calling the geriatrician to explain that 0.25 mg is subtherapeutic for the frail 91-year-old patient isn’t always time well spent, it is worth confirming that the dose prescribed was truly the maintenance dose intended (and documenting the conversation on the hardcopy accordingly).
With the duplicity of GLP-1 medications being marketed separately for Type II Diabetes Mellitus or Weight-loss, there is a heightened sense of off-label use when Ozempic® [instead of Wegovy®] is prescribed for weight loss. Likewise, Ozempic 0.25 mg could be considered “off-label use”, although PBMs seem reluctant to do anything [at least for now] to disrupt the gravy train that is GLP-1 rebates.
So, beyond validating the ongoing Ozempic 0.25 mg dosing, how should pharmacies bill the claim? There are only 6 pen needles in the box, so an argument could be made that the days’ supply should be 42. However, this would be wasting two weeks’ worth of medication, and pen needles can be dispensed and sold separately (as is the case with insulin pens).
CVS/Caremark is the only PBM with written guidance available on their Audit Tips: Injectable GLP-1 Receptor Agonist Medications resource. Caremark states that a box of Ozempic® 2 mg/3 mL giving 0.25 mg once weekly should be billed as a 56-day supply. With this billing guidance (which has not to our knowledge been spelled out before), it is likely to continue being an audit target. Caremark does state that if the plan limits the days’ supply to 34, to call the help desk to request a “Plan limitation exceeded” override and to document that information on the hard copy.
As for other PBMs, there has been no formal guidance as to the correct billing of the low-dose Ozempic®. PAAS has seen Express Scripts also indicate (per audit results) that low-dose Ozempic® at 0.25 mg once weekly ongoing as a 56-day supply. OptumRx, on the other hand, believes these directions constitute a 42 days’ supply (likely due to the limited pen needles available). PAAS considers the conservative approach to be always billing for a 56-day supply and dispensing/selling additional pen needles, as needed.
The recoupment risk for pharmacies billing a 42 days’ supply for low-dose Ozempic® is the initial dispensing will be flagged for incorrect days’ supply and subsequent refills may be deemed as refill too soon (facing full recoupment). Any refills that are dispensed prior to the PBM’s utilization threshold [based on the actual days’ supply] is easily identified by the PBM and low hanging fruit for auditors (before they even asked for prescription documentation). If the PBM wanted a 56 days’ supply and the utilization threshold is 75%, pharmacies refilling prior to 42 days could face recoupment.
PAAS Tips:
- PAAS recommends billing Ozempic® 0.25 mg weekly as a 56-day supply to maintain consistency and avoid potential recoupment
- Be careful of early refills if you must submit an altered day supply due to plan limitations
- Utilization thresholds vary by plan and PBM – be judicious when allowing refills to process
- See PAAS tool Exceeding Day’s Supply Plan Limitations for Unbreakable Packages to educate your team and develop a systematic process for handling these types of prescriptions
- Advise patient to NOT re-use pen needles
- Optum Rx Provider Manual states that the pharmacy should contact the help desk for an override if the days’ supply billed exceeds the plan limit, then document on the prescription hard copy
- Ozempic® 0.25 mg weekly is not considered to be a therapeutic dose and could be considered off-label use
- Medicare Part D and other federally funded plans will not pay for drugs for off-label use. Commercial plans can also deny payment, depending on the agreement/provider manual
- Ensure any diagnosis code present on the prescription is approved for use of Ozempic®
- If utilizing a coupon card, ensure it is being used in accordance with the terms and conditions listed
Are You Willing to Risk Recoupment for Missing DUR and SCC Documentation?
Pharmacies often work in a fast-paced environment with an increasing workload as we see stores closing, more transfer-ins, and higher patient demand. This results in an increased urgency to perform data entry faster, which can lead to the use of override codes to get the claim adjudicated quickly. PAAS National® is here to remind pharmacies to proceed with caution when handling clinical drug utilization reviews (DURs) and submission clarification codes (SCCs). Lack of proper documentation supporting the use of DURs and SCCs can result in audit recoupments.
DUR messages are designed as a warning to avert potential patient harm and require pharmacist intervention before proceeding. These are the more obvious DURs to spot and handle. Soft DURs can be easily overlooked but still require thorough review. For example, a DUR indicating the prescription was filled at another pharmacy should generate questions regarding current therapy or possible duplicate therapies the patient may be unaware of.
SCCs might be necessary to use when a patient is requesting a refill due to an upcoming vacation, lost or stolen medication, or a change in therapy. Some PBMs are known for auditing high dollar claims with override codes, like Express Scripts and Prime Therapeutics. Auditors are looking for documentation, including rationale on the prescription, when the override codes are used, but what does this mean? Below is an example of appropriate DUR and SCC documentation.
DUR Documentation: HD/M0/1B – Verified with Dr. Jones they are aware this is a high dose/Told to fill prescription as is/Pharmacist’s initials/date
SCC Documentation: SCC 03 – Susan is going on vacation to Italy from 01/06/2025 to 01/20/2025 & requires a vacation supply of medicine/date
Simply documenting the override codes utilized does not provide the auditor with the explanation of why it was appropriate to use. When under audit, be sure to make all clinical notes visible for the auditor. Rescan hard copies into your pharmacy software system when handwriting notes if necessary; this can help ensure the notes will not be missed when under audit.
PAAS Tips:
Vaginal Creams: Why 30 Days’ Supply Is Probably Not Appropriate
Topical medications like creams and ointments are always a target for PBMs to audit, but lurking in those topicals is a bullseye that PBMs are always aiming for – vaginal creams. Estrace® and Premarin® are easy targets due to the variety of discrepancies that could be found when auditing.
The most common error PAAS National® Analysts come across when reviewing vaginal cream prescriptions is …
related to days’ supply issues. Do the directions on the hard copy give a calculable day supply? Are there grams per application? If not, the pharmacy should clarify with the prescriber prior to dispensing and put a clinical note on the hard copy. Directions like “one application twice weekly” or “use as directed, a pea-sized amount” would also not suffice for calculable directions, as they are not specific enough, and most PBMs will not assume “pea-sized” amount is 0.25 g. PAAS recommends communicating with the provider to clarify and adding a clinical note to the hard copy. Be sure that these clarifications (frequency and/or volume) are also reflected on an updated patient label prior to dispensing.
Once you determine the prescription contains calculable directions, the next step would be to bill the accurate day supply. Pharmacies can fall into the trap of assuming a days’ supply exceeding 90 days will surely be rejected based on historical experience; therefore, a 90 days’ supply is billed to the insurance. This places the pharmacy at risk for an invalid day supply discrepancy, as well as potential refilled too soon discrepancies on subsequent refills. Unbeknownst to many pharmacies, PBMs have begun to allow accurate [>90] days’ supplies to be billed for certain types of medications, including vaginal creams. Our recommendation is to always submit a claim with the true and accurate days’ supply first. If the plan rejects the days’ supply, PAAS recommends contacting the insurance help desk for an override. If the insurance does not have an override for the day supply, document this on the hard copy and bill for the maximum day supply allowed by insurance. To prevent accidental early refills, PAAS recommends adding a note on the pharmacy label in the directions, making both staff and patients aware of the actual day supply. The more visibility the note is, the less likely an early refill will be missed.
PAAS Tips:
PBM Prescription Validation Requests – What Are They Looking At Now?
The July 2024 PAAS National® Newsline article, What’s New with Prescription Validation Requests in 2024? compared the top five drugs targeted in the first six months of 2024. The chart below shows the top drugs picked for claim reviews in the second half of 2024, and a recap of the first half of 2024.
As you can see (and probably not a surprise), Ozempic® is the top drug reviewed through all of 2024. Additionally, you can see how the PBMs shift their focus on which drugs they select to perform claim reviews on.
The top 5 comments noted by an analyst after claim review for the second half of 2024 are the same 5 from 2023:
PAAS Tips:
2025 PAAS Fraud, Waste & Abuse and HIPAA Compliance Program Updates
PAAS National®® continuously monitors legislative and regulatory changes that may impact your Fraud, Waste & Abuse and HIPAA Compliance Program. We keep a close eye on enforcement from the Department of Justice, Office of Inspector General, State Attorney Generals, and Office for Civil Rights to help ensure the program meets interpretative standards. Furthermore, PAAS works to keep pace with Pharmacy Benefit Managers as they continue to add credentialing requirements that can be extremely difficult, and a significant nuisance, to independent pharmacies.
PAAS has implemented changes to ensure pharmacies continue to have a robust program in place. PAAS FWA/HIPAA compliance program members can login to the member portal to view the 2025 FWAC and HIPAA Updates. This year’s updates included a procedure for CMS-10882 (Medicare Prescription Payment Plan), PHI safeguard considerations for Remote/Hybrid work, enhancements to the required HIPAA Security Risk Analysis, Pharmacy-to-Pharmacy Inventory Transfer Log, and a policy and procedure related to the 2024 Privacy Rule (request to access or release PHI potentially related to reproductive health).
Administrators should review all Compliance tasks (located in the left-hand navigation on the PAAS Member Portal) at least annually to keep the program up-to-date and in compliance. Section 2.6 Updates of Policies and Procedures of your manual contains information on maintaining open lines of communication and the distribution of changes.
If you’re not a member of PAAS’ FWA/HIPAA compliance program, contact us today at (608) 873-1342 or info@paasnational.com to add the program for a discounted rate.
Billing Ozempic® 0.25 mg Weekly as Maintenance – What PBMs Say
PAAS National® continues to see GLP-1 medications as a high audit target. Recall the FDA-approved initial dosing for Ozempic® is 0.25 mg injected subcutaneously once weekly for four weeks, followed by 0.5 mg once weekly (see section 2.2 of product labeling). However, pharmacies often see prescribers write for Ozempic® 0.25 mg weekly dose as maintenance. While …
calling the geriatrician to explain that 0.25 mg is subtherapeutic for the frail 91-year-old patient isn’t always time well spent, it is worth confirming that the dose prescribed was truly the maintenance dose intended (and documenting the conversation on the hardcopy accordingly).
With the duplicity of GLP-1 medications being marketed separately for Type II Diabetes Mellitus or Weight-loss, there is a heightened sense of off-label use when Ozempic® [instead of Wegovy®] is prescribed for weight loss. Likewise, Ozempic 0.25 mg could be considered “off-label use”, although PBMs seem reluctant to do anything [at least for now] to disrupt the gravy train that is GLP-1 rebates.
So, beyond validating the ongoing Ozempic 0.25 mg dosing, how should pharmacies bill the claim? There are only 6 pen needles in the box, so an argument could be made that the days’ supply should be 42. However, this would be wasting two weeks’ worth of medication, and pen needles can be dispensed and sold separately (as is the case with insulin pens).
CVS/Caremark is the only PBM with written guidance available on their Audit Tips: Injectable GLP-1 Receptor Agonist Medications resource. Caremark states that a box of Ozempic® 2 mg/3 mL giving 0.25 mg once weekly should be billed as a 56-day supply. With this billing guidance (which has not to our knowledge been spelled out before), it is likely to continue being an audit target. Caremark does state that if the plan limits the days’ supply to 34, to call the help desk to request a “Plan limitation exceeded” override and to document that information on the hard copy.
As for other PBMs, there has been no formal guidance as to the correct billing of the low-dose Ozempic®. PAAS has seen Express Scripts also indicate (per audit results) that low-dose Ozempic® at 0.25 mg once weekly ongoing as a 56-day supply. OptumRx, on the other hand, believes these directions constitute a 42 days’ supply (likely due to the limited pen needles available). PAAS considers the conservative approach to be always billing for a 56-day supply and dispensing/selling additional pen needles, as needed.
The recoupment risk for pharmacies billing a 42 days’ supply for low-dose Ozempic® is the initial dispensing will be flagged for incorrect days’ supply and subsequent refills may be deemed as refill too soon (facing full recoupment). Any refills that are dispensed prior to the PBM’s utilization threshold [based on the actual days’ supply] is easily identified by the PBM and low hanging fruit for auditors (before they even asked for prescription documentation). If the PBM wanted a 56 days’ supply and the utilization threshold is 75%, pharmacies refilling prior to 42 days could face recoupment.
PAAS Tips:
Compound Supplier Medisca Pays $21.75 Million Over Inflated AWPs
The Department of Justice recently announced that Medisca Inc. will pay $21.75 million to settle allegations of fraud involving inflated Average Wholesale Prices (AWPs) for two ingredients used in compound prescriptions – resveratrol and mometasone furoate. The government alleges that the scheme caused pharmacies to submit false claims to federal healthcare programs, including TRICARE and the Department of Labor’s Office of Workers’ Compensation Programs.
