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Our Take: CDC changes COVID-19 testing guidance, FDA issues EUA for convalescent plasma; both agencies face backlash

Aug 31, 2020

Editor’s note: Because of the upcoming holiday, Our Take will return on Sept. 14.

Last Monday, the Centers for Disease Control and Prevention (CDC) quietly revised its website; the site now reflects a different recommendation for testing people who have been in close contact with someone infected with SARS-CoV-2, the virus that causes COVID-19.

Before the change, the site said testing was recommended “for all close contacts of persons with SARS-CoV-2 infection.” Now, it says asymptomatic people who have been in close contact of a person with a COVID-19 infection for at least 15 minutes “do not necessarily need a test” unless they are vulnerable individuals or their health care provider or state or local public health officials recommend being tested. The site also recommends that these individuals monitor for symptoms and adhere to the CDC’s mitigation protocols.

Testing people who may be infected but are asymptomatic is a critical component of contact tracing, which is crucial to slowing the spread of the disease. According to the CDC’s own estimates, 40% of infections are asymptomatic and up to 50% of transmissions occur before symptoms appear.

It didn’t take long for the medical community and health experts across the country to weigh in on CDC’s revised guidance. For example, USA Today reported that Alison Galvani, director for the Center for Infectious Disease Modeling and Analysis at the Yale School of Medicine, tweeted, “Our work on the ‘silent’ spread underscored the importance of testing people who have been exposed to COVID-19 regardless of symptoms. This change in policy will kill.”

According to The Associated Press, officials at the CDC told the media to contact the Department of Health and Human Services (HHS) with inquiries about the change. HHS followed up with an email saying the guidance had been revised “to reflect current evidence and the best public health interventions” but did not specify what the new evidence was that prompted the change.

Meanwhile, The Hill reported that, “according to multiple reports, top political officials forced the CDC to make the change.”

Adm. Brett Giroir, M.D., the HHS assistant secretary for health and the Trump administration’s “testing tsar,” said the guidance language originated at the CDC but federal leaders outside of the CDC had provided input and been involved in editing the language. Dr. Giroir said the focus was to do more “appropriate” testing, not “less” testing, according to CNN.

STAT reported that Dr. Giroir said “all the docs” on the task force had signed off on the new guidance, but it was later revealed that Dr. Anthony Fauci was undergoing surgery when the task force finalized the guidance on Aug. 20. Dr. Fauci told CNN that he was worried the recommendation would “give people the incorrect assumption asymptomatic spread is not of great concern. In fact, it is.”

Former CDC Director Tom Frieden tweeted on Friday, “Not testing asymptomatic contacts allows COVID to spread. The CDC guidance is indefensible. No matter who wrote it and got it posted on the CDC site, it needs to be changed,” the Hill reported.

The confusion surrounding the change — and the lack of any announcement about it — led to speculation about why the guidance was revised. One possibility was the desire to slow down testing and thereby reduce the number of reported cases, a strategy President Trump alluded to on more than one occasion but which Dr. Giroir said was not the intent, according to NPR.

Another possibility was to ease the strain on testing supplies and resources. Dr. Redfield, the CDC director, noted in the USA Today report, “Everyone who wants a test does not necessarily need a test; the key is to engage the needed public health community in the decision with the appropriate follow-up action.”

“In fact, the goal is to make [testing] more strategic and intelligent by putting more power and more authority into the hands of the public health officials. That’s clearly the intent, and I think it’s explicit within the guidance,” Dr. Giroir told NPR.

Dr. Georges Benjamin, executive director of the American Public Health Association, didn’t find the intent to be so clear. “At the end of the day, this undermines the credibility of the CDC because now you’ve got everybody pointing fingers at one another,” he told NPR. “The truth of the matter is, if you want to make sure that the right people get tested with the right test at the right time, then you need a national testing strategy that’s been very thoughtful, that’s science-based, that’s in print, and that everybody understands. And they’ve not done that yet.”

On Friday, The New York Times reported that two groups representing almost 3,000 public health departments across the country sent a letter via email to Drs. Redfield and Giroir asking them to reverse the change.

In separate news, the FDA issued an emergency use authorization (EUA) on Aug. 23 for convalescent plasma as a treatment for hospitalized patients with suspected or laboratory-confirmed COVID-19. Collected from people who’ve recovered from COVID-19, convalescent plasma contains antibodies to SARS-CoV-2. The FDA said in a press release that, based on “scientific evidence available,” convalescent plasma “may be effective in treating COVID-19 and that the known and potential benefits … outweigh the known and potential risks.”

After the EUA was announced, the World Health Organization swiftly issued a statement in which it said the evidence supporting use of the experimental treatment was “low quality” and that the treatment should continue to be evaluated in well-designed randomized controlled trials (RCTs). To support the EUA, the FDA referred to results from a nonrandomized observational study that compared the benefit of treatment in patients who received plasma with a high dose of antibodies versus those who received plasma with a low dose of antibodies. The EUA acknowledges that “additional RCTs are needed.”

Separately, on Wednesday the FDA issued an emergency use authorization for the first COVID-19 antigen test that allows providers to read the results from the testing card in about 15 minutes. The point-of-care test involves swabbing the patient’s nose and then twirling the sample on the test card with a testing reagent. Because antigen tests can have a lower sensitivity than molecular tests, the FDA cautioned that negative results may need to be confirmed with a molecular test before treatment decisions are made.

The newly authorized antigen test was developed by Abbott Diagnostics Scarborough. President Trump announced on Thursday night at the Republican National Convention that the federal government would purchase 150 million of the tests for $750 million.

And on Friday the FDA broadened the EUA issued in May for Gilead Science’s Veklury (remdesivir). The original authorization was for severe COVID-19 cases only, but Veklury is now authorized for use in all hospitalized patients with confirmed or suspected COVID-19, regardless of severity.

What else you need to know

CMS announced new COVID-19 reporting requirements for hospitals, labs, and nursing homes last Tuesday. Effectively immediately, hospitals participating in Medicare and Medicaid programs must report daily data regarding the number of confirmed or suspected positive cases, the number of ICU beds occupied, and the availability of vital supplies and equipment. Hospitals that do not comply risk having their Medicare and Medicaid payments cut off. Labs that conduct COVID-19 testing — including those in hospitals and nursing homes — must report test results daily or, after a three-week grace period, they will be fined. Nursing homes participating in Medicare or Medicaid programs must routinely test their staff and offer testing to residents who show symptoms or if there is an outbreak at the facility. Those that fail to comply could face fines. All required data is to be reported to HHS.

The American Hospital Association (AHA) and the Federation of American Hospitals sharply criticized the interim final rule, which was issued without the usual notice and comment period. In its statement, the AHA pointed out that the federal government has changed its reporting requirements at least six times since February and said the rule should be “reversed immediately.”

Citing concerns about duplicate discounts, several leading drugmakers have taken steps to cut back on the discounts they provide under the 340B drug pricing program. Eli Lilly and AstraZeneca were the first to advise participating hospitals, health centers, and clinics that the drug companies would restrict discounts available through 340B contract (i.e., community-based) pharmacies. Specifically, Lilly said it would only permit contract pharmacies to get discounted units of ED drug Cialis in situations where providers did not have their own in-house pharmacy. Shortly thereafter, AstraZeneca said it would similarly restrict discounts on all of its drugs, starting Oct. 1. Subsequently, Merck, Sanofi, and Novartis indicated that they will require providers to report de-identified claims data for commercially insured, Medicaid, and Medicare Part D patients who fill prescriptions in a 340B contract pharmacy. Hospital groups, including America’s Essential Hospitals, the American Hospital Association, and 340B Health, have denounced the drug companies’ actions and asked the federal government to intervene.

Alphabet/Google further expanded into the health care world last week with two transactions. On Monday, Google Cloud issued a press release announcing a long-term partnership with Boston-based telehealth provider Amwell. A stated objective of the partnership is to simplify the health care experience and make virtual care more continuously accessible to underserved populations. As part of the agreement, Google Cloud will invest $100 million in Amwell. The same day, Amwell filed a preliminary prospectus with the Securities and Exchange Commission; Amwell reportedly confidentially filed for an initial public offering in June. On Tuesday, Alphabet life sciences subsidiary Verily announced a new subsidiary called Coefficient Insurance Co., which will focus on stop-loss insurance for self-funded employers and ways to help employers contain costs. Swiss Re Corporate Solutions is providing backing for the new insurance company. Financial details were not disclosed.

Blue Cross and Blue Shield of Minnesota and Allina Health signed a six-year value-based payment agreement with the intent of reducing “the cost trend of Blue Cross-specific care at Allina Health by 10% over five years,” the organizations said in a press statement. The portion of payments tied to achieving optimal patient outcomes in the “landmark” agreement is five to 10 times greater than what is usually delineated in outcomes-based, risk-bearing arrangements, the organizations said. They noted that Blue Cross and Blue Shield of Minnesota, which has approximately 2.6 enrollees, is Allina Health’s largest payer and Allina Health, which annually provides care for about 6 million patients in Minnesota, is Blue Cross’ largest provider of care for members in the state.

As many as 60,000 volunteers could participate in Johnson & Johnson (J&J)’s Phase III trial of the company’s investigational coronavirus vaccine, Reuters reported last week. The trial is scheduled to begin in late September, and up to 180 sites in the U.S., Brazil, Mexico, and other countries with high incidence rates could participate, according to Reuters. The targeted enrollment is at least twice that of many rival companies’ trials.

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