36C24620Q0006-004.docx
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- 36C24620Q0006
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36C24620Q0006
PAGE 1 OF
1. REQUISITION NO.
2. CONTRACT NO.
3. AWARD/EFFECTIVE DATE
4. ORDER NO.
5. SOLICITATION NUMBER
6. SOLICITATION ISSUE DATE
a. NAME
b. TELEPHONE NO. (No Collect Calls)
8. OFFER DUE DATE/LOCAL
TIME
9. ISSUED BY
CODE
10. THIS ACQUISITION IS
UNRESTRICTED OR
SET ASIDE:
% FOR:
SMALL BUSINESS
HUBZONE SMALL
BUSINESS
SERVICE-DISABLED
VETERAN-OWNED
SMALL BUSINESS
WOMEN-OWNED SMALL BUSINESS
(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED
SMALL BUSINESS PROGRAM
EDWOSB
8(A)
NAICS:
SIZE STANDARD:
11. DELIVERY FOR FOB DESTINA-
TION UNLESS BLOCK IS
MARKED
SEE SCHEDULE
12. DISCOUNT TERMS
13a. THIS CONTRACT IS A
RATED ORDER UNDER
DPAS (15 CFR 700)
13b. RATING
14. METHOD OF SOLICITATION
RFQ
IFB
RFP
15. DELIVER TO
CODE
16. ADMINISTERED BY
CODE
17a. CONTRACTOR/OFFEROR
CODE
FACILITY CODE
18a. PAYMENT WILL BE MADE BY
CODE
TELEPHONE NO.
DUNS:
DUNS+4:
PHONE:
FAX:
17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED
SEE ADDENDUM
19.
20.
21.
22.
23.
24.
ITEM NO.
SCHEDULE OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED.
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________
29. AWARD OF CONTRACT: REF. ___________________________________ OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DATED ________________________________. YOUR OFFER ON SOLICITATION
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY
(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE
ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED
SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:
30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED
AUTHORIZED FOR LOCAL REPRODUCTION
(REV. 2/2012)
PREVIOUS EDITION IS NOT USABLE
Prescribed by GSA - FAR (48 CFR) 53.212
7. FOR SOLICITATION
INFORMATION CALL:
STANDARD FORM 1449
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS
658-20-1-051-0001 36C24620Q0006 09-06-2019 Kimberly C. Wilson 09-16-2019
3:00 PM EST
Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667 X X 524292 $32.5 Million
NET 30 DAYS
N/A X Salem Virginia
VA
Medical Center 1970 Roanoke Blvd.
Salem VA 24153 Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667
Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp
X Contractor shall provide First-Fill Pharmacy Services for the Salem, Virginia VA Medical Center in accordance with the Statement of Work.
NOTE: This is a Total Service Disabled Veteran Owned Business Set-Aside.
To be considered for award company must be Verified in the VIP Database at www.vip.vetbiz.va.gov prior to solicitation submission.
X X Bernard D. Husted Contracting Officer
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 4 |
| B.1 CONTRACT ADMINISTRATION DATA | 4 |
| B.2 SCHEDULE OF SERVICE | 5 |
| B.3 STATEMENT OF WORK | 7 |
| SECTION C - CONTRACT CLAUSES | 24 |
| C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 24 |
| C.2 52.216-18 ORDERING (OCT 1995) | 24 |
| C.3 52.216-19 ORDER LIMITATIONS (OCT 1995) | 25 |
| C.4 52.216-21 REQUIREMENTS (OCT 1995) | 25 |
| C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) | 26 |
| C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) | 26 |
| C.7 52.219-6 NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE (NOV 2011) | 26 |
| C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018) | 27 |
| C.9 VAAR 852.219-11 VA NOTICE OF TOTAL VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION) | 27 |
| C.10 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018) | 28 |
| C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) | 29 |
| C.12 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984) | 30 |
| C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (NOV 2017) | 30 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 38 |
| D.1 WAGE DETERMINATION | 38 |
| D.2 BUSINESS ASSOCIATE AGREEMENT BETWEEN THE DEPARTMENT OF VETERANS AFFAIRS VETERANS HEALTH ADMINISTRATION | 39 |
| SECTION E - SOLICITATION PROVISIONS | 43 |
| E.1 INSTRUCTIONS TO OFFERORS | 43 |
| E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 49 |
| E.3 VAAR 852.271-70 NONDISCRIMINATION IN SERVICES PROVIDED TO BENEFICIARIES (JAN 2008) | 50 |
| E.4 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (OCT 2015) | 50 |
| E.5 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018) | 52 |
| E.6 52.216-1 TYPE OF CONTRACT (APR 1984) | 53 |
| E.7 52.233-2 SERVICE OF PROTEST (SEP 2006) | 53 |
| E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018) | 54 |
| E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018) | 54 |
| E.10 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008) | 54 |
| E.11 VAAR 852.273-74 AWARD WITHOUT EXCHANGES (JAN 2003) | 55 |
| E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (NOV 2017) | 55 |
Page 1 of
Page 1 of
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
1. Contract Administration: All contract administration matters will be handled by the following individuals:
| a. CONTRACTOR: | _________________________ |
| _________________________ | |
| _________________________ |
b. GOVERNMENT: Contracting Officer 36C246 Bernard Husted Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667
2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:
| [X] |
| 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or |
| [] |
| 52.232-36, Payment by Third Party |
3. INVOICES: Invoices shall be submitted in arrears:
| a. Quarterly | [] |
| b. Semi-Annually | [] |
| c. Other | [X] MONTHLY IN ARREARS |
4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.
Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
B.2 SCHEDULE OF SERVICE
This is a Firm Fixed-Price Requirements Type contract. The contractor shall provide pharmaceutical benefits management products and services to VA Beneficiaries at the Salem VA Medical Center Community Based Outpatient Clinics (CBOC): Danville CBOC 705 Piney Forest Road, Danville, VA 24540; Lynchburg CBOC 1600 Lakeside Drive, Lynchburg, VA 24501; Staunton CBOC 102 Business Way, Staunton, VA 24401; Tazewell CBOC 123 Ben Bolt Avenue, Tazewell, VA 24651; Wytheville CBOC 165 Peppers Ferry Road, Wytheville, VA 24382. The quantities specified in the Schedule are estimates only and are not purchased by this contract.
BASE YEAR – October 1, 2019 – September 30, 2020
| CLIN |
| DESCRIPTION |
| EST QTY |
| UNIT |
| UNIT PRICE |
| TOTAL ESTIMATED COST |
| 0001 |
| Pharmacy Dispensing Fee per Prescription |
| 9,000 |
| EA |
| $________ |
| $___________ |
| 0002 |
| Drug Costs: Average Wholesale Price |
AWP Generic -65% AWP Brand -11.6%
| Not to exceed: |
| $106,500.00 |
| TOTAL OF BASE YEAR: |
| $___________ |
OPTION YEAR ONE – October 1, 2020 – September 30, 2021
CLIN
DESCRIPTION
EST
QTY
UNIT
| UNIT PRICE |
| TOTAL ESTIMATED COST |
| 0001 |
| Combined Adm/Dispensing Fee per Script |
| 9,000 |
| EA |
| $________ |
| $___________ |
| 0002 |
| Drug Costs: Average Wholesale Price |
| Not to exceed: |
| $106,500.00 |
| TOTAL OF OPTION YEAR ONE: |
| $___________ |
OPTION YEAR TWO– October 1, 2021 – September 30, 2022
EST
QTY
UNIT
| UNIT PRICE |
| TOTAL ESTIMATED COST |
| 0001 |
| Combined Adm/Dispensing Fee per Script |
| 9,000 |
| EA |
| $________ |
| $___________ |
| 0002 |
| Drug Costs: Average Wholesale Price |
| Not to exceed: |
| $106,500.00 |
| TOTAL OF OPTION YEAR TWO: |
| $___________ |
OPTION YEAR THREE – October 1, 2022 – September 30, 2023
EST
QTY
UNIT
| UNIT PRICE |
| TOTAL ESTIMATED COST |
| 0001 |
| Combined Adm/Dispensing Fee per Script |
| 9,000 |
| EA |
| $________ |
| $___________ |
| 0002 |
| Drug Costs: Average Wholesale Price |
| Not to exceed: |
| $106,500.00 |
| TOTAL OF OPTION YEAR THREE: |
| $___________ |
OPTION YEAR FOUR – October 1, 2023 – September 30, 2024
EST
QTY
UNIT
| UNIT PRICE |
| TOTAL ESTIMATED COST |
| 0001 |
| Combined Adm/Dispensing Fee per Script |
| 9,000 |
| EA |
| $________ |
| $___________ |
| 0002 |
| Drug Costs: Average Wholesale Price |
| Not to exceed: |
| $106,500.00 |
| TOTAL OF OPTION YEAR FOUR: |
| $___________ |
TOTAL ESTIMATED COST OF BASE YEAR AND OPTION YEARS 1 THRU 4: ________________
B.3 STATEMENT OF WORK
Description of Service Salem VA Health Care System requires a Contractor to provide pharmacy benefit management first fill services. Under the authority of Public Law 104-262, 38 U.S.C. 8153 and Veterans Affairs Acquisition Regulation (VAAR) Part 873, the Contractor agrees to provide pharmaceutical benefits management products and services to VA Beneficiaries for the patients treated at the Salem VA Medical Center’s (VAMC) associated Community Based Outreach Clinics (CBOCs) and provide medication counseling per Omnibus Budget Reconciliation Act of 1990 requirements (OBRA-90). VA beneficiaries based out of Salem VAMC network may be approved for this benefit by the VAMC Pharmacy Chief.
