PAAS National® analysts want to remind pharmacies of the audit risks when medications are dispensed outside manufacturer storage/dispensing requirements. PBMs can easily identify claims billed for a quantity that does not match the package size for a particular NDC, making them an easy target for recoupment.
Manufacturers submit storage/dispensing requirements to the FDA, which in turn appears on the package and in the package insert. These requirements may be based on light or moisture sensitivity or simply that the product has not been tested outside the original container. Pharmacies can utilize the DailyMed website to find product labeling information; however, be aware that variations in labeling precautions exists. PAAS has spoken with the FDA about inconsistent verbiage for precautions, even amongst products from the same manufacturer. While standardization would provide clarity and be helpful for all dispensing pharmacists, the FDA defers this language choice to the manufacturers.
Another twist on quantity dispensed not divisible by package size is diabetic test strips – the NDC must match what you are dispensing. Claims billed for the 100-count box, but quantity billed is not divisible by 100 (e.g., 150) can result in a partial recoupment.
PAAS has created a chart for the most common medications targeted on audit for dispensing outside manufacturer requirements. Download the Dispense in Original Container Chart from the PAAS Member Portal and access many other Proactive Tips, Days’ Supply Charts, On-Demand Webinars and additional resources that further assist PAAS members and their staff.
While on the website, check out PAAS’ Upcoming Events for locations you can find us. Stop by our booth to say “hi” and pick up our new 5×7 inch, laminated Dispense in Original Container Chart and Considerations for Billing Insulin Vials magnet!
Remember to Maintain and Provide Complete Clinical Notes!
Physical storage for keeping paper records comes at a space premium for many pharmacies. With the significant increase of electronic prescriptions, many pharmacies are choosing not to keep printed copies, where allowed by state/federal law. Pharmacies must be very diligent with electronic documentation when electronically storing their prescriptions.
PAAS National® has always recommended four elements for clinical notations:
In the past, pharmacies would simply document this information on the prescription. If the prescription was audited, this information would be readily visible for the auditor’s review. If pharmacies are not printing electronic orders, these clinical notations are still imperative, but typically documented electronically. The same four elements are recommended for electronic notes, but preferably with date/time stamped user information.
During an audit, pharmacies must review prescriptions closely for any clinical notations, and ensure they are included with their documentation. Consult with your software vendor on the best ways to utilize the electronic notes field and how to easily access if needed.
Pharmacies that print images for audits must remember that faxed, written or telephone orders may have clinical notes written on the hard copy that did not get re-scanned in. Missing these clinical notations could lead to recoupments as the auditor can only see the information provided to them.
PAAS Tips:
Dispense in Original Container – Know the Audit Risks
PAAS National® analysts want to remind pharmacies of the audit risks when medications are dispensed outside manufacturer storage/dispensing requirements. PBMs can easily identify claims billed for a quantity that does not match the package size for a particular NDC, making them an easy target for recoupment.
Manufacturers submit storage/dispensing requirements to the FDA, which in turn appears on the package and in the package insert. These requirements may be based on light or moisture sensitivity or simply that the product has not been tested outside the original container. Pharmacies can utilize the DailyMed website to find product labeling information; however, be aware that variations in labeling precautions exists. PAAS has spoken with the FDA about inconsistent verbiage for precautions, even amongst products from the same manufacturer. While standardization would provide clarity and be helpful for all dispensing pharmacists, the FDA defers this language choice to the manufacturers.
Another twist on quantity dispensed not divisible by package size is diabetic test strips – the NDC must match what you are dispensing. Claims billed for the 100-count box, but quantity billed is not divisible by 100 (e.g., 150) can result in a partial recoupment.
PAAS has created a chart for the most common medications targeted on audit for dispensing outside manufacturer requirements. Download the Dispense in Original Container Chart from the PAAS Member Portal and access many other Proactive Tips, Days’ Supply Charts, On-Demand Webinars and additional resources that further assist PAAS members and their staff.
While on the website, check out PAAS’ Upcoming Events for locations you can find us. Stop by our booth to say “hi” and pick up our new 5×7 inch, laminated Dispense in Original Container Chart and Considerations for Billing Insulin Vials magnet!
PBM Communications to Network Pharmacies Can Help Prevent an Audit!
PAAS National® knows community pharmacies are busier than ever, making it difficult to keep up with all the PBM communications. Just as PAAS provides monthly Newsline articles to keep our members up-to-date on current PBM trends and audit tactics, the PBMs also have resources to communicate with network pharmacies. Below are PAAS tips outlining which PBMs send out communications, how often they are sent and a link to their website or login page. These resources often give insight on audit targets and network compliance issues.
PAAS Tips:
PBM’s expect their network pharmacies to be familiar with the topics and information they provide and will hold you accountable for network compliance. PAAS will help keep you up to date on relevant communications, but should you receive any direct PBM communications (via email or fax), be sure to forward them to PAAS for review.
OMIG compliance reviews are happening now – this includes independent pharmacies!
PAAS National® has started to see New York State Office of the Medicaid Inspector General (OMIG) conducting reviews on pharmacies to evaluate if they have a compliance program that meets the new requirements of Social Services Law 363-d and 18 NYCRR Part 521.
As of March 28, 2023 there are NEW requirements. If your current program has not been updated to reflect these changes, you are not compliant.
Avoid potential sanctions (including termination of your provider status) by joining the PAAS FWA/HIPAA Compliance Program.
PAAS has worked extensively to make sure our program meets NY Medicaid requirements! A typical pharmacy can have a fully customized compliance program up and running with only a few hours’ setup and general upkeep. PAAS also provides exceptional customer service, with pharmacists and technicians to help answer your questions about compliance related issues and guide you through a NY OMIG compliance review.
It’s NOT TOO LATE to get compliant! Ensure you have all your compliance bases met and attest with confidence.
Current members
If you receive a notification letter, please reach out to us to get customized guidance from an expert analyst, info@paasnational.com or (608) 873-1342 and we will guide you through a NY OMIG compliance review.
Social Media Mishap Leads to $30,000 Fine for Health Care Provider
When used correctly, social media can be a great tool for sharing the unique services your pharmacy has to offer patients and local community. However, be very cautious about what information is posted on social media because one slip up could land your pharmacy in the crosshairs of an Office for Civil Rights (OCR) investigation.
According to a U.S. Department of Health and Human Services press release on June 5, the OCR opened an investigation after a patient filed a complaint against a New Jersey health care provider specializing in adult and child psychiatric services, alleging the provider improperly disclosed protected health information (PHI). According to the press release, the patient claimed that the health center “posted a response to the patient’s negative online review that included specific information regarding the individual’s diagnosis and treatment of their mental health condition.” During the OCR’s investigation, improper disclosure of three additional patients’ information was found in responses to negative online reviews. To settle the complaint, the health care provider agreed to at least two years of monitoring by the OCR, to pay $30,000, and a corrective action plan (including written policies and procedures to meet the HIPAA Privacy Rule, providing additional staff training, issuing individual breach notifications, and issuing a breach notification to the Secretary of Health and Human Services).
PAAS Tips:
NEW PAAS Tool Available – The Insulin Flow Chart You NEED to Download Today!
Our PAAS National® Analyst team is at it again! A new tool has been developed to address and correct a common audit recoupment issue. Insulin remains at the heart of nearly all audits. Pharmacies often face recoupment for undocumented substitution (of non-interchangeable biologic drugs), dispensing more than the plan limit, billing an incorrect days’ supply (resulting in a subsequent early refill) and recoupment for non-calculable directions. In the May 2023 Newsline article, Insulin For a Pump: The Recoupment You Never Saw Coming, PAAS reminded pharmacies about a very different discrepancy seen on audit results—incorrectly billing insulin for a pump.
There is a complicated series of questions which must be answered when billing insulin, for patients who qualify for Medicare, to determine which of the patient’s Medicare benefits is the proper payor. Even pharmacies not enrolled to bill Medicare Part B [for insulin for a pump] need to go down this proverbial rabbit hole to determine the correct payor. Insulin claim(s) billed inappropriately to a patient’s Medicare Part D benefit could be fully recouped upon audit.
The new tool, Considerations for Billing Insulin Vials, provides a flow-chart of questions for pharmacy staff billing and verifying insulin. Designed as a quick reference guide for staff, it provides four pivotal questions used to determine if Medicare Part D or Part B is the appropriate payor. Visit the Proactive Tips section of the PAAS Member Portal to download a copy of this new tool today!
While on the website, check out PAAS’ Upcoming Events for locations you can find us. Stop by our booth to say “hi” and pick up our new 5×7 inch, Considerations for Billing Insulin Vials magnet and laminated Dispense in Original Container Chart!
Humana Provides Update on GLP-1 Prescriptions
PAAS National® has recently become aware of an update Humana published regarding new point-of-sale edits for specific medications. Included in this list are GLP-1 agonists.
Effective June 2023, Humana commercial, Medicare and Medicaid plans will now require diagnosis codes at point of sale in hopes of eliminating the “clinical misuse” of certain medications. Pharmacies can find this information posted on the Humana website under the Pharmacy Resources tab.
Be aware that a diagnosis field is likely not reviewed by the PBM unless the plan requires it on claim submission. Entering in a diagnosis code and receiving a paid claim does not affirm plan benefit design nor guarantee coverage.
Audit Risks with Schedule II Laddered Prescriptions
Pharmacies receiving laddered Schedule II prescriptions must be aware of the DEA requirements and potential audit risks. Missing these requirements can lead to Federal law violations and PBM audit recoupment.
Laddered prescriptions are multiple prescriptions written on the same date for current and future fills. Since Schedule II prescriptions cannot be refilled, the DEA has allowed prescribers to issue multiple prescriptions totaling up to a 90-day supply if all requirements have been met.
Requirements included in 21 CFR §1306.12:
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- Medication prescribed in a laddered series may not exceed a total of 90 days
- Check for exact fill dates on prescriptions other than the one for immediate use
- Claims billed prior to the earliest fill date can lead to recoupment
- Pharmacies should not alter Schedule II prescriptions unless their state law explicitly allows the alteration
- With laddered C-IIs, it’s likely best to request new prescriptions if changes are necessary
- See our October 2021 Newsline, Self-Audit Series #9: Controlled Substance Prescriptions
- See our September 2022 Newsline, Use and Posting Guidance Documents by DEA-What’s Changed with Controlled Substance Annotations?
- See our November 2022 Newsline, What’s Changed with C-II Prescription Annotations? (September Follow-Up)
Billing Tips for Dexcom G6®
Dexcom G6® sensors, transmitters, and receivers continue to be audit targets. Pharmacies have faced recoupment on their Dexcom G6® claims for billing an incorrect days’ supply, refilling the item too soon, and for having vague directions. The proper quantity and days’ supply can be found in the table below, along with suggested instructions. Following these billing guidelines will help decrease the risk of recoupment on the Dexcom G6® continuous glucose monitor and supplies.
(unit of measure)
(3 sensors/box)
PAAS Tips:
Off-Label Use Beyond GLP-1
GLP-1 medications being used off-label for weight loss, and the corresponding audit risk, has been a hot topic for awhile now, but there are other medications that PAAS National® frequently sees recoupments for when being used off-label, especially when billed to a Medicare plan.
Other medications recently recouped by Medicare Part D Plan Sponsors and PBMs include:
PBMs seem to selectively enforce these provisions, but the reality is they are pursuing easy targets with high rewards. Audits typically identify claim outliers, and expensive medications with narrow therapeutic indications increase the likelihood of an audit. Prescriptions being used within FDA guidelines are much less likely to be identified as being used off-label.
Section 1860D-2(e)(4) of the Social Security Act defines medically accepted indications for the Medicare Part D program by referencing Section 1927(k)(6). It states that a medically accepted indication is “any use for a covered outpatient drug which is approved under the Federal Food, Drug, and Cosmetic Act, or the use of which is supported by one or more citations include or approved for inclusion in any compendia described in Section 1927(g)(1)(B)(i)”.
When recoupments from off-label uses happen, they can be difficult to appeal. Remember to send PAAS your audit notices as soon as you receive them to have the best chance at success.
PAAS Tips: