Simply put, the days’ supply billed should take into account the entire cycle, including days in which the patient will not be taking medication. Xeloda® (capecitabine), an oral chemotherapy regimen, is commonly dosed twice daily for 14 days, followed by a 7-day break. The proper days’ supply to bill is 21 days.
Some common examples seen in pharmacy, despite the lower cost and audit risk, include:
- Birth control
- Bisphosphonates, such as Fosamax® and Actonel®
Let’s take a commonly seen Synthroid® dosing regimen where a patient is to take medication five days a week:
#5 tablets per week x 4 weeks = #20 tablets for a 28 days’ supply
Note the days’ supply is computed in terms of number of weeks. Billing the claim for a 30 days’ supply would be incorrect. Humana would charge a $5 penalty fee for every audited prescription (and all associated refills) billed with that invalid days’ supply.
In addition to the claim with an incorrect days’ supply, there is a potential recoupment risk with subsequent fills. Billing a days’ supply shorter than the true days’ supply could cause future refills to be filled early, resulting in claims being fully recouped. Conversely, a claim billed for a days’ supply longer than the true days’ supply could lead to an erroneous “refill too soon” rejections, resulting in an interruption to a patient’s medication therapy.
If there is ever a question about whether a days’ supply is properly calculated, PAAS Audit Assistance members can call (608) -873-1342, email info@paasnational.com or submit a question online through the PAAS Member Portal. We want to help pharmacies prevent audits, so we are always happy to work with pharmacy staff to calculate the correct days’ supply prior to it being called into question in an audit.
PAAS Tips:
- Unless explicitly stated in the directions that the medication is to be used as “extended cycling”, “continuous use”, or the like, take into account break days
Proper Billing for Intermittent Use Medications
Calculating proper days’ supply on continuous use medications can be hard enough; how do PBMs and auditors view medications that are used intermittently?
Simply put, the days’ supply billed should take into account the entire cycle, including days in which the patient will not be taking medication. Xeloda® (capecitabine), an oral chemotherapy regimen, is commonly dosed twice daily for 14 days, followed by a 7-day break. The proper days’ supply to bill is 21 days.
Some common examples seen in pharmacy, despite the lower cost and audit risk, include:
Let’s take a commonly seen Synthroid® dosing regimen where a patient is to take medication five days a week:
#5 tablets per week x 4 weeks = #20 tablets for a 28 days’ supply
Note the days’ supply is computed in terms of number of weeks. Billing the claim for a 30 days’ supply would be incorrect. Humana would charge a $5 penalty fee for every audited prescription (and all associated refills) billed with that invalid days’ supply.
In addition to the claim with an incorrect days’ supply, there is a potential recoupment risk with subsequent fills. Billing a days’ supply shorter than the true days’ supply could cause future refills to be filled early, resulting in claims being fully recouped. Conversely, a claim billed for a days’ supply longer than the true days’ supply could lead to an erroneous “refill too soon” rejections, resulting in an interruption to a patient’s medication therapy.
If there is ever a question about whether a days’ supply is properly calculated, PAAS Audit Assistance members can call (608) -873-1342, email info@paasnational.com or submit a question online through the PAAS Member Portal. We want to help pharmacies prevent audits, so we are always happy to work with pharmacy staff to calculate the correct days’ supply prior to it being called into question in an audit.
PAAS Tips:
Audit Trap: OptumRx’s Provider Manual Requirements
PAAS National® is starting to see more recoupments from OptumRx for missing prescription information. These recoupments stem from the provider manual requirements for prescription documentation that includes:
OptumRx is stating these items are required on all prescription documentation, regardless of the way it has been created, generated, or transmitted (e.g., telephone orders).
This section of the provider manual has rarely been enforced by OptumRx until very recently. When cited for missing elements, pharmacies are not provided a pathway to appeal, even though these items may not be required by state or federal regulations. Even pharmacies who have this information visible on backtags have struggled to get it accounted for. Independence Blue Cross has also been known to cite the OptumRx provider manual for missing prescription documentation.
OptumRx is not the only PBM that has this type of language in the provider manual. Both CVS/Caremark and Express Scripts have similar language, although PAAS has not seen these sections enforced. Since provider manuals are considered extensions of your contract with the PBM, they can enforcement the requirement, absent state law prohibitions and applicability.
PAAS Tips:
PHE for COVID-19 Ending May 11, 2023: Pharmacy and Audit Ramifications
On January 30, 2023, President Biden’s administration announced that both the national emergency and public health emergency (PHE) for COVID-19 would be ending on May 11, 2023. This will have far-reaching implications for everyone in healthcare, including pharmacy.
Audits
While the PBMs took a break from auditing pharmacies in the early days of the pandemic, most gradually started up again by the end of 2020. They started with desk audits and slowly added back in larger virtual audits to take the place of the onsite audits. Most recently, PBMs have reinstated onsite audits. If you feel like you have been seeing more audits, it is likely because you are.
PBMs also made concessions in other audit areas due to the COVID-19 pandemic, including relaxed restrictions on mailing and delivery to patients during the PHE. They also made concessions allowing pharmacies to dispense prescriptions without obtaining a signature from the patient. While some PBMs and payors have already reinstated signature requirements, PAAS National® expects both of these situations to return to pre-pandemic requirements no later than May 11, 2023.
PREP Act
Some Public Health and Emergency Preparedness (PREP) Act authorities will end May 11, 2023, unless made permanent through state legislation. Check with your Board of Pharmacy and/or state pharmacy association to see what will still be allowed in your state. Requirements relevant to pharmacies that will be ending include coverage with no cost share for at-home COVID-19 tests/testing related-services for patients with Medicare, Medicare Advantage, and commercial insurance. Commercial insurers will also no longer be required to cover eight OTC tests per month. Health plans will no longer be required to reimburse out-of-network providers for tests/testing-related services, or cover vaccines for COVID-19 without cost-sharing when provided by out-of-network providers. They will also no longer be required to reimburse these vaccines at a “reasonable” rate.
It is difficult to know how the different health plans will handle these changes. Patients have grown accustomed to not paying any cost-share amount for these items. Adding cost-share may add to vaccine hesitancy concerns or hinder a patient’s ability to continue receiving COVID-19 vaccines and tests. Pharmacies will be on the front lines again helping patients navigate changing coverages.
PAAS Tips:
Levemir® FlexPen® is Replacing the Levemir® FlexTouch®
Novo Nordisk® discontinued manufacturing the Levemir® FlexTouch® in early February 2023. The FlexTouch® will be distributed until stock is depleted and is being replaced with the FlexPen®. Please see the charts below for changes between the FlexTouch® and the FlexPen®.
PAAS Tips:
To Sign, or Not to Sign, the OptumRx® Recoupment Waiver … That Is the Question
If your pharmacy has recently been through an OptumRx® desk audit, you may have come across the OptumRx Provider Intent Form – Recoupment Waiver. This one-page form accompanies initial audit results and if signed, gives OptumRx® even greater power over the pharmacy. A signature on the form indicates the following:
There is no apparent benefit to the pharmacy by signing this form. Additionally, signing and agreeing to the preliminary audit findings could be construed as the pharmacy’s admission of wrongdoing. Only OptumRx® would benefit from this waiver and PAAS National® does not feel it is in the best interest of pharmacies to sign.
If you have additional questions or concerns regarding audit preparation, the audit appeal process, or safe billing and filling strategies, the PAAS team is here to guide you. Give us a call (608) 873-1342, email info@paasnational.com or submit a question online through the PAAS Member Portal.
First Step in Getting Help with an Audit
Oh no! You just received an audit, now what? Your first step is to get the audit notice to PAAS National® – the sooner that we are part of your team, the more benefit we can bring. Our all-inclusive membership means there are no hidden fees or limits to the audit assistance you can receive.
Make PAAS part of your audit process, every time. Review the 4 Steps to Using your PAAS Audit Assistance on the PAAS Member Portal for audit assistance members under Proactive Tips.
One of the best ways to get started is to create a workflow process when audits are received. Too many dollars are lost to PBMs due to missed deadlines or incomplete documentation – don’t let this happen to you. By putting a few simple steps in place, you can avoid costly mistakes in the future.
PAAS Tips:
Are Your Delivery/Signature Logs PBM Compliant for 2023?
A common component of a pharmacy audit request is the delivery/signature log. Delivery/signature logs are used to prove the patient received their medication and that they received it within the PBM return to stock timeframe. PAAS Audit Assistance members can refer to the PBM Return to Stock Chart on the PAAS National® Member Portal for a list of the major PBMs and their return to stock time frame allowances.
PAAS often sees delivery/signature logs flagged for having a pre-printed delivery date. Several PBMs do not accept these logs because they may not represent the actual delivery date. Here is an example:
Recent Elixir results state, per the Elixir pharmacy manual, “Receipt submitted states “Delivery.” Unless the prescription delivery is through a common courier, an electronic or manual signature should be recorded at time of delivery by the member or designated member representative. For deliveries, the date delivered cannot be pre-printed by the pharmacy.”
Some software systems allow a pharmacy to “scan out” a prescription and flag it for delivery. The driver can take this date/time stamped point of sale receipt (that notates delivery) to the patient’s address and have them sign. PAAS also sees many LTC facility delivery manifests containing a pre-printed date on the document. An auditor is not going to accept/assume the delivery took place the same day as the pre-printed date and will likely flag these logs as invalid. The pharmacy needs to provide documentation of when the delivery took place by having the patient, or representative, date their signature upon delivery. Consider adding a blank line for a handwritten date next to the signature line that can be completed upon delivery.
PAAS Tips:
Process for Dealing with a Patient HIPAA Complaint
Anyone can file a complaint if they feel their rights under the HIPAA Privacy, Security, or Breach Rules have been violated. They can file a complaint with the covered entity or business associate involved, or with the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (the OCR). The HHS.gov website has a full page dedicated to filing a complaint and is one of the first listings to appear if someone performs an internet search for “filing a HIPAA complaint”.
Appropriately handling the patient’s complaint by taking it seriously, investigating, and responding may help decrease the risk of the OCR launching an investigation into your pharmacy. Additionally, if an investigation does occur, following the steps listed below can help ensure that your pharmacy would have all the required information documented to prove you handled the situation pursuant to the HIPAA Rules.
Steps to follow if a patient believes their HIPAA rights have been violated:
If HIPAA Rule violations are found during an OCR investigation, the pharmacy can be forced to pay civil money penalties and can even be held accountable for an employee’s failure to adhere to company HIPAA policies and procedures. Additionally, individuals accessing or utilizing protected health information inappropriately can be charged civil money penalties or even face criminal charges (and jail time!) for violating the HIPAA Rules.
PAAS Tips:
Express Scripts Validating 340B Claim Eligibility
PAAS continues to see members receiving emails from Express Scripts (ESI) requesting pharmacies to “Please Review Your 340B Eligible Claims”. ESI’s goal is to verify manufacturer rebate eligibility and states “your claims reimbursement, network participation, and network status are not affected by a claim’s status as 340B-eligible or whether you respond”.
While seemingly haphazard in claim selection and frequency, Express Scripts is attempting to identify a subset of claim(s) that were initially processed as not 340B-eligible, but in actuality may have been dispensed/reimbursed as 340B. From communication with members, PAAS can see the algorithm ESI is using is far from perfect. Conjecture leads us to believe they are using the HRSA OPAIS website to look at providers and pharmacies, then targeting high dollar brand medications.
If the pharmacy agrees that the claims were 340B claims, no action is required and Express Scripts will reprocess the claim(s). If the pharmacy believes the claims were correctly adjudicated as non-340B eligible, the pharmacy should respond within 10 business days by emailing 340bclaims@express-scripts.com to refute Express Script’s conclusion.
PAAS Tips:
Update to PAAS’ Onsite Credentialing Guidelines
PAAS National® has created an Onsite Credentialing Guidelines, an extensive checklist to assist PAAS members with scheduled and/or unexpected visits from PBM auditors. Unannounced visits can catch pharmacy staff off guard when the Pharmacist-in-Charge (PIC) is not present. Be sure you are reviewing and advising your staff on the information included on this checklist so they are prepared.
There was an 11% increase in reported onsite audits over the past two years. PAAS takes pride in staying up to date on ever changing trends in pharmacy. Keeping our members informed on PBM inquiries during the credentialing process, or an onsite visit, is one of our priorities. We recently added the following updates to our Onsite Credentialing Guidelines:
Interested in having a customized FWA/HIPAA Compliance program? Contact PAAS to get started today! info@paasnational.com or 608-873-1342.