Omnibus Burden Reduction (Conditions of Participation) Final Rule CMS-3346-F Part 3 – Critical Access Hospitals

Omnibus Burden Reduction (Conditions of Participation) Final Rule
CMS-3346-F Part 3 – Critical Access Hospitals

The Omnibus Burden Reduction (Conditions of Participation) Final Rule issued September 26, 2019 by the Centers for Medicare & Medicaid Services (CMS) removes or revises Medicare regulations in an effort to reduce inefficiencies and improve the delivery of lower cost, high quality care with better patient outcomes.
Critical Access Hospitals
Periodic Review of Clinical Privileges and Performance (§ 485.631(d)(1) through (2)) retain the requirements under paragraphs § 485.641(b)(3) through (4), that are currently found under the “Periodic evaluation and quality assurance” CoP, and relocate them under a new standard under the “Staffing and staff responsibilities” CoP at § 485.631.

Provision of services (§ 485.635(a)(3)(vii)) CMS will be finalizing the revisions to §485.635(a)(3)(vii) that require individual patient nutritional needs be met in accordance with recognized dietary practices and the orders of the practitioner responsible for the care of the patients, or by a qualified dietician or qualified nutrition professional as authorized by the medical staff in accordance with State law governing dietitians and nutrition professionals. In addition, CMS proposed that the requirement of § 483.25(i) of this chapter is met with respect to inpatients receiving post hospital SNF care.

Provision of Services (485.635(g)) At § 485.635(g) CMS will be finalizing a new requirement regarding non-discriminatory behavior. Similar to our non-discrimination proposal for hospitals, we proposed to require that a CAH not discriminate on the basis of race, color, religion, national origin, sex (including gender identity), sexual orientation, age, or disability. CMS requires that CAHs establish and implement a written policy prohibiting discrimination on the aforementioned bases and that they inform each patient (and/or support person, where appropriate), in a language he or she can understand, of his or her right to be free from discrimination against them and how to file a complaint if they encounter discrimination. CAHs shall adhere to the non-discrimination requirements of Section 1557 of the Affordable Care Act.

Infection prevention and control and antibiotic stewardship programs (§ 485.640)

CMS will be finalizing the removal of the current requirements at § 485.635(a)(3)(vi) and § 485.641(b)(2)

CMS is adding a new infection prevention and control and antibiotic stewardship CoP at § 485.640 for CAHs because the existing standards for infection control do not reflect the current nationally recognized standards of practice for the prevention and elimination of healthcare-associated infections and for the appropriate use of antibiotics.

CMS is finalizing the proposal that each CAH has a facility-wide infection prevention and control and antibiotic stewardship programs that are coordinated with the CAH QAPI program, for the surveillance, prevention, and control of HAIs and other infectious diseases and for the optimization of antibiotic use through stewardship.

The CAH must ensure that the Infection control officer(s); and prevention and control of infections within the CAH and between the CAH and other healthcare settings be coordinated by an individual (or individuals), who is/are qualified through education, training, experience, or certified in infection, prevention and control, are appointed by the governing body, or responsible individual, as the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program at the CAH and that the appointment is based on the recommendations of medical staff and nursing leadership.

§ 485.640(a)(2): CMS will finalize that the infection prevention and control program, as documented in its policies and procedures, employ methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings. The program, as documented in its policies and procedures, would have to employ methods for preventing and controlling the transmission of infection within the CAH setting (for example, among patients, personnel, and visitors) as well as between the CAH (including outpatient services) and other institutions and healthcare settings.

§ 485.640(a)(3) Healthcare-associated infections (HAIs): CMS will finalize revisions at §485.640(a)(3) that the infection prevention and control program include surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also address any infection control issues identified by public health authorities.

§ 485.640(a)(4) Scope and complexity: CMS will finalize revisions at §485.640(a)(4) that the infection prevention and control program reflects the scope and complexity of the services provided by the CAH.

§ 485.640(b)(1) Leader of the antibiotic stewardship program: CMS will finalize revisions at §485.640(b)(1) that the CAH’s governing body ensure that an individual, who is qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship is appointed as the leader of the antibiotic stewardship program and that the appointment is based on the recommendations of medical staff and pharmacy leadership.

§ 485.640(b)(2)(i), (ii), and (iii) Goals of the antibiotic stewardship program: CMS will finalize revisions at §485.640(b)(2)(i), (ii), and (iii) would ensure that the following goals for an antibiotic stewardship program are met:

(i) Demonstrate coordination among all components of the CAH responsible for antibiotic use and resistance, including, but not limited to, the infection prevention and control program, the QAPI program, the medical staff, and nursing and pharmacy services;
(ii) Document the evidence-based use of antibiotics in all departments and services of the CAH; and
(iii) Demonstrate improvements, including sustained improvements, in proper antibiotic use, such as through reductions in, CDI and antibiotic resistance in all departments and services of the hospital. We believe that these three components are essential for an effective program.

§ 485.640(b)(3) and (4) Nationally recognized guidelines; and Scope and complexity: These provisions would require the CAH to ensure that the antibiotic stewardship program adheres to the nationally recognized guidelines, as well as best practices, for improving antibiotic use. The CAH’s stewardship program would have to reflect the scope and complexity of services offered.

§ 485.640(c)(1), (2), and (3) Governing body; Infection prevention and control professionals’: The Antibiotic stewardship program leader’s responsibilities include requirements that the governing body or responsible individual ensure that:

– Systems are in place and operational for the tracking of all infection surveillance, prevention, and control, and antibiotic use activities in order to demonstrate the implementation, success, and sustainability of such activities;and
– All HAIs and other infectious diseases identified by the infection prevention and control program and antibiotic use issues identified by the antibiotic stewardship program are addressed in collaboration with CAH QAPI leadership.

At § 485.640(c)(2)(i)-(vi): CMS will finalize revisions that the responsibilities of the infection prevention and control professionals would include the development and implementation of facility-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. The governing body or responsible individual would be responsible for all documentation, written or electronic, of the infection prevention and control program and its surveillance, prevention, and control activities.
The infection preventionist(s)/infection control professional(s) would be responsible for:

– Communication and collaboration with the CAH’s QAPI program on infection prevention and control issues;
– Competency-based training and education of CAH personnel and staff including professional health care staff and, as applicable, personnel providing services in the CAH under     agreement or arrangement, on the practical applications of infection prevention and control guidelines, policies and procedures;
– Prevention and control of HAIs, including auditing of adherence to infection prevention and control policies and procedures by CAH personnel; and
– Communication and collaboration with the antibiotic stewardship program.

CMS will finalize revisions that requirements for the leader of the antibiotic stewardship program similar to the proposed responsibilities for the CAH’s designated infection preventionist(s)/infection control professional(s) at paragraph (c)(2). The leader of the antibiotic stewardship program would be responsible for:

– The development and implementation of a facility-wide antibiotic stewardship program, based on nationally recognized guidelines, to monitor and improve the use of antibiotics.
– The antibiotic stewardship program would be responsible for all documentation, written or electronic, of antibiotic stewardship program activities.
– Be responsible for communicating and collaborating with medical and nursing staff, pharmacy leadership, and the CAH’s infection prevention and control and QAPI programs, on antibiotic use issues.
– Be responsible for the competency-based training and education of CAH personnel and staff, including medical staff, and, as applicable, personnel providing contracted services  in the CAHs, on the practical applications of antibiotic stewardship guidelines, policies, and procedures.

Take Away: This is a major program change requiring Critical Access Hospitals to have a complete infection prevention and control program, now including antibiotic stewardship programs. Ensure that appropriate plans, policies, nationally recognized guidelines and surveillance methods are established and implemented. Ensure the leaders appointed over these programs have appropriate training, education and experience (APIC 101 and 102 courses for Infection Prevention). Ensure that all Governing body, Nursing, Pharmacy and Medical staff have input into this program and the selection of the program leadership. Ensure that all staff are trained and familiar with the new program.

Quality Assessment and Performance Improvement (QAPI) Program (§ 485.641)

CMS will finalize revisions at § 485.641 (81 FR 39464) to establish new requirements for a QAPI program at a CAH. This new requirement for CAHs would replace the existing reactive annual evaluation and quality assurance review requirement with a proactive approach of a QAPI program. A QAPI program that enables the CAH to review its operating systems and processes of care to identify and implement opportunities to provide high quality and safe care to its patients focusing on improving health outcomes and preventing and reducing medical errors.

CMS will finalize revisions to retain the requirements under paragraphs § 485.641(b)(3)-(4) regarding the evaluation of the diagnosis and treatment furnished by physicians and nonphysician practitioners and relocate them to a new standard under the “Staffing and staff responsibilities” CoP at § 485.631.

CMS requires that the CAH meet the objectives of the QAPI program but will allow the CAH to determine the best way to do so with respect to determining detailed program requirements, requirements related to distinct improvement projects, and details of data use. In accordance with the new requirements under § 465.641(e), CAHs will be required to incorporate quality indicator data, including patient care data and other relevant data, in order to achieve the goals of the QAPI program.

CMS expects that CAHs incorporate other relevant data, such as data submitted to or received from national quality reporting and quality performance programs, into their data collection analysis; this data must be used by the CAH to achieve the objectives of the QAPI program, including addressing outcome indicators related to improved health outcomes and the prevention and reduction of medical errors, adverse events, CAH-acquired conditions, and transitions of care, including readmissions. This will ensure that the CAH’s quality improvement efforts are evidenced based and focused on the needs of the population served by the CAH in a manner that best suits the unique characteristics of the CAH.

Take Away: This is a major program change requiring Critical Access Hospitals to have a complete Quality Assessment and Performance Improvement program that is data-driven and hospital-wide. Ensure that appropriate plans, policies, nationally recognized guidelines and methods are established and implemented. Ensure the leaders appointed over these programs have appropriate training, education and experience (CPHQ, Six Sigma, Lean or other Quality training). Ensure that the Governing Body, Nursing, Pharmacy and Medical staff have input into this program and the selection of the program leadership. Ensure that all staff are trained and familiar with the new program. Ensure that data is collected, analyzed, and used to make performance improvements. CAH’s are still expected to annually review their policies and procedures.

References:
The final rule [CMS-3346-F] can be viewed at: https://www.federalregister.gov/documents/2019/09/30/2019-20736/medicare-and-medicaid-programs-regulatory-provisions-to-promote-program-efficiency-transparency-and
Section 1557 of The Patient Protection and Affordable Care Act can be viewed at: https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html
CMS Condition of Participation 42 CFR 482 and 485 respectively
CMS.gov Patients over Paperwork
Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (“Omnibus Burden Reduction”), published September 20, 2018.
January 30, 2017 Executive Order “Reducing Regulation and Controlling Regulatory Costs” (Executive Order 13771)
Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (“Omnibus Burden reduction”), published September 20, 2018;
Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement in Patient Care, published June 16, 2016;
Summary: Final Rule Implementing Section 1557 of the Affordable Care Act

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