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October 29, 2020

Why the prospects are fading for approving a coronavirus vaccine in 2020

Daily Briefing

    The Trump administration on Wednesday announced a new interim rule that seeks to have CMS and private insurers cover the costs of a potential vaccine against the novel coronavirus for many Americans—but the move comes amid new signs that it may still be a while before the United States has an authorized coronavirus vaccine.

    US new coronavirus cases top 8.9M, deaths surpass 227K

    The new interim rule comes as U.S. officials on Wednesday reported about 81,457 new cases of the novel coronavirus, bringing the total number of coronavirus cases reported in the country since the epidemic began to 8,932,900 as of Thursday morning—up from about 8,851,500 cases reported as of Wednesday morning.

    According to the New York Times, the United States' average daily number of newly reported coronavirus cases over the past week was 75,561—which is up by 41% when compared with the average from two weeks ago.

    As of Thursday morning, data from the Times showed that the rates of newly reported coronavirus cases were "staying high" in Guam, Puerto Rico, and 37 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alabama, Alaska, Arkansas, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, West Virginia, Wisconsin, and Wyoming.

    Eight states that have had comparatively low case rates were seeing those rates "going up" as of Thursday morning, according to the Times. Those states are Arizona, California, Louisiana, Maine, Maryland, New Hampshire, New York, and Vermont.

    In the seven remaining U.S. states and territories, rates of newly reported coronavirus cases were "staying low" as of Thursday morning, according to the Times' analysis.

    U.S. officials on Wednesday also reported about 1,016 new deaths linked to the novel coronavirus, bringing the total number of reported U.S. deaths linked to the virus since the country's epidemic began to 227,697 as of Thursday morning—up from about 226,681 deaths reported as of Wednesday morning.

    CMS releases rule seeking to cover coronavirus vaccine costs for many Americans

    FDA has said it may authorize a coronavirus vaccine candidate for use in the United States via an emergency use authorization, which caused some observers to worry the costs of receiving a vaccine wouldn't be covered for many Americans, including Medicare beneficiaries. As the Wall Street Journal reports, although federal policymakers in March approved a coronavirus relief package that sought to ensure a coronavirus vaccine would be covered for most Americans, Medicare typically does not cover the costs of treatments authorized for emergency use.

    However, CMS on Wednesday released an interim rule intended to ensure that as many Americans as possible will have access to a coronavirus vaccine with no out-of-pocket costs once one is authorized for emergency use or fully approved by FDA.

    CMS said, under the interim rule, Medicare will cover the cost of a coronavirus vaccine as a preventive treatment for beneficiaries, so they will not face out-of-pocket costs for the inoculation. In addition, CMS said the rule—which takes effect immediately—implements requirements called for by the coronavirus relief package approved earlier this year that requires most Medicaid and private health plans to cover a coronavirus vaccine with no out-of-pocket costs for members during the federally declared Covid-19 public health emergency.

    CMS in the interim rule also set Medicare reimbursement rates for providers for administering coronavirus vaccines. Under the rule, the Medicare reimbursement rate for administering a single-dose vaccine will be $28.39, while the rate for administering a two-dose vaccine will be $16.94 for the first dose and $28.39 for the second dose. CMS said those "rates will be geographically adjusted and recognize the costs involved in administering the vaccine, including the additional resources involved with required public health reporting, conducting important outreach and patient education, and spending additional time with patients answering any questions they may have about the vaccine."

    Further, CMS said it "is encouraging state policymakers and other private insurance agencies to utilize the information on the Medicare reimbursement strategy to develop their vaccine administration payment plan in the Medicaid program, CHIP, the Basic Health Program, and private plans." By doing so, states and private insurers could "match federal efforts in successfully administering the full vaccine to the most vulnerable populations," CMS said.

    The interim rule also:

    • Allows providers to receive reimbursement from the Provider Relief Fund for providing a coronavirus vaccine to uninsured Americans;
    • Establishes hospital payments for potential new Covid-19 treatments and dictates that Medicare beneficiaries would not have to meet any deductible or coinsurance requirements for such treatments;
    • Extends Performance Year 5 for the Comprehensive Care for Joint Replacement model; and
    • Requires all coronavirus test providers to publish their cash prices for their tests online.

    Although the rule takes effect immediately, it is open for public comment for 30 days. CMS said it could amend the rule after the comment period ends.

    Coronavirus vaccine may not become available until next year

    While the Trump administration is looking to ensure Americans will be able to access a coronavirus vaccine with no out-of-pocket costs, some experts are casting doubt that a coronavirus vaccine will be widely available by the end of this year.

    Last week, Paul Mango, deputy chief of staff for policy for at HHS, said, "We believe before the end of this year we will be able to vaccinate our most vulnerable citizens," and "[b]y the end of January, we believe we'll be able to vaccinate all seniors." He added, "By the March and April timeframe, we believe we'll be able to vaccinate any American who desires a vaccination."

    During an interview on Wednesday with JAMA Editor-in-Chief Howard Bauchner, Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said vaccine makers likely will have enough data for an independent safety monitoring board to review clinical trial results and potentially recommend that a drugmaker seek FDA's authorization for a coronavirus vaccine candidate by December. However, Fauci said FDA may not authorize an experimental vaccine for use until January at the earliest.

    Separately, Edward Belongia, a director at the Marshfield Clinic Research Institute who has advised CDC on the agency's vaccine committee, said, "It's a bit frustrating, but I think it would be unrealistic to expect that [a vaccine] is going to be widely available to older adults and people with high-risk conditions in early '21. That's clearly not going to be the case." Belongia added, "People are watching this process very closely. We have to get it right the first time. We have already lost a lot of public trust and the process needs to go well, with no hiccups."

    The experts' comments come after Pfizer, a key player in the race to develop a coronavirus vaccine, on Tuesday announced that it still does not have the data needed to determine whether its vaccine candidate is effective, Politico reports. The company had hoped to have enough data to support the vaccine candidate's effectiveness by October, but it hasn't yet met a threshold that the company set for an interim analysis of the experimental vaccine's clinical trial data.

    Anna Durbin, a vaccine researcher at Johns Hopkins Bloomberg School of Public Health, said although vaccine makers may start to release data on the efficacy of their vaccines later this year, "that doesn't mean we're going to have a vaccine available at the end of 2020." Durbin added, "I think what people can take from this is that the process is not being rushed. … That's a good thing. And certainly, I think the other message that has to be heard loud and clear is that even when an (emergency use authorizaion) is issued, we're not going to have enough vaccine for everybody (immediately)" (King, FierceHealthcare, 10/28; Armour, Wall Street Journal, 10/28; Alonso-Zaldivar, Associated Press, 10/28; CMS release, 10/28; CMS fact sheet, 10/28; Branswell, STAT News, 10/29; Owermohle, Politico, 10/27; Weixel, The Hill, 10/28; New York Times, 10/29; Armour, Wall Street Journal, 9/23).

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