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

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

Non-discrimination: CMS will be deferring to the nondiscrimination requirements of Section 1557 of the Patient Protection and Affordable Care Act – Section 1557 which states “Section 1557 prohibits discrimination based on race, color, national origin, sex, age or disability in certain health programs and activities”.
Section 1557 builds on long-standing and familiar Federal civil rights laws: Title VI of the Civil Rights Act of 1964 (Title VI), Title IX of the Education Amendments of 1972 (Title IX), Section 504 of the Rehabilitation Act of 1973 (Section 504), and the Age Discrimination Act of 1975 (Age Act). Most notably, Section 1557 is the first Federal civil rights law to prohibit discrimination on the basis of sex in all health programs and activities receiving Federal financial assistance. Section 1557 builds on prior Federal civil rights laws to prohibit sex discrimination in health care.
The final rule requires that women be treated equally with men in the health care they receive and also prohibits the denial of health care or health coverage based on an individual’s sex, including discrimination based on pregnancy.
For individuals with disabilities, the final rule requires covered entities to make all programs and activities provided through electronic and information technology accessible; to ensure the physical accessibility of newly constructed or altered facilities; and to provide appropriate auxiliary aids and services for individuals with disabilities.
Covered entities must take reasonable steps to provide meaningful access to each individual with limited English proficiency eligible to be served or likely to be encountered in their health programs and activities. In addition, covered entities are encouraged to develop and implement a language access plan.
The final rule on Section 1557 does not include a religious exemption; however, the final rule does not displace existing protections for religious freedom and conscience.
Take Away: Ensure that the proper notices are posted/provided to patients in regard to non-discrimination. Ensure that proper policies and procedures are in place to address non-discrimination practices. Ensure staff are properly trained on how to handle and report non-discrimination within the organization. Ensure that the facility is properly constructed to allow adequate access to all components of the facility including to non-gender specific / family restrooms.

Licensed Independent Practitioner (§ 482.13): CMS will finalize the following revisions:

1. Remove the modifying term “independent” from the CoPs at § 482.13(e)(5) and § 482.13(e)(8)(ii).
2. Revise § 482.13(e)(5) to state that the use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law.
3. Revise the provisions in sections § 482.13(e)(10), § 482.13(e)(11), § 482.13(e)(12)(i)(A), § 482.13(e)(14), and § 482.13(g)(4)(ii) that contain the term “licensed independent practitioner” by changing the term to simply “licensed practitioner.”
4. Remove the term “physician assistant” from the current provisions at § 482.13(e)(12)(i)(B) and § 482.13(e)(14).
Take Away: Ensure that facility policies, medical staff bylaws and rules/regulations include new definitions (as long as the new definition does not conflict with State law). Always keep the most stringent requirements as that is what will be enforced.

Quality assessment and performance improvement (QAPI) program (§482.21): CMS will be finalizing the change to the program data requirements at § 482.21(b), which requires the hospital QAPI program incorporate quality indicator data including patient care data submitted to or received from quality reporting and quality performance programs, including but not limited to data related to hospital readmissions and hospital-acquired conditions.

Take Away: Ensure the QAPI program includes all relevant data to reflect a hospital-wide, data driven QAPI program. The new data requirements may include items sent to State agencies, Quality Improvement Organization’s (QIO), Patient Safety Organization’s (PSO) and other report receiving entities (State reporting systems, CDC NSHN system, etc.).

Nursing Services (482.23) – CMS will be finalizing the revisions to the CoP (§482.23(b)) as follows:

– Currently there must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for bedside care of any patient. CMS will delete the term “bedside,” which might imply only inpatient services to some readers. The nursing service would have to ensure that patient needs were being met by ongoing assessments of patients’ needs and would have to provide nursing staff to meet those needs regardless of whether the patient was an inpatient or an outpatient. There would have to be sufficient numbers and types of supervisory and staff nursing personnel to respond to the appropriate nursing needs and care of the patient population of each department or nursing unit. When needed, a registered nurse would have to be available to care for any patient. CMS understands that the term “immediate availability” has been interpreted to mean physically present on the unit or in the department. It is also understood that there are some outpatient services where it might not be necessary to have a registered nurse physically present.
– CMS will revise (b)(4) (which currently requires that the hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient and that the plan may be part of an interdisciplinary care plan) that while a nursing care plan was needed for every patient, the care plan would be expected to reflect the needs of the patient and the nursing care to be provided to meet those needs. The care plan for a patient with complex medical needs and a longer anticipated hospitalization would be more extensive and detailed than the care plan for a patient with a less complex medical need expecting only a brief hospital stay. CMS expects that a nursing care plan would be initiated and implemented in a timely manner, include patient goals as part of the patient’s nursing care assessment and, as appropriate, physiological and psychosocial factors (such as specific physical limitations and available support systems), physical and behavioral health comorbidities, and patient discharge planning.
– In addition, it would have to be consistent with the plan for the patient’s medical care and demonstrate evidence of reassessment of the patient’s nursing care needs, response(s) to nursing interventions, and, as needed, revisions to the plan.
– CMS will revise (b)(6) (which currently states that non-employee licensed nurses working in the hospital must adhere to the policies and procedures of the hospital and that the director of nursing service must provide for the adequate supervision and evaluation of the clinical activities of non-employee nursing personnel)

– All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital.
– The Director of Nursing Services must provide for the adequate supervision and evaluation of the clinical activities of all nursing personnel (that is, all licensed nurses and any non-licensed personnel such as nurse aides, orderlies, or other nursing support personnel who are under the direction of the nursing service) which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel were obtained. CMS recognizes that there are a variety of arrangements under which hospitals obtain the services of licensed nurses. Mechanisms may include direct employment, the use of contract or agency nurses, a leasing agreement, volunteer services or some other arrangement. No matter how the services of a licensed nurse were obtained, in order to ensure the health and safety of patients, all nurses would have to know and adhere to the policies and procedures of the hospital and there must be adequate supervision and evaluation of the clinical activities of all nursing personnel who provide services that occur within the responsibility of the nursing service.
– CMS expects non-licensed personnel to be supervised by a licensed nurse.
Take Away: All CMS proposal mentioned above will be finalized in the final rule. Ensure nursing services are properly staffed and supervised for inpatient and outpatient areas relevant to the new changes. Nurses do not need to be physically available in all areas but must be available when needed. Ensure that patient care plans are individualized, specific to the patients care and treatment and specific to the patients needs. Care plans are intended for both inpatient and outpatient as long as they reflect the patient’s assessment, needs and is reassessed at frequent intervals.

Medical record services (§ 482.24) – CMS will be finalizing the revision to the CoP (§482.24(c)) that requires:

– The content of the medical record contains information to justify all admissions and continued hospitalizations, support the diagnoses, describe the patient’s progress and responses to medications and services, and document all inpatient stays and outpatient visits to reflect all services provided to the patent.
– All diagnoses specific to each inpatient stay and outpatient visit, which would include specifying any admitting diagnoses.
– The content of the record includes documentation of complications, hospital-acquired conditions, healthcare-associated infections, and adverse reactions to drugs and anesthesia.
– Progress notes, interventions, and responses to interventions added to the required documentation of ‘practitioners’ orders to emphasize the necessary documentation for both inpatients and outpatients.
– The content of the record must contain all practitioners’ progress notes and orders, nursing notes, reports of treatment, interventions, responses to interventions, medication records, radiology and laboratory reports, and vital signs and other information necessary to monitor the patient’s condition and to reflect all services provided to the patient. (Inpatient and Outpatient).
– All patient medical records must document discharge and transfer summaries with outcomes of all hospitalizations, disposition of cases, and provisions for follow-up care for all inpatient and outpatient visits to reflect the scope of all services received by the patient.
– The content of the medical record would contain final diagnoses with completion of medical records within 30 days following all inpatient stays, and within 7 days following all outpatient visits.

Take Away: Ensure that all medical records (inpatient and outpatient) contain all provider orders, progress notes, interventions, complications and responses to intervention. Inpatient and outpatient records must include all required elements and be made available to the patient upon their request. Outpatient visit must be completed with a final diagnosis within 7 days following the visit.

Infection Prevention and Control and Antibiotic Stewardship programs (§ 482.42) – CMS proposed and will be finalizing the following:

– A change to the title of this CoP to “Infection prevention and control and antibiotic stewardship programs.” By adding the word “prevention” to the CoP name, our intent is to promote larger, cultural changes in hospitals such that prevention initiatives are recognized on balance with their current, traditional control efforts. And by adding “antibiotic stewardship” to the title, we would emphasize the important role that a hospital should play in combatting antimicrobial resistance through implementation of a robust stewardship program that follows nationally recognized guidelines for appropriate antibiotic use.
– To change the introductory paragraph to require that a hospital’s infection prevention and control and antibiotic stewardship programs be active and hospital-wide for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship.
– That a program must demonstrate adherence to nationally recognized infection prevention and control guidelines for reducing the transmission of infections, as well as best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic-resistant organisms.
– To introduce the term “surveillance” into the text of the regulation. The addition of this term, which is also already in use in CMS Interpretive Guidelines for hospitals, is being proposed to bring the regulation up to date by reflecting current terminology in the field.
– A new requirement that hospitals demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic-resistant organisms.
– The language of §§ 482.42(a)(1) and 485.640(a)(1) to now require: “An individual (or individuals), who is qualified through education, training, experience, or certification in infection prevention and control, is appointed as the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program. The selection process must include meaningful opportunity for input from members of the medical and nursing staffs.”
– The language of §§ 482.42(b)(1) and 485.640(b)(1) to now require: “An individual (or individuals), who is qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship, is appointed as the leader(s) of the antibiotic stewardship program. The selection process must include meaningful opportunity for input from members of the medical, nursing, and pharmacy staffs.”
– The language at §§ 482.42(b)(2)(iii) and 485.640(b)(2)(iii) to now require: “Documents any improvements, including sustained improvements, in proper antibiotic use.”

Take Away: Major program change in how nationally recognized guidelines are utilized within the program, who can be in charge of the program and how the governing body must be involved. Ensure the practitioner over the Infection Prevention and Control has appropriate training, education or experience (most accrediting agencies is looking for APIC 101 and 102 courses). For Antibiotic Stewardship – ensure the practitioner is qualified by training, education or experience. Those selected to lead these programs can be 1 person or can be multiple people – they must have documented training, education or experience in the respective areas. The governing body along with other appropriate multi-disciplinary groups (pharmacy, nursing, medical staff) all have input into the selection and approval of the program leaders.

Technical Corrections – CMS removed Inappropriate References to § 482.12(c)(1). Upon review of the Hospital CoPs for the proposed rule, CMS discovered that there were several provisions that incorrectly reference § 482.12(c)(1), which lists the types of physicians and applies only to patients who are Medicare beneficiaries. CMS has chosen to apply § 482.12(c) to all patients, regardless of payment source, and not just Medicare beneficiaries. In order to clarify that these provisions apply to all patients and not only Medicare beneficiaries, we proposed to delete any inappropriate references to § 482.12(c). Therefore, we proposed to delete references to § 482.12(c) found in the following provisions: §§ 482.13(e)(5), 482.13(e)(8)(ii), 482.13(e)(14), and 482.13(g)(4)(ii) in the Patients’ Rights CoP; and §§ 482.23(c)(1) and 482.23(c)(3) in the Nursing Services CoP.

Take Away: Ensure that leadership and the Governing body are updated/educated to the fact that the Conditions of Participation are applied to and enforced for ALL patients within an organization.

The final rule [CMS-3346-F] can be viewed at:
Section 1557 of The Patient Protection and Affordable Care Act can be viewed at:
CMS Condition of Participation 42 CFR 482 and 485 respectively 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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