prescribing another drug that is clinically appropriate for an insured.(B) Prohibit generic drug substitutions under Section 4073 of the Business and Professions Code.(b) This section applies to a prescription drug that is prescribed off-label in accordance with Section 10123.195.(c) This section applies to a disability insurer and disability insurance policy that provides coverage for hospital, medical, surgical, or prescription drug benefits. This section does not apply to the insurance listed in paragraphs (1) through (8) of subdivision (b) of Section 106, a specialized health insurance policy that provides coverage only for dental or vision benefits, or a Medicare supplement policy.SEC. 4. Section 10123.195 of the Insurance Code is amended to read:10123.195. (a) No group A group, blanket, or individual disability insurance policy issued, delivered, or renewed in this state or certificate of group or blanket disability insurance issued, delivered, or renewed in this state pursuant to a master group policy issued, delivered, or renewed in another state that, as a provision of hospital, medical, or surgical services, directly or indirectly covers prescription drugs shall not limit or exclude coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a contracting licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a contracting licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the insurers formulary, if any.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the contracting prescriber to submit to the insurer documentation supporting compliance with the requirements of subdivision (a), if requested by the insurer.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the insurer.(g) This section shall not apply to a policy of disability insurance that covers hospital, medical, or surgical expenses which is issued outside of California to an employer whose principal place of business is located outside of California.(h) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(i) If an insurer denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under the Independent Medical Review System of Article 3.5 (commencing with Section 10169).(j) This section is not applicable to vision-only, dental-only, Medicare or Champus supplement, disability income, long-term care, accident-only, specified disease or hospital confinement indemnity insurance.SEC. 5. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.
CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION Senate Bill No. 70Introduced by Senator WienerJanuary 09, 2023 An act to amend Sections 1367.21 and 1367.22 of the Health and Safety Code, and to amend Section 10123.195 of, and to add Section 10123.190 to, the Insurance Code, relating to health care coverage. LEGISLATIVE COUNSEL'S DIGESTSB 70, as introduced, Wiener. Prescription drug coverage.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 provides for the regulation of health insurers by the Department of Insurance. Existing law generally authorizes a health care service plan or health insurer to use utilization review, under which a licensed physician or a licensed health care professional who is competent to evaluate specific clinical issues may approve, modify, delay, or deny requests for health care services based on medical necessity. Existing law prohibits a health care service plan contract that covers prescription drug benefits or a specified health insurance policy from limiting or excluding coverage for a drug on the basis that the drug is prescribed for a use that is different from the use for which it was approved by the federal Food and Drug Administration if specified conditions are met. Existing law also prohibits a health care service plan that covers prescription drug benefits from limiting or excluding coverage for a drug that was previously approved for coverage if an enrollee continues to be prescribed that drug, as specified.This bill would expand the above-described prohibitions to prohibit limiting or excluding coverage of a dose of a drug or dosage form, and would apply these prohibitions to a prescription drug that is prescribed for off-label use. The bill would prohibit a health care service plan contract from requiring additional cost sharing not already imposed for a drug that was previously approved for coverage. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program. The bill would also prohibit a disability insurer that covers prescription drug benefits from limiting or declining coverage for a drug or dose of a drug as prescribed if specified criteria are met.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.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES
CALIFORNIA LEGISLATURE 20232024 REGULAR SESSION
Senate Bill
No. 70
Introduced by Senator WienerJanuary 09, 2023
Introduced by Senator Wiener
January 09, 2023
An act to amend Sections 1367.21 and 1367.22 of the Health and Safety Code, and to amend Section 10123.195 of, and to add Section 10123.190 to, the Insurance Code, relating to health care coverage.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
SB 70, as introduced, Wiener. Prescription drug coverage.
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 provides for the regulation of health insurers by the Department of Insurance. Existing law generally authorizes a health care service plan or health insurer to use utilization review, under which a licensed physician or a licensed health care professional who is competent to evaluate specific clinical issues may approve, modify, delay, or deny requests for health care services based on medical necessity. Existing law prohibits a health care service plan contract that covers prescription drug benefits or a specified health insurance policy from limiting or excluding coverage for a drug on the basis that the drug is prescribed for a use that is different from the use for which it was approved by the federal Food and Drug Administration if specified conditions are met. Existing law also prohibits a health care service plan that covers prescription drug benefits from limiting or excluding coverage for a drug that was previously approved for coverage if an enrollee continues to be prescribed that drug, as specified.This bill would expand the above-described prohibitions to prohibit limiting or excluding coverage of a dose of a drug or dosage form, and would apply these prohibitions to a prescription drug that is prescribed for off-label use. The bill would prohibit a health care service plan contract from requiring additional cost sharing not already imposed for a drug that was previously approved for coverage. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program. The bill would also prohibit a disability insurer that covers prescription drug benefits from limiting or declining coverage for a drug or dose of a drug as prescribed if specified criteria are met.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.
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 provides for the regulation of health insurers by the Department of Insurance. Existing law generally authorizes a health care service plan or health insurer to use utilization review, under which a licensed physician or a licensed health care professional who is competent to evaluate specific clinical issues may approve, modify, delay, or deny requests for health care services based on medical necessity. Existing law prohibits a health care service plan contract that covers prescription drug benefits or a specified health insurance policy from limiting or excluding coverage for a drug on the basis that the drug is prescribed for a use that is different from the use for which it was approved by the federal Food and Drug Administration if specified conditions are met. Existing law also prohibits a health care service plan that covers prescription drug benefits from limiting or excluding coverage for a drug that was previously approved for coverage if an enrollee continues to be prescribed that drug, as specified.
This bill would expand the above-described prohibitions to prohibit limiting or excluding coverage of a dose of a drug or dosage form, and would apply these prohibitions to a prescription drug that is prescribed for off-label use. The bill would prohibit a health care service plan contract from requiring additional cost sharing not already imposed for a drug that was previously approved for coverage. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program. The bill would also prohibit a disability insurer that covers prescription drug benefits from limiting or declining coverage for a drug or dose of a drug as prescribed if specified criteria are met.
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.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 1367.21 of the Health and Safety Code is amended to read:1367.21. (a) No A health care service plan contract which that covers prescription drug benefits shall not be issued, amended, delivered, or renewed in this state if the plan limits or excludes coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, condition and the drug is medically necessary to treat that condition, and the drug is on the plan formulary. If the drug is not on the plan formulary, the participating subscribers request shall be considered pursuant to the process required by Section 1367.24. condition.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the participating prescriber to submit to the plan documentation supporting compliance with the requirements of subdivision (a), if requested by the plan.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug, subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the plan.(g) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(h) If a plan denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under Section 1370.4.(i) Health care service plan contracts for the delivery of Medi-Cal services under the Waxman-Duffy Prepaid Health Plan Act (Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code) are exempt from the requirements of this section.SEC. 2. Section 1367.22 of the Health and Safety Code is amended to read:1367.22. (a) A health care service plan contract, issued, amended, or renewed on or after July 1, 1999, that covers prescription drug benefits shall not limit or exclude coverage coverage, or require additional cost sharing not already imposed, for a drug drug, dose of a drug, or dosage form for an enrollee if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee and the plans prescribing provider continues to prescribe the drug for the medical condition, provided that the drug drug, dose of the drug, or dosage form is appropriately prescribed and is considered safe and effective for treating the enrollees medical condition. Nothing in this section shall This section does not preclude the prescribing provider from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to and does not prohibit generic drug substitutions as authorized by Section 4073 of the Business and Professions Code. For purposes of this section, a prescribing provider shall include a provider authorized to write a prescription, pursuant to subdivision (a) of Section 4059 of the Business and Professions Code, to treat a medical condition of an enrollee.(b) This section does not apply to coverage for any drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the federal Food and Drug Administration. Coverage for different-use drugs is subject to Section 1367.21.(c) (b) This section shall not be construed to restrict or impair the application of any other provision of this chapter, including, but not limited to, Section 1367, which includes among its requirements that plans furnish services in a manner providing continuity of care and demonstrate that medical decisions are rendered by qualified medical providers unhindered by fiscal and administrative management.(d) (c) This section does not prohibit a health care service plan from charging a subscriber or enrollee a copayment or a deductible for prescription drug benefits or from setting forth, by contract, limitations on maximum coverage of prescription drug benefits, provided that the copayments, deductibles, or limitations are reported to, and held unobjectionable by, the director and set forth to the subscriber or enrollee pursuant to the disclosure provisions of Section 1363.(d) This section applies to a prescription drug that is prescribed off-label in accordance with Section 1367.21.SEC. 3. Section 10123.190 is added to the Insurance Code, to read:10123.190. (a) (1) Notwithstanding Sections 10123.13, 10123.191, and 10123.201, or another section of this code to the contrary, a disability insurer that provides coverage for prescription drugs shall not limit or decline to cover a drug or dose of a drug as prescribed, or impose additional cost sharing for covering a drug as prescribed, if all the following apply:(A) An insured is undergoing a current course of treatment with the prescription drug for a covered medical condition or is seeking an authorization for continued coverage within a month of the date of expiration of the last prescription or refill.(B) The drug was previously covered by the insurer or the insureds prior private or public health care coverage for the insureds medical condition.(C) A prescribing provider prescribed the drug for the insureds medical condition, and the drug is appropriately prescribed and considered safe and effective under generally accepted standards of medical care for treating the insureds medical condition.(2) An insurer that verifies that a condition in paragraph (1) is satisfied shall not delay or deny coverage during the verification process, except if a drug is unsafe as prescribed. If a drug is unsafe as prescribed, an insurer shall notify the provider of its coverage determination, as provided by Section 10123.191. If an insurer determines that another condition in paragraph (1) is unsatisfied, it shall comply with Section 10123.13.(3) This subdivision does not do any of the following:(A) Preclude a provider from prescribing another drug that is clinically appropriate for an insured.(B) Prohibit generic drug substitutions under Section 4073 of the Business and Professions Code.(b) This section applies to a prescription drug that is prescribed off-label in accordance with Section 10123.195.(c) This section applies to a disability insurer and disability insurance policy that provides coverage for hospital, medical, surgical, or prescription drug benefits. This section does not apply to the insurance listed in paragraphs (1) through (8) of subdivision (b) of Section 106, a specialized health insurance policy that provides coverage only for dental or vision benefits, or a Medicare supplement policy.SEC. 4. Section 10123.195 of the Insurance Code is amended to read:10123.195. (a) No group A group, blanket, or individual disability insurance policy issued, delivered, or renewed in this state or certificate of group or blanket disability insurance issued, delivered, or renewed in this state pursuant to a master group policy issued, delivered, or renewed in another state that, as a provision of hospital, medical, or surgical services, directly or indirectly covers prescription drugs shall not limit or exclude coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a contracting licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a contracting licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the insurers formulary, if any.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the contracting prescriber to submit to the insurer documentation supporting compliance with the requirements of subdivision (a), if requested by the insurer.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the insurer.(g) This section shall not apply to a policy of disability insurance that covers hospital, medical, or surgical expenses which is issued outside of California to an employer whose principal place of business is located outside of California.(h) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(i) If an insurer denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under the Independent Medical Review System of Article 3.5 (commencing with Section 10169).(j) This section is not applicable to vision-only, dental-only, Medicare or Champus supplement, disability income, long-term care, accident-only, specified disease or hospital confinement indemnity insurance.SEC. 5. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Section 1367.21 of the Health and Safety Code is amended to read:1367.21. (a) No A health care service plan contract which that covers prescription drug benefits shall not be issued, amended, delivered, or renewed in this state if the plan limits or excludes coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, condition and the drug is medically necessary to treat that condition, and the drug is on the plan formulary. If the drug is not on the plan formulary, the participating subscribers request shall be considered pursuant to the process required by Section 1367.24. condition.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the participating prescriber to submit to the plan documentation supporting compliance with the requirements of subdivision (a), if requested by the plan.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug, subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the plan.(g) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(h) If a plan denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under Section 1370.4.(i) Health care service plan contracts for the delivery of Medi-Cal services under the Waxman-Duffy Prepaid Health Plan Act (Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code) are exempt from the requirements of this section.
SECTION 1. Section 1367.21 of the Health and Safety Code is amended to read:
### SECTION 1.
1367.21. (a) No A health care service plan contract which that covers prescription drug benefits shall not be issued, amended, delivered, or renewed in this state if the plan limits or excludes coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, condition and the drug is medically necessary to treat that condition, and the drug is on the plan formulary. If the drug is not on the plan formulary, the participating subscribers request shall be considered pursuant to the process required by Section 1367.24. condition.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the participating prescriber to submit to the plan documentation supporting compliance with the requirements of subdivision (a), if requested by the plan.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug, subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the plan.(g) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(h) If a plan denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under Section 1370.4.(i) Health care service plan contracts for the delivery of Medi-Cal services under the Waxman-Duffy Prepaid Health Plan Act (Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code) are exempt from the requirements of this section.
1367.21. (a) No A health care service plan contract which that covers prescription drug benefits shall not be issued, amended, delivered, or renewed in this state if the plan limits or excludes coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, condition and the drug is medically necessary to treat that condition, and the drug is on the plan formulary. If the drug is not on the plan formulary, the participating subscribers request shall be considered pursuant to the process required by Section 1367.24. condition.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the participating prescriber to submit to the plan documentation supporting compliance with the requirements of subdivision (a), if requested by the plan.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug, subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the plan.(g) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(h) If a plan denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under Section 1370.4.(i) Health care service plan contracts for the delivery of Medi-Cal services under the Waxman-Duffy Prepaid Health Plan Act (Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code) are exempt from the requirements of this section.
1367.21. (a) No A health care service plan contract which that covers prescription drug benefits shall not be issued, amended, delivered, or renewed in this state if the plan limits or excludes coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, condition and the drug is medically necessary to treat that condition, and the drug is on the plan formulary. If the drug is not on the plan formulary, the participating subscribers request shall be considered pursuant to the process required by Section 1367.24. condition.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the participating prescriber to submit to the plan documentation supporting compliance with the requirements of subdivision (a), if requested by the plan.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug, subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the plan.(g) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(h) If a plan denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under Section 1370.4.(i) Health care service plan contracts for the delivery of Medi-Cal services under the Waxman-Duffy Prepaid Health Plan Act (Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code) are exempt from the requirements of this section.
1367.21. (a) No A health care service plan contract which that covers prescription drug benefits shall not be issued, amended, delivered, or renewed in this state if the plan limits or excludes coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:
(1) The drug is approved by the FDA.
(2) (A)One of the following is true:
(A) The drug is prescribed by a participating licensed health care professional for the treatment of a life-threatening condition; or condition.
(B) The drug is prescribed by a participating licensed health care professional for the treatment of a chronic and seriously debilitating condition, condition and the drug is medically necessary to treat that condition, and the drug is on the plan formulary. If the drug is not on the plan formulary, the participating subscribers request shall be considered pursuant to the process required by Section 1367.24. condition.
(3) The drug has been recognized for treatment of that condition by any of the following:
(A) The American Hospital Formulary Services Drug Information.
(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:
(i) The Elsevier Gold Standards Clinical Pharmacology.
(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.
(iii) The Thomson Micromedex DrugDex.
(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.
(b) It shall be the responsibility of the participating prescriber to submit to the plan documentation supporting compliance with the requirements of subdivision (a), if requested by the plan.
(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug, subject to the conditions of the contract.
(d) For purposes of this section, life-threatening means either or both of the following:
(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.
(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.
(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.
(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the plan.
(g) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.
(h) If a plan denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under Section 1370.4.
(i) Health care service plan contracts for the delivery of Medi-Cal services under the Waxman-Duffy Prepaid Health Plan Act (Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code) are exempt from the requirements of this section.
SEC. 2. Section 1367.22 of the Health and Safety Code is amended to read:1367.22. (a) A health care service plan contract, issued, amended, or renewed on or after July 1, 1999, that covers prescription drug benefits shall not limit or exclude coverage coverage, or require additional cost sharing not already imposed, for a drug drug, dose of a drug, or dosage form for an enrollee if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee and the plans prescribing provider continues to prescribe the drug for the medical condition, provided that the drug drug, dose of the drug, or dosage form is appropriately prescribed and is considered safe and effective for treating the enrollees medical condition. Nothing in this section shall This section does not preclude the prescribing provider from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to and does not prohibit generic drug substitutions as authorized by Section 4073 of the Business and Professions Code. For purposes of this section, a prescribing provider shall include a provider authorized to write a prescription, pursuant to subdivision (a) of Section 4059 of the Business and Professions Code, to treat a medical condition of an enrollee.(b) This section does not apply to coverage for any drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the federal Food and Drug Administration. Coverage for different-use drugs is subject to Section 1367.21.(c) (b) This section shall not be construed to restrict or impair the application of any other provision of this chapter, including, but not limited to, Section 1367, which includes among its requirements that plans furnish services in a manner providing continuity of care and demonstrate that medical decisions are rendered by qualified medical providers unhindered by fiscal and administrative management.(d) (c) This section does not prohibit a health care service plan from charging a subscriber or enrollee a copayment or a deductible for prescription drug benefits or from setting forth, by contract, limitations on maximum coverage of prescription drug benefits, provided that the copayments, deductibles, or limitations are reported to, and held unobjectionable by, the director and set forth to the subscriber or enrollee pursuant to the disclosure provisions of Section 1363.(d) This section applies to a prescription drug that is prescribed off-label in accordance with Section 1367.21.
SEC. 2. Section 1367.22 of the Health and Safety Code is amended to read:
### SEC. 2.
1367.22. (a) A health care service plan contract, issued, amended, or renewed on or after July 1, 1999, that covers prescription drug benefits shall not limit or exclude coverage coverage, or require additional cost sharing not already imposed, for a drug drug, dose of a drug, or dosage form for an enrollee if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee and the plans prescribing provider continues to prescribe the drug for the medical condition, provided that the drug drug, dose of the drug, or dosage form is appropriately prescribed and is considered safe and effective for treating the enrollees medical condition. Nothing in this section shall This section does not preclude the prescribing provider from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to and does not prohibit generic drug substitutions as authorized by Section 4073 of the Business and Professions Code. For purposes of this section, a prescribing provider shall include a provider authorized to write a prescription, pursuant to subdivision (a) of Section 4059 of the Business and Professions Code, to treat a medical condition of an enrollee.(b) This section does not apply to coverage for any drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the federal Food and Drug Administration. Coverage for different-use drugs is subject to Section 1367.21.(c) (b) This section shall not be construed to restrict or impair the application of any other provision of this chapter, including, but not limited to, Section 1367, which includes among its requirements that plans furnish services in a manner providing continuity of care and demonstrate that medical decisions are rendered by qualified medical providers unhindered by fiscal and administrative management.(d) (c) This section does not prohibit a health care service plan from charging a subscriber or enrollee a copayment or a deductible for prescription drug benefits or from setting forth, by contract, limitations on maximum coverage of prescription drug benefits, provided that the copayments, deductibles, or limitations are reported to, and held unobjectionable by, the director and set forth to the subscriber or enrollee pursuant to the disclosure provisions of Section 1363.(d) This section applies to a prescription drug that is prescribed off-label in accordance with Section 1367.21.
1367.22. (a) A health care service plan contract, issued, amended, or renewed on or after July 1, 1999, that covers prescription drug benefits shall not limit or exclude coverage coverage, or require additional cost sharing not already imposed, for a drug drug, dose of a drug, or dosage form for an enrollee if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee and the plans prescribing provider continues to prescribe the drug for the medical condition, provided that the drug drug, dose of the drug, or dosage form is appropriately prescribed and is considered safe and effective for treating the enrollees medical condition. Nothing in this section shall This section does not preclude the prescribing provider from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to and does not prohibit generic drug substitutions as authorized by Section 4073 of the Business and Professions Code. For purposes of this section, a prescribing provider shall include a provider authorized to write a prescription, pursuant to subdivision (a) of Section 4059 of the Business and Professions Code, to treat a medical condition of an enrollee.(b) This section does not apply to coverage for any drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the federal Food and Drug Administration. Coverage for different-use drugs is subject to Section 1367.21.(c) (b) This section shall not be construed to restrict or impair the application of any other provision of this chapter, including, but not limited to, Section 1367, which includes among its requirements that plans furnish services in a manner providing continuity of care and demonstrate that medical decisions are rendered by qualified medical providers unhindered by fiscal and administrative management.(d) (c) This section does not prohibit a health care service plan from charging a subscriber or enrollee a copayment or a deductible for prescription drug benefits or from setting forth, by contract, limitations on maximum coverage of prescription drug benefits, provided that the copayments, deductibles, or limitations are reported to, and held unobjectionable by, the director and set forth to the subscriber or enrollee pursuant to the disclosure provisions of Section 1363.(d) This section applies to a prescription drug that is prescribed off-label in accordance with Section 1367.21.
1367.22. (a) A health care service plan contract, issued, amended, or renewed on or after July 1, 1999, that covers prescription drug benefits shall not limit or exclude coverage coverage, or require additional cost sharing not already imposed, for a drug drug, dose of a drug, or dosage form for an enrollee if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee and the plans prescribing provider continues to prescribe the drug for the medical condition, provided that the drug drug, dose of the drug, or dosage form is appropriately prescribed and is considered safe and effective for treating the enrollees medical condition. Nothing in this section shall This section does not preclude the prescribing provider from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to and does not prohibit generic drug substitutions as authorized by Section 4073 of the Business and Professions Code. For purposes of this section, a prescribing provider shall include a provider authorized to write a prescription, pursuant to subdivision (a) of Section 4059 of the Business and Professions Code, to treat a medical condition of an enrollee.(b) This section does not apply to coverage for any drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the federal Food and Drug Administration. Coverage for different-use drugs is subject to Section 1367.21.(c) (b) This section shall not be construed to restrict or impair the application of any other provision of this chapter, including, but not limited to, Section 1367, which includes among its requirements that plans furnish services in a manner providing continuity of care and demonstrate that medical decisions are rendered by qualified medical providers unhindered by fiscal and administrative management.(d) (c) This section does not prohibit a health care service plan from charging a subscriber or enrollee a copayment or a deductible for prescription drug benefits or from setting forth, by contract, limitations on maximum coverage of prescription drug benefits, provided that the copayments, deductibles, or limitations are reported to, and held unobjectionable by, the director and set forth to the subscriber or enrollee pursuant to the disclosure provisions of Section 1363.(d) This section applies to a prescription drug that is prescribed off-label in accordance with Section 1367.21.
1367.22. (a) A health care service plan contract, issued, amended, or renewed on or after July 1, 1999, that covers prescription drug benefits shall not limit or exclude coverage coverage, or require additional cost sharing not already imposed, for a drug drug, dose of a drug, or dosage form for an enrollee if the drug previously had been approved for coverage by the plan for a medical condition of the enrollee and the plans prescribing provider continues to prescribe the drug for the medical condition, provided that the drug drug, dose of the drug, or dosage form is appropriately prescribed and is considered safe and effective for treating the enrollees medical condition. Nothing in this section shall This section does not preclude the prescribing provider from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to and does not prohibit generic drug substitutions as authorized by Section 4073 of the Business and Professions Code. For purposes of this section, a prescribing provider shall include a provider authorized to write a prescription, pursuant to subdivision (a) of Section 4059 of the Business and Professions Code, to treat a medical condition of an enrollee.
(b) This section does not apply to coverage for any drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the federal Food and Drug Administration. Coverage for different-use drugs is subject to Section 1367.21.
(c)
(b) This section shall not be construed to restrict or impair the application of any other provision of this chapter, including, but not limited to, Section 1367, which includes among its requirements that plans furnish services in a manner providing continuity of care and demonstrate that medical decisions are rendered by qualified medical providers unhindered by fiscal and administrative management.
(d)
(c) This section does not prohibit a health care service plan from charging a subscriber or enrollee a copayment or a deductible for prescription drug benefits or from setting forth, by contract, limitations on maximum coverage of prescription drug benefits, provided that the copayments, deductibles, or limitations are reported to, and held unobjectionable by, the director and set forth to the subscriber or enrollee pursuant to the disclosure provisions of Section 1363.
(d) This section applies to a prescription drug that is prescribed off-label in accordance with Section 1367.21.
SEC. 3. Section 10123.190 is added to the Insurance Code, to read:10123.190. (a) (1) Notwithstanding Sections 10123.13, 10123.191, and 10123.201, or another section of this code to the contrary, a disability insurer that provides coverage for prescription drugs shall not limit or decline to cover a drug or dose of a drug as prescribed, or impose additional cost sharing for covering a drug as prescribed, if all the following apply:(A) An insured is undergoing a current course of treatment with the prescription drug for a covered medical condition or is seeking an authorization for continued coverage within a month of the date of expiration of the last prescription or refill.(B) The drug was previously covered by the insurer or the insureds prior private or public health care coverage for the insureds medical condition.(C) A prescribing provider prescribed the drug for the insureds medical condition, and the drug is appropriately prescribed and considered safe and effective under generally accepted standards of medical care for treating the insureds medical condition.(2) An insurer that verifies that a condition in paragraph (1) is satisfied shall not delay or deny coverage during the verification process, except if a drug is unsafe as prescribed. If a drug is unsafe as prescribed, an insurer shall notify the provider of its coverage determination, as provided by Section 10123.191. If an insurer determines that another condition in paragraph (1) is unsatisfied, it shall comply with Section 10123.13.(3) This subdivision does not do any of the following:(A) Preclude a provider from prescribing another drug that is clinically appropriate for an insured.(B) Prohibit generic drug substitutions under Section 4073 of the Business and Professions Code.(b) This section applies to a prescription drug that is prescribed off-label in accordance with Section 10123.195.(c) This section applies to a disability insurer and disability insurance policy that provides coverage for hospital, medical, surgical, or prescription drug benefits. This section does not apply to the insurance listed in paragraphs (1) through (8) of subdivision (b) of Section 106, a specialized health insurance policy that provides coverage only for dental or vision benefits, or a Medicare supplement policy.
SEC. 3. Section 10123.190 is added to the Insurance Code, to read:
### SEC. 3.
10123.190. (a) (1) Notwithstanding Sections 10123.13, 10123.191, and 10123.201, or another section of this code to the contrary, a disability insurer that provides coverage for prescription drugs shall not limit or decline to cover a drug or dose of a drug as prescribed, or impose additional cost sharing for covering a drug as prescribed, if all the following apply:(A) An insured is undergoing a current course of treatment with the prescription drug for a covered medical condition or is seeking an authorization for continued coverage within a month of the date of expiration of the last prescription or refill.(B) The drug was previously covered by the insurer or the insureds prior private or public health care coverage for the insureds medical condition.(C) A prescribing provider prescribed the drug for the insureds medical condition, and the drug is appropriately prescribed and considered safe and effective under generally accepted standards of medical care for treating the insureds medical condition.(2) An insurer that verifies that a condition in paragraph (1) is satisfied shall not delay or deny coverage during the verification process, except if a drug is unsafe as prescribed. If a drug is unsafe as prescribed, an insurer shall notify the provider of its coverage determination, as provided by Section 10123.191. If an insurer determines that another condition in paragraph (1) is unsatisfied, it shall comply with Section 10123.13.(3) This subdivision does not do any of the following:(A) Preclude a provider from prescribing another drug that is clinically appropriate for an insured.(B) Prohibit generic drug substitutions under Section 4073 of the Business and Professions Code.(b) This section applies to a prescription drug that is prescribed off-label in accordance with Section 10123.195.(c) This section applies to a disability insurer and disability insurance policy that provides coverage for hospital, medical, surgical, or prescription drug benefits. This section does not apply to the insurance listed in paragraphs (1) through (8) of subdivision (b) of Section 106, a specialized health insurance policy that provides coverage only for dental or vision benefits, or a Medicare supplement policy.
10123.190. (a) (1) Notwithstanding Sections 10123.13, 10123.191, and 10123.201, or another section of this code to the contrary, a disability insurer that provides coverage for prescription drugs shall not limit or decline to cover a drug or dose of a drug as prescribed, or impose additional cost sharing for covering a drug as prescribed, if all the following apply:(A) An insured is undergoing a current course of treatment with the prescription drug for a covered medical condition or is seeking an authorization for continued coverage within a month of the date of expiration of the last prescription or refill.(B) The drug was previously covered by the insurer or the insureds prior private or public health care coverage for the insureds medical condition.(C) A prescribing provider prescribed the drug for the insureds medical condition, and the drug is appropriately prescribed and considered safe and effective under generally accepted standards of medical care for treating the insureds medical condition.(2) An insurer that verifies that a condition in paragraph (1) is satisfied shall not delay or deny coverage during the verification process, except if a drug is unsafe as prescribed. If a drug is unsafe as prescribed, an insurer shall notify the provider of its coverage determination, as provided by Section 10123.191. If an insurer determines that another condition in paragraph (1) is unsatisfied, it shall comply with Section 10123.13.(3) This subdivision does not do any of the following:(A) Preclude a provider from prescribing another drug that is clinically appropriate for an insured.(B) Prohibit generic drug substitutions under Section 4073 of the Business and Professions Code.(b) This section applies to a prescription drug that is prescribed off-label in accordance with Section 10123.195.(c) This section applies to a disability insurer and disability insurance policy that provides coverage for hospital, medical, surgical, or prescription drug benefits. This section does not apply to the insurance listed in paragraphs (1) through (8) of subdivision (b) of Section 106, a specialized health insurance policy that provides coverage only for dental or vision benefits, or a Medicare supplement policy.
