Article
6.05. Independent Prescription Drug Medical Review System
14194.1.
(a) Commencing January 1, 2021, the department shall establish the Independent Prescription Drug Medical Review System.(b) For the purposes of this article, “disputed health care service” means any outpatient prescription drug eligible for coverage and payment by the Medi-Cal program that has been denied, modified, or delayed by a decision of the department, or by one of its contracting fiscal intermediaries for the administration of the prescription drug benefit if that entity makes a final decision, in whole or in part, due to a finding that the service is not medically necessary.
(c) (1) Any Medi-Cal beneficiary grievance involving a disputed health
care service is eligible for review under the Independent Prescription Drug Medical Review System if the requirements of this article are met. If the department finds that a beneficiary grievance involving a disputed health care service does not meet the requirements of this article for review under the Independent Prescription Drug Medical Review System, the beneficiary’s request for review shall be treated as a request for a fair hearing pursuant to Chapter 7 (commencing with Section 10950) of Part 2.
(2) If there appears to be any denial, modification, or delay based on medical necessity involving a disputed health care service, the denial, modification, or delay of coverage for the outpatient prescription drug shall be eligible for resolution pursuant to an Independent Prescription Drug Medical Review.
(d) (1) The department and its contracting fiscal
intermediary for the administration of the prescription drug benefit shall provide a beneficiary with the opportunity to seek an Independent Prescription Drug Medical Review whenever coverage for an outpatient prescription drug has been denied, modified, or delayed by the department, or by its contracting fiscal intermediary for the administration of the prescription drug benefit, if the decision was based, in whole or in part, on a finding that the proposed health care service is not medically necessary. For purposes of this article, a beneficiary may designate an authorized representative to act on their behalf. For purposes of this article, “authorized representative” has the same meaning as paragraph (1) of subdivision (g) of Section 14014.5. The beneficiary’s provider may join with or otherwise assist the beneficiary in seeking an Independent Prescription Drug Medical Review, and may advocate on behalf of the beneficiary.
(2) The
requirement to provide a beneficiary with the opportunity to seek an Independent Prescription Drug Medical Review whenever coverage for an outpatient prescription drug has been denied, modified, or delayed by the contracting fiscal intermediary for the administration of the prescription drug benefit, if the decision was based, in whole or in part, on a finding that the proposed health care service is not medically necessary shall, be available to the beneficiary only if the contractor is making a final decision on the denial, modification, or delay.
(e) The Independent Prescription Drug Medical Review process authorized by this article shall be in addition to any other procedures or remedies that may be available, including the fair hearing process established pursuant to Chapter 7 (commencing with Section 10950) of Part 2.
(f) (1) The availability of the
Independent Prescription Drug Medical Review System shall be included 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 an outpatient prescription drug 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 Prescription Drug Medical Review in any case that the beneficiary believes that a disputed health care service have been improperly denied, modified, or delayed by the department, or by one of its contracting fiscal intermediaries for the administration of the prescription drug benefits. 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, on any letter of denial or notice of adverse benefits determinations issued by the plan or its contracting organization, on the grievance forms required under Section 1368 of the Health and Safety Code or pursuant to Medi-Cal managed care plan contracts, and on all written responses to grievances.
(g) A beneficiary may apply to the department for an Independent Prescription Drug Medical Review when the Medi-Cal beneficiary’s provider has recommended an outpatient prescription drug as medically necessary and the disputed health care service has been denied, modified, or delayed by the department, or its contracting prescription drug fiscal intermediaries, based in whole or in part on a decision that the health care service is not medically necessary. The option to apply for an Independent Prescription Drug Medical Review whenever coverage for an outpatient prescription drug
has been denied, modified, or delayed by the contracting fiscal intermediary for the administration of the prescription drug benefit, if the decision was based in whole or in part on a finding that the proposed health care services are not medically necessary, shall be available to the beneficiary only if the contractor is making a final decision on the denial, modification, or delay.
(h) A beneficiary may apply to the department for an Independent Prescription Drug Medical Review of a decision taken pursuant to subdivision (b) to deny, modify, or delay any health care service based, in whole or in part, on a finding that the disputed health care service is not medically necessary, within six months of receipt of the notice of action. The director may extend the application deadline beyond six months if the circumstances of a case warrant the extension.
(i) The beneficiary shall
not pay any application or processing fee of any kind.
(j) As part of its notification to the beneficiary on a disposition of the beneficiary’s grievance that denies, modifies, or delays 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 Prescription Drug Medical Review. The department shall include on the form any information required by the department to facilitate the completion of the Independent Prescription Drug 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 either the department or fiscal intermediary for the administration of the prescription drug benefit 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 Prescription Drug Medical Review process in any way.
(k) Upon notice from the department that the beneficiary has applied for an Independent Prescription Drug Medical Review, the department and its contracting fiscal intermediaries for the administration of the prescription drug benefit shall provide to the Independent Prescription Drug Medical Review organization designated by the department a copy of any outpatient drugs dispensed to the Medi-Cal beneficiary. In addition, upon notice from the department that the beneficiary has applied for an Independent Prescription Drug Medical Review, the Medi-Cal managed care plan and the beneficiary’s providers shall provide to the
Independent Prescription Drug 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, and any outpatient prescription medication covered by the department.
(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 Prescription Drug Medical Review organization shall be forwarded immediately to the Independent Prescription Drug Medical Review organization. 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 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. The
confidentiality of any beneficiary 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 department and its contracting fiscal intermediary for the administration of the prescription drug benefit in determining whether any disputed health care service should have been provided, and any statements by the department and its contracting fiscal intermediaries for the administration of the prescription drug benefit 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.
14194.2.
(a) If there is an imminent and serious threat to the health of the beneficiary, as specified in subdivision (c) of Section 14194.4, all necessary information and documents shall be delivered to an Independent Prescription Drug 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 Prescription Drug 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 Prescription Drug 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 Prescription Drug Medical Review organization, as specified in Section 14194.4, shall conduct the review in accordance with Section 14194.3 and any regulations or orders of the director adopted pursuant thereto. The organization’s review shall be limited to an examination of the medical necessity of the disputed health care service.
14194.3.
(a) The department shall contract with one or more Independent Prescription Drug 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 Prescription Drug Medical Review organization shall be independent of any Medi-Cal managed care plan or the department’s contracting fiscal intermediary for the administration of the prescription drug benefit doing business in this state. The director may establish additional requirements, including conflict-of-interest standards, consistent with the purposes of this article, which an organization shall be required to meet to qualify for
participation in the Independent Prescription Drug Medical Review System and to assist the department in carrying out its responsibilities.(b) The Independent Prescription Drug 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 Prescription Drug Medical Review organization, any experts it designates to conduct a review, or any officer, director, or employee of the Independent Prescription Drug Medical Review organization shall not have any material professional, familial, or financial affiliation, as determined by the director, with any of the following:
(1) Any of the department’s contractors that support the administration of the Medi-Cal pharmacy benefit.
(2) A physician, the physician’s medical group, or the independent practice association involved in the health care service in dispute.
(3) 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 plan.
(4) The beneficiary or the beneficiary’s immediate family.
(d) In order to contract with the department for purposes of this article, an Independent Prescription Drug 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 pharmaceutical manufacturer. A board member, director, or officer of a pharmaceutical manufacturer or a trade association of pharmaceutical manufacturers shall not serve as a board member, director, officer, or employee of an Independent Prescription Drug 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 Prescription Drug 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 Prescription Drug 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 Prescription Drug 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 Prescription Drug 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 Prescription Drug 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 Prescription Drug Medical Review organization ensures compliance with the conflict-of-interest provisions of this section.
(3) The Independent Prescription Drug 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 Prescription Drug 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 Prescription Drug 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.
14194.4.
(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 Prescription Drug 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 information in subdivision (b) of Section 1374.33 of the Health and Safety Code.
(c) The Independent Prescription Drug 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 three days 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 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 Prescription Drug Medical Review organization shall provide the director, the fiscal intermediary for the administration of the prescription drug benefit, 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 Prescription Drug Medical Review organization shall keep the names of the reviewers confidential in all communications with entities or individuals outside the Independent Prescription Drug 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 Prescription Drug 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 Prescription Drug Medical Review organization, and shall promptly issue a written decision to the parties that shall be binding on the department and its contracting fiscal intermediaries for the administration of the prescription drug benefit.
(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 Prescription Drug 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 Prescription Drug Medical Review was for medically necessary services pursuant to this article or for experimental or investigational therapies pursuant to Section 14194.7.
(D) Whether the Independent Prescription Drug Medical Review was standard or expedited.
(E) Length of time from the receipt by the Independent Prescription Drug Medical Review organization of the application for review and supporting documentation to the rendering of a determination by the Independent Prescription Drug Medical Review organization in writing.
(F) Length of time from receipt by the department of the Independent Prescription Drug Medical Review application to the issuance of the director’s determination in writing to the parties that is binding on the department and its contracted fiscal intermediaries for the administration of the prescription drug benefit.
(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 Prescription Drug Medical Review among the total number of Medi-Cal beneficiaries receiving outpatient prescription drug coverage through the Medi-Cal program.
(B) The number, type, and resolution of Independent Prescription Drug Medical Review cases by
ethnicity, race, and primary language spoken.
14194.5.
(a) Upon receiving a decision adopted by the director pursuant to Section 14194.4 that a disputed health care service is medically necessary, the department and its contracting fiscal intermediaries for the administration of the prescription drug benefit 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 contracting fiscal intermediaries for the administration of the prescription drug benefit 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 1085 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 Prescription Drug Medical Review cases for the dual purposes of education and the opportunity to determine if any denials, modifications, or delays in the coverage of outpatient prescription drugs 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.
14194.6.
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 Prescription Drug Medical Review organization reviews, which may vary depending on the type of medical condition under review and on other relevant factors.14194.7.
(a) The department shall provide an external, independent review process to examine the department and its contracting fiscal intermediaries for the administration of the prescription drug benefit’s coverage decisions on experimental or investigational outpatient prescription drugs for any beneficiary who meets all of the following criteria:(1) The beneficiary has a life-threatening or seriously debilitating condition, as defined in subdivision (a) of Section 1370.4 of the Health and Safety Code.
(2) The beneficiary’s prescriber certifies that the beneficiary has a condition, as defined in paragraph (1), for which standard therapies have not been effective in improving the
condition of the beneficiary, for which standard therapies would not be medically appropriate for the beneficiary, or for which there is no more beneficial standard therapy covered by the department than the therapy proposed pursuant to paragraph (3).
(3) The beneficiary’s prescriber has recommended an outpatient prescription drug that the prescriber certifies in writing is likely to be more beneficial to the beneficiary than any available outpatient prescription drug.
(4) The beneficiary has been denied coverage by the department or its contracting fiscal intermediaries for the administration of the prescription drug benefit for an outpatient prescription drug recommended or requested pursuant to paragraph (3).
(5) The specific outpatient prescription drug recommended pursuant to paragraph (3) would be a covered
service, except for the department or its contracting fiscal intermediaries for the administration of the prescription drug benefit’s determination that the therapy is experimental or investigational.
(b) The department and its contracting fiscal intermediaries for the administration of the prescription drug benefit’s decision to delay, deny, or modify experimental or investigational therapies shall be subject to the independent medical review process under this article, except that, in lieu of the information specified in subdivision (b) of Section 1374.33 of the Health and Safety Code, an independent medical reviewer shall base their determination on relevant medical and scientific evidence, including, but not limited to, the medical and scientific evidence as defined in subdivision (d).
(c) The independent medical review process shall also meet all of the following
criteria:
(1) The department and its contracting fiscal intermediaries for the administration of the prescription drug benefit shall notify any eligible beneficiary in writing of the opportunity to request the external independent review within five business days of the decision to deny coverage.
(2) If the beneficiary’s physician determines that the proposed therapy would be significantly less effective if not promptly initiated, the analyses and recommendations of the experts on the panel shall be rendered within seven days of the request for expedited review. At the request of an expert, the deadline shall be extended by up to three days for a delay in providing the documents required. The timeframes specified in this paragraph shall be in addition to any otherwise applicable timeframes contained in subdivision (c) of Section 14194.4.
(3) Each expert’s analysis and recommendation shall be in written form and state the reasons the requested outpatient prescription drug is or is not likely to be more beneficial for the beneficiary than any available standard outpatient prescription drug, the reasons that the expert recommends that the outpatient prescription drug should or should not be provided by the department, citing the beneficiary’s specific medical condition, the relevant documents provided, and the relevant medical and scientific evidence, including, but not limited to, the medical and scientific evidence to support the expert’s recommendation.
(d) For the purposes of this section, “medical and scientific evidence” shall have the same meaning as in subdivision (d) of Section 1370.4 of the Health and Safety Code.