Pharmacy terminations based on aberrant quantities and products are becoming more and more prevalent. It is difficult to appeal such terminations due to broad definitions of aberrant products/quantities and PBMs’ excessive discretion on what constitutes such products and volumes.

For example, PBM manuals usually state that Provider “must not dispense aberrant quantities of” certain products “and/or high volume of claims within a therapeutic category (e.g. topicals, dermatologicals), as measured by number of claims, quantity dispensed or dollars, inconsistent with the habits of local Prescribers or Plan Sponsors formularies.” This is a very broad definition and does not give much guidance to the providers. Plus, it gives PBMs an exclusive discretion to determine what aberrant quantities are.

Based on my experience, anything above 10% could be classified as aberrant. In most cases, however it’s 25% or more  of the provider’s claims or dollars.

Also watch your reversals, as PBMs usually count them towards calculating aberrant volumes. While there is nothing in the manuals clarifying this issue (besides a provision that aberrant volume may be calculated on a number of claims), this issue has not been clarified in a legal proceeding. Therefore, it is recommended that the amount you bill to PBMs (not necessarily dispense) does not exceed 25% of your total claims billed (including reversals).

The DEA’s administrative action against Truepill is what first prompted me to write this blog post. Initially, I thought “interesting,” but I deal with over-dispensing allegations on a daily basis, so I didn’t think of writing about it. Then I started digging into the bedrock of this case. And the Truepill case has morphed into a national issue of a new “opioid crisis,” but this time relating to overprescribing of ADHD medications. The Truepill case is much more complicated than I originally thought and has a few important lessons.

The case illustrates potential issues that pharmacies often encounter when working with telehealth companies.

Truepill was a pharmacy contracted with Cerebral, a telehealth company marketing various ADHD treatments including Adderall and its generic forms.

Cerebral connected patients with prescribers via a telehealth visit and Truepill filled the scripts if such were prescribed. The problem with this set-up was the fact that Cerebral prescribed way too many ADHD medications and potentially failed to establish proper provider-patient relationship.  According to the Department of Justice (the “DOJ”) – which is currently investigating Cerebral’s prescribing patterns – the company was marketing and pushing ADHD medications to as many people as possible to increase its revenues. Ironically, Cerebral’s own employees complained that they were forced into over-prescribing.  For example, Cerebral’s ex-employees alleged that the company had implemented a policy of growth-at-all-cost when practitioners had to prescribe stimulants to up to 30 new patients a day, based on online evaluations that lasted as little as 10 minutes.

Because Truepill was providing Cerebral’s patients with the ADHD medications, it now found itself in the midst of a DEA administrative action and may potentially lose its DEA registration. By the way, the DEA alleges that Truepill has violated the Controlled Substances Act by exceeding the 90-day supply limits and/or filling scripts written by prescribers who did not possess the proper state licensing.

Truepill is not the only one who became a target of government investigations due to improper online prescribing. During the pandemic, telehealth providers enjoyed relaxed prescribing abilities which led to increased controlled substance prescribing. Many pharmacies were targeted due to increased dispensing of controlled substances for scripts coming from telehealth prescribers.

For instance, Trilliant Analytics published data that during the pandemic, 40% of all Adderall medications were prescribed via telehealth versus 2% during the pre-pandemic times.

Due to the suspension of the Ryan Haight Act (which requires an in-person examination before a controlled substance prescription is written), many telehealth providers targeted ADHD patients with new convenient means to obtain their prescriptions via mobile apps without much effort. As a result, we are facing a new “opioid crisis” when too many people are becoming dependent on large volumes of ADHD medications.

If you would like to read more on this issue and on the start-ups that sprouted due to the relaxed requirements during the pandemic, check out The Guardian’s coverage on mental health start-ups monetizing this problem and them going down due to the increased investigations.  

The case is a good illustration of new priorities for investigations and audits.  

Several government agencies (including the DEA) expressed concerns about aggressive prescribing and marketing of ADHD medications by telehealth companies. According to the Washington Post, prescriptions for Adderall have increased by 30%.

As a result, many enforcement agencies are trying to prevent a new crisis by getting ahead of it.   And there is no better way to prevent a crisis than by increasing supervision and scrutiny.  Fearing such scrutiny, most large pharmacy chains stopped filling Adderall prescriptions coming from telehealth companies.

This, in turn, resulted in increased volume of ADHD prescriptions being sent to  independent pharmacies. As a result, they need to be ready for increased PBM audits and government investigations. To avoid adverse determinations, pharmacies should understand whom they are working with by investigating telehealth companies, questioning their prescribing practices and obtaining as much information as possible on how telehealth prescribers establish provider-patient relationship.

All this increased prescribing of the ADHD meds resulted in significant shortages for those who need them most. Last year, the DEA refused to increase manufacturing quotas for 2023, which means that we have an increased demand but our supply stayed the same. In case you want to read more on this issue, The Wall Street Journal has published an article on the DEA’s letter to the manufacturers warning of increased investigations due to “the sheer volume of ADHD medications on the market coupled with aggressive marketing practices.”  

Finally, the case reminds that if you fill too much of one type of drug, an investigation (or an audit) is almost guaranteed to happen.

Stimulants, including generic forms of Adderall, amounted to 60% of all Truepill’s controlled substance fills. Moreover, one of its wholesaler cut its controlled substances supplies to a Truepill’s pharmacy due to this unproportionate dispensing of stimulants.  Similarly, I represented too many pharmacies in PBM audits, which stemmed from dispensing high amounts of a specific type of medications (such as compounding creams, Oxycodone, weight-loss medications, etc.). If you think your pharmacy has a similar concern, run an internal report on all your dispensing and determine if a specific type of product constitutes more than 25% of your overall volume (of claims or reimbursements). See a related blog post on aberrant products.

The bottom line…

The Truepill case serves as a good reminder to monitor Adderall and other ADHD medications due to heightened scrutiny by various government agencies as well as by PBMs. In addition, if you are working with telehealth companies, pay increased attention to their prescribing practices, scrutinize each prescription, and inquire how telehealth company establishes provider-patient relationship.

By way of illustration, last year, I represented a pharmacy who had to pay a large chargeback to a PBM because allegedly the scripts from a specific telehealth company were not based on a legitimate provider-patient relationship. (The prescribers working for this telehealth company prescribed non-controlled substances based on online questionnaires). Our appeal that the pharmacy had no means to verify how the relationship was established fell on deaf ears.

Plus, we – as society – are facing a new dilemma on how to protect people who really need the ADHD medication and to prevent a potential crisis. I am concluding with The Guardian’s words:

“Cerebral may have damaged the mental health profession’s credibility by overprescribing medication. But if the DEA takes the opposite tack – restricting the supply before it understands the demand – it, too, distorts patients’ access to care.”

 Due to extremely high demand, we created a second webinar on regulatory compliance. So, if you have not registered for our November 24th, 2020 webinar, we encourage you to register for this one, which will take place on December 2, 2020 at 6:30 pm PST. Both seminars have the same agenda. But we want to make sure everyone has an opportunity to ask questions and participate.

This webinar is geared towards pharmacy owners, managers, and pharmacists-in-charge, focusing on regulatory compliance.

Webinar’s Agenda:

1. PBM changes for 2021: formulary changes, aberrant quantities updates and strategies, preferred networks.

2. California regulatory changes: New CURES regulations, new prescription pads, collaborative practice agreements, Independent HIV Preexposure and Postexposure Prophylaxis Furnishing.

3. Medi-Cal managed care pharmacy benefit transition into fee-for-service.

4. Independent pharmacies’ plan to survive: overview of legal actions against PBMs, updates on PSAOs, national trends.

5. Q-&-A session

Please register here or email us directly:

We are looking forward to seeing you there!