The California Medical Treatment Utilization Schedule: SB 1160, New Treatment Guidelines, and Formulary

1 The California Medical Treatment Utilization Schedule: SB 1160, New Treatment Guidelines, and Formulary CC VI Ray Meister, MD, MPH Executive Medical Director Division of Workers Compensation Ellen Sims Langille, Esq. General Counsel Calif Workers Comp Institute 2 1

Section 1 Section 2 Section 3 Section 4 SB 1160 Impact of New Legislation The MTUS: Why? What? Where? Use recommendations found within or outside the MTUS guidelines for patient treatment How conflicting recommendations are evaluated by Utilization Review and Independent Medical Review physicians 3 3 Section 1 SB 1160 Impact of New Legislation SB 1160 added LC 4610(b): (b) Med tx (unless excepted under (c)) for DOIs o/a 1/1/18 shall be authorized without prospective UR if tx is: within 30 days of initial DOI for accepted body part/condition addressed by & consistent w MTUS by MPN/HCO member, predesignated physician, or ER selected physician/facility MPN/HCO, predesignated, ER selected physician who renders tx shall: submit the required DFR & complete RFA within 5 days of initial visit & evaluation Effective for DOI on or after 1/1/18 4 2

Section 1 SB 1160 Impact of New Legislation SB 1160 added LC 4610(c): (c) Unless authorized or rendered as emergency treatment, the following medical treatment exceptions, as defined in AD rules, are still subject to prospective UR: pharmaceutical (not exempted from prospective UR or authorized by formulary) surgery (including pre & post surgical services) psychological tx home health care imaging & radiology (not including X rays) DME with combined total value over $250 per OMFS electrodiagnostics (including electromyography & NCS) other services per AD rules Effective when AD adopts defining rules, expected by 1/1/18 5 Section 1 SB 1160 Impact of New Legislation SB 1160 added LC 4610(d): Starting in 2018, bills for medical treatment provided under passthrough provisions are required to be submitted within 30 days from the date of service. Pending legislation (SB 489) may extend this rule to 180 days for emergency room treatment. Effective 1/1/18 6 3

Section 1 SB 1160 Impact of New Legislation SB 1160 added LC 4610(e): The physician can be precluded from providing pass through treatment for the employee whose Doctor s First Report and complete RFA were not submitted within 5 days of initial visit & evaluation. This does not preclude the physician from providing pass through treatment for other employees receiving treatment from the same physician. A process for removing a physician from pass through privileges has not been established. Effective 1/1/18 7 Section 1 SB 1160 Impact of New Legislation SB 1160 added LC 4610(f): The only purpose for which retrospective UR can be used for treatment in the first 30 days is to determine compliance w/mtus If a pattern and practice of failure to comply with MTUS is established, the provider s pass through privileges may be revoked Provider can be precluded from pass through treatment for any/all EE, not just the ones included in the pattern and practice Even if no pattern and practice can be established, the C/A can still use noncompliance as basis for Petition to Change Treating Physician or to remove a provider from an MPN. Effective 1/1/18 8 4

Section 1 SB 1160 Impact of New Legislation SB 1160 amended LC 4610(g): Only a physician may deny a tx request due to insufficient information Claims administrator may not refer UR services to an entity in which it has a financial interest without prior written disclosure UR program must obtain accreditation, initially by URAC Description of UR process must be submitted to AD by 7/1/18 Once approved by the AD, the UR process description must be posted to the Internet Effective 1/1/18 9 Section 1 SB 1160 Impact of New Legislation SB 1160 amended LC 4610(i): Decisions on requests for treatment covered by the Drug Formulary must be made within five working days from receipt of the RFA This includes all Preferred drugs listed on the Formulary This includes all Non Preferred drugs listed on the Formulary Decisions on requests for Non Formulary treatment must be made within five working days of receipt of the RFA and reasonably necessary information, but no more than 14 days from the RFA. This includes drugs that are Not Listed on the Formulary This includes all other treatment requests Effective 1/1/18 10 5

Section 1 SB 1160 Impact of New Legislation SB 1160 amended LC 4610(i) and (j) : New detailed requirements when a denial is due to missing info Must immediately notify the physician and the EE that info is missing Notification must be in writing Must identify the particular missing information Once the info is received, determination must be made within the timeframes Effective 1/1/18 11 Section 1 SB 1160 Impact of New Legislation SB 1160 amended LC 4610.5: Beginning with disputes arising 1/1/18, UR and IMR will apply to disputed Formulary requests. UR and IMR determinations must be based on medical necessity, but medical evidence ranking language has been removed. Request for IMR must be made within 10 days from service of UR decision for Formulary disputes (30 days for all other tx disputes). After new regs are adopted, Claims administrators will have to electronically provide Maximus with copy of RFA, UR decision, and all other relevant medical records Effective 1/1/18 Effective 1/1/18 12 6

Section 1 SB 1160 Impact of New Legislation SB 1160 amended LC 4610.6(d): IMR review of Formulary disputes will have to be completed within 5 working days from receipt of documentation IMR review of all other tx disputes can still take up to 30 days to be completed Where the treatment has not been provided AND there is a serious and imminent threat to employee s health (potential death, loss of limb, or loss of other major body function), Maximus must complete expedited review within 3 days of receipt of documentation Effective 1/1/18 13 Section 1 SB 1160 Impact of New Legislation SB 1160 amended LC 6409(a): Physicians are going to have to start submitting their First Reports to the DWC Physicians are going to have to start submitting these reports electronically Claims administrators are going to have to start accepting these reports electronically DWC will need to have adopted electronic reporting standards and to have its electronic system in place Effective only after regs are promulgated 14 7

Section 2 The MTUS: Why? What? Where? Your Learning Objectives Define what the MTUS is and why it is critically important to the care of your patients. Identify the guidelines in the MTUS and learn how to use recommendations found in the MTUS guidelines for your patients treatment. Explain how to apply the MTUS Medical Evidence Search Sequence when considering recommendations found outside of the MTUS guidelines. Meet the Drug Formulary! 15 15 Section 2 The MTUS: Why? What? Where? Why is the MTUS important? It is the primary source of guidance for treating physicians and physician reviewers in workers compensation. It provides the pathway to providing appropriate patient care and getting treatment requests approved. 16 16 8

Section 2 The MTUS: Why? What? Where? What is the MTUS? The MTUS is a set of regulations found within the California Code of Regulations. Contains definitions, establishes the primary role of the guidelines in the MTUS, provides a Medical Evidence Search Sequence and a Methodology for Evaluating Medical Evidence when there are conflicting recommendations. Is based on the principles of evidence-based medicine (EBM). 17 17 Section 2 The MTUS: Why? What? Where? Elements of Patient Care Evidence Based Medical Guidelines Physician s Treatment Plan Patient Values & Expectations Clinical Expertise 18 18 9

Section 2 The MTUS: Why? What? Where? Where to find the MTUS guidelines? Clinical Topics Eye Chapter; Neck and Upper Back Complaints Chapter; Shoulder Complaints Chapter; Elbow Complaints Chapter; Forearm, Wrist and Hand Complaints Chapter; Low Back Complaints Chapter; Knee Complaints Chapter; Ankle and Foot Complaints Chapter; and The Stress Related Conditions Chapter. Available Online if Purchased or View in a DWC District Office Acupuncture Chronic Pain Postsurgical Opioids Special Topics Available Free Online 19 19 Section 2 The MTUS: Why? What? Where? Treatment Guidelines Updates to Current MTUS Topics General Approaches Neck and upper back Shoulder Elbow Forearm, wrist, and hand Low back Knee Ankle and foot Stress (Mental Health) Eye Chronic pain Opioids 20 10

Section 2 The MTUS: Why? What? Where? Treatment Guidelines New Topics to be Added Hip and Groin Interstitial lung disease Occupational asthma Traumatic brain injury 21 Section 2 The MTUS: Why? What? Where? MTUS Online Education Instruction on how to use the MTUS. Available online without charge. Free CME credit. Example cases. http://www.dir.ca.gov/dwc/californiadwccme.htm Next course under development: QME 22 11

Section 2 SUMMARY The MTUS: Why? What? Where? The MTUS is a set of regulations that provide an analytical framework for the evaluation and treatment of injured workers in the California workers compensation system. The recommendations found in the MTUS guidelines are presumed correct and provide a pathway for the most effective treatment for work related conditions. The DWC is planning to update all of the guidelines in the MTUS. 23 Section 3 Using recommendations found within or outside the MTUS for patient treatment. Introduction Recognize the process to follow when making a treatment request for any condition. Explain the process when making a treatment request where recommendations found within the MTUS supports treatment plan. Describe the two limited situations that may warrant a treatment based on recommendations found outside of the MTUS. Explain the process when making a treatment request found outside of the MTUS. Review the Medical Evidence Search Sequence. Explain the citation and clinical documentation requirements for approval in either circumstance. 24 24 12

Section 3 Using recommendations found within the MTUS for patient treatment. 25 25 Section 3 Using recommendations found within the MTUS for patient treatment The clinical documentation must substantiate the need for the requested treatment Request for Authorization (RFA) form (must include all treatment requests) Doctor s First Report (DFR) or Progress Report (PR 2) Without adequate documentation, the treatment request could be denied even if the recommendation is in the MTUS! 26 13

Section 3 Using recommendations found within the MTUS for patient treatment SUMMARY The physician should always begin by reviewing the MTUS guidelines. Next, the physician should determine if there is an MTUS guideline that addresses the patient s condition and if the recommendations support the physician s treatment plan. If Yes, the physician should then apply the MTUS guideline to the treatment and use the criteria to guide the physician s clinical documentation. Remember Citation to a recommendation from the MTUS is not enough by itself. Clinical documentation must support the use of that recommendation, for that patient, in that situation. Failure to properly document the MTUS requirements may result in a denial. 27 27 Section 3 Using recommendations found outside the MTUS for patient treatment 28 14

Section 3 Using recommendations found outside the MTUS for patient treatment 29 Section 3 Using recommendations found outside the MTUS for patient treatment 30 15

7/5/2017 31 31 Section 3 Using recommendations found outside the MTUS for patient treatment Proper Documentation when challenging the MTUS Physician s clinical documentation must substantiate the need for the requested treatment Request for Authorization (RFA) (include all treatment requests): Note that the MTUS is being challenged Cite the relevant study or guideline Doctor s First Report (DFR) or Progress Report (PR 2) If multiple citations, note the primary one Attach the study or guideline section 32 16

Section 3 Using recommendations found within or outside the MTUS for patient treatment SUMMARY Always begin by determining if the patient s condition is addressed by the MTUS guidelines. If the MTUS guidelines do not address the patient s condition, or if the MTUS recommendations do not support the desired treatment plan, the physician must find a recommendation outside of the MTUS that supports the treatment plan. The physician should follow the medical evidence search sequence to find a recommendation outside of the MTUS guidelines. Citing a recommendation found outside of the MTUS is not enough by itself. The physician s clinical documentation must support the use of that recommendation, for that patient, in that situation. Failure to properly document the MTUS requirements may result in a denial 33 Section 4 How conflicting recommendations are evaluated by Utilization Review and Independent Medical Review physicians. Introduction Recognize the roles of Utilization Review (UR) and Independent Medical Review (IMR) physicians. Describe how conflicting recommendations can occur. Explain the MTUS methodology for evaluating medical evidence. Recognize the citation and documentation requirements for Utilization Review and Independent Medical Review decisions. 34 17

