Days’ Supply Considerations for Eye Medications

PBM audits regularly target eye medications looking to recoup on claims for incorrect days’ supply or early refills. For this reason, it is important that pharmacies are both aware and have a proactive plan to ensure appropriate billing and documentation. As with all prescriptions, the day supply is a function of quantity dispensed and daily dose; however, there are a few additional considerations that may impact what days’ supply is correct.

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PBMs each have their own drops per mL estimates for eye drops that are published in Provider Manuals and vary from 15-20 drops per mL for solutions and 12-20 drops per mL for suspensions (or emulsions). There is no industry accepted conversion for gel or ointment products.

In addition to the mathematical days’ supply calculation, pharmacies must also consider the individual product beyond use date as specified by the manufacturer. In general, eye drop products are considered to be safe to use until the printed-on expiration date; however, there are a few products with specified beyond use dates (e.g., Xalatan® is 42 days). Pharmacies can visit DailyMed for medication information, including How Supplied/Storage and Handling requirements under Section 16 of the drug label information or review product labeling included inside the box. We encourage LTC pharmacies to review our June 2022 Newsline article, Beyond-Use Date vs. Nursing Home Storage Policy – Avoid this Recoupment Trap! for additional comments related to nursing home policies.

Additional considerations include if the patient has an antibiotic or steroid product with a specific treatment duration such as use for 10 days, then stop or if the patient is having cataract surgery separately on each eye and the prescriber wants the patient to discard the bottle used on the first eye and get a refill for the second eye for infection control purposes.

PAAS Tips:

  • Login to the PAAS Member Portal under “Days Supply Charts” to find the most current version of PAAS’ Eye Drop Chart with major PBM Drops per mL conversions
  • If billing eye drops for a PBM not listed on the PAAS chart, PAAS suggests using 20 drops per mL for solutions and 15 drops per mL for suspensions
  • A quantity of “1” or “one bottle” on a prescription should be interpreted as the smallest package size
  • PAAS suggests eye drop products NOT be included on LTC cycle fill or retail medication synchronization programs, and only refilled upon patient request

PBM Prescription Validation Requests Rose 123% in 2023 – What You Need to Know

PAAS National® saw the number of validation requests/concurrent claim reviews more than double in 2023! OptumRx®, who conducts the majority of these reviews, discusses the Prescription Validation Request (PVR) in their pharmacy manual as follows:

Administrator conducts limited scope prescription validation reviews for quality assurance purposes (“PVRs”), which are distinct from and are not considered audits. PVRs are utilized to verify the accuracy and validity of prescription claim submissions. Claims are monitored daily for appropriateness and potential billing errors and selected for review prior to payment. Network Pharmacy Providers are typically contacted via fax or email and asked to provide photocopies of specific documents and records related to its claims submitted to Administrator.

While they want to skirt audit laws by not calling them an audit, make no mistake – they are audits, and payment is at stake! Besides OptumRx®, we also see claim reviews from Caremark®, Express Scripts®, Humana®, MagellanRx, MedImpact and Prime Therapeutics. Below you can see the top 5 drugs reviewed in 2023 and the top 5 concerns  after reviewing each claim.

Top 5 drugs reviewed in 2023:

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  1. Lantus®
  2. Humalog®
  3. Creon®
  4. Levemir®
  5. Invega®

The top 5 concerns:

  1. Black out acquisition cost and/or profit margin values on the backtag
  2. Document the reason for the cut quantity – auditor will want to know why the pharmacy dispensed less than what was prescribed
  3. A clinical notation is needed and requires 4 elements: Date, who you spoke with and their title, what they confirmed and the pharmacy employee initials
  4. No backtag/sticker attached, typically requested by the PBM and also helpful for PAAS in order to review the billing elements
  5. Verify the quantity prescribed and make a clinical notation on the hard copy – Unit of Measure (UOM) is not specified or doesn’t make sense for the medication ordered

PAAS Tips:

Painful Lessons: What You Should Know About Return to Stock Timeframes

PBMs allow a limited amount of time for a prescription to be picked up or delivered to a patient before the claim must be reversed and the medication placed back into the pharmacy’s stock inventory. These time limits are in place to help prevent a claim from being paid for a medication that was never actually received by a patient.

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Unfortunately, there is no standard timeframe across the industry for a medication to be returned to stock, ranging anywhere from 10 calendar days to 15 business days. Pharmacies need to be aware of the individual PBMs’ timeframe or go with the shortest amount of time, 10 calendar days, to reverse and return unclaimed medications to stock.

PAAS National® regularly sees claims flagged for full recoupment when a prescription under audit has been dispensed after the allowed return to stock timeframe. These recoupments are difficult to appeal, so your best defense is to make sure you have a procedure in place to reverse claims not picked up within the PBM’s return to stock policy window. PAAS FWA/HIPAA members have access to an Unclaimed Prescription Reversal Log found in Appendix B of their policy and procedure manual to help with this task. Members should also review Section 4.1.1 Unclaimed Prescriptions of their policy and procedure manual and update their timeframe as needed.

PAAS Tips:

  • Review the Return to Stock chart on the PAAS Member Portal for the most current PBM policies
  • Update your FWA/HIPAA Policy & Procedure Manual as needed and update all staff on any changes
  • Run daily reports for claims not picked up within your pharmacy’s return to stock policy
  • Check with your software vendor to see if your point-of-sale system can be configured to stop the sale of any claims outside your return to stock policy
  • LTC claims and partial fills/completions are NOT exempt from return to stock policies
    • For LTC claims, the return to stock date is calculated from the date the claim is billed, not the date the medication is physically filled
  • Be aware that Risk Evaluation and Mitigation Strategies (REMS) products may have more stringent requirements for pick-up, review the June 2021 article, Would Your REMS Prescription Pass an Audit?
  • If a patient requests a medication be left on the shelf beyond the return to stock window, reverse and rebill the claim to restart the countdown to return to stock

Transfer Tragedy: A Timeworn PBM Target

It’s a tale almost as old as time – a patient’s medication is sent to one pharmacy only to have the patient decide they want it filled by your pharmacy instead. You contact the other pharmacy for a transfer, fill the medication and the patient is on their way. All is well until you receive a PBM audit. Suddenly, that transferred prescription is under scrutiny, and you are wondering what the problem could possibly be.

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Transferred prescriptions have become an easy target for PBMs due to their additional documentation each state requires, which can be easily forgotten in the rush to take down all the information. PBMs identify transferred prescriptions through the origin code billed and will look for any technicality to recoup (e.g., missing the word “transfer” on the prescription). Check your state’s transfer requirements to ensure all elements are present on your transferred prescriptions, regardless of how the transfer is received (e.g., via fax or verbally). The receiving pharmacy is responsible for ensuring all transfer requirements are present, so if any elements are missing, verify them and make note of the missing information on the prescription.

PBMs also look for other missing or inaccurate information. Some PBMs, like Humana, will interpret state laws referencing a transferred prescription be “reduced to writing” as needing to be hand-written by the receiving pharmacy. Additionally, if the original written date of the prescription is missing or entered incorrectly, the claim could be flagged for “wrong hard copy,” and risks being refilled after expiration. Finally, the quantity on a transfer needs to be specific and contain a unit of measure. For example: insulin pens written with a quantity of 15 without a unit of measure, should be clarified with the transferring pharmacy as 15 mL, 15 pens, or 15 boxes.

PAAS Tips:

  • Check with PAAS (or your Board of Pharmacy regulations) for your state’s transfer requirements
    • Have pre-printed transfer prescription pads available with blanks for all required information
    • Make sure pharmacy staff are aware of the importance of filling out the transfers completely
  • Print any internal transfer screens used to satisfy state requirements and send along with your prescription for audit
  • Never dispense more than the quantity remaining on the prescription
  • Enter the correct written date to avoid filling after expiration
  • Enter Origin Code 5 (sometimes listed as “Transfer” or “Pharmacy” in your software) no matter how you receive the transfer from the other pharmacy
  • Ensure the unit of measure is present on quantities that may have multiple interpretations
  • If the prescription was on hold at the transferring pharmacy, make note of it on the transfer

Elixir Audit Notice Delivery Methods

What is worse than receiving an audit notice? Receiving audit results which state “NRS – No Response to Audit Request” when the pharmacy never received the audit notice. Although pharmacies could potentially not receive an audit notice with any PBM, PAAS National® has commonly seen this be an issue with Elixir. In instances where the pharmacy did not respond to the audit, Elixir recoups on all fill dates for the prescription numbers instead of the originally audited fill date only.

So, how can pharmacies prevent audit notices from not being delivered or being missed in the shuffle?

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One option is to change the audit delivery method to email. The Elixir Pharmacy Audits Department states pharmacies can send an email informing them of their desire to update their delivery preference with “up to two email addresses to be programmed for future audit communications”. It is therefore suggested that pharmacies take the following steps to ensure delivery of audit notices:

  • Email PharmacyAudits@elixirsolutions.com to update your preferred audit notice delivery method to be electronic communication via email, adding up to two email addresses.
  • Add the Elixir email address to your safe senders list
  • Periodically check junk/spam folders
  • Many PBMs refer to a pharmacy’s NCPDP profile for contact information to use when communicating, including sending audit notifications. Ensure you keep your fax number and email address accurate to reduce the likelihood of missing important communications.
  • Contact PAAS (608) 873-1342 to help guide you through the appeals process

Staying Compliant with House Charge Accounts

Copays are used by insurers to sensitize patients to the cost of their medications and give patients financial incentives to reject medications that are not medically necessary or add little to no value to their treatment. PBMs require pharmacies to collect patient copayments in full and any deviation from that practice may be considered fraudulent behavior, with limited exceptions. Medicaid claims, where pharmacies are unable to withhold medication if a patient cannot pay their copay, and copay waivers for indigent patients (refer to the December 2023 Newsline article Best Practices for Financial Hardship Waivers for more details) are two of the most common exemptions.

All pharmacies should have policies and procedures in place to collect copayments in full, and retain proof for an audit. Nowadays, many pharmacies use sophisticated point of sale systems which make it relatively simple to provide an auditor with evidence of a payment by check, cash, or credit card (although additional documentation may be required). Many point of sale systems are also integrated with the pharmacy dispensing software and offer accounts receivable (i.e., house charge account) capabilities, which some pharmacies utilize. Allowing patients to charge their copays to a house account can be beneficial because it:

  • Is a service which could set your pharmacy apart from competitors, especially big-box and chain stores
  • Allows patients to make one monthly payment, which may be ideal for those on a fixed/limited income
  • May prevent a delay in treatment because it could allow a patient to pick up their medications when they are needed even if they will not have the money available to pay the copay until later in the month

While there are several benefits to providing house accounts, there can be a downside to using them as well; including the effort required to collect on them. Auditors are also suspicious of pharmacies using house accounts, as there have been “bad actors” who have used phony house accounts to “hide” patient copays by charging them to the house account with no intent of collecting payment. In essence, they are using the house account to provide a kickback to the patient by waiving their copay.

If your pharmacy offers house accounts, it is critical you have a robust policy and procedure in place for how those accounts are managed. Consider the following:

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  • Which patients will be eligible?
  • What credit limit will be set?
  • How often will you attempt to collect on the accounts? (PAAS National® recommends monthly statements.)
  • At what point will you freeze a patient’s account if they fail to pay down their balance?
  • What type of documentation will you maintain to prove you attempted to collect (e.g., logged phone calls, dated invoices, etc.)?
  • How will you capture the payment to the house account to prove the balance is being paid down?
  • Can you produce an itemized report that shows payments received and outstanding balances on the account which may be requested in the event of an audit?

