Archive for Coronavirus

Supreme Court Rules on Vaccine Mandates

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Supreme Court Rules on Vaccine Mandates

By: Brandy A. Boone, General Counsel of the Medical Association of the State of Alabama

The US Supreme Court (“the Court”) recently released differing opinions on the two-part Biden administration vaccine mandate.  In Biden v. Missouri1, the Court lifted a US District Court’s stay on enforcement of the Department of Health and Human Services’ (HHS) rule amending CMS Conditions of Participation to require covered staff to be vaccinated for COVID-19.  The Court took the opposite approach in National Federation of Independent Business v. Department of Labor2, by enjoining the enforcement of an OSHA standard requiring employers with at least 100 employees to require covered workers to be vaccinated.

The CMS rule, more commonly known as the healthcare worker vaccine mandate, was issued as an interim final rule for facilities regulated by CMS Conditions of Participation, including hospitals and long-term care facilities.   The rule requires covered facilities to have a plan for vaccinating all staff, a plan for the provision of medical and religious exemptions, and a plan for tracking and monitoring vaccinations and exemptions.  Because physician offices are not facilities regulated by CMS Conditions of Participation, this rule does not apply to physician offices or healthcare workers who work in physician offices, unless they are also on staff at a covered facility.

A number of states, including Alabama, filed lawsuits seeking injunctions to the enforcement of the healthcare worker vaccine mandate.  Those lawsuits were consolidated into two federal court actions, and in both, the federal district courts issued stays to enforcement.  The federal government petitioned the corresponding federal circuit courts for relief from the stays, and relief was denied in both courts. Following the circuit court denials, the government petitioned the US Supreme Court for the same relief, and the Court agreed to hear the specific issue of whether to lift the preliminary injunction.  

The Court issued a per curiam opinion on January 13, 2022, granting the government’s petition and lifting the US District Court’s stay on enforcement of the vaccine mandate. The Court noted in a 5-4 decision that the Department of Health and Human Services (HHS) is the administering agency for Medicare and Medicaid programs, and thus the HHS Secretary is charged by federal law to develop regulations to aid in efficient administration of those programs and to protect the health and safety of individuals served by them.  The Court also agreed that that the HHS Secretary was within his authority in issuing the vaccine mandate in an interim final rule, rather than through a usual notice and comment period, because of the highly infectious nature of COVID-19, and the particular vulnerability of populations served by Medicare and Medicaid. 

Although the Court lifted the preliminary injunction on enforcement of the healthcare worker vaccine mandate, it only ruled on that specific issue, so the state lawsuits to stop enforcement are back in the federal circuit courts, pending the federal government’s appeal, and a possible writ of certiorari.  However, the rule will remain in effect and enforceable pending the appeal and possible writ.  The Court’s opinion did not address or affect the available religious and medical exemptions to the rule, and it did not expand the scope of the rule beyond healthcare facilities with conditions of participation for Medicare and Medicaid Services, so it still does not apply to physician clinics or offices.

The other vaccine mandate, not specific to healthcare, came through the Occupational Safety and Healthcare Administration (“OSHA”), under the auspices of the Department of Labor.  OSHA enacted a temporary emergency standard covering employers with at least 100 employees.  The standard requires worker vaccinations, with no exceptions, other than daily masking and weekly testing at the employee’s expense.  

This new standard was challenged by states and business organizations in several federal courts, and one federal circuit court entered a stay on enforcement.  When all of the cases were consolidated under another federal circuit court, that court lifted the stay so the rule could go into effect.  The Supreme Court accepted an emergency petition from the states and business leaders on whether to impose a preliminary injunction on enforcement of the rule, pending the resolution of lawsuits consolidated with the Sixth Circuit Court of Appeals.

On the same day the Court lifted the stay on the healthcare worker vaccine mandate, the Court granted a stay of enforcement of the OSHA worker vaccine mandate.  In another per curiam opinion, this time a 6-3 decision, the Court reasoned that federal law authorizes OSHA to regulate workplace safety, but that Congress has not given OSHA specific authority to regulate “broad public health measures.”  Finding that while there is COVID-19 infection risk in the workplace, those risks are not relegated just to the workplace, and therefore, OSHA exceeded Congressional authority in enacting its temporary emergency standard requiring worker vaccinations.

As with the healthcare worker vaccine mandate, the Court’s ruling does not end the rule or the challenge to the rule.  The Court has stayed enforcement of this OSHA standard until the disposition of the legal challenges in the Sixth Circuit Court of Appeals and any potential writ of certiorari. 

  1.  Biden v. Missouri, Nos 21A240 and 21A241 (2022); https://www.supremecourt.gov/opinions/21pdf/21a240_d18e.pdf

National Federation of Independent Business v. Department of Labor, Nos 21A244 and 21A247 (2022);

https://www.supremecourt.gov/opinions/21pdf/21a244_hgci.pdf
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CMS Issues COVID-19 Health Care Staff Vaccination Interim Final Rule

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CMS Issues COVID-19 Health Care Staff Vaccination Interim Final Rule

by Lindsey Phillips, Burr & Forman, LLP

On November 4, 2021, the Centers for Medicare & Medicaid Services (“CMS”) announced its interim final rule regarding vaccination requirements for eligible staff of certain healthcare providers. The rule, which becomes effective on November 5, 2021, is expected to apply to approximately 76,000 healthcare providers and cover over 17 million healthcare workers across the United States.

What Are the New Requirements?

The Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (“IFC”) contains three primary requirements for covered providers:

  1. A plan for fully vaccinating all eligible staff.
  2. A plan for providing exemptions and accommodations for those who are exempt from vaccinations.
  3. A plan for tracking and documenting staff vaccinations.

Who Is Covered by the Requirements?

The vaccination requirements apply to eligible staff of Medicare and Medicaid-certified healthcare providers and supplier types that are subject to CMS’s health and safety regulations, which are commonly known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements of Participation. Covered providers include:

  • Ambulatory Surgery Centers
  • Clinics
  • Community Mental Health Centers
  • Comprehensive Outpatient Rehabilitation Facilities
  • Critical Access Hospitals
  • End-Stage Renal Disease Facilities
  • Home Health Agencies
  • Home Infusion Therapy Suppliers
  • Hospices
  • Hospitals
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities
  • Long-Term Care Facilities
  • Programs for All-Inclusive Care for the Elderly Organizations (PACE)
  • Psychiatric Residential Treatment Facilities (PRTFs)
  • Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Rural Health Clinics/Federally Qualified Health Centers
  • Rehabilitation Agencies

Of note, the requirements do not apply to Assisted Living Facilities, Group Homes, Home and Community-based Services, or physician’s offices. Additionally, Religious Nonmedical Health Care Institutions (RNHCIs), Organ Procurement Organizations (OPOs), and Portable X-Ray Suppliers are excluded. 

Please note that while physician’s offices are not covered by this mandate, physicians who practice at facilities that are covered by the mandate may be impacted. For example, while an anesthesiology private physician practice may not be subject to the mandate, the hospital where the anesthesiologist is on medical staff and provides certain services is subject to the mandate. As a provider who provides care within the hospital, the anesthesiologist would be subject to the vaccine mandate. 

Who Are Eligible Staff?

The vaccination requirements apply to staff members who provide any care, treatment, or other services for a covered provider or its patients. This includes individuals who provide care, treatment, or other services for the covered provider or its patients under contract or other similar arrangements. Examples of eligible staff include, but are not necessarily limited to:

  • Employees
  • Licensed practitioners
  • Students
  • Trainees
  • Volunteers

While the vaccination requirements do not apply to full time teleworkers (i.e. those who provide services 100% remotely and have no contact whatsoever with patients and other staff members), the requirements do apply to staff who work offsite and have contact with patients or other staff, such as home health providers. Additionally, the requirements apply to physicians admitting or treating patients in-person within a covered provider. For example, a physician who enters a long-term care facility or hospital to treat patients would need to be vaccinated.

What Exactly Does the New Rule Require? 

Plan for Vaccination

Covered providers must implement a plan for full vaccination of their eligible staff by December 5, 2021. Phase 1 requires that all eligible staff of covered providers have the first dose of a primary series or a single dose COVID-19 vaccine by December 5, 2021. Phase 2 requires that all eligible staff of covered providers complete the primary vaccination series by January 4, 2022. The completion of a primary vaccination series is defined as the administration of a single-dose vaccine (such as the Johnson & Johnson COVID-19 vaccine) or the administration of all required doses of a multi-dose vaccine (such as the Pfizer-BioNTech COVID-19 vaccine or the Moderna COVID-19 vaccine). Although additional doses of the vaccine are currently recommended to some individuals, the IFC does not require that staff receive booster doses to be fully vaccinated.

Plan for Providing Exemptions and Accommodations 

Because CMS has acknowledged that there may be limited circumstances when exemptions to the vaccination requirements are appropriate, covered providers must also implement a plan that establishes exceptions to the vaccine requirements. As a reasonable accommodation under the Americans with Disabilities Act (ADA), CMS requires covered providers to allow exemptions for eligible staff members who have medical conditions for which vaccines are contraindicated. Covered providers have the flexibility to establish their own processes that permit eligible staff to request medical exemptions. Any medical exemption must be signed and dated by a licensed practitioner. The documentation must also include information that specifies which of the authorized COVID-19 vaccines are clinically contraindicated and the recognized clinical reasons for the contraindications.

CMS also requires covered providers to allow exemptions for religious beliefs, observances, and practices, as part of the requirements of Title VII of the Civil Rights Act of 1964. Similar to medical exemptions, covered providers have the flexibility to establish their own processes that permit staff to request religious exemptions. Covered providers are encouraged to review the Equal Employment Opportunity Commission’s Compliance Manual on Religious Discrimination when determining whether an individual’s request for a religious exemption is valid. 

Plan for Documentation

As part of the IFC, covered providers must also implement a plan for tracking and documenting staff vaccinations. The IFC does not, however, establish any new data reporting requirements. Hospitals and long-term care facilities are expected to continue complying with their current facility-specific data reporting requirements.

How Will CMS Enforce the IFC?

CMS has stated that it will work with State Survey Agencies to regularly review compliance with the IFC. State survey agencies will assess all covered providers for compliance with the requirements during standard recertification surveys and will also assess for compliance during complaint surveys. 

How Does the IFC Interact with Other Rules?

On November 4, 2021, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) announced its COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS), which applies to employers with 100 or more employees. To the extent that the IFC contradicts any other rule, covered providers should look to the IFC first. In other words, if a healthcare provider participates in and is certified under the Medicare and Medicaid programs and is regulated by Conditions of Participation, Conditions for Coverage, or Requirements for Participation, then the covered provider must abide by the requirements set forth in the CMS Omnibus Staff Vaccination Rule. Similarly, this rule pre-empts any state law to the contrary.

The IFC is open for comment until January 4, 2022. All stakeholders are encouraged to submit feedback. 

For more information, please contact Lindsey Phillips at lphillips@burr.com or at (205) 458-5370. 

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NEW STATE OF EMERGENCY PROVIDES HEALTHCARE PROVIDER FLEXIBILITIES

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NEW STATE OF EMERGENCY PROVIDES HEALTHCARE PROVIDER FLEXIBILITIES

By Angie Cameron Smith with Burr & Forman, LLP

On July 6, 2021 Governor Kay Ivey allowed the State of Emergency in Alabama to expire.  She had previously proclaimed a State of Emergency due to the COVID-19 Pandemic effective March 13, 2020.  Along with that proclamation, came the invocation of Alabama’s Emergency Management Act.  When the state of emergency ended, so did the waivers or suspension of state regulatory requirements that were afforded to healthcare providers operating during the pandemic.  Due to the spike in COVID-19 cases, which appear to be related to the Delta variant, Governor Ivey proclaimed a new State of Emergency effective August 13, 2021.  Why does this matter?  Because many of the expired waivers that allowed for flexibilities for healthcare providers have now been renewed under the new State of Emergency.

Under Governor Ivey’s August 13 proclamation and pursuant to the authority granted to her under the Emergency Management Act, she cut “red tape for health care providers.”  The emergency proclamation removes barriers to allow additional healthcare providers and resources to address the surge in cases and is focused primarily on staffing at acute care hospitals.  The following apply to general acute care hospitals, critical access hospitals or specialized hospitals licensed by the Alabama Department of Public Health:  

  • A hospital’s chief of the medical staff or medical director may collaborate with or supervise an unlimited number of certified registered nurse practitioners (CRNP), certified nurse midwives (CNM); physician assistants (PA) and anesthesiology assistants (AA), and provide direction to an unlimited number of certified registered nurse anesthetists (CRNA);
  • CRNPs, CNMs, PAs and AAs working under the supervision of the chief of the medical staff at a hospital may implement the standard protocol and formulary approved by the Alabama Board of Medical Examiners;
  • CRNAs under direction of, and AAs under registration with, a hospital’s chief of the medical staff or medical director or his/her physician designee, are authorized to determine, prepare, monitor or administer legend and controlled medications for performance of anesthesia-related services, airway management (related or unrelated to anesthesia), and other acute care services within their scope of practice.
  • CRNPs, CNMs and CRNAs who possess an active, unencumbered nurse license or equivalent advanced practice approval issued by an appropriate licensing board of another state, the District of Columbia, or Canada, are authorized to practice in covered hospitals as if licensed in Alabama; and
  • Alabama’s Board of Pharmacy, Board of Nursing, Medical Licensure Commission, and State Board of Medical Examiners are authorized to adopt emergency rules to allow for expedited licensure and/or temporary permits for individuals possessing unencumbered licenses in other states.  At this time, this is limited to those practitioners providing care in inpatient units, emergency departments or other acute care units within acute care hospitals, critical access hospitals or specialized hospitals.

Another flexibility afforded under the Governor’s new proclamation is the authorization granted to the State Health Planning and Development Agency (SHPDA) to invoke the emergency rule passed last legislative session to allow for the issuance of emergency Certificates of Need.  This waiver was effective during the last Public Health Emergency to permit facilities to create alternate care sites.  Alternate care sites allow for a healthcare facility to convert parts of or entire facilities to provide care for which is not originally authorized.  For example, while hospitals struggle for placement of patients and surge capacities, these waivers would allow hospitals to create or use space not normally used for patient care or acute patient care.  Other healthcare providers may also seek waivers under the SHPDA Emergency Rule.  Under the previous health emergency skilled nursing facilities were able to transfer patients who did not require acute care but were in need of isolation and observation due to COVID to areas in a hospital not being used.  More information about alternate care sites can be found at https://www.alabamapublichealth.gov/covid19/assets/cov-adph-alt-care-site-app.pdf and http://shpda.alabama.gov/REQUEST%20FOR%20WAIVER%20Fillable%20Form.pdf.   

Another important aspect of the State of Emergency proclamation is the application of an alternative standard of care.  When evaluating whether a healthcare provider has breached the standard of care in a medical malpractice case, the analysis involves what a reasonable person would do in like or similar circumstances.  Under the alternative standards of care, if a provider has invoked its emergency operation plan in response to the public health emergency, it can implement alternative standards of care and those standards are “declared to be state-approved standard of care in healthcare facilities.” 

You may also recall that during the last legislative session there was an immunity statute passed to provide liability protections to healthcare providers and businesses during the COVID-19 pandemic.  This immunity statute should be unaffected by the gap between the last state of emergency ending on July 6, 2021, and the new state of emergency invoked on August 13, 2021.

The federal public health emergency (PHE) and the waivers under the U.S. Secretary of Health and Human Services Section 1135 declaration is also unaffected by the state of emergency.  The current federal PHE is set to last through October 18, 2021, with some indication from the federal administration that it will continue through the end of the year.

Angie Smith is a partner at Burr & Forman LLP and practices in the Healthcare Industry Group. Angie may be reached at (205) 458-5209 or acsmith@burr.com.

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Not a “Rock Throwing” Committee; Pandemic Response Task Force Holds First Meeting

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On Thursday, July 1, the first meeting of a legislatively-created task force to examine the state’s response to the COVID-19 pandemic was held in Montgomery.  During the 2021 Legislative Session, amidst a flurry of bills being introduced related to the pandemic (like Sen. McClendon’s bill to abolish the position of State Health Officer and abolish the State Committee of Public Health), the Medical Association asked state lawmakers to “press pause” on any such bills until an out-of-session, full and complete analysis of pandemic response could be completed.  That request was largely honored, and a task force was created to do just that. 

At the task force’s inaugural meeting, Gov. Kay Ivey, Senate President Pro Tem Greg Reed and House Speaker Mac McCutcheon addressed members of the task force.  All three agreed the past year created unprecedented challenges for Alabamians and that while there may have been and in some instances may continue to be disagreement among some regarding how the state handled certain things, the desire of the Governor, Sen. Reed and Speaker McCutcheon was for the task force to identify positive steps the state can take for the future.  Sen. Reed reminded the group there wasn’t a “manual” for how to manage a global pandemic within Alabama but that he wanted their help in moving the state forward.  

“We aren’t interested in rock throwing here,” Sen. Reed said.  “We want this group to identify how Alabama can be better prepared for the next pandemic.”

Speaker McCutheon echoed his words, adding COVID-19 had continued to change so rapidly that it made responding effectively difficult at times. He thanked State Health Officer Dr. Scott Harris and the Governor for their work and leadership during the pandemic.  Speaker McCutcheon said he wanted to be sure the task force had “facts to promote our [recommended] actions.”

In her remarks, Gov. Ivey encouraged Alabamians who haven’t been vaccinated to do so and outlined the “team effort” between her administration, Dr. Harris and the Health Department, Director Brian Hastings and the state Emergency Management Department and others.  She also acknowledged that business closures, the many lives lost and setbacks in education as some of the most difficult effects of the pandemic.  

“The response to the pandemic wasn’t perfect,” Gov. Ivey said, “and we regret some of the decisions made but [ultimately] we prevailed.” 

Task force co-chair Sen. Tim Melson, M.D., said his intention was for the task force to be a “fact-finding and not a fault-finding committee.”  Rep. Paul Lee, House Health Chairman and co-chair of the task force, said COVID-19 had been “a moving target” and that “hindsight is 20/20”.  Both Sen. Melson and Rep. Lee welcomed ideas from committee members and the public as to how to improve Alabama’s pandemic response moving forward.  The task force plans to meet again before the end of the summer.  

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Alabama Doctors Host Two Telethons to Answer Viewers’ Questions About COVID-19 Vaccines

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Alabama Doctors Host Two Telethons to Answer Viewers’ Questions About COVID-19 Vaccines

Last Thursday, doctors with the Medical Association of the State of Alabama and the Alabama Chapter of the American Academy of Pediatrics answered questions from over 200 callers about the safety and effectiveness of COVID-19 vaccines during newscasts on WBRC Fox 6.

Yesterday another group of our physicians went live on air with WKRG in Mobile and answered hundreds of more calls in regard to the vaccine.

Viewers of the television stations’ newscasts were invited to call in and speak one-on-one with a doctor about the vaccines.

“We were grateful for this opportunity to answer questions, allay fears and encourage people to get vaccinated.  It’s perfectly understandable to have questions and want more information.  As physicians, we want to do all we can to answer those questions and assure people that the vaccines are safe and effective,” said Dr. Aruna Arora, the President of the Medical Association.

Many callers had questions about the potential side effects of the vaccines, as well as how getting vaccinated could affect their underlying medical conditions.  Others asked how long protection from a COVID-19 vaccine lasts, if the vaccines are safe for children, and if they needed to get vaccinated after already having had COVID.

The Medical Association and the Alabama Chapter of the American Academy of Pediatrics are planning to do more vaccine call-in programs with television stations throughout the state. 

“We want to do all we can to help people get factual information about the vaccines,” said Dr. Arora.

In addition to Dr. Arora, other doctors who participated in the effort in Birmingham were: Dr. Hernando Carter, Dr. Aubrey Coleman, Dr. Candice Dye, Dr. Michael Saag, and Dr. Wesley Willeford.

Physicians who participated in Mobile included Dr. Michael Chang, Dr. Nina Ford Johnson, Dr. Peter Lutz, Dr. Katrina Skinner, and Dr. Prince C. Uzoije. Thank you to all who were involved!

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Are You Ready for Your PPP Loan Audit?

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Are You Ready for Your PPP Loan Audit?

By: Jim Hoover, Burr & Forman

PPP loans received by individuals and businesses under the CARES Act will be audited (“reviewed”) by the SBA.  PPP loans of $2 million or more will automatically be audited by the SBA.  Many PPP loans of less than $2 million will also be audited.

Borrowers will often receive notification of the audit through their lending bank, but the SBA is directly notifying PPP borrowers as well.  The SBA is receiving support from the Internal Revenue Service and other federal agencies in these audits such as the Department of Justice.  There have been several criminal investigations resulting from these audits.

PPP loan audits request documents and information from the borrower, including income and employment tax returns, payroll records, financial statements, and bank account statements including deposit and payment information in order to verify information reported by the borrower on its PPP loan application.  However, the SBA PPP loan audits focus on much more.

SBA audits of PPP loans have thus far focused on whether the individual or business was eligible to receive a PPP loan, and whether the borrower correctly calculated its PPP loan amount.  Specific issues being reviewed by the SBA in these audits include “economic necessity” for a PPP loan, and “head-count” related issues including affiliation with other businesses, the appropriate “NAICS” code for the business, and whether the business counted all employees – full-time, part-time, and even temporary – in filing the loan application.  The SBA is also looking at other “business-specific” issues of the borrower.

The PPP loan application contains a borrower certification that “[c]urrent economic uncertainty makes this loan request necessary to support the ongoing operations of the Applicant“.  This same certification is also required in new PPP loan applications under the “Economic Aid Act”.  For borrowers that received PPP loans of less than $2 million, the borrower is deemed by the SBA to have made this “economic necessity” certification in “good faith.” As a result, the SBA may not be looking specifically at this issue for borrowers that received loans of less than $2 million.  However, for PPP loans of $2 million or more, borrowers are not eligible for this “good faith economic necessity presumption”, and the SBA is auditing this certification issue.

Without being an alarmist, false certifications is the keystone issue for most False Claims Act prosecutions.  Accordingly, it is important for borrowers to carefully review and gather the documentation that supports the certification.  

The SBA is beginning many audits by sending out a “Loan Necessity Questionnaire” (SBA Form 3509), which the SBA first sends to the lending bank and then the bank sends the questionnaire to the borrower.  The borrower has a limited amount of time, 10 days, to complete and return the questionnaire to the bank, and the bank then provides the completed questionnaire to the SBA.

If a borrower applies for forgiveness of a PPP loan, the forgiveness application may be separately reviewed by the SBA and, as a practical matter, if a borrower files for forgiveness this will likely trigger or at least accelerate a full SBA audit of the PPP loan.

Once an SBA PPP loan audit is completed, and where an adverse audit determination is made by SBA, including that the borrower may not qualify for the loan, the borrower then has administrative appeal rights within the SBA to have the audit determination reviewed, which can lead to a hearing before a federal administrative law judge. Those appeal rights are the subject of a future article.  

______________________

Jim Hoover is a partner at Burr & Forman LLP and works exclusively within the firm’s Health Care Practice Group and predominantly handles healthcare litigation. Burr & Forman has a dedicated team to counsel individuals and businesses in government audits, investigations and defense-related to the PPP under the CARES Act, and also new PPP loans under the Economic Aid Act. The PPP and CARES Act Audit, Investigations and Defense Team represents and advises clients in audits and investigations involving PPP loans and tax benefits that may have been claimed under the CARES Act. This multidisciplinary team combines more than 230 years of legal experience and attorneys with previous government positions, including attorneys with IRS Chief Counsel, the United States Department of Justice, and United States Attorneys’ Offices.  More information can be found at www.burr.com.

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Op-ed: Alabama physicians face challenges head-on during vaccine rollout

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Op-ed: Alabama physicians face challenges head-on during vaccine rollout

By: John Meigs, Jr., MD, President – Medical Association of the State of Alabama

Because of a seemingly slow rollout of the COVID-19 vaccine, physicians have started to hear many concerns from their patients. Understandably, the people of Alabama are growing more eager each day to get vaccinated. Physicians were privileged to be included in the first tier of vaccine recipients and remain our patients’ biggest advocate for vaccination against the Coronavirus. 

In addition to issues like staffing shortages, a major obstacle we face is the fact that from week to week, our practices and hospitals are not alerted to when we are getting more vaccines or exactly how many we will receive. Even the Alabama Department of Public Health (ADPH) has no input into the quantity allocated and is typically notified less than 24 hours before the vaccine is shipped. This makes it extremely difficult to set up vaccination and follow-up appointments. 

It’s tempting but comparing Alabama’s response to surrounding states doesn’t necessarily make sense. The number of COVID-19 vaccine doses allocated to Alabama is based on our population and is not determined by how much vaccine is on hand in the state. The number of doses remaining from previous allocations does not affect the number of doses that the Centers for Disease Control and Prevention (CDC) authorizes for Alabama.

Alabama still faces struggles in figuring out the logistics of vaccine distribution and allocation but there are a few things your physician wants you to know about the process.

  • The Federal Government determines the quantity of vaccines that are allocated to the state.
  • There is a shortage of available vaccines in Alabama.
  • There are 326,000 healthcare providers, nursing home residents, law enforcement officers, firefighters and 350,000 persons 75 years of age and older that are currently eligible for the vaccine.
  • The number of first doses of the vaccine shipped to Alabama per week only averages around 50,000 to 60,000.

Wide distribution of the COVID-19 vaccine will take time. While we are anxious for the vaccine to be made available to all Alabamians, physicians also want to urge you to wait until you fall into the appropriate tier. As of January 28th, Alabama is administering vaccines to healthcare workers, residents and staff in long-term care facilities, first responders, and individuals 75 years of age and older. 

We know vaccines are the best bet to slow this pandemic down and get enough folks immunized so the virus won’t spread as easily. However for now, even after we get vaccinated, we need to continue to wear masks and physically distance. We want to protect folks from a disease that can be very deadly. If we all work together, we will be that much closer to getting life back to normal.

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Op-ed: Physicians are no longer on the front lines of this pandemic. You are.

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Op-ed: Physicians are no longer on the front lines of this pandemic. You are.

John Meigs, Jr. – President, Medical Association of the State of Alabama

State Health Officer is a difficult role to fill, especially this year. While partisanship and conspiracies continue to divide us, it is the job of the State Health Officer to make decisions for the good of all people throughout Alabama. This is exactly what Dr. Scott Harris has done for Alabamians during (and before) the COVID-19 pandemic.

After reading a recent article about Dr. Harris, I was appalled but not surprised by the fact that he has received death threats over mask mandates and other preventative measures to slow the spread of COVID-19. Governor Kay Ivey enacted the first mask mandate on July 16, 2020, at the recommendation of Dr. Harris and others. After the initial mandate, Alabama’s case average and death rates quickly fell. Neighboring states without mask mandates – including Mississippi, Georgia, Florida, and Tennessee – all continued to rise above Alabama’s average.

As President of the Medical Association of the State of Alabama, I would like to proudly declare my support of Dr. Harris and Governor Ivey in regard to the mask ordinance, social distancing guidelines, and other measures to protect the citizens of Alabama. Science and data have shown us time and time again that these guidelines work. That being said, why are there still Alabamians who push against these life-saving initiatives?

While appealing to a sense of personal responsibility should be effective enough, it has proved not to be. What happens when personal responsibility is not enough, and people are endangering others? Mask mandates. Social distancing guidelines. Occupancy limitations.

Physicians and other health care providers have worked tirelessly to serve our patients, even at the cost of our own health and safety. What if I told you that we are no longer on the front lines of this pandemic, but you are? You have the power and capability to stop the spread of the Coronavirus that has taken over 3,450 lives in Alabama and 1.39 million lives worldwide. All you have to do to potentially save a life is to wear a mask in public, socially distance, and wash your hands. These simple actions not only save lives but can also help our physicians and hospital systems not get overwhelmed with patients. You can help keep your family and our families safe at the same time.

As we head into this holiday season, we can’t require people to keep themselves safe, but we are asking them to keep other people safe. Many people could be infected and transmit the disease to others without even knowing they are sick. I just hope that we can recontextualize the mask mandate and see it as a simple act of kindness to protect those around you. It seems like the least we can do for our families, friends, loved ones, physicians, nurses, and communities as a whole.

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The Perfect Storm for Litigation Resulting From the Paycheck Protection Program (PPP) and Coronavirus Aid, Relief and Economic Security (CARES) Act

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The Perfect Storm for Litigation Resulting From the Paycheck Protection Program (PPP) and Coronavirus Aid, Relief and Economic Security (CARES) Act

By: Jim Hoover

Millions of American businesses and self-employed individuals applied for and received Paycheck Protection Program (PPP) loans authorized by the CARES Act. PPP loans are obtained from a bank and guaranteed by the Small Business Administration (SBA). The processes for obtaining loans and loan forgiveness are ripe for many types of possible litigation including administrative, civil, and criminal. 

Businesses and individuals were required to provide documents and information and make important certifications to their bank when they applied for a PPP loan. The certifications included the eligibility of the business or individual for a PPP loan meeting the many requirements of the CARES Act. In a PPP loan application a borrower also had to certify that “[c]urrent economic uncertainty make this loan request necessary to support the ongoing operations of the Applicant.” 

The CARES Act also allows PPP loans to potentially be forgiven subject to many conditions. Businesses and individuals seeking PPP loan forgiveness must provide additional documents and yet more certifications through an application filed with their PPP lending bank. It is the responsibility of the borrower to provide an accurate calculation of loan forgiveness and to attest to the accuracy of its reported information.

PPP loans under the CARES Act will be audited. The Department of the Treasury announced that all PPP loans over $2 million will be audited; other PPP loans will also certainly be audited.  For example, borrowers that seek forgiveness of a PPP loan increase their likelihood of being audited, and not limited just to forgiveness, but eligibility of the borrower for the loan and the accuracy of certifications made by the borrower in the borrower’s PPP loan application. 

The SBA also reserves the right to review and audit all PPP loans and related loan issues, including eligibility, borrower certifications, and forgiveness. The SBA may review whether a borrower calculated its loan amount correctly and whether the borrower used loan proceeds for allowable purposes. The SBA issued guidance stating that a borrower who received a PPP loan of less than $2 million will be deemed to have made this required certification in good faith. For borrowers who received a PPP loan of $2 million or more, the borrower may have to prove that its application was based on current economic uncertainty and that the PPP loan was necessary to support ongoing operations of the borrower.  If the SBA determines in the course of its audit/review that a borrower lacked an adequate basis for the required certification concerning the eligibility of the loan request, the SBA will seek repayment of the outstanding PPP loan balance and determine that the borrower is not eligible for loan forgiveness. If the borrower repays the loan after receiving notification, the SBA has announced that it will not pursue administrative enforcement or make referrals for enforcement to other agencies. 

Applicable to forgiveness, the SBA states that, to receive loan forgiveness, a borrower must complete and submit the Loan Forgiveness Application (or equivalent bank form) to the PPP lending bank (or the lender that is servicing the PPP loan). The bank will review the application and make a decision regarding loan forgiveness. Banks are expected to perform a good-faith review, in a reasonable time, of the borrower’s calculations and supporting documents concerning amounts eligible for loan forgiveness. The lender must issue a decision to the SBA regarding a loan forgiveness no later than 60 days after receipt of a completed loan forgiveness application.

That decision may take the form of an approval (in whole or in part), denial, or (if directed by the SBA), a denial without prejudice due to a pending SBA review of the loan for which forgiveness is sought. In the case of a denial without prejudice, the borrower may subsequently request that the bank reconsider its application for loan forgiveness, unless the SBA has determined that the borrower is ineligible for a PPP loan. If the bank determines that the borrower is entitled to forgiveness of some or all of the amount applied for, the SBA will, subject to any SBA audit or review of the loan or loan application, remit the appropriate forgiveness amount to the bank. If the bank denies forgiveness, in whole or in part, the bank must notify the borrower in writing that the lender has issued a decision to the SBA denying the loan forgiveness application. The SBA reserves the right to review the bank’s decision in its sole discretion. Within 30 days of notice from the bank, a borrower may request that the SBA review the bank’s decision.

In the event the SBA reviews or audits a borrower’s PPP loan, the SBA will notify the bank, who is required to notify the borrower in writing within five (5) business days of receipt of notice from the SBA and to request information from the borrower. The SBA may also request information directly from the borrower. A borrower’s failure to respond to the SBA may result in a determination that the borrower was ineligible for a PPP loan or ineligible to receive the loan amount or loan forgiveness.

If the SBA determines in the course of its audit or review that the borrower was ineligible for a PPP loan, the loan will not be eligible for forgiveness. If only a portion of the loan is forgiven, or if the forgiveness request is denied, any remaining balance due on the loan must be repaid by the borrower on or before the two-year maturity of the PPP loan. 

The CARES Act created the new “Office of the Special Inspector General for Pandemic Recovery,” whose task is to “conduct, supervise, and coordinate audits and investigations” of the financial assistance programs for businesses. Administrative appeal remedies from disputed PPP audits, including resulting litigation, are presently unclear. While adverse decisions of the Office of Hearings and Appeals are appealable to federal courts, more guidance from the SBA concerning PPP audits and appeal remedies will be issued. 

Borrowers must also be aware of the Federal False Claims Act (“FCA”).  Under the FCA, a claim generally means any request or demand, whether under a contract or otherwise, for money or property that–(i) is presented to an officer, employee, or agent of the United States; or (ii) is made to a contractor, grantee, or other recipient, if the money or property is to be spent or used on the Government’s behalf or to advance a Government program or interest, or (iii) will reimburse such contractor, grantee, or other recipient for any portion of the money or property which is requested or demanded.  31 U.S.C. § 3729.  Federal courts have ruled that loan applications are “claims” for FCA purposes.  Thus, a PPP loan and any corresponding forgiveness is subject to the “False Claims Act.” In fact, government authorities are beginning to focus substantial resources on CARES Act fraud and abuse. Although the U.S. Department of Justice began indicting borrowers in connection with PPP fraud as early as May of this year, on September 10, 2020, federal authorities charged 57 people in jurisdictions across the U.S. with “stealing” $175 million from the PPP.  Additionally, a government report issued in September found “tens of thousands of loans could be subject to fraud, waste, or abuse.” The U.S. Government Accountability Office further reported to the U.S. House of Representatives that the SBA’s fraud hotline had received more than 42,000 reports of alleged fraud. 

Because of the many types of litigation, it is important that recipients of PPP loans and other financial assistance programs, carefully review their applications and requests for forgiveness to ensure they have met all of the programs’ requirements. 

Jim Hoover practices with Burr & Forman LLP and works exclusively within the firm’s Health Care Industry Group and primarily handles healthcare litigation and compliance matters.

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Phase 3 Provider Relief Funds Announced by HHS

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Phase 3 Provider Relief Funds Announced by HHS

On October 1, 2020, the Department of Health and Human Services (“HHS”) announced an additional $20 billion in funding for healthcare providers to assist with losses and changes in operating expenses caused by the current COVID-19 pandemic. This additional funding is a result of the CARES Act and the Paycheck Protection Program and Health Care Enhancement Act. Not only can providers who have already received Provider Relief Fund payments apply for additional funds during Phase 3, but previously ineligible providers may also apply during Phase 3. For example, providers who began practicing between January 1, 2020 and March 31, 2020, as well as additional behavioral health providers (e.g., addiction counseling centers, mental health counselors, and psychiatrists) can apply for payments during Phase 3. Providers who previously received Provider Relief Funds equating to approximately 2% of annual revenue from patient care can apply for an additional payment during Phase 3.

For eligible providers, the payments will be allocated as follows:

  • All applications will be reviewed to determine if the applicant has previously received a Provider Relief Fund payment equal to 2% of patient care revenue.
  • If an applicant has not received a previous Provider Relief Fund payment equal to 2% of patient care revenue, the applicant will receive a payment designed to bring the total payments to the applicant (when all payments are combined) to 2% of patient care revenue.
  • If an applicant has received a previous Provider Relief Fund payment equal to 2% of patient care revenue, the applicant may receive an additional add-on payment, as determined equitable and appropriate by the Health Resources and Services Administration (“HRSA”).
  • With regard to the additional add-on payment, payments will be made to applicants based on the following considerations: changes in operating revenues from patient care, changes in operating expenses from patient care, and payments already received through the Provider Relief Fund.

The application period for Phase 3 Provider Relief Funds runs through November 6, 2020. All providers receiving a Phase 3 payment will be required to attest to its receipt and accept the applicable terms and conditions.

For more information, visit https://www.hhs.gov/coronavirus/cares-act-provider-relief-fund/index.html.

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