EPAP SOW 03232021.pdf

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STATEMENT OF WORK

Emergency Prescription Assistance Program (EPAP)

1. REQUIRING ORGANIZATION

Department of Health and Human Services

OS/ASPR/ORM

200 Independence Ave, SW

Rm 716-G

Washington, DC 20201

2. OBJECTIVE

2.1. The purpose of this requirement is to obtain services to perform the activities related to adjudicating prescription drug claims for medications, specific medical supplies, vaccines and

Durable Medical Equipment (DME) and reimbursing pharmacies enrolled in the Emergency

Prescription Assistance Program (EPAP) on the Government’s behalf.

2.2. Additionally, this requirement will permit the adjudication and reimbursement for the administration or dispensing of specific medications and vaccines by community pharmacies. This effort will allow any participating pharmacy in the United States and its territories (Puerto Rico and the US Virgin Islands) to use existing electronic pharmacy systems as an infrastructure to efficiently process prescription drugs, specific medical supplies, vaccines and DME for uninsured individuals that are eligible for the EPAP.

2.3. EPAP activities provide “essential assistance” to support state and local jurisdictions as defined in Section 403 and 502 of the Stafford Act, 42 USC 5170b. The Stafford Act defines United States and States includes the several States, the District of Columbia and territories and possessions of the

United States (US Territory). Program activation will occur under the Robert T. Stafford Disaster

Relief and Emergency Assistance Act or under the authorities of the National Disaster Medical

System (NDMS) to provide emergency medical care to the uninsured individuals of public health emergencies and catastrophic events that overwhelm the capacity of state and local emergency medical systems to respond to these disasters.

2.4. Section 2812 of the PHS Act provides that the Secretary may activate the NDMS to “provide health services, health-related social services, other appropriate human services, and appropriate auxiliary services to respond to the needs of victims of a public health emergency (whether or not determined to be a public health emergency under section 319).

3. BACKGROUND

3.1. Section 2811 of the Public Health Service Act establishes within the Department of Health and

Human Services (HHS) the position of the Assistant Secretary for Preparedness and Response

(ASPR) to serve as the principal advisor to the Secretary on all matters related to Federal public health and medical preparedness and response for public health emergencies. ASPR has agreed to accept a subtask from the Department of Homeland Security, Federal Emergency Management

Agency to provide pharmaceutical supplies, specific medical supplies, vaccines, limited DME and personnel sufficient to support disaster response operations.

3.2. In the aftermath of several natural disasters, community retail pharmacies were ready, willing and able to assist evacuees. Indeed, in many disaster areas, community pharmacists were on the scene

2 | M a r c h 1 3 , 2 0 2 1 before any other medical professionals providing first aid and prescription drug assistance to evacuees. Through the coordinating efforts of HHS, community pharmacists were able to set up and serve the emergency needs of evacuees from Katrina at the Astrodome, Kelly Air Force Base, the

Convention Center and hundreds of other evacuee sites using the existing private prescription drug distribution system.

3.3. Conflicting directions from Federal, State, local and private agencies, along with the lack of any established process for enlisting the help from this community resource were among the biggest challenges for these pharmacies. In fact, many pharmacies that dispensed medications to evacuees were unable to settle claims due to the lack of clarity about what agency is responsible for paying which prescription drugs dispensed during the disaster response.

3.4. Prescription drugs, specific medical supplies, vaccines and DME are critical first line therapies in treating both acute and chronic conditions. For this reason, assuring an adequate and readily available supply should be a priority for emergency planning.

3.5. As a byproduct of our experience with several natural disasters, the federal government established the EPAP to fully leverage private sector resources for efficient prescription drugs, specific medical supplies, vaccines and DME distribution. The EPAP will provide access to necessary prescription drugs, specific medical supplies, vaccines and limited DME for uninsured individuals who were affected by a major disaster or emergency and have a need for prescription drugs, medical supply, or DME coverage at any pharmacy in the nation or US territories.

3.6. Additionally, the EPAP will facilitate communications between government and private industry to identify and address any potential pharmaceutical and medical supply needs during the initial disaster response.

4. SCOPE

4.1. The Contractor shall provide access, to any EPAP-enrolled network retail pharmacy in the nation or U.S. territory to ASPR- identified prescription drugs, specific medical supplies, vaccines and limited DME for uninsured individuals who were affected by a major disaster or public health emergency. The activation of this requirement for adjudication and reimbursement for the administration or dispensing of specific prescription drugs, specific medical supplies, vaccines and limited DME by community pharmacies in response to a public health emergency will be by determined by the ASPR. EPAP should be the payer of last resort for prescription drugs, specific medical supplies, vaccines and limited DME with coverage effective only after other insurances

(private insurance, Medicare, and Medicaid) cannot be identified by the patient, pharmacy or by the

EPAP contractor through an eligibility database (Surescripts or similar database capability). This Third

Party Liability (TPL) program is meant to limit EPAP coverage only to individuals with no other forms of applicable coverage. The EPAP shall reject claims from individuals who have other prescription drugs, medical supplies, vaccines and DME coverage identified through the Third Party

Liability (TPL) program (see sample attachment #1). If other payer information is identified by the

EPAP contractor through the TPL program, the Contractor shall correct payer information to the dispensing pharmacy to facilitate patient access through appropriate coverage channels. The claims should be for prescription drugs written by an appropriately licensed clinical provider or prescription drugs refills on file at the pharmacy provided doing so is within the authority provided by the state, and the prescription drug or medical item is on the approved list. The contractor is responsible for all claim reimbursements to the pharmacy and will bill HHS monthly for claims processed for reimbursement to the contractor.

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4.2. Prescription drug bottles with refills remaining on a current prescription are considered adequate proof of an existing prescription where such prescription is not for a controlled substance, except if such prescription drug otherwise meets applicable state law requirements for emergency refills.

Contractor shall make reasonable efforts to review and monitor the cost effectiveness, interaction and resulting therapeutic implications of various prescription drugs, medical supplies, vaccines and DME.

The EPAP consists of three Phases.

5. APPLICABLE DOCUMENTS

The Emergency Prescription Assistance Program website https://www.phe.gov/preparedness/planning/epap/pages/default.aspx

Document Preparer Information/Instruction: List in this section all documents referenced in the Technical

Requirements/Tasks section. Whenever possible, tailor each referenced document to cite only the specific portion that applies to this requirement. Include the full title, date and version of each referenced document. Example:

National Response Plan ESF#08 http://FEMA National Response Plan ESF-08.pdf

HSPD #10

6. TECHNICAL REQUIREMENTS/TASKS

6.1. CONTRACTOR REQUIREMENTS:

6.1.1. PRE-ACTIVATION PHASE and MAINTENANCE (ONE TIME SYSTEM SET-UP)

Set up the EPAP to become fully operational within 15 days of requirement being awarded

Establish an interface with an eligibility database (Surescripts or similar database capability) to allow for real-time eligibility queries during the activation phase

Implement a mandatory fill program for the lowest price alternative between brand and generic, unless prescribed Dispense As Written (DAW) for a brand medication

Establish a 24/7 Call Center capable of providing telephonic Customer

Service Representative (“CSR”) support using an existing (“CSR”) 800 number, including an Interactive Voice Response (“IVR”) phone system or similar non- IVR decision tree phone system, immediately of activation, or in the case of US Territory within 24 hours, to provide automated information concerning the EPAP to:

o Retail Pharmacy Providers o Uninsured Individuals/Beneficiaries o Develop an appeal process if uninsured individuals want to appeal (so it will notify HHS/ASPR COR if there is an appeal)

Maintain or establish enrollment of existing pharmacy nation-wide network

(50,000+ retail pharmacies) as the EPAP pharmacy network. This network should be capable of providing eligible uninsured individuals with covered prescription drugs, medical supplies, vaccines and DME https://www.phe.gov/preparedness/planning/epap/pages/default.aspx http://www.fema.gov/pdf/emergency/nrf/nrf-esf-08.pdf

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Establish a testing and maintenance plan on the system to ensure EPAP workflow [see Appendix A] process is properly functioning

6.1.2. ACTIVATION PHASE (SYSTEM OPERATING)

Notify enrolled EPAP retail pharmacies in the affected areas of EPAP activation through fax, email message, text or other direct message

Activate EPAP and become fully operational within 24 hours of receiving issuance of task order from Contracting Officer

Provide EPAP coverage for prescription drugs, specific medical supplies, vaccines and limited DME [see Appendix B] determined by preset formulary for uninsured individuals who present a valid prescription at enrolled retail pharmacies across the nation during a qualifying event, at no cost to the uninsured individuals. The limited Durable Medical Equipment is cane, walker, crutch and wheelchair, however, additional DME may be added in the future.

Implement or use existing systems that enables real-time point-of-sale eligibility checks and edits for claims where the pharmacist has found no coverage

Adjudicate payment of legitimate pharmacy claims from participating network pharmacies on an as-needed basis

Allow enrollment of legitimate pharmacies (including during activation) into

EPAP nation-wide network provided pharmacies are willing to accept the standard terms and conditions of the EPAP pharmacy network contract

Communicate with network pharmacies for claims processing instructions, including updated payer sheets, eligibility criteria, approved prescription drugs, specific medical supplies, vaccines and limited DME, and program limitations within 24 hours

6.1.3. DE-ACTIVATION PHASE (SYSTEM END)

De-activate EPAP within 24 hours of receiving notification

Close out and pay all claims in accordance with the terms and conditions of task order

Auditing of claims to evaluate fraud and abuse of claims (average of 12,000 claims per response), review of prior authorization appropriateness, and validation of payer of last resort status. The results of the report may require redirecting payments to an appropriate third-party payer or other payment reconciliation with ASPR

Notify enrolled EPAP retail pharmacies in the affected areas of EPAP de-activation through fax, email, text or another direct message

6.2. OPTIONAL TASK 4 - TRANSITION IN/OUT PLAN

Sixty (60) days prior to the expiration of the contract, the contractor shall prepare and deliver transition in and transition out plan, including milestones, deliverables, timeline, roles and responsibilities, and government acceptance criteria. This shall include migration and transfer of all production, development and testing environments. The plan shall not exceed 10-page limit, 5 | M a r c h 1 3 , 2 0 2 1 excluding appendixes. All page margins (top, bottom, left, and right) should be 1 inch, with 12-point font typed in Times New Roman.

[NOTE: All reports under this contract shall be produced using HHS approved software (e.g.MS

Word and/or Excel). Reports shall be forwarded to the COR and TL by e-mail in an electronic format. Files should not be locked and should be able to be edited until after final production is approved.] "

7. GOVERNMENT FURNISHED RESOURCES AND INFORMATION

No Government furnished equipment or supplies.

8. REPORTING REQUIREMENTS

8.1. All reports/deliverables required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:

https://section508.gov/ http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

8.1.2. Contractor shall provide EPAP progress reports to the HHS/ASPR Project Officer, on an as needed basis, or at a minimum weekly, containing the following information:

a. Total contract cost, including detail claims adjudicated and other operational costs.

b. Suspicions of fraudulent EPAP billing activity among network pharmacies.

c. Contractor shall submit all claim reports within 3 days after each individual billing cycle. The claim report shall be an itemization of Claims accepted and shall forward such itemization (1) to the Participating Pharmacies in the form of a remittance advice; and (2) to HHS/ASPR in the form of a Paid Claims file.

d. Contractor shall also provide timely reports of eligibility checks, pharmacy communications, manufacturer donations, management and financial reports and any other operational activities to HHS/ASPR. Specific reports of product utilization, by manufacturer, will be necessary to facilitate charitable product donation.

https://section508.gov/ http://www.hhs.gov/web/508/index.html

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REPORTING REQUIREMENTS

Description Phases Delivery Schedule Addressee Method of Delivery

Activation Claim Reports

(detailed) Activation 3X/Week CO and COR

Electronic (Microsoft Excel or other)

Fraudulent Activity Activation Daily CO and COR Electronic (Microsoft Excel or other)

Progress Conference Activation As Needed CO and COR Teleconference

Rejection Claims Activation Weekly CO and COR Electronic (Microsoft Excel or other)

Auditing for Fraud and

Abuse Claims De-Activation

30 days after De-

Activation CO and COR

Electronic (Microsoft Excel or other)

9. PACKAGING, MARKING AND SHIPPING

N/A

10. INSPECTION AND ACCEPTANCE

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

11. PERIOD OF PEROFORMANCE

a. The period of performance of this contract shall be a base period of 12 months.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION the period of performance will be increased as listed below:

Option Option Periods

One

12 months

Two 12 months

Three 12 months

Four 12 months

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12. DELIVERABLES

DELIVERABLE

Description Phases Delivery

Schedule Addressee Delivery

Method

Kicky-Off Meeting Pre- Activation 1 week After

Award COR and CO

Face-to-Face

Conference

Program Management Plan Pre- Activation 15 Days After

Award COR and CO Electronic

Maintenance system to ensure adjudicating claims Pre- Activation

30 Days After Award and every 6 months COR and CO Conference

Finalized EPAP Workflow Pre- Activation 30 Days After Award COR and CO Electronic

Finalized DME Listing Pre- Activation 30 Days After Award COR and CO Electronic

Finalized Event Guide Pre- Activation 30 Days After

Award COR and CO Electronic

OPTIONAL TASK

Transition In/Out

At Award 1st week After

Award COR and CO Electronic & Face to Face

13. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

a. The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

b. The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any

8 | M a r c h 1 3 , 2 0 2 1 changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

c. The Government may unilaterally change its COR designation.

