Tag: coronavirus vaccine

Oregon Health Authority Adopts COVID-19 Vaccination and Masking Rules in Healthcare and K-12 Education

On January 31, 2022, the Oregon Health Authority (OHA) published permanent rules relating to COVID-19 vaccination and masking requirements in healthcare settings, just a few days after issuing similar rules for K-12 schools. The permanent rules replaced temporary rules that expire after 180 days.

The permanent rules for both healthcare and K-12 settings will “remain in effect unless the State Public Health Director or State Public Health Officer issues an order stating that the requirements . . . are no longer necessary to control COVID-19.” Under both rules, the factors that may lead to a loosening of restrictions or rescission of the permanent rules include the following:

  • “The degree of COVID-19 transmission”

  • “COVID-19 related hospitalizations and deaths”

  • “Disparate COVID-19 related health impacts on communities of color and tribal communities”

  • “Guidance from the U.S. Centers for Disease Control and Prevention”

  • “Proportion of the population partially or fully vaccinated”

The statewide temporary indoor mask mandate is set to expire on February 8, 2022. OHA is still reviewing public comments on a proposed permanent indoor mask mandate and expects to publish a permanent rule in the coming weeks. Healthcare and K-12 employers may want to revisit their COVID-19 policies and workplace practices to consider whether they are complying

© 2022, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.
For similar articles on public health, visit the NLR Health Care Law section.

CMS Requires COVID-19 Vaccine for Health Care Workers at all Facilities Participating in Medicare and Medicaid

On Nov. 4, 2021, the Centers for Medicare and Medicaid (CMS) released a new Interim Final Rule (IFR) regarding staff vaccination at facilities that participate in the Medicare and Medicaid programs. The IFR requires covered employers to ensure that staff receive their first dose no later than Dec. 5, 2021 and achieve full vaccination no later than Jan. 4, 2022.

The vaccine rule that was also released on Nov. 4, 2021 by the Occupational Safety and Health Administration (OSHA) does not apply to employees of health care entities who are covered under the CMS IFR. However, employees of health care providers who are not subject to the CMS IFR may be subject to the OSHA vaccine rule if the facility has more than 100 employees. For more information on the OSHA vaccine rule, please click here.

Justification for the Rule

CMS cited a number of reasons for the IFR, including the risk unvaccinated staff pose to patients, reports of individuals foregoing health care due to concerns of contracting COVID-19 from health facility staff, disrupted health care operations due to infected staff, and low vaccination rates among health care staff.

Scope of Coverage

The requirements of the IFR apply to health care facilities that participate in Medicare and Medicaid and that are subject to Conditions or Requirements of Participation, including but not limited to:

  • Ambulatory surgical centers;
  • Hospices;
  • Hospitals, such as acute care hospitals, psychiatric hospitals, hospital swing beds, long-term care hospitals, and children’s hospitals;
  • Long-term care facilities;
  • Home health agencies;
  • Comprehensive outpatient rehabilitation facilities;
  • Critical access hospitals;
  • Home infusion therapy suppliers; and
  • Rural health clinics/federally qualified health centers.

While the IFR does not directly apply to physician offices, which are not regulated by CMS Conditions or Requirements of Participation, physicians may nevertheless be required to vaccinate as a result of their relationships with other health care entities. For example, the IFR requires hospitals to implement policies and procedures to ensure “individuals who provide care, treatment, or other services under contract or by other arrangement” are fully vaccinated.

Covered Personnel

The IFR requires vaccinations for staff who routinely perform care for patients and clients inside and outside of the facility, such as home health, home infusion therapy, hospice, and therapy staff. CMS’s vaccination requirement also extends to all staff who interact with other staff, patients, residents, or clients, at any location, and not just those who enter facilities. However, staff who provide services 100% remotely—that is, staff who never come into contact with other staff, patients, residents, or clients—are not subject to the IFR vaccination requirements. Additionally, providers and suppliers are not required to ensure IFR vaccination compliance of one-off vendors, volunteers, or professionals, such as (a) those who provide infrequent ad hoc non-health care services (e.g. annual elevator inspectors), (b) those who perform exclusively off-site services (e.g. accounting services), or (c) delivery and repair personnel.

Definition of Full Vaccination

CMS considers “full vaccination” as 14 days after receipt of either a single-dose vaccine (such as the Johnson & Johnson vaccine) or 14 days after the second dose of a two-dose primary vaccination series (such as the Pfizer or Moderna vaccines). At this time, CMS is not requiring the additional (third) dose of mRNA vaccine for moderately/severely immunosuppressed persons or the “booster dose” in order for staff to be considered “fully vaccinated.” Additionally, CMS considers individuals receiving heterologous vaccines—doses of different vaccines—as satisfying the “fully vaccinated” definition so long as they have received any combination of two doses. In order to gauge compliance, CMS is requiring that providers and suppliers track and securely document the vaccination status of each staff member as well as vaccine exemption requests and outcome. The IFR does not specify that weekly testing, masking, and social distancing are an alternative to vaccination, meaning employers must ensure all employees are either (1) fully vaccinated or (2) exempted under a permissible exemption.

Exemptions

The IFR explicitly provides that employers must continue to comply with anti-discrimination laws and civil rights protections which allow employees to request and receive exemption from vaccination due to a disability, medical condition, or sincerely held religious belief or practice. Exemptions should be provided to staff with recognized medical conditions for which a vaccine is contraindicated as a reasonable accommodation under the Americans with Disabilities Act. For exemptions for a sincerely held religious belief or practice, CMS encourages health care entities to refer to the Equal Employment Opportunity Commission’s Compliance Manual on Religious Discrimination. Despite the ability to provide an exemption, CMS states that exemptions may be provided to staff only to the extent required by law, and that requests for exemption should not be provided to those who seek solely to evade vaccination. CMS also notes at length that the Food and Drug Administration considers approved vaccines safe. Accordingly, CMS will likely be unwilling to excuse provider and supplier noncompliance due to employees refusing vaccination based on fears about safety.

Penalties

Although the IFR does not identify specific penalties for non-compliance, CMS is expected to use enforcement tools such as civil money penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement. CMS will utilize State Survey Agencies to review compliance with the IFR through standard recertification surveys and complaint surveys. Noncompliance with the IFR will be addressed through established classification channels of “Immediate Jeopardy,” “Condition,” or “Standard” deficiencies.

Preemption

While CMS recognizes that some states and localities have established laws to prevent mandatory compliance with vaccine mandates, CMS ultimately considers the Supremacy Clause of the United States Constitution as preempting inconsistent state and local laws as applied to Medicare- and Medicaid-certified providers and suppliers.

© 2021 Dinsmore & Shohl LLP. All rights reserved.
For more updates on COVID-19, visit the NLR Coronavirus News section.

Costs of COVID-19 Vaccines: What We Do and Don’t Yet Know

The roll-out of vaccine approvals has led to some confusion over what charges consumers might be asked to cover. This echoes the confusion previously discussed with respect to COVID-19 diagnostic and antibody test pricing. But consumers, providers, and others that will have any involvement with vaccine production, distribution, or administration should be aware that the Coronavirus Aid, Relief, and Economic Security (CARES) Act provides different rules for treatment (including testing) than it does for preventative care, like the recently approved vaccines.

The CARES Act provides that all insurance plans that are subject to the Affordable Care Act’s preventative services coverage standards must cover any qualifying coronavirus preventive services, including approved vaccines, without cost-sharing. It also provides that Medicare plans must cover the cost of the COVID-19 vaccine and its administration, without cost-sharing. This coverage applies to both in- and out-of-network providers. In short, if the primary purpose of a medical visit is to receive a covered vaccine, then the vaccine recipient should not be responsible for any out of pocket costs. However, if their appointment or doctor’s visit includes health services unrelated to COVID-19—such as bloodwork—the recipient may be charged for those services.

Notably, federal rules require that coverage must begin to apply within 15 days of a vaccine’s approval by the Advisory Committee on Immunization Practices (ACIP), accelerating the usual timeline required for plans to incorporate a new recommendation. Insurance plans are therefore currently required to cover the cost of both of the vaccines that have been approved in the United States. (The ACIP provided its interim recommendation for the Pfizer-BioNTech COVID-19 vaccine on December 12, 2020 and subsequently issued its interim recommendation for the Moderna COVID-19 vaccine on December 19, 2020.)

Not all health care plans are covered by these requirements. Plans that are not subject to the ACA’s preventative services coverage standards are not subject to the CARES Act and its vaccine coverage requirement. These plans—which could include short-term health plans, fixed indemnity plans, or some grandfathered plans—may take varying approaches to vaccine coverage. It appears that these plans can require that beneficiaries pay cost sharing for vaccines or can exclude recommended vaccines from coverage altogether. Individual states may ultimately require plans to cover the vaccine and waive cost-sharing. Alternatively, the plans may decide, for any number of reasons (including, e.g., concerns about employee health and safety) to provide coverage, though they may or may not decide to waive cost-sharing. At least one such plan has already said that COVID-19 vaccine costs will be “shareable.”

Several open questions remain. First, it is unclear how much the vaccine could cost (either to recipients or to insurers) in the future, following the conclusion of the public health emergency.

Second, uninsured vaccine recipients may see differences in billing in the long term. Providers that administer an approved COVID-19 vaccine to uninsured recipients will be reimbursed for vaccine administration costs through a provider relief fund created by the CARES Act. The federal government has not indicated how it will handle these reimbursements if that relief fund should be depleted.

Third, because vaccine coverage arises from the ACA’s preventative services coverage standards, the Supreme Court’s forthcoming decision on a pending challenge seeking to invalidate the law’s individual mandate could greatly impact this area, and potentially eliminate or reduce cost coverage.

Finally, and of particularly salience for price gouging concerns, even though the vaccine itself is free, vaccine recipients might still see bills. Some providers can legally charge an administration fee for giving the shot, according to the CDC. Those providers can seek reimbursement for such a fee from either the recipient’s “public or private insurance company or, for uninsured patients, by the Health Resources and Services Administration’s Provider Relief Fund.” Several states prohibit price gouging for medical services, and it remains to be seen whether and how any fees could be justified or challenged under different state laws.

In summary, most but not all COVID vaccines costs should be covered without cost sharing to recipients, related additional charges for the treatment visit might not be covered, and all the non-covered charges likely are subject to state price gouging laws.

© 2020 Proskauer Rose LLP.
For more, visit the NLR Coronavirus News section.

COVID-19 Weekly Newsletter: Vaccine Progress Report

As countries in the Western Hemisphere prepare for the first shipments of vaccines, researchers continue to release new COVID-19 findings.

Vaccine News Galore!

  • U.K. Approves COVID-19 Vaccine, Ahead in the Western World: On December 2, the United Kingdom became the first country in the Western Hemisphere to approve a COVID-19 vaccine. Within days of the approval, 40 million doses of BioNTech/Pfizer’s two-dose vaccine were secured and will be distributed within days. Home care residents, health care workers, the elderly, and the medically vulnerable will be prioritized and get the two doses three weeks apart. The rest of the countries in the European Union (EU) could approve a vaccine for emergency use before the EU’s drug regulator, the European Medicines Agency (EMA), makes a decision, which is anticipated by December 29, but the European Commission has discouraged countries from doing so.
  • First Delivery of Pfizer Vaccine in the U.S. (Possibly) on December 15: The first shipment of the COVID-19 Pfizer vaccine for December 15 is contingent on the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) decision to recommend FDA to issue an EUA for the vaccine. The group will meet December 10 to review Pfizer’s data and a week later, on December 17, will review Moderna’s vaccine data. The first shipment of Moderna’s vaccine, also contingent on the VRBPAC’s decision, could be on December 22. The United States could vaccinate 100 million people against the coronavirus by the end of February, according to Moncef Slaoui, chief scientific adviser to the Trump administration’s vaccine program, Operation Warp Speed.
  • Top Priority Groups for Vaccine Allocation Identified: Health Care Workers, Long-term Care Facility Residents: The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) held an emergency meeting on Tuesday to determine who should be prioritized for the first doses of the COVID-19 vaccine. Though the Advisory Committee voted 13-1 to recommend health care workers and long-term care residents as the first group of people to get vaccinated, ACIP will refine and finalize its full recommendations for vaccine distribution after FDA authorizes a vaccine. In order to address vaccine skepticism, the American Medical Association (AMA), American Hospital Association (AHA) and the Americans Nurses Association (ANA), the same day as the ACIP meeting, released an open letter asking the American public to trust the vaccine development process and to understand the importance of herd immunity.

COVID-19 Relief Package Talks Again

On December 1, a bipartisan group of lawmakers released a $908 billion proposal that included aid to states and localities, unemployment insurance, small businesses, the transportation industry, schools and colleges. On the same day, Federal Reserve Chair Jerome Powell and Treasury Secretary Steven Mnuchin testified at the Senate Banking Committee hearing. Powell warned against being guarded in the next relief package, because when Congress has not done enough during past recessions, the economy and people suffered. Last month, Mnuchin was under fire when he decided to terminate several federal emergency lending programs — a decision which is explicitly within the Treasury secretary’s authority, and which he argued was in adherence to the requirements of the Coronavirus Aid, Relief and Economic Security (CARES) Act passed in March — at the start of the pandemic. Senate Democrats also introduced a COVID-19 relief package this week, offering additional unemployment benefits and aid to the Pandemic Unemployment Assistance (PUA) Program of the CARES Act. The bill would ensure workers who have run out of regular state benefits or are receiving them under the federal PUA program would get an additional 26 weeks of aid. Today, House Speaker Nancy Pelosi (D-CA) indicated she and Senate Majority Leader Mitch McConnell (R-KY) are hopeful to pass a legislative vehicle that includes COVID relief and federal government funding, which is set to run out next Friday.

CDC Shortens COVID-19 Quarantine

The CDC issued new guidance that cuts quarantine time for people exposed to COVID-19 from 14 days to 10 days without a COVID-19 test and seven days if the person tested negative. Public health authorities have identified this as a harm reduction move that factors in the public’s resistance to restrictions and pandemic fatigue. Though CDC officials encourage the 14-day quarantine, they have given some flexibility considering occupational and financial pressures that play into someone’s ability to comply to restrictions. It also reflects the CDC’s desire that people quarantine for a shorter period of time rather than foregoing quarantine altogether.

More Than Half of COVID-19 Transmissions Are Caused by Asymptomatic or Pre-symptomatic Individuals

The latest CDC analysis indicates that the majority of COVID-19 transmissions are due to pre-symptomatic or asymptomatic individuals who “shed” the virus, e.g., in their breath, without even realizing that they are already infected — and infectious — and therefore dangerous to others around them. Earlier studies had already shown that people are contagious well before (three or more days before), as well as after the onset of symptoms, and that most symptoms usually develop 5-6 days after the infection. All these findings underscore the importance of masking and social distancing in minimizing risk of infection. They also reinforce the need to (self)-isolate after contact with individuals whose health status is uncertain, such as during travel.

Mechanical Ventilation Has Higher Risk of Complications if Patient Has COVID-19

Our bodies need oxygen to sustain life. When breathing is impaired and the oxygen level in the blood fall dangerously low — as could happen due to pneumonia, drug overdose or other problems — the situation further becomes life-threatening or even fatal if not addressed immediately. As a life-saving measure, mechanical ventilation can be used while the underlying root-cause problem is getting resolved (e.g., a bacterial pneumonia gets treated with antibiotics). To connect a mechanical ventilator to the patient’s respiratory tract, a plastic tube is inserted into patient’s airways through the trachea (windpipe). As with any procedure, mechanical ventilation carries some risk of complications, ranging from the effects of anesthesia to unintentional damage to the trachea. COVID-19 patients often do require mechanical ventilation, and unfortunately, the COVID-19 condition increases the incidence of long-term tracheal complications more than 20 times compared to matched controls (i.e., similar patients without COVID-19 who needed mechanical ventilation for other reasons). Some of the reasons behind this dramatic increase in the rate of complications have to do with the disturbances in natural blood coagulation processes, as well as the weakening of the normally-protective mucosal layers in the respiratory tract — which, in turn, is a consequence of the viral infection and high-dose long-term steroids often used as part of the COVID-19 treatment.

Timeline of a COVID-19 Illness

The CDC researchers, building on the growing accumulated knowledge about COVID-19 manifestations and treatments, are laying down the groundwork for characterizing and monitoring the various stages of a COVID-19 illness. Broadly speaking, three main phases can be identified: acute COVID-19 (lasting about a week), post-acute hyperinflammatory illness (lasting a couple of weeks), and late inflammatory and virological sequelae (beyond 3-4 weeks). Each phase has distinct clinical presentations and corresponding medical response. Overall, such a higher-level understanding of the COVID-19 picture is a pre-requisite for an optimal management of the disease in each individual patient as well as for the development of most effective public health measures.

COVID-19 Related Mortality Is Higher in the U.S. Than in 18 Other Countries

Per capita deaths from COVD-19 itself and excess deaths during the pandemic (relative to similar pre-pandemic periods) were lower in the U.S. compared to other countries in the first few months of 2020, but since June 2020, that index has been rising and now surpasses that of other countries’ multiple fold. Among reasons for this high toll could be inconsistent and de-centralized public health messaging and interventions.

SARS-CoV-2 Was Present in the U.S. by Mid-December 2019

CDC researchers analyzed blood donated to the American Red Cross between December 13, 2019 and January 17, 2020, and found evidence of SARS-CoV-2 antibodies in 84 samples. Those infections may have been missed at the time because — as is known by now — the SARS-CoV-2 infection causes only mild or no symptoms in about half the cases; and when symptoms do occur (e.g., headache, muscle ache, cough), they are easily mistaken for other illnesses unless a specific test for SARS-CoV-2 is performed. Previously, the first reported case of COVID-19 in the U.S. was dated January 20, 2020. New evidence suggests that the virus was present in the U.S. before that time.

© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.
For more articles on the COVID-19 vaccine, visit the National Law Review Coronavirus News section.