Attachment J.26 - Pharmacy Prior Authorizations SOP (Draft).pdf

SOP TITLE: Prior Authorizations, Secondary and Tertiary Reviews SOP Number [Insert Unit Identifier]01

Version Number V1.0

Effective Date 06/01/2022 Date Last Reviewed 05/20/2022

SOP Owner Pharmacy Benefits Unit

INTRODUCTION

1.1 Background

PBM Transition On June 1st, 2022, the Program will transition Pharmacy Benefit Manager’s (PBM’s) from MCA-Optum to Express Script (ESI). As part of this transition, Prior Authorizations (PA’s) will be transferred in a file from Optum’s system to ESI on June 1st, 2022. The file will include –

• Active PA Approvals: Prior authorizations that are currently active and the expiration date. This means Members will be able to continue to get these medications until the prior authorization expires, at which time a new prior authorization will need to be processed using the process outlined below.

• Negative PA’s: All prior authorizations that had previously been denied will also be included in the file transfer and will be shown in the Members record. For a member to receive one of these medications, a PA would have to be submitted and approved using the process below.

Program Information Prescriptions for medications that require a prior authorization (PA) for the World Trade Center (WTC) Health Program must be approved for use through the PA process.

• Resources for Formulary Information: The WTC Health Program Formulary document provides formulary information for the Diagnostic, Standard, Cancer, and Mental Health formularies as well as clinical requirements for drug coverage and is maintained as the source of truth for Program formulary information. Formulary information will be available to the Clinical Centers of Excellence (CCEs), Nationwide Provider Network (NPN), and/or external prescribers through the following resources:

o Real Time Prescription Benefits (RTPB): RTPB is a feature that allows providers to see members’ pharmacy benefits, eligibility, drug coverage information, and PA requirements in real-time through the Electronic Health Record (EHR) and e-prescribing systems. CCEs/NPN and providers must work with their technology team to ensure the feature is turned on.

▪ This feature is widely used in the industry by providers.

▪ Many e-prescribing/EHR platforms already have this programmed as part of the platform.

▪ EPIC RTPB functionality varies by location/site. CCEs/NPN should check with their system administrator to determine if the Express Scripts (ESI) EPIC location is enabled for RTPB.

• EPIC’s RTPB tool is called “Price Estimates” and is available in v2018 or later software updates.

o Quantity Limit Exceptions: If it is appropriate for a member to receive a larger quantity of a prescription than the Formulary allows, CCEs/NPN can request quantity limit overrides by following the process outlined below for submitting prior authorizations.

CCEs/NPN can search quantity limits for Formulary drugs in ESI’s Electronic Service Delivery portal.

o PBM Resource Page: The formulary document as well as PA forms will be available through this website.

o Electronic Service Delivery (eSD): Formulary information can also be found by utilizing the drug coverage look-up tool within eSD under a member’s profile. This will provide specific drug coverage information related to members’ assigned formularies. eSD can also be used to look up network pharmacy information.

• Coverage Review Department (CRD):

o Approving Authority: NIOSH has delegated authority to the ESI CRD to review and make decisions on PA requests using drug criteria established by the WTC Health Program. PA requests for drugs that do not have criteria established by the Program must be reviewed by the WTC Health Program Pharmacy Benefits Unit (PBU) for a decision.

o Coverage 360 (C360): C360 is ESI’s PA management system, which will be used by both the ESI CRD as well as the WTC Health Program PBU to monitor, review, and make decisions on PA requests. CCEs/NPN will not have access to C360. All PA requests and documentation submitted to the ESI CRD are tracked in C360.

o PA decision (approval/denial) notification:

▪ Members are notified via automated phone call and letter.

▪ Prescribers are notified via electronic PA (ePA) portal, fax, or letter.

▪ CCEs/NPN can track PA status via eSD by following the steps below:

• Member Profile > Prior Authorization > Coverage Review Status

• The coverage review status page will display the case number, drug name, and status (approved/denied/pending).

• For denial reason or additional details about the case, click the “i” icon next to status.

• Review Process Time: All PAs will be addressed by ESI CRD or WTC Health Program PBU within 3 business days with a decision or a request for additional information from the provider.

