Healthcare During and After the Pandemic

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HEALTHCARE DURING AND AFTER THE PANDEMIC Tricia Shackelford, Wesley Butler, Bradley Sayles

I. OVERVIEW AND TIMELINE OF THE PANDEMIC

A. What is a Pandemic

Merriam-Webster’s Dictionary defines a “pandemic” as an outbreak of a disease that occurs over a wide geographic area (such as multiple countries or continents) and typically affects a significant proportion of the population: a pandemic outbreak of a disease. https://www.merriam- webster.com/dictionary/pandemic, last visited on January 25, 2021.

B. COVID-19 Pandemic Timeline

December 31, 2019 – The First Known Cases – Wuhan Municipal Health Commission, China, reported a cluster of cases of in Wuhan, Hubei Province. A novel coronavirus was eventually identified.

January 1, 2020 – The Initial World Response – The World Health Organization (“WHO”) had set up the IMST (Incident Management Support Team) across the three levels of the organization: headquarters, regional headquarters and country level, putting the organization on an emergency footing for dealing with the outbreak.

January 9, 2020 — WHO Announces Mysterious Coronavirus-Related Pneumonia in Wuhan, China – At this point, the World Health Organization (WHO) still has doubts about the roots of what would become the COVID-19 pandemic, noting that the spate of pneumonia-like cases in Wuhan could have stemmed from a new coronavirus. There are 59 cases so far, and travel precautions are already at the forefront of experts’ concerns.

January 20, 2020 — CDC Says 3 US Airports Will Begin Screening for Coronavirus – Three additional cases of what is now the 2019 novel coronavirus are reported in Thailand and Japan, causing the CDC to begin screenings at JFK International, San Francisco International, and Los Angeles International airports. These airports are picked because flights between Wuhan and the United States bring most passengers through them.

January 21, 2020 — CDC Confirms First US Coronavirus Case – A Washington state resident becomes the first person in the United States with a confirmed case of the 2019 novel coronavirus, having returned from Wuhan on January 15, thanks to overnight polymerase chain reaction testing. The CDC soon after deploys a team to help with the investigation, including potential use of contact tracing.

January 21, 2020 — Chinese Scientist Confirms COVID-19 Human Transmission – At this point, the 2019 novel coronavirus has killed four

1 and infected more than 200 in China, before Zhong Nanshan, MD, finally confirms it can be transmitted from person to person. However, the WHO is still unsure of the necessity of declaring a public health emergency.

January 23, 2020 — Wuhan Now Under Quarantine – In just two days, 13 more people died and an additional 300 were sickened. China makes the unprecedented move not only to close off Wuhan and its population of 11 million, but to also place a restricted access protocol on Huanggang, 30 miles to the east, where residents can’t leave without special permission. This means up to 18 million people are under strict lockdown.

January 31, 2020 — WHO Issues Global Health Emergency – With a worldwide death toll of more than 200 and an exponential jump to more than 9800 cases, the WHO finally declares a public health emergency, for just the sixth time. Human-to-human transmission is quickly spreading and can now be found in the United States, Germany, Japan, Vietnam, and Taiwan.

February 2, 2020 — Global Air Travel Is Restricted – By 5:00 p.m. on Sunday, those en route to the United States had to have left China or they can face a two-week home-based quarantine if they had been in Hubei province. Mainland visitors, however, will need to undergo health screenings upon their return, and foreign nationals can even be denied admittance. Other countries beginning to impose similar air-travel restrictions at this point include Australia, Germany, Italy, and New Zealand.

February 3, 2020 — US Declares Public Health Emergency – The Trump administration declares a public health emergency due to the coronavirus outbreak. The announcement comes three days after WHO declared a Global Health Emergency as more than 9800 cases of the virus and more than 200 deaths had been confirmed worldwide.

February 10, 2020 — China’s COVID-19 Deaths Exceed Those of SARS Crisis – The COVID-19 death toll surpasses that of the severe acute respiratory syndrome (SARS) outbreak from 17 years ago, totaling 908 reported deaths in China in the last month compared with 774 deaths in the SARS crisis.

February 25, 2020 — CDC Says COVID-19 Is Heading Toward Pandemic Status – Explaining what would signify a pandemic, Nancy Messonnier, MD, director of the CDC's National Center for Immunization and Respiratory Diseases, says that thus far COVID-19 meets two of the three required factors: illness resulting in death and sustained person-to- person spread. Worldwide spread is the third criteria not yet met at the time.

March 6, 2020 — 21 Passengers on California Cruise Ship Test Positive – Twenty-one people of just 46 tested aboard a cruise ship carrying more than 3500 people off the California coast test positive for COVID-19, with 19 being crew members. The ship is held at sea instead of being allowed to dock in San Francisco while testing is conducted. Since

2 the event, 60 passengers have sued the cruise line and parent company, Carnival Corp, for gross negligence in how passenger safety was handled.

March 11, 2020 — WHO Declares COVID-19 a Pandemic – In declaring COVID-19 a pandemic, Tedros Adhanom Ghebreyesus, director general of WHO, said at a briefing in Geneva the agency is “deeply concerned by the alarming levels of spread and severity” of the outbreak. He also expressed concern about “the alarming levels of inaction.”

March 13, 2020 — Trump Declares COVID-19 a National Emergency – President Donald Trump declares the novel coronavirus a national emergency, which unlocks billions of dollars in federal funding to fight the disease’s spread.

March 13, 2020 — Travel Ban on Non-US Citizens Traveling from Europe Goes into Effect – The Trump administration issues a travel ban on non-Americans who visited 26 European countries within 14 days of coming to the United States. People traveling from the United Kingdom and the Republic of Ireland are exempt.

March 17, 2020 — University of Minnesota Begins Testing Hydroxychloroquine – The University of Minnesota launches a clinical trial to investigate whether hydroxychloroquine can prevent an individual exposed to COVID-19 from becoming ill or reduce the severity of the infection. The trial is limited to those at high risk of exposure and aims to enroll 1500 individuals.

March 17, 2020 — CMS Temporarily Expands Use of Telehealth – CMS expands its telehealth rules, permitting use during the COVID-19 pandemic as a means to protect older patients from potential exposure. The relaxation allows Medicare to cover telehealth visits the same as it would regular in-person visits.

March 17, 2020 — Administration Asks Congress to Send Americans Direct Financial Relief – Trump asks Congress to expedite emergency relief checks to Americans as part of an economic stimulus package. The proposal comes just as the United States reports its 100th death from COVID-19.

March 19, 2020 — California Issues Statewide Stay-at-Home Order – California becomes the first state to issue a stay-at-home order, mandating all residents to stay at home except to go to an essential job or shop for essential needs. The order also instructs health care systems to prioritize services to those who are the sickest.

March 24, 2020 — With Clinical Trials on Hold, Innovation Stalls – Overwhelmed hospitals are keeping out everyone who does not need to be there, and that means delaying the start of new clinical trials, according to an interview. The Center for Biosimilars® reported that drugs with fresh FDA approvals are not likely to launch, as their chances of making it into

3 circulation are dim with hospitals struggling just to find enough personal protective equipment.

March 25, 2020 — Reports Find Extended Shutdowns Can Delay Second Wave – Mathematical models based on social distancing measures implemented in Wuhan, China, show keeping tighter measures in place for longer periods of time can flatten the COVID-19 curve.

March 26, 2020 — Senate Passes CARES Act – The Senate passes the Coronavirus Aid, Relief, and Economic Security (CARES) Act, providing $2 trillion in aid to hospitals, small businesses, and state and local governments, while including an elimination of the Medicare sequester from May 1 through December 31, 2020.

March 27, 2020 — Trump Signs CARES Act into Law – The House of Representatives approves the CARES act, the largest economic recovery package in history, and Trump signs it into law. The bipartisan legislation provides direct payments to Americans and expansions in unemployment insurance.

March 30, 2020 — FDA Authorizes Use of Hydroxychloroquine – FDA issues an emergency use authorization (EUA) for “hydroxychloroquine sulfate and chloroquine phosphate products” to be donated to the Strategic National Stockpile and donated to hospitals to treat patients with COVID- 19. The EUA would be rescinded June 15, except for patients in clinical trials, in the wake of reports of heart rhythm problems among some patients.

March 31, 2020 — COVID-19 Can Be Transmitted through the Eye – A report in JAMA Ophthalmology creates a stir with the finding that patients can catch the virus that causes COVID-19 through the eye, despite low prevalence of the virus in tears. The coverage of the study involving 38 patients from Hubei Province, China, drew some of AJMC.com’s highest readership of 2020, as the findings contradicted assumptions by leading professional societies.

April 8, 2020 — Troubles With the COVID-19 Cocktail – “What do you have to lose?” Trump asks when touting the malaria drug hydroxychlorquine or the related chloroquine as possible treatments for COVID-19. With a common antibiotic, azithromycin, the drug cocktail becomes an early candidate to prevent hospitalization or death. But Trump’s promotion of the combination, despite known heart risks for some patients, prompts the American Heart Association, the American College of Cardiology, and the Heart Rhythm Society to warn in a joint guidance that the drugs are not for everyone.

April 16, 2020 — “Gating Criteria” Emerge as a Way to Reopen the Economy – After Trump briefly entertains the idea of reopening the US economy in time for Easter Sunday, the White House releases broad guidelines for how people could return to work, to church, and to restaurants and other venues. The plan outlines the concept of “gating

4 criteria,” which call for states or metropolitan areas to achieve benchmarks in reducing COVID-19 cases or deaths before taking the next step toward reopening.

April 28, 2020 — Young, Poor Avoid Care for COVID-19 Symptoms – As the pandemic lingers, the term “deferred care” caught fire in health care circles—referring to the fact that many would avoid a doctor’s office or hospital for any procedure that could wait. But a Gallup poll finds a darker side to this phenomenon: one in seven Americans report they would not seek care for a fever or dry cough—the classic symptoms of COVID-19. The reason? Cost concerns. Those most likely to avoid medical treatment for symptoms are younger than age 30 and make less than $40,000 a year. By the end of April, 26.5 million Americans have filed for unemployment since mid-March.

April 29, 2020 — NIH Trial Shows Early Promise for Remdesivir – National Institutes of Health (NIH) trial data, which are not peer reviewed, show that remdesivir, made by Gilead Sciences, is better than placebo in treating COVID-19. Patients with advanced COVID-19 and lung involvement who received the antiviral had a 31 percent faster recovery time, or about four days.

May 1, 2020 — Remdesivir Wins EUA – Shortly after the trial data are published, FDA grants an EUA to remdesivir after preliminary data from an NIH trial found the treatment accelerated recovery in individuals with advanced COVID-19 and lung involvement.

May 9, 2020 — Saliva-Based Diagnostic Test Allowed for At-Home Use – The FDA broadens authorization of a saliva-based test to detect COVID- 19 infection; the EUA is granted to Rutgers Clinical Genomics Laboratory. The test makes it possible for those who cannot get to a collection center to get tested, including those who are home because they are ill, quarantined, or at high risk of infection due to their age or comorbidities.

May 12, 2020 — Death Toll Likely Underestimated, Fauci Testifies – Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, testifies before the US Senate that the US death toll of 80,000 is likely an underestimate. He warns against the relaxation of social distancing and says he is “cautiously optimistic” that a vaccine will be effective and achieved within one or two years.

May 21, 2020 — United States and AstraZeneca Form Vaccine Deal – The Trump administration and AstraZeneca announce a collaboration to speed development of a COVID-19 vaccine called AZD1222. HHS says it expects the first doses to be available as early as October 2020; phase three clinical studies are underway this summer.

May 28, 2020 — US COVID-19 Deaths Pass the 100,000 Mark – The CDC says surpassing 100,000 deaths is a “sobering development and a heart-breaking reminder of the horrible toll of this unprecedented pandemic.” It asks that Americans continue following local and state

5 guidance on prevention strategies, such as social distancing, good hand hygiene, and wearing a face mask while in public.

June 4 — Lancet, NEJM Retract COVID-19 Studies on Hydroxychloroquine – On the same day, The New England Journal of Medicine and The Lancet both retract 2 studies on the use of hydroxychloroquine in COVID-19, after the authors said they could not vouch for the data used. A private database of medical records compiled by a little-known firm called Surgisphere was used in both studies. The retractions bring to light the difficulty of publishing vital COVID-19 research while ensuring accuracy.

June 10, 2020 — US COVID-19 Cases Reach 2 Million – The number of confirmed cases of COVID-19 hits 2 million in the United States as new infections continue to rise in 20 states. Cases begin to spike as states ease social distancing restrictions.

June 16, 2020 — HHS Announces COVID-19 Vaccine Doses Will Be Free for Some – Officials associated with the United States’ Operation Warp Speed, a project to rapidly develop and deploy a COVID-19 vaccine, explain that the vaccine would be provided for free to elderly patients and other vulnerable populations who cannot afford it.

June 18, 2020 — WHO Ends Study Into Hydroxychloroquine – WHO announces it will stop testing hydroxychloroquine as a treatment for COVID-19. The data from the Solidarity Trial show the drug did not reduce mortality. According to WHO, patients who were previously administered the drug would finish their course or stop based on a supervisor’s discretion.

June 20, 2020 — NIH Halts Trial of Hydroxychloroquine – Just days after WHO ended its own trial, the NIH announces it is halting a clinical trial examining the safety and effectiveness of hydroxychloroquine as a treatment for COVID-19. The study indicates that the treatment does no harm, but also provides no benefit.

June 22, 2020 — Study Suggests 80 percent of Cases in March Went Undetected – A study in Science Translation Medicine suggests that as many as 80 percent of Americans who sought care for flu-like illnesses in March were actually infected with the virus that causes COVID-19. According to the research, if one-third of these patients sought COVID-19 testing, it may have amounted to 8.7 million infections.

June 26, 2020 — White House Coronavirus Task Force Addresses Rising Cases in the South – For the first time in two months, the White House Coronavirus Task Force holds a briefing. The focus of the discussion is the rising number of cases and growing positive test rate in some states. As cases rise, Texas and Florida both decide to halt reopening as each state records growing numbers of cases.

June 29, 2020 — Gilead Sets Price for Remdesivir at $3,120 – Gilead Sciences sets a price for remdesivir, which can shorten hospitalization stays for patients with COVID-19, at $520 a vial. With a treatment course of six vials, the typical treatment course will be $3,120 per patient for people covered with private insurance. Critics of the price point are quick to point out that taxpayers funded the COVID-19 remdesivir trial through the National Institute of Allergy and Infectious Diseases.

June 30, 2020 — Fauci Warns New COVID-19 Cases Could Hit 100,000 a Day – In his appearance before the Senate Health, Education, Labor, and Pensions Committee, Fauci warns that while the current daily number of new cases in the United States is hovering around 40,000, which could reach as high as 100,000 new cases per day given the outbreak’s current trajectory.

July 2, 2020 — States Reverse Reopening Plans – Several states, including California and Indiana, postpone or reverse plans to reopen their economies, as the United States records 50,000 new cases of COVID-19— the largest one-day spike since the pandemic’s onset. New Mexico also extends the state’s emergency public health order through July 15 and implements a $100 fine for those not adhering to required mask usage.

July 6, 2020 — Scientists, Citing Airborne Transmission, Ask WHO to Revise Guidance – Hundreds of scientists call on the WHO to revise recommendations on COVID-19 to better reflect its potential for airborne transmission. Previously, the organization stated that COVID-19 spreads primarily via small droplets from the nose or mouth emitted when an infected individual coughs, sneezes, or speaks.

July 7, 2020 — CMS Plans to Pay More for Home Dialysis Equipment – CMS proposes a rule aimed at keeping patients outside of dialysis centers for treatment as the nation faces rising cases. The transitional add- on payment for new and innovative equipment or supplies would allow greater access to home dialysis machines, improving accessibility for Medicare beneficiaries.

July 7, 2020 — US Surpasses 3 Million Infections, Begins WHO Withdrawal – The same day that the United States reports three million COVID-19 infections, the nation begins its withdrawal from WHO, citing its response to the global pandemic. The Trump administration notifies the United Nations of its decision, which would not take effect until 2021 and could be reversed by President-elect Joe Biden.

July 9, 2020 — WHO Announces COVID-19 Can Be Airborne – WHO announces that the novel coronavirus can be transmitted through the air after more than 200 scientists sign a letter urging the agency to revise its recommendations. In an updated scientific brief, WHO notes that the virus may linger in the air in crowded indoor spaces and emphasizes that the virus may be spread by asymptomatic individuals.

July 14, 2020 — States with COVID-19 Spikes Report Greatest Health Insurance Coverage Losses – As of May 2020, states with the greatest percentage of nonelderly adults who are currently uninsured included Florida, Texas, Oklahoma, Mississippi, North Carolina, South Carolina, and Georgia, according to an analysis from Families USA. These states also report the highest numbers of new COVID-19 cases per 100,000 residents as of July 12.

July 14, 2020 — Early Moderna Data Point to Vaccine Candidate’s Efficacy – Data from phase 1/2 trials of Moderna Inc.’s COVID-19 vaccine show that doses produced immune responses in all three groups of 15 volunteers. The company was the first to enter large-scale human trials. Adverse effects of the vaccine candidate, which is administered twice, 28 days apart, include injection site pain and chills.

July 15, 2020 — New Hospital Data Reporting Protocol Prompts Concern – An announcement mandates that all hospitals must bypass the CDC and send COVID-19–related information to a central database run by HHS Protect. Previously, data were sent to the CDC’s National Healthcare Safety Network site. Following the change, questions are raised regarding the future of COVID-19 data transparency and politicization.

July 16, 2020 — US Reports New Record of Daily COVID-19 Cases – The United States reported a record 75,600 cases of COVID-19 in a single day, breaking a record set the week prior. At this point, daily cases have seen 11 record totals in the past month alone. Texas, Hawaii, and Montana are among the 10 states reporting new record daily totals.

July 20, 2020 — Diagnostic Delays from COVID-19 May Increase Cancer-Related Deaths – The next several years could bear witness to thousands of additional deaths from cancer that could have been prevented through routine diagnostic care that was delayed because of the COVID-19 pandemic. Notably, delays in referrals and screenings for breast, colorectal, esophageal, and lung cancers were indicated in a pair of studies published in The Lancet Oncology to potentially lead to almost 10 percent (n = 3291-3621) more deaths in England over the next five years.

July 21, 2020 — Vaccines from AstraZeneca, CanSino Biologics Show Promising Results – Two experimental vaccines, one from AstraZeneca and the other from CanSino Biologics, show promising results against COVID-19. The interim results of AstraZeneca’s phase 1/2 COV001 trial of AZD1222 show that the vaccine was tolerated and generated robust immune responses against the virus in all participants who were evaluated. In the CanSino Phase two trial, the vaccine induced significant neutralizing antibody responses, with as many as 95 percent of patients showing either cellular or humoral immune responses at day 28 post vaccination.

July 22, 2020 — HHS, DOD Announce Vaccine Distribution Agreement With Pfizer and BioNTech – HHS and the Department of Defense (DOD) strike a partnership with biotech giants Pfizer and BioNTech for a

December delivery of 100 million doses of their COVID-19 vaccine candidate, BNT162, in a deal that could expand to 600 million doses if the vaccine receives approval or an EUA from the FDA, and even then only if phase three clinical trial results confirm that the vaccine is safe and effective.

July 23, 2020 — Antibody Levels Drop After First 3 Months of COVID- 19 Infection – Findings from a research letter published in the New England Journal of Medicine indicate that levels of antibodies against SARS-CoV-2, the virus that causes COVID-19, dropped dramatically across the first three months of infection. At this rate, researchers note that antibody resistance would be depleted within a year, although experts note that the possibility of being infected again with the virus is very unlikely.

July 23, 2020 — Antibody Cocktail May Treat, Prevent COVID-19 – Researchers conceive of an antibody cocktail that uses antibodies directed at different locations on the familiar “spike” on SARS-CoV-2 that gives the virus its “corona.” The scientists found the antibodies fell into two distinct groups, targeting different regions of the viral spike. Thus, they say, the battle against COVID-19 could be waged on separate fronts, much like those against HIV and some forms of cancer.

July 27, 2020 — Moderna Vaccine Begins Phase Three Trial, Receives $472M From Trump Administration – In beginning the first phase three clinical trial to examine a vaccine candidate against COVID-19, Moderna announces that the Trump administration increased funding by $472 million to expand the trial to 30,000 US participants. The move now brings the total investment made by the Biomedical Advanced Research and Development Authority to $955 million.

July 27, 2020 — Senate Introduces HEALS Act – Republicans introduce a package of bills known together as the Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act, which provides provisions for another stimulus check, more money for small businesses, and liability protections for companies seeking to bring employees back to the workplace during the pandemic.

July 29, 2020 — FDA Grants Truvian EUA for Rapid Antibody Test – FDA grants Truvian Sciences an EUA for its Easy Check COVID-19 IgM/IgG antibody test after it was shown to exceed EUA requirements, including a sensitivity rate of 98.44 percent and a specificity of 98.9 percent. The announcement follows the FDA’s increased oversight of antibody tests on May 5, requiring them to meet standards of other molecular tests.

August 3, 2020 — New US Pandemic Phase; US to Pay Sanofi, GlaxoSmithKline $2B for Vaccine – Coronavirus response coordinator Deborah Birx, MD, says the United States has entered a new phase of the pandemic, as widespread cases nationwide differ from early concentrated outbreaks first reported in March and April. Birx’s comments come as the United States agrees to a $2.1 billion deal with GlaxoSmithKline and Sanofi

Pasteur in an effort to develop, manufacture, and scale up delivery of a COVID-19 vaccine.

August 4, 2020 — Rural Hotspots Face Lack of Intensive Care Unit Beds – Almost five months after the pandemic was declared a national emergency in the United States, 49 percent of low-income areas have no free beds in their intensive care units vs. 3 percent of the wealthiest. Hospitals are now being forced to transfer their sickest patients to care facilities in these wealthier areas, with the Southwest and West facing an especially difficult bed shortage.

August 7, 2020 — Talks Stall on Second Relief Package – Stimulus checks from the first package rolled out seemingly quickly, but talks stall between the White House and Democrats on a potential subsequent round of relief, even as jobless claims reach a record high of 1.186 million. Trump continues to claim he will issue executive orders if a deal cannot be reached.

August 11, 2020 — Trump Administration Reaches Deal With Moderna – Despite still waiting on final data, the Trump administration reportedly agrees to pay $1.5 billion to Moderna for 100 million doses of its vaccine candidate, mRNA-1273, or an average per-dose price of $15. The vaccine, however, is still under investigation in the joint phase 3 COVE trial Moderna is conducting with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.

August 12, 2020 — Severe Obesity Increases Mortality Risk From COVID-19 – Investigators from Kaiser Permanente publish their findings showing that patients with a body mass index (BMI) of 40 to 44 kg/m2 have a risk of death from COVID-19 that is more than twice that of individuals whose BMI is 18.5 to 24 mg/m2. An abundance of comprehensive patient data enabled the team to isolate obesity’s effects compared with those resulting from more than 20 comorbidities, health care use, and population density, among others. At the heart of this finding is that excess fat exacerbates the breathing issues brought on by COVID-19.

August 13, 2020 — Biden Calls for Three-Month Mask Mandate – Still a presidential nominee, Joe Biden calls on all governors to require their citizens to wear masks anytime they go out in public through November, and he claims he will mandate the practice if elected. At this point, there are a reported 165,000 deaths from COVID-19, and the measure is estimated to save 40,000 lives in the coming months. At this point, mask mandates still vary greatly among the states and regions.

August 15, 2020 — FDA Approves Saliva Test – The federal agency issues an EUA for SalivaDirect, a test developed by researchers at the Yale School of Public Health that is less invasive compared with the current standard nasal swabs. With shorter wait times not affecting test sensitivity, labs can reportedly run 90 test samples, which are collected in sterile containers, in under three hours. The test is also inexpensive and produces results similar to nasal swabbing.

August 17, 2020 — COVID-19 Now the Third-Leading Cause of Death in the US – In just four days, there’s been a 3.2 percent uptick in COVID- 19–related deaths, to 170,434, giving the disease a number three ranking behind heart disease in the top spot and cancer at number two. Deaths now exceed 1000 per day and nationwide cases exceed 5.4 million. Testing has dropped off by an average 68,000 per day, despite death being eight times more likely in the United States vs. in Europe.

August 23, 2020 — Convalescent Plasma Is Cleared for Use by FDA – The FDA issues another EUA, this time for convalescent plasma from recovered patients as a therapy to fight COVID-19. There is ongoing debate about the treatment, which is rooted in experts’ skepticism that all patient populations will derive benefit from it, due to a lack of efficacy data. Meanwhile, White House Press Secretary Kayleigh McEnany claims it is a therapeutic breakthrough.

August 24, 2020 — Remdesivir’s Clinical Benefits Questioned – A global, multicenter study finds that the antiviral drug remdesivir had little effect on patients hospitalized with COVID-19. The findings, published in JAMA, indicate there were no significant differences in duration of supplemental oxygen or hospitalization between the intervention group given remdesivir and the control group given standard care.

August 25, 2020 — CDC Changes Testing Guidance, but Later Reverses Itself – The CDC quietly changes its guidance on who should get tested for COVID-19, saying that individuals who are asymptomatic, but have been exposed, do not need testing. After it is revealed the decision had bypassed CDC’s usual scientific review process and without internal review, the changes are reversed.

August 26, 2020 — FDA Grants EUA to Abbott’s Rapid Test – A portable rapid COVID-19 test that can deliver results in less than15 minutes was cleared by the FDA under an EUA. The test is aimed at places like workplaces and schools.

August 28, 2020 — First Known Case of COVID-19 Reinfection Reported in the US – A 25-year-old man from Nevada became reinfected with COVID-19 in late May after recovering from a mild case in April, reports say. It marks the first reported case of reinfection in the United States; the second occurrence resulted in a much more severe case, requiring hospitalization and oxygen. A full study of the case is published in Lancet Infectious Disease Journal in October.

September 1, 2020 — US Rejects WHO Global COVID-19 Vaccine Effort – The United States says it will not participate in an initiative by the WHO to develop, make, and distribute a COVID-19 vaccine. COVAX, with 172 countries participating, was launched so that an eventual vaccine could be distributed evenly to poor and developing countries.

September 3, 2020 — Steroids Reduce Mortality in Severe Cases; Sanofi, GSK Begin Human Vaccine Trials – Three studies report that inexpensive steroids are the most effective treatment to date for serious COVID-19. Results from the studies find that the use of systemic corticosteroids can reduce the risk of death by one-third in individuals hospitalized with COVID-19 compared with usual care or placebo. Additionally, Sanofi and GlaxoSmithKline (GSK) start a clinical trial of their protein-based vaccine; the COVID-19 vaccine uses the same protein- based technology as one of Sanofi’s influenza vaccines and is combined with an adjuvant, or booster, developed by GSK.

September 3, 2020 — Bioethicists Weigh In on Equitable Vaccine Distribution – Nineteen bioethicists outline measures for equitable distribution of limited supplies of any COVID-19 vaccine; the plan, called the Fair Priority Model, considers three types of harms caused by COVID- 19 and three values that must be adhered to when considering the allocation of a scarce supply of vaccine.

September 8, 2020 — AstraZeneca Halts Phase 3 Vaccine Trial – The phase 3 trial for AstraZeneca’s potential COVID-19 vaccine is halted for a safety data review following an unknown adverse reaction in a patient. The patient was part of the United Kingdom arm of the trial. At the time, the nature of the adverse reaction was not known, but the company did say that the participant was expected to recover. AstraZeneca says the hold was initiated as “a routine action.”

September 14, 2020 — US Airports Stop Screening International Travelers – The government announces it will stop screenings taking place at some airports since January. In March, incoming flights from high- risk countries, including China, Iran, and much of Europe, were funneled through 15 designated airports, but as of September 14, the flights will no longer be redirected, and all passenger screenings will be halted. As part of the screening process, passengers had their temperatures taken and were subject to a basic health screening about typical COVID-19 symptoms before they could go through passport control and customs.

September 14, 2020 — Pfizer, BioNTech Expand Phase Three Trial – After initially aiming to recruit 30,000 participants, Pfizer and BioNTech announce they will expand the phase three trial of their COVID-19 vaccine by 50 percent to 44,000. The goal of expanding the trial is to increase data on safety and efficacy and promote a more diverse population, including adolescents as young as 16 years and patients with HIV, hepatitis C, or hepatitis B. The Pfizer/BioNTech vaccine is provided as two shots given three weeks apart, but the vaccine must be kept at a temperature of –70 degrees Celsius (–94 degrees Fahrenheit), which may make distribution a challenge.

September 14, 2020 — NIH Launches Investigation into Halted AstraZeneca Trial – After AstraZeneca put its phase three trial on hold, the NIH announces it is launching an investigation into the adverse reaction before the FDA decides whether or not to resume the trial. The

12 participant suffered spinal cord damage, and there remained some uncertainty about what happened to cause the damage.

September 15, 2020 — CDC Reports on Spread of COVID-19 at Restaurants – A study published in Morbidity and Mortality Weekly Report finds that people who recently tested positive for COVID-19 were 2.4 times more likely to have dined out. The study considered restaurant dining to include being seated at a patio, being seated outdoors, and being seated indoors. The odds jumped almost four-fold for participants who had been to a bar or café. The majority of participants (71 percent) claimed to have worn masks in the two weeks before their diagnosis.

September 16, 2020 — Trump Administration Releases Vaccine Distribution Plan – A plan devised by HHS and the DOD aims to make a COVID-19 vaccine free for all Americans, with the vaccine being rolled out in January 2021. Once a vaccine is authorized, the plan dictates that 6.6 million kits of supplies needed to administer vaccines will also be distributed. The plan does not include a decision on who would be the first to receive the vaccine.

September 17, 2020 — Europe Reports Rising COVID-19 Cases – Europe reports a sharp increase in COVID-19 cases, with numbers growing at a higher rate than they did during the previous peak in March. In the first half of September, more than half of all European countries reported an increase greater than 10 percent.

September 21, 2020 — CDC Pulls Guidance Saying COVID-19 Transmission Is Airborne – The CDC removes guidance from its website that had been posted three days earlier saying that the transmission of COVID-19 is airborne. CDC says the document was posted in error and the guidance was a “draft version of proposed changes.”

September 21, 2020 — Johnson & Johnson Begins Phase Three Vaccine Trial – Johnson & Johnson announces that it began a large phase three clinical trial of its COVID-19 vaccine candidate. This vaccine does not need to be frozen and may require one administration instead of two. The trial is expected to test the vaccine in 60,000 participants, making it the largest phase three trial of all vaccines currently being tested.

September 23, 2020 — A New, More Contagious Strain of COVID-19 Is Discovered – A study conducted at Houston Methodist Hospital finds a more contagious strain of COVID-19 in a large portion of recent patient samples. Investigators analyzed samples from the earliest phase of the pandemic and a more recent infection wave, finding that nearly all strains from the more recent phase had a mutation that allows the virus to bind and infect more cells.

September 25, 2020 — Midwest States See Increase in COVID-19 Cases – Over the course of September, Midwest states experience a dramatic rise in COVID-19 cases, with South Dakota alone having a 166 percent increase and 10 other states reporting record one-day increases.

The annual Sturgis motorcycle rally, school and university reopenings, and Labor Day weekend celebrations have all been cited as case links.

September 28, 2020 — Global COVID-19 Deaths Surpass One Million – The number of deaths linked to COVID-19 worldwide crosses the one million mark, according to The New York Times, surpassing the deaths caused by HIV, dysentery, malaria, influenza, cholera, and measles combined in 2020.

September 29,2020 — HHS to Distribute 100 Million Rapid Tests to States – HHS announces a plan to send 100 million rapid COVID-19 tests, developed by Abbott, to states by the end of the year. The rapid tests are cheaper and faster than laboratory tests and can return results in about 15 minutes. The plan was designed to assist K-12 schools in reopening.

September 29, 2020 — Regeneron Announces Positive Results for Monoclonal Antibody Treatment – Regeneron releases study results from its ongoing phase one/two/three trial showing that its proposed monoclonal antibody treatment for COVID-19, REGN-COV2, was linked to quicker recovery, reduced viral load, and the need for fewer medical visits. REGN-COV2 is a mixture of two monoclonal antibodies (REGN10933 and REGN 10987).

October 2, 2020 — Trump, First Lady Test Positive for COVID-19; Trump Enters Hospital – President Trump announces that he and First Lady Melania Trump have tested positive for COVID-19. After experiencing mild symptoms of the disease, Trump was taken to Walter Reed National Military Medical Center, “out of an abundance of caution,” said Press Secretary Kayleigh McEnany in a statement.

October 5, 2020 — Trump Leaves Hospital, Continues Receiving Treatment – After three days, Trump is discharged from the hospital and transported back to the White House, where he would continue to receive treatment for COVID-19 and be monitored. White House physician Sean Conley, DO, says that the president’s fever is gone and that his oxygen levels are normal. During his time at the hospital, Trump’s treatment consisted of Regeneron’s investigational antibody cocktail, remdesivir, and dexamethasone.

October 8, 2020 — NEJM Criticizes Trump’s COVID-19 Response; 39 States See Case Spikes – In an editorial published by the New England Journal of Medicine (NEJM), 34 editors call out the Trump administration’s response of the COVID-19 pandemic, stating that leaders have “taken a crisis and turned it into a tragedy.” Additionally, 39 states report seeing a rise in COVID-19 cases. Nine states set seven-day records for infections, and Wisconsin and Hawaii report a record number for deaths in a seven- day period.

October 8, 2020 — More Americans Trust Biden to Lead Health Care System – A poll released on this date by Gallup-West Health, but taken before Trump’s COVID-19 diagnosis, finds that more Americans trust Biden

14 to lead the US health care system through the pandemic. The poll notes that Biden had the support of 52 percent of voters on this issue, compared with 39 percent who supported Trump, with the remaining undecided. The results leave room for Trump to narrow Biden’s wide lead in the national polls.

October 8, 2020 — White House COVID-19 Outbreak Grows to 34 – By this date, the cluster of people infected by the COVID-19 outbreak connected to the Rose Garden ceremony for Supreme Court Justice Amy Coney Barrett has grown to 34, including several White House staff members, according to The Washington Post. CDC experts offer assistance with contact tracing.

October 9, 2020 — US Signs Deal With AstraZeneca – The Trump administration signed a $486 million agreement with AstraZeneca to develop an antibody treatment for COVID-19, which would call for HHS and the DOD to work with the company to roll out late-stage development and large-scale manufacturing of AZD7442, a cocktail of two monoclonal antibodies with potential to treat or prevent the disease.

October 12, 2020 — Johnson & Johnson Halts Vaccine Trial – Johnson & Johnson halts recruitment for its phase three ENSEMBLE trial for its COVID-19 vaccine halts vaccine trial over a patient’s unexplained illness, a development first reported in POLITICO. The company reports at the time that adverse events that temporarily pause recruitment are not uncommon and mean that clinical trials are being conducted in a safe manner. It later resumes the study of its one-dose regimen, which is unique among the leading vaccine candidates. The company has also launched ENSEMBLE two to study a two-dose version of the vaccine.

October 15, 2020 — US Cases Spike Again; Studies Connect Blood Type and COVID-19 Risk – The United States reports 60,000 new COVID- 19 cases, a number not reached since early August. Cases rise countrywide, and 44 states report caseloads surpassing those seen in mid- September. More rural states see numbers even higher than during first waves in the spring. A pair of studies in Blood Advance suggest that the risk of becoming infected with COVID-19 or developing life-threatening complications from the virus might be related to blood type. Researchers caution that the results do not point to any blood type being completely protective or vulnerable to the virus.

October 19, 2020 — Global Cases Top 40 Million – Data from Johns Hopkins University indicate that COVID-19 cases have topped 40 million worldwide as the United States and other countries see their highest rates of new cases in months. More than 1.1 million people have been killed by the virus worldwide so far, and nearly 220,000 of those deaths were in the United States, which remains the hardest-hit country in the world.

October 22, 2020 — FDA Approves Remdesivir as First COVID-19 Drug – Gilead’s remdesivir is the first FDA-approved drug to treat COVID- 19 after three randomized trials found it to decrease the length of hospital

15 stays and reduce the likelihood that patients will require oxygen. None of the trials showed reduced risk of mortality, however, and a WHO-backed study found that the drug had “little to no effect” on hospitalized patients. The FDA does not mention the WHO trial in its risk-benefit assessment of remdesivir, stating that an NIH-backed trial supporting the approval was better suited to assess time to recovery than the WHO-backed trial.

October 23, 2020 — AstraZeneca and Johnson & Johnson Announce Restart of COVID-19 Vaccine Trials – AstraZeneca and Johnson & Johnson announce plans to restart clinical trials for their respective COVID-19 vaccine candidates after they both stopped due to safety concerns. Johnson & Johnson’s stalled on October 11, and a patient in the AstraZeneca trial developed neurological symptoms before its study was halted on September 6. An independent monitoring committee determined that the trial for the latter vaccine candidate was safe to continue.

October 28, 2020 — CMS Issues Vaccine, Treatment Coverage Rules – CMS provides new rules for insurance coverage, increasing what Medicare pays hospitals for COVID-19 treatments. Trump and Congress had enacted legislation calling for COVID-19 vaccines to be free, but new rules were necessary to fit that policy into the various payment requirements for public and private insurance. The new rules waive copays or deductibles on vaccines for seniors with Medicare.

November 4, 2020 — US Reports Unprecedented 100,000 Cases in One Day – The US hits a grim milestone with 100,000 new COVID-19 cases reported in a single day for the first time. The unprecedented spike in cases leads to a shortage of N95 face masks at health care facilities despite increased production, and workers continue to ration and reuse masks with no end in sight.

November 5, 2020 — Study Predicts Difficulties in Nationwide COVID- 19 Immunity – An analysis of flu vaccination rates during the 2019-2020 flu season suggests that the path to vaccinating the majority of the country for SARS-CoV-2, thus achieving sufficient immunity, will not be an easy one. Just 52 percent of the US population received a flu vaccine in the time frame of the analysis, and the study also highlighted disparities: Lower vaccination rates were recorded in Black and Hispanic adults than White adults, and elderly adults were more likely to receive a vaccine.

November 9, 2020 — President-Elect Biden Announces COVID-19 Transition Team; Pfizer Publishes Vaccine Results – After former Vice President Joe Biden is determined to be the president-elect on November 7, he announces the names of the scientific, medical, and public health professionals who will serve on his Transition COVID-19 Advisory Board. The same day, Pfizer releases data from its COVID-19 vaccine trial showing that the vaccination was 90 percent effective.

November 9, 2020 — FDA Issues EUA for Eli Lilly’s Antibody Treatment – The FDA issues an EUA for Eli Lilly’s bamlanivimab, a monoclonal antibody treatment that mimics the immune system’s response

16 to infection with SARS-CoV-2 and appears to protect high-risk patients with COVID-19 from progressing to more severe forms of the disease. Clinical trials showed reductions in COVID-19–related hospitalizations or emergency visits in these patients within 28 days of treatment compared with placebo.

November 11, 2020 — Indoor Venues Responsible for Much of COVID- 19’s Spread – A new study in Nature observes that most new cases of COVID-19 originated from indoor gatherings in places like restaurants, gyms, and grocery stores, according to analysis of cell phone mobility data from large cities. The authors suggest that low-income neighborhoods have higher new case burdens because their public venues are more crowded and residents are more likely to work outside their homes.

November 16, 2020 — Moderna Reveals Vaccine Efficacy Results – The positive vaccine news continues with Moderna’s announcement that its experimental vaccine reduces the risk of COVID-19 infection by 94.5 percent in participants who received it. Like Pfizer’s vaccine, the Moderna vaccine works using mRNA, an innovative approach that has not yet been used in approved vaccines against any disease.

November 16, 2020 — FDA to Move Rapidly on EUAs for Pfizer, Moderna Vaccines – On CNBC’s “Squawk Box,” HHS Secretary Alex Azar says the FDA will move “as quickly as possible” to clear Pfizer’s and Moderna’s vaccine candidates for emergency use as long as the data support authorization. Both authorization applications are currently being completed, but Azar says that the FDA’s teams are working with both companies to “remove any unnecessary bureaucratic barriers.”

November 17, 2020 — Fauci Highlights the Need for Long-term Follow-up of COVID-19 Effects – During a talk at the American Heart Association Scientific Sessions, Fauci discusses the cardiovascular implications of COVID-19 and highlights the need to follow up with patients to better understand the long-term effects of infection. He points to symptoms like profound fatigue, shortness of breath, muscle aches, sporadic fevers, and an inability to concentrate, which up to one-third of patients live with for weeks or months after contracting COVID-19.

November 18, 2020 — Pfizer, BioNTech Vaccine Is 95 Percent Effective – The results of a nearly 44,000-person trial demonstrate that the COVID-19 vaccine from Pfizer and BioNTech is 95 percent effective, making it as effective as vaccines for shingles and measles. Pfizer also announces that it will seek FDA approval within days so that distribution of the vaccine can happen by the end of the year.

November 20, 2020 — Pfizer, BioNTech Submit EUA Application; CDC Warns against Holiday Travel – Pfizer and BioNTech submit their COVID-19 vaccine to the FDA for an EUA, making them the first companies to seek such an approval in the United States. The EUA submission includes safety data on about 100 children between the ages of 12 and 15 years. At the same time, the CDC urges Americans to stay home for

Thanksgiving amid national spikes in COVID-19 cases and hospitalizations. The agency recommends that people avoid mingling with people who have not resided in their household for the last 14 days. As cases in the United States surpass 11 million, CDC officials worry that the situation could worsen during the holiday season.

November 23, 2020 — AstraZeneca Reports Vaccine Is 90 Percent Effective; FDA Grants EUA for Second Antibody Treatment – When AstraZeneca’s COVID-19 is administered as a half dose followed by a full dose at least a month later, it can be approximately 90 percent effective. This vaccine is easier to distribute and scale up than other vaccines, and the drug maker says it can have as many as 200 million doses by the end of 2020 and 700 million by the end of the first quarter of 2021. Meanwhile, the FDA grants an EUA for a second COVID-19 antibody treatment. The cocktail, manufactured by Regeneron, was administered to Trump when he was battling COVID-19 at the beginning of October. In a clinical trial of 800 people, the treatment significantly reduced virus levels within days.

December 10, 2020 — FDA Advisory Panel Recommends Pfizer, BioNTech COVID-19 Vaccine – An FDA advisory panel endorses the first COVID-19 vaccine. The application for the Pfizer and BioNTech’s vaccine is heard in a public, day-long meeting; voting 17-4, with one abstention, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) decides the benefits of the vaccine outweigh the risks for those 16 and older.

December 11, 2020 — FDA Agrees to EUA for COVID-19 Vaccine from Pfizer, BioNTech – A day after the panel votes, the FDA agrees to an EUA for the Pfizer, BioNTech vaccine, allowing shipments to begin; vaccinations of health care workers begin within days.

December 17, 2020 — FDA Panel Backs Moderna COVID-19 Vaccine – A week after hearing the application for the country’s first COVID-19 vaccine, the same FDA advisory panel meets and agrees that a second vaccine, from Moderna, will benefit individuals 18 years and older. The vote is 20-0, with one abstention. The Moderna vaccine is given 28 days apart; the Pfizer-BioNTech, 21 days apart.

December 18, 2020 — FDA Signs Off on EUA for Moderna's COVID-19 Vaccine – The FDA issues the second EUA allowing shipments of the Moderna COVID-19 vaccine to begin.

December 21, 2020 — New COVID-19 Variant Circling the UK – The UK announces that a new strain of the virus that causes COVID-19, B.1.1.7, is spreading across the country. The novel variant is more contagious, but does not appear to be more lethal or lead to more severe disease.

December 23, 2020 — US Buys More Pfizer Vaccine – The Trump administration announces it will buy an additional 100 million doses of Pfizer and BioNTech’s vaccine.

December 28, 2020 — Novavax Starts Phase Three Trial of COVID-19 Vaccine – Novavax begins a phase three clinical trial, PREVENT-19, for its investigational COVID-19 vaccine, NVX-CoV2373, in 30,000 volunteers in Mexico and the United States.

December 29, 2020 — First US Case of New COVID-19 Variant Found in Colorado – The recently discovered novel variant found a week prior in the United Kingdom is detected in a Colorado man in his 20s with no travel history. Scientists say they are concerned, but not surprised, since viruses are known to mutate.

December 30, 2020 — UK Approves Emergency Authorization for the AstraZeneca and Oxford COVID-19 Vaccine – As UK cases surge, regulators clear a vaccine from AstraZeneca and Oxford, AZD1222, for individuals 18 years and older.

December 31, 2020 — US Falls Short of Goal to Give 20 Million Vaccinations by Year End – As the year closed, the CDC says about 2.8 million people so far have received an initial vaccination. The US says on December 30 that about 14 million doses have been distributed, out of total of 20 million allocated doses.

C. Additional Resources 1. https://www.who.int/news/item/27-04-2020-who-timeline---COVID- 19. 2. https://www.ajmc.com/view/spotlighting-top-health-care-issues-to- monitor-in-2021.

II. TELEMEDICINE AND REMOTE PATIENT MONITORING

A. What is Telemedicine

Telemedicine is defined as a two-way, real time interactive communication between a patient and a provider located at a distant site for the purpose of improving the patient’s health through the use of telecommunications equipment that includes, at a minimum, audio and video equipment.

B. What is Telehealth

Use of electronic information and telecommunications technologist to support and promote long-distance clinical healthcare, patient and professional health-related education, public health, and health administration.

C. What is the Difference Between Telemedicine and Telehealth

Telehealth is different than telemedicine in that it refers to a broader scope of remote health care services than telemedicine. Telemedicine refers

specifically to remote clinical services whereas telehealth refers to remote non-clinical services.

The COVID-19 pandemic created a need for health care delivery via a virtual platform to reduce staff exposure to infected persons, preserve personal protective equipment (PPE), and minimize the impact of patient surges on health care facilities. After conducting numerous studies, the American Telemedicine Association has concluded that there is no patient subgroup that does not benefit from or that is harmed by healthcare provided through remote video conferencing and the American Medical Association has found that 78 percent of ER urgent care and doctor visits can be handled safely and effectively over the phone.

III. CONSIDERATIONS FOR IMPLEMENTING A TELEMEDICINE PRACTICE

A. Determine the Need

A practice needs to look at which patients and services are appropriate for telemedicine services and determine whether telemedicine will replace or complement existing in-person health care services.

B. Select the Technology

Synchronous technology consists of real-time telephone or live audio-video interaction through the use of a smartphone, tablet, or computer. Asynchronous technology, also known as “store and forward” technology, allows for the electronic transmission of messages, images, and data to be reviewed and interpreted at a later time. Remote patient monitoring refers to the direct transmission of a patient’s clinical measurements from a distance to a provider.

C. Address the Legal and Regulatory Considerations

Legal considerations include how and when a provider-patient relationship is formed and obtaining informed consent from a patient. Providers need to be mindful of the licensure requirements to provide care to patients on a virtual platform. Finally, providers must ensure that their telemedicine platforms are HIPAA compliant.

D. Obtain Reimbursement

Providers must understand the difference between an originating telemedicine site and a distant telemedicine site. Originally, FQHCs and RHCs could only function as an originating site. However, the CARES Act allows FQHCs and RHCs to now serve as a distant site for the duration of the pandemic.

