Medicare claims for genetic most cancers assessments face rising rejection charges

Each using 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 willpower 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 potential explanations for the will increase.

Suppliers might have been sluggish to change how they use superior genetic testing for most cancers in response to the Medicare protection determination. 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 College of Well being

It’s also potential that the declare denials replicate a lag between scientific remedy 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 willpower (NCD).

NGS is a complicated genomic testing methodology that may establish 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 remedies that may immediately 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 willpower for NGS is the primary and solely nationwide reimbursement commonplace for genomic testing.

“We anticipated that there can be extra certainty round how NGS companies 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. “Further efforts to scale back uncertainty round NGS protection and lift consciousness of potential monetary penalties are essential.”

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 price 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 have been practically twice as more likely to be denied in the event that they have been carried out in impartial laboratories as a substitute of a hospital however the purpose for that is unsure (about half of claims for NGS have been positioned exterior a hospital);
• Claims have been about 3 times extra more likely to be denied in the event that they have been for testing 50 or extra genes; and
• The median cost value 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 excellent 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 because of NGS testing. Certainly, Kang, notes, though indirectly associated to this present examine, certainly one of her deliberate, and not too long ago funded research, can be an try to achieve a greater understanding of value-based precision drugs and its impacts on monetary points of such care.

“As extra superior NGS testing replaces decrease value, decrease worth diagnostic options, we have to know the way a lot it will influence 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 College 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.