Dr. Hudson-DiSalle is the manager in the Medication Assistance Program and Reimbursement Services at the Wexner Medical Center and James Cancer Hospital in Columbus, OH. She is responsible for managing and advocating for the Medication Assistance Program for patients who cannot afford their medications, as well as overseeing reimbursement authorization for off label medication use, high dollar therapy usage, infused medication and medication denials. Dr. Hudson-DiSalle serves on the Board of the Charitable Pharmacy of Central Ohio, the Health Policy Committee of the Hematology/Oncology Pharmacy Association (HOPA), and the Legislative Committee of the Ohio Society of Health System Pharmacists.
As with other high-cost treatments, integration of immunotherapies
into practice requires a thorough understanding
of payer policies and requirements for reimbursement.
Working within the clinical policies of third party payers is paramount
to a successful foundation for payment. Almost all payer types
have created clinical policies for immuno-oncology (IO) agents.
Payers (commercial, federal- and state-funded plans) create clinical
policies to provide guidance on medical necessity for an IO agent(s)
from the payer’s point of view. Commercial payers often have written
policies, while government payers may set generic parameters with
diagnosis codes that must be followed. These generic parameters
require the practice to interpret if guidelines are met prior to therapy.
A key step in successful reimbursement is for providers to
become thoroughly familiar with each payer’s clinical policy and
understand any required biomarker testing or exclusions. For
example, clinical policies for IO agents may require biomarker
testing for some agents but not others, even when such testing
is not indicated by the FDA label. Payers’ clinical policies may also
include: exclusion criteria based on past therapies (or lack of those
therapies), length of coverage for therapies, or past or current
concurrent disease states (e.g., Hepatitis C). When payers lack a
clinical policy, the program or practice intending to deliver the IO
agent must request a complementary pre-determination.
As more new agents and new indications receive FDA approval,
another reimbursement challenge occurs. Payers’ clinical policies
and published drug compendia may lag 3-6 months behind
published FDA approvals. Providers need to be proactive. Submit
a pre-determination that includes recent peer-reviewed literature
and an updated product package insert.
Anticipate that you will need to obtain prior authorization for
immunotherapies and, with the exception of Medicare, that you will
need to ask payers for permission to treat with these agents. Even
though you receive prior authorization, your denials team needs to
be adept at writing appeals proving medical necessity with these
agents. Be ready for denials on authorization requests for agents
that are used outside of approved two IO agent combinations, or
an IO agent and other chemotherapy agent (IV or oral) for patients
previously treated with a checkpoint agent, or when sequential
therapy is interrupted.
Establishing a foundation for proactively managing payer
relationships and leveraging those relationships with IO is
beneficial. Payers usually have a process for submission of clinical
policy material; however, convincing payers to consider a change
in policy is challenging unless sufficient peer-reviewed literature
is available. The largest opportunity lies with your local Medicare
fiscal intermediary’s development of Local Coverage Determinations
(LCDs). The fiscal intermediary will take into consideration the
NCCN Compendia and NCCN Practice Guidelines and view these
as the gold standard for medical necessity, as well as for successful
reconsiderations of an LCD policy.