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Friend–
We are on the road to recovery but there is still much work that needs to be done. I wanted to share with you some of the more positive news that reflects the strides our nation and the Commonwealth have been making in the health and economic response to the Coronavirus.
I will continue to call on my colleagues in Congress, as well as work with members of federal and state agencies, to ensure that we are on track for recovery when that time comes. We must continue to practice safe social distancing measures as directed by medical professionals until guidance determines it safe to do otherwise in order to stop the spread of this deadly virus. The time will come when life will once again return to normal, but we must stay united in our fight against COVID-19 and see it through to the end.
Testing
- Over 5.1 million tests have been performed across America. That is more tests than any other country in the world.
- One month ago, the United States had only conducted 80,000 tests in total. The Administration continues to work with the nation's governors to increase testing further.
- Last week, the FDA issued an Emergency Authorization Use for the first test that can be completed at-home by the patient. On Friday, FDA Commissioner Stephen Hahn said that the Administration has quickly reviewed and authorized 63 tests - both diagnostic and serologic - and they are working with more than 400 test developers who are pursuing authorization for their diagnostics.
- NIH began a Shark-Tank style challenge to speed up innovation in coronavirus tests. The RADx (Rapid Acceleration of Diagnostics) initiative offers scientists and investors working on diagnostic testing a share of a $500 million pool, funded by recent Congressional appropriations. Entrants in the pool will be paired with manufacturers and business experts to speed production of tests.
- Several national retailers, including CVS Health, Kroger Health, Walmart, Walgreens, announced they would significantly expand coronavirus testing efforts in May.
- On Monday, the Centers for Disease Control and Prevention broadened its priority for testing, adding symptomatic first responders and people in long term-care facilities, prisons and shelters to the top tier. The priority list for the first time includes people without symptoms at a clinician or public-health authority’s discretion.
- To date, FDA has authorized 50 test kit manufacturers and laboratories.
Treatments
- Preliminary results from an NIH study show Gilead’s drug remdisivir could shorten recovery time for coronavirus patients by 31 percent. Gilead also released results from another trial that showed that patients could be effectively treated with fewer doses of the drug. This could expand the number of patients who could be treated with Gilead’s existing supply of the drug and reduce the number of days that patients will need to receive treatment.
- Regeneron Pharmaceuticals Inc. and Sanofi SA said their rheumatoid arthritis drug Kevzara may only work for the sickest COVID-19 patients following the results of a study on the drug as a potential treatment. Regeneron is actively developing drugs specific to COVID-19 after their success with a drug to treat Ebola.
- FDA’s Coronavirus Treatment Acceleration Program (CTAP) has 72 therapies being tested and another 211 are in active planning for clinical trials.
Vaccines
- The Trump administration is working on a program called "Operation Warp Speed" that will consist of private drugmakers, government agencies and the military, all of which will aim to reduce the development time of a COVID-19 vaccine by as much as eight months. The program seeks to develop 300 million doses of a vaccine by January.
- FDA Commissioner Hahn said last Friday that 72 trials of therapeutics are underway in the United States under FDA oversight, and 211 are in the planning stages. This includes convalescent plasma, as well as antiviral therapies. He also said that two firms have been given FDA approval to authorize their vaccine trials.
- Moderna announced it has submitted an application to the FDA to move intoPhase 2 studies of its vaccine.
- Pfizer announced it will begin testing its vaccine in the US as early as next week.
- University of Oxford researchers have begun testing a COVID-19 vaccine in human volunteers. Around 1,110 people will take part in the trial, half receiving the vaccine and the other half receiving a widely available meningitis vaccine as a control.
- Sanofi CEO Paul Hudson said that one of the world’s challenges over the next year will be manufacturing enough of the eventual vaccine. He cited the Biomedical Advanced Research and Development Authority, a government agency in the U.S. that backs vaccine development, as the reason that the U.S. may be in a position to vaccinate first. There’s no similar coordination in Europe.
Provider Support
- Over $9 billion in payments went out automatically to providers that have 2018 costs reports on file with the Centers for Medicare & Medicaid Services via electronic deposit. Medicare providers who did not have cost reports on file will need to submit their revenue data, as this data is needed to calculate their payment from the $20 billion.
- Medicare providers’ total allocation (their payment from the initial $30 billion + their payment from the $20 billion) from the entire $50 billion general distribution is proportional to their 2018 net revenue.
As our nation continues down the road to recovery, we must remember that this is a marathon and not a sprint. I will continue to advocate for folks on the front lines in the battle against this virus and for folks who are combatting the effects of COVID-19 at home, at their necessary places of business, and throughout our nation.
Sincerely,
Rob
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