Dosing Increments for Insulin Pens

While insulin pens allow ease and convenience for diabetic patients, they also come with increased audit risks, for a variety of reasons, including dosing.

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Prescribers are often unaware of what each insulin pen is capable of dispensing. Pharmacies must be hypervigilant of possible instructions that the insulin pen would not be able to deliver. Clinically, the patient would not be able to receive the prescribed number of units, and an audit discrepancy could be flagged. Appealing these types of discrepancies can often be very difficult.

While most insulin pens can be dialed in 1-unit increments, this is not the case for all pens. There are strengths of insulin pens that can only be dialed in 0.5-unit, 2-unit and 5-unit increments. Prior to dispensing these exceptions, the pharmacy must ensure the instructions for use are administrable with the pen prescribed. If the directions don’t coincide with the dosing increments (e.g., 57 units of Tuojeo® Max Solostar®), contact the prescriber for a correction.

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

PAAS Tips:

  • Educate all pharmacy staff on the different insulin pens and their dosing ability
  • Contact prescribers if dosing or strength must be adjusted and add a clinical notation
    • Clinical notes should contain the date/time, person to whom the call was made (and their title), a brief summary of the discussion, and the pharmacy employee’s name/initials
    • Ensure the patient label is updated, and patients are counseled, accordingly
  • Be sure to utilize our Insulin Medication Days’ Supply Chart, available on the PAAS Member Portal, for additional insulin information

Employer Pays $4.75 Million after Employee Stole, then Sold, Protected Health Information

While HIPAA training may feel tedious and appear to be a waste of time and payroll, it’s crucial not to take shortcuts when it comes to compliance!

First, HIPAA Privacy and Security Rules were created to protect sensitive patient information and improve the quality of care patients receive. Patients should feel comfortable sharing their most private health information with healthcare providers during their examinations and treatments. If patients fear their information will not remain confidential, they are less likely to be transparent, potentially impacting the care they receive.

Second, as a Covered Entity under HIPAA, the pharmacy is responsibility to ensure staff are adequately trained and appropriate safeguards are in place to secure protected health information (PHI). Look no further than the February 6, 2024 press release from the U.S. Department of Health and Human Services Office for Civil Rights (OCR) to see how expensive brushing off your obligations to the HIPAA Security Rule can be. According to the release, Montefiore Medical Center settled with OCR for a jaw dropping sum of $4.75 million dollars for several potential violations of the HIPAA Security Rule. As outlined in the release, an employee stole the electronic PHI of 12,517 patients and sold that information to an identity theft ring. The police notified Montefiore Medical Center of the situation after they had “evidence of theft of a specific patient’s medical information”. Only after the police notified Montefiore, two years after the employee stole the data, did the Medical Center perform an internal investigation and find the breach.

During the OCR’s investigation, they found “multiple potential violations of the HIPAA Security Rule, including failures by Montefiore Medical Center to analyze and identify potential risks and vulnerabilities to protected health information, to monitor and safeguard its heath information systems’ activity, and to implement policies and procedures that record and examine activity in information systems containing or using protected health information. Without these safeguards in place, Montefiore Medical Center was unable to prevent the cyberattack or even detect the attack had happened until years later.”

Lastly, learn from Montefiore Medical Center mistakes and follow these PAAS Tips:

  • Prioritize having a comprehensive HIPAA training program
    • In place for all employees involved in the handling of PHI
    • Ensures HIPAA Rules are equally enforced across all levels of staff
    • Employees understand the importance of taking their training seriously.
    • HIPAA training should include information about civil, monetary, and criminal penalties for violations of the HIPAA Rules to reinforce the importance of compliance.
  • Review and update, no less then annually, your HIPAA Risk Analysis to ensure you have the proper safeguards in place. This is a required HIPAA form and must be retained for six years.
  • Ensure there are adequate safeguards in place to prevent and detect malicious behavior; for more information review the following Newsline articles:

If you are not sure where to start, contact PAAS National®® (608) 873-1342 for more information on PAAS’ FWA/HIPAA Compliance Program that is easy to set-up, web based and customized for your pharmacy.

Additional Audit Assistance Member Benefits

As we start 2024, keep in mind your Audit Assistance membership includes more than just assistance on audits and a monthly printed newsletter. Members have access to additional Newsline content online in the Member Portal, in addition to an archive of articles.

Plus, as a member benefit you have access to additional audit tactics and prevention tips:

PAAS Audit Assistance Administrators can keep their employees engaged and lower audit risk by adding employees to the Portal so the entire staff can access these resources and the eNewsline.

If you have any questions on accessing the Member Portal or need help adding employees, please contact us at (608) 873-1342 or info@paasnational.com and our staff can assist you.

Insulin Substitution Review: Understanding Purple Book Terminology

PAAS National® frequently gets questions about whether pharmacies may substitute various medications and if such substitutions require the approval of the prescriber. For biological products, pharmacies can refer to the FDA Purple Book to identify biosimilarity and interchangeability.

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Pharmacy level substitution of a reference product is only allowed if biologic drugs are either identified as (i) an interchangeable biosimilar OR (ii) an unbranded biologic with the same BLA number of a reference product. Importantly, unbranded biologics are NOT separately listed in the Purple Book as explained by FDA here (see FAQ #11). For biologic drugs that don’t fall into these two categories, you must obtain prescriber approval prior to substituting.

Additionally, pharmacy level substitution is regulated at the state level. If you’re unsure of your requirements, Cardinal Health has a great website to find biosimilar interchangeability laws for each state.

It is also important to understand the terminology used in the Purple Book as biologic products are not described in familiar terms like “brand”, “generic” or “AB-rated” that most pharmacy staff have been trained on. Here is a short summary of the different terms:

  1. Reference product is a single biological product approved under a 351(a) BLA.

Think of these products like brand drugs in the FDA Orange Book – they cannot be substituted for other brand drugs without prescriber approval.

  1. Biosimilar products are approved through an abbreviated BLA pathway under a 351(k) biosimilar

Think of these products like B-rated generic drugs in the FDA Orange Book – they cannot be substituted for brand drugs without prescriber approval.

  1. 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 

Think of these products like A-rated generic drugs in the FDA Orange Book – they CAN be substituted for brand drugs without prescriber approval (where allowed by state law).

  1. Unbranded biologic products are NOT listed in the Purple Book but are approved under the reference product’s 351(a)

Think of these products like authorized generic drugs in the FDA Orange Book – they CAN be substituted for brand drugs without prescriber approval.

Here are some insulin examples to help understand the relationship between various products that have a similar proper name and when pharmacies can (or cannot) substitute without prescriber approval (where allowed by state law).

Insulin Glargine

Proprietary Name Proper Name BLA Number Labeler BLA Type RPh Substitute*
Lantus® Insulin glargine 021081 Sanofi 351(a) Reference product Yes
Insulin glargine Insulin glargine 021081 Winthrop Unbranded biologic Yes
Semglee® Insulin glargine-yfgn 761201 Biocon 351(k) Interchangeable Yes
Insulin glargine-yfgn Insulin glargine-yfgn 761201 Biocon Unbranded biologic Yes
RezvoglarTM Insulin glargine-aglr 761215 Eli Lilly 351(k) Interchangeable Yes
Basaglar® Insulin glargine 205692 Eli Lilly 351(a) Reference product No

*Where allowed by state law

Insulin Lispro

Proprietary Name Proper Name BLA Number Labeler BLA Type RPh Substitute*
Humalog® Insulin lispro 020563 Eli Lilly 351(a) Reference product Yes
Insulin lispro Insulin lispro 020563 Eli Lilly Unbranded biologic Yes
Admelog® Insulin lispro 209196 Sanofi 351(a) Reference product No
LyumjevTM Insulin lispro-aabc 761109 Eli Lilly 351(a) Reference product No

*Where allowed by state law

Insulin Aspart

Proprietary Name Proper Name BLA Number Labeler BLA Type RPh Substitute*
NovoLog® Insulin aspart 020986 Novo 351(a) Reference product Yes
Insulin aspart Insulin aspart 020986 Novo Unbranded biologic Yes
Fiasp® Insulin aspart 208751 Novo 351(a) Reference product No

*Where allowed by state law

PAAS Tips:

Inventory Purchase Reminders for Successful Audits

With a 29% increase in PBM audits in 2023, PAAS National® wants to help you avoid PBM scrutiny, especially when it comes to drug procurement.

PBMs conduct invoice audits to confirm pharmacies have purchased enough medication to support the claims they have billed for. This is the primary method PBMs can identify false/phantom claims, where a pharmacy is billing for medications that never get dispensed. The auditor will reconcile claims billed with invoices provided, over a certain timeframe. After the reconciliation is complete, any inventory shortages must be explained or resolved by the pharmacy, or it could result in recoupment of claims and even termination of contract if there are substantial issues.

PAAS analysts have assisted with countless invoice audits and are eager to provide helpful tips for success.

PAAS Tips:

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  • Take the proper steps to vet any wholesaler you intend to purchase from
    • Confirm they are licensed in your state
    • Check the NABP website for Accredited Drug Distributors (formerly “VAWD”)
    • Verify you have a direct contact to request invoices on a timely manner
    • Be sure wholesaler can provide Drug Supply Chain Security Act (DSCSA) information if requested
  • Diabetic test strips have unique requirements
    • OptumRx requires OTCs dispensed via prescription to be bought from a licensed wholesaler accredited by NABP
    • Caremark and Express Scripts require Authorized Distributors of the manufacturer
      • If the pricing is substantially better, they’re likely not authorized – even if they’re affiliated with one that is (i.e. McKesson-authorized; River City Pharma & Masters-not authorized)
    • Authorized Distributors can be verified at the links below
      • Abbott https://www.diabetescare.abbott/support/distributors.html
      • Ascensia https://www.ascensiadiabetes.com/ (click on “distributors” at the bottom of the page)
      • LifeScan genuineonetouch.com
      • Roche https://rxvp.accu-chek.com/welcome/adr_list
      • Trividia Health https://www.trividiahealth.com/where-to-buy/
    • Limit pharmacy to pharmacy purchases to a minimum
    • Be sure the NDC billed is the NDC dispensed, this includes package size
      • Bar code scanning is highly recommended during the filling process
    • Remember Caremark requires pharmacies to notify them of any bulk purchases
    • Verify your pharmacy is appropriately reversing claims that are not dispensed

Need assistance with an invoice audit? Engage PAAS early for information and guidance for the best possible outcome. Call (608) 873-1342 or email to info@paasnational.com

Addressing “Weird” Days’ Supply

Days’ supply errors are one of the easiest audit triggers a PBM can pursue. Algorithms can be set for any days’ supply that does not correspond with typical dispensing of a medication and have an audit sent almost as soon as the claim adjudicates. We know that days’ supply should be billed based on the mathematically calculable directions, but what happens when the days’ supply does not fall in the easily calculable 30- or 90-day spectrum? What if it is “weird?”

The answer is …

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that you should still attempt to bill your claim for the correct days’ supply! Many plans have built-in overrides in place for medications that are known to be greater than 90-day supply, like Prolia®. This medication is typically administered once every six months and should be billed for a 180-day supply. Do NOT assume that the claim will not go through. PAAS National® has seen many claims adjudicate correctly at this days’ supply. A patient may end up with a higher copay, but that is because they are receiving six months’ worth of medication.

Other “weird” days’ supply medications to be aware of:

  • Vaginal Creams: Typical directions vary, but a majority of the time they are only used a couple of times a week making a tube last much longer than 30 days, sometimes as much as 210 days.
  • Annovera® should be billed as 1 each for a 364-day supply (thirteen 28-day cycles).
  • Dexcom receiver should be billed as 1 each for a 365-day supply.
  • Tobramycin inhalation solution is typically used as one single-dose ampule twice daily for 28 days, then stop for 28 days, and should be billed as 280 mL (56 vials) for a 56-day supply.
  • Bowel preps: 1- or 2-day supply based on whether or not the patient is doing a “split” prep.
  • Vaccines: NCPDP billing guidance states all vaccines should be billed as a 1-day supply.