10123.190. (a) (1) Notwithstanding Sections 10123.13, 10123.191, and 10123.201, or another section of this code to the contrary, a disability insurer that provides coverage for prescription drugs shall not limit or decline to cover a drug or dose of a drug as prescribed, or impose additional cost sharing for covering a drug as prescribed, if all the following apply:(A) An insured is undergoing a current course of treatment with the prescription drug for a covered medical condition or is seeking an authorization for continued coverage within a month of the date of expiration of the last prescription or refill.(B) The drug was previously covered by the insurer or the insureds prior private or public health care coverage for the insureds medical condition.(C) A prescribing provider prescribed the drug for the insureds medical condition, and the drug is appropriately prescribed and considered safe and effective under generally accepted standards of medical care for treating the insureds medical condition.(2) An insurer that verifies that a condition in paragraph (1) is satisfied shall not delay or deny coverage during the verification process, except if a drug is unsafe as prescribed. If a drug is unsafe as prescribed, an insurer shall notify the provider of its coverage determination, as provided by Section 10123.191. If an insurer determines that another condition in paragraph (1) is unsatisfied, it shall comply with Section 10123.13.(3) This subdivision does not do any of the following:(A) Preclude a provider from prescribing another drug that is clinically appropriate for an insured.(B) Prohibit generic drug substitutions under Section 4073 of the Business and Professions Code.(b) This section applies to a prescription drug that is prescribed off-label in accordance with Section 10123.195.(c) This section applies to a disability insurer and disability insurance policy that provides coverage for hospital, medical, surgical, or prescription drug benefits. This section does not apply to the insurance listed in paragraphs (1) through (8) of subdivision (b) of Section 106, a specialized health insurance policy that provides coverage only for dental or vision benefits, or a Medicare supplement policy.
10123.190. (a) (1) Notwithstanding Sections 10123.13, 10123.191, and 10123.201, or another section of this code to the contrary, a disability insurer that provides coverage for prescription drugs shall not limit or decline to cover a drug or dose of a drug as prescribed, or impose additional cost sharing for covering a drug as prescribed, if all the following apply:
(A) An insured is undergoing a current course of treatment with the prescription drug for a covered medical condition or is seeking an authorization for continued coverage within a month of the date of expiration of the last prescription or refill.
(B) The drug was previously covered by the insurer or the insureds prior private or public health care coverage for the insureds medical condition.
(C) A prescribing provider prescribed the drug for the insureds medical condition, and the drug is appropriately prescribed and considered safe and effective under generally accepted standards of medical care for treating the insureds medical condition.
(2) An insurer that verifies that a condition in paragraph (1) is satisfied shall not delay or deny coverage during the verification process, except if a drug is unsafe as prescribed. If a drug is unsafe as prescribed, an insurer shall notify the provider of its coverage determination, as provided by Section 10123.191. If an insurer determines that another condition in paragraph (1) is unsatisfied, it shall comply with Section 10123.13.
(3) This subdivision does not do any of the following:
(A) Preclude a provider from prescribing another drug that is clinically appropriate for an insured.
(B) Prohibit generic drug substitutions under Section 4073 of the Business and Professions Code.
(b) This section applies to a prescription drug that is prescribed off-label in accordance with Section 10123.195.
(c) This section applies to a disability insurer and disability insurance policy that provides coverage for hospital, medical, surgical, or prescription drug benefits. This section does not apply to the insurance listed in paragraphs (1) through (8) of subdivision (b) of Section 106, a specialized health insurance policy that provides coverage only for dental or vision benefits, or a Medicare supplement policy.
SEC. 4. Section 10123.195 of the Insurance Code is amended to read:10123.195. (a) No group A group, blanket, or individual disability insurance policy issued, delivered, or renewed in this state or certificate of group or blanket disability insurance issued, delivered, or renewed in this state pursuant to a master group policy issued, delivered, or renewed in another state that, as a provision of hospital, medical, or surgical services, directly or indirectly covers prescription drugs shall not limit or exclude coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a contracting licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a contracting licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the insurers formulary, if any.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the contracting prescriber to submit to the insurer documentation supporting compliance with the requirements of subdivision (a), if requested by the insurer.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the insurer.(g) This section shall not apply to a policy of disability insurance that covers hospital, medical, or surgical expenses which is issued outside of California to an employer whose principal place of business is located outside of California.(h) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(i) If an insurer denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under the Independent Medical Review System of Article 3.5 (commencing with Section 10169).(j) This section is not applicable to vision-only, dental-only, Medicare or Champus supplement, disability income, long-term care, accident-only, specified disease or hospital confinement indemnity insurance.
SEC. 4. Section 10123.195 of the Insurance Code is amended to read:
### SEC. 4.
10123.195. (a) No group A group, blanket, or individual disability insurance policy issued, delivered, or renewed in this state or certificate of group or blanket disability insurance issued, delivered, or renewed in this state pursuant to a master group policy issued, delivered, or renewed in another state that, as a provision of hospital, medical, or surgical services, directly or indirectly covers prescription drugs shall not limit or exclude coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a contracting licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a contracting licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the insurers formulary, if any.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the contracting prescriber to submit to the insurer documentation supporting compliance with the requirements of subdivision (a), if requested by the insurer.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the insurer.(g) This section shall not apply to a policy of disability insurance that covers hospital, medical, or surgical expenses which is issued outside of California to an employer whose principal place of business is located outside of California.(h) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(i) If an insurer denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under the Independent Medical Review System of Article 3.5 (commencing with Section 10169).(j) This section is not applicable to vision-only, dental-only, Medicare or Champus supplement, disability income, long-term care, accident-only, specified disease or hospital confinement indemnity insurance.
