The United States Pharmacopeia (USP) revealed that more than 8 million U.S. healthcare workers are exposed to hazardous drugs each year and that more than 12 billion doses of hazardous drugs are handled by U.S. providers each year, with pharmacists and pharmacy technicians at the top of the list.
Community pharmacies have been dispensing hazardous drugs long before the potential for harm (due to low dose, long term exposure) was known. Exposure to a hazardous drug is often inadvertent and unknown to the employee. There is some surprise when presented with the list of hazardous drugs which includes pharmaceuticals that you may handle on a daily basis including; fluconazole, fluoxetine, carbamazepine, warfarin and oral contraceptives. There are more than 400 hazardous drugs and their unique dosage forms.
Occupational exposure to hazardous drugs, or their residue, can be an everyday experience and the true effect of this exposure is unknown for many, and may result in both acute and chronic health issues due to trace exposure to hazardous drugs. Acute toxicity may present as nausea, rashes, hair loss, kidney damage, hearing loss and cardiac toxicity. Long term effects may include cancer, infertility, and other reproductive health issues. Certain populations, including, those that are immunosuppressed, and women and men of childbearing age may therefore be more at risk.
This occupational exposure extends to everyone working in the pharmacy, from the pharmacists and pharmacy technicians who handle HDs, to those who work at the pharmacy counter or in the receiving and delivery areas. The exposure risk extends to anyone who may come into contact with HD particles or residue.
Exposure can occur:
- thru the skin or oral mucosa when counting and pouring
- by inhalation of dust particles when splitting a tablet or when working with an uncoated tablet that simply creates a lot of dust
- by ingestion if eating or with hand to mouth contact without cleaning or hand washing
- by injection, as is the case with an accidental needlestick
Different activities in the pharmacy come with different levels of potential risk:
- dispensing a unit of use or a blister package of a hazardous drug may have a very low risk of exposure
- counting and pouring an uncoated hazardous drug tablet or capsule increases the risk
- splitting a hazardous drug tablet where dust can be created creates potential for increased exposure
- cleaning a spill of a liquid hazardous drug introduces another level of risk
The key is developing good practices to contain or greatly reduce risk. Per OSHA, the safe handling of hazardous drugs in accordance with USP 800 is now considered a “national professional standard” as a pharmacy process “to protect the safety and health of employees”. A USP 800 compliance program is a necessary step to protect the health and safety of your employees, patients in your pharmacy, and the environment. It can also help reduce employer liability from frivolous lawsuits through employee training, competency documentation and employee acknowledgements.
Let PAAS National® help you get compliant while protecting your business and creating a safer environment for your pharmacy employees.
Top 10 PAAS National Articles of 2023
PAAS Audit Assistance members receive a monthly newsletter with new audit tactics and prevention tips. The printed newsletter, PAAS National® Newsline (sample) is only a fraction of the content that we put out each month as members have access to additional content online in the Member Portal, in addition to an archive of articles.
The top 10 Newsline articles for 2023 include:
Top eNewsline Exclusives: Articles that did NOT make print
PAAS Audit Assistance Admins can also keep their employees informed to increase engagement and lower audit results by adding employees to the Portal so that their whole staff has access to the eNewsline.
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.
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:
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:
The top 5 concerns:
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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.
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:
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.
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:
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?
News Article with Protected Health Information Led to an $80,000 HIPAA Settlement
According to a November 2023 press release from the Office for Civil Rights (OCR), Saint Joseph’s Medical Center (“Saint Joseph’s”) of New York state agreed to pay $80,000 and implement a corrective action plan in response to their unauthorized release of Protected Health Information (PHI). The OCR press release states a national publication from the Associated Press regarding Saint Joseph’s response to the COVID-19 pandemic included pictures of the facility and PHI about three patients. Since Saint Joseph’s did not obtain prior written authorization from the patients, or their authorized representatives, to release information about their COVID-19 diagnosis, their current medical status and medical prognosis, vital signs, or treatment plan, Saint Joseph’s was in potential violation of the HIPAA Privacy Rule.
In addition to the $80,000 settlement and corrective action plan, Saint Joseph’s must also develop written policies and procedures to ensure their facility and workforce is compliant with the HIPAA Privacy Rule. They will also be monitored by the OCR for two years to ensure they are compliant with their updated policies and procedures and the HIPAA Privacy Rule.
PAAS Tips:
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:
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:
PAAS Tips:
USP 800 Sets New “National Professional Standard”
The United States Pharmacopeia (USP) revealed that more than 8 million U.S. healthcare workers are exposed to hazardous drugs each year and that more than 12 billion doses of hazardous drugs are handled by U.S. providers each year, with pharmacists and pharmacy technicians at the top of the list.
Community pharmacies have been dispensing hazardous drugs long before the potential for harm (due to low dose, long term exposure) was known. Exposure to a hazardous drug is often inadvertent and unknown to the employee. There is some surprise when presented with the list of hazardous drugs which includes pharmaceuticals that you may handle on a daily basis including; fluconazole, fluoxetine, carbamazepine, warfarin and oral contraceptives. There are more than 400 hazardous drugs and their unique dosage forms.
Occupational exposure to hazardous drugs, or their residue, can be an everyday experience and the true effect of this exposure is unknown for many, and may result in both acute and chronic health issues due to trace exposure to hazardous drugs. Acute toxicity may present as nausea, rashes, hair loss, kidney damage, hearing loss and cardiac toxicity. Long term effects may include cancer, infertility, and other reproductive health issues. Certain populations, including, those that are immunosuppressed, and women and men of childbearing age may therefore be more at risk.
This occupational exposure extends to everyone working in the pharmacy, from the pharmacists and pharmacy technicians who handle HDs, to those who work at the pharmacy counter or in the receiving and delivery areas. The exposure risk extends to anyone who may come into contact with HD particles or residue.
Exposure can occur:
Different activities in the pharmacy come with different levels of potential risk:
The key is developing good practices to contain or greatly reduce risk. Per OSHA, the safe handling of hazardous drugs in accordance with USP 800 is now considered a “national professional standard” as a pharmacy process “to protect the safety and health of employees”. A USP 800 compliance program is a necessary step to protect the health and safety of your employees, patients in your pharmacy, and the environment. It can also help reduce employer liability from frivolous lawsuits through employee training, competency documentation and employee acknowledgements.
Let PAAS National® help you get compliant while protecting your business and creating a safer environment for your pharmacy employees.
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.
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: