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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.

 

Do Doctors and Nurses Have to Self-Report to the Florida Department of Health if Arrested?

In our society, Medical Professionals have always been held to a higher-than-average standard. Doctors, nurses, and physicians must abide by several professional rules of conduct that not many other employees have to keep in mind. This in turn also means that your personal life is up for scrutiny as well. Ethical standards and moral values are usually private assumptions but for those who have chosen the medical field, those normally private matters can have a deep affect your employment status. Any serious off-duty conduct issue must be reported, reviewed, and taken care of on a case-by-case basis.

Florida Requirements for Self-Reporting

In Florida, doctors are required to report all criminal activities committed after they receive their medical license even though it is not in relation to employment and occurs after regular working hours. Any report or complaint filed towards a medical professional will be investigated by the Florida Department of Health. Being placed under arrest can trigger disciplinary action from the state licensing boards. Medical disciplinary actions require a much lower burden of proof than federal cases. It is possible to be penalized, face Medicare/Medicaid exclusion, and potentially have your license revoked based on the severity of the crime and investigation. It is entirely possible that a physician can face the loss of their medical license even if an investigation does not result in criminal prosecution and a conviction at a trial.

Complaints Against Medical Professionals

The most common criminal concerns leading to the harshest disciplinary actions towards a medical professional involve healthcare fraud, solicitation, moral turpitude, dishonesty, or deceit in any jurisdiction in the state. According to the Florida Department of Health’s website, they do not carry out complaints regarding the fees charged for individual procedures, missed, or cancelled appointments, unfair customer service, rudeness or disrespect, bedside manner, professionalism or personality conflicts again medical professionals.

Complaints against medical professionals can lead the Board of Medicine to issue citations based on the type of and severity of the complaint. It is completely free to file complaints against medical professionals. The only potential fees may be for requesting copies of medical records if deemed necessary. Complaints remain confidential until the panel determines reasonable cause, and a violation is issued.

How to Report

According to the Florida Board of medicine, all criminal activities after receiving your medical license must be timely reported. The Board provides various options for reporting including email, online service portal, or via regular mail. If a complaint is issued via sending an email or letter, the correspondence must include the date of the offense, the activity that happened, and the county and state of jurisdiction. The complaint cannot reach processing without the proper information.

The Florida Department of Health’s Medical Quality Assurance (MQA) launched a user-friendly online portal. The portal was developed in collaboration with the Agency for Health Care Administration (AHCA) to allow for easy reporting of any complaints again medical providers from fraud to unlicensed activity and violations. The portal offers education on the different federal agencies for complaints as well.

See below for email, website and address:

MQAOnlineService@FLHealth.Gov
www.mqa-vo.doh.state.fl.us./datamart/voservicesportal
Florida Department of Health

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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.

Do I need to Register to Perform In-Office Surgeries in Florida

Developments of new drugs and medical technology have enabled physicians to perform treatments and procedures in the comfort of medical offices that were once only able to be performed in hospital settings. To confirm whether obtaining an Office Surgery License is required for your office to perform these surgeries you must carefully examine the rules on office surgeries because they have changed recently.

 

The Office Surgery Rule

On June 25, 2019, Governor Ron DeSantis signed Senate Bill 732 into law. This rule provides guidance on how office procedures can be performed. It also delivers certain standards for these offices and requires that any office performing office surgery procedures be registered with the Department of State. As of January 2020, all offices performing liposuctions over 1000ccs, or Level 2 or Level 3 surgeries must register and comply with statute requirements. According to the Florida Board of Medicine, any office performing “Level 2 procedures lasting more than 5 minutes, and all level 3 surgical procedures in an office setting must register the office with the department unless that office is licensed as a facility under chapter 395, 458.309(3) F.A.C.)”. In any case, office surgical procedures should not result in blood loss of more than 10 percent of estimated blood volume in a patient or directly engage any main blood vessels, or be considered life threatening in nature.

 

What are the levels of Office Surgery?

Level 1 Surgeries are procedures that require none to minimal pre-operative medications or tranquilizations. Any anesthesia used must be local and conscious altering medication is not administered. This includes but is not limited to excision of moles, warts, lesions, cysts; liposuction, removing less than 4000cc of fat, skin biopsies, drainage of superficial abscesses, etc.

Level 2 Surgeries can use sedation or peri-operative medicines that alter levels of consciousness which, in turn, require some post-operative monitoring. These procedures include, but are not limited to breast biopsies, colonoscopies, hernia repair, etc.

Level 3 Surgeries are procedures that absolutely should utilize general anesthesia or pre-operative sedation. This can include intravenous sedation, major conductive anesthesia, and general anesthesia.

For each level, there are specific outlines for medication, equipment, and registration requirements which can be found by visiting: http://www.doh.state.fl.us/mqa/medical/osr_home.html.

 

Pain Management Facilities

While anesthesia blocks are considered ‘surgical procedures’ by the Florida Board of Medicine, the level of sedation would determine the surgery procedure level.

 

How to Register for an Office Surgery License

The registering Surgeon should submit an Office Surgery Registration form with an original signature. The office must also provide proof of completion of necessary training (i.e. certificates/diplomas) by all physicians. If any physicians that will also be performing Level 2 or Level 3 surgeries are hired to the office after the approval, the Department must be notified immediately to update records.

 

Other Requirements

If an office plans to engage in surgeries that require a license and recognition with the Department of Health, there are ethics standards to be upheld and requirements that must be complied with. The requesting medical offices are subject to be inspected by the Department of Health and each office should have a designated physician responsible for ensuring compliance. Medical offices also need to exhibit the required minimal financial responsibility as outlined by the State.

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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.

How to Open a Group Home for Children, Disabled Persons, and the Elderly in Florida

What is A Group Home?

A group home by definition is a residence that offers full time care for those who are unable to care for themselves. Group homes offer assistance for those who are unable to care for themselves due to age or medical disability and can’t be cared for by family members.

Group homes are usually smaller than other care facilities with more centralized care and fewer residents (usually 6 beds or under). Typically, 24-hour care and supervision is provided by at least one caregiver around the clock. Group Homes are not typically responsible for the personal care of residents such as bathing or using facilities. While health insurance does not typically cover the cost of a group home, long term care insurance might.

Who Can A Group Home Serve?

Children. Children who are unable to safely remain in their homes and have been removed from their parent or guardian may be placed in a home with full time supervision. They are placed in the custody of the Department of Children and Families and are then placed in a group home if foster is not a viable fit.

Disabled persons. Persons with disabilities who are unable to care for themselves may also find support in a group home. These facilities can offer training and basic life skills for individuals with intellectual and developmental disabilities. This experience can provide an opportunity for education and growth of social skills and basic life functions.

Elderly. Finding the right care for an aging family member can be a difficult decision to make. When there is an aging loved one with special medical needs in the family, it can take a toll on everyone. A group home is a great option for a more personalized care setting. In Florida, group homes offer medical care including transportation to health-related appointments. This setting also promotes socialization and a familiar cozy mood unlike the feel of a sterile nursing home. This can reduce the possibility of loneliness and depression.

Steps to Opening A Facility

Applicants will need to provide their licensing department with a business plan and operations manual along with the prospective location and community plan, geographical plan, zoning requirements, etc. Applicants may be eligible to receive Community Development Grant Block Funding to set up their home. Local community offices provide information on funding and assistance for group homes.

The Department of Children and Families licenses those homes for children under 19 years old without disabilities. In addition to the standard requirements, a group home for minors requires pre-approved menus from a licensed dietician, educational schedules, and daily activities.

The Agency for Health Care Administration is the licensing office for group homes with elderly and disabled patients.

The Department of Health frequently inspects homes unannounced to confirm the standard of living for residents. If the home assists with disabled persons, the Agency for Persons with Disabilities will also offer guidance and provide monthly monitoring visits to ensure that all requirements are met. Staff is usually rotated on a semi-monthly basis to maximize the efficiency of care. Depending on the type of home and number of patients, specialized permits and licensing may be required. Background checks on staffing is always required.

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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.

Florida Legal Requirements for an Adult Family Care Home

Adult Family Care Homes are Agency for Health Care Administration (“AHCA” or Agency) licensed facilities that provide care to disabled adults and frail elders in a family-type living environment. These adults choose to live with an individual or a family in a private home. One key distinction between an Assisted Living Facility and an Adult Family Care Home (“AFCH”) is that the Provider must also live in the home, which can be owned or rented by that Provider. The home has to meet the local zoning requirements prior to obtaining the AHCA license. The intent behind the Adult Family Care Home Act is to allow for residents of AFCHs to remain as independent as possible and to avoid placement in a nursing home or other licensed facility.

 

AFCH means a full-time, family-type living arrangement, in a private home, under which a person who owns or rents the home provides room, board, and personal care, on a 24-hour basis, for no more than five disabled adults or frail elders who are not relatives. Personal care services includes individual assistance with or supervision of the activities or daily living and the self-determination of medication, and other similar services. A resident who requires 24-hour nursing supervision may not be retained in an AFCH unless such resident is an enrolled hospice patient and the resident’s continued residency is mutually agreeable to the resident. Certain types of family-type living arrangements are not required to be licensed as an AFCH.

 

Although no more than five adults may reside in the home, the licensed maximum capacity of each AFCH is based on the service needs of the residents and the capability of the provider to meet the needs of the residents. Any relative who lives in the adult family-care home and who is a disabled adult or frail elder must be included in that maximum resident count.

 

AFCH Requirements and License Restrictions

AFCHs must designate at least one licensed space for a resident receiving optional state supplementation. AFCHs are required to provide all residents: (1) room and board; (2) assistance necessary to perform the activities of dialing living; (3) assistance necessary to administer medication; (4) supervision of residents; (5) health monitoring; and (6) social and leisure activities.

 

Each AFCH license is effective for 2 years from the date of issuance or renewal. These licenses are non-transferable and is valid only for the provider named, the capacity stated, and the premises described on the license.

 

AFCHs may advertise but these accommodations and services may not be listed in the yellow pages under the heading of “nursing home” or “assisted living facility”. The advertisement must include the term Adult Family-Care Home and the license number.

 

Resident Requirements

In order to be admitted as a resident of an AFCH, an individual must be: (1) at least 18 years of age; (2) free from apparent signs and symptoms of any communicable disease; (3) capable of self-preservation in an emergency situation involving the immediate evacuation of the AFCH, with ambulation; (4) be able to perform, with supervision or assistance, activities of daily living; (5) not be a danger to self or others; (6) not require licensed professional mental health treatment on a 24-hour a day basis; and (7) not be bedridden, to name a few.

 

Prior to admission to an AFCH, an individual must have a face-to-face medical examination conducted by a licensed healthcare provider. Every year thereafter, or after a significant change, the resident must have a face-to-face medical examination.

 

Prior to, or at the time of admission, the AFCH must provide the resident or their representative with the following: (1) a copy of the AFCH house rules; (2) Resident’s Bill of Rights, and (3) the procedure for making complaints to AHCA, the Department of Children and Families, or the Florida Department of Health.

 

Each resident has a statutorily defined Bill of Rights that the AFCH is required to adhere to. Some of these rights include: (a) living in a safe and decent living environment, free from abuse and neglect; (b) keep and use the resident’s own clothes and other personal property in the resident’s immediate living quarters, so as to maintain individuality and personal dignity; (c) unrestricted private communication, including receiving and sending unopened correspondence, having access to a telephone, and visiting with any person of his or her choice, at any time between the hours of 9 a.m. and 9 p.m. at a minimum; (d) management or resident’s own financial affairs; (e) share a room with the resident’s spouse if both are residents of the home; (f) exercise of civil and religious liberties; (g) access to adequate and appropriate healthcare; and (i) to be free from chemical and physical restraints.

 

Each resident must enter into a residency agreement with the provider, which is to be executed prior to or on the date of admission. The residency agreement must be kept on file for five years after expiration of the agreement. Additionally, each residency agreement must specify the personal care and accommodations to be provided by the AFCH, the rate or charges, a requirement of at least 30 days’ notice before a rate increase, and any other provisions required by AHCA or any other governing agency.

 

A resident shall not be discharged without 30 days’ written notice stating reasons for the move or transfer. The only exception to this written notice requirement is if the resident’s health requires immediate relocation; resident’s behavior poses an imminent danger to self or others, significantly interferes with the orderly operation of the home, or is continually offensive to other residents; or if the AFCH had its license denied, revoked, or voluntarily surrendered its license.

 

Provider Requirements

An AFCH Provider must bet at least 21 years old, live in the home, complete the required training and be able to read, write and complete written materials involved in applying for an AFCH license and maintaining an AFCH.

 

Each AFCH Provider must complete training and education programs. Training and education programs must include information relating to the appropriateness of placement of residents in an AFCH; identifying and reporting abuse, neglect, and exploitation; monitoring the health of residents and identifying and meeting the special needs of disabled adults and frail elders.

 

Conclusion

There are many other considerations that one must take into account when deciding to run an AFCH. An AFCH has certain personal services and supervision requirements, incident reporting requirements, health monitoring, food service and nursing services requirements, relief person and training requirements, records requirements, general requirements, fire safety standards, and emergency procedure requirements that were not addressed in this blog post but are critically important to operating your AFCH. If you are interested in operating an AFCH I would encourage you contact an experience health law attorney at Jones Health Law to assist you with navigating these requirements and others.

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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.