PBM Industry Day - PDF 6.17.24.pdf

OWCP Pharmacy Benefit Management Industry Day

WELCOME

Today’s event is being hosted by the Office of the Senior Procurement Executive (OSPE), Office of Acquisition Services (OAS) and the Office of Workers’ Compensation Programs (OWCP).

Introductions:

• Government Representatives

• Contractor Representatives

Industry Day Objectives:

• Early industry engagement and promote competition

• Provide an overview of the requirement for OWCP, with an opportunity for Q&A

• Obtain market intelligence

Government Panel

▪ Office of the Senior Procurement Executive (OSPE)

▪ Broderick Morris, Deputy Director OAS

▪ Helen A. Williams, Branch Chief, Customer Acquisitions Services (CAS) Division 3

▪ Office of the Chief information Officer (OCIO)

▪ Kim Andersson, Cyber Security

Analyst

▪ Office of Workers' Compensation Programs (OWCP) Division of Administrative Services (DAO)

▪ Michelle Wood, Contracting

Officer Representative

▪ Bianka Franklin, Business Operations Manager

▪ Karyn J. Condie, Deputy Chief Medical Officer

▪ G. Elliott Cook, Chief Pharmacist

▪ Peter H. Vu, Clinical Pharmacist

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RULES OF ENGAGEMENT & OVERVIEW

• Mute your microphone when not speaking

• Nothing said here today is binding unless issued via a solicitation or amendment

• This session is being recorded for Government record and use ONLY

• This is not a capabilities briefing

Presentation Instructions:

During the session:

• No recording or pictures are to be taken during this session

• All questions should be emailed to the Contracting Officer, Helen A. Williams @ Williams.helen.a@dol.gov no later than June 25, 2024. Responses to the questions will be posted to SAM.gov as an amendment to the RFI

Next Steps:

• No tentative solicitation issuance date

• Contract type to be determined

• Monitor SAM.gov

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Agenda

▪ Overview of U.S. Office of Workers' Compensation Programs

▪ Pharmacy Utilization and Spend

▪ PBM Performance Work Statement (PWS)

▪ Drug Pricing Structure

▪ DME and Diagnostic Pricing Structure

▪ PBM Incentives

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DOL 2022-02 Advancing Equity in the Pool of Medical and Pharmaceutical Service Supporting Office of Workers’ Compensation Programs (OWCP)

▪ In accordance with the statutes and regulations governing OWCP, including 5 U.S.C. Section 8103, implementing regulations at 20 C.F.R. Sections 10.300 et seq., as well as Executive Order (E.O.) 13985 and E.O. 14091, which orders federal agency heads to advance equity for all by recognizing and working to redress inequities in policies and programs that serve as barriers to equal opportunity, the contractor shall to the greatest extent practicable provide a diverse pool of medical service providers and shall adopt policies and practices for the engagement of medical service providers (whether through hiring as employees, by subcontracting, or otherwise) that promote fair, just, and impartial treatment of all individuals.

U.S. Office of Workers’ Compensation Programs

▪ An agency of the U.S. Department of Labor

▪ Provides wage replacement, cash benefits, medical treatment, vocational rehabilitation, and other benefits to mitigate the financial burden on covered workers, their dependents, or survivors resulting from work-related illness, injury, disease, or death.

▪ Major Programs

▪ Black Lung Benefits Act (BLBA)

▪ Energy Employees Occupational Illness Compensation Program Act

(EEOICPA)

▪ Federal Employees' Compensation Act (FECA)

▪ Longshore and Harbor Workers’ Compensation Act (LHWCA)

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Black Lung Benefits Act Program

▪ $183.6M in compensation and benefits in 2022

▪ Provides the following benefits

▪ Lifetime disability compensation

▪ Medical treatment benefits

▪ Compensation to eligible survivors

▪ Benefits paid from general revenues, by mine operators, or the Black Lung Disability Trust Fund

▪ Benefits offset by state benefits

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Black Lung Benefits Act Program

▪ BLBA enacted in 1972; amended several times

▪ Covers persons totally disabled due to pneumoconiosis arising out of coal mine employment, and provides compensation to eligible survivors

▪ 28,628 beneficiaries and their families in 2022

▪ Incidence/prevalence of pneumoconiosis rising

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Energy Employees Occupational Illness Compensation Act Program

▪ EEOICPA enacted in 2000; amended in 2004

▪ Covers current or former employees (or eligible survivors) diagnosed with a radiogenic cancer, chronic beryllium disease, beryllium sensitivity, or chronic silicosis from exposure to radiation, beryllium, or silica while employed at nuclear weapons facilities and uranium miners, millers, and ore transporters for occupational illnesses that are linked to toxic exposures at covered facilities.

▪ 18,585 beneficiaries

Energy Employees Occupational Illness Compensation Act Program

▪ $1.8B in total compensation and benefit payments in 2022

▪ Provides the following benefits

▪ One lump-sum payment

▪ Medical treatment benefits

▪ Wage loss benefits

▪ Impairment compensation

▪ Compensation to eligible survivors

▪ Benefits paid from the Energy Compensation Fund

Federal Employees Compensation Act Program

▪ FECA enacted in 1916; most recent substantive amendments in 1974

▪ Covers 2.6M federal employees, and

▪ Peace Corps and AmeriCorps Volunteers in Service to America volunteers

▪ Federal petit and grand jurors

▪ Civil Air Patrol volunteers

▪ Reserve Officer Training Corps cadets

▪ Job Corps, and Youth Conservation Corps enrollees

▪ Non-federal law enforcement officers when injured under certain circumstances involving crimes against the United States

▪ 178,583 beneficiaries in 2022

Federal Employees Compensation Act Program

▪ $2.9B in total compensation and benefit payments in 2022

▪ Provides the following benefits

▪ Continuation of full pay for ≤ 45 days

▪ Wage-replacement payments at 66⅔% of the employee’s salary or 75% if there is a dependent

▪ Payments for reasonable and necessary medical treatment related to the injury

▪ Vocational rehabilitation training and job-placement assistance to help disabled workers

▪ Compensation for permanent impairment of limbs and other parts of the body

▪ Compensation for survivors of employees due to a work-related death

▪ Benefits paid from

▪ Employees’ Compensation Fund; reimbursed by agencies for benefits paid for their employees

▪ Direct appropriation for Job Corps enrollees, certain federally supported volunteers, and others

Longshore and Harbor Workers’ Compensation Act Program

▪ LHWCA enacted in 1927; benefits extended to other groups in 1941, 1952, 1953, and

▪ Covers maritime employees working over the navigable waters of the United States who are excluded from state workers’ compensation, and

▪ Private employees on U.S. military bases overseas, land used for military purposes in U.S.

territories and possessions, and U.S. Government contracts overseas

▪ Civilian employees in military exchanges, service clubs, and other non-appropriated fund activities

▪ Employees of firms working on the outer continental shelf of the United States engaged in the exploration for and development of natural resources

▪ Claims filed under the District of Columbia Workmen’s Compensation Act (DCCA) filed before

July 26, 1982

▪ 2600 recurring benefit recipients in 2022

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Longshore and Harbor Workers’ Compensation Act Program

▪ $9.2M in benefits to remaining DCCA beneficiaries in 2022

▪ Provides oversight for

▪ Private administration of claims by 545 insurance carriers and self-insured employers that provide workers’ compensation protection

▪ $3.7B held in security deposits

▪ Two carrier/employer-funded funds

▪ Collection of $96M in annual assessments in 2022

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Pharmacy, DME, and Diagnostic/Testing Utilization and Spend

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CY2023 FECA DEEOIC DCMWC LHWCA Total Total Number of Claimants* 37,149 11,133 2,723 22 51,027 Total Number of Prescriptions 485,299 306,295 48,019 602 840,215

% Brand Prescriptions 6.81% 18.28% 29% 12.8% 12.26% % Generic Prescriptions 93.19% 81.72% 71% 87.2% 87.74%

Total Pharmacy Spend $51,802,205.53 $124,640,996.27 $12,456,971.26 $115,702.13 $189,015,875.19 % Brand Spend 50.52% 72.24% 72.85% 48.4% 66.31% % Generic Spend 49.48% 27.76% 27.15% 51.6% 33.69%

*Receiving at least one prescription

CY2023 FECA DEEOIC DCMWC LHWCA Total DME: Claimants* 8,677 8,419 158 N/A 17,254 DME: Number of Transactions 15,852 34,325 991 N/A 51,168 DME: Spend $10,181,142 $19,646,233 $248,598 N/A $30,075,973 Diagnostic and Testing Services:

Claimants* 52,815 5,784 1,028 N/A 59,627 Diagnostic and Testing Services:

Number of Transactions 120,428 14,376 2,407 N/A 137,211

Diagnostic and Testing Services: Spend $41,180,064 $8,541,512 $282,918 N/A $50,004,495 *Receiving at least one transaction

PBM Performance Work Statement (PWS)

▪ Pharmacy benefit management (PBM) services for all four OWCP programs.

▪ One base period of 12-months with four 12-month option periods

▪ Full implementation: No later than 1 year after award

▪ The contractor must continue to make system and clinical improvements to keep pace with industry standards and OWCP policies at no additional cost to the government.

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Maximum Allowable Dates for Key Implementation Activities (counting from contract start date) no more than 150 days no more than 265 days no more than 365 days

Begin processing DEEOIC and DCMWC claims as third-party provider through OWCP’s current pharmacy system

Begin GAT for DEEOIC, DCMWC and DFELHWC (assumes implementation on day 365)

Fully implement all PBM Services for DEEOIC, DCMWC and

DFELHWC

Key Personnel

▪ The following personnel are considered key personnel by the government:

▪ Program Manager

▪ Alternate Program Manager

▪ Lead Clinical Pharmacist (PharmD)

▪ Alternate Clinical Pharmacist (PharmD)

▪ Medical Director

▪ Lead Fraud, Waste, and Abuse Expert

▪ Technical Manager

▪ Lead Data Analyst

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1.6.8 Security Requirements

▪ 1.6.8.3 This is a non-Federal system so the standard you are expected to conform to is NIST Special Publication (SP) 800-171, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations and the DOL Cybersecurity Policy Portfolio (CPP)

▪ Prior to the deployment of the web portal, the contractor must provide:

▪ System Security Plan (SSP),

▪ Contingency/Disaster Recovery Plan, and

▪ Incident Response Plan

▪ 1.6.8.2 Memorandum of Understanding (MOU) and Interconnection Security Agreement (MOU/ISA) – OWCP will provide templates for these documents as soon as a contract is awarded.

▪ Transfer of Data Protocols

▪ 1.6.8.5 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 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).

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

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1.6.8.3 Privacy

▪ 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.

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

▪ 1.6.8.4.1.1 The contractor must use a government-approved incident reporting form to notify the Government (via zzowcpsecurity@dol.gov) of all security incidents, disclosures, breaches, disasters involving PII within one (1) hour of becoming aware of the incident, whether suspected or confirmed.

▪ The contractor must have a process in the event of a breach or disclosure that also 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 to the Government in their proposal.

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

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5.2 Pharmacy Benefits Management (Task One)

▪ 5.2.1 Pharmacy Networks

▪ The contractor is responsible for providing and maintaining a pharmaceutical network that is easily accessible to all DEEOIC, DFELHWC, and DCMWC claimants in the United States, Native American Tribal Lands and Reservations, and permanently inhabited territories of the United States as specified in 4.6 of this PWS.

▪ Chain pharmacies

▪ Independent pharmacies

▪ Mail order pharmacies

▪ Specialty pharmacies

▪ 5.2.12 Provider Enrollment Data

▪ The ID, Federal Employer Identification Number (FEIN), location, or other criteria to be specified by contractor must implement and maintain a provider enrollment system and database accessible to the OWCP, which contains current information on each enrolled pharmacy location and DME vendor location, and allows validation of qualifications, ownership and banking information, and contact information (physical address, mailing address, and telephone number). This database must allow the OWCP to search by pharmacy name, NCPDP the Government.