• Length of PA approvals: The Program allows PAs to be approved up to 1 year. The length of approval may depend on the type of medication (maintenance or acute), rationale provided for approval, or Program policy. If the PA expires, the medication will reject at the point of sale with the message “PA required”, then the steps outlined in section 1.1 should be followed to submit a new PA request.

• Diagnosis Codes / Automation of Prior Authorization: Where possible, the use of ICD-9 and/or ICD-10 codes will be leveraged to automate PA decisions. When PA criteria requires a specific WTC Health Program certification, ESI’s system will match the drug requested to the ICD-9/ICD- 10 code(s) associated with the specified criteria. For automation to take place at the point of sale, members must have matching ICD-9/ICD-10 codes in their eSD profiles. If matching ICD- 9/ICD-10 code(s) are not present on the member’s eSD profile, the claim will reject at the point of sale, and the provider will need to submit a manual PA via ePA portal, fax, or phone.

o Example: Member is prescribed Trelegy Ellipta for COPD or asthma. If the member has an ICD-9/ICD-10 code related to COPD or asthma in their profile on eSD, the clinical automation rule will match those ICD-9/ICD-10 codes from the member to the drug being prescribed, which will allow the claim to process at the point of sale. In this example, a manual PA will not need to be submitted for approval.

• Negative Prior Authorizations (i.e., blocking medications): The CCEs/NPN can prevent members from having certain medications covered through their WTC Health Program prescription benefit plan by blocking the medication in their profile, known at Express Scripts as a Negative PA. If the CCE/NPN identifies a medication that the Member has filled or may attempt to fill through the Program that should not be covered, the CCE/NPN can contact ESI or PBU to request a Negative PA. If the Member attempts to fill a medication that has a Negative PA, the “drug not covered” rejection will occur at the pharmacy.

1.2 Purpose

This SOP describes the process for submitting a prescription PA for approval, the review process, and the process for appeals. This SOP also describes reasons medications are blocked and procedures to block medications not related to a member’s World Trade Center (WTC) certified condition.

PROCESS AND PROCEDURE

Prior Authorization Transfer Process: All active PA’s in Optum’s system on June 1st, 2022, will be transferred in a file to ESI

Prior Authorizations can be submitted using a Prospective or Retrospective Process.

• Prospective Process: Prospective PA requests are PAs that are submitted in advance of prescribing or at the time of prescribing a medication (i.e., writing the Rx and sending to the pharmacy).

Providers with RTPB will know at the time of prescribing if something needs PA. CCE/NPN Providers also can reference the formulary to determine if the drug needs a PA at the time of prescribing. Prospective PA requests are preferred and Providers or their delegates(s) are encouraged to submit all requests via ePA, since many of the PA decisions can be provided in real-time prior to the member going to the pharmacy. This reduces member wait time at the pharmacy as well as calls to the office requesting a PA.

• Retrospective Process: Retrospective PA requests are PAs that are submitted after the pharmacy tries to bill the prescription, but the claim rejects because there is no PA on file. The pharmacy will inform the provider and member that a PA is required for the medication.

Step 1: Notification that Prior Authorization is Required

• Prospective PA: If the prescribing provider has RTPB in their e-prescribing software or activated in their EHR, they will be notified at the time of e-prescribing if a particular medication requires a PA, and the formulary status (covered/not covered). They can then decide to submit a PA request prior to prescribing the medication, change the medication based on the formulary requirements, or determine if the prescription needs to be billed to the Member’s Primary Insurance.

• Retrospective PA: The prescribing providers are notified that a PA is required by o The pharmacy calling or faxing the information, o The pharmacy submitting a case in the ePA system, o Member calls the providers office.

Step 2: Submitting the PA

• Mechanisms for Submitting Prior Authorizations:

o Electronic Prior Authorization (ePA) (various platforms) – Preferred Method: ePA systems are used to submit PAs electronically directly to the ESI Coverage Review

Department for review. Express Scripts systems are compatible with most ePA systems used in the industry. Note: Most ePA systems are not managed or owned by ESI. ePA systems can either be imbedded into the EHR system, like EPIC, or in providers can use the web portal to set up an account and submit PA’s. While submitting the PA request via ePA, the prescriber will be asked to answer a series of questions that will determine if the Member meets the criteria. If a prospective PA is submitted via ePA and an approval is provided in real time, the prescription can be submitted to the pharmacy and the member can obtain their medication.

