OptumRx discrepancy is listed as 3H-Directions on prescription different from computer records. No post-dispensing validation accepted. No verbal orders/annotations accepted.
Caremark discrepancy is listed as MIF-Prescription dispensed was filled with incorrect drug, strength, directions or patient. This discrepancy does not require further documentation.
Pharmacies are often very familiar with prescribers and what they may intend to include on the prescription but don’t. This can range from a clear quantity to actual instructions for the patient. Unfortunately, pharmacies supplementing or documenting clinical notations that do not make it on to the patient’s prescription label can face recoupment as a “misfilled” prescription.
Some of the common examples PAAS analysts see are when information was clarified or confirmed with the prescriber and added to the prescription but not included on the patient label:
- Max daily dose for insulin with sliding scale or titration
- Number of snack and/meals for pancreatic enzymes
- Grams per application or area applied for topical medications
Additionally, PAAS is seeing issues where the pharmacy’s backtag and label do not include the entire set of instructions (i.e., an extended sig/label). Many software vendors only allow so many characters in the instruction field and may require additional instructions to be entered/printed separately. Not providing all the instructions the patient received [upon audit] would likely result in the claim being flagged for recoupment.
PAAS Tips:
- Verifying information with the prescriber prior to dispensing
- Clinical notes to document clarifications should include 4 elements
- Date/time
- Name and title of who you speak with
- Summary of discussion
- Pharmacy staff initials
- Educate all data entry staff to include information on patient label that is related to the instructions for use
- When submitting documentation for audit, be sure the auditor is receiving all information
Recent DEA Rule Change – Transferring Electronic Prescriptions for Controlled Substances for Initial Fill
The DEA published a couple rule changes recently which pharmacies need to be aware of. In the September 2023 Newsline, the updated rule regarding partial fills for controlled substances was discussed. The other recent change published in the Federal Register was titled, Transfer of Electronic Prescription for Schedules II-V Controlled Substances Between Pharmacies for Initial Filling. This rule went into effect August 28, 2023, and clarified the DEA’s previous rule on the transferring of controlled substances. Pursuant to 21 CFR § 1306.08, Electronically Prescribed Controlled Substances (EPCS) can be transferred for initial filling on a one-time basis, upon the request of the patient and all authorized refills on C-III, C-IV and C-V prescriptions are transferred along with the original prescription. All the following additional requirements must also be met:
According to the Federal Register notice, NCPDP confirmed SCRIPT Standard Version 20177071 had the appropriate functionality to allow the electronic transfer of an EPCS. Since this SCRIPT Standard is widely used among software vendors for chain and independent pharmacies, the capability to electronically transfer these prescriptions should be available; however, pharmacies may need to talk with their vendors about activating this functionality.
When a patient requests the transfer, the receiving pharmacy must initiate the process by electronically requesting the transfer. The “transferring pharmacy” must update their records to show the prescription was transferred out and include:
The “receiving pharmacy” must document:
The software system may pre-populate the data entry fields if the pharmacist verifies the accuracy of the information.
PAAS Tips:
[FREE PAAS Webinar] Awareness to Action: Initiating USP 800 Compliance in Community Pharmacies
Join Vice President of PAAS National®, Carmen Fusselman, PharmD as she discusses:
We will allow for some Q&A at the end of the webinar. If you would like to submit questions prior to the webinar, please click here.
PAAS Audit Assistance members will have access to a recording on the PAAS Member Portal if they are unable to attend the live event.
Auditors’ Latest Trick for Flagging “Misfilled” Prescriptions
PAAS National® analysts are noticing more prescriptions being flagged for recoupment based on “incorrect” instructions for use on the patient label. Pharmacies and PBM auditors have very different perspectives on what a “misfilled” prescription is. PBMs will look to categorize a claim as a “misfill” if the directions on the patient label do not include all instructions (including any clarifications made with prescriber). Appealing these discrepancies successfully can be a fruitless endeavor, predicated on circumstances and PBM guidelines.
OptumRx discrepancy is listed as 3H-Directions on prescription different from computer records. No post-dispensing validation accepted. No verbal orders/annotations accepted.
Caremark discrepancy is listed as MIF-Prescription dispensed was filled with incorrect drug, strength, directions or patient. This discrepancy does not require further documentation.
Pharmacies are often very familiar with prescribers and what they may intend to include on the prescription but don’t. This can range from a clear quantity to actual instructions for the patient. Unfortunately, pharmacies supplementing or documenting clinical notations that do not make it on to the patient’s prescription label can face recoupment as a “misfilled” prescription.
Some of the common examples PAAS analysts see are when information was clarified or confirmed with the prescriber and added to the prescription but not included on the patient label:
Additionally, PAAS is seeing issues where the pharmacy’s backtag and label do not include the entire set of instructions (i.e., an extended sig/label). Many software vendors only allow so many characters in the instruction field and may require additional instructions to be entered/printed separately. Not providing all the instructions the patient received [upon audit] would likely result in the claim being flagged for recoupment.
PAAS Tips:
An Easy Procedural Change That Will Prevent Recoupments
As previously reported in an April 2023 Newsline article, Prepare Yourselves! Onsite Audits Are Coming in Strong, PAAS National® saw a 300% increase in onsite audits in just the 3rd Quarter of 2022, and we have continued to see the number of audits, as well as the information requested in these audits, increase. It is therefore pertinent that pharmacies review and enforce their FWA/HIPAA policies and procedures, such as return to stock, to prevent petty recoupments.
Return to Stock, the timeframe PBMs require prescriptions to be picked up or the claim reversed based on the fill date of a prescription, is a focus of onsite audits when the auditor inspects the Will Call bin or desk audits when a signature log is requested. If the auditor identifies the sold/received date is beyond the PBM’s Return to Stock threshold, there is risk for full recoupment of the claim.
When determining what Return to Stock window is appropriate for your pharmacy, consider the following:
All above information should be considered when reviewing your pharmacy’s FWA/HIPAA policy and procedure manual (Section 4.1.1 Unclaimed Prescriptions for those utilizing PAAS’ FWA/HIPAA Compliance program). Make modifications as seen fit.
Lastly, see if your pharmacy system can help stop prescriptions that would be sold beyond your designated Return To Stock window. Certain dispensing platforms, with an integrated Point of Sale system, can have claims stopped at the register to avoid noncompliance.
PAAS Tips:
Utilizing the PAAS Audit Activity Tracker
While seemingly mundane, the PAAS National® Audit Activity Tracker can serve a very important purpose. While pharmacy personnel may use this tool to stay organized with various audits coming their way, this tool can also be used to defend the pharmacy should an audit go awry. It’s better to document and have a record at the onset than to think back months ago about your individual efforts on an audit. This tool provides a structure to document important information during your audit process. Utilizing this tracker can provide credible documentation of a PBM’s (or auditors) ineffectual communication during an audit. This could help support an audit manager’s review of the auditor’s conduct or provide you with information to complain to your state insurance commissioner.
Here are some recommendations to include on the Audit Activity Tracker:
Example:
PAAS Tips:
Podcast: A Deep Dive into LTC Audits with Trent Thiede
Trent Thiede, President of PAAS National® and host of Amplify Long-Term Care Pharmacy Podcast, Frances Nahas talk all things pharmacy audits, from transitions of care to the complicated (and necessary) role PBMs play. Tune in to learn surprising insight of LTC audits to take your long-term care program to the next level.
PAAS Defends Community Pharmacies by Engaging DME Medicare Administrative Contractor CGS
In our August Newsline Standard Written Order and Medicare Part B Audit Risks – New Guidance, we shared a few examples some of our members are having on audit results regarding their Standard Written Order (SWO). Beyond writing the Newsline, PAAS National® also reached out and engaged nurse medical reviewers with CGS about our concerns on the three topics below.
Issue #1: DME MACs state corrections on an SWO must be signed off by prescriber
Issue #2: While refills are not a required element on the SWO, if the practitioner writes for refills, they will be honored exactly as specified regardless of the quantity dispensed
Issue #3: OmniSYS memo – “An important Update About Medicare Part B Insulin Coinsurance Reductions and Deductible Waivers” when using insulin in a pump
While the meeting with the nurse medical reviewers from both jurisdictions B and C at CGS was fruitless, we were able to escalate our concerns to the medical directors at CGS jurisdictions B and C. The directors were very open to discussion and receptive with our concerns regarding the SWO and OmniSYS issues discussed above. The directors have promised to forward our differing interpretations of section 5.2.2 to the CMS division of medical review and update us on any additional CMS guidance. PAAS will keep our members informed as things develop.
Best Practices for Billing Vaginal Creams to Avoid Recoupment
PAAS National® analysts frequently receive questions regarding the proper billing of creams and ointments, an easy audit target for PBMs. This article focuses on vaginal creams due to their high cost, lack of sufficient instructions for use and plan limits that cause pharmacies problems. When a PBM auditor sees a claim for Premarin® or Estrace® vaginal cream, they see dollar signs and often take back 100% recoupment on not just one fill, but multiple refills. To help reduce the risk of an audit recoupment, please review the table and PAAS Tips below.
Here is an example prescription:
PAAS Tips:
PAAS Pit Stop: On-Demand Webinars
Over the last three years, PAAS National®’s President, Trent Thiede, has presented on-demand webinars, ranging from 15 to 45 minutes, to ensure our members gain the knowledge needed to avoid audits, stay abreast on the latest topics in the pharmacy world, and provide information on the more difficult topics in an easy-to-understand manner. During the live events, members are able to ask questions on the topics presented.
PAAS understands the busy and unpredictable nature of your day-to-day pharmacy practice, so we are happy to offer the recorded webinars on the PAAS Portal. It’s a great tool for training and developing staff, as well as keeping up with hot topics in the industry. If you have questions while watching the on-demand webinar, contact PAAS and we’ll be glad to assist.
PAAS strives to pick webinar topics that are relevant to our members, if you have suggestions, please contact us.
PAAS Webinars:
Ransomware Attacks – Is Your Data Protected?
Safeguarding electronic Protected Health Information (ePHI) is as important for a big Fortune 1000 company as it is for independent pharmacies. The HIPAA Security Rule was designed to be flexible to accommodate providers of different sizes and with varying scopes of practice; therefore, the size of your pharmacy does not matter…the Security Rule still applies. That means administrative, technical and physical safeguards are all required to protect patient information.
A recent breach at PharMerica Corporation should serve as a reminder to reassess your pharmacy’s own safeguards to help decrease the risk of a successful malicious cyberattack. According to the PharMerica breach notification posted online in the Maine Attorney General Data Breach Notifications database, the breach affected over 5.1 million people. The attack occurred between March 12 and March 13, 2023 and was discovered on March 21, 2023. A sample of PharMerica’s breach notification letter explained that hackers gained access to patient records including “name, address, date of birth, Social Security number, medications, and health insurance information”. A ransomware gang claimed to be behind the attack and when PharMerica did not pay the ransom to buy back their stolen data, the information was published online.
Administrative safeguards such as firewalls, anti-virus software, log-in monitoring and password management are just several examples of methods to protect ePHI. Here are several questions to consider about your own program:
PAAS Tips: