Draft Performance Work Statement.docx

PERFORMANCE WORK STATEMENT

WSNC BPA PHARMACY CONTINGENCY CONTRACT

Contract Title

PHARMACY CONTINGENCY CONTRACT

Provides outsourced pharmacy benefit management (PBM), 1st fill of initial prescriptions, compounded sterile or non-sterile products and vaccines for Veterans seen by a VA provider.

Statement of need:

Department of Veterans Affairs, Western States Network Consortium (WSNC) has identified a need for PHARMACY CONTINGENCY contract agreement to meet the needs of VA network pharmacy facilities to facilitate the filling of initial supply of medication(s), compounded sterile or non-sterile products and vaccines for Veterans seen by a VA provider or a VA authorized healthcare provider.

Background Based on standards identified in regulating the management of medication supply, VA pharmacies are required to use commercially available supply of medication(s), compounded sterile or non -sterile preparation and vaccines. If commercially prepared products are unavailable, VA medical facility pharmacies must compound or may outsource sterile drug preparations as needed in accordance with VHA DIRECTIVES 1761 and 1108.12. Vaccines are another common medication that Veterans are often unable to receive due to their inability to get to a VA facility. The WSNC Board of Directors is proposing the purchase of Pharmacy contingency services to include Veterans needing medication as 1st fill prescriptions to any local community pharmacy for processing or compounded sterile or non -sterile preparation and vaccines – administration.

1.0. SCOPE

The Contractors shall provide pharmacy benefit management (PBM) and fill an initial supply of prescriptions for Veterans seen by a VA provider or a VA authorized healthcare provider, henceforth be reference as Providers. Contractor shall also provide both seasonal and non-seasonal vaccines including those administered for travel abroad and medication counseling by a Pharmacist consistent with Omnibus Budget Reconciliation Act 1990 (OBRA-90) and adhere to the VA National Formulary. VA PBM services: https://www.pbm.va.gov/nationalformulary.asp.

The Government anticipates that pharmacy contingency services will be performed across five VISNs (17, 19, 20, 21 and 22). All facilities may require PBM services described in this Statement of Work, as the VA responds to changing mission requirements over time. When requested by the Contracting Officer, the Contractor shall negotiate in good faith to add other facilities to this BPA in accordance with the procedures in the Changes clause in FAR 52.212-4.

1.1 Service Description.

· Brand Name Prescriptions: Discount from AWP

· Generic Prescriptions: Discount from AWP

· Vaccination Vaccine and Administering

· Generic Prescription Specialty Compound Medication

· Brand Name Prescription Specialty Compound

· Compounded sterile or non-sterile products.

1.2. Eligible Beneficiaries

Patients eligible for prescription filling services are Veterans who are currently enrolled in VA health care. Eligibility for VA health care enrollment is determined by each ordering VA facility. Veterans eligible to have prescriptions filled under this agreement will present a completed vendor-developed “pharmacy certificate” along with the prescription(s) written by an authorized VA prescriber.

1.3. Facility Hours of operations

Standard operating hours for CBOCs and facility outpatient services are normally 8:00 AM to 4:30 PM Monday through Friday in the time zone of the facility, excluding federal holidays. VA Emergency Departments normally operate with 24-hour coverage.

Federal holidays are:

· New Year’s Day

· Martin Luther King Jr Birthday

· President’s Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving Day

· Christmas Day

2.0 PRESCRIPTION REQUIREMENTS

A new prescription is defined as a written prescription from the VA for a drug product and strength that has not been previously dispensed to the beneficiary . Prescription shall be prescribed by a VA authorized provider for medication on the VA emergent drug list (EDL) unless otherwise authorized.

2.1 First Fill Prescription

This process is only for new, one-time prescriptions. No refills will be authorized. Contractor’s pharmacies will fill and dispense original prescriptions that are written by VA providers assigned to VA facilities.

ACCELERATED ACCESS INITIATIVES AND COMMUNITY CARE NETWORK (CCN) MISSION ACT PROVIDERS for Virtual VA Healthcare Hubs and Clinical Call Centers, Non-VA Care/ Non-VA Providers): These initiatives will require the Contractor to facilitate the filling of an initial supply of medication(s). Veterans needing medication will be allowed to take the 1st fill prescriptions to any local community pharmacy for processing. The providers will fax or mail subsequent prescription forms to the respective Outpatient Pharmacy for processing and mail-out to the Veterans.

2.2 Sterile Compounding preparation

Specialty Compounded medications are defined as those that need to be manufactured for specific patients or dispensed directly to Veterans by a licensed compounding pharmacy. This includes sterile and non-sterile compounded preparations. Contractor’s pharmacies will compound prescriptions if necessary. Prescriptions to be filled will be presented to the contract pharmacy on a legal Rx Prescription form for non-controlled substances. This form will have the certificate information listed at the top and the prescription information to follow. This certificate will have a “wet” signature from the VA provider. Verbal or telephone medication orders may only be accepted in an emergency. VA providers may also send the prescriptions electronically, via fax, or in any other legal manner. For controlled substances (CII – CIV), the certificate will also be accompanied by a hand-written prescription on VA Form 10-2577F, or other legally acceptable form.

Contractor shall follow FDA's policy 503A and 503B concerning certain prescription requirements and outsourcing compounding for human drug products. Compounding pharmacies shall meet VA’s “ Guidance for Outsourcing Compounded Sterile and Non-Sterile Preparations”. These pharmacies must be licensed and in good standing with the State Board of Pharmacy, or registered with the FDA and in good standing, respectively.

2.3 Vaccinations

VA Administrations and Staff Offices must implement all FDA-authorized and mandatory vaccination program in accordance with VA guidelines and regulations. Contractor shall cover both seasonal and non-seasonal vaccines including those administered for travel abroad.

2.4 Exceptions

In rare instances (i.e. hurricanes or other natural disaster) where refills may be necessary, there shall be a pre-authorization by the VA authorized pharmacist (or designee) at the cognizant VA Medical Center Pharmacy and noted on the invoice. Exceptions may be made for second courses of antibiotic therapy. In order to receive reimbursement, prescriptions filled by the contractor’s dispensing pharmacies shall be in written form and in accordance with VA policy, procedures, and applicable state and federal regulations. Prescriptions from non-VA authorized practitioners shall not be reimbursed under the contract. Medications not on the EDL will not be filled and dispensed without prior approval by authorized VA pharmacy personnel.

The Contractor shall not make authorizations to the contract pharmacies for prescriptions that fall outside of the normal constraints as stated. If this occurs, the Contractor will be responsible for reimbursing the contract pharmacy for the prescription.

3.0. REQUIREMENTS – ADMINISTRATION

3.1. The Health Insurance Portability and Accountability Act of 1996 (HIPPA) requires that patient lists, names of patients, and any information concerning patients, are considered privileged information and shall not be disclosed or revealed in any way for use outside the VA. The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such information as the VA. Patient confidentiality will be protected at all times.

3.2. As Contractor personnel will potentially have access to any patient information related to their performance of duties under this BPA, Contractor shall make its personnel aware that any such information that they might become aware of during the course of their performance is considered privileged information and shall not be disclosed or revealed in any way outside communications with the COR(s) and pharmacists.

3.3. Contractor shall have an established policy and procedures in vetting and selecting a pharmacy.

3.4. Contractor shall obtain, verify, and maintain all necessary licenses, certification, permits and other legal prerequisites necessary to provide service under this BPA and shall be made available upon request by the Contracting Officer (CO).

3.5. Contractor shall have an established third-party prescription payer/ administrator to process claims (e.g. Optum, Caremark, Express Script, etc…) with a current and active bank identification number (BIN) and Processor Control Number (PCN).

3.6. Contractor shall have an extensive pharmacy network that will satisfy the requirement of this BPA.

3.7. contractor shall comply with all VA Accelerated Access Initiatives and Community Care Network (CCN) mission acct, VA Vaccination guidelines, regulations and Sections 503A and 503B of the FD&C Act .

3.8. The Contractor shall keep all information concerning VA beneficiaries confidential and contractor shall not be disclosed to any person, except when authorized in writing and according to applicable laws.

3.9. The Contractor shall report all adverse drug events reported to a service provider by a Veteran under this BPA. The Contractor shall report to the associated facility’s Contracting Officer Representative (COR) and the CO. Adverse drug events include dispensing errors, drug allergies, and adverse drug reactions.

3.10. For Recalls, the Contractor shall follow a standard policy, as well as State and Federal regulations, for notification of affected Veterans.

3.11. The Contractor shall have a documentation system for product traceability and lot number recordings for product recalls. The Contracting Officer must be notified immediately by telephone and within five (5) days a written notice. The Contractor shall follow a standard policy, as well as State and Federal regulations, for notification of affected patients.

3.12. The Contractor shall communicate with the VA via secure e-mail messaging. Contractor agrees to fulfill all requirements needed to establish and maintain secure email messaging and to comply with all HIPAA requirements concerning Veteran health information.

3.13. The Contractor Shall provide monthly reports will detail the prescription fill activity by prescribing Healthcare System. Reports will be site specific and detail the number of prescriptions prescribed, total drug cost, brand or generic used, therapeutic breakdown of prescribing, top 25 drugs prescribed, and total dollar claims per site. Reports detailing classification of drugs spend analysis, and performance metrics will also be required monthly. These reports will be sent via encrypted electronic email to the respective Chief of Pharmacy (or designee) for review before monthly payment will occur.

3.14. Contractor shall have a network of pharmacies to ensure licensed pharmacist are within a 5-mile radius of main Medical Center campus, CBOCs, OPC, or Veterans’ location unless approved in advance by the Contracting Officer.

3.15. Contractors shall ensure all pharmacies provides service during the core hours, Monday through Friday, 8:00 am to 6:00 pm local time.

3.16. Contractor shall have an establish procedure to resolve any conflicts with the pharmacy during both normal and afterhours to ensure minimal delays to Veterans medication.

3.17. Telehealth Voucher: Upon the receipt of direction from authorized VA personnel, Contractor may create a separate voucher, referred to as a telehealth voucher, to cover instances where Veterans meet with a health care professional in a virtual environment i.e. by telephone, video conference, or any other method not requiring an in-person visit. Veterans shall not be required to present the telehealth voucher. The telehealth voucher may be faxed by the appropriate VA personnel to the appropriate pharmacy.

4.0. REQUIREMENT – PHARMACIST

The personnel assigned by the Contractor to perform the services covered by this BPA shall be licensed as a Registered Pharmacist in a State, Territory, or Commonwealth of the United States or the District of Columbia .

4.1. Contractor’s pharmacies shall be available during the following core hours, Monday through Friday, 8:00 am to 6:00 pm local time.

4.2. Contractor’s pharmacies shall ensure Veterans receive the filled prescription within two hours of authorization by a Pharmacist .

4.3. Contractor’s pharmacies shall ensure Veterans receive counseling from a Pharmacist for each prescription filled.

4.4. The Contractor shall provide a Registered Pharmacist who shall :

4.4.1. Collect, synthesize and interpret the prescription and disease data

4.4.2. Check for actual and potential drug related problems, including:

4.4.2.1. Therapeutic duplication

4.4.2.2. Drug-disease contradictions

4.4.2.3. Drug-drug interactions (including interactions with over-the-counter drugs)

4.4.2.4. Incorrect drug dosage

4.4.2.5. Drug-allergy interactions

4.4.3. Contractor’s pharmacies shall identify, clarify and resolve drug-related problems with prescriber and the Veteran.

4.4.4. Contractor’s pharmacies shall offer the Veteran counseling by a Pharmacist consistent with Omnibus Budget Reconciliation Act (OBRA) 1990 requirement to ensure appropriate use and optimal outcomes from drug therapy. The counseling shall include but not be limited to:

4.4.4.1. Name, description and use of medication;

4.4.4.2. Dose, dosage form and route;

4.4.4.3. Special directions and precautions;

4.4.4.4. Common side effects and action required if they occur;

4.4.4.5. Techniques for self-monitoring drug therapy;

4.4.4.6. Action to be taken if dosage is missed;

4.4.4.7. Proper storage;

4.4.4.8. What the Veteran can expect from the medication;

4.4.4.9. The balance of the prescribed medication that will be mailed from the

4.4.4.10. associated healthcare system’s pharmacy;

4.4.4.11. If applicable, conduct an inquiry with the prescribing facility about the Veteran’s balance of prescriptions.

4.5. Contractor’s pharmacies shall be available to answer any drug related questions that a Veteran may have after the prescription is filled.

4.6. Contractor’s pharmacies shall treat all Veterans with dignity, courtesy and respect.

4.7. The Contractor’s pharmacy network shall maintain documentation for all prescriptions filled. Veterans will sign for each prescription received.

4.8. The Contractor’s pharmacy network shall ensure all prescriptions must have proper auxiliary labels attached and counseling consistent with Medicaid Regulation.

5.0. DISPENSING LOCATIONS

5.1 The pharmacy locations for filling and dispensing prescriptions must be within a five-mile radius of the respective CBOC, OPC, or Veterans’ location.

5.2 The Contractor must have a minimum of one licensed pharmacy in each of the areas identified for coverage.

5.3 The location of each pharmacy filling and dispensing prescriptions under this BPA shall be provided to the Contracting Officer.

5.4 NO Prescription will be mailed to Veteran patient.

6.0. DISPENSING INFORMATION

6.1. Prior Authorization Procedures: The Contractor shall support a prior authorization procedure which must be:

6.1.1. Real time

6.1.2. Electronic

6.1.3. Secure

6.1.4. Allow for multiple contacts

6.2. Contractor’s pharmacies shall fill and dispense medication from original prescriptions written by the Provider.

6.3. Contractor’s pharmacies shall accept only prescriptions from VA providers, prescription must be written on VA form 10-2577F. Any approved non-VA providers shall use a prescription blank meeting Federal and State legal requirements. Providers may send the prescriptions electronically, via fax, or in any other legally required or acceptable manner.

6.4. Unless otherwise pre-authorized, oral medication dispensed shall not exceed a fourteen (14) day supply. For prescriptions that exceed beyond 14 days, the prescribing provider shall be contacted and made aware of the restrictions.

6.5. Specialty compounded medications

6.5.1 all compounded sterile preparations (CSPs) shall accurately identified, measured, diluted, mixed, prepared, packaged, sealed, labeled, stored, dispensed, procured, and distributed in accordance with: (1) United States Pharmacopeia (USP) Compounding standards (2) VHA Pharmacy Benefits Management (PBM) Guidance and Procedural Requirements for CSPs. may not exceed the amount ordered by the Provides or Federal or State law allowances.

6.5.2 contrator shall ensure that all compounded medication must be prepared in an appropriate area separated from routine non-hazardous sterile product preparations. Compounded medication must be prepared in a manner compliant with USP standards and NIOSH requirements.

6.5.3 Contractor shall ensure that all compounded medication must be prepared in accordance with FDA 50A3 and 503B Compounding Pharmacy Designations & Regulations.

6.6. There shall be no refills of oral prescriptions. The Contractor shall fill ONLY NEW PRESCRIPTIONS.

6.7. Prescriptions will be filled and dispensed only for drugs that are on the VA national formulary, a list can be found at the VA Pharmacy Benefits Management Services website: https://www.pbm.va.gov/nationalformulary.asp.

6.8. Formulary list may be reduced by each site; however, it may not expand beyond the national formulary list.

6.9. Prescriptions filled under this BPA shall be generic drugs, to the extent permitted by law, the least expensive drug product the pharmacy has in stock will be dispensed. All generic products used must follow Federal and State requirements. A product is not considered a generic equivalent unless the strength, quantity and dosage are the same as the brand name. All generic drugs must be Federal Drug Administration (FDA) AB rated generics. The generic name must be displayed on all labels for all medication.

6.10. The only exception to this will be for the drugs on the VA DRUG STANDARDIZATION LIST, https://www.pbm.va.gov/nationalformulary.asp which will be filled by the name brand only.

6.11. The price the Contractor invoices the VA shall not exceed the price the Contractor charges the general public or the Contractor’s lowest third-party reimbursement plan. THERE WILL BE NOT CO-PAY TO THE VETERAN.

7.0. EMERGENCY DISASTER ACTIVATION

7.1. Contractor shall support any emergency disaster activations such as:

7.1.1. Under special conditions, i.e. hurricanes, fires, other natural or manmade disasters, the CO may authorize refills thru written approval.

7.1.2. Under the emergency disaster activation, the CO may authorize a refill on an active prescription. A Veteran, with a valid ID, may take an active VA prescription bottle, last filled within 180 days, with remaining refills, to a participating retail pharmacy to be filled, excluding all controlled substances.

8.0. OTHER INFORMATION

8.1. Clinical or other medical records of VA beneficiaries treated by the Contractor shall remain the property of the VA.

8.2. The parties agree that such personnel shall not be considered a VA employee for any purpose and shall be considered employees of the Contractor.

8.3. The parties agree that such personnel shall not be considered a VA employee for any purpose and shall be considered employees of the Contractor.

8.4. In order to facilitate increased pharmacy participation for Veterans enrolled in VA Accelerated Access or CCN programs, the Contractor may create an “Open Pharmacy, Open Provider Purchase Care” voucher upon direction of the COR or CO. This voucher will not require the pharmacy or provider to be specifically enrolled with the Contractor to provide emergency first fill prescription services. The purpose of the open-ended voucher is to make it easier for Veterans to receive emergency first fills especially in more remote areas where pharmacy participation/registration with the Contractor may be difficult to recruit. Prescription purchases made with the open-ended voucher will be included on the monthly Contractor as specified by the servicing VA COR.

8.5. Vaccinations shall cover both seasonal and non-seasonal vaccines including those administered for travel abroad. Vaccinations shall include all administrative fees and ingredient costs, with no dispense fees charged to the VA. Below are the potential vaccinations that may be required:

8.6.1. Flu (Influenza) – Seasonal

8.6.2. Td (Tetanus, Diphtheria)

8.6.3. Tdap (Whooping Cough)

8.6.4. Meningitis (Meningococcal)

8.6.5. Pneumonia (Pneumococcal)

8.6.6. Chickenpox (Varicella)

8.6.7. HPV (Human Papillomavirus)

8.6.8. Hepatitis A (Hep A)

8.6.9. Hepatitis A/Hepatitis B combination

8.6.10. Hepatitis B (Hep B)

8.6.11. MMR (Measles, Mumps and Rubella)

8.6.12. Polio

8.6.13. Shingles (Herpes Zoster)

8.6.14. Yellow Fever

8.6.15. Japanese Encephalitis

8.6.16. Typhoid Rabies

8.6.17. RSV, COVID

9.0. PAYMENT

9.1. The VA agrees to reimburse the Contractor on a unit basis for resources furnished at the prices listed in the Schedule of Supplies\Services portion of this BPA.

9.2. Payment of sums due will be paid monthly upon submission, by the Contractor, of a properly prepared invoice receipt and the appropriate VA office. The VA will review the records for agreement with the VA records and verify that the coverage provided for the month is in accordance with the BPA. Payment will be authorized by the VA upon verification by the VA of the services bill.

9.3. Billings rendered by the Contractor to the VA for services furnished a VA beneficiary under the terms of this BPA shall be billings in full. Neither the beneficiary, nor his/her insurer nor any other third party shall be billed.

9.4. In the event the coverage is not provided in accordance with this BPA, the payment to the Contractor shall be reduced in direct ratio to the reduction in coverage. Any additional costs incurred by the VA as a result of obtaining coverage from a source other than the Contractor, due to the Contractor’s failure to provide adequate coverage, will be assessed against the Contractor.

10.0 AUDIT

The VA may randomly audit Services listed under this PWS. The VA shall have access during regular business hours and upon reasonable notice to such books, records, invoices, and prescription files as deemed necessary to verify claim information, prescription volume, and the usual and customary charges to the general public for covered Pharmacy services. The Contractor shall make all orders records and invoices available at the time of the audit. Contract pharmacies shall maintain a log of VA prescriptions filled and vaccine provided. Contractor shall have the patient sign next to each prescription number for each prescription or vaccine received. A copy of the log shall be maintained at the contract pharmacy and be readily accessible for random VA audit. Should the VA find discrepancies in the billing, a request will be made to the Contractor to provide a copy of the service in question. If record of the service in question is not able to be produced within 15 calendar days, the Contractor will adjust the statement by the amount in question. This review process will only be available for 90 days after the date of the relevant prescription fill. The contract pharmacies will only be required to keep hard copies available for 90 days.