This week in Washington: Congress remains in a district work period, while COVID-19 legislative talks continue.
E&C Democrats Ask if FDA Chief Hahn is Avoiding Political Pressure From Trump Administration
On Aug. 24, House Energy and Commerce Chair Frank Pallone (D-NJ), Health subcommittee Chair Anna Eshoo (D-CA) and Oversight subcommittee Chair Diana DeGette (D-CO) wrote to Food and Drug Administration (FDA) Chief Stephen Hahn concerned that the Trump administration is putting political pressure on the FDA. The members asked Hahn how he is protecting the FDA’s credibility and wanted to ensure the FDA adheres to rigorous safety and efficacy data standards for any future COVID-19 vaccine authorization or approval. Find the letter here.
FDA Will Hold COVID-19 Vaccine Advisory Committee Meeting Oct. 22
On Aug. 27, the Food and Drug Administration (FDA) will hold an advisory committee meeting on Oct. 22, 2020, to discuss general COVID-19 vaccine development and emergency use authorization (EUA) or licensure policies. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will not discuss any specific application.
FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
On Aug. 26, the Food and Drug Administration (FDA) issued its first emergency use authorization (EUA) to a COVID-19 antigen test where the results can be read directly from the testing card. The FDA said the test can be made broadly available in point-of-care settings, such as doctors’ offices, emergency rooms and some schools. The test, Abbott Diagnostics’ BinaxNOW COVID-19 Ag Card, will cost $5, and the manufacturer plans to have 50 million tests available per month by the beginning of October. The Department of Health and Human Services (HHS) awarded a $760 million contract to Abbott Diagnostics to produce and deploy 150 million of the BinaxNOW tests. Find the EUA here.
FDA Issues EUA for Use of Convalescent Plasma in COVID-19 Patients
On Aug. 23, the Food and Drug Administration (FDA) Chief Stephen Hahn announced that the FDA granted emergency use authorization (EUA) to convalescent plasma for use as a COVID-19 therapy. Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA were met.
CMS Pushes Back By a Year Timeline for Finishing Stark Law Reforms
On Aug. 26, the Center for Medicare and Medicaid Services (CMS) delayed by one year its timeframe for finalizing reforms to the physician self-referral rule, but the Department of Health and Human Services (HHS) Office of Inspector General did not mention a similar extension for pending reforms to the anti-kickback statute. While CMS’s rule continues to be reviewed by the Office of Management and Budget (OMB), CMS announced it is continuously working to finalize the physician self-referral changes, even as the new extension says that the complexity of the issue kept CMS from meeting its prior deadline.
CMS: Nursing Homes in COVID-19 Hotspots Must Test Staff Twice a Week
On Aug. 26, the Center for Medicare and Medicaid Services (CMS) issued a memo for nursing homes on how often to test their staff for COVID-19 based on community spread. This memo follows the final interim rule released this week that required nursing homes to immediately test staff or face fines. The memo said that nursing homes in areas with high COVID-19 positivity rates must test staff twice a week. The memo explained that nursing homes should first test staff with symptoms and then test the rest of the staff when there is an outbreak. During an outbreak, testing must be done for all staff, even if they previously tested negative, until no new cases are identified.
DOJ Seeks Data on Governors’ COVID-19 Nursing Home Policies
On Aug. 26, the Department of Justice (DOJ) issued a press release asking Democratic governors of New York, New Jersey, Pennsylvania and Michigan for information on how COVID-19 affected public nursing home residents. The press release mentioned that the DOJ might open investigations under the Civil Rights of Institutionalized Persons Act, arguing that the governors required nursing homes to admit COVID-19 patients to their vulnerable populations, without adequate testing.
Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.