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CMS Approves CureOne Registry to Collect MIPS-Related Metrics Around Cancer Molecular Testing

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NEW YORK (GenomeWeb) – The US Centers for Medicare & Medicaid Services has approved CureOne's N1 Registry as a repository to which doctors can submit data and show that they are meeting quality metrics around cancer biomarker testing tied to payment.

The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) created new ways for CMS to pay physicians based on the quality and effectiveness of the care they provide to Medicare beneficiaries. One of the payment pathways created by the law is the Merit Based Incentive Payments System (MIPS), under which a physician's performance is measured according to parameters around quality, resources used, clinical practice improvements, and meaningful use of electronic health records. Physician compensation is adjusted according to whether their performance score falls above or below a mean score.

Doctors can submit these quality metrics through CMS-approved Qualified Clinical Data Registries (QCDR). The non-profit CureOne has built a prospective, open-access registry for collecting data on cancer patients tested on NGS panels, and announced this week that CMS has approved its application to make its N1 Registry a QCDR.

CureOne also developed metrics around biomarker testing indications that are approved by the US Food and Drug Administration and supported by expert guidelines. CMS approved 11 of the biomarker testing metrics proposed by CureOne — six effective care measures and five outcomes measures. If physicians submit these metrics, they would be tied to quality improvement-based payments under MIPS.

The six effective care measures are on EGFR, ALK, ROS1, BRAF, and PD-L1 testing in non-small cell lung cancer, and BRAF testing in melanoma. For example, oncologists that decide to submit data through the N1 Registry for MIPS-based payment will have to report the percentage of newly diagnosed NSCLC patients this year who are 65 years or older, tested positive for an EGFR alteration, and received a US Food and Drug Administration-approved targeted drug. 

The five outcomes measures are on EGFR, ALK, ROS1, and BRAF testing in NSCLC, and BRAF testing in melanoma. Doctors will report the percentage of newly diagnosed patients 65 years or older who have these alterations, received an FDA-approved drug, and whose disease did not progress within six months of starting therapy.

PD-L1 testing is currently done on immunohistochemistry and there is variability in the way testing is performed in the context of prescribing immunotherapy. This makes it more challenging to collect outcomes data in the N1 Registry, which is designed to collect data from NGS testing, said Rebecca Owens, CureOne's chief commercial officer. 

Although groups like the NCCN have issued guidelines recommending molecular testing in these and other cancer indications, there are no broadly accepted quality metrics tied to physician payment. Meanwhile, studies to date have shown that genetic testing adoption is inconsistent despite the availability of FDA-approved precision oncology drugs and testing recommendations issued by NCCN and other expert groups.

A study sponsored by drugmaker Boehringer Ingelheim a few years ago found that 81 percent of newly diagnosed advanced NSCLC patients received testing for EGFR mutations to determine whether they would benefit from EGFR inhibitors, such as Gilotrif (afatinib) or Roche/Genentech's Tarceva (erlotinib). EGFR inhibitors were some of the first personalized cancer drugs that came to market and there is plenty of evidence demonstrating that NSCLC patients with certain EGFR mutations benefit from these targeted therapies. And yet, oncologists in this survey started one in four advanced NSCLC patients on first-line treatment before they received test results, and 51 percent said that their patients' EGFR mutation status did not impact the drug they prescribed. 

Last year, diagnostic commercialization consultancy and market research firm Diaceutics tracked the use of 13-cancer linked biomarker tests and found that each year as many as 78,000 patients who could have benefitted from personalized, targeted treatments were not receiving them due to suboptimal testing. After the commercialization of a personalized drug, the adoption of the test often lags behind, Diaceutics' data further showed, given that eight years after a test is launched only 50 percent of the intended population receives it. 

CureOne is hoping to bring greater standardization to precision cancer treatments now that doctors will be able to report MIPS-based effective care and outcomes measures related to biomarker testing within the N1 Registry.

"If clinicians don't subscribe to the MIPS program … then they actually lose money," said Owens. "Because we are a registry that is trying to standardize NGS testing and clinical data and outcomes to demonstrate evidence around NGS, it only made sense for us to give another motivation to clinicians to participate in our registry, because they could easily file their quality metrics with CMS."

CureOne highlighted that its N1 Registry is the only repository that connects precision medicine and quality outcomes and has achieved QCDR status. In order to achieve this, CureOne had to submit a data validation plan, describe its methodology for collecting data, provide information about the proposed metrics, and have at least 25 eligible doctors participating in the registry by Jan. 1.

Owens noted that a number of clinics joined the N1 Registry well before it achieved QCDR status. However, CureOne hasn't yet publicly named the participating clinics.

Separate from garnering QCDR status for the N1 Registry, CureOne is also discussing with CMS how its N1 Registry can meet the data collection criteria the agency outlined as part of a draft national coverage determination for NGS cancer panels. In the draft NCD issued late last year, CMS is proposing to cover NGS cancer panels under three pathways for recurrent, metastatic, or advanced stage IV cancer patients.

One of the pathways is a coverage with evidence development (CED) option for FDA-approved or cleared tests without a CDx indication, but which can be used to guide cancer care alongside other tools and information. In order to qualify for CED, tested patients must be enrolled in a prospective registry that tracks their overall survival, progression-free survival, response rate, and other data. 

Owens noted that CureOne's broader aim is to demonstrate the overall clinical utility and evidence underlying NGS testing, particularly in indications lacking evidence in the literature. "Under the NCD the purpose is to collect the data and demonstrate clinical utility across the board," she said. "The hope is that as we collect patient data and outcomes, [and] that we can then demonstrate areas in which [NGS testing] is clinically relevant."

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