Program Manager, Cellular Therapy

Department Overview

This position provides program management for the Cellular Therapy Program. The program includes adult and pediatric clinical programs providing cellular therapy products to eligible patients. Responsibilities include program development, coordination, and advocacy; program operations; patient enrollment; tracking of operational and financial data; management of regulatory requirements and compliance; quality management; and maintenance of program data.

 

As a part of accomplishing program goals, this position will interface with nurse managers on 14K, DCH 10S and outpatient infusion, adult and pediatric nurse coordinators, Cellular Therapy Lab (CTL) manager and technicians, and Apheresis Unit manager and nurses. This position will be the content expert for and interface with Patient Billing Services (PBS), Hospital Financial Services (HFS), coding personnel, and Managed Care Contracting.

 

The incumbent must be self-directed while working both independently and in collaboration with the Cellular Therapy Program Medical Directors and the Cellular Therapy Program Director.

Function/Duties of Position

Program Development and Management:

• Development of the program’s infrastructure to include work processes with nurse coordinators, Apheresis Unit, CTL, Pharmacy Supply Chain and Logistics, and Patient Business Services.
• Contact person identified on the OHSU web site for program inquiries.
• Develops standard work process breakdown documents for all aspects of the program – patient enrollment, patient scheduling, product PO requests and monitoring, assists nurse coordinators in development of patient education documents.
• Co-facilitates development of new business as additional cellular therapyproducts become FDA approved alongside the Cellular Therapy Program Director. Ensures the certification audit process results in approval; submits required adult and pediatric program information; sets-up initial training of physicians, APPs, nurse coordinators, and nursing staff with the managers of each department (IP Units, OP).
• Works collaboratively alongside the Cellular Therapy Program Director with the adult and pediatric Cellular Therapy Program Medical Directors to achieve program objectives.
• Monitors and reports on program performance.

Operations:

• Coordinates and manages the day-to-day operations of the Cellular Therapy Program:
  • Enrolls patients on pharmaceutical companies’ electronic applications (e.g., Cell Chain, Kite Konnect).
  • Requests PO numbers from Pharmacy at time of patient enrollment.
  • Tracks all patients and key information (product PO#, collection date, preparation dates, infusion dates, manufacturing patient identifier).
  • Tracking of Pediatric patient remission status and submission of appropriate form to Novartis in the case of non-remission per outcomes based agreement
  • Participates in the creation of Epic forms and smart phrases alongside RNC’s needed for patient management; used by physicians, APPs, nursing (e.g. CRS, neuro toxicity, neuro assessment documentation).

Finance:

• Monitors financial reports for correct routing of revenue and expense associated with cellular therapy products.
• Ensures that required forms are submitted to pharmaceutical companies to support contractual provisions for payment/non-payment.
• Establishes and maintains knowledge of commercial payer requirements related to coding and billing.
• Subject matter expert with Patient Business Services, Hospital Financial Services, coders and Oncology Financial Counselors.
• Establishes and maintains knowledge of Medicare rules and regulations, coding and billing. Taps into resources available from the ASTCT and Product Manufacturers.

Regulatory:

• This position is the delegate or Second-Designee for the Authorized Representative who oversees the implementation and compliance with the Risk Evaluation and Mitigation Strategy (REMS) Program for all pharmaceutical companies with which OHSU is certified to dispense their cellular therapy product. To that end, this position will work to:
  • Helps to maintain records of faculty and clinical staff training for internal compliance.
  • Ensures Pharmacy verification of Tocilizumab is on-site per REMS requirement.
  • Helps facilitate annual refresher training of faculty and staff.
  • Be the point person for CAR-T related audits performed by pharmaceutical companies per FDA requirements
• Report adverse events related to CRS and neurological toxicities to the pharmaceutical company and/or the FDA.

Quality Management:

• Facilitates the CAR-T Patient Revie