36C26320Q0292-0002001.docx

Contract Opportunity Amendment to a Previous Combined Solicitation

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ZIP-CODE

SOLICITATION NUMBER

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RESPONSE DATE (MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

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CONTRACTING OFFICE

ADDRESS

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(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

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ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Amendment to a Previous Combined Solicitation R408 Pharmacy Benefit Management (PBM) First Fill Services VA Central Iowa and Sioux Falls VA Health Care System Period of Performance: 07-01-2020 to 06-30-2025 Solicitation Amendment 0002 to Revise SOW 57105 36C26320Q0292 04-03-2020 N

SDVOSBC

524292 Sioux Falls Services Team Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St.

Sioux Falls SD 57105 Doug Reed Contracting Officer E-mail: douglas.reed3@va.gov Please refer to "Locations Covered" within Section B.3 (Statement of Work).

Solicitation is hereby amended as detailed on attached pages.

5.

PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF

SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the soli citation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV.

11/2016) is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITE M 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 4

3.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes refere nce to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14.

DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME

AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY

APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) N/A; to be included on task orders issued on BPA None Sioux Falls Services Team Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St.

Sioux Falls SD 57105 Sioux Falls Services Team Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St.

Sioux Falls SD 57105 To all Offerors/Bidders

36C26320Q0292 03-21-2020

X X X

N/A; to be included on all BPA task orders issued against Blanket Purchase Agreement (BPA).

Pharmacy Benefit Management First Fill Services to support the VA Central Iowa Health Care System and Sioux Falls VA Health Care System Period of Performance: 07-01-2020 to 06-30-2025 Solicitation is hereby amended as follows and as attached pages:

1) Revisions are made to Section B.3 (Statement of Work) as highlighted in yellow

2) Amendment provides Government responses to technical questions.

All other terms and conditions of the solicitation remain UNCHANGED.

The Government is no longer accepting technical questions.

Doug Reed Contracting Officer

VA-VHA-SAOC-2016-AC23EC83

CONTINUATION PAGE

Government Responses to Technical Questions Solicitation: 36C26320Q0292 Description: Pharmacy Benefit Management First Fill Services – VA Central Iowa Health Care System and Sioux Falls VA Health Care System

B.3 STATEMENT OF WORK (SOW)

Description of Service The Sioux Falls VA Health Care System (SF) and VA Central Iowa Health Care System (CI) is seeking a Contractor to provide pharmacy benefit management first fill services. Contractor shall fill first time prescriptions for patients seen at these facilities and the associated Community Based Outreach Clinics (CBOCs) and provide medication counseling per Omnibus Budget Reconciliation Act of 1990 requirements (OBRA-90). Prices shall be offered with respect to Average Wholesale Price (AWP).

This solicitation will result in a single award Blanket Purchase Agreement (BPA).

The resulting BPA is not a contract. Task orders may be issued from the BPA. There is no minimum guaranteed award amount, nor is there a maximum amount to the resulting BPA.

Locations Covered

Sioux Falls VA Health Care System 2501 West 22nd Street Sioux Falls, SD 57105

And associated CBOCs

Aberdeen CBOC 2301 8TH Avenue Aberdeen, SD 57401

Sioux City CBOC 380 West Anchor Drive Dakota Dunes, SD 57049

Spirit Lake CBOC 1850 Royal Avenue Spirit Lake, IA 51360

Wagner CBOC 400 West Highway 46 Wagner, SD 57380

Watertown CBOC 917 29th Street SE Watertown, SD 57201 VA Central Iowa Health Care System 3600 30th Street Des Moines, IA 50310

And associated CBOCs:

Carroll CBOC 311 S. Clark Street, Suite 275 Carroll, IA 51401

Fort Dodge CBOC 2419 2nd Avenue N Fort Dodge, IA 50501

Knoxville CBOC 1607 North Lincoln Street Knoxville, IA 50138

Marshalltown CBOC 101 Iowa Avenue West Marshalltown, IA 50158

Mason City CBOC 520 S. Pierce, Suite 150 Mason City, IA 50401

Period of Performance This is a single award Blanket Purchase Agreement (BPA) for five (5) years, from 07-01-2020 to 06-30-2025; task orders will be issued against BPA for each ordering period:

Task orders will be issued by the Government at its discretion based on continued need for services, Contractor performance, and availability of fiscal year funds for a given task order.

