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:
- 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.
- 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.
- 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).
- 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:
- Be cautious when interpreting wholesaler ordering websites or pharmacy management software that may “link” products together based on Medi-Span® GPI as this may lead to incorrect conclusions about which products may (or may not) be substituted for one another
- Other PAAS resources include:
- Please contact PAAS at (608) 873-1342 or info@paasnational.com if your team has a question about a specific product
Continuous Glucose Monitor (CGM) Billing and Supply Allowance
CMS has issued an update on the Glucose Monitor – Policy Article effective as of January 1, 2024. A supplier now has the option to bill and dispense up to a 90-day supply for procedure codes A4238 (Adjunctive CGM) and A4239 (Non-Adjunctive CGM).
The policy article states:
“Up to a maximum of three (3) months, ninety (90) days of the supply allowance may be billed for code A4238 or A4239 to the DME MAC at a time and suppliers may not dispense more than a ninety (90) day supply.”
Below is a helpful chart to categorize the Dexcom and FreeStyle CGM products, their respective NCPDP billing units, and corresponding days’ supply.
PAAS Tips:
Be on the Lookout for Eye Drops Requiring Extra Billing Consideration
Correctly billing eye drops requires a little extra thought and consideration, but it does not have to be a daunting task. Follow these simple steps and remember to be on the lookout for the unique eye drops listed below.
00023-9163-60
Carton of 60 vials
Caution: Restasis® is also available in a 5.5 mL multi-dose preservative-free bottle NDC 00023-5301-05
PAAS Tips:
2024 DMEPOS Series #1: Diabetic Test Strips
Many pharmacies struggle with DMEPOS audits due to the complexity in medical billing and the onerous documentation requirements. Medicare Part B suppliers need to be able to produce all the required documentation if audited and make sure all documentation meets Medicare Part B standards. This DMEPOS series is intended to help you understand these complexities and gather the needed documents.
In particular, you should be able to show the following if audited on diabetic test strips:
Standard Written Order (SWO):
Dispensing/Proof of Delivery:
Delivery/Mailing:
Medical Records:
Billing:
PAAS Tips:
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.
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.
PAAS Tips:
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:
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.
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:
Think of these products like brand drugs in the FDA Orange Book – they cannot be substituted for other brand drugs without prescriber approval.
Think of these products like B-rated generic drugs in the FDA Orange Book – they cannot be substituted for brand drugs without prescriber approval.
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).
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
*Where allowed by state law
Insulin Lispro
*Where allowed by state law
Insulin Aspart
*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:
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 …
Other “weird” days’ supply medications to be aware of:
PAAS Tips:
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 …
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: