Navigating Access and Reimbursement Through Uncertainty

Copay, Reimbursement, and Access Congress—an Informa Connect conference held in Philadelphia this past November—provided an essential forum for healthcare professionals, policy experts, and industry leaders to tackle some of the most pressing challenges in the evolving access and reimbursement landscape. With a diverse array of panel discussions and presentations, the three-day conference shed light on national policy trends, strategic solutions, and best practices for advancing patient access to care and optimizing stakeholder reimbursement strategies.

Among the standout sessions were two presentations focusing on key legislative and regulatory updates and actionable strategies to enhance access and affordability for medical benefit products.

The session titled "Legislative and Regulatory Update: Executive Policy Address" was delivered by Mark Gooding, managing director at Avalere Health, and Kate Sikora, deputy vice president of policy and research at the Pharmaceutical Research and Manufacturers of America (PhRMA). This presentation centered on the impact of shifting healthcare policies and legislative changes, particularly in anticipation of the new Congress and Presidential administration set to take shape this month.

The panel discussion focused on two key topics:

1. State of play across key healthcare policies: Gooding and Sikora detailed several critical issues influencing patient access, including copay adjustment programs (accumulators and maximizers), alternative funding programs (AFPs), and ongoing pharmacy benefit manager (PBM) reforms. Additionally, the speakers highlighted the Inflation Reduction Act policies set to launch in 2025, such as the Medicare Prescription Payment Plan (also known as Part D out-of-pocket smoothing), and the potential impacts on drug pricing.
2. Post-election landscape and legislative priorities: The session also explored how the 2024 elections outcomes will lead to an expected shift in priorities. Both speakers addressed the likelihood of increased legislative activity around transparency in copay support, PBM payment structures, and additional state-level restrictions on accumulator programs (see Figure 1).

Implications for stakeholders

Gooding emphasized that stakeholders, including manufacturers and payers, need to prepare for regulatory uncertainties and the evolving policy environment. Sikora reiterated the importance of tracking legislative developments, particularly state-level reforms that often serve as precursors to federal action.

The significance of coding and billing

Another session at the Congress, “Optimizing Coding and Billing Strategies to Enhance Access in Programs for Medical Benefit Products,” featured Jessica Cortez, principal at Avalere Health; Ticia Cawley, vice president of client solutions at ConnectiveRx; and Lilian Buch, director of reimbursement strategy at Amgen. This session focused on the role of coding and billing in ensuring seamless access to medical benefit products and reducing barriers for patients.

Three key areas that were highlighted in the session include the following.

1. Understanding coding systems and their relevance: The panel outlined common coding frameworks, including the Healthcare Common Procedure Coding System (HCPCS), Current Procedural Terminology (CPT), and the National Drug Codes (NDCs). They emphasized the importance of precise coding for coverage and reimbursement. Cortez noted that codes start translating the patient journey into payer language, while inaccurate coding can impact coverage decisions, reimbursement rates, and the financial health of providers and patients.
2. Affordability programs and product launch considerations: Buch shared best practices for aligning affordability programs with product-specific coding and billing strategies. She stressed tailoring support to address payer requirements and ensuring that benefit verification processes are streamlined. Cawley discussed emerging trends in buy-and-bill claims, assignment of benefits (AOB) processes, and hybrid coverage models that combine pharmacy and medical benefits programs.
3. Legal and operational compliance: A key takeaway here was the need to remain updated with evolving coding and billing standards. The panel highlighted risks, such as coding errors, misaligned documentation, and the impact of off-label use. Attendees were urged to implement robust environmental analysis of coding changes by following CMS for ICD-10 dockets, Physician Payment rulemaking, and the American Medical Association (AMA)’s CPT dockets and provider notices to understand how the evolution of the coding system will change their access and affordability program post-launch.

Best practices for success

The panelists emphasized the importance of having clear communication between stakeholders—manufacturers, reimbursement teams, and field staff—to ensure successful program execution. Cawley recommended leveraging technology to track key performance indicators, such as claim patterns, average copay amounts, and persistency data to optimize access programs.

The importance of building resilience through strategic partnerships

The insights shared in both sessions underscored the interconnected nature of policy changes, coding strategies, and access optimization. Key takeaways include:

• Staying informed: Stakeholders must proactively monitor legislative and regulatory changes, particularly given the shifting political environment post-2025 elections.
• Streamlining coding and billing: Accurate and efficient coding processes are critical to minimizing access barriers and improving affordability.
• Leveraging partnerships: Collaboration with expert organizations can help manufacturers and payers navigate complex policy shifts and operational challenges.

As the access and reimbursement landscape evolves, forums like the Copay, Reimbursement, and Access Congress are facilitating dialogue among stakeholders and sharing solutions. By embracing innovation, compliance, and strategic partnerships, industry stakeholders can ensure that patients maintain access to needed therapies while navigating an increasingly complex regulatory environment.

About the Authors

Jessica Cortez is a principal at Avalere Health with experience establishing partnerships with life sciences companies to drive strategic initiatives focused on transformation. Cortez leads the annual review of the Medicare Physician Fee Schedule (MPFS), specializing in coverage, coding, regulatory, and economics.

Mark Gooding, also of Avalere Health, is a managing director who provides life sciences companies strategic guidance on policy developments and reimbursement considerations. He analyzes federal- and state-level policies, and develops strategies to drive coverage and improve market access.