Cal. Code Regs. Tit. 8, § 9792.25.1 - Mtus Methodology for Evaluating Medical Evidence

(a) When competing recommendations are cited to guide medical care, Utilization Review and Independent Medical Review physicians shall apply the MTUS Methodology for Evaluating Medical Evidence to evaluate the quality and strength of evidence used to support the recommendations that are at variance with one another. The MTUS Methodology for Evaluating Medical Evidence provides a process to evaluate studies, not guidelines. Therefore, the reviewing physician shall evaluate the underlying study or studies used to support a recommendation found in a guideline. Medical care shall be in accordance with the recommendation supported by the best available evidence. The MTUS Methodology for Evaluating Medical Evidence shall be applied as follows:

(1) The reviewing physician shall determine if different guidelines or studies were cited to guide the injured worker's medical care by the treating physician, the Utilization Review physician and/or the Independent Medical Review physician that contain recommendations that are at variance with one another.

(2) If different guidelines or studies were cited to guide the injured worker's medical care containing recommendations that are at variance with one another, the reviewing physician shall evaluate the quality of evidence by determining if the studies used to support the recommendations are applicable to the injured worker and his or her medical condition or injury. Applicability refers to the extent to which the individual patients, subjects, settings, interventions, and outcome measures of studies used to support a recommendation are similar to the worker and his or her medical condition or injury. A recommendation supported by inapplicable studies should not be used as the source to support, deny, delay or modify an RFA. Reviewing physicians shall provide an explanation of their rationale in the Utilization Review or Independent Medical Review decision if they conclude a recommendation is supported by studies inapplicable to the worker and his or her medical condition or injury.

(A) The evaluation of medical evidence can end after this step if a citation to a guideline or a study contains a recommendation supported by inapplicable studies and the other citation contains a recommendation that is supported by studies applicable to the injured worker's medical condition or injury.

(3) If the guidelines or studies cited contain recommendations supported by studies applicable to the worker and his or her medical condition or injury, then the reviewing physician shall continue to evaluate the quality of evidence by determining what factors, if any, bias may have had in the studies used to support the recommendations. Factors to consider include, but are not limited to, vested interests such as financial interests, academic interests, industry influence, and the methodological safeguards to protect against biases related to the generation of the randomization sequence, concealment of allocation, blinding, selective outcome reporting, early stopping, intention to treat, and confounding bias. A recommendation supported by studies determined to be of poor quality due to the presence of bias should not be used as the source to support, deny, delay or modify an RFA. Reviewing physicians shall provide an explanation of their rationale in the Utilization Review or Independent Medical Review decision if they conclude a recommendation is supported by studies determined to be of poor quality due to the presence of bias.

(A) The evaluation of medical evidence can end after this step if a citation to a guideline or a study contains a recommendation supported by studies determined to be of poor quality due to the presence of bias and the other citation contains a recommendation that is supported by studies determined to be of good quality due to the absence of bias.

(4) If the guidelines or studies cited contain recommendations supported by studies applicable to the worker and his or her medical condition or injury and if the recommendations are supported by studies that are determined to be of good quality due to the absence of bias, then the reviewing physician shall determine the strength of evidence used to support the differing recommendations by applying the Hierarchy of Evidence for Different Clinical Questions set forth in 9792.25.1(b). To apply the Hierarchy of Evidence for Different Clinical Questions, the following steps shall be taken:

(A) Determine the design of the study used to support the recommendation. Study designs are categorized as one of the following categories:

1. Systematic Review of:

(aa) Randomized Controlled Trials

(bb) Prospective or Cohort Studies

2. Randomized Controlled Trials

3. Observational studies:

(aa) Prospective study or Cohort Study

(bb) Cross-sectional study

(cc) Case-control study

(dd) Case-series

(ee) Uncontrolled or observational study

(ff) Case report

4. Published expert opinion

(B) Determine which of the four clinical questions in the MTUS Hierarchy of Evidence for Different Clinical Questions as set forth in Section 9792.25.2(b) the study is answering and then apply the corresponding hierarchy(ies) of evidence. The sequence to be followed for each of the four clinical questions is as follows:

1. If the original study answers the question "How useful is Treatment X in treating patients with Disease Y?" then the hierarchy of evidence set forth under Treatment Benefits shall apply.

2. If the original study answers the question "How useful is Test X in diagnosing patients with Disease Y?" then the hierarchy of evidence set forth under Diagnostic Test shall apply.

3. If the original study answers the question "What will happen to a patient with Disease Y if nothing is done?" then the hierarchy of evidence set forth under Prognosis shall apply.

4. If the original study answers the question "What are the harms of intervention (treatment or diagnostic test) X in patients with Disease Y?" then the hierarchy of evidence set forth under Treatment Harms shall apply.

(C) In each Clinical Question category, the levels of evidence are listed from highest to lowest, as defined by the principles of Evidence-Based Medicine. Levels of evidence shall be applied in the order listed. Recommendation for or against medical treatment based on a lower level of evidence shall be permitted only if every higher ranked level of evidence is inapplicable to the employee's medical condition.

1. The level of evidence for each published study (e.g. 1a, 1b, 2, etc.) shall be documented and included with the citation in the Utilization Review or Independent Medical Review decisions.

2. When relying on lower levels of evidence, a written statement shall be provided that states higher levels of evidence are absent.

(b) MTUS Hierarchy of Evidence for Different Clinical Questions shall apply:

MTUS Hierarchy of Evidence for Different Clinical Questions
Evidence Level	Treatment Benefits How useful is Treatment X in treating patients with Disease Y?	Diagnostic Test How useful is Test X in diagnosing patients with Disease Y?	Prognosis What will happen to a patient with Disease Y if nothing is done?	Treatment Harms What are the harms of intervention (treatment or diagnostic test) X in patients with Disease Y?
1a	Systematic review of randomized controlled trials with low risk of bias	Systematic review of high-quality prospective studies (homogeneous sample of patients, consecutively enrolled, all undergoing the index test and reference standard) or systematic review of randomized controlled trials with low risk bias	Systematic review of inception cohort studies or of control arms of randomized controlled trials with low risk of bias	Systematic review of randomized controlled trials with low risk of bias
1b	Randomized controlled trials with low risk of bias	High-quality prospective study or cohort study or randomized controlled trials with low risk of bias	Inception cohort study or control arm from one randomized controlled trial with low risk of bias	Randomized controlled trials with low risk of bias
1c	One or more randomized controlled trials with identified risks of bias (or systematic review of such trials)	Biased cross-sectional study	Cohort study or control arm of randomized controlled trials with identified risks of bias	Prospective study
2	Non-randomized cohort studies that include controls	Case-control study enrolling a broad spectrum of patients and controls with conditions that may be confused with the disease being considered	Case-series or case control studies	Randomized controlled trial(s) with identified risk of bias
3	Case-control studies or historically controlled studies	Case-control study using severe cases and healthy controls		Non-randomized controlled cohort/follow-up study (post-marketing surveillance)
4	Uncontrolled studies (case studies or case reports)		Uncontrolled studies (observational studies, case studies, or case reports)	Consistent case reports (for example, individual case safety reports from US Food and Drug Administration, which are available at the following website: www.fda.gov/ForIndustry/DataStandards/IndividualCaseSafety Reports/default.htm
5	Published expert opinion	Published expert opinion	Published expert opinion	Toxicological or mechanistic data that demonstrate or support biologic plausibility

Notes

Cal. Code Regs. Tit. 8, § 9792.25.1

1. New section filed 4-20-2015; operative 4-20-2015 pursuant to Government Code section 11343.4(b)(3) (Register 2015, No. 17).

Note: Authority cited: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code. Reference: Sections 77.5, 4600, 4604.5, 4610.5 and 5307.27, Labor Code.

1. New section filed 4-20-2015; operative 4/20/2015 pursuant to Government Code section 11343.4(b)(3) (Register 2015, No. 17).