Medicare covers the costs of clinical trials—but only in certain situations. National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) highlight what Medicare will and will not pay for. By identifying and understanding the applicable NCDs and LCDs for your studies, you can ensure smooth and compliant Medicare coverage for your site.
What Are Medicare NCDs and LCDs?
NCDs are written rules that standardize coverage for all Medicare patients across the country. In relation to clinical trials, they indicate diseases or situations in which Medicare will cover a test (“indications”), as well as diseases or situations in which it won’t (“limitations”).
Local Coverage Determinations (LCDs) come from regional Medicare contractors; while LCDs include indications and limitations as well, they do not contradict NCDs. Rather, they serve to clarify NCDs or provide guidance on items without a NCD. LCDs only apply to a contractor’s region.
Where to Look Up NCDs and LCDs
Don’t rely on Google! You can find official NCDs and LCDs in the Medicare Coverage Database (MCD) at CMS.gov. The MCD receives real-time updates on national coverage information, as well as weekly updates on local coverage information. That makes the MCD your best bet for accurate and up-to-date documentation.
The MCD lets you search for NCDs and LCDs separately or together. You can look them up by name, code, or document ID. In addition to these search features, CMS.gov provides an alphabetical index of NCDs by clinical area and a state index of LCDs. No matter how you find your NCDs and LCDs, make sure they’re the current versions and not archived copies.
NCD and LCD Best Practices
Researchers must pay close attention to coverage for signs and symptoms. One smart way to do this is asking yourself whether a participant will meet the NCD or LCD conditions at every visit. In some cases, a patient’s signs and symptoms will always be apparent and support Medicare coverage. In other instances, this kind of predetermination may be impossible.
To help figure out how this can impact your protocols, always read the determination’s indications and limitations—both may address your participants’ signs and symptoms. Also, keep in mind that it may be easier to interpret guidelines by separating decisions by visit or visit grouping. After all, coverage may be different before, during, or after therapy.
NCDs and LCDs may outline specific coverage scenarios or offer broad guidance. And coverage information itself may not always be clearly written. As a result, you may be able to interpret the determination in more than one way. In these instances, choose an approach that makes the most sense based on the protocol situation and your research.
Be sure to document the applicable NCD or LCD in your coverage analysis; both NCDs and LCDs can justify billing practices. For instance, if you know an NCD or LCD will limit coverage, you can use negotiate a budget that has your sponsor cover those costs. On the other hand, you can directly bill items to patients if you know Medicare will cover them without issues.
Learn more best practices for Medicare NCDs and LCDs with this webinar from our CTMS Resources series.