2021 Outlook: Five Themes That Will Define Co-Pay Assistance

As the pharmaceutical industry turns the calendar to 2021, co-pay assistance faces a handful of significant considerations that will define how successful manufacturer programs are in the year ahead. From legislative and regulatory issues to the shift toward integrated offerings and interoperable technologies, co-pay has become a complex facet of any brand’s patient access strategy. Understanding these themes and developing a detailed strategy around them will be key to positioning a program for success both in the immediate year ahead and into the future.

Accumulators and Maximizers – Increased Prevalence and New Federal Rules Complicate an Already Problematic Area for Manufacturers

Pharmaceutical manufacturers will have to contend with an increased prevalence of co-pay accumulators and maximizers in the new year. The 2021 Notice of Benefit and Payment Parameters gives health plans broad flexibility to incorporate these tactics, which do not apply the value of the assistance toward a patient’s deductible. As a result, the cost burden for specialty therapeutics shifts away from the plan sponsor to the patient and the pharmaceutical manufacturer. Maximizers saw increased utilization in 2020 and this trend is likely to continue in 2021. They are, in the eyes of the plan sponsor, a more “patient-friendly” approach, as the benefit of the manufacturer offer is drawn down in a way that prevents the patient from experiencing a significant out-of-pocket expense.

To further complicate matters, the Centers for Medicare and Medicaid Services (CMS) finalized a rule in December 2020 that requires manufacturers to ensure the benefit of these programs is realized only by patients to prevent them from being counted as a price concession in Medicaid’s best price calculation. While it is a small win for pharma and patients that this portion of the rule does not take effect until 2023, its looming impact will bring about significant challenges in the coming years as manufacturers are forced to adjust their program designs.

Interoperability Drives Interaction – Technology Interfaces Become Increasingly More Critical to Gaining Program Adoption

Interoperability is at the core of today’s healthcare technology ecosystem, and co-pay assistance programs are no exception to this trend. With a data-driven market giving rise to multitudes of platforms and vendors, the ability to “plugin” to disparate infrastructure sets to create a frictionless experience is paramount to being a serious player in any portion of the space. For co-pay, this includes standard API integrations for program enrollment, connectivity to commonly used practice management systems, and holistic patient engagement platforms such as Mercalis' (formerly TrialCard) Mango Health. The ability to integrate programs with other healthcare technologies makes it easier for prescribers to introduce patients to manufacturer assistance offerings. For patients, these types of technological synergies result in greater access to information to guide their treatment journey.

No longer a standalone asset, co-pay assistance is increasingly viewed by pharmaceutical manufacturers as a piece of the integrated patient support puzzle. Co-pay services need to fit easily within the construct of the manufacturer’s program design and should be able to operate within the life cycle of a prescription, touching nearly every point in the patient journey–from diagnosis to dispensing and onward to the level of data reporting necessary to provide quantitative insights into program performance.

Legislative Impact – Government Policies Will Influence How Manufacturers Design and Deliver Patient Assistance

The impact of the new co-pay accumulator and best price rules are only some of the areas where government action will be felt in the co-pay space. Additionally, new price transparency rules finalized at the end of 2020 will take effect in 2023, requiring health plans to disclose the use of accumulator adjustments. The lack of such a requirement has long been a point of contention against these tactics, as plans are often vague in how they communicate these plan details to members. Clearly articulated access to this information, prescribed by the rule, further allows patients to understand how their plan accounts for manufacturer assistance.

It will be important to see whether the growing push for increased state legislation to curb the use of accumulators and maximizers continues to gain support, ultimately driving legislative action. To date, only five states have imposed laws prohibiting health plans from using these tactics. However, the American Medical Association and organizations like the All Copays Count Coalition, a collection of over 60 groups serving the interests of people with chronic and serious health conditions, have called on government officials to bring forth federal and state legislation to curb accumulator use. In November 2020, Jason Zemcik, Mercalis' (formerly TrialCard) Senior Director of Product Management, participated in a panel discussion at the National Black Caucus of State Legislators Annual Conference, highlighting the impact of accumulators on patients.

State legislation will continue to impact co-pay assistance outside of accumulators as well. Some states have imposed certain restrictions as to when and how patients can use manufacturer assistance. Massachusetts, which had previously prohibited residents from using manufacturer assistance, instituted a law in 2012 that allowed the practice; this was recently extended to 2023. This extension came after a comprehensive study conducted earlier in the year by the Massachusetts Health Policy Commission found that manufacturer coupons were significantly beneficial in helping patients access and remain on therapy.

Finally, another aspect of state activity to heed in the context of co-pay assistance is the increasing trend of Medicaid expansion, driven largely in part by economic conditions resulting from the COVID-19 pandemic. As the government-insured patient population increases, manufacturers must take a refreshed view of the government exclusion controls incorporated in their co-pay programs to avoid being caught flat-footed on a topic that generated significant industry chatter a few years ago until recently being overshadowed by accumulators. Incorporating controls at multiple points throughout the patient’s interaction with a program – at enrollment, at the pharmacy counter, and most importantly, through real-time claim processing logic at the point of adjudication – is critical to meeting the standard of ensuring appropriate safeguards placed on pharmaceutical manufacturers by the 2014 Office of the Inspector General (OIG) special advisory bulletin on this topic.

Beyond Financial Assistance – Manufacturer Programs Have an Opportunity to Differentiate Through Supporting Services

Integrated support offerings are quickly supplanting singularly focused programs as the new wave of patient assistance, as manufacturers seek to optimize outcomes by affecting multiple determinants of patient health beyond just financial considerations. The recognition that overcoming cost barriers to access therapy is only the starting point on a patient’s treatment journey and that effective patient support must address multiple needs for the patient and his or her support system, will continue to drive the formation of full-service support programs. Pharmaceutical manufacturers that effectively select and incorporate service providers and capabilities will be best positioned to drive successful patient outcomes.

Complementary services like transportation assistance, disease state education, injection training, and other supporting functions designed to enhance the effectiveness of the patient’s treatment are no longer separate from co-pay assistance, but rather parallel paths that must be integrated into the overall offering.

Fraud and Abuse Prevention – Combating Exploitation Through Data Insights and Investigative Experience

A natural byproduct of increasingly generous co-pay offers for high-cost specialty medications is exposure to fraud and abuse. Once considered largely associated with government programs, pharmacy fraud has recently expanded to the point that manufacturer programs are a specific target. In December 2019, the U.S. Attorney’s Office for the Eastern District of Michigan handed down an indictment on a $46M co-pay fraud scheme involving 26 pharmacies. To date, Mercalis (formerly TrialCard) has returned just over $10 million to pharmaceutical manufacturers after identifying, investigating, and removing from its processing network those pharmacies found to be processing false claims against co-pay programs.

Implementing an effective fraud prevention program requires both data insights and human action. Like strategies employed by financial institutions to monitor suspicious account activity, having a claim analysis algorithm that detects suspicious behavior is the cornerstone of a sound co-pay fraud monitoring system. Incorporating multiple data sources like claim activity, pharmacy and prescriber attributes, and public records help establish fraud profiles to detect future illicit activity. Additional characteristics gleaned from each newly-identified pharmacy can be added on an ongoing basis to help manufacturers remain at the forefront of fraud monitoring. The final piece to a holistic fraud prevention strategy comes in the form of investigators, who evaluate cases of potential fraud to determine if further audit and removal from a network are warranted.

Whether your brand is preparing for launch or looking to optimize performance in a crowded therapeutic class, Mercalis' (formerly TrialCard) suite of patient support services can help drive increased patient participation and adherence to deliver better health outcomes.

Contact sales@mercalis.com today to schedule a discussion about your specific areas of focus for the coming year.

Jason Zemcik, Senior Director of Product Management at Mercalis (formerly TrialCard)