The U.S. FDA said it has issued an emergency use authorization to Genscript USA Inc., of Piscatawy, N.J., for the company’s C-Pass SARS-CoV-2 neutralization antibody test kit, a serology test that can detect neutralizing antibodies from recent or previous infections. The antibodies detected by the test have been observed in a lab setting to decrease viral infection of cells, the agency said, adding that the effect of neutralizing antibodies is still under investigation. The agency has authorized more than 50 serology tests, but those were all directed toward binding, rather than neutralizing, antibodies. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said detection of neutralizing antibodies may assist in understanding of the impact of these antibodies on patients. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies tell us about potential immunity,” Stenzel said, adding that the Genscript test will assist in the agency’s evaluation of neutralizing antibodies. However, he cautioned that the presence of such antibodies is not dispositive of the question of immunity. The agency also advised that the results of this type of test should not be used as an indication that preventive measures, such as mask wearing and social distancing, are not necessary.
FDA tweaks export final guidance per CARES Act
The U.S. FDA posted the final guidance for the process involved in requesting a review of an agency decision to not issue an export certificate for medical devices, which incorporates changes mandated by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. This final version is a reissue of the November 2019 guidance, the scope of which was limited to instances in which a person or persons was denied a certificate to a foreign government. The final expands the scope of the guidance to address scenarios in which a device authorized for marketing in the U.S. is exported from one non-U.S. nation to another, and thus provides for a “certificate for device not exported from the United States,” which assumes that device is authorized for marketing in the U.S. The agency reminded that any device legally marketed and manufactured in the U.S. can be exported without notification to the agency.
OIG: CMS should act to recover payments for device credits
The Office of Inspector General (OIG) at the U.S. Department of Health and Human Services said an audit of outpatient hospital claims billed to the Medicare program for calendar years 2016-2018 demonstrated that the Centers for Medicare & Medicaid Services (CMS) failed to ensure that claim amounts were adjusted to account for medical device credits. OIG noted that Medicare regulations require that hospitals and ambulatory surgical centers (ASCs) report the occurrence of credits received from manufacturers for any devices that are replaced, which can be either half the cost or the entire cost of the device, depending on the circumstances. The audit captured more than 4,600 outpatient claims, which included payments of more than $56 million, in which a device credit and a device offset amount were included. Based on the results of the audit, OIG said the CMS may have overpaid hospitals and ASCs by as much as $35.4 million for the three surveyed years. The CMS did not agree with the OIG recommendation to work with Medicare administrative contractors to recover the overpayments but acknowledged that did not codify changes to the associated billing practices in its regulations.