The U.S. FDA posted an enforcement policy for telethermographic systems for the COVID-19 pandemic, which would be used for screening by checking body temperatures. The agency noted that not all telethermographic systems are marketed as medical devices, and that the scope of the policy is principally restricted to such systems marketed as FDA-regulated products. The policy includes performance standards that such systems must meet, including the 2017 edition of IEC 80601-2-59 for safety and performance. Manufacturers of units not previously labeled for medical use may offer their products for screening purposes if the performance of any such systems is checked against secondary methods, such as noncontact infrared thermometers.
The U.S. Department of Justice (DoJ) said a medical equipment company located in California had conspired to pay kickbacks to physicians serving Medicare beneficiaries located in southern Georgia in exchange for orders of durable medical equipment that were billed to the Medicare program. The scheme was detected by U.S. Postal Service inspectors, and DoJ said Scott Hirsch, of J1 Medical Inc., is one of several defendants named in an investigation into a fraud said to have accounted for more than $410 million in fraudulent claims.
The U.S. Centers for Medicare and Medicaid Services posted the draft inpatient rehabilitation facility prospective payment schedule for fiscal 2021, which would allow nonphysician practitioners to perform any coverage service and documentation requirements. Currently, these services must be handled by physicians, the agency said, adding that it may drop the requirement that a postadmission evaluation be conducted within 24 hours of admission. This change is proposed because such evaluations provide much the same data that is obtained in preadmission screening and the development of a patient’s plan of care. The agency is seeking public comment on whether any one or more of four categories of procedures and services might meet the criteria for exclusion from consolidated billing, a list that includes customized prosthetic devices, chemotherapy items and administrative services, and radioisotope services. The agency is taking comment on the draft rule through June 15 at docket no. CMS-1729-P.
The European Parliament (EP) voted to postpone implementation of the Medical Device Regulations by one year via a 693-1 tally that drew two abstentions. The new implementation date will be May 26, 2021, assuming the member states move to affirm the change, which the EP said should be handled by the existing implementation date of May 26. The EP statement noted that the delay is due to the prospect that implementation would create device shortages at a time when the COVID-19 pandemic is exerting pressure on availability. BioWorld will report on this development in greater detail in an upcoming issue.