Receiving a PBM onsite audit notice can be intimidating but the pharmacy typically has some time to prepare before the auditor arrives. However, are you aware that pharmacies can receive unannounced onsite visits from PBMs, FDA inspectors, DEA agents or Board of Pharmacy inspectors? Being prepared for an unannounced audit is crucial and PAAS National® wants to make sure you have the tools to be successful. PAAS has become aware that OptumRx is again performing their unannounced onsite audits, see the tips below to help you be prepared should you get an unexpected visit.
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- Utilize our Onsite Credentialing Guidelines resource
- Provides a list of frequently asked questions from the PBM auditors
- Includes references to the PAAS National® Policy and Procedure Manual for our Fraud, Waste & Abuse and HIPAA Compliance members
- These audits typically focus on credentialing requirements and not prescription review
- Auditors may check licenses, on-hand stock of certain medications and may ask permission to take a few photos – If you are a PAAS Vault member and have uploaded licenses to the portal, those licenses are available at your fingertips
- Two auditors may be present, and the visit is usually about 30 minutes
- See the OptumRx Provider Manual for more information regarding an onsite audit.
- “Administrator or its designee shall have the right, with or without notice, at reasonable times, to access, inspect, and review on-site the facilities, licenses and credentialing documents/records of Network Pharmacy Providers and pharmacy locations applying to participate in any of Administrator’s Benefit Plans, as well as make copies of the licenses credentialing documents/records etc. maintained by pharmacy. Pharmacy agrees to cooperate with Administrator or its designee with the on-site visit and acknowledges non-cooperation with an on-site visit may result in denial or termination of network participation.”
- See the July 2022 Newsline, Is Your Pharmacy Ready for an Unannounced Audit?
Medicare Extends Part B Coverage for Kidney Transplant Drugs
Patients with Medicare because of End-Stage Renal Disease (ESRD) currently lose coverage 36 months after a kidney transplant unless otherwise eligible for Medicare. A recently published final rule will extend coverage for patients who meet certain criteria to qualify for continuous Medicare-covered immunosuppressive drugs starting January 1, 2023. This new benefit is called Medicare Part B Immunosuppressive Drug (Part B-ID).
There are a few important limitations to be aware of including:
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Beware of the New Problem with the Updated Online Santyl® Calculator
Santyl® ointment 250 units/gram is a topical medication indicated for debriding chronic dermal ulcers and severely burned areas. This medication is frequently targeted by auditors because correctly calculating the quantity needed and days’ supply requires knowledge about the wound size and treatment duration.
Prior to the recent update to the Santyl® online calculator, only the quantity needed for one wound could be calculated at a time and the total amount of ointment needed was rounded to the nearest 30 g or 90 g increment since these are the two commercially available package sizes. This led to an increased risk of overbilling and incorrect days’ supply calculations as previously discussed in the October 2021 Newsline article, Santyl® Dosing Calculator—Manufacturer’s Rounding May Lead to Recoupment.
Now, the calculator can determine the amount of ointment needed for more than one wound at a time and it provides the exact amount needed for the wound, or wounds, and specified treatment duration. However, what is not addressed with the online calculator is that once the pharmacy selects the total amount to dispense based on a 30 g or 90 g tube (or multiples thereof) the days’ supply may need to be recalculated to account for the extra dispensed which is necessary to accommodate the commercially available package sizes.
To determine the correct days’ supply, follow the example below:
Prescription: Santyl® ointment qs 20 days with zero refills; sig: apply to affected area(s) once daily; wound #1 is 5 cm x 2 cm, wound #2 is 3 cm x 1 cm
Online Calculator: After inputting the wound length and width for each of the two wounds and the 20-day treatment duration, you will see that 45 g would be needed. However, the pharmacy can only choose from a 30 g tube or 90 g tube (or multiples thereof) when dispensing, therefore, the calculator states that two of the 30 g tubes, or 60 g total, would be needed.
Manual Days’ Supply Calculation: Since the pharmacy must dispense 60 g to provide the patient with enough ointment to finish their course of treatment, the pharmacy must calculate the true days’ supply for all 60 g dispensed. To do this, you must:
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Express Scripts Reminds Pharmacies of Copay Collection Obligations
Express Scripts sent a memo to network providers the middle of October, pertaining to copayment collection, to ensure requirements are being met in the appropriate manner. There is emphasis placed on network providers being adherent to Section 2.3 of the ESI Provider Manual stating “Network Providers agree that it shall collect the full Copayment from Members, and that the Copayment is not changed or waived unless required by law”. The memo also discusses what documentation is required in case of an audit, which includes credit card receipt, point of sale (POS) receipt which reflects cash payment, and/or copy of cancelled check.
As a reminder, Express Scripts, in addition to other PBMs, reserve the right to terminate your provider status if failure to collect copays is discovered.
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What Do Bowel Preps, EpiPen®, and Migraine Medications Have in Common?
Prescriptions for medications whose dosing is standardized in the industry often come with directions that simply state, “Use as directed.” These types of products typically have the standard dosing right on the package being dispensed to the patient like bowel preps for colonoscopy, EpiPen®, starter dose kits (e.g., Eliquis® 30-Day Starter Pack), and dose packs (e.g., Medrol® DosepakTM). Similarly, migraine rescue medications, insulin with a sliding scale, and topical medications tend to be generically written with directions that have no mathematical way to calculate the days’ supply.
Auditors require
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DMEPOS Mini-Series #8 – The Six Medicare Auditing Entities and Their Purpose
The six Medicare auditing entities are responsible for auditing records, claims and payments. While they may use different methods to conduct audits, they all aim to detect, correct, and prevent improper payments to curb fraud, waste, and abuse and protect the Medicare Trust Fund. The Medicare Program Integrity Manual contains the policies and responsibilities for the entities tasked with medical and payment review.
What is the rationale for having these auditing entities? Taxpayers and future Medicare beneficiaries benefit when Medicare payments are returned to the Medicare Trust Fund. Subsequently, these audits lower the Medicare payment error rates. On occasion, pharmacies can benefit if there are any underpayments identified during an audit, in which case those dollars will be repaid to the pharmacy.
Listed below are six Medicare contractors that conduct audits and their main objectives:
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Navigating PBM Audits
Working collaboratively can be key to either avoiding a PBM audit altogether or making the process as painless as possible.
Be on the Lookout for OptumRx Unannounced Onsite Audits
Receiving a PBM onsite audit notice can be intimidating but the pharmacy typically has some time to prepare before the auditor arrives. However, are you aware that pharmacies can receive unannounced onsite visits from PBMs, FDA inspectors, DEA agents or Board of Pharmacy inspectors? Being prepared for an unannounced audit is crucial and PAAS National® wants to make sure you have the tools to be successful. PAAS has become aware that OptumRx is again performing their unannounced onsite audits, see the tips below to help you be prepared should you get an unexpected visit.
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- Utilize our Onsite Credentialing Guidelines resource
- Provides a list of frequently asked questions from the PBM auditors
- Includes references to the PAAS National® Policy and Procedure Manual for our Fraud, Waste & Abuse and HIPAA Compliance members
- These audits typically focus on credentialing requirements and not prescription review
- Auditors may check licenses, on-hand stock of certain medications and may ask permission to take a few photos – If you are a PAAS Vault member and have uploaded licenses to the portal, those licenses are available at your fingertips
- Two auditors may be present, and the visit is usually about 30 minutes
- See the OptumRx Provider Manual for more information regarding an onsite audit.
- “Administrator or its designee shall have the right, with or without notice, at reasonable times, to access, inspect, and review on-site the facilities, licenses and credentialing documents/records of Network Pharmacy Providers and pharmacy locations applying to participate in any of Administrator’s Benefit Plans, as well as make copies of the licenses credentialing documents/records etc. maintained by pharmacy. Pharmacy agrees to cooperate with Administrator or its designee with the on-site visit and acknowledges non-cooperation with an on-site visit may result in denial or termination of network participation.”
- See the July 2022 Newsline, Is Your Pharmacy Ready for an Unannounced Audit?
Fraud, Waste, and Abuse Compliance Programs Are Not Optional
PAAS National® analysts continue to see audits requesting documentation of compliance policies and procedures. FWA Training and OIG/GSA exclusion checks are not enough to be compliant as they do not constitute a compliance program. Since 2009, PAAS’ Fraud, Waste & Abuse and HIPAA Compliance program has been designed to meet CMS’ seven core elements required to adopt and implement an effective compliance program, which include:
PBM Provider Agreements require pharmacies to have a compliance program that meets CMS standards, and they reserve the right to request documentation of your compliance policies and procedures.
Consider the following:
Ensure you have all your compliance bases met so you can provide proof when requested for credentialing or audit. Don’t have an FWA/HIPAA Compliance Program? Contact PAAS, info@paasnational.com or (608) 873-1342 and get started today!
Caremark Bulk Purchase Requirements
As 2022 comes to a close, we know that many pharmacies will make “bulk purchases” ahead of the new year in anticipation of price increases or to obtain wholesaler rebates. Remember that Caremark requires pharmacies to provide notice of any bulk purchases that may impact future invoice audits, in accordance with Section 8.05 of the Caremark Provider Manual.
If your pharmacy plans to make any large purchases, be sure to
Pharmacies should submit notifications to the addresses provided below.
Email: PharmacyAudit@CVSHealth.com
Mail:
CVS Caremark
Attn: Bulk Purchase Notification, MC 020
9501 E. Shea Blvd. Scottsdale, AZ 85260
PAAS National® analysts have seen a few Caremark response letters that state the following, “review of the recent purchases made show they are routine in nature and would not be considered a bulk purchase”. It is unclear what criteria are used to make this determination; however, PAAS believes it is in your best interest to submit such notifications when the purchases are larger than what is “normal” for your pharmacy. We suggest that pharmacies retain this response from Caremark such that you could use it in the event of a future audit to demand that these purchases are included.
Lastly, some pharmacies have been confused by automatic email replies from Caremark with subject of Automatic Reply: Pharmacy Audit and the body of the email stating that the email address is a general mailbox for potential pharmacy audit issues and provides further instructions on how to submit “internal requests” and “external requests”. PAAS has confirmed that these are simply automatically generated replies and that pharmacies will receive a response specific to the bulk purchase notification within a few days.
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On-Demand Webinar: Don’t Give PBMs a Reason to Audit (Or Terminate): Off-Label Drug Use and Compliance Requirements
On November 9, 2022 PAAS National® hosted “Don’t give PBMs a reason to audit (or terminate): Off-label drug use and compliance requirements” webinar. PAAS Audit Assistance members have access to the recorded webinar, in addition to many other tools and resources on the PAAS Member Portal.
For easy viewing, we’ve split the webinar into three separate recordings.