Locations Covered VA Community Based Outpatient Clinic ‐ Danville 705 Piney Forest Road, Danville, VA 24540 Phone: 434‐710‐4210 Hours: Monday‐Friday 8:00am ‐ 4:00pm
VA Community Based Outpatient Clinic ‐ Lynchburg 1600 Lakeside Drive, Lynchburg, VA 24501 Phone: 434‐316‐5000 Hours: Monday‐Friday 8:00am ‐ 4:00pm
VA Community Based Outpatient Clinic‐ Staunton 102 Business Way, Staunton, VA 24401 Phone: (540) 886‐5777 Hours: Monday‐Friday 8:00am – 4:00pm
VA Community Based Outpatient Clinic ‐ Tazewell 123 Ben Bolt Avenue, Tazewell, VA 24651 Phone: (276) 988‐2526 Hours: Monday‐Friday 8:00am – 4:00pm
VA Community Based Outpatient Clinic ‐ Wytheville 165 Peppers Ferry Road, Wytheville, VA 24382 Phone: (276) 223‐5400 Hours: Monday‐Friday 8:00am – 4:00pm
Salem VA Medical Center 1970 Roanoke Blvd, Salem, VA 24153 Phone: (540)982-2463 Hours: 24 hour per day/ 7 days per week
Scope of Work Contractor shall provide a list of pharmacies that fit the demographic requirements (within 10 miles of each location listed above). From this list, the VAMC will choose which pharmacy they would like to use for the services based on location, parking, and other veteran convenience factors as determined by the Salem VA Health Care System
After a selection has been made, the Contractor shall create custom networks such that only the chosen pharmacy for each CBOC can be used for prescriptions from the providers from that CBOC. The CBOCs operating hours are normally 8:00 a.m. to 4:30 p.m. Eastern Standard Time, Monday-Friday, excluding federal holidays. Unless otherwise pre-authorized, prescription fills will be limited to a maximum of a 10-day supply unless standard packing prevents this (eye drops, inhalers for example).
During broad based disaster emergency situations (i.e. Hurricane), the contractor must be able to provide an expanded network of pharmacies to provide emergent fills throughout the United States. During this time fills of up to 30 days’ supply will be allowed and VA formulary medications will be allowed to be filled. This emergent plan can only be enacted at the request of Salem VAMC Director, Chief of Staff, or Pharmacy Chief. The contractor must be able to both initiate and terminate an emergent disaster plan within 24 hours of Salem VAMC request.
Federal holidays are:
· New Year’s Day
· Martin Luther King Jr Birthday
· President’s Day
· Memorial Day
· Independence Day
· Labor Day
· Columbus Day
· Veterans Day
· Thanksgiving Day
· Christmas Day
· And, Any other day specifically declared by the President of the United States to be a federal holiday.
In addition, the services outlined above will be provided for patients of the Salem VA Medical Center. These services shall be also provided for patients seen in the Salem VA Emergency Department. Unless prior approval is requested by Salem VA Pharmacy Management members, pharmacy benefits help desk services shall be available at a minimum from 7:30am to 8:00pm Eastern Standard Time, and expandable as requested for disaster related emergencies. All prior authorizations shall be good for 96 hours only. Pharmacy Benefits Management online transmission services will be available 24 hours a day every day.
The pharmaceutical benefits management products and services to VA Beneficiaries additionally as follows:
a. Only new prescriptions written by providers will be filled. In rare instances where refills may be necessary, there must be a pre-authorization by the Chief, Pharmacy Service, or designee, at the VA Medical Center, Salem, Virginia.
b. Unless otherwise pre-authorized, prescription fills will be limited to a maximum of a 10-days’ supply.
c. Prescriptions will be filled for a limited list of legend drugs provided by the Pharmacy Service, VAMC, Salem, VA. The medications listed are all in the Department of Veterans Affairs Formulary of Drugs and Expendable Supplies. A copy will be provided to the contractor.
d. Prescriptions filled under this contract will be, to the extent permitted by law, the least expensive drug product the pharmacy has in stock.
e. Generic drugs will be dispensed whenever possible. A product is not considered a generic equivalent unless the strength, quantity and dosage is the same as the brand name. The generic name must be displayed on all labels for all medication.
f. The following drug product must be dispensed by brand name only: Dilantin.
g. Contractor must have multiple licensed pharmacies accepting its plan in most cities in Virginia. The Contractor shall provide a list of potential pharmacies within 10 miles of the Salem VA Health Care. From this list, the Salem VAMC will choose which pharmacy they would like to use for the services based on location, parking and other veteran convenience factors as determined by the Salem VA. After a selection has been made, the Contractor shall create a custom network such that only the chosen pharmacy for the Salem VA can be used for prescriptions from the providers from the Salem VAMC 658 system.
h. Contractor will provide regular monthly billing indicating patient, date of service, drug(s) dispensed, quantity and cost of each prescription and prescriber. Other reports may be requested upon demand from the contractor by authorized VAMC pharmacy staff.
i. Contractor needs network capability to provide authorization for services from certified compounding pharmacies that provide approved compounded sterile preparations (CSP) if needed by VAMC 658 in the CBOC areas.
General Requirements
*** This process is only for new, one-time prescriptions. No refills will be authorized. ***
Prescription Fill Process
Contract pharmacy will fill and dispense original prescriptions that are written by VA providers assigned to the Salem VA CBOCs.
Prescriptions to be filled will be presented to the contract pharmacy on a consult form for non-controlled substances. This form will have the certificate information listed at the top and the prescription information to follow. This consult will have a "wet" signature from the VA provider. For controlled substances (CII – CIV) the consult will also be accompanied by a hand-written prescription on VA Form 10-2577F. Pharmacists will be able to provide a verbal prescription in urgent situations (non-controlled substances). Should the state in which the dispensing pharmacy operate require other than the VA Form 10-2577F, Security Prescription Form, it will be the Contractor’s responsibility to provide the Salem VA Health Care, Chief of Pharmacy, with the proper security form. The successful Contractor may obtain a sample of each VA Form from the COR.
Salem VA has developed a list of prescription drug products that are pre-approved to be sent to contract pharmacy for veterans. This list is known as the “Emergent Drug List" (EDL). The Salem VA will be responsible for updating, maintaining, and providing copies of the EDL to the Contractor. The EDL will be updated no more often than every six (6) months in an attempt to minimize database maintenance efforts by the Contractor.
Prescriptions filled and dispensed through emergent fill contracts will be limited to medications of urgent need as determined by VA clinical staff and will follow safe and effective formulary management principles practiced within the VA. This may include adjudication of medications on a case-by-case basis as defined by local medical center procedure. Salem VA will maintain an emergent drug list of medication the contractor may fill without prior authorization. The Chief of Pharmacy or designee will email this “emergent drug list” to the Contractor at the time of contract award and provide updates to the list as necessary. There shall be a mechanism in place, provided by the Contractor, to provide real-time messaging and hard edits to the pharmacies in order to limit dispensed medications to the specified “emergent drug list” and to prevent medications that require prior authorization from being dispensed. Medications not on the “emergent drug list” will not be filled and dispensed without prior approval by authorized VA pharmacy personnel.
Reimbursement shall be determined by the average wholesale price (AWP) discounted by the applicable Contractor percentage plus the applicable dispensing fee as specified on B.2 (Price Schedule). The total price charged to the Salem VA shall not exceed that AWP charged to the general public and shall not exceed the price charged by the Contractor’s lowest third-party reimbursement plan.
Prescriptions shall be filled with generic drugs to the extent permitted by law. Generic drugs shall be dispensed if in the professional judgment of the pharmacist, the substitute product is available, safe, effective, and to the greatest extent possible, contains the same chemical ingredients of the same strength, quantity, and dosage of the brand name.
All generic products used must be in compliance with Federal and State requirements. Brand name drugs will only be reimbursed if no AB rated generic form of the drug exists in the market place.
“AB rated” means that drugs that have been proven to meet the necessary bioequivalence requirements through in vivo and/or in vitro testing compared to a reference standard that is currently approved. AB is the most common designation. Drugs coded as AB under a specific product heading are considered therapeutically equivalent only to other drugs coded as AB under that heading. Thus, products in this category are considered to be generic drugs. However, an AB-rated product may carry an individual brand name. Under no circumstances may an AB-rated generic product use the patented brand name of the reference standard.
VA beneficiaries will pick up their own prescriptions at the dispensing pharmacy. No prescriptions are to be mailed. No prescriptions are to be delivered.
If the contract pharmacy is having difficulty with any claim or any other situation, they will contact the contractor. The contract pharmacy will not contact employees of the Salem VA. If it is determined that a claim for a non-EDL medication was not approved, the contract pharmacy will refer the veteran to contact their Salem VA healthcare provider.
Updates of providers (additions/deletions) will typically take from 24 to 48 hours, depending on when the changes are entered into the system and the system update cycle. However, the contractor will attempt to expedite the process whenever possible.
The contractor shall not make authorizations to the contracted pharmacies for prescriptions that fall outside of the normal constraints as stated within. If this occurs, the contractor will be responsible for reimbursing the local pharmacy for the prescription.
VA reserves the right to fill any prescription through the use of its own resources and/or personnel.
Audits
The VA shall randomly audit prescription fills. 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 prescriptions. The Contractor shall make all prescription records and invoices available at the time of the audit.
Contract pharmacies shall maintain a log of VA prescriptions filled and have the patient sign next to each prescription number for each prescription received. A copy of the log shall be maintained at the contract pharmacy and be readily accessible for random VA audit.
Pharmacy Service at the Salem VA shall review the monthly statements provided by the contractor regarding fills at the local emergent fill pharmacies. Should the Salem VAMC find discrepancies in the billing, a request will be made by the Salem VA to the contractor to provide a copy of the consult in question.
If the consult in question is not able to be produced within 10 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 prescription fill in question. Thus, the contract pharmacies will only be required to keep the hard copies available for 90 days.
Labeling
All prescriptions must have proper auxiliary labels attached and appropriate counseling and drug interaction sheets provided to VA beneficiaries.
Privacy Requirements
The contractor shall comply with the requirements of the Federal Privacy Act of 1974 (Public Law 93-579), HIPAA (Public Law 104-191), and the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment and Rehabilitation Act of 1972 (Public Law 83-255), as well as other statues regarding confidentiality of patient information during and after the execution of this contract.
The contractor and the contracted pharmacies shall keep all information concerning VA beneficiaries confidential and shall not release or disclose information to any person, except as authorized in writing and according to all applicable laws.
The contractor shall not store patient information on a mobile device. A verbal contact is sufficient to obtain prior authorization when needed. The contactor is prohibited from transferring Personnel Health Information (PHI) by fax or email to and/or from a VA facility.
The contracted pharmacies including subcontracted pharmacies that are authorized to fill prescriptions under the contract and subsequent task orders must 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 from VA, and according to all applicable laws.
2. Representatives of VA are authorized to visit the contractor’s sites and the premises of any pharmacy filling VA prescriptions during regular business hours for the purposes of auditing and evaluation, which may include the inspection of clinical records.
3. The contractor shall report all adverse drug events reported by VA beneficiaries to the Salem VA Health Care System Chief of Pharmacy, VA Contracting Officer, VA Contracting Officer’s Representative (COR), and to the prescribing CBOC provider, or Emergency Room provider.
4. Pharmaceutical services provided to VA beneficiaries shall meet all standards applicable to Medicaid recipients in the State where services are provided, and standards set forth in the current version of The Joint Commission accreditation manual for Ambulatory Care/Pharmaceutical Services.
Licensing and Qualification Requirements
Pharmacies utilized by the contractor shall be in good standing with their respective State Board of Pharmacy in Virginia.
Pharmacies utilized by the contractor shall have a current Drug Enforcement Administration (DEA) license, controlled substance license, and license from the respective State Board of Pharmacy.
Pharmacists Requirements:
· Graduate of an Accreditation Council for Pharmacy Education (ACPE) College of Pharmacy
· Licensed in the State of Virginia (as applicable) and in good standing with the State Board of Pharmacy.
Pharmacy Requirements:
· Licensed pharmacy in the State of Virginia.
· Current DEA, controlled substance license
Business Associate Agreement
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 adhered to at all times.
As Contractor personnel will potentially have access to any patient information related to their performance of duties under this contract, 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 Salem VA COR and pharmacists.
Contractor shall sign a Business Associate Agreement (see Solicitation Attachment 1 – BAA Template) upon award, adhering to this policy.
Service Contract Act Requirements
Work performed by the following personnel related to Contractor and contract pharmacies is applicable to FAR Subpart 22.10 (Service Contract Labor Standards) and such shall follow U.S Department of Labor Wage Determinations:
12250 – Pharmacy Technician
Please refer to D.1 (Wage Determinations) for listing of wage determinations applicable to Salem VA and CBOCs.
AWP Pricing Methodology
The Contractor’s pricing shall be based on MediSpan, one of the leading national drug-pricing systems used in the pharmaceutical industry. A contractor’s pricing methodology/system is based on the IT platform of its PBM (Pharmacy Benefits Management) claim adjudication system. The contractor’s claim system is linked to MediSpan, which allows them to monitor and adjust to pharmaceutical industry pricing on a daily basis, thereby providing the VA with the most current pricing available.
Special Contract Requirements Key Personnel
Key personnel will be identified in the proposal and shall be considered key personnel essential for the successful completion of the work performed under the contract. The contractor agrees that such personnel shall not be removed, diverted, or replaced from the work without prior written approval of the Contracting Officer. The contractor shall submit written notice of proposed personnel changes to the Contracting Officer for approval at least thirty (30) business days in advance.
Background Investigations
A full background check is not required for this position; however, all contract employees must bring photo identification and advance notice from the requiring service to obtain a VA Badge in order to work on a VA Facility.
Quality Assurance Surveillance Plan
The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the contractor’s performance. The oversight provided for in the order and in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term. Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance and provides verifiable input for the required Past Performance Information Assessments. The QASP will be finalized immediately following award and a copy provided to the Contractor after award. The QASP is a living document and may be updated by the Government as necessary.
Billing and Payment
The contractor shall submit payment requests in electronic form via VA’s Electronic Invoice Presentment and Payment System. (See Web site at http://www.fsc.va.gov/einvoice.asp.)
The Department of Veterans Affairs published a final rule in the Federal Register on November 27, 2012 to require contractors to submit payment requests in electronic form in order to enhance customer service, departmental productivity, and adoption of innovative information technology, including the appropriate use of commercial best practices. The rule is effective December 27, 2012. Invoices shall be submitted monthly, in arrears, and shall include at a minimum: Date of Invoice, Contract Number, Purchase Order Number, Vendor Name, Invoice Number, CLIN & Date of Service.
Al contractors shall be registered as a vendor with the FSC Mandatory Electronic Invoice Submission at time of award.
Contractor Performance Assessment Reporting System (CPARS)
(a) FAR 42.1502 direct all Federal agencies to collect past performance information on contracts. The Department of Veterans Affairs has implemented use of the Contractor Performance Assessment Reporting System (CPARS) to comply with this regulation. One or more past performance evaluations will be conducted in order to record your contract performance as required by FAR 42.15.
(b) The past performance evaluation process is a totally paperless process using CPARS. CPARS is a web-based system that allows for electronic processing of the performance evaluation report. Once the report is processed, it is available in the Past Performance Information Retrieval System (PPIRS) for Government use in evaluating past performance as part of a source selection action.
(c) Please furnish the Contracting Officer with the name, position title, phone number, and email address for each person designated to have access to your firm’s past performance evaluation(s) for the contract no later than 30 days after award. Each person granted access will have the ability to provide comments in the Contractor portion of the report and state whether or not the Contractor agrees with the evaluation, before returning the report to the Assessing Official. The report information must be protected as source selection sensitive information not releasable to the public.
(d) When your Contractor Representative(s) (Past Performance Points of Contact) are registered in CPARS, they will receive an automatically-generated email with detailed login instructions. Further details, system requirements, and training information for CPARS are available at www.cpars.gov. The CPARS User Manual, registration for online training for Contractor Representatives may be found at this site.
(e) Within 60 days after the end of a performance period, the Contracting Officer will complete an interim or final past performance evaluation and the report will be accessible at www.cpars.gov Contractor Representatives may then provide comments in response to the evaluation, or return the evaluation without comment. Comments are limited to the space provided in Block 22. Your comments should focus on objective facts in the Assessing Official’s narrative and should provide your views on the causes and ramifications of the assessed performance. In addition to the ratings and supporting narratives, blocks 1-17 should be reviewed for accuracy, as these include key fields that will be used by the Government to identify your firm in future source selection evaluations. If you elect not to provide comments, please acknowledge receipt of the evaluation by indicating, “No Comment” in Block 22, and then signing and dating Block 23 of the form. Without a statement in Block 22, you will be unable to sign and submit the evaluation back to the Government. If you do not sign and submit the CPAR within 30 days, it will automatically be returned to the Government and will be annotated: “The report was delivered/received by the contractor on (date). The contractor neither signed nor offered comment in response to this assessment.” Your response is due within 30 calendar days after receipt of the CPAR.
(f) The following guidelines apply concerning your use of the past performance evaluation:
(1) Protect the evaluation as “source selection information.” After review, transit the evaluation by completing and submitting the form through CPARS. If for some reason you are unable to view and/or submit the form through CPARS, contact the Contracting Officer for instructions.
(2) Strictly control access to the evaluation within your organization. Ensure the evaluation is never released to persons or entities outside of your control.
(3) Prohibit the use of or reference to evaluation data for advertising, promotional material, pre-award surveys, responsibility determination, production readiness reviews, or other similar purposes.
(g) If you wish to discuss a past performance evaluation, you should request a meeting in writing to the Contracting Officer no later than seven days following your receipt of the evaluation. The meeting will be held in person or via telephone or other means during your 30-day review period.
(h) A copy of the completed past performance evaluation will be available in CPARS for your viewing and for Government use supporting source selection actions after it has been completed.
Contract Administration
Notwithstanding the Contractor's responsibility for total management during the performance of this contract, the administration of the contract will require maximum coordination between the Government and the Contractor.
The Contracting Officer (CO) is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes that shall affect price, quantity, or quality of performance of this contract.
The COR shall be responsible for the overall technical administration of this contract as outlined in the COR Delegation of Authority. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.
VA Information and Information Systems Security/Privacy Language
GENERAL
Contractors and contractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.
Access to VA Information and VA Information Systems
a. A contractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.
b. All contractors and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.
c. Contract personnel who require access to national security programs must have a valid security clearance.
National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.
d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.
e. The contractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor’s employ. The Contracting Officer must also be notified immediately by the contractor prior to an unfriendly termination.
VA Information Custodial Language
a. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor’s rights to use data as described in Rights in Data - General, FAR 52.22714(d) (1).
b. VA information should not be co-mingled, if possible, with any other data on the contractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.
c. Prior to termination or completion of this contract, contractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and
d. Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.
e. The contractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.
f. The contractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor electronic storage media for restoration in case any electronic equipment or data used by the contractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.
g. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.
h. If a VHA contract is terminated for cause, the associated BAA must also be terminated, and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.
i. The contractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA approved encryption tools that are, at a minimum, FIPS 140-2 validated.
j. The contractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.
k. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.
l. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor is in receipt of a court order or other requests for the above-mentioned information, that contractor shall immediately refer such court orders or other requests to the VA contracting officer for response.
m. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.
Information System Design and Development
a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.
b. The contractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.
c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.
d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.
e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.
f. The contractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.
a. The contractor agrees to:
(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:
(a) The Systems of Records (SOR); and
(b) The design, development, or operation work that the contractor is to perform;
(2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and
(3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.
b. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor is considered to be an employee of the agency.
(1) “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.
(2) “Record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.
(3) System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.
c. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.
d. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 30 days.
e. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 30 days.
f. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.
Information System Hosting, Operation, Maintenance, Or Use
a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval.
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