Amendment_0004_-_PBM_Solicitation_1605DC-18-R-00020.pdf

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

OPS

S-4307 200 Constitution Ave, NW Office of Procurement Services US Department of Labor

CODE 16. ADMINISTERED BYCODE

X

X

524292

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED OROPS

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

07/09/2018 0830 ES

06/29/2018

202-693-7161JAMES JOHNSON

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

1605DC-18-R-00020

5. SOLICITATION NUMBER

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

1 102 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

Washington DC 20210

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Washington DC 20210 S-4307 200 Constitution Ave, NW Office of Procurement Services

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$32.50

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

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

US Department of Labor

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

The purpose of Amendment 0004 of Solicitation Number 1605DC-18-R-00020 is to:

1. Attach / upload the “Questions and Answers” submitted in response to the solicitation.

2. Attach / upload Amendment 0004 of Solicitation Number 1605DC-18-R-00020, which incorporates all changes related to the Questions and Answers document.

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

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED

JAMES M. JOHNSON

. 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 FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

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:

REF.

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. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Period of Performance: 09/05/2018 to 09/04/2019

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

102 2 of

B - Schedule of Supplies/Services

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

BASE PERIOD

Item No Supplies/Services Quantity Unit Unit Price Amount Pharmacy Benefits Management (PBM) Services: All basic services in this requirement will be included in the price below.

Services include, but are not limited to, formulary management, fee schedule, PBM utilization review, durable medical equipment (DME), diagnostic services and testing, customer support, assistance with business rules, eligibility verification and processing claims for payment, electronic funds transfer (EFT) enrollment checks, fraud/waste/abuse monitoring, reporting, and information management.

Net Discount Proposed shall be as follows:

Item Description Net Discount Proposed

Brand Name retail Generic retail Brand Name (mail order or 90 day supply) Generic (mail order or 90 day supply) Compound Medications (3 or fewer ingredients) Compound Medications (more than 3 ingredients) Durable Medical Equipment

(DME)

Diagnostic Services and Testing

12 Months

Item No Supplies/Services Quantity Unit Unit Price Amount

OPTIONAL: Specialty Pharmacy

Net Discount Proposed shall be as follows:

Item Description Net Discount Proposed

Brand Name retail Generic retail Brand Name (mail order or day supply)

Generic (mail order or 90 day supply)

0003 OPTIONAL: Patient Compliance Program 2,000 Cases

0004 OPTIONAL: Disease Management Program 2,000 Cases

OPTION PERIOD ONE (1)

Item No Supplies/Services Quantity Unit Unit Price Amount Pharmacy Benefits Management (PBM) Services: All basic services in this requirement will be included in the price below.

Services include, but are not limited to, formulary management, fee schedule, PBM utilization review, durable medical equipment (DME), diagnostic services and testing, customer support, assistance with business rules, eligibility verification and processing claims for payment, electronic funds transfer (EFT) enrollment checks, fraud/waste/abuse monitoring, reporting, and information management.

Net Discount Proposed shall be as follows:

Item Description Net Discount Proposed

Brand Name retail Generic retail Brand Name (mail order or 90 day supply) Generic (mail order or 90 day supply) Compound Medications (3 or fewer ingredients) Compound Medications (more than 3 ingredients) Durable Medical Equipment

(DME)

Price Amount

OPTIONAL: Specialty Pharmacy

Net Discount Proposed shall be as follows:

Item Description Net Discount Proposed

Brand Name retail Generic retail

Brand Name (mail order or 90

Generic (mail order or 90 day

1003 OPTIONAL: Patient Compliance Program 2,000 Cases

1004 OPTIONAL: Disease Management Program 2,000 Cases

OPTION PERIOD TWO (2)

Item No Supplies/Services Quantity Unit Unit Price Amount Pharmacy Benefits Management (PBM) Services: All basic services in this requirement will be included in the price below.

Services include, but are not limited to, formulary management, fee schedule, PBM utilization review, durable medical equipment (DME), diagnostic services and testing, customer support, assistance with business rules, eligibility verification and processing claims for payment, electronic funds transfer (EFT) enrollment checks, fraud/waste/abuse monitoring, reporting, and information management.

Net Discount Proposed shall be as follows:

Item Description Net Discount Proposed

Brand Name retail Generic retail Brand Name (mail order or 90 day supply) Generic (mail order or 90 day supply) Compound Medications (3 or fewer ingredients) Compound Medications (more than 3 ingredients) Durable Medical Equipment

(DME)

Price Amount

OPTIONAL: Specialty Pharmacy

Brand Name retail Generic retail

2003 OPTIONAL: Patient Compliance Program 2,000 Cases

2004 OPTIONAL: Disease Management Program 2,000 Cases

OPTION PERIOD THREE (3)

Item No Supplies/Services Quantity Unit Unit Price Amount Pharmacy Benefits Management (PBM) Services: All basic services in this requirement will be included in the price below.

Services include, but are not limited to, formulary management, fee schedule, PBM utilization review, durable medical equipment (DME), diagnostic services and testing, customer support, assistance with business rules, eligibility verification and processing claims for payment, electronic funds transfer (EFT) enrollment checks, fraud/waste/abuse monitoring, reporting, and information management.

Net Discount Proposed shall be as follows:

Item Description Net Discount Proposed

Brand Name retail Generic retail Brand Name (mail order or 90 day supply) Generic (mail order or 90 day supply) Compound Medications (3 or fewer ingredients) Compound Medications (more than 3 ingredients) Durable Medical Equipment

(DME)

Price Amount

OPTIONAL: Specialty Pharmacy

Brand Name retail Generic retail

3003 OPTIONAL: Patient Compliance Program 2,000 Cases

3004 OPTIONAL: Disease Management Program 2,000 Cases

OPTION PERIOD FOUR (4)

Item No Supplies/Services Quantity Unit Unit Price Amount Pharmacy Benefits Management (PBM) Services: All basic services in this requirement will be included in the price below.

Services include, but are not limited to, formulary management, fee schedule, PBM utilization review, durable medical equipment (DME), diagnostic services and testing, customer support, assistance with business rules, eligibility verification and processing claims for payment, electronic funds transfer (EFT) enrollment checks, fraud/waste/abuse monitoring, reporting, and information management.

Net Discount Proposed shall be as follows:

Item Description Net Discount Proposed

Brand Name retail Generic retail Brand Name (mail order or 90 day supply) Generic (mail order or 90 day supply) Compound Medications (3 or fewer ingredients) Compound Medications (more than 3 ingredients) Durable Medical Equipment

(DME)

Price Amount

OPTIONAL: Specialty Pharmacy

Brand Name retail Generic retail

4003 OPTIONAL: Patient Compliance Program 2,000 Cases

4004 OPTIONAL: Disease Management Program 2,000 Cases

C - Description/Specifications

Performance Work Statement (PWS) For

Office of Workers’ Compensation Programs (OWCP) Pharmacy Benefits Management Services

PART 1

GENERAL INFORMATION

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, tools, materials, supervision, and other items and non-personal services necessary to perform Pharmacy Benefits Management (PBM) Services as defined in this Performance Work Statement, except as specified in Part 3 as government furnished property, equipment, and services. The Contractor shall provide all of the services included herein with the only costs to the Government being the “Net Proposed Price/Discount” (CLINS 0001- 4001) for PBM basic services. The Contractor shall pay the provider directly and invoice OWCP. All invoices for medical services and medical support services provided to claimants under the resulting contract shall be sent to and approved by OWCP. The contractor shall factor all of these requirements, as well as the cost of obtaining the necessary medical support services, into the total discount that it can provide to the government for those services. The Contractor shall be required to adhere to all applicable laws / regulations irrespective of the Price / Discount structure utilized.

The PBM Services requirement as defined in this Performance Work Statement (PWS) represents new services.

As a result, there is no Incumbent Contractor currently providing PBM Services.

1.2 Background:

The Office of Workers’ Compensation Programs (OWCP) Division of Federal Employees’ Compensation (DFEC) is composed of a National Office responsible for policy setting, performance metrics and other program-wide functions, and twelve district offices located throughout the United States, which process compensation claims and authorize wage replacement and medical benefits.

The Federal Government employs a workforce of approximately 2.7 million Federal civilian employees.

These employees are covered by the Federal Employees’ Compensation Act (FECA) for employment-related injuries and occupational diseases. FECA benefits include medical support services (such as diagnostic testing, treatment, pharmaceuticals, and durable medical equipment (DME) and supplies for conditions that are accepted by DFEC as being related to the employment injury for as long as DFEC determines such medical support services are necessary for the employment injury or illness. The statute, regulations and program policy provide guidance for the administration of FECA claims. There were 220,707 Federal workers’ compensation (WC) cases under management between 30 November 2016 and 30 November 2017. These cases generated 911,131 prescriptions for drugs costing $235,685,753.

In September 2003, industry standard and program specific medical bill processing services were implemented centrally. The program provides medical benefits only to the extent that the medical care is related to the medical condition(s) accepted as employment-related during the period(s) of eligibility.

While bill-processing activities have been decoupled from the claims examination and adjudication functions, the DFEC claims examiner (CE) function for determining the accepted condition and authorizing certain medical treatments has been preserved. Data from the bill processing system keep the CE informed of the nature and quantity of treatment for a given accepted condition and requests for treatment that require prior authorization by the CE.

Industry standard requirements include but are not limited to eligibility edits, validity edits, required field checks, consistency edits, medical appropriateness, correct coding, duplicate checking, service limitations, application of OWCP fee schedules and financial accounting, auditing, and reporting.

Under the current medical bill processing contract, medical bill input, bill processing, and resolution occur at contractor sites. The bill processing contractor is also responsible for provider enrollment, generating and mailing remittance advice with explanation of benefits (EOB) information, handling provider inquiries (call center), and preparing a payment tape for transmission to the Department of the Treasury.

In addition, the bill processing contractor authorizes certain specified medical support services in accordance with DFEC criteria and refers the requests for authorization of more complex services to the DFEC district office staff managing the case. A contractor-run facility also provides the real-time processing of pharmacy bills.

There are two groups of federal civilian employees eligible for coverage under this program.

1. Group 1 is comprised of those who have an existing FECA claim. These employees have fully adjudicated WC claims, and have coverage for all prescriptions that meet the OWCP DFEC requirements for their accepted injury.

2. Group 2 is comprised of new FECA claimants. These employees are newly injured on the job and have filed FECA claims pending adjudication by OWCP DFEC.

1.3 Objectives:

Provide a system for first-fill prescription coverage for employees who sustain a traumatic injury at work.

Provide full prescription coverage for work-related injuries to all injured employees upon filing a FECA claim for traumatic injury.

Provide a pharmacy card system to employees who experience traumatic injuries, or occupational illnesses, once claim eligibility is determined by DFEC.

1.4 Scope: The contractor shall implement and operate a PBM in the United States and its territories for the Division of Federal Employees’ Compensation Programs (DFEC) that injured federal employees will generally be required to use in order to access pharmacy benefits. The PBM includes a program that services Federal employees with work-related injuries or illness, that have an accepted workers’ compensation case with DFEC, and require prescription medications, diagnostic services (e.g., magnetic resonance imaging (MRI), computerized tomography, (CT), radiography, electromyography (EMG)), and durable medical equipment (DME). The contractor shall provide a system for first-fill prescription coverage for employees who sustain a traumatic injury at work. The contractor shall establish a formulary1 for approval by OWCP to better manage costs, improve safety, and implement drug utilization review processes.

1.5 Period of Performance: The period of performance shall be for one (1) base period of 12 months with four

(4) 12-month options. The Period of Performance are as follows:

Base Period: September 05, 2018 – September 04, 2019 Option Period I: September 05, 2019 – September 04, 2020 Option Period II: September 05, 2020 – September 04, 2021 Option Period III: September 05, 2021 – September 04, 2022 Option Period IV: September 05, 2022 – September 04, 2023

Milestone dates within the period of performance include:

Contract Start: September 05, 2018 (based on estimated contract award of September 04, 2018) Phase 1 “90 MED” Implementation2: no later than October 4, 2018 Phase 1 Full Implementation: no later than November 3, 2018

1 It is noted that this will be the first formulary established for DFEC, as one does not currently exist.

2 This milestone is specific to the Phase 1 functionality required for approximately 3,000 individuals receiving 90 MED or higher of prescribed opioids.

Phase 2 Implementation: no later than December 3, 2018 Phase 3 Implementation: no later than March 3, 2019

1.6 General Information

1.6.1 Quality Control: The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is the means to assure that work complies with the requirement of the contract. At a minimum, the contractor shall develop quality control procedures that address the areas identified in Technical Exhibit 1, “Performance Requirements Summary.” After acceptance of the quality control plan, the contractor shall receive the Contracting Officer’s acceptance in writing of any proposed change to that plan.

1.6.2 Quality Assurance: The government shall evaluate the contractor’s performance under the resulting contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.6.3 [RESERVED]

1.6.4 Recognized Holidays: The contractor shall ensure services 365 days per year.

1.6.5 Hours of Operation/Place of Performance: The contractor is responsible for conducting PBM services at contractor facilities. The contractor must at all times maintain an adequate work force for the uninterrupted performance of all tasks defined within this statement of work. When hiring personnel, the contractor shall keep in mind that the stability and continuity of the work force are essential. The contractor’s system and web portal shall be available 24 hours per day, 7 days per week except for 5 hours of maintenance per week. Maintenance periods shall be coordinated to occur at off-peak times and must be approved by

OWCP.

1.6.6 [RESERVED]

1.6.7 Security Requirements

1.6.7.1 INFORMATION SECURITY: The contractor shall be responsible for safeguarding all government information provided for contractor use.

1.6.7.1.1 The contractor shall be responsible for ensuring compliance by its employees with the security regulations of DOL and other government installations or contractor facilities where work is performed under the resulting contract. The contractor shall ensure the security of all DOL property, building ID badges, key cards and standard keys issued to contractor staff. For employees leaving the project permanently or for an extended period, the contractor shall return all badges, property, key cards, parking placards, and keys the same day the employees leave the project.

1.6.7.1.2 For any contract employees and/or sub-contractors who regularly work at government facilities, the contractor is responsible for the safekeeping and display of a government-provided photo ID badge while these employees are in federally owned or leased property as described in Section 4, Place of Performance.

1.6.7.2 PERSONAL INFORMATION AND PRIVACY: The contractor shall provide personal information and privacy support to ensure compliance to the Privacy Act and other Federal Privacy related policies including, but not limited to, OMB Memorandum M-06-16, Protection of Sensitive Agency Information, and M-07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information.

The contractor shall evaluate their existing privacy-related policies and procedures to ensure 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 shall perform the necessary updates/revisions to bring the documents and/or system into compliance as requested by the Contracting Officer or COR at no additional cost to the Government. The contractor shall also ensure that all identified privacy vulnerabilities and areas of noncompliance have been documented and resolution tracked.

1.6.7.2.1 The contractor shall ensure conformance to the most recent DOL implementation of Federal 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-07-16, Safeguarding Against the Breach of Personally Identifiable Information, May 22, 2007.

OMB Memorandum M-06-19, Reporting Incidents Involving Personally Identifiable Information and Incorporating the Cost for Security in Agency Information Technology Investments, July 12, 2006.

OMB Memorandum M-06-16, Protection of Sensitive Agency Information, June 23, 2006.

OMB Memorandum M-06-15, Safeguarding Personally Identifiable Information, May 22, 2006.

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

FIPS PUB 200, Minimum Security Requirements for Federal Information Systems:

http://csrc.nist.gov/publications/fips/fips200/FIPS-200-final-march.pdf

NIST Special Publication (SP) 800-53, Rev. 4, Security and Privacy Controls for Federal Information Systems and Organizations: https://csrc.nist.gov/publications/detail/sp/800-53/rev- 4/final

US DOL Computer Security Handbook (DOL’s implementation of NIST SP 800-53). (Reference Attachment 25 - Computer Security Handbook 5.0)

DLMS – 9 – Chapter 1200, DOL Safeguarding Sensitive Data Including Personally Identifiable Information (Reference Attachment 26 - Department of Labor Manual Series (DLMS) 9 Chapter 1200) http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf http://csrc.nist.gov/publications/fips/fips200/FIPS-200-final-march.pdf

1.6.7.2.2 The Contractor shall obtain an Authority to Operate (ATO) from DOL prior to the deployment of the web portal in Phase 3 of the project, which will include the production of a system security plan and testing by DOL of the controls in place to safeguard the web portal.

1.6.7.3 PRIVACY RESPONSIBILITIES.

1.6.7.3.1 The contractor shall ensure that every employee completes all mandated Federal security-training requirements prior to the employee’s first day of work under the contract unless the Government provides a signed waiver agreement.

1.6.7.3.2 The contractor shall ensure that all information and reports generated under the terms of the resulting contract are, and shall always remain, the property of the Government.

1.6.7.3.3 The contractor shall protect the personally identifiable information (PII) of all claimants, providers, and Government employees from unauthorized disclosure.

1.6.7.3.4 The contractor shall use a government-approved incident reporting form to notify the Government (via zzowcpsecurity@dol.gov) of all security incidents, disclosures, breaches, disasters involving personally identifiable information (PII) within one (1) hour of becoming aware of the incident. This written notification shall 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. Upon notification, the contractor shall investigate the suspected or actual incident to discover the facts about the incident.

As additional information becomes available, the contractor shall complete the Incident Report form and provide to zzowcpsecurity@dol.gov.

1.6.7.3.5 The contractor shall have a process in the event of a breach or disclosure that also includes corrective action to ensure that a similar breach does not occur in the future. The contractor shall submit a privacy disclosure or breach of personal information plan to the Government in their proposal.

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

1.6.7.3.7 In the event of a confirmed PII breach by the contractor, the contractor shall provide, at its own cost, one

(1) year of credit monitoring services for the affected claimant(s).

