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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.

Can I become a Federally Qualified Health Center?

Federally Qualified Health Centers (“FQHC”) are community-based healthcare providers that receive money for providing primary care services to under-served populations or areas. FQHCs were enacted under Section 1861(aa) of the Social Security Act and was amended by Section 4161 of the Omnibus Budget Reconciliation Act of 1990.

FQHCs are required to adhere to certain criteria, including, but not limited to, providing comprehensive healthcare services (either on-site or by arrangement with another provider) on a sliding fee scale based on ability to pay and operating under a governing board that includes patients. These comprehensive services may include: (1) preventive health services; (2) dental services; (3) mental health and substance abuse services; (4) Transportation services necessary for adequate patient care; and (5) hospital and specialty care. FQHCs must also implement an ongoing quality assurance program.

 

FQHC Certification

To be certified as an FQHC, a healthcare provider must meet one of the following requirements:

  • Receive a grant under Section 330 of the Public Health Service Act (“PHS Act”) or receive funding from such a grant and meets other requirements.
  • Is not receiving a grant under Section 330 of the PHS Act but is determined by the Secretary of the Department of Health & Human Services to meet the requirements for receiving such a grant based on the recommendation of the Health Resources and Services Administration (“HRSA”).
  • Was treated by the Secretary of HHS for purposes of Medicare Part B as a comprehensive Federally-funded health center as of January 1, 1990.
  • Is operating as an outpatient health program or facility of a tribe or tribal organization under the Indian Self-Determination Act or as an urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act as of October 1991.

 

For certification as an FQHC, the entity must meet all of these requirements:

  • Provide comprehensive services and have an ongoing quality assurance program
  • Meet other health and safety requirements
  • Not be concurrently approved as a Rural Health Clinic.

 

FQHC Eligibility

Once eligible, FQHCs will qualify for funding under Section 330 of the Public Health Service Act, as well as, enhanced reimbursement form Medicare and Medicaid. FQHCs are paid based on the FQHC Prospective Payment System (“PPS”) for medically-necessary primary health services and qualified preventive health services furnished by a FQHC practitioner.

 

Examples of FQHC

A FQHC visit is medically-necessary face-to-face medical or mental health visit or a qualified preventive health visit between the patient and a physician, NP, PA, CNM, CP, or CSW during which time one or more qualified FQHC services are furnished.  FQHCs include:

  • Community health centers
  • Migrant health centers
  • Healthcare for the homeless health centers
  • Health centers for residents of public housing
  • Health center program “look-alikes”

 

Telehealth Services

FQHCs are authorized to serve as an originating site for telehealth services if the FQHC is located in a qualifying area. An originating site is the location of an eligible Medicare patient at the time the service being furnished via a telecommunications system occurs. FQHCs that serve as an originating site for telehealth services are paid an originating site facility fee.

FQHCs are not authorized to serve as a distant site for telehealth consultations. A distant site is the location of the practitioner at the time the telehealth service is furnished. The cost of a visit may not be billed or included on the cost report.

 

FQHC Reimbursements

FQHCs set their own charges for the services they provide and determine which services to include in the bundle of services associated with each FQHC code. Charges must be uniform for all patients.

Payment is for professional services only. Laboratory tests and the technical component of billable visits are paid separately. Procedures are included int eh payment of an otherwise qualified visit and are not separately billable. If a procedure is associated with a qualified visit, include the charges for the procedure on the claim with the visit.

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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 information listed above.

All of the information and references made to laws, 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.

Reinstatement After A Healthcare Entity or Individual is Placed on the OIG and Florida’s Exclusion List

What is the Exclusion List?

The Office of Inspector General’s (“OIG”) list of Excluded Individuals and Entities (“LEIE”) provides information to the healthcare industry, patients and the public regarding individuals and entities currently excluded from participation on in Medicare, Medicaid and all other Federal healthcare programs.

OIG imposes exclusions under the authority of sections 1128 and 1156 of the Social Security Act. On May 8, 2013, the OIG released a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs, which states that no federal healthcare program payment may be made for items or services furnished by (1) an excluded person or (2) at the medical direction or on the prescription of an excluded person.

 

What is the Administrative Process for LEIE?

When an individual or entity gets a “Notice of Intent to Exclude” (“NOI”), it does not necessarily mean that they will be excluded. OIG will carefully consider all material provided by the person who received the NOI before making a decision. All exclusions implemented by OIG may be appealed to an HHS Administrative Law Judge (“ALJ”), and any adverse decision may be appealed to the HHS Department Appeals Board (“DAB”). Judicial review in Federal court is only available after a final decision by the DAB.

If the OIG decided to proceed with exclusion, they will send the individual or entity a Notice of Exclusion along with information about the effect of the exclusion and appeal rights. Exclusions are effective 20 days are the Notice of Exclusion is mailed, and notice to the public is provided on OIG’s website.

When a permissive exclusion (discussed below) is being considered, the NOI allows the individual or entity to request an opportunity to present oral argument to an OIG official before a decision about whether to exclude is reached. This is in addition to the right to submit documentary evidence and written argument. The process and requirements vary depending on which section of the Social Security Act is violated.

 

How do I determine if I’ve been placed on the list?

The following are two options available to determine whether you are on the LEIE:

  1. The Online Searchable Database enables users to enter the name of an individual or entity and determine whether they are currently excluded. If a match is made on an individual, the database can verify with an individual’s Social Security Number that the match is unique. Employer Identification Numbers are available for verification of excluded entities.

 

  1. The Downloadable Database enables users to download the entire LEIE to a personal computer. Supplemental exclusion and reinstatement files are posted monthly to the OIG’s website, and these files can be merged with the previously downloaded data file to update the list.

The OIG recommends that you check the exclusion list on a monthly basis. Monthly checks should be documented so that an organization can demonstrate that they have acted in good faith to screen against excluded individuals or entities. Both databases are updated by the middle of each month. You can search here: https://exclusions.oig.hhs.gov/

Providers must also review Florida’s exclusion database while it is performing background searches.

 

Are there different types of exclusion?

There are two types of exclusions under the Social Security Act:

  1. Mandatory Exclusion – The OIG is required by law to exclude from participation in all federal healthcare programs individuals and entities convicted of the following criminal offenses: Medicare or Medicaid fraud, as well as any other offenses related to the delivery of items or services under Medicare, Medicaid, SCHIP, or other state healthcare programs; patient abuse or neglect; felony convictions for other healthcare related fraud, theft, or other financial misconduct; and felony convictions relating to the unlawful manufacture, distribution, prescription, or dispensing of controlled substances.

 

  1. Permissive Exclusion – The OIG has discretion to exclude individuals and entities on a number of grounds including, but not limited to, misdemeanor convictions related to healthcare fraud other than Medicare or a state health program; fraud in a program (other than a healthcare program) funded by any federal, state, or local government agency; misdemeanor convictions relating to the unlawful manufacture, distribution, prescription, or dispensing of controlled substances, suspension, revocation, or surrender of a license to provide healthcare for reasons bearing on professional competence, professional performance, or other financial integrity; provision of unnecessary or substandard services; submission of false or fraudulent claims to a federal healthcare program; engaging in unlawful kickback arrangements; defaulting on a health education loan or scholarship obligation; and controlling a sanctioned entity as an owner, officer, or managing employee.

For all proposed mandatory exclusions lasting longer than the mandatory minimum five-year period, and most proposed permissive exclusions the administrative process is the same. OIG will send out a written NOI to any individual that they are considering excluding. The NOI included the basis for the proposed exclusion and a statement about the potential effect of an exclusion.

If you’ve already hired someone or contracted with a vendor prior to discovering that they are on the LEIE you may be required to Self-Disclose the hiring.

 

Reinstatement from the LEIE

Reinstatement of an excluded individual or entity is not automatic once the specified period of exclusion ends. In order to participate in Medicare, Medicaid, and all Federal healthcare programs once the term of exclusion ends, the individual or entity must apply for reinstatement and receive written notice from OIG that reinstatement has been granted.

An individual or entity with a defined period of exclusion (e.g., 5 years) may begin the process of reinstatement 90 days before the end of the period specified in the exclusion notice letter.

An individual or entity excluded under section 1128(b)(4) of the Social Security Act, whose period of exclusion is indefinite, may apply for reinstatement when they have regained the license referenced in the exclusion notice. In addition, under some conditions an individual or entity excluded under section 1128(b)(4) or the Act may apply for reinstatement if they have (1) obtained a different healthcare license in the same state; (2) any healthcare license in a different state; or (3) have been excluded for a minimum period of 3 years.

To apply for reinstatement, an excluded individual or entity must send a written request to the OIG. If the individual is eligible to apply for reinstatement, the OIG will then mail Statement and Authorization forms that must be completed. Once the information have been evaluated, a written notification of OIG’s final decision on reinstatement will be provided via mail. If reinstatement is denied, the excluded individual or entity is eligible to reapply after one year.

Individuals and entities who have been reinstated are removed from the LEIE.

Penalties for Excluded Individuals or Entities

OIG may impose civil monetary penalties of up to $10,000 for each item or service furnished by the excluded person for which federal program payment is sought. They may also be forced to pay treble damages and program exclusion.

An excluded person may be civilly liable under the False Claims Act for knowingly presenting or causing to be presented a false or fraudulent claim for payment. Violations could also lead to criminal prosecutions if an excluded person knowingly conceals or fails to disclose any action affecting the ability to receive any benefit or payment with the intent to fraudulently receive such benefit or payment. Additional criminal statutes may also apply to such violations.

The information above only scratches the surface of dealing with LEIE issues. Depending on the facts of your case the circumstances, procedures, and potential outcome can vary greatly. If you have received an NOI, discovered that one of your contractors or employees is on the LEIE, or you have been excluded from receiving Federal program dollars and desire to be reinstated you should contact us immediately. We have experienced Health Law attorneys on staff who can help you navigate the entire process.

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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 information listed above.

All of the information and references made to laws, 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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