The U.S. Court of Appeals for the Federal Circuit said the U.S. Patent Trial and Appeal Board did not err in determining that claims 1-20 of the 7,587,241 patent were unpatentable as obvious, handing a win to Nevro Corp., of Redwood City, Calif. Boston Scientific Neuromodulation Corp., of Valencia, Calif., had sued Nevro in 2017 in the U.S. Delaware District Court for infringement of the ’241 and a number of other patents in connection with Nevro’s Senza spinal cord stimulation system, although Nevro had filed suits against Boston Scientific over some of the related patents as well. Nevro had previously prevailed in a Federal Circuit decision dated April 9 in connection with a number of claims across several Nevro patents. Boston Scientific had challenged the outcome at PTAB, and the three Federal Circuit judges determined that all 20 contested claims in the BSX patent were obvious due to prior art.
The U.S. FDA said on May 19 that it has entered a collaboration agreement with Aetion Inc., of New York to develop advanced analytical techniques to answer urgent questions about the COVID-19 pandemic. The agency said the collaboration will seek to inform the use of diagnostics and medications, as well as clarify the risk factors for poor outcomes for those afflicted with the SARS-CoV-2 pathogen. The FDA said it has taken steps in recent years to make more use of real-world data to inform its regulatory work, but noted that the pandemic “has brought an urgency to these efforts,” and thus the collaboration with Aetion. The statement points to the FDA’s participation in other such efforts, such as the COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation in conjunction with the Friends of Cancer Research. The FDA said also that it is engaged with a few other stakeholders, including industrial interests and patient groups, “to harness the power of data during this emergency.”
Several members of the U.S. Senate have voiced their support for the Right to Test Act of 2020, which would give states more leeway to approve and distribute diagnostic tests when a federally declared state of emergency is in effect. The bill, written by Sen. Ted Cruz (R-Texas), is co-sponsored by three other GOP senators, including Mike Lee (Utah), and applies to labs and hospitals certified under the Clinical Laboratory Improvement Amendments of 1988. The bill specially calls out suspension of FDA authority for enforcement so long as distribution of the test does not cross state lines, although the FDA could resume enforcement 180 days after the public state of emergency has expired.
U.S. Rep. Michael Burgess (R-Texas) said the Advancing 3D Printing Act of 2020 would require the Consumer Product Safety Commission (CPSC) to undertake a study of the nation’s additive manufacturing industry with an eye toward actions the federal government could take to foster 3D manufacturing and innovation. Burgess said that one lesson to be taken away from the pandemic is “that we cannot wait for other nations, namely China, to gain advantage in emerging technology industries.”
Two members of the U.S. House of Representatives have announced legislation that would create a competition for development of at-home testing for the SARS-CoV-2 virus. Reps. Don Beyer (D-Va.) and Anthony Gonzalez (R-Ohio) said the At-Home Testing Prize Competitions Act would direct two U.S. federal government agencies to “quickly launch prize competitions” to develop tests that can be reliable used by “ordinary people in their homes.” The bill stipulates that the test turn around results in 30 minutes or less, but does not stipulate a funding amount.
The U.S. Centers for Medicare and Medicaid Services (CMS) said in a May 19 bulletin that rates for the CDC molecular test for the SARS-CoV-2 virus under HCPCS code U0001 will be either $35.91 or $35.92, depending on the Medicare administrative contractor (MAC). Lab diagnostics practicing a non-CDC test will receive $51.31 across all MACs, the same rate as is paid under CTP 87635, again for all MACs. Two codes created for serology tests (CPT codes 86769 and 86328) will be paid $42.13 and $45.23, respectively. Julie Khani, president of the American Clinical Laboratory Association said in a May 19 statement, “we applaud CMS’ release of a Medicare reimbursement rate that will encourage a broad cross section of laboratories to rapidly scale up capacity for accurate and reliable serological testing” for the pandemic. Khani also said low rates had been an impediment for many labs to test in the pandemic.
The U.S. Department of Health and Human Services issued an advisory opinion regarding the authorization of pharmacists to order and administer tests for the SARS-CoV-2 virus during the pandemic. The opinion states that the public health emergency preempts any state and local law or regulation that prohibits or impedes a pharmacist from ordering and administering such a diagnostic test that has been authorized by the FDA. The National Community Pharmacists Association said in a May 20 statement that the new guidance “demonstrates that pharmacists should be able to order and provide” the tests, adding that the 21,000 independent pharmacists in the U.S. can, as a consequence of the opinion, “make an even bigger contribution to the war against COVID-19.”