On October 4, 2016, CMS issue a Final rule making extensive changes to long term care facilities (LTCFs) requirements of participation (ROP) with the goal of aligning LTCF requirements with current clinical practice standards to improve resident safety and the quality and effectiveness of the care and services delivered to residents. Kris D’Ann Maples, in-house counsel at Hillcrest Health Services and Lyn Bentley, MSW, Vice President, Quality and Regulatory Affairs, American Health Care Association (AHCA), addressed significant provisions of the new rules that will impact health care providers at the 2017 Health Care Compliance Association Compliance Institute on March 26, 2017.
The Final rule
The new requirements (81 FR 68688, October 4, 2016) represent the first significant revision of LTCF requirements for Medicare and Medicaid since 1991. The revised requirements are aimed at reducing unnecessary hospitalizations and health care acquired infections, improving behavioral health care, safeguarding LTCFs residents from the use of unnecessary psychotropic drugs, enhancing care planning, and improving quality assurance and performance improvement. In addition to the changes to the requirements, CMS is developing a new survey process that will go into effect November 2017. The new survey process incorporates the new requirements and merges with the quality indicator system. The LTC rules take effect in three phases. Phase 1 took effect November 28, 2016, Phase 2 will take effect November 28, 2017, and Phase 3 is scheduled for November 28, 2018.
Maples told attendees to be on the alert to changes in the regulations prior to implementation dates based on the current administration’s plan to abolish the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). Section 6102(b) of the ACA amended Social Security Act Sec. 1128I, and mandated the operating organization have a compliance and ethics program in place. Such programs must be effective in preventing and detecting criminal, civil, and administrative violations under the Social Security Act and promoting quality of care consistent with the regulations promulgated by the HHS Secretary working with the HHS Office of Inspector General (OIG).
Themes of the rule
Bentley noted that the Final rule reflects the dramatic cultural and technology changes over three decades. She recommended providers closely read the new definitions CMS included in the Final rule, emphasizing that CMS has changed the definition of a number of terms. Among the themes identified by Bentley are patient centered-care, facility based-responsibility, quality of care and quality of life, and the changing patient population, which includes patients with behavioral health issues. Regarding facility-based responsibilities, Bentley pointed out that LTCFs must know the center, patients and staff, which requires a competency-based approach.
Bentley added that the new rule that requires LTCFs to establish a grievance policy, notify residents how and where to file a grievance, and identify a grievance officer who would be responsible for grievance process. Among the grievance officer’s responsibilities are receiving and tracking grievances, leading investigations, maintaining confidentiality, meeting documentation requirements, and issuing decisions to the resident. In addition, the grievance officer must coordinate with state and federal agencies and meet state and federal laws and regulations (42 C.F.R. Sec. 483.10(j)). The regulation also includes additional notification requirements.
Significant is use of the word “willful” in the definition of abuse as it relates to the regulation addressing freedom from abuse, neglect, and exploitation (42 C.F.R. Sec. 483.12). Bentley specifically pointed out that “willful” in the definition means that “the individual acted deliberately, not that the individual intended to inflict injury or harm.” According to the Bentley, the term “willful” as used in the definition could raise serious questions about behavior that would not be considered abuse. For example, if a nurse is bathing a patient in one bed and she sees the patient in nearby bed about to fall, while preventing the patient about to fall from falling, the other patient might try to get out of bed and fall. In this case, the nurse’s actions were deliberate and there was no intention to inflict injury or harm to the patient that she was bathing.
Compliance and Ethics rules
New regulations (42 C.F.R. Sec. 483.85) require the operating organization for each LTCF to have a compliance and ethics program that meets certain requirements in the rule by November 28, 2017 (Phase 2), and the other requirements implemented by November 28, 2019 (Phase 3). Maples explained that the Final rule codifies the OIG compliance program guidance from 2000 and 2008 and that compliance will be part of the survey process going forward.
Maples identified the minimum components of a compliance program, which must be in place by November 28, 2017. These components include:
|1.||written compliance and ethics standards; policies and procedures that reduce the prospect of criminal, civil, and administrative violations under the law and promote quality of care;|
|2.||corrective/disciplinary standards that outline consequences of committing violations, are enforced consistently, and provide consequences for failure to detect or report a violation;|
|3.||the designation of a “high level” individual” in the organization who oversees compliance and ethics program;|
|4.||sufficient resources and authority given the designated high level individual to reasonably assure program standards are met;|
|5.||effectively communicate standards policies and procedures, including mandatory training; and|
|6.||taking reasonable steps after a violation.|
According to Maples, by the Phase 3 effective date, LTCFs must have had an annual review of the program to make any changes to reflect changes in applicable laws and regulations and improve performance promoting quality of care and deterring False Claims Act violations. LTCFs that have five or more facilities must conduct annual compliance training for all staff member, designate a compliance officer whose major responsibility in operating the compliance program requires the individual to report directly to the organizations governing body and cannot report to the general counsel, chief operating officer, or chief operating officer.