Section 4 How conflicting recommendations are evaluated by Utilization Review and Independent Medical Review physicians. What are the roles of UR and IMR physicians? UR and IMR physicians determine if the treatment request is medically necessary Utilization Review (UR) Independent Medical Review (IMR) 35 Section 4 How conflicting recommendations are evaluated by Utilization Review and Independent Medical Review physicians. Medically Necessary Treating Physician When can conflicts occur? When the treatment that the physician recommends is not supported by an MTUS guideline OR When the patient s condition is not covered by an MTUS guideline. Evidence shows it s not Medically Necessary UR or IMR Physician 36 18

Section 4 How conflicting recommendations are evaluated by Utilization Review and Independent Medical Review physicians. Applying the MTUS Methodology for Evaluating Medical Evidence UR and IMR physicians are required to: Apply the MTUS Methodology for Evaluating Medical Evidence when there are conflicting recommendations. Evaluate the quality and strength of the underlying studies used to support each recommendation to determine which is supported by the best available evidence. The recommendation supported by the best available evidence will then be used to determine the medical necessity of the requested treatment. 37 Section 4 How conflicting recommendations are evaluated by Utilization Review and Independent Medical Review physicians. UR & IMR Decisions Physician reviewers should include: A citation to the guideline or study The level of evidence for each published study If more than one citation, provide a copy of each with an explanation of how it provides additional information not addressed in the primary citation A statement that higher levels of evidence are absent if relying on lower levels of evidence 38 19

Section 4 How conflicting recommendations are evaluated by Utilization Review and Independent Medical Review physicians. SUMMARY Utilization Review and Independent Medical Review physicians determine if the treatment requests are medically necessary. When there are conflicting recommendations, the MTUS Methodology for Evaluating Medical Evidence is applied. To determine which recommendation is supported by the best available evidence, the quality and strength of the evidence is evaluated. Reviewing physicians must provide specific documentation to justify their decisions 39 Formulary - Creation and Goals AB 1124 directed the DWC to create a workers comp formulary. RAND Study recommendation: Treatment guidelines and the formulary should incorporate the evidence based standards of care that best meet the needs of California's injured workers. Goal in implementing AB 1124: Adopt an evidence based drug formulary, consistent with the MTUS, to augment provision of timely and high quality medical care, while reducing administrative burden and cost https://www.dir.ca.gov/dwc/mtus/mtus.html 40 20

Rulemaking Procedure/Timeline Notice of Rulemaking published March 17, 2017 45 day comment period closed and Public Hearing held May 1, 2017 15 day written comment period to follow (still being planned) Formulary shall be adopted by July 1, pursuant to Govt. Code Administrative Procedure Act 41 Formulary is Designed to Meet Goals Goals accomplished through Formulary structure MTUS Treatment Guidelines The Backbone MTUS Drug List Preferred drugs No Prospective Review if in accord with MTUS Non Preferred & Unlisted Drugs Prospective Review required Special Fill & Perioperative Fill of specified Non Preferred drugs Ancillary Formulary Rules 42 21

Formulary Preferred Drugs Preferred Drug Criteria o Being noted as a first line therapy weighs in favor of being preferred. o Recommended for most acute and or acute/chronic conditions addressed in clinical guidelines weighs in favor of being preferred. o A safer adverse effects (risk) profile weighs in favor of being preferred. o Drugs listed for the treatment of more common work related injuries and illnesses weighs in favor of being preferred. No Prospective Review if in accord with MTUS 43 Formulary Non-Preferred Drugs Formulary Unlisted Drugs Non Preferred Prospective Review required Expedited UR required Expedited IMR required Unlisted Drugs Prospective Review required No expedited UR No expedited IMR 44 22

CWCI Study: Implementing the Drug Formulary Measured Preferred, Non Preferred, or Not Listed drugs 100% Source: CWCI 2017 75% 50% 25% 0% % of Prescriptions % of Payments Preferred 25.8% 19.7% Non Preferred 53.4% 48.1% Not Listed 20.7% 32.2% 26% of currently dispensed drugs are fast tracked to be dispensed without prospective UR 74% of currently dispensed drugs remain eligible for prospective UR 45 Formulary Special Fill Medications Special Fill Medications certain Non Preferred drugs 4 day supply only limited situations: omust be within 7 days from DOI omust be dispensed at the first visit opatient must demonstrate pain warranting use of opiate medication still subject to retrospective review 46 23

Formulary Peri-Operative Medications Perioperative Fill Medications No prospective review of certain Non Preferred drugs during the perioperative period Perioperative period is defined as 2 days prior to surgery to 4 days after surgery Day of surgery is counted as Day Zero Subject to retrospective review 47 Ancillary Formulary Rules Intended to support the provision of appropriate, cost effective, high quality medical care Access to non preferred and unlisted drugs Off label use Generic drug preference; requirements for brand name drug Compounded drugs Physician dispensing 48 24

MTUS Formulary Drug List Structure of MTUS Drug List: Organized by active drug ingredient Preferred / Non Preferred status Special Fill & Perioperative Fill Drug class Reference in Guideline legend ( ) ( ) Recommended Not Recommended ( No Recommendation 49 MTUS Formulary Drug List Drug Ingredient Preferred / Non Preferred* Special Fill** Peri Op*** Drug Class 1 Acetaminophen Preferred Analgesics NonNarcotic Reference in Guidelines Ankle and Foot Disorders Cervical and Thoracic Spine Disorders Chronic Pain Elbow Disorders Eye Hand, Wrist, and Forearm Disorders Hip and Groin Disorders Knee Disorders Low Back Disorders Shoulder 50 25

Formulary Legend Example Reference in Guideline legend 63 Dantrolene Sodium Non Preferred Musculoskeletal Therapy Agents (Muscle Relaxants) Cervical and Thoracic Spine Disorders Chronic Pain Hip and Groin Disorders Knee Disorders Low Back Disorders Shoulder 51 Potential Problems Failure to meet statutory deadline Delay of implementation date Lack of cost containment mechanisms Transition of legacy treatment 52 26

Additional Provisions Provision re: health & safety regulations such as California occupational Blood Borne Pathogens standard Quarterly Updates P & T Committee DWC may maintain and post a listing by National Drug Codes (NDC) of drug products on the MTUS Drug List Provision regarding Special Fill: DWC to evaluate effect on injured worker s use of opioids 53 Long-Term Opioid Use Following Treatment of Acute Pain CDC MMWR 3/17/17 In a representative sample of opioid naïve, cancer free adults who received a prescription for opioid pain relievers, the likelihood of chronic opioid use increased with each additional day of medication supplied starting with the third day, with the sharpest increases in chronic opioid use observed after the fifth and thirty first day on therapy https://www.cdc.gov/mmwr/volumes/66/wr/pdfs/mm6610a1.pdf 54 27

MTUS Formulary and Guidelines The State of California requires the use of the MTUS Guidelines and Drug Formulary for physicians treating workers compensation cases. Since the proposed updates to the MTUS treatment guidelines and the Drug Formulary are built on the foundation of ReedGroup s ACOEM Practice Guidelines and Formulary, a commercial license from ReedGroup is required when providers use the guidelines to treat patients. Purchase your annual commercial license to the ACOEM guidelines and formulary at a discounted rate of $100/year: http://go.reedgroup.com/mtus 55 55 SB 1160 + MTUS + Formulary = Better Treatment The three components we have examined today create a platform that: Aligns all treatment, including prescription medication, with the standard of care (MTUS guidelines) Improves quality of care by reducing variability Begins to reduce friction costs by fast tracking 26% of all commonly prescribed drugs (preferred) Lowers cost by better targeting questionable prescriptions Allows for future modification to better control price variation 56 28

Thanks for your participation 57 29