a specialized online calculator developed by the ointment’s manufacturer to aid in appropriate dosing calculations and dispensing. When the ointment is being used for a chronic wound, prescriptions for Santyl
® must include the wound length and width (in centimeters) and the treatment duration to appropriately utilize the online calculator. When prescribed for a burn, the total body surface area and number of applications is required. Prescriptions missing applicable measurements will be flagged for non-calculable directions and will face full recoupment. Auditors are drawn to these scripts because they are high dollar claims and prescribers, and pharmacy personnel, often forget to include or obtain the measurements. Without this critical information documented, the claim will meet its demise upon audit.
Another pitfall to avoid with Santyl® ointment claims is the inherent rounding with the online calculator that could inadvertently cause the pharmacy to bill an incorrect days’ supply. The dosing calculator rounds UP to the nearest tube size (packed as 30 or 90 grams), therefore, the true days’ supply must be calculated by the pharmacy to ensure you are not dispensing more medication than what is needed.
Example Wound Calculation:
Wound dimensions in centimeters and the duration of therapy = 6 cm x 2 cm for 30 days
- Manufacturer calculator results indicate a total of 62 g would be needed, and it suggests dispensing 90 g total
- The patient would need 3.6 cm per application if dispensing the 90 g tube (or 6.2 cm per application for the 30 g tube due to the tube opening diameter difference)
- The calculation details state 1.78 cm = 1 g for the 90 g tube size
- 90 g x 1.78 cm/g = 160.2 cm in the 90 g tube
- 2 cm / 3.6 cm = 44.5 days’ supply
- If the pharmacy were to dispense the 90 g tube for a 30-day supply, they would be dispensing too much medication
The pharmacy should dispense two 30-gram tubes in this example
- The 30 g tube needs 6.2 cm per application (tube opening is smaller than the 90 g tube)
- The calculation details state 3.04 cm = 1 g for the 30 g tube size
- 30 g x 3.04 cm/g = 91.2 cm in the 30 g tube
- 2 cm / 6.2 cm = 14.7 days’ supply
- Therefore, two 30 g tubes = 29.4 days’ supply
The SIMPLEST Method
The calculation method above is accurate, but also time consuming! The simplest method for calculating the correct quantity and days’ supply for Santyl® for a chronic wound is utilizing the PAAS National® Rx Days’ Supply Calculator app! The wound(s) dimensions are still required but the user-friendly interface has been designed to enhance efficiency and empower pharmacy staff with confidence. The PAAS Rx Days’ Supply Calculator app eliminates the inherent rounding issue seen with the manufacturer’s calculator and provides precise calculations.
Rather than getting zapped with a recoupment, be prepared; have all the appropriate documentation accounted for at the time the claim is billed and bill for an accurate days’ supply. When audited, the claim has a higher probability of passing with no discrepancies and sending the auditor buzzing off with zero recoupment.
PAAS Tips:
- Add a flag to the 30 g (NDC 50484-010-30) and 90 g (NDC 50484-010-90) tubes of Santyl® ointment in your pharmacy software system reminding pharmacy staff to review the prescription for the wound length and width (in centimeters) and treatment duration
- If more than one wound is being treated, be sure measurements and the treatment duration for each wound is documented
- Consider revaluating wound measurements periodically as the wound is (hopefully) decreasing in size during the course of therapy
- Contact the prescriber’s office and obtain a new prescription if the wound size has changed
- Plug in the new measurements into the PAAS Rx Days’ Supply Calculator app or Santyl® online calculator and bill for the appropriate quantity and days’ supply
- Note: the Santyl® calculators will only allow a 30-day maximum duration of therapy, likely to reiterate the importance of wound revaluation
- For the treatment of a burn, only the Santyl® manufacturer’s online calculator can be utilized for determining the appropriate quantity; just remember to back-calculate the correct days’ supply by following the method outlined above
- Download the PAAS Rx Days’ Supply Calculator app for a free 7-day trial ($5.99/year thereafter) by visiting the Apple App Store or Android Google Play Store, or check out the website at com/app
Auditors Are Drawn to Santyl® Like Moths to a Flame
Summer is here and so are the bugs! While mosquitos, gnats, moths and the like have next to nothing to do with Santyl® ointment for debriding chronic dermal ulcers and severely burned areas, the visualization of auditors being drawn to claims for Santyl® ointment being akin to moths (or other bugs) being drawn to a flame is a parallel not to be ignored.
