OSHA Withdraws the Mandatory Vaccination & Testing Emergency Temporary Standard (ETS)
Please either Join!
orPlease either Join!
orPlease either Join!
orPlease either Join!
orPlease either Join!
orOn December 15, 2021, the United States Court of Appeals for the Fifth Circuit issued a ruling which modifies an earlier court national injunction related to the CMS mandatory vaccination rules. In the latest ruling, the court upheld the injunction issued by the United States District Court for the Eastern District of Missouri as it applied to the fourteen (14) plaintiff states, Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky, and Ohio. However, it overturned the lower court’s expansion of that injunction to other, non-plaintiff states, in the injunction. Meaning that between the 5th and 8th Circuit Court rulings, the CMS mandatory vaccination injunction only applies to the following 24 states:
5th Circuit Plaintiffs: Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky, Ohio
8th Circuit Plaintiffs: Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, North Dakota and New Hampshire.
States not covered by the CMS mandatory vaccination injunction:
California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington, and Wisconsin
This decision, follows another mandatory vaccine related decision issued by the United States Court of Appeals for the Eleventh Circuit which criticized the Louisiana court for expanding the CMS vaccine mandate nationwide given that a Florida District Court had already refused to issue an injunction and because it felt that it was likely that the mandate was likely authorized under current CMS rules.
What does this mean for employers?
If you are an employer in one of the states not covered by an injunction, you should consult with any covered healthcare facility that your organization performs services under contract. These covered healthcare facilities will be required to mandate vaccination for their staff and for any contractor staff that interacts with their employees or patients. Additionally, they will be seeking proof that your staff is vaccinated against COVID-19, unless they have a protected medical or religious accommodation.
Employers should have already taken the initial steps toward compliance with the CMS mandatory vaccination rules, including having a list of all employees with their vaccination status. Additionally, employers should have an established policy related to mandatory vaccination and a procedure for requesting and processing an exception/accommodation requests. Lastly, healthcare institutions may independently institute mandatory vaccination rules for their employees and can require this of anyone entering their facility, including EMS staff.
We will continue to keep you post as these cases proceed through the legal system. These facilities may still independently require your staff to be vaccinated. If your organization has questions or need assistance deciphering or preparing for these requirements, please contact the AAA by emailing hello@ambulance.org.
Please either Join!
orPlease either Join!
orPlease either Join!
orOn Monday, November 29, 2021, the United States District Court for the Eastern District of Missouri – Eastern Division has issued a preliminary injunction staying the Centers for Medicare and Medicaid Services (CMS) Mandatory Vaccination Emergency Temporary Standards (ETS) which were set to take effect on January 4, 2022. This preliminary injunction currently only applies to healthcare providers in the plaintiff states.
On November 10, 2021, the States of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, and New Hampshire filed a nine (9) count complaint in the United States Court for the Eastern District of Missouri seeking relief from the CMS Emergency Temporary Standard (ETS) which requires certain certified healthcare facilities to mandate COVID-19 vaccination of all employees, contractors, and those performing services “under arrangement.” The complaint alleged that the ETS violates numerous provisions of the Administrative Procedures Act (APA), the Social Security Act (SSA), that CMS failed to consult with the state agencies that would be charged with enforcing such a mandate, failure to perform an impact analysis of the new rules, and several other Constitutional violations.
In the ruling, U.S. District Judge Matthew T. Schelp, agreed with the plaintiffs that a preliminary injunction was warranted because it posed an irreparable harm and that the plaintiffs demonstrated a likelihood of success on the merits of their complaint. The thirty-two (32) page ruling cites that Congress did not give CMS the authority to enact the mandatory vaccination regulations, nor authorized CMS to issue regulations that pre-empt validly enacted state legislation that contradict these new rules. The court believed that the plaintiffs would likely be able to show that CMS violated numerous administrative and rulemaking procedures.
Throughout the ruling the court cited the likelihood of significant harm to state sovereignty and how the implementation of the rule’s requirements would cause substantial economic harm to both the states and the healthcare facilities. Not only through the cost of implementation but also through the impact to a healthcare facility’s ability to provide care due to employees who refuse to get vaccinated.
This ruling is only applicable to covered healthcare facilities in the states of Missouri, Nebraska, Arkansas, Kansas, Iowa, Wyoming, Alaska, South Dakota, and New Hampshire. It is unknown if the stay will be expanded to other jurisdictions. Additionally, the OSHA Vaccination & Testing ETS is currently enjoined and OHSA has announced that they will halt implementation and enforcement associated with those rules. Despite these rulings, many EMS employers are subject to the mandatory vaccination requirements under the Safer Federal Workforce Task Force COVID-19 Workplace Safety: Guidance for Federal Contractors and Subcontractors.
I advise employers to take the initial steps toward compliance while these cases proceed through the legal system. EMS employers are already required to have policies and procedures to determine and maintain a log of their employee’s vaccination status. Additionally, many EMS employers have already been contacted by their contracted healthcare facilities who have enacted a vaccine mandate, either prior to, or in response to the CMS ETS. These facilities may still independently require your staff to be vaccinated.
I recognize that these are incredibly challenging times. If your organization has questions or need assistance deciphering or preparing for these requirements, please contact the AAA by emailing hello@ambulance.org.
Please either Join!
orby Scott Moore, J.D. & Kathy Lester, J.D. M.P.H.
Today, the Occupational Health and Safety Administration (OSHA) and Centers for Medicare & Medicaid Services (CMS), released the highly anticipated mandatory COVID-19 vaccination regulations for employers with 100 or more employees and new COVID-19 vaccination requirements in the Conditions of Participation (COPs)/Conditions for Coverage (CfCs).
OSHA COVID-19 Vaccination Regulations
A summary of the new rules can be found on the OSHA website. Under this latest rule, OSHA stated that any employer who is subject to the Healthcare ETS released in June, 2021 is not subject to the Vaccination and Testing ETS. This would include many EMS employers. However, healthcare employers should refer to the Healthcare ETS to ensure that they are in compliance with those requirements.
It is important for EMS employers to note, where they have “healthcare support services”, as defined under §1910.502(vi) of the Healthcare ETS, that are not subject to the Healthcare ETS because these employees are segregated in non-healthcare settings (stand-alone administrative facilities), those employees will be subject to the requirements Vaccination and Testing ETS.
There was nothing in the latest ETS that prevents employers from instituting a mandatory vaccination requirement for its employees. Many EMS employers are already required to mandate vaccination under a state or local law. These employers may continue to require vaccinations for its employees.
CMS COVID-19 Health Staff Vaccination Rule
CMS also released an Interim Final Rule with Comment (IFC) governing health care staff vaccination requirements, as well as a Press Release, Fact Sheet, and Frequently Asked Questions. While the IFC regulations do not directly apply to ground ambulance suppliers, the definition of staff that includes individuals contracted with or that have other arrangements with facilities directly regulated will be indirectly subject to the rules through their arrangements with the facilities. For example, an EMS service that has no contract or arrangement with any of the directly covered health care facilities listed below should not be subject to the CMS requirements. However, a ground ambulance service that has a contract with a nursing home to provide interfacility transports, for example, would be indirectly affected because of the requirement on the nursing home to ensure that contractors meet the vaccine requirements. Additionally, there the regulations do not prevented a health care facility from creating their own requirements on vendors that do not have an existing contract with the facility.
The ICF amends the existing Conditions or Participation / Conditions for Coverage for the following facilities:
The IFC requires facilities to develop and implement policies and procedures to ensure that all staff are fully vaccinated for COVID-19. Exclusions from the requirement are permitted for staff (or contactors) who have pending requests for, or who have been granted, exceptions to the vaccine requirements or those staff for whom COVID-19 vaccinations must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.
Staff is defined to include employees, as well as licensed practitioners, students, trainees, volunteers, and “[i]ndividuals who provide care, treatment, or other services for the facility and/or its patients, under contract or by other arrangement.”
The IFC excludes (1) staff that exclusively provide telehealth/telemedicine services outside of the facility setting and that do not have direct contact with patients and (2) staff that provide support services exclusively outside of the facility setting and that do not have direct contact with patients.
The IFC defines an individual as fully vaccinated when 2 weeks or more has passed since the staff completed a primary vaccination series for COVID-19. That can be either the administration of a single-dose vaccine or the administration of all required doses of a multi-dose vaccine. It does not include booster shots.
Facilities directly regulated by the COPs/CfCs will have to have policies and procedures to implement the requirement. Among these requirements is a process for ensuring the implementation of additional precautions, intended to mitigate transmission and spread of COVD-19, for all staff (and contractors) who are not fully vaccinated. There are also contingency planning requirements and documentation and tracking requirements.
The IFC provides facilities 30 days to make sure that staff have received at least the first dose of a primary series or a single dose of COVID-19 vaccine prior the staff providing any care, treatment, or other services for the facility and/or its patients. Within 60 days, the facility must ensure that staff have completed the primary vaccination services (except for those who have been granted an exemption or exclusion).
CMS will enforce the regulations through the existing onsite compliance review process with state survey agencies. Accreditation organizations will also be required to update their survey processes. If a facility is not in compliance, the existing enforcement remedies related to the COPs/CfCs, which can include termination from the Medicare program, will apply.
The rule preempts state law under Article VI § 2 of the U.S. Constitution.
The rule takes effect November 5, but stakeholders have 60 days to provide comments with comments due by January 4, 2022.
From CMS on September 24, 2021
CMS Will Pay for COVID-19 Booster Shots, Eligible Consumers Can Receive at No Cost
Coverage without cost-sharing available for eligible people with Medicare, Medicaid, CHIP, and Most Commercial Health Insurance Coverage
Following the Food and Drug Administration’s (FDA) recent action that authorized a booster dose of the Pfizer COVID-19 vaccine for certain high-risk populations and a recommendation from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS) will continue to provide coverage for this critical protection from the virus, including booster doses, without cost sharing.
Beneficiaries with Medicare pay nothing for COVID-19 vaccines or their administration, and there is no applicable copayment, coinsurance or deductible. In addition, thanks to the American Rescue Plan Act of 2021 (ARP), nearly all Medicaid and CHIP beneficiaries must receive coverage of COVID-19 vaccines and their administration, without cost-sharing. COVID-19 vaccines and their administration, including boosters, will also be covered without cost-sharing for eligible consumers of most issuers of health insurance in the commercial market. People can visit vaccines.gov (English) or vacunas.gov (Spanish) to search for vaccines nearby.
“The Biden-Harris Administration has made the safe and effective COVID-19 vaccines accessible and free to people across the country. CMS is ensuring that cost is not a barrier to access, including for boosters,” said CMS Administrator Chiquita Brooks-LaSure. “CMS will pay Medicare vaccine providers who administer approved COVID-19 boosters, enabling people to access these vaccines at no cost.”
CMS continues to explore ways to ensure maximum access to COVID-19 vaccinations. More information regarding the CDC COVID-19 Vaccination Program Provider Requirements and how the COVID-19 vaccine is provided through that program at no cost to recipients is available at https://www.cdc.gov/
###
Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter @CMSgov
The Biden Administration Issues Several Executive Orders Requiring Mandatory COVID-19 Vaccination
On September 9, 2021, the Biden Administration issued several Executive Orders which impact more than 100 million workers in an effort to end the COVID-19 pandemic. The two Executive Orders, Executive Order on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees and Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors were highlighted during a Presidential press conference.
During his announcement, President Biden said that there are more than 80 million Americans, who are not vaccinated. As a result he stated that “it is essential that Federal employees take all available steps to protect themselves and avoid spreading COVID-19 to their co-workers and members of the public.” Additionally, the President stated he issued these orders “to promote the health and safety of the Federal workforce and the efficiency of the civil service, it is necessary to require COVID-19 vaccination for all Federal employees, subject to such exceptions as required by law.”
The orders will require that all Federal employees and employees of Federal Contractors mandate vaccination. The President stated that if businesses and individuals want to work with the federal government, they must be vaccinated. Under the order, The Safer Federal Workforce Task Force (Task Force), will issue guidance to all covered agencies consistent with these Orders within seven (7) days.
The President also announced that the U.S. Department of Labor (U.S. DOL) will be issuing emergency rules that will require employers of 100 or more employees to require vaccination or mandatory weekly COVID-19 testing for all workers. Additionally, the President announced that he is expanding requirements for employers to provide paid leave to employees so that they can obtain the COVID-19 vaccinations. He provided no details on how much the paid leave requirement will be expanded.
Lastly, the Centers for Medicare and Medicaid Services (CMS) announced that it will be expanding the vaccination requirements for healthcare facilities that bill Medicare. Currently, the Biden Administration requires that all long-term care staff working for facilities that bill Medicare must be vaccinated against COVID-19. In the latest announcement, CMS stated that it will be expanding the mandatory vaccination requirements to other Medicare-certified facilities, including hospitals, dialysis facilities, ambulatory surgical settings, and home health agencies, and others, as a condition for participating in the Medicare and Medicaid programs. CMS is developing an Interim Final Rule with Comment Period that will be issued sometime in October.
The President’s expanded COVID-19 plan follows numerous states, such as Connecticut, Rhode Island, California, Massachusetts, and several others that have already enacted mandatory vaccination requirements for healthcare, county or municipal, and long-term care workers. Many of states that have enacted mandatory vaccination requirements provided for no vaccination exceptions, or made provisions for medical exceptions to the vaccination requirements.
We will not know the specific vaccine mandate requirements under these new rules until the Task Force, the U.S. DOL, and CMS publishes these emergency rules. It is important for employers to understand that they are still required to engage any employee seeking an accommodation from the mandatory vaccination requirements in the interactive process as required under the Americans with Disabilities Act (ADA) or Title VII of the Civil Rights Act. We recommend employers follow a consistent documented process and seek legal advice when handling any accommodation requests.
We will continue to monitor developments with these new requirements. Be sure to contact the AAA if you have questions about these Executive Orders or need assistance in ensuring you are in compliance.
From EMS.gov on August 27, 2021
To assist EMS agencies in planning, the NHTSA Office of EMS and HHS Office of the Assistant Secretary for Preparedness and Response have developed a template protocol for state EMS offices and EMS Medical Directors to use to assist in these programs. Some states have created blanket state-level authorizations for EMS administration; some states will still require provider authorization prior to administration. Please follow local protocols and regulations. This template is only designed to facilitate the development of those local protocols as needed. Please contact the NHTSA Office of EMS with any questions.
From CMS on August 25, 2021
Today, the Centers for Medicare & Medicaid Services (CMS) released two new resources with information on Medicare beneficiaries on whose behalf at least one fee-for-service (FFS) claim for the administration of the COVID-19 vaccine has been submitted to the Medicare program.
First, we released a paper titled Assessing the Completeness of Medicare Claims Data for Measuring COVID-19 Vaccine Administration. This paper presents preliminary findings on the count of individuals ages 65 and older with at least one COVID-19 vaccine administration claim in the Medicare data compared to the count of people 65+ with at least one COVID-19 vaccine dose in the data reported by the Centers for Disease Control and Prevention (CDC). Using data as of June 4th, 2021, we estimate that CMS received a claim for COVID-19 vaccine administration for roughly half of Medicare beneficiaries who have received at least one COVID-19 vaccine dose as compared to the estimated counts based on adjusted CDC figures (17.5 million out of 36.6 million). As a result, we recommend that the public apply significant caution when analyzing COVID-19 vaccine administration trends using Medicare claims data.
Second, we released the Medicare COVID-19 Vaccine Public Use File (PUF) which presents a high-level and preliminary overview of Medicare utilization and spending information from Medicare FFS claims for the administration of the COVID-19 vaccine. The PUF shows that between December 11, 2020 and June 30, 2021, Medicare payments for administration of the COVID-19 vaccine were over $1.1 billion. The PUF is based on Medicare FFS claims CMS received by August 6, 2021.
[Note: The Medicare FFS program is paying for COVID-19 vaccine administration on behalf of MA beneficiaries as well as for FFS beneficiaries receiving COVID-19 vaccinations in 2020 and 2021.]
From CMS on June 9, 2021
As part of President Biden’s commitment to increasing access to vaccinations, CMS announced an additional payment amount for administering in-home COVID-19 vaccinations to Medicare beneficiaries who have difficulty leaving their homes or are otherwise hard-to-reach. This announcement further demonstrates continued efforts of the Biden-Harris Administration to meet people where they are and make it as easy as possible for all Americans to get vaccinated. There are approximately 1.6 million adults 65 or older who may have trouble accessing COVID-19 vaccinations because they have difficulty leaving home.
While many Medicare beneficiaries can receive a COVID-19 vaccine at a retail pharmacy, their physician’s office, or a mass vaccination site, some beneficiaries have great difficulty leaving their homes or face a taxing effort getting around their communities easily to access vaccination in these settings. To better serve this group, Medicare is incentivizing providers and will pay an additional $35 per dose for COVID-19 vaccine administration in a beneficiary’s home, increasing the total payment amount for at-home vaccination from approximately $40 to approximately $75 per vaccine dose. For a two-dose vaccine, this results in a total payment of approximately $150 for the administration of both doses, or approximately $70 more than the current rate.
“CMS is committed to meeting the unique needs of Medicare consumers and their communities – particularly those who are home bound or who have trouble getting to a vaccination site. That’s why we’re acting today to expand the availability of the COVID-19 vaccine to people with Medicare at home,” said CMS Administrator Chiquita Brooks-Lasure. “We’re committed to taking action wherever barriers exist and bringing the fight against the COVID-19 pandemic to the door of older adults and other individuals covered by Medicare who still need protection.”
Delivering COVID-19 vaccination to access-challenged and hard-to-reach individuals poses some unique challenges, such as ensuring appropriate vaccine storage temperatures, handling, and administration. The CDC has outlined guidance to assist vaccinators in overcoming these challenges. This announcement now helps to address the financial burden associated with accommodating these complications.
The additional payment amount also accounts for the clinical time needed to monitor a beneficiary after the vaccine is administered, as well as the upfront costs associated with administering the vaccine safely and appropriately in a beneficiary’s home. The payment rate for administering each dose of a COVID-19 vaccine, as well as the additional in-home payment amount, will be geographically adjusted based on where the service is furnished.
As this action demonstrates, a person’s ability to leave their home should not be an obstacle to getting the COVID-19 vaccine. As states and the federal government continue to break down barriers – like where vaccines can be administered – resources for connecting communities to vaccination options remain key. Unvaccinated individuals and those looking to assist friends and family can:
The federal government is providing the COVID-19 vaccine free of charge or with no cost-sharing for all people living in the United States. As a condition of receiving free COVID-19 vaccines from the federal government, vaccine providers cannot charge patients any amount for administering the vaccine.
Because no patient can be billed for COVID-19 vaccinations, CMS and its partners have provided a variety of information online for providers vaccinating all Americans regardless of their insurance status:
The Biden-Harris Administration is providing free access to COVID-19 vaccines for every adult living in the United States. For individuals who are underinsured, providers may submit claims for reimbursement for administering the COVID-19 vaccine through the COVID-19 Coverage Assistance Fund administered by HRSA after the claim to the individual’s health plan for payment has been denied or only partially paid. Information is available at https://www.hrsa.gov/covid19-coverage-assistance.
For individuals who are uninsured, providers may submit claims for reimbursement for administering the COVID-19 vaccine to individuals without insurance through the Provider Relief Fund, administered by HRSA. Information on the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program is available at https://www.hrsa.gov/CovidUninsuredClaim.
More information on Medicare payment for COVID-19 vaccine administration – including a list of billing codes, payment allowances and effective dates – is available at https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
More information regarding the CDC COVID-19 Vaccination Program Provider Requirements and how the COVID-19 vaccine is provided through that program at no cost to recipients is available at https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html.
From Rob Lawrence’s EMS One Stop Podcast at EMS1
The American Ambulance Association HR Consultant discusses options open to EMS managers to ensure providers are vaccinated
The word of the week is vaccine, but is it giving EMS leaders a headache already? Host Rob Lawrence discusses the issues with American Ambulance Association HR Consultant, Scott Moore. Rob and Scott discuss the options open to managers to ensure all are vaccinated, while acknowledging the hope that science and understanding will prevail. They also discuss the other major news item of the week, EMS funding and the lack of it as reduced incomes put the very viability of service delivery at risk.
Scott Moore is a Massachusetts licensed attorney and possesses certifications as both a Professional in Human Resources (PHR) and the Society for Human Resources Management Certified Professional (SHRM-CP). He is a member of the American Bar Association (ABA), the Massachusetts Bar Association (MBA), the Northeast Human Resource Association (NEHRA), and the Society for Human Resource Management (SHRM).
In addition, Scott is an active member of the American Ambulance Association and has been a site reviewer for the Commission for the Accreditation of Ambulance Services (CAAS) for many years.
Read Rob’s article, “The word of the week is vaccine,” and listen to the podcast below.
As reported in various media outlets, on December 1 the Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted 13-1 to recommend that health care providers, expressly including EMS personnel, be prioritized to receive the COVID-19 vaccines during Phase 1a of the vaccine distribution plan. The complicating factor is that State and local governments have the final say in whether these recommendations are incorporated into their own distribution plans. Thus, we encourage all AAA members to engage actively with their State and local governments to urge the adoption of the CDC recommendation. The AAA has developed a toolkit for members to use in reaching out to their state and local government officials.
View and Download Toolkit Here►
The AAA has been engaging with ACIP and other federal policy makers to urge them to prioritize EMS in the vaccine distribution plan. On November 19, the AAA submitted a comment letter to the ACIP advocating that the advisory committee specifically include EMS personnel in their recommendation of groups in the first phase of receiving the vaccination. Even though States and local governments will create their own list, having EMS listed in Phase 1a CDC recommendations is a critically important step toward influencing the State and local process.
During its second emergency meeting in less than a month, ACIP met to develop recommendations on the prioritization of vaccines, given that it will be impossible to provide access to everyone in the United States immediately after the vaccines are approved. In both virtual meetings, Committee members noted the importance of EMS personnel having access to the vaccine in the very top tier for prioritization. Other health care personnel on this list are defined as hospitals, long-term care facilities, outpatient clinics, home health care, pharmacies, and public health. The Phase 1a tier also includes residents of nursing homes, assisted living facilities, and other residential care settings, given that approximately 40 percent of all COVID-19 deaths have occurred in these settings. The final recommendation approved states:
When a COVID-19 vaccine is authorized by FDA and recommended by ACIP, vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a) should be offered to both 1) health care personnel§ and 2) residents of long-term care facilities.
Health care personnel are defined as paid and unpaid persons serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials.
Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently.
The CDC plans to publish this recommendation in the Morbidity Mortality Weekly Report as well.
The only controversial issue related to whether long-term care facility residents should receive the vaccine given the limited information available about its effectiveness and safety in these populations.
Because President Trump has indicated that State and local governments do not have to follow the CDC recommendations, it is critically important that AAA members work closely with their State and local governments to ensure that the CDC recommendations with regard to EMS are adopted by them as well. The AAA has posted a tool kit on our website to help our members provide the necessary information to their State and local governments as they are making these decision.
ACIP will continue to evaluate the distribution prioritization for Phase 1b, which will likely be non-health care essential workers, and Phase 1c, which will include adults with high-risk medical conditions and adults 65 years or older.