New Breed of Denials Is a Test of Fortitude

Tony Hagen @oncobiz
Published: Friday, Dec 16, 2016
Niesha Griffith

Niesha Griffith

Many things are happening with payer practices as a result of the plethora of new immuno-oncology agents. Providers need to be aware of these developments and become substantially more cautious and vigilant about observing payment policies to avoid denials, said Niesha Griffith, vice president, Cancer Services, for the West Virginia University Health System.

Much more is at stake than previously in an unexpected drug payment denial, she said. Not only can practices be hit directly by financial expense but their staff members who regularly deal with payer interaction, billing, and coding can find themselves swamped with additional work. Griffith spoke on the issue at the September Clinical Immuno-Oncology National Conference, in Philadelphia.

Just because the FDA is approving new drugs doesn’t mean that providers can expect private payers to shape their policies respectively, Griffith said. In fact, confronted with rising expense, payers are becoming much more finicky about payment. This makes it necessary for providers to check and double-check approval requests and pre-certifications to make absolutely sure, because denials can still take practices by surprise, she said.

Private payers “originally started out approving everything for the FDA-approved indications, and now they actually have very specific coverage policies. You have to make sure that you meet those qualifications.” Also, she said, performance status rankings for patients have become a factor in approvals. Patients need to be in fairly good condition—cancer notwithstanding—to qualify. “Patients have to have a performance status of 0 to 2 to be able to receive these agents,” she said.

Providers must take care to fully understand payer policies and updates to those policies, and pharmacy personnel should sit in on discussions with payers to share perspective on how well the payment process is working. Payers can be unforgiving for overlooked updates or even small departures from policy, Griffith said. “When they finally do get a policy and post it, it may take a couple of weeks for you to actually get that information, depending on how information flows at your organization. And so, if they have a policy that maybe is a little bit more restrictive than the label and you didn’t know about it, you could end up having a denial, which is essentially what we’ve seen happen. They do not honor any type of retro-authorization.”

Getting the dosage right is another important safeguard to getting paid, Griffith said. Payers are actually calculating patients’ body weight to determine whether the dosage was figured correctly, and payment requests are being denied based on failure to meet this criterion, she added. Surprisingly, she said, drug payments are being held up by dosage calculations that are based on National Drug Code (NDC) labeling. NDC labels include manufacturer recommendations for strength and dosage form. Further, there’s a danger that approvals may not be sufficient for the amount of drug that is needed. Approvals may be disproportionate, meaning that the payer gives approval for nine months of a drug, but when a provider does the calculation it is discovered that there is only enough drug approved for a substantially shorter period of time, such as six months, Griffith said.

Payment for unused or “wasted” drug is a significant issue with expensive new oncolytics, as well, she said. “Not all payers will actually pay you for waste, and some will only pay you for part of the waste, not all of the waste. I’m not sure what the rhyme or reason is behind all of that, but again, it’s just one of the issues we’ve been seeing,” she said.

Oncologists are eager to use new drugs as soon as they become available, in both on-label and off-label applications. This makes it essential for practices to have clear and well-enforced policies on the use of new drugs so that their deployment doesn’t run ahead of the financial processes needed to pay for them, Griffith said. Physician activities should be scrutinized in this regard, “making sure the evidence is there, making sure the peer review is there, making sure that the patient’s been appropriately notified. Just make sure you have all of those pieces in place. If you haven’t done it, these drugs certainly beg it to be done.”

Nowadays, drugs often become available through wholesalers before payers have crafted a policy for coverage, she said. Doctors, meanwhile, have been following the trials and want to capitalize on the potential of these compounds right away. “We call the payer, and they don’t have a policy on that yet. It hasn’t held us back from using it if it’s on-label. We’re still calling, and we’re telling that we’re going to use it,” Griffith said.


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