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April 21, 2020

CMS wants to give clinicians credit for participating in Covid-19 clinical trials. Here's how.

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    CMS on Monday announced that clinicians who participate in the Quality Payment Program's Merit-based Incentive Payment System (MIPS) can receive credit for participating in clinical trials testing potential Covid-19 treatments by reporting the activity and their findings through clinical data registries or repositories.

    Your Covid-19 checklist to expand capacity

    US Covid-19 cases surpass 780K, death toll tops 37K

    The announcement comes as the number of reported cases of Covid-19, the disease caused by the new coronavirus, and related deaths in the United States continues to grow. As of Tuesday morning, U.S. officials had reported 780,536 cases of Covid-19 in the country—up from 753,317 cases as of Monday morning.

    Officials as of Tuesday morning also had reported 37,818 U.S. deaths linked to the new coronavirus—up from 36,109 deaths reported as of Monday morning.

    CMS creates MIPS measure for reporting Covid-19 clinical trials

    To encourage clinicians to report data on potential Covid-19 treatments, CMS on Monday said clinicians who participate in MIPS can receive substantial credit toward their MIPS scores for being involved in a clinical trial testing a possible treatment for Covid-19 and reporting their findings to CMS.

    To receive the credit, clinicians must confirm their involvement in a clinical trial for a prospective biologic or drug to treat Covid-19 and report their findings through either a clinical data registry or repository, such as Oracle's Covid-19 Therapeutic Learning System, during the trial, CMS said. The agency said qualifying clinical trials can include an NIH study and traditional double-blind placebo-controlled trials, as well as adaptive-design trials that flex clinical and work practices.

    CMS said clinicians who participate in a qualifying clinical trial and report the activity and associated findings will automatically receive "half of the total credit needed to earn a maximum score in the MIPS improvement activities performance category, which counts as 15% of the MIPS final score."

    CMS Administrator Seema Verma said, "The best scientific and medical minds in the world are working night and day to find treatments to combat [the new coronavirus]. But without solid data, their efforts are liable to run up against a brick wall.."

    Trump admin, Congress near agreement on a 4th stimulus package with $75B for providers

    Also on Monday, the Trump administration and federal lawmakers neared an agreement on a fourth legislative package intended to stimulate the economy and help Americans, health care providers, and businesses grappling with the United States' coronavirus epidemic.

    Under the agreement, the nearly $500 billion measure would include $370 billion in funding for small businesses, $75 billion in funding for hospitals and health care providers, and $25 billion in funding to support efforts to expand testing for the new coronavirus.

    However, the administration and congressional leaders have yet to finalize details on a testing strategy supported by Democratic lawmakers that would put the federal government in charge of dividing the testing funding and supplies equitably, a Democratic aide said Monday.

    Department of the Treasury Secretary Steven Mnuchin and other administration officials have indicated they would prefer a "state-driven approach and flexibility," according to senior administration officials who spoke with the Washington Post on the condition of anonymity. President Trump in a tweet posted Monday wrote, "States, not the [f]ederal [g]overnment, should be doing the [t]esting[.] But [the administration] will work with the [g]overnors and get it done."

    Senate Majority Leader Mitch McConnell (R-Ky.) said the Senate will convene Tuesday afternoon with the goal of passing a final version of the legislative package. If the Senate approves the bill on Tuesday, the House could vote on the measure as early as Thursday, House Majority Leader Steny Hoyer (D-Md.) said.

    Trump to 'temporarily suspend' legal immigration in effort to prevent coronavirus' spread

    Separately, Trump in another tweet posted Monday announced that he intends to sign an executive order "to temporarily suspend immigration into the United States" in an effort to prevent the new coronavirus' spread.

    Under the order, the administration would temporarily stop approving applications from immigrants to live and work in the United States, which would effectively shut down the country's legal immigration system, the New York Times reports. The order would remain in place for an undetermined amount of time.

    Two White House officials told the Post that Trump could sign the executive order as soon as Tuesday (King, FierceHealthcare, 4/20; Modern Healthcare, 4/20; CMS release, 4/20; Werner, Washington Post, 4/21; Duehren, Wall Street Journal, 4/20; Miroff et al., Washington Post, 4/21; Rogers et al., New York Times, 4/21; Associated Press, 4/21; New York Times, 4/21).

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