A pharmacy billing a claim for Santyl® ointment is likely to see the claim audited in the future because Santyl® ointment has …
Another pitfall to avoid with Santyl® ointment claims is the inherent rounding with the online calculator that could inadvertently cause the pharmacy to bill an incorrect days’ supply. The dosing calculator rounds UP to the nearest tube size (packed as 30 or 90 grams), therefore, the true days’ supply must be calculated by the pharmacy to ensure you are not dispensing more medication than what is needed.
Example Wound Calculation:
Wound dimensions in centimeters and the duration of therapy = 6 cm x 2 cm for 30 days
The pharmacy should dispense two 30-gram tubes in this example
The SIMPLEST Method
The calculation method above is accurate, but also time consuming! The simplest method for calculating the correct quantity and days’ supply for Santyl® for a chronic wound is utilizing the PAAS National® Rx Days’ Supply Calculator app! The wound(s) dimensions are still required but the user-friendly interface has been designed to enhance efficiency and empower pharmacy staff with confidence. The PAAS Rx Days’ Supply Calculator app eliminates the inherent rounding issue seen with the manufacturer’s calculator and provides precise calculations.
Rather than getting zapped with a recoupment, be prepared; have all the appropriate documentation accounted for at the time the claim is billed and bill for an accurate days’ supply. When audited, the claim has a higher probability of passing with no discrepancies and sending the auditor buzzing off with zero recoupment.
PAAS Tips:
Metformin HCl ER – Audit Considerations
Metformin HCl ER is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It is commonly prescribed for patients who have gastrointestinal side-effects when taking the original. non-ER. version of the medication. Unfortunately, the cost difference can be significant, leading to an increased risk for audit – especially when a patient is taking Glumetza® or Fortamet®.
To add to the confusion, there are three different versions of metformin HCl ER, with three different extended-release mechanisms.
You may only dispense a generic formulation of the above if the TE code matches.
PAAS Tips:
Diabetic Test Strip Authorized Distributors
Independent pharmacies continue to receive threatening letters from LifeScan and an affiliated law firm on a monthly basis. These letters argue that pharmacies submitted more claims for LifeScan’s OneTouch® diabetic test strip products to PBMs than are supported by purchase history from authorized distributors. This is essentially an “invoice audit” conducted behind the scenes and pharmacies are not participants until they receive the negative results.
Additionally, these letters threaten to expose pharmacies to harm by withholding rebate dollars owed to PBMs and notify PBMs of the pharmacy’s “non-compliance” unless the pharmacy pays a large amount of money to make the issue “go away”.
As readers are well aware, it is difficult to make a profit on insured claims where PBMs control the selling price, so it is logical to look to lower your cost of goods as much as possible to either squeak out a little profit or minimize the losses. What becomes problematic is trying to buy at the lowest cost possible while also adhering to PBM contractual requirements and ensuring that products obtained through the supply chain are legitimate.
Because diabetic test strips are classified by the FDA as OTC medical devices, they fall outside of the Drug Supply Chain Security Act (DSCSA) and there is no requirement for a “pedigree” to ensure sourced product is legitimate and not stolen, counterfeit or previously dispensed (gray market). Pharmacies need to take extra care when considering sourcing product that is advertised at a lower cost compared to your primary wholesaler. Manufacturers have developed and maintained “lists” to aid supply chain partners like pharmacies.
Manufacturer Authorized distributor lists for major diabetic test strips:
It is also important to understand what each of the major PBMs have to say about sourcing diabetic test strips. While OptumRx does NOT explicitly require pharmacies to purchase test strips from authorized distributors, they do require that pharmacies source all products (including OTC test strips) from vendors that are both (i) licensed as a drug wholesaler in your state and (ii) an NABP accredited drug distributor. Both Caremark and Express Scripts have language in their respective Provider Manuals to require network pharmacies purchase test strips from authorized distributors only.
Finally, there are two states (California and New Jersey) that have regulations pertaining to the purchase and distribution of OTC diabetic test strips.
PAAS Tips:
Ensuring Audit Readiness: What PBMs Look for in Signature Logs and Proof of Delivery
One of the most common questions PAAS National® receives from our members is: what are the requirements for audits when signature logs are requested. This article contains reminders and requirements auditors will be looking for to help ensure your pharmacy will be prepared.
With the end of the Public Health Emergency on May 11, 2023, PBM waivers were rescinded regarding signature collection and mailing allowances, except for Humana who permitted the mailing waiver until December 31, 2023. Pharmacies must remind all staff to collect signatures at the time of prescription pickup and delivery. Not complying could result in big audit recoupments and lots of hassle for pharmacies to appeal.
Pharmacies and patients alike became used to not having to sign at prescription pick up, or like the convenience of having their local pharmacy mail or deliver medications to them. Unfortunately, getting patients to understand what their insurance requires can be difficult, but is necessary.
The large PBMs like Caremark, Humana, OptumRx and Express Scripts allow delivery of prescriptions, but some do have limitations or restrictions. Some PBMs may include these restrictions in their pharmacy contract agreements and not their provider manuals.
Two of the largest PBMs restrict delivery as follows:
PAAS Tips:
2024 Self-Audit Series #5: Topical Prescriptions
Topical medications are easy audit targets, especially with the rising costs of some of these medications. The discrepancy that is commonly cited for topical medications is …
Pharmacies must do their due diligence to ensure the appropriateness of what is being billed. Prescriptions that include the number of grams per application and a frequency can easily be billed with an accurate days’ supply. Vague instructions for use should be clarified with the prescriber and documented with a clinical notation on both the prescription and added to the patient’s label (an OptumRx requirement!).
Pharmacies must not rely on the days’ supply field indicated on an electric prescription as this is not accepted by PBM auditors. Prescriptions written for a quantity of “1”, are generally flagged for “incomplete quantity”. Auditors require a specific quantity in grams, milliliters, or pumps to be indicated. Verifying and documenting can help avoid audit recoupments!
PAAS Tips:
How to Safeguard Your Pharmacy from Fraudulent Electronic Prescriptions
PAAS National® has recently assisted pharmacies who received fraudulent electronic prescriptions from prescribers that had their electronic prescribing credentials hacked or stolen. There was a recent widespread e-prescription fraud reported earlier this year where criminals issued over 18,000 prescriptions to pharmacies in 18 states in just a 5-hour span.
Fraudulent prescriptions that are billed to the patient’s insurance are subject to full recoupment when audited by the PBM. Unfortunately, pharmacies will need to cooperate with the PBM audit process and prove that they were not willing participants by explaining their process of “due diligence” to authenticate the prescriptions. To offset the financial losses from PBM recoupment, pharmacies will need to lean on their business insurance or separately pursue legal action against the perpetrators.
Of course, it would be much better to avoid dispensing (and billing) these fraudulent prescriptions from the start. Although electronic prescriptions are generally safer than written or telephone prescriptions, they are still vulnerable to exploitation by criminals targeting unsuspecting pharmacies.
Here are some techniques to spot fraudulent electronic prescriptions at your pharmacy:
PAAS Tips:
What’s New with Prescription Validation Requests in 2024?
In the PAAS National® January 2024 Newsline article PBM Validation Requests Rose 123% in 2023 – What You Need to Know, we discussed the PBM trends we saw in 2023. Below is a list of drugs reviewed and analyst comments that have been compiled through the first six months of 2024 for comparison.
Top 5 drugs reviewed in 2023 compared to first half of 2024:
While Creon® is still one of the top PBM targets, you can see that during the first half of 2024, the PBMs have shifted their focus from monitoring insulin claims to GLP-1s and migraine medications, demonstrating how PBM audit trends change over time. Be assured that the PBMs will continue to send claim reviews for insulin as well. While they may not show in the top 5 drugs of 2024 so far, Tresiba®, Humalog®, Levemir®, insulin lispro and Toujeo® were all right behind Ubrelvy® in the number of claim reviews the PBMs have issued to date in 2024.
The top 5 comments noted by an analyst after claim review mimic the same 5 from 2023:
PAAS Tips:
Proper Billing of Nayzilam® and Valtoco® Nasal Sprays
A subset of patients who experience seizures due to epilepsy suffer from seizure clusters, despite being on maintenance epilepsy medications. Nayzilam® and Valtoco® are both FDA-approved for the “acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern” in patients 12 years and older and 6 years and older, respectively. Regardless, if your patient is prescribed Nayzilam® or Valtoco®, the perplexing billing opens the door for easy recoupments from PBMs.
The first step to take when receiving either a Nayzilam® or Valtoco® prescription is to ensure it has clear directions and quantity prescribed.
Per the manufacturer product label, the initial dose of Nayzilam® is one spray into one nostril. If needed, and the directions support, an additional spray may be administered into the opposite nostril 10 minutes after the initial dose if the patient has not responded to the initial dose. For Valtoco®, the number of sprays per dose is dependent on the strength prescribed. According to the manufacturer product label, the initial dose for the 5 mg and 10 mg strengths is one spray into one nostril while the initial dose for the 15 mg and 20 mg strengths is two sprays – one spray into each nostril. If needed, and the directions support, a second dose may be administered at least 4 hours after the initial dose if the patient has not responded to the initial dose.
Also, it is necessary to know the maximum number of episodes the patient is allowed to treat per month to correctly calculate the days’ supply. FDA-approved directions recommend no more than two doses of Nayzilam® should be used to treat a single episode and it should not be used to treat more than one episode every three days with a maximum of five episodes per month. Similarly, FDA-approved directions recommend no more than two doses of Valtoco® should be used to treat a single episode and it should not be used to treat more than one episode every five days with a maximum of five episodes per month.
See the chart below and PAAS Tips for recommended billing guidance, in addition to other prescription components necessary to best protect your pharmacy from audit recoupments:
PAAS Tips:
On-Demand Webinar: Cybersecurity Considerations for Community Pharmacies
On May 8, 2024, PAAS National® hosted a webinar: Cybersecurity Considerations for Community Pharmacies. PAAS Audit Assistance members have access to the recorded webinar, in addition to many other tools and resources on the PAAS Member Portal.
In a world where threats lurk around every digital corner, safeguarding sensitive information has never been more crucial. Recent events, such as the Change Healthcare cyberattack, serve as stark reminders of the pressing need for robust cybersecurity measures. In pharmacies, where compliance with regulations like HIPAA are of great importance, the stakes are higher than ever.
President of PAAS, Trent Thiede, discussed:
Should you have any questions, or need assistance getting access, call 608-873-1342 or email info@paasnational.com.
PAAS Tips:
The Different Cyclosporine Eye Drops That Could Cause Audit Trouble
Cyclosporine eye drops are used to increase tear production in individuals with certain eye conditions and dry eye disease. You are likely familiar with Restasis® and Restasis MultiDose®, but the newest cyclosporine product Vevye®, hit the market in late 2023.
00023-9163-60
60 Each
Caution: Restasis® is also available in a 5.5 mL multi-dose preservative-free bottle NDC 00023-5301-05
⃰ Written correspondence from manufacturer confirms 200 drops in a 2 mL bottle. 2 mL/0.01 mL per drop = 200 drops
PAAS Tips: