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 …

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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:

  1. You receive a prescription for Lantus® Solostar® pens, quantity 15, UOM “unspecified.”
    1. Did the prescriber intend for the prescription to be written as 15 mL, 15 pens, or 15 boxes?
  2. You receive a prescription for Combigan® solution, quantity 1, UOM “bottle.”
    1. Did the prescriber intend for the 5 mL, 10 mL, or 15 mL bottle?
  3. You receive a prescription for Trelegy Ellipta, quantity 1, UOM “inhaler.”
    1. At first glance, this may seem like an acceptable prescription. However, Trelegy comes in two sizes. Did the prescriber intend for the 60 each retail package or the 28 each institutional size package? “Each” is the proper UOM per NCPDP guidelines.
  4. You receive a prescription for Trelegy Ellipta, quantity 1, UOM “each.”
    1. The correct billing unit is “each,” but the quantity should either be 60 for the retail package or 28 for the institutional package. Third party auditors will often flag the “1 each” combination – contact the prescriber to avoid ambiguity.

The following table shows the medications PAAS typically sees UOM troubles with and the typical billing units that should be used:

Drug TypeCorrect Billing UnitUOM Needing Clarification
Eye DropsmL, each*bottle
InjectablesmL, each*kit
Nasal InhalersmL, gm, each*inhaler
Oral Inhalersgm, each*inhaler
InsulinmLeach
TopicalsmL, gmtube

*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:

  • Ambiguous or missing UOM should be clarified with the prescriber with a clinical note added to the prescription before dispensing
  • The best quantity clarification will contain the actual billing unit per NCPDP for the drug, leaving no room for misinterpretation
  • Clinical notes should contain the date, name and title of who you spoke with, summary of discussion, and your initials
  • Pay close attention to electronic prescription quantities which have the biggest potential for incorrect or “unspecified” UOM
  • Other prescription origins (written, fax, and transfer) may need clarification for missing UOM
  • Notating UOM on all telephone orders would be considered best practice
  • Some PBMs may consider a quantity of “1” to be the smallest package size; therefore, clarify the quantity with the prescriber if dispensing a larger size

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):

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Symbicort® prescriptions 10.2 grams

  • Typical dosing: Two puffs twice daily = 30 days’ supply
  • Atypical dosing: One puff twice daily = 60 days’ supply

Azelastine HCL 0.1% nasal spray prescriptions

  • Typical dosing: One to two sprays in each nostril twice daily = 25 days’ supply
  • Atypical dosing: One spray in each nostril twice daily = 50 days’ supply

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:

  • Confirm the prescription quantity is complete. Many inhalers have two sizes available, so best practice is to confirm quantity includes puffs or grams based on NCPDP billing units
  • Check for “calculable instructions” to accurately bill the days’ supply
  • Use caution when switching albuterol inhalers, as not all are interchangeable or have the same package size
  • Consult the Oral Inhalers Chart or DailyMed for inhalers that have a “Beyond Use Date” (BUD). If an inhaler’s BUD is less than the calculated days’ supply, the days’ supply billed should reflect the BUD as the inhaler must be discarded appropriately after open date
  • Automatic refilling should not be used for “as needed” inhalers or inhaler prescriptions with days’ supply that exceeds plan limit
  • Monitoring and self-auditing your oral and nasal inhaler prescriptions regularly can prevent potential audit recoupments

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.

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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:

  • NADAC files are published monthly here
  • Consider responding if you are being paid below your cost on Medicaid claims; your actual costs can be added to the survey data
  • Pharmacies may want to consider requesting a Non-Disclosure Agreement from Myers & Stauffer LC
  • Steps to take with your documents if responding
    • Print “Confidential” on each invoice page
    • Only include the documents requested, no PHI should be included
  • Contact the NADAC helpdesk, operated by Myers and Stauffer, at (855) 457-5264 or survey@mslcrps.com if you have additional questions about the survey

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:

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  1. Levemir® FlexPen, 15 mL (single unbreakable package), inject 35 units once daily
    1. 1500 units/35 units per day = 42 days’ supply but the plan limit is 30 days
    1. Important to clearly read the reject messaging as it can often guide you in the right direction
    1. If you call the PBM help desk for a days’ supply override and they deny it, then you must bill the 15 mL for a 30 days’ supply
    1. Be sure to make a clinical note about your call to the PBM (including their denial/refusal and if they told you a certain way to bill the claim)
    1. Document the calculated days’ supply in the directions for patient use
    1. Counsel patient and monitor refill intervals to prevent an early refill from occurring
  2. Creon® 24,000 (NDC 00032-2636-01), 400 capsules (multiple unbreakable packages), take 3 capsules with each meal and 1 capsule with up to two snacks per day
    1. 400/11 = 36 days’ supply but the plan limit is 30 days
    1. Per the manufacturer, Creon® must be dispensed in its original container
    1. Pharmacy must reduce the quantity to 300 capsules for a 27 days’ supply
    1. Document on the hard copy that the plan limit is 30 days

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:

  • Days’ supply calculations
  • Drug substitutions
  • Billing practices
  • Required documentation
  • Record retention
  • Internal audit procedures

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.

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

2024 Self-Audit Series #9: Eye Drop Days’ Supply

Billing the accurate days’ supply for eye drops can be challenging. Despite what is drilled into pharmacists during schooling, there is no industry standard for drops/mL, and PBMs often use their own specific conversion factors. This variability adds complexity to accurately determining the appropriate days’ supply.” The PAAS National® Eye Drop Guidance chart has been created for our members to have the most up to date information from the major PBM provider manuals to assist them with this process. 

Pharmacies must also take into consideration several eye drops that do not fall under the typical drops/mL conversion due to beyond use dating, single use vials, or atypical drop size. Recognizing these extra billing considerations is imperative to avoid potential audit issues.

Please refer to the following Newsline articles for information on some of these specific eye drops:

PAAS Tips:

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  • Verify the prescription has mathematical instructions for use and clarify any ambiguous directions
  • Download the PAAS National® Rx Days’ Supply Calculator app
  • Do not assume the days’ supply indicated on electronic prescriptions is correct, always calculate days’ supply according to instructions for use
  • Best practice is for quantity prescribed to include a unit of measure; however, if written for a quantity of “1 bottle”, it should be interpreted as the smallest package size
  • When billing a PBM not listed on the Eye Drop Guidance, PAAS recommends using 15 drops/mL for suspensions or emulsions, and 20 drops/mL for solutions, unless otherwise specified by the manufacturer
  • Billing eye drops for LTC patients carries the same audit risk, refer to the following June 2022 Newsline article, Beyond-Use Date vs. Nursing Home Storage Policy – Avoid this Recoupment Trap
  • Prescriptions with a treatment duration (e.g., “use for 10 days”) that is less than calculated days’ supply, should still be submitted per calculation

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.

Hundreds of Patient Information Requests for Medicare: What This Means for Your Pharmacy

Pharmacy personnel are all tasked with keeping patient protected health information (PHI) secure. When a request to access or release PHI is received by the pharmacy, panic may ensue if staff are not well versed in how to handle the requests to be compliant with 45 CFR §164.524.

First, a patient must …

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be granted access to their own medical records (unless otherwise indicated as per 45 CFR §164.524(a)(2) or (a)(3)) whether they are asking for a copy to be provided to them personally or directed to another entity. The Office for Civil Rights [OCR] takes a patient’s right to access their records very seriously and will investigate [and potentially assess a monetary penalty] when a covered entity is found to not be appropriately following HIPAA Privacy Rules. The covered entity is encouraged to respond as soon as possible but must respond no later than 30 calendar days from the date of the request. If the covered entity is unable to comply with the request within 30 calendar days, they can be granted a one-time 30-day extension to their deadline, but they must notify the individual (in writing) of the reason for the delay and provide the date by which they will provide the records (refer to 45 CFR §164.524(b)(2) for additional information). Note some state privacy laws may be more stringent (e.g., Texas).

The request for PHI can be harder to validate when it is not coming from the patient for their own records. Recently, Anthem has been requesting information from numerous pharmacies across the United States. Each request has been issued by Episource, Datavant, or Cotiviti, purportedly on behalf of Anthem, Healthy Blue, or Wellpoint, and the request has been for patient information from January 2023 through current and can range from one patient to several dozen.

The request likely stems from recent investigations with the Office of Inspector General (OIG) looking into numerous Medicare Advantage plans which have uncovered an overabundance of up-coded claims with unsupported diagnosis codes. In an OIG report posted September 25, 2024, they describe selecting one Medicare Advantage organization (Humana) and “focused on eight groups of high-risk diagnosis code (high-risk groups). Our objective was to determine whether Humana’s submission of selected diagnosis codes to CMS, for use in CMS’s risk adjustment program, complied with Federal requirements.”

The results were astonishing! “For the eight high-risk groups covered by our audit, most of Humana’s submission of the selected diagnosis codes to CMS for use in CMS’s risk adjustment program did not comply with Federal requirements. Specifically, for 202 of the 240 sampled enrollee-years, the diagnosis codes that Humana submitted to CMS were not supported by the medical records and resulted in $497,225 in overpayments.” They go on to say, “On the basis of our sample results, we estimated that Humana received at least $13.1 million in overpayments for 2017 and 2018.”

Moreover, in October, OIG issued a report: Medicare Advantage: Questionable Use of Health Risk Assessments Continues to Drive Up Payments to Plans by Billions. It is likely that Medicare Advantage plans are fearful that their claims are up for review next. With such a large potential for CMS overpayment, it is probable that OIG will continue to investigate and try to put a stop to this inappropriate spending.

If your pharmacy receives one of these requests, it should be given to your pharmacy’s Privacy Officer for further evaluation and action. For PAAS Fraud, Waste and Abuse and HIPAA Compliance members, send us a copy of the request and we will walk you through considerations to facilitate your validation of the PHI request and potential documentation requirements.

PAAS Tips:

  • Pharmacies are allowed to disclose PHI for the purposes of payment, treatment or healthcare operations (PTO)
  • For non-PTO authorized disclosures, document all HIPAA requests to access or release PHI; PAAS FWA and HIPAA Compliance members can use the Request to Access or Release Protected Health Information form from Appendix B in your Policy & Procedure Manual
  • All HIPAA-related documents must be maintained for a minimum of six years after the last effective date
  • For additional guidance on grounds to deny the release of PHI, refer to 45 CFR §164.524(a)(2) and (a)(3); PAAS FWA and HIPAA Compliance members can review Sections 10.4 through 10.5.3 of your Policy & Procedure Manual for additional information

If you are not a PAAS FWA/HIPAA Compliance member and you are interested in adding this service or learning more, please contact us at (608) 873-1342 or email info@paasnational.com

Avoid This Billing Pitfall with Your Medicare Part B Nebulizer Solution Claims

Correctly billing Medicare Part B can be tough. The Local Coverage Determinations and associated Policy Articles for each DMEPOS category, along with the Standard Documentation Requirements for All Claims Submitted to DME MACs, are filled with billing and documentation guidelines which suppliers must fully comprehend and follow to avoid claim chargeback. The PAAS National® 2024 DMEPOS Newsline Series is a great starting point for pharmacies to building their comprehension of these unique requirements. Simply keyword search “DMEPOS series” to read these articles in the archives.

A general overview of billing DMEPOS nebulizer solutions can be found in the April Newsline article, 2024 DMEPOS Series #2: Nebulizer Solutions. During recent Targeted Probe and Educate (TPE) audits from DME MAC CGS, PAAS analysts have seen an uptick in discrepant claims due to billing a larger amount than allowed as medically necessary.

Why This is Happening

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Claims are flagged because a beneficiary is on either albuterol, albuterol/ipratropium combination, levalbuterol, or metaproterenol as a rescue or supplemental medication in addition to either formoterol or arformoterol. The presence of formoterol or arformoterol as an active medication for the beneficiary triggers a lower monthly maximum milligrams/month policy limit on the rescue or supplemental medication (i.e., albuterol, albuterol/ipratropium combination, levalbuterol, or metaproterenol).

Inhalation Drugs and SolutionsStandard MaximumReduced Maximum When Beneficiary is Also on Formoterol or Arformoterol
Albuterol465 mg/month78 mg/month
Albuterol/Ipratropium combination186 units/month31 units/month
Levalbuterol232.5 mg/month – 465 units/month39 mg/month – 78 units/month
Metaproterenol2800 mg/month – 280 units/month470 mg/month – 47 units/month

How to Avoid This Pitfall

Pharmacies supplying any one of these four inhalation drugs in the table above should be reviewing all evidence prior to billing the claim to Part B to verify which monthly limit is applicable for the claim; here are several considerations:

  • Review the patient’s medication profile at your pharmacy to see if they are getting any medication with formoterol (e.g., formoterol nebulizer solution [Perforomist®]; budesonide and formoterol inhaler [Symbicort®, BreynaTM]; glycopyrrolate and formoterol inhaler [Bevespi Aerosphere®]; budesonide, glycopyrrolate, and formoterol [Breztri Aerosphere®]; mometasone and formoterol [Dulera®]; etc.) or arformoterol [Brovana®] nebulizer solution
  • Obtain medical records from the prescriber’s office from within 12 months prior to the date of the claim and review the records for any active formoterol or arformoterol
  • Ask the patient or their representative if they are using any prescription products with formoterol or arformoterol

If the investigation to any of the above considerations shows active formoterol or arformoterol, be sure:

  1. The order being billed for one of the four inhalation drugs in the table above falls within the reduced maximum supply limit, or
  2. Contact the prescriber to adjust the order to be within the reduced maximum policy limit, or
  3. Complete an Advanced Beneficiary Notice of Non-Coverage (ABN) prior to dispensing because the claim is not expected to be covered.

PAAS Tips:

  • Refer to the December 2021 Newsline article, Advanced Beneficiary Notice of Non-coverage Changes, for more information about the use of an ABN
  • The Same and Similar tool on the DME MAC website may not be helpful as some of the formoterol-containing items would not be billed to Medicare Part B (but instead, Part D) and because suppliers have 12 months to file a Part B claim, meaning the data may not be up to date

Third Amendment to the PREP Act Expiring Soon!

As previously discussed in the April 2024 Newsline article, New COVID-19 Booster Dose & The Final Frontier of the PREP Act, the Public Readiness and Emergency Preparedness Act (PREP Act) will expire as of December 31st, 2024, meaning the liability protections that enabled pharmacists, pharmacy interns, and pharmacy technicians to independently administer vaccines by means of the PREP Act will no longer exist. The following is an excerpt from the article:  

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As stated on the Administration for Strategic Preparedness & Response’s (ASPR) PREP Act Questions & Answers webpage, the amended PREP Act “authorize[s] pharmacists to continue to administer COVID-19 and seasonal influenza vaccines to individuals aged three and above and order and administer COVID-19 tests in accordance with an FDA license, approval, or authorization through December 31, 2024.”

With the end of the year’s quick approach, this leaves pharmacies not only confirming employees are compliant with annual federal obligations (see this month’s Newsline article, The Clock is Ticking: Complete Your Annual Training!), but also ensuring they are safeguarded, from both liability and audit risks, to continue to administer vaccines in the new year.

In the September 2024 Newsline article, Flu Shot Season – Are You Prepared?, the requisites of an audited vaccine prescription are discussed. Fittingly, the first requirement listed is “authority to administer”. Pharmacies need to either have a signed order from an authorized prescriber or have a signed protocol or collaborative practice agreement (CPA) that lists the specific vaccinations that can be administered. In some cases, this may require the pharmacy pursue an amended protocol/CPA with the supervising prescriber that includes COVID-19 vaccines or conduct a staff meeting to re-educate the team on the state regulations surrounding vaccine administration, such as age requirements and which staff members are allowed to administer COVID-19 and influenza vaccines.

PAAS National® is unable to forecast how PBMs will react to the conclusion of the PREP Act; however, our guidance is to ensure proper compliance is in place by the start of the new year to ward off preventable recoupments due to nonadherence of vaccination requirements.

PAAS Tips:

  • Be sure to follow your state’s laws in relation to what ages can be vaccinated or tested.
  • Follow your state specific laws and guidelines when determining who in the pharmacy can vaccinate and administer COVID-19 testing. 
  • Prior to sending PBMs audit responses that include vaccinations, reach out to PAAS National® to ensure all required paperwork is sent with the initial submission, alleviating subsequent work that needs to be done on appeal