Experts weigh in on LTC requirements for patient care, provider compliance

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.

Residents’ rights

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.

FDA establishes farming standards to prevent contamination of produce

The FDA has established standards related to produce in an effort to reduce the impact of foodborne illnesses among consumers. These standards to not apply to produce that is usually not consumed raw, grown for personal consumption, or not a raw agricultural product. Additionally, produce that goes through commercial processing techniques that adequately reduce contamination is eligible for exemption. The Final rule will publish in the Federal Register on November 27, 2015. The FDA has also issued a final environmental impact statement that will publish along with the rule.

Standards

These standards, implemented under the Food Safety Modernization Act (FSMA) (P.L. 111-353), are intended to address the situations in which produce can be contaminated with microorganisms of public health significance during growing, harvesting, packing, or holding. The FDA has made changes after considering public comments following the Proposed rule in January 2013 and the supplemental notice of proposed rulemaking issues in September 2014.

Water

The rule establishes criteria for microbial water quality. No detectable generic E. coli are allowed when it is reasonably likely that dangerous microbes would be transferred to the produce. This includes water used: for washing hands, for rinsing food-contact surfaces, in direct contact with produce (including water used to make ice), and for sprout irrigation. If generic E. coli is detected, the water use must be discontinued and corrective actions implemented. For water that is applied directly to growing produce, the FDA has established geometric mean (GM) and statistical threshold values (STV) for the permissible amount of E. coli. The rule also establishes standards for testing untreated water.

Soil amendments

At this time, the FDA considers adherence to the U.S. Department of Agriculture’s (USDA)’s National Organic Program standards for the application of raw manure as a soil amendment to be appropriate in minimizing the likelihood of contamination. The standards call for a 120-day interval between the application of this amendment and harvesting for crops in contact with soil, with a 90-day interval for crops not in contact. The agency is conducting extensive research on the risk of contamination and the number of days needed between application and harvesting.

Sprouts

Sprouts are particularly vulnerable to microbes and have been associated with outbreaks of bacteria. The rule contains standards specific to sprouts, such as preventing the transfer of microbes onto seeds used for sprouting and testing spent irrigation water for pathogens. The time frame for enforcing the standards for sprout operations will be shorter than for the other provisions of the rule.

Other provisions

Workers who are ill or infected must inform their supervisors of any health condition that may result in contamination. Visitors and workers must take measures to prevent contamination of produce and food-contact surfaces. Farm workers must be trained on health and hygiene. The rule includes standards related to sanitation of equipment, tools, and buildings. Farms that rely on grazing or working animals are required to identify and refrain from harvesting produce that is likely to be contaminated by these animals, similar to standards in place for intrusion by wild animals.

Environmental impact

The FDA identified four standards in the rule that could potentially significantly impact the human environment. The FDA considered implementing different GM and STV for water applied to growing produce. It also considered a range of standards for the application intervals for untreated and treated biological soil amendments as well as how farms would respond to domesticated and wild animals and alternatives to the general provision establishing which farms would be covered under the rule.