The American Clinical Laboratory Association (ACLA) said member labs have borne witness to “a steady increase” in the volume of orders for testing for the COVID-19 pandemic in recent weeks, but that the volume of orders is expected to jump significantly in the weeks ahead. ACLA President Julie Khani said member labs expanded their testing volumes between early April and June 27, from roughly 100,000 tests per day to triple that amount. Khani said, “the reality of this ongoing global pandemic is that testing supplies are limited,” and that ACLA is “in active conversations with the administration and supply partners about ways to address” the resurgent strain on supply chains.
The U.S. Centers for Medicare and Medicaid Services said the update for the calendar year 2021 home health fee schedule will make permanent an expanded coverage for telehealth initially undertaken in response to the COVID-19 pandemic. The agency said the coverage change assumes the telecommunication technology is related to the skilled services being furnished and is outlined in the patient’s plan of care. Such telehealth encounters cannot be used to substitute for an in-person home visit that is part of the patient’s plan of care, however.
Reps. Mikie Sherrill (D-N.J.) and Kevin Hern (R-Okla.) announced the Protect Telehealth Access Act of 2020, which the duo said removes the requirement that a beneficiary receiving telehealth services must be located in a rural area or an area designated as a health professional shortage area. Sherrill said, “we’ve seen the benefits of expanded telehealth services during the COVID-19 pandemic and the importance of making sure access to care is available if patients have to stay at home,” adding, “that value won’t go away when the pandemic ends. I’m working with Representative Hern to ensure Medicare beneficiaries do not lose access to these important services.” Hern said Americans became reliant on telehealth “almost overnight” earlier this year, adding that such services “will be necessary long after coronavirus is neutralized.” He said coverage for telehealth is “a bipartisan priority.”
The Medical Imaging & Technology Alliance (MITA) said in a June 29 statement that it had sent a letter to the FDA alleging that I-Fixit, of San Luis Obispo, Calif., has posted proprietary service manuals for use by unregulated service providers. MITA executive director Patrick Hope said the uncontrolled release of the manuals to service providers that lack compliance systems “raises the risk of improper servicing of medical devices.” MITA did not request that the FDA take action against I-Fixit, but urged the agency to “take immediate action to implement consistent quality, safety and regulatory requirements” for all entities that service medical imaging equipment.
Palmetto GBA, of Columbia, S.C., said it has extended the comment period for the draft local coverage determination (dLCD) for liquid biopsies for organ transplant. DL38568 was originally posted with a comment period closing date of June 3, but Palmetto extended the comment period through July 7 to allow stakeholders more time to comment, given the COVID-19 pandemic.
A group of more than 300 organizations have petitioned leaders in the U.S. Congress to make permanent the recent changes to telehealth service coverage in the Medicare program that were the consequence of the COVID-19 pandemic. The petition requests that Congress take action to remove restrictions regarding the geographic location of the patient, and to ensure that federally funded health centers and rural health clinics can continue to provide telehealth services once the federal government lifts the public health emergency. The petitioners also requested that Congress empower the Department of Health and Human Services to provide a waiver for telehealth for future emergencies.