The first step is to make note of any reject messages received when processing for the correct days’ supply. For example, if the insurance limits the quantity to a 30 days’ supply, write “ILQ 30” on the prescription. Then reduce the quantity, if possible, and rebill the claim with the adjusted [accurate] days’ supply based on the revised quantity. Reduce the quantity further if the claim still rejects, until you reach the smallest unbreakable package size.
If the smallest unbreakable package size still does not go through with an accurate day’s supply:
- PBMs may provide claim reject messaging to prompt submission of “SCC 10” to allow the true day supply for accurate refill intervals, reimbursement and copays. Document use of this on the prescription.
- Call the PBM helpdesk and request an override – document on the prescription if approved or denied.
- If no smaller package size exists and PBM can’t (or won’t) issue an override, most PBMs will allow the smallest package to be billed for the maximum days’ supply identified in the original reject message.
If the above process is used, and you processed the claim with an adjusted [inaccurate] days’ supply, you are at risk for early refills because the PBM adjudication logic will allow you to submit a refill claim when the utilization threshold is met based on the previous days’ supply adjudicated, not the actual days’ supply. PBMs still require the pharmacy to monitor utilization and only refill when appropriate based off the accurate [calculated] days’ supply and not the adjudicated days’ supply. Remember, the claim rejection for “refill too soon” will not be appropriately triggered when the pharmacy is forced to bill a smaller days’ supply than the true calculated day’s supply. To help avoid this, PAAS National® suggests documenting the actual days’ supply in the directions for use (e.g., “actual days’ supply=37”) so that it prints on the label to alert staff and patients of the appropriate refill intervals.
Another situation pharmacies run into is when the accurate days’ supply is rejected due to exceeding the plan limit for a maximum daily dose.
For example, a prescription written for OxyContin® 30 mg, quantity 90, with directions to “take one tablet 3x daily” may receive a rejection for “Maximum two tablets per day.”
In this situation, pharmacies should not reduce the quantity to 60 tablets for a 30-day supply (this would be considered bypassing the plan limit). Instead, pharmacies should pay close attention to any messages given on how to resolve the rejection, including calling the PBM help desk for an override or getting a prior authorization started with the prescriber. Alternatively, the prescriber could decide to change the dose or prescribe an alternative medication.
What if the prescriber refuses to obtain a prior authorization or change the prescription to a clinically appropriate dose? Can the claim be split-billed? PAAS National® highly recommends against split billing or processing a claim as cash to circumvent a plan limit or prior authorization requirement. A doctor who refuses to obtain a prior authorization or change the medication/dose could be a red flag for diversion with controlled substances. Most plan limits are put in place based on appropriate clinical use and bypassing them can lead to easy recoupments for PBMs. Pharmacists have a corresponding responsibility to ensure that prescriptions are for legitimate medical purposes, especially for controlled substances.
PAAS Tips:
- Always bill an accurate days’ supply based on the directions first; many PBMS have overrides in place for the smallest package sizes
- Only follow the ILQ process above if you are dispensing the smallest unbreakable package size
- Billing a 30-day supply on two boxes of insulin that should last 50 days is not appropriate. Instead, you must resubmit one box for 25 days if the plan limit is 30 days
- Include a notation on the patient label to help notify patients and pharmacy staff of the true days’ supply
- Check with your software vendor to see if additional days’ supply fields are available for internal tracking
- Avoid med sync or cycle fill programs for products whose correct days’ supply cannot be submitted for the smallest single package size
- Educate all pharmacy staff to identify rejection messages and how to properly resolve them
- Any DUR verifications, especially if using “M0” (prescriber consulted) to override the DUR, should have supporting documentation on the prescription or within retrievable electronic records
- Do not split bill rejected claims
- Charging the patient cash often leads to complaints [from the patient to an employer or PBM] and can be considered non-compliance with the provider manual and lead to remediation, including potential network termination
- If you have exhausted all plan options (including pursuing PAs and/or alternative therapies) and the patient insists on paying cash for the full prescription, be sure that you document authorization from the patient that they desire to pay the full cost and will not seek reimbursement from the insurance.
- Review our Can You Bill It As 30 Days? document under Proactive Tips on the Member Portal
How to Submit Your Audit Documents for an Effective Review
PAAS National® analysts continue to see an increasing amount of PBM audits demanding large audit volumes of documents for reviews. Our goal is to help pharmacies respond accurately and efficiently as you submit documentation.
PAAS analysts review your documents as if we are performing remote pharmacist verification, so it is helpful if we can see both the prescription AND the billing information at the same time.
Upon receiving an audit notice, send it to PAAS. This allows for the analyst on your case to provide guidance from the very beginning of the audit process, which can result in you saving time gathering less paperwork. Additionally, it allows the analyst to provide guidance on what to look for as documents are pulled, such as any electronic clinical notes that need to be added to the hardcopy. This can result in a more efficient, and seamless, pre-audit consult after documents have been reviewed by your analyst, ensuring an effective review for your audit.
General
Prescription Hardcopies
hardcopy
Signature Log
Copay Collection
PAAS Tips:
OptumRx® Provider Manual Updates May Shift Audits – Especially LTC
OptumRx® updates their Provider Manual several times throughout the year and publishes the full version on its publicly available webpage. Since a PBM’s Provider Manual is an extension of their contract, the terms and conditions within the Provider Manual are expected to be followed and non-adherence can cause problems for pharmacies. Such problems may consist of audit chargebacks, fraud, waste and abuse investigations, and even contract termination.
The latest OptumRx® Provider Manual publication is the 2024 Fourth Edition Version 4.1. PAAS National® analysts want you to be aware of the following changes and potential implications it will have on the documents you maintain and provide for an audit as well as changes you may see in your audit results report.
The ever-changing OptumRx® Provider Manual is just another whirlwind which pharmacies are caught in and must learn to navigate. Remember, PAAS is here to help, and our dedicated team is just a phone call, email, or web inquiry away!
PAAS Tips:
Insulin Pens: Understanding Dosing Increments and Audit Risks
PAAS National® continues to see auditors flag insulin pen prescriptions for containing a dosage that does not align with the product. Most insulin pen products can be dosed in 1-unit increments; however, there are some insulin pens that range from 0.5-unit increments to 5-unit increments.
If prescriptions are written with directions that conflict with the dosing of the medication, pharmacies should clarify the directions with the prescriber and make a clinical note on the prescription. For example…
a prescription written for Toujeo® Max Solostar® with directions indicating 89 units daily must be clarified because the pen can only be dialed in 2-unit increments (i.e., the directions should either be 88 units daily of 90 units daily).
The following table outlines which insulin pens you should pay close attention to when dispensing:
PAAS Tips:
What to Do (and Not Do) When Your Days’ Supply is Rejected
Insurance companies require pharmacies to bill an accurate days’ supply based on mathematical calculations from the directions. Pharmacies should not guesstimate the days’ supply or process every claim as 30 days for simplicity. Not all claims will adjudicate when processing the correct days’ supply, usually due to plan limitations. What should be done in these situations?
The first step is to make note of any reject messages received when processing for the correct days’ supply. For example, if the insurance limits the quantity to a 30 days’ supply, write “ILQ 30” on the prescription. Then reduce the quantity, if possible, and rebill the claim with the adjusted [accurate] days’ supply based on the revised quantity. Reduce the quantity further if the claim still rejects, until you reach the smallest unbreakable package size.
If the smallest unbreakable package size still does not go through with an accurate day’s supply:
If the above process is used, and you processed the claim with an adjusted [inaccurate] days’ supply, you are at risk for early refills because the PBM adjudication logic will allow you to submit a refill claim when the utilization threshold is met based on the previous days’ supply adjudicated, not the actual days’ supply. PBMs still require the pharmacy to monitor utilization and only refill when appropriate based off the accurate [calculated] days’ supply and not the adjudicated days’ supply. Remember, the claim rejection for “refill too soon” will not be appropriately triggered when the pharmacy is forced to bill a smaller days’ supply than the true calculated day’s supply. To help avoid this, PAAS National® suggests documenting the actual days’ supply in the directions for use (e.g., “actual days’ supply=37”) so that it prints on the label to alert staff and patients of the appropriate refill intervals.
Another situation pharmacies run into is when the accurate days’ supply is rejected due to exceeding the plan limit for a maximum daily dose.
For example, a prescription written for OxyContin® 30 mg, quantity 90, with directions to “take one tablet 3x daily” may receive a rejection for “Maximum two tablets per day.”
In this situation, pharmacies should not reduce the quantity to 60 tablets for a 30-day supply (this would be considered bypassing the plan limit). Instead, pharmacies should pay close attention to any messages given on how to resolve the rejection, including calling the PBM help desk for an override or getting a prior authorization started with the prescriber. Alternatively, the prescriber could decide to change the dose or prescribe an alternative medication.
What if the prescriber refuses to obtain a prior authorization or change the prescription to a clinically appropriate dose? Can the claim be split-billed? PAAS National® highly recommends against split billing or processing a claim as cash to circumvent a plan limit or prior authorization requirement. A doctor who refuses to obtain a prior authorization or change the medication/dose could be a red flag for diversion with controlled substances. Most plan limits are put in place based on appropriate clinical use and bypassing them can lead to easy recoupments for PBMs. Pharmacists have a corresponding responsibility to ensure that prescriptions are for legitimate medical purposes, especially for controlled substances.
PAAS Tips:
Medicare and Vaccine Billing: What You Need to Know
Pharmacies need to be aware of the risks of billing claims [to Medicare B/D] for patients under a Medicare Part A stay. Recently, a member asked the question of vaccine coverage for patients on a Medicare A stay, and how the billing should be done. Pharmacies can refer to Medicare Claims Processing Manual, Chapter 6 for guidance on the appropriate billing.
Let us first break down the Medicare coverage for vaccines:
Medicare Part B includes coverage for four preventive vaccines. These are typically vaccines that protect against diseases that are more common among older adults and those with chronic conditions. Here are the vaccines covered under Medicare Part B:
Medicare Part D, which covers prescription drugs, may include vaccines that are not covered under Part B. This includes:
Now the question of how to bill Medicare for vaccines when the patient is under a Part A stay? If the patient is receiving a vaccine:
PAAS Tips:
Scare Away the Unwanted: Four Facility Access Controls You Need!
Safeguarding the pharmacy’s Protected Health Information (PHI) is critical. Cyberattacks receive a lot media attention and a brief discussion of the threat to community pharmacies can be found in the June 2024 Newsline article, Independent Pharmacies are NOT Safe from Cyberattacks. The HIPAA Privacy and Security Rules require pharmacies to take a multi-faceted approach to securing the pharmacy’s PHI. With the release of the August 2024 Office for Civil Rights (OCR) Cybersecurity Newsletter (which focuses on the HIPAA Security Rule Facility Access Controls) now is a great time to review information about this safeguard.
The fundamental requirement of Facility Access Controls [as per 45 CFR 164.310(a)(1)] is to “[i]mplement policies and procedures to limit physical access to its electronic information systems and the facility or facilities in which they are housed, while ensuring that properly authorized access is allowed.” Under the Facility Access Controls, there are four addressable implementation specifications to which a covered entity and/or business associate must assess whether it would be reasonable and appropriate for them to adopt an implementation specification as an appropriate safeguard for their environment. If it is appropriate, they would implement it and if it is not reasonable or appropriate, they would document why and implement an equivalent alternative measure if reasonable and appropriate. Below is a table which outlines the four addressable implementation specifications for Facility Access Controls, what they are, and suggestions for pharmacies.
145 CFR 164.310
PAAS Tips:
Avoid OptumRx® Double Chargeback Pitfalls – Review Your Days’ Supply
OptumRx® has employed a new strategy to recoup more money on your pharmacy claims. Often upon an audit, if a pharmacy submitted an incorrect days’ supply, the PBM will re-adjudicate the claim with the correct days’ supply.
After the days’ supply has been adjusted, some of the subsequent [refilled] claims may be flagged as early refills – which result in a full chargeback. Now, if the interval between two fill dates is appropriate (i.e., not refilled early – typically 75% utilization of an accurate days’ supply for OptumRx®), OptumRx® will still look to chargeback any additional copay(s) that would have been incurred when the correct days’ supply was submitted (up to the plan limit for the actual days’ supply).
Here is an example where the patient has a $40 copay per 30 days billed:
Prescription is written for Symbicort® 80 mcg retail package size of 10.2 grams with directions of 1 puff twice a day. Symbicort® 80 mcg contains 120 puffs and therefore the calculated days’ supply would be 60. If the pharmacy accidently billed for a 30 days’ supply instead of 60 and the Symbicort® was refilled monthly, OptumRx® will flag every other fill as a refill too soon (2Z) and chargeback the full amount. On the dates of service flagged as invalid days’ supply only (1N), OptumRx® will chargeback an additional copay that would have incurred had the pharmacy billed the claim correctly (assuming the plan didn’t limit the days’ supply to 30).
*1N – invalid days’ supply
*2Z – refill too soon
PAAS Tips:
Caremark® Continues to Recover Payments for Unapproved Coupons
PAAS National® continues to see pharmacies face full recoupment on claims that are processed to coupons and copay cards in violation of Caremark’s® policy found in section 3.03.03 of the 2024 Pharmacy Provider Manual. Violations are considered [by Caremark®] to be an inappropriate waiver of patient pay amounts and could result in additional sanctions, including termination.
As defined in the current Provider Manual:
“Pharmaceutical Manufacturer Coupon” means any item or mechanism, including but not limited to, paper coupons, copay cards, e-vouchers, mail-in rebates, and electronic coupon codes funded by a manufacturer, repackager, or supplier of pharmaceutical, chemical, or compounding products, that reduces the portion of the Patient Pay Amount that an Eligible Person is required to pay for a Covered Item.”
Manufacturer coupons may be accepted if:
Log into the Caremark® Pharmacy Portal to find an electronic copy of the Provider Manual to become aware of the Pharmaceutical Manufacturer Programs and other associated programs that are excluded. Network pharmacies are mailed a paper copy of the Provider Manual every even year and small supplements in odd years.
PAAS Tips:
Rethink Corrective Action Plans
PAAS National® analysts continue to see PBMs demand pharmacies complete formal Corrective Action Plans (CAPs) in response to negative audit outcomes; particularly from MedImpact, OptumRx, and Caremark.
The demand for CAPs can be daunting, and excessive; however, CAPs may also help uncover the root causes for audit errors, allowing the pharmacy to potentially fix a systemic problem(s) that caused the negative audit outcome and prevent future non-compliance (and subsequent audit exposure).
Here is a suggested stepwise process to consider if you are faced with a demand for a CAP:
Step 1 Identify and investigate each possible unique problem to find the root cause(s)
Step 2 Develop and implement a corrective action plan for each unique root cause identified in step 1
Step 3 Train staff and implement a corrective action plan
Step 4 Perform internal scheduled audits to ensure that corrective actions are working
See the January 2023 Newsline article, Essential Elements of Corrective Action Plans for an example related to invoice audit shortages.
PAAS Tips:
Unveiling a Health Care Fraud and Illegal Black-Market Conspiracy
The Department of Justice recently announced the sentencing for a California (CA) pharmacy owner and their co-conspirator for submitting fraudulent claims to Medicare and CA Medicaid for prescription drugs that were never dispensed to beneficiaries.
Investigators from the Federal Bureau of Investigation, the Office of Inspector General and the CA Department of Justice uncovered the fraudulent scheme, in addition to discovering the conspirators were selling drugs on the black market over an eight-month period.
The pharmacy owner was sentenced to two years and three months in prison and their co-conspirator one year and eleven months. The jury convicted both the pharmacy owner and their co-conspirator of one count of conspiracy to commit health care fraud and one count of conspiracy to engage in the unlicensed wholesale distribution of prescription drugs. The co-conspirator was also convicted of an additional three counts of health care fraud.
The pharmacy owners’ co-conspirators created the fraudulent prescriptions based on the owner’s recommended combinations of expensive prescription medications, including HIV drugs. The pharmacy owner would check eligibility of patients for reimbursement, bill the claims to Medicare and Medicaid, but never dispensed them to the patients. Instead, these medications were provided to a co-conspirator (who was not a medical professional) to be sold on the illegal market.
Ensure your pharmacy has a robust Fraud, Waste and Abuse Compliance Program in place for employees to understand the repercussions of violating laws and regulations such as the False Claims Act. Contact PAAS National®® for more information on PAAS’ FWA/HIPAA Compliance Program.