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5.2 Pharmacy Benefits Management (Task One)

▪ 5.2.11.1 If the contractor’s systems utilize switch vendors to communicate electronically with pharmacies, and if the switch vendor fails to transmit electronic transactions, the contractor must implement a new solution within 24 hours to regain electronic transmission. This could be the use of another switch vendor or a different strategy.

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5.3 Customer Support (Task two)

▪ 5.3.1 Welcome Packet

▪ 5.3.1.2 The welcome packet must include an MBIC that is specific to the claimant.

▪ 5.3.1.3 Benefit cards generated for the Black Lung, Energy, Longshore, and FECA programs must bear the appropriate BIN, processor control number (PCN), and group.

▪ 5.3.1.4 The contractor is responsible for all costs associated with the development, printing, and distribution of MBIC and marketing materials that it provides in connection with the PWS.

▪ 5.3.2 The contractor must develop connections with the ECOMP via an application programming interface (API) to facilitate system integration that will support, among other tasks, electronic benefit card distribution and claimant, advocate, and federal agency access to pharmacy data pertaining to specific cases.

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5.3 Customer Support (Task two)

▪ 5.3.3 The contractor must provide a call center with hardware, software, dedicated telephone lines and other infrastructure to support this PWS. The call center must be staffed by trained personnel dedicated solely to supporting the compensation programs served by this PWS.

▪ Provide the Government with real-time, remote call monitoring capabilities.

▪ 5.3.6 The contractor must be available to meet with the Government in accordance with TECHNICAL EXHIBIT 1 for an unscheduled meeting from the Government, with no more than two exceptions per month.

▪ 5.3.7 The contractor must provide an agenda to the Government for each meeting with the Government at least one business day before the meeting is scheduled and must ensure the presence of the contractor’s SME at each meeting.

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5.4 Assisting with Business Rules (Task three)

▪ 5.4.1 The contractor must stay abreast of advancements in the healthcare industry and changes in industry standards. The contractor must continually strive to improve the quality and efficiency of the services it provides in connection with this PWS and assist the Government in improving benefit delivery by providing expert advice regarding trends in pharmacy benefit management, DME supply, and the provision of diagnostic services. The contractor must make system changes necessary to operationalize changes in statutes, regulations, policies and industry standards.

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5.5 Processing Claims for Payment (Task four)

▪ 5.5.1 The contractor’s system must identify transactions by claimant name and case number—not date of injury. BLACK LUNG and ENERGY claimants do not have a date of injury; some FECA claimants have more than one active case and financial responsibility for each of the cases may rest with a different government agency.

▪ 5.5.2 The contractor’s claims processing system must conform to NCPDP standards.

▪ 5.5.3 Each transaction—including paid, reversed, resubmitted, and denied transactions--must generate a unique transaction record with a unique transaction ID number.

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▪ 5.5.9 The contractor must have a fully functional mailroom for all OWCP programs to receive and process claimant paper claims and other documents related to prior authorizations and claimant eligibility. The mailroom must have scanning and imaging capabilities, including an image repository.

▪ 5.5.10 Claims for reimbursement received from claimants on Form OWCP-915 must be converted into electronic format to detail necessary claim elements. After conversion into electronic format, claimant claims must undergo all edits and meet formulary requirements before payment.

▪ 5.5.12 The contractor must develop procedures for processing so-called “split claims” where a claimant submits both medical and pharmacy bills on a single Form OWCP-915 to the contractor’s mailroom. The contractor must adjudicate the pharmacy bill and coordinate with the OWCP designated medical bill processer for adjudication of the medical bill.

▪ 5.5.13 The contractor must develop procedures for coordinating with the OWCP medical bill processing contractor to adjudicate the pharmacy bill on so-called “split claims” where a claimant submits both medical and pharmacy bills on a single Form OWCP-915 to the OWCP medical bill processing contractor’s mailroom and the OWCP medical bill processing contractor has adjudicated the medical bill.

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▪ 5.5.15 The contractor must load all historical pharmacy transaction data provided by the OWCP in its adjudication system and use this data when processing both POS transactions and claimant paper claims received in the contractor’s mailroom.

▪ 5.5.16 The contractor must not alter or delete claimant data—including, but not limited to claimant data in the Bill History File, Eligibility File, and Pharmacy Data File.

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▪ 5.5.22 Eligibility. The Eligibility File for each compensation program will be provided by the OWCP after contract award. The contractor must upload the Eligibility File for each compensation program into its system prior to processing transactions. The contractor must establish data interfaces with the compensation program case management systems to facilitate daily updates of eligibility data after the initial load of the Eligibility Files.

▪ 5.5.17 The contractor must accept and apply updated Eligibility Files from the OWCP in accordance with TECHNICAL EXHIBIT 1 to ensure that eligibility and coverage determinations are accurate.

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▪ 5.5.25 The contractor must obtain all claimant authorizations for covered services from the prior contractor prior to full implementation of the contract and ensure that the authorizations are uploaded into the contractor’s system and used for processing of pharmacy transactions.

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5.6 Fee Schedule (Task five)

▪ 5.6.1 Classification of Drugs as Generic or Brand Name

▪ The contractor must develop and implement a system for the classification of drugs as “name brand” or “generic” based on the definitions and Drug Classification Table below. The system procedures must use Medi-Span multi-source code, brand name code, and the FDA application, at a minimum. The classification system will apply to all drugs provided to OWCP claimants— including specialty drugs.

▪ The Government may audit transactions at any time to determine whether the correct brand name/generic classification was made.

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5.7 Fraud, Waste, and Abuse Monitoring (Task six)

▪ 5.7.1 The contractor must provide the following capabilities to identify and report activity that may indicate fraud, waste, and abuse (FWA):

• State-of-the-art tools and industry best practices to detect potential FWA in the prescribing, dispensing, and utilization of medical support services;

• Scheduled and ad hoc reviews to ensure payments have been made in accordance with law, regulation, and procedure;

• Tools to track potential FWA cases from identification to reporting to resolution;

• Quarterly reports of the status of all open cases of possible and actual FWA;

• Supporting data when requested by OIG as needed to support OIG investigations; and

• Supporting data when requested by OWCP and OIG as needed to support prosecution of fraud.

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5.8 Reporting and Data (Task seven)

▪ 5.8.2 The contractor must provide an internet-based reporting tool…

▪ 5.8.3 The contractor must provide reports, on a schedule and in a format to be developed by the contractor and agreed to by the OWCP

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5.9 Information Management (Task eight)

▪ 5.9.2 The contractor must work with the OWCP to create an automated process to insert any images, including, but not limited to letters to prescribers and/or claimants into claimant case files in a compensation program-specified format using compensation program-approved indexing rules.

▪ 5.9.5 All claims' data transmitted from the OWCP to the contractor remains the property of the Government and is subject to the relevant DCMWC, DEEOIC, and DFELHWC records retention schedules.

▪ 5.9.6 The contractor must provide the OWCP with an electronic copy, in an agreed upon format, of any written correspondence pertaining to any individual case. Each copy must include the OWCP case number of the case to which the correspondence pertains.

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5.10 Claimant, Prescriber, and Staff Portals (Task nine)

▪ The claimant, prescriber, and staff portals must provide a custom interface allowing access to their pharmacy transaction history, and the status of prior authorization requests together with related documentation. The interface must be customized to OWCP specifications to display labels and data and must have search and export functionality.

▪ The portal must provide OWCP with the ability to query and check claimant specific drug coverage.

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5.11 Formulary Management (Task Ten)

▪ 5.11.1 Pharmacy and Therapeutics Committee. The contractor must provide a pharmacy and therapeutics (P&T) committee to develop and maintain a formulary and provide clinical recommendations and pharmacoeconomic analysis for each compensation program.

▪ 5.11.2 Drug Formulary System

▪ 5.11.2.1 All Programs

▪ …The formularies, changes to the formularies, and formulary edits must be approved by the

OWCP. The contractor must make the formularies available on its prescriber and staff portals and conveniently searchable by prescribers and staff.

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▪ 5.11.2.2 BLACK LUNG Program.

▪ All BLACK LUNG claimants have pneumoconiosis, but the BLACK LUNG program covers other conditions, which are not in its eligibility files. Thus, the BLACK LUNG program is better served through a covered and pended drug list. All pended drugs should be pended at the POS and reviewed by one of the contractor’s pharmacists. Clinical indicators, to include, but not limited to surgery and transplant recipients may drive formulary coverage. Formularies must be developed to accommodate claimants with these clinical indicators.

▪ 5.11.2.3 ENERGY Program.

▪ Most ENERGY claimants are elderly and suffer from cancer or chronic conditions associated with occupational exposure. The contractor’s system must be able to assess multiple accepted conditions for a single case and adjudicate prescriptions appropriately. The contractor’s system must link the claimant’s accepted conditions to appropriate formularies (e.g., cardiac conditions, pulmonary conditions, renal conditions) for coverage. Clinical indicators, to include, but not limited to surgery and transplant recipient may drive formulary coverage. Formularies must be developed to accommodate claimants with these clinical indicators. For all formularies, the contractor should anticipate that the Government will set some GPI to reject 75 for safety and efficacy reasons, which will require one of the contractor’s pharmacists to review the prescription before it can be processed.

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▪ 5.11.2.4 FECA Program.

▪ FECA claimants suffer from traumatic injuries, behavior health conditions and other occupational diseases; many have multiple accepted conditions; some have more than one active case--and the cases may have different status codes (e.g., Administrative Authorization of Limited Benefits, CA-15 and CA-16). The contractor’s system must be able to assess multiple accepted conditions across multiple cases and adjudicate prescriptions appropriately. The contractor’s system must link the claimant’s accepted conditions and statuses to appropriate formularies (e.g., behavioral health, infectious diseases, musculoskeletal) for coverage. Formularies must consider acute and chronic drug coverage based on the number of days since a claimant sustained their injury. Clinical indicators, to include, but not limited to surgery and transplant recipient may drive formulary coverage. Formularies must be developed to accommodate claimants with these clinical indicators. Finally, a first fill formulary must be created to improve access to medications. The contractor must not bill the OWCP for prescriptions filled under the first fill formulary unless the case has been accepted. For all formularies, the contractor should anticipate that the Government will set some GPI to reject 75 for safety and efficacy reasons, which will require one of the contractor’s pharmacists to review the prescription before it can be processed.

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▪ 5.11.2.5 Longshore Program.

▪ Most LS claimants suffer from traumatic injuries and/or behavioral health conditions. Claimants usually have only 1 case being directly from the LS Special Fund. The contractor’s system must be able to assess multiple accepted conditions and adjudicate prescriptions appropriately. The contractor’s system must link the claimant’s accepted conditions and statuses to appropriate formularies (e.g., behavioral health, infectious diseases, musculoskeletal) for coverage. Formularies must consider acute and chronic drug coverage based on the number of days since a claimant sustained their injury. Clinical indicators, to include, but not limited to surgery and transplant recipient may drive formulary coverage. Formularies must be developed to accommodate claimants with these clinical indicators. For all formularies, the contractor should anticipate that the Government will set some GPI to reject 75 for safety and efficacy reasons, which will require one of the contractor’s pharmacists to review the prescription before it can be processed.

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5.12 PBM Drug Utilization Review (Task Eleven)

▪ 5.12.1 Prospective Drug Utilization Review (DUR). The contractor must adjudicate claims using real-time, POS edits consistent with industry best practices, and compensation program formularies and policies.

▪ 5.12.10 The contractor must have the ability to apply morphine equivalent dose (MED) edits on a per transaction basis and on a cumulative MED basis.

▪ 5.12.11 The contractor must have the ability to adjust and lock a claimant’s cumulative MED and not allow processing over certain MED thresholds that are claimant-specific. Opioid transactions exceeding a claimant's cumulative MED threshold must be pended at the POS and reviewed by one of the contractor’s pharmacists.

▪ 5.12.12 The contractor must collaborate with the OWCP to designate “hard” edits and “soft” edits and develop “message only” POS alerts during the development of the drug formulary system.

▪ 5.12.13 The contractor must collaborate with the OWCP to develop custom messaging for NCPDP reject codes that provides the dispensing pharmacist with additional, compensation program-specific guidance.

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5.12 PBM Drug Utilization Review (Task Eleven)

▪ 5.12.19 Concurrent and Retrospective DUR. The contractor must perform clinical review of ongoing drug therapy and historical claims.

▪ 5.12.17 The contractor’s clinical pharmacists must adjudicate held, rejected, non-formulary, PA-related, and LMN-related transactions in accordance with compensation program policy. Claimant medical records in compensation program record systems will be available for use by the contractor’s clinicians as needed. Transactions requiring an exception to policy must be approved in advance by the OWCP. All coverage decisions must be tracked and reported to the OWCP through the claimant, prescriber, and staff web portals.

▪ 5.12.20.2 90 MED Program

▪ The contractor must adjudicate all POS opioid prescriptions for FECA claimants that exceed the claimant’s cumulative MED lock.

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5.13 Durable Medical Equipment (DME) (Task Twelve)

▪ 5.13.4 DME suppliers must be accredited by the Centers for Medicare and Medicaid Services to furnish Durable Medical Equipment, Prosthetics, Orthotics, and Supplies

(DMEPOS).

▪ 5.13.2 The contractor must maintain a list of the DME suppliers in its network, to include the number of DME suppliers by state and territory and provide a search function within the claimant portal.

▪ 5.14.3.1 The contractor must bill for medical imaging and testing services using current, valid Current Procedural Terminology (CPT®) codes.

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5.14 Diagnostic Services and Testing (Task Thirteen)

5.15 Specialty Pharmacy Services (Task Fourteen)

▪ 5.15.1 The contractor must provide specialty pharmacy services for claimants with complex medical needs (e.g., biologics, biosimilars, and injectables). Specialty pharmacy services must include but are not limited to overnight delivery to the claimant’s home or prescriber’s office with no additional charge for shipping; proper handling, packaging, and instructions for drugs requiring refrigeration or special storage; the provision of appropriate ancillary supplies (e.g., syringes, alcohol swabs, and sharps containers); and culturally competent patient education materials. While the OWCP may approve a larger supply in specific cases, in most cases, prescription refills for specialty drugs will be limited to a 30-day supply.

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5.16 Testing (Task Fifteen)

▪ 5.16.1 The contractor must develop and submit for government approval a testing plan that addresses all aspects of the contractor’s testing program.

▪ 5.16.2 The contractor must develop and maintain a comprehensive Requirements Traceability Matrix (RTM) that accurately maps all programs requirements to test cases, ensuring full coverage and traceability of each requirement throughout the project lifecycle.

▪ 5.16.6 The contractor must perform regression testing after post-testing corrections are made to ensure the corrections did not introduce new errors.

▪ 5.16.10 The contractor must update specification documents, Standard Operating Procedures (SOP), and RTM based on test results and corrections. Testing may reveal that critical items were missed, or that User Interface (UI) changes are needed to enable adequate and accurate review capability for government staff. The results from GAT/User Acceptance Testing (UAT) may require development and additional testing. This iterative process is one of the primary reasons for user acceptance testing, and the resulting system updates must not be considered new requirements.

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5.17 System Audits (Task Sixteen)

▪ 5.17.1 The contractor must cooperate with scheduled and ad hoc audits performed by DOL and its independent auditors, including, but not limited to IT security, financial, and Federal Information System Controls Audit Manual (FISCAM) audits.

▪ The contractor must obtain the services of an independent auditor on an annual basis, effective at commencement of operations, to perform an audit for the period specified by the DOL on the general controls and application controls surrounding the services provided under this PWS. A System and Organization Controls (SOC) 1, Type 2 audit is normally required.

▪ The contractor must implement corrective actions to resolve weaknesses identified during audits. The government will require tracking of any weaknesses and evidence to demonstrate they have been resolved.

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Drug Pricing Structure

▪ The contractor must provide all the services included in this PWS with the only cost to the Government being a single “Net Proposed Price/Discount/Rebate” (CLINS 0001-4001) applied per transaction. The contractor must pay the rendering provider directly and invoice the OWCP in accordance with OWCP bill processing procedures. The contractor must consider all PWS requirements and the cost of obtaining necessary support services when determining the total discounts and rebates it will provide to the Government. The contractor must use the current AWP unit price in the Wolters Kluwer Medi-Span database on the date of service as the benchmark for determining the price for the drug dispensed.

▪ Rebates must be expressed in dollars per transaction and be applied at point of sale for specialty and non-specialty brand name drugs.

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DME and Diagnostic Pricing Structure

▪ DME and Diagnostic Pricing will be based on OWCP’s Medical Fee Schedule

▪ OWCP Fee Schedule - XX%

▪ View OWCP Fee schedule Effective May 31, 2024 | U.S. Department of Labor (dol.gov)

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Discount CLINs Category Pricing Formula Brand Name Retail AWP – XX% Generic Name Retail* AWP – XX% Brand Name (Mail Order or 84 or more day supply) AWP – XX% Generic Name (Mail Order or 84 or more day supply) AWP – XX% Compounded Drugs AWP – XX% Specialty Drugs (Brand Name Retail) AWP – XX% Specialty Drugs (Generic Name Retail) AWP – XX% Specialty Drugs (Brand Name Mail Order or 84 or more day supply)

AWP – XX%

Specialty Drugs (Generic Name Mail Order or 84 or more day supply)

AWP – XX%

Supplies Dispensed from a Pharmacy AWP – XX% Durable Medical Equipment (DME) OWCP Fee Schedule – XX% Diagnostic Services and Testing OWCP Fee Schedule – XX%

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*A PBM incentive allowance may be granted if the PBM achieves contracted performance incentives

Rebate CLINs Category Rebate Brand Name Retail $XX Brand Name (mail order or 84 or more day supply) $XX Specialty Drugs (Brand Name Retail) $XX Specialty Drugs (Brand Name Mail order or 84 or more day supply)

$XX

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PBM Incentives

▪ Option Year 2 – 4

▪ OWCP will increase the PBM’s revenue during the last nine months of the option year if the PBM achieves one or more of the performance measures for the FECA, Energy, or Black Lung programs.

▪ The increase will be above the net proposed price/discount for generic drugs from retail pharmacies for the respective OWCP program.

▪ Example:

▪ If the PBM were to achieve all the performance measures for FECA they would increase their net proposed price/discount for generic drug spend from retail pharmacies by 3.25% in the FECA program.

▪ Bonus Option Year Award

▪ The Contractor will be evaluated on their effectiveness and efficiency to achieve for all four

OWCP programs within 365 days of contract start. If successful, the Contractor will be eligible to earn no more than one (12-month) Award Term period. The Award Term Rates will be priced and evaluated as part of the source selection process.

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In Conclusion…

NEXT STEPS

▪ Interested parties should submit all additional questions in writing via email to Helen Williams @ Williams.helen.a@dol.gov No later than June 25, 2024.

Responses to the questions will be posted to SAM.gov as an amendment to the

RFI

▪ All questions and feedback will be considered as we prepare the final RFP

▪ Presentations and questions and answers will be made available to all potential offerors via an amendment to the RFI Notice as soon as possible

▪ We appreciate your time and interest in our requirement. This concludes today’s Industry Day Event

6/17/202451 mailto:Williams.helen.a@dol.gov mailto:illiams.helen.a@dol.gov