1367.04.
(a) (1) Not later than January 1, 2006, the department shall develop and adopt regulations establishing standards and requirements to provide health care service plan enrollees with appropriate access to language assistance in obtaining health care services. The department shall also develop and adopt regulations establishing standards and requirements for a health care service plan to collect accurate and complete member-level demographic data on its enrollee population to more effectively measure and reduce health disparities.(2) The department shall revise the regulations adopted pursuant to
subdivision (a) no later than July 1, 2023. 2024.
(b) In developing the revised regulations, the department shall require every health care service plan and specialized health care service plan to assess the individual cultural, linguistic, and health-related social needs of the enrollee population, excluding Medi-Cal beneficiaries, for the purpose of identifying and addressing health disparities, improving health care quality and outcomes, addressing population health, and to provide for translation and interpretation for medical services, as indicated.
The individual cultural, linguistic, and health-related social needs of the enrollee population shall be identified based on accurate and complete member-level demographic data that is self-reported by the enrollee. A health care service plan that participates in the Healthy Families Program may assess the Healthy Families Program enrollee population separately from the remainder of its enrollee population for purposes of subparagraph (A) of paragraph (1) of subdivision (c). A health care service plan that chooses to separate its Healthy Families Program enrollment from the remainder of its enrollee population shall treat the Healthy Families Program population separately for purposes of determining whether subparagraph (A) of paragraph (1) of subdivision (c) is applicable, and shall also treat the Healthy Families Program population separately for purposes of applying the percentage
and numerical thresholds in subparagraph (A) of paragraph (1) of subdivision (c).
(c) The regulations shall include the following:
(1) Requirements for the translation of vital documents that include the following:
(A) A requirement that all vital documents, as defined pursuant to subparagraph (B), be translated into an indicated language, as follows:
(i) A health care service plan with an enrollment of 1,000,000 or more shall translate vital documents into the top two languages other than English as determined by the needs assessment as required by this subdivision and any additional languages when 0.75 percent or 15,000 of the enrollee population, whichever
number is less, excluding Medi-Cal enrollment and treating Healthy Families Program enrollment separately indicates in the needs assessment as required by this subdivision a preference for written materials in that language.
(ii) A health care service plan with an enrollment of 300,000 or more but less than 1,000,000 shall translate vital documents into the top one language other than English as determined by the needs assessment as required by this subdivision and any additional languages when 1 percent or 6,000 of the enrollee population, whichever number is less, excluding Medi-Cal enrollment and treating Healthy Families Program enrollment separately indicates in the needs assessment as required by this subdivision a preference for written materials in that language.
(iii) A health care service plan with an enrollment of less than 300,000 shall translate vital documents into a language other than English when 3,000 or more or 5 percent of the enrollee population, whichever number is less, excluding Medi-Cal enrollment and treating Healthy Families Program enrollment separately indicates in the needs assessment as required by this subdivision a preference for written materials in that language.
(B) Specification of vital documents produced by the plan that are required to be translated. The specification of vital documents shall not exceed that of the United States Department of Health and Human Services (HHS) Office for Civil Rights (OCR) Policy Guidance (65 Federal Register 52762 (August 30, 2000)), but shall include all of the following:
(i) Applications.
(ii) Consent forms.
(iii) Letters containing important information regarding eligibility and participation criteria.
(iv) Notices pertaining to the denial, reduction, modification, or termination of services and benefits, and the right to file a grievance or appeal.
(v) Notices advising limited-English-proficient persons of the availability of free language assistance and other outreach materials that are provided to enrollees.
(vi) Translated documents shall not include a health care service plan’s explanation of benefits or similar claim processing information that is sent to enrollees, unless
the document requires a response by the enrollee.
(C) (i) For those documents described in subparagraph (B) that are not standardized but contain enrollee specific information, health care service plans shall not be required to translate the documents into the threshold languages identified by the needs assessment as required by this subdivision, but rather shall include with the documents a written notice of the availability of interpretation services in the threshold languages identified by the needs assessment as required by this subdivision. A health care service plan subject to the requirements in Section 1367.042 shall also include with the documents a written notice of the availability of interpretation services in the top 15 languages spoken by limited-English-proficient (LEP) individuals in California as determined
by the State Department of Health Care Services.
(ii) Upon request, the enrollee shall receive a written translation of the documents described in clause (i). The health care service plan shall have up to, but not to exceed, 21 days to comply with the enrollee’s request for a written translation. If an enrollee requests a translated document, all timeframes and deadline requirements related to the document that apply to the health care service plan and enrollees under the provisions of this chapter and under any regulations adopted pursuant to this chapter shall begin to run upon the health care service plan’s issuance of the translated document.
(iii) For grievances that require expedited plan review and response in accordance with subdivision (b) of Section 1368.01, the health
care service plan may satisfy this requirement by providing notice of the availability and access to oral interpretation services.
(D) A requirement that health care service plans advise limited-English-proficient enrollees of the availability of interpreter services.
(2) Standards to ensure the quality and accuracy of the written translations and that a translated document meets the same standards required for the English language version of the document. The English language documents shall determine the rights and obligations of the parties, and the translated documents shall be admissible in evidence only if there is a dispute regarding a substantial difference in the material terms and conditions of the English language document and the translated document.
(3) (A) Requirements for surveying and assessing the language
preferences, and cultural, linguistic, and health-related social needs of health care service plan and specialized health care service plan enrollees at the individual enrollee level within one year of the effective date of the regulations, which shall ensure health care service plans utilize survey best practice methods for member-level data collection and reporting compatible with identifying disparities in access, utilization, quality and outcomes for smaller populations, including, but not limited to, Asian, Native Hawaiian and Pacific Islander, American Indian or Alaska Native, Lesbian, Gay, Bisexual,
Transgender, and Queer+ populations, persons with disabilities, including cognitive and functional, as well as accommodation needs, and other historically disadvantaged populations. These best practices include, but are not limited to, health care service plan provider and staff training on data collection, its legality and uses, and how to work with patients to improve comfort levels in sharing this data, oversampling, and collection of self-reported demographic data at the individual encounter level, as well as through existing enrollment and renewal processes. Health care service plans shall supplement their cultural, linguistic, and population needs assessments through regional surveys, enrollee meetings, and listening sessions, subscriber newsletters, or other mailings, and shall update the needs assessment, demographic profile, and language translation requirements every year.
three years.
(B) In implementing this section, the department shall do all of the following:
(i) Require health care service plans to obtain National Committee for Quality Assurance Health Equity Accreditation.
Accreditation, and require specialized health care service plans to obtain an appropriate accreditation. If an appropriate accreditation is not available for a specialized health care service plan, the plan shall develop and implement an annual quality improvement plan that includes specific health equity and disparities reduction goals and activities until an appropriate accreditation is available and the plan obtains that accreditation. For a specialized dental plan, the annual quality improvement plan shall use Dental Quality Alliance or other nationally endorsed dental quality measures.
(ii) Establish standardized categories for the collection and reporting of self-reported demographic and health-related social needs data, including, but not limited to, data by race, ethnicity, language, sexual orientation and gender identity, and disability. Standardized
categories shall take into account federal standards, including
the most recent versions of the Office of Management and Budget (OMB) revised Standards for the Classification of Federal Data on Race and Ethnicity, the Office of the National Coordinator (ONC) for Health Information Technology certification standards (2015), and United States Core Data for Interoperability version 2 and 3 standards for the federal Centers for Medicare and Medicaid Services (CMS) Office of Minority Health (OMH) publications “Guide to Developing a
Language Access Plan” and “Building an Organizational Response to Health Disparities.” The department shall ensure standards align with California’s health information exchange and California’s Health Care Payments Data (HPD) Program. The department shall finalize these standards by July 1, 2023, 2024, and plans shall be required to utilize these standards by January 1, 2024. 2025.
(iii) Establish To
the extend federal funds are available, establish a program to provide technical assistance and other support to plans and providers, including education and training on self-identified demographic data collection and the collection of health-related social needs data at the encounter level. The department shall fund the program by pooling state and federal funds, including from fines on health care service plans that do not meet annual quality and equity performance standards.
(4) Requirements for individual enrollee access to interpretation services that include the following:
(A) A requirement that an interpreter meets, at a minimum, all of the following qualifications:
(i) Demonstrated proficiency
in both English and the target language.
(ii) Knowledge in both English and the target language of health care terminology and concepts relevant to health care delivery systems.
(iii) Adheres to generally accepted interpreter ethics principles, including client confidentiality.
(B) A requirement that the enrollee with limited English proficiency shall not be required to provide their own interpreter or rely on a staff member who does not meet the qualifications described in subparagraph (A) to communicate directly with the limited-English-proficient enrollee.
(C) A requirement that the enrollee with limited English proficiency shall not be required to rely
on an adult or minor child accompanying the enrollee to interpret or facilitate communication except under either of the following circumstances:
(i) In an emergency, as described in Section 1317.1, if a qualified interpreter is not immediately available for the enrollee with limited English proficiency.
(ii) If the individual with limited English proficiency specifically requests that the accompanying adult interpret or facilitate communication, the accompanying adult agrees to provide that assistance, and reliance on that accompanying adult for that assistance is appropriate under the circumstances.
(5) Standards to ensure the quality and timeliness of oral interpretation services provided by health care service
plans.
(d) In developing the regulations, standards, and requirements, the department shall consider the following:
(1) Publications and standards issued by federal agencies, such as the Culturally and Linguistically Appropriate Services in Health Care issued by the United States Department of Health and Human Services Office of Minority Health in December 2000, the United States Department of Health and Human Services Office for Civil Rights Policy Guidance (65 Federal Register 52762 (August 30, 2000)), OMB revised Standards for the Classification of Federal Data on Race and Ethnicity, the ONC Health Information Technology issued standards for demographic data collection in certified health IT (2015), and United States Core Data for Interoperability version 2 standards
CMS OMH publications, “Guide to Developing a Language Access Plan” and “Building an Organizational Response to Health Disparities.”
(2) Other cultural and linguistic requirements under state programs, such as Medi-Cal Managed Care Policy Letters, cultural and linguistic requirements imposed by the State Department of Health Care Services on health care service plans that contract to provide Medi-Cal managed care services, and cultural and linguistic requirements imposed by the Managed Risk Medical Insurance Board on health care service plans that contract to provide services in the Healthy Families Program.
(3) Standards adopted by other states pertaining to language assistance requirements for health care service plans.
(4) Standards established by California or nationally recognized accrediting, certifying, or licensing organizations and medical and health care interpreter professional associations regarding interpretation services.
(5) Publications, guidelines, reports, and recommendations issued by state agencies or advisory committees, such as the report card to the public on the comparative performance of plans and reports on cultural and linguistic services issued by the Center for Data Insights and Innovation and the report to the Legislature from the Task Force on Culturally and Linguistically Competent Physicians and Dentists established by former Section 852 of the Business and Professions Code.
(6) Examples of best practices relating to language assistance services by
health care providers and health care service plans, including existing practices.
(7) Information gathered from complaints to the HMO Helpline and consumer assistance centers regarding language assistance services.
(8) The cost of compliance and the availability of translation and interpretation services and professionals.
(9) Flexibility to accommodate variations in plan networks and method of service delivery. The department shall allow for health care service plan flexibility in determining compliance with the standards for oral and written interpretation services.
(e) The department shall work to ensure that the biennial reports required by this section,
and the data collected for those reports, are consistent with reports required by government-sponsored programs and do not require duplicative or conflicting data collection or reporting.
(f) The department shall seek public input from a wide range of interested parties through advisory bodies established by the director.
(g) A contract between a health care service plan and a health care provider shall require compliance with the standards developed under this section. In furtherance of this section, the contract shall require providers to cooperate with the plan by providing any information necessary to assess compliance.
(h) The department shall report biennially to the Legislature and advisory bodies established
by the director regarding plan compliance with the standards, including results of compliance audits made in conjunction with other audits and reviews. The reported information shall also be included in the publication required under subparagraph (B) of paragraph (1) of subdivision (b) of Section 136000. The department shall also utilize the reported information to make recommendations for changes that further enhance standards pursuant to this section. The department may also delay or otherwise phase-in implementation of standards and requirements in recognition of costs and availability of translation and interpretation services and professionals.
(i) (1) Except for contracts with the State Department of Health Care Services Medi-Cal program, the standards developed under this section shall be considered the minimum
required for compliance.
(2) The regulations shall provide that a health care service plan is in compliance if the plan is required to meet the same or similar standards by the Medi-Cal program, either by contract or state law, if the standards provide as much access to cultural and linguistic services as the standards established by this section for an equal or higher number of enrollees and therefore meet or exceed the standards of the regulations established pursuant to this section, and the department determines that the health care service plan is in compliance with the standards required by the Medi-Cal program. To meet this requirement, the department shall not be required to perform individual audits. The department shall, to the extent feasible, rely on audits, reports, or other oversight and enforcement methods used by the
State Department of Health Care Services.
(3) The determination pursuant to paragraph (2) shall only apply to the enrollees covered by the Medi-Cal program standards. A health care service plan subject to paragraph (2) shall comply with the standards established by this section with regard to enrollees not covered by the Medi-Cal program.
(j) This section does not prohibit a government purchaser from including in their contracts additional translation or interpretation requirements, to meet linguistic or cultural needs, beyond those set forth pursuant to this section.
(k) For purposes of this section:
(1) “Demographic profile” means data specific to an individual enrollee that is self-reported by the enrollee.
(1)
(2) “Disparity” means variation in disease occurrence, including communicable diseases and chronic conditions, as well as health care access, utilization, and outcomes between population groups by age, geographic area, primary language, race, ethnicity, sex, gender identity, sexual orientation, and disability status.
(2)
(3) “Health-related social needs” means health-harming conditions such as food insecurity, housing instability, and lack of transportation.