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
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:
Billing and Filling: Glucagon Emergency Products
Glucagon emergency products are typically low audit risk – when billed correctly. Billing the wrong unit of measure, like “EA” instead of “mL”, is an easy target for auditors to flag. Below is a table to aid in billing the correct unit of measure.
PAAS Tips:
Why Adhering to Your Return to Stock Policy Is So Important
Pharmacies often struggle with patients not picking up prescriptions on a timely basis. The lag time could be caused by several reasons – cost concerns, transportation issues, mental health factors, or miscommunication are just a few of the possibilities. While pharmacies are sympathetic to patient situations, it is prudent to be aware of the consequences for not following a strict return to stock policy.
PBM return to stock policies range from 10 to 30 calendar days. Accordingly, PAAS National® advises pharmacies…
to abide by the most stringent 10-day policy to eliminate risk of full claim recoupment during an audit. Unfortunately, these discrepancies are often not appealable. PAAS has created the Return to Stock tool to assist pharmacies with staying up to date on each major PBM’s requirement.
PAAS Tips:
Interested in a customized FWA/HIPAA Compliance Policy and Procedure program? Contact PAAS National® at info@paasnational.com or (608) 873-1342 to get started today!
Medicare Prescription Drug Coverage and Your Rights (CMS-10147)
When a pharmacy receives an NCPDP Reject Code 569 <Provide Notice: Medicare Prescription Drug Coverage and Your Rights> on a Medicare Part D claim, the pharmacy “must” provide the patient with the CMS-10147 form, also known as the Medicare Prescription Drug Coverage and Your Rights notice. The notice instructs enrollees about their right to contact their Part D plan to request a “coverage determination” or prior authorization.
In general, all pharmacies must arrange for this form to be distributed to the patient. While retail pharmacies must provide the notice at point-of-sale, mail order and specialty pharmacies have up to 72 hours to provide it to the patient. Importantly, CMS recognizes the uniqueness of LTC settings and that there is no practical means to deliver the notice directly to the patient; as a result, if the pharmacy can resolve the matter and ensure the LTC patient receives the needed medication or an appropriate substitute, they do not need to deliver the notice. If the matter cannot be resolved, then the pharmacy must deliver the notice within 72 hours to the patient, patient’s representative, prescriber or appropriate staff person at the LTC facility.
The 569 reject will NOT be returned in the following scenarios:
While documentation is not required when distributing the CMS-10147, your pharmacy should have a policy and procedure in place addressing how and when the form is being distributed to patients. PBM field auditors may ask you questions about your process and will possibly want to see a copy of your form to ensure you have the most up-to-date version. OptumRx auditors may even look to see if you have a copy of the CMS-10147 posted in the pharmacy. However, the OptumRx Provider Manual does not require the form to be posted, and Chapter 18 of the Prescription Drug Benefit Manual does not obligate the pharmacy to post the notice.
PAAS Tips:
Proof of Patient Consent for a Refill Request: What You Need to Know
If you are a DMEPOS supplier billing Medicare Part B claims, then you should be familiar with the proof of refill request requirement. All DMEPOS items and supplies billed to Medicare Part B that are delivered or mailed require proof of refill request and an affirmative response to occur and be documented prior to shipment. PAAS National®’s Proof of Refill Request and Affirmative Response for DMEPOS Items form can be downloaded from the Member Portal.
For non-Part B claims, many PBM provider manuals include language requiring pharmacies to obtain (and retain) proof of member consent prior to delivery. However, enforcement of this requirement is often at the PBM’s discretion (i.e., variable). These policies, at least in part, originate from the 2020 CMS Call letter revisions concerning Part D Mail Order Auto-Ship Modifications. While PBM requests are uncommon, they may ask pharmacies to provide “proof of patient consent to refill” during audits‒ often catching pharmacies off guard. When PAAS National® sees this request, there is typically an underlying reason and it is a seemingly effortless way for the PBMs to recoup claims if the pharmacy does not have the proof. PBM audit algorithms are looking for Fraud, Waste and Abuse conducted by bad actors and will use data analysis as a reason to audit suspicious claims. See the PAAS Tips below for potential reasons why a PBM may ask for proof of refill request upon an audit, and how to ensure compliance of an automatic refill or medication synchronization program.
PAAS Tips: