When PBMs violate state law, pharmacies need to scream from the mountain tops. Get the ball rolling by filing a complaint with your state regulators. As a local state representative said, “If there are no complaints, then we assume all of the regulations put forth are working great”. If you’re not sure where to start, the National Community Pharmacists Association’s (NCPA) has a webpage that provides instructions on how to file a complaint in your state.
Over the past several years, nearly every state has passed some type of PBM reform. While there have been great strides with comprehensive regulations, and court victories, this can be diminished if no complaints are reported [when laws are violated] and states are not held accountable for enforcing the laws being put in place.
You must be proactive and hold your state agency’s feet to the fire. You do that by filing complaints when the insurers/PBMs are NOT following the law. It surely does not shock any community pharmacy that PBMs willing violate these laws. The more detailed, factual-based complaints regulators receive, the more likely they are to investigate and ENFORCE the law.
Not only does failing to report violations undermine the effort that went into getting the law passed, but it also makes future PBM reform more difficult. With minimal complaints on record, legislators (and PBM lobbyists) may use that as rationale not to take up additional reform (i.e., the existing regulations are effective).
Some of the common complaints with audits are:
- Failure to adhere to audit timelines or limitations
- Identifying audits as FWA or ‘investigational’ seemingly only to avoid state audit parameters
- Auditors refusing to accept documentation
- Inconsistent application of audit rules and guidelines
- Recoupments for technical discrepancies
Pharmacies are often fearful of filing complaints due to the potential for PBM retaliation. Consequently, many states have included non-retaliation language in the reform. While it can understandably give pharmacy owners pause, if you’re not willing to stand up for your pharmacy, who will?
PAAS Tips:
- Be familiar with your state PBM regulations
- If you feel state laws have been violated – file a complaint
- Unsure of whether an audit situation is complaint worthy? Talk with PAAS
- Provide all necessary documentation to support (and explain) your dispute
- Maintain thorough documentation of all pharmacy transactions and interactions relevant to the situation
Flu Shot Season – Are You Prepared?
Flu shot season is just around the corner and PAAS National® wants to make sure you reduce your risk of audit recoupments. As busy as the flu season can be, it is important to follow the best practices and PAAS tips below to ensure you have all documentation in place.
What you will need for an audit:
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:
2024 DMEPOS Series #7: Therapeutic Shoes for Diabetics
Many pharmacies struggle with DMEPOS audits due to the complexity in medical billing and the onerous documentation requirements. Medicare Part B suppliers need to be able to produce all the required documentation if audited, and make sure all documentation meets Medicare Part B standards. This DMEPOS series is intended to help you understand these complexities and gather the needed documents.
Specifically, you need to demonstrate the following in case of an audit regarding therapeutic shoes for diabetics:
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:
Back to School: How to Ace EpiPen® Billing and Avoid an Audit
PAAS National® has seen an increase in prescription validation requests and audits for EpiPen® and, with back-to-school in full swing, we want all pharmacy employees to be aware of potential billing issues for this life-saving medication.
According to section 1 Indications and Usage of the FDA product labeling, “EpiPen® and EpiPen Jr® are indicated for the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.”
Emergency medications are frequently audited, and EpiPens® have their own unique set of audit issues, including:
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:
The Double Threat: Ransomware Attack Followed by HIPAA Non-Compliance Settlement
Imagine getting a papercut then moments later, cleansing your hands with alcohol hand sanitizer—you can almost feel the instantaneous sting the alcohol causes in the fresh wound. Not only are you subjected to the initial affliction, but also the second round of pain from the alcohol in the wound. Now, imagine a deeper “cut” directed this time at your pharmacy. The initial barrage is a malicious ransomware attack to capture your pharmacy’s electronic protected health information (ePHI), and the secondary “sting” comes when the Office for Civil Rights (OCR) investigates the pharmacy’s policies and procedures. The pharmacy then forks over a hefty monetary settlement for HIPAA Rule non-compliance. Ouch!
A health system servicing patients in Pennsylvania, Ohio and West Virginia found themselves in this exact scenario. According to the published OCR Resolution Agreement and Corrective Action Plan, the OCR initiated a compliance review of Heritage Valley Health System (HVHS) after media reports that HVHS experienced a data security incident. The following HIPAA Security Rule non-compliance issues were identified:
HVHS settled with OCR for a whopping $950,000, agreed to three years of OCR monitoring, and were required to take steps to resolve potential violations of the HIPAA Security Rule.
In addition to detailing the settlement with HVHS, OCR’s July 1, 2024 press release stated there has been a 264% increase in large breaches reported to OCR involving ransomware attack since 2018. This alarming statistic reflects the harsh reality that pharmacies, and their ePHI, are targets for criminals. Pharmacies are directly in the crosshairs of malicious actors and pharmacy owners [and employees] must take steps to safeguard their data. Not only is it the law, but it is your data, reputation, time and money on the line!
PAAS Tips:
Are PBM Regulations Being Enforced by Your State? Let Your Voice Be Heard!
When PBMs violate state law, pharmacies need to scream from the mountain tops. Get the ball rolling by filing a complaint with your state regulators. As a local state representative said, “If there are no complaints, then we assume all of the regulations put forth are working great”. If you’re not sure where to start, the National Community Pharmacists Association’s (NCPA) has a webpage that provides instructions on how to file a complaint in your state.
Over the past several years, nearly every state has passed some type of PBM reform. While there have been great strides with comprehensive regulations, and court victories, this can be diminished if no complaints are reported [when laws are violated] and states are not held accountable for enforcing the laws being put in place.
You must be proactive and hold your state agency’s feet to the fire. You do that by filing complaints when the insurers/PBMs are NOT following the law. It surely does not shock any community pharmacy that PBMs willing violate these laws. The more detailed, factual-based complaints regulators receive, the more likely they are to investigate and ENFORCE the law.
Not only does failing to report violations undermine the effort that went into getting the law passed, but it also makes future PBM reform more difficult. With minimal complaints on record, legislators (and PBM lobbyists) may use that as rationale not to take up additional reform (i.e., the existing regulations are effective).
Some of the common complaints with audits are:
Pharmacies are often fearful of filing complaints due to the potential for PBM retaliation. Consequently, many states have included non-retaliation language in the reform. While it can understandably give pharmacy owners pause, if you’re not willing to stand up for your pharmacy, who will?
PAAS Tips:
PBM Audits on Ozempic®: 5 Common Discrepancies Revealed
Popularity for GLP-1 medications, like Ozempic®, continues to grow and, consequently, PAAS National® encounters these drugs on PBM audits frequently. This article outlines five common discrepancies observed in audit findings for Ozempic®.
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:
Audit Risk: Prescriber Scope of Practice and Treating Self or Family
Everyone knows that PBMs do not perform “random” audits, nor do they select “random” claims in these audits. PBMs have sophisticated algorithms to look at thousands (if not millions) of prescription claims to find abnormalities and patterns that may be indicators of fraud, waste, or abuse. Two of the not-so-sophisticated formulas include comparing prescriber specialty to the drugs prescribed and matching last names of prescriber and patient.
In addition to having PBM audit risk …
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:
Nondiscrimination in Health Programs and Activities – Cultural Competency Training is a Must!
Earlier this year the Office for Civil Rights (OCR) released the 2024 Final Rule under Section 1557 of the Affordable Care Act (ACA), reestablishing many of the 2020 Finale Rule protections that were removed by the prior administration. One of the noteworthy changes (or reinstated regulations) appears in 45 CFR 92.11, which requires covered entities who receive federal funding to let patients know that language assistance services and auxiliary aids and services are available if needed. The notice is to be provided in English plus at least the 15 most common languages spoken by individuals with limited English proficiency (LEP) in the United States. In addition, the notice should be provided via alternate formats for those individuals with disabilities that require auxiliary aids in order to provide equal access to services rendered by covered entities. Despite this seemingly large undertaking, OCR is giving covered entities until July 5th, 2025 to implement this requirement plus is providing sample “Notice of Availability of Language Assistance Services and Auxiliary Aids and Services” that have already been translated.
The notice is but a fraction of the overarching theme the 2024 Final Rule carries: inequality of services provided amongst federally-funded programs is not tolerated. Covered entities must urgently become mindful of their Section 1557 obligation of providing non-discriminatory services on the basis of race, color, national origin, sex, age, or disability as this has been enforced since its inception in 2020, primarily by OCR receiving and investigating discrimination grievances.
Although it may seem as though the likelihood of being in OCR’s crosshairs for a Section 1557 violation is low, by the time covered entities receive notice of an investigation for discriminatory actions, it is too late. Be proactive with Cultural Competency training to help avoid an investigation in the first place, and demonstrate that your pharmacy is making strides to provide equivalent access to care.
Pharmacies that complete cultural competency training, and have the training documented, should ensure their NCPDP profile reflects that training. Learn more about PAAS’ Cultural Competency Training here, or contact us today to add the training to your membership.
2024 National Health Care Fraud Takedown
On June 27th the U.S. Department of Justice (DOJ) issued a press release outlining a National Health Care Fraud Enforcement Action that resulted in 193 defendants charged, including doctors, nurses and pharmacists, and over $2.75 billion in false claims. This year marked the highest numbers since 2020 and included coordinated efforts by the DOJ, US attorneys’ offices, HHS Office of Inspector General, FBI, and the DEA.
Takedowns related to prescription drugs included:
For 15 years, PAAS National®’s FWA/HIPAA compliance program has helped educate community pharmacies on federal regulations. Coupled with audit assistance and the Newsline, PAAS serves as a guiding light, steering pharmacies away from trouble and towards compliance. The FWA program not only meets CMS’ definition (and PBM requirements) of an effective compliance program, but also helps with written Policies and Procedure for credentialing.
PAAS Tips:
For more insight into these compliance issues, PAAS Audit Assistance members can consider reading the following articles (many more articles available on our eNewsline):
The Need for Clarification on Prescription Labels
Pharmacy staff frequently receive prescriptions from prescribers that lack (or are missing) complete quantities or instructions for use. Clarifying these details before dispensing can help prevent audit discrepancies. Pharmacies must document these clarifications made with the prescriber’s office utilizing a clinical note that contains all four essential elements:
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: