Since 2009, PAAS National® Fraud, Waste & Abuse and HIPAA Compliance program was designed to meet the CMS requirements, with the full support of our expert staff – pharmacists and technicians just like you, with years of experience helping community pharmacies with FWA and HIPAA compliance. Don’t be fooled by offers for training and exclusion checks – work with the best compliance program available to community pharmacies!
Consider the following:
Humana’s 2022 Notice of Program Requirements
Humana’s Compliance Policy for Contracted Healthcare Providers explicitly states pharmacies must have a compliance program that meets the seven elements outlined by CMS, including written policies, procedures and standards of conduct. Per the 2022 Pharmacy Compliance Education and Training Requirements FAQs: “Humana reserves the right to request documentation (e.g., policies and tracking records) confirming that your organization has an effective compliance program that meets the requirements outlined in the Compliance Policy and Standards of Conduct.”
PerformRx Pharmacy Compliance Attestation 2022/2023
PerformRx requires attestations to the following:
The pharmacy has implemented and maintains a compliance program that is consistent, at minimum, with applicable federal and state requirements, including, but not limited to the standards set forth in 42 CFR §423.504(b)(4)(vi) and other Centers for Medicare & Medicaid Services (CMS) guidance set forth in the Medicare Part D Prescription Drug Benefit Manual.
Be proactive. Be prepared. Be protected. Ensure you have all your compliance bases met so that when you attest to having one, you can provide proof if requested for credentialing or audit.
Don’t have an FWA/HIPAA Compliance Program? Contact PAAS and receive a $126 discount when you combine services with your audit assistance. Get started today! info@paasnational.com or (608) 873-1342.
On-Demand Webinar: Caremark’s Bulk Purchasing Requirements and the Importance of Cultural Competency
On June 15, 2022 PAAS National® hosted Caremark’s Bulk Purchasing Requirements and the Importance of Cultural Competency webinar. PAAS Audit Assistance members have access to the recorded webinar, in addition to many other tools and resources on the PAAS Member Portal.
For easy viewing, we’ve split the webinar into two separate recordings.
The importance of Cultural Competency reviews:
Caremark’s Bulk Purchasing Requirements reviews:
New Tools Available! Biologic and Non-Biologic Injectable Medication Reference Charts
Ever wonder if you were billing the correct NDC for a Humira® prescription and had to spend precious time investigating? Or how about questioning if you were billing the correct package size for Gvoke® and had to consult multiple references just to try and figure out the answer? Perhaps you had audit on Ajovy® only to find your pharmacy facing recoupment because the auto-injector was billed but the script was written for the pre-filled syringe.
PAAS National® now has two new reference charts available to help you and your staff with billing these unique injectable products correctly. Check out the Biologic Injectable Medication Chart and Non-Biological Injectable Medication Chart under the Tools & Aids section of the PAAS Member Portal.
PAAS Tips:
A Need for a Compliance Program – Attest with Confidence
Since 2009, PAAS National® Fraud, Waste & Abuse and HIPAA Compliance program was designed to meet the CMS requirements, with the full support of our expert staff – pharmacists and technicians just like you, with years of experience helping community pharmacies with FWA and HIPAA compliance. Don’t be fooled by offers for training and exclusion checks – work with the best compliance program available to community pharmacies!
Consider the following:
Humana’s 2022 Notice of Program Requirements
Humana’s Compliance Policy for Contracted Healthcare Providers explicitly states pharmacies must have a compliance program that meets the seven elements outlined by CMS, including written policies, procedures and standards of conduct. Per the 2022 Pharmacy Compliance Education and Training Requirements FAQs: “Humana reserves the right to request documentation (e.g., policies and tracking records) confirming that your organization has an effective compliance program that meets the requirements outlined in the Compliance Policy and Standards of Conduct.”
PerformRx Pharmacy Compliance Attestation 2022/2023
PerformRx requires attestations to the following:
The pharmacy has implemented and maintains a compliance program that is consistent, at minimum, with applicable federal and state requirements, including, but not limited to the standards set forth in 42 CFR §423.504(b)(4)(vi) and other Centers for Medicare & Medicaid Services (CMS) guidance set forth in the Medicare Part D Prescription Drug Benefit Manual.
Be proactive. Be prepared. Be protected. Ensure you have all your compliance bases met so that when you attest to having one, you can provide proof if requested for credentialing or audit.
Don’t have an FWA/HIPAA Compliance Program? Contact PAAS and receive a $126 discount when you combine services with your audit assistance. Get started today! info@paasnational.com or (608) 873-1342.
Is Your Pharmacy Ready for an Unannounced Audit?
Pharmacies are often startled with the limited amount of time a PBM offers prior to an onsite audit. However, PBM auditors, DEA agents, FDA inspectors and state Board of Pharmacy inspectors can also make unannounced visits.
Ensuring your staff members are prepared in case of an unannounced visit is essential. Since these visits occur without warning, the Pharmacist-in-Charge (PIC) and/or owner may not be working or available to assist. Keeping information in a central location and advising staff on how to handle these intimidating visits will make the process go much smoother.
PAAS National® has created a document to help pharmacies prepare for PBM visits. Located on our website, under the Tools & Aids Section, you can find our Onsite Credentialing Guidelines. This tool provides a list of frequently asked questions from auditors. The guide also includes references to the Policy and Procedure Manual for PAAS National® Fraud, Waste & Abuse and HIPAA Compliance members.
PAAS Tips:
Don’t have an FWA/HIPAA Compliance Program? Contact PAAS and receive a $126 discount when you combine services with your audit assistance. Get started today! info@paasnational.com or (608) 873-1342.
Beware: DEA and Wholesalers are Cracking Down on Controlled Substance Dispensing
Take note – the DEA is coming after pharmacies dispensing illegitimate controlled substance prescriptions. Pharmacists should all be aware of their corresponding responsibility and the need for a legitimate medical purpose when dispensing controlled substance prescriptions. A review of recent Department of Justice settlements provides guidance on some prescriptions that require additional scrutiny.
Consider the following dispensing activities to be of high risk:
Dispensing combinations of controlled substances that have no legitimate medical purpose, are highly addictive and specifically used to create or enhance abusive and euphoric effects, is a violation of 21 CFR 1306.04(a). Pharmacists have a responsibility to ensure the appropriateness of the prescriptions they are dispensing. While turning away business is never easy, being fined and sanctioned by the DEA is a much more painful process to endure.
Consider a few DEA settlements over the last couple years:
Drug wholesalers are also pulled into the fray with their responsibility to identify and report “suspicious orders” of controlled substances. McKesson, Cardinal Health, and AmerisourceBergen have all had settlements and/or civil penalties (as high as $150 million) related to Controlled Substance Act violations. In 2019, there were felony criminal charges filed against a distributor and its executives for illegal distribution of controlled substances. Their failure to effectively oversee suspicious orders caused them to go out of business.
Consequently, wholesalers are increasing their constraints on controlled substance purchasing. There are more rigorous applications, wholesaler audits, and purchasing thresholds which cannot be exceeded. PAAS National® has also become aware of wholesalers (nearly immediately) terminating a pharmacy’s ability to purchase controlled substances. In its notice to the pharmacy, the wholesaler flagged the following practices:
PAAS Tips:
When Should I Obtain a Diagnosis Code for Ozempic?
Since Ozempic® was FDA approved December 5, 2017, PAAS National® has fielded many questions regarding dispensing this expensive injectable diabetic medication. The questions relate to dosing, calculations, billing, and off-label use. PAAS cannot overemphasize the importance of calculating the correct days’ supply. Use the chart below and prior PAAS articles to help pharmacy staff calculate the correct days’ supply.
0.5 mg only
Maintenance Dose (0.5 mg)
Off-label use is a concern because of Wegovy™, which has the same analog name (semaglutide) as Ozempic®, but is FDA approved for weight loss. To reduce audit risk, pharmacies should be vigilant in attempting to identify when a prescriber is working around a plan exclusion or prior authorization by prescribing Ozempic® instead of Wegovy™. With the FDA’s approval of 2 mg weekly dosing for Ozempic in March 2022, this became more challenging as higher dosing is not necessarily indicative of off-label use. Keep in mind, federal programs like Medicare Part D and Medicaid do not pay for off-label use and claims billed for non-diabetic patients could be recouped. Consider obtaining a diagnosis code if any of the following apply when starting patients on Ozempic:
Pharmacies dispensing Ozempic prescriptions for weight loss may incur significant audit recoupments. Consider collaborating with prescribers to educate them on the risks to help ensure appropriate billing practices.
PAAS Tips:
Insulin Glargine (Winthrop) – Unbranded Biologic of Lantus®
Insulin glargine labeled by Winthrop U.S. came to market in May 2022, and with it a lot of additional confusion regarding pharmacy level substitution.
Keen eyed observers will notice that Winthrop is “a Sanofi company”, and that both Lantus® and insulin glargine (Winthrop) have the same Biologics Licensing Application (BLA) number BLA021081 – which makes it an “unbranded biologic” of Lantus®.
Please see a few important notes about unbranded biologics from FDA Purple Book FAQ #9:
Remember that pharmacy level substitution of a reference product is only allowed if biologic drugs are either (i) identified as interchangeable OR (ii) an unbranded biologic with the same BLA number. For biologic drugs that don’t fall into these two categories, you must obtain prescriber approval prior to substituting.
Here is a summary table of how to understand insulin glargine products:
BLA 021081
Reference Product
BLA 021081
Unbranded biologic
BLA 761201
Reference Product
BLA 761201
Unbranded biologic
BLA 205692
Reference Product
*Treat this like a situation where prescription is written as “albuterol sulfate HFA inhaler”
PAAS Tips:
Why PAAS Cultural Competency?
Developed by pharmacists for community pharmacies, PAAS National® brings you a tailored approach to Cultural Competency and Linguistically Appropriate Services using the PAAS Care Model. Your training history is documented, retrievable and easily tracked throughout the year. Simply put, the training is more realistic for pharmacy staff, and documented should you ever need evidence of completion – training, done better.
“We understand there is a need to address federal and state requirements and meet PBM credentialing requirements,” stated Trent Thiede, President at PAAS National®, “The PAAS CARE Model can be used in any patient interaction to help identify a patient’s cultural differences and guide the pharmacy on how to proceed.”
The PAAS CARE Model is an acronym for Competence Evaluation, Adherence, Realistic, Evaluate and Educate in the training module. Our adage of “Be aware to CARE” uses real-life, pragmatic examples to serve as a launching pad for enhancing patient experiences. PAAS’ unique approach to training ensures its content resonates with all pharmacy staff, making the goal of cultural competence achievable, across the board.
Plus, if you are already a PAAS Fraud, Waste & Abuse and HIPAA Compliance member, your employees will have the ease of completing their FWA, HIPAA and Cultural Competency training on one screen. No clicking to multiple programs or browsers to access the yearly training for your staff.
If you would like more information about PAAS Cultural Competency Training Program starting at $99/year, please visit paasnational.com/culturalcompetency or contact PAAS National® at (608) 873-1342 or info@paasnational.com.
Beyond-Use Date vs. Nursing Home Storage Policy – Avoid this Recoupment Trap!
Manufacturers go through rigorous testing to bring their products to market and part of the tedious approval process includes stability, sterility, and beyond-use date (BUD) testing. Pharmacies should be familiar with a product’s stability, sterility, and BUD information since these timeframes may come into play when determining the correct quantity and days’ supply to bill. Insulin pens and vials are the most commonly billed products where the BUD may influence the days’ supply. For example, a single vial of Lantus® or NovoLog® is good for 28 days once the top is punctured; therefore, a single vial of either of these insulins should always be billed for 28 days or less. Alternatively, a single vial of Levemir® is good for 42 days once it has been punctured; therefore, a single vial of Levemir® should always be billed for 42 days or less. For additional BUD information, refer to Section 16 of the manufacturer product labeling, or see PAAS’ various Days Supply Charts found in the Tools & Aids section of the PAAS Member Portal.
Pharmacies billing for nursing home patients may come across yet another “date of importance” – the maximum time a product may be stored according to the facility’s storage policy. PAAS National® analysts see pharmacies billing eye drops, inhalers, and insulin products as a 28-day or 30-day supply even though the directions on the prescription, the manufacturer product sterility information, and the BUD all support a longer days’ supply. Using the Levemir® example from above, if a pharmacy had a prescription for a Levemir® vial 100 units/mL, injecting 12 units subcutaneously nightly (dispense 10 mL), a single vial would have 83.3 doses or 83 days of medication. However, the BUD of a single vial is only 42 days; therefore, this should be billed as a 42-day supply. If a nursing home facility has a policy to discard all insulin vials after 28 days, then a pharmacy would be tempted to bill this as a 28-day supply but be aware of the repercussions this billing process could have! Nursing home practices and policies do not invalidate FDA/manufacturer sterility testing. Adjusting the days’ supply to 28 days to follow the facility’s policy often leads to “invalid day supply” penalty fees and full recoupments on early refills since PBMs will not take into consideration nursing home policies when determining days’ supply.
PAAS Tips:
DMEPOS Mini-Series #2 – Ostomy Supplies
PAAS National® often sees recoupments on ostomy supplies due to unsupported medical records. Insufficient documentation accounted for 86.8% of improper payments for ostomy supplies in 2019, around $65.5 million. Please see the tips provided below to help ensure Medicare B coverage and payment for a beneficiary’s ostomy supplies.
PAAS Tips:Join today!
- Coverage
- Beneficiary must have a surgical created opening (stoma) to divert urine or fecal matter outside the body
- The location, construction and skin condition surrounding the stoma must be discussed in the medical record
- Diagnosis driven by the type of ostomy the beneficiary has:
- Colostomy – opening into the colon (large intestine)
- Ileostomy – opening into abdominal wall (small intestine)
- Urostomy – opening into abdominal wall that connects to urinary tract
- Ostomy supplies are not separately payable when in a covered home health stay
- Continued Medical Need
- Once the initial medical need has been met, the ongoing need for ostomy supplies is assumed to be met.
- If the beneficiary continues to meet the medical guidelines, no further documentation is required
- Coding Guidelines
- Diagnosis must be documented in the medical record as well as submitted on the claim for coverage consideration
- Barrier (also known as a Wafer or Faceplate) – protects skin from stoma output and keeps the pouch in place
- Solid barrier
- Liquid barrier – liquid OR spray and individual wipes OR swabs may be used but not both
- Pouches – can be one-piece or two-piece
- Tape and adhesive – an AU (Item furnished in conjunction with a urological, ostomy, or tracheostomy supply) modifier code must be billed for tape and adhesive
- If a continent stoma:
- use only one type of supply per day
- can be a stoma cap, stoma plug, stoma absorptive cover or gauze pads
- Covered diagnosis, Healthcare Common Procedure Coding System (HCPCS) codes, modifiers and maximum allowances per month can be found in the LCD and policy articles
- Quantity of supplies needed depends on the type of stoma, condition of skin surface, location, and construction
- If beneficiary resides in a nursing facility, pharmacies are limited to billing a one-month supply
- If beneficiary resides in their home, pharmacies can bill for a 3-month supply and will need a narrative on the claim for the 3-month supply
- See the June 2022 Newsline article CGS® and Noridian Self-Service Tools and Resources for Durable Medical Equipment, Prosthetics, Orthotics and Supplies for guidance on claim status, eligibility, same or similar items and more
- Additional Resources
- Jurisdictions JB and JC Portal – MyCGS
- Jurisdictions JA and JD Portal