14. TASK ORDER PROCEDURES

14.1. This contract provides for the issuance of Task Orders on a negotiated basis as follows:

14.2. Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the

Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this SECTION.

This contract provides for the issuance of Task Orders as follows:

[X] in writing;

[X] via electronic mail (e-mail); and/or

[X] via telephone

14.3. The Task Orders will communicate relevant details for the Activation phase of the EPAP as it relates to an event identified as a disaster by ASPR. For a specific disaster, ASPR will directly collaborate with state and local public health emergency management to determine if a response requirement exists for the use of EPAP and the issuance of a Task Order. EPAP claims processing during an Activation

Phase will be terminated via a Deactivation Phase notification. Similar to the Activation Phase, the

Deactivation Phase of EPAP will be determined by ASPR through direct communications with the public health emergency management officials leading the local disaster response effort. Subsequent, Task

Orders may be issued for the ACTIVATION phase as required for newly occurring disasters as determined by ASPR.

14.4. The Contractor may incur increased price [EPAP Claims during Activation CLIN] under this contract during the performance of task orders and task order modifications issued in accordance with this section. This may be the case when a Task Order is issued and the reimbursement of claims is larger than the initial request of funds, or additional areas need to be added to a Task Order.

14.5. Only the Contracting Officer is authorized to issue orders under the contract.

14.6. No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

14.7. The Contractor shall notify the Contracting Officer in writing whenever it has reason to believe that the task order price the Contractor expects to incur under the task order will exceed 75 percent of the stated not to exceed (NTE) amount on the Task Order.

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15. EMERGENCY TASK ORDER PROCEDURES

15.1. Emergency work is defined as work of such an unusual or compelling nature that the public would suffer serious or irreparable damage if the work is not completed immediately. The Government reserves the right to award an emergency Task Order to the contract holder.

15.2. Emergency work is received by the HHS/ASPR/ORM and they will notify the EPAP Contracting

Officer Representative (COR). The COR notifies the Contractor Officer (CO) and Contractor via telephone or e-mail of the nature and the location of the emergency; and, the Contractor, upon receipt of a

Contracting Officer's verbal or written Notice to Proceed (NTP) shall mobilize without delay in response to such calls be on-site and ready to commence work at the designated time arranged by the COR.

15.3. Where the Contract is specifically directed to perform designated emergency work, the Contractor shall be entitled to add a surcharge to his standard (non-premium time) labor rates when work is performed outside of regular work hours. For emergency work outside normal work hours, the Contractor shall use the fixed labor rates for Evening/Weekend work as identified in the Fixed Labor Rate tables in

Section B of the contract.

15.4. The COR will accompany the Contractor to inspect finished emergency Task Order work upon notification by the Contractor that work is complete before the Contractor is released.

15.5. This contract provides for the issuance of Emergency Orders issued under this contract may be placed as follows:

[X] Oral - Oral Orders will be confirmed in writing within 4 days of issuance, unless otherwise stated; and/or

[X] via telephone.

15.6. Only the Contracting Officer (or other designated CO) is authorized to issue emergency orders, and provide written confirmation of oral orders, if applicable, under the contract.

16. INVOICE SUBMISSION

16.1. The Contractor shall deliver electronically to the Contracting Officer (CO), the Contracting

Officer’s Representative (COR) and PSC electronically. Invoice reports should contain the following information: payee information (name and contact information), a unique identifier (such as an invoice number) from the payee, and an accounting of the payments that were/are to be made for each recipient of payment, transaction date of claim.

16.2. Unless otherwise specified by the Contracting Officer all deliverables and progress reports furnished to the Government under the resultant contract (including invoices) shall be addressed as follows:

NAME NAME Email invoices to:

Contracting Officer Contracting Officer Representative

HHS/ASPR/ORM

Representative PSC_Invoices@psc.hhs.gov

200 C St., S.W.

Washington, DC 20209

Frederick, MD 21703 mailto:PSC_Invoices@psc.hhs.gov

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Email: To Be Determined

Email: To Be Determined

17. POST AWARD EVALUATION OR CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared annually.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the

Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure website for review and comment at the following address:

https://www.cpars.gov mailto:long.pham@hhs.gov https://www.cpars.gov/