1300.68 GRIEVANCE SYSTEM

Section 1300.68 (a): Definitions

We support the broad definition of "grievance," [p. 1, lines 14-18] which encompasses any oral or written expression of dissatisfaction by an enrollee. It is important that all consumer complaints be recognized, responded to, and recorded, without requiring complaint forms or other obstacles at the initial contact.

We also strongly support the definition of "resolved," [p.2, lines 1-2] which requires that all levels of a health plan's internal appeals be completed within 30 days. This is clearly the intent of Health & Safety Code Section 1368(b)(1)(A), which establishes the enrollee's right to file a grievance with the Department of Managed Health Care after participating in the plan's internal grievance process for 30 days. Allowing health plans to continue their own internal processes beyond this time could engender confusion among enrollees and would likely discourage them from pursuing their grievance rights with the Department.

The 30-day time limit was clearly envisioned as a finite period in which any review or appeal was to be concluded, including review by contracting medical groups. However, we suggest further clarification to prevent an interpretation that allows the medical group or other delegated entity to have 30 days to review, with an appeal to the plan or other entity triggering additional 30-day periods.

Amend Section 1300.68(a) as follows:

The grievance system shall be established, pursuant to written procedures, for the receipt, handling and resolution of grievances within 30 calendar days of receipt by the plan, or the entity contracted by the plan to administer its grievance system, or any entity to which the plan has delegated decision-making authority. The following definitions shall apply with respect to the rules relating to grievance systems:

(1) "Grievance" means any written or oral expression of dissatisfaction and shall include any complaint, dispute, request for reconsideration or appeal made by an enrollee or the enrollee's representative to a plan or to any entity with delegated authority to resolve grievances on behalf of the plan. Where the plan is unable to distinguish between grievances and inquiries, they shall be considered grievances.

(2) "Complaint" is the same as "grievance."

(3) "Complainant" means the person who filed the grievance whether on his or her own behalf or on the behalf of the enrollee.

(4) "Resolved" means that the grievance has reached a final conclusion and that there are no pending appeals within the plan or any entity to which the plan has delegated decision-making authority.

(A) If the plan has multiple internal levels of grievance resolution or appeal, including review or appeal by the contracting medical group, all levels must be completed within 30 days of the plan's receipt of the grievance….

Section 1300.68 (b): Features of Plan Grievance Systems

Cultural and Linguistic Access

Subsection 3: The proposed regulations require a health plan to assess the linguistic needs of their enrollee populations and provide written and oral translations in any language for which the plan determines that 10% or more of the enrollee population in a service area speak a language other than English. [p. 2, line 23 - p. 3, line 2].

We are deeply concerned that this 10% threshold will leave many enrollees without the language services necessary to understand the grievance process and file grievances with their health plans. This provision also fails to address the special needs of health enrollees with disabilities. It literally closes the door to millions of Californians. The 10% threshold should be deleted.

Every health plan enrollee should be able to file a grievance in their own language and without facing barriers created by disability, especially when interpreter services for spoken communications are broadly available. Furthermore, the grievance process must be culturally competent as well: that is, those taking the grievances must comprehend not only the literal interpretation and translation of words but the wide variation in approaches to health care within a state as diverse as California. These regulations should be amended to require cultural competency training for all who participate in handling grievances.

Title VI of the 1964 Civil Rights Act prohibits recipients of "federal financial assistance," whether they be state or local governmental agencies, public or private health plans, or providers from discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any activities. In 1974, the United States Supreme Court in Lau v. Nichols ruled that Title VI requires "federal financial recipients" to take affirmative steps to ensure that language barriers do not exclude limited English speaking persons from effective participation in benefits and services.(1) This decision, as well as litigation involving the Office for Civil Rights and individual plaintiffs over the last 26 years, is also the basis for the recently issued guidance by the Office for Civil Rights of the U.S. Department of Health and Human Services, "Title VI of the Civil Rights Act of 1964; Policy Guidance on the Prohibition Against National Origin Discrimination As It Affects Persons With Limited English Proficiency".(2) The National Health Law Program's analysis of this guidance, which appears on their web site, is extremely helpful in clarifying this law. (3)

Since virtually all health care service plans cover Medicare beneficiaries and some also cover Medicaid enrollees, these plans are subject to Title VI. For this reason, the Department's regulations regarding the grievance process of the health plans should be consistent with Title VI. The Department's own processes and independent medical review should be consistent with whatever standards are adopted for the health plans regarding cultural and linguistic competency.

Given the significance of these issues for the regulation of managed care and the more general implications for all of the regulations governing managed care, we suggest that the Department of Managed Health Care consider convening a working group to look at issues of cultural and linguistic competency as well as access for those with disabilities.

Other Cultural and Linguistic Standards

Massachusetts has dispensed with the notion of threshold requirements and guarantees "competent" interpreter services for every non-English speaker and hearing impaired person who seeks care at an acute care hospital. [Mass. Ann. Laws, Ch. 111, Sec. 25(J)]

Similarly, New York law states that "skilled interpreters" must be available to help patients exercise their rights to treatment without discrimination, receive the information necessary to give informed consent, access their patient records, and exercise their other rights under the Patients' Bill of Rights.(4) New York also requires hospitals to have "skilled interpreters and translation of all significant forms to ensure effective oral and written communications with all persons receiving treatment regardless of language."(5) The only qualification to this requirement is that "regularly available interpreters and translations need only be available for non-English speaking groups comprising more than 1% [one] of the hospital's service area."(6) New York also requires that interpreters must be available in inpatient and outpatient settings within 20 minutes and in Emergency Rooms within 10 minutes of a request.(7)

Currently under California law, the Dymally-Alatorre Bilingual Services Act, which applies to state and local governmental agencies, sets a 5% threshold for the provision of linguistically appropriate services.(8) California Health & Safety Code Section 1259, which applies to acute-care hospitals sets a 5% threshold. Medi-Cal requires providers to provide language services for language groups with 3000 or more eligible beneficiaries. And, in December 1999, MRMIB, contrary to Medi-Cal, and over strong community objection, adopted a 5% standard for Healthy Families model contracts. Many of the organizations signing this letter opposed the MRMIB standard and support the Title VI standard.

Moreover, the Department must provide appropriate standards for assessing enrollee populations. The Department's broad mandate to health plans to assess the linguistic needs of their enrollees allows health plans the discretion to base their assessments on a service area that encompasses the entire state or even the country. In addition, there are no guidelines on the types of data on which health plans must base their assessments. Under the proposed regulations, a health plan could use anything from census data to an informal enrollment survey. Standards assuring that assessments are accurate and appropriate are necessary to protect health plan enrollees.

In addition, because enrollees must request translation services in order to receive them, the Department must require health plans to make known to enrollees the availability of translated materials and interpreter services. A notice that both translations and interpreter services and materials in languages other than English are available should appear in key languages on all required disclosures to health plan enrollees.

Access for the Disabled

In order to effectively accommodate the needs of enrollees with disabilities, we recommend that the Department require health plans to make grievance materials, and explanations of grievance processes, available in a variety of formats, and to have auxiliary aids and services readily accessible to health plan enrollees. Health plans should also have methods of screening for special needs so that appropriate services are made available to enrollees at the outset of grievance processes.

Auxiliary aids and services for those with disabilities should include:

· notetakers, computer-aided transcription services, assistive listening devices, telecommunications devices (TDD's), or other effective methods of making aurally delivered materials available to individuals with hearing impairments;

· qualified readers, taped texts, audio recordings, Braille materials, large print materials, or other effective methods of making visually delivered materials available to individuals with visual impairments;

· notetakers or computer-aided transcription services to meet the needs of persons with manual impairments.

Finally, the Department should require that health plan grievance departments have the capacity to communicate with persons who already have assistive devices for communication. The Department should also encourage sensitivity to persons who have their own unique methods of communication.

Amend Section 1300.68(b)(3) as follows:

The plan shall assess the linguistic and cultural needs of the enrollee population and the needs of the enrollee population with disabilities and shall file that assessment with the Department. The plan shall make written translations of grievance materials and translators interpreters available by telephone in any language which the plan determines that 10 percent or more of the enrollee population in any service area speaks a language other than English. These translations shall be made available upon request by the enrollee or an enrollee's representative. A notice that both translations and interpreter services in languages other than English are available shall appear in languages other than English on all required disclosures to health plan enrollees. The plan shall also provide grievance materials and processes that are accessible to those with visual, hearing or manual impairments.

Subsection 6: We support the recording requirement [p. 3, lines 10-12], which provides an important mechanism for plans to monitor the nature, timing, and disposition of the grievances filed with them. This requirement will facilitate fulfillment of the grievance tracking requirement in Section (d). However, in addition to the plan, Department staff should also review each plan's records of grievances to determine whether individual grievances are part of a pattern or practice by a plan. If so, the Department should use its regulatory and enforcement powers to correct wrongful patterns or practices by a plan.

Amend Section 1300.68(b)(6) as follows:

As to each grievance received in person or by telephone at a grievance location, a written record shall be made, including the date, identification of the individual recording the grievance, and disposition. A written record of tabulated grievances from shall be reviewed periodically by the Department, by the governing body of the plan, by the public policy body created pursuant to Section 1300.69, and by an officer of the plan or his designee. The plan's review procedure shall be documented, including documentation of the procedure or mechanism used to tabulate grievances periodically and review them in relation to policy and procedure review determinations.

Section 1300.68 (c): Plan Response to Grievances

Subsection 4: The exemption from the requirement to send written responses to a complainant for cases resolved the same day they are received [p. 4, line 20 - p. 5, line 2] should reduce the burden of paperwork on the plan without harm to the enrollee. Since the exemption does not apply to disputes involving coverage, medical necessity, or experimental or investigational treatment, and as long as the grievance is logged as required, this exemption is appropriate. However, in order to provide a meaningful picture of enrollees' experiences with the grievance process, the plan's log should be required to indicate whether the enrollee was satisfied with the resolution achieved.

The Department should review the log of grievances to determine whether individual grievances are the result of a pattern or practice by a plan. If so, the Department should use its regulatory and enforcement powers to correct wrongful patterns or practices by a plan. The Department should also audit the reported resolution of logged grievances to ensure the accuracy of the data. This audit should involve a random sample of logged grievances followed by contacting enrollees to verify their satisfaction with the resolution of a grievance.

Amend Section 1300.68(c)(4) as follows:

Grievances that are not coverage disputes, disputed health care services involving medical necessity, or disputes involving experimental or investigational treatment, and that are received over the telephone and resolved the same day they are received are exempt from the requirement to send written acknowledgments and written responses to the complainant. However, for all such grievances, the plan shall maintain a written (or electronic) log containing the date of the call, the name of the complainant, member identification number, nature of the grievance, nature of resolution, and identification of plan representative(s) who took the call and resolved the grievance. The log shall also indicate for each grievance whether the enrollee was satisfied with the resolution. The log of these grievances shall be reviewed by the plan officer responsible for the grievance process as set forth in subsection (b)(1), above. The Department shall periodically review a plan's log of grievances. The Department shall also periodically audit the record of grievances in the log to ensure the accuracy of entries reporting consumer satisfaction with a grievance resolution by randomly selecting such consumers and contacting them to verify satisfaction with the resolution.

Subsection 6: In order to accurately reflect the legislative intent behind Health and Safety Code Section 1374.30(b), this provision should clarify that any denial, delay or modification of health care services based in any way on elements of medical necessity shall be subject to independent review.

Amend Section 1300.68(c)(6) as follows:

Written responses to grievances involving the denial, modification, or delay of health care services based in whole or in part on a finding that the service is not medically necessary shall include notice of the enrollee's right to participate in the department's independent medical review system….

Subsection 7: Language must be added to reflect the legislative intent of Health and Safety Code Section 1374.30(d)(2) that the Department, and not the plan, has "final authority to determine whether the enrollee grievance is a disputed health care service or a coverage decision." Therefore, even when a plan characterizes its decision as based on coverage, it should be required to give the enrollee notice of the right to dispute that characterization and seek independent medical review.

Amend Section 1300.68(c)(7) as follows:

Written responses to grievances involving a finding that the requested service is not a covered benefit shall specify the provisions in the contract that exclude the coverage. The response shall cite the name of the document and page where the provision is found and shall quote the provision verbatim. The response also shall explain in clear concise language how the cited provision applies to the specific health care service requested by the subscriber or enrollee, and shall contain the following notice:

"If we deny care because we determine the care is not medically necessary, then the Department of Managed Health Care's Independent Medical Review system may review the decision. We have denied your request for care on the grounds that it is not a covered benefit. Such decisions based solely on coverage are not eligible for Independent Medical Review. However, the Department of Managed Health Care, not us, has the final say as to whether or not our decision was based on coverage or medical necessity. If you believe that your request was in fact denied on the grounds that it is not medically necessary, you should contact the Department to find out if you are eligible for Independent Medical Review."

Section 1300.68 (d): Plan Grievance Tracking System

In order to accurately reflect the grievances filed by enrollees, plan grievance systems must also track grievances received by medical groups. [p. 6, lines 10-11]

Amend Section 1300.68(d) as follows:

The plan's grievance system shall track grievances received by the plan, or any entity to which the plan has delegated resolution of grievances or any entity to which the plan has delegated decision-making authority.

Section 1300.68 (e): Quarterly Reporting of Grievances

We support the regular reporting of grievances to the Department, as required by the statute. [p. 7, lines 5-20] Valid comparisons of plan grievance systems are possible only if the reports use uniform criteria regarding which grievances to count as pending and unresolved, and include standard measures such as: the number of late grievances per 10,000 enrollees, the percentage of late grievances compared to all grievances filed with the plan, and the average time to resolve grievances.(9) Clarification that grievances to be reported on include all those that, at any time during the quarter, were pending and unresolved for 30 days or more will standardize practice in a way that enables comparisons. Thus, if an open and unresolved grievance more than 30 days old is closed during the quarter, it would still have to be reported. To ensure that this is understood, below we have added the phrase "at any time."

In addition, the reported information must also be made available to the public pursuant to Health and Safety Code Section 1341.5, which requires that information filed with the Department generally be published or made available for public inspection. This information, in a standardized, consumer-friendly format, will enable consumers and their representatives to compare plans and identify trends in the types of, and responses to, grievances filed.

Amend Section 1300.68(e) as follows:

(1) The quarterly report shall be prepared for the quarter ending on March 31st, June 30th, September 30th and December 31st of each calendar year, and shall include grievances pending and unresolved for thirty (30) days or more at any time during the quarter, including grievances from Medicare and Medi-Cal enrollees until those grievances are resolved by the Center for Health Dispute Resolution or by Fair Hearing. The quarterly report shall not contain personal or confidential information with respect to any enrollee.

(2) The quarterly report shall specify the licensee's name, quarter and date of the report, categories of grievances reported, type of grievance system based on levels of appeal, and a breakdown of the total number of pending and unresolved grievances for each category and for each level of the plan's grievance system, total enrollment, complaints per 10,000 enrollees, percentage rate of late grievances compared to all grievances filed with the plan; and the mean and median lengths of time to resolve grievances. The breakdown shall include the number of grievances for each corresponding reason for lateness specified in the report. If a grievance system provides two or more levels of appeal, each level shall be separately listed in the report and shall include the same information required by the report for First-Level Appeals.

(3) The quarterly report shall be signed by a person authorized to do so by the plan, verified, and filed along with two copies of the quarterly report, in the Department's Sacramento Office to the attention of the Filing Clerk no later than thirty (30) days from the close of the quarter. The quarterly report need not be filed as an amendment to the plan application.

(4) The Department shall publish the quarterly reports or make them available for public inspection, as well as publish an annual summary report based on an independent analysis of the data submitted. The Department shall use the quarterly reports and its analysis to identify patterns and practices by the health plans for purposes of fulfilling its regulatory duties, including, but not limited to, licensing, auditing, and enforcement.

Section 1300.68(f): Department Review of Grievances

The proposed regulations would delete the Department's ability to waive the requirement that an enrollee participate in the plan's internal grievance process before submitting the grievance to the Department for review. [p. 7, lines 24-25] We oppose deleting this provision, as the Department should maintain flexibility in this area. The regulations should also explicitly state that cases involving an imminent and serious threat to the health of the patient are exempted from this requirement, as specified in Health and Safety Code Section 1368(b).

Moreover, this section must make clear that an enrollee may contact the Department for information and assistance at any time, even if not yet permitted to file a formal grievance. When the Department refers an enrollee back to the plan for completion of the grievance process for 30 days, it should follow up to make sure the enrollee's grievance has been satisfactorily resolved.

Amend Section 1300.68(f) as follows:

An enrollee may submit a grievance to the Department for review after (1) completing the plan's grievance process, or (2) having participated in the plan's grievance system for thirty (30) days; however, this requirement shall be waived in any case involving an imminent and serious threat to the health of the enrollee or if the Department determines that an earlier review is necessary. Nothing in this section shall preclude an enrollee from seeking assistance from the Department or from the Office of the Patient Advocate prior to completion of the plan's grievance process or having participated in the plan's grievance process for 30 days.

The Department shall review a sample of the grievances resolved by the plan and contact the enrollees to determine whether the grievance was satisfactorily resolved.

Upon receipt of such grievance, the Department shall notify the plan. . . .

We strongly support the provision allowing the Department to rule in an enrollee's favor on any issue that it cannot decide as a result of the plan's failure to submit requested information [p. 8, lines 20-22]. This provision is essential to the Department's ability to enforce the time frames for plans to submit requested information.

1300.68.01 EXPEDITED REVIEW OF GRIEVANCES

Section 1300.68.01(a): Plan Review of Urgent Grievances

We support the requirement that plans act on urgent grievances within 3 days of receipt [p. 12, lines 18-20], as specified in Health and Safety Code Section 1368.01(b). When a grievance involves an imminent and serious threat to an enrollee's health, it is critical that both the plan and the Department respond as quickly as possible.

This provision should explicitly define cases involving "an imminent and serious threat to the health of the enrollee" [p. 12, line 13] in accordance with Health and Safety Code Section 1368.01(b). Thus an enrollee suffering from severe pain is entitled to expedited review even if the condition does not ultimately threaten life or limb. Situations in which delaying a medical treatment would reduce the effectiveness of the treatment for the enrollee who has a debilitating, chronic or serious health condition should also constitute imminent and serious threats to the health of enrollee.

There may be some cases where an enrollee may not be able to submit an urgent grievance and may not have a representative to act on his or her behalf. In such a case, an enrollee's physician should be allowed to submit an urgent grievance to the Department on the enrollee's behalf.

In addition, health plans must ensure that every enrollee for whom requested care has been denied, delayed, or modified is notified of that decision. For example, if the enrollee is in the hospital, mailing a letter to the enrollee's home is clearly inappropriate.

Finally, we are concerned that health plans may require burdensome proof that a grievance is urgent. According to the statute, expedited review is triggered when "the plan has notice of a case requiring expedited review." We recommend clarifying what constitutes such notice.

Amend Section 1300.68.01(a) as follows:

Every plan shall include within its grievance system, procedures for the expedited review of grievances involving an imminent and serious threat to the health of the enrollee ("urgent grievances"). Cases involving an imminent and serious threat to the health of the enrollee shall include, but not be limited to, severe pain; potential loss of life, limb, or major bodily function; and any situation in which delaying a medical treatment would reduce the effectiveness of the treatment for an enrollee who has a debilitating, chronic or serious health condition. An enrollee, an enrollee's representative, or the enrollee's physician may notify the Department of an urgent grievance.

Notice to the plan that a grievance is urgent shall include, but is not limited to, any of the following: documentation from a prescribing or treating provider; a statement by the enrollee; or other information in the possession of a plan indicating the likelihood that the expedited review timeframe applies.

At a minimum, plan procedures for urgent grievances shall include the following:

(1) The plan shall immediately notify the complainant enrollee, the enrollee's representative, and the enrollee's physician of his/her right to notify the Department of the grievance.

(2) The plan shall provide the complainant enrollee, the enrollee's representative, and the enrollee's physician and the Department with a written statement on the disposition or pending status of the urgent grievance within three (3) days of receipt.

(3) The enrollee's medical condition shall be considered by the plan when determining the response time.

(4) The plan shall be able to document that it has notified every enrollee for whom a requested health care service has been denied, delayed, or modified of the availability of independent medical review.

Section 1300.68.01(b): System for Plan Contact with Department

We support the requirement that plans respond to Department contacts regarding urgent grievances within 30 minutes during normal business hours and within one hour at all other times. [p. 12, line 23 - p. 13, line 9] These prompt response times by a plan representative with decision-making authority are fundamental to the Department's ability to resolve urgent grievances. Enrollees in severe pain or emergency situations should not have to wait merely because it is the weekend or because a particular plan staff member is unavailable.

Section 1300.68.01(c): Changes to Medical Services Pending Urgent Grievance Resolution

The requirement that a plan notify the Department before changing medical services [p. 14, lines 1-4] is inadequate to protect the interests of the patient who has filed an urgent grievance. The plan must be prohibited from discharging an enrollee from the hospital against his or her wishes before the Department has rendered a decision. Unless the status quo is maintained pending resolution of the grievance, an enrollee's request to remain in the hospital would likely become moot. However, enrollees in this situation must also be informed that they will have to pay for the additional care if the grievance is not resolved in their favor.

Amend Section 1300.68.01(c) as follows:

If pPrior to the Department's resolution of an urgent grievance, the plan or its contracting providers determine shall not make changes to the medical services are necessary, such as a discharge from a hospital, and if the enrollee or the enrollee's representatives object, the plan shall immediately notify the Department. The plan or its contracting providers shall notify the enrollee or the enrollee's representatives that they will have to pay for additional care provided pursuant to this provision if the urgent grievance is not resolved in their favor.
 

 1300.70.4 INDEPENDENT MEDICAL REVIEWS: EXPERIMENTAL/INVESTIGATIONAL
 

Section 1300.70.4(a)
 

Subsection 2: Conditions Necessary to Qualify for Review
 

We support the provision requiring the Department to accept the certification of an enrollee's physician as sufficient. [p. 15, lines 1-3] An enrollee's physician is in the best position to assess whether the condition is life threatening or seriously debilitating, and enrollees facing such conditions should not have to face additional obstacles to review. For similar reasons, we agree that the Department must have discretion to waive the stated conditions for review in exceptional circumstances or where the need for urgent review makes it impossible to obtain all of the information in writing. [p. 16, lines 22-23]
 

Subsection 3: Enrollee Application for Review
 

We support the provision exempting an enrollee from seeking review of a denial through the plan's grievance system prior to applying for independent medical review under this section. [p. 17, lines 5-7] In contrast to the eligibility criteria for independent review in disputes over medical necessity, the legislation on independent review for experimental/investigational treatment does not require exhaustion of the plan's internal grievance process. [See Health and Safety Code Section 1370.4(a)]
 

1300.74.30 INDEPENDENT MEDICAL REVIEW SYSTEM: MEDICAL NECESSITY
 

Cultural and Linguistic Access and Access for the Disabled
 

These regulations fail to address the issue of access to the independent medical review process for enrollees who do not speak English, come from diverse cultural backgrounds, and live with disabilities. Without specific provisions ensuring access to every aspect of the process, millions of California health plan enrollees will be unable to participate in the independent review system which is meant to protect them. Every document necessary to the independent review process must be made available in the languages of the enrollee population, including notice of the right to independent review, the application form, requests for information, and the summary of the IRO decision. Interpreter services and auxiliary aids for those with disabilities must be available for enrollees seeking information about or assistance with the independent review process.
 

Add language to Section 1300.74.30 as follows:
 

The plan shall assess the linguistic and cultural needs of the enrollee population and the needs of the enrollee population with disabilities and shall file that assessment with the Department. The Department and the plan shall make written translations of independent medical review materials and interpreters available by telephone in any language which the plan determines that the enrollee population in any service area speaks. These translations shall be made available upon request by the enrollee or an enrollee's representative. A notice that both translations and interpreter services in languages other than English are available shall appear in languages other than English on all required disclosures to health plan enrollees. The plan shall also provide materials and processes for independent medical review that are accessible to those with visual, hearing or manual impairments.
 

Inclusion of All Entities with Decision-Making Authority
 

We strongly support the application of this section to decisions made not only by health plans but also by any entity to which the plan has delegated decision-making authority. [p. 17, lines 15-19] Given the widespread delegation of decision-making authority to medical groups which contract with health service plans, their inclusion is critical to a meaningful system of independent medical review for California health care consumers.
 

Characterization of Health Plan Decision
 

We oppose the proposed language suggesting that an enrollee's right to seek independent medical review depends upon the health plan's characterization of its decision as based on medical necessity. According to Health and Safety Code Section 1374.30(d)(3), the Department - and not the plan -- is charged with the final determination of the nature of the health plan decision and of the grievance's eligibility for independent medical review. This provision must be amended to prevent health plans from denying access to independent medical review simply by characterizing their decisions as coverage decisions.
 

Definition of Health Care Service
 

The proposed definition of a health care service does not adequately protect the interests of health care consumers because it includes only procedures, treatments, etc., for a condition which has been diagnosed. [p. 17, lines 19-23] In fact, there may be patients who face symptoms for which there is no clear diagnosis, but for whom some form of treatment could still be beneficial. Moreover, there will be instances in which independent medical review is necessary to resolve a dispute regarding the medical necessity of a diagnostic procedure itself. Neither of these circumstances are excluded from independent medical review by statute. The definition of a health care service should be expanded to include all such disputes.
 

Amend Section 1300.74.30 as follows:
 

Every health care service plan shall provide an enrollee with the opportunity to seek independent medical review procedures for independent medical review of decisions made by the plan or any entity to which the plan has delegated decision-making authority when health care services have been denied, delayed, or modified based upon a finding that the requested health care service is not medically necessary or is experimental or investigational. A plan's characterization of a decision to deny, delay or modify a health care service as a "coverage decision", as defined in Section 1374.30(c), shall not affect an enrollee's opportunity to seek independent medical review. The department shall be the final arbiter when there is a question as to whether a dispute concerns medical necessity, experimental or investigational therapies, or a coverage decision.
 

For purposes of this section, a "health care service" is any medical care procedure, treatment, therapy, medication, or device that is sought to prevent, diagnose, detect, treat, or palliate a medical condition, disease, illness, injury, pregnancy, genetic defect or congenital defect or to maintain, restore or prevent further deterioration of functional ability for the treatment of a medical condition which has been diagnosed by a qualified health care provider acting within the scope of his or her professional practice.
 

Section 1300.74.30(a): Qualifying Conditions
 

Subsection 3: Because an enrollee must see an in-plan provider to qualify for independent medical review under this provision [p. 18, lines 5-7], the enrollee's ability to see an in-plan provider promptly is essential. This provision should reiterate the requirement of Health and Safety Code Section 1374.30(j)(1)(C) that the plan must expedite access to an in-plan provider upon request of an enrollee.
 

Amend Section 1300.74.30(a)(3) as follows:
 

In the absence of (1) or (2), the enrollee has been seen by an in-plan provider for the diagnosis or treatment of the medical condition for which the enrollee seeks independent medical review. The plan shall expedite access to an in-plan provider upon request of an enrollee.
 

Section 1300.74.30(b): Use of Out-of-Plan Providers
 

We are concerned that this provision restricts the scope of review in cases where the enrollee obtained emergency services from an out-of-plan provider to determining whether the services provided were medically necessary "to screen and stabilize the enrollee's condition" [p. 18, lines 10-13], and ignores those instances in which an enrollee reasonably believed that an emergency did exist. For this reason, we suggest the following changes:
 

Amend Section 1300.74.30(b) as follows:
 

To qualify under (a)(1) and (a)(2), the provider may be a provider outside of the plan's network. If the plan disputes that the urgent or emergency service was medically necessary, the case shall be submitted to independent medical review on that issue. In cases where the enrollee obtained emergency services from an out-of-plan emergency provider, the independent medical review shall determine whether the services provided were medically necessary to screen and stabilize the enrollee's condition or to maintain the enrollee's stabilized condition up to the time that health care service plan effectuates the enrollee's transfer or the enrollee is discharged. In cases where the enrollee obtained urgent, but not emergency, services from an out-of-plan provider, independent medical review shall determine whether time was a critical factor in providing the service to the enrollee. For purposes of this section "emergency services" are services for emergency medical conditions as defined in Section 1300.71.4 of these rules and shall include those for which an enrollee reasonably believed that an emergency existed….
 

Section 1300.74.30(c): Qualifying Under (a)(3)
 

We strongly support the provision stating that a recommendation from the in-plan provider is not required to qualify for independent medical review. [p.18, lines 23-25] This provision accurately reflects Health & Safety Code Section 1374.30(j) and protects a patient's right to seek recommendations from medical professionals independent of the health plan.
 

Section 1300.74.30(d): Eligibility Criteria
 

Subsection 1: This provision should make clear that a dispute is eligible for independent review if it raises any issue regarding medical necessity, even if other issues are raised as well.
 

Amend Section 1300.74.30(d)(1) [p. 19, lines 5-8] as follows:
 

A decision by the plan or any entity to which the plan has delegated decision-making authority to deny, delay or modify a requested health care service under any of the qualifying events specified in subsection (a) above based in whole or in part on a finding by the plan or the Department that the requested service is not medically necessary or is experimental or investigational.
 

Subsection 4: This provision states that an enrollee must participate in the plan's grievance process for at least 30 days before becoming eligible for independent medical review. [p. 19, lines 15-16] In fact, as reflected elsewhere in these regulations, Health and Safety Code Section 1374(j)(3) also renders cases eligible for independent review when the disputed decision is upheld by the plan's grievance process, even if that process is completed in less than 30 days.
 

Amend Section 1300.74.30(d)(4) as follows:
 

The disputed decision has been upheld by the plan or the enrollee has participated in the plan's grievance process for at least thirty (30) days; and
 

Subsection 5: This provision is contrary to the statute because it omits the director's discretion to extend the six-month deadline for good cause. [Health and Safety Code Section 1374.30(k)] This should be added to the regulation. We also propose including examples of good cause for an extension, which we have adapted from federal regulations concerning extensions of time to file requests for redetermination of federal OASDI benefits. [20 C.F.R. 404.911]
 

In addition, the words "whichever is later" should be added [p. 19, line 19] to clarify that the enrollee will be given the longest amount of time possible under the statute to apply for independent medical review. Moreover, enrollees should have six months from the completion of the plan's internal grievance process to apply for independent review, since only then can the enrollee be considered to have notice of the plan's final determination.
 

Amend Section 1300.74.30(d)(5) as follows:
 

The request for independent medical review is filed with the plan or the department within six months of the qualifying event(s) as set forth in subsection (a), above, or within six months from the time of notice to the enrollee, whichever is later. An enrollee cannot be considered to have received notice of a denial of requested treatment until the plan's internal grievance process has been exhausted or the grievance remains unresolved after 30 days.
 

Notwithstanding this provision, the director may extend the application deadline beyond six months if the circumstances of a case warrant the extension. Circumstances warranting an extension may include, but are not limited to:

(A) Where any actions or statements by the plan, the enrollee's provider, or the Department misrepresented the deadlines or other requirements for independent medical review, delayed the receipt of the request by the Department, or misled the enrollee regarding the independent medical review generally;
 

(B) Where the enrollee did not understand the requirements of the Act;

(C) Where the enrollee had any physical, mental, educational, or linguistic limitations (including any lack of facility with the English language) that prevented the enrollee from filing a timely request or from understanding or knowing about the need to file a timely request for review;
 

(D) Where the enrollee was seriously ill or incapacitated and was unable to contact the Department directly, or through a friend, relative, or other person;

(E) Where there was a death or serious illness in the enrollee's immediate family;

(F) Where the enrollee did not receive notice, or received inadequate notice, of the determination or decision to deny a health care service;

(G) Where the enrollee sent the request to another government agency, to the enrollee's plan, or to the enrollee's provider in good faith within the time limit and the request did not reach the Department until after the time period had expired; and

(H) Where there are other unusual or unavoidable circumstances that demonstrate that the enrollee could not have known of the need to file timely, or that prevented the enrollee from filing timely.
 

Section 1300.74.30(e): Application for Review
 

We strongly oppose the proposed application process, which places the burden on the enrollee to provide copies of medical documentation [p. 20, lines 6-11] and correspondence with the plan [p. 20, lines 1-3, 15-17, 20-22]. The application process is supposed to be as simple as possible, as is clearly contemplated by the statutory language requiring a one-page application form [Health and Safety Code Section 1374.30(m)]. While the statute requires informing enrollees of their right to submit documentation in support of their claim, nowhere does it suggest that an enrollee - who may well be bed-ridden or in severe pain - is required to do so. In fact, Health and Safety Code Section 1374.30(n) clearly places the burden of producing all relevant documentation on the plan.
 

In short, the application process must require only the one-page form with a signature authorizing the release of confidential medical records. The application should also ask for, but not require, that an enrollee include a copy of the plan's adverse determination if available, in order to facilitate the process for both the Department and the plan. At the same time, the Department must ensure that enrollees wishing to submit additional documentation are provided the opportunity to do so.
 

Amend Section 1300.74.30(e) as follows:
 

Applications for independent medical reviews shall be submitted on a one-page form provided by the department or provided by the plan and approved by the department. The form shall include:

1) notice that a decision not to participate in the independent medical review process may cause the enrollee to forfeit any statutory right to pursue legal action against the plan regarding the disputed health care service;

2) a statement indicating the enrollee's consent to obtain any necessary medical records for the plan, any of its contracting providers, and any out-of-plan provider the enrollee may have consulted on the matter, to be signed by the enrollee or a person authorized pursuant to law to consent to health care for the enrollee;

3) notice of the enrollee's right to provide information or documentation, either directly or through the enrollee's provider, in support of the grievance; and

4) a request that the enrollee include a copy of the plan's adverse determination if available.
 

The application shall consist of the one-page form and the following attachments:

(1) A copy of any adverse determination notifying the enrollee that the request for health care services was modified or denied in whole or in part based on a decision that it is not medically necessary or is considered experimental or investigational;

(2) In the case of a denied claim for payment of urgent or emergency services, a copy of the notice of denial; As applicable for the type of qualifying event, a statement from the enrollee's physician and relevant medical records or other documents in the possession of the enrollee, or the enrollee's representative indicating that a health care service is recommended and medically necessary; that urgent or emergency care provided was medically necessary; or that the enrollee has been seen by a plan provider for diagnosis or treatment for the medical condition that is the subject of the disputed health care. An application shall not be considered incomplete or untimely solely on the basis that the enrollee's physician has failed to submit such documentation within the six-month timeframe to apply for an independent medical review request pursuant to Section 1374.30(k).

(3) A copy of the grievance filed by the enrollee or the enrollee's representative with the plan or with any entity to which the plan has delegated grievance resolution;

(4) A copy of the plan's or the delegated entity's response to the grievance, if any;

(5) The signature of the enrollee, or a person authorized pursuant to law to consent to health care for the enrollee, authorizing release of medical and treatment information.

(6) Any additional information considered relevant to the determination of issues presented, including all information submitted to the plan, or any of its contracting providers, in support of the grievance.
 

Subsection 2: We support the provision stating that an application shall not be considered incomplete or untimely solely because the enrollee's physician fails to submit the required documentation within the six-month timeframe. [p. 20, lines 11-14] An individual patient, particularly one who is ill and seeking treatment, cannot be held responsible for the physician's compliance with these regulations.
 

Subsection 7: We are concerned that this language [p. 20, line 23 - p. 21, line 2] suggests that only a statement by the physician may qualify a dispute for expedited review. In fact, while we agree that a physician statement should suffice, the law also allows the Department to determine on its own that a dispute is eligible for expedited review in medical necessity cases. [Health and Safety Code Section 1374.33(c)] Our proposed language corrects this inaccuracy.
 

Moreover, this provision fails to address a number of logistical questions critical to enabling enrollees to request expedited review in an emergency situation such as a dispute over discharge from the hospital. As noted earlier, health plans must ensure that every enrollee for whom requested care has been denied, delayed, or modified is notified of that decision, as well as of the right to seek independent review. In addition, in urgent situations, the enrollee should not be required to file the form described in this section, but instead should be able to request expedited independent medical review by telephone or fax communications.
 

Amend Section 1300.74.30(e)(7) as follows:
 

The plan shall be able to document that it has notified every enrollee for whom a requested health care service has been denied, delayed, or modified of the availability of independent medical review.

Notwithstanding any other requirements of this section, requests fFor expedited independent medical reviews under Sections 1370.4(c)(2) or 1374.33(c) may be submitted by telephone or facsimile.
 

For expedited independent medical review under Section 1370.4(2), the statement from the enrollee's physician must indicate that the disputed care, treatment or therapy would be significantly less effective if not promptly initiated or that an imminent and serious threat to the health of the enrollee may exist without the requested health care service. For expedited independent medical reviews under Section 1374.33(c), either the enrollee's provider or the Department must certify in writing that an imminent and serious threat to the health of the enrollee may exist.|
 

Subsection 8: We agree that the Department should advise the appropriate parties when portions of an application are incomplete. [p. 21, lines 3-7] However, as explained above, we strongly oppose requiring the enrollee to submit anything except the one-page application form in order to apply for independent review. Thus, there would be no case in which the Department needed to advise an enrollee of an incomplete application unless the form itself was incomplete. In that case, the incomplete application should be considered timely if submitted within the six-month timeframe. This is the policy followed in New York, where an "application is…considered timely if submitted within the requisite timeframe, regardless of whether the application is complete."(10)
 

Section 1300.74.30(f): Evaluation of Applications
 

Subsection 1: We strongly oppose the use of the Medi-Cal fair hearing process "in lieu of" the independent review process. [p. 21, lines 12-14] Health and Safety Code Section 1374.30(f) expressly states that Medi-Cal beneficiaries shall not be excluded from independent medical review. As beneficiaries of a state-sponsored program as well as enrollees in a health plan, they have a right to participate in both the Medi-Cal fair hearing process and the independent review process when a dispute arises regarding the medical necessity of health services.
 

The right to a fair hearing is a federal constitutional right and cannot be limited by state regulations. The right to independent review is a statutory right and likewise cannot be limited by this regulation. Finally, these are not interchangeable proceedings. The independent review is a paper review, without representation, and is limited to a determination of medical necessity. The fair hearing is an administrative proceeding with a right to representation and can encompass many issues including eligibility or coverage as well as medical necessity.
 

Amend Section 1300.74.30(f)(1) as follows:
 

Immediately upon receipt of any application from a Medi-Cal enrollee, the enrollee and the health plan will be notified by the department of the enrollee's right to participate in the Medi-Cal fair hearing process in lieu of and independent medical review. If requested, the enrollee does not elect to participate in the Medi-Cal fair hearing process, the department will evaluate whether the application meets the criteria for independent medical review. Coverage disputes and other disputes that are not eligible for independent medical review shall be reviewed through the department's internal grievance resolution process. The department shall review cases in accordance with the statutes and regulations of the Medi-Cal program.
 

Subsection 2: We oppose the exclusion of Medicare cases from California's independent review process. [p. 21, lines 20-24] Health and Safety Code Section 1374.30(f) precludes the exclusion of Medicare beneficiaries unless expressly preempted by federal law. The language in this section should parallel the recommended language of the above section on Medi-Cal.
 

Amend Section 1300.74.30(f)(2) as follows:
 

Immediately upon receipt of any application for independent medical review or a grievance involving a coverage dispute from an enrollee enrolled in the Medicare program, the department shall notify the enrollee and the health plan that the complaint will be forwarded to the Center for Health Dispute Resolution (CHDR) for a determination in addition to being subject to the department's review and independent medical review processes. The department will not review cases that are within CHDR's jurisdiction; however, this shall not prevent the department for reviewing complaints from Medicare enrollees that are not reviewed by CHDR.
 

Subsection 3: As discussed above, the Department has the responsibility to determine whether a disputed service should be referred for independent review. [Health and Safety Code Section 1734.30(d)(3)] Even if a plan explicitly excludes certain benefits, the dispute may be eligible for independent review if there are some instances when the plan approves those benefits for some enrollees.
 

Amend Section 1300.74.30(f)(3) [p. 22, lines 1-4] as follows:
 

For all other cases, the Department shall determine whether or not the case will be referred to independent medical review. The Department shall determine whether an enrollee grievance regarding a disputed health care service is based, in whole or in part, on consideration of medical necessity. In so doing, the Department shall review any assertion by the enrollee or a provider that the decision was based, in whole or in part, on consideration of medical necessity. In making this determination, in addition to the eligibility criteria set forth above, the Department may consider other factors such as the enrollee's medical condition, and the nature of the requested service, and other factors indicating that the disputed health care service may be medically necessary, such as the plan's history of approving similar services for enrollees.
 

Subsection 4: If the Department "cannot determine whether the enrollee's grievance relates to a plan finding that a health care service is not medically necessary," [p. 22, lines 6-7] then the Department should refer the grievance to independent medical review for review of any medical necessity issues that may arise. The plain intent of the law was to refer grievances in which any question of medical necessity arose to independent medical review. This language is murky and could be used to undermine the intent of the law.
 

Amend Section 1300.74.30(f)(4) as follows:
 

If the Department determines that the case should not be referred to independent medical review, or cannot determine whether the enrollee's grievance relates to a plan finding that a health care service is not medically necessary, the Department shall review and evaluate the case through the department's internal complaint resolution process. The enrollee (or representative), health plan and any involved provider shall be advised of the Department's determination.
 

Subsection 6: This provision states that the Department "may" impose administrative penalties on plans that do not comply with the independent medical review system. [p. 22, lines 16-22] However, only the consistent assessment of penalties for every case of misconduct will effectively ensure compliance with the independent review system. Therefore, the word "may" should be deleted and replaced by "shall." Mandatory penalties are consistent with Health and Safety Code Section 1374.34(b), which provides that "the plan shall be subject to an administrative penalty…."

Amend Section 1300.74.30(f)(6) as follows:

When the Department finds that the plan fails to advise enrollees of the availability of independent medical review in cases that the Department determines meet the criteria set forth in subsection (a), above, discourages enrollees from seeking independent medical review, engages in a practice of mis-characterizing decisions substantially based on medical necessity as coverage decisions, or otherwise interferes with the rights of enrollees to obtain independent medical review, the Department may shall impose administrative penalties on the plan in accordance with Section 1374.34 of the Act.
 

Section 1300.74.30(g): Departmental Decision
 

This provision requires the Department to notify the enrollee and the plan if an application is eligible for independent review within 48 hours for an expedited review. [p. 22, lines 23-26]. These regulations should indicate that the status quo must be preserved while the Department makes this decision. Thus, an enrollee disputing a hospital discharge could not be discharged while waiting for a response from the Department.
 

Amend Section 1300.74.30(g) as follows:

The director shall notify the enrollee and the enrollee's health care plan if an application for independent medical review is determined to be eligible for independent medical review within seven days of receipt of a completed application for a routine request and within 48 hours of receipt of a completed application for an expedited review. The notification shall include identification of the independent medical review organization; the number of medical providers who shall review the case; and whether the review shall be conducted on an expedited or routine basis. The director shall also transmit to the enrollee's health care plan a copy of the enrollee's signed release of medical and treatment information and copies of all other materials submitted with the enrollee's application. Prior to the resolution of an expedited independent medical review, the plan or its contracting providers shall not make changes to the medical services, such as a discharge from the hospital, if the enrollee or the enrollee's representatives object.
 

Section 1300.74.30(h): Plan Submission of Information
 

For the sake of consistency with the opening provision of these regulations, the phrase "or any entity to which the plan has delegated decision-making authority" should be added after each reference to the plan. [p. 23, lines 12, 16, 17]
 

Amend Section 1300.74(h) as follows:
 

The plan shall submit the following information within three (3) calendar days after receipt of the notification for a regular review and one (1) calendar day in the case of an expedited review, unless otherwise advised in the notification: 1) a copy of all correspondence from and received by the plan concerning the disputed health care service, including but not limited to, any enrollee grievance relating to the requested service, 2) the plan's response to any additional issues raised in the enrollee's application for independent medical review, 3) a complete and legible copy of all medical records and other information used by the plan, or any entity to which the plan has delegated decision-making authority, in making its decision regarding the disputed health care service, 4) a copy of the cover page of the applicable evidence of coverage and other relevant pages of the evidence of coverage with the specific sections pertaining to the enrollee's grievance underlined, 5) any other relevant information the plan, or any entity to which the plan has delegated decision-making authority, used to reach its decision, 6) any other information the plan believes is relevant to the independent medical review determination, and 7) if the plan, or any entity to which the plan has delegated decision-making authority, did not use medical records or did not rely upon any information other than evidence of coverage to make its decision, the plan shall so state. The health plan shall provide sufficient number of complete sets of materials for independent review organization and for each reviewer. Copies of the materials shall also be sent to the enrollee and/or the enrollee's provider and to the Department at the same time they are submitted to the independent review organization.
 

Section 1300.74.30(k): Number of Reviewers
 

The use of one independent reviewer for standard cases and three for experimental or investigational therapies [p. 24, lines 19-23] appropriately reflects the greater complexity of the latter in most instances. These are the same numbers of reviewers used in New York.(11) However, there may be cases not involving experimental or investigational therapies that are highly complex, and these may require three reviewers as well, according to the judgment of the Department. This provision should clarify that the Department, and not the independent review organization (IRO), has sole authority to determine the number of reviewers for a given case.
 

Amend Section 1300.74.30(k) as follows:
 

Reviews performed under this section for determination of medical necessity shall normally be assigned one independent reviewer. Reviews performed for experimental or investigational therapies shall be assigned to a panel of three reviewers. The Department and, in consultation with the independent medical review organization, shall have sole authority to determine the medical specialties and number of reviewers assigned to a particular case.
 

In the event more than one reviewer reviews a case, the recommendation of the majority shall prevail. If the reviewers' determinations are evenly split, the decision shall be in favor of providing the service.
 

New Section 1300.74.30(l): Medical Necessity Decisions (with remaining sections to be renumbered)
 

These regulations fail to enumerate the possible bases for a finding of medical necessity, which are specified in Health and Safety Code Section 1374.33(b). These bases, and the fact that there is no hierarchy among them (i.e., no one basis is preferable over another), were the subject of intensive legislative debate, and should be recited in the regulations.
 

Amend Section 1300.74.30 (p. 24, after line 26) by adding a new subparagraph (l) as follows:
 

Following its review, the reviewer or reviewers shall determine whether the disputed health care service was medically necessary based on the specific medical needs of the enrollee 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.

In making the determination as to whether the disputed health care service was medically necessary, the reviewer or reviewers shall not give preference to any of the five standards listed and shall in all cases give due consideration to the specific medical needs of the enrollee.
 

Section 1300.74.30(l): Reviewers' Determinations
 

This section fails to describe the dissemination of the reviewers' analyses and determinations. [p. 25, lines 1-2] We recommend that it be amended to reflect Health and Safety Code Section 1374.33(e), which requires the IRO to provide the analyses and determinations (as well as a description of the reviewers' qualifications) to the Department, the plan, the enrollee and the provider.
 

In addition, the IRO should be required to provide the enrollee with a layperson's summary of its reviewers' determination, in order to comply with Health and Safety Code Section 1374.33(c), which requires determinations to be "in layperson's terms to the maximum extent practicable." While the proposed regulation would have the reviewers "use plain English where possible" [p. 25, line 2], it is unlikely that the reviewing clinicians themselves will successfully do so to the extent necessary for comprehension by patients with limited literacy skills. Thus the burden rests with the IRO to provide a readable analysis to the enrollee.
 

Amend Section 1300.74.30(l) as follows:
 

Each assigned reviewer shall issue a separate written analysis of the case, explaining the determination made, using plain English where possible to the maximum extent practicable. Reviewers shall determine whether or not the dispute service is medically necessary for the enrollee. The analysis will describe how the determination relates to the enrollee's medical condition and history, relevant medical records and other documents considered, and references to the specific medical and scientific evidence listed in Sections 1370.4(d) or 1370.33(b) of the Act, as applicable. In experimental or investigational reviews, reviewers will reference the medical and scientific evidence considered in assessing whether or not the requested health care service is likely to be more beneficial for the enrollee than any available standard therapy. The analysis may also discuss the risks and benefits considered by the reviewer in considering proposed and standard treatments. The independent review organization shall provide the department, the plan, the enrollee, and the enrollee's provider the analyses and determinations of each of the reviewers, and a description of the qualifications of the reviewers. The independent review organization shall provide, in layperson's terms to the maximum extent practicable, a summary of the reviewers' decision to the department and the enrollee.
 

New Section 1300.74.30(o): Enforcement of Decisions
 

The proposed regulations fail to track the statute's provisions for ensuring health plan compliance with an IMR decision. For example, Section 1374.34(b) prohibits plans from prolonging the IMR process and provides for administrative penalties on the plan for noncompliance with an IMR decision. These provisions should be included in the regulations.
 

Amend Section 1300.74.30 (p. 25, after line 20) by adding a new subparagraph (o) as follows:
 

(o) A plan shall not engage in any conduct that has the effect of prolonging the independent review process. The engaging in that conduct, or the failure of the plan to properly implement the decision, is a violation of the Act and shall subject the plan to the penalties set forth in Section 1374.33(b) of the Act. In the case of a decision to provide a disputed health care service, the plan shall report to the Department whether it has in fact provided the service within 5 days of the date the service was first provided to the enrollee. The Department shall also periodically audit to ensure the accuracy of plan reports of compliance with a decision that a disputed health care service must be provided by randomly selecting such cases and contacting the enrollee or the enrollee's representative to verify plan compliance with the decision.
 

New Section 1300.74.30(p): Reporting and Use of Independent Medical Review Decisions
 

As with plan grievances, the Department should publish a report analyzing the cases received for independent medical review so that health care consumers and their representatives can compare health plans and identify trends in independent medical review decision-making. This report should be annual and should include figures on the numbers and types of requests for review, broken down by plan and type of disputed health care services (e.g., inpatient hospital lengths of stays, surgical services, and mental health care), with experimental/investigational cases distinguished from medical necessity cases.
 

In addition, the Department should compile and make publicly available brief summaries of every independent medical review decision, while ensuring the confidentiality of the enrollee. This information will enable plans to identify trends in medical necessity decisions, modify practice guidelines accordingly, and thereby improve treatment outcomes. Finally, the Department should use this compilation to inform its other regulatory duties, such as licensing, auditing, and enforcement. For example, if the summaries demonstrate that plan denials of a certain procedure have repeatedly been overturned in independent review, the Department may consider imposing administrative penalties on a plan which continues to deny that procedure.
 

Add Section 1300.74.30(p) as follows:
 

1) The Department shall publish an annual report analyzing the cases received for independent medical review. The report shall include, in total and separately for each plan: the number of requests for review; the number of cases found eligible for review; the numbers of requests and eligible cases per 10,000 enrollees; the numbers of eligible cases upheld and overturned; and the types of disputed health care services (e.g., inpatient hospital lengths of stays, surgical services, and mental health care). The report shall distinguish experimental/investigational cases from cases based on a determination of medical necessity.
 

2) The Department shall make available a brief summary of every independent medical review decision. These summaries shall preserve the confidentiality of the enrollees. The Department shall periodically review the decisions and summaries to identify patterns and practices by the health plan for purposes of fulfilling its regulatory duties, including, but not limited to, licensing, auditing, and enforcement.

______
NOTES:

(1) 414 U.S. 563 (1974).

(2) 65 Fed. Reg. 52762-52774, dated August 30, 2000.

(3) www.healthlaw.org

(4) Id.

(5) New York Codes Rules & Regulations, Section 405.7(a)(7). (Emphasis added).

(6) Id. (Emphasis added).

(7) Id.

(8) Calif. Gov't Code Sec. 7299.6

(9) Consumers Union and Center for Health Care Rights, "Manage to Care: How California Can Better Inform Consumers About Managed Care," pp. 28-29. June 1999.

(10) New York State Insurance Department and New York State Health Department, "External Appeal Program Annual Report: July 1, 1999 - June 30, 2000." p. 15.

(11) New York State Insurance Department and New York State Health Department, "External Appeal Program Annual Report: July 1, 1999 - June 30, 2000." p. 1.

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