Amended IN Senate April 18, 2022 Amended IN Senate March 31, 2022 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Senate Bill No. 958Introduced by Senators Limn and PortantinoFebruary 09, 2022 An act to add Article 6.15 (commencing with Section 1385.010) to Chapter 2.2 of Division 2 of the Health and Safety Code, and to add Article 1.6 (commencing with Section 10128.5) to Chapter 1 of Part 2 of Division 2 of the Insurance Code, relating to health care coverage. LEGISLATIVE COUNSEL'S DIGESTSB 958, as amended, Limn. Medication and Patient Safety Act of 2022.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 requires a health care service plan contract or health insurance policy that provides coverage for outpatient prescription drugs to cover medically necessary prescription drugs.This bill would prohibit a health care service plan or health insurer, or its designee, from arranging for or requiring a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration. The bill would prohibit authorize a plan or insurer, or its designee, from requiring to arrange for an infused or injected medication to be administered in an enrollees or insureds home as a condition of coverage, unless when the treating health care provider determines and patient determine home administration is safe and appropriate. in the best interest of the patient. The bill would prohibit a plan or insurer, or its designee, from requiring an infused or injected medication to be supplied by a vendor specified by the plan or insurer, or its designee, as a condition of coverage, unless specified criteria are met. Because a willful violation of the bills requirements relative to health care service plans would be a crime, the bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.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. (a) This act shall be known, and may be cited, as the Medication and Patient Safety Act of 2022.(b) The Legislature finds and declares all of the following:(1) Californians suffering from serious and potentially life-threatening diseases may be treated with infused and injected medications, which include drugs that are infused or injected by a health care provider in an outpatient setting. In many cases, these medications are the only hope for a normal quality of life or, in some cases, survival. These medications are used to treat cancer, transplant rejection, HIV/AIDS, immune disorders, Parkinsons disease, Duchenne muscular dystrophy, multiple sclerosis, inherited and genetic diseases, metabolic diseases, emphysema, amyotrophic lateral sclerosis, blood disorders, asthma, ulcerative colitis, Crohns disease, osteoporosis, and other debilitating diseases and disorders.(2) Typically, a patient with one of these diseases schedules an appointment to receive the medication. On the day of the appointment, the patient is assessed, which often includes sending blood or other specimens to a clinical laboratory for rapid analysis or, in some cases, weighing the patient and evaluating overall clinical status. Based on the physicians assessment of these parameters, the treatment plan may change, requiring a different drug or different strength than planned.(3) Patients with cancer, threatened organ rejection, or other life-threatening diseases and conditions may need emergency treatment with infused or injected medications due to rapid deterioration or exacerbation of their condition.(4) Health care service plans and health insurers have begun to implement various policies that inappropriately restrict Californians access to critical medications, as well as high-quality infusion and injection services. Some plans and insurers have implemented a policy by which they contract with a vendor to deliver these medications to the patients home, and the patient brings the medication to the health care provider for administration. This practice, sometimes referred to as brown-bagging, raises serious safety concerns. Many medications need special handling, such as refrigeration, or must be used within a certain time period. Also, many medications will not be effective if shaken, as that may cause deterioration. When a patient brings a medication to a health care provider for administration, the provider has no way of knowing whether the medication was appropriately handled. For example, a patient may not be able to miss work to wait for the delivery of their medication at home, and as a result, the medication might sit on the patients porch in the heat for several hours before the patient can refrigerate it. Or, the patients refrigerator may not be operating at the correct temperature for the medication. It is crucial that these medications follow known quality and safety channels.(5) Similarly, some plans and insurers have adopted policies that are sometimes referred to as white-bagging. These policies require a health care provider to accept delivery from a plans or insurers vendor of a medication labeled for a specific patient in advance of the patients visit. The health care provider is not permitted to give any other medication to the patient, even if the patients same-day assessment indicates that a different medication, strength, or dosage is better suited for the patient and the provider has that medication in stock. The patient and provider must then choose between using the suboptimal previously shipped medication, admitting the patient to a hospital for treatment, or delaying the treatment until the more appropriate medication can be shipped, even if the provider has the appropriate medication in stock.(6) Delaying treatment may put the patients health at risk due to disease progression, and often leads to patient distress. Patients prepare mentally and physically for the day of chemotherapy. They arrange time off work, rides, and babysitters, and family members may rearrange their schedules, too. Patients count on their medication to control or cure their disease. To tell a patient when they arrive and have their lab test that the medication needs to be changed and their treatment will be delayed while the plan or insurer arranges to get a different medicine shipped is callous and inhumane, especially if the health care provider has the proper medication available, but the plan or insurer refuses to cover it.(7) Some plans and insurers have required patients to stop going to their health care provider for infusion or injection services, and instead require that the patient be given their medication at home by a home health agency. While at times this may be appropriate, this is often not the case. Many infused and injected medications have serious and toxic side effects and should be administered in a setting with specially trained physicians and nurses experienced in managing side effects and reactions, and with the necessary equipment and medications to treat these patients. This is especially important for pediatric patients, frail elderly patients, patients taking multiple medications, and patients receiving a medication for the first time. A plan or insurer should not require a medication to be administered at home unless the patients treating health care provider determines it is safe and appropriate.(8) Some plans and insurers have required patients to receive their infused and injected medications from a different provider, even if the physician or another provider who has been treating the patient is in the plans or insurers network. Disrupting these long-standing relationships is detrimental to patients. Infused and injected medications are complex, as are the diseases and disorders they treat. It often takes a great deal of back-and-forth for the patient and physician to figure out the best treatment regimen for the patient and how to minimize side effects. Plans and insurers should not be permitted to interfere in the choice of health care provider if the desired provider is in the plans or insurers network.(9) Patients are negatively impacted by these policies, particularly low-income patients, patients of color, and patients with limited access to health care, childcare, or transportation services. Patients may be forced to make duplicate trips to a health care providers location, discontinue care with their current provider and find a new one, sometimes in the middle of their course of treatment, travel a longer distance to receive care, or be admitted to the hospital due to a worsening of their disease or condition. Pediatric patients have also been especially affected, as they often need specialized physicians and other providers with experience treating children with these medications.(10) It is the intent of the Legislature to ensure that infused and injected medications and related services remain available to all Californians who need them.SEC. 2. Article 6.15 (commencing with Section 1385.010) is added to Chapter 2.2 of Division 2 of the Health and Safety Code, to read: Article 6.15. Medication and Patient Safety Act of 20221385.010. For purposes of this article:(a) Designee means a capitated medical group or risk-bearing organization identified as such by the Department of Managed Health Care, a pharmacy benefit manager, or a similar entity that contracts with a health care service plan to arrange for or approve medications for an enrollee.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.1385.011. (a) A health care service plan or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an enrollee in the enrollees home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the plan or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the enrollees same-day clinical presentation, the drug does not require adjustment based on the enrollees weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the enrollees same-day clinical presentation.(2)The enrollee receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment. enrollee as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing.(9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the plan notifies the enrollee in advance that a vendor will call the enrollee to obtain billing information for any cost-sharing amount. The plan shall provide the name of the vendor and the cost-sharing amount to the enrollee.(12)(10) The health care service plan or designee allows the treating health care provider to administer the medication to the enrollee and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health care service plan obtains the enrollees, or the enrollees legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the plan.(d) A health care service plan or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health care service plan or its designee shall not interfere with the enrollees right to obtain a covered, medically necessary infused or injected medication from a participating provider of the enrollees choosing. A health care service plan or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health care service plan opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the plan shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the plan a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the enrollee to receive the medication from the plan or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health care service plan or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health care service plans or designees review shall be completed within seven calendar days of the providers submission of the relevant enrollee information. However, the review shall be completed within 24 hours if the enrollees discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the enrollee is not likely to be able to be safely and appropriately treated with the drug from the plans vendor within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment, the plan or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health care service plan shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health care service plan or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the enrollee and the treating provider within the time limits prescribed by Section 1367.241.(h) This section does not require a health care service plan to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an enrollee pursuant to this section shall obtain the enrollees consent and disclose a good faith estimate of the enrollees applicable cost-sharing amount.SEC. 3. Article 1.6 (commencing with Section 10128.5) is added to Chapter 1 of Part 2 of Division 2 of the Insurance Code, to read: Article 1.6. Medication and Patient Safety Act of 202210128.5. For purposes of this article:(a) Designee means a medical group, a pharmacy benefit manager, or a similar entity that contracts with a health insurer to arrange for or approve medications for an insured.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.10128.6. (a) A health insurer or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an insured in the insureds home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the insurer or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the insureds same-day clinical presentation, the drug does not require adjustment based on the insureds weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the insureds same-day clinical presentation.(2)The insured receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the insured, in the treating health care providers reasonable medical judgment. insured as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing. (9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the insurer notifies the insured in advance that a vendor will call the insured to obtain billing information for any cost-sharing amount. The insurer shall provide the name of the vendor and the cost-sharing amount to the insured.(12)(10) The health insurer or designee allows the treating health care provider to administer the medication to the insured and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health insurer obtains the insureds, or the insureds legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the insurer.(d) A health insurer or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health insurer or its designee shall not interfere with the insureds right to obtain a covered, medically necessary infused or injected medication from a participating provider of the insureds choosing. A health insurer or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health insurer opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the insurer shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the insurer a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the insured to receive the medication from the insurer or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health insurer or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health insurers or designees review shall be completed within seven calendar days of the providers submission of the relevant insured information. However, the review shall be completed within 24 hours if the insureds discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the insured is not likely to be able to be safely and appropriately treated with the drug from the insurers vendor within the time period needed by the insured, in the treating health care providers reasonable medical judgment, the insurer or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health insurer shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health insurer or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the insured and the treating provider within the time limits prescribed by Section 10123.191.(h) This section does not require a health insurer to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an insured pursuant to this section shall obtain the insureds consent and disclose a good faith estimate of the insureds applicable cost-sharing amount.SEC. 4. 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.
Amended IN Senate April 18, 2022 Amended IN Senate March 31, 2022 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Senate Bill No. 958Introduced by Senators Limn and PortantinoFebruary 09, 2022 An act to add Article 6.15 (commencing with Section 1385.010) to Chapter 2.2 of Division 2 of the Health and Safety Code, and to add Article 1.6 (commencing with Section 10128.5) to Chapter 1 of Part 2 of Division 2 of the Insurance Code, relating to health care coverage. LEGISLATIVE COUNSEL'S DIGESTSB 958, as amended, Limn. Medication and Patient Safety Act of 2022.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 requires a health care service plan contract or health insurance policy that provides coverage for outpatient prescription drugs to cover medically necessary prescription drugs.This bill would prohibit a health care service plan or health insurer, or its designee, from arranging for or requiring a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration. The bill would prohibit authorize a plan or insurer, or its designee, from requiring to arrange for an infused or injected medication to be administered in an enrollees or insureds home as a condition of coverage, unless when the treating health care provider determines and patient determine home administration is safe and appropriate. in the best interest of the patient. The bill would prohibit a plan or insurer, or its designee, from requiring an infused or injected medication to be supplied by a vendor specified by the plan or insurer, or its designee, as a condition of coverage, unless specified criteria are met. Because a willful violation of the bills requirements relative to health care service plans would be a crime, the bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES
Amended IN Senate April 18, 2022 Amended IN Senate March 31, 2022
Amended IN Senate April 18, 2022
Amended IN Senate March 31, 2022
CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION
Senate Bill
No. 958
Introduced by Senators Limn and PortantinoFebruary 09, 2022
Introduced by Senators Limn and Portantino
February 09, 2022
An act to add Article 6.15 (commencing with Section 1385.010) to Chapter 2.2 of Division 2 of the Health and Safety Code, and to add Article 1.6 (commencing with Section 10128.5) to Chapter 1 of Part 2 of Division 2 of the Insurance Code, relating to health care coverage.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
SB 958, as amended, Limn. Medication and Patient Safety Act of 2022.
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 requires a health care service plan contract or health insurance policy that provides coverage for outpatient prescription drugs to cover medically necessary prescription drugs.This bill would prohibit a health care service plan or health insurer, or its designee, from arranging for or requiring a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration. The bill would prohibit authorize a plan or insurer, or its designee, from requiring to arrange for an infused or injected medication to be administered in an enrollees or insureds home as a condition of coverage, unless when the treating health care provider determines and patient determine home administration is safe and appropriate. in the best interest of the patient. The bill would prohibit a plan or insurer, or its designee, from requiring an infused or injected medication to be supplied by a vendor specified by the plan or insurer, or its designee, as a condition of coverage, unless specified criteria are met. Because a willful violation of the bills requirements relative to health care service plans would be a crime, the bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.
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 requires a health care service plan contract or health insurance policy that provides coverage for outpatient prescription drugs to cover medically necessary prescription drugs.
This bill would prohibit a health care service plan or health insurer, or its designee, from arranging for or requiring a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration. The bill would prohibit authorize a plan or insurer, or its designee, from requiring to arrange for an infused or injected medication to be administered in an enrollees or insureds home as a condition of coverage, unless when the treating health care provider determines and patient determine home administration is safe and appropriate. in the best interest of the patient. The bill would prohibit a plan or insurer, or its designee, from requiring an infused or injected medication to be supplied by a vendor specified by the plan or insurer, or its designee, as a condition of coverage, unless specified criteria are met. Because a willful violation of the bills requirements relative to health care service plans would be a crime, the bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. (a) This act shall be known, and may be cited, as the Medication and Patient Safety Act of 2022.(b) The Legislature finds and declares all of the following:(1) Californians suffering from serious and potentially life-threatening diseases may be treated with infused and injected medications, which include drugs that are infused or injected by a health care provider in an outpatient setting. In many cases, these medications are the only hope for a normal quality of life or, in some cases, survival. These medications are used to treat cancer, transplant rejection, HIV/AIDS, immune disorders, Parkinsons disease, Duchenne muscular dystrophy, multiple sclerosis, inherited and genetic diseases, metabolic diseases, emphysema, amyotrophic lateral sclerosis, blood disorders, asthma, ulcerative colitis, Crohns disease, osteoporosis, and other debilitating diseases and disorders.(2) Typically, a patient with one of these diseases schedules an appointment to receive the medication. On the day of the appointment, the patient is assessed, which often includes sending blood or other specimens to a clinical laboratory for rapid analysis or, in some cases, weighing the patient and evaluating overall clinical status. Based on the physicians assessment of these parameters, the treatment plan may change, requiring a different drug or different strength than planned.(3) Patients with cancer, threatened organ rejection, or other life-threatening diseases and conditions may need emergency treatment with infused or injected medications due to rapid deterioration or exacerbation of their condition.(4) Health care service plans and health insurers have begun to implement various policies that inappropriately restrict Californians access to critical medications, as well as high-quality infusion and injection services. Some plans and insurers have implemented a policy by which they contract with a vendor to deliver these medications to the patients home, and the patient brings the medication to the health care provider for administration. This practice, sometimes referred to as brown-bagging, raises serious safety concerns. Many medications need special handling, such as refrigeration, or must be used within a certain time period. Also, many medications will not be effective if shaken, as that may cause deterioration. When a patient brings a medication to a health care provider for administration, the provider has no way of knowing whether the medication was appropriately handled. For example, a patient may not be able to miss work to wait for the delivery of their medication at home, and as a result, the medication might sit on the patients porch in the heat for several hours before the patient can refrigerate it. Or, the patients refrigerator may not be operating at the correct temperature for the medication. It is crucial that these medications follow known quality and safety channels.(5) Similarly, some plans and insurers have adopted policies that are sometimes referred to as white-bagging. These policies require a health care provider to accept delivery from a plans or insurers vendor of a medication labeled for a specific patient in advance of the patients visit. The health care provider is not permitted to give any other medication to the patient, even if the patients same-day assessment indicates that a different medication, strength, or dosage is better suited for the patient and the provider has that medication in stock. The patient and provider must then choose between using the suboptimal previously shipped medication, admitting the patient to a hospital for treatment, or delaying the treatment until the more appropriate medication can be shipped, even if the provider has the appropriate medication in stock.(6) Delaying treatment may put the patients health at risk due to disease progression, and often leads to patient distress. Patients prepare mentally and physically for the day of chemotherapy. They arrange time off work, rides, and babysitters, and family members may rearrange their schedules, too. Patients count on their medication to control or cure their disease. To tell a patient when they arrive and have their lab test that the medication needs to be changed and their treatment will be delayed while the plan or insurer arranges to get a different medicine shipped is callous and inhumane, especially if the health care provider has the proper medication available, but the plan or insurer refuses to cover it.(7) Some plans and insurers have required patients to stop going to their health care provider for infusion or injection services, and instead require that the patient be given their medication at home by a home health agency. While at times this may be appropriate, this is often not the case. Many infused and injected medications have serious and toxic side effects and should be administered in a setting with specially trained physicians and nurses experienced in managing side effects and reactions, and with the necessary equipment and medications to treat these patients. This is especially important for pediatric patients, frail elderly patients, patients taking multiple medications, and patients receiving a medication for the first time. A plan or insurer should not require a medication to be administered at home unless the patients treating health care provider determines it is safe and appropriate.(8) Some plans and insurers have required patients to receive their infused and injected medications from a different provider, even if the physician or another provider who has been treating the patient is in the plans or insurers network. Disrupting these long-standing relationships is detrimental to patients. Infused and injected medications are complex, as are the diseases and disorders they treat. It often takes a great deal of back-and-forth for the patient and physician to figure out the best treatment regimen for the patient and how to minimize side effects. Plans and insurers should not be permitted to interfere in the choice of health care provider if the desired provider is in the plans or insurers network.(9) Patients are negatively impacted by these policies, particularly low-income patients, patients of color, and patients with limited access to health care, childcare, or transportation services. Patients may be forced to make duplicate trips to a health care providers location, discontinue care with their current provider and find a new one, sometimes in the middle of their course of treatment, travel a longer distance to receive care, or be admitted to the hospital due to a worsening of their disease or condition. Pediatric patients have also been especially affected, as they often need specialized physicians and other providers with experience treating children with these medications.(10) It is the intent of the Legislature to ensure that infused and injected medications and related services remain available to all Californians who need them.SEC. 2. Article 6.15 (commencing with Section 1385.010) is added to Chapter 2.2 of Division 2 of the Health and Safety Code, to read: Article 6.15. Medication and Patient Safety Act of 20221385.010. For purposes of this article:(a) Designee means a capitated medical group or risk-bearing organization identified as such by the Department of Managed Health Care, a pharmacy benefit manager, or a similar entity that contracts with a health care service plan to arrange for or approve medications for an enrollee.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.1385.011. (a) A health care service plan or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an enrollee in the enrollees home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the plan or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the enrollees same-day clinical presentation, the drug does not require adjustment based on the enrollees weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the enrollees same-day clinical presentation.(2)The enrollee receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment. enrollee as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing.(9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the plan notifies the enrollee in advance that a vendor will call the enrollee to obtain billing information for any cost-sharing amount. The plan shall provide the name of the vendor and the cost-sharing amount to the enrollee.(12)(10) The health care service plan or designee allows the treating health care provider to administer the medication to the enrollee and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health care service plan obtains the enrollees, or the enrollees legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the plan.(d) A health care service plan or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health care service plan or its designee shall not interfere with the enrollees right to obtain a covered, medically necessary infused or injected medication from a participating provider of the enrollees choosing. A health care service plan or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health care service plan opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the plan shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the plan a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the enrollee to receive the medication from the plan or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health care service plan or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health care service plans or designees review shall be completed within seven calendar days of the providers submission of the relevant enrollee information. However, the review shall be completed within 24 hours if the enrollees discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the enrollee is not likely to be able to be safely and appropriately treated with the drug from the plans vendor within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment, the plan or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health care service plan shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health care service plan or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the enrollee and the treating provider within the time limits prescribed by Section 1367.241.(h) This section does not require a health care service plan to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an enrollee pursuant to this section shall obtain the enrollees consent and disclose a good faith estimate of the enrollees applicable cost-sharing amount.SEC. 3. Article 1.6 (commencing with Section 10128.5) is added to Chapter 1 of Part 2 of Division 2 of the Insurance Code, to read: Article 1.6. Medication and Patient Safety Act of 202210128.5. For purposes of this article:(a) Designee means a medical group, a pharmacy benefit manager, or a similar entity that contracts with a health insurer to arrange for or approve medications for an insured.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.10128.6. (a) A health insurer or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an insured in the insureds home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the insurer or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the insureds same-day clinical presentation, the drug does not require adjustment based on the insureds weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the insureds same-day clinical presentation.(2)The insured receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the insured, in the treating health care providers reasonable medical judgment. insured as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing. (9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the insurer notifies the insured in advance that a vendor will call the insured to obtain billing information for any cost-sharing amount. The insurer shall provide the name of the vendor and the cost-sharing amount to the insured.(12)(10) The health insurer or designee allows the treating health care provider to administer the medication to the insured and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health insurer obtains the insureds, or the insureds legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the insurer.(d) A health insurer or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health insurer or its designee shall not interfere with the insureds right to obtain a covered, medically necessary infused or injected medication from a participating provider of the insureds choosing. A health insurer or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health insurer opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the insurer shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the insurer a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the insured to receive the medication from the insurer or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health insurer or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health insurers or designees review shall be completed within seven calendar days of the providers submission of the relevant insured information. However, the review shall be completed within 24 hours if the insureds discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the insured is not likely to be able to be safely and appropriately treated with the drug from the insurers vendor within the time period needed by the insured, in the treating health care providers reasonable medical judgment, the insurer or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health insurer shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health insurer or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the insured and the treating provider within the time limits prescribed by Section 10123.191.(h) This section does not require a health insurer to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an insured pursuant to this section shall obtain the insureds consent and disclose a good faith estimate of the insureds applicable cost-sharing amount.SEC. 4. 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. (a) This act shall be known, and may be cited, as the Medication and Patient Safety Act of 2022.(b) The Legislature finds and declares all of the following:(1) Californians suffering from serious and potentially life-threatening diseases may be treated with infused and injected medications, which include drugs that are infused or injected by a health care provider in an outpatient setting. In many cases, these medications are the only hope for a normal quality of life or, in some cases, survival. These medications are used to treat cancer, transplant rejection, HIV/AIDS, immune disorders, Parkinsons disease, Duchenne muscular dystrophy, multiple sclerosis, inherited and genetic diseases, metabolic diseases, emphysema, amyotrophic lateral sclerosis, blood disorders, asthma, ulcerative colitis, Crohns disease, osteoporosis, and other debilitating diseases and disorders.(2) Typically, a patient with one of these diseases schedules an appointment to receive the medication. On the day of the appointment, the patient is assessed, which often includes sending blood or other specimens to a clinical laboratory for rapid analysis or, in some cases, weighing the patient and evaluating overall clinical status. Based on the physicians assessment of these parameters, the treatment plan may change, requiring a different drug or different strength than planned.(3) Patients with cancer, threatened organ rejection, or other life-threatening diseases and conditions may need emergency treatment with infused or injected medications due to rapid deterioration or exacerbation of their condition.(4) Health care service plans and health insurers have begun to implement various policies that inappropriately restrict Californians access to critical medications, as well as high-quality infusion and injection services. Some plans and insurers have implemented a policy by which they contract with a vendor to deliver these medications to the patients home, and the patient brings the medication to the health care provider for administration. This practice, sometimes referred to as brown-bagging, raises serious safety concerns. Many medications need special handling, such as refrigeration, or must be used within a certain time period. Also, many medications will not be effective if shaken, as that may cause deterioration. When a patient brings a medication to a health care provider for administration, the provider has no way of knowing whether the medication was appropriately handled. For example, a patient may not be able to miss work to wait for the delivery of their medication at home, and as a result, the medication might sit on the patients porch in the heat for several hours before the patient can refrigerate it. Or, the patients refrigerator may not be operating at the correct temperature for the medication. It is crucial that these medications follow known quality and safety channels.(5) Similarly, some plans and insurers have adopted policies that are sometimes referred to as white-bagging. These policies require a health care provider to accept delivery from a plans or insurers vendor of a medication labeled for a specific patient in advance of the patients visit. The health care provider is not permitted to give any other medication to the patient, even if the patients same-day assessment indicates that a different medication, strength, or dosage is better suited for the patient and the provider has that medication in stock. The patient and provider must then choose between using the suboptimal previously shipped medication, admitting the patient to a hospital for treatment, or delaying the treatment until the more appropriate medication can be shipped, even if the provider has the appropriate medication in stock.(6) Delaying treatment may put the patients health at risk due to disease progression, and often leads to patient distress. Patients prepare mentally and physically for the day of chemotherapy. They arrange time off work, rides, and babysitters, and family members may rearrange their schedules, too. Patients count on their medication to control or cure their disease. To tell a patient when they arrive and have their lab test that the medication needs to be changed and their treatment will be delayed while the plan or insurer arranges to get a different medicine shipped is callous and inhumane, especially if the health care provider has the proper medication available, but the plan or insurer refuses to cover it.(7) Some plans and insurers have required patients to stop going to their health care provider for infusion or injection services, and instead require that the patient be given their medication at home by a home health agency. While at times this may be appropriate, this is often not the case. Many infused and injected medications have serious and toxic side effects and should be administered in a setting with specially trained physicians and nurses experienced in managing side effects and reactions, and with the necessary equipment and medications to treat these patients. This is especially important for pediatric patients, frail elderly patients, patients taking multiple medications, and patients receiving a medication for the first time. A plan or insurer should not require a medication to be administered at home unless the patients treating health care provider determines it is safe and appropriate.(8) Some plans and insurers have required patients to receive their infused and injected medications from a different provider, even if the physician or another provider who has been treating the patient is in the plans or insurers network. Disrupting these long-standing relationships is detrimental to patients. Infused and injected medications are complex, as are the diseases and disorders they treat. It often takes a great deal of back-and-forth for the patient and physician to figure out the best treatment regimen for the patient and how to minimize side effects. Plans and insurers should not be permitted to interfere in the choice of health care provider if the desired provider is in the plans or insurers network.(9) Patients are negatively impacted by these policies, particularly low-income patients, patients of color, and patients with limited access to health care, childcare, or transportation services. Patients may be forced to make duplicate trips to a health care providers location, discontinue care with their current provider and find a new one, sometimes in the middle of their course of treatment, travel a longer distance to receive care, or be admitted to the hospital due to a worsening of their disease or condition. Pediatric patients have also been especially affected, as they often need specialized physicians and other providers with experience treating children with these medications.(10) It is the intent of the Legislature to ensure that infused and injected medications and related services remain available to all Californians who need them.
SECTION 1. (a) This act shall be known, and may be cited, as the Medication and Patient Safety Act of 2022.(b) The Legislature finds and declares all of the following:(1) Californians suffering from serious and potentially life-threatening diseases may be treated with infused and injected medications, which include drugs that are infused or injected by a health care provider in an outpatient setting. In many cases, these medications are the only hope for a normal quality of life or, in some cases, survival. These medications are used to treat cancer, transplant rejection, HIV/AIDS, immune disorders, Parkinsons disease, Duchenne muscular dystrophy, multiple sclerosis, inherited and genetic diseases, metabolic diseases, emphysema, amyotrophic lateral sclerosis, blood disorders, asthma, ulcerative colitis, Crohns disease, osteoporosis, and other debilitating diseases and disorders.(2) Typically, a patient with one of these diseases schedules an appointment to receive the medication. On the day of the appointment, the patient is assessed, which often includes sending blood or other specimens to a clinical laboratory for rapid analysis or, in some cases, weighing the patient and evaluating overall clinical status. Based on the physicians assessment of these parameters, the treatment plan may change, requiring a different drug or different strength than planned.(3) Patients with cancer, threatened organ rejection, or other life-threatening diseases and conditions may need emergency treatment with infused or injected medications due to rapid deterioration or exacerbation of their condition.(4) Health care service plans and health insurers have begun to implement various policies that inappropriately restrict Californians access to critical medications, as well as high-quality infusion and injection services. Some plans and insurers have implemented a policy by which they contract with a vendor to deliver these medications to the patients home, and the patient brings the medication to the health care provider for administration. This practice, sometimes referred to as brown-bagging, raises serious safety concerns. Many medications need special handling, such as refrigeration, or must be used within a certain time period. Also, many medications will not be effective if shaken, as that may cause deterioration. When a patient brings a medication to a health care provider for administration, the provider has no way of knowing whether the medication was appropriately handled. For example, a patient may not be able to miss work to wait for the delivery of their medication at home, and as a result, the medication might sit on the patients porch in the heat for several hours before the patient can refrigerate it. Or, the patients refrigerator may not be operating at the correct temperature for the medication. It is crucial that these medications follow known quality and safety channels.(5) Similarly, some plans and insurers have adopted policies that are sometimes referred to as white-bagging. These policies require a health care provider to accept delivery from a plans or insurers vendor of a medication labeled for a specific patient in advance of the patients visit. The health care provider is not permitted to give any other medication to the patient, even if the patients same-day assessment indicates that a different medication, strength, or dosage is better suited for the patient and the provider has that medication in stock. The patient and provider must then choose between using the suboptimal previously shipped medication, admitting the patient to a hospital for treatment, or delaying the treatment until the more appropriate medication can be shipped, even if the provider has the appropriate medication in stock.(6) Delaying treatment may put the patients health at risk due to disease progression, and often leads to patient distress. Patients prepare mentally and physically for the day of chemotherapy. They arrange time off work, rides, and babysitters, and family members may rearrange their schedules, too. Patients count on their medication to control or cure their disease. To tell a patient when they arrive and have their lab test that the medication needs to be changed and their treatment will be delayed while the plan or insurer arranges to get a different medicine shipped is callous and inhumane, especially if the health care provider has the proper medication available, but the plan or insurer refuses to cover it.(7) Some plans and insurers have required patients to stop going to their health care provider for infusion or injection services, and instead require that the patient be given their medication at home by a home health agency. While at times this may be appropriate, this is often not the case. Many infused and injected medications have serious and toxic side effects and should be administered in a setting with specially trained physicians and nurses experienced in managing side effects and reactions, and with the necessary equipment and medications to treat these patients. This is especially important for pediatric patients, frail elderly patients, patients taking multiple medications, and patients receiving a medication for the first time. A plan or insurer should not require a medication to be administered at home unless the patients treating health care provider determines it is safe and appropriate.(8) Some plans and insurers have required patients to receive their infused and injected medications from a different provider, even if the physician or another provider who has been treating the patient is in the plans or insurers network. Disrupting these long-standing relationships is detrimental to patients. Infused and injected medications are complex, as are the diseases and disorders they treat. It often takes a great deal of back-and-forth for the patient and physician to figure out the best treatment regimen for the patient and how to minimize side effects. Plans and insurers should not be permitted to interfere in the choice of health care provider if the desired provider is in the plans or insurers network.(9) Patients are negatively impacted by these policies, particularly low-income patients, patients of color, and patients with limited access to health care, childcare, or transportation services. Patients may be forced to make duplicate trips to a health care providers location, discontinue care with their current provider and find a new one, sometimes in the middle of their course of treatment, travel a longer distance to receive care, or be admitted to the hospital due to a worsening of their disease or condition. Pediatric patients have also been especially affected, as they often need specialized physicians and other providers with experience treating children with these medications.(10) It is the intent of the Legislature to ensure that infused and injected medications and related services remain available to all Californians who need them.
SECTION 1. (a) This act shall be known, and may be cited, as the Medication and Patient Safety Act of 2022.
### SECTION 1.
(b) The Legislature finds and declares all of the following:
(1) Californians suffering from serious and potentially life-threatening diseases may be treated with infused and injected medications, which include drugs that are infused or injected by a health care provider in an outpatient setting. In many cases, these medications are the only hope for a normal quality of life or, in some cases, survival. These medications are used to treat cancer, transplant rejection, HIV/AIDS, immune disorders, Parkinsons disease, Duchenne muscular dystrophy, multiple sclerosis, inherited and genetic diseases, metabolic diseases, emphysema, amyotrophic lateral sclerosis, blood disorders, asthma, ulcerative colitis, Crohns disease, osteoporosis, and other debilitating diseases and disorders.
(2) Typically, a patient with one of these diseases schedules an appointment to receive the medication. On the day of the appointment, the patient is assessed, which often includes sending blood or other specimens to a clinical laboratory for rapid analysis or, in some cases, weighing the patient and evaluating overall clinical status. Based on the physicians assessment of these parameters, the treatment plan may change, requiring a different drug or different strength than planned.
(3) Patients with cancer, threatened organ rejection, or other life-threatening diseases and conditions may need emergency treatment with infused or injected medications due to rapid deterioration or exacerbation of their condition.
(4) Health care service plans and health insurers have begun to implement various policies that inappropriately restrict Californians access to critical medications, as well as high-quality infusion and injection services. Some plans and insurers have implemented a policy by which they contract with a vendor to deliver these medications to the patients home, and the patient brings the medication to the health care provider for administration. This practice, sometimes referred to as brown-bagging, raises serious safety concerns. Many medications need special handling, such as refrigeration, or must be used within a certain time period. Also, many medications will not be effective if shaken, as that may cause deterioration. When a patient brings a medication to a health care provider for administration, the provider has no way of knowing whether the medication was appropriately handled. For example, a patient may not be able to miss work to wait for the delivery of their medication at home, and as a result, the medication might sit on the patients porch in the heat for several hours before the patient can refrigerate it. Or, the patients refrigerator may not be operating at the correct temperature for the medication. It is crucial that these medications follow known quality and safety channels.
(5) Similarly, some plans and insurers have adopted policies that are sometimes referred to as white-bagging. These policies require a health care provider to accept delivery from a plans or insurers vendor of a medication labeled for a specific patient in advance of the patients visit. The health care provider is not permitted to give any other medication to the patient, even if the patients same-day assessment indicates that a different medication, strength, or dosage is better suited for the patient and the provider has that medication in stock. The patient and provider must then choose between using the suboptimal previously shipped medication, admitting the patient to a hospital for treatment, or delaying the treatment until the more appropriate medication can be shipped, even if the provider has the appropriate medication in stock.
(6) Delaying treatment may put the patients health at risk due to disease progression, and often leads to patient distress. Patients prepare mentally and physically for the day of chemotherapy. They arrange time off work, rides, and babysitters, and family members may rearrange their schedules, too. Patients count on their medication to control or cure their disease. To tell a patient when they arrive and have their lab test that the medication needs to be changed and their treatment will be delayed while the plan or insurer arranges to get a different medicine shipped is callous and inhumane, especially if the health care provider has the proper medication available, but the plan or insurer refuses to cover it.
(7) Some plans and insurers have required patients to stop going to their health care provider for infusion or injection services, and instead require that the patient be given their medication at home by a home health agency. While at times this may be appropriate, this is often not the case. Many infused and injected medications have serious and toxic side effects and should be administered in a setting with specially trained physicians and nurses experienced in managing side effects and reactions, and with the necessary equipment and medications to treat these patients. This is especially important for pediatric patients, frail elderly patients, patients taking multiple medications, and patients receiving a medication for the first time. A plan or insurer should not require a medication to be administered at home unless the patients treating health care provider determines it is safe and appropriate.
(8) Some plans and insurers have required patients to receive their infused and injected medications from a different provider, even if the physician or another provider who has been treating the patient is in the plans or insurers network. Disrupting these long-standing relationships is detrimental to patients. Infused and injected medications are complex, as are the diseases and disorders they treat. It often takes a great deal of back-and-forth for the patient and physician to figure out the best treatment regimen for the patient and how to minimize side effects. Plans and insurers should not be permitted to interfere in the choice of health care provider if the desired provider is in the plans or insurers network.
(9) Patients are negatively impacted by these policies, particularly low-income patients, patients of color, and patients with limited access to health care, childcare, or transportation services. Patients may be forced to make duplicate trips to a health care providers location, discontinue care with their current provider and find a new one, sometimes in the middle of their course of treatment, travel a longer distance to receive care, or be admitted to the hospital due to a worsening of their disease or condition. Pediatric patients have also been especially affected, as they often need specialized physicians and other providers with experience treating children with these medications.
(10) It is the intent of the Legislature to ensure that infused and injected medications and related services remain available to all Californians who need them.
SEC. 2. Article 6.15 (commencing with Section 1385.010) is added to Chapter 2.2 of Division 2 of the Health and Safety Code, to read: Article 6.15. Medication and Patient Safety Act of 20221385.010. For purposes of this article:(a) Designee means a capitated medical group or risk-bearing organization identified as such by the Department of Managed Health Care, a pharmacy benefit manager, or a similar entity that contracts with a health care service plan to arrange for or approve medications for an enrollee.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.1385.011. (a) A health care service plan or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an enrollee in the enrollees home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the plan or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the enrollees same-day clinical presentation, the drug does not require adjustment based on the enrollees weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the enrollees same-day clinical presentation.(2)The enrollee receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment. enrollee as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing.(9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the plan notifies the enrollee in advance that a vendor will call the enrollee to obtain billing information for any cost-sharing amount. The plan shall provide the name of the vendor and the cost-sharing amount to the enrollee.(12)(10) The health care service plan or designee allows the treating health care provider to administer the medication to the enrollee and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health care service plan obtains the enrollees, or the enrollees legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the plan.(d) A health care service plan or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health care service plan or its designee shall not interfere with the enrollees right to obtain a covered, medically necessary infused or injected medication from a participating provider of the enrollees choosing. A health care service plan or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health care service plan opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the plan shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the plan a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the enrollee to receive the medication from the plan or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health care service plan or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health care service plans or designees review shall be completed within seven calendar days of the providers submission of the relevant enrollee information. However, the review shall be completed within 24 hours if the enrollees discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the enrollee is not likely to be able to be safely and appropriately treated with the drug from the plans vendor within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment, the plan or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health care service plan shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health care service plan or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the enrollee and the treating provider within the time limits prescribed by Section 1367.241.(h) This section does not require a health care service plan to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an enrollee pursuant to this section shall obtain the enrollees consent and disclose a good faith estimate of the enrollees applicable cost-sharing amount.
SEC. 2. Article 6.15 (commencing with Section 1385.010) is added to Chapter 2.2 of Division 2 of the Health and Safety Code, to read:
### SEC. 2.
Article 6.15. Medication and Patient Safety Act of 20221385.010. For purposes of this article:(a) Designee means a capitated medical group or risk-bearing organization identified as such by the Department of Managed Health Care, a pharmacy benefit manager, or a similar entity that contracts with a health care service plan to arrange for or approve medications for an enrollee.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.1385.011. (a) A health care service plan or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an enrollee in the enrollees home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the plan or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the enrollees same-day clinical presentation, the drug does not require adjustment based on the enrollees weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the enrollees same-day clinical presentation.(2)The enrollee receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment. enrollee as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing.(9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the plan notifies the enrollee in advance that a vendor will call the enrollee to obtain billing information for any cost-sharing amount. The plan shall provide the name of the vendor and the cost-sharing amount to the enrollee.(12)(10) The health care service plan or designee allows the treating health care provider to administer the medication to the enrollee and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health care service plan obtains the enrollees, or the enrollees legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the plan.(d) A health care service plan or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health care service plan or its designee shall not interfere with the enrollees right to obtain a covered, medically necessary infused or injected medication from a participating provider of the enrollees choosing. A health care service plan or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health care service plan opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the plan shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the plan a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the enrollee to receive the medication from the plan or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health care service plan or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health care service plans or designees review shall be completed within seven calendar days of the providers submission of the relevant enrollee information. However, the review shall be completed within 24 hours if the enrollees discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the enrollee is not likely to be able to be safely and appropriately treated with the drug from the plans vendor within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment, the plan or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health care service plan shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health care service plan or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the enrollee and the treating provider within the time limits prescribed by Section 1367.241.(h) This section does not require a health care service plan to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an enrollee pursuant to this section shall obtain the enrollees consent and disclose a good faith estimate of the enrollees applicable cost-sharing amount.
Article 6.15. Medication and Patient Safety Act of 20221385.010. For purposes of this article:(a) Designee means a capitated medical group or risk-bearing organization identified as such by the Department of Managed Health Care, a pharmacy benefit manager, or a similar entity that contracts with a health care service plan to arrange for or approve medications for an enrollee.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.1385.011. (a) A health care service plan or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an enrollee in the enrollees home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the plan or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the enrollees same-day clinical presentation, the drug does not require adjustment based on the enrollees weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the enrollees same-day clinical presentation.(2)The enrollee receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment. enrollee as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing.(9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the plan notifies the enrollee in advance that a vendor will call the enrollee to obtain billing information for any cost-sharing amount. The plan shall provide the name of the vendor and the cost-sharing amount to the enrollee.(12)(10) The health care service plan or designee allows the treating health care provider to administer the medication to the enrollee and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health care service plan obtains the enrollees, or the enrollees legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the plan.(d) A health care service plan or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health care service plan or its designee shall not interfere with the enrollees right to obtain a covered, medically necessary infused or injected medication from a participating provider of the enrollees choosing. A health care service plan or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health care service plan opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the plan shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the plan a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the enrollee to receive the medication from the plan or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health care service plan or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health care service plans or designees review shall be completed within seven calendar days of the providers submission of the relevant enrollee information. However, the review shall be completed within 24 hours if the enrollees discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the enrollee is not likely to be able to be safely and appropriately treated with the drug from the plans vendor within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment, the plan or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health care service plan shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health care service plan or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the enrollee and the treating provider within the time limits prescribed by Section 1367.241.(h) This section does not require a health care service plan to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an enrollee pursuant to this section shall obtain the enrollees consent and disclose a good faith estimate of the enrollees applicable cost-sharing amount.
Article 6.15. Medication and Patient Safety Act of 2022
Article 6.15. Medication and Patient Safety Act of 2022
1385.010. For purposes of this article:(a) Designee means a capitated medical group or risk-bearing organization identified as such by the Department of Managed Health Care, a pharmacy benefit manager, or a similar entity that contracts with a health care service plan to arrange for or approve medications for an enrollee.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.
1385.010. For purposes of this article:
(a) Designee means a capitated medical group or risk-bearing organization identified as such by the Department of Managed Health Care, a pharmacy benefit manager, or a similar entity that contracts with a health care service plan to arrange for or approve medications for an enrollee.
(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.
(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.
1385.011. (a) A health care service plan or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an enrollee in the enrollees home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the plan or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the enrollees same-day clinical presentation, the drug does not require adjustment based on the enrollees weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the enrollees same-day clinical presentation.(2)The enrollee receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment. enrollee as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing.(9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the plan notifies the enrollee in advance that a vendor will call the enrollee to obtain billing information for any cost-sharing amount. The plan shall provide the name of the vendor and the cost-sharing amount to the enrollee.(12)(10) The health care service plan or designee allows the treating health care provider to administer the medication to the enrollee and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health care service plan obtains the enrollees, or the enrollees legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the plan.(d) A health care service plan or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health care service plan or its designee shall not interfere with the enrollees right to obtain a covered, medically necessary infused or injected medication from a participating provider of the enrollees choosing. A health care service plan or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health care service plan opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the plan shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the plan a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the enrollee to receive the medication from the plan or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health care service plan or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health care service plans or designees review shall be completed within seven calendar days of the providers submission of the relevant enrollee information. However, the review shall be completed within 24 hours if the enrollees discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the enrollee is not likely to be able to be safely and appropriately treated with the drug from the plans vendor within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment, the plan or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health care service plan shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health care service plan or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the enrollee and the treating provider within the time limits prescribed by Section 1367.241.(h) This section does not require a health care service plan to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an enrollee pursuant to this section shall obtain the enrollees consent and disclose a good faith estimate of the enrollees applicable cost-sharing amount.
1385.011. (a) A health care service plan or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.
(b) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an enrollee in the enrollees home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.
(c) A health care service plan or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the plan or designee unless all of the following are true:
(1) The choice of drug, strength, or dose drug or strength does not depend on the enrollees same-day clinical presentation, the drug does not require adjustment based on the enrollees weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the enrollees same-day clinical presentation.
(2)The enrollee receiving the drug is 18 years of age or older.
(3)The drug does not require sterile compounding.
(2) The medication cannot be compounded at the location of administration.
(4)
(3) The drug does not contain controlled substances.
(5)
(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.
(6)
(5) The vendor is able to, and does, deliver the drug within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment. enrollee as determined by the treating health care provider.
(7)
(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.
(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing.
(9)
(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.
(10)
(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.
(11)
(9) If applicable, the plan notifies the enrollee in advance that a vendor will call the enrollee to obtain billing information for any cost-sharing amount. The plan shall provide the name of the vendor and the cost-sharing amount to the enrollee.
(12)
(10) The health care service plan or designee allows the treating health care provider to administer the medication to the enrollee and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.
(13)
(11) Administration of a drug procured in this manner does not violate any state or federal law.
(14)
(12) The health care service plan obtains the enrollees, or the enrollees legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the plan.
(d) A health care service plan or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.
(e) A health care service plan or its designee shall not interfere with the enrollees right to obtain a covered, medically necessary infused or injected medication from a participating provider of the enrollees choosing. A health care service plan or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.
(f) If a health care service plan opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the plan shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the plan a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the enrollee to receive the medication from the plan or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health care service plan or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health care service plans or designees review shall be completed within seven calendar days of the providers submission of the relevant enrollee information. However, the review shall be completed within 24 hours if the enrollees discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the enrollee is not likely to be able to be safely and appropriately treated with the drug from the plans vendor within the time period needed by the enrollee, in the treating health care providers reasonable medical judgment, the plan or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health care service plan shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.
(g) A health care service plan or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the enrollee and the treating provider within the time limits prescribed by Section 1367.241.
(h) This section does not require a health care service plan to cover any new or additional health care benefits.
(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an enrollee pursuant to this section shall obtain the enrollees consent and disclose a good faith estimate of the enrollees applicable cost-sharing amount.
SEC. 3. Article 1.6 (commencing with Section 10128.5) is added to Chapter 1 of Part 2 of Division 2 of the Insurance Code, to read: Article 1.6. Medication and Patient Safety Act of 202210128.5. For purposes of this article:(a) Designee means a medical group, a pharmacy benefit manager, or a similar entity that contracts with a health insurer to arrange for or approve medications for an insured.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.10128.6. (a) A health insurer or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an insured in the insureds home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the insurer or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the insureds same-day clinical presentation, the drug does not require adjustment based on the insureds weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the insureds same-day clinical presentation.(2)The insured receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the insured, in the treating health care providers reasonable medical judgment. insured as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing. (9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the insurer notifies the insured in advance that a vendor will call the insured to obtain billing information for any cost-sharing amount. The insurer shall provide the name of the vendor and the cost-sharing amount to the insured.(12)(10) The health insurer or designee allows the treating health care provider to administer the medication to the insured and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health insurer obtains the insureds, or the insureds legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the insurer.(d) A health insurer or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health insurer or its designee shall not interfere with the insureds right to obtain a covered, medically necessary infused or injected medication from a participating provider of the insureds choosing. A health insurer or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health insurer opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the insurer shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the insurer a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the insured to receive the medication from the insurer or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health insurer or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health insurers or designees review shall be completed within seven calendar days of the providers submission of the relevant insured information. However, the review shall be completed within 24 hours if the insureds discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the insured is not likely to be able to be safely and appropriately treated with the drug from the insurers vendor within the time period needed by the insured, in the treating health care providers reasonable medical judgment, the insurer or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health insurer shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health insurer or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the insured and the treating provider within the time limits prescribed by Section 10123.191.(h) This section does not require a health insurer to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an insured pursuant to this section shall obtain the insureds consent and disclose a good faith estimate of the insureds applicable cost-sharing amount.
SEC. 3. Article 1.6 (commencing with Section 10128.5) is added to Chapter 1 of Part 2 of Division 2 of the Insurance Code, to read:
### SEC. 3.
Article 1.6. Medication and Patient Safety Act of 202210128.5. For purposes of this article:(a) Designee means a medical group, a pharmacy benefit manager, or a similar entity that contracts with a health insurer to arrange for or approve medications for an insured.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.10128.6. (a) A health insurer or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an insured in the insureds home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the insurer or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the insureds same-day clinical presentation, the drug does not require adjustment based on the insureds weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the insureds same-day clinical presentation.(2)The insured receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the insured, in the treating health care providers reasonable medical judgment. insured as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing. (9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the insurer notifies the insured in advance that a vendor will call the insured to obtain billing information for any cost-sharing amount. The insurer shall provide the name of the vendor and the cost-sharing amount to the insured.(12)(10) The health insurer or designee allows the treating health care provider to administer the medication to the insured and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health insurer obtains the insureds, or the insureds legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the insurer.(d) A health insurer or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health insurer or its designee shall not interfere with the insureds right to obtain a covered, medically necessary infused or injected medication from a participating provider of the insureds choosing. A health insurer or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health insurer opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the insurer shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the insurer a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the insured to receive the medication from the insurer or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health insurer or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health insurers or designees review shall be completed within seven calendar days of the providers submission of the relevant insured information. However, the review shall be completed within 24 hours if the insureds discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the insured is not likely to be able to be safely and appropriately treated with the drug from the insurers vendor within the time period needed by the insured, in the treating health care providers reasonable medical judgment, the insurer or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health insurer shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health insurer or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the insured and the treating provider within the time limits prescribed by Section 10123.191.(h) This section does not require a health insurer to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an insured pursuant to this section shall obtain the insureds consent and disclose a good faith estimate of the insureds applicable cost-sharing amount.
Article 1.6. Medication and Patient Safety Act of 202210128.5. For purposes of this article:(a) Designee means a medical group, a pharmacy benefit manager, or a similar entity that contracts with a health insurer to arrange for or approve medications for an insured.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.10128.6. (a) A health insurer or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an insured in the insureds home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the insurer or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the insureds same-day clinical presentation, the drug does not require adjustment based on the insureds weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the insureds same-day clinical presentation.(2)The insured receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the insured, in the treating health care providers reasonable medical judgment. insured as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing. (9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the insurer notifies the insured in advance that a vendor will call the insured to obtain billing information for any cost-sharing amount. The insurer shall provide the name of the vendor and the cost-sharing amount to the insured.(12)(10) The health insurer or designee allows the treating health care provider to administer the medication to the insured and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health insurer obtains the insureds, or the insureds legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the insurer.(d) A health insurer or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health insurer or its designee shall not interfere with the insureds right to obtain a covered, medically necessary infused or injected medication from a participating provider of the insureds choosing. A health insurer or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health insurer opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the insurer shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the insurer a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the insured to receive the medication from the insurer or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health insurer or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health insurers or designees review shall be completed within seven calendar days of the providers submission of the relevant insured information. However, the review shall be completed within 24 hours if the insureds discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the insured is not likely to be able to be safely and appropriately treated with the drug from the insurers vendor within the time period needed by the insured, in the treating health care providers reasonable medical judgment, the insurer or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health insurer shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health insurer or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the insured and the treating provider within the time limits prescribed by Section 10123.191.(h) This section does not require a health insurer to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an insured pursuant to this section shall obtain the insureds consent and disclose a good faith estimate of the insureds applicable cost-sharing amount.
Article 1.6. Medication and Patient Safety Act of 2022
Article 1.6. Medication and Patient Safety Act of 2022
10128.5. For purposes of this article:(a) Designee means a medical group, a pharmacy benefit manager, or a similar entity that contracts with a health insurer to arrange for or approve medications for an insured.(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.
10128.5. For purposes of this article:
(a) Designee means a medical group, a pharmacy benefit manager, or a similar entity that contracts with a health insurer to arrange for or approve medications for an insured.
(b) Infused or injected medication means an outpatient prescription medication or biologic, other than a vaccine, that cannot reasonably be self-administered by the patient to whom it is prescribed or by a family member or another individual assisting the patient with the self-administration, and that is typically administered by a licensed health care provider acting within the scope of their professional licensure and in a physicians office, clinic, infusion center, or hospital outpatient department.
(c) Vendor means a pharmaceutical manufacturer, pharmaceutical distributor, or pharmacy. Vendor does not mean an integrated health systems internal pharmacy that dispenses a patients prescription medication and transports the product to the health systems location of drug administration.
