Durable vs. Disposable Pumps
Medicare Part B will cover a durable insulin pump if the beneficiary meets specific eligibility criteria. Refer to the September 2020 Newsline article, Billing Insulin for a Pump is Tricky, Especially for Medicare Patients. If the pump is covered by Part B, the drug for inside the pump is also covered by Part B. Tubeless pumps (such as V-Go® and Omnipod®) are not considered durable medical equipment because they cannot withstand repeated use; therefore, tubeless pumps do not meet Medicare Part B coverage criteria. Simply put, both the tubeless pump and the insulin used within the tubeless pump should be billed to Medicare Part D.
V-Go®
V-Go® disposable pumps have unique limitations which must be considered when calculating the days’ supply for the insulin used with the device. These pumps should only be used by patients with Type 2 diabetes and each of the three V-Go® devices have different insulin reservoir capacities; the device must be filled to the maximum capacity and must be changed every day. Therefore, if the patient is using a V-Go® 30 they would need 66 units per day, and for a 30-day supply they would need 20 mL of insulin (2000 units divided by 66 units/day equals a 30 days’ supply). Dispensing more insulin than what can be held in the prescribed V-Go® device for the duration of that claim can lead to chargebacks. Dispensing too little could lead to “refill too soon” rejections when the patient attempts to refill their insulin.
| V-Go® Device |
NDC |
Package |
Day’s Supply considerations |
Estimated Days’ Supply of Insulin* |
| Contents |
Billing Quantity |
Total Device Capacity |
Basal Rate + Bolus Capability |
10 mL |
20 mL |
30 mL |
| V-Go® 20 |
08560-9400-03 |
30 devices |
30 EA |
56 units |
20 units/24 hours plus max 36 units for bolus dosing |
17 days |
35 days |
53 days |
| V-Go® 30 |
08560-9400-02 |
30 devices |
30 EA |
66 units |
30 units/24 hours plus max 36 units for bolus dosing |
15 days |
30 days |
45 days |
| V-Go® 40 |
08560-9400-01 |
30 devices |
30 EA |
76 units |
40 units/24 hours plus max 36 units for bolus dosing |
13 days |
26 days |
39 days |
*Mankind pharmaceuticals, who now owns V-Go, has reported through their Medical Affairs team that there is approximately 8 units daily that are wasted due to priming and dead space in the device. This has not been confirmed in writing, nor found in the package insert, so PAAS’ calculations do not consider this. Mankind is planning to update their literature, which would support pharmacies including this waste into days’ supply calculations.
Omnipod®
These disposable pumps can be worn for up to 72 hours; however, they could be changed earlier based on the patient’s insulin utilization. Each pod holds a maximum of 200 units of insulin; therefore, patients will change the pod at least every 3 days, sooner if they have used all 200 units. To appropriately bill the insulin used with the Omnipod®, the insulin prescription must take into consideration the frequency the pod is changed and the total amount of insulin the patient utilizes. Billing an accurate days’ supply is vital to the claim passing an audit.
| Omnipod® Device |
NDC |
Package |
Days’ Supply Considerations |
| Contents |
Billing Quantity |
Total Pod Capacity |
Frequency to Change Pod |
| Omnipod® 5 G6 Intro Kit (Gen 5) |
08508-3000-01 |
1 controller + 10 pods |
1 EA |
200 units |
Every 48-72 hours* |
| Omnipod® 5 G6 Pods (Gen 5) Refill |
08508-3000-21 |
5 pods per box |
5 EA |
200 units |
Every 48-72 hours* |
| Omnipod® DASH Intro Kit (Gen 4) |
08508-2000-32 |
1 PDM± and 10 pods |
1 EA |
200 units |
Every 48-72 hours* |
| Omnipod® DASH Pods (Gen 4) Refill |
08508-2000-05 |
5 pods per box |
5 EA |
200 units |
Every 48-72 hours* |
*Based on total daily insulin usage or 72-hour max wear-time
±Personal Diabetes Manager (PDM)
Insulin Overview
Not all insulins are designed to be used in a pump. Only vials of rapid acting such as insulin aspart (NovoLog®, Fiasp®), insulin lispro (Admelog®, Humalog®, Lyumjev®), or insulin glulisine (Apidra®) have been approved for use in a pump. Long-acting, pre-mixed, and concentrated insulins (e.g., U-500) have not been approved for use in a pump, and neither have insulin pens. Using unapproved insulin products in a pump could lead to patient safety issues and chargebacks.
PAAS Tips:
- PAAS analysts encourage pharmacy staff to follow these steps when processing claims for insulin vials to ensure the correct plan is billed
- Determine if the insulin vials are being used with insulin syringes or with a pump
- Determine if the insulin pump is disposable or durable
- If the pump is durable, determine if the patient has a Medicare Part D plan (PDP) or a Medicare Advantage Plan (MAPD)
- It is often helpful to look at the patient’s insurance card
- Clues it may be a Medicare Advantage Plan include “MAPD”, “Advantage” or a contract number that starts with “H” or “R” in the MA Plan Directory
- Pharmacies billing insulin for a patients enrolled in a MAPD should bill the MAPD; the plan will separate the Part B claims from the Part D claims and take care of the proper billing on the backend
- Contract numbers starting with “S” or “E” are PDP; refer to the PDP Plan Directory for more details
- If claims are billed to Part D incorrectly, and subsequently audited and recouped, you can rebill the claim to Part B within 12 months of the date of service, but only if you were enrolled as a DMEPOS supplier on the claim date of service
- Watch for “red flags” on insulin claims to avoid future recoupments
- Prescriptions for insulin vials without insulin syringes could indicate the patient is using a pump; it is advisable to follow up with the patient and/or the prescriber for additional clarification
- Prescriptions for insulin pens, long-acting insulin, pre-mixed insulin, or concentrated insulin with directions “use in pump” would warrant a discussion with prescriber’s office
- Watch for adjudication messaging and “soft rejects” instructing the pharmacy to complete a Part D vs. Part B determination on claims for insulin vials
Carry Clinical Notes Forward for Audit Coverage
Seasoned pharmacy staff can often list off the patients who prefer brand drug or whose insurance requires the brand name for certain medications. Some pharmacy staff know their customers so well that they know exactly how to adjudicate a claim without receiving any rejects. In fact, that is one of the many benefits of independent pharmacy – the high-level of personalized experience customers receive. However, issues arise when an auditor, who has no prior knowledge about your patients, reviews hardcopies as part of an audit and does not see supporting documentation to substantiate how the claim was adjudicated. That is why it is of the utmost importance that…
For example, pharmacies may opt to forego billing for generic attention-deficit/hyperactivity disorder (ADHD) medication knowing that a longtime pharmacy customer’s insurance requires brand. A clinical note stating “insurance requires brand” or producing proof of the generic being rejected on a prior adjudication would still be needed to substantiate billing the DAW 9. For the instances where a DAW 2 is used (“Substitution Allowed – Patient Requests Product Dispensed”), those clinical notes need to be included on each prescription as well, or else there is risk that the PBM will look to recoup the claim.
When DUR rejects occur, especially for Express Scripts, showing what steps were taken to give due diligence to the reject is required, such as contacting the prescriber to ensure they were aware of a potentially harmful drug-drug interaction. Pharmacies may opt to not call every month on the same DUR reject and therefore notation of the last time the DUR was addressed is necessary. This brings up the question of how often to rechallenge billing the generic medication or to reconfirm the clinical note with the prescriber. There is not a steadfast rule; however, it is our guidance that pharmacies rechallenge with each new prescription, apart from C-II medications, medication dosage changes, and the beginning of each plan year.
PAAS Tips:
Medication Error Reporting Through PAAS’ FWA/HIPAA Compliance Program
The importance of having an internal process to record and monitor medication errors cannot be overstated. Being able to identify how medication errors occur can help pharmacy owners avoid repeat issues and pinpoint an area for operational improvement. Medication error reports can also help mitigate legal action if brought against the pharmacy.
PBMs require pharmacies to have a medication error reporting tool as part of credentialing, resulting in pharmacies commonly asking if PAAS offers a medication error reporting tool. The answer is yes! The PAAS Fraud, Waste, and Abuse & HIPAA Compliance Program offers a robust section pertaining to quality assurance incident reporting, including medication error reporting and close call reporting. Section 4.4 “Quality Assurance” speaks to the pharmacy’s dedication to ensuring medication errors and drug interactions are caught and corrected expeditiously in addition to what procedures are implemented to minimize the likelihood of errors occurring. The actionable parts of your medication error reporting can be found in Appendix B in the section entitled Quality Assurance Incident Reporting system (QuAIR). QuAIR meets the federal requirements for pharmacies to have a medication error reporting system in place. For pharmacies looking to develop more robust policies, the Policy & Procedure Manual now allows for custom content in a new section.
If you are not yet an FWA/HIPAA compliance member and would like to schedule a time for a virtual service overview, you can sign up for a time by visiting PAASNational.com/contact. Current FWA/HIPAA member admins and officers can review their compliance tasks in the Member Portal to confirm that your compliance program is up-to-date for 2023. If you would like a PAAS team member to walk-thru the program with you, schedule a virtual meeting here or call us at (608) 873-1342.
LifeScan Extortion – Diabetic Test Strip “Authorized Distributors”
For the second time in the last three years, numerous pharmacies have received, what PAAS National® would consider extortionary, letters from LifeScan. These letters state the pharmacy has a discrepancy between purchases (from their authorized distributor) and rebates paid to PBMs for the pharmacy’s claims of diabetic test strips, specifically OneTouch® Verio® and Ultra®. The letters threaten the pharmacy to pay LifeScan to resolve the shortage or else LifeScan will notify PBMs and withhold rebates to incentivize the PBMs to come after the pharmacies.
The manufacturer of OneTouch® Ultra® and OneTouch® Verio® branded test strips has collected data from PBMs regarding pharmacy dispensing (via rebate claims) and from authorized distributors regarding pharmacy purchasing information to conclude where they have paid inappropriate rebates to PBMs.
Since diabetic test strips are OTC medical devices, they fall outside of the FDA’s Drug Supply Chain Security Act (DSCSA) and have been a long-time concern for manufacturers and regulators due to counterfeit and gray market products. Because of this regulatory blind spot, manufacturers have created, and publicly posted, lists of “authorized distributors”. These supply chain partners have agreed to manufacturer terms and conditions, including provisions that they will not purchase or sell counterfeit or diverted goods or sell any authorized product to non-authorized distributors.
Listed below are the major diabetic test strip manufacturer websites (not all inclusive) where you can validate that your suppliers are authorized. If your wholesaler is not on the list, then you should question where they received their product from.
Test strips purchased from non-authorized distributors may be offered at a lower sticker price, but these front-end savings may disappear on the back-end if you are subject to a PBM audit. Additionally, your patients may be at risk if the products are counterfeit and the measurements are not reliable.
Caremark and Express Scripts revised their Pharmacy Provider Manuals in 2016 in response to a large Abbott lawsuit against 57 wholesalers for reimporting foreign product in 2015 and they aggressively targeted pharmacies with invoice audits to recoup lost rebate payments from Abbott. OptumRx does not explicitly require pharmacies to use authorized distributors for diabetic test strips; however, they require pharmacies to be purchasing from an NABP Accredited Drug Distributor and a wholesaler who is licensed in your state (i.e., not OTC distributors).
Lastly, two state boards of pharmacy (CA, NJ) have explicit rules for pharmacies that require purchases of diabetic test strips directly from the manufacturer or their authorized distributors. The California Board of Pharmacy even has a website where pharmacies can find most of the manufacturer authorized lists in one place.
PAAS Tips:
Audit Target – Pre-Filled Injectable Pens and Syringes
Audit Target – Pre-Filled Injectable Pens and Syringes
Pre-filled injectable medication such as insulin, Invega®, Humira®, Enbrel® and Ozempic® remain a big target for audit risk due to their high cost and potential billing pitfalls. One claim error can cost you thousands of dollars. PAAS National® often sees prescriptions for pre-filled injectable medications flagged for recoupment due to one or more of the following reasons:
PAAS Tips:
Post-PHE Claim Submission Requirements for Continuous Glucose Monitors
Centers for Medicare and Medicaid Services (CMS ) did not enforce clinical indications for specific product categories during the Public Health Emergency (PHE), including Continuous Glucose Monitors (CGMs). During this time, the provider only needed to indicate the CGM and related supplies were reasonable and necessary. Pharmacies had to identify that these claims were excluded from enforcement by submitting a Catastrophe/Disaster Related (CR) modifier and a COVID-19 narrative on those claims.
Now that the PHE has ended and CMS is enforcing clinical indications for CGMs and supplies, pharmacies are left wondering what will happen with continued or refilled claims for CGM related supply items initially provided during the PHE under the waiver/non-enforcement.
PAAS Tips:Join today!
- For continued CGM supplies and accessories initially provided during the PHE under the waiver/non-enforcement:
- Suppliers need to continue to use the CR modifier and COVID-19 narrative for dates of service after May 12, 2023. These actions allow the DME MACs to use new edits on the PHE dispensed items and be able to identify these claims for future review
- Suppliers should continue to bill the KX, and/or CG modifiers as applicable
- During the PHE, CMS stated there must be an order and documentation to confirm medical need for items under waiver/non-enforcement
- Medical need for supplies is typically established and documented when the item is initially provided; Medicare plans to primarily focus medical reviews on claims with initial dates of service after the PHE
- Potential medical reviews for CGMs would likely occur at least 6 months after the end of the PHE to ensure the treating practitioner has an in-person or approved telehealth visit with the beneficiary to meet the face-to face requirement
- For a CGM and/or related supplies with initial dates of service on and after May 12, 2023, clinical indications for coverage will be enforced
- Resources for this coverage criteria:
- See the April 2023 Newsline article, A Documentation Checklist for Continuous Glucose Monitor Claims for Medicare coverage requirements, updated as of 4/16/2023
- Glucose Monitor/CGM LCD
- Glucose Monitor/CGM Policy Article
- Suppliers must be diligent in recognizing when the initial CGM dispensing took place
- If on or after May 12, 2023, then suppliers need to follow the new LCD coverage requirements for CGMs and related supplies
- If during the PHE, continue to affix the CR modifier and COVID-19 narrative (where appropriate) and be sure the item continues to be reasonable and necessary to prevent recoupment
Appropriate Billing for CeQur SimplicityTM Patch and Insulin
CeQur SimplicityTM is a meal-time insulin patch which can be worn for up to three days and is designed to replace up to nine meal-time insulin doses for type 1 or type 2 diabetic patients. The patch delivers rapid-acting insulin in 2-unit doses through a flexible cannula by depressing two buttons, one on each side of the patch.
Use the following information when billing CeQur Simplicity TM patches and the rapid-acting insulin used within the patch to decrease your risk of recoupment upon audit.
PAAS Tips:
Quantity Changes Cause Audit Appeal Trouble
PAAS National® is seeing more discrepancies for “unauthorized” refills on audits and PBMs continue to make these discrepancies difficult to appeal.
What is considered an “unauthorized refill?” Examples include:
In all the above cases, good documentation is key to avoiding audit discrepancies. It is preferable to have date and time stamped electronic notes at the time of dispensing. Check with your software vendor about your system’s capabilities.
PAAS Tips:
Insulin For a Pump: The Recoupment You Never Saw Coming
There are many billing pitfalls related to insulin claims, which is why auditors love to target them. The claim can face recoupment for a missing or incorrect strength, formulation, substitution, days’ supply calculation and so on, but one recoupment many pharmacies never see coming is insulin for a pump being inappropriately billed.
Even if your pharmacy is not enrolled as a Medicare Part B supplier, you are still responsible for knowing how the patient is using their insulin because it determines which Medicare benefit is responsible for payment. If the claim is inappropriately billed to Medicare Part D, it would face full recoupment upon audit. PBM algorithms can easily pick out these claims when insulin vials are routinely being billed without insulin syringes. Additionally, the type of pump can impact the amount of insulin covered due to pump capacity and how frequently the disposable pump must be changed. To prevent chargebacks during an audit, pharmacies must be aware of the intricacies related to insulin pumps and the insulin used within them.
