RFP 1605C3-24-R-00011.pdf

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Attached to
PHARMACY BENEFITS MANAGEMENT SERVICES (PBM) Federal contract opportunity
Solicitation number
1605C3-24-R-00011
Issued by
Department of Labor Office of the Assistant Secretary for Administration and Management

About this file

This document is a Request for Proposal (RFP) for Pharmacy Benefits Management (PBM) Services on behalf of the U.S. Department of Labor (DOL), Office of Workers' Compensation Programs (OWCP). The Government anticipates a single award fixed-price contract for comprehensive PBM services, including prescription drugs, durable medical equipment (DME), and diagnostic services, to support four compensation programs administered by OWCP: Black Lung, Energy, Federal Employees' Compensation Act (FECA), and Longshore.

The contract has a base period of 15 months, followed by four 12-month option periods and a 9-month award term. Key objectives include establishing a pharmacy network, providing customer support, processing claims for payment, and assisting with business rules. The contractor must meet specific service levels and have qualified staff, including a Program Manager, Lead Clinical Pharmacist, and Medical Director. Questions on the RFP are due by October 21, 2024, and the proposal due date will be provided in a later amendment. Pricing must be submitted using the provided workbook, and the contract will be awarded on a firm-fixed price basis.

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Other files for this federal contract opportunity

Other files attached to PHARMACY BENEFITS MANAGEMENT SERVICES (PBM), newest first.
File Type Posted
RFP PBM Amend 0004.pdf PDF
1605C3-24-R-00011 Amend 00003.pdf PDF
QAs Amend 0002- FINAL.pdf PDF
RFP PBM Amend 0002.pdf PDF
A19-J.14 - PWS TECHNICAL EXHIBIT 6 - FULL PASS THROUGH PRICING EXAMPLES.docx DOCX document
PBM III QUESTION_AND_ANSWERS.xlsx XLSX spreadsheet
A19 - REVISED SOLICITATION 1605C3-24-R-00011.pdf PDF
A19-J.4 – PBM DISCOUNT REBATE FEES WORKBOOK rev.xlsx XLSX spreadsheet
A19-J.15 - DOL Cybersecurity Policy Portfolio.pdf PDF
A19-J16- DLMS 7 Chapter 1100.pdf PDF
A19-J.17 - OWCP Award Term Plan-.docx DOCX document
A19-J.3 - QUESTION AND ANSWER SPREADSHEET.xlsx XLSX spreadsheet
A19-J.1 – PAST PERFORMANCE QUESTIONNAIRE.docx DOCX document
A19-J.13 -PWS TECHNICAL EXHIBIT 5- EXAMPLES OF FORMULARY FILES AND THEIR REQUIRED DATA (1).xlsx XLSX spreadsheet
A19-J.9 -PWS TECHNICAL EXHIBIT 3C- CY2023 PHARMACY TRANSACTIONS FOR THE FECA PROGRAM.xlsx XLSX spreadsheet
A19-J.4 – PBM DISCOUNT REBATE FEES WORKBOOK.xlsx XLSX spreadsheet
A19-J.10-PWS TECHNICAL EXHIBIT 3D-CY2023 PHARMACY TRANSACTIONS FOR THE LS PROGRAM.xlsx XLSX spreadsheet
A19-J.12- PWS TECHNICAL EXHIBIT 4- STAFF PORTAL DATA ELEMENTS (2).docx DOCX document
A19-J.8 -PWS TECHNICAL EXHIBIT 3B- CY2023 PHARMACY TRANSACTIONS FOR THE DEEOIC PROGRAM.xlsx XLSX spreadsheet
A19-J.7-PWS TECHNICAL EXHIBIT 3A- CY2023 PHARMACY TRANSACTIONS FOR THE DCMWC PROGRAM (1).xlsx XLSX spreadsheet
A19-J.5-PWS TECHNICAL EXHIBIT 1- PERFORMANCE REQUIREMENTS SUMMARY.docx DOCX document
A19-J.11-PWS TECHNICAL EXHIBIT 3E- DME AND DIAGNOSTICS BILLS FOR ALL PROGRAMS.xlsx XLSX spreadsheet
A19-J.6-PWS TECHNICAL EXHIBIT 2- DELIVERABLES SCHEDULE (1).docx DOCX document
A19-J.2 – SMALL BUSINESS SUBCONTRACTING PLAN TEMPLATE 9.29.24.xlsx XLSX spreadsheet
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SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

CAS

Washington DC 20210 200 Constitution Ave, NW S-4307 Customer Acquisition Services US Department of Labor

OWCP DC NAT SHIP CODE 16. ADMINISTERED BYCODE

X

X

524292

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORCAS

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

09/30/2024

(215) 446-3708Philip Ward (No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIME

See Section L

b. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

1605C3-24-R-00011

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 112 1638-DAO-24-NAT-0096OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

WASHINGTON DC 20210

ROOM S3524

200 CONSTITUTION AVE, NW

US DEPARTMENT OF LABOR

15. DELIVER TO

Washington DC 20210 200 Constitution Ave, NW S-4307 Customer Acquisition Services

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$45.5

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULEX

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

US Department of Labor

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

The Government anticipates a single award fixed priced contract for Pharmacy Benefits Management (PBM) Services on behalf of the U.S. Department of Labor (DOL), Office of Workers' Compensation Programs (OWCP).

