20150727_EPAP_DRAFT_STATEMENT_OF_WORK_FINAL.pdf

DRAFT STATEMENT OF WORK

Emergency Prescription Assistance Program (EPAP) Support

EPAP Claims Adjudication and Reimbursement

C.1 INTRODUCTION

C.1.1 EPAP activities provide “essential assistance” to support state and local jurisdictions as defined in Sections 403 and 502 of the Stafford Act, 42 USC 5170b.

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 victims of public health emergencies and catastrophic events that overwhelm the capacity of state and local emergency medical systems to respond to these disasters. Section 2812 of the Public Health Service (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.

C.1.2 BACKGROUND

C.1.2.1 Section 2811 of the PHS Act establishes within the Department of Health and Human Services the position of the Assistant Secretary for Preparedness and Response (HHS/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.

In accordance with the National Response Framework, ASPR on behalf of the HHS receives a mission assignment from the Federal Emergency Management Agency during Stafford Act Declarations or exercises its own authorities from Congress during Public Health Emergencies to provide pharmaceutical supplies, specific medical supplies, limited durable medical equipment and personnel sufficient to response operations.

C.1.2.2 In the aftermath of Hurricane Katrina, community retail pharmacies were ready, willing and able to assist uninsured disaster survivors with obtaining critical drugs and medical equipment. However, conflicting guidance from Federal, State, local and private agencies, along with the lack of any established process for enlisting the help from community pharmacies and payment for services were among the biggest challenges for these pharmacies. In fact, many pharmacies that dispensed medications to Katrina disaster survivors were unable to settle claims due to the lack of clarity about what agency was responsible for paying such prescriptions.

C.1.1.3 As a result of this experience, the federal government established the EPAP to fully leverage private sector resources for efficient prescription drug, specific medical supplies and DME distribution. EPAP will facilitate adjudication and reimbursement of eligible prescription claims to provide necessary prescription drugs, specific medical supplies, and limited durable medical equipment (DME) to uninsured disaster survivors during an emergency. EPAP will also facilitate communications between government and private industry to identify and address any potential pharmaceutical and medical supply needs during the initial disaster response. Prescription drugs, specific medical supplies, and durable medical equipment (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.

C.1.3. OBJECTIVE - The objective of this contract is to acquire the services of a commercial contractor to service and provide access to any eligible pharmacy capable of supporting EPAP nationwide or in U.S. territories. Activities include but are not limited to the following:

C.1.3.1 Ensure the EPAP is activated and operational within 48 hours of receiving activation notification.

C.1.3.2 Adjudicate and reimburse administration or dispensing of specific medications and vaccines by community pharmacies.

C.1.3.3 Support any 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 prescriptions, specific medical supplies, and DME for individuals that are eligible for the EPAP.

C.1.3.4 Ensure all enrolled and/or eligible Pharmacies are notified of EPAP activation through fax, email messages, and/or text messages.

C.1.3.5 Facilitate claims adjudication and reimbursement of covered prescription drugs, medical supplies, and DME for eligible uninsured disaster survivors who present a valid prescription at a pharmacy during a qualifying event at no cost to the affected individual.

C.1.3.6 Contractor shall limit pharmaceutical, specific medical supplies, and DME written prescription assistance to disaster survivors for a one time fill of up to a 30-day supply for a medication to treat an acute or chronic condition, to replace maintenance prescription drugs or medical equipment lost as a direct result of the declared emergency, or as a secondary result of loss or damage caused while in transit from the emergency site to the designated shelter facility.

C.1.3.7 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 for dispensing of EPAP covered drugs, specific medical supplies, and DME to eligible individuals.

C.1.3.8 Provide timely reports and relevant information of EPAP claims, eligibility checks, call-center activities, pharmacy communications, and pharmacy payments to ASPR.

C.1.3.9 Participate in disaster-related conference calls, as identified by ASPR, to facilitate communications with private industry and volunteer organizations.

C.1.3.10 Adjudicate legitimate pharmacy claims from pharmacy locations and other out of network pharmacies on an as-needed basis.

C.2. SCOPE

C.2.1The contractor shall solicit and enroll pharmacies for adjudicating prescription drug claims for medications, specific medical supplies, and durable medical equipment (DME) and reimbursing pharmacies enrolled in the Emergency Prescription Assistance Program (EPAP).

During the state-steady (warm-base) phase of this contact, the contractor shall sustain the appropriate capabilities to quickly activate EPAP and monitor public news for situational awareness of a developing incident that could potentially activate EPAP. During periods of heightened concern, the Contractor can request guidance from ASPR on the potential for EPAP activation. In response to an emergency event, when EPAP is activated, the contractor will provide claims adjudication and reimbursement for the administration or dispensing of specific medications, DME, medical supplies, and vaccines by pharmacies.

C.2.2 TECHNICAL REQUIREMENTS/TASKS

C.2.2.1 Program Management Plan - The Contractor shall provide a Program Management Plan (PMP) that fully documents its management approach for this contract as outlined below. At a minimum, the PMP shall:

C.2.2.3 Provide information on the Contractor’s management organization, internal management policies and procedures. The Contractor shall provide a single point of contact for coordination, management activities, internal policies and procedures to work with the Government as needed.

C.2.2.4 The Contractor shall maintain relationships and conduct regular meetings and reviews with Government personnel related to the activities and deliverables of the Contract at the request of the Government with a minimum of a meeting and review to take place once every 90 days.

C.2.2.5 Provide an organizational chart of the Contractor’s organization to be used in performance of the contract and narrative describing how the Contractor shall fully integrate the management of the elements of this contract and if the plan includes subcontractors, other than individual subcontractors, provide organizational information about potential subcontractors and include subcontractor organizational elements in the project organization chart.

C.2.2.6 Describe a subcontracting management plan that the Contractor intends to implement of how activities of any potential subcontractors shall be managed and organizational relationship shall be maintained between the prime and subcontractors and methods of requirement flow-down and activity progress reporting back to the prime Contractor.

C.2.2.7 The Contractor shall follow and illustrate an approach to selecting subcontractor(s) and maintaining the quality of products produced by subcontractor(s);

subcontractor’s role under the contract, its relationship to the Contractor.

C.2.2.8 Identify key technical and management personnel who shall be assigned to the contract.

C.2.2.9 Describe internal policies and procedures to be used in managing the contract.

C.2.2.10 Describe management and process for addressing work increases (spikes) and lulls as work priorities and schedules shift.

C.2.2.11 Describe the approach and method for the identification, assessment, and mitigation of program risks including provisions for identifying risk areas, assessing risk factors, assigning appropriate resources to reduce risk factors, identifying and analyzing alternative actions available, identifying the most promising alternatives, and planning for implementation of risk reduction.

C.2.2.12 Contractor shall provide a Project Plan with schedules through completion of system functionality.

C.2.3 Introduction to Pre-Activation Preparedness Phase (Warm Base Activities) - During the Pre-Activation Preparedness Phase (Warm Base Activities) when emergency event is not active, it is the expectation of the Government that the Contractor shall maintain a state of readiness to be able to have EPAP active within 48 hours after CO notification .. Contractor shall provide all labor, supervision, and training to provide qualified tasks to perform the specific tasks stated below:

C.2.3.1 Pre-Activation Preparedness Phase (Warm Based Activities) - During the pre-activation phase, the contractor shall maintain appropriate communication with pharmacies nationwide (including US Territories), preparedness staff, and infrastructure to active within 48-hours an EPAP to perform claims adjudication, processing, and payment during an emergency. During this phase, the contractor shall maintain minimal staff, necessary information technology (IT) and telecom systems, subscriptions, infrastructure to include communication with the government and standby support personnel in a preparedness-state to activate EPAP. The goal of the Government is to coordinate with the Contractor’s resources, capabilities, and business processes to perform the preparedness functions. The capability to activate EPAP should be tested at least twice annually (January and July) to validate preparedness. The government shall provide the drug formulary for upload in the contractor’s adjudication or claims processing system. The government shall maintain the EPAP website and the contractor shall provide the list of enrolled pharmacies and any other information for the public for upload to this website, as required. Below are the critical tasks to ensure EPAP program readiness:

C.2.3.2 The Contractor shall solicit enrollment of any national pharmacy to participate in the EPAP pharmacy network. This network should be capable of providing uninsured disaster survivors with covered drugs and DME across the nation and US Territories.

