Plan limit rejections are intended to help control costs, provide clinical edits, and assist pharmacies in ensuring patient safety. When you bill a claim for the calculated days’ supply [based on the quantity and directions] and receive a rejection, you must identify and address the underlying rejection message. Paying attention to these rejection messages is key to avoiding audit recoupments. Here are a few examples:
- “Exceeds maximum daily dose, prior authorization required”
Prescription: Insulin Aspart FlexPen, 45 mL
Sig: Inject 40 units before breakfast, lunch, and supper plus correction scale. Max daily dose of 185 units.
Days’ Supply Calculation: 4500 units/185 units per day = 24 days’ supply
Initial Rejection with accurate days’ supply: “Exceeds maximum daily dose, prior authorization required”
Pharmacy Action: Rebilled the days’ supply for 30.
Audit Discrepancy: The claim was flagged as an incorrect days’ supply indicating a prior authorization (PA) is required for the dose prescribed
Potential Recoupment: full claim amount
Recommended Action Upon Initial Rejection: pursue prior authorization. Most limits are based on typical clinical use and/or FDA approved dosing.
Prescription: Oxycontin 80 mg, #90 tablets
Sig: One tablet three times a day
Days’ Supply Calculation: 90 tablets/3 tablets per day = 30 days’ supply
Initial Rejection with accurate days’ supply: “Plan limit exceeded. Maximum two tablets per day.”
Pharmacy Action: Rebilled the claim for #60 for 30 days
Audit Discrepancy: The claim was flagged as an incorrect days’ supply indicating a prior authorization (PA) is required for the dose prescribed
Potential Recoupment: full claim amount
Recommended Action Upon Initial Rejection: pursue prior authorization. Bypassing these edits for opioids can lead to overdoses or diversion. Especially for controlled substances, pharmacists have a corresponding responsibility to ensure that prescriptions are for a legitimate medical purpose 21 CFR 1306.04(a). The prescriber should obtain a prior authorization, change the dose or prescribe an alternative medication.
While we have recently seen OptumRx® be more aggressive with pharmacies “willfully” bypassing plan limits, all PBMs can easily identify when a claim rejected and was then immediately rebilled for the same quantity but different days’ supply or different quantity but same days’ supply (i.e., the quantity/day ratio change from the initial adjudication to a subsequent adjudication). This raises a red flag and is an easy audit target for PBMs.
PAAS Tips:
- Always bill for the accurate days’ supply based on the quantity and the directions given on the prescription
- Educate all pharmacy staff to identify rejection messages, how to properly resolve them, and avoid inputting an incorrect days’ supply or quantity to get a paid claim
- Check with the PBM help desk for guidance on rejects that are vague or unclear
- Do not split bill rejected claims
- Charging the patient cash often leads to complaints (from the patient to an employer or PBM) and can be considered non-compliance with the provider manual and lead to remediation, cease and desist letters, or even network termination
- If you have exhausted all plan options (including pursuing a PA or alternative therapy) and the patient insists on paying cash for the full prescription, be sure that you document authorization from the patient that they desired to pay the full cost and did not want to wait for the proper channels, and they will not seek reimbursement from the insurance
- If the prescriber does not follow through on obtaining a PA, enlist the patient to help. The patient could contact the prescriber and/or file a complaint with their insurance which may speed up the process
- See the following Newsline articles for more information on claim rejections
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.
Understanding the Medicare Prescription Payment Plan (MPPP or M3P): What You Need to Know
As part of the Inflation Reduction Act, all Medicare prescription drug plans (Medicare Part D plans) – including both standalone Medicare prescription drug plans and Medicare Advantage (MA) plans with prescription drug coverage – will be required to offer the Medicare Prescription Payment Plans (MPPP or M3P). This option allows patients to manage their copays and deductibles evenly throughout the year, benefiting those facing high drug costs early in the year. While participation is optional, enrolled patients will have a $0 copay at the pharmacy and will receive a monthly bill from their Part D or Advantage Plan, which features 0% interest and no fees. Patients can choose to enroll or opt out of the program at any time. Enrollment can be completed via phone, mail, or website of their selected Medicare Plan Sponsor. However, if patients fail to pay their bill by the end of the grace period (typically 60 days), they may be automatically opted out. It’s important to note that pharmacies are not responsible for enrolling patients or collecting payments on an M3P bill (nor are pharmacies able to enroll patients).
Starting January 1, 2025, if a prescription copay for a Medicare beneficiary exceeds $600, Plan Sponsors (via CMS directive) will require the pharmacy to provide the patient with the standard “Likely to Benefit” Notice (CMS Form 10882). The notification to issue this notice will be sent as an online adjudication response Approved Message Code 056 from the PBM, indicating that the patient is “likely to benefit” from the M3P. Since the patient needs to contact the plan to enroll, it won’t happen real time at the pharmacy counter. If the patient wants to opt in prior to picking up the prescriptions, they will need to return to the pharmacy at a later time once they have successfully enrolled. Once enrolled, all unsold prescriptions should be reversed and reprocessed to the Part D/MA plan, any secondary payor and then the M3P (i.e., the date of service should be the same for the Part D claim, any secondary payor [when applicable] and the M3P transaction). Prescriptions that were sold before opting in does not need to be submitted to the M3P processor, as the patient has already paid the copay.
If the patient has already opted in but does not have their M3P plan information, pharmacies can retrieve the necessary processing details by adjudicating a claim and checking for Approval Message Code 057. CMS mandates that all PCNs for M3P begin with “MPPP”. Paid claim responses will include M3P processing details in the “Coordination of Benefits/Other Payors” segment of the claim information. Note the M3P processing information will not be found in the E1 eligibility response.
Other things to know:
PAAS Tips:
Reap the Benefits of the PAAS National® Newsline Archive
Did you know that you can save time by searching past Newsline articles to find answers to your common questions? In fact, the Newsline archive offers articles going back to 2016! The search feature makes it simple to find that one article you know you read a while ago, but can’t seem to remember what it said.
When using the PAAS eNewsline on the Member Portal, you are able to search the Newsline Archive by date or by using a keyword. All the articles with that keyword will pop up for you. This is a convenient feature when looking for a quick answer to your question!
Some of the top Newsline articles used by PAAS analysts to answer questions are:
Try it out by looking up any keyword or you can try these below:
You can always contact us for assistance on using the Newsline search feature.
PAAS Tips:
Adjusting Quantity or Days’ Supply Disproportionately Will Cost You!
PAAS National® wants to emphasize the importance of submitting the correct days’ supply on claims. We see many audit results that could have been avoided had the pharmacy addressed the initial rejection and not bypassed the plan limit. A prevention strategy is important because these discrepancies are often difficult to appeal successfully. Pharmacy employees should be taught that a paid claim [at adjudication] may not remain paid [upon audit] and is no substitute for a claim that is billed accurately.
Plan limit rejections are intended to help control costs, provide clinical edits, and assist pharmacies in ensuring patient safety. When you bill a claim for the calculated days’ supply [based on the quantity and directions] and receive a rejection, you must identify and address the underlying rejection message. Paying attention to these rejection messages is key to avoiding audit recoupments. Here are a few examples:
Prescription: Insulin Aspart FlexPen, 45 mL
Sig: Inject 40 units before breakfast, lunch, and supper plus correction scale. Max daily dose of 185 units.
Days’ Supply Calculation: 4500 units/185 units per day = 24 days’ supply
Initial Rejection with accurate days’ supply: “Exceeds maximum daily dose, prior authorization required”
Pharmacy Action: Rebilled the days’ supply for 30.
Audit Discrepancy: The claim was flagged as an incorrect days’ supply indicating a prior authorization (PA) is required for the dose prescribed
Potential Recoupment: full claim amount
Recommended Action Upon Initial Rejection: pursue prior authorization. Most limits are based on typical clinical use and/or FDA approved dosing.
Prescription: Oxycontin 80 mg, #90 tablets
Sig: One tablet three times a day
Days’ Supply Calculation: 90 tablets/3 tablets per day = 30 days’ supply
Initial Rejection with accurate days’ supply: “Plan limit exceeded. Maximum two tablets per day.”
Pharmacy Action: Rebilled the claim for #60 for 30 days
Audit Discrepancy: The claim was flagged as an incorrect days’ supply indicating a prior authorization (PA) is required for the dose prescribed
Potential Recoupment: full claim amount
Recommended Action Upon Initial Rejection: pursue prior authorization. Bypassing these edits for opioids can lead to overdoses or diversion. Especially for controlled substances, pharmacists have a corresponding responsibility to ensure that prescriptions are for a legitimate medical purpose 21 CFR 1306.04(a). The prescriber should obtain a prior authorization, change the dose or prescribe an alternative medication.
While we have recently seen OptumRx® be more aggressive with pharmacies “willfully” bypassing plan limits, all PBMs can easily identify when a claim rejected and was then immediately rebilled for the same quantity but different days’ supply or different quantity but same days’ supply (i.e., the quantity/day ratio change from the initial adjudication to a subsequent adjudication). This raises a red flag and is an easy audit target for PBMs.
PAAS Tips: