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.

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CeQur Simplicity TM 2-unit device, 10 each per box NDC 73108-0000-01
CeQur Simplicity TM Inserter (reusable), 1 each per box NDC 73108-0001-00
Number of priming units needed per patch 20 units
Minimum fill volume 100 units
Maximum fill volume 200 units
Maximum wear time 3 days
Water-resistant To a depth of 1 meter for up to 30 minutes
Equation to calculate the amount of insulin needed per patch (daily bolus insulin use in units) x (# of days) + 20 priming units

 

PAAS Tips:

  • Bill one 10-count box of CeQur Simplicity TM patches as “10 EA”; the proper days’ supply will be determined by the patient’s insulin utilization and should never be more than a 30-day supply per 10 patches
    • Example: CeQur SimplicityTM, #10 + 11 refills; use with Novolog U-100 insulin up to 18 units TID; change patch every 3 days; bill # 10 as a 30-day
  • CeQur SimplicityTM patches are disposable and NOT durable, therefore, the patches and the insulin to be used within the patch are not covered under a patient’s Medicare Part B/DMEPOS benefit
  • Be sure the patient receives one CeQur Simplicity TM Inserter when they begin using the CeQur SimplicityTM patch; the patient should call the manufacturer if a replacement inserter is needed
  • Include the 20 priming units of insulin in the days’ supply calculation of the rapid-acting insulin; below is a sample calculation
    • Prescription: Novolog® U-100, 30 mL + 11 refills; administer up to 18 units TID using CeQur SimplicityTM patch
    • Amount of insulin needed per patch: (18 units TID) x (3 days/patch) + 20 priming units = 182 units
    • Amount of insulin needed for the corresponding #10 CeQur patches: 10 patches x 182 units/patch = 1,820 units total (18.2 mL)
    • Suggested billing: 20 mL = 32 days’ supply -OR- 10 mL = 16 days’ supply

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.

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For example, Humana only allows electronically stored date and time stamped pharmacy notes validating the increase in quantity and/or refills (and the date authorized). Similarly, OptumRx will only accept a prescriber statement on appeal for unauthorized refills if the causality is not an undocumented/unapproved increase in quantity.

What is considered an “unauthorized refill?” Examples include:

  • Dispensing a quantity larger than written without documented prescriber approval.
    • If a prescriber writes for 3 mL on an insulin pen, you cannot simply increase the quantity to 15 mL to dispense a full box.
  • In states where consolidating refills without prescriber approval is allowed, you cannot dispense more than the total original quantity and refills written without consulting with the prescriber.
    • If a prescriber writes for 3 mL plus 2 refills on an insulin pen, you can only dispense 9 mL total without consultation with the prescriber.
  • Transfer prescriptions need to be entered carefully. Pay close attention to “total fills remaining” vs “1+x refills remaining.”
  • Pay attention to electronic prescription fields of “authorized fills” vs “refills” as discussed in our October 2020 Newsline article, Are You Overbilling? Refills vs Authorized Fills.
  • Having a clear unit of measure on a written quantity prevents confusion.
    • If a prescriber writes for 15 “unspecified” for a quantity on an insulin pen, an auditor may argue it is unclear if the prescriber meant 15 mL, 15 pens, or 15 boxes.
    • If a prescriber writes for a quantity of “1” on inhalers, topical medications, or eye drops, the auditor will assume the smallest package size even if that is an institutional size pack not regularly dispensed by retail pharmacies.
    • If a prescriber writes “one month” for a quantity, ensure your days’ supply is NOT more than 30 days. For example, an insulin pen written for 45 units daily and a one-month supply has an actual days’ supply of 33 not 30. This quantity should be clarified to ensure over-dispensing does not occur.

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:

  • Ensure documentation is consistent and thorough when handling quantity changes
  • Clarify any ambiguous quantities or unspecified units of measure with the prescriber
  • Be sure your transferred prescription refills are entered appropriately. See our June 2022 Newsline article, Best Practice for Entering Transfers with Partial Refills Remaining
  • Understand the nuances of refill wording and how this can affect claims
  • When contacting the prescriber about changing or clarifying quantities or refills, be sure you document the prescription with a complete clinical note
    • A complete clinical note includes the date, name and title of who you spoke with, summary of what was discussed, and pharmacy employee initials
  • See our October 2022 Newsline article, “Unauthorized Refills” Audit Discrepancies; How Does This Happen? for more information on unauthorized refills

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.

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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

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…

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obtain a new prescription when switching from the 1.5 mL pen to the 3 mL pen. While the instructions, as well as the number and strength of the deliverable doses remain the same, the concentration for the pen which delivers 0.25 mg or 0.5 mg per dose has decreased (from 1.34 mg/mL to 0.68 mg/mL) and the total volume to dispense has doubled (from 1.5 mL to 3 mL). Without a new prescription, pharmacies could run into major audit issues if they over dispense what the prescription is originally authorized for.

