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.
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:
Liraglutide Injection Marks Debut as First Authorized Generic GLP-1 Product
In late June, Teva Pharmaceuticals launched the first “generic” GLP-1 (Glucagon-Like-Peptide-1) receptor agonist in the United States, known as Liraglutide injection (6 mg/mL). This authorized generic of Victoza® is a once daily noninsulin injection approved to treat type 2 diabetes in adults and children aged 10 and older. It is also approved to reduce the risk of cardiovascular events like heart attacks and stroke in adults with type 2 diabetes and heart disease.
The FDA defines an authorized generic (AG) drug as the brand name drug that is marketed without the brand name on its label. So other than not having Victoza® on the label, Liraglutide is the exact same drug product as the brand Victoza®. An AG may be marketed by the brand name drug company or another company with the brand’s permission. While it is the same as the brand name product, companies typically choose to sell the AG at a slightly lower cost than the brand.
PAAS Tips:
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 #6: Immunosuppressive Drugs for Transplant
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 immunosuppressive drugs for transplant:
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:
DAW 8: Documentation When the Generic is Not Available
DAW code billing on multi-source brand medications is a frequent audit target for PBMs due to their potential higher cost, change in pharmacy reimbursement, and impact on patient copays. PAAS National® recommends …
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:
Do The Math and Avoid the Recoupment
Proper mathematical calculations are critical to billing prescriptions correctly. The action of translating directions on the prescription into a mathematical equation seems simple, but PAAS National® analysts see claims billed with incorrect days’ supply every day! Though many PBMs may not recoup for a simple days’ supply calculation error, the error itself can cause additional discrepancies on the claim, which usually do result in a financial penalty. For instance, if the pharmacy bills three 10.2 g Symbicort® 160 mcg/4.5 mcg inhalers with directions of 1 puff BID as a 90 days’ supply when it should be a 180 days’ supply, that will likely result in several discrepancies. First, an invalid days’ supply discrepancy. Second, the claim is usually flagged with an overbilled quantity discrepancy which results in a partial recoupment when the plan limit is 30 or 90 days. Third, it could cause a refill too soon penalty on the next fill which would result in a full recoupment of the subsequent claim. The penalties and subsequent recoupments can add up fast!
For many medications, the mathematical calculation is straightforward; however, not all medications are easily calculated. Below is a table of the common days’ supply calculation pitfalls and ways to avoid them.
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 Self-Audit Series #6: Return to Stock
PAAS National® analysts continue to see pharmacies face recoupment on audits due to return to stock violations. Pharmacies argue the patient received the medication, so how can the claim be recouped? Unfortunately, each PBM contract has a specific number of days, within which, the pharmacy must dispense the medication. Dispensing outside this time frame will likely result in full recoupment of the claim if discovered upon audit.
PBM return to stock windows range from 10 – 30 calendar days. With no industry standard interval, PAAS recommends …
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:
Don’t have written compliance policy and procedures? Consider joining the PAAS National® FWA/HIPAA Compliance Program today! info@paasnational.com or (608) 873-1342.
NEW Dispense as Written (DAW) Code Revealed
Chances are you have come across a claim or two (or several thousand!) with a DAW code of 1, 2, or 9. Pharmacy staff are usually knowledgeable about when to use these DAW codes – that a DAW 1 may be appropriate to use when the prescriber does not authorize generic substitution on a multi-source brand, a DAW 2 when the patient requested the brand name, and a DAW 9 when the plan explicitly indicates the brand name product is preferred. The same DAW guidance applies for biologic reference products (e.g., Lantus®) with an interchangeable biosimilar (i.e., Semglee®).
While those three DAW scenarios are fairly straightforward, real-world claim adjudication can be a bit more complex and a single numeric DAW code may not accurately convey the true billing situation. Take for instance a patient with a commercial plan for their primary coverage and Medicaid as their secondary. Sometimes, one payor may prefer the brand while the other prefers the generic. Then what?!
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: