is flagging migraine medications as 1N-Incorrect Days Supply: Submitted Days’ Supply on Claim is Incorrect. Prior Authorization Required for Correct Days’ Supply. The auditor has calculated the days’ supply strictly based on the prescription instructions, without accounting for the fact that the medication is prescribed to be taken as needed. Consider the following example:
Prescription is written for Ubrelvy® 100 mg, #16 tablets. Instructions are to take 1 tablet at onset and repeat in 2 hours if needed. Pharmacy billed this claim as a 30-day supply based on a plan limit rejection (when the pharmacy billed #16 for an 8 days’ supply); however, the auditor also calculated the days’ supply to be 8, and stated this prescription, as written, would require prior authorization.
PBMs simply don’t allow pharmacists to use their professional judgement to determine the days’ supply. Prescribers should be contacted to obtain the specific number of headaches per week/month they anticipate the patient to treat, or the maximum number of tablets the patient may use per week/month. This information should be obtained prior to dispensing, documented on the prescription, and included on the patient label.
Injectable, maintenance migraine medications have their own set of audit risks. Pharmacies must bill the days’ supply according to the exact instructions. If the patient is to inject “monthly”, the claim should be billed as a 30-day supply. When the patient is injecting “every 4 weeks,” the claim should be billed as a 28-day supply. While you may not think two days can make a difference, understating the days’ supply can create an opportunity for the PBM to argue a refill was too early.
PAAS Tips:
- Obtain utilization (headache frequency or maximum dosing over time) information directly from prescribers – patient notes are often not accepted by PBMs
- Update the patient label accordingly
- A complete clinical note should include:
- Date and time
- Name and title of individual providing information
- Specific information clarified
- Pharmacy staff initials
- As needed migraine medications should only be refilled upon patient request
Manufacturer Coupons: Why It’s Important to Read the Fine Print
While PAAS National® sees a vast array of PBM audits daily, did you know that claims billed to a manufacturer coupon can also be audited by the coupon administrator? Each manufacturer coupon…
has Terms and Conditions that need to be followed in order to be compliant in the program.
Each coupon or card has its own set of limitations/parameters for use. All coupons and copay cards are not allowed if a patient is enrolled in any Federal-paying prescription program (such as Medicaid, Medicare Part D, and Tricare) due to the Anti-kickback Statute (42 U.S.C. 1320a-7b). A question that is often asked is: “what if the drug isn’t covered by the federal plan?” The answer to this question would come down to the wording in the Terms and Conditions. Many cards will say it cannot be used for patients covered under Medicare or Medicaid. However, even though the drug isn’t covered, the patient is still enrolled in the federally funded program and the coupon or copay card should not be applied.
What if the pharmacy uses a discount card (instead of the primary insurance) or bypasses the primary insurance plan altogether? The answer should be in the details. For example, Linzess® has a copay savings card available (called the Linzess® savings program). After finding terms and conditions for the card, the first sentence states, “This offer is valid only for patient with commercial prescription insurance coverage…”. It would likely be considered a violation of the program to directly bill a discount card instead of the patient’s primary insurance coverage (with the exception of discount cards embedded in plans) and could result in recoupment of the money paid to the pharmacy, and possibly termination from the coupon’s processor. Many coupons are processed by the same payers and PBMs, which could exclude you from multiple coupon cards/discount programs and possibly draw scrutiny to commercial claims and contracts unknowingly.
PAAS Tips:
Fraudulent Prior Authorization Submissions Costs Pharmacy Over $1 Million
A Florida-based pharmacy plead guilty to healthcare fraud and agreed to pay over $1 million to resolve False Claims Act violations stemming from falsified prior authorizations. The pharmacy dispensed Evzio® (injectable naloxone product for emergency treatment of opioid overdose—discontinued in October 2020) which frequently required prior authorizations due to its high cost. Instead of sending the prior authorization information and/or forms to the prescribers, the pharmacy would complete the forms and, in some cases, sign the required forms. It was made to appear that the physician (not the pharmacy) was submitting the information. Pharmacy staff also provided false information to the insurer that the patients had tried and failed to successfully use Narcan®.
A pharmacy may believe they are “helping out” the prescriber by doing the prior authorization for them, but there is language in PBM provider manuals on this topic. For example, the Caremark provider manual section 5.06 states “For prior authorization, the Prescriber is required to supply additional documentation to Caremark or the Plan Sponsor to determine whether certain criteria are met for the drug to be covered under the Plan.” The restriction is intended to prevent kickbacks to prescribers from pharmacies for medication referrals, as well as falsification or manipulation of prior authorization information.
PAAS Tips:
Preventing Misfill Recoupments Through Documentation
PAAS National® recommends attention to detail when it comes to typing directions for patient labels. Pharmacies are often very familiar with prescribers and what they likely intended to include on the prescription, but didn’t. This can range from a specifying a quantity to providing detailed patient instructions. Unfortunately,…
when a pharmacy supplements or documents clinical notations that are not explicitly written on the prescription (and do not appear on the patients prescription label), it risks the claim being considered a “misfill”. OptumRx and Caremark are very particular about the directions on the patient label matching exactly what the prescription, and any relevant clinical notations, contains.
Some of the following are examples of those errors:
Victoza® is another example of a problematic patient label issue, which typically has directions in MG, but is often typed on the patient label as ML.
PAAS Tips:
New PAAS Tool! Flowchart for Multi-Payor Claims with Conflicting Coverage
In last month’s Newsline article, “A” for Abandoned: The Short Life of DAW Code A and What it Means for Multi-Payor Claims, PAAS National® provided insight into the revised billing process for multi-payor claims where one payor prefers the brand and the other payor prefers generic. Due to the complexity of this billing process, a new PAAS tool has been developed, Conflicting Coverage: When One Payer Covers Brand and the Other Prefers Generic.
This new tool will provide staff with a billing flowchart to follow when the primary payor prefers brand and a second chart to follow when the secondary prefers brand. These flowcharts can serve as a quick reference guide that can be printed out and posted at the data entry station for easy reference. At the end of this new tool, there is a table with a more in-depth explanation of this multi-payor billing process.
While the majority of the pharmacy’s claims are likely to process through just one payor, it is not uncommon to have a patient with a secondary payor (e.g., Medicaid). While Medicaid as a secondary payor is not the only scenario where this tool will be helpful, it is likely the most common. Primary payors often have different formulary preferences for multi-source brand products than Medicaid due to various manufacturer rebates. PAAS analysts frequently receive questions about the proper way to bill these claims and which DAW code is appropriate to use. While an analyst is always happy to guide you through these scenarios, this tool can be at your fingertips and can also guide you through the process of how to correctly bill these claims.
Find this tool, and other amazing PAAS tools and aids, on the Member Portal. Here you can find Proactive Tips, Days’ Supply Charts, and even On-Demand Webinars! If you are not able to find something you’re looking for, just reach out to a PAAS representative for additional guidance.
Reduce Vaccine Audit Risk Through Accurate Quantity Billed
To enhance profitability, pharmacy owners and operators have frequently incorporated immunization services into their offerings. While vaccines tend to carry a lower audit risk, the higher the cost of the vaccine, the more likely it is to be audited. The audit risk also increases when core billing elements of the vaccine claim are adjudicated incorrectly.
NCPDP billing standards determine the billing quantity and unit of measure on claims so that all parties involved in the billing transaction are “speaking the same language”. This holds true for vaccines, such that each vaccine has a set quantity based on the NDC billed. Therefore, billing a quantity incongruent with the standard may trigger a third-party payor’s claim algorithm and result in an audit. Knowing the appropriate quantity and NCPDP billing unit for each vaccine the pharmacy bills, and how your pharmacy software system handles these quantities, is critical for billing vaccines correctly.
Listed in the chart below are many of the vaccines commonly billed by pharmacies, including their appropriate quantity and NCPDP billing unit. One factor that should immediately stand out is that many of these vaccines are billed with the NCPDP unit of “ML”, but most are less than 1 ML. If the pharmacy’s billing software is unable to handle/display decimals in the quantity field, the pharmacy must closely monitor these claims to ensure the vaccines are set up appropriately so the correct quantity is transmitting to third-party payors. The easiest way to confirm that the quantity is entered appropriately on the claim is to double check the cost of the vaccine on the claim. If the cost is double what you expect, it is possible the vaccine is not setup appropriately in the system. Take steps to correct the vaccine data elements before billing the claim to reduce audit risk.
PAAS Tips:
PBMs Are Criticizing Clinical Notes!
Calling a prescriber’s office due to a prescription with missing elements, or needing clarification, is an inescapable task. If you are failing to document that phone call with a valid clinical note, PBMs may flag the claim upon audit and try to recoup. We have seen OptumRx, Humana, Navitus, and ESI/Prime results citing pharmacy clinical notes. Many of the provider manuals have language on what a valid clinical note should minimally contain. Our experience upon reviewing audit documents, results, and provider manuals is that a clinical note should contain four elements. If the following elements for a clinical note are present, they will reduce an auditor’s ability to recoup upon audit.
PAAS National® recommends these four elements be attached to all clinical notes:
PAAS Tips:
Delivering to a Clinic? Avoid Audit Risks!
Traditional dispensing for independent pharmacies continues to transform. Beyond dispensing prescriptions at the pharmacy counter, some pharmacies are providing patient-specific prescriptions directly to clinics for administration. Pharmacies must be aware and protect themselves from the heightened audit risks.
While PAAS National® has written countless Newsline articles on signature, delivery, and mailing requirements to help our members ensure proper documentation is being obtained, additional consideration should be given for medications delivered to clinics for administration. Pharmacies are often under the assumption once the medication is delivered and signed for by clinic staff that their responsibility has ended; however, PAAS has seen many pharmacies run into PBM audit issues where additional controls were absent.
Long-acting antipsychotic injectables are a frequent audit target due to their complexity and high cost. Additionally, the [potentially transient] patient population is more likely to create patient denial discrepancies (an auditor’s best friend). While PAAS has written articles about passive denials (the patient never acknowledges the auditor’s inquiry), this dispensing practice is more likely to lead to active denials. Do these patients know that your pharmacy provides the medication? In many cases, the answer might be no; so, having documentation and controls in place becomes paramount.
Moreover, given the patient population, how likely are they to miss appointments? Does the clinic communicate with the pharmacy if the patient cancels? PAAS has seen pharmacies continue to deliver medications for extended periods of time only to find out the patient hasn’t been keeping their appointments, and the clinic has been stockpiling the medication. Without additional measures in place, the pharmacy carries the financial burden.
Insurance companies will simply not pay for medications the patient never actually receives. Setting up policies and procedures with the clinics you deliver to should be mandatory to protect your claims. Remember, you are the only one with money at stake. While there are no specific requirements, questions to consider include:
PAAS Tips:
Unannounced CMS Site Visits
PAAS National® has recently seen an uptick in the number of unannounced CMS site visits related to Medicare enrollment or revalidation. These visits are currently being conducted by Novitas Solutions, the contracted National Provider Enrollment East (NPEast) contractor and Palmetto GBA® for the NPWest. Site visits are performed to verify the business location and ensure that suppliers meet DME supplier standards.
Pharmacies will typically receive a notice that indicates a site visit will be forthcoming and that they cannot provide specific information on when the visit will be conducted. The notice includes a list of items to be examined by personnel including, but not limited to, the following:
Pharmacies often have questions about requirements for the inventory, complaints, warranty coverage notification, rent/purchase option notification, and patient instructions for use.
Create a resource folder with all the applicable documents to help your pharmacy be prepared. Staff should be made aware of an impending visit and where to locate the resource folder. Auditors will conduct the audit whether or not the pharmacy is prepared (and regardless of whether the owner is present). PAAS has seen these audits go awry because staff were unaware and ill-equipped, failing to provide the auditor with any documentation.
Site visits are typically short. If you do not have all the required documents for the site inspectors during the visit, or if you fail the site visit for any other reason, you may receive a non-compliance notice and revocation letter which typically requires a Corrective Action Plan (CAP) and Reconsideration Request for appeal.
PAAS Tips:
From Headache to Hassle Free: Best Practices in Migraine Medication Billing
Migraine medications continue to be targeted for audit by all PBMs. With new products on the market, rising costs, and frequency of refills, PBMs are looking for billing errors to claw back payments on audit.
OptumRx’s latest tactic…
is flagging migraine medications as 1N-Incorrect Days Supply: Submitted Days’ Supply on Claim is Incorrect. Prior Authorization Required for Correct Days’ Supply. The auditor has calculated the days’ supply strictly based on the prescription instructions, without accounting for the fact that the medication is prescribed to be taken as needed. Consider the following example:
Prescription is written for Ubrelvy® 100 mg, #16 tablets. Instructions are to take 1 tablet at onset and repeat in 2 hours if needed. Pharmacy billed this claim as a 30-day supply based on a plan limit rejection (when the pharmacy billed #16 for an 8 days’ supply); however, the auditor also calculated the days’ supply to be 8, and stated this prescription, as written, would require prior authorization.
PBMs simply don’t allow pharmacists to use their professional judgement to determine the days’ supply. Prescribers should be contacted to obtain the specific number of headaches per week/month they anticipate the patient to treat, or the maximum number of tablets the patient may use per week/month. This information should be obtained prior to dispensing, documented on the prescription, and included on the patient label.
Injectable, maintenance migraine medications have their own set of audit risks. Pharmacies must bill the days’ supply according to the exact instructions. If the patient is to inject “monthly”, the claim should be billed as a 30-day supply. When the patient is injecting “every 4 weeks,” the claim should be billed as a 28-day supply. While you may not think two days can make a difference, understating the days’ supply can create an opportunity for the PBM to argue a refill was too early.
PAAS Tips:
Bowel Prep Kit Billing Under CMS Review: PBMs in Focus
Recent CMS audits have brought renewed attention to how PBMs oversee pharmacy billing for bowel preparation kits. Common issues listed below are leading to potential compliance violations and recoupments. Pharmacies and PBMs alike are urged to review current practices to ensure alignment with federal guidelines and reduce audit risks.
PAAS National® is seeing the following common issues when reviewing documents for CMS audits:
PAAS Tips: