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.
2024 Update: CMS Mandatory E-Prescribing Requirements for Controlled Substances – Final Rule
2024 Update: CMS Mandatory E-Prescribing Requirements for Controlled Substances – Final Rule
The SUPPORT Act was created to address the opioid crisis in our nation. Section 2003 states that all Schedule II-V controlled substance prescriptions under Medicare Part D and Medicare Advantage plans (MA-PD) must be transmitted electronically. Prescribing controlled substances electronically has many benefits such as improved patient safety, more efficient workflow, fraud deterrence and medication adherence. The CMS Electronic Prescribing for Controlled Substances (EPCS) Program is separate from any state EPCS program requirements. PAAS National® last updated our members regarding the enforcement of EPCS in January 2023. On November 16, 2023, CMS released the Calendar Year 2024 Physician Fee Schedule Final Rule. See below for three major takeaways regarding the CMS EPCS program and a timeline table.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
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.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
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:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
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.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
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.
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
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?
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
PAAS Tips:
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:
Did you know there is much more to your audit assistance membership than just help with audits? The PAAS Member Portal contains a wealth of information and resources to assist you with audits and member service questions. Below is a list of 6 pages found on the Audit Assistance section of the PAAS Member Portal to assist you and your pharmacy staff to be proactive when it comes to audits.
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.