▪ Getting access to ePA system:

• CCE’s/NPN should check with their institutions to determine if an ePA system is already available to them through their e-prescribing or current eHR vendor.

• If CCE/NPN or external provider does not have access to any of these systems already, they can sign up for an account for free through the online web portals (see links below). Providers can assign delegates to manage PAs on their behalf.

▪ Most popular ePA systems:

• CoverMyMeds: (https://www.covermymeds.com)

• Surescripts:

(https://providerportal.surescripts.net/ProviderPortal/login) o Fax: PA requests may also be submitted to the ESI CRD using the general PA request form found at www.express-scripts.com/PA under “other PA options”. Prior authorizations for drugs/drug classes that do not have specified criteria should be placed on the general PA request form. The ESI CRD will route these requests to PBU for review/decision (see Step 3).

▪ 877-251-5896

▪ If the provider submits the general form via fax, and the drug requested requires specific criteria, CRD will contact the provider to answer the criteria question set. They will attempt up to 3 times via fax, then by phone, to answer the criteria question set.

o Phone: PA requests may also be submitted to ESI CRD by calling 844-431-9672.

Step 3: PA Decision Once a PA is submitted to the ESI CRD for review, a PA “case” is opened.

• Automated Decisions: Some PA decisions will be automated based on whether the answers to the questions on the PA form meet Program criteria.

• PA’s that need review: Intake for all PAs will be managed by ESI. All PA requests submitted via ePA, fax, phone will be assigned a case number in C360.

o Formulary PA Request: PA requests for medications with specific criteria (e.g., antidepressants, antipsychotics, etc.) will be reviewed by the CRD for determination. In situations where there is not enough information to decide, the case will be pended, and additional information will be requested from the prescriber via fax and/or an outbound call.

o Non-formulary PA Request: PA requests for medications that do not have specific criteria in the formulary, CRD will route the PA to NIOSH PBU for review and determination.

1. Information that may be required for the PA include:

• member information

• details regarding the WTC Health Program certified condition being treated, https://www.covermymeds.com/ https://providerportal.surescripts.net/ProviderPortal/login

• detailed information for drug being requested,

• member specific prescribing information,

• use of preferred formulary medications,

• explanation of medical necessity, and

• supporting documentation for use of the drug.

• A decision will be made based on the Program’s drug coverage criteria, the off-label policy, and the member’s certified condition. If the PA submission is incomplete or unclear, the PA will be routed back to the prescriber for more information for a determination to be made.

o Missing Information: If the information submitted for the PA is incomplete or unclear, it will be routed back to the provider for more information. Three attempts will be made for requests for information from providers. If there is no response in 3 business days (excludes weekends and holidays), the case will be closed1.

Step 4: Communication of PA status and Decisions:

PA status and decisions are communicated to both the prescribing provider and member.

o Member (approval, denial, missing information):

1. CRD Generated Letter mailed to their home (approval, denial, missing information)

2. Status can be viewed in account on the ESI Member Web Portal

3. Automated phone call o Provider (approval, denial, missing information):

1. Electronic Communications of PA status sent through ePA system

2. CRD generated letters are faxed or mailed to the office when Rx is not submitted through ePA o CCE/NPN:

1. PA status is visible in eSD o Pharmacy:

1. If the pharmacy initiated the PA via one of the ePA platforms (CoverMyMeds, Sure Scripts, or ExpressPath), PA status is visible via that ePA platform.

Prescribing Provider: All PA notifications are sent to the prescribing provider, whether that is an internal provider at the CCE/NPN or external provider. The CCE’s/NPN will not be notified that a PA is needed unless they are the prescribing provider.

• Submitting PAs for external providers: The ePA system allows providers to start a PA case even if the Rx is written by a different physician. The system allows clinical information to be added and 1) sent to the prescribing provider to prompt them to submit the PA or assist in providing information needed for the PA, 2) sent to the plan for review.

o CCE’s/NPN should only submit PAs to the plan for review if they have the necessary clinical information to ensure the member meets the clinical criteria. This information should be clearly documented in the member’s medical record.

Duplicate PAs

1 This time frame is applied to all PA’s that are waiting response with no apply, including secondary and final reviews. The Program and ESI are looking into making the timer 10 business days for PA’s that require Program review, however any change will be done after go-live.

