HealthCare Roundtable e-News – August 11, 2020

White House Takes Executive Action as COVID-19 Relief Package Talks Stall

Last week, White House officials and Democrat Congressional leaders met several times to negotiate policies in the latest coronavirus relief package. Both sides appeared to be in a deadlock after a three-hour meeting in the office of the House Speaker Nancy Pelosi (D-Calif.), where the Speaker and Senate Minority Leader Chuck Schumer (D-N.Y.) had been pushing for a relief package costing more than $3 trillion. Democrats had blamed the White House for failing to reach a bipartisan agreement and opting to keep the price tag closer to $1 trillion.

Treasury Secretary Steven Mnuchin and White House chief of staff Mark Meadows have claimed that the Democrats have been unreasonable in the negotiations, after the officials offered to resume federal unemployment benefits at $400 per week for four months, as well as providing $200 billion to state and local governments, among other concessions. But the Democrats have rejected the proposals, claiming that the offers do not adequately address the fallout from the coronavirus pandemic.

After rejecting House Democrat’s’ proposal and opting to take executive action if negotiations between the leaders failed, the president issued executive orders on Friday (Aug. 7) to extend COVID-19 relief, including enhanced unemployment benefits, protections from the federal eviction moratorium, a payroll tax holiday and further suspension of federal student loan payments. Experts are skeptical of the value in the executive orders, noting that many of the items covered in the orders can only be put to action through legislation. There is currently no insight into how states will cover the additional costs. Schumer told the press that the orders “will leave most people out, will not cover the broad expanse of what’s needed, will be litigated in court and be awkward and difficult to implement.”

Trump Signs Executive Order Directing FDA, EPA to Speed Approvals and Ease Regulations

Last Thursday (Aug. 6), President Trump signed an executive order directing the FDA to work closely with the Environmental Protection Agency (EPA) to speed domestic approvals of essential medical products, loosen continuous manufacturing regulations, identify supply chain vulnerability, and target dangerous counterfeit drug and medical product imports.

The order, titled “Combating Public Health Emergency and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs are Made in the United States,” is part of a larger administration initiative to bring the medical supply chain back to the United States and help the country become less reliant on other foreign entities. (InsideHealthPolicy)

White House trade and manufacturing chief Peter Navarro told the media during a press conference that the administration is seeking to determine a “more rational and streamlined regulatory process,” commenting that FDA and EPA have rules that disadvantage domestic manufacturers. Navarro claimed that the order will help to ensure a process that’s “consistent with rapid response to the pandemic.” (InsideHealthPolicy)

But not all industry leaders agree that the order will streamline processes. Steve Ubl, head of industry trade group PhRMA, responded to the orders claiming the president’s plan “creates even more barriers to ongoing biopharmaceutical manufacturing and innovation.” Ubl commented that many companies are working “around the clock” to deliver solutions to the pandemic, but each new executive order “adds another roadblock, making it harder to fight.”

Trump Health Officials Say FDA Will Uphold Safety Standards for COVID-19 Vaccines

While Trump administration health officials have sought out to address concerns that the federal government will lower its drug approval standards to obtain a COVID-19 vaccine, the administration appears to be sending mixed messages. FDA chief Stephen Hahn published an op-ed in the Washington Post on Wednesday evening (Aug. 5) detailing the standards the government is adhering to ensure the safety and effectiveness of any potential COVID-19 vaccine, coincidentally the day before the President Trump signed a “Buy American” executive order (see above) that directs the FDA and EPA to jointly speed domestic approvals of drugs and ease regulations. (InsideHealthPolicy)

“To prepare for the completion of tests and data submission, our agency has announced that any authorized or approved covid-19 vaccine would need to show that it prevents the disease or decreases its severity in at least 50 percent of people who are vaccinated. This is a reasonable standard given the nature and impact of the pandemic,” Hanh noted in the article.

Congressional leaders and public health experts have expressed concerns that the White House is putting a significant amount of pressure on the agency, particularly since the FDA has granted emergency use authorization of hydroxychloroquine in March, which was touted by President Donald Trump as a “game changer.” Critics said the EUA had been granted based on insufficient data. (InsideHealthPolicy)

Some have been turned off by the name of the administration’s vaccine and therapeutics partnership between HHS and the department of defense, Operation Warp Speed, which National Institute of Allergy and Infectious Diseases Director Anthony Fauci, confirmed makes many in the industry think of reckless speed. But according to the director, the FDA is not cutting corners.

Insurers’ Earnings Indicate Medicaid, Obamacare Utilization Normalized in Q2

Health insurers Anthem, Molina Health and Centene shared with investors recently that utilization of Medicaid managed care and Affordable Care Act plans had returned to 90% of normal by June after massive declines earlier in the quarter. While there are signs that usage dipped again in July as the pandemic surged, the insurers still expect health care usage will return to or rise above baseline by the end of year.

The insurers have continued to stress that the dynamics are changing daily as the pandemic evolves and the outbreak projections vary from what insurers expect over the course of every few weeks. Each had proposed an increased Medicaid federal match would be helpful in taking the pressure off of their states as they negotiate Medicaid managed care rates. (InsideHealthPolicy)

Centene CEO Michael Neidorff offered one prediction on possible outcomes of another COVID-19 pandemic relief package. The chief anticipates the package will include unemployment benefits, a stimulus check, and an extension of eviction protections which, in total, will likely cost somewhere between $1.5 trillion and $2 trillion. (InsideHealthPolicy)