Regulatory Compliance Impacts Retirement Communities, ALFs and Nursing Homes

HIGHLIGHTS:

  • Long-term care companies in Florida need to review their regulatory compliance plans to see if updates are needed in light of several bills that passed during the regular legislative session of 2015.
  • Significant changes to the regulatory landscape impact retirement communities, assisted living facilities and nursing homes.
  • ALF regulations have been strengthened, including increased penalties.

Long-term care companies in Florida need to dust off their regulatory compliance plans to see if updates are needed in light of several bills that passed during the regular legislative session of 2015. If they are signed by the governor, these bills will bring about significant changes to the regulatory landscape for retirement communities, assisted living facilities and nursing homes.

Right to Try Act

Under House Bill 269, Florida joins a handful of states that allow certain patients with terminal conditions to elect to use investigational drugs, biological products, or devices. According to the bill's staff analysis, the Food and Drug Administration (FDA) has a process to allow patients to gain access to unapproved investigational drugs, but the process may be burdensome. This bill creates an alternative to the FDA's emergency use expanded access program. To take advantage of the new option, the following criteria must be met:

  • The patient's treating physician must document that the patient has a terminal condition that is confirmed by a second independent physician.
  • The patient has considered all other FDA-approved treatment options for the condition.
  • The patient has given written informed consent.
  • The investigational treatments must have successfully completed the initial phase of a clinical trial, but they need not be approved for general use by the FDA.
  • Eligible patients must have a progressive disease or condition that causes significant functional impairment and is considered to be irreversible even with the administration of FDA-approved treatment options.
  • Eligible patients must have a condition that is expected to result in death within one year after diagnosis if the condition runs its normal course.

The bill sets forth specific requirements for the written informed consent to be signed by the patient, guardian, or healthcare surrogate. Among other things, the document must include a realistic description of the most likely outcomes of using the treatment. The document must also describe the possibility that different or worse symptoms could result. The patient's health plan, third-party administrator and physician are not obligated to pay for care that results from the use of the investigational treatment unless required to do so by law or contract. The bill does not expand an insurer's coverage requirements under the Florida Insurance Code. Physicians who make recommendations to patients regarding access to these treatments may not be subject to adverse licensure actions solely because of those recommendations.

The bill does not create a private cause of action for any harm to the patient that is a result of the use of the investigational drug, device or biological product, as long as the manufacturer and other entities involved complies in good faith with the statute and exercises reasonable care.

If approved by the governor, this bill becomes effective on July 1, 2015.

Hospital Observation Status

There have been a number of media reports about the problems that some Medicare beneficiaries face when, after a multi-day hospital stay, they learned that they were never admitted as an inpatient. Although they were presumably too sick to go home, they were not considered to be inpatients and, therefore, would not be eligible for certain Medicare benefits, such as post-hospital skilled nursing facility care. Patients may be unaware of their observation status, and could be faced with significant and unexpected out-of-pocket costs. To help remedy this, the Legislature passed House Bill 309. The bill requires hospitals and other facilities licensed under Chapter 395 to document the patient's observation status on the discharge papers so that the patient or the patient's proxy receives notice of the situation.

If approved by the governor, this bill becomes effective on July 1, 2015.

Vaccination of Nursing Home Residents

Currently, all nursing home residents must be assessed to determine whether they are eligible for a certain vaccine to prevent pneumonia, bacteremia and meningitis. If indicated, the statute requires the resident to receive a pneumococcal polysaccharide vaccination (PPV). The Centers for Disease Control (CDC), however, recommends two vaccines to prevent pneumococcal disease, PPV and pneumococcal conjugate vaccine (PCV13). Senate Bill 332 allows eligible residents to be vaccinated in accordance with CDC recommendations, and removes the language requiring a particular type of vaccine.

Senate Bill 332 was approved by the governor on May 14, 2015, and becomes effective on July 1, 2015.

Assisted Living Facilities

For a number of years, the Legislature has considered bills aimed at strengthening assisted living facility (ALF) regulation. This effort was sparked by a series of Miami Herald articles published in 2011 that detailed horrific conditions in particular facilities. Later that year, Gov. Rick Scott directed the Agency for Health Care Administration (AHCA) to examine ALF regulation and oversight. AHCA formed a task force to develop recommendations for ways to improve Florida's ability to promote and monitor safety in ALFs and quality of care to residents. The task force made a number of recommendations in 2012.

Although it has taken several years, the Legislature has finally passed House Bill 1001, which is designed to strengthen ALF regulation and improve quality. Some of these changes relate to residents with certain mental conditions who live in ALFs. The bill states that Medicaid managed care plans are responsible for enrolled mental health residents, and managing entities under contract with the Department of Children and Family Services are responsible for mental health residents who are not enrolled in a Medicaid health plan. ALFs currently must have a limited mental health (LMH) license if they serve three or more mental health residents. Under the bill, a LMH license is required for an ALF that serves even just one mental health resident.

ALFs with extended congregate care (ECC) or limited nursing services (LNS) specialty licenses also have new requirements. These licensure designations allow ALFs to provide services that go beyond those that may be provided in a regular ALF. ECC licenses may be issued to each facility that has been a licensed ALF for two years or more, and may be issued to a facility that has a provisional ECC license. Provisional ECC licenses, lasting no longer than six months, may be issued to ALFs that have been licensed less than two years. ALFs with ECC licenses may admit residents not otherwise appropriate for an ALF if they are determined to be appropriate for admission to the ECC facility. AHCA must inspect an ECC facility at least twice per year (rather than the current quarterly requirement). AHCA may waive one of the required yearly monitoring visits if the facility:

  • has held the ECC license for at least 24 months
  • has had no class I or class II violations and no uncorrected class III violations
  • has had no ombudsman council complaints that resulted in a licensure citation

An ALF with a LNS licensure designation must be inspected at least annually, rather than twice per year. The required yearly monitoring visit may be waived for an ALF that has had a LNS license for at least 24 months; no class I or class II violations and no uncorrected class III violations; and no ombudsman council complaints that resulted in a licensure citation. AHCA must inspect all licensed ALFs at least once every 24 months. AHCA must inspect the ALF again in six months if it is cited for a class I violation or three or more class II violations in separate surveys within a 60-day period or due to unrelated circumstances during the same survey.

Penalties for ALFs Increased

The bill increases penalties for ALFs. AHCA must deny or revoke an ALF license if the facility has two moratoria imposed within a two-year period. The license must also be revoked if AHCA cites the facility for two or more class I violations arising from unrelated circumstances during the same survey or investigation, or the facility is cited for two or more class I violations arising from separate surveys or investigations within a two-year period. AHCA must impose an immediate moratorium if the ALF fails to provide AHCA with access to the facility or prohibits AHCA from conducting an inspection. The ALF must permit AHCA staff to access and copy records and conduct confidential interviews with staff or residents. Failure to comply with background screening requirements will result in a $500 fine.

Trained Staff Assistance Expanded

The bill expands the types of services that trained staff may provide relating to assisting residents who self-administer medications. Specifically, staff may perform functions such as:

  • taking an insulin syringe that is prefilled with the proper dosage by a pharmacist and an insulin pen that is prefilled by the manufacturer from where it is stored and bringing it to the resident
  • assisting with the use of a nebulizer, including removing the cap, opening the unit dose of solution, and pouring the medication into the dispensing cup of the nebulizer
  • using a glucometer to perform blood-glucose level checks
  • assisting with putting on or taking off anti-embolism stockings
  • assisting with applying and removing oxygen cannulas, but not titrating the oxygen setting
  • assisting with the use of a CPAP device, but not with titrating the device's setting
  • assisting with measuring vital signs
  • assisting with colostomy bags

Under the bill, consumers will be able to go online and find ALF information more easily. The bill requires AHCA to create content that is easily accessible on a searchable website that enables the public to find out information regarding ALFs more easily. The website must be up and running by Nov. 1, 2015.

The bill strengthens ALF resident rights. It requires that each resident or the resident's representative, upon admission to a long-term care facility, must receive information indicating that the resident may not be retaliated against for presenting grievances or for exercising any other resident right. The bill requires AHCA to adopt rules for uniform criteria and standards that will be used to determine whether the ALF has complied with residents’ rights. An ALF may not evict or otherwise retaliate against a resident who exercises his or her rights. If the facility wants to terminate the residency of the individual, the ALF must show good cause in court, or pay a $2,500 fine in addition to other penalties.

The bill also includes certain other changes relating to personal property of residents, staffing levels and staff training. For example, a community offering multiple levels of care must meet staffing requirements only for those residents who receive personal, limited nursing, or extended congregate care. Assuming the bill becomes law, ALFs will need to update their policies and procedures to ensure that they comply with the new requirements.

If approved by the governor, this bill becomes effective on July 1, 2015.

State Ombudsman Program

House Bill 1001 and Senate Bill 7018 both contain provisions relating to the state Ombudsman Program. House Bill 1001 requires the local ombudsman council to conduct an exit consultation with the facility administrator or a designee to discuss concerns and make recommendations for improvement. Senate Bill 7018 revises the operating structure and internal procedures of the State Long-Term Care Ombudsman Program (LTCOP), which is housed in the Department of Elder Affairs (DOEA), to reflect current practices, maximize operational and program efficiencies, and conform to the federal Older Americans Act. The bill revises the appointment process for three at-large positions to the State Long-Term Care Council whereby the appointments are no longer made by the governor but by the secretary of the DOEA.

Senate Bill 7018 was approved by the governor on May 14, 2015, and becomes effective on July 1, 2015.

Continuing Care Retirement Communities

House Bill 749 pertains to continuing care communities. A continuing care community (CCC) is a retirement community that offers a continuum of services and living arrangements at a single location, including independent living apartments, assisted living, memory support care and skilled nursing care. CCCs are regulated by the Department of Financial Services, the Agency for Health Care Administration and the Office of Insurance Regulation (OIR) pursuant to chapter 651, F.S. Currently, there are 71 CCCs in Florida.

A resident of a CCC must pay an entrance fee upon entering into a contract with a facility. The contract must include the terms under which a resident is due a refund of any portion of the entrance fee. If the contract provides that the resident does not receive a transferable membership or ownership right in the facility, and the resident has occupied his or her unit, the refund must be calculated on a pro-rata basis with the facility retaining up to 2 percent per month of occupancy by the resident and up to a 5 percent processing fee, the balance of which must be paid within 120 days after the resident gives notice of intent to cancel. Similarly, a contract may provide a 1 percent declining-scale refund, paid from the proceeds of the next entrance fees received by the provider for units for which there are no prior claims.

  • The bill makes several changes to ch. 651, F.S. Specifically, the bill:
  • requires a CCC contract, paying a 2 percent refund, to provide for payment to a resident within 90 days after the contract is terminated and the unit is vacated, instead of 120 days after notice of intent to cancel
  • requires a CCC contract, paying a 1 percent refund, to provide for payment to a resident for the unit that is vacated, or a like or similar unit, whichever is applicable, by specified time frames
  • clarifies that CCCs must be accredited without stipulation or condition for OIR to waive statutory requirements
  • makes a CCC contract a preferred claim, in receivership or liquidation proceedings
  • requires OIR to notify the executive office of the governing body of the CCC provider of all deficiencies found during an examination
  • requires a CCC to provide a copy of any final examination report and corrective action plan to the executive officer of the governing body of the provider within 60 days after issuance of the report
  • requires all CCCs to establish residents’ councils to provide input on subjects that impact residents’ quality of life
  • authorizes the board of directors or governing board of a provider to allow a facility resident to be a voting member of the board or governing body of the facility
  • requires all CCCs to provide a copy of the most recent third-party financial audit to the president or chair of the residents’ council within 30 days of filing the annual report with OIR

If approved by the governor, this bill becomes effective on Oct. 1, 2015.

Healthcare Representatives

House Bill 889 amends laws on healthcare surrogates and creates statutory forms. Current law provides several methods for a person to make healthcare decisions, and in some instances access health information, on behalf of another person. One such method is the designation by an adult person of another adult person to act as a healthcare surrogate. A healthcare surrogate is authorized to review confidential medical information and to make healthcare decisions in the place of the principal. Generally, a determination of incapacity of the principal is required before the healthcare surrogate may act.

Because a principal may regain capacity and in some instances, especially with the elderly, may vacillate in and out of capacity, a redetermination of incapacity is frequently necessary to provide ongoing authorization for the healthcare surrogate to act. This process can hinder effective and timely assistance and is cumbersome. Further, some competent persons desire the assistance of a healthcare surrogate with the sometimes complex task of understanding healthcare treatments and procedures and with making healthcare decisions.

This bill amends the healthcare surrogate law to allow a person to designate a healthcare surrogate, who may act at any time, including while an adult is still competent and able to make his or her own decisions. While competent, the decisions of the principal control over any contrary decision of the surrogate.

This bill also creates a means for designating a healthcare surrogate for the benefit of a minor when the parents, legal custodian, or legal guardian of the minor cannot be timely contacted by a healthcare provider or are unable to provide consent for medical treatment.

The bill creates sample forms that may be used to designate healthcare surrogates for adults and minors.

If approved by the governor, this bill becomes effective on Oct. 1, 2015.