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.
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.
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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.
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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!
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:
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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,
“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.
PAAS Tips:
Avoiding MedImpact Recoupments for Bypassing Plan Limits
Pharmacies receive many rejections while billing claims throughout the day. Paying attention to these rejection messages is key to avoiding audit recoupments, which may occur years later. One such rejection occurs when a pharmacy bills a claim that exceeds a plan limit. This can be due to:
Actions to consider including …
MedImpact has a history of recouping claims which have been rebilled incorrectly to bypass plan limits. PAAS National® has seen numerous audits on blood glucose test strips where a pharmacy attempted to bill the correct days’ supply, received a rejection stating they will only cover a certain number of test strips per month, then rebilled for that quantity and with a different days’ supply even though it is not mathematically correct. This makes it very easy for MedImpact to come back and audit the claim because they already saw the pharmacy put in one days’ supply, then rebilled for a new days’ supply after receiving a rejection (especially when it occurs within seconds of the first rejection). Audit results will often state, “Incorrect billing of the day supply in order to bypass system edits (or the PA process) is not acceptable. MedImpact will reverse this claim.”
These recoupments can be difficult to appeal. It is better to ensure you are entering the correct days’ supply based on the mathematical calculation of the directions and following plan rejections appropriately at the start of the claim than to try to appeal later.
PAAS Tips:
Documentation Deep Dive: Meeting Auditors’ Standards in DUR and SCC
PAAS National® frequently sees claims audited that contain a clinical drug utilization review (DUR) or submission clarification code (SCC), particularly from Express Scripts and Prime Therapeutics. Auditors are looking for proper documentation when these codes are used, but pharmacies are often unaware of what this should include.
When a claim is being processed, a DUR conflict message may appear as a warning to prevent potential patient harm. The pharmacist must be made aware of it so that they can use their professional judgement before dispensing the medication. These should not be automatically overridden without pharmacist input.
Once the pharmacist has reviewed the DUR conflict, they will determine the appropriate “professional service” and “result of service” codes. A full clinical note documenting the situation must then be recorded to prevent audit recoupment. Simply documenting the override codes used does not meet this criterion or provide the auditor with the explanation for why the override used was appropriate.
Inappropriate Documentation: HD/M0/1B
Appropriate Documentation: 01-01-2020/Verified with Dr. Jones they are aware this is a high dose/Told to fill prescription as is/Pharmacist’s initials
Claims billed with an SCC code require similar documentation. These are typically overrides done for situations like a vacation supply, lost or stolen prescription, or therapy change. The code used, the date, and the reason should be documented in these cases.
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All Pharmacies Face Medicare Part A vs Part D Billing Risks, Especially Combo Shops
Pharmacies that service long-term care (LTC) and assisted living facilities (ALF) as well as retail patients, known as “Combo Shops”, may not be aware of the potential recoupment risks from Medicare. PAAS National® wants to inform our members of these risks and how to best avoid them.
Many times, patients residing in long-term care or assisted living facilities have a temporary stay under Medicare Part A. A change in Medicare coverage status is typically linked to the patient’s admission and discharge dates from a hospital or skilled nursing facility (SNF) stay.
When a patient is covered under Part A, the facility providing the stay is paid for the medications, supplies, and services during the coverage period. This means Medicare Part D will not be responsible for claims billed during that time (Medicare won’t pay under Part A and Part D at the same time). CMS provides Part D sponsors a Long-Term Institutionalized (LTI) report on a quarterly basis. This information is utilized by the plan to identify any misbilled claims due to overlapping Part A coverage. Unfortunately, PBMs do not have the information at the point-of-sale to stop these claims from being billed inappropriately.
It is vital that pharmacies stay in constant contact with facilities prior to billing and delivering prescriptions to ensure there has not been any changes in patients’ Medicare coverage due to an admission. Medications that are delivered to facilities when a patient is “in-patient” (under a Part A stay) should be returned to the pharmacy until the Part A stay has ended. Claims can be billed once again to Part D the day after the last covered day of the Part A stay. Any sooner and the claim would face full recoupment – even if there’s only one day of overlap!
LTC and ALF claims are not the only ones at risk. Prescriptions billed for patients that are on a Part A stay (for use at home) would also fall under this risk. Families and facilities frequently request pharmacies to fill prescriptions in anticipation of discharge. This in theory is a great idea; however, if Part A has already paid for that patient on that day(s), Part D will not pay for duplicate coverage. While difficult to catch, imagine the scenario of a husband being in the hospital (under Part A) and the wife presenting to the pharmacy for prescriptions. Even if the prescriptions are routine refills, they are subject to full recoupment! If the spouse (or an authorized representative) mentions that the patient is in the hospital right now, and they’re on Medicare, you will want to ask more questions before dispensing.
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