UPDATE: March 5, 2020: The Senate voted Thursday afternoon to approve the spending package, which now awaits President Donald Trump's signature.
- The U.S. House of Representatives approved an $8.3 billion funding bill Wednesday for ongoing efforts to respond to COVID-19, with 11 deaths related to the disease reported as of Thursday morning. The Senate is scheduled to vote on the legislation Thursday with approval likely and President Donald Trump is expected to sign it into law before the end of the week.
- The package allocates about $6.5 billion to HHS, including to the Centers for Disease Control and Prevention to help local and state governments with testing and containment efforts, and $3.1 billion for medical supplies like masks as well as research into treatments and vaccines. Some of the $836 million to the National Institutes of Health is marked for training "to prevent and reduce exposure of hospital employees" and others at risk of exposure through work duties.
- Meanwhile Wednesday, lab testing companies including LabCorp, Quest Diagnostics and Thermo Fisher met with Trump administration officials who encouraged them to ramp up efforts regarding the novel coronavirus.
On the testing front, Vice President Mike Pence, who is currently leading the administration's response effort, said 2,500 kits with more than 1.5 million tests are now available to hospitals that have requested them. Earlier this week, CDC adjusted guidance to say patients need only their doctor's approval to be tested.
Pence said the objective is to make sure the tests are broadly available to the American public. "We want to make sure the American people can go to their doctor, can go to the local MedCheck or CVS, and obtain access to coronavirus" tests, he said.
From the clinical lab industry's perspective, key challenges remain meeting demand for COVID-19 testing while maintaining normal diagnostic operations, needing clearer guidelines on how to prioritize who to test now that CDC has greatly widened test criteria, and needing better recommendations on how to properly transport specimens and protect lab workers, according to a statement following the meeting from the American Clinical Laboratory Association (ACLA).
In the statement, issued the same day as ACLA's annual meeting, President Julie Khani also urged FDA to OK emergency use authorizations “for as many test platforms and instruments as possible."
At ACLA's meeting FDA Commissioner Stephen Hahn said in prepared remarks that despite recent development increasing test access and capacity, "we strongly encourage additional developers in this space."
"I understand and can empathize with laboratories within academic medical centers who have tight budgets and perhaps don’t always have the funds they need," Hahn also said. "To this end, I call on the larger institutions to give the laboratories operating within their walls the financial support they need to work within an appropriate framework of regulatory oversight."
Following the White House meeting, Quest Diagnostics said Thursday morning it will launch a COVID-19 test service, with plans to begin receiving specimens and carrying out testing on March 9.
The funding legislation provides the FDA with $61 million to facilitate the development and review, both pre-market and post-market, of medical countermeasures, devices, therapies, and vaccines to combat the coronavirus.
The bill also grants HHS the authority to temporarily waive or modify certain Medicare requirements like geography and site origination for telehealth services provided during the emergency period, an adjustment providers had requested.
Hospitals will be disappointed the legislation does not address provider reimbursement for treatment of coronavirus patients who are uninsured. The American Hospital Association on Tuesday called for HHS to consider using a national disaster program for such treatment. It generally pays providers at 110% of Medicare rates.
Still, hospitals applauded the funding. The Federation of American Hospitals said the bill provides essential assistance to those on the front lines.
"Hospitals are often the first line of defense in local communities across the country," FAH CEO Chip Kahn said in a statement. "Our patients depend on us and this funding will help us with 'job one,' providing critical health care to our patients and assisting in keeping Americans healthy and safe."
Hospitals throughout the country have been scrambling to prepare isolation areas and stock up on personal protective equipment like masks and gloves as the virus continues to spread. HHS said Wednesday it plans to buy 500 million N95 masks over the next 18 months for the Strategic National Stockpile. Pence is slated to visit mask manufacturer 3M in Minnesota on Thursday.
Earlier this week, FDA granted a CDC request to allow healthcare personnel to use masks not regulated by the FDA for health settings during the emergency.
The amount in the funding bill making its way through Congress dwarfs the original White House request of $2.5 billion from last week. The number of coronavirus cases internationally and in the U.S. has continued to increase, with more than 95,000 confirmed globally. Several recent U.S. cases have indicated community spread, including in major metropolitan areas like Seattle and New York City.
The loosened restrictions for telehealth reimbursement will be welcome news to those pushing for more virtual visits to keep potentially infected people from spreading the virus.
"While it's unclear how the new funding from Congress will flow to telemedicine companies like Teladoc and privately-held American Well, we view it as an incremental positive and is in line with our thesis on the growth of telemedicine as a standard of care," Cowen analysts wrote.
American Well on Wednesday said it is launching a COVID-19 telehealth response program. The company is putting an infection control officer on call at all times, has created a readiness team specific to the disease and is implementing workflows designated for its treatment.
"Not only can telehealth greatly minimize the demands on in-person primary care, urgent care, and emergency departments across the country; it can also reduce unnecessary risk to patients and care teams from further exposure to this highly infectious virus," American Well CMO Peter Antall said in a press release.
Also Wednesday, CMS provided additional guidance for providers as they face more cases of COVID-19 and attempt to limit infection. The agency said that until further notice, facility infections will be focused exclusively on infection control issues along with immediate jeopardy complaints.
The funding bill provides more than $2 billion for the Biomedical Advanced Research and Development Authority for vaccine development and requires that vaccines, therapeutics or diagnostics developed using taxpayer money be "available for purchase by the Federal government at a fair and reasonable price" and also allows the HHS secretary to ensure those products would be "affordable in the commercial market."
Multiple pharmaceutical companies have announced COVID-19 vaccine developments are underway, including Takeda and Moderna as well as Johnson & Johnson and Sanofi, which are partnering with BARDA for their efforts. While the pharmas say they will move as quickly as possible, experts say a realistic development process puts a widely available vaccine at least a year away.