FIRST, DO NO HARM

Primum non nocere ensures the well-being of patients. As Health Care Workers and Professionals, we pride ourselves on beneficence—acting in the best interest of our patients.

A CVS Specialty Pharmacist recently shared with me that CVS had been using an integrated digital MMAS (Morisky Medication Adherence Scale) within their vendor platform since obtaining URAC approval in 2016. For nearly a decade, CVS pharmacists regularly administered the MMAS-4 and MMAS-8, collecting data on patient adherence to medications every single day.

Ironically, less than a year prior, in 2015, the current Senior Vice President & Head of Specialty Operations at CVS Specialty was part of a team at Teva Pharmaceuticals that negotiated a large contract for the use of #MMAS in a MS Care Patient Support Program that spanned multiple countries. This individual was clearly aware of the importance of the MMAS in improving patient outcomes, based on their role in Teva's MS Care Program. If this same person failed to ensure that the MMAS had appropriate licensing requisites and the data was used appropriately to improve patient care, then I have a lot of questions about CVS internal protocols and ethical considerations.

Vendor article touts adherence of platform improving outcomes

It turns out that this vendor's platform illegally integrated an invalid and unauthorized version of the MMAS technology. The vendor then sold its subscription-based platform to what I counted on their website is at least 20 companies in the specialty pharmacy sector, bundling it with call center services and other ancillary offerings. I believe this company has pocketed tens or hundreds of millions of dollars over the course of nearly a decade using the MMAS as a selling point and primary focus on their medication adherence program.

The MMAS module was made illegally available to anyone who had access to this platform.

As someone deeply patient-focused, my concern here revolves around what CVS Health did with the data it collected. There are so many ethical and legal questions about the utilization of this patient data that have so far been unanswered.

Did CVS use the MMAS data to help patients?

Given that low MMAS scores are strongly correlated with uncontrolled blood pressure and a higher risk of cardiovascular mortality, I would have expected that CVS would use this data to intervene and support patients who were at risk due to poor medication adherence. If CVS was aware that patients with low MMAS scores had a significantly increased risk of serious health issues, including death, there is an ethical obligation to act.

If CVS just provided the patient with a score, sent the patient on their way home and collected the data without providing an intervention to improve patient adherence or to manage their conditions, this goes directly against "first, do no harm."

If CVS didn’t save any data at all, it would be a completely devastating missed opportunity—one that could have had dire, life-altering consequences. The potential to intervene and improve patient outcomes through the use of the MMAS was right there, but if this data wasn’t utilized, innocent lives may have been lost unnecessarily. It’s not just a lost chance for insight; it’s a tragedy of unrealized potential in preventing avoidable deaths. When it comes to patient care, such an oversight is nothing short of catastrophic.

What other data did CVS collect?

 Beyond MMAS scores, it is very likely that CVS collected or has access to additional patient data like their medical history, medication regimens, health outcomes (e.g., BP readings), and possibly SDoH. I want to understand how all these various data points were integrated and used to improve patient care—or if they did this at all.

If CVS had access to comprehensive data indicating that low adherence was leading to severe health outcomes like uncontrolled hypertension, and didn't do anything, this would be a huge breach of their duty of care.

If CVS used the MMAS data and sold it without proper authorization or patient consent, the consequences could be severe and far-reaching. If CVS monetized this data, it would suggest a blatant disregard for patient welfare in favor of profit.

There is a bright spot to all of this, however. If CVS can demonstrate that even one patient benefited from the use of this tool—if even one life was saved—then this could signal a turning point. The power of the MMAS lies in its ability to identify patients at risk due to poor medication adherence, and if CVS can show that they used this data to intervene and help a patient manage their condition, it could shift the narrative entirely. I would go easy on them.

Imagine the impact of showing that a single patient who might have faced uncontrolled blood pressure, a potential heart attack, or stroke, instead received timely intervention and is alive today because the MMAS flagged that risk. It would prove that, despite the controversy, the tool did what it was designed to do: save lives. This could restore some faith in CVS’s mission as a healthcare provider and offer a redeeming light in an otherwise difficult situation.

That one patient could serve as living proof of the value and power of the MMAS, highlighting that in the midst of this legal battle and ethical concerns, the true focus remains on patient outcomes. If CVS can show that even one life was positively impacted, it would bring to the forefront the potential of technology like the MMAS to be a life-saving tool when used properly. Such an example would not only soften the consequences of the allegations but could open the door for a more ethical, transparent approach moving forward—using the MMAS correctly and to its full potential in order to save even more lives.

I am always optimistic, sometimes overly, and I tend to think that everyone has the same mindset as I do in putting patients first.

Disagreeing with the allegations from CVS Health

I am perplexed and am struggling to understand why CVS Health is disagreeing with the allegations that are laid out in the lawsuit. Is this a standard statement that all companies are trained to say? From my perspective, the situation is straightforward: CVS got caught using a pirated version of the MMAS. I would think it would make sense for them to admit to their transgressions, address the issue, and move forward.

It's been proven that if you show genuine concern off the top, people will be more apt to listen to the rest of your messages. But many companies go rogue and deny all allegations. This tactic is all too familiar, as shown in its remarkably weak response to the trademark infringement lawsuit. Despite overwhelming evidence from their own employees, CVS chose to issue this statement disagreeing with the allegations regarding their use of the MMAS for nearly 10 years without authorization.

The reality is that their decision to deflect blame instead of taking responsibility speaks volumes about how large companies handle wrongdoing. In moments like these, transparency and accountability are essential.

Respecting intellectual property is critical to maintaining professional integrity in the healthcare industry. Intellectual property protections exist to foster innovation, reward creators of valuable tools, and uphold ethical business practices. In this case, the MMAS represents years of research and development, providing a powerful resource for improving medication adherence and patient outcomes.

By disregarding these protections, CVS not only undermines trust but also endangers the patients who rely on these tools. Theft of technology and piracy in healthcare aren’t just corporate disputes; they have real-world consequences for patients. They deserve to know whether an unauthorized tool was used in their care and how it may have affected their health outcomes.

Changing the corporate culture of denial and deflection is long overdue. In cases like this, it’s not just about intellectual property or trademark infringement—it’s about holding companies accountable for actions that directly impact patient care and safety.

CVS Specialty Pharmacy clearly had an advantage vs competitors by using the MMAS and they did so without paying for it. Did they bill Medicare under CCM, TCM, or MTM or was it a fee for services? How did they account for the countless hours the pharmacists spent on administering the validated assessments? It seems like they enjoyed its use for nearly a decade. Now they got caught. So now they don't want to use it anymore?

The discovery process awaits.

Silenced Progress: How CVS Blocked a Lifesaving Partnership with Aetna

The last allegation hurts 10 fold. Earlier this year I was randomly contacted by Aetna Medicaid Care Management Program Senior Manager and began discussions on integrating the MMAS within their care program. Discussions were going very well. Hoping to revive communications with the Senior Vice President & Head of Specialty Operations at CVS Specialty, I emailed this person again and asked if they could perhaps partner and facilitate a discussion on how to get all of CVS Health on board with the MMAS and put away the issues currently at hand. I was ultimately ghosted. No further responses, no follow-ups, complete silence.

What’s more concerning is that shortly after, a lawyer for CVS reached out, instructing me through my attorney to refrain from directly contacting any CVS employees from that point onward. This raises serious concerns about the intentions and transparency within CVS. Why, after expressing interest in working with Aetna to improve patient care through the MMAS, would they suddenly shut down all communication and throw legal barriers in the way?

This kind of interference suggests a deeper issue at play. Instead of supporting a partnership that could have brought the MMAS’s proven benefits to a larger population through Aetna, CVS appeared to be more focused on controlling the narrative and perhaps protecting its own internal interests. It’s unsettling to think that such a promising opportunity to advance patient care could be stalled due to internal maneuvering and corporate gatekeeping. Blocking progress like this not only limits innovation but could potentially harm patients who might have benefited from the MMAS's life-saving insights.

My Thoughts

As I reflect on this entire case, I can't help but feel frustrated and disheartened. The whole thing is a travesty! What started as a tool designed to improve patient outcomes has turned into a tangled web of corporate disregard for intellectual property and, more importantly, patient well-being. The unauthorized use of the MMAS by CVS is not just a violation of mine and my fathers work—it's a violation of the trust that patients place in their healthcare providers.

My biggest concern isn’t just about the misuse of a tool but the missed opportunities to help countless patients who could have benefited from timely interventions. If CVS collected this data for nearly a decade and failed to act on it to improve patient care, it raises serious ethical questions. And if they monetized that data, putting profits over patient outcomes, the consequences are even more alarming.

At the heart of this issue are the patients—people who rely on healthcare systems to prioritize their health and safety. When companies put profits over people, it undermines the very purpose of healthcare. This case is not just about protecting intellectual property; it’s about holding corporations accountable for their impact on real lives. It’s time for companies like CVS to step up, admit their mistakes, and ensure that tools like the MMAS are used ethically and effectively to make a positive difference in patient care.

Adherence v. CVS Health Corporation, 2:24-cv-01590

Citations:

1. Gu Q, Dillon CF, Burt VL, Gillum RF. Association of hypertension treatment and control with all-cause and cardiovascular disease mortality among US adults with hypertension. Am J Hypertens. 2010 Jan;23(1):38-45. doi: 10.1038/ajh.2009.191. Epub 2009 Oct 22. PMID: 19851295.

2. Oliveira-Filho, Alfredo Dias de et al. “Association between the 8-item Morisky Medication Adherence Scale (MMAS-8) and blood pressure control.” Arquivos brasileiros de cardiologia 99 1 (2012): 649-58.

Disclaimer:

The opinions expressed in this article are solely those of the author and are based on publicly available information and personal experiences. This article is not intended to provide legal, medical, or professional advice. All claims and assertions regarding CVS Health, the MMAS, and any related entities are based on allegations in ongoing legal matters and should not be interpreted as proven facts unless confirmed by a court of law or other authoritative body. Readers are encouraged to seek independent legal counsel or professional advice for any specific concerns related to the content of this article.