C.2.3.2.1 The Contractor shall maintain situational awareness of public news and national level events that could potentially result in the activation of EPAP.

C.2.3.2.2 The contractor shall provide participating pharmacies the standard terms and conditions of the pharmacy enrollment program and shall outline the terms and condition of pharmacy agreements through submission of a signed agreement. The purpose of the signed agreement is to ensure that participating pharmacies are in compliance with all local, state and federal laws and regulations.

C.2.3.2.3 The Contractor shall provide to ASPR via the Contracting Officer (CO) and Contracting Officer’s Representative (COR) all current primary and alternate key staff contacts that are authorized to immediately activate the EPAP.

In the instance personnel responsibilities change, the Government (CO and COR) shall be notified 24 hours before change occurs.

C.2.3.2.4 The Contractor shall validate the legitimacy of all enrolled pharmacies in accordance with their internal policies and procedures before processing claims from these pharmacies.

C.2.3.2.5 The contractor shall maintain a preparedness posture to activate a Call Center within 48-hours to provide customer service to eligible pharmacies to sign-up, process claims, or provide technical support. The call center shall be prepared to field approximately 100 incoming calls, 50 outgoing calls, and 100 calls into automated phone system per day. The call center shall be prepared to provide staffing and services during 0700-2359 hours of the affected time zone(s).

C.2.3.2.6 The contractor shall maintain a preparedness posture to within 48 hours of EPAP activation communicate with enrolled pharmacies through an electronic notification system that is capable of sending a combination of approximately 2,000 faxes, email messages, or text messages for activation and deactivation of the EPAP.

C.2.3.2.7 The Contractor shall upload a pre-determined formulary established by ASPR and provided by the COR to the Contractor.

C.2.3.2.8 The contractor shall maintain the necessary IT interfaces to facilitate Third Party Liability (TPL) adjudication and processing of claims for uninsured disaster survivors.

C.2.4 Activation Phase - During the Activation Phase occurs when an emergency event has been declared and is ongoing, it is the expectation of the Government that the Contractor shall initiate and start to perform the activities needed to deliver EPAP within 48 hours after issuance of notification for activation.

C.2.4.1 - The goal of the activation phase is to activate within 48-hours an EPAP to immediately begin performing claims adjudication, processing, and payment during an emergency to facilitate providing eligible uninsured disaster survivors with covered prescription drugs, medical supplies, and DME who present a valid prescription at a pharmacy at no cost to the uninsured disaster survivor.

C.2.4.2 The Government shall provide written notification to activate the EPAP . The contractor shall immediately notify and provide EPAP instructions to eligible pharmacies in the eligible affected area and immediately stand-up a toll-free number and call center to service customers. The contactor shall provide the Government confirmation that activation tasks are complete and program is full activated. The Government will activate the EPAP website on the HHS www.phe.gov website. The Government will also message through government Public Affairs channels the activation of the program. The contractor shall provide a current listing of enrolled pharmacies in the affected area and be prepared to begin providing immediate reporting of claims processing and invoicing every 24-hours upon activation. Below are the critical tasks to ensure EPAP program activation:

C.2.4.2.1 Contractor shall fully activate EPAP within 48 hours.

C.2.4.2.2 Contractor shall activate required staffing to include a Call Center http://www.phe.gov/ coordinate and perform EPAP activation activities, coordinate communication with pharmacies in the affected area and the government, and conduct near real-time reporting and invoicing. Staffing requirements shall be seven days a week, up to 24 hours per day in the affected regional time zone(s).

C.2.4.2.3 Contractor shall provide Customer Service Representative (CSR) and Interactive Voice Response (IVR) through a toll free number within 48 hours of activation to service pharmacy providers, disaster survivors or beneficiaries.

C.2.4.2.4 Contractor shall have the capability during activation to notify eligible pharmacies of EPAP activation through faxes, email messaging, text messaging and other reasonable means to achieve activation. The estimated notification workload during the activation phase is a combination of approximately 2,000 faxes, email messages and text messages.

C.2.4.2.5 Contractor shall allow any recognized retail pharmacy to file claims provided they accept the standard EPAP network contract terms and conditions. Contractor shall provide EPAP enrolled network pharmacies with claims processing instructions, including updated payer sheets, eligibility criteria to include the list of approved drugs formulary, specific medical supplies, and DME lists provided by the government. The estimated workload distribution of pharmacy provider network information and EPAP instructions is approximately 2,000 instructions sent via fax and email messaging).

C.2.4.2.6 COR may further restrict the established formulary at their discretion and will communicate such changes to the Contractor. Upon receipt of the updated formulary, the Contractor shall update their proprietary database within 24 hours after receipt.

C.2.4.2.7 Contractor shall provide program software to interface with and establish dedicated EPAP server link to RxHub for Third Party Liability (TPL) real time adjudication.

C.2.4.2.8 Contractor shall require participating pharmacies to verify patient’s eligibility of EPAP assistance prior to submitting the claim by verifying the disaster survivors is from the affected area, has no existing TPL program, and has a valid prescription for a covered drug, medical supply, or DME item.

C.2.4.2.9 When screening for TPL program, the Contractor shall reject claims for disaster survivors who have other prescription drug, specific medical supplies, or DME coverage identified through the TPL program unless the government has specifically waived this requirement in writing.

C.2.4.2.10 Contractor shall make reasonable efforts to review and monitor the cost effectiveness and resulting therapeutic implications of various drugs, specific medical supplies, and DME.

C.2.4.2.11 Contractor shall implement a mandatory fill program for the lowest price alternative between brand and generic, unless prescribed Dispense As Written (DAW) for a brand medication.

C.2.5 Post-Activation/Maintenance Phase - During the post-activation phase the Contractor shall sustain EPAP capability (24/7) during a response to conduct claims adjudication, processing, payment, reporting, and customer services during an emergency to facilitate providing eligible uninsured disaster survivors with covered prescription drugs, medical supplies, and DME who present a valid prescription at a pharmacy at no cost to the uninsured disaster survivor. The contractor shall sustain necessary staffing and capabilities to include any required redundant capabilities to sustain the EPAP throughout the response operational period. The contactor shall conduct required reporting and remain diligent in preventing fraud to the EPAP through its adjudication process. The contractor shall continue to enroll eligible retail pharmacies and provide updates to the COR to update the EPAP website. Throughout this phase, funding will be provided for prescription drugs, vaccines, specific medical supplies, and DME to include Contractor expenses for drug transaction costs, reports, pharmacy communications, and other necessary operational expenses incurred under the performance of this contact. Below are the critical post-activation tasks to be reported to the COR (if not stated, then at COR request) to ensure EPAP sustainment:

C.2.5.1 Contractor shall provide EPAP weekly progress reports to the COR containing the following information. Reporting frequency may be updated by the COR, as required. Weekly Progress Reports shall include:

C.2.5.1.1 Total performance costs, including detail claims adjudicated and other operational costs.

C.2.5.1.2 Current accounting as expressed by percentage of total Contractor expended funds over total Government distributed funds to the Contractor each week in performance of the contract as expressed in the weekly progress report.

C.2.5.1.3 Suspicious or fraudulent EPAP billing activity among network pharmacies

C.2.5.2 Prescription Cost and Additional Post Activation Processing Costs: Report of all prescriptions that were distributed during activation phase which details total prescription costs and the following information:

C.2.5.2.1 Pharmacy drug cost (includes dispensing fee/drug cost/sales tax)

C.2.5.2.2 Dispensing fee

C.2.5.2.3 Vaccine administration fee

C.2.5.2.4 TPL confirmation per claim

C.2.5.2.5 Administration price per Rx claim paid or denied

C.2.6 Deactivation Phase - During the deactivation phase the Contractor shall conduct an orderly transition of the EPAP to the Pre-Activation Preparedness phase. During this phase, the contractor shall notify participating pharmacies of program deactivation while sustain minimal necessary staff to conduct limited auditing, invoicing and reporting, customer services, and communications.

C.2.6.1 The contractor shall deactivate the Call Center and EPAP Response Pharmacy Network in the affected areas. Events associated with this task include the orderly reduction of call center staffing and deactivation communications.

C.2.6.2 The contractor shall continue to audit claims for fraudulent claims and an evaluation to identify personnel that refilled numerous prescription with different physicians. The estimated workload is approximately 12,000 claims per response.

C.2.6.3 The contractor shall provide a pharmacist medication and DME utilization report that depicts the medication and DME by common category, geographic area, and timeframe (monthly).

C.2.6.4 The contractor shall continue reporting on claims, invoicing, and reportable areas outlined in the activation phase of the contract.

C.2.6.5 The contractor shall provide a final report on overall program statistics and results that includes participating pharmacies, DME by common category, geographic area, and other available statistics or program demographics that will assist the government in future planning and program improvement.

C.2.7 BILLING and REPORTING SCHEDULE

C.2.7.1 Contractor shall provide EPAP weekly progress reports to the COR containing the below information. COR may change reporting based on requirements.

C.2.7.1.1 Total performance costs, including detail claims adjudicated and other operational costs.

C.2.7.1.2. Current accounting as expressed by percentage of total Contractor expended funds over total Government distributed funds to the Contractor each week in performance of the contract as expressed in the weekly progress report.

C.2.7.1.3 Suspicious or fraudulent EPAP billing activity among network pharmacies.

C.2.7.1.4 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.

C.2.7.1.5 Contractor shall submit all claim reports within three (3) days after each individual billing cycle:

C.2.7.1.6 Contractor shall prepare an itemization of claims accepted and provide information to (1) to the Participating Pharmacies in the form of remittance advice; and (2) ASPR in the form of an Adjudicated Claims file.

C.2.7.1.7 Contractor shall also provide timely reports of eligibility checks, pharmacy communications, manufacturer donations, management and financial reports and any other operational activities to the COR and CO.

C.2.7.1.8 Submission of invoices will be in accordance with 48 CFR 52.212- 4(g).

C.2.8 APPLICABLE DOCUMENTS

C.2.8.1. - N/A

C.2.9 GOVERNMENT FURNISHED RESOURCES AND INFORMATION

C.2.9.1. - N/A

C.2.10 REQUIREMENTS FOR HANDLING SENSITIVE/PROPRIETARY

INFORMATION

C.2.10.1 All documents that contain information covered under the Privacy Act, 5 USC 552(a), and/or the Health Insurance Portability and Accountability Act (PL 104-191) and their various implementing regulations and must be protected in accordance with those provisions. Healthcare information is personal and sensitive and must be treated accordingly.

C.2.11. DELIVERABLES

C.2.11.1 Steady-state (warm-base) preparedness of the EPAP to facilitate activation of the EPAP within 48 hours. This include designation of and contact information for key personnel to activate the program.

C.2.11.2 Infrastructure, systems, and staffing to facilitate enrollment, customer service, communication with retails pharmacies for the EPAP.

C.2.11.3 Claims processing, adjudication, and payment for prescription, specific medical supplies, and DME claims in real time at enrolled pharmacies to provide service uninsured disaster survivors during a disaster response of emergency.

C.2.11.4 Auditing and reporting of claims processing, adjudication, and statistics during EPAP activation, post-activation, and deactivation

C.2.11.5 The Contractor shall follow and illustrate an approach to selecting subcontractor(s) and maintaining the quality of products produced by subcontractor(s);

subcontractor’s role under the contract, its relationship to the Contractor.

C.2.11.6 Describe management and process for addressing work increases (spikes) and lulls as work priorities and schedules shift.

C.2.12. PERFORMANCE/DELIVERY PERIOD

C.2.12.1 - 12 month Base period with four (4) 12 month option years

C.2.13. PLACE/LOCATION OF PERFORMANCE/DELIVERY

C.2.13.1 - Contractor shall perform all work at the Contractor’s site.

C.2.14. TRAVEL REQUIREMENTS

C.2.14.1 - No travel requirements.

C.2.15. GOVERNMENT POINTS OF CONTACT

C.2.15.1 Contracting Issues: George J. Keane, Jr., Contract Specialist, Department of Health and Human Services, email: george.keane@hhs.gov, Phone: 202- 260-5169

C.2.16. SPECIAL REQUIREMENTS

C.2.16.1 - N/A

C.2.17. SECURITY AND BUILDING ACCESS REQUIREMENTS

mailto:george.keane@hhs.gov

C.2.17.1 - N/A