PSM Oral Exam Study
Questions & Answers
Explain Assignment of Benefits (AOB). - ANSWERSAssignment of Benefits is a scenario where a
product covered under the medical benefit may be accessed via a specialty pharmacy (SP) or
specialty distributor. When an AOB option is offered by a payer, many times the payer mandates
that a specific SP provider is used.
How can Otsuka Patient Support (OPS) work with sites to better understand how to navigate the
prior authorization (PA) process? - ANSWERSOPS can address questions regarding insurance,
medical benefit, high copay, specialty pharmacy, denials, letters of medical necessity, appeals,
and peer to peers, as well as prior authorization support. OPS can also identify solutions for
transition of care and local care centers, and provide support for the REMS process.
What is the Risk Evaluation and Mitigation Strategies (REMS) Program for JYNARQUE®
(tolvaptan)? - ANSWERSThe JYNARQUE REMS program is a Food and Drug Administration (FDA)-
mandated, restricted distribution program implemented due to the risk of serious and
potentially fatal liver injury for patients prescribed JYNARQUE.
What are the key factors in determining if a product is covered under the medical or pharmacy
benefit? - ANSWERS• Provider administering the drug
• Route of administration
• Site of service for the administration
• Patient needs associated with the treatment.
What forms are needed to onboard an LCC once a nomination has been approved? - ANSWERS•
Confidentiality Agreement (CDA)
• Administering Local Care Center (LCC) Services Agreement
, What information in the Prescribing Information (PI) can a PSM address for ABILIFY MAINTENA®
(aripiprazole)? - ANSWERSIndication: Treatment of schizophrenia in adults and maintenance
monotherapy treatment of bipolar I disorder in adults
Dosing: 300-mg and 400-mg strength
Formulation: A single-dose, pre-filled, dual chamber syringe or single-dose vial kit
If asked a clinical question, the PSM must defer to the Account Manager (AM) or Medical
Science Liaison (MSL) and provide the HCP with the PI.
Explain the steps of the Buyand-bill process for a provider who injects and prescribes ABILIFY
MAINTENA in their office. - ANSWERS• Provider can purchase ABILIFY MAINTENA from one of
our 2 specialty distributors (McKesson Specialty or Besse Medical) or the prescriber can
purchase the medication from a local pharmacy.
• After the product is obtained, the nurse will call the patient to schedule the injection
appointment.
• Provider administers ABILIFY MAINTENA to patient
• Provider submits medical claim to payer for cost of drug plus drug administration service.
• Provider bills patient for any applicable cost-share (eg, deductible, coinsurance, copay).
What are Local Care Centers (LCCs)? How can LCCs provide support for patients and HCPs? -
ANSWERSLCCs are alternative injection sites where patients can receive ABILIFY MAINTENA®
(aripiprazole) on a consistent basis. They include retail pharmacies, urgent care clinics, dialysis
centers, and infusion centers.
For inpatient providers, LCCs help bridge the gap between discharge and the patient's next
injection. Referring a patient to an LCC helps to provide an alternative injection option for the
patient.
Questions & Answers
Explain Assignment of Benefits (AOB). - ANSWERSAssignment of Benefits is a scenario where a
product covered under the medical benefit may be accessed via a specialty pharmacy (SP) or
specialty distributor. When an AOB option is offered by a payer, many times the payer mandates
that a specific SP provider is used.
How can Otsuka Patient Support (OPS) work with sites to better understand how to navigate the
prior authorization (PA) process? - ANSWERSOPS can address questions regarding insurance,
medical benefit, high copay, specialty pharmacy, denials, letters of medical necessity, appeals,
and peer to peers, as well as prior authorization support. OPS can also identify solutions for
transition of care and local care centers, and provide support for the REMS process.
What is the Risk Evaluation and Mitigation Strategies (REMS) Program for JYNARQUE®
(tolvaptan)? - ANSWERSThe JYNARQUE REMS program is a Food and Drug Administration (FDA)-
mandated, restricted distribution program implemented due to the risk of serious and
potentially fatal liver injury for patients prescribed JYNARQUE.
What are the key factors in determining if a product is covered under the medical or pharmacy
benefit? - ANSWERS• Provider administering the drug
• Route of administration
• Site of service for the administration
• Patient needs associated with the treatment.
What forms are needed to onboard an LCC once a nomination has been approved? - ANSWERS•
Confidentiality Agreement (CDA)
• Administering Local Care Center (LCC) Services Agreement
, What information in the Prescribing Information (PI) can a PSM address for ABILIFY MAINTENA®
(aripiprazole)? - ANSWERSIndication: Treatment of schizophrenia in adults and maintenance
monotherapy treatment of bipolar I disorder in adults
Dosing: 300-mg and 400-mg strength
Formulation: A single-dose, pre-filled, dual chamber syringe or single-dose vial kit
If asked a clinical question, the PSM must defer to the Account Manager (AM) or Medical
Science Liaison (MSL) and provide the HCP with the PI.
Explain the steps of the Buyand-bill process for a provider who injects and prescribes ABILIFY
MAINTENA in their office. - ANSWERS• Provider can purchase ABILIFY MAINTENA from one of
our 2 specialty distributors (McKesson Specialty or Besse Medical) or the prescriber can
purchase the medication from a local pharmacy.
• After the product is obtained, the nurse will call the patient to schedule the injection
appointment.
• Provider administers ABILIFY MAINTENA to patient
• Provider submits medical claim to payer for cost of drug plus drug administration service.
• Provider bills patient for any applicable cost-share (eg, deductible, coinsurance, copay).
What are Local Care Centers (LCCs)? How can LCCs provide support for patients and HCPs? -
ANSWERSLCCs are alternative injection sites where patients can receive ABILIFY MAINTENA®
(aripiprazole) on a consistent basis. They include retail pharmacies, urgent care clinics, dialysis
centers, and infusion centers.
For inpatient providers, LCCs help bridge the gap between discharge and the patient's next
injection. Referring a patient to an LCC helps to provide an alternative injection option for the
patient.
