CMS Finalizes New Regulations for Facilities: Part 4

Review of Changes to Sections on Infection Control, Compliance and Ethics Program, Physical Environment and Training Requirements

This is the fourth article in a series discussing the complete overhaul of Part 483 to Title 42 of the Code of Federal Regulations, the Requirements for States and Long-Term Care Facilities by the Centers for Medicare & Medicaid Services (“CMS”).

Because CMS’s Final Regulations (“Final Regulations”) impose numerous requirements on long-term care facilities, we will be issuing a series of articles on various components of the Final Regulations. This article focuses on provisions regarding Infection Control, Compliance and Ethics Program, Physical Environment and Training Requirements.

Recently, Hall Render published an overview of Final Regulations components as well as Parts 1, 2 and 3 in the series, which are located here, here and here.

Background

On September 28, 2016, CMS released a complete overhaul of Part 483 to Title 42 of the Code of Federal Regulations, the Requirements for States and Long-Term Care Facilities. CMS’s Final Regulations cover many regulatory requirements for long-term care facilities and create new compliance obligations for providers. The Final Regulations seek to target rehospitalizations, facility-acquired infections, overall quality and resident safety.

Infection Control – Sec. 483.80

The final regulations redesignated the current regulations for infection control at Section 483.65 to Section 483.80. The final regulations now address infection “prevention” in addition to infection control. Facilities must now have an “Infection Prevention and Control Program” (“IPCP”) that must prevent the development and transmission of communicable disease in addition to infections. The IPCP must include an antibiotic stewardship program that addresses antibiotic use protocols and systems for monitoring antibiotic use. The IPCP must be reviewed annually and updated as deemed necessary by the facility. The final regulations also require facilities to appoint an Infection Prevention Control Officer (“IPCO”) and at least one Infection Preventionist (“IP”).

Implementation Timeframe. Section 483.80 will be implemented in Phase 1, upon the effective date of the Final Regulations, November 28, 2016 with the following exceptions:

• (a) As linked to Facility Assessment at Section 483.70(e) will be implemented in Phase 2.
• (a)(3) Antibiotic Stewardship will be implemented in Phase 2.
• (c) IP participation on the Quality Assessment & Assurance (“QAA”) committee will be implemented in Phase 3.

Detailed Summary. In addition to requiring facilities to implement an IPCP, appoint an IPCO and at least one IP and establish an antibiotic stewardship program, this Final Regulation sets forth other requirements. These requirements include:

• The Final Regulation expands the elements that must be included in an IPCP. These elements include, but are not limited to:

1. 1. A system for preventing, identifying, reporting, investigating and controlling infections and communicable disease. This includes staff, visitors, volunteers and others performing contracted services to the facility.
   2. Written standards, policies and procedures.
   3. When and how isolation will be utilized for a resident.

• The IPCP must have a system for reporting incidents and corrective action taken by the facility in response to the incident(s).
• The IP takes responsibility for the IPCP. The IP must have professional training in nursing, microbiology, medical technology, epidemiology or a related field. The IP must work at least part-time at the facility and have completed specialized training in infection prevention and control. The IP is part of the QAA.
• Before offering an influenza or pneumococcal immunization, the resident or the resident’s representative must receive education on the benefits and side effects of the immunization. After receiving education on the immunization, the resident or resident’s representative may refuse the immunization.

Compliance and Ethics Programs – Sec. 483.85

The Final Regulations created a new Section 483.85 requiring facilities to have a compliance and ethics program. This new regulation is a result of Section 6102 of the Affordable Care Act that adds a new Subsection 1128(b) to the Social Security Act. The compliance and ethics  program must have written standards, policies and procedures that are capable of reducing the prospect of criminal, civil and administrative violations and promote quality of care consistent with federal regulations.

Implementation Timeframe. Section 483.85 will be implemented in Phase 3. However, please note that while the implementation spreadsheet contained in the Final Regulations states the implementation timeframe is Phase 3, new Section 483.85(b) sets forth an implementation date of November 28, 2017, which is Phase 2.

Detailed Summary. New Section 483.85 sets forth a new definition for high-level personnel. This rather broad definition states high-level personnel are individual(s) who have substantial control over the operating organization or have a substantial role in the making of policy within the organization. Another new definition for operating organization was created. Operating organization is defined as the individual(s) or entity that operates a facility.

New Section 483.85(c) sets forth the required compliance program components for all facilities. These required components include:

• Written compliance and ethics standards, policies and procedures. This includes delegation of an appropriate contact to which individuals may report violations or suspected violations anonymously without fear of retribution.
• Assignment of individuals within the high-level personnel to oversee the compliance program of the facility. This includes the CEO, board members or directors of major divisions within the operating organization.
• High-level personnel are given sufficient resources and authority to ensure compliance with the written standards, policies and procedures.
• Due care must be exercised to not give discretionary authority to individuals the operating organization knew or had reason to know engage in criminal, civil and administrative violations under the Social Security Act.
• The compliance and ethics program must be communicated to staff and volunteers in accordance with their roles and contracted individuals.
• Implementation of monitoring and auditing systems that are reasonably designed to detect criminal, civil and administrative violations under the Social Security Act.
• Consistent enforcement of facility standards, policies and procedures through appropriate disciplinary mechanisms for failure to detect and report compliance violations.
• Once a violation is identified, the operating organization must take all reasonable steps to appropriately respond to the violation and to prevent similar violations that would include modifications to existing compliance standards, policies and procedures.

New Section 483.85(d) addresses additional compliance components for operating organizations with five or more facilities. In addition to the requirements set forth in Sections 483.85(a),(b),(c) and (e), operating organizations with five or more facilities must include these additional components in their compliance and ethics programs:

• Mandatory annual training program on the operating organization’s compliance and ethics program.
• A designated compliance officer who reports directly to the operating organization’s governing body. The compliance officer is not subordinate to the general counsel, chief financial officer or chief operating officer of the operating organization.
• Compliance liaisons are located at each facility of the operating organization.

New Section 483.85(e) addresses the annual review of the operating organization’s compliance and ethics program. The compliance and ethics program must be reviewed annually and make revisions for any changes in laws or regulations or changes within the operating organization.

Physical Environment – Sec. 483.90

The Final Regulations redesignate the Physical Environment Regulation previously found at Section 483.70 as a new Section 483.90. The Final Regulations will require facilities that are constructed, reconstructed or newly certified after the effective date of the Final Regulations to accommodate no more than two residents per bedroom. Reconstruction is identified as a reconfiguration of space such that the space is not permitted to be occupied or the entire building or entire occupancy within the building or wing is modified. The Final Regulations also require facilities that are constructed or newly certified after the effective date of the Final Regulations to have a bathroom with at least a commode and sink in each room.

Implementation Timeframe. Section 483.90 will be implemented in Phase 1, upon the effective date of the Final Regulations, November 28, 2016 with the following exceptions:

• (f)(1) Addressing a call system from each resident’s bedside will be implemented in Phase 3.
• (h)(5) Addressing policies regarding smoking will be implemented in Phase 2.

Detailed Summary. The Final Regulations redesignate the Physical Environment Regulation previously found at Section 483.70 as a new Section 483.90.

• Section 483.90(c) now requires the facility to have sufficient space and equipment to provide services in accordance with the resident’s assessment and plan of care.
• A new Section 383.90(c)(3) was added requiring facilities to conduct regular inspection of bed frames, mattresses and bed rails as part of the facility’s maintenance program to identify areas of possible entrapment.
• Section 483.90(g) requires the facility to have a resident call system that allows residents to call a staff member or centralized work area from the resident’s bedside, toilet and bathing facilities.
• Section 483.90(h)(5) requires facilities to establish smoking policies on smoking  and tobacco cessation, safe smoking and smoking areas taking into account non-smoking residents in accordance with applicable federal, state and local laws and regulations.

Training Requirements – Sec. 483.95

The Final Regulations create a new Section 483.95 that sets forth all requirements for an effective training program that facilities must develop, implement and maintain. These training requirements are applicable for all new and existing staff, contract providers and volunteers.

Implementation Timeframe. The training requirements will be implemented during Phase 3, November 28, 2019, with certain aspects implemented in Phase 1, as noted below.

Detailed Summary. The Final Regulations require facility training programs for all staff, contract providers and volunteers to be implemented by Phase 3. However, certain training requirements are effective in Phase 1, November 28, 2016.

The facility must develop, implement and maintain an effective training program. This is applicable to all existing and new staff, individuals providing services under a contract and volunteers consistent with their expected roles.

The training regime must include the needs identified in the facility assessment, required under Section 483.70.

• The facility must train on abuse, neglect and exploitation. This education must include what activities constitute abuse, neglect, exploitation and misappropriation of resident property; the procedures for reporting incidents of abuse, neglect, exploitation or the misappropriation of resident property; and also dementia management and abuse prevention. (Phase 1, November 28, 2016)
• The training topics must also include education on effective communication; residents’ rights and facility responsibilities; the facility’s Quality Assurance and Performance Improvement program; infection control; compliance and ethics; in-service training for nurse aides; required training for feeding assistants; and behavioral health.
• The in-service training for nurse aides must be no less than 12 hours per year and be sufficient to ensure the continued competence of nurse aides; include dementia management and resident abuse prevention training; and address the care of the cognitively impaired for nurse aides providing services to individuals with cognitive impairments. These provisions of the nurse aide training are effective in Phase 1, November 28, 2016.
• The facility must not use any individual working in the facility as a paid feeding assistant unless that individual has completed a state-approved training program for feeding assistants. (Phase 1, November 28, 2016)

Practical Takeaways

• The compliance and ethics program must have written standards, policies and procedures that are capable of reducing the prospect of criminal, civil and administrative violations and promote quality of care consistent with federal regulations.
• The Final Regulations will require facilities that are constructed, reconstructed or newly certified after the effective date of the Final Regulations to accommodate no more than two residents per bedroom.
• Certain training requirements are effective in Phase 1, November 28, 2016, including the facility must develop, implement and maintain an effective training program.
• While many of the Final Regulations are revisions to current regulations, facilities should keep in mind that many of the Final Regulations have changes that could impact facility operations.

If you have questions or would like additional information about this topic, please contact:

• Todd Selby at 317.977.1440 or tselby@wp.hallrender.com;
• Brian Jent at 317.977.1402 or bjent@wp.hallrender.com;
• David Bufford at 502.568.9368 or dbufford@wp.hallrender.com;
• Sean Fahey at 317.977.1472 or sfahey@wp.hallrender.com; or
• Your regular Hall Render attorney.

Please visit the Hall Render Blog at http://blogs.hallrender.com/ or click here to sign up to receive Hall Render alerts on topics related to health care law.