Senate Bill #862 (2017)

AN ACT RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES - STEP THERAPY PROTOCOL

Requires health insurers, nonprofit hospital service corporations, nonprofit medical service corporations and health maintenance organizations that issue policies that provide coverage for prescription drugs and use step therapy protocols.

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  • 2017 – S 0862
  • 2017 – S 0862 SUBSTITUTE A AS AMENDED
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  • LC002482
  • LC002482/SUB A/2
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  • S T A T E O F R H O D E I S L A N D
  • S T A T E O F R H O D E I S L A N D
  • IN GENERAL ASSEMBLY
  • JANUARY SESSION, A.D. 2017
  • ____________
  • A N A C T
  • ____________
  • A N A C T
  • RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES -
  • STEP THERAPY PROTOCOL
  • STEP THERAPY PROTOCOL
  • Introduced By: Senators Gallo, Goodwin, Miller, and Satchell
  • Date Introduced: May 04, 2017
  • Referred To: Senate Health & Human Services
  • It is enacted by the General Assembly as follows:
  • SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness Insurance Policies" is hereby amended by adding thereto the following sections:
  • 27-18-83. Definitions. –
  • (a) As used in this chapter:
  • (1) "Clinical practice guidelines" means a systematically developed statement to assist decision making by health care providers and patients about appropriate health care for specific clinical circumstances and conditions.
  • SECTION 1. Chapter 27-18 of the General Laws entitled "Accident and Sickness Insurance Policies" is hereby amended by adding thereto the following section:
  • 27-18-83. Step therapy protocol.
  • (a) As used in this section the following words shall, unless the context clearly requires otherwise, have the following meanings:
  • (1) "Clinical practice guidelines" means a systematically developed statement to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.
  • (2) "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols and practice guidelines used by an insurer, health plan, or utilization review organization to determine the medical necessity and appropriateness of health care services.
  • (3) "Step therapy protocol" means a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition that are medically appropriate for a particular patient and are covered as a pharmacy or medical benefit, including self-administered and physician-administered drugs, are covered by an insurer or health plan.
  • (4) "Step therapy override determination" means a determination as to whether step therapy should apply in a particular situation, or whether the step therapy protocol should be overridden in favor of immediate coverage of the patient's and/or prescriber's preferred drug. This determination is based on a review of the patient's and/or prescriber's request for an override, along with supporting rationale and documentation.
  • (5) "Utilization review organization" means an entity that conducts utilization review, other than a health carrier performing utilization review for its own health benefit plans.
  • (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or renewed within the state that provides coverage for prescription drugs and uses step therapy protocols shall have the following requirements and restrictions:
  • (1) Clinical review criteria used to establish step therapy protocols shall be based on clinical practice guidelines:
  • (i) Independently developed by a multidisciplinary panel with expertise in the medical condition, or conditions, for which coverage decisions said criteria will be applied; and
  • (ii) That recommend drugs be taken in the specific sequence required by the step therapy protocol.
  • (c) When coverage of medications for the treatment of any medical condition are restricted for use by an insurer, health plan, or utilization review organization via a step therapy protocol, the patient and prescribing practitioner shall have access to a clear and convenient process to request a step therapy exception determination. An insurer, health plan, or utilization review organization may use its existing medical exceptions process to satisfy this requirement. The process shall be disclosed to the patient and health care providers, including documenting and making easily accessible on the insurer's, health plan's or utilization review organization's website.
  • (d) A step therapy override exception determination request shall be expeditiously considered if:
  • (1) The required drug is contraindicated;
  • (2) The enrollee has tried the step therapy-required drug while under their current health plan, or another drug in the same pharmacologic class or with the same mechanism of action and such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
  • (3) The patient is stable on a drug recommended by their health care provider for the medical condition under consideration while on a current or previous health insurance or health benefit plan and no generic substitution is available. This subsection shall not be construed to allow the use of a pharmaceutical sample to meet the requirements for a step therapy override exception.
  • (e) Upon the granting of a step therapy override exception request, the insurer, health plan, utilization review organization, or other entity shall authorize coverage for the drug prescribed by the enrollee's treating health care provider, provided such drug is a covered drug under such terms of policy or contract.
  • (f) This section shall not be construed to prevent:
  • (1) An insurer, health plan, or utilization review organization from requiring an enrollee try an AB-rated generic equivalent prior to providing reimbursement for the equivalent branded drug;
  • (2) A health care provider from prescribing a drug they determine is medically appropriate.
  • SECTION 2. Chapter 27-19 of the General Laws entitled "Nonprofit Hospital Service Corporations" is hereby amended by adding thereto the following section:
  • 27-19-74. Step therapy protocol.
  • (a) As used in this section the following words shall, unless the context clearly requires otherwise, have the following meanings:
  • (1) "Clinical practice guidelines" means a systematically developed statement to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.
  • (2) "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols and practice guidelines used by an insurer, health plan, or utilization review organization to determine the medical necessity and appropriateness of health care services.
  • (3) "Step therapy protocol" means a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition that are medically appropriate for a particular patient and are covered as a pharmacy or medical benefit, including self-administered and physician-administered drugs, are covered by an insurer or health plan.
  • (4) "Step therapy override determination" means a determination as to whether step therapy should apply in a particular situation, or whether the step therapy protocol should be overridden in favor of immediate coverage of the patient's and/or prescriber's preferred drug. This determination is based on a review of the patient's and/or prescriber's request for an override, along with supporting rationale and documentation.
  • (5) "Utilization review organization" means an entity that conducts utilization review, other than a health carrier performing utilization review for its own health benefit plans.
  • (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or renewed within the state that provides coverage for prescription drugs and uses step therapy protocols shall have the following requirements and restrictions:
  • (1) Clinical review criteria used to establish step therapy protocols shall be based on clinical practice guidelines:
  • (i) Independently developed by a multidisciplinary panel with expertise in the medical condition, or conditions, for which coverage decisions said criteria will be applied; and
  • (ii) That recommend drugs be taken in the specific sequence required by the step therapy protocol.
  • (c) When coverage of medications for the treatment of any medical condition are restricted for use by an insurer, health plan, or utilization review organization via a step therapy protocol, the patient and prescribing practitioner shall have access to a clear and convenient process to request a step therapy exception determination. An insurer, health plan, or utilization review organization may use its existing medical exceptions process to satisfy this requirement. The process shall be disclosed to the patient and health care providers, including documenting and making easily accessible on the insurer's, health plan's or utilization review organization's website.
  • (d) A step therapy override exception determination request shall be expeditiously considered if:
  • (1) The required drug is contraindicated;
  • (2) The enrollee has tried the step therapy-required drug while under their current health plan, or another drug in the same pharmacologic class or with the same mechanism of action and such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
  • (3) The patient is stable on a drug recommended by their health care provider for the medical condition under consideration while on a current or previous health insurance or health benefit plan and no generic substitution is available. This subsection shall not be construed to allow the use of a pharmaceutical sample to meet the requirements for a step therapy override exception.
  • (e) Upon the granting of a step therapy override exception request, the insurer, health plan, utilization review organization, or other entity shall authorize coverage for the drug prescribed by the enrollee's treating health care provider, provided such drug is a covered drug under such terms of policy or contract.
  • (f) This section shall not be construed to prevent:
  • (1) An insurer, health plan, or utilization review organization from requiring an enrollee try an AB-rated generic equivalent prior to providing reimbursement for the equivalent branded drug;
  • (2) A health care provider from prescribing a drug they determine is medically appropriate.
  • SECTION 3. Chapter 27-20 of the General Laws entitled "Nonprofit Medical Service Corporations" is hereby amended by adding thereto the following section:
  • 27-20-70. Step therapy protocol.
  • (a) As used in this section the following words shall, unless the context clearly requires otherwise, have the following meanings:
  • (1) "Clinical practice guidelines" means a systematically developed statement to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.
  • (2) "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols and practice guidelines used by an insurer, health plan, or utilization review organization to determine the medical necessity and appropriateness of health care services.
  • (3) "Step therapy protocol" means a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition that are medically appropriate for a particular patient and are covered as a pharmacy or medical benefit, including self-administered and physician-administered drugs, are covered by an insurer or health plan.
  • (4) "Step therapy override determination" means a determination as to whether step therapy should apply in a particular situation, or whether the step therapy protocol should be overridden in favor of immediate coverage of the patient's and/or prescriber's preferred drug. This determination is based on a review of the patient's and/or prescriber's request for an override, along with supporting rationale and documentation.
  • (5) "Utilization review organization" means an entity that conducts utilization review, other than a health carrier performing utilization review for its own health benefit plans.
  • (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or renewed within the state that provides coverage for prescription drugs and uses step therapy protocols shall have the following requirements and restrictions:
  • (1) Clinical review criteria used to establish step therapy protocols shall be based on clinical practice guidelines:
  • (i) Independently developed by a multidisciplinary panel with expertise in the medical condition, or conditions, for which coverage decisions said criteria will be applied; and
  • (ii) That recommend drugs be taken in the specific sequence required by the step therapy protocol.
