Medicare Coverage Analysis: Tips for Creating the Billing Grid

Written by: Nicole Bruecker

Billing Grid Tips and Best Practices

Creating a comprehensive and usable Medicare Coverage Analysis (MCA) billing grid is a crucial step in ensuring accurate billing for clinical trials. The billing grid not only ensures that study-related costs are accounted for properly but also prevents potential billing compliance issues. This guide provides a practical approach to building a robust billing grid by using essential tips and best practices.

Whether new to Medicare Coverage Analysis (MCA) or a seasoned pro, it is sometimes helpful to revisit the basics of how to create MCAs to ensure your processes are working as intended.

Our Senior Director, Nicole Bruecker, presented at MAGI @ Home on Tuesday, October 22, 2024. This is a Billing Compliance session focused on "Creating the Medicare Coverage Analysis."

This session walked through a variety of MCA topics to build the framework on how to complete an MCA, along with best practice tips. This includes one of the key fundamentals worth your attention: building the billing grid. While there is no set required or “correct” way to build the grid, there are several important tips you should keep in mind.

Building the MCA Billing Grid Template: Collaborate with Key Stakeholders

Creating a billing grid/coverage analysis process is not a one-size-fits-all task. Each site has specific needs, and it’s essential to engage all relevant parties who will be using the final MCA. This can include:

  • Study Team Staff

  • Billing Staff

  • Financial Analysts

  • Regulatory Staff

By working together, you can tailor the grid to meet site-specific needs and avoid oversights or miscommunications about protocol and billing requirements. Collaborative input is critical to ensure that nothing is missed and that the grid supports both compliance and financial objectives.

Study Specific Steps

1. Understand the Study: Read the Informed Consent (ICF) Carefully

Start by reviewing the Informed Consent Form (ICF) to gain a layman's understanding of the trial. The ICF outlines key aspects of the study, including its goals, procedures, and the care the patient will receive. Pay close attention to any items or services that are promised free of charge to the patient, as these must be flagged for sponsor billing rather than being billed to Medicare or other third-party payers.

While the ICF is written for the patient’s understanding, it’s an excellent foundation for you to grasp the scope of what’s being promised and what needs to be incorporated into the billing grid.

2. Start with the Schedule of Events (SOE)

The Schedule of Events (SOE) is your starting point for building a billing grid. The SOE outlines all the study activities and their respective timepoints. As you review the SOE, make sure to thoroughly read the footnotes, which often contain additional instructions or clarifications regarding procedures.

3. Dive Deeper: Study Requirements Outside the SOE

Once you’ve reviewed the SOE, it’s time to further investigate the detailed requirements of the protocol and other study documents. Here are some key considerations to keep in mind:

  • Labs: Are the labs being conducted locally or centrally? Understanding the lab requirements impacts whether they are potentially billable to insurance as well as how the costs are accounted for in the budget. Additionally, make sure you know which specific labs are required (e.g. "chemistry" is too vague and should be specified, such as "complete metabolic panel" and the add-on labs which may need to be accounted for separately).

  • Hospitalization: Will the patient need to be hospitalized during the study, or are they already hospitalized for another reason? Understanding whether the patient is hospitalized will greatly impact billing. 

  • Imaging: What types of imaging are required? Is alternative imaging required under certain circumstances?

  • Medications: Does the trial require any additional medications, such as supportive drugs or other medications (potentially given in combination with the study drug)? 

  • PKs and Extended Visits: If multiple pharmacokinetic (PK) samples are required, especially over extended time periods, consider whether you need to reserve a room for these longer stays. This can add logistical complexity, which may also affect billing (e.g. nursing hours or facility use fees).

  • Central Reads and Response Assessments: Does the protocol require central reads or response assessments? If so, these should be captured in the billing grid to ensure they are included in the budget.

4. Add CPT/HCPCS Codes for Procedures

After mapping out all the necessary services, the next step is to assign the appropriate CPT (Current Procedural Terminology) or HCPCS (Healthcare Common Procedure Coding System) codes. 

Benefits:

  • Aids in identifying applicable NCDs and LCDs.

  • Determine costs for protocol required items when building the budget from the MCA.

  • Helps identify charges on claims to ensure they are sent to insurance or pulled off to bill to the sponsor as appropriate.

Conclusion

Creating a Medicare Coverage Analysis billing grid requires meticulous attention to detail and collaboration across teams. By starting with reading the ICF, reviewing the Schedule of Events, thoroughly investigating other protocol requirements, and assigning accurate CPT/HCPCS codes, you can develop a billing grid that supports both compliance and financial accuracy. This process not only protects your site from billing errors but also enables the creation of a comprehensive budget, allowing for the smooth execution of clinical trials.

Elevate Clinical Research Solutions encourages sites to invest the time and resources needed to build comprehensive billing grids, forming the basis of the MCA, and ultimately creating a vital billing compliance tool.