NDC Label Color Dose Administered Initial or Maintenance Dose Number of Pens Per Box Total mg per Box Billing Quantity Per Box
00169-4181-13 Red Pen delivers 0.25 mg or 0.5 mg only Initial Dose
(0.25 mg) or Maintenance Dose (0.5 mg)		 1 Pen 2 mg 3 mL
00169-4130-13 Blue Pen delivers 1 mg only Maintenance Dose 1 Pen 4 mg 3 mL
00169-4772-12 Yellow Pen delivers 2 mg only Maintenance Dose 1 Pen 8 mg 3 mL

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:

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  1. Patient has confirmed type 2 diabetes mellitus (T2DM)
  2. Patient does NOT have confirmed T2DM and claim pays at point-of-sale:
    1. WITH utilization management edit (Prior Authorization)
    2. WITH utilization management edit (Diagnosis Restricted)
    3. WITHOUT utilization management edit
  3. Prescription indicates it’s for off-label use via directions or diagnosis code

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.

Approach Pharmacy Action Patient & Prescriber Pushback Risk of PBM Audit Recoupment
Red Light

STOP

 Refuse to dispense High Lowest
Yellow Light

SLOW DOWN

 Tell patient the insurance plan may not cover unless type 2 diabetes and that you want to confirm coverage before dispensing Moderate Low
Green Light

GO

 Dispense if paid claim Low Highest

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:

  • Pharmacists should review patient profile for medications that may imply a diagnosis of T2DM
  • Always obtain diagnosis code (ICD-10) for GLP-1 medications to show you performed “due diligence”
    • While reviewing a patient profile for proxy medications like metformin may be sufficient, inclusion of medications is not definitive for type 2 diabetes
    • Without a confirmed (and documented) diagnosis from prescriber, PBMs could conclude that you “didn’t do enough”
  • If the prescriber does not provide a diagnosis code, send initial claims WITHOUT a diagnosis code to determine if the drug is diagnosis restricted
    • This will help in the event of a future audit if the claim is not diagnosis restricted, bolstering your defense as you can argue that the PBM/Plan “should have asked for proof of diagnosis upon adjudication”
  • If being used for T2DM (code E11), then there is no risk of audit recoupment for off-label dispensing
  • If being used for anything other than T2DM, then confirm coverage with insurance plan before dispensing (note, you will need to talk with prior authorization department and not the regular help desk)
    • Alternatively, consider obtaining a prescription for Wegovy® or Saxenda® – FDA approved GLP-1s for weight loss

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.

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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:

  • If a patient received a CGM during the PHE, PAAS suspects effective May 12, 2023, these patients will need to meet Medicare coverage criteria and may not be grandfathered in
  • See the April 2023 Newsline article, A Documentation Checklist for Continuous Glucose Monitor Claims for Medicare coverage requirements, updated as of 4/16/2023
  • Run an internal report for patients utilizing a CGM that was paid for by Medicare
  • If the patient IS on insulin, then they meet Medicare guidelines for coverage of a CGM if they continue to have a visit with their provider every six months to document CGM compliance
  • If the patient is NOT on insulin, proactively reach out to the provider’s office to obtain medical records to support the patient has a history of problematic hypoglycemia (see LCD for details)
    • If the medical records do not support hypoglycemia, we would suggest reaching out to the provider and moving this patient back to a Blood Glucose Monitor (BGM) to lessen audit risk and payment denial
  • Watch for updates on the DME MAC websites
  • Review the Local Coverage Determinations (LCD) and Policy Articles (PA)
  • Utilize the Dear Physician Letter created by Medicare to assist the treating practitioner on what elements need to be in the beneficiary’s medical record to support initial and continued coverage as well as medically necessity

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

  • Consider writing to your elected officials to recommend legislative action for PBM reform
  • Consider involvement in your state or national pharmacy organizations to assist them with legislative efforts
  • If you are within a state with PBM oversight laws, consider reviewing applicable law to ensure you are aware of your, and your patients’, rights and file complaints as applicable

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).

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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)

ReliOn® NDC Retail NDC
10 mL vial 00169-2100-11 00169-7501-11
5×3 mL FlexPen® 00169-2101-25 00169-6339-10

Novolin 70/30 (OTC)

ReliOn® NDC Retail NDC
10 mL vial 00169-1837-02 00169-1837-11
5×3 mL FlexPen® 00169-3007-25 00169-3007-15

Novolin N (OTC)

ReliOn® NDC Retail NDC
10 mL vial 00169-1834-02 00169-1834-11
5×3 mL FlexPen® 00169-3004-25 00169-3004-15

Novolin R (OTC)

ReliOn® NDC Retail NDC
10 mL vial 00169-1833-02 00169-1833-11
5×3 mL FlexPen® 00169-3003-25 00169-3003-15

PAAS Tips:

  • PAAS is not aware of any results or recoupments from these reviews
  • We suggest that pharmacies exercise caution when sourcing these insulin products, since 3 of the 4 products are over the counter (OTC), they fall outside of DSCSA pedigree requirements and wholesalers/distributors may not have track and trace documents to prove that products are legitimate