Medisca reported highly inflated AWPs to price listing agencies, increasing reimbursements for its customers and creating massive profit spreads. For example:
These inflated prices incentivized pharmacies to use Medisca’s ingredients, over competitor products, leading to fraudulent billing that overcharged federal programs by thousands per prescription.
The case was brought under the False Claims Act (FCA) by a qui tam relator (a Texas pharmacist) who will receive $3.4 million of the settlement. The settlement underscores the government’s commitment to combating healthcare fraud and protecting taxpayer funds.
The investigation involved collaboration between the Justice Department’s Civil Division, U.S. Attorneys’ Offices in Texas, and federal investigative agencies such as the Defense Criminal Investigative Service (DCIS) and U.S. Postal Service Office of Inspector General.
The government filed similar complaints against other compound ingredient suppliers in 2019 and 2021.
PAAS Tips:
Optimizing Prescriber Statements: Best Practices and Tips
Prescriber statements have become one of the most valuable tools a pharmacy can use when needing to appeal claims found to be discrepant for a variety of reasons. They commonly take the form of a letter written by the prescriber to the PBM confirming, clarifying, or validating a prescription filled by your pharmacy. While every PBM has their own requirements, PAAS National® analysts have compiled a list of the typically required elements below.
Prescriber statements should have all the elements of the original prescription, in statement form, and address the reason for the discrepancy:
PAAS Tips:
CMS Updates HIV PrEP Supply Fee Code, Effective 01/01/2025
In December 2024, PAAS National® brought you the Medicare Part B Coverage of HIV PrEP Newsline article which provided an in-depth look into appropriately billing HIV PrEP medications to Medicare Part B. The original shift from billing these medications from Medicare Part D to Part B was effective just a few months ago (September 30, 2024, to be precise), and CMS has already instituted a change to the supply fee HCPCS billing code.
The left column of the table below shows the appropriate supply fee HCPCS codes and associated descriptions which were effective September 30, 2024, through December 31, 2024. The column on the right shows the new supply fee code effective January 1, 2025. In essence, one new supply fee code replaced the five original supply fee codes. For pharmacies that utilize a third-party billing intermediary for their Medicare Part B claims, this change will undoubtedly occur in the background as the pharmacy claim date is “translated” into medical claim data by the intermediary.
*Refer to PrEP for HIV & Related Preventative Services webpage under “How Do I Bill Starting January 1,2025?” for sample scenarios where billing for an additional supply fee would be appropriate
To complicate things even further, there were additional diagnosis codes approved (effective December 24, 2024) that are now accepted on Medicare Part B HIV PrEP claims which may not have been accepted previously. For more details, visit the CMS PrEP for HIV & Related Preventive Services webpage and click on the “What Diagnosis Code Can I Use?” heading.
Pharmacies that bill Medicare Part B must remain vigilant to ensure their claims will meet Medicare’s strict coverage requirements. An overview of DMEPOS claim guidance can be found within the 2024 PAAS National® DMEPOS Article Series. If you have any questions or concerns, or you have a Medicare Part B-related audit, contact PAAS!
2024-2025 Self-Audit Series #11: Controlled Substance Prescriptions
The opioid epidemic continues to make controlled substance prescriptions an increased focus for PBM audits. The potential for fraud, diversion, overdoses, and abuse remains high and pharmacies must stay vigilant when dispensing these prescriptions.
Due to federal and state requirements, controlled substance prescriptions have an increased risk of audit discrepancies. When found discrepant, PBMs typically cite as “law violations”, which are very difficult to overturn on audit appeal. Taking time to look over controlled prescriptions closely could prevent audit recoupment. Be sure to share the following tips with your pharmacy staff:
PAAS Tips:
New Tool on PAAS Portal – DMEPOS Article Series 2024
PAAS National® wrote a DMEPOS article series this year, which includes seven articles to be proactive in preventing Medicare Part B audits. We recently combined these articles into one tool for easy reference and review with your staff. The 2024 DMEPOS Article Series includes:
PAAS is continuously updating and creating new tools to help our members. Check out the Proactive Tips section of the Member Portal for a multitude of new and updated resources.
All employees can be granted access to the Member Portal to view these tools, along with the electronic Newsline. This also allows employees to send filling and billing questions to PAAS without having to call. If you have questions about permissions and website access visit the ‘Member Portal User Guide’ located under ‘Help’ in the left-hand navigation, or simply contact PAAS.