HealthCare Roundtable e-News – May 13, 2020

U.S. House Reveals Details of Latest $3T Coronavirus Relief Plan

On Tuesday (May 12), House Democrats unveiled the text of the latest economic rescue plan including the latest priorities supporting pandemic relief. The “Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act” will provide states and local governments nearly $1 trillion that could be used to replace drastic revenue shortfalls. It would also provide another round of $1,200 direct payments to Americans.

President Trump and other members of the GOP have opposed the latest bill, claiming that there hasn’t been enough time since the $2 trillion CARES Act, H.R. 748 (116), passed to determine whether new legislation is needed or necessary. House Speaker Nancy Pelosi (D-Calif.) and other top Democrats have argued that a 14.7 percent unemployment rate justifies the need for Congress to “think big” in its response to the pandemic, despite criticism from progressives that the bill does not go far enough. Some have urged fellow lawmakers to add drug price provisions to the bill as patients across the country continue to be ravaged by test and treatment fees.

The bill follows four previous bills that have expanded the federal deficit to nearly $4 trillion this year, the Congressional Budget Office projects. Senate Majority Leader Mitch McConnell (R-Ky.) has said the party is still “assessing what we’ve done already,” while raising concerns about the toll on the federal debt and focusing on designing liability protections for businesses as states look to reopen their economies in the coming weeks.

Ways & Means Chair Neal Asks CMS to Slow Reopenings of Facilities for Non-Emergency Health Services

Last week, House Ways & Means Committee Chair Richard Neal (D-Mass.) issued a letter calling on CMS to slow the reopening of health care facilities across the country to non-emergency services and to consider employee and patient safety and well-being when issuing recommendations on reopening. Neal asks in the letter that CMS, “not to move forward with promoting the delivery of comprehensive health care services until your agency reinstates the recently waived patient and staff safety standards and frontline workers are assured the necessary personal protective equipment (PPE) and testing to minimize risk.”

The letter comes as Neal and other lawmakers have cautioned that CMS’ directive on health institutions, released last month, reopening facilities for non-COVID-19 care. The Committee Chair warned that the U.S. has not conducted enough COVID-19 testing nationwide to justify reopening health systems for non-emergency care. (InsideHealthPolicy)

CMS’ directive for reopening the facilities for non-emergency services includes requirements that they meet certain gating criteria in their region, including a 14-day reduction of regional cases reported. Neal recommended that the agency also consider additional requirements that all health facilities test all incoming patients, have enough personal protective equipment for all staff and patients, and prove they can care for elective surgery patients and COVID-19 patients “without resorting to crisis standards of care.”

Trump Continues to Side with Plaintiffs in ACA SCOTUS Case, Supports Scrapping Law

Last week, President Trump confirmed that the administration would be “staying with Texas” in a high-profile court case against the Affordable Care Act, formerly known as United States vs. Texas but is now California vs. Texas. The president made the statement the same day that the coalition of Democrat attorneys general filed opening briefs with the Supreme Court reiterating their arguments that the GOP coalition, led by the Texas attorney general, lacked standing and that even if justices find the individual mandate illegal, that the remainder of the law is clearly severable and can remain. Texas leads 18 GOP states arguing that the law is unconstitutional because a 2017 tax bill abolished its individual mandate.

Republicans in the case argued that, since Congress had zeroed out the ACA’s penalty for not having coverage, the remaining part of the provision that says Americans shall purchase insurance is no longer valid.In their briefs, the coalition of Democrat attorneys general from California claimed, “those arguments have no basis in law or in congressional intent…This Court should decline respondents’ invitation to impose a breathtakingly broad national policy change under the guise of constitutional adjudication.” (InsideHealthPolicy)

The case has become even more significant in recent months as millions of unemployed Americans are without healthcare due to impacts from the coronavirus crisis. As unemployment numbers increase, up to 43 million people could lose their employer-sponsored insurance, according to one estimate from the Robert Wood Johnson Foundation, raising the demand for ACA exchange and Medicaid coverage.

FDA Receives Praise for First Coronavirus Antigen Test Approval

Last week, Trump administration officials shared their praise for the work the FDA has been doing to fast-track trials for potentially life-saving drugs in the fight against the novel coronavirus. The FDA has been more active in authorizing COVID-19 treatment and vaccination tests, including the latest Emergency Use Authorization (EUA) of the first COVID-19 antigen test, which can provide rapid results faster than the traditional and complex nucleic acid tests that have come to market so far during the COVID-19 pandemic.

Quidel Corporation’s Sofia 2 SARS Antigen Fluorescent Immunoassay test, which was granted EUA by the FDA on Saturday (May 9), is approved for use in point-of-care settings and in high- and moderate-complexity labs. The White House confirmed that it expects Quidel to put 300,000 of its antigen tests on the market within the next couple of weeks.

During a press call last week, one senior official noted that the FDA, “has done a fantastic job in authorizing new tests. There have been 79 diagnostic tests that have been authorized on 25 different testing devices. Now many of these diagnostic tests are ones that are performed in the laboratory.” (InsideHealthPolicy)