NCPA Multiple Locations Conference Panel Discussion Part 2 of 2
On February 25, 2023, President of PAAS National®, Trent Thiede, had the privilege of participating in a Panel Discussion entitled Marketplace Prescription Dynamics Sure to Shape Your Business Strategies. While traversing several different topic areas, there are two core issues that are important for PAAS members: discount/cash cards and biosimilar adoption in 2023. PAAS Audit Assistance members can see Discount/Cash Cards Are Disruptors in the Industry from our March Newsline.
While Semglee® was the first interchangeable biosimilar to market back in 2021, Humira has been grabbing attention because of its status as the pharma-GOAT: Greatest Of All Time (in terms of sales) as coined by Doug Hoey from NCPA. If you’re not familiar with the onslaught of biosimilars, reference this chart below from Cardinal Health’s biosimilar landscape overview. To summarize, there are 8 FDA approved biosimilars, and 5 more pending FDA approval. Cyltezo, which should be coming to market this summer, has been approved as an interchangeable biosimilar. Four additional products referenced are seeking interchangeability status.
FDA Approved
| Product |
Company |
Estimated launch |
Concentration |
Seeking interchangeability |
Citrate free |
Latex free |
Needle size |
| Amjevita™ |
Amgen |
January 31, 2023 |
Low (50MG) |
No |
Yes |
Yes |
29G Syr. / 27G Pen |
| Hadlima™ |
Organon |
July 1, 2023 |
Low (50MG) |
No |
No |
Yes |
29G Syr. / 29G Pen |
| Cyltezo™ |
Boehringer
Ingelheim |
July 1, 2023 |
Low (50MG) |
Yes, Approved
October 18, 2021 |
Yes |
No |
27G Syr. / 27G Pen |
| Yusimry™ |
Coherus |
July 1, 2023 |
Low (50MG) |
No |
Yes |
Yes |
Unknown |
| Hulio™ |
Viatris |
July 31, 2023 |
Low (50MG) |
No |
Yes |
Yes |
29G Syr. / 29G Pen |
| Hyrimoz™ |
Sandoz |
July 1, 2023 |
Low (50MG) |
No |
No |
No |
27G Syr. / 27G Pen |
| Abrilada™ |
Pfizer |
November 20, 2023 |
Low (50MG) |
Yes |
Yes |
Yes |
29G Syr. / 29G Pen |
| Idacio™ |
Fresenius Kabi |
September 30, 2023 |
Low (50MG) |
No |
Yes |
Yes |
29G Syr. / 29G Pen |
Pending Approval
| Product |
Company |
Estimated launch |
Concentration |
Seeking interchangeability |
Citrate free |
Latex free |
Needle size |
| SB5-HC |
Organon |
July 1, 2023 |
High (100MG) |
Yes |
Yes |
Yes |
29G Syr. / 29G Pen |
| AVT-02 |
Teva |
July 1, 2023 |
High (100MG) |
Yes |
Yes |
Yes |
Unknown |
| Yuflyma |
Celltrion |
July 1, 2023 |
High (100MG) |
No |
Yes |
Yes |
29G Syr. / 29G Pen |
| ABP – 501 HC |
Amgen |
TBD |
High (100MG) |
Yes |
Yes |
No |
29G Syr. / 27G Pen |
| Hyrimoz HCF |
Sandoz |
July 1, 2023 |
High (100MG) |
No |
Yes |
No |
27G Syr. / 27G Pen |
While Amjevita™ came to market in January, pharmacies need to be cognizant that it is a biosimilar but does not have interchangeability status. PAAS Audit Assistance members can see Biologic Drug Substitution in this month’s Newsline for additional information on biologic substitutions.
Biosimilar adoption relies, at least in part, on pharmacists. There was a report issued by Cardinal Health that identified > 60% of dermatologists, rheumatologists, and gastroenterologists would NOT feel comfortable prescribing a biosimilar if it did not have the interchangeability designation. Pharmacists can think of these biosimilars as alternative brands. There’s not likely to be great uptake in market share unless providers are aware and more willing to prescribe.
Additionally, OptumRx, Express Scripts and Prime Therapeutics are keeping Humira on formulary at parity with biosimilars, meaning patients won’t have a financial reason to switch. Why change to a biosimilar if you can continue to take Humira for no additional cost? Perhaps patients new to therapy could try a biosimilar first, but it seems to reason that adoption will be slow in 2023.
PAAS Tips:
Become an audit assistance member today to continue reading this article. As a member, you’ll have access to hundreds of articles and receive our monthly proactive newsletter!
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
- Access Services
- Audit Documentation Submission Guidance
- An online form to submit safe filling and billing questions
- Your PAAS Membership Manual
- Newsline
- Monthly newsletter articles, written by our expert PAAS analyst team, provide safe filling and billing tips and relays relevant/current PBM trends to be help prevent audits
- Search the Newsline Archive to get PAAS tips at the click of a button
- Special Edition Newslines including: Top 10 articles of the prior year, DMEPOS Article Series and a Self-Audit Article Series
- Ability to print monthly issues or individual articles
- Proactive Tips
- Audit flags – list of various claim attributes the PBMs use to select claims for audit
- Billing insulin vials – flowchart to assist whether you should bill Medicare Part B vs Part D
- DAW Codes Explained – use to understand when to effectively use DAW codes, their definitions and why claims may be flagged for audit if a DAW code is used incorrectly
- Basic DMEPOS documentation guidance
- Onsite Credentialing Checklist and expanded definitions of policies and procedures
- Proof of refill request and affirmative response form for DMEPOS items
- Steps on how to prepare for an onsite audit
- And more!
- Days’ Supply Charts
- Utilize the days’ supply charts for inhalers, insulins, nasal sprays, eye drops and topicals to aid you in calculating the correct days’ supply
- Guidance on overbilled quantities and incorrect days’ supply account for a sizable portion of audit chargebacks
- Additional miscellaneous charts, which include: Dispense in Original Container and Return to Stock
- Forms
- Signature Logbook for print
- Signature Trifold Mailer
- Fax and Email Coversheet
- Patient Attestation for over-the-counter COVID-19 test kits
- On-Demand Webinars
- Short webinars on hot topics in the PBM industry. Here are a few examples:
- USP 800 Compliance
- Cultural Competency Training
- Dispensing Prescriptions Off-Label
- Biologic Medications and Interchangeability
- Continuous Glucose Monitor Requirements for Medicare Part B
PAAS Tips:
- MORE AUDITS, MORE INSIGHT – PAAS National® is the industry-leading defender of community pharmacy dealings with Prescription Benefit Programs, including Caremark, Express Scripts, Humana, Medicaid, OptumRx, Prime Therapeutics., and more. PAAS assists on all third-party audits, including: desktop audits, onsite audits, invoice audits, OIG/Medicaid audits, Medicare B audits. The PAAS team is dedicated to helping you! We have five pharmacists and a complement of technician analysts with over 50 years of dedicated audit assistance experience. PAAS continuously updates their database with every audit received — in fact, we even keep a scorecard on individual auditors.
- Get answers to your questions on days’ supply calculations, drug substitutions, billing practices, required documentation, prior authorization requirements, record retention, and internal audit procedures – just to name a few. As a trusted partner, we will provide tailored guidance to help you proactively prevent audits. Remember, the prescription claims you submit today are the audits of the future.
- Keep your employees engaged and help lower audit risk by adding all employees to the portal and giving them permission to access these tools, resources and eNewsline. For more information review September 2019 Newsline article, What Are You Waiting For? Make Sure ALL of Your Employees are Added to the PAAS Portal!
- Contact PAAS at (608) 873-1342, if you would like a tour of your PAAS Member Portal, so you can reap all the benefits of your PAAS Audit Assistance. We appreciate you being a member.
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).
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Nuances of Insulin Pens and How They May Differ
Priming insulin pens prior to use helps ensure the appropriate dose is being administered. Calculating the priming units in your days’ supply is very important. These additional units added for “priming” or “safety checking” the insulin pen and pen needle for each injection, could greatly influence the quantity and days’ supply you are billing.
Most insulin pens require two units per injection to prime; however, there are three products that require more.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
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:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
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):
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
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.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Caremark Resumes Signature Log Requirements Effective May 12, 2023
Caremark issued a Pharmacy Update memo on March 8, 2023, stating that they would resume signature log requirements for audits effective May 12, 2023. This coincides with Health and Human Services (HHS) announcement that the formal COVID-19 public health emergency (PHE) will expire on May 11, 2023.
PAAS National® expects other PBMs to follow suit in short order and we recommend that pharmacies begin to transition staff and patients back to pre-pandemic workflow, if you have not done so already. Remember that upon audit, PBMs want to see at least three elements on signature logs – the prescription number, the date dispensed and the signature of patient or representative (some PBMs, like Humana, may also want to see the fill date or fill “number”). For prescriptions that are mailed, make sure that you maintain tracking/delivery confirmation as well.
PAAS Tips:
Biosimilar Adoption for Humira in 2023
NCPA Multiple Locations Conference Panel Discussion Part 2 of 2
On February 25, 2023, President of PAAS National®, Trent Thiede, had the privilege of participating in a Panel Discussion entitled Marketplace Prescription Dynamics Sure to Shape Your Business Strategies. While traversing several different topic areas, there are two core issues that are important for PAAS members: discount/cash cards and biosimilar adoption in 2023. PAAS Audit Assistance members can see Discount/Cash Cards Are Disruptors in the Industry from our March Newsline.
While Semglee® was the first interchangeable biosimilar to market back in 2021, Humira has been grabbing attention because of its status as the pharma-GOAT: Greatest Of All Time (in terms of sales) as coined by Doug Hoey from NCPA. If you’re not familiar with the onslaught of biosimilars, reference this chart below from Cardinal Health’s biosimilar landscape overview. To summarize, there are 8 FDA approved biosimilars, and 5 more pending FDA approval. Cyltezo, which should be coming to market this summer, has been approved as an interchangeable biosimilar. Four additional products referenced are seeking interchangeability status.
FDA Approved
Ingelheim
October 18, 2021
Pending Approval
While Amjevita™ came to market in January, pharmacies need to be cognizant that it is a biosimilar but does not have interchangeability status. PAAS Audit Assistance members can see Biologic Drug Substitution in this month’s Newsline for additional information on biologic substitutions.
Biosimilar adoption relies, at least in part, on pharmacists. There was a report issued by Cardinal Health that identified > 60% of dermatologists, rheumatologists, and gastroenterologists would NOT feel comfortable prescribing a biosimilar if it did not have the interchangeability designation. Pharmacists can think of these biosimilars as alternative brands. There’s not likely to be great uptake in market share unless providers are aware and more willing to prescribe.
Additionally, OptumRx, Express Scripts and Prime Therapeutics are keeping Humira on formulary at parity with biosimilars, meaning patients won’t have a financial reason to switch. Why change to a biosimilar if you can continue to take Humira for no additional cost? Perhaps patients new to therapy could try a biosimilar first, but it seems to reason that adoption will be slow in 2023.
PAAS Tips:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
PerformRxSM Investigational Audits Are on the Rise
PAAS National® has recently seen a new trend with investigational audits completed by PerformRxSM. These audits are a combination of an invoice, desk, and a compliance audit. Pharmacies must obtain invoices for the requested date range, 25-60 prescriptions, signature logs and proof of copay collection for all refills.
This investigational audit also includes an extensive questionnaire. The questionnaire may have unique questions based on idiosyncrasies the PBM has identified for your pharmacy. Mailing and delivery procedures and automatic refill policies are just some of the questions pharmacies must address.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
Looking for an FWA/HIPAA Compliance program? Schedule a service overview with PAAS National® today and learn how to get started on customizing your Policy and Procedure Manual.
LifeScan Continues to Pursue Pharmacies Purchasing from Unauthorized Distributors
Test strip manufacturers sit in a unique position when it comes to monitoring nonprescription diabetic supply purchasing and dispensing. Manufacturers acquire purchase histories from authorized distributors regarding the volume of test strip products ordered by a pharmacy. Additionally, manufacturers can obtain information regarding the amount of test strip-associated rebates paid to PBMs by NCPDP number. With simple math, the manufacturer can identify when a pharmacy has not ordered diabetic test strips from a source they authorize.
This has occurred repeatedly with Lifescan, with recoupment demands last seen in 2021. Like previous communications, these letters are borderline extortionary – demanding payment in a short time and threatening to notify PBMs for non-compliance.
PAAS National® has assisted on numerous cases pertaining to test strip manufacturers (and PBMs) trying to recoup funds on the premise of pharmacies utilizing unauthorized distributors. PAAS can help your pharmacy further navigate the demand. If you’ve been contacted by LifeScan, be protected and contact PAAS (608) 873-1342 to get guidance and one-on-one support from a PAAS analyst.
LIVE WEBINAR MAY 4th: Audit Preparation for the End of the Public Health Emergency
Join President of PAAS National®, Trenton Thiede, PharmD, MBA for a LIVE webinar “Audit Preparation for the End of the Public Health Emergency ” on May 4, 2023 from 2-2:45pm CT as he discusses:
We will allow for some Q&A at the end of the webinar. If you would like to submit questions prior to the webinar, please click here.
PAAS Audit Assistance members will have access to a recording on the PAAS Member Portal if they are unable to attend the live event.