(Reuters)—U.S. drugmakers Eli Lilly and Co. and Bristol Myers Squibb said they are delaying the start of new clinical trials in part to free up doctors and healthcare facilities to deal with the surge in patients infected with the new coronavirus. Lilly and Bristol are the biggest drugmakers yet to announce clinical trial delays in…
Roche Gets FDA Nod for Trial to Test Arthritis Drug on COVID-19 Patients
March 23 (Reuters)—Roche Holding AG said on Monday it has received the U.S. Food and Drug Administration‘s clearance to test its rheumatoid arthritis treatment on patients hospitalized with severe pneumonia caused by the coronavirus. The company said it was beginning a late-stage study to test the drug in what would be the first well-controlled study…
ACR Urges Commercial Payers to Provide Relief from Prior Authorizations, Practice Disruptions
The ACR is urging insurance companies to expand access to telehealth services and provide relief from administrative burdens to help providers focus on patient care at this critical time.
ACR Advocates Against Payer Mandates on Specialty Pharmacy Acquisition of In-Office Treatments
In partnership with rheumatology and other specialty organizations, the ACR is working against payer and employer policies that mandate specialty pharmacy acquisition of in-office treatments.
Sarilumab Investigated to Treat COVID-19
A study investigating sarilumab’s effects on patients with COVID-19 has begun in New York. The treatment blocks IL-6, which may play a role in the respiratory distress caused by the virus…
2019 MIPS Deadline Extension & Policy Update
CMS has extended the deadline for 2019 MIPS submission to 8 p.m. EDT on April 30, 2020.
Enemy at the Gates: The Emerging Threat of COVID-19
On Dec. 30, 2019, an ophthalmologist named Li Wenliang notified his colleagues about an illness that was reminiscent of severe acute respiratory syndrome (SARS) in a city in the Hubei province of China called Wuhan. As an ophthalmologist, this was not directly relevant to his practice; he merely wanted to warn colleagues that they might…
Regeneron Plans Early Summer Trials for New Antibodies Against Coronavirus
(Reuters)—Regeneron Pharmaceuticals Inc. said on Tuesday it had identified hundreds of antibodies that could treat or prevent the coronavirus (COVID-19) and was preparing to begin clinical trials by early summer, sending the drugmaker’s shares up 12%. The company will select the top two antibodies to develop a “cocktail” treatment and scale up its manufacturing to…
HHS Relaxes HIPAA Enforcement
Effective immediately, the HHS Office for Civil Rights (OCR) has stated it will not impose any noncompliance penalties under the Health Insurance Portability and Accountability Act (HIPAA) on physicians using any non-public facing service or audio or video communication technology (e.g., Apple FaceTime, Skype, Facebook Messenger, etc.) for telehealth services. This discretion applies to telehealth…
CMS Relaxes Telehealth Restrictions
President Trump announced that CMS will broaden access to telehealth services during the COVID-19 pandemic. The CMS published a fact sheet outlining the types of visits that will be covered, the providers eligible to use the expanded services and coding considerations. The ACR is working with other specialty societies and the AMA to provide additional…