Duplicate PA’s cases will be closed out by the CRD team when identified. A PA case is considered a duplicate when there is current open case for the same drug and strength, by the same provider. If a PA for the same drug and strength is submitted by a different provider, a separate case will be opened. It is not recommended to open a new PA case if there is currently a PA pending by a different provider, since this creates additional administrative burden at the providers office, CRD team, and CCE/NPN.

Prior Authorization Workflow The below workflow outlines the process that occurs when a PA review request is submitted to ESI.

Escalation of Prior Authorization Denials Providers can request escalation of denied prior authorization if they believe it was denied in error or have additional information to support approving the drug. These are referred to as additional “reviews”.2 To submit the secondary or final reviews listed below, the provider can indicate on the PA request that there was a previous denial for the drug, or if the same provider submits a PA for the same drug, strength, and Member within 180 days of a previous denial, ESI will automatically categorize the PA a secondary or final review depending on what level the previous denial was. If a different provider submits the PA, it will start a new primary review case.

1. Secondary Review: If the initial prior authorization results in a denial, a request for a secondary review can be submitted to CRD within 180 days from the initial denial date. As part of the secondary review, additional supporting documentation can be provided by the provider.

2. Final Review: If the secondary review is denied, a tertiary review can be submitted to CRD within 180 days from the secondary denial date. All tertiary reviews will be routed by ESI to PBU for final decision.3

3. Appeals Process: If the tertiary review is denied, the Member may submit an appeal through the WTC Health Program Treatment Appeals Process. More information about this process can be found under “Appeal Process for Denial of Authorization of Treatment for a Certified Health Condition” at

2 ESI typically refers to these additional reviews as “appeals”; however, the Program is using different verbiage to differentiate from the Program’s official appeals process.

3 The CRD team will open the case and collect the documentation before routing to the WTC Health Program.

the following link: Appeals - World Trade Center Health Program (cdc.gov)

Communication of Prior Authorization Decisions: Decisions for all levels of prior authorization reviews (initial, secondary, and tertiary reviews) will be communicated to both the member and requesting provider through the following methods:

o Member: Automated phone call, CRD Letter and ESI member web portal o Provider: Notification through ePA system or via fax/letter if the PA was not submitted via ePA

Review Levels Time to Process Time to file

Primary- First level review Urgent - 1 business day

Non-urgent – 3 business days

Secondary review- Second level after Primary has been denied

Urgent - 3 business day

Non-urgent – 7 business days

180 days from when the primary was denied

Final Review – After secondary has been denied

3 business days - Routed to

NIOSH

180 days from the denial of the secondary review

Negative PAs (Blocked Medications) There may be circumstances when a medication is billed to the Program and go through even though it’s inappropriate. This could be because the drug is not treating a WTC-related condition or does not meet

Program criteria. When this is identified, the CCE/NPN should contact ESI CRD or PBU to enter a

Negative PA in eSD to prevent further fills being paid by the Program inappropriately. Please see SOP titled Negative PA (Blocking Medications) for instructions on this process.

If a medication that has a negative PA (i.e., blocked) on a member’s profile is billed to the WTC Health Program, it will reject “Drug Not Covered” at the point of sale. There will no option to initiate a PA.

Negative PA’s can be entered for any length of time.4

CCE/NPN Negative PA Process: Negative PA’s can be entered into eSD by NIOSH or ESI’s Client Service

Center (CSC). CCE/NPN has “read only” access only to eSD and will not be able to enter Negative PA’s.

There are two options for submitting Negative PA requests:

1. CSC or PBU: CCE’s/NPN can contact CSC or PBU through CARE or via phone that a medication should be blocked to initiate a Negative PA. This should only be done when the request is urgent or a one-off request. Larger requests should use option 2. Requests to CSC or PBU for Negative PA should include

a. Member name/911#

b. Drug or class of drugs to be blocked

c. Length of time of the block (temporary or permanent)

d. Rationale for the block

2. Larger Negative PA files: The CCE/NPN can submit an excel file with all negative PA’s that can be uploaded into the ESI system. There are two ways to obtain the file (below). Files are then sent

4 If the CCE/NPN wishes for the negative PA to be indefinite, it’s recommended to put a date far into the future (e.g., 1/1/2099) https://www.cdc.gov/wtc/appeals.html through CARE to ESI using DL-PBM-REPORTS distribution list. Uploads take 3 days.

a. Resource Page: A blank excel file is available on the resource page. The CCE/NPN can fill out all the data elements in the excel file and send it to ESI for upload.

b. Trend Central: The CCE/NPN can download a claims file in the format needed to submit negative PA’s. They can then review the claims, identify the claims that require a negative PA, remove the records that don’t require a negative PA, and submit the file. ESI will work with the CCE’s/NPN to set up these recurring reports in Trend Central.

3. Therapeutic Class Requests: If the CCE/NPN wants to block an entire therapeutic class for a member then that request should be sent to the pharmacy mailbox.

If the pharmacy tries to fill a prescription that has a Negative PA, the prescription will reject for “Drug

Not Covered”. If the CCE/NPN needs to reverse the Negative PA, they will need to contact CSC to have it reversed.

Transition

PA’s and blocks that are still active the Optum system at the time of transition, will be transferred in a file on June 1st, 2022, and uploaded into the ESI system. All blocks and PA’s will be input with the existing expiration date.

The CCE’s/NPN will have access to Optum’s VitalPoint system for 30 days after go-live (this is flexible).

This will allow the CCE’s/NPN to see any pending claims in the queue, but they are not actionable.

Optum’s system will no longer be able to process any claims after 11:59pm on 5/31. There are three scenarios where this will impact claims processing for members -

• Drugs that are still pending in Optum’s queue at transition time on June 1: if a drug rejects prior to June 1st but is not approved/denied in the system and rebilled by the pharmacy before June 1st, the prescription will have to be reprocessed under Express Scripts with a date of service of June 1st or later. Optum will proactively reach out to pharmacies with prescriptions still pending on or after June 1st, to ask them to rebill to the new Express Scripts PBM.

• Rebills for medications with a date of service before June 1st, that the pharmacy is trying to process after June 1st: This applies to situations where a member picks up a prescription before June 1st that they paid for out of pocket, or it was billed to the wrong insurance, and they would like to have it rebilled to the Program after June 1st. In this case, if the pharmacy tries to rebill the claims to Optum it will reject and inform the pharmacy that the Member is no longer eligible, and they need to bill ESI. If they bill ESI, the claim will reject that the member is not eligible, because the date of service is before 6/1. If the member calls ESI, they will refer the Member to the CCE/NPN.

If the CCE/NPN determines this claim should be rebilled through the Program, they should contact the Pharmacy Benefits Unit who will work with ESI to process the claim. The Program expects very limited situations where this would occur.

• Reversals of claims from 5/31 and earlier, done after 6/1: Optum can process reversals after 6/1.

Quality Assurance All PAs are subject to audit to ensure they meet clinical criteria required by the Program, including auditing medical records of the CCE/NPN for submitted PAs. The CCE/NPN may copy decision justification from eSD to include in members’ medical records for documentation and auditing purposes. ESI will also produce reports on PAs and Negative PAs to support auditing purposes.

ACRONYMS AND DEFINITIONS

Term Definition

Standard Operating Procedure (SOP)

An SOP is internal documentation that provides a detailed description of key activities and operations with agreed upon steps and specifications.

Unit Identifier The unit identifier is used in the introductory SOP table under the SOP Number field. The unit identifier is used to standardize SOP naming conventions (e.g., Medical Benefits and Certifications Unit=MBCU, Contract Management Unit=CBU, Member Services and Enrollments Unit= MSEU, Pharmacy Benefits Unit=PBU, Communications Unit=CU, Technology Solutions Unit=TSU, Administrative & Business Support Unit=ABSU, Program Integrity & Risk Management=PIRM, Research Planning & Care Integration=RPCI).

WTC Negative PA File

Load Sample Template.xlsx

RECORD OF CHANGE

Instructions: The table below serves as a record of change throughout the document lifecycle.

DOCUMENT APPROVAL

Unit Chief, [Insert Unit Identifier] Deputy Director (or Deputy Director) (or Associate Administrator)

Version Number

Date Section Number

Description of Change

1.0 04/10/2020 All • Initial version using version control box

• Modified definitions of work queues

• Added PA3 expiration rules

• Revised approving authority language

2.0 03/01/2021 All • Removal of verbal authorizations for Pas

• Clarify use of claim notes

3.0 03/18/2022 All • Revised to reflect changes in procedures related to pharmacy benefits manager transition