Nuedexta® National Audit: A Tale of Medically Accepted Indications

PAAS National® stresses the importance of medications being prescribed for a medically accepted indication (MAI), particularly for Medicare, Medicaid and Tricare, as this carries an audit risk that is difficult to overturn on appeal. Nuedexta®, a medication approved for the treatment of Pseudobulbar Affect, or PBA, underwent a national audit conducted by Centers for Medicare & Medicaid Services (CMS) and Plan Program Integrity Medicare Drug Integrity Contractor (PPI MEDIC). PBA disorder is a neurological condition that results in an individual experiencing “emotional lability”. However, the FDA chose to use a more specific definition of PBA when determining Nuedexta®’s MAI. According to Section 1 – “Indications and Usage” in the package insert, it states “PBA occurs secondary to a variety of otherwise unrelated neurologic conditions…” and is a “specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.”

CMS’ desire to conduct a national audit was substantiated by the fact that in September 2019, Avanir Pharmaceuticals, Inc., the manufacturer of Nuedexta®, paid over $95 million to the Department of Justice (DOJ) to resolve allegations of kickbacks and false or misleading marketing efforts that lead to long-term care patients being prescribed Nuedexta® outside of the MAI. Therefore, the goal of the Nuedexta® National Audit was to assess for fraud, waste, and abuse associated with the medication in addition to the risk the medication poses if not used in a clinically supported manner.

From January 1, 2019 through December 31, 2020, select plan sponsors were asked to submit prescription drug event (PDE) documentation that would substantiate their coverage of Nuedexta®. According to the results, CMS agreed with most of the prior authorization parameters put in place by plan sponsors. In the instances that documentation was improper, CMS had plan sponsors address their process that resulted in Nuedexta® being covered inappropriately, such as relying on patients’ historical medical claims or information from prior coverage requests instead of clarifying Nuedexta®’s intended use with prescribers or denying prior authorization requests on the basis of non-MAI uses. In conclusion, CMS is requesting all plan sponsors to evaluate their coverage and payment of Nuedexta® based on their formulary and utilization management edits in place, to prevent Nuedexta® from being used outside of its MAI.

PAAS Tips:

  • Be mindful of a medication’s indication for patients on government sponsored health plans to ensure you are lowering your risk for audit
  • Use pharmacist drug utilization reviews to your advantage to ensure medication is being used properly. Do not disregard or bypass system flags without due diligence.

Discount/Cash Cards Are Disruptors in the Industry

NCPA Multiple Locations Conference Panel Discussion Part 1 of 2

On February 25, 2023, President of PAAS National®, Trent Thiede, had the privilege of participating in a Panel Discussion entitled Marketplace Prescription Dynamics Sure to Shape Your Business Strategies. While traversing several different topic areas, there are two core issues that are important for PAAS members: discount/cash cards and biosimilar adoption in 2023.

IQVIA published a white paper entitled Pharmacy Discount Card Utilization and Impact in August of 2022 with several interesting findings. Among them, discount card utilization has grown to 5.4% of all pharmacy adjudications in 2021, a 63% increase over 2017 – of which “Not So GoodRx” now represents 46%. Only 9% of discount card transactions are for branded products. For Medicare patients, nearly 1 in 5 (19%) used a discount card. Commercial patients were 12%, but that doubled to 24% for those with an observed deductible. Cash paying patients represented 56% of all patients, and 52% of transactions.

While the discount card growth has been remarkable, what makes them disruptors in the industry has been their impact on the traditional PBM model. Discount cards have been effective at undermining the perceived benefit that PBMs are supposed to provide (i.e., why is GoodRx able to offer a better price on my prescriptions than my insurance).  Additionally, patients’ out of pocket costs are typically not captured when they use discount cards unless a patient is going to submit claims on their own (in addition to gaps in adherence metrics and other quality measures). In response, Express Scripts announced a partnership with GoodRx to include a “lesser of” logic when processing prescription claims through their Price Assure program. Not to be outdone, OptumRx launched Price Edge which will review direct-to-consumer prescription drug prices and offer members the lowest available price. Comically, OptumRx said they currently offer the best price to their members about 90% of the time, meaning 10% of the time patients are getting a raw deal. Both of these programs are automatically including these drug purchases into member’s deductibles going forward.

Pharmacies know that discount cards are really just another form of spread pricing, benefiting the discount card provider and PBM. GoodRx reports that it earns 15% of the patient’s total retail prescription cost, and that doesn’t include a fee for the PBM processor. Interestingly, GoodRx had disclosed that Kroger had accounted for only 5% of participating pharmacies, but nearly 25% of prescription transaction revenue. How could it have been that high? As a chain, Kroger was more likely dutiful in their utilization and/or promotion of GoodRx for patients. Most independents despise GoodRx and will create work arounds to avoid utilizing the card (e.g., with aggressive cash pricing or price-matching). Pharmacies should always be careful not to jeopardize their usual and customary. With the integration from these new programs by the PBMs, bypassing discount cards will likely no longer be an option for insured patients. The impact on BER, GER and even DIR fees for 2023, and beyond, are not clear.

Speaking of jeopardizing your Usual & Customary pricing, Amazon’s RxPass should be a flop. If you haven’t heard or read about it, Amazon is offering their Prime members “eligible medications for one flat, low monthly fee of $5, and have them delivered free of charge”. Patients with Medicare, Medicaid, or located in one of the seven states they exclude are not eligible to participate. The broader question is how long it will take the DOJ and HHS-OIG to enforce the U&C issue that has already played out with Walgreens (and many others). PAAS previously illuminated the $60 million settlement with the Prescription Savings Club in a March 2019 Newsline: AVOID “Discount Clubs” for Cash Patients. That same DOJ announcement also discussed the infamous Insulin Pen Box Settlement for $200 million. Amazon clearly missed this settlement, as the PillPack subsidiary paid a $5.79 million settlement in May 2022 for the same insulin pen dispensing practices.

Stay tuned for our second core issue from the NCPA MLC panel discussion in the April 2023 Newsline where we’ll discuss biosimilar adoption, insurance coverage and audit risks.

Not-So-GoodRx Reprimanded $1.5 million for Sharing Consumers’ Information

The article GoodRx Shares Consumer Data appeared in the April 2020 Newsline, which pertained to GoodRx sharing their consumers’ data with various platforms, including Facebook and Google. Key information from the article include:

  • Both Facebook and Google denied utilizing information, specifically personal health information, obtained from GoodRx to target ads to mutual consumers.
  • Despite Facebook and Google’s claims, GoodRx did issue an apology for their role they played in sharing consumer information to the platforms and vowed to “do better”
  • Since GoodRx is “a private company with no doctors or hospitals involved, it does not have to protect the health data a consumer gives it”

One could speculate that GoodRx was hoping this would be the end of the ordeal. However, it was not.

For the first time, the Federal Trade Commission (FTC) has enforced the Health Breach Notification Rule, due to “GoodRx Holdings Inc…failing to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google, and other companies.” Pending federal court approval, the Proposed Order will include numerous provisions that GoodRx will need to follow, including:

  • Prohibited from sharing user health data with applicable third parties for advertising purposes
  • Require user consent for sharing health information outside of advertising purposes
  • Implement a privacy program which includes safeguards from unauthorized access to user data
  • Mandatory outreach to third parties requesting consumer health data be deleted and disclose information about the breach of their health information and FTC’s legal action to consumers
  • Limit the amount of time consumers’ health information will be retained
  • Make available to the public how long their information will be retained, what information is collected, and why the information collected is necessary
  • Pay a civil penalty of $1.5 million due to “sharing sensitive personal health information for years with advertising companies and platforms -contrary to its privacy promises…”.

As alluded to above, GoodRx is not a HIPAA covered entity and therefore not legally bound to the same notification rules as covered entities. As such, patients should be made aware of this if they choose to upload information into GoodRx’s app or website or request that a pharmacy submit claims information to GoodRx. Patients can refer to  GoodRx’s updated “Privacy Policy” for more information.

Proof of Copay Collection – Secondary Payers Hidden in Plain Sight

If your pharmacy has not had to deal with proof of copay collection on an audit, your time is coming. More frequently, PBM auditors are comparing the copay amount on a point-of-sale receipt against the copay the PBMs expect based on the plan design and claim adjudicated. Copays are used by insurers to make patients aware of the cost of their medications and incentivize them to try less expensive alternatives. Waiving or discounting copays (unless permitted by law) or placing copays on a house account (with no intent to collect) are all fraudulent actions and may put your contract at risk.

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PAAS National® analysts are here to walk you through the documentation required to prove the pharmacy collected the copay. It is very important to show that the full copay amount was collected to avoid any accusations of fraudulent activity. Sometimes, it is very straightforward (e.g., the claim had one payer and the returned copay was collected via credit card payment, which is evidenced by providing a copy of the point-of-sale receipt); however, it is not always that simple. When a secondary payer modifies the copay, this causes the point-of-sale receipt to have an amount less than what the primary payer would expect. Identifying a secondary payer is often easy when it is Medicaid, a second insurance plan, or a manufacturer coupon, but one secondary payer is often overlooked – the eVoucher. This type of copay reduction is a discount applied during adjudication by your switch and is usually from the product’s manufacturer.

It is not always obvious to pharmacy staff when an eVoucher is applied, but if a PBM auditor asks for proof of copay collection, it will be obvious to them that the copay collected does not match the copay they expect. It is critical that pharmacies check claim data for this “hidden” secondary payer when proof of copayment collection is requested so evidence of how much the eVoucher lowered the copay can be provided to the PBM auditor. Information about how much the eVoucher covered may be found in the returned adjudication message (possibly found under the Electronic Data Interchange [Received] in your pharmacy software system).

If you would like to speak to an analyst about proof of copay collection concerns, call (608) 873-1342, email info@paasnational.com or submit a question online through the PAAS Member Portal.

PAAS Tips:

  • It is critical to provide PBM auditors with all the information related to proof of copay collection – this may include:
    • register or point-of-sale receipts
    • secondary payer coordination of benefits screen print
    • secondary payer plan information (e.g., BIN, PCN, ID, group number)
    • eVoucher data
    • payment information which may include the last four digits of the credit card used to pay the copay, a copy of the front and back of the patient’s check used to pay the copay and deposited at your bank, or even cash deposit slips to show copay paid in cash was fully collected
  • PAAS FWA/HIPAA compliance members can refer to Section 4.1.5 of their Policy and Procedure manual
    • This includes language for non-routine waivers for cost-sharing amounts imposed under a federal health care program
  • For additional information on proof of copay collection, review the following Newsline articles:

LTC Is Different … Do Auditors Agree?

PAAS National® analysts frequently assist pharmacies that service LTC facilities. Not only does PAAS work with many combo shops, but we also service numerous closed-door LTC pharmacies. The pharmacies servicing Skilled Nursing Facilities (SNFs) often struggle to provide the appropriate documentation that auditors look for. It is important to know most PBMs follow similar requirements for both retail and LTC during the audit process.

Three audit flags PAAS analysts frequently see for LTC pharmacies:

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  1. Missing a valid order/prescription (consider reviewing Humana Guidelines for LTC)
    1. Patient Name
    2. Date of issuance
    3. Name of the Drug
    4. Strength of the Drug
    5. Dosage form of drug (if applicable)
    6. Directions for Use

Some of more common items that are missed or a concern to refresh pharmacy staff on are:

    1. Quantity
    2. Duration of Therapy (number of refills or clear start/stop dates, or a disclaimer regarding duration)
    3. Missing DEA Elements on Controlled Substances
    4. Prescriber’s printed name and signature on the physician order
  1. Billing and dispensing at inappropriate times
    1. Delivering prior to Billing
    2. Delivering outside the PBM’s Return to Stock window
  1. Insufficient documentation for signature/delivery logs
    1. Patient name
    2. Prescription number(s)
    3. Date filled or fill number
    4. Date of delivery to facility – cannot be pre-printed
    5. Facility name and address
    6. Signature and date of representative accepting delivery
    7. Proof that full amount billed was received

While standard for retail pharmacies, those servicing LTC facilities may fall short. Pharmacies should consider putting procedures in place to mitigate these issues during the audit process. Trying to obtain this information at the time of the audit, or appealing post-audit, can be very difficult and time consuming.

PAAS Tips:

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?

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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

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:

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  • patient full name
  • patient address
  • patient date of birth
  • prescriber full name
  • prescriber address
  • prescriber telephone number
  • other required identifiers of the prescriber (NPI, DEA, etc.)

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:

  • Get into the habit of creating good documentation for prescriptions, especially telephone orders and transfers that may be handwritten.
  • Familiarize staff with provider manual requirements for prescription documentation.
  • Check your state regulations for additional prescription documentation requirements.

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.

  • January 2023, PAAS helped with 969 audits. A 30% increase year over year!

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:

  • We recommend pharmacies start collecting signatures from patients for prescription pick-ups on or before May 11, 2023, if you have not already.
  • PAAS Audit Assistance members can review the February 2023 Newsline article, Are Your Delivery/Signature Logs PBM Compliant for 2023?
  • Check your state’s legislation to see what PREP Act authorities have been made permanent in your state.

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®.

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Levemir® FlexTouch® New! Levemir® FlexPen®
Changes
NDC 00169-6438-10 00169-6432-10
Pen Needle NovoFine® or NovoTwist® NovoFine® or NovoFine® Plus
Max # of units per single injection Up to 80 units Up to 60 units
Remains the Same
Type of Insulin Insulin detemir Insulin detemir
Manufactured 3 mL single patient use prefilled pen 3 mL single patient use prefilled pen
Unbreakable package size 5 x 3 mL pens 5 x 3 mL pens
How units are dialed Dialed in 1-unit increments Dialed in 1-unit increments
AWP $554.65 $554.65
# of units needed to prime each pen prior to use 2 units 2 units

PAAS Tips:

  • Due to the different features and functions on how to use
    • Review the new instructions for the Levemir FlexPen®
    • Get an updated prescription to minimize disruption to patient care

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.