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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 current Medicare nationwide protection dedication that established protection requirements for NGS testing.
The evaluation by Georgetown College researchers and colleagues seems in JAMA Community Open.
The researchers level to a number of potential explanations for the will increase. “Providers may have been slow to modify how they use advanced genetic testing for cancer in response to the Medicare coverage decision,” says So-Yeon Kang, Ph.D., MBA, assistant professor within the Division of Well being Administration and Coverage on the Georgetown College Faculty of Well being.
“We’ve seen evidence of limited responsiveness to national coverage determinations in other contexts.”
It is usually potential that the declare denials mirror a lag between medical therapy pointers and protection pointers, Kang notes. Moreover, the researchers consider that uncertainty could 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 varied 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 commonplace for genomic testing.
“We expected that there would be more certainty around how NGS services are covered with the NCD in 2018, but what we found is that there is a lot of uncertainty still, and potentially even growing uncertainty,” says Kang. “Additional efforts to reduce uncertainty around NGS coverage and raise awareness of potential financial consequences are necessary.”
Of their evaluation, the researchers checked out near 30,000 cancer-related NGS claims filed by virtually 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 almost five-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 almost twice as more likely to be denied in the event that they have been carried out in unbiased laboratories as a substitute of a hospital however the motive for that is unsure (about half of claims for NGS have been positioned outdoors 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 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 all her deliberate research can be an try to achieve a greater understanding of value-based precision medication and its impacts on monetary features of such care.
“As more advanced NGS testing replaces lower-cost, lower-value diagnostic alternatives, we need to know how much this will impact the outcomes of cancer care, which is a key question,” Kang concludes.
Extra info:
Declare Denials for Most cancers-Associated Subsequent Era Sequencing in Medicare, JAMA Community Open (2025). DOI: 10.1001/jamanetworkopen.2025.5785
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Georgetown College Medical Middle
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Evaluation reveals rise in declare denial charges for cancer-related superior genetic testing (2025, April 18)
retrieved 19 April 2025
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