While an NDC on an electronic prescription might give you reassurance on the product prescribed, pharmacies need to exercise caution. According to the NCPDP Representative NDC Use in Electronic Prescribing Fact Sheet,
“The representative NDC used is not intended to infer specificity or preference to the embedded manufacturer/labeler. The receiving pharmacy should not assume physician intent and can utilize their own drug selection and substitution logic based on proprietary logic and compliance with any state/federal laws and regulations as needed.”
Additionally, an NDC is not required to be sent by a prescriber on an electronic prescription, only the description of the medication. PBM auditors are likely to ignore the NDC on an electronic prescription in most cases and require a pharmacy to clarify any ambiguous product descriptions. For example, a prescription for Metformin HCL ER 500 mg with no other indication of dosage form. Even if a representative NDC is present that would imply a particular dosage form, an auditor will likely expect the pharmacy to clarify if the generic for Glucophage® XR, Fortamet®, or Glumetza® was intended.
However, being hypocrites, auditors will also try to use the representative NDC against a pharmacy. For example, if a prescription indicated representative NDC 00186-0370-28 (which is for Symbicort® 160/4.5 as a 6.9 g institutional pack size), but the pharmacy dispensed Symbicort® 160/4.5 inhaler at the retail pack size of 10.2 g; PAAS has seen auditors mark these claims as discrepant for dispensing the ‘wrong product’ even though it goes against NCPDP guidance (also predicated on quantity/unit of measure being prescribed).
PAAS Tips:
- Prescribers typically do not know what product NDC they are selecting from their drop-down boxes in their electronic software, so pharmacies should not rely on the representative NDC on the electronic prescription as prescriber intent.
- Clarify any ambiguous product descriptions or mismatched information with the prescriber before dispensing and make a clinical note on the prescription.
- Clinical notes should include the date, name and title of who you spoke with, summary of discussion, and your initials.
Forteo® Package Size Update – Are You Billing the Correct Cost?
Forteo® (teriparatide injection) is a parathyroid hormone analog (PTH 1-34) used in the treatment of osteoporosis, specifically for postmenopausal women at high risk for fractures, men with primary or hypogonadal osteoporosis, and individuals with osteoporosis associated with sustained glucocorticoid therapy. It is designed to increase bone mass and reduce fracture risk in patients who have failed or are intolerant to other osteoporosis therapies. Administered via a prefilled pen, each pen delivers 28 daily doses of 20 mcg.
In a recent update on August 23, 2024…
the FDA revised the product labeling to reflect a change in the pen’s composition from a 600 mcg/2.4 mL pen to a 560 mcg/2.24 mL pen. Despite this adjustment, the pen continues to deliver 28 subcutaneous doses, and the NCPDP billing quantity and unit still reflect the previous 2.4 mL measure.
PAAS National® has been in contact with NCPDP about this discrepancy, and has learned the following:
What does this mean for your pharmacy? You should verify how your software currently bills Forteo®. Make sure that when submitting a claim, the metric quantity aligns with what is displayed in your software system’s compendia and that the correct cost for one pen is included in your transmission. As of the time of publication of this article, the approximate wholesale accusation cost (WAC) for one pen is $4,200.
PAAS Tips:
Why the Unit of Measure Matters in Audits: A Small Factor with Big Consequences
A unit of measure (UOM) provides standards to define physical quantities. Without a UOM, a number is left open for interpretation, and while common sense often prevails for pharmacies, third-party auditors look for explicit instruction. With an ambiguous, or absent, UOM (primarily an issue with electronic prescriptions), an auditor may flag the claim as discrepant and attempt to recoup the claim.
PAAS National® regularly sees auditors claiming …
that the correct quantity cannot be determined without the proper UOM being present. To combat the discrepancy, pharmacies may need to obtain a letter from the prescriber to substantiate what the pharmacy billed was indeed the correct quantity. These letters are often difficult to obtain, especially when claims are several years old, prescribers have relocated, or your pharmacy doesn’t have a working relationship with the office.
If your pharmacy receives a prescription without a UOM, or a UOM that is ambiguous, PAAS recommends contacting the prescriber for clarification and documenting with a clinical note.
Examples:
The following table shows the medications PAAS typically sees UOM troubles with and the typical billing units that should be used:
*The “each” UOM may need to be clarified if the quantity doesn’t correspond to an “each” unit of measure (e.g., 10 each on an eye drop likely indicates 10 mL vs 10 bottles of 10 mL)
When in doubt, clarify the prescription. Do not leave the UOM interpretation to a third-party auditor who has no reason to give you the benefit of the doubt and every reason to interpret it to their advantage.
PAAS Tips:
2024 Self-Audit Series #10: Nasal and Oral Inhaler Prescriptions
Nasal and oral inhaler prescriptions are frequently targeted for audit by all PBMs. Not only have these medications increased in cost but are frequently billed incorrectly, creating the potential for easy recoupments.
Pharmacy staff should be trained to accurately bill days’ supply for all inhalers. PAAS National® has created tools for our members to aid in the data entry process. Visit the Member Portal to access these resources – Nasal Inhalers Chart and Oral Inhalers Chart – and share with staff for easy reference when billing inhalers.
The following are examples of inhaler prescriptions at a higher risk of being flagged as refill too soon due to atypical dosing (when plan limits days’ supply to 30):
Symbicort® prescriptions 10.2 grams
Azelastine HCL 0.1% nasal spray prescriptions
Whether the days’ supply is miscalculated, or the days’ supply exceeds the plan limit, the pharmacy could be in jeopardy of refilling too soon. Early refills are the most common audit discrepancy for inhalers and can result in full recoupment of “overbilled” claims. See PAAS’ Exceeding Days’ Supply Plan Limits for Unbreakable Package resource for information on how to navigate plan limits appropriately.
PAAS Tips:
PAAS Audit Assistance members can search the Newsline archive for keyword “2024 self-audit” to read previous articles in this series. If you have any questions on accessing the Member Portal, or need help adding employees so they have access, please contact us.
NADAC Survey: What is It and Do I Need to Respond?
Pharmacies that receive a National Average Drug Acquisition Cost (NADAC) Survey frequently contact PAAS National® for information and guidance. While this survey remains voluntary, pharmacies may want to take a minute to understand what the survey is about.
The Affordable Care Act required that Medicaid programs shift pharmacy reimbursement to an acquisition cost-based model. CMS Final Rule (CMS-2345-FC) set a compliance date for State Medicaid Programs to be effective no later than April 1, 2017.
The NADAC file was created to provide pricing files for state Medicaid agencies to utilize when creating their acquisition cost-based pricing methods for Fee-for-service (FFS) Medicaid plans. Some PBMs have started to use this data for reimbursement formulas on commercial and Medicare Part D claims as well (e.g., Capital Rx).
CMS has contracted with Myers & Stauffer, LC (a professional accounting firm) to conduct these retail pricing surveys. Outpatient pharmacies are randomly selected to receive these surveys, requesting invoices for purchases made over a one-month period. The data collected from these invoices are used to update the NADAC file on a weekly basis.
Again, these surveys are currently voluntary, and pharmacies are under no obligation to respond. However, this may change with a newly introduced bill, Drug Pricing Transparency in Medicaid Act of 2023 (H.R. 1613). If passed, this bill would make the surveys mandatory for pharmacies and simultaneously include updates to ban spread pricing in State Medicaid Plans. NCPA has a summary “one-pager” on H.R. 1613 that pharmacies can share with their legislators here.
PAAS Tips:
New Tool on PAAS Portal – Exceeding Days’ Supply Plan Limits for Unbreakable Packages
PAAS National® is continuously updating and creating new tools to help our members address common audit recoupment issues. Pharmacies frequently face recoupments due to overbilling multiple unbreakable packages or refilling claims too soon when billing for a single unbreakable package that exceeded the plan’s days’ supply limit.
The new tool, Exceeding Days’ Supply Plan Limits for Unbreakable Packages, provides a flow chart to follow based upon whether you are billing single or multiple unbreakable packages and receive a days’ supply plan limit rejection. Here is an example of each scenario:
Access the new tool on the Member Portal under Proactive Tips. You can also see PAAS’ Can You Bill It as 30 Days? resource when transmitting a claim for a quantity that exceeds the plan limitations. If you have questions about Member Portal access or this new tool, please contact PAAS for assistance.
Ask a PAAS Expert
While PAAS National® prides itself on being audit experts, audit assistance is more than just reactive support when an audit notice arrives. PAAS works tirelessly to provide pharmacies with tools and resources to reduce their audit risk and lessen the chances of being audited. Moreover, PAAS serves as a guiding light for community pharmacies with day to day pharmacy audit questions. Get expert answers to your questions on:
As a trusted partner, we provide tailored guidance to help you prevent audits. Remember, the prescription claims you submit today are the audits of the future.
Work to audit-proof your pharmacy today, do it right, and avoid future recoupments. Contact us to submit a question or complete the form on the Member Portal.
Ensure Your Team Is Prepared for PBM Audits
In an interview with Pharmacy Times at the National Association of Community Pharmacists 2024 Convention & Expo, Trent Thiede, PharmD, president of Pharmacy Audit Assistance Service (PAAS) International, discussed how pharmacy teams can remain prepared for audits from pharmacy benefit managers (PBMs).
Q: What are the common types of PBM audits that pharmacies face, and what specific documentation or records are typically requested? How do you stay informed about evolving audit requirements and best practices?
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Click here to read more at PharmacyTimes.com
Best Practices for Proactively Preventing PBM Audit Issues | NCPA 2024
Pharmacy Benefit Managers (PBMs) routinely conduct audits on independent pharmacies with the stated goal of preventing fraud, waste, and abuse in medication dispensing. However, PBM audits often lack clear metrics and can include certain requirements without an explicit reason why. As these audits increase—in 2023 they shot up by as much as 29%1—many pharmacists who have failed them cite it as the primary reason why they can’t stay in business.2
Click here to continue to read the complete article at DrugTopics.com
Billing Coupons for Medicare Part D Patients – When Is It Okay?
The Office of Inspector General (OIG) has made it clear that using manufacturer coupon cards with federally funded programs is prohibited by Anti-Kickback Statutes [42 U.S.C. 1320a-7b]. However, pharmacies should be aware of organizations, like …
The Patient Access Network Foundation (PAN Foundation), that work as non-profits to help patients receive otherwise unaffordable treatment. The PAN Foundation website offers a section called PAN’s OIG Advisory Opinions and Bulletins that helps address how independent charitable patient assistant programs (PAPs) can maintain compliance with federal laws, regulations, and guidelines while providing cost-sharing assistance to Medicare Part D patients.
In the article OIG Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees, the OIG concludes that, “pharmaceutical manufacturer PAPs that subsidize Part D cost-sharing amounts present heightened risks under the anti-kickback statute. However, in the circumstances described in this Bulletin, cost-sharing subsidies provided by bona fide, independent charities unaffiliated with pharmaceutical manufacturers should not raise anti-kickback concerns, even if the charities receive manufacturer contributions.”
Be careful treading these waters as there have been previous concerns about the legitimacy of some of these charities. While PAAS National® cannot determine whether a specific copay card meets the requirements, the OIG has an advisory opinion process for individuals or entities that want affirmation that they will not infringe on fraud and abuse laws. Visit Advisory Opinion FAQs for more information.
PAAS Tips:
Representative NDC on Electronic Prescriptions Do Not Infer Specificity
When electronic prescriptions were first introduced, they were supposed to be more convenient for patients and cause less errors at the pharmacy (due to the legible nature of the information being sent from the prescriber). In practice, we know this has not always been the case. The directions may be confusing, the quantity not specified, and even the product selection could be left to interpretation.
While an NDC on an electronic prescription might give you reassurance on the product prescribed, pharmacies need to exercise caution. According to the NCPDP Representative NDC Use in Electronic Prescribing Fact Sheet,
“The representative NDC used is not intended to infer specificity or preference to the embedded manufacturer/labeler. The receiving pharmacy should not assume physician intent and can utilize their own drug selection and substitution logic based on proprietary logic and compliance with any state/federal laws and regulations as needed.”
Additionally, an NDC is not required to be sent by a prescriber on an electronic prescription, only the description of the medication. PBM auditors are likely to ignore the NDC on an electronic prescription in most cases and require a pharmacy to clarify any ambiguous product descriptions. For example, a prescription for Metformin HCL ER 500 mg with no other indication of dosage form. Even if a representative NDC is present that would imply a particular dosage form, an auditor will likely expect the pharmacy to clarify if the generic for Glucophage® XR, Fortamet®, or Glumetza® was intended.
However, being hypocrites, auditors will also try to use the representative NDC against a pharmacy. For example, if a prescription indicated representative NDC 00186-0370-28 (which is for Symbicort® 160/4.5 as a 6.9 g institutional pack size), but the pharmacy dispensed Symbicort® 160/4.5 inhaler at the retail pack size of 10.2 g; PAAS has seen auditors mark these claims as discrepant for dispensing the ‘wrong product’ even though it goes against NCPDP guidance (also predicated on quantity/unit of measure being prescribed).
PAAS Tips: