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
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:
Best Practices for Dispensing GLP-1 Medications and Reducing Recoupment Risk
Pharmacies continue to see a large number of prescriptions for GLP-1 medications like Ozempic® and MounjaroTM and have concerns about the risk of PBM audits and recoupments. While PAAS National® sees audits for these medications every day, there are only a few audits where the PBM has pursued recoupment for off label use. However, with continued popularity of these medications, audit practices may change.
PAAS National®® previously discussed this topic in our February 2023 article, Ozempic® and MounjaroTM Prescriptions – Between a Rock and a Hard Place which included an in-depth discussion on the background of how PBM adjudication systems appear to handle these medications. Outlined below is a systematic approach that we suggest pharmacies consider when evaluating which scenarios pose the most audit risk and how to balance patient care, pushback from patients & prescribers, and audit risk.
Three different scenarios, ranked from lowest to highest risk:
The risk of PBM audit recoupment for “off label” use is non-existent in scenario #1. Additionally, #2a and #2b seem to have minimal risk as the PBM has identified the indication for use BEFORE approval and payment of the claim. Number #2c poses a higher potential for recoupment for off label use because the PBM is not confirming diagnosis upon adjudication. While it shouldn’t be the pharmacists’ responsibility to confirm a diagnosis (and CMS tends to agree), some PBMs have language in their provider manuals to define a ‘clean claim’ as one that is being used for a medically accepted indication (i.e., not for off-label weight loss). The #3 scenario is the highest risk because an auditor will be able to easily identify off-label use if the prescription is audited.
From a practical standpoint, it may be impossible for pharmacy staff to differentiate between #2b, and #2c if the pharmacy is sending a diagnosis code with every initial claim submission. If the prescriber does not provide a diagnosis code, consider sending initial claims without a diagnosis code so you can tell the difference. Beyond diagnosis code E11 (T2DM), PAAS is not aware of any other ‘acceptable’ diagnosis codes.
Unsurprisingly, PBMs continue to be mute on the subject – all too happy to collect rebates and administrative fees for high price drugs. Due to their lack of fiduciary duty to often uninformed Plan Sponsors (i.e., employers), utilization management edits are slow to implement. However, at $12,000 per patient annually, you can bet self-insured payors will figure it out quickly and push for recoupment of claims paid outside the benefit design. Consider reading the February 2023 AI Alert from Codoxo: Gains and Losses with Weight Loss Prescription Drugs. While a smaller auditing entity, Codoxo is providing analytics on prescribers and pharmacies dispensing weight loss drugs to Plan Sponsors looking for potential Fraud. Plan Sponsors can redesign the plan benefit and conduct audits, but they also, importantly, control which pharmacies participate in their network; and pharmacies disproportionately dispensing GLP-1s could find themselves out of network if they’re an outlier.
Most pharmacies want to know what they should do with prescriptions that fit into the #2c or #3 bucket. While PAAS National® ® cannot tell you what is right for your pharmacy, there are three possible approaches with varying levels of patient & prescriber pushback and audit risk.
STOP
SLOW DOWN
GO
Conservatively, PAAS would recommend pharmacies slow down by taking the yellow light approach. This minimizes risk of audit recoupment because you confirm that the payer knows why the patient is using the medication and that they approve before you dispense. While patients are eager to start therapy, these are long-term treatments, and patients are unlikely to suffer clinical harm while awaiting coverage confirmation. For those patients very eager to begin therapy, consider encouraging them to contact their insurance and prescriber to expedite a response.
PAAS Tips:
Continuous Glucose Monitors and Potential Audit Risk with PHE Ending
As the COVID-19 Public Health Emergency (PHE) declaration comes to an end on May 11, 2023, preparing for some changes to current flexibilities, actions and waivers that have been in place since COVID-19 began is crucial. While clinical indications for Continuous Glucose Monitors (CGMs) have not been enforced by Medicare during the PHE, PAAS National® advises pharmacies to take special precaution for any patients who obtained a CGM during this time.
PAAS questioned Noridian and CGS on this topic:
For beneficiaries who obtained a CGM during the PHE (when clinical indications for coverage of CGMs was not enforced), will those beneficiaries be grandfathered in, or will they need to meet the current coverage criteria?
While awaiting Noridian’s response, CGS responded that they are awaiting an answer from CMS for this exact question. Once the DME MACs receive direction from CMS, they will email notifications to suppliers. The MACs will also be hosting webinars, ask-the-contractor (ACT) teleconference calls and post topics under the Education section on their websites to address the end of the PHE.
PAAS Tips:
PBMs on the Hot Seat in Key Legal and Administrative Battles
In a not-so-strange turn of events, pharmacy benefits managers (PBMs) are under scrutiny for alleged legal and administrative violations in states with robust PBM reform. Additionally, the United States Senate Committee on Finance gathered insight from experts at an official hearing on PBM reform. Although the legal disputes and senate hearing are seemingly unrelated, together they offer optimism that PBM conduct will continue to be questioned in state and federal spotlights.
Ohio Attorney General Sues Multiple PBMs for Anticompetitive Practices
The Ohio Attorney General has filed a lawsuit against Express Scripts, Prime Therapeutics, and Humana Pharmacy Solutions, among other subsidiary and parent entities. The filing alleges that the three largest PBMs (Caremark, Express Scripts, and OptumRx) which control more than 75% of market share use mutually owned group purchasing organizations (GPOs) to collude on drug rebate negotiations. This produces a monopolistic environment which may benefit PBMs and harm patients by inflating drug list prices. Ohio’s Valentine Act prohibits such practices and is punishable by fines and banishment from doing business in Ohio.
CVS Caremark Faces Administrative Action in Oklahoma for Steering Practices
The Oklahoma Insurance Department, an agency responsible for PBM oversight, has filed administrative action against CVS Caremark for allegedly violating the Oklahoma Patient Right to Pharmacy Choice Act. The notice of hearing outlines over 100 instances where Caremark misinformed patients regarding their right to use an in-network pharmacy of their choice for 90-day drug supplies. Caremark coerced patients to use pharmacies they owned by rejecting drug claims and then telling patients via phone that they must use CVS or their mail-order pharmacies. Furthermore, upon initial warning by authorities, Caremark sent letters to patients falsely stating that they could no longer obtain 90-day drug supplies due to action by the Oklahoma government.
U.S. Senate Hearing on PBMs and the Drug Supply Chain
The U.S. Senate Committee on Finance heard from a panel of economists, business experts, and law experts to gather insights into the need for federal PBM reform. Throughout the hearing, Senate members demonstrated thorough understanding of the harms of PBMs by asking questions about rebate aggregation, increasing drug list prices, vertical integration within the healthcare system, and direct and indirect remuneration fees. Senate members called for more transparency in PBM practices and continued efforts to regulate the PBM industry. Watch the recording here.
PAAS Tips
HIPAA Breach Notification Letter Sent to 82,466 Patients Due to Improperly Shared Data
According to the U.S. Department of Health and Human Services breach portal, the mail-order pharmacy Healthy Options dba Kroger Postal Prescription Services (PPS) reported a breach of information which affected 82,466 patients. Kroger’s March 10, 2023 press release described the incident as “an internal error” which caused patient names and email addresses affiliated with Kroger PPS to be “improperly shared with its affiliated grocery business”.
This breach comes two years after the Accellion incident which also affected Kroger. Accellion is a company which provides secure third-party data file transfer services to businesses, one of which was Kroger. Their services were used to send human resources data, pharmacy patient information, clinic patient information, and money services records through secure file transfers. Kroger’s internal review indicated the Kroger systems were not directly accessed, and that the information was obtained only through Accellion. Kroger cut their ties with Accellion and sent out HIPAA breach notification letters to the affected individuals.
As these two incidents illustrate, breaches can happen—sometimes they are malicious in nature and sometimes it is due to poor training or lack of appropriate safeguards. PAAS National® analysts suggest regularly evaluating your pharmacy’s HIPAA compliance program and implementation to identify deficiencies so improvements can be made in a timely manner. If you are not sure where to begin or what a “top of the line” HIPAA program looks like, just contact us (608) 873-1342 for a virtual overview of the PAAS National® Fraud, Waste and Abuse and HIPAA Compliance Program. We are here to guide you through compliance – get started today.
Caremark Memo: Novolog® and Novolin® ReliOn®
In March 2023, many pharmacies received a fax from Caremark labeled Claim Submission Education pertaining to claims billed for Novolog® and Novolin® ReliOn® NDCs. The Caremark memo includes a list of ReliOn® claims that the pharmacy billed and requests that pharmacies confirm if they have billed the correct NDC. If the NDC was submitted correctly, pharmacies must provide a copy of a wholesaler invoice and information to support DSCSA pedigree or track and trace (transaction statement, transaction history, transaction statement).
In theory, the ReliOn® branded insulins are made exclusively for Walmart and Sam’s club pharmacies and Caremark is questioning if pharmacies billed the incorrect NDC or obtained products from an inappropriate source.
Here are the ReliOn® products under review:
Novolog (Rx only)
Novolin 70/30 (OTC)
Novolin N (OTC)
Novolin R (OTC)
PAAS Tips:
Nuances of Insulin Pens and How They May Differ
Priming insulin pens prior to use helps ensure the appropriate dose is being administered. Calculating the priming units in your days’ supply is very important. These additional units added for “priming” or “safety checking” the insulin pen and pen needle for each injection, could greatly influence the quantity and days’ supply you are billing.
Most insulin pens require two units per injection to prime; however, there are three products that require more.
Another consideration between insulin pens is the number of units the pen can dial. While most pens deliver doses in 1-unit increments, there are four specific insulin products that do not. Be mindful that these products can only deliver doses in discrete intervals and be prepared to clarify instructions for use that cannot be administered.
PAAS Tips: