Existing federal law requires the United States Secretary of Health and Human Services to enter into an agreement with each manufacturer of covered outpatient drugs to ensure the amount a covered entity is required to pay for those drugs does not exceed the average manufacturer price of the drug under the federal Medicaid program. Existing state law requires a covered entity to dispense only drugs subject to these federal pricing requirements to Medi-Cal beneficiaries. Existing law prohibits a pharmacy benefit manager from discriminating against a covered entity or its pharmacy in connection with dispensing a drug subject to federal pricing requirements or preventing a covered entity from retaining the benefit of discounted pricing for those drugs. This bill would prohibit a prescription drug manufacturer from engaging in discriminatory practices that would impose additional conditions, prohibit, restrict, deny, or interfere with a qualifying nonhospital 340B community clinic's purchase or delivery of a drug subject to federal pricing requirements if the qualifying nonhospital 340B community clinic utilizes a specified pharmacy, including a contract pharmacy, that dispenses the drug to an eligible patient of the qualifying nonhospital 340B community clinic. The bill would define "discriminatory practices" and "qualifying nonhospital 340B community clinic" for these purposes. The bill would require qualifying nonhospital 340B community clinics to annually perform specified activities to ensure compliance with program rules and guidance from the federal Health Resources and Services Administration. The bill would make related intent statements.
Existing law provides for the licensure and regulation of various types of clinics, including alternative birth centers, by the State Department of Public Health, and makes a violation of those provisions a crime. Existing law defines an alternative birth center as a clinic that is not part of a hospital and that provides comprehensive perinatal services and delivery care to pregnant women who remain less than 24 hours at the facility. Existing law requires a licensed alternative birth center specialty clinic, and a licensed primary care clinic that provides services as an alternative birth center, to meet certain criteria, including, among others, being located in proximity to a facility with the capacity for management of obstetrical and neonatal emergencies, as specified. Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. Existing law sets forth certain criteria for Medi-Cal reimbursement to alternative birth centers for facility-related delivery costs. Under existing law, as a criterion under both the licensing provisions and the Medi-Cal reimbursement provisions described above, the facility is required to be a provider of comprehensive perinatal services as defined in the Medi-Cal provisions. This bill would remove, under both sets of criteria, the certification condition of being a provider of comprehensive perinatal services as defined in the Medi-Cal provisions. The bill would require the facility to provide perinatal services that are comprehensive in nature, as specified, consistent with certain standards. The bill would remove the above-described proximity requirement and would instead require a written policy for hospital transfer. The bill would require the policy to include certain requirements relating to, among other things, arrangements for the referral of a complication, arrangements for the transfer of care, provision of medical records, information about the estimated transfer time, and a clear explanation of the facility's overall emergency transfer plan, as specified. The bill would also make a technical change to an obsolete reference within a related provision. By creating new requirements for an alternative birth center or a primary care clinic that provides services as an alternative birth center, the violation of which is 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.
(1) Existing law, the Medical Practice Act, provides for the licensure and regulation of physicians and surgeons by the Medical Board of California and requires the board to adopt and administer standards for the continuing education of those licensees. Existing law requires the board, in determining its continuing education requirements, to consider including a course in menopausal mental or physical health. This bill would delete that requirement of the board. The bill would require, beginning July 1, 2026, and until July 1, 2032, a qualifying physician and surgeon, as defined, who completes continuing medical education courses in perimenopause, menopause, and postmenopausal care to receive 2 hours of credit for each hour completed of that coursework, as specified. Existing law, the Osteopathic Act, provides for the licensure and regulation of osteopathic physicians and surgeons by the Osteopathic Medical Board of California and requires the board to adopt and administer standards for the continuing education of those licensees. This bill would require osteopathic physicians and surgeons to receive the same credit as described above for completed coursework relating to perimenopause, menopause, and postmenopausal care. (2) Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of the act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. Existing law sets forth specified coverage requirements for health care service plan contracts and health insurance policies. This bill would require a health care service plan contract or health insurance policy that covers outpatient prescription drugs, except as specified, that is issued, amended, or renewed on or after January 1, 2026, to include coverage for evaluation and treatment options for symptoms of perimenopause and menopause. The bill would require a health care service plan or health insurer to annually provide clinical care recommendations, as specified, for hormone therapy to all contracted primary care providers who treat individuals with perimenopause and menopause. Because a willful violation of these provisions by a health care service plan would be a crime, the bill would impose a state-mandated local program. (3) 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 establishes, under the Medi-Cal program, certain time and distance standards for specified Medi-Cal managed care covered services, consistent with federal regulations relating to network adequacy standards, to ensure that those services, including certain specialty care, are available and accessible to enrollees of Medi-Cal managed care plans in a timely manner. Existing law sets forth other timely access requirements for health care service plans and health insurers, including with regard to referrals to a specialist. Existing law establishes various health professions development programs, within the Department of Health Care Access and Information, for the promotion of education, training, and recruitment of health professionals to address workforce shortage and distribution needs. Existing law sets forth various provisions for the authorized use of telehealth in the delivery of health care services. This bill would, subject to an appropriation, require the California Health and Human Services Agency, in collaboration with the Department of Health Care Access and Information and the State Department of Health Care Services, to establish a demonstration project for a grant program. Under the bill, the grant program would be aimed at facilitating a telehealth and other virtual services specialty care network or networks that are designed to serve patients of safety-net providers consisting of qualifying providers, as defined. Under the bill, the purpose of the demonstration project would be to improve access to specialty care for Medi-Cal beneficiaries through development of a financially sustainable specialty care network or networks that are focused on serving the needs of the health care safety net. The bill would authorize the focus of the project to include increasing access to behavioral and maternal health services and additional specialties prioritized by the agency. The bill would state the intent of the Legislature that implementation of the demonstration project would facilitate compliance with any applicable network adequacy standards. The bill would require the agency to administer the grant program to award grant funds to one or more grantees based on an application process and by meeting specified conditions. The bill would require a grantee to use the funds to develop a network or networks by, among other things, providing health information technology and technical assistance to support both the specialists and any primary care provider care coordination, referral, or electronic consultations. The bill would require the agency to arrange an independent evaluation of the demonstration project. The bill would require the evaluation to examine the extent to which the project was successful in achieving certain objectives, including, among others, reducing structural barriers to access experienced by patients. The bill would require a grantee to report data and information to allow for monitoring and evaluation of the project. The bill would require the agency to ensure that lessons learned, recommendations, and best practices from the project are publicly disseminated to inform the development of a telehealth and specialty care network or networks to serve the needs of the health care safety net.
Existing law provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes the willful violation of its provisions a crime. Existing law also 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. For a health care service plan contract or health insurance policy issued, amended, or renewed on or after January 1, 2026, this bill would prohibit a health care service plan, health insurer, or pharmacy benefit manager from engaging in specified steering practices, including, among others, requiring an enrollee or insured to use a retail pharmacy for dispensing prescription oral medications, as specified, and imposing any requirements, conditions, or exclusions that discriminate against an in-network physician in connection with dispensing prescription oral medications. The bill would require a health care provider, physician's office, clinic, or infusion center to obtain consent from an enrollee or insured and disclose a good faith estimate of the enrollee's or insured's applicable cost-sharing amount before supplying or administering an injected or infused medication to an enrollee or insured, or sending an enrollee or insured to receive an injected or infused medication, if the setting or manner of administration is different than the setting or manner of administration for which the health care service plan, health insurer, or pharmacy benefit manager directed the enrollee or insured, as specified. Because a willful violation of these provisions 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 requires a health facility, clinic, physician's office, or office of a group practice that uses generative artificial intelligence to generate written or verbal patient communications pertaining to patient clinical information, as defined, to ensure that those communications include both (1) a disclaimer that indicates to the patient that a communication was generated by generative artificial intelligence, as specified, and (2) clear instructions describing how a patient may contact a human health care provider, employee, or other appropriate person. Existing law exempts from this requirement a communication read and reviewed by a human licensed or certified health care provider. This bill would require developers and deployers, as defined, of an artificial intelligence system that produces a prediction, classification, recommendation, evaluation, or analysis that aids decisionmaking related to diagnosis or treatment, known as a clinical decision support system, to make reasonable efforts to identify clinical decision support systems developed for use by deployers that are known or have a reasonably foreseeable risk for biased impacts resulting from deployment of the system in health programs or activities. The bill would require developers to make a statement describing the intended uses and known or reasonably foreseeable risks associated with the use of the clinical decision support system and certain documentation available to deployers, as specified. The bill would require developers to make reasonable efforts to mitigate known or reasonably foreseeable risk for biased impacts resulting from use of the clinical decision support system in health programs or activities. The bill would require deployers to regularly monitor clinical decision support systems and take reasonable and proportionate steps to mitigate known or reasonably foreseeable risk of biased impacts. The bill would specify that a person, partnership, state or local governmental agency, or corporation may be both a developer and a deployer.
Existing law establishes the Medi-Cal program, which is administered by the State Department of Health Care Services and under which qualified low-income individuals receive health care services, including federally qualified health center (FQHC) services as described by federal law. The Medi-Cal program is, in part, governed and funded by federal Medicaid program provisions. This bill would require each FQHC to have an annual mission spend ratio, as defined, of no less than 90% and would provide a methodology for calculation of that ratio, as specified, until the State Department of Public Health (department) has adopted a methodology for this purpose, with a goal of implementation of the latter methodology by January 1, 2028. By June 30, 2027, and annually thereafter by June 30, the bill would require each FQHC or its parent corporation to report to the department total revenues collected in a form to be determined by the department. The bill would require each report to include, among other things, one of certain Internal Revenue Service (IRS) forms. The bill would require each FQHC to submit an annual registration fee in an amount to be determined by the department and adjusted as necessary to fund these provisions. The bill would require the department to calculate and prepare a report of each FQHC's mission spend ratio no later than 90 days after the deadline for receipt of each FQHC's submission. The bill would require the department to conduct an audit of the financial information reported by FQHCs every 3 years, as specified. This bill would impose penalties for failure of an FQHC to comply with the above-described reporting and mission spend ratio requirements, including an administrative fine of $5,000 for a first violation and $10,000 for each subsequent month that an FQHC fails to submit an annual report. The bill would require those penalties to be deposited into the Mission Spend Ratio Penalty Account, which would be subject to appropriation by the Legislature, within the Special Deposit Fund. This bill would require an FQHC to abate the violation within 2 years after the department imposes an administrative penalty. The bill would prohibit the FQHC from being required to pay the penalty if it meets specified requirements within the abatement period, including reaching an agreement with the department on a plan to spend the total amount of the administrative penalty on mission-directed expenses within 2 years. The bill would require the department to conduct annual audits of any FQHC that has reached an agreement with the department. If the department determines that an FQHC is not in substantial compliance with the agreed-upon plan, the bill would require the FQHC to pay the imposed administrative penalty within 2 working days and to pay other costs, as specified. The bill would provide that appeals run concurrently with the abatement period. This bill would authorize an FQHC to apply to the department for a waiver providing a temporary pause of the above-described reporting and mission spend ratio requirements or for an alternative mission spend ratio requirement on the basis of unexpected or exceptional circumstances or the FQHC's economic condition. The bill would provide that a waiver or alternative mission spend ratio is for a term of one calendar year. The bill would prescribe various types of information to be reported by an FQHC to obtain a waiver or alternative mission spend ratio. The bill would authorize the department to provide an alternative mission spend ratio to an FQHC to adjust, exclude, or otherwise account for imminently planned capital improvement, as specified, if the assessed penalty will result in the inability for the planned capital improvement to move forward during the next calendar year. The bill would authorize an FQHC to apply to renew a waiver or alternative mission spend ratio at any time no fewer than 180 days before the expiration of the existing waiver or alternative mission spend ratio. This bill would make its provisions inapplicable to an FQHC or FQHC look-alike that is owned or operated by a political subdivision of the state or by a tribe or tribal organization or urban Indian organization receiving certain federal funding, as specified, or to an FQHC or FQHC look-alike participating in a bona fide labor-management cooperation committee. The bill would require the department to adopt all regulations necessary to implement these provisions and would authorize the department to implement, interpret, or make specific these provisions, in whole or in part, by means of information notices, all-county letters, or other similar instructions without taking regulatory action. The bill would make its provisions severable. The bill would define various terms for purposes of these provisions.
Existing law establishes various healing arts boards within the Department of Consumer Affairs that license and regulate various healing arts licensees. Existing laws, including, among others, the Medical Practice Act and the Dental Practice Act, make it a crime for a person who is not licensed as a specified health care professional to use certain words, letters, and phrases or any other terms that imply that they are authorized to practice that profession. Existing law requires, with certain exemptions, a health facility, clinic, physician's office, or office of a group practice that uses generative artificial intelligence, as defined, to generate written or verbal patient communications pertaining to patient clinical information, as defined, to ensure that those communications include both (1) a disclaimer that indicates to the patient that a communication was generated by generative artificial intelligence, as specified, and (2) clear instructions describing how a patient may contact a human health care provider, employee, or other appropriate person. Existing law provides that a violation of these provisions by a physician shall be subject to the jurisdiction of the Medical Board of California or the Osteopathic Medical Board of California, as appropriate. This bill would make provisions of law that prohibit the use of specified terms, letters, or phrases to falsely indicate or imply possession of a license or certificate to practice a health care profession, as defined, enforceable against an entity who develops or deploys artificial intelligence (AI) or generative artificial intelligence (GenAI) technology that uses one or more of those terms, letters, or phrases in its advertising or functionality. The bill would prohibit the use by AI or GenAI technology of certain terms, letters, or phrases that indicate or imply that the advice, care, reports, or assessments being provided through AI or GenAI is being provided by a natural person with the appropriated health care license or certificate. This bill would make a violation of these provisions subject to the jurisdiction of the appropriate health care profession board, and would make each use of a prohibited term, letter, or phrase punishable as a separate violation. By expanding the scope of existing crimes, this 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.