10128.6. (a) A health insurer or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.(b) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an insured in the insureds home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.(c) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the insurer or designee unless all of the following are true:(1) The choice of drug, strength, or dose drug or strength does not depend on the insureds same-day clinical presentation, the drug does not require adjustment based on the insureds weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the insureds same-day clinical presentation.(2)The insured receiving the drug is 18 years of age or older.(3)The drug does not require sterile compounding.(2) The medication cannot be compounded at the location of administration. (4)(3) The drug does not contain controlled substances.(5)(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.(6)(5) The vendor is able to, and does, deliver the drug within the time period needed by the insured, in the treating health care providers reasonable medical judgment. insured as determined by the treating health care provider.(7)(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing. (9)(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.(10)(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.(11)(9) If applicable, the insurer notifies the insured in advance that a vendor will call the insured to obtain billing information for any cost-sharing amount. The insurer shall provide the name of the vendor and the cost-sharing amount to the insured.(12)(10) The health insurer or designee allows the treating health care provider to administer the medication to the insured and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.(13)(11) Administration of a drug procured in this manner does not violate any state or federal law.(14)(12) The health insurer obtains the insureds, or the insureds legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the insurer.(d) A health insurer or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.(e) A health insurer or its designee shall not interfere with the insureds right to obtain a covered, medically necessary infused or injected medication from a participating provider of the insureds choosing. A health insurer or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.(f) If a health insurer opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the insurer shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the insurer a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the insured to receive the medication from the insurer or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health insurer or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health insurers or designees review shall be completed within seven calendar days of the providers submission of the relevant insured information. However, the review shall be completed within 24 hours if the insureds discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the insured is not likely to be able to be safely and appropriately treated with the drug from the insurers vendor within the time period needed by the insured, in the treating health care providers reasonable medical judgment, the insurer or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health insurer shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.(g) A health insurer or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the insured and the treating provider within the time limits prescribed by Section 10123.191.(h) This section does not require a health insurer to cover any new or additional health care benefits.(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an insured pursuant to this section shall obtain the insureds consent and disclose a good faith estimate of the insureds applicable cost-sharing amount.
10128.6. (a) A health insurer or its designee shall not arrange for or require a vendor to dispense an infused or injected medication directly to a patient with the intent that the patient will transport the medication to a health care provider for administration.
(b) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, may arrange for an infused or injected medication to be administered to an insured in the insureds home unless when the treating health care provider determines and patient determine administration in the home setting is safe and appropriate. in the best interest of the patient. The treating health care provider shall document the reasons in the patients medical record.
(c) A health insurer or its designee shall not require as a condition of coverage or payment, and shall not offer an incentive for, an infused or injected medication to be supplied by a vendor specified by the insurer or designee unless all of the following are true:
(1) The choice of drug, strength, or dose drug or strength does not depend on the insureds same-day clinical presentation, the drug does not require adjustment based on the insureds weight, and the drug does not otherwise require same-day adjustment. presentation, and sufficient medication is provided to allow for adjustment of dosage as necessary based on the insureds same-day clinical presentation.
(2)The insured receiving the drug is 18 years of age or older.
(3)The drug does not require sterile compounding.
(2) The medication cannot be compounded at the location of administration.
(4)
(3) The drug does not contain controlled substances.
(5)
(4) The federal Food and Drug Administration does not require a risk evaluation and mitigation strategy to manage known or potential serious risk or elements to assure safe use for the drug.
(6)
(5) The vendor is able to, and does, deliver the drug within the time period needed by the insured, in the treating health care providers reasonable medical judgment. insured as determined by the treating health care provider.
(7)
(6) The vendor provides appropriate cold chain logistics or another ability to ensure that drugs remain at the appropriate temperature through all stages of supply, shipping, and storage.
(8)The vendor complies with the federal Drug Supply Chain Security Acts product tracing requirements applicable to wholesale distributors found in Section 360eee-1(c) of Title 21 of the United States Code and all other statutes, regulations, and guidance regarding drug tracking, dispensing, and redispensing.
(9)
(7) The vendor is accredited by a nationally recognized accreditation organization and maintains 24-hour-per-day, 7-day-per-week pharmacist availability for health care providers and patients to ask questions.
(10)
(8) The vendor notifies the receiving hospital pharmacy, clinic, physicians officer, or infusion center, as applicable, of the expected date and time of arrival of the drug and of any shipping delays.
(11)
(9) If applicable, the insurer notifies the insured in advance that a vendor will call the insured to obtain billing information for any cost-sharing amount. The insurer shall provide the name of the vendor and the cost-sharing amount to the insured.
(12)
(10) The health insurer or designee allows the treating health care provider to administer the medication to the insured and reimburses the provider for the medication at the contracted rate. rate if a delay or other problem with delivery of the medication occurs. Reimbursement for the medication shall be separate from the administration fee, which shall reimburse the provider for the services and other supplies needed to infuse or inject the medication. medication at the contracted rate. The treating health care provider shall document the patients consent and the delay or problem that occurred.
(13)
(11) Administration of a drug procured in this manner does not violate any state or federal law.
(14)
(12) The health insurer obtains the insureds, or the insureds legally authorized representatives, consent for the infused or injected medication to be supplied by a vendor selected by the insurer.
(d) A health insurer or designee that implements a policy requiring, as a condition of coverage or payment, that an infused or injected medication be supplied by a specified vendor as permitted by subdivision (c) shall provide written notification to the treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication, at least 45 business days in advance of the effective date of the proposed change. The treating health care provider, the entity authorized to contract for the providers services, and the facility in which the provider administers the medication has the right to negotiate this material change to the contract. If the parties to the contract cannot agree, any party shall have the right to terminate the contract before the implementation of the change.
(e) A health insurer or its designee shall not interfere with the insureds right to obtain a covered, medically necessary infused or injected medication from a participating provider of the insureds choosing. A health insurer or its designee shall not refuse to authorize or approve, exclude coverage for, deny payment for, or offer an incentive for, an infused or injected medication administered by a participating provider based on the site of service, whether the site is a physicians office, clinic, infusion center, or hospital outpatient department.
(f) If a health insurer opts to require an infused or injected medication to be supplied by a specified vendor as permitted by subdivision (c), the insurer shall implement a patient-specific exception process. This process shall be initiated when the treating health care provider submits to the insurer a letter stating that, in the providers reasonable medical judgment, it is unsafe or inappropriate for the insured to receive the medication from the insurer or designees vendor based on the drug characteristics, profile and stability of the medication, required storage and preparation conditions, side-effect management protocols, prior history of adverse reactions, or other patient characteristics. The provider shall document the reasons for their determination in the patients medical record. The health insurer or designee shall conduct or arrange for a review by a pharmacist and a practicing physician in the same or similar specialty who treats the medical condition or provides the treatment for which the particular medication is used. physician. The health insurers or designees review shall be completed within seven calendar days of the providers submission of the relevant insured information. However, the review shall be completed within 24 hours if the insureds discharge from an inpatient facility will be delayed until the infused or injected medication is available. If either the reviewing pharmacist or reviewing physician determines, or if the reviewing pharmacist and reviewing physician agree, that the insured is not likely to be able to be safely and appropriately treated with the drug from the insurers vendor within the time period needed by the insured, in the treating health care providers reasonable medical judgment, the insurer or designee shall reimburse the health care provider for the medication and its administration at the contracted rate. The health insurer shall inform all contracting providers how to initiate the exception process, if the providers scope of practice authorizes them to prescribe infused or injected medications.
(g) A health insurer or designee that requires, as a condition of coverage or payment, prior authorization for an infused or injected medication shall provide written notification of approval or denial of the prior authorization request to the insured and the treating provider within the time limits prescribed by Section 10123.191.
(h) This section does not require a health insurer to cover any new or additional health care benefits.
(i) A physicians office, clinic, infusion center, or hospital outpatient department that supplies and administers an infused or injected medication to an insured pursuant to this section shall obtain the insureds consent and disclose a good faith estimate of the insureds applicable cost-sharing amount.
SEC. 4. 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. 4. 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. 4. 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. 4.