  • (c) When coverage of medications for the treatment of any medical condition are restricted for use by an insurer, health plan, or utilization review organization via a step therapy protocol, the patient and prescribing practitioner shall have access to a clear and convenient process to request a step therapy exception determination. An insurer, health plan, or utilization review organization may use its existing medical exceptions process to satisfy this requirement. The process shall be disclosed to the patient and health care providers, including documenting and making easily accessible on the insurer's, health plan's or utilization review organization's website.
  • (d) A step therapy override exception determination request shall be expeditiously considered if:
  • (1) The required drug is contraindicated;
  • (2) The enrollee has tried the step therapy-required drug while under their current health plan, or another drug in the same pharmacologic class or with the same mechanism of action and such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
  • (3) The patient is stable on a drug recommended by their health care provider for the medical condition under consideration while on a current or previous health insurance or health benefit plan and no generic substitution is available. This subsection shall not be construed to allow the use of a pharmaceutical sample to meet the requirements for a step therapy override exception.
  • (e) Upon the granting of a step therapy override exception request, the insurer, health plan, utilization review organization, or other entity shall authorize coverage for the drug prescribed by the enrollee's treating health care provider, provided such drug is a covered drug under such terms of policy or contract.
  • (f) This section shall not be construed to prevent:
  • (1) An insurer, health plan, or utilization review organization from requiring an enrollee try an AB-rated generic equivalent prior to providing reimbursement for the equivalent branded drug;
  • (2) A health care provider from prescribing a drug they determine is medically appropriate.
  • SECTION 4. Chapter 27-41 of the General Laws entitled "Health Maintenance Organizations" is hereby amended by adding thereto the following section:
  • 27-41-87. Step therapy protocol.
  • (a) As used in this section the following words shall, unless the context clearly requires otherwise, have the following meanings:
  • (1) "Clinical practice guidelines" means a systematically developed statement to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.
  • (2) "Clinical review criteria" means the written screening procedures, decision abstracts, clinical protocols and practice guidelines used by an insurer, health plan, or utilization review organization to determine the medical necessity and appropriateness of health care services.
  • (3) "Medically necessary" means health services and supplies that under the applicable standard of care are appropriate:
  • (i) To improve or preserve health, life, or function; or
  • (ii) To slow the deterioration of health, life, or function; or
  • (iii) For the early screening, prevention, evaluation, diagnosis, or treatment of a disease, condition, illness, or injury.
  • (4) "Step therapy override exception determination" means a determination as to whether a step therapy protocol should apply in a particular situation, or whether the step therapy protocol should be overridden in favor of immediate coverage of the health care provider's selected prescription drug. This determination is based on a review of the patient's or prescriber's request for an override, along with supporting rationale and documentation.
  • (5) "Step therapy protocol" means a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition and medically appropriate for a particular patient are covered by an insurer or health plan.
  • (6) "Utilization review organization" means an entity that conducts a utilization review, other than an insurer or health plan performing utilization reviews for its own health benefit plans.
  • 27-18-84. Exceptions process transparency.
  • (a) Exceptions process. When coverage of a prescription drug for the treatment of any medical condition is restricted for use by an insurer, health plan, or utilization review organization through the use of a step therapy protocol, the patient and prescribing practitioner shall have access to a clear, readily accessible and convenient process to request a step therapy exception determination. An insurer, health plan, or utilization review organization may use its existing medical exceptions process to satisfy this requirement. The process shall be made easily accessible on the insurers, health plans, or utilization review organization's website.
  • (b) Exceptions. A step therapy override exception determination request shall be expeditiously granted if:
  • (1) The required prescription drug is contraindicated, or will likely cause an adverse reaction or physical or mental harm to the patient;
  • (2) The required prescription drug is expected to be ineffective based on the known clinical characteristics of the patient, and the known characteristics of the prescription drug regimen;
  • (3) The patient has tried the required prescription drug while under their current or a previous health insurance or health benefit plan, or another prescription drug in the same pharmacologic class, or with the same mechanism of action and such prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
  • (4) The required prescription drug is not in the best interest of the patient based on medical necessity;
  • (5) The patient is stable on a prescription drug selected by their health care provider for the medical condition under consideration; and
  • (6) The required prescription drug is likely to be diverted.
  • (c) Effect of exception. Upon the granting of a step therapy override exception determination, the insurer, health plan, or utilization review organization shall authorize coverage for the prescription drug prescribed by the patient's treating health care provider.
  • (d) Limitations. This section shall not be construed to prevent:
  • (1) An insurer, health plan, or utilization review organization from requiring a patient to try an AB-rated generic equivalent prior to providing coverage for the equivalent branded prescription drug; and
  • (2) A health care provider from prescribing a prescription drug that is determined to be medically appropriate.
  • 27-18-85. Regulations.
  • Notwithstanding any provision of the general or public laws to the contrary, the office of the health insurance commissioner shall promulgate any regulations necessary to enforce the provisions of §§27-18-83 and 27-18-84 in accordance with the provisions of chapter 35 of title 42 ("administrative procedures act").
  • SECTION 2. This act shall take effect upon passage and shall apply only to health insurance and health benefit plans delivered, issued for delivery, or renewed on or after June 1, 2017.
  • (3) "Step therapy protocol" means a protocol or program that establishes the specific sequence in which prescription drugs for a specified medical condition that are medically appropriate for a particular patient and are covered as a pharmacy or medical benefit, including self-administered and physician-administered drugs, are covered by an insurer or health plan.
  • (4) "Step therapy override determination" means a determination as to whether step therapy should apply in a particular situation, or whether the step therapy protocol should be overridden in favor of immediate coverage of the patient's and/or prescriber's preferred drug. This determination is based on a review of the patient's and/or prescriber's request for an override, along with supporting rationale and documentation.
  • (5) "Utilization review organization" means an entity that conducts utilization review, other than a health carrier performing utilization review for its own health benefit plans.
  • (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or renewed within the state that provides coverage for prescription drugs and uses step therapy protocols shall have the following requirements and restrictions:
  • (1) Clinical review criteria used to establish step therapy protocols shall be based on clinical practice guidelines:
  • (i) Independently developed by a multidisciplinary panel with expertise in the medical condition, or conditions, for which coverage decisions said criteria will be applied; and
  • (ii) That recommend drugs be taken in the specific sequence required by the step therapy protocol.
  • (c) When coverage of medications for the treatment of any medical condition are restricted for use by an insurer, health plan, or utilization review organization via a step therapy protocol, the patient and prescribing practitioner shall have access to a clear and convenient process to request a step therapy exception determination. An insurer, health plan, or utilization review organization may use its existing medical exceptions process to satisfy this requirement. The process shall be disclosed to the patient and health care providers, including documenting and making easily accessible on the insurer's, health plan's or utilization review organization's website.
  • (d) A step therapy override exception determination request shall be expeditiously considered if:
  • (1) The required drug is contraindicated;
  • (2) The enrollee has tried the step therapy-required drug while under their current health plan, or another drug in the same pharmacologic class or with the same mechanism of action and such drugs were discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event;
  • (3) The patient is stable on a drug recommended by their health care provider for the medical condition under consideration while on a current or previous health insurance or health benefit plan and no generic substitution is available. This subsection shall not be construed to allow the use of a pharmaceutical sample to meet the requirements for a step therapy override exception.
  • (e) Upon the granting of a step therapy override exception Request, the insurer, health plan, utilization review organization, or other entity shall authorize coverage for the drug prescribed by the enrollee's treating health care provider, provided such drug is a covered drug under such terms of policy or contract.
  • (f) This section shall not be construed to prevent:
  • (1) An insurer, health plan, or utilization review organization from requiring an enrollee try an AB-rated generic equivalent prior to providing reimbursement for the equivalent branded drug;
  • (2) A health care provider from prescribing a drug they determine is medically appropriate.
  • SECTION 5. This act shall take effect upon passage and shall apply only to health insurance and health benefit plans delivered, issued for delivery, or renewed on or after January 1, 2018.
  • ========
  • LC002482/SUB A/2
  • ========
  • LC002482
  • EXPLANATION
  • BY THE LEGISLATIVE COUNCIL
  • OF
  • A N A C T
  • RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES -
  • STEP THERAPY PROTOCOL
  • ***
  • This act would require health insurers, nonprofit hospital service corporations, nonprofit medical service corporations and health maintenance organizations that issue policies that provide coverage for prescription drugs and use step therapy protocols, to base step therapy protocols on appropriate clinical practice guidelines or published peer review data developed by independent experts with knowledge of the condition or conditions under consideration; that patients be exempt from step therapy protocols when inappropriate; and that patients have access to a fair, transparent and independent process for requesting an exception to a step therapy protocol when the patients physician deems appropriate.
  • This act would take effect upon passage and would apply only to health insurance and health benefit plans delivered, issued for delivery, or renewed on or after January 1, 2018.
  • ========
  • EXPLANATION
  • BY THE LEGISLATIVE COUNCIL
  • OF
  • A N A C T
  • RELATING TO INSURANCE - ACCIDENT AND SICKNESS INSURANCE POLICIES -
  • STEP THERAPY PROTOCOL
  • ***
  • This act would allow for a step therapy exception determination when coverage of a prescription drug for the treatment of a medical condition is restricted for use by an insurer, health plan, or utilization review organization.
  • This act would take effect upon passage and would apply only to health insurance and health benefit plans delivered, issued for delivery, or renewed on or after June 1, 2017. ======== LC002482 ========
  • LC002482/SUB A/2
  • ========

Votes

NOTE: Electronic voting records are unofficial and may not be accurate. For an official vote tally, check the House or Senate Journal from the day of the vote.

Floor vote for Approval of Amendment

June 29, 2017 at 5:04pm
Yeas: 36 / Nays: 0 / Not voting: 1 / Recused: 0
Legislator Vote
Sen. Algiere Y
Sen. Archambault Y
Sen. Calkin Y
Sen. Ciccone Y
Sen. Conley Y
Sen. Cote Y
Sen. Coyne Y
Sen. Crowley Y
Sen. DaPonte Y
Sen. DiPalma Y
Sen. Doyle NV
Sen. Felag Y
Sen. Fogarty Y
Sen. Gallo Y
Sen. Gee Y
Sen. Goldin Y
Sen. Goodwin Y
Sen. Jabour Y
Sen. Kettle Y
Sen. Lombardi Y
Sen. Lombardo Y
Sen. Lynch Prata Y
Sen. McCaffrey Y
Sen. Metts Y
Sen. Miller Y
Sen. Morgan Y
Sen. Nesselbush Y
Sen. Paolino Y
Sen. Pearson Y
Sen. Picard Y
Sen. Quezada Y
Sen. Raptakis Y
Sen. Ruggerio Y
Sen. Satchell Y
Sen. Seveney Y
Sen. Sheehan Y
Sen. Sosnowski Y

Floor vote for Passage as Amended

June 29, 2017 at 5:05pm
Yeas: 36 / Nays: 0 / Not voting: 1 / Recused: 0
Legislator Vote
Sen. Algiere Y
Sen. Archambault Y
Sen. Calkin Y
Sen. Ciccone Y
Sen. Conley Y
Sen. Cote Y
Sen. Coyne Y
Sen. Crowley Y
Sen. DaPonte Y
Sen. DiPalma Y
Sen. Doyle NV
Sen. Felag Y
Sen. Fogarty Y
Sen. Gallo Y
Sen. Gee Y
Sen. Goldin Y
Sen. Goodwin Y
Sen. Jabour Y
Sen. Kettle Y
Sen. Lombardi Y
Sen. Lombardo Y
Sen. Lynch Prata Y
Sen. McCaffrey Y
Sen. Metts Y
Sen. Miller Y
Sen. Morgan Y
Sen. Nesselbush Y
Sen. Paolino Y
Sen. Pearson Y
Sen. Picard Y
Sen. Quezada Y
Sen. Raptakis Y
Sen. Ruggerio Y
Sen. Satchell Y
Sen. Seveney Y
Sen. Sheehan Y
Sen. Sosnowski Y