IV. BENEFITS AND LIMITATIONS OF TELEMEDICINE

A. Benefits of Telemedicine

1. COVID screening.

2. Providing low-risk urgent care.

3. Access providers for management of chronic conditions and medication management.

4. Provide coaching/support for chronic health conditions – weight loss management and nutrition counseling.

5. Participate in physical therapy, occupational therapy and other modalities as a hybrid approach to in-person care.

6. Monitor clinical signs for chronic conditions (blood pressure, blood glucose, etc.).

7. Engage in case management for patients who have difficulty accessing care.

8. Follow up with patients after hospitalization.

9. Deliver advanced care planning and counseling to patients and caregivers for live threatening events and medical emergencies.

10. Provide non-emergency care to residents in long-term care facilities.

11. Provide education and training for HCPs through peer-to-peer professional medical consultations that are not locally available (patients in rural areas).

B. Limitations of Telemedicine

1. The need to address sensitive topics, especially if there is patient discomfort or concern for privacy.

2. Limited access to technological devices (smartphones, tablets, computers) needed for virtual visits or connectivity issues.

3. Level of comfort with technology for HCPs and patients.

4. Cultural acceptance of conducting virtual visits in lieu of in-person visits by HCPs and patients.

V. TELEMEDICINE AND PROVIDER LIABILITY

As providers move from pandemic response to recovery, attention has turned to potential liability concerns arising from COVID-19. Senate Bill 150 (Sen. Alvarado) gives providers a defense to civil liability for negligence if they render care in good faith to a COVID-19 patient during the State of Emergency. The Bill protects providers from both their acts and omissions, protects off-label medicine uses for COVID-19, and protects providers from liability for acting outside of a provider’s scope of practice.

VI. THE PUBLIC HEALTH EMERGENCY, REGULATORY WAIVERS, AND EXECUTIVE ORDERS

The COVID-19 pandemic represents an unprecedented public health emergency and the United States government responded with unprecedented waivers and flexibilities to loosen the constraints of governmental regulation on health care providers. Health care is considered one of the most regulated industries, but the regulatory environment presented a significant obstacle as the government sought to mobilize health care providers to respond to the public health threat posed by the SARS-CoV-2 virus. The pandemic caused governments to view health care resources differently, physicians and nurses were akin to front-line “soldiers” and hospitals became the “battlefields.” Health care workers needed resources and the operational freedom to prepare for and address the fight. Federal and State governments reacted with a vigor often seen only in times of war.

A. The Federal Response to the COVID-19 Public Health Emergency

Although wide-spread public health emergencies are rare in U.S. history, they are not without precedent. Federal laws have been in place for years offering a general outline for an anticipated response to an infectious disease pandemic. But much like a car that is seldom driven, the mechanics of those laws and whether they would work as intended raised many questions and doubts. As government leaders started to address the mechanics of responding to a public health emergency, the speed of events left little margin for error or rest. The first official report of “viral pneumonia” in Wuhan, China was December 31, 2019. Merely three weeks later the first confirmed case of the SARS-CoV-2 virus was reported in the U.S. Ten days later, on January 31, 2020, the Secretary of the U.S. Department for Health and Human Services (HHS) declares a Public Health Emergency. On March 13, President Trump proclaimed a national emergency. These events triggered federal laws authorizing the Secretary of HHS to exercise emergency powers under Section 1135 of the Social Security Act.

Through Section 1135 Waivers Congress gave HHS authority to temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program requirements to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in those programs. These waivers allow health care providers, who provide services in good faith, to be reimbursed and exempted from sanctions absent any determination of fraud or abuse. Although HHS waiver powers are not unlimited, the HHS Secretary is granted broad authority to waive regulatory requirements down to the minimum of statutory requirements. The 1135 Waiver authority applies only to Federal requirements and does not apply to State health oversight requirements, such as licensure.

Section 1135 Waivers are relatively common, but often limited to specific geographic locations or time periods. The most common examples in recent history where Section 1135 Waivers have been issued are hurricanes and similar natural disasters. In these contexts, the 1135 Waiver process had been designed with specific oversight components to minimize

22 the potential for abuse. States or health care providers would apply for specific waivers of regulatory requirements and HHS, often through the Centers for Medicare and Medicaid Services (CMS), would grant very specific waivers on a selective or individual basis according to demonstrated need. Examples of 1135 Waivers include:

• Conditions of participation or other certification requirements.

• Preapproval requirements.

• Certain program requirements on licensure, excepting that state laws ultimately govern whether a provider is authorized to provide services in the state without state licensure.

• Emergency Medical Treatment and Labor Act (EMTALA) sanctions for redirection or transfers of individuals pursuant to a state pandemic preparedness plan necessitated by the circumstances of the declared emergency.

• Stark self-referral sanctions.

• Performance deadlines and timetables may be adjusted (but not waived).

• Limitations on payment to permit Medicare enrollees to use out of network providers in an emergency situation.

Section 1135 Waivers typically end when the emergency expires or 60 days from the date the waiver is first published. Waiver of EMTALA requirements for emergencies that involve a pandemic disease last until the termination of the pandemic-related public health emergency.

The early stages of the COVID-19 pandemic, however, presented a different type of problem because the scope of the emergency was the entire United States and the needs facing health care providers were difficult to anticipate because there had not been a comparable infectious disease pandemic in modern history. The United States was planning for the pandemic largely by watching the sobering experiences of other countries, such as Italy and Greece.

Initially HHS followed the natural disaster protocols for waiver requests. States, providers, and health care trade associations flooded HHS with broad waiver requests based upon needs anticipated from watching the virus sweep through and overwhelm the care delivery systems in European countries. Throughout March 2020, HHS struggled to articulate and follow a cohesive game plan, partly due to the novelty of the threat and partly due to the complexity of a bureaucratic framework that took decades to develop. By the end of March 2020, HHS took a more general approach to Section 1135 Waivers and authorized CMS to implement “Blanket” 1135 Waivers, for which no waiver application was needed and allowing for easy, periodic updates as needs and threats changed. As of this writing, HHS

continues to utilize Blanket 1135 Waivers, expanding the original list of approximately 10 pages to its recent versions that cover 42 pages. All waivers were made retroactive to March 1, 2020. The HHS Secretary has continuously extended these waivers as the emergency declarations have repeatedly been renewed throughout the COVID-19 pandemic.

The Blanket 1135 Waivers have changed in wording and scope over time. However, certain topics have been consistently referenced in waivers throughout the Public Health Emergency. A summary outline of pertinent Section 1135 Waivers is listed below, along with references to any applicable statutory or regulatory authorities that may be implicated by the waiver:1

1. Medicare telehealth services.

a. Waives requirements that specify the types of practitioners that may bill for their services when furnished as Medicare telehealth services from the distant site. Expands the types of health care professionals that can furnish distant site telehealth services to include all those that are eligible to bill Medicare for their professional services. Allows health care professionals who were previously ineligible to furnish and bill for Medicare telehealth services, including physical therapists, occupational therapists, speech language pathologists, and others, to receive payment for Medicare telehealth services.

• Authorities – CARES Act section 1834(m)(4)(E) and §410.78 (b)(2)

b. Waives requirements for use of interactive telecommunications systems to the extent they require use of video technology, for certain services. Allows the use of audio-only equipment to furnish services described by the codes for audio-only telephone evaluation and management services, and behavioral health counseling and educational services.

• Authorities – CARES Act section 1834(m)(1) and §410.78(a)(3))

2. Hospitals, psychiatric hospitals, and critical access hospitals, including long-term care hospitals.

a. EMTALA.

1 The 1135 Waivers were in effect as of January 2021. However, the precise waiver language and the regulatory authorities implicated by the waiver are subject to frequent changes and often without formal notice. The outline should be considered only general guidance. 24

i. Waives enforcement of Section 1867(a) (screening) so hospitals can screen patients at a location offsite from the hospital’s campus.

ii. This is permitted only if doing so is consistent with a state’s emergency preparedness or pandemic plan. b. Verbal orders.

i. Waives certain requirements related to verbal orders where read-back verification is required, but authentication may occur later than 48 hours.

ii. Only specific requirements are waived.

iii. Authorities: §482.23(c)(3)(i); §482.24(c)(2); and §482.24(c)(3); §485.635(d)(3). c. Reporting requirements.

i. Waives certain requirements that hospitals report patients in an ICU whose death is caused by their disease, but who required soft wrist restraints.

ii. Hospitals must still report if restraint may have contributed to death.

iii. Authority: §482.13(g) (1)(i)-(ii). d. Patient rights.

i. Waives certain patient rights requirements, including:

(a) §482.13(d)(2) - timeframes in providing a copy of a medical record.

(b) §482.13(h) - patient visitation, including the requirement to have written policies and procedures on visitation of patients who are in COVID-19 isolation and quarantine processes.

ii. Only applies to hospitals considered to be impacted by a widespread outbreak of COVID-19 according to CDC website – CDC States Reporting Cases of COVID-19 (low threshold). e. Sterile compounding.

i. Waives certain requirements to permit face masks to be removed and retained in the compounding area so that they can be re-donned and reused during the same work shift in the compounding area only.

ii. CMS will not review the use and storage of face masks under these requirements.

iii. Authorities: §482.25(b)(1) and §485.635(a)(3) f. Detailed information sharing for discharge planning for hospitals and CAHs.

i. Waives certain requirements to provide detailed information regarding discharge planning, including:

(a) Hospital must assist patients in selecting a post-acute care provider by using and sharing relevant data that includes, HHA, SNF, IRF, LTCH quality measures and resource use measures applicable to the patient’s goals of care and treatment preferences.

(b) Still must comply with discharge planning requirements that ensure a patient is discharged to an appropriate setting with the necessary medical information and goals of care as described in §482.43(a)(1)-(7) and (b).

ii. Authorities: §482.43(a)(8); §482.61(e); and §485.642(a)(8). g. Limiting detailed discharge planning for hospitals.

i. Waives certain requirements related to post-acute care services, including:

(a) §482.43(c)(1): Include in the discharge plan a list of HHAs, SNFs, IRFs, or LTCHs that are available to the patient.

(b) §482.43(c)(2): Inform the patient or the patient’s representative of their freedom to choose among participating Medicare providers and suppliers of post-discharge services. (c) §482.43(c)(3): Identify in the discharge plan any HHA or SNF to which the patient is referred in which the hospital has a

disclosable financial interest, as specified by the Secretary, and any HHA or SNF that has a disclosable financial interest in a hospital under Medicare.

ii. Still must comply with discharge planning requirements that ensure a patient is discharged to an appropriate setting with the necessary medical information and goals of care as described in §482.43(a)(1)-(7) and (b). h. Medical staff.

i. Waives certain requirements to allow physicians whose privileges will expire to continue practicing at the hospital and for new physicians to be able to practice before full medical staff/governing body review and approval to address workforce concerns related to COVID-19 (Please also refer to Practitioner Locations Blanket Waiver listed below.)

ii. Authorities: §482.22(a)(1)-(4) i. Medical Records.

i. Waives certain requirements concerning:

(a) the organization and staffing of the medical records department;

(b) requirements for the form and content of the medical record; and

ii. Flexibilities may be implemented so long as they are not inconsistent with a state’s emergency preparedness or pandemic plan.

iii. Allows flexibility for requirement of completing medical records within 30 days following discharge from a hospital.

iv. Authorities: §482.24(a)-(c); §482.24(c)(4)(viii).

j. Flexibility in Patient Self Determination Act requirements (advance directives).

i. Waives certain requirements requiring hospitals to provide information about advance directive policies to patients.

ii. Authorities: Sections 1902(a)(58) and 1902(w)(1)(A) of the Act (for Medicaid); 1852(i) of the Act (for Medicare Advantage); and 1866(f) of the Act and §489.102 (for Medicare) k. Physical environment.

i. Waives certain physical environment requirements under Medicare CoPs so hospitals can use facility and non-facility space not normally used for patient care for patient care or quarantine.

ii. Location must be approved by the state (ensuring that safety and comfort for patients and staff are sufficiently addressed) and consistent with the state’s emergency preparedness or pandemic plan.

iii. Allows for appropriate cohorting of COVID-19 patients.

iv. States must still comply with integration mandate of the ADA to avoid subjecting persons with disabilities to unjustified institutionalization or segregation.

v. Authorities: §482.41 and §485.623 l. Telemedicine.

i. Waives certain telemedicine provisions for hospitals so telemedicine services can be furnished to the hospital’s patients through an agreement with an offsite hospital.

ii. Authorities: §482.12(a) (8)(9); §485.616(c) m. Physician services.

i. Waives certain requirements regarding Medicare patients being under the care of a physician to allow hospitals to use other practitioners to the fullest extent possible.

ii. Waiver may be implemented so long as it is consistent with a state’s emergency preparedness or pandemic plan.

iii. Authorities: §482.12(c)(1)-(2); and §482.12(c)(4).

28 n. Anesthesia services.

i. Waives certain requirements that a CRNA must be under the supervision of a physician.

ii. CRNA supervision will be at the discretion of the hospital and state law.

iii. CRNAs allowed to function to the fullest extent of their licensure.

iv. Waiver may be implemented so long as it is consistent with a state’s emergency preparedness or pandemic plan.

v. Authorities: §482.52(a)(5); §485.639(c)(2); and §416.42(b)(2). o. Utilization review.

i. Waives certain requirements that hospitals must have a utilization review plan that meets specified requirements.

ii. Entire UR CoP at §482.30 is waived, which requires that a hospital must have a UR plan with a UR committee that provides for a review of services furnished to Medicare and Medicaid beneficiaries to evaluate the medical necessity of the admission, duration of stay, and services provided.

iii. Flexibilities may be implemented so long as it is consistent with a state’s emergency preparedness or pandemic plan.

iv. Authorities: §482.1(a)(3); and §482.30. p. Written policies and procedures for appraisal of emergencies at off campus hospital departments.

i. Waives certain requirements for surge facilities only concerning written policies and procedures for staff to use when evaluating emergencies.

ii. Flexibilities may be implemented so long as it is inconsistent with a state’s emergency preparedness or pandemic plan.

iii. Authority: §482.12(f)(3). q. Emergency preparedness policies and procedures.

i. Waives certain requirements for hospitals to develop and implement emergency preparedness policies and procedures.

ii. Surge sites would not be expected to have communication plans with specific contact information for staff, entities providing services under arrangement, patients’ physicians, other hospitals and CAHs, and volunteers.

iii. Authorities: §482.15(b); and §485.625(b), §482.15(c)(1)-(5) and §485.625(c)(1)-(5). r. Quality Assessment and Performance Improvement Program.

i. Waives certain requirements related to QAPI programs.

ii. Flexibilities may be implemented so long as it is consistent with a state’s emergency preparedness or pandemic plan.

iii. Any improvements to a QAPI plan should focus on the Public Health Emergency (PHE).

iv. Hospitals are still required to maintain an effective, ongoing, hospital-wide, data-driven QAPI program.

v. Authorities: §482.21(a)-(d) and (f); and §485.641(a), (b), and (d) s. Nursing services.

i. Waives certain requirements for nursing services, including:

(a) Requirement that nursing staff develop and keep current a nursing care plan for each patient.

(b) Requirement that hospital have policies and procedures in place establishing which OP departments are not required to have a registered nurse present.

ii. Flexibilities may be implemented so long as it is consistent with a state’s emergency preparedness or pandemic plan.

iii. Authorities: §482.23(b)(4); §482.23(b)(7); and §485.635(d)(4)

t. Respiratory care services.

i. Waives certain requirements that hospitals designate in writing the personnel qualified to perform specific respiratory care procedures and the amount of supervision required for personnel to carry out specific procedures.

ii. Flexibilities may be implemented so long as they are not inconsistent with a state’s emergency preparedness or pandemic plan.

iii. Authority: §482.57(b)(1)

3. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).

a. Certain staffing requirements.

i. Waives the requirement that a nurse practitioner, physician assistant, or certified nurse-midwife be available to furnish patient care services at least 50 percent of the time the RHC operates.

ii. This does not waive the requirement that a physician, nurse practitioner, physician assistant, certified nurse-midwife, clinical social worker, or clinical psychologist be available to furnish patient care services at all times the clinic or center operates.

iii. Authority: §491.8(a)(6).

b. Physician supervision of NPs in RHCs and FQHCs.

i. Modifies the requirement that physicians must provide medical direction for the clinic’s or center’s health care activities and consultation for, and medical supervision of, the health care staff, only with respect to medical supervision of nurse practitioners, and only to the extent permitted by state law.

ii. The physician, either in person or through telehealth and other remote communications, continues to be responsible for providing medical direction for the clinic or center’s health care activities and

consultation for the health care staff, and medical supervision of the remaining health care staff.

iii. Authority: §491.8(b)(1).

c. Temporary expansion locations.

i. Waives the location restrictions to allow flexibility for existing RHCs/FQHCs to expand services locations to meet the needs of Medicare beneficiaries.

ii. Flexibility includes areas which may be outside of the location requirements 42 CFR §491.5(a)(1) and (2), but will end when HHS determines there is no longer a PHE due to COVID-19.

iii. Authority: §491.5(a)(3)(iii).

4. Long-term care facilities and Skilled Nursing Facilities (SNFs) and/or Nursing Facilities (NFs)

a. Three-day prior hospitalization.

i. Waives the requirement for a three-day prior hospitalization for coverage of a SNF stay, which provides temporary emergency coverage of SNF services without a qualifying hospital stay, for those people who experience dislocations, or are otherwise affected by COVID-19.

ii. For certain beneficiaries who recently exhausted their SNF benefits, it authorizes renewed SNF coverage without first having to start a new benefit period (this waiver will apply only for those beneficiaries who have been delayed or prevented by the emergency itself from commencing or completing the process of ending their current benefit period and renewing their SNF benefits that would have occurred under normal circumstances).

iii. Authority: Section 1812(f) of the Social Security Act.

b. Physician visits in Skilled Nursing Facilities/Nursing Facilities.

i. Waives the requirement for physicians and non- physician practitioners to perform in-person visits for nursing home residents and allow visits to be conducted, as appropriate, via telehealth options.

ii. Authority: §483.30.

B. The State Response to the COVID-19 Public Health Emergency

Although there is a fair argument that the federal government has the more substantial influence on the health care industry, oversight of health care delivery continues to be predominately regulated by state governments. As health care providers were attempting to navigate the changing federal regulatory environment, they were simultaneously working with state government leaders on waivers of state regulations. Unfortunately, Kentucky does not have a statutory framework for addressing regulatory waivers similar to that at the federal level, so the state waiver approach was initially cumbersome and fragmented. Additionally, many state leaders had been on the job for only a few weeks with little time to transition fully. Despite these obstacles, many state leaders moved swiftly to implement a variety of regulatory flexibilities so that health care providers could react to the pandemic without substantial concern of regulatory constraints.

About one month after HHS declared a national Public Health Emergency, the first cases of COVID-19 entered Kentucky and Governor Andy Beshear declared a State of Emergency for Kentucky on March 6, 2020 through Executive Order 2020-215. The state declaration initiated the emergency responses of various agencies, including the Department of Public Health, to coordinate resources and communications.

Three days later, Governor Beshear issued Executive Order 2020-220, ordering the Department of Insurance to initiate directives that waived copays, deductibles, cost-sharing and diagnostic testing fees for private insurance and state employees. The Governor also directed regulatory flexibilities to allow patients to seek treatment outside their normal health plan network. A cascade of executive orders and directives followed to respond to more targeted needs in addressing the pandemic, such as allowing pharmacists to extend refills for up to 30 days and restricting visitations at long term care facilities.

One of the more significant directives to impact health care providers came on March 14, 2020, when the Governor requested that hospitals cease elective procedures by March 18. The request became a mandate on March 23, 2020 by directive of the Cabinet for Health and Family Services. Although the directive allowed health care professionals to exercise clinical judgment in implementing the restriction, such discretion was often reserved for circumstances in which the failure to perform the elective procedure would pose a substantial threat to the patient. Elective restrictions were implemented by many states and were viewed by many as a practical necessity to mitigate the spread of the virus and to preserve resources for the anticipated surge in care. The mandatory cessation of elective procedures lasted nearly six weeks, when a phased-in return was scheduled to begin May 6, 2020. Most hospitals were not able to resume elective surgeries in a meaningful way until June 2020, as scheduling and prioritization became a logistical challenge. The practical and personal

costs on patients, who had to wait longer for necessary surgeries,2 and the financial costs on providers were extensive, the full consequences of which have yet to be evaluated in full.

The Office of Inspector General (OIG), the state agency with arguably the most significant health care oversight, was also the state agency with the most sweeping regulatory waiver. On April 6, 2020, Inspector General Adam Mather issued a one-page directive that waived “any requirement in state law or administrative regulation that is more stringent than the HHS emergency declaration 1135 blanket waivers, which took effect March 1, 2020.” Rather than issue directives with targeted waivers, the OIG issued one waiver to align state health care regulations with federal health care waivers. Although this approach was initially met with cautious speculation on how health care operations should interpret the waiver details, the OIG’s public statements of relaxed and flexible enforcement ultimately proved to be a workable solution. The OIG – particularly the Inspector General – kept an open-door policy in which health care providers could seek informal guidance on enforcement questions and often received a prompt response.

The OIG also implemented broad waivers to the Certificate of Need (CON) Program. Hospital bed and service capacities, which would otherwise be constrained by CON requirements and processes, were given emergency application protocols. To address pandemic needs providers could add beds or services only by providing notice to the OIG and such actions were deemed approved by the agency as a general emergency, without resort to lengthy or contentious CON processes.

Finally, the Department for Medicaid Services (DMS) implemented several waivers designed to provide a mix of financial relief to Medicaid beneficiaries and payment flexibilities to providers. Beneficiary cost sharing and provider pre-authorization for COVID-19-related services were waived. DMS promulgated Emergency Regulation 907 KAR 3:300E to give the agency increased flexibility on coverage, benefits, and reimbursement. Waivers were generally published through frequently asked questions for both providers and Medicaid managed care organizations, to offer detail on what items and services will be reimbursed and how to bill for such services. The more notable flexibilities related to the freedoms granted for the coverage of telehealth services. Although many providers may argue that reimbursement for telehealth services still lags, the breadth of coverage for telehealth has been widely accepted as a success by many health care providers.

VII. COVID-19 AND LEGAL LIABILITY

As health care providers move from pandemic response to recovery, attention has gradually turned to potential liability concerns arising from COVID-19. By the end

2 The phrase “elective surgery” can be misunderstood as meaning that the surgery is optional or not necessary, such as some cosmetic surgeries. However, the vast majority of elective surgeries are, in fact, medically necessary surgeries and the elective nature of the surgery usually reflects that the surgery is not emergent and may be scheduled within a particular timeframe. 34

of 2020, one complaint tracker noted approximately 8,000 lawsuit complaints that referenced COVID-19 in some manner. Anecdotal evidence suggests that many of these litigated cases regard employment, insurance, and contract issues – not liability claims. Some argue that the nature of the SARS-CoV-2 virus, particularly what is still unknown about its transmission, makes the ability to prove causation in a liability claim very difficult. Others counter that medical liability claims will be hard to anticipate until statutes of limitation press the issue and, moreover, the creativity of attorneys cannot be underestimated. Regardless, health care providers continue to seek legislative protections against liability for COVID-19 for fear that future lawsuits will cripple the health care industry, thwarting any chance of economic recovery.

