Top News Stories for the Week of October 19

COVID-19 Outbreaks Led to Dangerous Delay in Cancer Diagnoses

Wall Street Journal

The COVID-19 pandemic brought much of the U.S. health care system to a standstill this spring, which oncologists blame for a spike in advanced cancer cases and a likely substantial number of cases that remain undiagnosed. Routine cancer screenings were suspended amid the public health crisis and, even where they were available, many patients chose to skip in-person medical visits despite nagging, unexplained symptoms. Data from insurance claims, lab orders, Medicare billings, and records from oncology practices appear to back up the trend, which has provided time for some cancers to progress quickly. Newly diagnosed patients increasingly are already in the advanced stages, with fewer treatment options and an elevated likelihood of unfavorable outcomes. "There's really almost no way that doesn't turn into increased mortality," said Norman E. "Ned" Sharpless, director of the National Cancer Institute. The agency predicted earlier this year that missed screenings and other pandemic-related impacts on care could trigger about 10,000 additional deaths from breast and colon cancer alone over the next decade—an estimate he now believes is conservative.

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FDA Finalizes Biotin Interfering Testing Guidance

Regulatory Focus

The Food and Drug Administration (FDA) finalized a guidance document related to biotin interference testing for in vitro diagnostic devices (IVDs). The document largely retains language from the June 2019 draft guidance, which recommended that sponsors contact the appropriate review division when biotin interference is detected. The draft also laid out recommendations for interference testing and communication of test results. FDA declined to recommend evaluating a concentration level less than 3,500 ng/mL. The agency said that "this level is consistent with best practices among the industry to test at 3 times the highest concentration levels observed, as recommended in the FDA-recognized standard published by the Clinical Laboratory Standards Institute." In addition, FDA said device labeling should include results of biotin interference testing, percent differences in test results at tested biotin concentrations, and whether results were inaccurately elevated or depressed because of high biotin concentrations. The agency declined to specify which additional mitigation measures might be necessary, but the guidance reflects "FDA's thinking that labeling alone may not be sufficient to mitigate the risk of incorrect results from biotin interference in all cases." The guidance also states, "Additional mitigation strategies may be considered when the risk of potentially incorrect results from biotin interference could significantly affect patient or public health."

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CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing

CMS Press Release

The Centers for Medicare & Medicaid Services (CMS) unveiled new actions to pay for expedited COVID-19 test results. Starting on January 1, 2021, Medicare will pay $100 to laboratories that complete high throughput COVID-19 diagnostic tests within two calendar days of collecting the specimen. These laboratories also must have completed, in the previous month, most of their high throughput COVID-19 diagnostic tests in two calendar days or less for all of their patients, not just their Medicare patients. For laboratories that take longer than two days to complete these tests, Medicare will pay a rate of $75, effective January 1, 2021. CMS is implementing the new requirements to support faster high throughput COVID-19 diagnostic testing and to ensure all patients, not just Medicare beneficiaries, receive faster testing. These actions will be implemented under the amended Administrative Ruling (CMS-2020-1-R2) and coding instructions for the $25 add-on payment (HCPCS code U0005). COVID-19 testing using high throughput technologies allows for increased testing capacity using an automated process that can administer more than 200 tests per day. The new payment amounts reflect the resource costs laboratories face for completing COVID-19 diagnostic tests using high throughput technology in a prompt manner during the COVID-19 public health emergency.

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