VISN 8 Performance Work Statement Emergent First Fill.docx

VISN 8 Pharmacy Benefits Management

Performance Work Statement The contractor will provide Emergent First Fill and Emergency pharmaceutical benefits management products and services to Veterans Affairs (VA) beneficiaries in the Veterans Integrated Service Network (VISN 8) and extended services by the Clinical Contact Center to the Southeastern States Network Consortium as follows:

a. Prescriptions may only be filled from an authorized VA provider employed by the Department of Veterans Affairs under this contract. The contractor must review all prescriptions to ensure that the prescriber is a VA authorized provider. Prescriptions from non-VA authorized providers may not be filled under the contract and will not be reimbursed.

b. Only new prescriptions shall be filled. In rare instances where refills may be necessary, there shall be a pre-authorization by the Chief, Pharmacy Service at the responsible Veteran Affairs Medical Center (VAMC) and so noted on the invoice.

c. Pharmacy Benefit Management services provided under this contract shall be provided by the contractor Monday through Sunday (7 days a week) to include all federal holidays and weekends. Hours of operation (0000hrs to 2400hrs) daily.

d. The contractor shall provide VA with an after-hours point of contact and phone number in the event of an emergency or the provider needing to authorize a non-formulary approval for an emergent prescription.

e. The contractor will have an emergent enrollment process to assist patients, VA staff and contract pharmacies 24 hours per day, 7 days per week and 365 days per year.

f. The Community Based Outpatient Clinics (CBOC’s) normal operating hours are Monday – Friday 8:00am to 5:00pm, (excluding federal holidays). Some locations have extended hours of operation. A full list of locations and hours of operation are included in attachment A.

g. The VISN 8 Clinical Contact Center (CCC) provides twenty-four (24) hour coverage for all veteran beneficiaries within VISN 8 and the Southeastern States Network Consortium during off hours. The VISN 8 Clinical Contact Center operates twenty-four (24) hours a day, including all eleven federal holidays (365 days per year).

h. Prescriptions filled will be in written form provided by authorized VA providers and shall be identified with the name and address of each CBOC, or VISN 8 VAMC location. (VA Form 10-2577F, Security Prescription Form). Prescriptions may also be faxed or telephoned into the pharmacies by the Clinical Contact Center or at the discretion of each VAMC. When available prescriptions may be electronically written by authorized VA providers and electronically transmitted (outbound e-RX prescribing) to the contracted retail pharmacies at the discretion of the VAMCs.

i. Unless otherwise pre-authorized, prescription fills shall be limited to a maximum of a ten (10) day supply. The balance of the patients prescribed medication shall be mailed from the VA Mail-Out Pharmacy. Each VA Medical Center may independently choose a shorter day limit if so desired.

j. Prescriptions shall be filled for legend drugs “only” according to the authorized “Emergency Medication Formulary List”, a small subset derived from medications on the VA National Formulary determined and approved by VISN 8 PBM VPE and/or designee. There shall be a mechanism in place, provided by the contractor to provide real-time messaging and hard edits to the pharmacies to prevent any drug outside of the approved list being dispensed without prior authorization. Prior authorization shall be required for any medication outside of the approved list including all medications on VA National Formulary, a Non-Formulary or any medication considered restricted.

k. Prescriptions filled under this contract shall be, to the extent permitted by law, the least expensive drug product the pharmacy has in stock.

l. Generic (AB rated) shall be dispensed whenever possible. A product is not considered a generic equivalent unless the strength, quantity and dosage are the same as the brand name. The generic name shall be displayed on all labels for all medication. All generic products used shall comply with Federal and State regulations.

m. All prescriptions are to be picked up at the filling pharmacy by the Veteran patient or designee with ample identification. Veteran patients must present a valid photo ID and sign for all prescriptions upon pickup.

n. Contractor shall provide a minimum of three licensed pharmacies accepting its plan within approximately 5 miles or less from each VA facility, CBOC, Outpatient Clinic (OPC) and Community Based Clinic (CBC) except for the US Virgin Islands where at least two licensed pharmacies within a 10-mile radius or less is acceptable. Facilities located in each of the following cities: Bay Pines, Cape Coral, Sarasota, St. Petersburg, Port Charlotte, Naples, Bradenton, Palm Harbor, Sebring, Miami, Deerfield Beach, Pembroke Pines, Hollywood, Homestead, Key Largo, Key West, Sunrise City, West Palm Beach, Boca Raton, Delray Beach, Ft. Pierce, Okeechobee, Stuart, Vero Beach, Moore Haven, Clewiston, Port Saint Lucie Gainesville, Lake City, Ocala, Waycross (GA), Jacksonville, Valdosta (GA), Saint Augustine, Tallahassee, The Villages, Saint Mary’s (GA), Marianna, Middleburg, Palatka, Perry, San Juan, Arecibo, Ceiba, Comerio, Guayama, Kings Hill (St. Croix), Mayaguez, Ponce, Saint Thomas (VI), Utuado, Vieques, Tampa, Brooksville, Lakeland, Lecanto, New Port Richey, South Hillsborough and Zephyrhills, Lake Nona, Orlando, Viera, Daytona Beach, Kissimmee, Deltona, Tavares and Clermont

The cognizant Pharmacy Service for these areas are associated with the station listed below and further detailed in Attachment A.

1) Bay Pines – Bay Pines, Cape Coral, Sarasota, St. Petersburg, Port Charlotte, Naples, Bradenton, Palm Harbor and Sebring

2) Miami – Miami, Deerfield Beach, Pembroke Pines, Hollywood, Homestead, Key Largo, Key West, and Sunrise City

3) West Palm –West Palm Beach, Boca Raton, Delray Beach, Ft. Pierce, Okeechobee, Stuart, Vero Beach, Moore Haven, Clewiston, and Port Saint Lucie

4) North Florida/South Georgia - Gainesville, Lake City, Ocala, Waycross (GA), Jacksonville, Valdosta (GA), Saint Augustine, Tallahassee, The Villages, Saint Mary’s (GA), Marianna, Middleburg, Palatka, and Perry

5) Puerto Rico – San Juan, Arecibo, Ceiba, Comerio, Guayama, Kings Hill (St. Croix), Mayaguez, Ponce, Saint Thomas (VI), Utuado and Vieques

6) Tampa – Tampa, Brooksville, Lakeland, Lecanto, New Port Richey, South Hillsborough, and Zephyrhills

7) Orlando – Lake Nona, Orlando, Viera, Daytona Beach, Kissimmee, Deltona, Tavares, and Clermont

8) Clinical Contact Center – provides twenty-four (24) coverage for all locations within the VISN 8 network and provides extended services to the Southeastern States Network Consortium (SSNC) during off hours. SSNC (V6, V7, V8, V9 and V16)

o. Contractor shall not mail filled prescriptions to the patient. Contractor shall not deliver prescriptions to patient.

p. Pharmacies authorized to fill prescriptions under the contractor’s plan shall agree to the following conditions:

1) All information concerning VA beneficiaries shall be kept confidential and shall not be disclosed to any person, except as authorized in writing and according to all applicable laws. The contractors should complete VA privacy training.

2) Representatives of the VA are authorized to visit the premises of any pharmacy filling VA prescriptions under the contractor’s plan during business hours. The purpose of reviewing VA information including auditing and evaluation, which may include the inspection of clinical records.

3) All adverse drug events reported to the contractor’s pharmacies by beneficiaries of the VA shall be reported to cognizant Pharmacy Service. Adverse drug events include dispensing errors, drug allergies, and adverse drug reactions.

4) Pharmaceutical care provided to beneficiaries under this contract shall meet all standards applicable to Medicaid recipients in the State where the services are provided for Ambulatory Care/Pharmaceutical Services.

5) Payments made by the Department of Veterans Affairs under this contractor shall constitute the total costs of services provided by the Contractor. Contractor hereby agrees that in no event shall contractor bill, charge, collect deposit from, seek compensation, remuneration or reimbursement from, or have any resource against the beneficiary, the beneficiary’s family, private insurer, Medicare, or any other entity acting on the beneficiary’s behalf, for services provided pursuant to this contract.

6) A pharmacist consistent with Omnibus Budget Reconciliation Act (OBRA) 1990 requirement to ensure appropriate use and optimal outcomes from drug therapy shall offer all patients counseling. Counseling at a minimum shall include the following information:

a. Name, description and use of the medication

b. Dose, dosage form and route

c. Special directions and precautions

d. Common side effects and action required if they occur

e. Techniques for self-monitoring drug therapy

f. Action to be taken if a dose is missed

g. Proper storage

h. What the patient can expect from the medication

i. Food-drug interactions A pharmacist shall be available to answer any drug related questions that a patient may have after the prescription is filled. In addition, include documentation (include patient refusal), demonstration of patient understanding, or any other pertinent issue such as “provided to caregiver”.

q. The contractor shall bill the cognizant VA Hospital monthly for services rendered. The VA will audit all billings. Pharmacies accepting payment through the contractor shall make records available to the auditor in a timely manner at the location where dispensed.

All invoices shall reference the following information:

1) Contract number

2) Patient name

3) Patient’s social security number

4) Prescription number

5) Name and NDC number of the medication dispensed

6) Quantity dispensed

7) RX Cost

8) Average Wholesaler Price (AWP)

9) Brand or Generic identifier

10) Pharmacy Name/location

11) Doctor’s Name

12) Contractor’s charge fee

r. Contractor shall provide VISN 8 a listing of licensed pharmacies that will accept its plan.

s. Records maintained by the contractor should have a definite time for retention and a clear method of disposal.

t. The contractor must complete the Contractor Security Control Assessment (CSCA) within 30 days of contract approval and yearly on exercise of any options.

u. Any disclosure of records to any third party must have an accounting of release of disclosure.

v. Offeror shall quote the most favorable discount from the latest edition of an officially recognized US drug database (i.e., First Databank, MediSpan, Multum, Redbook, etc.) or Maximum Allowable Cost (MAC), the most favorable dispensing fee and administration fee and shall meet the requirements as stated in the solicitation.

w. In the event of an emergency or special situation such as any manmade or natural disaster, other National Emergency, temporary closing of a VISN 8 facility or interruption of mail services or where prescription delivery services are impaired, the contractor may be authorized to provide prescription services to veteran patients ordered by authorized VA staff. Under the emergency disaster activation, the VA Chief of Pharmacy may authorize a refill on an active prescription. A Veteran patient 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. The contractor shall provide prescription services for the disruption of normal VA pharmacy prescription filling by VISN 8, CMOP pharmacy for designated VISN 8 VA patients or where mail delivery, USPO or UPS delivery of VA filled prescriptions is impaired, prevented or otherwise interrupted.

x. The emergency disruption clause can only be implemented with the approval of the VISN 8 Chief Medical Officer, Chief Operations Officer, Network Director or, if unavailable due to circumstances, the VAMC Medical Center Director, Associate Director, or Chief of Staff. The Network or VAMC would determine the start and stop date of this service. Prescription status and prescription quantity from the normal ten days supply up to a maximum of ninety days (all VA Formulary without prior approval or limited) will be established when the emergency/special situation necessitates the activation of this provision.

y. The contractor shall have a mechanism in place to notify retail pharmacies the emergency disaster plan has been activated to include VA location (s), start/stop date, authorized days’ supply, restricted or VHA National Formulary and provide the retail pharmacy with contractor contact information for assistance with a VA prescription or billing questions in accordance with VA National policies, directives, DEA, Federal and State laws.

Qualifications:

Personnel assigned by the Contractor to perform the services covered by this contract shall be, licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by personnel working on this contract shall be full and unrestricted licenses. Each person assigned to work under this contract shall be, licensed in accordance with the requirements set forth by the area of jurisdiction, State of Florida, State of Georgia, or the U.S. Territory of Puerto Rico or the U.S. Virgin Islands.

Key Personnel and Temporary Emergency Substitutions:

The Contractor shall assign to this contract the following key personnel:

Program Manager/Contract Representative During the first ninety (90) days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death, or termination of employment. The Contractor shall notify the Contracting Officer, in writing, within 15 calendar days after the occurrence of any of these events and provide the information as required for a qualified substitute as described below. After the initial 90-day period of the contract, the Contractor shall submit the information required by the Contracting Officer at least 15 days prior to making any permanent substitutions.

The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the Contracting Officer. Proposed substitutes shall have comparable qualifications to those of the person being replaced. The Contracting Officer shall notify the Contractor within 15 days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel.

For temporary substitutions where the key person will not be reporting to work for three (3) consecutive workdays or more, the Contractor shall provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period extending two weeks will require the procedure as stated above.

Contract Performance Monitoring:

The Chief, Pharmacy Service at each cognizant VA Medical Center or COR designee shall be the VA official responsible for verifying contract compliance in accordance with the Quality Assurance Surveillance Plan (QASP) outlined in attachment G. After contract award, any incidents of contractor noncompliance as evidence by monitoring procedures shall be forwarded immediately to the Contracting Officer.

Contractor shall maintain an ongoing performance measurement, assessment, and improvement process to assess the services provided under this contract (e.g., customer satisfaction survey).

An annual report outlining the assessment or measurement tool used, results of the assessment and any improvements initiated will be provided to the COR’s and the VISN 8 PBM COR no later than 14 business days after the end of the base year contract as well as the end of any option period exercised

Quality Control/Improvement All medication errors and medication related incidents shall be recorded and reported to the prescribers and the Chief, Pharmacy Service immediately.

Customer complaints, suggestions, compliments shall be recorded and forwarded to the Chief, Pharmacy Service immediately.

Reports Contractor shall provide each cognizant VAMC Pharmacy Chief or designee a monthly report by station/location which summarizes how many RX’s, brand vs. generic and costs; a detailed report by station/location listing each RX (patient, drug, generic/brand, cost etc.); a top 10 medication report by station/location. Information provided will be used to consider additions or removal from the VA’s approved “Emergency Medication Formulary Drug List”.

Contractor shall provide VISN 8 Pharmacy Benefits Management Pharmacy Executive or designee with a quarterly business review summarized by each station VAMC; to include the top 25 medications by station and a summary report by station VAMC summarizing total number of RX’s filled (per month), Total Cost of medication (per month), Total Dispense Fee (per month) Total rollup of overall costs (per month) and Total number of Brand versus Generic RX’s filled.

QUALITY ASSURANCE SURVEILLANCE PLAN

For: Pharmacy Service

Contract Number: TBD

Contract Description: Pharmacy Benefit Management Emergent First Fill Services

Contractor’s name: TBD

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO: Collen Houser Organization or Agency: Department of Veterans Affairs, Network Contracting Office 8

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall ensure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COR: TBD

c. Other Key Government Personnel:

Dr. Ivan Itebejac, PBM Pharmacy Executive VISN 8 Dr. Kim Reno-Ly, PBM Deputy Pharmacy Executive VISN 8 Dr. Peter Wills, Clinical Contact Center Pharmacy Chief

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

a. Program Manager – TBD

b. Other Contractor Personnel – TBD Title: TBD

4. PERFORMANCE STANDARDS

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Performance Requirements Summary Matrix in the Performance Work Statement (PWS), includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Task ID Indicator Standard Acceptable Quality Level Method of Surveillance Incentive Rating

When available prescriptions may be electronically written by authorized VA providers and electronically transmitted (outbound e-RX prescribing) to the contracted retail pharmacies at the discretion of the VAMCs.

100% Analysis of Contractor’s Reports Exercise of Option Period and Past Performance.

5. INCENTIVES

The Government shall use Exercise of Option Period (if applicable) and Past Performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. METHODS OF QA SURVEILLANCE*

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

N/A

b. PERIODIC INSPECTION. (Evaluates outcomes on a periodic basis. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.)

N/A

c. USER SURVEY. (Combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction. May also generate inspections and sampling.)

N/A

d. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.)

Performance Standard(s) ID: 1, 6, 7, 11 and 12

e. 100% INSPECTION. (Evaluates all outcomes.)

Performance Standard(s) ID #: 1

f. PERIODIC SAMPLING. (Variation of random sampling. However, sample is only taken when a problem/deficiency is suspected. Sample results are applicable only for the specific work inspected. Since sample is not entirely random, it cannot be applied to total activity performance.)

N/A

g. RANDOM SAMPLING. (Designed to evaluate performance by randomly selecting and inspecting a sample of cases.

N/A

h. Progress or status meetings.

N/A

i. Analysis of contractor's progress reports. (Evaluate cost, schedule, maintenance documentation, etc.)

Performance Standard(s) ID #: 2, 3, 4, 5, 8, 9, 10, 13, & 14.

7. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Excellent = Exceeds Standards Satisfactory = Meets Standards Unsatisfactory = Fails to Meet Standards

8. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

9. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.

During contract performance, the COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR shall meet with the contractor quarterly via telephone (if necessary, i.e. if any problems exist) to assess performance and shall provide a written quarterly assessment.

Signature – Contractor Program Manager

Signature – Contracting Officer’s Representative