In response to these concerns, Kentucky was one of the first states to enact legislation addressing COVID-19 related claims. Senate Bill 150 (2020), sponsored by Senator (and physician) Ralph Alvarado, was passed in the waning days of the 2020 Session of the General Assembly, when Kentucky was only beginning to respond to the pandemic. SB 150 offers health care providers a civil defense to negligence if they render care in good faith to a COVID-19 patient during the emergency. The defense extends to the provider’s actions or failure to act, and defends practitioners from liability when they act outside their normal scope of practice. The legislation also protects providers for using medicines off- label. In the earlier days of the pandemic little was known about clinical strategies to treat severe COVID-19 and physicians were encouraged to try safe, but otherwise novel, approaches to treat the disease conditions resulting from the virus. SB 150 falls well short of granting immunity to health care providers for COVID-19 claims, as many states have since enacted, but the legislation offers some hope that the standards of care may be viewed more leniently in COVID-19 litigation.

VIII. VACCINE DEVELOPMENT AND EMERGENCY USE AUTHORIZATION

Vaccine development is typically a lengthy process taking on average 10-12 years from the initial research to FDA approval and licensure.3 The stages of development in the United States includes six stages:

A. Exploratory Stage

B. Pre-Clinical Stage

C. Clinical Development

D. Regulatory Review and Approval

E. Manufacturing

F. Quality Control

3 Jens-Peter Gregersen, DVM “What History Tells Us About Vaccine Timetables” (June 9,2020), available at: https://www.criver.com/eureka/what-history-tells-us-about-vaccine-timetables; see also, “Vaccine Development, Testing, and Regulation” (January 17, 2018), available at: https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation. 35

The clinical development stage is the one often discussed when covering the FDA approval process. Under this stage, the possible vaccine undergoes three clinical trial phases. The phase one trial is an administration of the vaccine to a small group of adults ranging from 20 to 80 people.4 As the vaccine enters phase two, the clinical study is expanded and the vaccine is given to people who have similar characteristics (such as age, particular health conditions, etc.) to those for whom the vaccine is intended.5 In phase three even more people receive the vaccine in effort to study the vaccine’s efficacy and safety broadly.6

Following the phase three clinical trials, a vaccine manufacturer would then apply with the FDA’s Center for Biologics Evaluation and Research for a Biologics License Application.7 After approval, the FDA continues to oversee manufacturing and administration of the vaccine and many vaccines undergo continuing studies (phase four trials).8 Further, the FDA and CDC continue to monitor effects of approved vaccines through the Vaccine Adverse Event Reporting System.9

While this whole process can take several years, under the public health emergency, efforts were made to expedite the vaccine development process. Operation Warp Speed is the national program to accelerate the development, manufacturing, and distribution of COVID-19 vaccines. The target goal was to have an approved vaccine by January 2021. The public-private partnership tasked with leading Operation Warp Speed, aligned the protocols for demonstration of safety and efficacy allowing selected COVID-19 vaccines to undergo simultaneous phase one to phase three trials.10 Additionally, through funds made available under the CARES Act (nearly $10 billion), investments were made for the research and manufacturing of the vaccines. Selected candidates were also permitted to advance the manufacturing processes during the phase trials rather than scaling up post-authorization and licensure.11 Operation Warp Speed, through the Department of Defense and other regulatory agencies, built plans and

4 Hallie Levine, “The 5 Stages of COVID-19 Vaccine Development: What You Need to Know About How a Clinical Trial Works” (September 23, 2020), available at: https://www.jnj.com/innovation/the- 5-stages-of-COVID-19-vaccine-development-what-you-need-to-know-about-how-a-clinical-trial- works.

5 Tulsi Chugh, “Timelines of COVID-19 Vaccines”, Curr Med Res Pract. 10(4), pp. 137-138 (2020 July-August), available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7372259/.

6 Id.

7 Id.

8 Id.

9 CDC, “Vaccines & Immunizations: Approval Process” (May 1, 2014), available at: https://www.cdc.gov/vaccines/basics/test-approve.html.

10 Chugh, “Timelines of COVID-19 Vaccines.”

11 HHS, “Trump Administration Announces Framework and Leadership for ‘Operation Warp Speed’”, (May 15, 2020), available at: https://www.hhs.gov/about/news/2020/05/15/trump- administration-announces-framework-and-leadership-for-operation-warp-speed.html.

infrastructure for distribution, including expanding of supplies and resources such as cold-chain storage.

As a result of the expedited clinical trial phases and early ramp up of manufacturing, several vaccines moved quickly through the early stages of vaccine development. While this expedited development process permitted earlier broad studies of vaccines, it was anticipated that vaccines would not obtain FDA licensure approval prior to January 2021. The FDA sought to exercise its authority under section 564(b)(1) of the FD&C Act (21 U.S.C. 360bbb-3(b)(1)), permitting Emergency Use Authorization (“EUA”) of the vaccines. The EUA authority permits the FDA to allow unapproved medical products or unapproved uses of approved medical products to be used during public health emergencies (“PHE”). The determination that a PHE exists, does not itself enable the FDA to issue EUAs. A separate determination and declaration are needed. On March 27, 2020 the Secretary of HHS issued the necessary determination declaring that circumstances exited justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic.12

As vaccines moved through trial phases at record pace, the FDA worked to develop guidelines for exercising EUA authority related to COVID-19 vaccines. In October 2020, the FDA issued industry guidance for the “Emergency Use Authorization for Vaccines to Prevent COVID-19.”13 The guidance included instructions on trial, manufacturing, and safety and efficacy information that must be submitted with applications and an outline of the EUA approval process. The guidance fully anticipates continued trials following the issuance of an EUA. Requests for EAU approval are required to include strategies that will be implemented to ensure that ongoing clinical trials of the vaccine are able to assess long-term safety and efficacy in sufficient numbers of subjects to support vaccine licensure.14 If safety or effectiveness concerns arise with a vaccine under EUA, FDA has the authority to revoke the EUA. As of the date of this writing, two manufacturers have applied for and received EUA.

12 Secretary HHS, “Emergency Use Authorization Declaration”, (March 27, 2020), available at: https://www.federalregister.gov/documents/2020/03/27/2020-06541/emergency-use- authorization-declaration.

13 FDA, “Emergency Use Authorization for Vaccines to Prevent COVID-19” (October 2020), available at: file:///C:/Users/bsayles/Downloads/Emergency_Use_Authorization_for_Vaccines_to_Prevent_CO VID-19_-_Guidance_for_Industry_-_October_2020.pdf.

14 Id. at p. 11.

The first EUA was issued on December 11, 2020 was to Pfizer-BioNTech.15 The second EUA was issued seven days later to Moderna.16 Both vaccines contain genetic material of the SARS-CoV-2 virus known as messenger RNA (“mRNA”).17 The mRNA instructs cells in the body to make the virus’s distinctive “spike” protein. “When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.”18 The vaccines are both administered in two doses, three to four weeks apart. To date other manufacturers have yet to apply for an EUA; however, it is anticipated that Johnson & Johnson may seek approval for its COVID-19 vaccine by February 2021.19 Johnson & Johnson’s vaccine candidate differs in that it does not use the mRNA, but uses a weakened version of the common cold virus and requires only one dose.

Once an EUA is issued, there is no specific timeline set for the manufacturer to submit a Biologics License Application. The FDA anticipates “that the data supporting the EUA, together with those that will be collected during use of vaccine under EUA, and additional data collected from ongoing trials will be sufficient to support licensure (approval) of a vaccine authorized under EUA.”20 EUAs may be terminated or amended by the FDA during a public health emergency. Unless terminated by the FDA, the EUAs remain in effect until the EUA declaration is terminated.21

15 FDA, “FDA Takes Key Action in Fight Against COVID-19 by Issuing Emergency Use Authorization for First COVID-19 Vaccine”, (December 11, 2020), available at: https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against- COVID-19-issuing-emergency-use-authorization-first-COVID-19; see also FDA, “FDA Takes Additional Action in Fight Against COVID-19 by Issuing Emergency Use Authorization for Second COVID-19 Vaccine”, (December 18, 2020), available at: https://www.fda.gov/news-events/press- announcements/fda-takes-additional-action-fight-against-COVID-19-issuing-emergency-use- authorization-second-COVID.

16 Id.

17 Id.

18 Id.

19 Jacqueline Howard and Nick Neville, “Johnson & Johnson COVID-19 Vaccine on Track to Apply for Emergency Use Authorization at End of the Month” CNN (January 12, 2021), available at: https://www.cnn.com/world/live-news/coronavirus-pandemic-vaccine-updates-01-12- 21/h_2b80bdf2e866dd9b8d0aaafe1b5b7d72.

20 FDA, “Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions” (January 28, 2021), available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory- and-policy-framework/pfizer-biontech-COVID-19-vaccine-frequently-asked-questions.

21 FDA, “Emergency Use Authorization of Medical Products and Related Authorities”, (January 2017), available at: https://www.fda.gov/media/97321/download.

IX. VACCINE ADMINISTRATION, MANDATES, AND EXEMPTIONS

A. Administration Phases

While vaccines were being developed at warp speed, federal and state agencies worked to develop plans for the administration of the anticipated vaccines. The CDC’s Advisory Committee on Immunizations Practices (“ACIP”) issued guidance on the phased allocation of COVID-19 vaccines. The guidance included three phases. Under phase 1a, vaccines should be offered first to high-risk health workers and long-term care residents. Phase 1b and 1c, include administration to persons 65 and older and those 16-64 years of age with high-risk medical conditions. Phase 2 would see administration to teachers and child-care workers, staff and inmates in prisons and jails, and other adults not included in Phase 1. Children and individuals not included in Phases 1 and 2 would receive the vaccines in Phase 3. It is important to note, that currently the available vaccines are not approved for use in persons under the age of 16.

Each state has also adopted vaccine administration plans. Kentucky issued its COVID-19 Vaccination Plan in October 2020, and tracks the guidelines adopted by the CDC.22 Kentucky’s administration phases turn on the availability of the vaccine. Phase 1 includes three groups: 1A will initially target critical populations (health care workers and long-term care residents); 1B first responders, anyone age 70 and older, and K-12 school personnel; 1C expands to any age 60 or older and those age 16 and older with high-risk COVID-19 conditions. Once the supply of vaccines is sufficient to meet the demands of Phase 1, Phase 2 will include any age 40 or older. Phase 3 anticipates wide-spread availability of the vaccine and will be made available to anyone age 16 or older. Kentucky’s plan to administer the vaccine to those under the age of 16 (estimated 18 percent of the population) will come in phase 4 if the vaccine is approved for this age group.

B. Mandating the Vaccine

States have long had the authority to enforce compulsory vaccination under the state’s police powers, with some limitations. In Jacobson v. Massachusetts, 197 U.S. 11 (1905), a Massachusetts law permitted city boards of health to enforce mandatory free vaccines for adults over the age of 21, if the municipality determined it was necessary for the public health or safety of the community. Adults who refused were subject to a monetary fine. In 1902, the city of Cambridge, Massachusetts adopted a regulation ordering the smallpox vaccination of all residents. Jacobson challenged the mandatory vaccination asserting that subjecting him to a fine or imprisonment for refusing the vaccination was “unreasonable, arbitrary and oppressive.” Justice John Marshall Harlan delivering the majority’s opinion

22 Kentucky Department for Public Health, “Final Interim Draft Kentucky’s COVID-19 Vaccination Plan” (October 2020), available at: https://chfs.ky.gov/agencies/dph/COVID19/DraftKentuckyVaccinationPlan.pdf.

(7-2) ruled in favor of Massachusetts, finding that mandatory vaccinations are neither arbitrary nor oppressive so long as they do not “go so far beyond what was reasonably required for the safety of the public.”

Since Jacobson, state and local authorities in every state have adopted some form of compulsory vaccination. However, the majority of these laws focus on vaccination requirements for daycare and school entry. For example, Kentucky requires that all guardians, and other persons having care, custody, or control of any child shall have the child immunized against diphtheria, tetanus, poliomyelitis, pertussis, measles, rubella, mumps, hepatitis B, and haemophilis influenzae disease, or other immunizations as may be required by the Cabinet for Health and Family Services.23 All states provide for some medical exemption and several include religious exemptions, including Kentucky.24 Adult vaccine mandates are rare. However, pursuant to KRS 214.036, CHFS may mandate immunization of all persons within an area of epidemic. On January 5, 2021 KY House Bill 36, titled “Ensuring Bodily Autonomy and Informed Consent Act” was introduced proposing to amend KRS 214.036.25 If passed, the vaccine mandate authority would be removed and replaced with language explicitly prohibiting CHFS “or any other agent or instrumentality of the Commonwealth of Kentucky to require the immunization of any person.” With current vaccines approved under EUA, it is not likely that states will enact mandatory COVID-19 vaccinations for adult populations absent further establishment of long-term safety or more uncontrolled breakouts.

Whether employers can mandate vaccination of its employees involves a host of other legal considerations. On the federal level this involves analysis of several laws, including the Americans with Disabilities Act (“ADA”), the Rehabilitation Act, and other equal employment opportunity laws. On December 16, 2020, the Equal Employment Opportunity Commission attempted to provide clarity through guidance making it clear that employers can mandate COVID-19 vaccines for their employees under the ADA if (1) the employees get the vaccine at a third-party health care provider or pharmacy that does not have a contract with their employer to administer the vaccine; and (2) the employers make accommodations for religious objections under Title VII of the Civil Rights Act and disability- related objections under the ADA.26

If an exemption under these laws is requested an employer should evaluate whether reasonable accommodations would allow the employee to continue to perform the job without compromising the safety of others.

23 KRS 214.034; see also 902 KAR 2:060.

24 KRS 214.036.

25 KY HB36 (2021).

26 EEOC, “What You Should Know about COVID-19 and the ADA, the Rehabilitation Act, and other EEO Laws”.

Reasonable accommodations must be provided unless (1) the accommodations create an “undue hardship” for the employer or (2) the employee poses a “direct threat” even after reasonable accommodation. State employment laws and protections must also be considered. In response to the federal interpretive guidance, several state legislatures have proposed legislation to restrict employer mandated vaccinations. Employers should seek legal guidance prior mandating vaccination as the full capability and liability of doing so will vary.

X. PAYMENT FOR THE VACCINE AND ADMINISTRATION

The vaccine initially is being procured and distributed by the federal government at no cost to enrolled COVID-19 vaccination providers. Generally, the goal of vested parties related to payment for administration of the COVID-19 vaccines has been to ensure widespread access at no cost to patients. Vaccine providers may not seek any reimbursement, including through balance billing, from the vaccine recipient.

While the vaccines are currently being provided at no cost to the providers, providers may be entitled to reimbursement for administration. There are some general rules to conditions of coverage and payment. First, the vaccine must have received FDA authorization, either EUA or FDA licensure. The vaccine must be administered consistent with the FDA approval and it must be administered by a provider or entity operating within their applicable scope of practice.

The CARES Act establishes coverage for the COVID-19 under Medicare Fee-for- Service (Part B), rather than Medicare Part D (prescription drug coverage). Under Medicare Part B the vaccine will be provided without any cost-sharing. For 2021, Medicare Part B will also pay directly for beneficiaries enrolled in Medicare Advantage Plans. Following 2021, Medicare Advantage Plans will be responsible for payment of the vaccine and administration. Currently, for single-does vaccines Medicare is reimbursing $28.39 and for vaccines requiring a series of two or more doses, $16.94 for the initial dose(s) and $28.39 for the final dose, subject to geographical adjustment.27 While Medicare will not pay for the initial doses of vaccines already purchased by the government, if eventually the vaccine is reimbursed by Medicare, it will be reimbursed at 95 percent of the Average Wholesale Price, similar influenza vaccines.

Similarly, state Medicaid agencies are adopting policies to cover the payment for administration of the vaccine to Medicaid beneficiaries. Under Kentucky Medicaid, as long as the doses remain purchased by the federal government, reimbursement will only be provided for the administration of the vaccine at the same Medicare

27 CMS, “Medicare COVID-19 Vaccine Shot Payment”, (January 6, 2021), available at: https://www.cms.gov/medicare/COVID-19/medicare-COVID-19-vaccine-shot-payment.

rates.28 Medicaid providers seeking to receive and administer the vaccine are required to enroll with the Kentucky Department for Health as vaccine providers.29

The CARES Act also requires that Individual and employer-sponsored private health plans subject to the Affordable Care Act’s preventive services coverage standards provide coverage for individuals to receive vaccines without cost sharing.30 During the PHE, private insurance plans will be required to cover all the costs of a COVID-19 vaccine even if administered by an out-of-network provider.

Uninsured patients are also addressed in the current provision of doses purchased with federal funds. Providers that participate in the CDC COVID-19 Vaccination Program contractually agree to administer a COVID-19 vaccine regardless of an individual’s ability to pay and regardless of their coverage status, and also may not seek any reimbursement, including through balance billing, from a vaccine recipient. The vaccine provider can, however, seek reimbursement for an administration fee when provided to an uninsured patient from the HRSA Provider Relief Fund.31

XI. LIABILITY PROTECTIONS AROUND VACCINE ADMINISTRATION

Liability considerations in the administration (or failure to administrate) an EUA approved vaccine is of obvious concern to providers, manufacturers, and recipients. In 2005, following the avian influenza outbreak, Congress enacted the Public Readiness and Emergency Preparedness Act (“PREP Act”). The PREP Act authorizes the Secretary of HHS to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines, except for claims involving “willful misconduct.” For the PREP Act to apply, the Secretary of HHS must determine that a disease or other threat to health constitutes a public health emergency, or that there is a credible risk of such an emergency. The PREP Act declaration is distinct from the power to declare a public health emergency and it must identify each countermeasure, the particular disease, time period, population, and geographic area covered.

On March 10, 2020, the Secretary of HHS issued the initial PREP Act Declaration for medical countermeasures against COVID-19.32 Since that time, the PREP Act Declaration has undergone five additional amendments expanding upon the initial

28 CHFS, “Provider Letter COVID-19 Vaccine”, (December 14, 2020), available at: https://chfs.ky.gov/agencies/dms/ProviderLetters/ProviderLetterCOVID19Vaccine.pdf.

29 CHFS, “Provider Letter COVID-19 Vaccine Providers”, (December 30, 2020), available at: https://chfs.ky.gov/agencies/dms/ProviderLetters/GeneralProviderLetter108COVID19VaccineProv iderLetter.pdf.

30 85 Fed. Reg. 71142, 71175 (November 6, 2020).

31 See https://www.hrsa.gov/COVIDUninsuredClaim.

32 85 Fed. Reg. 15198 (March 17, 2020).

declaration.33 The first amendment in April 2020, expanded the declaration to explicitly include covered countermeasures authorized by the CARES Act (such as respiratory protective devices). Subsequent amendments have continued to add additional categories to covered countermeasures and qualified persons.

In general, under the PERP Act and COVID-19 PERP Act Declaration, a covered person is immune from all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of covered countermeasures. This includes but is not limited to claims for loss: (1) sounding in tort or contract, or (2) relating to compliance with local, state, or federal laws or legal requirements. PREP Act Immunity applies to claims for: death, physical, mental or emotional injury, illness, disability, fear of such harm or need for medical monitoring, and damage to property, including business interruption loss.

Covered Countermeasures include all qualified pandemic and epidemic products under the PREP Act, including COVID-19 testing and vaccines that receive EUA approval. Covered persons include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States. A “program planner” includes a person who supervises or administers the administration, dispensing, distribution, provision or use of a vaccine. Qualified persons is defined to include licensed health professional or other individual who is authorized to prescribe, administer, or dispense covered countermeasures under the law of the State in which the countermeasure was prescribed, administered, or dispense or those identified as qualified in the declaration. Based on the most recent Amendments to the COVID-19 PREP Act Declaration, qualified persons also include:

• Persons authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with the public health and medical emergency response, or who are authorized to perform an activity under an EAU;

• State licensed pharmacists and pharmacy technicians who order and administer certain COVID-19 tests and vaccines authorized/approved by the FDA. COVID-19 vaccines must be ordered and administered according to COVID-19 vaccine recommendations after having completed required immunization training;

• Health care personnel who are permitted to order and administer a Covered Countermeasure through telehealth in a state may do so for patients in another state (state laws prohibiting qualified persons from ordering and administering Covered Countermeasures through telehealth are preempted); and

33 85 Fed. Reg. 21012 (April 15, 2020); 85 Fed. Reg. 35100 (June 8, 2020); 85 Fed. Reg. 52136 (August 24, 2020); 85 Fed. Reg. 79910 (December 9, 2020); and see the fifth amendment issued January 28, 2020 available at: https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID- Amendment5.aspx.

• Certain health care providers who have held an active license or certification to prescribe, dispense, or administer vaccines under the law of any state with in the last five years , which is inactive, expired or lapsed, so long as the license or certification was active and in good standing prior to the date it went inactive, expired or lapsed and was not revoked by the licensing authority, surrendered while under suspension, discipline, or investigation by a licensing authority or surrendered following an arrest, and the individual is not on the List of Excluded Individuals/Entities maintained by the Office of the Inspector General.

The Fourth Amendment to the PREP Act Declaration issued on December 3, 2020 added a third method of distribution that would provide liability protections for private-distribution channels. This opens up the liability protection for entities that may not have a federal contract, cooperative agreement, grant or other agreement or other federal or state authority to distribute Covered Countermeasures, so long as the covered person manufactures, tests, develops, distributes, administers, or uses the Covered Countermeasure pursuant to the FDA licensure, approval, clearance, or authorization.

The Fourth Amendment to the PREP Act Declaration makes explicit Administration of Covered Countermeasures means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for the purpose of distributing and dispensing countermeasures. Failure to distribute a countermeasure can lead to immunity under the PREP Act in certain contexts (e.g., countermeasures have not been administered due to shortages or other distribution limitations). Claims do not have to be tied to a specific use or actual distribution of countermeasures.

Since its enactment, the PREP Act’s immunity has been used sparingly and the scope of many of its protections is unchartered in the courts. In Parker v. St. Lawrence County Public Health Department, a parent of a child who was inoculated for the H1N1 influenza without the parent’s consent, filed a lawsuit in New York state court against the health department that administered the vaccine.34 The Appellate Division of the Supreme Court of New York held that the lawsuit was preempted by the PREP Act and dismissed the case.35 Two years after Parker, a New York state court would again revisit PREP Act immunity in Casabianca v. Mount Sinai Medical Center, Inc.36 There the court held that a hospital’s failure to inoculate the plaintiff for H1N1 influenza was not a covered countermeasure under the PREP Act because the vaccine was never given, tying the immunity to administration and use of Covered Countermeasure.37

34 102 A.D.3d 140 (N.Y. App. Div. 2012).

35 Id.; see also, Kehler v. Hood, 2012 WL 1945952 (E.D. Mo. May 30, 2012) (upholding immunity of a vaccine manufacturer under the PREP Act.).

36 Kehler v. Hood, 2012 WL 1945952, 2014 N.Y. Slip Op. 33583 (N.Y. Sup. Ct. 2014).

37 Id. 44

Similarly, some recent decisions related to COVID-19 and PERP Act immunity have rejected immunity where the claim asserted was for the non-use of covered countermeasures.38 In response, HHS released the Advisory Opinion 21-01, “On the Public Readiness and Emergency Preparedness Act Scope of Preemption” on January 8, 2021.39 Setting forth the agency’s interpretation of the PREP Act, as both applicable to use and non-use of Covered Countermeasures and arguing for complete preemption. With the further expanse of the COVID-19 PREP Act Declarations, unprecedented use of Covered Countermeasures, and rift in agency and judicial interpretations of the PERP Act, further litigation is undoubted. The COVID-19 PREP Act Declaration extends through the PHE and at least until October 1, 2024.

38 See e.g., Lutz v. Big Blue Healthcare, Inc., 480 F.Supp.3d 1207, 1218 (D. Kan. 2020).

39 Available at: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance- documents/2101081078-jo-advisory-opinion-prep-act-complete-preemption-01-08-2021-final-hhs- web.pdf. 45