Task order periods of performance may be for entire ordering period stated above or a portion of, depending on Government need for services.

Estimated Quantities The following estimates are estimated amount based on VA historical needs. The estimates are not a guarantee to the Contractor. Actual estimates on BPA task orders issued against BPA could be equal, lesser, or greater than estimated amounts listed:

Scope of Work Contractor shall provide a list of potential pharmacies that fit the demographic requirements (within 3 miles of the main facility and affiliated CBOC locations listed above). From this list, SF and CI will choose which pharmacies they would like to use for the services based on location, parking, and other veteran convenience factors as determined by each facility.

After a selection has been made, the Contractor shall create custom networks such that only the chosen pharmacies for each main facility and affiliated CBOC locations can be used for prescriptions from the providers from each main facility and affiliated CBOC locations. The CBOCs operating hours are normally 8:00 a.m. to 4:30 p.m. Central Standard Time (CST)., Monday-Friday, excluding federal holidays.

Federal holidays are:

New Years Day Martin Luther King Jr Birthday President’s Day Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

In addition, the services outlined above will be provided for patients of both main facilities. These services shall be provided for patients seen in both facilities Emergency Departments 24 hours a day, 7 days per week, 365 days per year.

As outlined above, the Contractor shall provide a list of potential pharmacies within 3 miles of both facilities. From this list, SF and CI will choose which pharmacy they would like to use for the services based on location, parking and other veteran convenience factors as determined by each facility. After a selection has been made, the Contractor shall create a custom network such that only the chosen pharmacy can be used for prescriptions from the providers from each facility.

General Requirements

Prescription Fill Process

Contract pharmacy will fill and dispense original prescriptions that are written by VA providers assigned to both facilities and CBOCs.

For Sioux Falls VA Health Care System, the Contractor shall establish a pharmacy network to provide greater flexibility to patients in locations not necessarily located in same community as Sioux Falls VA Health Care System. The pharmacy network must be presented to Sioux Falls Chief of Pharmacy for approval prior to starting performance. The Contractor shall establish a provider network comprised of VA providers affiliated with and performing patient care services at the Sioux Falls VA Health Care System and affiliated CBOC locations listed in this Statement of Work. The Contractor may only use, on a case by case basis, a non-VA provider outside of the established provider network with prior approval of the Sioux Falls VA Health Care System Chief of Pharmacy.

For VA Central Iowa Health Care System, the Contractor shall establish a pharmacy network that has a single pharmacy identified for each the main facility and affiliated CBOC locations listed in this Statement of Work. The Contractor may only use, on a case by case basis, an authorized pharmacy outside of the established pharmacy network with prior approval of VA Central Iowa Health Care System Chief of Pharmacy. The pharmacy network must be presented to Central Iowa Chief of Pharmacy for approval prior to starting performance. The Contractor shall establish a provider network comprised of VA providers affiliated with and performing patient care services at VA Central Iowa Health Care System and affiliated CBOC locations listed in this Statement of Work. The Contractor may only use, on a case by case basis, a non-VA provider outside of the established provider network with prior approval of VA Central Iowa Chief of Pharmacy.

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 handwritten prescription on VA Form 10-2577F. Pharmacists will be able to provide a verbal prescription in urgent situations (non-controlled substances).

Prescriptions filled will be in written form provided by the VA or VA-contracted provider(s). Dispensing pharmacies shall be able to accept the written prescription on VA Form 10-2577F (Security Prescription Form) or in case of consult by phone situations, the VA provider will use a VA fax prescription form signed by the VA provider(s) or VA-contracted providers. Examples of both forms can be provided by TPOCs to Contractor at Contractor request.

In any case, the Contractor shall accept faxed prescriptions from VA or VA-contracted provider(s).

The Contractor and contracting pharmacy shall not require the patient to provide more information than their name, last four of Social Security Number, and date of birth. There is no justification by the Contractor and contracting pharmacy to require the patient to give the full social security number.

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 both facilities, Chief of Pharmacy, with the proper security form. The successful Contractor may obtain a sample of each VA Form from the COR.

SF and CI have 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) and also designates the days supply amount allowable for the given drug. Both facilities 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. Each facility will have a separate and distinct EDL that they will present to 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. SF and CI 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 SF and CI pharmacy personnel.

This process is only for new, one-time prescriptions. No refills will be authorized.

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.3 (Price Schedule). The total price charged to both facilities 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 both facilities. 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 SF and CI 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 will randomly audit prescription fills at their discretion. 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. The Contractor shall provide each facility with detailed monthly reports which include patient, provider, date(s) of service, medication, and cost information broken down by main facility and affiliated CBOC locations for auditing.

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 both facilities shall review the monthly statements provided by the contractor regarding fills at the local emergent fill pharmacies. Should SF and/or CI find discrepancies in the billing, a request will be made by both facilities 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 BPA.

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 BPA 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 both facilities’ Chief of Pharmacy, COR, to the prescribing CBOC provider, and Emergency Room provider if applicable.

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 Iowa (VA Central Iowa Health Care System).

Pharmacies utilized by the contractor shall be in good standing with their respective State Board of Pharmacy in Iowa, Minnesota, Nebraska, and South Dakota (Sioux Falls VA Health Care System).

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 (Both Facilities).

Requirements for Pharmacists are:

· Graduate of an Accreditation Council for Pharmacy Education (ACPE) College of Pharmacy

· Licensed and in good standing with the State of Iowa (VA Central Iowa Health Care System)

· Licensed and in good standing with the States of Iowa, Minnesota, Nebraska, and South Dakota (Sioux Falls VA Health Care System) 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 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 SF and CI COR and pharmacists.

Contractor shall sign a Business Associate Agreement (see Attachment 1 – BAA Template) upon award, adhering to this policy.

Service Contract Labor Standards Work performed by the 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 (see Attachment 2 – USDOL Wage Determinations); updated USDOL wage determinations will also be provided as part of each task order issued against the BPA.

Limitations on Subcontracting

By submission of an offer and execution of a contract, the Offeror/Contractor agrees in performance of the contract in the case of a contract for Services, it will not pay more than 50 percent of the amount paid by the Government for contract performance to subcontractors that are not similarly situated entities. Any work that a similarly situated entity further subcontracts will count toward the 50 percent subcontract amount that cannot be exceeded.

An independent contractor shall be considered a subcontractor. “Similarly Situated” means that entity subcontracted to is same type of entity as the Prime Contractor (i.e., SDVOSB subcontracts to SDVOSB, small business subcontracts to small business).

National Archives and Records Administration (NARA) Records Management

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C. Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

a. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

b. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

c. The Government Agency owns the rights to all data/records produced as part of this contract.

d. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

e. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

f. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

g. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

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.

Completion of VA Privacy Training No Protected Health Information or Computer Access Form (VA 20939) During performance of the BPA and related BPA task orders, Contractor will not have access to VA IT systems. However, as Contractor is still providing Protected Health Information (PHI), Contractor staff overseeing this BPA shall complete the attached VA 20939 Form (see Attachment 3: VA 20939 in Section D) within five (5) business days after award and provide copies of completed forms via e-mail to Contracting Officer with cc to VA Central Iowa Health Care System and Sioux Falls VA Health Care System technical points of contact.

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