Durable vs. Disposable Pumps
Medicare Part B will cover a durable insulin pump if the beneficiary meets specific eligibility criteria. Refer to the September 2020 Newsline article, Billing Insulin for a Pump is Tricky, Especially for Medicare Patients. If the pump is covered by Part B, the drug for inside the pump is also covered by Part B. Tubeless pumps (such as V-Go® and Omnipod®) are not considered durable medical equipment because they cannot withstand repeated use; therefore, tubeless pumps do not meet Medicare Part B coverage criteria. Simply put, both the tubeless pump and the insulin used within the tubeless pump should be billed to Medicare Part D.
V-Go®
V-Go® disposable pumps have unique limitations which must be considered when calculating the days’ supply for the insulin used with the device. These pumps should only be used by patients with Type 2 diabetes and each of the three V-Go® devices have different insulin reservoir capacities; the device must be filled to the maximum capacity and must be changed every day. Therefore, if the patient is using a V-Go® 30 they would need 66 units per day, and for a 30-day supply they would need 20 mL of insulin (2000 units divided by 66 units/day equals a 30 days’ supply). Dispensing more insulin than what can be held in the prescribed V-Go® device for the duration of that claim can lead to chargebacks. Dispensing too little could lead to “refill too soon” rejections when the patient attempts to refill their insulin.
*Mankind pharmaceuticals, who now owns V-Go, has reported through their Medical Affairs team that there is approximately 8 units daily that are wasted due to priming and dead space in the device. This has not been confirmed in writing, nor found in the package insert, so PAAS’ calculations do not consider this. Mankind is planning to update their literature, which would support pharmacies including this waste into days’ supply calculations.
Omnipod®
These disposable pumps can be worn for up to 72 hours; however, they could be changed earlier based on the patient’s insulin utilization. Each pod holds a maximum of 200 units of insulin; therefore, patients will change the pod at least every 3 days, sooner if they have used all 200 units. To appropriately bill the insulin used with the Omnipod®, the insulin prescription must take into consideration the frequency the pod is changed and the total amount of insulin the patient utilizes. Billing an accurate days’ supply is vital to the claim passing an audit.
*Based on total daily insulin usage or 72-hour max wear-time
±Personal Diabetes Manager (PDM)
Insulin Overview
Not all insulins are designed to be used in a pump. Only vials of rapid acting such as insulin aspart (NovoLog®, Fiasp®), insulin lispro (Admelog®, Humalog®, Lyumjev®), or insulin glulisine (Apidra®) have been approved for use in a pump. Long-acting, pre-mixed, and concentrated insulins (e.g., U-500) have not been approved for use in a pump, and neither have insulin pens. Using unapproved insulin products in a pump could lead to patient safety issues and chargebacks.
PAAS Tips:
On-Demand Webinar: Audit Preparation for the End of the Public Health Emergency
On May 4, 2023, PAAS National® hosted a webinar: Audit Preparation for the End of the Public Health Emergency. 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.
Should you have any questions, or need assistance getting access, call 608-873-1342 or email info@paasnational.com.
Ozempic® Package Size Change
In March 2023, Novo Nordisk introduced a new pen size for the 0.25 mg and 0.5 mg dose of Ozempic®. The previous pen was a 1.5 mL and the new pen is 3 mL. All strengths of Ozempic® now come in 3 mL pens. Pharmacies have frequently asked how this change affects patients’ current prescriptions.
PAAS National® analysts recommend pharmacies…
(0.25 mg) or Maintenance Dose (0.5 mg)
Pharmacies must also be aware of potential incorrect dosing instructions with injections like Ozempic® and Victoza®. The dose counters on these medications are measured by mg not mL, which can increase the risk of error. Additionally, the pens are not interchangeable, and patients must receive the pen that corresponds with the appropriate dose prescribed.
PAAS Tips: