Article
3.1. Independent Medical Review System for the Medi-Cal program
14124.16.
For purposes of this article, the following definitions apply:(a) “Disputed health care service” means any service covered under the Medi-Cal program that has been denied, modified, or delayed by a decision of the department, or by one of its contractors that makes a final decision, in whole or in part, due to a finding that the service is not medically necessary.
(b) “Medi-Cal managed care plan” means an individual, organization, or entity that enters into a contract with the department to provide general health care services to enrolled Medi-Cal beneficiaries pursuant to any of the following:
(1) Chapter 3 (commencing with Section
101675) of Part 4 of Division 101 of the Health and Safety Code.
(2) Article 2.7 (commencing with Section 14087.3), including dental managed care programs developed pursuant to Section 14087.46.
(3) Article 2.8 (commencing with Section 14087.5).
(4) Article 2.81 (commencing with Section 14087.96).
(5) Article 2.82 (commencing with Section 14087.98).
(6) Article 2.9 (commencing with Section 14088).
(7) Article 2.91 (commencing with Section 14089).
(8) Chapter 8 (commencing with Section 14200), including dental managed care plans.
(9) Chapter 8.9 (commencing with Section 14700).
(10) A county Drug Medi-Cal organized delivery system authorized under the California Medi-Cal 2020 Demonstration, Number 11-W-00193/9, as approved by the federal Centers for Medicare and Medicaid Services and described in the Special Terms and Conditions. For purposes of this paragraph, “Special Terms and Conditions” has the same meaning as set forth in subdivision (o) of Section 14184.10.
(c) “Medically necessary” and “medical necessity” has the same meaning as those terms are described under Section 14059.5.
14124.165.
(a) Commencing January 1, 2022, the department shall establish the Independent Medical Review System.(b) (1) Any Medi-Cal beneficiary appeal involving a disputed health care service is eligible for review under the Independent Medical Review System if the requirements of this article are met. If the department determines that a beneficiary grievance involving a disputed health care service does not meet the requirements of this article for review under the Independent Medical Review System, the beneficiary’s request for review shall be automatically treated as a request for a fair hearing pursuant to Chapter 7 (commencing with Section 10950) of Part 2.
(2) If there is any denial, modification, or delay based on medical necessity involving a disputed health care service, the denial, modification, or delay of coverage for the service shall be eligible for resolution pursuant to an Independent Medical Review.
(c) (1) The department shall prominently display information on the availability of the Independent Medical Review System in the “myMedi-Cal: How to Get the Health Care You Need” publication, on the department’s internet website, and on any notice of action involving a disputed health care service, as described in subdivision (b), denying, modifying, or delaying coverage for a service on the basis of medical necessity.
(2) A Medi-Cal managed care plan shall prominently display information on the right of a beneficiary to request an Independent Medical Review in any case that the beneficiary
believes that a disputed health care service has been improperly denied, modified, or delayed by the department, or contractor. This information shall be displayed in its plan member handbook or relevant informational brochure, in its plan contract, on beneficiary evidence of coverage forms, on any copy of plan procedures for resolving grievances and appeals, on any notice of adverse benefits determinations issued by the plan or its contracting organization, on any required grievance or appeal forms.
(d) A beneficiary may request an Independent Medical Review from the department when a provider has recommended a service as medically necessary and the disputed health care service has been denied, modified, or delayed by the department, or its contractor or agent, based in whole or in part on a decision that the health care service is not medically necessary. A beneficiary shall have the option to apply for an Independent Medical Review whenever
a service has been denied, modified, or delayed by the contractor or agent, if the decision was based in whole or in part on a finding that the proposed health care services are not medically necessary, only if the department, a contractor or agent is making a final decision on the denial, modification, or delay.
(e) A beneficiary may apply to the department for an Independent Medical Review of any denial, reduction, or delay of any health care service, pursuant to subdivision (b), based, in whole or in part, on a determination that the disputed health care service is not medically necessary, within six months of receipt of the notice of adverse benefits determination or notice of action. The director shall extend the application deadline beyond six months if the circumstances of a case warrant the extension or there is good cause as defined in Section 10951.
(f) The beneficiary
shall not be required to pay an application or processing fee to request or obtain an Independent Medical Review.
(g) As part of its notice of adverse benefits determination or notice of action to the beneficiary concerning a denial, modification, or delay of any health care service, the department shall provide the beneficiary with a one- or two-page application form and an addressed envelope, which the beneficiary may return to initiate an Independent Medical Review. The department shall include on the form any information required by the department to facilitate the completion of the Independent Medical Review, such as the beneficiary’s diagnosis or condition, the nature of the disputed health care service sought by the beneficiary, a means to identify the beneficiary’s case, and any other material information. The form shall also be available on the department’s public internet website, and shall include all of the following:
(1) A statement indicating the beneficiary’s consent to obtain any necessary medical records from the Medi-Cal managed care plan and the beneficiary’s providers, which shall be signed by the beneficiary.
(2) Notice of the beneficiary’s right to provide information or documentation, either directly or through the beneficiary’s provider, on any of the following:
(A) A provider recommendation indicating that the disputed health care service is medically necessary for the beneficiary’s medical condition.
(B) Medical information or justification that a disputed health care service, on an urgent care or emergency basis, was medically necessary for the beneficiary’s medical condition.
(C) Reasonable
information supporting the beneficiary’s position that the disputed health care service is or was medically necessary for the beneficiary’s medical condition, including all information provided to the beneficiary by the Medi-Cal managed care plan or the beneficiary’s provider, which remains in possession of the beneficiary, concerning the department or contractor’s decision on any disputed health care service, and a copy of any material the beneficiary submitted to the Medi-Cal managed care plan, which remains in possession of the beneficiary, in support of the grievance, and any additional material that the beneficiary believes is relevant.
(3) A section designed to collect information on the beneficiary’s ethnicity, race, and primary language spoken that includes both of the following:
(A) A statement of intent indicating that the information is used only for statistics in order
to ensure that each beneficiary has access to the best care possible.
(B) A statement indicating that providing this information is optional and will not affect the Independent Medical Review process in any way.
(h) Upon notice from the department that the beneficiary has applied for an Independent Medical Review, the department and its contractor shall provide to the Independent Medical Review organization designated by the department a copy of all of the following documents within three business days of the receipt of the department’s notice of a request by a beneficiary for an independent review:
(1) (A) A copy of all of the beneficiary’s medical records in the possession of the Medi-Cal managed care plan or providers relevant to each of the following:
(i) The beneficiary’s medical condition.
(ii) Any health care service being provided by the Medi-Cal managed care plan or providers for the condition.
(iii) Any disputed health care service requested by the beneficiary for the condition.
(B) Any newly developed or discovered relevant medical records in the possession of the beneficiary’s assigned Medi-Cal managed care plan or providers after the initial documents are provided to the Independent Medical Review organization shall be forwarded immediately to the Independent Medical Review organization.
(2) A copy of all information provided to the beneficiary by the Medi-Cal managed care plan and providers concerning any decision by the plan or
any provider on the beneficiary’s condition and care, and a copy of any materials the beneficiary or the beneficiary’s provider submitted to the Medi-Cal managed care plan and to the providers in support of the beneficiary’s request for disputed health care services.
(3) A copy of any other relevant documents or information used by the department and its contracting organization in determining whether any disputed health care service should have been provided, and any statements by the department and its contractor explaining the reasons for the decision to deny, modify, or delay disputed health care services on the basis of medical necessity. The department shall concurrently provide a copy of documents required by this paragraph, except for any information found by the director to be legally privileged information, to the beneficiary and the beneficiary’s provider.
(i) With
respect to the documents described under subdivision (h), the confidentiality of any beneficiary medical information shall be maintained pursuant to applicable state and federal laws.
14124.17.
(a) If there is an imminent and serious threat to the health of the beneficiary, as specified in subdivision (c) of Section 14124.18, all necessary information and documents shall be delivered to an Independent Medical Review organization within 24 hours of approval of the request for review.(b) The department shall expeditiously review requests and immediately notify the beneficiary 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 department, after submitting all of the required material to the Independent Medical Review organization, shall promptly issue a notification to the beneficiary that includes an annotated list of
documents submitted and offer the beneficiary the opportunity to request copies of those documents.
(c) An Independent Medical Review organization, as described in Section 14124.175, shall conduct the review in accordance with Section 14124.18 and any regulations or orders of the director adopted within 48 hours of receipt. The organization’s review shall be limited to an examination of the medical necessity of the disputed health care service.
14124.175.
(a) The department shall contract with one or more Independent Medical Review organization in the state to conduct reviews for purposes of this article. The department may enter into an intra-agency agreement with the Department of Managed Health Care to perform some or all of the department’s activities specified in this article. The Independent Medical Review organization shall be independent of any Medi-Cal managed care plan. The director may establish additional requirements, including conflict-of-interest standards, consistent with the purposes of this article, that an organization must satisfy to qualify for participation in the Independent Medical Review System and to assist the department in carrying out its responsibilities.(b) The Independent Medical Review organization 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.
(c) The Independent Medical Review organization, any experts it designates to conduct a review, or any officer, director, or employee of the Independent Medical Review organization shall not have any material professional, familial, or financial affiliation, as determined by the director, with any of the following:
(1) The department.
(2) The Medi-Cal managed care plan or any officer, director, or employee of that plan.
(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 plan, would be provided.
(5) Any of the department’s contractors that support the administration of the Medi-Cal pharmacy benefit.
(6) The development or manufacture of the principal drug, device, procedure, or other therapy proposed by the beneficiary whose treatment is under review, or the alternative therapy, if any, recommended by the department or plan.
(7) The beneficiary or the beneficiary’s immediate family.
(d) In order to contract with the department for purposes of this article, an Independent Medical Review organization shall meet all
of the following requirements:
(1) The organization shall not be an affiliate or a subsidiary of, nor in any way be owned or controlled by, a health plan, or a trade association of health plans. A board member, director, or officer of a health plan or a trade association of health plan shall not serve as a board member, director, officer, or employee of an Independent Medical Review organization.
(2) The organization shall submit to the department all of the following information upon initial application to contract for purposes of this article, and, except as otherwise provided, annually thereafter upon any change to any of the following information:
(A) The name of any stockholder and owner of more than 5 percent of any stock or options, if a publicly held organization.
(B) The name of any holder of a bond or note in excess of one hundred thousand dollars ($100,000), if any.
(C) The name of any corporation and organization that the Independent Medical Review organization controls or is affiliated with, and the nature and extent of any ownership or control, including the affiliated organization’s type of business.
(D) The name and biographical sketch of any director, officer, and executive of the Independent Medical Review organization, and a statement on any past or present relationship that a director, officer, or executive may have with any Medi-Cal managed care plan, disability insurer, managed care organization, provider group, or board or committee of a managed care plan, managed care organization, or provider group.
(E) (i) The percentage of revenue the Independent Medical Review organization receives from expert reviews, including, but not limited to, external medical reviews, quality assurance reviews, and utilization reviews.
(ii) The name of any Medi-Cal managed care plan or provider group for which the Independent Medical Review organization provides review services, including, but not limited to, utilization review, quality assurance review, and external medical review. Any change in this information shall be reported to the department within five business days of the change.
(F) A description of the review process, including, but not limited to, the method of selecting expert reviewers and matching the expert reviewers to specific cases.
(G) A description of the system the Independent
Medical Review organization uses to identify and recruit medical professionals to review treatment and treatment recommendation decisions, the number of medical professionals credentialed, and the types of cases and areas of expertise that the medical professionals are credentialed to review.
(H) A description of how the Independent Medical Review organization ensures compliance with the conflict-of-interest provisions of this section.
(3) The Independent Medical Review organization shall demonstrate that it has a quality assurance mechanism in place that does all of the following:
(A) Ensures that any medical professional retained is appropriately credentialed and privileged.
(B) Ensures that any review provided by any medical professional is timely,
clear, and credible, and that those reviews are monitored for quality on an ongoing basis.
(C) Ensures that the method of selecting any medical professional for an individual case achieves a fair and impartial panel of medical professionals who are qualified to render recommendations on the clinical conditions and the medical necessity of treatments or therapies in question.
(D) Ensures the confidentiality of medical records and the review materials, consistent with the requirements of this section and applicable state and federal laws.
(E) Ensures the independence of any medical professional retained to perform the reviews through conflict-of-interest policies and prohibitions, and ensures adequate screening for conflicts of interest.
(4) Any medical
professional selected by an Independent Medical Review organization to review any medical treatment decision shall meet the requirements of, and be subject to the restrictions in, subdivision (d) of Section 1374.32 of the Health and Safety Code.
(e) The department, upon the request of any interested person, shall provide a copy of all nonproprietary information, as determined by the director, filed with the department by an Independent Medical Review organization seeking to contract under this article. The department may charge a nominal fee to the interested person for photocopying the requested information.
14124.18.
(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 beneficiary, provider reports, and any other information submitted to the organization as authorized by the department or requested from any of the parties to the dispute by the reviewers. If any reviewer 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 their review, the reviewer or reviewers
shall determine whether the disputed health care service was medically necessary based on the specific medical needs of the beneficiary 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 that are likely to provide a benefit to a patient for conditions for which other treatments are not clinically efficacious.
(c) The Independent Medical Review 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 director. If the disputed health care service has not been provided and the beneficiary’s provider or the department certifies in writing that an imminent and serious threat to the health of the beneficiary 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 beneficiary, the analyses and determinations of the reviewers shall be expedited and rendered within 72 hours of the receipt of the information. Subject to the approval of the department, the deadlines for analyses and determinations involving both regular and expedited reviews may be extended by the director 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 necessary. An analysis shall cite the beneficiary’s medical condition, the relevant documents in the record, and the relevant findings associated with the criteria set forth in 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 director, the contractor, the beneficiary, and the beneficiary’s 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 any case that 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 director 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 department and its contractor.
(g) After removing the names of the parties, including, but not limited to, the beneficiary and all medical providers, the director’s decision adopting a
determination of an Independent Medical Review organization shall be made available by the department to the public in a searchable database on the department’s internet website in a similar format to the database used by the Department of Managed Health Care for a similar purpose, upon considering applicable laws governing disclosure of public records, confidentiality, and personal privacy.
(h) (1) Information on each director decision provided by the database specified in subdivision (g) shall include all of the following:
(A) Beneficiary demographic profile information, including age and gender.
(B) The beneficiary diagnosis and disputed health care service.
(C) Whether the Independent Medical Review was for medically necessary
services pursuant to this article.
(D) Whether the Independent Medical Review was standard or expedited.
(E) Length of time from the receipt by the Independent Medical Review organization of the application for review and supporting documentation to the rendering of a determination by the Independent Medical Review organization in writing.
(F) Length of time from receipt by the department of the Independent Medical Review application to the issuance of the director’s determination in writing to the parties that is binding on the department and its contractor.
(G) Credentials and qualifications of the reviewer or reviewers.
(H) The nature of the criteria set forth in subdivision (b) that
the reviewer or reviewers used to make the case decision.
(I) The final result of the determination.
(J) The year the determination was made.
(K) A detailed case summary that includes the specific standards, criteria, and medical and scientific evidence, if any, that led to the case decision.
(2) The database referenced in subdivision (g) shall be accompanied by all of the following:
(A) The annual rate of Independent Medical Review among the total number of Medi-Cal beneficiaries through the Medi-Cal program.
(B) The number, type, and resolution of Independent Medical Review cases by ethnicity, race, and primary language
spoken.
14124.185.
(a) Upon receiving a decision adopted by the director pursuant to Section 14124.18 that a disputed health care service is medically necessary, the department and its contractor shall promptly implement the decision. In the case of reimbursement for services already rendered, the department shall reimburse the provider or the beneficiary, whichever applies, within five working days. In the case of any service not yet rendered, the department and its contracting fiscal intermediaries shall authorize the services within five working days of receipt of the written decision from the director, or sooner if appropriate for the nature of the beneficiary’s medical condition, and shall inform the beneficiary and the provider of the authorization.(b) The department and its contractor shall not engage in any conduct that has the effect of prolonging the independent review process. A beneficiary may bring a writ of mandate under Section 1094.5 of the Code of Civil Procedure if the department or its contracting fiscal intermediaries engage in that conduct or fail to promptly implement the decision.
(c) The director shall perform an annual audit of Independent Medical Review cases for the dual purposes of education and the opportunity to determine if any denials, modifications, or delays in the coverage of service necessitate an evaluation of the department’s coverage policies.
(d) This article does not limit the department’s responsibility to provide any medically necessary health care service pursuant to federal Medicaid program requirements.
14124.19.
After considering the results of a competitive bidding process and any other relevant information on program costs, the director shall establish a reasonable, 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.