10123.195. (a) No group A group, blanket, or individual disability insurance policy issued, delivered, or renewed in this state or certificate of group or blanket disability insurance issued, delivered, or renewed in this state pursuant to a master group policy issued, delivered, or renewed in another state that, as a provision of hospital, medical, or surgical services, directly or indirectly covers prescription drugs shall not limit or exclude coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a contracting licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a contracting licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the insurers formulary, if any.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the contracting prescriber to submit to the insurer documentation supporting compliance with the requirements of subdivision (a), if requested by the insurer.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the insurer.(g) This section shall not apply to a policy of disability insurance that covers hospital, medical, or surgical expenses which is issued outside of California to an employer whose principal place of business is located outside of California.(h) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(i) If an insurer denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under the Independent Medical Review System of Article 3.5 (commencing with Section 10169).(j) This section is not applicable to vision-only, dental-only, Medicare or Champus supplement, disability income, long-term care, accident-only, specified disease or hospital confinement indemnity insurance.
10123.195. (a) No group A group, blanket, or individual disability insurance policy issued, delivered, or renewed in this state or certificate of group or blanket disability insurance issued, delivered, or renewed in this state pursuant to a master group policy issued, delivered, or renewed in another state that, as a provision of hospital, medical, or surgical services, directly or indirectly covers prescription drugs shall not limit or exclude coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:(1) The drug is approved by the FDA.(2) (A)One of the following is true:(A) The drug is prescribed by a contracting licensed health care professional for the treatment of a life-threatening condition; or condition.(B) The drug is prescribed by a contracting licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the insurers formulary, if any.(3) The drug has been recognized for treatment of that condition by any of the following:(A) The American Hospital Formulary Services Drug Information.(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:(i) The Elsevier Gold Standards Clinical Pharmacology.(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.(iii) The Thomson Micromedex DrugDex.(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.(b) It shall be the responsibility of the contracting prescriber to submit to the insurer documentation supporting compliance with the requirements of subdivision (a), if requested by the insurer.(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug subject to the conditions of the contract.(d) For purposes of this section, life-threatening means either or both of the following:(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the insurer.(g) This section shall not apply to a policy of disability insurance that covers hospital, medical, or surgical expenses which is issued outside of California to an employer whose principal place of business is located outside of California.(h) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.(i) If an insurer denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under the Independent Medical Review System of Article 3.5 (commencing with Section 10169).(j) This section is not applicable to vision-only, dental-only, Medicare or Champus supplement, disability income, long-term care, accident-only, specified disease or hospital confinement indemnity insurance.
10123.195. (a) No group A group, blanket, or individual disability insurance policy issued, delivered, or renewed in this state or certificate of group or blanket disability insurance issued, delivered, or renewed in this state pursuant to a master group policy issued, delivered, or renewed in another state that, as a provision of hospital, medical, or surgical services, directly or indirectly covers prescription drugs shall not limit or exclude coverage for a drug drug, dose of a drug, or dosage form on the basis that the drug drug, dose of the drug, or dosage form is prescribed for a use use, dose, or dosage form that is different from the use use, dose, or dosage form for which that drug has been approved for marketing by the federal Food and Drug Administration (FDA), provided that all of the following conditions have been met:
(1) The drug is approved by the FDA.
(2) (A)One of the following is true:
(A) The drug is prescribed by a contracting licensed health care professional for the treatment of a life-threatening condition; or condition.
(B) The drug is prescribed by a contracting licensed health care professional for the treatment of a chronic and seriously debilitating condition, the drug is medically necessary to treat that condition, and the drug is on the insurers formulary, if any.
(3) The drug has been recognized for treatment of that condition by any of the following:
(A) The American Hospital Formulary Services Drug Information.
(B) One of the following compendia, if recognized by the federal Centers for Medicare and Medicaid Services as part of an anticancer chemotherapeutic regimen:
(i) The Elsevier Gold Standards Clinical Pharmacology.
(ii) The National Comprehensive Cancer Network Drug and Biologics Compendium.
(iii) The Thomson Micromedex DrugDex.
(C) Two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer reviewed medical journal.
(b) It shall be the responsibility of the contracting prescriber to submit to the insurer documentation supporting compliance with the requirements of subdivision (a), if requested by the insurer.
(c) Any coverage required by this section shall also include medically necessary services associated with the administration of a drug subject to the conditions of the contract.
(d) For purposes of this section, life-threatening means either or both of the following:
(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.
(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.
(e) For purposes of this section, chronic and seriously debilitating means diseases or conditions that require ongoing treatment to maintain remission or prevent deterioration and cause significant long-term morbidity.
(f) The provision of drugs and services when required by this section shall not, in itself, give rise to liability on the part of the insurer.
(g) This section shall not apply to a policy of disability insurance that covers hospital, medical, or surgical expenses which is issued outside of California to an employer whose principal place of business is located outside of California.
(h) Nothing in this section shall be construed to This section does not prohibit the use of a formulary, copayment, technology assessment panel, or similar mechanism as a means for appropriately controlling the utilization of a drug that is prescribed for a use that is different from the use for which that drug has been approved for marketing by the FDA.
(i) If an insurer denies coverage pursuant to this section on the basis that its use is experimental or investigational, that decision is subject to review under the Independent Medical Review System of Article 3.5 (commencing with Section 10169).
(j) This section is not applicable to vision-only, dental-only, Medicare or Champus supplement, disability income, long-term care, accident-only, specified disease or hospital confinement indemnity insurance.
SEC. 5. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.
SEC. 5. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.
SEC. 5. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.
### SEC. 5.