PAAS Tips:

  • House account policies and procedures must be in place long before an audit (i.e., Caremark will NOT consider efforts to collect if the first documented effort occurred after the audit was initiated!)
  • If you have additional questions, give us a call at (608) 873-1342 and a PAAS National® analyst would be happy to provide additional guidance

Zepbound (tirzepatide) Means Decreased Audit Risk…Right?

On November 3, 2023, Eli-Lilly was granted the highly anticipated weight loss indication on their tirzepatide injection, ZepboundTM. ZepboundTM is indicated as an adjunctive therapy for adults with a body mass index (BMI) of 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) plus at least one weight-related comorbidity, such as type 2 diabetes mellitus, dyslipidemia, or hypertension – the same indication as Wegovy® and Saxenda®. Although this is an exciting advancement in the realm of GLP-1 agonist prescribing, PAAS National® would like to take this opportunity to update our members on what PBM trends we have seen thus far, draw attention to the guidelines laid out by PBMs and regulations in which we can rely on, and give our thoughts on the current audit situation in the hopes of allowing you to make the most informed business decision.   

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As of this publication, recoupments on type 2 diabetes mellitus (T2DM) GLP-1 agonists due to off-label indication use, defined as anything other than being used as an adjunct therapy for adults with T2DM, is nominal. Elixir communicated via their Pharmacy Audit Whisperer from April 2023 that Ozempic® and MounjaroTM being used for an indication of obesity or weight loss would not be covered and they have pursued recoupment of such claims. Caremark has been sending notices to pharmacies dispensing GLP-1 agonist at a volume identified as an outlier in their region. We’ve also seen OptumRx/EXL Health flag Ozempic® for off-label use. Notably, PAAS is aware of nine state Medicaid programs that were negotiating prices for Wegovy® earlier this year.

Despite the de minimis recoupments seen thus far, PBMs and insurance companies have put out communications advising pharmacies they reserve the right to report suspected improper dispensing practices to federal or state agencies, which may result in an additional level of scrutiny placed on pharmacies. As it states in Section 10.6 – “Medically-Accepted Indication” of the Medicare Part D Manual, “Part D sponsors are responsible for ensuring that covered Part D drugs are prescribed for medically-accepted indications using the tools and data available to them to make such determinations.” Therefore, according to this guideline, Medicare Part D may pay for a GLP-1 agonists prescribed for its appropriate indication but will not pay for a GLP-1 agonist with an indication that does not match the patient’s intended use. In addition to being mindful of the CMS billing guidelines, pharmacies must be mindful of individual PBM’s expectations for billing practices. Some PBM’s have explicit language in their Provider Manuals that define “clean claims” as one that is used for a medically accepted indication or outlines “appropriate dispensing practices”, both alluding to claims that are for medically accepted indications. Yet pharmacies have processed prescriptions for off-label use without issue. If Medicare Part D states they will not pay for off label use, then why are these claims to go through without issue? If commercial plans state they will only cover medication for certain indications, why not put diagnosis restrictions in place to stop claims from going through at the point of adjudication? We know that PBMs have highly intricate algorithms that can focus in on prescription specifications; why aren’t they targeting GLP-1 agonists being used off-label on audits? One could speculate due to the vast amount of administration fees and rebates they are currently reaping there isn’t a reason to impose their regulation at this time, but these claims may be in the PBM’s crosshairs in the coming years. After all, audits typically target claims from previous years and PBMs do not mind using a “pay and chase” approach because they can just withhold future payments.

Beyond audits originating from PBMs for off-label use, manufacturers can cause trouble as well. Eli Lilly and Novo Nordisk have sued medi-spas, clinics, and compounding pharmacies over counterfeit versions of their GLP-1 agonists.

Ultimately, we urge you to consider the following when deciding how to handle adjudicating GLP-1 agonist prescriptions for off-label use: “How much do you trust the PBM to act favorably to your pharmacy – now and in the future?” While the future of GLP-1 agonist audits is obscure, our guidance remains conservative – tread cautiously.

PAAS Tips:

  • When diagnosis codes are known, be sure the prescription is written for the appropriate GLP-1
    • If you are dispensing MounjaroTM for weight loss, best practice would be to contact the prescriber for a new prescription for ZepboundTM
  • Refresh yourself on PAAS’ suggested workflow when approaching GLP-1 agonist claims, outlined in the May 2023 Newsline article, Best Practices for Dispensing GLP-1 Medications and Reducing Recoupment Risk

Unveiling a Multi-Million Dollar Fraud and Kickback Scheme

According to an August 18, 2023 press release from the Department of Justice (DOJ), a pharmacy operations manager and some co-conspirators have pled guilty to committing healthcare fraud and to paying illegal kickbacks for Medicare and Medicaid claims that were never dispensed to patients. The two pharmacies in New Jersey and New York, now closed, operated as “specialty pharmacies” processing expensive medications to treat Hepatitis C, Crohn’s disease, and rheumatoid arthritis.

The pharmacies in question obtained retail contracts with several PBMs, which allowed them to receive payment for the specialty medication claims that were falsely billed. In order to increase the number of prescriptions being filled, bribes were paid to doctors and their staff to steer prescriptions to their pharmacies. Some of the bribes were expensive meals, cash, checks, wire transfers and paying an employee to work inside a doctor’s office. While the pharmacies usually dispensed the initial prescriptions to the patients, they billed for refills of these same medications without ever dispensing them to the patients.

For five years, the pharmacies received tens of millions of dollars for claim reimbursement from Medicare, Medicaid and private insurances that were not only never dispensed, but never even ordered from their wholesaler. The PBMs began to investigate by conducting routine audits for these “specialty pharmacies.” One of the co-conspirators told employees to falsify records by forging shipping documents to make it appear as if the medications were being shipped to the patient when they were not. The conspiracy to commit healthcare fraud has a maximum sentence of ten years in prison and the conspiracy to pay illegal kickbacks has a maximum of five years in prison. Both counts face a $250,000 fine, or twice the gross gain or loss from the offence, whichever is greatest.

Ensure your pharmacy has a robust Fraud, Waste and Abuse Compliance Program in place for employees to understand the repercussions of violating laws and regulations such as the False Claims Act and the Anti-Kickback laws. 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.

Insufficient/Missing Clinical Notes Yield Audit Recoupments

PAAS National® analysts are seeing more prescriptions flagged for recoupment when insufficient or missing information is not verified with a valid clinical note. Nothing is more frustrating than having the validity of the clinical notes questioned by a PBM auditor because they are incomplete, but that is exactly what is happening!

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In particular, OptumRx and Humana are creating headaches for pharmacies, requiring prescribers to validate the clinical note to avoid recoupment.

Inevitably, pharmacies will receive prescriptions that contain missing elements or need clarification. To avoid a potential recoupment, clear documentation is essential.

PAAS recommends four elements for clinical notes:

  1. Date (and preferably time) of the call/conversation
  2. Name and title of who you spoke with
  3. Specific details about the clarification
  4. Initials or name of the pharmacy employee making the clarification

PAAS Tips:

  • Instruct staff and have a policy on how clinical notes will be documented
  • Some pharmacies have created customized ink stamps to facilitate and promote this documentation process for staff
  • Check with your software vendor on how to utilize the electronic notes field
  • If making handwritten clinical notes, ensure you rescan the prescription into your software
  • Any notations made on previous prescriptions that are still valid should be carried forward to the new prescription
  • If the patient instructions are clarified, ensure the patient label is updated prior to dispensing to reflect the new directions
  • Upon an audit, be sure all clinical notations are clearly visible to the auditor
  • See the June 2023 Newsline article, Carry Clinical Notes Forward for Audit Coverage
  • See the August 2023 Newsline article, Electronic Clinical Notes: Are They Required?

Auditors Become Increasingly Stringent on Quantity and Unit of Measure Appeals

You may recall the article Quantity Changes Cause Audit Appeal Trouble from the May 2023 Newsline. The article discusses how PAAS National® saw an increase in the number of discrepancies for “unauthorized” refills. Consider the excerpt,

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“Humana only allows electronically stored date and time stamped pharmacy notes validating the increase in quantity and/or refills (and the date authorized)…OptumRx will only accept a prescriber statement on appeal for unauthorized refills if the causality is not an undocumented/unapproved increase in quantity”. Six months later, PAAS has now learned that OptumRx will no longer accept prescriber statements as a means of appeal for “unauthorized” refills. As a result of the decreased tolerance for quantity and unit of measure errors, it is important to ensure each are correctly documented from the beginning.

“Unauthorized refills” are instances where a pharmacy dispenses a quantity of medication that exceeds the total written quantity of the prescription, whether that be in a single fill or over the lifetime of the prescription.

Example of a Prescription Received Electronically: Insulin glargine pen injector is prescribed with a written quantity of “3 unspecified” with 4 additional refills.
Scenario #1: No clarification notated on hardcopy/electronic notes field The auditor may assume the smallest amount, which would be 3 mL in this example. Therefore, they believe the total written quantity of the prescription to be 15 mL. If the pharmacy interprets “3 unspecified” to be “3 boxes” (e.g., based on the sig), the total written quantity the pharmacy believes they have would be 15 boxes, or 180 mL. Assuming the pharmacy does not break boxes, each fill would face full recoupment.
Scenario #2: Pharmacy crosses out “unspecified” and writes “boxes” There is a high probability the auditor will take issue with the lack of documentation, although it is lower in comparison to Scenario #1. They would want to see a full clinical note showing the prescriber or their agent clarified the prescribed quantity. As a reminder, a clinical note includes who you spoke to including name and job title, what you spoke about, when the conversation occurred, and your initials.
Scenario #3:  Pharmacy calls prescriber and notates in the clinical note “Per Julie RN, Approved dispensing #15 mL 01/01/2001 RPH”

 

 Although the risk of recoupment is decreased due to the presence of a clinical note, there is still the possibility of the prescription being marked discrepant due to “unauthorized refills”. The auditor may interpret the clinical note to mean the pharmacy is allowed to dispense a #15 mL box of insulin according to the conversation with the prescriber’s office, but still assume the prescription to be 3 mL with 4 additional refills, using up the entire written quantity on the first fill. Any additional refills beyond the initial date of fill would face full recoupment.
Scenario #4: Pharmacy calls prescriber and notates in the clinical note “Per Julie RN, Prescription to be written as 3 boxes with 4 additional refills 01/01/2023 RPH” The risk of the prescription being marked discrepant due to unauthorized refills is greatly reduced. The quantity and unit of measure is clearly notated and there is no question of what quantity is remaining on the prescription.

PAAS Tips:

  • Refer to September 2023 Newsline article, Easy Audit Recoupment Prevention: Document Changes in Quantity Dispensed to ensure your pharmacy is properly documenting increases and decreases in dispensed quantity compared to written quantity.
  • Refer to this month’s article, Insufficient/Missing Clinical Notes Yield Audit Recoupments
  • Follow your state regulations regarding pharmacy-level ability to consolidate refills
  • In cases of transfers, be intentional when notating the quantity of medication remaining on the prescription
  • If a prescription is written for a quantity of “1” on inhalers, topical products, or eye drops, the auditor will likely assume the smallest package size, even if it is an institutional size package that is not regularly dispensed by retail pharmacies
  • If a prescription is written for a “30 days’ supply”, the auditor will assume the doctor wrote for an amount that is exactly 30 days, even if that quantity is not feasible, such as a fraction of an insulin pen