EPAP_2015_-_DRAFT_STATEMENT_OF_WORK.pdf

SOLICITATION 15-100-SOL-00011

Emergency Prescription Assistance Program Support

ATTACHMENT 1 - STATEMENT OF WORK

EPAP Claims Adjudication and Reimbursement

1. REQUIRING ORGANIZATION

Department of Health and Human Services

OS/ASPR/OEM

2. OBJECTIVE

The purpose of this contract is to obtain services to perform the activities related to 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) on the Government’s behalf. Additionally, this contract will permit the adjudication and reimbursement for the administration or dispensing of specific medications and vaccines by community pharmacies. This effort will allow 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. 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. 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 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

Section 2811 of the Public Health Service 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. ASPR has agreed to accept a subtask from HHS/ASPR to provide pharmaceutical supplies, specific medical supplies, limited durable medical equipment and personnel sufficient to support disaster response operations.

In the aftermath of Hurricane Katrina, community retail pharmacies were ready, willing and able to assist victims and evacuees. Indeed, in many disaster areas, community pharmacists were on the scene before any other medical professionals providing first aid and prescription drug assistance to victims. Through the coordinating efforts of DHHS/ASPR, 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 drug distribution system.

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 Katrina evacuees were unable to settle claims due to the lack of clarity about what agency is responsible for paying which prescriptions dispensed during the Katrina 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.

As a byproduct of our experience with Hurricane Katrina, the federal government established the Emergency Prescription Assistance Program (EPAP) to fully leverage private sector resources for efficient prescription drug, specific medical supplies and DME distribution. The EPAP will provide access to necessary prescription drugs, specific medical supplies, and limited durable medical equipment (DME) for individuals who were affected by a major disaster or emergency and have a need for drug, medical supply, or DME coverage (including co-payments as a separate optional requirement for those underinsured) at any pharmacy in the nation or U.S.

territories. 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

The Contractor shall provide access, at any EPAP-enrolled pharmacy in the nation or U.S.

territory to ASPR- identified prescription drugs, medical supplies, and limited DME for individuals who were affected by a major disaster or emergency. The activation of this contract for adjudication and reimbursement for the administration or dispensing of specific medications and vaccines by community pharmacies in response to a public health emergency will be by determined by the ASPR.

5. APPLICABLE DOCUMENTS

o Rate Schedule

6. TECHNICAL REQUIREMENTS/TASKS

Programmatic Goals:

o Ensure the EPAP program is activated and operational within 12 hours of receiving activation notification.

o Ensure all enrolled Pharmacies are notified of EPAP activation through fax.

o Ensure access to covered prescription drugs, medical supplies, and DME for eligible individuals who present a valid prescription at a pharmacy during a qualifying event, at no cost to the affected individual as defined in Section C-IV.

o Contractor shall limit pharmaceutical, specific medical supplies, and DME written prescription assistance to an individual patient for a one time fill of up to a 30-day supply for a medication to treat an acute 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.

o Implement a system that enables real-time point-of-sale eligibility checks and edits for claims where the pharmacist has found no coverage or limit coverage (co-payment) dispensing of EPAP covered drugs, specific medical supplies, and DME to eligible individuals.

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

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

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

o Establish and maintain a public website for EPAP information and resources sharing

Program Management Plan

• The Contractor shall provide a Program Management Plan (PMP) that fully documents its management approach for this contract. The Contractor shall update its PMP when changes to the required information change. At a minimum, the PMP shall:

o provide information on the Contractor’s management organization, internal management policies and procedures;

o summarize how the Contractor will maintain relationships and conduct regular meetings and reviews with Government personnel related to the activities and deliverables of the Contract;

o provide an organizational chart of the contractor’s organization to be used in performance of the contract and narrative describing how the Contractor will fully integrate the management of the elements of this contract and if the plan includes subcontractors, other than individual subcontractors, provide organizational information about the subcontractor and include subcontractor organizational elements in the project organization chart;

o describe how activities of subcontractors will be managed and organizational relationship will be maintained between the prime and subcontractors and methods of requirement flow-down and activity progress reporting back to the prime Contractor;

o describe the: Contractor’s 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, and its experience (over the past three (3) years at a minimum); and any subcontractor independent verification and validation process;

o identify key technical and management personnel who will be assigned to the contract;

o describe internal policies and procedures to be used in managing the contract;

o describe management and process for addressing work increases (spikes) and lulls as work priorities and schedules shift;

o 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.

o Contractor shall deliver a Project Plan with schedules and will update on a bi-weekly, or more frequent, basis until system development gets completed.

Specific Tasks:

The Contractor shall provide all labor, supervision, and training to provide qualified personnel to perform the specific tasks stated below.

Pre-Activation Phase:

Contractor shall make whatever provisions it considers necessary in order to activate EPAP at the time a Task Order may be issued. We have provided examples of some activities we consider reasonable to ensure EPAP program readiness.

o Contractor shall identify an existing pharmacy network as the EPAP pharmacy network. This network should be capable of providing eligible individuals with covered drugs and DME.

Standard terms and conditions of Contractor’s pharmacy network contract must meet ASPR’s approval.

o Contractor shall validate the legitimacy of all enrolled pharmacies before processing claims from these pharmacies.

o The Contractor shall provide to ASPR an updated organizational structure and contact information for staff authorized to activate the EPAP, including back-ups and recommended communications protocols, each January and July and as otherwise updated, to facilitate immediate program activation during an emergency.

ACTIVATION PHASE

o The Contractor shall activate the EPAP by request of the ASPR for public health emergencies, allowing EPAP claims processing, within 12 hours of receipt of a Task Order document from ASPR. The Task Order shall include specify the required activities as stated in the overall Contract. EPAP Event Guide.

o Contractor shall notify network pharmacies of EPAP activation via fax, web, call center and other reasonable means immediately upon program activation.

o Contractor shall allow any willing retail pharmacy to file claims provided they accept the standard EPAP network contract terms and conditions. The contr o Contractor shall provide network pharmacies with claims processing instructions, including updated payer sheets, eligibility criteria, approved drug, specific medical supplies, and DME lists (to be provided), and program limitations within 12 hours of EPAP activation o ASPR may further restrict covered drugs, specific medical supplies, and DME, eligibility, data required in the payer sheet and other program limitations in the Task Order activating the EPAP provided those further restrictions reflect the sub task issued by HHS.

o Contractor will provide program software to interface with and establish dedicated EPAP server link to RxHub for Third Party Liability (TPL) adjudication.

o Contractor shall require participating pharmacies to verify patient’s eligibility prior to submitting the claim by inquiring if the patient is from the affected area and checking patient eligibility for other drug or DME coverage..

o Applying the TPL services, contractor shall reject claims for affected individuals who have other prescription drug, specific medical supplies, or DME coverage identified through the TPL program unless the option to cover co-payments is specifically activated. When available, correct payor information shall be provided to the pharmacies.

o Contractor shall administer the EPAP for prescription drugs, specific medical supplies and limited DME as defined by the ASPR.

o Formulary Design and Implementation – Contractor shall load and administer a

Formulary that follows Medicare Part D guidelines for a Formulary (see attached Formulary). The following exclusions shall be implemented and administered regardless of whether covered under a Medicare Part D Formulary unless otherwise indicated in the Contractor Plan Implementation document for EPAP.

Reference appendix entitled Plan Implementation document.

Cosmetic Agents Contraceptives Fertility Agents Erectile Dysfunction Weight Loss Medications Over-The-Counter (OTC) medications o Contractor shall approve claims for prescriptions written by an appropriately licensed clinical provider or prescription refills on file at the pharmacy provided doing so is within the authority provided by the state, and the drug or medical item is on the approved list. Prescription 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 and Pharmacy has a commercially reasonable ability to verify the existing prescription, except if such prescription otherwise meets applicable state law requirements for emergency refills.

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

o 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.

o Contractor may request ASPR facilitate necessary coordination with FEMA for transportation or security logistical support if it is required to perform an individual task order.

o Contractor shall provide 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 (within 24 hours) of activation, or in the case of OCONUS , including Alaska, Hawaii, Puerto Rico and the US Virgin Islands, area, within 72 hours, to provide automated information concerning the EPAP to:

Pharmacy Providers Affected Individuals/Beneficiaries

POST-ACTIVATION / MAINTENANCE PHASE

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

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

Notification when EPAP expenditures reach 75% of allowable contract cost

Total donated manufacturer product, by manufacturer, if such amount reaches 75% of a previously agreed upon donation limit.

Suspicions of fraudulent EPAP billing activity among network pharmacies.

o ASPR acknowledges and agrees that, in addition to any pharmacy reimbursement funds for prescription drugs, specific medical supplies, and DME as required by this Contract, it shall pay Contractor for transaction costs, reports, pharmacy communications, and other necessary operational expenses incurred at the direction of ASPR.

7. BILLING and REPORTING SCHEDULE

• 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. Notification when EPAP expenditures reach 75% of allowable contract cost

c. Total donated manufacturer product, by manufacturer, if such amount reaches 75% previously agreed upon donation limit.

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

e. Invoice reports every 24??? hours that contains 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.

• Contractor shall submit all claim reports within 3 days after each individual billing cycle.

a. Contractor shall prepare 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. 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.

b. Submission of invoices will be in accordance with 52.212-4(g).

7. GOVERNMENT FURNISHED RESOURCES AND INFORMATION

N/A

8. REQUIREMENTS FOR HANDLING SENSITIVE/PROPRIETARY INFORMATION

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 its various implementing regulations and must be protected in accordance with those provisions. Healthcare information is personal and sensitive and must be treated accordingly.

9. DELIVERABLES

a. Processing of prescription, specific medical supplies, and DME claims in real time at enrolled pharmacies.

b. System for the enrollment of pharmacies and real time web based tracking of enrolled pharmacies.

c. Notification via multiple mechanisms of activation and de-activation of claims processing.

d. Establish and maintain a public website for EPAP information and resources sharing

10. PERFORMANCE/DELIVERY PERIOD

12 month Base period with one (1) 12 month option

11. PLACE/LOCATION OF PERFORMANCE/DELIVERY

The contractor shall perform all work at the contractor’s site.

12. TRAVEL REQUIREMENTS

No travel requirements.

13. GOVERNMENT POINTS OF CONTACT

Contracting Issues: Forest Crumpler, Contract Specialist Department of Health and Human Services Forest.crumpler@hhs.gov 202-205-3623

14. SPECIAL REQUIREMENTS

See attachments

15. Security and Building Access Requirements.

N/A