RFI_ADAP PBM.pdf

SAP

State of South Carolina

REQUEST FOR INFORMATION

Solicita�on:

Date Issued:

Procurement Officer:

E-Mail Address:

5400026371

14-DEC-2023

REBECCA NICHOLS

NICHOLRJ@dhec.sc.gov

DESCRIPTION: RFI – ADAP Pharmacy Benefit Management Services

USING GOVERNMENTAL UNIT: SOUTH CAROLINA DEPT OF HEALTH & ENVIRON CONTROL

SUBMIT ALL CORRESPONDENCE BY EMAILTO:

nicholrj@dhec.sc.gov with RFI: ADAP PBM Services in subject line.

SUBMIT RESPONSE BY 5:00 PM ET – January 19, 2024

QUESTIONS MUST BE RECEIVED BY: Midnight – December 29, 2023

PURPOSE:

This Request for Information (RFI) is being used to gather market research, to include the potential cost(s) to the South Carolina Department of Health and Environmental Control (DHEC). This is not a solicitation for purchase. Following this RFI, and using information obtained through this process, DHEC plans conduct a future solicitation.

South Carolina Department of Health and Environmental Control (DHEC) is seeking a pharmaceutical care service provider, experienced as a South Carolina AIDS Drug Assistance Program (SC ADAP) provider, to provide all services associated with the operation and management of directly performing pharmaceutical order / dispensing / shipping functions and providing a cost-effective pharmacy services benefit for all eligible SC ADAP clients in the State of South Carolina, to include a full array of ac�vity / data / accountability reports for SC ADAP staff, over an approximate 7-year contract period. The Offeror must not require a minimum or maximum threshold as the number of SC ADAP clients to be served.

INTRODUCTION:

The Ryan White HIV/AIDS Treatment Extension Act of 2009 provides for medical and support services to individuals and families affected by HIV/AIDS. Several sec�ons known as “Parts” comprise the Ryan White legisla�on and it is through these �tles that federal Ryan White funds are dispersed. The major Parts of the legisla�on are Part A, Part B, Part C, Part D, Part F, Minority AIDS Ini�a�ve, and Special Projects of Na�onal Significance. In South Carolina (SC), as with all other states, Part B provides base funding for the SC AIDS Drug Assistance Program (SC ADAP). Authorized under Part B of the Federal Ryan White legisla�on, ADAPs are administered by each state and territory that receives federal Ryan White Part B ADAP funds. In South Carolina, the ADAP is administered by the South Carolina Department of Health and Environmental Control (DHEC) which serves as the State’s public health agency. Therefore, the acronyms ADAP, SC ADAP and DHEC are used interchangeably throughout this document since services that a Contractor must perform for SC ADAP (as a DHEC-administered program) are also considered as services that must be performed for DHEC. The individuals eligible for SC ADAP services are o�en referred to as “enrollees” or “clients.”

The SC ADAP provides access to HIV/AIDS treatments to low-income, uninsured, or underinsured People Living with HIV/AIDS (PLWHA) through three service �ers:

a. The Direct Dispensing Program (DDP) which serves individuals with no or inadequate insurance;

b. The Insurance Assistance Program (IAP) which provides support for premiums, deduc�bles, and copays for individuals with private insurance, and mailto:nicholrj@dhec.sc.gov

c. The Medicare Part D Assistance Program (MAP) which provides assistance with Medicare Part D Prescrip�on Drug Plan (PDP) premiums, co-payments, co-insurance and deduc�bles. SC ADAP does not serve clients who are eligible for Medicare Part D with Full Low-Income Subsidy (FLIS).

In South Carolina, applica�ons for ADAP are available through local health departments, Ryan White HIV Service Providers, HIV Care physicians’ offices, and the South Carolina Department of Health and Environmental Control (DHEC).

SC ADAP has approximately 1,800 clients in the uninsured program (DDP). This equates to a potential 3,600 fills per month. However, the State does not guarantee this amount.

SC ADAP’s goals for a contract are as follows:

• Facilitate access to medications by providing pharmacy benefits managements including claims adjudication, coordination of benefits and point of sale processing to eligible SC ADAP enrollees through the DDP service tier.

• Establish, maintain and/or expand a limited network of pharmacies which provide mail order and walk-in services to all SC ADAP DDP eligible enrollees. Pharmacies must be able to dispense medications included on the SC ADAP Formulary and serve the various geographical areas within South Carolina. When a drug manufacturer implements a limited pharmacy network for a certain medication, the PBM must work to ensure at least one pharmacy from that network will be added to the DDP network to dispense those medications to ADAP enrollees.

• Provide and manage a data system to collect client level data on each payment provided by the Contractor on behalf of an SC ADAP enrollee. This information shall be provided to ADAP on a monthly basis in a loadable format (i.e. MS Excel, CSV, Tab Delimited etc.) for the DDP service tier.

Ensure that DHEC does not pay for a medication that is not approved by the SC ADAP and is not on the SC ADAP formulary.

REQUIREMENTS:

The Ryan White legislation allows states significant flexibility in the design of the AIDS Drug Assistance Program (ADAP). The Contractor shall function as the Pharmacy Benefit Manager (PBM) and provide all services associated with the operation and management of directly performing pharmaceutical ordering / dispensing / shipping functions and providing a cost-effective pharmacy services benefit for all eligible SC ADAP clients in the State of South Carolina, to include a full array of activity / data / accountability reports for SC ADAP staff.

The Offeror must not require a minimum or maximum threshold as the number of SC ADAP clients to be served.

3.1 The Contractor shall:

3.1.1. Provide medication dispensing services through a network of pharmacies within the requirements of the federal, state and SC ADAP on a 30-day fulfillment cycle unless prior approval for a 60-day supply.

3.1.2. Maintain a data system capable of implementing and monitoring medication clinical and payment prior authorizations as established by SC ADAP. Establish (if necessary) and maintain a limited network of pharmacies for the SC ADAP. Out-of-state pharmacies and mail order pharmacies are eligible for provider enrollment with South Carolina Medicaid’s pharmacy program, subject to SC Medicaid policies (https://www.scdhhs.gov/ProviderRequirements) and SC Board of Pharmacy requirements for such pharmacies. It is the PBM’s responsibility to obtain any information regarding South Carolina Medicaid from the South Carolina Department of Health and Human Services.

3.1.2.1. The network of pharmacies must be able to dispense geographically throughout the State of

South Carolina and have at least one mail order pharmacy option available for SC ADAP enrollees who reside in remote areas.

3.1.3. Not “up sell” any other products or services to ADAP enrollees that are not listed on the prescription.

3.1.4. Maintain complete records of prescription claims throughout the contract period.

3.1.4.1. At the end of the contract period, records shall either be transferred to DHEC or managed within SC ADAP/DHEC retention requirements.

3.1.4.2. All such records shall be the property of DHEC and must be returned upon demand.

3.1.5. All services and deliverables under the contract shall be provided in a manner consistent with acceptable industry standards, customs, and practices.

3.2. Related services shall be provided as listed below:

3.2.1. Secure Electronic Communications –All data transferred between DHEC and the Contractor shall be secure and client confidentiality must be maintained.

3.2.1.1. Any special software, including that maybe developed/modified by the Contractor, equipment, connectivity, and so forth, is the responsibility of the Contractor.

3.2.1.1.1. The Contractor may opt to utilize Secure File Transport Protocol (SFTP) service as provided by SC ADAP. However, secure email systems must be provided and maintained by the Contractor.

3.2.2. The Contractor is responsible to receive the SC ADAP DDP eligibility file on a daily basis since ADAP enrollment may end at any time in the month (i.e., client fails to recertify, is deceased, moves out of the state, etc.).

3.2.2.1. The Contractor is responsible to securely send, at least once monthly:

3.2.2.1.1. Monthly invoice containing Protected Health Information (PHI);

3.2.2.1.2. Monthly dispense log or shipments file containing PHI.

3.2.3. Coordination of Benefits - Verify participant eligibility, coordinate benefits, work with a network of pharmacies, adjudicate prescription claims.

3.2.4. Verification of Eligibility - Verify an individual’s eligibility for the ADAP on the date service is requested using the electronic eligibility file provided by the ADAP.

3.2.4.1. The Contractor must verify ADAP eligibility before coordinating with the participating pharmacy.

3.2.4.2. The Contractor must also verify the individual’s eligibility for Medicaid before coordinating payment.

3.2.4.3. The Contractor shall ensure that Medicaid and/or a third-party insurer, and not the ADAP, is billed as the primary payer.

3.2.4.4. To ensure timely and coordinated access to ARV, the daily eligibility file must be available to the Contractor’s front-line staff within one (1) business day to allow enrollees to establish profile and/or request medications immediately after ADAP enrollment is complete and verified.

3.2.4.5. Obtain prior authorization from SC ADAP to ship prescriptions to a delivery address located outside of South Carolina. Any shipments to non-South Carolina addresses are subject to prior approval by SC ADAP.

3.2.5 Reporting of DDP Scripts Filled and Inventory

3.2.5.1. The Contractor shall submit a detailed monthly invoice to DHEC, no later than thirty (30) days after the services have been rendered.

3.2.5.1.1. Submit a loadable invoice (i.e., MS Excel, CSV, etc.), via secure electronic mechanisms, as approved by SC DHEC.

3.2.5.2. The invoice must include, but is not limited to, the following details:

3.2.5.2.1. Patient details (first/last name, date of birth, SSN, ADAP patient identifier, address);

3.2.5.2.2. Drug dispensed (date of service, National Drug Code [NDC] number, quantity, dosage).

3.2.5.3. Contractor shall not fax or mail the invoice containing Protected Health Information.

3.2.5.3.1. A de-identified, summarized invoice may be sent to SC DHEC in addition to the detailed loaded invoice that is submitted electronically.

3.2.5.4. The Contractor may dispense medications that are not on the ADAP Formulary depending on the enrollee’s choice of pharmacy.

3.2.5.4.1. The ADAP shall not reimburse the Contractor for out-of-pocket costs associated with medications that are not on the SC ADAP Formulary under the scope of this contract agreement.

3.2.5.4.2. The Contractor must not withhold dispensing of ADAP Formulary medications to enrollees due to outstanding balances incurred by the ADAP enrollee for non- SC ADAP Formulary medications.

3.2.5.5. Provide a “virtual inventory” throughout the term of this contract. (Replenishment)

3.2.5.5.1. Order drugs from DHEC’s state procured pharmaceutical wholesaler, Cardinal

Health, to replenish the ADAP’s limited network of pharmacies.

3.2.5.5.2. Monitor and manage a direct purchase virtual inventory replenishment model for the network pharmacies to include inventory accountability, maintaining appropriate inventory control, and shall be subject to periodic DHEC evaluations or audits including self-reviews conducted by the PBM to ensure DHEC that on-going quality controls are in place and working successfully.

3.2.5.5.3. Provide the SC ADAP a monthly summary of SC ADAP’s virtual inventory summary that compares drugs ordered to replenish pharmacies to what was dispensed for that pharmacy. This summary shall include but is not limited to units by NDC number and be submitted in an electronic and loadable format, such as Microsoft® Excel or other SC ADAP approved format.

3.2.5.5.4. Maintain records and submit a monthly report on any dispensed prescriptions that were lost or mishandled during shipment, or reported by the client as lost or mishandled.

3.2.6 Network of Pharmacies

3.2.6.1 The Contractor may enter into a contract with a limited network of pharmacies that are ready and willing to become a 340B pharmacy for the SC ADAP DDP program.

3.2.6.2 The Contractor shall assist in locating, negotiating, and setting these pharmacies up as the SC

ADAP 340B contract pharmacies.

3.2.6.3 The network of pharmacies must be capable of serving all geographical areas throughout the

State of South Carolina and have at least one mail order pharmacy option available for the SC ADAP enrollees.

3.2.7 Help Desk - Maintain a help desk that shall provide technical assistance to pharmacies and the SC ADAP for billing and claims system issues.

3.2.7.1. At a minimum, the help desk staff must be readily available between the hours of 8 a.m. to

5 p.m. Eastern Time, Monday through Friday.

3.2.7.2. The Contractor shall provide a 24-hour toll-free telephone line with access to on-call customer service support for clinicians and hospitalization emergencies.

3.2.8 Data Collection and Reporting - Provide all data required to complete grantee reports as specified by the HIV/AIDS Bureau of the Health Resources and Services Administration (HRSA) or SC ADAP on a monthly and/or other recurring basis, as well as data required for special reports when/if needed.

3.2.8.1. Reports must be provided in a loadable format (i.e., MS Excel, CSV, tab delimited, etc.).

3.2.9 The Contractor must also provide to ADAP a monthly report within 15 days of the billing cycle that contains, but is not limited to, the following information:

3.2.9.1. Medications dispensed (inclusive of, but not limited to a prescription drug claim’s routine data element such as date of service, drug name, National Drug Code (NDC) number)

3.2.9.2 The transaction fee for the required communication.

3.2.9.3. The client level data including name, social security number, date of birth, and demographics.

3.2.9.4. Prescriber information, including clinician name, clinician address, clinician phone number, clinician NPI number.

3.2.9.5. Interpretable offsets for billing reconciliations.

3.2.10. Contractual Requirements and Performance Measures:

The Contractor shall conduct all tasks described in this contract, including (but not limited to):

3.2.10.1. Submit required program data within negotiated DHEC timeframes,

3.2.10.2. Convene (i.e., organize and conduct), at least quarterly, an SC ADAP/PBM Contractor conference call to discuss programmatic issues that occurred during the previous quarter.

3.2.10.2.1. The Contractor shall submit a written summary of each call to DHEC within two

(2) weeks of the call. DHEC may request an action plan from the Contractor regarding programmatic issues or deficiencies that were identified.

3.2.10.2.2. Such action plans are due to DHEC within two (2) weeks of the date they are requested.

3.2.10.2.3. Contractor must take actions directed by DHEC following the agency’s review of the plan submitted and must do so within the timeframes directed by DHEC.

3.2.10.3. Upon termination of Contract by either party, the Contractor must coordinate with SC ADAP to develop a transition plan to ensure the continuity of care for clients served under this Contract.

3.2.10.3.1. Transition planning includes but is not limited to 1) current industry ORT file formats to be provided to ADAP or its authorized agent within the required time period; 2) extended dispense(s)/supply of therapy upon transition (i.e., 60-day supply); 3) service history and profile data as needed for continued treatment; 4) claim reversals/charge back processing for services provided prior to contract end date.

3.3 Electronic Communication Requirements

3.3.1. Comply with all Health Insurance Portability and Accountability Act (HIPAA) privacy and electronic transaction rules and must be able to assure that electronic data can be transferred in both directions on a daily (business days) basis.

3.3.1.1. Determination of appropriate compliance shall be established and confirmed by ADAP. This task shall be completed and fully tested and approved at least fifteen (15) days prior to the initiation of the Contract.

3.3.2. Provide a description and documentation of compliance with HIPAA standardized codes and their implementation of HIPAA procedures to assure privacy and security specific to their role as a provider of services to a population living with HIV disease.

3.3.3. Comply with industry-standard mechanisms of health information exchange (HIE), including but not limited to: Secure File Transport Protocol (SFTP), FTP-ES, FTP-SSL and FTP Secure; etc.

3.3.3.1. To ensure the secure exchange, transport, and storage of Protected Health Information (PHI), the SC ADAP contracts the services of Groupware Technologies Inc. (GTI), the developers of the Provide Enterprise® system.

3.3.3.2. Provide Enterprise® serves as SC ADAP’s intake, eligibility verification, enrollment management, and service monitoring system, in order for SC ADAP to report client-level data and other information as required by Health Resources and Services Administration (HRSA).

3.3.3.3. The model of data exchange required by the Contract may be navigated through GTI, as a contracted agent of SC ADAP, to facilitate continuous and real-time security, accessibility, archival, and posting of files via the Provide Enterprise® system.

3.3.3.4. The Contractor shall receive instructions and support from GTI to exchange and format PHI, as specified by SC ADAP.

3.3.3.5. Data exchange mechanisms, such as SFTP, shall be availed and supported by GTI.

3.3.3.6. Systems of email encryption shall be provided and maintained by the Contractor.

3.3.3.7. Format of HIE is subject to change, per the requirements of HRSA or other conditions incurred by SC ADAP.

3.4. Incident Reporting Requirements

All privacy and security incidents must be reported to DHEC within twenty-four (24) hours.

3.5. Quality Management (QM) Requirements

Have quality management systems in place to assure, at a minimum, that appropriate reviews are scheduled and conducted; data and reports are prepared and reviewed for quality control; and provided within the periods specified. The Offeror must describe their current quality management system(s) in its proposal.

3.5.1. Inappropriate Antiretroviral Regimen: The Health Resources and Services Administration (HRSA);

HIV/AIDS Bureau (HAB) requires all ADAP programs to avoid dispensing medication combinations that should not be offered/filled at any time.

3.5.2. The US Public Health Service Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection specify antiretroviral regimens or components are not generally recommended because of suboptimal antiviral potency, unacceptable toxicities, or pharmacologic concerns. ADAP programs are included as core medical services funded by the Ryan White HIV/AIDS Program, and are therefore, required to provide care and treatment consistent with PHS guidelines. Clinical Review Process: In the event of a request to fulfill an inappropriate or atypical therapy (i.e. in the HAB Inappropriate Antiretroviral Regimen list, combination medications containing duplicate therapies, with clinical contraindications, etc.) or the enrollees identifies as being pregnant, the Contractor must contact the ADAP Team Lead to begin the Clinical Review Process prior to dispense.

3.5.2.1. The ADAP QM Coordinator shall serve as liaison to contact the ADAP Clinical Consultant

(Physician). Once contacted by ADAP, the ADAP Clinical Consultant shall contact the prescribing physician to review the patient therapy and other information provided by the Contractor and SC ADAP.

3.5.2.2. The ADAP Clinical Consultant shall provide feedback for SC ADAP to determine one of the following: authorize payment for dispense as prescribed due to patient-centered needs, authorize an alternate therapy as determined by the prescribing physician, or deny payment due to inappropriate ARV regimen.

3.6. Pharmacy Requirements

3.6.1. Contractor must have in place a network of pharmacies approved by SC ADAP that can serve the participants in the SC ADAP throughout the State, including mail-order option.

3.6.1.1. Must ensure that the pharmacies in the network can dispense all medications for SC ADAP clients across the state.

3.6.1.2. Ensure that at least one pharmacy in the limited network can dispense specialty medications which have restricted pharmacy networks (i.e., Cabenuva by ViiV and Sunlenca by Gilead).

3.7. Business Continuity Plan

3.7.1. The Contractor must have a business continuity/back-up plan for coordinating claims with insurance providers, including Medicare, for ADAP enrollees in the event of a national, state, or local emergency, which precludes normal operations and procedures established under this contract.

3.7.1.1. This plan shall include a current remote data back-up process and storage location.

3.7.2. The State and the Contractor shall update the Business continuity plan as necessary.

3.8. Optional Services

The Contractor shall provide optional services as proposed and agreed to by the State. Such services shall be within the scope of this contract. Examples of optional services are as follows:

3.8.1 Client Satisfaction Survey: Provide enhanced service offerings to include an objective process of identifying and collecting client feedback to improve service quality.

3.8.1.1 For enhanced service models, the results shall be provided to SC ADAP at least twice annually.

3.8.1.2 Client feedback shall be integrated into standard operational practices and monitored to improve service quality.

3.8.2. Enhanced client reporting to SC ADAP - Describe enhanced data files that may be available to SC ADAP to include but not limited to:

3.8.2.1. Unable to reach;

3.8.2.2. Deceased;

3.8.2.3. Moved out of state;

3.8.2.4. Incarcerated;

3.8.2.5. Med Hold placed by physician, etc.

3.8.3. Enhanced adherence monitoring systems: Describe enhanced adherence files that may be available to

SC ADAP.

3.8.4 Enhanced program services: Describe enhanced program services that may be available to SC ADAP.

3.9. Key Staff

The Contractor’s must assign key staff as listed below, at minimum. 3.2.8.3. The Contractor is responsible for maintaining appropriate levels of staffing.

3.9.1 Account Manager: The Account Manager shall have at least five (5) years of experience providing the same or similar management services on similar projects. The Account Manager shall at a minimum:

3.9.1.1. Serve as primary day-to-day contact with the Program.

3.9.1.2. Attend, lead, and prepare materials for meetings as requested.

3.9.1.3. Ensure all necessary operational components are completed prior to implementation of the

PBM services.

3.9.1.4. Troubleshoot and correct problems after implementation of the PBM services;

3.9.1.5. Designate an alternate contact for when the Account Manager is unavailable; and

3.9.1.6. Deliver required documents to DHEC in a timely and appropriate manner.

3.9.1.7. Provide timely response and resolution of ADAP Concern/Complaint or Pharmacy Incidents reported to ADAP or the Contractor.

3.9.2 Technology Coordinator: Responsible for providing technical support and data integration needed to establish secure electronic communications. The technology coordinator shall have at least three (3) years of related experience, establishing secure communications.

3.9.3 Customer Service Personnel: Shall have experienced in health insurance including Medicare Part D claim adjudication.

3.9.4 Other Proposed Key Staff

3.10 DHEC’s Services/Responsibilities to the Contractor

3.10.1 Perform eligibility determination services for SC ADAP services as it relates to initial and ongoing eligibility for SC ADAP applicants/enrollees and Medicare Part D current or potential enrollment.

Secure Electronic Communications – ADAP can provide technical information to enable the Contractor to exchange files securely with SC ADAP using SFTP for standard file exchange. The Contractor may determine to provide systems for secure electronic communications. The Contractor must be able to work with the State’s personnel and information system procedures, practices/policies, and requirements to assure acceptable electronic data transfers. The State shall determine whether the electronic mechanisms and processes proposed do in fact meet State requirements and standards for secure data transfer and client confidentiality. The Contractor shall provide secure email systems.

3.10.2 Verification of Eligibility - ADAP shall provide the Contractor with an electronic list of eligible enrollees and shall update the list electronically on a daily (workdays) basis. Participants provided in the file are enrolled in the ADAP DDP Program at the time of eligibility determination.

3.10.3. SC ADAP Formulary - Provide the Contractor a copy of the current SC ADAP Formulary and shall give the Contractor prior notice of any changes to the Formulary. A copy of the most recent Formulary can be found at the following URL: ADAP-Formulary-FINAL-7-2022.pdf (scdhec.gov)

3.10.4. Tracking Program Activity, Maintaining Programmatic Data and Data Collection and Reporting - ADAP shall work with the Contractor to optimize the efficiency and quality of the tracking, data collection and reporting processes. ADAP shall provide feedback to the Contractor on a regular basis and shall put any questions/concerns or requests for additions/changes in writing for Contractor’s response.

3.11. Transition and Implementation Plan of the New Contract

3.11.1 The Contractor shall, but not limited to, perform/provide the following as part of the implementation plan within 90 days of receipt of a Purchase Order:

3.11.2 Provide a detailed comprehensive work plan for this contract transition and implementation phase within ten (10) working days of receipt of a Purchase Order. The work plan must detail the specific timeframes, tasks, responsibilities, and key milestones with the associated dates that are necessary to ensure a successful transition and implementation process preceding the start of active operations.

3.11.3 Provide a process for the transition/transfer of any pharmaceuticals or products purchased by and therefore belonging to SC ADAP, regardless of whether the transfer occurs in the form of actual product or cash/credit.

3.11.4 Outline the specific tasks, data requirements, and resources that shall be needed from both the Contractor and SC ADAP to accomplish the transition.

INFORMATION REQUESTED:

-Business Name;

-Primary point of contact and �tle;

-Direct email address;

-Direct telephone number;

-Webpage link to your business site;

-Simple Cost Es�mate to include per transac�on fee and implementa�on fee, if applicable.

RESPONSE POINT OF CONTACT:

All responses should be emailed with the subject line: RFI: ADAP PBM Services to:

Rebecca Nichols Email: nicholrj@dhec.sc.gov SC DHEC Division of Procurement Services 301 Gervais Street Columbia SC 29201-3073 803-898-1262

This is not a solicita�on for purchase.

Following this RFI, and using informa�on obtained through this process, DHEC may conduct a future solicita�on for purchase.

mailto:nicholrj@dhec.sc.gov