Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing.

The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic.

The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic. The term of the delays of compliance for several of these rules is not uniform, ranging from “late 2020” to “spring 2021,” and vendors thus will have to be vigilant to ensure they do not cross any compliance tripwires.

The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy.

The Trump administration has proposed a policy to gradually reopen the U.S. for business, part of which is to allow a resumption of elective procedures and treatments in outpatient settings. While patients with urgent medical needs presumably are being treated already, the policy would seem to promise a boost in volumes for certain devices, such as coronary artery stents, knee implants and transcatheter aortic valve replacement (TAVR) devices, all of which enjoy at least limited Medicare coverage for outpatient use.

The U.S. FDA’s routine guidance agenda may be badly disrupted by the COVID-19 outbreak, but the agency continues to pump out guidances and emergency use authorizations (EUAs) directed to the pandemic. While the FDA has included only one serological test under the diagnostic EUA paradigm, Rep. Diana DeGette penned a letter inquiring into when the agency intends to move more decisively on serological tests, arguing that the absence of action on this front endangers the nation’s economic health as well as the public’s health.

The U.S. capacity for SARS-CoV-2 testing is limited by several items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide 2 million reactions per week, a volume that should increase to 5 million per week in April.

The Office of the National Coordinator (ONC) and CMS both posted their final rules for electronic health records (EHRs), and analysts with Cowen Washington Research Group said both rules essentially replicate the draft versions. The provisions dealing with data blocking and interoperability are expected to benefit developers of HER systems in the near term, and telehealth should also benefit, albeit over a longer scale of time.

The Senate passed by a vote of 96-1 the spending bill for the outbreak of the new coronavirus (COVID-19), which will be on President Donald Trump’s desk by week’s end. The bill provides $7.8 billion in new funds to tackle the outbreak and another $490 million in existing funds for telehealth, all with the aim of speeding the response to the pathogen.

The March 4 congressional hearing on the budget for the NIH was peppered with questions about the COVID-19 outbreak, although the general sentiment is that the agency will receive yet another boost in appropriations in fiscal 2021.