PAAS Tips:

  • Always attempt to bill the actual days’ supply calculated first. If the correct days’ supply does not go through, call the plan help desk and ask for a days’ supply override.
  • If the plan cannot (or will not) issue a days’ supply override, bill for the plan maximum, and note the plan limit on the hard copy (ILQ=90 or ILQ=30).
  • Review our Can You Bill It As 30 Days? document under Proactive Tips on our website.
  • Be careful with auto-fill or med sync programs – do not run for a 30-day supply when the actual days’ supply is 130.
  • Utilize separate fields for “billed” and “actual” days’ supply if needed and if your pharmacy system supports them.
  • Note the actual days’ supply on the patient label to help flag pharmacy employees not to refill early.
  • Days’ supply should be billed for the length of therapy needed (e.g., birth control with 3 weeks on and one week off is a 28-day supply, not a 21-day supply).
  • Products billed weekly should not be billed as a 30-day or 90-day supply. They should be billed as a 28-day supply (4 weeks) or an 84-day supply (12 weeks) respectively.

Caremark Bulk Purchase Notification

PAAS National® analysts continue to see a large volume of Caremark invoice audits. Remember that Caremark will only review aggregate purchases over the selected date range plus the 30 days prior to. If pharmacies want Caremark to consider purchases made prior to the selected date range, then there must be a “bulk purchase notification” on file in accordance with Section 8.05 of the Caremark Provider Manual. Since future audit date ranges cannot be known in advance, it is in your best interest to report any purchase that is subjectively “large” based on your normal purchase patterns – consider quarter or year-end bulk purchase if you are trying to meet wholesaler rebate thresholds or inventory that you are purchasing with intention to last greater than one month.

If your pharmacy plans to make any large purchases, be sure to …

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notify Caremark by mail or email within 21 days after the purchase and provide the following information:

  1. Pharmacy NCPDP
  2. Contact email address
  3. Drug name
  4. NDC
  5. Total quantity purchased
  6. Name of wholesaler used

Pharmacies should submit notifications to the addresses provided below.

Email:   PharmacyAudit@CVSHealth.com

Mail:     CVS Caremark

Attn: Bulk Purchase Notification, MC 020

9501 E. Shea Boulevard

Scottsdale, AZ 85260

Pharmacies do not need to include cost information when submitting. Some pharmacies have received a notification back stating that their purchase was routine in nature and would not be considered a bulk purchase. This is laughable, since Caremark doesn’t clearly define what constitutes ‘bulk’. This response can actually be used in the pharmacy’s defense and should not deter pharmacies from reporting. PAAS recommends continuing to inundate CVS with notifications for ‘bulk’ purchases.

During Caremark invoice audits, it is typical that Caremark will only consider purchases for the selected date range upon initial review. During the audit appeal, Caremark will factor in purchases made during the 30-day period prior to the selected date range as well as any bulk purchase products that were on hand more than 30 days in advance.

PAAS Tips:

Adapting to Change: Levemir® Phase Out and Its Implications for Pharmacies

In November 2023, Novo Nordisk® announced that it would be phasing out the company’s long-acting insulin, Levemir®, in the United States. The company cited “global manufacturing constraints, formulary losses impacting patient access, and the availability of alternative options” as the reasons for discontinuing this medication.

The Novo Nordisk® website shows that supply disruptions of Levemir® FlexPen® would start mid-January with discontinuation complete on April 1, 2024. The Levemir® vial would be discontinued by December 31, 2024. Product will only be available while supplies last. There has been no indication that Novo’s other long-acting insulin, Tresiba®, is being discontinued.

PAAS National® has already seen some audit implications with this phase out of Levemir® products.

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The company switch from the Levemir® FlexTouch® to the Levemir® FlexPen® has caused confusion due to the slight differences in product and similar name. See the March 2023 Newsline article, Levemir® FlexPen® is Replacing the Levemir® FlexTouch®, for more on the previous switch.

We do expect PBMs to audit Levemir® through discontinuation of the product. As supply dwindles, and patients are switched to another product, the best thing you can do to protect yourself from audits is to have a conversation with the patient and prescriber and obtain a new prescription for an alternative product before supply gets constrained.