Delivery: 365 Days After Award

BASE PERIOD (DISCOUNT CLINS, REBATE CLINS,

Continued ...

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

X

XX

DATED

Broderick Morris

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

SERVICE FEE PAID PER TRANSACTION)

Product/Service Code: R499

1001 OPTION PERIOD I (DISCOUNT CLINS, REBATE CLINS,

SERVICE FEE PAID PER TRANSACTION)

(Option Line Item)

(Anticipated Option Exercise Date) 0

Product/Service Code: R499

2001 OPTION PERIOD II (DISCOUNT CLINS, REBATE CLINS,

SERVICE FEE PAID PER TRANSACTION)

(Option Line Item)

(Anticipated Option Exercise Date) 0

Product/Service Code: R499

3001 OPTION PERIOD III (DISCOUNT CLINS, REBATE CLINS,

SERVICE FEE PAID PER TRANSACTION)

(Option Line Item)

(Anticipated Option Exercise Date) 0

Product/Service Code: R499

4001 OPTION PERIOD IV (DISCOUNT CLINS, REBATE CLINS,

SERVICE FEE PAID PER TRANSACTION)

Continued ...

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

112 2 of

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 112

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

1605C3-24-R-00011

(Option Line Item)

(Anticipated Option Exercise Date) 0

Product/Service Code: R499

5001 AWARD TERM (DISCOUNT CLINS, REBATE CLINS, SERVICE

FEE PAID PER TRANSACTION)

(Option Line Item)

(Anticipated Option Exercise Date) 0

Product/Service Code: R499

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

B - Supplies or Services/Prices

B.1. General

The contractor shall furnish Pharmacy Benefits Management (PBM) services for the U.S. Department of Labor, Office of Workers’ Compensation Programs (OWCP) in accordance with the terms and conditions set forth in the solicitation document (including all amendments/modifications), and the resulting contract.

B.2 Discounts

Offerors shall factor in all costs and any applicable discounts of performing the requirements under this Solicitation.

B.3 Pricing

All pricing shall be completed using the attached pricing spreadsheet named A19-J.4 – PBM DISCOUNT/REBATE/FEES

WORKBOOK.

C - Description/Specifications

Performance Work Statement (PWS) Pharmacy Benefits Management (PBM) Services

Department of Lab or (DOL) Office of Workers’ Compensation Programs (OWCP)

PART 1 - GENERAL INFORMATION

1.1 Description of Services/Introduction

In accordance with Federal Acquisition Regulation 37.401, the services required are non-personal services to manage and provide comprehensive pharmacy benefits management (PBM) services in accordance with this performance work statement (PWS).

The Government will provide guidance within the general scope of the PWS and within contract terms and conditions, but the Government will not exercise any supervision (or control) over the contractor’s employees. Contract employees must remain under the contractor’s direct supervision (and control) during the entire performance period. This also applies to the subcontracted service providers utilized in the performance of these services.

Service providers will be considered independent subcontractors responsible for performing the required services. All subcontracted service providers will be accountable solely to the contractor who, in turn, is responsible to the Government to ensure services are managed and rendered in accordance with the general scope and within contract terms and conditions.

1.2 Background

The U.S. Department of Labor’s (DOL) Office of Workers’ Compensation Programs (OWCP) administers four occupational illness/injury compensation programs, which mitigate (through the provision of wage replacement, cash benefits, medical treatment, vocational rehabilitation, and other benefits) the financial burden on certain covered workers or their dependents or survivors resulting from certain work-related illness, injury, disease, or death. All four programs are included in this performance work statement.

The four programs administered by the OWCP are the BLACK LUNG program, the ENERGY program, the FECA program, and the LONGSHORE program. The four programs are managed by three separate divisions within the OWCP. The BLACK LUNG program is managed by the Division of Coal Mine Workers’ Compensation (DCMWC). The ENERGY program is managed by the Division of Energy Employees Occupational Illness Compensation (DEEOIC). The FECA and LONGSHORE programs are managed by the Division of Federal Employees, Longshore and Harbor Workers’ Compensation. Each program is unique. Each administers one or more unique statutes with unique implementing regulations, policies, and procedures.

The DCMWC administers claims filed under the Black Lung Benefits Act of 1973. The Act provides compensation to coal miners who are totally disabled by pneumoconiosis arising out of coal mine employment, and to survivors of coal miners whose deaths are attributable to the disease. In addition to monthly compensation, the DCMWC provides eligible miners with medical coverage for the treatment of certain lung diseases.

The DEEOIC administers the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended. Part B of the Act compensates current or former employees (or their survivors) of the Department of Energy (DOE), its predecessor agencies, and certain of its vendors, contractors, and subcontractors, who were diagnosed with a radiogenic cancer, chronic beryllium disease, beryllium sensitivity, or chronic silicosis, because of exposure to radiation, beryllium, or silica while employed at covered facilities.

The Act also provides compensation to individuals (or their eligible survivors) awarded benefits by the Department of Justice under Section 5 of the Radiation Exposure Compensation Act (RECA). Part E of the Act compensates DOE contractor and subcontractor employees, eligible survivors of such employees, and uranium miners, millers, and ore transporters as defined by RECA Section 5, for any occupational illnesses that are causally linked to toxic exposures in the DOE or mining work environment.

The DFELHWC administers the Federal Employees' Compensation Act (FECA), War Hazards Compensation Act, Longshore and Harbor Workers' Compensation Act (LHWCA), Defense Base Act, Non-appropriated Fund Instrumentalities Act, and Outer Continental Shelf Lands Act.

The FECA provides coverage to federal civilian employees who have suffered work-related injuries or disease by providing appropriate monetary and medical benefits. Monetary benefits include compensation for lost wages and permanent impairment.

Medical benefits include payment for reasonable and necessary medical treatment for work-related injuries or diseases that OWCP considers likely to cure, relieve or lessen the period of disability.

The LHWCA provides compensation, medical care (including medications), and vocational rehabilitation services to employees disabled from on-the-job injuries that occur on the navigable waters of the United States, or in adjoining areas customarily used in the loading, unloading, repairing, or building of a vessel.

The FECA program has a contractor providing full PBM services; the other three compensation programs do not. The PBM services defined in this PWS will be a continuation of services for the FECA program, and new services for the BLACK LUNG, ENERGY, and LONGSHORE programs. The BLACK LUNG, ENERGY, AND LONGSHORE programs have a pharmacy bill processor, but not a formulary; they use a system that matches accepted conditions to drug classes. If a billed drug is not normally used for the accepted condition, payment is denied, and the prescribing physician has the option to request an exception to policy. The BLACK LUNG program uses a covered list and a pended drug list when deciding whether to pay for drugs.

1.3 Objective

The Government’s objective is to obtain comprehensive PBM services, including prescription drugs, durable medical equipment (DME), and diagnostic services for the BLACK LUNG, ENERGY, FECA, and LONGSHORE programs.

1.4 Scope

The contractor must provide comprehensive PBM services in the United States, Native American Tribal Lands and Reservations, and the permanently inhabited territories of the United States in support of the BLACK LUNG, ENERGY, FECA, and LONGSHORE programs administered by the OWCP.

Comprehensive services required include:

· Prescription drugs, DME, and diagnostic services for claimants’ accepted conditions,

· Medical benefit identification cards (MBIC) for claimants once their eligibility is determined by the OWCP,

· First fill drug program for FECA claimants injured at work, and

· Drug formularies approved by the OWCP for each program.

1.5 Period of Performance

The period of performance will be for one base period of fifteen months, followed by the potential for four twelve-month options, and one nine-month award term. The award term period is contingent upon the contractor’s ability to implement a successful go-live per the award term plan, the Government’s determination of contractor’s eligibility, and the contractor’s acceptance of Award Term. The contractor may decline Award Term in accordance with the Award Term Plan. The Period of Performance is as follows if the award term is executed:

Base Period: April 25, 2025 - July 24, 2026 Option Period I: July 25, 2026 - July 24, 2027 Option Period II: July 25, 2027 - July 24, 2028 Option Period III: July 25, 2028 - July 24, 2029 Option Period IV: July 25, 2029 - July 24, 2030 Award Term: July 25, 2030 - April 24, 2031

Milestone dates within the period of performance include:

· Contract Start: April 25, 2025

· Full Implementation: No later than 1 year after contract award

1.6 General Information

1.6.1 Quality Control

As defined in PART 2 of this PWS, the contractor must submit a written quality control plan (QCP) for government review and approval in accordance with TECHNICAL EXHIBIT 2. The Contracting Officer (CO) will notify the contractor in writing when the QCP is approved and when there are proposed change(s) to the contractor’s proposed QC procedures.

The contractor will have the opportunity to correct all unsatisfactory services or deficiencies in accordance with TECHNICAL EXHIBIT 2. In no case will the contractor bill for non-conforming deliverables or services, or bill for an amount that exceeds the terms of the contract.

1.6.2 Quality Assurance

As defined in PART 2 of this PWS, the Government will evaluate the contractor’s performance in accordance with the Government’s Quality Assurance Surveillance Plan (QASP) to ensure deliverables and services are performed in accordance with this PWS and Technical Exhibits 1 and 2. The Government not pay for non-conforming deliverables or services.

1.6.3 Government Remedies

The Contracting Officer shall follow FAR 52.212-4, “Contract Terms and Conditions-Commercial Items” or 52.246-4, “Inspection of Services-Fixed Price” for contractor’s failure to perform satisfactorily or to correct non-conforming services.

1.6.4 Recognized Holidays

The Department of Labor will be closed on the following holidays, but the contractor must ensure services continue 365 days per year:

· New Year's Day (January 1)

· Birthday of Martin Luther King, Jr. (Third Monday in January)

· Presidents Day (Third Monday in February)

· Memorial Day (Last Monday in May)

· Juneteenth National Independence Day (June 19)

· Independence Day (July 4)

· Labor Day (First Monday in September)

· Columbus Day (Second Monday in October)

· Veterans Day (November 11)

· Thanksgiving Day (Fourth Thursday in November)

· Christmas Day (December 25)

1.6.5 Hours of Operation

The contractor’s system and web portal must be available 24 hours per day, 7 days per week except for 2 hours of maintenance per week.

1.6.5.1 Maintenance

Maintenance periods must be coordinated to occur at off-peak times and must be approved in advance by the OWCP. The contractor must provide notice when the system is temporarily unavailable due to maintenance by displaying a message on the web portal to that effect. The contractor must always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this performance work statement. When hiring personnel, the contractor must keep in mind that the stability and continuity of the workforce are essential.

1.6.5.2 Notice to the Government of Delay

Performance delays are to be reported immediately to the COR and government project management team verbally and, within 24 hours of occurrence, in writing.

1.6.5.3 Continuity of Operations

The contractor must be prepared to continue performing essential services off-site during an event that disrupts or interferes with operations at, or access to, facilities where services are ordinarily performed. Events that may require the activation of the continuity of operations plan (COOP) may be natural (e.g., earthquake, flood, hurricane, pandemic), man-made (e.g., civil unrest, terrorist threat or attack), cyber (e.g., denial of service/ransomware) or technological (e.g., building fire, chemical spill, utility outage).

The contractor must submit a COOP for approval by the CO in accordance with TECHNICAL EXHIBIT 2. The COOP must consider, at a minimum, the continuity of all essential services for a period of between one and sixty days during a natural, man-made, or technological event that disrupts or interferes with operations at, or access to, facilities where services are ordinarily performed.

The required recovery time objective (RTO) is 12-24 hours with a recovery point objective (RPO) of 24-48 hours for all types of events.

All basic services required under PART 5 of this PWS are considered essential to support the OWCP mission. At a minimum, the COOP must:

· Include procedures for communicating with the OWCP during the event.

· Provide a list of telephone numbers and electronic mail addresses (primary and alternate, if available) for all managers currently performing work under the contract,

· Identify suitable off-site workplaces (e.g., employee homes, contractor operated locations),

· Identify essential positions/labor categories that are authorized to perform work off-site,

· Include requirements and procedures for identifying, training, and equipping essential personnel who will be relocating to off-site workplaces,

· Include alert and notification procedures for mobilizing and communicating with essential personnel during the event,

· Identify measures to ensure the quality of work performed by staff working off-site, and

· Include policies and procedures related to the printing, storage, and disposition of documents bearing personally identifiable information (PII) while working off-site.

During an event that merits the activation of the COOP, the contractor must work with each of the compensation program directors or their representatives and the COR to revise the COOP to meet the circumstances.

The contractor must comply with CO/COR requests to edit the COOP throughout the period of performance. All changes to the COOP require approval by the CO/COR.

1.6.6 Place of Performance

The contractor is responsible for conducting PBM services at contractor facilities.

1.6.7 Contract Type

This is a firm fixed-price contract.

1.6.8 Security Requirements

All work under this contract must be performed at contractor facilities. No contractor personnel will work in DOL facilities.

1.6.8.1 Information Security

The contractor is responsible for safeguarding all government information provided for contractor use. The contractor is responsible for ensuring its employees comply with the security regulations of DOL and other government installations or contractor facilities where work is performed under this PWS.

The contractor must ensure the security of all DOL property issued to contractor staff--including personal identity verification (PIV) cards. The contractor must return PIV cards and government computers issued to contractor personnel who leave the project--on the day they leave the project--if they are expected to be away for more than 60 days or permanently.

1.6.8.2 Memorandum of Understanding (MOU) and Interconnection Security Agreement (MOU/ISA)

The contractor must work with the DOL to draft an MOU and an accompanying ISA, using DOL furnished templates, which cover the security and privacy-related expectations surrounding data exchange and the connection mechanism. The DOL and the contractor must not transmit sensitive data, including PII and protected health information (PHI) in the absence of a fully executed MOU and ISA. The MOU and ISA may be digitally signed by the signature authorities.

1.6.8.3 Privacy

The contractor must ensure compliance with the Privacy Act and the DOL Cybersecurity Policy Portfolio (CPP). The contractor must evaluate their existing privacy-related policies and procedures to ensure that they comply with federal privacy-related policies--including the 1-hour notification timeframe for security incidents. Where the contractor’s policies and procedures do not comply, the contractor must revise them to ensure compliance at no additional cost to the Government. The contractor must ensure that all identified areas of noncompliance and related corrective actions have been fully documented.

The contractor must comply with the most recent federal and DOL information security guidelines, currently defined as:

· The Freedom of Information Act, as amended (5 USC §522), which provides for the disclosure of information maintained by Federal agencies to the public, while allowing limited protection for privacy.

· The Privacy Act of 1974, as amended (5 USC §522a), including the Computer Matching and Privacy Act of 1988 (Public Law 100-503)

· The Federal Information Security Modernization Act of 2014 (FISMA), 44 USC §3551 et seq.

· OMB Circular A-130, Management of Federal Information Resources, which provides instructions to Federal agencies on how to comply with the fair information practices and security requirements for operating automated information systems.

· OMB Memorandum M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2017/m-17-12_0.pdf

· FIPS PUB 199, Standards for Security Categorization of Federal Information and Information Systems at http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199- final.pdf

· FIPS PUB 200, Minimum Security Requirements for Federal Information Systems at https://csrc.nist.gov/pubs/fips/200/final

· NIST Special Publication (SP) 800-171, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations

· US DOL Cybersecurity Policy Portfolio (CPP) (DOL’s implementation of NIST SP 800-53). (Reference Attachment 25 - Cybersecurity Policy Portfolio)

· Department of Labor Manual Series (DLMS) – 7, Chapter 1100, DOL Safeguarding Sensitive Data Including Personally Identifiable Information (Reference Attachment 26 – DLMS 7, Chapter 1100)

Prior to the deployment of the web portal, the contractor must provide a System Security Plan (SPP), Contingency/Disaster Recovery Plan, and an Incident Response Plan pertaining the information system(s) that will be used to provide services under this contract.

The Government must review the documents and make a risk-based decision before granting permission for deployment of the web portal. The contractor must repair any defects that are discovered during the review, specifically defects that arise from non-compliance with NIST 800-171 and/or the DOL CPP.

1.6.8.4 Privacy Responsibilities

The contractor must ensure that every employee completes all mandated federal security-training requirements prior to the employee’s first day of work under the contract.

The contractor must ensure that all information and reports generated under this PWS are and remain the property of the Government.

The contractor must protect the PII of all claimants, providers, and government employees from unauthorized disclosure.

1.6.8.5 Security Incidents, Disclosure, Breach or Disaster

The contractor must use a government-approved incident reporting form to notify the Government (via zzowcpsecurity@dol.gov) of all security incidents, disclosures, or breaches, disasters involving PII within one (1) hour of becoming aware of the incident, whether suspected or confirmed. The notification must describe the security incident, disclosure, breach, or disaster in detail and state the measures taken to protect the confidentiality, integrity, and availability of OWCP information. The contractor must investigate the suspected or actual incident to discover the facts surrounding the incident. As additional information becomes available, the contractor must complete the Incident Report form and send it to zzowcpsecurity@dol.gov.

The contractor must have a process in place for responding to a breach or disclosure that includes corrective action to ensure that a similar breach does not recur. The contractor must submit a privacy disclosure or breach of personal information plan in their proposal to the Government.

In the event of a breach, the contractor is not to contact the claimant(s) or their authorized representative until authorized by the Government. The Government will make the first notification to the claimant(s).

In the event of a confirmed PII breach by the contractor, the contractor must provide, at its own expense, one year of comprehensive credit monitoring services that includes identity theft insurance for the affected claimant(s).

https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2017/m-17-12_0.pdf http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf https://csrc.nist.gov/pubs/fips/200/final mailto:zzowcpsecurity@dol.gov mailto:zzowcpsecurity@dol.gov

The contractor is responsible for any liability resulting from its security incident, disclosure, or breach involving a claimant’s PII, including financial harm to the Government.

The Government shall approve the contractor’s resolution of the incident.

If more than three breaches occur in a calendar month, the contractor must investigate to identify the root cause(s) and take steps to prevent future breaches.

1.6.8.6 System Security

The contractor must comply with Binding Operational Directive 18-01 “Enhance Email and Web Security”, and OMB M-15-13 “The HTTPS-Only Standard”.

In addition to the security guidelines listed above, the contractor must adhere to DOL and Federal security standards as they apply for “moderate” systems (defined by FIPS PUB 199). At a minimum, the contractor must ensure compliance with the following federal guidance documents:

· NIST SP 800-18 Rev. 1 Guide for Developing Security Plans for Information Technology Systems

· NIST SP 800-30, Risk Management Guide for Information Technology Systems

· NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Lifecycle Approach

· DLMS 7 – Chapter 400, IT Security

· NIST SP 800-63-3, Digital Identity Guidelines as found at http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63- 3.pdf

The contractor must use a Federal Identity, Credential, and Access Management (FICAM) compliant authentication method for authenticating external users. The Contractor may leverage the DOL FICAM solution to meet this requirement.

The contractor must comply with NIST SP 800-63-3, Digital Identity Guidelines, when identifying and authenticating their employees on systems that contain OWCP data. The contractor may leverage the DOL FICAM solution to meet this requirement.

The contractor must successfully pass security audits that may be conducted by government third-party contractors on the facilities, personnel, hardware, and software used to process OWCP claims.

The contractor must complete the DOL Third-Party Security Monitoring Checklist and submit updated security documents to support the answers on the Checklist on an annual basis in accordance with TECHNICAL EXHIBIT 1. The initial DOL Third-Party Security Monitoring Checklist must be submitted along with the final system security plan prior to deployment in accordance with TECHNICAL EXHIBIT 2. On a quarterly basis, the contractor must also provide proof of monthly audit log reviews, user account reviews, vulnerability scans, and additional security documentation as required by the DOL third-party security monitoring program in accordance with TECHNICAL EXHIBIT 2.

All contractor staff using the DOL LAN/WAN and computer systems to perform duties under this PWS must sign the DOL Rules of Behavior for Computer Use and a Non- Disclosure Agreement. A copy of each signed and witnessed Non-Disclosure Agreement must be submitted to the COR prior to the employee performing any work under this PWS.

The Contractor must work with the DOL to establish a secure file transfer protocol (SFTP) connection between the DOL and the contractor as the solution for providing site-to-site connections using only registered IP addresses. The purpose of the secure connection is to facilitate file transfers between the DOL “landing zone” and the contractor’s “landing zone”. Interface files will be transmitted to the contractor’s “landing zone”, a secure file transfer protocol server within the contractor’s private network. The contractor must conform to the DOL standard for push/pull transmission between the DOL and the contractor. The contractor must have the ability to establish a folder structure to accommodate the various programs and types of file transmissions (multiple folders and subfolders for each program). The contractor must be able to accommodate at least 40 simultaneous file connections between the two “landing zones”.

The contractor must provide proactive network operations center (NOC) monitoring capabilities. The contractor must record end-to-end response times to and from network devices, services, and applications, to aid in pinpointing areas of excessive network latency or identifying service outages.

http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63-3.pdf http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63-3.pdf

Data must be encrypted using cryptography that is compliant with FIPS 140-3 and any new NIST or DOL requirements.

1.6.8.7 Background Investigations

The contractor must perform a background investigation on each employee who will have access to OWCP data. The background investigation must be thorough enough to establish the trustworthiness of the individual to handle federally owned, Unclassified Information.

The contractor must provide a signed Security Documentation Review Certification and signed non-disclosure agreement (NDA) to the government project manager or COR in accordance with TECHNICAL EXHIBIT 2 prior to each contractor employee’s entry on duty

(EOD).

1.6.9 Special Qualifications

1.6.9.1 PBM Billing/Costs

The contractor must provide all the services included in this PWS with the only cost to the Government being the full pass-through price from the network pharmacy plus a service fee, billed per paid generic drug transaction and the full pass-through price from the network pharmacy plus a service fee minus a rebate for brand name drug transactions. Rebates must be expressed in dollars per transaction and be applied at point of sale for all specialty and all non-specialty brand name drugs. The service fee and rebate must be differentiated from the full pass-through price on the OWCP pharmacy data file, in any reports, and on the PBM portals. The service fee must be included in the price billed to the Government for each paid transaction; for reversals, the price, including the service fee, must be included in the reversal. The contractor must pay the network pharmacy the amount the contractor bills the OWCP minus the service fee.

1.6.9.2 Generic Drug Transaction Incentive Fees

The Government will revise the price structure applicable to the last nine months of any option period after the first option period of the contract according to the tables below to increase the contractor’s revenue during that option period if the contractor achieves the associated goal during the prior option period. These incentives do not apply to the base period of the contract or to Option Period I. These incentives only apply to generic drug transactions and do not apply to DME or brand transactions.

FECA

Measure

Incentive fee the PBM is allowed to bill above the pass-through price for generic drugs from retail pharmacies for the current option period

Reduces total non-cancer opioid expenditures in the FECA program by 5% year-over-year 0.5% of AWP, not to exceed $10 per transaction

Reduces non-cancer opioid utilization by total population MED in the FECA program year-over-year by 5%

0.5% of AWP, not to exceed $10 per transaction

Reduces benzodiazepine utilization in the FECA program by 5% year-over-year 0.5% of AWP, not to exceed $10 per transaction

Reduces the combined use of opioids and benzodiazepines in the FECA program by 5% year-over-year

0.5% of AWP, not to exceed $10 per transaction

Reduces Z-hypnotic utilization year-over-year in the FECA program by 5% 0.5% of AWP, not to exceed $10 per transaction

Increases OWCP DME market penetration rate by 2% year-over-year 0.5% of AWP, not to exceed $10 per transaction

Increases OWCP diagnostic services market penetration rate by 0.5% year-over-year 0.25% of AWP, not to exceed $10 per transaction

ENERGY

Incentive fee the PBM is allowed to bill above the pass-through price for generic drugs from retail pharmacies for the current option period Reduces the use of drugs meeting the current American Geriatrics Society Beers Criteria® for

Potentially Inappropriate Medication Use in Older Adults in the ENERGY program by 5% year-over-year

0.5% of AWP, not to exceed $10 per transaction

Reduces spend on brand name specialty drugs that have a higher net cost (including the manufacturer-derived revenue) than generic alternatives in the ENERGY program by 5% year-over-year (This can be in favor of generic drugs, biosimilars, or interchangeable biologics.).

1% of AWP, not to exceed $10 per transaction

Increases OWCP DME market penetration rate by 2% year-over-year 0.5% of AWP, not to exceed $10 per transaction

Increases OWCP diagnostic services market penetration rate by 0.5% year-over-year 0.25% of AWP, not to

BLACK LUNG

Incentive fee the PBM is allowed to bill above the pass-through price for generic drugs from retail pharmacies for the current option period Reduces oral steroid utilization (not counting lung transplant cases) in the BLACK LUNG program by 5% year-over-year 0.5% of AWP, not to exceed $10 per transaction Increases OWCP DME market penetration rate by 2% year-over-year 0.5% of AWP, not to exceed $10 per transaction Increases OWCP diagnostic services market penetration rate by 0.5% year-over-year 0.25% of AWP, not to

[1] See Part 2 Acronyms and Definitions for the “full pass-through price” definition.

The Government will provide the contractor with the method it uses to calculate the measures in the tables above within three months of contract award. Within 90 days after the end of the first option period and each option period thereafter, the Government will calculate the measures in the tables above and inform the contractor of the revised price structure that will be effective during the final nine months of the then current option period. When billing the Government, the allowed incentive fee must be differentiated from the pass-through price on the OWCP pharmacy data file, in any reports, and on the PBM staff portal.

1.6.9.3 Improvements

The contractor must make system and clinical improvements to keep pace with industry standards and changes in OWCP policies at no additional cost to the Government. If the contractor wishes to leverage generative or multimodal artificial intelligence that interacts with Government claimants or providers to improve efficiencies or enhance clinical outcomes, it must be fully tested, approved by the Government, and perform better than standard processes.

