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

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.

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Insulin Priming Units
Toujeo® Solostar® 3 units
Toujeo® Max Solostar® 4 units
Humulin® R U-500 KwikPen 5 units

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.

Insulin Dosing Increments
Humalog® Junior KwikPen® 0.5 units
Humulin® R U-500 KwikPen 5 units
Tresiba® Flextouch® 200 units/mL 2 units
Toujeo® Max Solostar® 2 units

PAAS Tips:

  • Document the number of priming units on the prescription if used in your days’ supply calculation
  • Remember priming units are not applicable with insulin vials
  • Non-insulin pen products that have pre-set dosages (i.e., Ozempic®), do not use priming units

Resist the Urge: Don’t Reverse Claims After Receiving an Audit

Consider the following situation: after pulling hard copy prescriptions for an audit, a billing error is identified; such as an incorrect days’ supply or billed quantity. The initial thought may be to reverse and rebill the claim – a seemingly reasonable action to take; however, one must resist the urge to reverse the claim.

Depending on the PBM, type of audit and auditor preference, the process given to resolve the incorrect claim may differ. Additionally, reversing a claim outside the billing window, without proper authorization, may result in a claim that is unable to be reprocessed. There are also unique exceptions to the guidance of not reversing the claim prior to obtaining direction. For example, some audits of recent claims may include explicit instructions to correct claims if any errors are found. To save time and avoid costly mistakes, Engage PAAS National®® upon receiving an audit notice.

PAAS Tips: 

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  • Review the September 2019 Newsline article, Claim Reversal Best Practices
  • If given permission by the auditor to reverse and rebill the claim, include a print screen of the adjudication reflecting the claim was reversed and subsequently rebilled correctly
  • Respond to the audit unless explicitly told otherwise
  • Sometimes “final results” are given for small desk audits with claims submitted shortly before the date the audit was issued. This is merely a means of closing out the audit. The recoupment amount reflects the old claim being reversed and it is likely the new claim has a paid status. No action is required by the pharmacy.
    • If you want to ensure the plan sponsor has received the corrected claim, call the PBM help desk to inquire

Avoiding Humana Audits for Deceased Patients

Humana has recently sent out another round of audits to pharmacies with the subject line: Review of claim(s) billed after member’s deceased date. The review is taking place, sometimes more than a year after the date of service, because Humana identified some Medicare Part D claims paid after the member passed away. Why would Humana wait so long to review these claims, and why did they not stop them at point of sale? Unfortunately, there is usually significant lag time from when a patient passes away to when this information is reported to the Social Security Administration, and then to CMS and plan sponsors.

Pharmacies have 30 days from the date on the audit letter to provide evidence demonstrating the appropriate billing of these claims. Please see the Humana guidelines set below to combat these recoupments.

Claim date would need to be within 14 days from deceased date for claims billed to patients not in a long-term care facility (retail) and 32 days from deceased date for patients who reside in a long-term care facility.

Accepted documentation for a deceased member (not all-inclusive):

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  • Signature log (of personal representative)
  • Delivery log/mail order shipping receipt
  • Manifest
  • Obituary with different deceased date
  • E-kit Rx

Accepted documentation for a member who is NOT deceased:

  • Signed signature log
  • Signed delivery log
  • Obituary with different deceased date
  • Prescriber statement
  • Member statement

PAAS Tips:

  • Always obtain member consent prior to delivery of any auto-refilled medications
    • This is a Medicare requirement to prevent waste
  • If dispensing a medication to a physician’s office for administration (e.g., Invega®), the pharmacy should have a log or reconciliation process to ensure the patient receives the medication in a timely fashion
  • Leaving a medication at a patient’s door without obtaining a signature can result in the claim being flagged for recoupment (if audited). To mitigate this risk, include a PAAS National® Trifold Mailer form with the delivery which the patient can return to the pharmacy to ensure adequate proof of dispensing is on file
  • Use extra caution with controlled substances, especially if being requested by a different family member or if only controlled substances are being refilled
  • Please see the following Newsline articles for more information on compliant delivery/signature logs:

Biologic Drug Substitution Best Practices (Update)

**Article update from initial publication in January 2021 due to entry of unbranded biologics in the marketplace and change to BLA approval type for SemgleeTM and RezvoglarTM**

PAAS National® frequently gets questions about whether pharmacies may substitute various medications and if such substitutions require the approval of the prescriber. Pharmacies must refer to the FDA Purple Book to identify if biologic products may be substituted. Additionally, “pharmacy level substitution” is regulated at the state level and you must refer to your individual state pharmacy practice laws. Cardinal Health has a great website to find biosimilar interchangeability laws for each state.

In a June 2020 Newsline article, PAAS discussed the new definition of a biologic product, which now includes commonly dispensed products like insulin, human growth hormone, and pancreatic enzymes. Now licensed as “biologic drugs,” these medications are approved by the FDA under a Biologic Licensing Application (BLA), and listed in FDA’s Purple Book instead of the Orange Book that many pharmacy staff are familiar with.

When reviewing the Purple Book, you will find that pharmacy level substitution of a reference product is only allowed if biologic drugs are either (i) identified as interchangeable OR (ii) an unbranded biologic with the same BLA number of a reference product. For biologic drugs that don’t fall into these two categories, you must obtain prescriber approval prior to substituting.

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  • If a prescription is written for the “proper name” (e.g., insulin lispro), the FDA does not provide interpretative guidance on whether the biologic product can be openly substituted. Some Boards of Pharmacy may require further clarification from the prescriber under these circumstances. PAAS recommends proceeding with caution until further industry guidance is established.

Let’s look at a few types of insulins as examples.

Insulin lispro U-100

Product Name Proper Name BLA Number Labeler BLA Type Substitute without prescriber approval?
Admelog® Insulin lispro 209196 Sanofi 351(a) reference product No
Humalog® Insulin lispro 020563 Eli Lilly 351(a) reference product Yes
Insulin lispro Insulin lispro 020563 Eli Lilly Unbranded biologic Yes
LyumjevTM Insulin lispro-aabc 761109 Eli Lilly 351(a) reference product No

Insulin glargine U-100

Product Name Proper Name BLA Number Labeler BLA Type Substitute without prescriber approval?
Lantus® Insulin glargine 021081 Sanofi 351(a) reference product Yes
Insulin glargine Insulin glargine 021081 Winthrop Unbranded biologic Yes
SemgleeTM Insulin glargine-yfgn 761201 Mylan 351(k) interchangeable Yes
Insulin glargine-yfgn Insulin glargine-yfgn 761201 Mylan Unbranded biologic Yes
Basaglar® Insulin glargine 205692 Eli Lilly 351(a) reference product No
RezvoglarTM Insulin glargine-aglr 761215 Eli Lilly 351(k) interchangeable Yes

FDA approved interchangeable status to Semglee in July 2021 and Rezvoglar in November 2022

Biologic products are not described in familiar terms like “brand”, “generic” or “AB-rated” and the Purple Book uses new terms that are not found in the Orange Book. Here is a short summary of the different terms:

  1. “Reference product” is a single biological product approved under a 351(a) BLA.
  2. “Biosimilar” products are approved through an abbreviated BLA pathway under a 351(k) biosimilar BLA.
  3. “Interchangeable” biological products are biosimilar products that have been deemed interchangeable with a reference product after going through additional switching studies and are approved under a 351(k) interchangeable BLA.
  4.  “Unbranded biologic” products are NOT listed in the Purple Book but are approved under the reference product’s 351(a) BLA.

FDA has more detailed definitions on the Purple Book website here. Additionally, there is a frequently asked question section that discusses unbranded biologics (FAQ #11).

PAAS Tips:

  • Pharmacy level substitution of biologic products is only allowed if products are either (i) identified as interchangeable AND your state pharmacy practice law allows OR (ii) an unbranded biologic with the same BLA number.
  • See FDA Purple Book to determine interchangeability status of a particular biologic drug
  • State pharmacy laws may limit biosimilar interchangeability, but this does not apply to unbranded biologics. For information about your state laws:
  • If you are ever in doubt about whether products may be substituted it is best to call the prescriber to obtain approval – don’t forget to document with a clinical note.
  • PAAS has created the following resources
  • FDA has a website with educational materials for both patients and healthcare professionals including frequently asked questions, handouts and videos here.