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1st Addendum 07/18/2012 DANNY L. KOLHAGE CLERK OF THE CIRCUIT COURT DATE: July 26, 2012 TO: Maria Z Fernandez - Gonzalez Senior Administrator - Benefits FROM: Pamela G. Hanco «�D. C. At the July 18, 2012, Board of County Commissioner's meeting, the Board granted approval and authorized execution of Item B30 Coverage Determination and Appeals Process Addendum to the Pharmacy Benefit Management Services agreement with EnvisionRXOptions to administer and invoice for both an internal and external appeals process for covered individuals who wish to appeal the determination of non - coverage of a medication. Enclosed is a duplicate original of the above - mentioned for your handling. Should you have any questions please do not hesitate to contact this office. cc: County Attorney w/o document Finan e File COVERAGE DETERMINATION AND APPEALS PROCESS ADDENDUM TO PHARMACY BENEFIT MANAGEMENT SERVICES AGREEMENT This Coverage Determination and Appeals Process Addendum (hereinafter this "Addendum "), effective as of the 1 day of January, 2012, is entered into by and between Envision Pharmaceutical Services, Inc. (hereinafter "Envision "), and Monroe county Board of County Commissioners (hereinafter "Plan Sponsor "). RECITALS WHEREAS, Envision and Plan Sponsor are parties to a Pharmacy Benefit Management Services Agreement dated October 1 2011 (the "Agreement "), under which Envision provides PBM Services to and on behalf of Plan Sponsor; and WHEREAS, Plan Sponsor wishes for Envision to administer and invoice for both an internal and external appeals process for Covered Individuals who wish to appeal the determination of non - coverage of a medication under The Department of Health and Human Services 45 CFR Part 147 and the Department of Labor's 29 CFR Part 2590. Now, therefore, Envision and Plan Sponsor agree as follows: 1. PBM Services 1.1 Envision shall administer a coverage determination and appeals process under Plan Sponsor's direction as described in Exhibit 1 -A. The coverage determination and appeals process will include: (i) real -time adjudication to determine coverage /non - coverage status of a claim, (ii) initial determinations, (iii) redeterminations, and (iv) external appeals utilizing an independent review organization. The coverage determination and appeals process will meet the requirements of the Department of Labor's 29 CFR 2590.715 -2719. 2. Plan Sponsor Responsibilities 2.1 Plan Sponsor shall pay Envision the following fees for the applicable steps within the coverage determinations and appeal process. Determinations Performed Internally by Envision Initial coverage determination (Clinical Prior Authorization) $8.00 Redetermination $85.00 Independent Reviews Performed by Independent Review Organization (IRO) Standard Turnaround Time (2 days or greater) 100% pass through invoice amount from IRO. Expedited Turnaround Time (Less than 2 days) 100% pass through invoice amount from IRO. Standard Turnaround Time for Complex Independent Review* 100% pass through invoice amount Appeals Process Addendum 091311(r3) • from IRO. Expedited Turnaround Time for Complex Independent Review* 100% pass through invoice amount • from IRO. *Complex Independent Review is defined as requiring greater than one hundred pages of clinical documentation. 3. All other terms and conditions of the Agreement not modified by this Addendum or any prior amendment or addenda shall remain unchanged. • IN WITNESS WHEREOF, Envision and Plan Sponsor have executed this Agreement as of the Effective Date above. For ENVISION: For PLAN SPONSOR: B �� �� 66- �'• B By: y. / Barry' . Katz, R. Ph., President Mayor David P. Rice Print Name and Title 07/18/2012 ?eieover) t W F o i 241 _ t _ L MALI G O DANNY L. c DEP!)TY CLEF!' Appeals Process Addendum 091311(r3) EXHIBIT 1 -A Envision Covera;_e Determination, Redetermination (Internal Appeal) and Independent Review (External Appeal) Program Description (Revision date 09/16/2011) EnvisionRxOptions maintains a process for coverage determinations, redeterminations and independent review organization submissions. Envision utilizes a claim adjudication platform to determine real -time coverage /non - coverage status for prescription claims submitted electronically at the point of sale. Claims failing one or more benefit design coverage rules are rejected at the point of sale and information regarding the reject reason(s) is conveyed to the dispensing pharmacy at the point of sale. Pharmacy personnel may contact the Envision Customer Service department to begin the coverage determination process or they may inform the patient of the reason(s) for the rejection and provide the patient with instructions to contact Envision Customer Service in the event the patient would like to initiate a coverage determination. Initial Determination When a coverage determination request is initiated, the information from the rejected prescription is conveyed by Envision to the patient's dispensing physician via fax with a request for specific information regarding the patient's medication history and disease diagnosis. The physician completes the form and returns it to Envision where the information provided by the physician is evaluated by an Envision clinical pharmacist. Expedited request determinations occur within 24 hours of receipt of the request and standard determinations occur within 72 hours of receipt of the request. If the information provided meets the criteria to allow an override of the initial rejection, an override will be configured in the adjudication system that will allow the claim to process. If the clinical review determines the prescription fails to meet the coverage standard, the prescription will remain in rejected status. For approved coverage determinations, a confirmation is communicated to the patient, the prescribing physician and the dispensing pharmacy. In the event the coverage determination is denied, a Model Notice is used for notification of the denial to the patient. The prescribing physician and the dispensing pharmacy are also notified. The patient and prescribing physician are provided denial letters with the specific reason for the denial and instructions about their right to initiate a redetermination review (internal appeals process). Additionally, the model denial notice provides information about the internal and external appeals process and also provides the contact information for the HHS Office of Consumer Assistance. Redetermination (First Level Internal Appeal ) A redetermination is the Envision equivalent to a first level internal appeal. Upon initiation of a redetermination by the patient or their appointed representative, additional supporting documentation may be received by Envision from the physician. Expedited redetermination request evaluations occur within 24 hours of receipt of the request and standard evaluations Appeals Process Addendum 091311(r3) 3 occur within 72 hours of receipt of the request. The evaluation is performed by an Envision clinical pharmacist other than the pharmacist that denied the original coverage determination request to maintain impartiality within the review process. If the redetermination information supports an override of the coverage determination denial, an override will be configured in the adjudication system which will allow the claim to process. For approved redeterminations, a confirmation is communicated to the patient, the prescribing physician and the dispensing pharmacy. If evaluation determines the redetermination request fails to meet the coverage standard, the prescription will stay in rejected status. Notification of the denial occurs via Model Notice to the patient. The prescribing physician and the dispensing pharmacy are also notified. The patient and prescribing physician are provided denial letters with the specific reason for the denial. The model Final Internal Adverse Determination notice contains instructions about the patient's right to initiate an independent review with an Independent Review Organization (IRO) (information on the external appeals process) and also the contact information for the HHS Office of Consumer Assistance. External Appeal (Independent Review Organization) When a patient or patient's appointed representative initiates an external appeal request with an Independent Review Organization (IRO), Envision provides the claim information, plan exclusion and coverage criteria documentation, and clinical review criteria to the IRO. This external appeal request must be made within four months after the redetermination request (final internal appeal decision). Envision is contracted with three separate IRO's to ensure an impartial decision is reached for each request. External appeal requests are assigned and rotated to the IRO's in succession to avoid selection bias. Each contracted IRO holds URAC accreditation status to conduct external reviews. They are not bound by the previous redetermination decision and review each case against the terms of the plan exclusion & coverage documentation. The IRO will convey a final decision to Envision within 45 days for standard reviews and within 72 hours for expedited reviews. Expedited reviews are permitted when standard review timeframes would seriously jeopardize the life or health of the patient. If the IRO reverses Envision's adverse redetermination decision, then Envision will provide coverage and/or payment of the claim within twenty -four hours of notification of the IRO decision. If the IRO upholds Envision's adverse redetermination decision, the IRO will communicate the decision to Envision and the member. If the physician files the request on behalf of the patient, then the physician would be notified as well. The patient and prescribing physician (if applicable) are provided denial letters with the specific reason for the denial and the contact information for the HHS Office of Consumer Assistance. Section 2719(a)(1)(B) requires that a group health plan and health insurance issuer offering group or individual health coverage shall provide notice to enrollees, in a culturally and linguistically appropriate manner, of available internal and external appeals processes. Under the IFR at 45 CFR §147.136(e), plans and issuers meet the culturally and linguistically appropriate Appeals Process Addendum 091311(r3) • requirement if they provide notices, upon request, in the non - English language to populations that meet the following thresholds: • In the group market, for a plan that covers fewer than 100 participants at the beginning of a plan year, the plan must make culturally and linguistically appropriate notices available to populations in which 25 percent of all plan participants are literate only in the same non - English language. For a plan that covers 100 or more participants at the beginning of a plan year, the threshold is the lessor of 500 participants, or 10 percent of all plan participants, being literate only in the same non - English language. The thresholds are adapted from the Department of Labor's regulations regarding style and format for a summary plan description, at 29 CFR 2520.102 -2(c). • In the individual market, the determination of whether issuers are considered to be providing relevant notices in a culturally and linguistically appropriate manner is made at the county level. If at least 10 percent of the population residing in a county is literate only in the same non - English language, the issuer must provide the appeals- related notices in that language, upon request by an individual claimant residing in that county. It is the Client's responsibility to notify Envision if one of these requirements is applicable to their members. Appeals Process Addendum 091311(r3)