Medicare claims for genetic most cancers checks face rising rejection charges

Each the usage of next-generation sequencing (NGS) testing for most cancers and the speed of declare denials for such testing elevated between 2016 and 2021, regardless of implementation of a latest Medicare nationwide protection dedication that established protection requirements for NGS testing.

The evaluation by Georgetown College researchers and colleagues, and funded by a grant from the Nationwide Most cancers Institute on the Nationwide Institutes of Well being, seems April 18, 2025, in JAMA Community Open.

The researchers level to a number of attainable explanations for the will increase.

Suppliers might have been gradual to switch how they use superior genetic testing for most cancers in response to the Medicare protection resolution. We have seen proof of restricted responsiveness to nationwide protection determinations in different contexts.” 

So-Yeon Kang, PhD, MBA, Assistant Professor, Division of Well being Administration and Coverage on the Georgetown College Faculty of Well being

It’s also attainable that the declare denials replicate a lag between medical therapy pointers and protection pointers, Kang notes. Moreover, the researchers imagine that uncertainty might stay about protection requirements for superior genetic testing for most cancers in circumstances not addressed by the Medicare nationwide protection dedication (NCD).

NGS is a sophisticated genomic testing methodology that may determine a number of tumor genetic markers, providing exact details about numerous tumor mutations that may, in some circumstances, be utilized in therapeutic decision-making, significantly with therapies that may straight goal recognized gene mutations.

In 2018, Medicare issued an NCD to codify reimbursement requirements for NGS. The NCD was additional up to date in 2020. Medicare’s protection dedication for NGS is the primary and solely nationwide reimbursement normal for genomic testing.

“We anticipated that there can be extra certainty round how NGS providers are lined with the NCD in 2018, however what we discovered is that there’s a lot of uncertainty nonetheless, and doubtlessly even rising uncertainty,” says Kang. “Extra efforts to cut back uncertainty round NGS protection and lift consciousness of potential monetary penalties are obligatory.”

Of their evaluation, the researchers checked out near 30,000 cancer-related NGS claims filed by nearly 25,000 distinctive Medicare beneficiaries, culled from a 20% random pattern of Medicare recipients. They discovered:

• The variety of cancer-related NGS testing claims elevated practically 5-fold, from 2016 to 2021;
• The declare denial charge was 16.8% earlier than the NCD in 2018, 20.3% after the implementation of the NCD, and 27.4% after the NCD was amended in 2020 to incorporate hereditary mutations present in breast and ovarian cancers;
• Claims for NGS testing had been practically twice as more likely to be denied in the event that they had been carried out in impartial laboratories as a substitute of a hospital however the motive for that is unsure (about half of claims for NGS had been positioned outdoors a hospital);
• Claims had been about thrice extra more likely to be denied in the event that they had been for testing 50 or extra genes; and
• The median cost price amongst denied NGS claims, which represents the higher restrict of supplier or affected person legal responsibility, was $3,800. If NGS is roofed, sufferers pay nothing.

An impressive unanswered query is whether or not, regardless of elevated prices related to NGS, there have been concomitant reductions in total care prices due to higher diagnostic capabilities due to NGS testing. Certainly, Kang, notes, though in a roundabout way associated to this present research, one in every of her deliberate, and not too long ago funded research, shall be an try to realize a greater understanding of value-based precision drugs and its impacts on monetary facets of such care.

“As extra superior NGS testing replaces decrease price, decrease worth diagnostic options, we have to know the way a lot it will impression the outcomes of most cancers care, which is a key query,” Kang concludes.

Along with Kang, Carole Roan Gresenz, PhD, additionally participated within the analysis at Georgetown. Ilina Odouard, MPH, participated within the analysis at Johns Hopkins Bloomberg Faculty of Public Well being, Baltimore.

Kang and her co-authors report having no private monetary pursuits associated to this analysis.

This analysis was supported partly by Nationwide Most cancers Institute grant #3R01CA277599-02S1.