World Trade Center Health Program Administrative Manual

TABLE OF CONTENTS

Last Revised – December 5, 2019

1.0 Purpose and Scope

This chapter describes the pharmacy benefits that are available through the WTC Health Program under the James Zadroga 9/11 Health and Compensation Act of 2010 (the Act) and its reauthorization.

1.1 Statutory and Regulatory References

The following sections of the Act are applicable to this chapter:

1. Section 3312(b)(1)(A)(ii) directs that the WTC Health Program shall pay for medically necessary treatment for WTC-related health conditions, assuming certain conditions are met;
2. Section 3312(b)(3)-(5) relates to medical necessity for healthcare services, including a process for determining medical necessity, the scope of treatment, appeals of decisions regarding medical necessity, and the provision of treatment pending certification;
3. Section 3312(c)(1)(B) specifies that the Administrator of the WTC Health Program shall establish a program for paying for the medically necessary outpatient prescription pharmaceuticals prescribed for WTC-related health conditions;
4. Section 3321(b) provides for initial health evaluations (screening) for screening-eligible WTC survivors; and
5. Section 3322 allows for follow-up monitoring and treatment of certified-eligible WTC survivors.

Program regulations relating to pharmacy benefits are established in the following sections of 42 C.F.R. Part 88:

1. Section 88.1 Definitions;
2. Section 88.20 Authorization of treatment;
3. Section 88.22 Reimbursement for medical treatment and services;.
4. Section 88.23 Appeal of reimbursement denial; and
5. Section 88.24 Coordination of benefits and recoupment.

1.2 Roles and Responsibilities

The parties involved in providing WTC Health Program pharmacy benefits and their responsibilities are detailed below:

1. The Administrator of the WTC Health Program or Designee establishes pharmacy policies for the Program, manages the formulary and medication criteria, and manages prior authorization requests for non-formulary medications.
2. The Clinical Centers of Excellence (CCEs) and Nationwide Provider Network (NPN) provide medical services and write and approve prescriptions for eligible WTC Health Program members. The CCEs and NPN review specific Prior Authorizations (PAs) and manage system rules and restrictions, when necessary, for certain medications. (See Section 3.5, Level 2 Prior Authorization).
3. The Pharmacy Benefit Manager (PBM) is responsible for receiving, adjudicating, and processing payment for pharmacy claims. Additionally, the PBM manages the pharmacy network, CCE/NPN user-interface system, and formulary and pharmacy adjudication rules and restrictions. The PBM provides customer service for Program members and provides quality assurance to the WTC Health Program and CCEs/NPN through data analytics and reporting. For customer-service contact information for the PBM, please visit https://www.cdc.gov/wtc/pharmacy.html
4. The Health Program Support (HPS) ) contractor manages member eligibility for pharmacy benefits, based on certification status and prescriber files, and exchanges payment to and from the PBM. The HPS contactor transfers data on the member’s pharmacy benefit eligibility to the PBM, as the PBM does not have direct access to member eligibility information and certification information, nor the ability to alter member information or eligibility. For more information on member eligibility, see Chapter 2: Eligibility and Enrollment.

2.0 Pharmacy Services

2.1 Pharmacy Network

The WTC Health Program does not have restrictions on retail pharmacy access. Any pharmacy contracted with the PBM may submit a claim to the Program. This includes most major chains and many community pharmacies. Members can talk to their respective CCE/NPN or contact the PBM to find a pharmacy. Members may also visit https://www.cdc.gov/wtc/pharmacy.html.

2.2 Home Delivery and Specialty Pharmacy Services

The PBM offers home delivery and specialty pharmacy services to all members that would like to participate. Home delivery and specialty pharmacy services provide medications at a reduced cost to the Program. They can also help improve health outcomes for members through increased medication compliance. The home delivery and specialty pharmacy provides maintenance medications to the member by mail. Maintenance medications are prescription drugs taken on a regular or on-going basis. Specialty medications are defined as high-cost prescription medications used to treat complex, chronic conditions like cancer and often require special handling (such as refrigeration during shipping) and administration (such as infusions).

Home delivery and specialty pharmacy services provide many benefits to members. Prescriptions can be conveniently mailed to the member’s home or location of choice, with no need to travel to or wait at the pharmacy. Home delivery and specialty pharmacy services also reduce the risk of running out of medication or missing a medication dose, while allowing for synchronization of medication refills. Members also have access to expert pharmacist advice 24/7.

1. Home Delivery Criteria for Member
   1. Member is certified for a condition;
   2. Member has a 28-day supply or more on one transaction; and
   3. There are at least two fills of the medication.
2. Enrollment: To utilize home delivery or specialty pharmacy services, members must enroll. Enrollment is not automatic. Members may contact the pharmacy customer service number on the back of their WTC Health Program Prescription Card. For additional information, please visit https://www.cdc.gov/wtc/pharmacy.html.
3. Requesting Refills: Members using the home delivery or specialty pharmacy should contact the pharmacy to request a refill two weeks prior to running out of medication. This will ensure that the prescription is processed and mailed before running out of medication. Some medications are eligible for automatic refills. To inquire about automatic refills at home delivery, please contact the pharmacy.

2.3 Prescriber Networks

The HPS contractor is also responsible for enrolling and maintaining the WTC Health Program prescriber networks (See Chapter 6, Section 6: Provider Networks). The HPS contactor transfers data on prescribers to the PBM.

1. Clinical Centers of Excellence: Each CCE maintains its own distinct prescriber network that is separate from all other CCEs. This allows the CCE to evaluate the appropriateness of the prescribers for WTC Health Program members. The CCEs can provide Program-related training and information to prescribers and have oversight of prescriptions. Each CCE must enroll and remove prescribers with the HPS contractor, which maintains the prescriber network for each CCE. The HPS contractor provides the PBM with prescriber information through data exchanges on a weekly basis. Once the data is received by the PBM, the prescriber lists are then uploaded into the pharmacy adjudication system. Providers should only be enrolled as prescribers when:
   1. The provider is going to be providing ongoing care to the member;
   2. The provider is involved with the member’s long term care (i.e., is not an emergency room doctor, urgent care physician, surgeon, or other type of provider providing short-term care); and
   3. The provider has been informed of the WTC Health Program requirements and rules and agrees to provide care to the member under these provisions.
2. Nationwide Provider Network (NPN) and William Street Clinic (WSC): The NPN/WSC does not have a prescriber network for the WTC Health Program. Prescriptions for members affiliated with the NPN can be prescribed by any provider affiliated with the NPN network. The WSC pharmacy benefit is administered by the NPN and has the same rules and restrictions applied as the NPN. The NPN and WSC use other types of point of sale restrictions to ensure that prescriptions filled are appropriate under the Program rules.
3. Exclusions:The Program will remove all prescribers on the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) provider exclusion list. Providers may be removed at the Program’s discretion if there is an indication of fraud, abuse, misconduct, or if the provider’s license(s) and Drug Enforcement Administration (DEA) numbers have been revoked or suspended.

3.0 Point of Sale Adjudication Rules and Restrictions

1. Pharmacy Approval: Prescription drugs are approved at the point of sale (POS) through submission and adjudication of claims at the pharmacy. Members provide their WTC Health Program coverage information to the pharmacy, which validates enrollment through the PBM.
2. Point of Sale Rules and Restrictions: These refer to system rules that must be met prior to the pharmacy claim being adjudicated. If the prescription does not meet the Program’s rules, the prescription claim will be rejected at the point of sale. Point of sale rules and restrictions include (described in more detail below):
   1. Prescriber Not in Member’s CCE Prescriber Network
   2. Drug Utilization Review (DUR)
   3. Refill Too Soon
   4. Quantity and Days’ Supply Limits
   5. Level 2 Prior Authorization
   6. Level 3 Prior Authorization
3. Claim Rejection: The above rules and restrictions will cause a pharmacy claim to be rejected at the point of sale. Rejections may be managed by the CCE/NPN, PBM, or WTC Health Program depending on the rejection reason, as detailed in the sections below.
4. Approving Authority: Selected point of sale rules and restrictions listed above may be approved for fill by the CCE/NPN in certain situations. The CCE/NPN is responsible for training and monitoring any designated staff reviewers’ actions to ensure that policy and procedures are followed in line with Program rules and standards of care. The CCE/NPN is ultimately accountable for all actions designated staff reviewers.

3.1 Prescriber Not in Member’s CCE Prescriber Network

If pharmacy claims are submitted to the PBM by a provider who is not enrolled in the appropriate CCE’s prescriber network for the member (See Section 2.3: Prescriber Networks), the claim will be rejected at the point of sale with a message to the pharmacy stating “Prescribing Physician Not in Member Network.” If this occurs, the CCE may override the rejection for up to 90 days when appropriate to treat the member’s certified WTC-related health condition, or health condition medically associated with a certified WTC-related health condition. This does not apply to the NPN/WSC.

CCEs may override rejections when:

1. The CCE has decided to enroll the prescriber in their prescriber network and needs to allow the member to receive their WTC Health Program related medications until the PBM system’s weekly update; or
2. The CCE has decided not to enroll the prescriber in their prescriber network because they do not meet one of the requirements in above Section 2.3: Prescriber Network (e.g., the prescriber is an emergency room physician, urgent care physician, etc.), but has confirmed that the medication is for the member’s certified WTC-related health condition, or health condition medically associated with a certified WTC-related health condition.

The following exceptions apply to the prescriber not-in-network edit:

1. For FDNY: FDNY has placed additional restrictions on prescribers in order to maintain better oversight on prescriptions prescribed by providers external to the CCE. The CCE reviewer may override rejections for enrolled providers who regularly provide Program care, but are not enrolled as prescribers for up to one year. The rationale for this decision must be documented.
2. Samaritan Fill: If the prescriber not-in-network rejection happens outside of normal business hours for the CCE/NPN, and the prescription is urgent in nature and does not have any other rejections, the dispensing pharmacist may contact the PBM to obtain authorization for a short-term (5 days) “Samaritan fill.” The PBM customer service line is open 24 hours a day, 7 days a week. For PBM contact information, please see https://www.cdc.gov/wtc/pharmacy.html.

3.2 Drug Utilization Review (DUR)

The PBM system performs a drug utilization review (DUR) on each claim by screening the drug against previously submitted claims. The purpose of DUR is to improve patient safety and prevent waste. DUR rules are utilized by all federal pharmacy programs and managed by the dispensing pharmacy. If the prescription does not meet the Program’s rules, then the claim will be rejected at the point of sale. The pharmacy has the ability to override DUR rules based on their professional judgment. DUR rules enforced by the PBM system include:

1. Allergy Screening
2. Drug-Drug Interaction Screening
3. Drug-Diagnosis Caution Screening
4. Drug-Inferred Health State Screening
5. Dosing/Duration Screening
6. Drug-Age Caution Screening
7. Drug-Sex Caution Screening
8. Duplicate Rx Screening
9. Duplicate Therapy Screening

3.3 Refill Too Soon

Refill too soon (RTS) point of sale rejections mitigate waste by preventing a member from receiving more medication than is medically necessary. Seventy-five percent of the previous refill must be exhausted based on days’ supply prior to the adjudication of another fill (e.g., ≥23 days of a 30-day supply, ≥68 days of a 90 day supply). If the refill is submitted prior to the 75% threshold, the prescription will reject at the point of sale. The pharmacist may call the PBM for an override in the following circumstances:

1. Lost or Stolen Medication: If a patient reports a medication was lost or stolen, the Program allows one lost or stolen medication override per year per medication. The member should file a police report if they suspect a medication was stolen.
2. Vacation Supply: If the member is going on vacation and will not be able to fill the medication while they are away, the Program allows one vacation medication override per year, per medication, to ensure the member does not run out of medication while on vacation. The Program will allow both the lost or stolen medication and vacation supply to be processed within the same year if warranted.

3.4 Quantity and Days’ Supply Limits

Certain select medications may have limitations on quantities based on Program rules outlined in the formulary. These quantity limits are enforced through point of sale rules and restrictions. The Program has placed limits on the number of days’ supply allowed for certain medications, with a maximum days’ supply of 90 days for all medications allowed by the Program. Starting October 1st, 2019, the WTC Health Program will only allow up to a 30-day supply of medication for each fill at retail or community pharmacies. For any medication fills over 30 days and up to 90 days, the member must use home delivery service. For information on home delivery, please visit https://wtchomedelivery.optum.com/.

3.5 Level 2 Prior Authorization

Certain select medications on the formulary are subject to Level 2 Prior Authorization (PA) requirements and must be authorized by the member’s CCE/NPN. If the medication requires a Level 2 PA, the prescription will be rejected at the point of sale and require review by the CCE/NPN. The CCE/NPN can authorize the medication based on medical necessity and prior authorization criteria outlined in the formulary. As with all prescriptions, members should contact the pharmacy to make sure a prescription has been processed prior to picking up the medication.

3.6 Level 3 Prior Authorization

Medications that are not on the formulary will be rejected at the point of sale and require a Level 3 Prior Authorization (PA). To obtain approval, the CCE/NPN must submit a Request for a Level 3 PA to the WTC Health Program. Once the request is received, the WTC Health Program will decide whether to approve the Level 3 PA based on specific criteria outlined in the formulary and/or Program policy.

The WTC Health Program reviews Requests for a Level 3 PA for the following:

1. Evidence that the condition being treated is a certified WTC-related health condition, or health condition medically associated with a certified WTC-related health condition;
2. Evidence the member meets the clinical criteria described in the formulary, if applicable;
3. Evidence of medical necessity; and
4. Determination that formulary medications are either not available or not clinically appropriate.

3.7 Point of Sale Rules and Restrictions - Nationwide Provider Network (NPN) and William Street Clinic (WSC)

The NPN has more Level 2 and Level 3 Prior Authorization requirements, restrictions, and point of sale rules on medications than the CCEs. These restrictions apply to all members assigned to the NPN and the William Street Clinic (WSC); WSC pharmacy benefits are administered by the NPN and have the same rules and restrictions applied as the NPN for pharmacy claims. These additional restrictions are in place to permit the proactive review of medications prior to claim adjudication since the NPN/WSC does not have a closed prescriber network (See Section 2.3: Prescriber Networks).

4.0 Medical Necessity Documentation Requirements

All prescriptions dispensed under the WTC Health Program must be medically necessary to manage, ameliorate, or cure a certified WTC-related health condition or health condition medically associated with a certified WTC-related health condition. Please see Chapter 4, Section 4.0 for more detail on covered conditions.

All treatments, including prescriptions, covered by the Program must have documentation of medical necessity. Documentation should include:

1. Information regarding the certified WTC-related health condition, or health condition medically associated with a certified WTC-related health condition, to be treated by the medication; and
2. Evidence supporting that the use of the medication is medically necessary (i.e., clinical need for the drug) to manage, ameliorate, or cure the certified WTC-related health condition, or health condition medically associated with the WTC-related health condition.

4.1 Documentation Guidance

In some cases, the member’s certification may be a form of documentation of medical necessity. For example, if the member is certified for asthma and is receiving a Food and Drug Administration (FDA) approved asthma inhaler, the certification alone can be used as documentation of medical necessity.

If the clinical use of the drug cannot be determined by reviewing the member’s certified condition(s), then the CCE/NPN should document the certified condition being treated and the rationale for medical necessity. For example, the CCE/NPN should document when a drug has multiple indications, some of which are not WTC-related health conditions, or if the member is using the drug to treat a side effect or ancillary condition related to the certified condition. (See Chapter 4, Section 2.4: Treatment Benefit Plan).

All documentation related to medical necessity for medication should be easily retrievable and available in the event of audits or drug utilization reviews. All authorizations performed in the PBM pharmacy claims processing system must have documentation in the system. The CCE/NPN must also document medical necessity of a medication in the electronic medical record, and/or other files as determined by the CCE/NPN.

4.2 Documentation Requirements for CCE/NPN Pharmacy Adjudication Decisions

Decisions made by the CCE/NPN for transactions that require Level 2 Prior Authorization and other point of sale rules and restrictions must be documented in the pharmacy adjudication system provided by the PBM.

This documentation must include:

1. An explanation of medical necessity as described in Sections 4.0 and 4.1 above; and
2. Rationale that supports the prior authorization criteria outlined in the formulary.

5.0 Pharmacy Formularies

The WTC Health Program uses benefit plans to determine what kind of treatment a member is eligible to receive. Benefit plans are groupings developed by the WTC Health Program that define the acceptable scope of treatment for specific categories of covered health conditions. For more on benefit plans, please refer to Chapter 4, Section 2.0: Approved Benefit Plans.

The WTC Health Program assigns members to the appropriate Pharmacy Formulary based on the member’s certified health conditions, benefit plan, and membership type (e.g., responder, screening-eligible or certified-eligible survivor, or immediate family of deceased FDNY firefighters). This section summarizes the current Pharmacy Formularies and provides highlights regarding formulary eligibility criteria and content.

5.1 Diagnostic Formulary

1. Eligibility Criteria: All members except FDNY family members, regardless of certification status, are eligible for the diagnostic formulary during the initial monitoring period for responders or the initial health evaluation period for survivors.
2. Formulary Content: The diagnostic formulary is limited to those medications used for the purpose of diagnosing an illness and/or managing immediate symptoms.
3. Drug Quantity Limitations:
   1. 30-day supply limit per fill; and
   2. Maximum of 90 days’ supply of medication total
4. Criteria for use of the diagnostic formulary:
   1. Diagnostic evaluation for a WTC-related health condition (See Chapter 4, Section 2.3: Diagnostics Benefit Plan and Section 2.6: Cancer Diagnostics Benefit Plan).
   2. Diagnostic evaluation for a health condition medically associated with a certified WTC-related health condition;
   3. Preparation for an approved cancer screening benefit (e.g., colon or breast cancer); or
   4. Medically necessary care for a health condition for which the CCE/NPN properly submitted a certification request to the WTC Health Program with a request for Treatment Pending Certification (See Chapter 4, Section 3.5: Authorization of Treatment Pending Certification).

5.2 Standard Treatment Formulary

1. Eligibility Criteria: Members with at least one certified condition are eligible for the standard treatment formulary, with the exception of most cancer certifications, Program approved transplants, and FDNY family members.
2. Formulary Content: The standard treatment formulary includes medications for the treatment of most certifiable conditions.

5.3 FDNY Family Mental Health Formulary

1. Eligibility Criteria: Immediate family members of FDNY Responders who died on 9/11 responding to the terrorist attacks and who are enrolled in the Program with at least one mental health certification.
2. Formulary Content: The FDNY family mental health formulary includes a subset of medications in the standard treatment plan for certified mental health conditions.

5.4 Trans