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

1.6.7.3.9 The Government shall approve the contractor’s resolution to the incident.

1.6.7.4 SYSTEM SECURITY

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

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

NIST SP 800-18 Guide for Developing Security Plans for Information Technology Systems mailto:zzowcpsecurity@dol.gov mailto:zzowcpsecurity@dol.gov

NIST SP 800-30, Rev 1, Risk Management Guide for Information Technology Systems

NIST SP 800-37, Rev 1, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Lifecycle Approach

DLMS 9 – 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

1.6.7.4.3 The contractor shall ensure that the PBM System is Federal Identity, Credential, and Access Management (FICAM) compliant and capable of validating DOL-issued Personal Identity Verification (PIV) Authentication (PIVAuth) certificates for logical access for DOL and contractor employees. The contractor shall comply with applicable agency personal identity verification procedures identified in the contract3.

1.6.7.4.4 The contractor shall ensure certificate status information (i.e., certificate revocation lists (CRL) or online certificate status protocol (OCSP)) is checked for each authentication to the PBM system by internal contract employees and DOL employees.

1.6.7.4.5 The contractor shall require the use of a DOL-issued PIV card for logical access by contractor and DOL employees to the PBM system and to data hosted by that system within 180 days.

1.6.7.4.6 All contractor workstations that access the PBM system must leverage operating systems that support the use of DOL-issued PIV cards for authentication.

1.6.7.4.7 Domain controllers that support the PBM system must leverage modern operating systems that support the use of DOL-issued PIV cards for authentication by contractor and DOL employees.

1.6.7.4.8 Domain controllers that support the PBM system must leverage domain controller certificates issued by an accredited Certification Authority (CA) that meets or exceeds the requirements for a CA operated under the Federal public key infrastructure (PKI) as a medium assurance CA. A certificate authority is a trusted entity that issues electronic documents that verify a digital entity’s identity on the Internet.

1.6.7.4.9 Contractor shall provide the Department of Labor’s (DOL) Security Center with accurate user principal names (UPNs) that match the UPNs of accounts on the PBM system. A UPN is a unique identifier like a userid that will be associated with the PIV card and will be used to authenticate that PIV card for that user.

1.6.7.4.10 The PBM system domain controllers must trust the Entrust Managed Service Offering (MSO) Root and Shared Service Provider (SSP) certification authority (CA) certificates (certificates to be provided by

DOL).

1.6.7.4.11 The contractor must maintain the required documents on file and make them available to OWCP upon request.

1.6.7.4.12 The contractor shall 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.

1.6.7.4.13 The contractor shall comply with the Federal Information Security Modernization Act of 2014 (FISMA), 44 USC § 3551 et seq. All products and deliverables developed under this PWS shall comply with DOL Computer Security guidelines and the guidelines contained in OMB Circular A-130. All contract staff working in DOL office space and/or using the DOL LAN/WAN and computer systems to perform duties under this PWS shall agree to and sign the DOL Rules of Behavior for Computer Use and a Non- Disclosure Agreement. A copy of each signed and witnessed Non-Disclosure Agreement shall be

3 For more information on the PIV credentialing process, please visit USAccess.

http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-63-3.pdf submitted to the COR prior to the employee performing any work under any task order.

1.6.7.5 BACKGROUND INVESTIGATIONS.

1.6.7.5.1 The contractor shall comply with applicable agency personal identity verification procedures identified in the contract that implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24, and Federal Information Processing Standards Publication (FIPS PUB) Number 201.

1.6.7.5.2 The contractor shall provide the following documents to the Federal Project Manager or COR two weeks prior to entry on duty (EOD):

OF- 306

Prior Investigation Checklist (PIC) form USAccess form Signed Computer Security Training Signed non-disclosure agreement (NDA)

1.6.7.5.3 The contractor shall have employees who require DOL-issued PIV badges to visit the nearest USAccess credentialing center for enrollment and for activation, at appropriate times during the background investigation process. All employees with access to DOL facilities, systems and/or data shall require DOL-issued PIV badges, regardless of citizenship.

1.6.7.5.4 The contractor shall have employees complete eQIP applications (SF85/85P/86 as appropriate) upon notice of eQIP initiation/enrollment.

1.6.8 [RESERVED]

1.6.9 Post Award Conference/Periodic Progress Meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The Contracting Officer, Contracting Officers Representative (COR), and other government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the Contracting Officer will apprise the contractor of how the Government views the contractor's performance and the contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.6.10 Contracting Officer Representative (COR): A COR will be delegated under separate cover.

1.6.11 Key Personnel:

The follow personnel are considered key personnel by the government:

Program Manager (PM)

Alternate PM

Clinical Pharmacist (Pharm.D. or equivalent)

Qualifications for all key personnel are listed below:

1.6.11.1 Program Manager (PM) / Alternate PM

The contractor shall provide a Program Manager who shall be responsible for the performance of the work.

The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the Contracting Officer’s Representative (COR). The Program Manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of the resulting contract and be the primary interface with OWCP management and the point of contact on all OWCP claims and contract performance matters. The Program manager or alternate shall be available between 8:00am to 5:00pm, Monday thru Friday, except Federal holidays or when the government facility is closed for administrative reasons.

The Program Manager (PM) must have at least five (5) years’ experience managing a state and/or Federal PBM program of similar volume to these requirements. The proposed PM must hold a current Project Management Professional (PMP) credential, and a bachelor's degree is preferred.

The Government requires one (1) full-time Alternate PM with at least three (3) years’ experience managing a state and/or Federal PBM program. The Alternate PM will serve as the backup when the assigned PM is unavailable, and have authority to act on behalf of the primary PM. The proposed alternate PM must hold a current Project Management Professional (PMP) credential, and a bachelor's degree is preferred.

1.6.11.2 Clinical Pharmacist (Pharm.D. or equivalent)

The contractor shall provide a designated Clinical Pharmacist (Pharm.D. or equivalent) to support the contract. The position requires a doctoral degree in Pharmacy that is recognized by the Accreditation Council for Pharmacy Education (ACPE) or an accrediting body recognized by the U.S. Department of Education at the time the degree was granted. The 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 Clinical Pharmacist shall have 5 years’ experience providing pharmaceutical information and modeling, and assisting with policy development, implementation, oversight, evaluation, and reporting.

While not a requirement for acceptability as “Key Personnel”, OWCP seeks a clinical pharmacist that has actual or equivalent experience providing support to roles such as OWCP/DFEC’s senior leadership, Chief Medical Officer, Clinical Pharmacist, and program fraud and integrity analysts regarding PBM operations.

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 an impression in the minds of members of the public that they are government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is disclosed. For any contract employees and/or sub-contractors who regularly work at government facilities, this includes the safekeeping and display of a government-provided photo ID badge while these employees are in federally owned or leased property as described in Place of Performance.

PART 2

DEFINITIONS & ACRONYMS

2.1 Definitions:

2.1.1 Abuse - Practices that are inconsistent with professional standards of care; medical necessity; or sound fiscal, business, or medical practices. Examples include but are not limited to billing for services that were not medically necessary, charging excessively for services or supplies, and billing which is not in accordance with industry standards. Importantly, intent is the key distinction between fraud and abuse. An allegation of waste and abuse can escalate into a fraud investigation.

2.1.2 Contracting Officer’s Representative (COR) - A representative from the requiring activity assigned by the Contracting Officer to perform surveillance and to act as liaison to the contractor.

2.1.3 Defective Service - A service output that does not meet the standard of performance associated with it in the Performance Work Statement.

2.1.4 eQIP – Electronic Questionnaires for Investigations Processing. The OPM system to facilitate processing of standard investigation forms used when conducting background investigations for Federal security, suitability, fitness, and credentialing purposes. eQIP allows the user to electronically enter, update and transmit their personal investigative data over a secure internet connection to a requesting agency.

2.1.5 Fraud - An intentional deception or misrepresentation made by a person with the knowledge that the deception could result in some unauthorized benefit to him or some other person. It includes any act that constitutes fraud under applicable federal or state law. Examples include, but are not limited to: billing for drugs or DME that were not rendered, altering claim forms to receive a higher payment rate, providing drugs or DME to someone other than the claimant using a claimant’s enrollment card, prescribing and billing for medications for claimant conditions other than those that have been accepted by OWCP, and charging for administrative services not rendered or items not provided. Importantly, intent is the key distinction between fraud and abuse. An allegation of waste and abuse can escalate into a fraud investigation.

2.1.6 Quality Assurance Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.7 Quality Control. Those actions taken by a contractor to control the performance of services so that they meet the requirements of the PWS.

2.1.8 Quality Assurance. Those actions taken by the Government to assure services meet the requirements of the Performance Work Statement.

2.1.9 USAccess – The GSA program providing civilian agencies with badging solutions, including nationwide secure, shared service facilities for credential issuance, maintenance, and lifecycle management.

2.1.10 Waste - The failure to control costs associated with federal program funding. Waste results in taxpayers not receiving reasonable value for their money in connection with any government-funded activities due to an inappropriate act or omission by payers with control over or access to government resources.

Importantly, waste relates primarily to mismanagement, inappropriate actions, or inadequate oversight.

Examples include, but are not limited to: use of higher-priced drugs and DME that have negligible or no health benefits over less-expensive alternatives, writing high-cost prescriptions over less expensive but equivalent generic prescriptions, and overtreatment.

2.1.11 Medical support services – Services and supplies provided by or under the supervision of a physician.

Examples include, but are not limited to, diagnostic testing, medical treatment, pharmaceuticals, and durable medical equipment (DME) and supplies.

2.1.12 Average Wholesale Price - Defined as the average value at which wholesalers sell drugs to physicians, pharmacies, and other customers. For OWCP purposes, AWP is based on First Databank before 10/01/2011 and MediSpan thereafter – or as otherwise specified by OWCP in the event of a subsequent change - determined by the fill date.

2.1.13 Maximum Allowable Cost – Defined as a list of drugs, usually multisource generics, in which the PBM establishes the maximum price it will reimburse for each of the drugs on the list. Instead of using only AWP to price these medications, the PBM uses a proprietary formulary, taking into account wholesale acquisition cost and other pricing benchmarks in order to establish a maximum price more in line with the actual cost of the drug.

2.2 Acronyms

2.2.1 AWP – Average Wholesale Price

2.2.2 CA – Certification Authority

2.2.3 CBP – Central Bill Process

2.2.4 CDC – Centers for Disease Control and Prevention

2.2.5 CE – Claims Examiner

2.2.6 CPT® - Current Procedural Terminology

2.2.7 COPD – Chronic Obstructive Pulmonary Disease

2.2.8 CRL – Certificate Revocation Lists

2.2.9 CT – Computerized Tomography

2.2.10 DEA – Drug Enforcement Administration

2.2.11 DFEC – Division of Federal Employees’ Compensation

2.2.12 DLMS – Department of Labor Manual Series

2.2.13 DME - Durable Medical Equipment

2.2.14 DMEPOS - Durable Medical Equipment, Prosthetics, Orthotics, and Supplies

2.2.15 DOL - Department of Labor

2.2.16 DSCSA – Drug Supply Chain Security Act

2.2.17 DUR – Drug Utilization Review

2.2.18 EFT – Electronic Funds Transfer

2.2.19 EMG – Electromyography

2.2.20 EOB – Explanation of Benefits

2.2.21 FDA – Food and Drug Administration

2.2.22 FECA – Federal Employees’ Compensation Act

2.2.23 FICAM – Federal Identity, Credential, and Access Management

2.2.24 FIPS – Federal Information Processing Standards

2.2.25 FISMA – Federal Information Security Modernization Act

2.2.26 FWA – Fraud, Waste, and Abuse

2.2.27 GSA – General Services Administration

2.2.28 HCPCS - Healthcare Common Procedure Coding System

2.2.29 HHS – Department of Health and Human Services

2.2.30 HIPAA – Health Insurance Portability and Accountability Act

2.2.31 ICD – International Classification of Diseases

2.2.32 ID – Identification

2.2.33 LAN – Local Area Network

2.2.34 MAC – Maximum Allowable Cost

2.2.35 MME – Morphine Milligram Equivalent

2.2.36 MRI – Magnetic Resonance Imaging

2.2.37 MSO – Managed Service Offering (MSO)

2.2.38 NCPDP – National Council for Prescription Drug Programs

2.2.39 NDC – National Drug Code

2.2.40 NIST – National Institute of Standards and Technology

2.2.41 NPI – National Provider Identifier

2.2.42 OCSP – Online Certificate Status Protocol

2.2.43 OPM – Office of Personnel Management

2.2.44 OWCP – Office of Workers’ Compensation Programs

2.2.45 OMB – Office of Management and Budget

2.2.46 P&T – Pharmacy and Therapeutics

2.2.47 PBM – Pharmacy Benefits Management

2.2.48 Pharm.D. – Doctor of Pharmacy professional degree

2.2.49 PHI – Protected Health Information

2.2.50 PII – Personally Identifiable Information

2.2.51 PIV – Personal Identity Verification

2.2.52 PIVAuth – Personal Identity Verification Authentication

2.2.53 PKI – Public Key Infrastructure

2.2.54 PM – Project Manager

2.2.55 PWS – Performance Work Statement

2.2.56 RR – Review and Reporting

2.2.57 SSP – Shared Service Provider

2.2.58 UI – User Interface

2.2.59 UPN – User Principal Names

2.2.60 WAN – Wide Area Network

2.2.61 WC – Workers’ Compensation

2.2.62 WCMBP – Workers’ Compensation Medical Bill Process contract with vendor CNSI

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3.1 GENERAL: The Government shall provide the services and materials listed below.

Upon the expiration or termination of the contract, all Government-furnished property, equipment, data and information shall be returned promptly to DOL within fifteen days of the effective date of such expiration or termination, unless the contracting officer directs the contractor to do otherwise. In addition, at any time during the term of the contract, upon the contracting officer’s request, the contractor shall provide DOL-furnished data/information promptly to the contracting officer within five days of such request.

3.1.1 Services: The Government will provide necessary information and data on FECA cases and eligibility in order for the contractor to perform successfully. The Government will provide access to the DFEC Pharmacy Fee Schedule and OWCP Fee Schedule for DME and services, subject matter expertise and points of contact as needed.

The DFEC Pharmacy Fee Schedule and OWCP Fee Schedule can be accessed via the following web link:

https://www.dol.gov/owcp/regs/feeschedule/fee/feeSept3017/Effective_September_30_2017_Read_Me_First.htm

Additionally, upon award, the Government will provide a list of entities to which payments should not be made. The Contractor is responsible for ensuring that payments are not made to these entities. DOL will update this list monthly as new entities are identified. The Contractor is expected to update this system within 24 hours of being provided any updated information.

3.1.2 Utilities. In the event it is necessary for contract staff to work at a Federal site, all utilities in the facility will be available for the contractor’s use in performance of duties outlined in this PWS. The contractor shall instruct employees in utilities conservation practices. The contractor shall be responsible for operating under conditions that preclude the waste of utilities.

https://www.dol.gov/owcp/regs/feeschedule/fee/feeSept3017/Effective_September_30_2017_Read_Me_First.htm

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 General: Except for those items specifically stated to be government-furnished in Part 3, the contractor shall furnish everything required to perform this PWS.

4.2 Data Rights. The Government’s and the contractor’s rights in deliverables identified in Exhibit 2 shall governed by FAR 52.227-14, Rights in Data – General, incorporated by reference in section I of this RFP.

For the contractor’s services described in Part 5 that are not deliverables, including but not limited to the “Pharmacy Networks” and the “Web Portal”, authorized users of the services reserve the rights to access and use the services during the term of the contract as necessary to carry out the purpose of the contract. In addition, where the performance of such services will require that DOL be subject to a vendor’s commercial software license or related agreement, the contractor represents that each such commercial license / agreement satisfies DOL’s requirements under this FRP and otherwise is consistent with federal law.

PART 5

SPECIFIC TASKS

5.1 BASIC SERVICES. The contractor shall provide services to include, at minimum, the following. All references to “days” shall be read as “calendar days”. The contractor shall be capable of providing services in a way that allocates individual service cost to the individual claimant case.

5.1.1 PERSONNEL

5.1.1.1 The contractor shall provide healthcare professionals licensed or registered by the applicable state agency and certified by the applicable professional organization to perform formulary management services.

5.1.2 PHASE 1 – services shall begin no later than 60 days after award. To address the opioid epidemic public health emergency, this functionality will be required within 30 days of award for approximately 3,000 individuals receiving 90 MED or higher of prescribed opioids. OWCP will identify these individuals in its full eligibility file for all beneficiaries, provided to the PBM within 5 days of award.

5.1.2.1 PHASE 1 PHARMACY BENEFITS MANAGEMENT

5.1.2.1.1 Pharmacy Networks. The contractor is responsible for providing and maintaining a pharmaceutical network that is accessible for all FECA claimants both within the Continental United States (CONUS) and its permanently inhabited territories, and outside the Continental United States (OCONUS), to ensure FECA program claimants are able to obtain prescribed medications quickly and conveniently, within timeframes that are consistent with industry best practices.

5.1.2.1.1.1 The contractor shall maintain a listing of the retail and mail order pharmacies in its network. The listing shall include the total number of pharmacy locations by state and territory.

5.1.2.1.1.2 The contractor shall make all efforts to ensure network provider availability such that claimant travel distance is minimized. It is anticipated that claimant traveling more than 50 miles to visit a network provider will be limited and for situations such as less populated areas.

5.1.2.1.1.3 The contractor shall have the capability to allow claimants to refill program-authorized prescriptions in person, by telephone, or via the internet, where allowed by law.

5.1.2.1.1.4 The contractor shall provide a system for first fill prescription coverage for employees who sustain a traumatic injury at work.

5.1.2.1.2 E-Prescribing. The contractor shall offer e-Prescribing, which allows prescribers to send prescription orders electronically to network pharmacies, where allowed by law. The e-Prescribing system shall support the National Council for Prescription Drug Programs (NCPDP) e-Prescribing Standards 101, or its successor, providing prescribers with electronic access to their patients' prescription benefit coverage, eligibility coverage, formulary, and medication history. The contractor’s e-Prescribing capabilities must comply with HIPAA and the HIPAA Administrative Simplification Rules, and provide user-friendly electronic support for OWCP prescriber networks

5.1.2.1.3 Mail-Order. The contractor’s pharmacy network shall include a mail order pharmacy that allows claimants to refill prescriptions by mail, telephone (toll-free), or via the Internet 24 hours per day, seven…