The U.S. Centers for Medicare & Medicaid Services (CMS) said it is updating its payment policy for diagnostic testing for the SARS-CoV-2 virus to reflect turn-around times for those tests. The agency had boosted payment in April 2020 from $51 to $100 for high-throughput testing results, but as of Jan. 1, 2021, rates will remain at $100 only when the testing lab reports the results within two calendar days of the date of specimen collection. Any tests turned around longer than two days will yield a payment of only $75 as of that date, a measure the agency said is part of an emphasis on ensuring that those who test positive can self-isolate and seek medical care. CMS characterized the change as a reset of the base payment rate to $75 with a $25 bonus for the two-day turn-around. The American Clinical Laboratory Association (ACLA) said the association’s member labs have already worked on innovative solutions and operational reworks to tighten turn-around times, but ACLA President Julie Khani said, “we’re concerned that this policy could create a domino effect where patient access to testing is severely reduced.” Khani said that while the ACLA is reviewing the policy, a rate cut will not address the problem with turn-around times. Those times are “driven largely by fluctuations in demand and access to critical supplies,” adding that a new surge in cases ensures that global demand for testing supplies will continue to crunch supplies.

FDA posts guidance agenda for FY 2021

The U.S. FDA unveiled its guidance agenda for fiscal year 2021, with the usual A and B lists reflecting priorities for draft and final guidances. On the A list for final guidances are those for clinical decision support (CDS) software, the Safer Technologies Program (STEP) for medical devices, and additional device-specific criteria for safety and performance-based evaluation of devices for premarket applications. On the B list for final guidances is a guidance for implanted brain-computer interfaces for paralysis or amputation, and patient engagement for medical device clinical trials. The A list for draft guidances lists an update to the 2016 guidance for Section 522 postmarket surveillance studies as well as a guidance for software assurance for computers used in device manufacturing and device facility quality assurance programs. The B list for draft guidances includes a draft for change control plans for artificial intelligence and machine learning algorithms, and one for risk categorization for software as a medical device. In a separate notice, the FDA said stakeholders should provide feedback on which draft and final guidances that are of highest priority so the agency staff can allocate resources accordingly. The related document is FDA-2012-N-1021 (sub-docket for FY 2021 not added as of press time, Oct. 16, 2020).

Third-party 510(k) review report posted

The FDA posted a performance report for third-party reviews of 510(k) applications for the fourth quarter of FY 2020, which noted that submissions to third parties rose to 85, an increase from 78 in the fourth quarter of the prior fiscal year. Roughly three-fourths of these have rendered a determination as to whether the filing meets the substantially equivalent standard, with 96% of those turned around within 30 FDA days. The report breaks down those turn-around times per the 11 third-party review organizations, only three of which have processed five 510(k) applications or more in FY 2020. The annual volume of 510(k) applications made to the FDA or to third parties typically exceeds 3,000.

NIOSH testing flunks more imported filter masks

The FDA advised that some filtering facepiece respirator masks imported from China may fail to provide consistent and adequate protection to health care professionals from the SARS-CoV-2 virus, a determination made by testing conducted by the U.S. National Institute for Occupational Safety and Health (NIOSH). Given the results of the NIOSH testing, the FDA is recommending that the affected masks not be decontaminated for reuse, and consequently has revised a May 7, 2020, emergency use authorization (EUA) policy for these masks, itself a revision of an earlier edition.

OIG says Cedars-Sinai billed for non-compliant bariatric surgeries

The Office of Inspector General (OIG) at the U.S. Department of Health and Human Services said Cedars-Sinai Medical Center in Los Angeles billed Medicare for 25 bariatric surgery procedures between January 2015 and December 2016 that did not meet Medicare requirements for those procedures. The report states that the Centers for Medicare & Medicaid Services (CMS) had paid $372 million in claims overall for bariatric surgery services during the survey period, adding that Cedars-Sinai had filed a total of 62 claims over that time frame for a total of $1.3 million. Of the 25 faulty claims, 13 were failed to meet the standards for local coverage articles published by Noridian Healthcare Solutions LLC for $175,000, while the remaining 12 claims came up short of standards under Noridian local coverage determinations for $154,000. The report states that some of the contested claims are not eligible for reopening, given that more than 48 months have elapsed. OIG recommended that Cedars-Sinai refund any overpayments that are still subject to the four-year reopening rule, and that the CMS work with Noridian to ensure claims are properly vetted prior to payment.

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