Delivery of Care

Chapter 6. Delivery of Care

140600.

(a) All health care providers licensed or accredited to practice in California may participate in the system.
(b) No health care provider whose license or accreditation is suspended or revoked may participate in the system.
(c) If a health care provider is on probation, the licensing or the accrediting agency shall monitor the health care provider in question, pursuant to applicable California law. The licensing or accrediting agency shall report to the chief medical officer at intervals established by the chief medical officer, on the status of health care providers who are on probation and on measures undertaken to assist health care providers to return to practice and to resolve complaints made by patients.
(d) Health care providers may accept eligible persons for care according to the health care provider’s ability to provide services needed by the patient and according to the number of patients a health care provider can treat without compromising safety and care quality. A health care provider may accept patients in the order of time of application.
(e) A health care provider shall not refuse to care for a patient solely on any basis that is specified in the prohibition of employment discrimination contained in the Fair Employment and Housing Act (Part 2.8 (commencing with Section 12900) of Division 3 of Title 2 of the Government Code).
(f) Choice of health care provider:
(1) Persons eligible for health care services under this division may choose a primary care provider.
(A) Primary care providers include family practitioners, general practitioners, internists and pediatricians, nurse practitioners and physician assistants practicing under supervision as defined in California codes, and doctors of osteopathy licensed to practice as general doctors.
(B) Women may choose an obstetrician-gynecologist, in addition to a primary care provider.
(2) Persons who choose to enroll with integrated health care delivery systems, group medical practices, or essential community providers that offer comprehensive services, shall retain membership for at least one year after an initial three-month evaluation period during which time they may withdraw for any reason.
(A) The three-month period shall commence on the date when an enrollee first sees a primary care provider.
(B) Persons who want to withdraw after the initial three-month period shall request a withdrawal pursuant to dispute resolution procedures established by the commissioner and may request assistance from the patient advocate in the dispute process. The dispute shall be resolved in a timely fashion and shall have no adverse effect on the care a patient receives.
(3) Persons needing to change primary care providers because of health care needs that their primary care provider cannot meet may change primary care providers at any time.

140601.

(a) Primary care providers shall coordinate the care a patient receives or shall ensure that a patient’s care is coordinated.
(b) (1) Patients shall have a referral from their primary care provider, or from a health care provider rendering care to them in the emergency room or other accredited emergency setting, or from a health care provider treating a patient for an emergency condition in any setting, or from their obstetrician-gynecologist, to see a physician or nonphysician specialist whose services are covered by this division, unless the patient agrees to assume the costs of care or pay a copayment, if implemented by the commissioner pursuant to Section 140504. A referral shall not be required to see a dentist or to see an ophthalmologist or optometrist for a routine vision examination.
(2) Referrals shall be based on the medical needs of the patient and on guidelines, which shall be established by the chief medical officer to support clinical decisionmaking.
(3) Referrals shall not be restricted or provided solely because of financial considerations. The chief medical officer shall monitor referral patterns and intervene as necessary to assure that referrals are neither restricted nor provided solely because of financial considerations.
(4) For the first six months of the system’s operation, no specialist referral or copayment shall be required for patients who had been receiving care from a specialist prior to the initiation of the system. Beginning with the seventh month of the system’s operation, all patients shall be required to obtain a referral from a primary or emergency care provider for specialty care if the care is to be paid for by the system. No referral is required if a patient pays the full cost of the specialty care and the specialist accepts that payment arrangement.
(5) Where referral processes are in place prior to the initiation of the system, the chief medical officer shall review the referral processes to assure that they meet the system’s standards for care quality and shall assure needed changes are implemented so that all Californians receive the same standards of care quality and access to specialty care.
(6) A specialist may serve as the primary care provider if the patient and the provider agree to this arrangement and if the provider agrees to coordinate the patient’s care or to ensure that the care the patient receives is coordinated.
(7) The commissioner shall establish or ensure the establishment of a computerized referral registry to facilitate the referral process and to allow a specialist and a patient to easily determine whether a referral has been made pursuant to this division.
(8) A patient may appeal the denial of a referral through the dispute resolution procedures established by the commissioner and may request the assistance of the patient advocate during the dispute resolution process.

140602.

(a) The purpose of the Office of Health Planning is to plan for the short- and long-term health care needs of the population pursuant to the health care and finance standards established by the commissioner and by this division.
(b) The office shall be headed by a director appointed by the commissioner. The director shall serve pursuant to provisions of subdivisions (c), (d), and (e) of Section 140100 and subdivisions (j) and (k) of Section 140101.
(c) The director shall do all the following:
(1) Administer all aspects of the Office of Health Planning.
(2) Serve on the Healthcare Policy Board.
(3) Establish performance criteria in measurable terms for health care goals in consultation with the chief medical officer, the regional planning directors, and regional medical officers and others with experience in health care outcomes measurement and evaluation.
(4) Evaluate the effectiveness of performance criteria in accurately measuring quality of care, administration, and planning.
(5) Assist the health care regions to develop operating and capital requests pursuant to health care and financial guidelines established by the commissioner and by this division. In assisting regions, the director shall do all of the following:
(A) Identify medically underserved areas and health care service and asset shortages.
(B) Identify disparities in health outcomes.
(C) Establish conventions for the definition, collection, storage, analysis, and transmission of data for use by the system.
(D) Establish electronic systems that support dissemination of information to health care providers and patients about integrated health network and integrated health care delivery systems and community-based health care resources.
(E) Support establishment of comprehensive health care databases using uniform methodology that is compatible among the regions and between the regions and the agency.
(F) Provide information to support effective regional planning and innovation.
(G) Provide information to support interregional planning, including planning for access to specialized centers that perform a high volume of procedures for conditions requiring highly specialized treatments, including emergency and trauma, and other interregional access to needed care, and planning for coordinated interregional capital investment.
(H) Provide information for, and participate in, earthquake retrofit planning.
(I) Evaluate regional budget requests and make recommendations to the commissioner about regional revenue allocations.
(6) Estimate the health care workforce required to meet the health care needs of the population pursuant to the standards and goals established by the commissioner, the costs of providing the needed workforce, and, in collaboration with regional planners, educational institutions, the Governor, and the Legislature, develop short- and long-term plans to meet those needs, including a plan to finance needed training.
(7) Estimate the number and types of health facilities required to meet the short- and long-term health care needs of the population and the projected costs of needed facilities. In collaboration with the commissioner, regional planning directors and regional medical officers, the chief medical officer, the Governor, and the Legislature, develop plans to finance and build needed facilities.

140603.

The Technology Advisory Group shall explore the feasibility and the value to the health of the population of the following electronic initiatives:
(a) Establish integrated statewide health care databases to support health care planning and determine which databases should be established on a statewide basis and which should be established on a regional basis.
(b) Assure that databases have uniform methodology and formats that are compatible among the regions and between the regions and the agency.
(c) Establish mandatory database reporting requirements and penalties for noncompliance. Monitor the effectiveness of reporting and make needed improvements.
(d) Establish means for anonymous reporting to the chief medical officer and regional medical officers of medical errors and other related problems, and for anonymous reporting to the commissioner and regional planning directors of problems related to ineffective management, and establish guidelines for the protection of persons coming forward to report these problems.
(e) In collaboration with the chief medical officer, the Office of Patient Advocacy, and regional patient advocates, investigate the costs and benefits of electronic and online scheduling systems and means of health care provider-patient communication that allow for electronic visits, and make recommendations to the chief medical officer regarding the use of these concepts in the system.
(f) In collaboration with the chief medical officer, establish electronic systems and other means that support the use of standards of care based on clinical efficacy to guide clinical decisionmaking by all who provide services in the system.
(g) In collaboration with the chief medical officer, support the development of disease management programs and their use in the system.
(h) Establish electronic initiatives that reduce administration costs.
(i) Collaborate with the chief medical officer and regional medical officers to assure the development of software systems that link clinical guidelines to individual patient conditions, and guide clinicians through diagnosis and treatment algorithms derived from research based on clinical efficacy and best medical practices.
(j) Collaborate with the chief medical officer and regional medical officers to assure the development of software systems that offer health care providers access to guidelines that are appropriate for their specialty and that include current information on prevention and treatment of disease.
(k) In collaboration with the Partnerships for Health and regional medical officers, establish Web-based, patient-centered information systems that assist people to promote and maintain health and provide information on health conditions and recent developments in treatment.
(l) Establish electronic systems and other means to provide patients with easily understandable information about the performance of health care providers. This shall include, but not be limited to, information about the experience that health care providers have in the field or fields in which they deliver care, the number of years they have practiced in their field and, in the case of medical and surgical procedures, the number of procedures they have performed in their area or areas of specialization.
(m) Establish electronic systems that facilitate health care provider continuing medical education that meets licensure requirements.
(n) Recommend to the commissioner means to link health care research with the goals and priorities of the system.

140604.

(a) The Director of the Office of Health Planning shall establish standards for culturally and linguistically competent care, which shall include, but not be limited to, all of the following:
(1) State Department of Health Care Services and the Department of Managed Care guidelines for culturally and linguistically sensitive care.
(2) Medi-Cal Managed Care Division (MMCD) Policy Letters 99-01 to 99-04 and MMCD All Plan Letter 99005.
(3) Subchapter 5 of the Civil Rights Act of 1964 (42 U.S.C. Sec. 2000d).
(4) United States Department of Health and Human Services’ Office of Civil Rights; Title VI of the Civil Rights Act of 1964; Policy Guidance on Prohibition Against National Origin Discrimination as It Affects Persons with Limited English Proficiency (February 1, 2002).

(5) United States Department of Health and Human Services’ Office of Minority Health; National Standards on Culturally and Linguistically Appropriate Services (CLAS) in Health Care–Final Report (December 22, 2000).
(b) The director shall annually evaluate the effectiveness of standards for culturally and linguistically competent care and make recommendations to the commissioner, the Office of Patient Advocacy, and the chief medical officer for needed improvements. In evaluating the standards for culturally and linguistically sensitive care, the director shall establish a process to receive concerns and comments from consumers.
(c) The director shall pursue available federal financial participation for the provision of a language services program that supports the system’s goals.

140605.

(a) Within the agency, the commissioner shall establish the Office of Health Care Quality.
(b) The office shall be headed by the chief medical officer who shall serve pursuant to provisions of subdivisions (c), (d), and (e) of Section 140100 and subdivisions (j) and (k) of Section 140101 regarding qualifications for appointed officers of the system.
(c) The purpose of the Office of Health Care Quality is the following:
(1) Support the delivery of high quality, coordinated health care services that enhance health; prevent illness, disease, and disability; slow the progression of chronic diseases; and improve personal health management.
(2) Promote efficient care delivery.
(3) Establish processes for measuring, monitoring, and evaluating the quality of care delivered in the system, including the performance of individual health care providers.
(4) Establish means to make changes needed to improve health care quality, including innovative programs that improve quality.
(5) Promote patient, health care provider, and employer satisfaction with the system.
(6) Assist regional planning directors and medical officers in the development and evaluation of regional operating and capital budget requests.

140606.

(a) In supporting the goals of the Office of Health Care Quality, the chief medical officer shall do all of the following:
(1) Administer all aspects of the office.    (2) Serve on the Healthcare Policy Board.
(3) Collaborate with regional medical officers, regional planning directors, health care providers, consumers, the Director of the Office of Health Planning, the patient advocate of the Office of Patient Advocacy, and directors of Partnerships for Health to develop community-based networks of solo providers, small group practices, essential community providers, and providers of patient care support services in order to offer comprehensive, multidisciplinary, coordinated services to patients.
(4) Establish standards of care based on clinical efficacy for the system that shall serve as guidelines to support health care providers in the delivery of high quality care. Standards shall be based on the best evidence available at the time and shall be continually updated. Standards are intended to support the clinical judgment of individual health care providers, not to replace it, and to support clinical decisions based on the needs of individual patients.
(b) In establishing standards, the chief medical officer shall do all of the following:
(1) Draw on existing standards established by California health care institutions, on peer-created standards, and on standards developed by other institutions that have had a positive impact on care quality, such as the Centers for Disease Control and Prevention, the National Quality Forum, and the Agency for Health Care Quality and Research.
(2) Collaborate with regional medical officers in establishing regional goals, priorities, and a timetable for implementation of standards of care.
(3) Assure a process for patients to provide their views on standards of care to the patient advocate of the Office of Patient Advocacy who shall report those views to the chief medical officer.
(4) Collaborate with the Director of the Office of Health Planning and regional medical officers to support the development of computer software systems that link clinical guidelines to individual patient conditions, guide clinicians through diagnosis and treatment algorithms based on research and best medical practices based on clinical efficacy, offer access to guidelines appropriate to each medical specialty and to current information on disease prevention and treatment, and that support continuing medical education.
(5) Where referral processes for access to specialty care are in place prior to the initiation of the system, the chief medical officer shall review the referral processes to assure that they meet the system’s standards for care quality and shall assure that needed changes are implemented so that all Californians receive the same standards of care quality.
(c) In collaboration with the Director of the Office of Health Planning and regional medical officers, the chief medical officer shall implement means to measure and monitor the quality of care delivered in the system. Monitoring systems shall include, but shall not be limited to, peer and patient performance reviews.
(d) The chief medical officer shall establish means to support individual health care providers and health systems in correcting quality of care problems, including timeframes for making needed improvements and means to evaluate the effectiveness of interventions.
(e) In collaboration with regional medical officers, regional planning directors, and the Director of the Office of Health Planning, the chief medical officer shall establish means to identify medical errors and their causes and develop plans to prevent them. Means shall include a process for anonymous reporting of errors and guidelines to protect those who report the errors against recrimination, including job demotion, promotion discrimination, or job loss.
(f) The chief medical officer shall convene an annual statewide conference to discuss medical errors that occurred during the year, their causes, means to prevent errors, and the effectiveness of efforts to decrease errors.
(g) The chief medical officer shall recommend to the commissioner a benefits package based on clinical efficacy for the system, including priorities for needed benefit improvements. In making recommendations, the chief medical officer shall do all of the following:
(1) Identify safe and effective treatments.
(2) Evaluate and draw on existing benefit packages.
(3) Receive comments and recommendations from health care providers about benefits that meet the needs of their patients.
(4) Receive comments and recommendations made directly by patients or indirectly through the Office of Patient Advocacy.
(5) Identify and recommend to the commissioner and the Healthcare Policy Board innovative approaches to health promotion, disease and injury prevention, education, research, and care delivery for possible inclusion in the benefit package.
(6) Identify complementary and alternative modalities that have been shown by the National Institutes of Health, Division of Complementary and Alternative Medicine to be safe and effective for possible inclusion as covered benefits.
(7) Recommend to the commissioner and update as appropriate, pharmaceutical and durable and nondurable medical equipment formularies based on clinical efficacy. In establishing the formularies, the chief medical officer shall establish a Pharmacy and Therapeutics Committee composed of pharmacy and health care providers, representatives of health facilities and organizations having system formularies in place at the time the system is implemented, and other experts that shall do all the following:
(A) Identify safe and effective pharmaceutical agents for use in the system.
(B) Draw on existing standards and formularies.
(C) Identify experimental drugs and drug treatment protocols for possible inclusion in the formulary.
(D) Review formularies in a timely fashion to ensure that safe and effective drugs are available and that unsafe drugs are removed from use.
(E) Assure the timely dissemination of information needed to prescribe safely and effectively to all California health care providers and the development and utilization of electronic dispensing systems that decrease pharmaceutical dispensing errors.
(8) Establish standards and criteria and a process for health care providers to seek authorization for prescribing pharmaceutical agents and durable and nondurable medical equipment that are not included in the system’s formulary. No standard or criteria shall impose an undue administrative burden on patients or health care providers, including pharmacies and pharmacists, and none shall delay care a patient needs.
(9) Develop standards and criteria and a process for health care providers to request authorization for services and treatments, including experimental treatments that are not included in the system’ s benefit package.
(A) Where such processes are in place when the system is initiated, the chief medical officer shall review those processes to assure that they meet the system’s standards for care quality and shall assure that needed changes are implemented so that all Californians receive the same standards of care quality.
(B) No standard or criteria shall impose an undue administrative burden on a health care provider or a patient and none shall delay the care a patient needs.
(10) In collaboration with the Director of the Office of Health Planning, regional planning directors and regional medical officers, identify on a regional basis appropriate ratios of general medical providers to specialty medical providers and appropriate ratios of medical providers to patients in order to meet the health care needs of the population and the goals of the system.
(11) Recommend to the commissioner and to the Payments Board, financial and nonfinancial incentives and other means to achieve recommended provider ratios.
(12) Collaborate with the Director of the Office of Health Planning and regional medical officers and patient advocates in the development of electronic initiatives, pursuant to Section 140603.
(13) Collaborate with the commissioner, the regional medical officers, and the directors of the Payments Board and the Healthcare Fund to formulate a health care provider reimbursement model that promotes the delivery of coordinated, high quality health care services in all sectors of the system and creates financial and other incentives for the delivery of high quality health care.
(14) Establish or assure the establishment of continuing medical education programs about advances in the delivery of high quality health care.
(15) Annually report to the commissioner, the Healthcare Policy Board, and the public on the quality of health care delivered in the system, including improvements that have been made and problems that have been identified during the year, goals for care improvement in the coming year, and plans to meet these goals.
(h) No person working within the agency or a member of the Pharmacy and Therapeutics Committee or serving as a consultant to the agency or to the Pharmacy and Therapeutics Committee, may receive fees or remuneration of any kind from a pharmaceutical company.

140607.

(a) The patient advocate of the Office of Patient Advocacy, in collaboration with the chief medical officer, the regional patient advocates, medical officers, and planning directors shall establish a program in the agency and in each region called the Partnerships for Health.
(b) The purpose of the Partnerships for Health is to improve health through community health initiatives, to support the development of innovative means to improve health care quality, to promote efficient coordinated care delivery, and to educate the public about the following:
(1) Personal maintenance of health.
(2) Prevention of disease.
(3) Improvement in communication between patients and providers.
(4) Improving quality of care.
(c) The patient advocate shall work with the community and health care providers in proposing Partnerships for Health projects and in developing project budget requests that shall be included in the regional budget request to the commissioner.
(d) In developing educational programs, the Partnerships for Health shall collaborate with educators in the region.
(e) Partnerships for Health shall support the coordination of system and public health programs.

140610.

(a) The patient advocate of the Office of Patient Advocacy, in consultation with the chief medical officer, shall establish a grievance system for all grievances involving the delay, denial, or modification of health care services. The patient advocate shall do all of the following with regard to the grievance regarding delay, denial, or modification of health care services:
(1) Establish and maintain a grievance system approved by the commissioner under which enrollees of the system may submit their grievances to the system. The system shall provide reasonable procedures that shall ensure adequate consideration of enrollee grievances and rectification when appropriate.
(2) Inform enrollees upon enrollment in the system and annually hereafter of the procedure for processing and resolving grievances. The information shall include the location and telephone number where grievances may be submitted.
(3) Provide printed and electronic access for enrollees who wish to register grievances. The forms used by the system shall be approved by the commissioner in advance as to format.
(4) (A) Provide for a written acknowledgment within five calendar days of the receipt of a grievance. Grievances received by telephone, by facsimile, by e-mail, or online through the system’s Internet Web site that are resolved by the next business day following receipt are exempt from the requirements of this subparagraph and paragraph
(5). The acknowledgment shall advise the complainant of the following:
(i) That the grievance has been received.
(ii) The date of receipt.
(iii) The name, telephone number, and address of the system representative who may be contacted about the grievance.
(B) The patient advocate shall maintain a log of all grievances. The log shall be periodically reviewed by the patient advocate and shall include the following information for each complaint:
(i) The date of the call.
(ii) The name of the enrollee.
(iii) The enrollee’s system identification number.
(iv) The nature of the grievance.
(v) The nature of the resolution.
(vi) The name of the system representative who took the call and resolved the grievance.
(5) Provide enrollees of the system with written responses to grievances, with a clear and concise explanation of the reasons for the system’s response. The system response shall describe the criteria used and the clinical reasons for its decision, including all criteria and clinical reasons related to medical necessity.
(6) Keep in its files copies of all grievances, and the responses thereto, for a period of five years.
(7) Establish and maintain an Internet Web site that shall provide an online form that enrollees of the system can use to file with a grievance online.
(b) In any case determined by the patient advocate to be a case involving an imminent and serious threat to the health of the enrollee, including, but not limited to, severe pain or the potential loss of life, limb, or major bodily function, or in any other case where the patient advocate determines that an earlier review is warranted, an enrollee shall   not be required to complete the grievance process.
(c) If the enrollee is a minor, or is incompetent or incapacitated, the parent, guardian, conservator, relative, or other designee of the enrollee, as appropriate, may submit the grievance to the patient advocate as a designated agent of the enrollee. Further, a health care provider may join with, or otherwise assist, an enrollee, or the agent, to submit the grievance to the patient advocate. In addition, following submission of the grievance to the patient advocate, the enrollee, or the agent, may authorize the health care provider to assist, including advocating on behalf of the enrollee. For purposes of this section, a “relative” includes the parent, stepparent, spouse, domestic partner, adult son or daughter, grandparent, brother, sister, uncle, or aunt of the enrollee.
(d) The patient advocate shall review the written documents submitted with the enrollee’s grievance. The patient advocate may ask for additional information, and may hold an informal meeting with the involved parties, including health care providers who have joined in submitting the grievance or who are otherwise assisting or advocating on behalf of the enrollee. If after reviewing the record, the patient advocate concludes that the grievance, in whole or in part, is eligible for review under the independent medical review system, the patient advocate shall immediately notify the enrollee of that option and shall, if requested orally or in writing, assist the enrollee in participating in the independent medical review system.
(e) The patient advocate shall send a written notice of the final disposition of the grievance, and the reasons therefor, to the enrollee, to any health care provider that has joined with or is otherwise assisting the enrollee, and to the commissioner within 30 calendar days of receipt of the grievance, unless the patient advocate, in his or her discretion, determines that additional time is reasonably necessary to fully and fairly evaluate the grievance. In any case not eligible for independent medical review, the patient advocate’s written notice shall include, at a minimum, the following:
(1) A summary of findings and the reasons why the patient advocate found the system to be, or not to be, in compliance with any applicable laws, regulations, or orders of the commissioner.
(2) A discussion of the patient advocate’s contact with any health care provider, or any other independent expert relied on by the patient advocate, along with a summary of the views and qualifications of that health care provider or expert.
(3) If the enrollee’s grievance is sustained in whole or in part, information about any corrective action taken.
(f) The patient advocate’s order shall be binding on the system.
(g) The patient advocate shall establish and maintain a system of aging of grievances that are pending and unresolved for 30 days or more that shall include a brief explanation of the reasons each grievance is pending and unresolved for 30 days or more.
(h) The grievance or resolution procedures authorized by this section shall be in addition to any other procedures that may be available to any person, and failure to pursue, exhaust, or engage in the procedures described in this section shall not preclude the use of any other remedy provided by law.
(i) Nothing in this section shall be construed to allow the submission to the patient advocate of any health care provider grievance under this section. However, as part of a health care provider’s duty to advocate for medically appropriate health care for his or her patients pursuant to Sections 510 and 2056 of the Business and Professions Code, nothing in this subdivision shall be construed to prohibit a health care provider from contacting and informing the patient advocate about any concerns he or she has regarding compliance with or enforcement of this division.

140612.

(a) The patient advocate shall establish an independent medical review system to act as an independent, external medical review process for the system to provide timely examinations of disputed health care services and coverage decisions regarding experimental and investigational therapies to ensure the system provides efficient, appropriate, high quality health care, and that the system is responsive to enrollee disputes.
(b) For the purposes of this section, “disputed health care service” means any health care service eligible for coverage and payment under the system that has been denied, modified, or delayed by a decision of the system, or by one of its contracting health care providers, in whole or in part due to a finding that the service is not medically necessary. A decision regarding a disputed health care service relates to the practice of medicine and is not a coverage decision. If the system, or one of its contracting providers, issues a decision denying, modifying, or delaying health care services, based in whole or in part on a finding that the proposed health care services are not a covered benefit under the system, the statement of decision shall clearly specify the provisions of the system that exclude coverage.
(c) For the purposes of this section, “coverage decision” means the approval or denial of the system, or by one of its contracting entities, substantially based on a finding that the provision of a particular service is included or excluded as a covered benefit under the terms and conditions of the system.
(d) Coverage decisions regarding experimental or investigational therapies for individual enrollees who meet all of the following criteria are eligible for review by the independent medical review system:
(1) (A) The enrollee has a life-threatening or seriously debilitating condition.
(B) For purposes of this section, “life-threatening” means either or both of the following:
(i) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted.
(ii) Diseases or conditions with potentially fatal outcomes, where the end point of clinical intervention is survival.
(C) For purposes of this section, “seriously debilitating” means diseases or conditions that cause major irreversible morbidity.
(2) The enrollee’s physician certifies that the enrollee has a condition, as defined in paragraph (1), for which standard therapies have not been effective in improving the condition of the enrollee, for which standard therapies would not be medically appropriate for the enrollee, or for which there is no more beneficial standard therapy covered by the system than the therapy proposed pursuant to paragraph (3).
(3) Either (A) the enrollee’s physician, who is under contract with the system, has recommended a drug, device, procedure, or other therapy that the physician certifies in writing is likely to be more beneficial to the enrollee than any available standard therapies, or (B) the enrollee, or the enrollee’s physician who is a licensed, board-certified or board-eligible physician qualified to practice in the area of practice appropriate to treat the enrollee’s condition, has requested a therapy that, based on two documents from the medical and scientific evidence, is likely to be more beneficial for the enrollee than any available standard therapy. The physician certification pursuant to this section shall include a statement of the evidence relied upon by the physician in certifying his or her recommendation. Nothing in this subdivision shall be construed to require the system to pay for the services of a nonparticipating physician provided pursuant to this division, that are not otherwise covered pursuant to the system’s benefits package.
(4) The enrollee has been denied coverage by the system for a drug, device, procedure, or other therapy recommended or requested pursuant to paragraph (3).
(5) The specific drug, device, procedure, or other therapy recommended pursuant to paragraph (3) would be a covered service, except for the system’s determination that the therapy is experimental or investigational.
(e) (1) All enrollee grievances involving a disputed health care service are eligible for review under the independent medical review system if the requirements of this section are met. If the patient advocate finds that a grievance involving a disputed health care service does not meet the requirements of this section for review under the independent medical review system, the enrollee’s grievance shall be treated as a request for the patient advocate to review the grievance. All other enrollee grievances, including grievances involving coverage decisions, remain eligible for review by the patient advocate.
(2) In any case in which an enrollee or health care provider asserts that a decision to deny, modify, or delay health care services was based, in whole or in part, on consideration of medical appropriateness, the patient advocate shall have the final authority to determine whether the grievance is more properly resolved pursuant to an independent medical review as provided under this section.
(3) The patient advocate shall be the final arbiter when there is a question as to whether an enrollee grievance is a disputed health care service or a coverage decision. The patient advocate shall establish a process to complete an initial screening of an enrollee grievance. If there appears to be any medical appropriateness issue, the grievance shall be resolved pursuant to an independent medical review.
(f) For purposes of this chapter, an enrollee may designate an agent to act on his or her behalf. The agent may join with or otherwise assist the enrollee in seeking an independent medical review, and may advocate on behalf of the enrollee.
(g) The independent medical review process authorized by this section is in addition to any other procedures or remedies that may be available.
(h) The office of the patient advocate shall prominently display in every relevant informational brochure, on copies of the system’s procedures for resolving grievances, on letters of denials issued by either the system or its contracting providers, on the grievance forms, and on all written responses to grievances, information concerning the right of an enrollee to request an independent medical review in cases where the enrollee believes that health care services have been improperly denied, modified, or delayed by the system, or by one of its contracting providers.
(i) An enrollee may apply to the patient advocate for an independent medical review when all of the following conditions are met:
(1) (A) The enrollee’s health care provider has recommended a health care service as medically appropriate.
(B) The enrollee has received urgent care or emergency services that a health care provider determined was medically appropriate.
(C) The enrollee seeks coverage for experimental or investigational therapies.
(D) The enrollee, in the absence of a health care provider recommendation under subparagraph (A) or the receipt of urgent care or emergency services by a health care provider under subparagraph (B), has been seen by a system health care provider for the diagnosis or treatment of the medical condition for which the enrollee seeks independent review. The system shall expedite access to a system health care provider upon request of an enrollee. The system health care provider need not recommend the disputed health care service as a condition for the enrollee to be eligible for an independent medical review.    (2) The disputed health care service has been denied, modified, or delayed by the system, or by one of its contracting providers, based in whole or in part on a decision that the health care service is not medically appropriate.
(3) The enrollee has filed a grievance with the patient advocate and the disputed decision is upheld or the grievance remains unresolved after 30 days. The enrollee shall not be required to participate in the system’s grievance process for more than 30 days. In the case of a grievance that requires expedited review, the enrollee shall not be required to participate in the system’s grievance process for more than three days.
(j) An enrollee may apply to the patient advocate for an independent medical review of a decision to deny, modify, or delay health care services, based in whole or in part on a finding that the disputed health care services are not medically appropriate, within six months of any of the qualifying periods or events. The patient advocate may extend the application deadline beyond six months if the circumstances of a case warrant the extension.
(k) The enrollee shall pay no application or processing fees of any kind.    (l) Upon notice from the patient advocate that the enrollee has applied for an independent medical review, the system or its contracting providers shall provide to the independent medical review organization designated by the patient advocate a copy of all of the following documents within three business days of the system’s receipt of the patient advocate’s notice of a request by an enrollee for an independent medical review:
(1) (A) A copy of all of the enrollee’s medical records in the possession of the system or its contracting providers relevant to each of the following:
(i) The enrollee’s medical condition.    (ii) The health care services being provided by the system and its contracting providers for the condition.
(iii) The disputed health care services requested by the enrollee for the condition.
(B) Any newly developed or discovered relevant medical records in the possession of the system or its contracting providers after the initial documents are provided to the independent medical review organization shall be forwarded immediately to the independent medical review organization. The system shall concurrently provide a copy of medical records required by this subparagraph to the enrollee or the enrollee’s health care provider, if authorized by the enrollee, unless the offer of medical records is declined or otherwise prohibited by law. The confidentiality of all medical record information shall be maintained pursuant to applicable state and federal laws.
(2) A copy of all information provided to the enrollee by the system and any of its contracting providers concerning their decisions regarding the enrollee’s condition and care, and a copy of any materials the enrollee or the enrollee’s health care provider submitted to the system and to the system’s contracting providers in support of the enrollee’s request for disputed health care service. This documentation shall include the written response to the enrollee’ s grievance. The confidentiality of any enrollee medical information shall be maintained pursuant to applicable state and federal laws.
(3) A copy of any other relevant documents or information used by the system or its contracting providers in determining whether disputed health care services should have been provided, and any statements by the system and its contracting providers explaining the reasons for the decision to deny, modify, or delay disputed health care services on the basis of medical necessity. The system shall concurrently provide a copy of documents required by this paragraph, except for any information found by the patient advocate to be legally privileged information, to the enrollee and the enrollee’s health care provider.    The patient advocate and the independent review organization shall maintain the confidentiality of any information found by the patient advocate to be the proprietary information of the system.

140614.

(a) If there is an imminent and serious threat to the health of the enrollee, all necessary information and documents shall be delivered to an independent medical review organization within 24 hours of approval of the request for review. In reviewing a request for review, the patient advocate may waive the requirement that the enrollee follow the system’s grievance process in extraordinary and compelling cases, if the patient advocate finds that the enrollee has acted reasonably.
(b) The patient advocate shall expeditiously review requests and immediately notify the enrollee in writing as to whether the request for an independent medical review has been approved, in whole or in part, and, if not approved, the reasons therefor. The system shall promptly issue a notification to the enrollee, after submitting all of the required material to the independent medical review organization that includes an annotated list of documents submitted and offer the enrollee the opportunity to request copies of those documents from the system. The patient advocate shall promptly approve an enrollee’s request whenever the system has agreed that the case is eligible for an independent medical review. To the extent an enrollee’s request for independent review is not approved by the patient advocate, the enrollee’s request shall be treated as an immediate request for the patient advocate to review the grievance.
(c) An independent medical review organization shall conduct the review in accordance with a process approved by the patient advocate. The review shall be limited to an examination of the medical necessity of the disputed health care services and shall not include any consideration of coverage decisions or other issues.
(d) The patient advocate shall contract with one or more independent medical review organizations in the state to conduct reviews for purposes of this section. The independent medical review organizations shall be independent of the system. The patient advocate may establish additional requirements, including conflict-of-interest standards, consistent with the purposes of this section that an organization shall be required to meet in order to qualify for participation in the independent medical review system and to assist the patient advocate in carrying out its responsibilities.
(e) The independent medical review organizations and the medical professionals retained to conduct reviews shall be deemed to be medical consultants for purposes of Section 43.98 of the Civil Code.
(f) The independent medical review organization, any experts it designates to conduct a review, or any officer, patient advocate, or employee of the independent medical review organization shall not have any material professional, familial, or financial affiliation, as determined by the patient advocate, with any of the following:
(1) The system.
(2) Any officer or employee of the system.
(3) A physician, the physician’s medical group, or the independent practice association involved in the health care service in dispute.
(4) The facility or institution at which either the proposed health care service, or the alternative service, if any, recommended by the system, would be provided.
(5) The development or manufacture of the principal drug, device, procedure, or other therapy proposed by the enrollee whose treatment is under review, or the alternative therapy, if any, recommended by the system.
(6) The enrollee or the enrollee’s immediate family.    (g) In order to contract with the patient advocate for purposes of this section, an independent medical review organization shall meet all of the requirements pursuant to subdivision (d) of Section 1374.32.

140616.

(a) Upon receipt of information and documents related to a case, the medical professional reviewer or reviewers selected to conduct the review by the independent medical review organization shall promptly review all pertinent medical records of the enrollee, provider reports, as well as any other information submitted to the organization as authorized by the patient advocate or requested from any of the parties to the dispute by the reviewers. If reviewers request information from any of the parties, a copy of the request and the response shall be provided to all of the parties. The reviewer or reviewers shall also review relevant information related to the criteria set forth in subdivision (b).
(b) Following its review, the reviewer or reviewers shall determine whether the disputed health care service was medically appropriate based on the specific medical needs of the patient and any of the following:
(1) Peer-reviewed scientific and medical evidence regarding the effectiveness of the disputed service.
(2) Nationally recognized professional standards.
(3) Expert opinion.
(4) Generally accepted standards of medical practice.
(5) Treatments likely to provide a benefit to an enrollee for conditions for which other treatments are not clinically efficacious.
(c) The organization shall complete its review and make its determination in writing, and in layperson’s terms to the maximum extent practicable, within 30 days of the receipt of the application for review and supporting documentation, or within less time as prescribed by the patient advocate. If the disputed health care service has not been provided and the enrollee’s health care provider or the patient advocate certifies in writing that an imminent and serious threat to the health of the enrollee may exist, including, but not limited to, serious pain, the potential loss of life, limb, or major bodily function, or the immediate and serious deterioration of the health of the enrollee, the analyses and determinations of the reviewers shall be expedited and rendered within three days of the receipt of the information. Subject to the approval of the patient advocate, the deadlines for analyses and determinations involving both regular and expedited reviews may be extended by the patient advocate for up to three days in extraordinary circumstances or for good cause.
(d) The medical professionals’ analyses and determinations shall state whether the disputed health care service is medically appropriate. Each analysis shall cite the enrollee’s medical condition, the relevant documents in the record, and the relevant findings associated with the provisions of subdivision (b) to support the determination. If more than one medical professional reviews the case, the recommendation of the majority shall prevail. If the medical professionals reviewing the case are evenly split as to whether the disputed health care service should be provided, the decision shall be in favor of providing the service.
(e) The independent medical review organization shall provide the patient advocate, the system, the enrollee, and the enrollee’s health care provider with the analyses and determinations of the medical professionals reviewing the case, and a description of the qualifications of the medical professionals. The independent medical review organization shall keep the names of the reviewers confidential in all communications with entities or individuals outside the independent medical review organization, except in cases where the reviewer is called to testify and in response to court orders. If more than one medical professional reviewed the case and the result was differing determinations, the independent medical review organization shall provide each of the separate reviewer’s analyses and determinations.
(f) The patient advocate shall immediately adopt the determination of the independent medical review organization and shall promptly issue a written decision to the parties that shall be binding on the system.
(g) After removing the names of the parties, including, but not limited to, the enrollee and all medical providers, the patient advocate’s decisions adopting a determination of an independent medical review organization shall be made available by the patient advocate to the public upon request, at the patient advocate’s cost and after considering applicable laws governing disclosure of public records, confidentiality, and personal privacy.

140618.

(a) Upon receiving the decision adopted by the patient advocate that a disputed health care service is medically appropriate, the system shall promptly implement the decision. In the case of reimbursement for services already rendered, the health care provider or enrollee, whichever applies, shall be paid within five working days. In the case of services not yet rendered, the system shall authorize the services within five working days of receipt of the written decision from the patient advocate, or sooner if appropriate for the nature of the enrollee’s medical condition, and shall inform the enrollee and health care provider of the authorization.
(b) The system shall not engage in any conduct that has the effect of prolonging the independent medical review process.
(c) The patient advocate shall require the system to promptly reimburse the enrollee for any reasonable costs associated with those services when the patient advocate finds that the disputed health care services were a covered benefit and the services are found by the independent medical review organization to have been medically appropriate and the enrollee’s decision to secure the services outside of the system was reasonable under the emergency or urgent medical circumstances.

140619.

(a) The patient advocate shall utilize a competitive bidding process and use any other information on program costs reasonable to establish a per case reimbursement schedule to pay the costs of independent medical review organization reviews, which may vary depending on the type of medical condition under review and on other relevant factors.    (b) The costs of the independent medical review system for enrollees shall be borne by the system.

140620.

The patient advocate shall, on a biannual basis, report to the chief medical officer on the number, types, and outcomes of all patient grievances relating to the denial, delay, or modification of health care services.