PAAS Tips:

  • If receiving a prescription for a patient new to Levemir®, contact the prescriber and have a conversation about alternative medications – the last thing a patient wants is to be introduced to a medication just as it is being discontinued.
  • Obtain a new prescription for the alternative product instead of making clinical notes on the original to avoid audit issues.
  • Make sure patients and prescribers are aware of any supply chain disruptions to temper expectations.
  • Send all audits to PAAS right away for your best chance of success:

Best Practices for DAW Billing in Pharmacies

In what should be a fairly straightforward process, proper DAW billing practices can be convoluted. Despite NCPDP guidance to standardize adjudication practices, PBMs do not always adopted these standards, leaving the pharmacy in a gray area of what proper DAW billing should look like.

Due to the variability between each PBM’s (and even individual Plan Sponsor) expectations for DAW billing, pharmacies need to have a multi-pronged approach that includes understanding biologic terminology (PAAS Audit Assistance members can see this month’s article, Insulin Substitution Review: Understanding Purple Book Terminology), a list of core “DAW billing guidelines” to follow, and additional considerations to guide your pharmacy in the scenarios where billing may not be straightforward.

Every claim adjudication comes with its own unique set of circumstances, making it difficult to establish a process that can be applied universally. Furthermore, audit tactics continue to morph and industry dynamics, such as the 2024 elimination of retroactive DIR fees, make the pharmacy’s reimbursement more transparent at point-of-sale, potentially driving DAW considerations. As such, having a grasp on the suggested DAW best practices is necessary.

PAAS Tip 1:

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When using a DAW, be sure to have supporting documentation

Pharmacies must ensure documentation exists on the hardcopy anytime they are billing a DAW (other than DAW 0). If the PBM audits a claim with a particular DAW, documentation on the hardcopy needs to support the DAW billed or the pharmacy will risk potential recoupment. Passive DAW 1 indicators on electronic scripts (e.g., a simple DAW checkbox) have been known to be challenged by PBMs, requiring further documentation. Additionally, pharmacies need to be mindful of their state laws and Medicaid requirements on DAW 1. Some state Medicaid programs require an explicit handwritten or electronic note stating “Brand Medically Necessary” in order for a DAW 1 to be billed appropriately.

PAAS Tip 2: Where applicable, bill the generic/interchangeable biosimilar of the medication utilizing a DAW 0 first, unless the prescriber or patient has indicated a preference for the product dispensed (DAW 1, DAW 2, respectively). Make note of any rejected messages received and follow adjudication logic.

Let’s walk through an example of billing a Lantus® prescription, including the suggested corresponding DAW, for a patient who has never been on this medication before. Claim adjudication would typically begin with Semglee®, an interchangeable biosimilar product to Lantus®, utilizing a DAW 0, similar to choosing an A or AB-rated generic medication to bill first in place of a brand medication.

In instances where there is only an unbranded biologic or an authorized generic on the market, such as the case with Humalog®, pharmacies can attempt to bill the unbranded biologic (insulin lispro) first. Recall that an authorized generic or unbranded biologic is considered the same product as the brand name/reference product since they have the same NDA/BLA number, per the Orange Book and #11 in the Purple Book FAQ Resource. Therefore, both the reference product (Humalog®) and the unbranded biologic (insulin lispo) can be billed as a DAW 0.

Subsequent steps should be guided by the reject message received. For example, if a patient’s plan requires a different reference product be dispensed, such as Basaglar®, the prescriber must be contacted to approve as this is not considered to be a product that can be freely substituted. In addition, documentation of the conversation should be included in a clinical note that includes the date, title, and name of the person spoke with, a recap of the conversation, and pharmacy staff initials.

If the claim for Semglee® returns the reject message “Lantus required by plan”, Lantus® should be billed with a DAW 9 – plan requires brand – along with a notation on the hardcopy. Should the plan require an unbranded biologic equivalent (e.g., insulin glargine-yfgn), PAAS would recommend billing that as a DAW 0.

Unfortunately, adjudication rejections are not always explanatory – not surprising with opaque PBMs, but frustrating for pharmacies and technicians. Their lack of communication can be intentional, leading to underpaid claims or forcing pharmacies to play a guessing game of how to bill the claim correctly based on formularies. If there are predominate plans/payors in your market, having access to their formulary may help save you team a lot of headaches.

PAAS Tip 3: Do not use DAW 9 unless adjudication logic or plan formulary explicitly shows the plan requires brand.

This is a newer piece of guidance. In the absence of an adjudication reject that states, “Drug X not on Formulary, bill Drug Y as DAW 9” (or something analogous), PBMs have questioned why a DAW 9 was used when in fact the plan formulary does not show the drug product billed is plan-preferred. The better question is why didn’t the PBM reject the claim if it wasn’t not covered? Protect yourself by being able to substantiate why the pharmacy is billing a brand or reference product as DAW 9 (as stated in PAAS Tip #1). Looking at the plan’s formulary may help guide your decision on whether a DAW 9 is appropriate or not. Express Scripts and Humana put out communications that list products they expect to be billed as DAW 9, but be mindful that some Plans may not accept DAW 9 on any claims and formularies can change at any time. Technicians need to watch adjudication messaging closely – even for paid claims. If a PBM rejects a DAW 9 stating the Plan Benefit design doesn’t allow the use, a DAW 0 may be the pharmacy’s only choice.

PAAS Tip 4: In instances where adjudication rejections are unclear, take an all-encompassing approach to determine what medication and DAW to bill.

One of the more common DAW questions we get at PAAS encompasses the situation where both the brand and generic (or reference product and interchangeable biosimilar), result in a paid claim with DAW 0, one with a positive margin and the other in a negative margin. What options does the pharmacy have without increasing their risk of recoupment?

One consideration is cost of the product to the patient. State laws commonly have language obligating the pharmacy to dispense the most cost-effective medication to the patient. Therefore, the copay of the brand vs. generic needs to be taken into consideration when determining if the pharmacy can bill for the product that results in a positive margin. In cases where the copays are the same and the patient truly prefers the brand, billing DAW 2 may be appropriate in that scenario (and consider researching the Plan Formulary for a DAW 9 indication). If the copays are not the same, review the adjudication messaging results for any clues and consult the plan’s formulary. PBMs have been known to prefer a Brand and, instead of rejecting the generic, significantly underpaying on the generic. With so many claims underwater, it’s hard to know the difference, so diligence may be prudent. In instances where a product’s unbranded biologic/authorized generic results in a lower cost to the patient, a DAW 0 can be used. Ultimately, determining which product to bill should not be based solely on pharmacy reimbursement.

PAAS Tip 5: Watch claim adjudication messaging carefully – even on paid claims. Rechallenge DAW 9 when new prescriptions are issued and be careful at the beginning of Plan years (particularly the New Year).  

Pharmacies can fall into the habit of billing a DAW 9 solely based on history. Plan formularies change often and sporadically with new medications being introduced to the market, and products having generic/interchangeable biologics available that previously were not. Therefore, ensuring the DAW historically used is still warranted is a great preventative step.

PAAS Tips:

Tip to Federal Agents Leads to Jail Time for Pharmacy Owner

The Department of Justice announced a Nebraska pharmacist, and owner of two pharmacies, was sentenced to two months of imprisonment, three years of supervised release, and ordered to pay restitution in the amount of $573,000.

The pharmacist was found guilty of making a false, fictitious, and fraudulent statement related to health care services. The investigation began in 2020 based on a tip to Federal Agents, and included pharmacy staff interviews, patient interviews and an inventory audit. The inventory audit reconciled claims billed to both Medicare and Medicaid with invoice purchases made by the pharmacy.

Upon completion of the investigation, the inventory audit identified significant shortages. Investigators discovered the pharmacist was billing for brand name drugs but ordering and dispensing the generics. Additionally, the pharmacist in question was submitting claims that were never dispensed to the patient.

PAAS Tips:

 Contact PAAS National®®  today and start your robust Fraud, Waste and Abuse and HIPAA Compliance Program, ensuring your pharmacy employees are informed and trained against fraudulent activities.