Att K - Scope of Work.docx

Attachment K – Scope of Work Table of Contents

Introduction and Background ……………………………………………...page 2 Objectives ...............................................................................................page 2 Applicable Standards ..............................................................................page 3 Agency Overview/Current Services…………………………………………page 3 Need……………...…………………………………………………………… page 3-4 Current Operations...………………………………………………………… page 4-5

ATTACHMENT K

SCOPE OF WORK

RFP 26-84426

1.4 SUMMARY SCOPE OF WORK

Introduction and Background

The purpose of this document is to provide interested parties with information to enable them to prepare and submit proposals for the 340B Drug Program Contract Pharmacy Services for the Indiana Department of Correction (IDOC). Interested vendors will submit comprehensive proposals for all 21 IDOC facilities.

The Indiana Department of Correction receives in-kind services from the Indiana Department of Health (IDOH) and was awarded enrollment into the federally funded 340B Drug Pricing Program. It is the desire of the Indiana Department of Correction to provide Hepatitis C treatment to all eligible patients that are housed in one of the IDOC’s 21 facilities. IDOC operates 18 adult facilities across the state, from minimum to maximum security. The IDOC also operates 3 juvenile facilities. The interested parties shall provide 340B prescriptions for all eligible IDOC facilities.

The Mission of the IDOC is to promote public safety by providing meaningful, effective opportunities for successful reentry. The vision of the IDOC focuses on best correctional practices that strive to return productive citizens to our communities and inspire a culture of accountability, integrity, and professionalism. The Health Services Division focuses on patient centered and holistic care with services that range from the time of initial incarceration through the return to our communities.

Objectives

The objective for this Request for Proposal (RFP) is to solicit proposals for the procurement, management, inventory tracking, and dispensing of 340B medications as ordered by eligible providers for the eligible patients in accordance with 340B regulations and laws. The IDOC purchases drugs from the Wholesaler who then sends the medications to the selected pharmacy. The contracted pharmacy will prepare medications for distribution to the applicable IDOC facilities.

Applicable Standards

The pharmacy services provided under this contract will be restricted to 340B covered medications only to serve eligible patients. Pharmacy services provided under this contract must comply with:

· Indiana Department of Correction (IDOC) Health Care Services Directives

· Indiana Code

· Applicable Federal statutes in connection with the 340B program.

· Indiana State Pharmacy Board Rules and Regulations

· Multistate Pharmacy Board Rules and Regulations.

In the event of a conflict between vendor standards and IDOC policy, IDOC policy shall prevail. If this RFP sets requirements that exceed state, local, or federal requirements this document shall take precedence.

In accordance with applicable federal regulations the pharmacy services agree to continue to meet all 340B program requirements and does not create diversion of 340B drugs or duplicate discounts.

Pharmacy must be a licensed mail order pharmacy authorized to do business in the State of Indiana and be willing to provide contract pharmacy services to eligible patients.

Agency Overview/Current Services

The objective for this Request for Proposal (RFP) is to solicit proposals for the procurement, management, inventory tracking, and dispensing of 340B medications as ordered by eligible providers for the eligible patients in accordance with 340B regulations and laws. The IDOC purchases drugs from the Wholesaler who then sends the medications to the selected pharmacy. The contracted pharmacy will prepare medications for distribution to the applicable IDOC facilities.

Need

IDOC requires a contracted 340B specialty pharmacy to provide Hepatitis C medications at or below the current ceiling price. The IDOC is responsible for ensuring that individuals housed at an IDOC facility and living with a diagnosis of Hepatitis C receive treatment as clinically indicated. Medication management for this vulnerable and underserved population must be provided without fail. Any lack of performance on the part of the selected contracted pharmacy provider may cause the IDOC to lose its enrollment in the federal 340B drug pricing program which would then cause a disruption to patient care.

The selected contract pharmacy must agree to abide by and meet all the applicable federal, state, and local laws, regulations, and ordinances. The IDOC requires a contracted pharmacy to serve patients eligible to receive 340B discounted drugs as permitted under and in accordance with guidance issued by the federal Health Resources and Services Administration (HRSA) in connection with the 340B Program, including but not limited to, guidance issued by HRSA at 75 Fed. Reg. 10272 (3/5/2010), as amended from time to time. The selected pharmacy is a licensed mail order pharmacy authorized to do business in the State of Indiana, and willing to provide contract pharmacy services to eligible patients.

The selected contract pharmacy shall also abide by all ethical requirements that apply to people who have a business relationship with the State as set forth in IC § 4-2-6, et seq., IC § 4-2-7, et seq. and any regulations after.

Current Operations

IDOC operates 18 adult facilities and 3 juvenile facilities and oversees comprehensive medical services for all facilities including treatment for patients living with Viral Hepatitis C. Currently, the IDOC utilizes a 340B specialty pharmacy to obtain direct acting antivirals for the treatment of Hepatitis C. All medications are ordered by eligible practitioners for eligible patients in the electronic medical record. Weekly a list of eligible patients with pending orders is sent to the contract pharmacy to review orders and check for any contraindication. The contracted pharmacy has provided access to the electronic medical record to complete the order verification. The contract pharmacy orders medication from an identified wholesaler at 340B or lower pricing. Medications are received at the pharmacy and then shipped to the ordering facility. The Covered Entity is responsible for ensuring that the process for distribution of 340B Drugs complies with 340B statutory obligations to ensure against the diversion of 340B Drugs and to prevent duplicate discounts. In accordance with HRSA Guidance, CE shall undertake annual, independent audits for the purpose of ensuring that the prohibitions against diversion and duplicate discounts are not breached.

The CE is responsible for making notifications of any immediate remedial action to OPA. The CE is solely responsible for maintaining 340B program requirements and eligibility. The CE shall audit the contract pharmacy in accordance with HRSA Guidance. The CE shall ensure that enrollment in the OPA database is accurate and up to date. CE will notify the pharmacy of any changes to its 340B enrollment status. CE will register the pharmacy as a contact pharmacy in the 340B OPAIS and take all reasonable steps to ensure placement of pharmacy on CE’s list of contract pharmacies maintained on the 340B database.

The CE will provide the pharmacy with a prescriber list quarterly and notify immediately of any changes. The CE will ensure the wholesaler supplies the pharmacy with a parsable electronic invoice file in addition to a paper copy of the invoice, of 340B replenishment orders placed by the pharmacy on the CE’s wholesaler account in order to complete the tracking process in their inventory management system.

The pharmacy vendor will provide monthly reports to IDOC routinely and upon request for auditing and 340B oversight.

A complete list of the IDOC facilities along with the incarcerated population of each facility is included in this RFP as Attachment B-IDOC Facility Bed Counts.

The services to be provided by this RFP are currently being provided by a private vendor, Boswell Pharmacy, under a contract that is due to expire after June 30, 2026. The selected vendor to this RFP will be required to ensure a seamless transition.

The selected vendor must submit a transition plan within 15 business days and a continuous quality improvement plan (including defined clinical indicators, mortality reviews, patient safety tracking, and feedback loops) within 60 days of contract award.