1.6.9.4 Specific System Requirements

All transactions submitted by DME suppliers, diagnostic services providers, and pharmacies must be submitted electronically to the appropriate contractor for processing. Claimants may submit reimbursement requests to the medical bill processing contractor’s mailroom using Form OWCP-915, Claim for Medical Reimbursement, which is available on each compensation program’s website.

1.6.9.5 Post Award Conference / Periodic Progress Meetings

The contractor must attend any post-award conference convened by the Government in accordance with Federal Acquisition

Regulation (FAR) Subpart 42.5. The CO, COR, and other government personnel may meet periodically with the contractor to review the contractor's performance. At these meetings, the CO will apprise the contractor of how the Government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. These meetings must be attended by the contractor at no additional cost to the Government.

The contractor is responsible for arranging and coordinating periodic virtual meetings requested by the COR. The contractor must provide detailed meeting minutes and audio recordings of all project-related meetings. Additionally, the contractor must establish and maintain a secure web directory or Microsoft SharePoint site, which hosts meeting minutes and recordings, and other contract documents. The site must be organized, and the directory labeled to allow easy search by document type, topic, compensation program, and date-range. The contractor must ensure secure, yet convenient access to the web directory or Microsoft SharePoint site for authorized government personnel.

1.6.9.6 Contracting Officer’s Representative

The COR will be designated in writing by the DOL and a copy of the letter of designation will be forwarded to the contractor. The COR monitors the technical aspects of the contract and assists in contract administration, but the COR is not authorized to make changes to the terms and conditions of the contract. Changes to the terms and conditions of the contract must be made by the CO.

The COR oversees contract performance, assures that the contractor adheres to the technical requirements of the contract, communicates with the contractor concerning the technical aspects of the contract, issues written interpretations of the technical requirements, and notifies the CO and the contractor of any deficiencies in the contractor’s performance. All contract-related communication from the contractor must be forwarded to the COR.

1.6.9.7 Personnel

Although the position titles may be different than those listed below, and the functional responsibilities may be distributed differently (e.g., one position may perform multiple functions or several positions may share functions), the contractor must have, and assign to this project, personnel who possess the qualifications listed below and are able to fulfill the functional responsibilities and perform the tasks described in Part 5 of this PWS. The contractor’s staffing plan must include:

• A chart showing all proposed personnel (including outside consultants and subject matter experts) by task and hours. The chart must include names of proposed key and non-key personnel mapped to the proposed labor categories, project roles, and appropriate tasks that support the strategic initiatives.

• The qualifications and experience of any proposed professional non-key personnel and outside consultants, including any relevant education, skills, and work experience applicable to their proposed responsibilities.

• The minimum qualifications/standards for each proposed labor category that is not included among the key personnel, and their reporting relationships.

• The contractor must clearly specify the role and responsibilities of each proposed staff member and discuss the qualifications of the individuals proposed for specific tasks. The proposal must identify the labor category for each individual and include a summary of the individual’s experience and qualifications and an explanation of how the individual’s experience and qualifications relate to the tasks for which he or she will be utilized.

The contractor must indicate whether the personnel proposed for work are currently employed by the contractor, employed by a subcontractor, serve as consultants, or are a planned hire. If subcontractors or outside assistance are proposed, organizational control and specific responsibilities with respect to all tasks must be clearly delineated to demonstrate and ensure responsiveness to the needs of the Government. The contractor must submit the staffing plan to the Government in accordance with TECHNICAL EXHIBIT 2.

1.6.10 Key Personnel

The follow personnel are considered key personnel by the Government:

• Program Manager (PM)

• Alternate PM

• Lead Clinical Pharmacist (PharmD)

• Alternate Clinical Pharmacist (PharmD)

The contractor must notify the Government of vacancies in key positions in accordance with TECHNICAL EXHIBIT 2. The contractor must provide the Government with resumes of all candidates for key position. The contractor must ensure that no key position remains vacant for more than 30 days. The Government may request a “meet and greet” with any potential candidate.

Qualifications for all key personnel are listed below:

1.6.10.1 Program Manager (PM)/Alternate PM

The contractor must provide a full-time program manager and a full-time alternate PM who will be responsible for the performance of the work. The name of this person and an alternate who will act for the contractor when the manager is absent must be provided in writing to the COR. The Program Manager or alternate will be the primary point of contact for OWCP management and must have full authority to act for the contractor on all contract matters relating to daily operation of the contract. The Program manager or alternate must be available Monday through Friday except on federal holidays.

The Program Manager (PM) and alternate PM must have at least five years’ experience managing a state, federal, or commercial PBM program of similar volume to these requirements. The proposed PM and alternate PM must hold a current Project Management Professional (PMP) credential and, preferably, a bachelor's degree.

1.6.10.2 Lead Clinical Pharmacist

The contractor must provide a designated lead clinical pharmacist (PharmD) to support the contract. The position requires a doctor’s degree in Pharmacy that is recognized by the Accreditation Council for Pharmacy Education (ACPE), or an accrediting body recognized by the Department of Education at the time the degree was granted. The Lead Clinical Pharmacist must also have passed the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE) and be currently licensed to practice pharmacy in a state, the District of Columbia, the Commonwealth of Puerto Rico, or other territory of the United States. The Lead Clinical Pharmacist must also have completed a Postgraduate Year One (PGY1) pharmacy residency and, preferably, an additional advanced degree.

The Lead Clinical Pharmacist must have five years’ experience providing pharmaceutical information and modeling, and assisting with policy development, implementation, oversight, evaluation, and reporting. Ideally, the incumbent will have experience providing support to senior clinical (Chief Medical Officer, Chief Pharmacist) and non-clinical executives (agency director, division directors), and fraud and integrity analysts regarding PBM operations.

1.6.10.3 Alternate Lead Clinical Pharmacist

The contractor must provide a designated alternate lead clinical pharmacist (PharmD) to support the contract. The position requires a doctor’s degree in Pharmacy that is recognized by the Accreditation Council for Pharmacy Education (ACPE), or an accrediting body recognized by the Department of Education at the time the degree was granted. The Alternate Lead Clinical Pharmacist must also have passed the North American Pharmacist Licensure Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination (MPJE) and be currently licensed to practice pharmacy in a state, the District of Columbia, the Commonwealth of Puerto Rico, or other territory of the United States. The Alternate Lead Clinical Pharmacist must also have completed a Postgraduate Year One (PGY1) pharmacy residency and, preferably, an additional advanced degree.

The Alternate Lead Clinical Pharmacist must have five years’ experience providing pharmaceutical information and modeling, and assisting with policy development, implementation, oversight, evaluation, and reporting.

1.6.11 Other Personnel

1.6.11.1 Medical Director

The contractor must provide a medical director (MD) to support the contract. The position requires a doctor’s degree in Medicine accredited by the Liaison Committee on Medical Education (LCME), Association of American Medical Colleges, or an accrediting body recognized by the Department of Education at the time the degree was granted. The Medical Director must also have completed graduate medical education and be certified as a specialist by a member board of the American Board of Medical Specialties, and possess a current, active, full, and unrestricted license as a physician from a state, the District of Columbia, the Commonwealth of Puerto Rico, or another territory of the United States.

1.6.11.2 Lead Fraud, Waste, and Abuse (FWA) Expert

The contractor must provide a full-time lead fraud, waste, and abuse expert to lead a team of FWA specialists and support all aspects of the proposed FWA solution. The Lead FWA Expert must have seven years of experience identifying FWA in PBM programs and must have a health care fraud investigator (AHFI) designation from the National Health Care Anti-Fraud Association or an equivalent certification. The Lead FWA Expert will work with DOL Office of the Inspector General (OIG), OWCP program integrity personnel, and others to investigate FWA.

1.6.11.3 Technical Manager

The contractor must provide a full-time technical manager to lead a team of information technology (IT) personnel and coordinate all technical and systems engineering tasks necessary to implement and maintain the contractor’s PBM solution. Under the guidance of the Program Manager, the Technical Manager will be responsible for the overall management of the design, development, implementation, and operation of all PBM systems and subsystems used to execute contract requirements. The Technical Manager will analyze user needs to determine functional and cross-functional requirements, allocate the resources necessary to complete required tasks, ensure that technical solutions are implemented according to the project schedule, and plan integration with other functional systems.

1.6.11.4 Lead Data Analyst

The contractor must provide a full-time lead data analyst to lead a team of data analysts and support all aspects of data management, validation, analysis, and reporting. The position requires a degree in a quantitative discipline such as analytics, data science, statistics, or a related field. The Lead Data Analyst must have at least five years of experience in SQL, Power BI, and at least one statistical software or programming language (e.g., R, SAS, Python), data validation, analytics, and reporting related to the pharmaceutical industry, and be able to independently solve complex problems. The Lead Data Analyst will operate as a subject matter expert on PBM data solutions, perform routine and ad hoc analyses derived from internal and external data, and effectively communicate with DOL data scientists regarding processes and findings. The Lead Data Analyst and his or her team will be responsible for developing and updating data dictionaries and defining data elements

1.6.11.5 Pharmacists

The contractor must provide enough full-time pharmacists (in addition to the Lead Clinical Pharmacist and Alternate Lead Clinical Pharmacist positions) to review prior authorization requests, process held or rejected prescriptions, review letters of medical necessity, and perform comprehensive drug utilization review, in accordance the performance metrics for requirements 5.12.17 and 5.12.20.1 in TECHNICAL EXHIBIT 1, and to perform other PBM-related tasks as needed. At least one of the pharmacists should have an Oncology Pharmacy Specialty Certification (BCOP) from the Board of Pharmacy Specialties.

1.6.11.6 Registered Nurses

Any registered nurses (RN) that perform clinical services must have a bachelor’s or higher degree from an accredited professional nursing educational program. This education must have been accredited by the Commission on Collegiate Nursing Education, Council on Accreditation of Nurse Anesthesia Educational Programs, Accreditation Commission for Midwifery Education, or an accrediting body recognized by the Department of Education at the time the degree was granted. Nurses must also be currently licensed to practice nursing in a state, the District of Columbia, the Commonwealth of Puerto Rico, or other territory of the United States.

1.6.12 Identification of Contractor Employees

All contract personnel attending meetings, answering government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating the impression that they are government officials or employees. Contractor employees must also ensure that all documents or reports they produce are suitably marked as a company product or the company’s participation is appropriately disclosed.

1.6.13 Organizational Conflict of Interest

Contractor and subcontractor personnel performing work under this contract action may receive, have access to, or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services that may create a current or…

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