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Who Enforces Health and Safety Law?

Health and Safety laws are regulated by various agency officials and theses are arguably the most crucial jobs in our community. Most people do not take the time to adequately research their healthcare providers prior to receiving healthcare services or medication. However, several agencies have been established to safeguard and regulate the health and safety of the healthcare services that consumers receive. These agencies can’t replace individual due diligence but they make every attempt to prevent patient harm and to eliminate fraudulent activity in the healthcare system.

Florida Department of Health

The Florida Department of Health (DOH) was the first accredited public health system in the United States. Their mission is to protect and improve on the health of all people in Florida by regulating healthcare practitioners and facilities. They offer programs and services for the Florida community, but they are also responsible for the licensing and regulation of various healthcare practitioners and facilities. Various healthcare professions must be licensed and are regulated via the Florida Department of Health such as: medical doctors, acupuncturist, optometrists, and many more. Certain facilities such as piercing salons and pharmacies are also regulated by the Department of Health. Complaints can be filed against any of the practitioners or facilities, which will then be investigated by an officer for violations. The complaint is referred over to the Probably Cause Panel, which will determine whether to file an Administrative Complaint against the healthcare provider based on the weight of the evidence that is provided by the complainant and the provider who under investigation. It is not uncommon for the DOH to place an emergency restriction on a provider’s license if they pose an imminent danger to patient safety. If a violation is found, the Department of Health will determine appropriate disciplinary action to enforce the regulations, which includes, probation, suspension, or even revocation of a healthcare provider’s license.

Agency for Health Care Administration

The Agency for Health Care Administration (“AHCA”) was established in Florida to regulate the Medicaid system and healthcare providers who offer services to Medicaid beneficiaries. AHCA administers background screening, compiles healthcare data, and monitors the quality of care and civil rights complaints within healthcare facilities. They also license various healthcare facilities throughout Florida such as assisted living facilities, health care clinics, home health agencies, and many more.

Department of Health and Human Services

The Department of Health and Human Services has a family of agencies to provide services on local levels through state and county agencies. Some of these agencies include:

  • Centers for Medicare and Medicaid Services (“CMS”) proposes and publishes regulations yearly for those programs under medicare.gov, healthcare.gov, and more. CMS also enforces compliance with clearinghouses and healthcare providers and conducts audits regularly. CM provides health coverage to more than 100 million people through Medicare, Medicaid, the Children’s Health Insurance Program, and the Health Insurance Marketplace. CMS seeks to strengthen and modernize the Nation’s health care system, to provide access to high quality care and improved health at lower costs.
  • The Centers for Disease Control and Prevention (“CDC”) is one of the most widely known organizations within the Department of Health and Human Services. The mission statement of the CDC to protect the America people from health, safety and security threats, both foreign and in the U.S. Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities and citizens to do the same. CDC increases the health security of our nation. As the nation’s health protection agency, CDC saves lives and protects people from health threats. The CDC conducts critical science and provides health information that protects America against expensive and dangerous health threats, and responds when these arise. This is a science based organization that works to protect communities from health threats. The U.S. Secretary for Human and Health Services has authorized the CDC to carry out and enforce functions for isolation and quarantine to prevent exposure to contagious diseases.
  • The Office of Inspector General (“OIG”) is another department within the Department of Health and Human Services that works to improve the efficiency of many health based programs. They are the largest office in the Federal Government. They investigate complaints based on fraud, waste, abuse, and misconduct. The majority of the agency’s resources go towards the oversight of Medicare and Medicaid — programs that represent a significant part of the Federal budget and that affect this country’s most vulnerable citizens. The OIG has the authority to exclude individuals and entities from Federally funded health care programs for a variety of reasons, including a conviction for Medicare or Medicaid fraud. Those that are excluded can receive no payment from Federal health care programs for any items or services they furnish, order, or prescribe. This includes those that provide health benefits funded directly or indirectly by the United States (other than the Federal Employees Health Benefits Plan).
  • The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA conducts research on various food and drug safety protocols. They create reports to share with the general public to spread accurate information. The FDA also works closely with drug manufacturers to ensure the production of safe and effective drugs. They are accountable for overseeing quality control, delays, and discontinuations of drugs and medications. The agency works closely to reduce or prevent shortages. The supervision and regulation of the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors is also a crucial role played by the FDA.

 

These are just a few of the hundreds of agencies established to protect our communities from safety and health emergencies. Each agency regulates their own sections within each community or program.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

 

Criminal Liability for Rationing Medical Equipment During the Coronavirus Pandemic

Recently, a physician client called me and she was very concerned about potentially being charged with murder for rationing medical equipment, such as ventilators, during the COVID-19 Pandemic. She had been instructed by superiors to use the ventilators, which were in scarce supply, only on those patients that had the best chance of recovery. For the others, she would effectively be sentencing them to death and this caused added stress to an already stressful situation. I took the time to alleviate her concerns about potential liability and thought that I would share it with you as well.

 

  1. Can I Be Convicted of Murder for Rationing Medical Equipment?

 

In Florida, Excusable Homicide is defined as “the killing of a human is excusable, and therefore lawful when the killing is committed by accident and misfortune in doing any lawful act by lawful means with usual ordinary caution and without any unlawful intent.” I am not a criminal law attorney, but I believe that a physician could use Excusable Homicide as a defense in the very unlikely event that he finds himself in a position where murder charges were brought against him in connection with the death of a patient who didn’t receive certain medical treatment due to equipment rationing.

Florida has 3 different degrees of murder but I will only discuss the most serious, first-degree murder. First degree murder is defined as any intentional murder that is willful and premeditated. For a first-degree murder conviction, premeditation and deliberation must be proven. This doesn’t mean that a specific period of time must be involved in the planning of the murder. A prosecutor would only have to show that the perpetrator had enough time to consciously form a plan to commit the act with the intent to kill while also having enough time for a reasonable person to stop themselves from committing the act. It is not the intent of a healthcare provider to kill a patient when they ration medical equipment or supplies. They have limited resources and are making the best use of those resources given the circumstances. Absent any evidence to the contrary, I believe that any deliberation by the provider would be about prolonging human life and not willfully ending it. This is why I’m confident that no healthcare providers will be charged or convicted of first-degree murder, or any of the lesser degrees, for rationing of medical equipment during this pandemic.

  1. Can I Refuse to Provide Emergency Treatment to a Patient During the Pandemic?

 

The most obvious situation when a physician can refuse treatment is if the physician does not treat patients with the patient’s specific condition. In 1986, President Ronald Reagan signed the Emergency Medical Treatment and Active Labor Act (“EMTALA”) into law. The legislative intent of the law was very straightforward. A hospital with an emergency department could not turn away patients needing care because of their inability to pay. Hospitals are also prohibited from “dumping” patients onto other facilities for reasons other than receiving advanced treatment. Under EMTALA, if a patient presents herself to an ED with an emergency condition the ED is required to stabilize and treat the patient, regardless of her ability to pay. It’s important to note that a hospital may correctly follow EMTALA guidelines but still be responsible for malpractice damages if they misdiagnose a patient.

There may be situations where a hospital and its physicians do not have the capability to fully stabilize and treat a patient. In those situations, EMTALA allows a hospital to transfer the patient to get the appropriate level of care. For example, if a hospital is short on ventilators due to the Coronavirus that hospital may transfer the patient to another hospital that has an available ventilator so long as the patient is stable enough to physically handle the transfer and they’ve received informed consent.

Under EMTALA, a patient cannot directly sue a physician or hospital for not complying with EMTALA’s requirements, but physicians may be subject to civil monetary penalties and may be subject to exclusion from participation in the Medicare and Medicaid programs for repeated violations of EMTALA.

  1. Prohibited Activities and Liability during the Coronavirus Pandemic

 

Under Florida Statute §458.3295(1), which is titled “Concerted effort to refuse emergency room treatment to patients; penalties”, A Florida licensed physician may not instigate or engage in a concerted effort to refuse or get physicians to refuse to render services to a patient or patients in a hospital emergency room by failing to report for duty, absenting themselves from their positions, submitting their resignations, abstaining from the full and faithful performance of their medical duties, or otherwise causing conduct that adversely affects the services of the hospital. For the purposes of this subsection, the term “concerted” means contrived or arranged by agreement, planned or devised together, or done or performed together in cooperation.

Under Florida Statute §395.1041, Neither the hospital nor its employees, nor any physician, dentist, or podiatric physician are liable if a refusal to render emergency services or care is made after screening, examining, and evaluating the patient, and is based on the determination, exercising reasonable care, that the person is not suffering from an emergency medical condition or a determination, exercising reasonable care, that the hospital does not have the service capability or is at service capacity to render those services. If a hospital does not have capacity, the necessary medical equipment or supplies to treat a patient due to the Coronavirus pandemic, the hospital and its providers cannot be held liable for refusing to render certain emergency services or care.

  1. Final Thoughts

 

Presently, we are dealing with an extremely unusual set of circumstances and difficult decisions have to be made. The reality is that we have to ration the ventilators. We have over 350 million people in this country and estimates are that 40-60% of the population have or will contract COVID-19. Italy, Spain, France and China have had to ration their ventilators. Even healthcare providers are becoming sick and are using the ventilators.

The federal government, so far at least, is not providing national rationing guidelines for the coronavirus outbreak other than those issued by the CDC, HHS and VA. The Centers for Disease Control and Prevention has laid out general principles for how to allocate scarce resources in a pandemic response plan, but it leaves most of the details to individual states and institutions. States are coming up with their own ethical principles to determine need, while others are prioritizing patients based on their health condition, preexisting health problems and age. Countries around the world are doing the same thing. It’s not a first-come first-serve model right now. Hospitals are transferring patients to less crowded hospital or healthcare facilities, sanitizing and reusing supplies, coming up with makeshift ventilators, cancelling elective surgeries and procedures etc. Anything they can do to treat patients. To avoid conflicts of interest and the emotional toll of life-or-death judgments, many state plans call for a senior, supervisory doctor or a panel of doctors — similar to a “three wise men” protocol developed in Britain for this scenario — who are not the provider directly caring for the patient.

The Coronavirus Pandemic has been compared to a war and our doctors and nurses are the front line of defense. They’re our soldiers in this battle. They are basically operating under combat medicine guidelines, which means that they have to triage patients and prioritize care in a discriminate way based upon their chances of recovery but not discriminatorily. I can’t imagine a scenario where a prosecutor would bring charges against a physician for making the difficult decisions that they had to make during this pandemic. Even if they do, I doubt that a jury of their peers would find them guilty of murder given the circumstances. When this pandemic is behind us, I don’t believe that any healthcare providers will be charged or convicted of murder for rationing any medical equipment or supplies.

 

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

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