[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Rules and Regulations]
[Pages 51732-51834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20736]



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Vol. 84

Monday,

No. 189

September 30, 2019

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid





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42 CFR Parts 403, 416, 418, 441, et al.





Medicare and Medicaid Programs; Regulatory Provisions To Promote 
Program Efficiency, Transparency, and Burden Reduction; Fire Safety 
Requirements for Certain Dialysis Facilities; Hospital and Critical 
Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and 
Improvement in Patient Care; Final Rule

  Federal Register / Vol. 84 , No. 189 / Monday, September 30, 2019 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 403, 416, 418, 441, 460, 482, 483, 484, 485, 486, 488, 
491, and 494

[CMS-3346-F; CMS-3334-F; CMS-3295-F]
RIN 0938-AT23


Medicare and Medicaid Programs; Regulatory Provisions To Promote 
Program Efficiency, Transparency, and Burden Reduction; Fire Safety 
Requirements for Certain Dialysis Facilities; Hospital and Critical 
Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and 
Improvement in Patient Care

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule reforms Medicare regulations that are 
identified as unnecessary, obsolete, or excessively burdensome on 
health care providers and suppliers. This final rule also increases the 
ability of health care professionals to devote resources to improving 
patient care by eliminating or reducing requirements that impede 
quality patient care or that divert resources away from furnishing high 
quality patient care. Additionally, this rule updates fire safety 
standards for Medicare and Medicaid participating End-Stage Renal 
Disease (ESRD) facilities by adopting the 2012 edition of the Life 
Safety Code and the 2012 edition of the Health Care Facilities Code. 
Finally, this final rule updates the requirements that hospitals and 
Critical Access Hospitals (CAHs) must meet to participate in the 
Medicare and Medicaid programs. These requirements are intended to 
conform to current standards of practice and support improvements in 
quality of care, reduce barriers to care, and reduce some issues that 
may exacerbate workforce shortage concerns.

DATES: 
    Effective date: These regulations are effective on November 29, 
2019. The incorporation by reference of certain publications listed in 
the rule is approved by the Director of the Federal Register as of 
November 29, 2019.
    Implementation dates: The regulations at Sec.  485.641 regarding 
Quality Assessment and Performance Improvement Programs (QAPI) in 
critical access hospitals (CAHs) must be implemented by March 30, 2021.
    The regulations at Sec.  482.42(b) and Sec.  485.640(b) regarding 
hospital and critical access hospital (CAH) antibiotic stewardship 
programs must be implemented by March 30, 2020.

FOR FURTHER INFORMATION CONTACT: 
    For issues related to Regulatory Provisions to Promote Program 
Efficiency, Transparency, and Burden Reduction, contact Kristin 
Shifflett, (410) 786-4133.
    For issues related to Fire Safety Requirements for Certain Dialysis 
Facilities, contact Kristin Shifflett, (410) 786-4133.
    For issues related to the Hospital and Critical Access Hospital 
(CAH) Changes to Promote Innovation, Flexibility, and Improvement in 
Patient Care, contact CAPT Scott Cooper, USPHS, (410) 786-9465, Mary 
Collins, (410) 786-3189, Alpha-Banu Wilson, (410) 786-8687, or Kianna 
Banks, (410) 786-3498.

SUPPLEMENTARY INFORMATION: We note that this rule finalizes provisions 
that were proposed in three separate proposed rules that were published 
in the Federal Register on separate dates. Specifically, we are 
finalizing the provisions of the following proposed rules, discussed as 
follows:
     ``Regulatory Provisions to Promote Program Efficiency, 
Transparency, and Burden Reduction,'' published September 20, 2018 (83 
FR 47686);
     ``Hospital and Critical Access Hospital (CAH) Changes to 
Promote Innovation, Flexibility, and Improvement in Patient Care,'' 
published June 16, 2016 (81 FR 39448); and
     ``Fire Safety Requirements for Certain Dialysis 
Facilities,'' published November, 4, 2016 (81 FR 76899)
    To assist readers in referencing sections contained in this 
preamble, we are providing a table of contents.

Table of Contents

I. Final Rule: Regulatory Provisions To Promote Program Efficiency, 
Transparency, and Burden Reduction
    A. Executive Summary and Background
    1. Purpose
    2. Summary of Major Provisions
    3. Summary of Costs and Benefits for Regulatory Provisions To 
Promote Program Efficiency, Transparency, and Burden Reduction
    B. Provisions of the Proposed Rule and Analysis and Response to 
Public Comments
    1. Religious Nonmedical Health Care Institutions (RNHCIs)--
Discharge Planning
    2. Ambulatory Surgical Centers
    3. Hospice
    4. Hospitals
    5. Transplant Centers
    6. Home Health Agencies
    7. Comprehensive Outpatient Rehabilitation Facility (CORF)--
Utilization Review Plan
    8. Critical Access Hospitals
    9. Community Mental Health Center
    10. Portable X-Ray Services
    11. Rural Health Clinics (RHCs) and Federally Qualified Health 
Centers (FQHCs)
    12. Emergency Preparedness for Providers and Suppliers
    13. Technical Corrections
    14. Waiver of Proposed Rulemaking
    C. Collection of Information Requirements
II. Final Rule: Fire Safety Requirements for Certain Dialysis 
Facilities
    A. Background
    B. Provisions of the Proposed Rule and Analysis and Response to 
Public Comments
    1. 2012 Edition of the Life Safety Code
    2. Incorporation by Reference
    3. Ambulatory Health Care Occupancies
    4. 2012 Edition of the Health Care Facilities Code
    5. Technical Corrections
    C. Collection of Information Requirements
III. Final Rule: Hospital and Critical Access Hospital (CAH) Changes 
To Promote Innovation, Flexibility, and Improvement in Patient Care
    A. Background
    B. Provisions of the Proposed Rule and Analysis and Response to 
Public Comments for Hospitals
    1. General Comments
    2. Implementation Timeframe
    3. Non-Discrimination
    4. Licensed Independent Practitioner
    5. Quality Assessment and Performance Improvement (QAPI) Program
    6. Nursing Services
    7. Medical Record Services
    8. Infection Prevention and Control and Antibiotic Stewardship 
Programs
    9. Technical Corrections
    C. Provisions of the Proposed Regulations and Responses to 
Public Comments for Critical Access Hospitals
    1. Organization Structure
    2. Periodic Review of Clinical Privileges and Performance
    3. Provision of Services (Sec.  485.635(a)(3)(vii))
    4. Provision of Services (Sec.  485.635(g))
    5. Infection Prevention and Control and Antibiotic Stewardship 
Programs (Sec.  485.640)
    6. Quality Assessment and Performance Improvement (QAPI) Program 
(Sec.  485.641)
    7. Technical Corrections
    D. Requirements for Issuance of Regulations
    E. Collection of Information Requirements for Hospital and 
Critical Access Hospital (CAH) Changes To Promote Innovation, 
Flexibility, and Improvement in Patient Care
IV. Economic Analyses
    A. Regulatory Impact Analysis for Regulatory Provisions To 
Promote Program Efficiency, Transparency, and Burden Reduction
    1. Statement of Need
    2. Overall Impact
    3. Anticipated Effects

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    4. Alternatives Considered
    5. Uncertainty
    6. Conclusion
    B. Regulatory Impact Statement for Fire Safety Requirements for 
Certain Dialysis Facilities
    C. Regulatory Impact Analysis for Hospital and Critical Access 
Hospital (CAH) Changes to Promote Innovation, Flexibility, and 
Improvement in Patient Care
    1. Statement of Need
    2. Overall Impact
    3. Anticipated Effects
    4. Effects on Small Entities
    5. Alternatives Considered
    6. Conclusion
    D. Accounting Statement and Table
    E. Regulatory Reform Analysis Under E.O. 13771

I. Final Rule: Regulatory Provisions To Promote Program Efficiency, 
Transparency, and Burden Reduction

A. Executive Summary and Background

1. Purpose
    Over the past several years, we have revised our requirements, 
Conditions of Participation (CoPs) and Conditions for Coverage/
Conditions for Certification (CfCs) to reduce the regulatory burden on 
providers and suppliers while emphasizing health and safety. We 
identified obsolete and burdensome regulations that could be eliminated 
or reformed to improve effectiveness or reduce unnecessary reporting 
requirements and other costs, with a particular focus on freeing up 
resources that health care providers, health plans, and States could 
use to improve or enhance patient health and safety. We also examined 
policies and practices not codified in rules that could be changed or 
streamlined to achieve better outcomes for patients while reducing 
burden on providers and suppliers of care, and we identified non-
regulatory changes to increase transparency and to become a better 
business partner. In addition, the Centers for Medicare & Medicaid 
Services (CMS) and the Department of Health and Human Services (HHS) 
have reaffirmed their commitment to the vision of creating an 
environment where agencies incorporate and integrate the ongoing 
retrospective review of regulations into Department operations to 
achieve a more streamlined and effective regulatory framework. The 
objectives were to improve the quality of existing regulations 
consistent with statutory requirements; streamline procedural solutions 
for businesses to enter and operate in the marketplace; maximize net 
benefits (including benefits that are difficult to quantify); and 
reduce costs and other burdens on businesses to comply with 
regulations.
    In accordance with these goals, we published three final rules that 
identified unnecessary, obsolete, or excessively burdensome regulations 
on health care providers, suppliers, and beneficiaries. These rules 
further increased the ability of health care professionals to devote 
resources to improving health care by eliminating or reducing 
requirements that impede quality patient care or that divert providing 
high quality patient care:
     ``Reform of Hospital and Critical Access Hospital 
Conditions of Participation'', published May 16, 2012 (77 FR 29034);
     ``Regulatory Provisions to Promote Program Efficiency, 
Transparency, and Burden Reduction'', published May 16, 2012 (77 FR 
29002) and;
     ``Regulatory Provisions to Promote Program Efficiency, 
Transparency, and Burden Reduction; Part II'', published May 12, 2014 
(79 FR 27105).
    This final rule is a continuation of our efforts to reduce 
regulatory burden and is in accordance with the January 30, 2017 
Executive Order ``Reducing Regulation and Controlling Regulatory 
Costs'' (Executive Order 13771). We are finalizing changes to the 
current requirements, CoPs, and CfCs that will simplify and streamline 
the current regulations and thereby increase provider flexibility and 
reduce excessively burdensome regulations, while also allowing 
providers to focus on providing high-quality healthcare to their 
patients. This final rule will also reduce the frequency of certain 
required activities and, where appropriate, revise timelines for 
certain requirements for providers and suppliers and remove obsolete, 
duplicative, or unnecessary requirements. We believe these policies 
balance patient safety and quality, while also providing broad 
regulatory relief for providers and suppliers.
    In the proposed rule, we stated that we seek to reduce burdens for 
health care providers and patients, improve the quality of care, 
decrease costs, and ensure that patients and their providers and 
physicians are making the best health care choices possible. Therefore, 
we solicited public comments on additional regulatory reforms for 
burden reduction in future rulemaking. Specifically, we sought public 
comment on additional proposals or modifications to the proposals set 
forth in the proposed rule, ``Regulatory Provisions to Promote Program 
Efficiency, Transparency, and Burden Reduction,'' published September 
20, 2018 (83 FR 47686) that would further reduce burden on Medicare and 
Medicaid participating providers and suppliers and create cost savings, 
while also preserving quality of care and patient health and safety. We 
also noted in the proposed rule (83 FR 47686), consistent with our 
``Patients Over Paperwork'' Initiative, that we are particularly 
interested in improving existing requirements, within our statutory 
authority, where the requirements as currently written make providing 
quality care difficult or less effective. We also noted that such 
suggestions could include or expand upon comments submitted in response 
to Requests for Information (RFIs) that were included in the 2017 
prospective payment regulations for most provider types.
2. Summary of Major Provisions
    We are reducing regulatory burden on providers and suppliers by 
modifying, removing, or streamlining current regulations that we now 
believe are unnecessary, obsolete or excessively burdensome. 
Specifically, we are finalizing the following revisions:
a. Discharge Planning in Religious Nonmedical Health Care Institutions 
(RNHCIs)
    We have revised the requirements at 42 CFR 403.736(a) and (b) 
pertaining to a discharge plan. This revision simplifies the discharge 
process for RNHCIs by requiring them to assess the need for a discharge 
plan and provide discharge instructions to the patient and the 
patient's caregiver as necessary when the patient is discharged home.
b. Ambulatory Surgical Center (ASC): Transfer Agreements With Hospitals
    We are replacing the requirement at Sec.  416.41(b)(3), that ASCs 
have written transfer agreements or privileges with the local hospital 
with a requirement that ASCs must periodically provide the local 
hospital with written notice of its operation and patient population 
served.
c. ASC Requirements for Comprehensive Medical History and Physical 
Assessment
    We are removing the current requirements at Sec.  416.52(a) for a 
History and Physical within 30 days of the procedure and replacing them 
with requirements that defer, to a certain extent, to the ASC policy 
and operating physician's clinical judgment to ensure that patients 
receive the appropriate pre-surgical assessments tailored to the 
patient and the type of surgery being performed. We still require the 
operating physician to document any pre-existing medical conditions and 
appropriate test results, in the medical record, before, during and 
after surgery.

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In addition, we have retained the requirement that all pre-surgical 
assessments include documentation regarding any allergies to drugs and 
biologicals, and that the medical history and physical examination 
(H&P), if completed, be placed in the patient's medical record prior to 
the surgical procedure.
d. Hospice Requirements for Medication Management
    We are removing the procedural requirements at Sec.  418.106(a)(1), 
related to having on the hospice staff, an individual with specialty 
knowledge of hospice medications.
e. Hospice Requirements: Orientation of Skilled Nursing Facility (SNF) 
and Intermediate Care Facilities for Individuals With Intellectual 
Disabilities (ICF/IID) Staff
    We are revising the requirements at Sec.  418.112(f) to explicitly 
require hospices to coordinate with SNFs/NFs and ICFs/IID for assuring 
orientation of facility staff.
f. Hospital Quality Assessment and Performance Improvement Program 
(QAPI Program)
    We are finalizing a new standard at 42 CFR 482.21(f), ``Unified and 
integrated QAPI program for multi-hospital systems.'' For a hospital 
that is part of a hospital system, consisting of multiple separately 
certified hospitals using a system governing body that is legally 
responsible for the conduct of two or more hospitals, the system 
governing body can elect to have a unified and integrated QAPI program 
for all of its member hospitals if the arrangement is in accordance 
with all applicable State and local laws. The system governing body is 
responsible and accountable for ensuring that each of its separately 
certified hospitals meets all of the requirements of this section.
g. Hospital Requirements for Comprehensive Medical History and Physical 
Examinations (Sec. Sec.  482.22, 482.24, and 482.51)
    We are allowing hospitals the flexibility to establish a medical 
staff policy describing the circumstances under which such hospitals 
can utilize a pre-surgery/pre-procedure assessment for an outpatient, 
instead of a comprehensive medical history and physical examination 
(H&P). We believe that allowing this option will greatly reduce the 
burden on the hospital, the practitioner, and the patient. In order to 
exercise this option, a hospital must document the assessment in a 
patient's medical record. The hospital's policy must consider patient 
age, diagnoses, the type and number of surgeries and procedures 
scheduled to be performed, comorbidities, and the level of anesthesia 
required for the surgery or procedure; nationally recognized guidelines 
and standards of practice for assessment of specific types of patients 
prior to specific outpatient surgeries and procedures; and applicable 
state and local health and safety laws.
h. Hospital Infection Control Program
    We are broadly revising Sec.  482.42, and issuing a new standard at 
Sec.  482.42(d), ``Unified and integrated infection prevention and 
control and antibiotic stewardship programs for multi-hospital 
systems.'' Like the requirement for a unified and integrated QAPI 
program, the standard for infection control permits a hospital that is 
part of a hospital system consisting of multiple separately certified 
hospitals using a single governing body, such body can elect to have a 
unified and integrated infection prevention and control program for all 
of its member hospitals in accordance with all applicable State and 
local laws. The system governing body is responsible and accountable 
for ensuring that each of its separately certified hospitals meets all 
of the requirements of this section. Each separately certified hospital 
within the system must demonstrate that--the unified and integrated 
infection control program is established in a manner that takes into 
account each member hospital's unique circumstances and any significant 
differences in patient populations and services offered in each 
hospital; the unified and integrated infection control program 
establishes and implements policies and procedures to ensure that the 
needs and concerns of each of its separately certified hospitals, 
regardless of practice or location, are given due consideration, and 
that the unified and integrated infection control program has 
mechanisms in place to ensure that issues localized to particular 
hospitals are duly considered and addressed; and a qualified individual 
(or individuals) has been designated at the hospital as responsible for 
communicating with the unified infection control program and for 
implementing and maintaining the policies and procedures governing 
infection control as directed by the unified infection control program.
i. Special Requirements for Psychiatric Hospitals
    At Sec.  482.61(d), we are clarifying the scope of authority for 
non-physician practitioners or Doctors of Medicine and Doctors of 
Osteopathic Medicine (MD/DOs) to document progress notes of patients 
receiving services in psychiatric hospitals.
j. Special Requirement for Transplant Centers and Definitions
    We are making a nomenclature change at 42 CFR part 482 and the 
transplant center regulations at Sec. Sec.  482.68, 482.70, 482.72 
through 482.104, and at Sec.  488.61. This change updates the 
terminology used in the regulations to conform to the terminology that 
is widely used and understood within the transplant community, thereby 
reducing provider confusion.
k. Data Submission, Clinical Experience, and Outcome Requirements for 
Re-Approval of Transplant Centers
    We are removing the requirements at Sec.  482.82 that state that 
transplant centers must meet all data submission, clinical experience, 
and outcome requirements in order to obtain Medicare re-approval. 
Transplant centers will still be required to comply with the CoPs at 
Sec. Sec.  482.72 through 482.104 and the data submission, clinical 
experience, and outcome requirements for initial Medicare approval 
under Sec.  482.80.
l. Special Procedures for Approval and Re-Approval of Organ Transplant 
Centers
    We are revising Sec.  488.61(f) through (h) to remove the 
requirements with respect to the re-approval process for transplant 
centers. This change corresponds to the proposed removal of the 
provisions at Sec.  482.82. We are retaining the requirements in Sec.  
488.61(f) through (h) that pertain to the initial approval process for 
transplant centers.
m. Home Health Agency (HHA) Requirements for Verbal Notification of 
Patient Rights and Responsibilities
    We are removing the requirements for verbal (meaning spoken) 
notification of all patient rights at Sec.  484.50(a)(3), and replacing 
it with a requirement that verbal notice must be provided for those 
rights related to payments made by Medicare, Medicaid, and other 
federally funded programs, and potential patient financial liabilities 
as specified in the Social Security Act (the Act).
n. Personnel Requirements for Portable X-Ray Technologists
    We are revising Sec.  486.104(a), ``Condition for coverage: 
Qualifications, orientation and health of technical personnel'', to 
focus on the qualifications of the individual performing services.

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o. Portable X-Ray Requirements for Orders
    We are revising the requirements for portable x-ray orders at Sec.  
486.106(a)(2) by removing the requirement that physician or non-
physician practitioner's orders for portable x-ray services must be 
written and signed and replacing the specific requirements related to 
the content of each portable x-ray order with a cross-reference to the 
requirements at 42 CFR 410.32, which also apply to portable x-ray 
services.
p. Emergency Preparedness Requirements: Requirements for Emergency 
Plans
    We are removing the requirements from our emergency preparedness 
rules for Medicare and Medicaid providers and suppliers that facilities 
document efforts to contact local, tribal, regional, State, and Federal 
emergency preparedness officials, and that facilities document their 
participation in collaborative and cooperative planning efforts.
q. Emergency Preparedness Requirements: Requirements for Annual Review 
of Emergency Program
    We are revising this requirement so that applicable providers and 
suppliers review their Emergency program biennially, except for Long 
Term Care facilities, which will still be required to review their 
emergency program annually.
r. Emergency Preparedness Requirements: Requirements for Training
    We are revising the requirement that facilities develop and 
maintain a training program based on the facility's emergency plan 
annually by requiring facilities to provide training biennially (every 
2 years) after facilities conduct initial training for their emergency 
program, except for long term care facilities which will still be 
required to provide training annually. In addition, we are requiring 
additional training when the emergency plan is significantly updated.
s. Emergency Preparedness Requirements: Requirements for Testing
    For inpatient providers, we are expanding the types of acceptable 
testing exercises that may be conducted. For outpatient providers, we 
are revising the requirement such that only one testing exercise is 
required annually, which may be either one community-based full-scale 
exercise, if available, or an individual facility-based functional 
exercise, every other year and in the opposite years, these providers 
may choose the testing exercise of their choice.
2. Proposals That Reduce the Frequency of Activities and Revise 
Timelines
a. Comprehensive Outpatient Rehabilitation Facility (CORF) Utilization 
Review Plans
    We are amending the utilization review plan requirements at Sec.  
485.66 to reduce the frequency of utilization reviews from quarterly to 
annually. This would allow an entire year to collect and analyze data 
to inform changes to the facility and the services provided.
b. CAH Annual Review of Policies and Procedures
    We are changing the requirement at Sec.  485.635(a)(4) to require a 
CAH's professional personnel to, at a minimum, conduct a biennial 
review of its policies and procedures instead of an annual review.
c. Community Mental Health Center (CMHC) Requirements for Updating the 
Client Assessment
    At Sec.  485.914, we are removing the requirement that all CMHC 
clients receive an updated assessment every 30 days. Instead, we would 
require updates of the patient assessment in accordance with client 
needs and standards of practice. For clients receiving partial 
hospitalization services, we are retaining the 30-day assessment update 
time frame to be consistent with existing Medicare payment requirements 
for recertification of partial hospitalization services.
d. Rural Health Clinic (RHC) and Federally Qualified Health Center 
(FQHC) Review of Patient Care Policies
    We are revising the requirement at Sec.  491.9(b)(4) that RHC and 
FQHC patient care policies be reviewed at least annually by a group of 
professional personnel, to review every other year in order to reduce 
the frequency of policy reviews.
e. RHC and FQHC Program Evaluation
    We are revising the requirement at Sec.  491.11(a) by changing the 
frequency of the required RHC or FQHC evaluation from annually to every 
other year.
3. Proposals That Are Obsolete, Duplicative, or That Contain 
Unnecessary Requirements
a. Hospice Aide Training and Competency Requirements
    We are revising Sec.  418.76(a)(1)(iv) to remove the requirement 
that a State licensure program meet the specific training and 
competency requirements set forth in Sec.  418.76(b) and (c) in order 
for such licensure to qualify a hospice aide to work at a Medicare-
participating hospice, deferring to State licensure requirements.
b. Medical Staff: Autopsies
    We are finalizing our proposal to remove the requirement for 
hospitals at Sec.  482.22(d), which states that a hospital's medical 
staff should attempt to secure autopsies in all cases of unusual deaths 
and of medical-legal and educational interest. We are deferring to 
State law regarding such medical-legal requirements.
c. Hospital and CAH Swing-Bed Requirements
    We are removing the cross reference to Sec.  483.10(f)(9) at Sec.  
482.58(b)(1) (for hospital swing-bed providers) and Sec.  485.645(d)(1) 
(for CAH swing-bed providers); the repealed provisions gave a resident 
the right to choose to, or refuse to, perform services for the facility 
if they so choose.
    We are removing the cross-reference to Sec.  483.24(c) at Sec.  
482.58(b)(4) (for hospital swing-bed providers) and Sec.  485.645(d)(4) 
(for CAH swing-bed providers) requiring that the facility provide an 
ongoing activity program based on the resident's comprehensive 
assessment and care plan directed by a type of qualified professional 
specified in the regulation.
    We are removing the cross-reference to Sec.  483.70(p) at Sec.  
482.58(b)(5) (for hospital swing-bed providers) and Sec.  485.645(d)(5) 
(for CAH swing-bed providers requiring facilities with more than 120 
beds to employ a social worker on full-time basis).
    We are removing the cross-reference to Sec.  483.55(a)(1) at Sec.  
482.58(b)(8) (for hospital swing-bed providers) and Sec.  485.645(d)(8) 
(for CAH swing-bed providers) requiring that the facility assist 
residents in obtaining routine and 24-hour emergency dental care.
d. Home Health Agency Home Health Aide Requirements
    We are revising Sec.  484.80(c)(1) to clarify that skill 
competencies may be assessed by observing an aide performing the skill 
with either a patient or a pseudo-patient as part of a simulation. We 
are defining the terms ``pseudo-patient'' and ``simulation'' in Sec.  
484.2.
    We are revising the requirement at Sec.  484.80(h) related to 
completing a full competency evaluation when an aide is found to be 
deficient in one or more skills. Instead of completing a full 
competency evaluation, an aide would only be required to complete 
retraining

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and a competency evaluation directly related to the deficient skills.
e. CAH Disclosure Requirements
    We are removing Sec.  485.627(b)(1), the requirement for CAHs to 
disclose the names of people with a financial interest in the CAH. This 
is currently a requirement under the program integrity requirements at 
42 CFR 420.206, which are referenced in the provider agreement rules in 
42 CFR 489.53(a)(8), making this CAH CoP requirement duplicative of 
those regulations.
3. Summary of Costs and Benefits for Regulatory Provisions To Promote 
Efficiency, Transparency, and Burden Reduction
1. Overall Impact
    This final rule will create savings and reduce burden in many 
areas. Several of the changes will create measurable monetary savings 
for providers and suppliers, while others will create less quantifiable 
savings of time and administrative burden. We anticipate a total first 
year net savings of approximately $843 million, and slightly more in 
future years.
2. Section-by-Section Economic Impact Estimates
    Table 1 summarizes the provisions for which we are able to provide 
specific estimates for savings or burden reductions (these estimates 
are uncertain and could be substantially higher or lower, as explained 
in the regulatory impact analysis section of this final rule):

                                  Table 1--Summary of Net Savings by Provision
----------------------------------------------------------------------------------------------------------------
                                                                  Number of
   Provider and supplier type and            Frequency            affected       Estimated savings (annualized,
 description of proposed provisions                               entities                 $millions)
----------------------------------------------------------------------------------------------------------------
Religious Nonmedical Health Care
 Institutions:
     Discharge Planning.....  As patients are                      18  (*)
                                       discharged (Estimated
                                       619 annual discharges).
Ambulatory Surgical Centers:
     Governing Body and       Upon failed hospital              5,557  (*)
     Management.                       transfer agreement
                                       attempts.
     Patient Admission,       Every patient                     5,557  77.
     Assessment and Discharge          registration at an ASC
     (History and Physical).           or at a hospital
                                       outpatient/.
                                      ambulatory surgery
                                       department.
     Medical Records........  Recurring annually.....           5,557  0.
Hospices:
     Drugs and Biologicals,   Recurring annually.....           4,602  94.
     Medical Supplies, and Durable
     Medical Equipment ***.
     Hospices That Provide    Recurring annually.....           4,602  1.
     Hospice Care to residents of a
     SNF/NF or ICF/IID.
     Hospice Aide and         Recurring annually.....           4,602  2.
     Homemaker Services.
Hospitals:
     Quality Assessment and   Recurring annually.....           4,823  31.
     Performance Improvement Program.
     Medical staff:           Recurring annually.....           4,823  0.
     Autopsies.
     Infection Control......  Recurring annually.....           4,823  115.
     Special requirements     Recurring annually.....             478  30.
     for hospital providers of long-
     term care services (``swing-
     beds'').
     Special Requirements     Recurring annually.....             620  154.
     for Psychiatric Hospitals.
     Patient Admission,       Every patient                     4,823  77.
     Assessment and Discharge          registration at an ASC
     (History and Physical).           or at a hospital
                                       outpatient/ambulatory
                                       surgery department.
Transplant programs:
     Various provisions       Recurring annually.....             750  Not Quantified.
     related to performance **.
Home Health Agencies:
     Patient rights.........  Recurring annually.....          12,624  57.
     Home health aide         Recurring annually.....          12,624  Not Quantified.
     services.
     Clinical records.......  Recurring annually.....          12,624  Not Quantified.
Critical Access Hospitals:
     Provision of Services..  Recurring biennially...           1,353  1.
     Organizational           Recurring annually.....           1,353  (*)
     structure.
     Special requirements     Recurring annually.....           1,246  77.
     for CAH providers of long-term
     care services (``swing-beds'').
Comprehensive Outpatient
 Rehabilitation Facilities:
     Utilization Review Plan  Recurring annually.....             188  (*)
Community Mental Health Centers:
     Assessment Update......  Recurring annually.....              52  (*)
Portable X-Ray Services:
     Qualifications of X-ray  Recurring annually.....             500  31.
     technicians ***.
     Removing written orders  Recurring annually.....             500  28.
RHC (4,160 clinics) & FQHC (7,874
 center locations):
     Patient Care Policies    Recurring biennially...          12,034  4.
     Review.
     Program Evaluation.....  Recurring biennially...          12,034  5.
Emergency Preparedness for Providers
 and Suppliers:
     Review of Emergency      Recurring biennially...          56,983  70.
     Preparedness Program.
     Emergency Plan.........  Recurring annually.....          68,275  7.
     Training and Testing--   Recurring biennially...          53,543  26.
     Training Program.

[[Page 51737]]

 
     Training and Testing--   Recurring annually.....          36,971  21.
     Testing.
----------------------------------------------------------------------------------------------------------------
* Amount is less than half a million dollars and rounds to zero.
** These include changes to the following requirements: Special Requirements for Transplant Programs; Data
  submission, Clinical Experience, and Outcome Requirement for Re-approval of Transplant Programs; and Special
  Procedures for Approval and Re-Approval of Organ Transplant Programs.
*** This estimate is for first full year savings only and will increase in future years.

B. Provisions of the Proposed Rule and Analysis and Response to Public 
Comments on ``Medicare and Medicaid Programs; Regulatory Provisions To 
Promote Program Efficiency, Transparency, and Burden Reduction''
    In response to our September 20, 2018 proposed rule (83 FR 47686), 
we received 620 public comments. Commenters included individuals, 
healthcare professionals and corporations, national associations, 
health departments and emergency management professionals, and 
individual facilities that would be impacted by the regulation. 
Generally, the comments received were supportive. Most comments were 
centered around the proposed revisions to the emergency preparedness 
regulations for Medicare and Medicaid providers and suppliers. We have 
organized our responses to the comments as follows: (1) Comments 
specific to individual types of providers and suppliers (2); general 
comments; and (3) comments regarding our savings estimates.
1. Religious Nonmedical Health Care Institutions (RNHCIs)--Discharge 
Planning (Sec.  403.736(a) and (b))
    Section 1861(ss)(1) of the Act defines the term ``Religious 
Nonmedical Health Care Institution'' (RNHCI) and lists the requirements 
that a RNHCI must meet to be eligible for Medicare participation.
    Section 403.736(a) and (b) of the RNHCI's CoPs, as amended in the 
November 28, 2003 Federal Register (68 FR 66710), requires RNHCIs to 
have a discharge planning process for patients.
    Since the RNHCI's religious tenets prohibit conventional or 
unconventional medical treatment of a beneficiary, and medical post-
institution services are not utilized by RNHCI patients, we believe 
that extensive discharge requirements are unnecessarily burdensome. 
Therefore, we proposed a more condensed and flexible process for 
discharge planning and instructions for RNHCIs. We proposed to remove 
the requirements at Sec.  403.736(a) and (b), and proposed instead to 
require RNHCIs to provide discharge instructions to the patient or the 
patient's caregiver when the patient is discharged home.
    The majority of commenters expressed strong support for the 
proposed changes to the RNHCIs discharge planning process. We did not 
receive any comments in opposition to the proposed requirement; 
therefore, we are incorporating the changes as proposed in this final 
rule.
    Comment: One commenter stated that they agreed with allowing 
flexibility and giving the institution the freedom to determine which 
patients should be provided a discharge plan. However, they commented 
that there should be a way to monitor this process to make institutions 
accountable and not omit providing a discharge plan if a patient needs 
one.
    Response: As for all providers and suppliers, Medicare surveys 
RNHCIs for compliance with the CoPs. We believe this enforcement 
process adequately ensures that RNHCIs are correctly interpreting and 
following our requirements.
    Comment: The majority of the commenters stated that they agree with 
the changes proposed to the discharge planning process at Sec.  
403.736(a) and (b). They stated that this change would reduce burden 
and allow greater flexibility to the RNHCIs.
    Response: We appreciate the comments received on the proposed 
changes for RNHCIs and will finalize the changes as proposed.
    Final Rule Action: We are finalizing the proposed changes without 
changes.
    Contact: Mary Collins, (410) 786-3189.
2. Ambulatory Surgical Centers
    Section 416.2 of our rules defines an ambulatory surgical center 
(ASC) as any distinct entity that operates exclusively for the purpose 
of providing surgical services to patients not requiring 
hospitalization, in which the expected duration of services would not 
exceed 24 hours following an admission. The surgical services performed 
at ASCs are scheduled, primarily elective, non-life-threatening 
procedures that can be safely performed in an ambulatory setting. We 
received 99 timely public comments on our proposed changes to the ASC 
CfC requirements. Commenters included ASC industry associations, 
healthcare systems, national accreditation organizations, clinician 
associations, individual ASCs, and clinicians. Overall, the majority of 
the commenters were supportive of the goals of the proposed changes. 
Summaries of the major issues and our responses are set forth below.
a. Governing Body and Management; Hospitalization Requirements (Sec.  
416.41(b)(3)(i) and (ii))
    We proposed to remove the requirement for a written hospital 
transfer agreement or hospital physician admitting privileges at Sec.  
416.41(b)(3). The requirements in Sec.  416.41(b)(1) and (2) continue 
to require the ASC to have an effective procedure for the immediate 
transfer, to a hospital, of patients requiring emergency medical care 
beyond the capabilities of the ASC and that the hospital must be a 
local hospital that meets the requirements for payment for emergency 
services under Sec.  482.2. As part of this revision, ASCs are not 
precluded from obtaining hospital transfer agreements or hospital 
physician admitting privileges when possible.
    Comment: The comments submitted regarding the removal of the 
transfer agreement were almost evenly split between supporters and 
opponents. Specifically, the ASCs supported the removal of the transfer 
agreement and hospitals were opposed to the removal of the transfer 
agreement. Comments in support of removal of the written hospital 
transfer agreement stated that the current requirement is unnecessary, 
obsolete and extremely burdensome because of the small number of 
patient transfers, the creation of The Emergency Medical Treatment and 
Labor Act (EMTALA), and the exhaustive administrative paperwork and 
negotiation burden that is required when the local hospital system 
refuses to sign the written hospital transfer agreement. Comments in 
support of the

[[Page 51738]]

removal also stated that ASCs should not be forced to close their 
businesses because regulations cannot be met due to competition issues 
with the local hospital and their outpatient surgery center. Comments 
opposing removal of the written hospital transfer agreement stated that 
transfer agreements have the potential to ensure that there is a plan 
for emergencies, that appropriate continued care will be delivered, and 
that both the ASC and hospital communicate with one another. In 
addition, we received several comments that suggested the regulation 
should instead specify that the ASC would be deemed to have met the 
hospital transfer agreement provision if a ``good faith effort'' was 
documented. One commenter suggested that instead of an all or nothing 
provision, ASCs should periodically provide local hospitals with a 
written notice. The commenter contended that this requirement would 
notify the hospital of ASC services in the community and the types of 
patients that are receiving care that may need additional care beyond 
the capability of the ASC.
    Response: We continue to believe that, because of the existing 
EMTALA regulations, the small number of transfers, and the burden ASCs 
incur when faced with local hospital competition issues, removing this 
requirement is necessary and appropriate. We agree that communication 
between ASCs and hospitals is important; however, we do not agree that 
a mandated transfer agreement is a necessary or effective method to 
assure this communication. In response to the commenter's suggestions 
described above, and to assure that hospitals are aware of the 
potential for receiving patient transfers from an ASC, we are revising 
our proposal at Sec.  416.41(b)(3) to require the ASC to periodically 
provide the local hospital with written notice of its operation and 
patient population served. For example, the notice would include 
details such as hours of operation and the procedures that are 
performed in the ASC. Providing written notice, rather than securing a 
transfer agreement, will alleviate the administrative burden of 
negotiating or being denied negotiating opportunities associated with 
the requirement of a written transfer agreement between the ASC and 
hospital. We are requiring that the notice be provided ``periodically'' 
to the local hospital to ensure the ASC keeps the local hospital 
informed and up-to-date on ASC information and any patient population 
changes. The ``periodically'' phrasing is similar to the reappraisal 
requirement for the medical staff privileges in ASCs located at Sec.  
416.45(b), ``Medical staff- Standard: Reappraisals'', and is meant to 
have the same meaning. This change does not preclude those ASCs and 
hospitals with functional working relationships to continue to have 
written transfer agreements, which we encourage, and prior preparations 
in place for patient transfers in the event of an emergency.
b. Patient Admission, Assessment and Discharge (Sec.  416.52(a)(1), 
(2), (3) and (4))
    The current regulations at Sec.  416.52 require ASCs to ensure that 
a physician or other qualified practitioner provide a comprehensive 
medical history and physical assessment (H&P) completed not more than 
30 days before the date of the scheduled surgery.
    We proposed to remove the current requirements at Sec.  416.52(a) 
and replace them with requirements under the facility's established 
policies for pre-surgical medical histories and physical examinations 
(H&P), including any associated testing, and the operating physician's 
clinical judgment, to ensure patients receive the appropriate pre-
surgical assessments that are tailored for the patient and the type of 
surgery being performed. We proposed to require each ASC to establish 
and implement a policy that identifies patients who require an H&P 
prior to surgery. We proposed that the policy would include the time 
frame for the H&P to be completed prior to surgery. We proposed that 
the policy would be required to consider the age of patients, their 
diagnoses, the type and number of surgeries that are scheduled to be 
performed at one time, all known comorbidities, and the planned level 
of anesthesia for the surgery to be performed. ASCs would not be 
limited to these factors, and would be permitted to include others to 
meet the needs of their patient populations. Furthermore, we proposed 
that each ASC's policy would be required to follow nationally 
recognized standards of practice and guidelines, as well as applicable 
state and local health and safety laws. To conform to the proposed 
changes to the medical history and physical examination requirements at 
Sec.  416.52(a), we proposed to revise the requirement at Sec.  
416.47(b)(2), that states ``Significant medical history and results of 
physical examination,'' by adding ``as applicable.''
    Comment: A majority of commenters supported the proposed change to 
remove the medical H&P examination requirement no more than 30 days 
before the date of the scheduled surgery, and defer to the ASCs 
established policies for pre-surgical H&Ps and the operating 
physician's clinical judgment. The comments agreed that allowing ASCs 
flexibility to establish patient policies, and encouraging the use of 
clinician judgment, are appropriate to assure patient health and safety 
while also reducing the burden on patients and providers, and reducing 
expenditures on potentially unnecessary pre-operative testing that is 
performed because it is required by policy. However, a small number of 
comments supported only part of this change, suggesting instead that 
CMS should retain the H&P requirement while allowing the ASC the 
discretion to determine the timeframe for the H&P relative to the date 
of surgery. Another commenter opposed any changes and recommended 
retaining the H&P requirement and 30-day time frame. One commenter 
stated that they believe the burden of assessing patients prior to 
surgery would be shifted from one provider (the primary care physician) 
to another (the anesthesiologist), and that allowing ASCs the 
flexibility to establish their own policies based on their clinical 
judgment and patient population needs would burden ASCs and healthcare 
workers, create inefficiencies, and lead to variations in standards of 
care from facility to facility.
    Response: We appreciate the support of the vast majority of 
commenters, and continue to believe that the change is appropriate to 
support patient health and safety while eliminating the burdens of 
potentially unnecessary examinations and tests. The content of ASC-wide 
policies surrounding the appropriate use of medical histories and 
physicals, as well as pre-operative testing, could be informed by 
specialty societies, medical literature, past experience, or other 
factors. We disagree that variations between facilities would be an 
inherently undesirable effect of the change; variations to take into 
account unique patient needs and facility characteristics are 
preferable to a ``one size fits all'' approach of mandatory 30 day 
H&Ps. Allowing ASCs and physicians to work together to implement their 
own policies, based on their clinical judgment and patient population 
served, will provide the most optimal balance between burden and 
necessary examinations and testing, by identifying when a medical H&P 
examination should be completed, if appropriate. We are finalizing the 
proposal to require ASCs to address certain patient characteristics, 
such as age, diagnosis, the type and number of procedures, 
comorbidities and the planned anesthesia level, when

[[Page 51739]]

developing their policies and procedures for pre-surgical examinations 
and testing. We believe this change will ensure those patients who 
would actually be protected by a medical H&P examination will receive 
one based on ASC policy, and in a time frame established by that 
policy, thereby reducing burden on physicians, facilities, and 
patients. We reiterate that ASCs are still required to perform a 
patient assessment upon admission before surgery, that the ASC is not 
precluded from retaining the H&P requirement in facility policies, and 
that we are not discouraging pre-surgical H&Ps where clinically 
indicated.
    Comment: One commenter expressed concern over the wording of the 
proposed regulation text in Sec.  416.52(a)(1)(iii), stating that the 
ASC policy must follow nationally recognized standards of practice and 
guidelines. The commenter believed the term ``follow'' could be 
problematic for ASCs, and be interpreted as being required to 
``adhere'' to national guidelines that are not delineated, thus 
depriving the ASC of the ability to determine what clinical practices 
make the best sense for its patients.
    Response: We agree and have revised the regulation text to be 
consistent with the regulation text that is being finalized for 
hospital outpatient H&P requirements. We are finalizing the regulation 
text to state that the ASC policy must be based on any applicable 
nationally recognized standards of practice and guidelines, and any 
applicable State and local health and safety laws.
    Comment: One commenter asked CMS to coordinate any changes to the 
regulations with updates to the accreditation organizations (AOs) 
standards.
    Response: National accreditation organizations must meet or exceed 
CMS standards, and their standards must be updated, as appropriate, to 
reflect changes in the CMS regulations. As AOs may choose to exceed CMS 
requirements, so they may choose to retain any or all of the 
requirements that we are removing in this final rule to the extent that 
they do not conflict with any of our revisions.
    We did not receive any public comments on the proposed technical 
change to the medical records proposed at Sec.  416.47(b)(2) and are 
finalizing the technical change to the medical records section as 
proposed.
    Final Rule Action:
    1. Rather than deleting, we are finalizing revisions to Sec.  
416.41(b)(3) to require ASCs to periodically provide the local hospital 
with written notice of its operation and patient population served.
    2. We are finalizing the proposal to revise the requirement at 
Sec.  416.47(b)(2), to state ``Significant medical history and results 
of physical examination, as applicable.''
    3. We are finalizing the proposal to eliminate the requirement at 
Sec.  416.52(a) for each patient to have a medical history and physical 
assessment completed by a physician not more than 30 days before the 
scheduled surgery, and replace it with the requirement for ASCs to 
develop and maintain a policy that identifies those patients who 
require a medical history and physical examination prior to surgery. In 
addition, require the policy to include the timeframe for the medical 
history and physical examination to be completed prior to surgery. The 
policy must also address, but not be limited to, the following factors: 
Patient age, diagnosis, the type and number of procedures scheduled to 
be performed on the same surgery date, known comorbidities, and the 
planned anesthesia level. Upon admission, each patient must have a pre-
surgical assessment completed by a physician or other qualified 
practitioner in accordance with applicable State health and safety 
laws, who will be performing the surgery.
    4. We are revising Sec.  416.52(a)(1)(iii) to clarify that the ASC 
policy must be based on nationally recognized standards of practice and 
guidelines, and applicable State and local health and safety laws.
    Contact: CAPT Jacqueline Leach, USPHS, 410-786-4282.
3. Hospice
a. Hospice Aide and Homemaker Services (Sec.  418.76)
    We proposed to revise Sec.  418.76(a)(1)(iv) to remove the 
requirement that a hospice aide training State licensure program must 
meet the specific training and competency requirements set forth in 
Sec.  418.76(b) and (c) in order to be deemed an appropriate 
qualification for employment. This change would defer to State 
licensure requirements, except in states where no requirements exist.
    Comment: Many comments supported the proposed revision to defer to 
existing state requirements for hospice aide training, and only impose 
Federal requirements in the absence of state standards. However, other 
comments did not support this proposed change, arguing that state 
education and training standards for hospice aides should not be 
accepted as being sufficient to assure patient health and safety.
    Response: Deference to state-established standards regarding the 
training and competency of health care professionals is standard 
practice. States already establish such standards for health care 
professions such as nursing, laboratory technicians, phlebotomists, and 
therapists, to name a few. Seventy-six percent of states have already 
established their own qualification standards for aides, aides 
furnishing services in those states are already permitted to provide 
services to individuals through private pay agencies without meeting 
the Medicare standards, and there is no indication that these already 
applicable standards are insufficient to assure patient health and 
safety. As deference to state standards is the norm across the health 
care spectrum, and as current state standards are already demonstrated 
to be sufficient to assure patient health and safety, we see no reason 
to impose a separate Federal standard. Therefore, we are finalizing 
this proposed change. In the absence of state requirements, hospices 
will continue to be required to assure that an aide meets the Federal 
training standards. Furthermore, all hospices in all states will 
continue to be required to comply with the existing requirements that 
hospice aides may only perform those skills that are consistent with 
the training that the aide has received (Sec.  418.76(g)(2)(iv)), and 
that, if an area of concern is verified by the hospice during an on-
site aide supervision visit, then the hospice must conduct, and the 
hospice aide must complete, a competency evaluation in accordance with 
Sec.  418.76(c) and (h)(1)(iii).
b. Drugs and Biologicals, Medical Supplies, and Durable Medical 
Equipment (Sec.  418.106(a)(1) and (e)(2)(i))
    We proposed to delete the requirements at Sec.  418.106(a)(1), 
which required hospices to ensure that the interdisciplinary group 
confers with an individual with education and training in drug 
management as defined in hospice policies and procedures and State law, 
who is an employee of or under contract with the hospice, to ensure 
that drugs and biologicals meet each patient's needs. Meeting each 
patient's needs would continue to be the responsibility of all 
Medicare-participating hospices in accordance with the requirements of 
all other hospice CoPs.
    Comment: We received numerous comments that both supported and 
opposed the proposal to eliminate the process requirement that a 
hospice must confer with an individual with expertise in medication 
management regarding

[[Page 51740]]

the plan of care for each patient. Many commenters agreed that this 
process requirement is no longer necessary because this is standard 
practice in hospices. However, other commenters, while agreeing that it 
is standard practice, still believe that there is value in having a 
distinct regulatory requirement to this effect, due to the important 
role that medications play in hospice care and the potential for safety 
lapses.
    Response: Hospices would continue to be required to comprehensively 
assess patients on a regular schedule and on an as needed basis in 
accordance with the requirements of Sec.  418.54(a), (b) and (d), and 
to assure that each patient's plan of care is developed and continually 
updated to meet each patient's needs as identified in the assessment 
process in accordance with the requirements ofSec.  418.56(b) through 
(d). These existing regulations, which we are not revising, focus on 
assuring the outcomes of safe, effective, patient-centered care. 
Furthermore, hospices will still be required to comply with the quality 
assessment and performance improvement (QAPI) CoP at Sec.  418.58, 
which requires hospices to monitor patient outcomes and implement 
improvement projects to address identified areas of concern. To the 
extent that patient outcomes are not being achieved due to problems 
with medication management, both the hospice's internal QAPI program 
and the external hospice survey process will be capable of identifying 
and addressing those problems, regardless of the removal of this 
process requirement. In light of these existing requirements, and in 
response to the support for the proposed change expressed by a variety 
of commenters, we are finalizing the proposed change to remove the 
process requirement at Sec.  418.106(a)(1) without revisions.
    We proposed to replace the requirement at Sec.  418.106(e)(2) that 
hospices provide a physical paper copy of policies and procedures, 
which are written to guide the actions of hospice staff, with a 
requirement that hospices provide information regarding the use, 
storage, and disposal of controlled drugs to the patient or patient 
representative, and family, which can be developed in a manner that 
speaks to the perspectives and information needs of patients, families, 
and caregivers. This information would be provided in a more user-
friendly manner, as decided by each hospice. Hospices would be free to 
choose the content and format(s) that best suits their needs and the 
needs of their patient population. We proposed to require that, 
regardless of the format chosen, this information would have to be 
provided to patients, families and caregivers in a manner that allowed 
for access to the information on a continual, as-needed basis.
    We would continue to require that hospices discuss the information 
regarding the safe use, storage and disposal of controlled drugs with 
the patient or representative, and the family/caregiver(s), in a 
language and manner that they understand to ensure that these parties 
are effectively educated. This requirement is included in the current 
hospice CoPs and is consistent with Department of Health and Human 
Services guidance regarding Title VI of the Civil Rights Act 
(``Guidance to Federal Assistance Recipients Regarding Title VI 
Prohibition Against National Origin Discrimination Affecting Limited 
English Proficient Persons,'' 68 FR 47311, August 8, 2003, https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/guidance-Federal-financial-assistance-recipients-title-VI/). We continue to expect hospices to utilize technology, such 
as telephonic interpreting services and any other available resources 
for oral communication in the individual's primary or preferred 
language. We would also continue to require that hospices document in 
the patient's clinical record that the information was provided and 
discussed.
    Comment: We received many comments regarding the proposed change to 
allow hospices to determine the content and form of the controlled drug 
storage, use, and disposal notice for patients and families. Commenters 
universally supported the goal of improving patient and family 
education on this subject and supported the shift away from providing 
policies and procedures. However, a few commenters raised concern about 
the intersection of this change with section 3222 of the recently 
adopted Substance Use-Disorder Prevention that Promotes Opioid Recovery 
and Treatment for Patients and Communities Act (``SUPPORT Act'') (Pub. 
L. 115-271), that requires hospices, which permit their employees to 
dispose of medications in the patient's home, to provide their written 
policies and procedures to patients, families and caregivers. This 
provision, which amends section 302 of the Controlled Substances Act 
(21 U.S.C. 822), is under the jurisdiction of the Department of 
Justice.
    While most commenters expressed appreciation for the proposal to 
allow hospices to determine the form and content of the notice, other 
commenters suggested that CMS should develop education materials that 
hospices must provide to patients and families. Whether hospice or CMS-
generated, commenters suggested that using alternative formats such as 
pictorial infographics and videos may be valuable tools in 
communicating this important information. Commenters also suggested 
that the information should be accessible to all individuals, 
regardless of impairments or language spoken.
    Response: In light of the changes included in section 3222 of the 
SUPPORT Act, it is not appropriate to finalize this proposed change. 
However, we encourage hospices to develop easily understood materials 
that explain safe storage, use, and disposal of controlled drugs to 
patients, their families, and caregivers in addition to meeting the 
regulatory requirement to provide a copy of the hospice's clinical 
policies and procedures. We continue to believe that providing such 
materials is a positive practice for improving comprehension of this 
crucial information and improving compliance with safe handling, use, 
and disposal practices.
c. Hospices That Provide Hospice Care to Residents of a SNF/NF or ICF/
IID (Sec.  418.112(c)(10) and (f))
    Section 418.112(f) of the hospice CoPs, as finalized in the 2008 
Hospice CoP final rule (73 FR 32088), requires hospices to assure 
orientation of Skilled Nursing Facility/Nursing Facility (SNF/NF) or 
ICF/IID staff furnishing care to hospice patients. We proposed to 
remove Sec.  418.112(f) and add a new requirement at Sec.  
418.112(c)(10), ``Written agreement,'' to permit both entities to 
negotiate the mechanism and schedule for assuring orientation of 
facility staff.
    Comment: While comments supported the intent behind the proposed 
change to permit hospices and long term care facilities to negotiate 
the roles and responsibilities for orienting long term care facility 
staff to the hospice philosophy of care and hospice procedures, some 
comments did not support moving the topic into the content of the 
written agreement. Comments stated that requiring this subject to be 
addressed in the written agreement would create a onetime burden for 
hospices of renegotiating the written agreement with each long term 
care facility, and that this burden was not acceptable even in light of 
the potential long-term regulatory relief of the proposed change. Some 
comments suggested that the current regulations at

[[Page 51741]]

Sec.  418.112(f) instead be revised to allow for hospices and 
facilities to negotiate their respective roles and responsibilities 
outside of the written agreement.
    Response: We agree with commenters that the goal of regulatory 
flexibility is worthwhile, and we appreciate the feedback regarding the 
scope of the regulatory burden that would be incurred when 
renegotiating existing contracts with long term care facilities. In 
light of the burden concerns raised in the comments, we agree that a 
different approach to achieving the same goal is warranted. We are not 
finalizing the proposal to move the requirements related to facility 
staff orientation and training from a standalone requirement to a 
provision in the written agreement. In order to achieve the original 
regulatory goal of adding flexibility and reducing hospice costs for 
this activity, we are revising existing Sec.  418.112(f), Orientation 
and training of staff, to clarify that a hospice must consult with and 
thus share responsibility with the facility to assure facility staff 
orientation and training. We received 26 timely public comments 
pertaining to all proposed changes to the hospice requirements. 
Commenters included hospice industry associations, individual hospice 
providers, national accrediting organizations, clinician associations, 
and consumer advocacy groups. Overall, the majority of commenters were 
supportive of the goal of the proposed changes. Comments not directly 
related to our proposals are summarized below.
    Comment: A few comments specifically related to the hospice CoPs 
were submitted in response to the solicitation for ideas for further 
burden reduction efforts. Comments included removing the core services 
requirement for dietary counseling and providing waivers for social 
worker supervision.
    Response: We appreciate the suggestions, and will consider revising 
the social work supervision requirements in future rulemaking. The 
hospice interpretive guidelines related to Sec.  418.114(b)(3) (State 
Operations Manual, Pub. 100-07, Appendix M, https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_m_hospice.pdf, accessed on January 16, 2019) state, ``Each 
hospice must employ or contract with at least one MSW to serve in the 
supervisor role. . . .'' We believe that this existing flexibility 
regarding contracting for this service, when coupled with the fact that 
the supervision role can be performed remotely, is adequate to address 
concerns regarding the provision of social work supervision at this 
time while we consider this waiver suggestion. Dietary counseling as a 
core service is a statutory requirement (see section 
1861(dd)(2)(A)(ii)(I) of the Act)) and cannot be repealed through 
regulatory mechanisms.
    Comment: We received numerous comments with suggestions related to 
Medicare payment requirements for hospice services (for example, notice 
of election requirements and the coverage requirements for continuous 
home care level of care), use of the CMS Common Working File, hospice 
quality measures, Medicaid payment issues, and Medicare audits.
    Response: These comments are not within the scope of this 
regulation, which is related to the health and safety standards for 
Medicare providers. We publish an annual proposed hospice payment rule, 
and comments related to payment policies and rates may also be 
submitted to that rule for consideration. All out of scope comments 
have been shared with the appropriate components within CMS.
    Final Rule Action:
    1. We are finalizing the proposed changes to Sec. Sec.  
418.76(a)(1)(iv) and 418.106(a)(1) without change. We are not 
finalizing our proposed change to 418.106(e)(2)(i).
    2. Revise Sec.  418.112(f) to require hospice and facilities to 
share responsibility for facility staff orientation and training.
    Contact: Danielle Shearer, 410-786-6617.
4. Hospitals
a. Quality Assessment and Performance Improvement Program (Sec.  
482.21)
    We proposed a new standard at Sec.  482.21(f), ``Unified and 
integrated QAPI program for multi-hospital systems.'' We would allow 
that for a hospital that is part of a hospital system consisting of two 
or more separately certified hospitals subject to a system governing 
body legally responsible for the conduct of each hospital, the system 
governing body could elect to have a unified and integrated QAPI 
program for all of its member hospitals after determining that such a 
decision is in accordance with all applicable State and local laws. The 
system governing body would be responsible and accountable for ensuring 
that each of its separately certified hospitals meets all of the 
requirements of this section. Each separately certified hospital 
subject to the system governing body would have to demonstrate that: 
The unified and integrated QAPI program was established in a manner 
that took into account each member hospital's unique circumstances and 
any significant differences in patient populations and services offered 
in each hospital; and the unified and integrated QAPI program 
establishes and implements policies and procedures to ensure that the 
needs and concerns of each of its separately certified hospitals, 
regardless of practice or location, are given due consideration, and 
that the unified and integrated QAPI program has mechanisms in place to 
ensure that issues localized to particular hospitals are duly 
considered and addressed.
    Comment: Most commenters supported the proposal to allow hospitals 
that are part of a multi-hospital system to have a unified and 
integrated QAPI program. A few commenters expressed appreciation for 
the expanded flexibility that this proposal would afford hospitals by 
reducing burden, increasing efficiencies, and eliminating the 
duplication of efforts.
    A few commenters generally supported this proposal, but recommended 
that individual, hospital-specific data be recorded and made available 
to the system's governing body and the public. These data, the 
commenters stated, would help to identify best practices and processes 
from facilities that are excelling in certain areas and will account 
for and address performance outliers across the broader hospital 
system. Finally, another commenter expressed concern that the proposed 
requirement might group QAPI scores together and hide poor performance, 
which they stated may mislead consumers about the site-specific care 
they are receiving.
    Response: We thank the commenters for their support. We believe 
that a hospital's governing body should be afforded the option of 
unifying and integrating the various member hospitals within their 
multi-hospital system into a unified QAPI program. Such a model would 
incorporate each individual hospital's QAPI program, which would enable 
increased efficiencies, innovations, provider flexibility, and allow 
for the dissemination of best practices for patient care while also 
potentially improving patient safety and outcomes. We also believe that 
a unified QAPI model is a natural progression for a multi-hospital 
system that utilizes a system governing body (as allowed at Sec.  
482.12) and a unified medical staff (as allowed at Sec.  482.22).
    In response to the commenter's concerns regarding individual 
hospital data, we agree that hospital specific data should be used to 
address specific

[[Page 51742]]

individual hospital issues and to identify and disseminate best 
practices. As we have proposed, ``the system governing body is 
responsible and accountable for ensuring that each of its separately 
certified hospitals meets all of the requirements of this section.'' We 
do not see this requirement as prohibiting an individual hospital from 
reporting its own data to the governing body and most especially to the 
unified and integrated QAPI program, since we are requiring that each 
separately certified hospital in the system demonstrate that the 
unified and integrated QAPI program takes into account each member 
hospital's unique circumstances as well as any significant differences 
in patient populations and services offered in each hospital. Each 
hospital must also demonstrate that the unified and integrated program 
has mechanisms in place to ensure that issues localized to particular 
hospitals are duly considered and addressed.
    We are unclear as to what the commenter means by ``QAPI scores'' 
and to what the commenter is referring regarding the grouping of ``QAPI 
scores together'' in order to ``hide poor performance.'' The current 
QAPI CoP does not require anything related to ``QAPI scores'' and we 
are not finalizing any such requirements in this rule. We believe that 
the commenter might have been confusing QAPI with the various data that 
are collected for the Inpatient Quality Reporting Program. These 
programs are unrelated and the quality reporting program remains 
unchanged by this rule.
    Comment: One commenter recommended that CMS include the following 
language in proposed Sec.  482.21(f)(2) regarding a hospital's medical 
staff: ``. . . Including consulting with each of its separately 
certified hospital's medical staff.'' The commenter stated that a 
hospital's medical staff brings a unique clinical perspective to the 
activities of the governing body with regard to quality and safety 
issues. The commenter also urged CMS to clarify that the proposed 
requirement will not include an Ongoing Professional Practice 
Evaluation and Focused Professional Practice Evaluation, which they 
state, is the responsibility of the hospital's medical staff.
    Response: While we agree with the commenter that a hospital's 
organized medical staff brings a unique clinical perspective to the 
activities of the governing body with regard to quality and safety 
issues, we believe that a number of the hospital CoPs already 
effectively ensure that this clinical perspective is heard by the 
governing body while also holding the medical staff responsible and 
accountable for these patient safety and quality of care issues. For 
example, the provision at Sec.  482.12(a)(1), under the hospital 
Governing body CoP, requires that the hospital's governing body must, 
``consult directly with the individual assigned the responsibility for 
the organization and conduct of the hospital's medical staff, or his or 
her designee. At a minimum, this direct consultation must occur 
periodically throughout the fiscal or calendar year and include 
discussion of matters related to the quality of medical care provided 
to patients of the hospital.'' This requirement applies to all 
hospitals, governing bodies, and medical staffs, regardless of 
organizational structure.
    Additionally, the QAPI CoP itself, at Sec.  482.21(e), contains a 
standard that requires the hospital medical staff (among other hospital 
leaders) to be responsible and accountable for ensuring that the QAPI 
program is focused on improved quality of care and patient safety. 
Similarly, the Medical staff CoP requirement at Sec.  482.22(b) 
requires that the hospital's medical staff ``must be well organized and 
accountable to the governing body for the quality of the medical care 
provided to patients.'' And finally, at Sec.  482.22(b)(4)(iii) and 
(iv), the CoPs require that a separately certified hospital, which uses 
a unified and integrated medical staff accountable to a system 
governing body, must demonstrate that its unified and integrated 
medical staff: (1) Is established in a manner that takes into account 
each member hospital's unique circumstances and any significant 
differences in patient populations and services offered in each 
hospital and (2) establishes and implements policies and procedures to 
ensure that the needs and concerns expressed by members of the medical 
staff, at each of its separately certified hospitals, regardless of 
practice or location, are given due consideration, and that the unified 
and integrated medical staff has mechanisms in place to ensure that 
issues localized to particular hospitals are duly considered and 
addressed. Therefore, we do not believe that any additional language is 
needed here.
    Comment: One commenter requested that CMS include ``affiliates'' 
and CAHs in the unified and integrated QAPI and infection control 
requirements. The commenter defines ``affiliates'' as hospitals and 
providers within a healthcare system that may bill under separate Tax 
Identification Numbers (TINs). The commenter noted that this option 
would afford hospitals additional flexibility and ease administrative 
burden.
    Response: We are not clear on whether the commenter is confusing 
TINs and CMS Certification Numbers (CCNs), which CMS uses to 
distinguish separately certified hospitals, CAHs, and other Medicare-
participating providers and suppliers for survey and certification 
purposes in determining compliance with the CoPs and CfCs specific to 
each provider and supplier type. We do not use TINs in our 
determination of when a facility requires separate certification.
    A CAH must be separately evaluated for its compliance with the CAH 
CoPs (found at 42 CFR part 485, subpart F), which would not include the 
requirements included in this section of the rule since these are 
hospital CoPs. It would not be possible to evaluate the CAH's 
compliance as part of an evaluation of a hospital's compliance. 
However, this does not preclude a multi-hospital system's single 
governing body from also serving as the CAH's governing body, so long 
as the governing body clearly identifies the policies and decisions 
that are applicable to the CAH.
    Final Rule Action: We are finalizing the requirements in Sec.  
482.21(f), without modification.
    Contact: Alpha-Banu Wilson, 410-786-8687.
b. Medical Staff, Medical Records Services, and Surgical Services 
(Sec. Sec.  482.22, 482.24, and 482.51)
Hospital Medical History and Physical Examination Requirements
    We proposed to revise the current requirements at Sec.  
482.22(c)(5)(i) and (ii) with respect to medical staff bylaws, and to 
allow for an exception under the proposed paragraph (c)(5)(iii). We are 
retaining the current language in paragraphs (c)(5)(i) and (ii) that 
the H&P, and any update to it, must be completed and documented by a 
physician (as defined in section 1861(r) of the Act), an oral and 
maxillofacial surgeon, or other qualified licensed individual in 
accordance with State law and hospital policy. We proposed to include 
this same language regarding who can complete and document the 
assessment in the proposed provision at Sec.  482.22(c)(5)(iii). This 
provision would require the medical staff bylaws to state that an 
assessment of the patient (in lieu of the requirements of paragraphs 
(c)(5)(i) and (ii)) be completed and documented after registration, but 
prior to surgery or a procedure requiring anesthesia services, when the 
patient is

[[Page 51743]]

receiving specific outpatient surgical or procedural services and when 
the medical staff has chosen to develop and maintain a policy that 
identifies, in accordance with the requirements at paragraph (c)(5)(v), 
specific patients as not requiring a comprehensive medical history and 
physical examination, or any update to it, prior to specific outpatient 
surgical or procedural services. The proposed paragraphs (c)(5)(iii) 
and (iv) would require the medical staff to develop and maintain a 
policy that identifies those patients for whom the assessment 
requirements of paragraph (c)(5)(iii) would apply. We also proposed a 
new requirement at paragraph (c)(5)(v) for a medical staff that chooses 
to develop and maintain a policy for the identification of specific 
patients to whom the assessment requirements in paragraph (c)(5)(iii) 
would apply. Under this proposed paragraph, if the medical staff 
exercised the option to perform a simplified assessment in some cases, 
the written policy would have to indicate the specific outpatient 
surgical or procedural services to which it applied. The policy for 
each procedure would need to indicate the hospital's consideration of 
patient age, diagnoses, the type and number of surgeries and procedures 
scheduled to be performed, comorbidities, and the level of anesthesia 
required for the surgery or procedure; nationally recognized guidelines 
and standards of practice for assessment of specific types of patients 
prior to specific outpatient surgeries and procedures; and applicable 
State and local health and safety laws.
    In order to make clear that this proposed requirement would be an 
option that a hospital and its medical staff could elect to use at 
their discretion, we proposed language that states ``the provisions of 
paragraphs (c)(5)(iii), (iv), and (v) do not apply to a medical staff 
that chooses to maintain a policy that adheres to the requirements of 
paragraphs (c)(5)(i) and (ii) for all patients.'' In other words, a 
hospital and its medical staff would be free to exercise their clinical 
judgment in determining whether a policy for identifying specific 
patients as not requiring a comprehensive H&P (or any update to it) 
prior to specific outpatient surgical or procedural services, and 
instead requiring only a pre-surgical assessment for these patients, 
would be their best course. Or, if a hospital and its medical staff 
decided against such a policy, then only the current H&P and update 
requirements (at Sec. Sec.  482.22, 482.24, and 482.51) would continue 
to apply and the proposed requirements for this CoP, as well as those 
proposed for Sec. Sec.  482.24 and 482.51, would not apply.
    For the current CoP at Sec.  482.24, ``Medical Record Services,'' 
we specified that we would revise the provisions at Sec.  
482.24(c)(4)(i)(A) and (B) regarding an H&P and its update to allow for 
an exception under proposed paragraph (c)(4)(i)(C) where we proposed to 
add a new requirement that, if applicable, the medical record would 
have to document assessment of the patient (in lieu of the requirements 
of paragraphs (c)(4)(i)(A) and (B)) after registration, but prior to 
surgery or a procedure requiring anesthesia services, for specific 
outpatient surgical or procedural services.
    We also proposed to revise the current CoP, Sec.  482.51, 
``Surgical Services,'' to allow for an exception to the requirements at 
Sec.  482.51(b)(1)(i) and (ii). Under proposed paragraph (b)(1)(iii), 
we proposed a new requirement that, prior to surgery or a procedure 
requiring anesthesia services and except in the case of emergencies, an 
assessment of the patient must be completed and documented after 
registration (and in lieu of the requirements of paragraphs (b)(1)(i) 
and (ii)). This proposed requirement would only apply in those 
instances when the patient is receiving specific outpatient surgical or 
procedural services and when the medical staff has chosen to develop 
and maintain a policy that identifies, in accordance with the 
requirements at Sec.  482.22(c)(5)(v), specific patients as not 
requiring a comprehensive medical history and physical examination, or 
any update to it, prior to specific outpatient surgical or procedural 
services.
    Comment: As reflected in the public comments for similar proposed 
changes for ASCs that we have previously discussed, the majority of 
comments submitted were supportive of the proposed changes that would 
give a hospital and its medical staff the flexibility to establish a 
policy for a pre-surgical or pre-procedural assessment of the patient 
(in lieu of the requirements of paragraphs (c)(5)(i) and (ii) for a 
comprehensive pre-surgical or pre-procedural H&P and its update), 
provided that the patient assessment is completed and documented after 
registration, but prior to surgery or a procedure requiring anesthesia 
services, and the patient is receiving specific outpatient surgical or 
procedural services as outlined in the policy. Several commenters 
stated that they appreciated the regulatory flexibility to establish 
specific patient policies such as these as long as they are based on 
recognized guidelines and best practices as well as on the clinical 
judgment of the medical staff. They stated that they believe such 
parameters are necessary to ensure patient health and safety while 
still allowing for reasonable methods to reduce the burden on both 
patients and providers, including the additional expense of pre-
operative testing that is often performed unnecessarily on many 
patients undergoing only minor outpatient procedures and may be an 
unintended consequence of the requirement for a comprehensive H&P 
within 30 days of admission or registration for all hospital patients 
regardless of the surgery or procedure that they are undergoing.
    Response: We thank the commenters for their support and agree that 
the flexibility provided by these revisions will reduce unnecessary 
regulatory burden affecting both patients and providers. We believe 
that it also has the potential to greatly reduce unnecessary costs 
associated with the current requirements for a comprehensive H&P for a 
specific class of patients undergoing low-risk outpatient surgeries and 
procedures for which there exist clear guidelines regarding the extent 
of pre-operative patient assessment and testing needed.
    Comment: Some commenters either did not support these changes or 
had certain reservations about them, even though they supported the 
overall intent of the changes. One commenter stated that the change 
will not serve those beneficiaries with advanced illness well, 
recommended that the rule be revised to require that the assessment 
must be consistent with the patient's situation, medical complexity, 
and the proposed procedure, and believes that the requirements must err 
on the side of more, rather than less, comprehensiveness. Another 
commenter stated that while they appreciated CMS' recognition that the 
timing of H&Ps may, in some instances, be duplicative and cause 
unnecessary burden, they were aware of cases where the current H&P 
requirements prevented an adverse event. They also stated that the 
proposed revisions will be just as, and possibly more, burdensome than 
the current requirements; that CMS should consider comments before 
proceeding; and that, while they agree that there seems to be no 
evidence supporting a strict 30-day requirement, additional flexibility 
would be appreciated. One commenter stated that they believe the burden 
of assessing patients prior to surgery would be shifted from one 
provider (the primary care physician or the surgeon) to another (the 
anesthesiologist), and

[[Page 51744]]

expressed concerns over the increased responsibility and liability that 
might be then imposed on an anesthesiologist (beyond his or her primary 
responsibility for anesthesia services and care provided to a patient) 
for a surgery or procedure in which he or she was not the operating 
practitioner. A few commenters also expressed concerns over whether 
reimbursement requirements and rates would now change for outpatient 
surgeries and procedures that would only require an assessment and not 
a comprehensive H&P, including concerns over which practitioner would 
now be reimbursed for the assessment (for example, the patient's 
primary care practitioner versus the operating practitioner).
    Response: We appreciate the concerns raised by commenters and have 
thoroughly considered them. However, we must again note and emphasize 
to readers that this revision will be a regulatory option available to 
hospitals and one that a hospital and its medical staff must make the 
policy decision to exercise. We expect that this decision will be based 
on the clinical judgment and recommendations of the medical staff, 
which must be supported by nationally recognized evidence and 
guidelines for best practices in this area, in order for the hospital 
to determine if the best course would be to establish a policy for 
identifying specific patients as not requiring a comprehensive H&P (or 
any update to it) prior to specific outpatient surgical or procedural 
services, and instead require a more limited pre-surgical assessment 
for these patients. We expect that most hospitals and their medical 
staffs will perform risk/benefit analyses to inform their decisions. We 
also expect that a number of these hospitals, based on their analyses, 
will decide to maintain a policy that continues to follow the current 
H&P and update requirements (at Sec. Sec.  482.22, 482.24, and 482.51) 
and will not choose to exercise this option in any way. Conversely, we 
also expect that some will choose to exercise this option fully and to 
the broadest extent possible while still remaining in compliance with 
the requirements finalized. We further expect that another significant 
subset of hospitals will fall somewhere in the middle in their policy 
decisions and will most likely elect to exercise this option within an 
even more narrow and stringent set of parameters than CMS is requiring 
here. The regulatory flexibility and framework of these final 
requirements will allow each hospital to establish and tailor its own 
policy parameters according to its specific patient populations, 
individual institutional needs and resources, and own medical staff 
recommendations as long as the policies and procedures established and 
implemented meet or exceed the requirements finalized in this rule. As 
finalized here, these requirements, while providing a hospital with an 
alternative and less burdensome approach to pre-surgical patient 
assessment, will also at the same time ensure that a hospital takes 
into consideration all patient safety factors and quality of care 
issues, such as the degree of complexity of the patient's medical 
condition as well as that of the planned procedure itself, when it 
establishes a process to identify those patients to whom such a policy 
would apply.
    In response to the commenter who stated that, under this new 
option, the assessment of patients prior to surgery will be ``shifted 
from one provider (the primary care physician or the surgeon) to 
another (the anesthesiologist),'' we note that the Anesthesia services 
CoP contains a separate provision (separate and distinct from the H&P, 
update, and pre-surgical assessment requirements in the Surgical 
services CoP) that requires that a ``. . . preanesthesia evaluation 
[be] completed and documented by an individual qualified to administer 
anesthesia . . .'' and that it must be ``. . . performed within 48 
hours prior to surgery or a procedure requiring anesthesia services.'' 
The anesthesiologist is responsible for this evaluation, but not for 
the H&P, update, and pre-surgical assessment requirements that we are 
finalizing here. While an anesthiologist could certainly qualify to 
perform any of these pre-surgical assessments, we expect the operating 
practitioner, who is also responsible for the pre-, intra-, and post-
operative care of the patient and must be a physician (as defined in 
section 1861(r) of the Act), an oral and maxillofacial surgeon, or, in 
accordance with State law and hospital policy, another qualified 
licensed individual (who would most likely be a member of the operating 
practitioner's team, such as an NP or PA, and who, by extension, would 
also be responsible for the care of the patient) to perform the pre-
surgical assessment as required in this final rule. If a hospital and 
its medical staff choose to establish policies and procedures that 
delineate the duties and responsibilities of any individual 
anesthiologist (or any individual qualified to administer anesthesia) 
to include performance of the pre-surgical assessments included under 
this rule, then the hospital would need to demonstrate that these pre-
surgical assessments are separate and distinct from the pre-anesthesia 
evaluations of patients required at Sec.  482.52. Furthermore, a 
hospital must also ensure that any such policies and procedures, which 
assign these pre-surgical assessment duties and responsibilities to an 
individual anesthiologist (or an individual qualified to administer 
anesthesia) as discussed here, are not only in accordance with State 
law, but are also consistent in this regard with the current standards 
of both anesthesia care and surgical care.
    The comments regarding reimbursement requirements and rates for 
outpatient surgeries and procedures are outside the scope of the CoPs 
and this rule.
    Comment: A few commenters were concerned about compliance with the 
revised requirements if no clear and recognized guidelines or 
recommendations exist for pre-surgical patient assessment for specific 
classes of patients undergoing certain outpatient surgeries and 
procedures.
    Response: The revised requirements, which allow for the option of 
establishing a policy for identification of specific patients to whom 
the assessment requirements in Sec.  482.22(c)(5)(iii) would apply, are 
conditioned upon a hospital and its medical staff demonstrating 
evidence that the specific parameters required in this final rule are 
met. A hospital and its medical staff should not include those classes 
of patients and those outpatient surgeries and procedures in its pre-
surgical patient assessment policy if the hospital finds that it cannot 
meet the requirements we are finalizing at Sec. Sec.  482.22(c)(5)(v), 
including the requirement that the medical staff must demonstrate 
evidence that its policy is based on nationally recognized guidelines 
and standards of practice for the assessment of specific types of 
patients prior to specific outpatient surgeries and procedures.
    Final Rule Action: We are finalizing the requirements in Sec. Sec.  
482.22, 482.24, and 482.51, with only minor modifications. 
Specifically, we are changing the term ``oromaxillofacial surgeon'' to 
the correct term of ``oral and maxillofacial surgeon'' where indicated.
    Contact: CAPT Scott Cooper, USPHS, 410-786-9465.
c. Medical Staff: Autopsies (Sec.  482.22(d))
    We proposed to remove the requirement at Sec.  482.22(d), which 
states that a hospital's medical staff should attempt to secure 
autopsies in all cases of unusual deaths and of medical-legal

[[Page 51745]]

and educational interest. The mechanism for documenting permission to 
perform an autopsy must be defined and there must be a system for 
notifying the medical staff, and specifically the attending 
practitioner, when an autopsy is being performed.
    Comment: Several commenters agreed with the proposal, which they 
stated would remove duplicative administrative work and allow hospitals 
to defer to State requirements when an autopsy is necessary. Many 
commenters, including national associations representing medical 
examiners and pathologists, disagreed with the removal of the 
requirement that a hospital's medical staff attempt to secure autopsies 
for unusual deaths or educational purposes. The commenters stated that 
hospitals should attempt to obtain family permission for autopsies 
related to deaths resulting from questions about efficacy of treatment, 
for educational purposes, or for issues of unintended outcomes of 
treatment or medical uncertainty and these commenters also expressed 
concern that the removal of this proposal would lead to a further 
reduction in an already low national autopsy rate.
    However, many of these commenters stated that hospitals should not 
be required to attempt to obtain family permission, or perform 
autopsies, in cases of medical-legal interest. In those circumstances, 
the commenters stated, hospitals should report the death to, and 
consult with, the authority of their local medical examiner, coroner, 
or medicolegal death investigative authority.
    Finally, one commenter requested that CMS specifically state that 
hospitals are not prohibited from performing autopsies.
    Response: We agree that hospitals should not attempt to secure 
autopsies in medical-legal cases without first contacting their State's 
medical examiner or medical authority, in accordance with their State's 
laws. We will defer to state law on this issue, since each State has 
their own standards and laws regarding the performance of autopsies for 
medical-legal purposes, and we therefore are removing this as a 
requirement in the CoPs for hospitals. Furthermore, we believe that it 
is appropriate to remove the duplicative and burdensome requirement 
that hospitals attempt to secure autopsies for other cases of unusual 
deaths or for educational interest. We clarify that removing this 
requirement would not prohibit hospitals from performing autopsies and 
we believe that hospitals will implement their own policies regarding 
autopsies. While we understand the commenter's concerns regarding the 
decline in the national autopsy rate, we disagree that the removal of 
this specific requirement will cause a measurable decrease in the 
autopsy rate, impact quality of care, or dissuade hospitals from 
performing autopsies. As commenters themselves have noted, there are 
various causes that may have contributed to the reduction in the 
autopsy rate including risk adversion due to litigation concerns and 
concerns about reimbursement rates, and we have no additional evidence 
that would lead us to the conclusion that the removal of this 
requirement would exacerbate these numbers. We therefore are finalizing 
our proposal to remove the requirements at Sec.  482.22(d). Although we 
are finalizing our proposal, we note that the removal of this 
requirement should not be construed as a diminution of our support for 
hospitals continuing to perform autopsies for various purposes, and we 
encourage hospitals to establish policies regarding autopsies, where 
appropriate.
    Comment: A few commenters suggested that all hospital admissions 
require the patient (or his or her representative) to affirmatively 
allow or prohibit an autopsy in the event of death. One commenter also 
stated that autopsies should be required for any hospital death, unless 
explicitly rejected by next of kin.
    Response: Mandating that hospitals perform autopsies, or that 
hospitals ask permission to perform an autopsy upon a patient's 
admission, would be unduly burdensome to hospitals and contrary to the 
purpose of the CoPs, which establish baseline health and safety 
requirements. However, hospitals may choose to establish their own 
policy that would require patients or their representatives to permit 
or decline autopsies upon admission, if they believe such a requirement 
is appropriate. As we previously stated, there is no prohibition 
against autopsies and hospitals are free to enact policies regarding 
autopsies if they choose to do so.
    Additionally, requiring hospitals to perform autopsies could 
potentially conflict with State and local laws regarding autopsies for 
medical-legal cases. For instance, certain State laws require that 
hospitals report deaths arising from medical-legal circumstances to 
their local medical examiner or other authoritative body, so that a 
determination can be made as to whether an autopsy must be performed.
    Final Rule Action: We are finalizing the proposal to remove Sec.  
482.22(d), without modification.
    Contact: Alpha-Banu Wilson, 410-786-8687.
d. Infection Control (Sec.  482.42)
    We proposed a new standard at Sec.  482.42(c), ``Unified and 
integrated infection control program for multi-hospital systems.'' Like 
the proposed requirements for a unified and integrated QAPI program, 
the proposed standard for infection control would allow that for a 
hospital that is part of a hospital system consisting of multiple 
separately certified hospitals subject to a system governing body 
legally responsible for the conduct of each hospital, such system 
governing body could elect to have a unified and integrated infection 
control program for all of its member hospitals after determining that 
such a decision was in accordance with all applicable State and local 
laws. The system governing body would be responsible and accountable 
for ensuring that each of its separately certified hospitals met all of 
the requirements of this section. Each separately certified hospital 
subject to the system governing body would have to demonstrate that the 
unified and integrated infection control program: (1) Was established 
in a manner that took into account each member hospital's unique 
circumstances and any significant differences in patient populations 
and services offered in each hospital; (2) established and implemented 
policies and procedures to ensure that the needs and concerns of each 
of its separately certified hospitals, regardless of practice or 
location, are given due consideration; (3) had mechanisms in place to 
ensure that issues localized to particular hospitals are duly 
considered and addressed; and (4) designated a qualified individual(s) 
at the hospital with expertise in infection prevention and control to 
be responsible for communicating with the unified infection control 
program, for implementing and maintaining the policies and procedures 
governing infection control, and for providing infection prevention 
education and training to hospital staff.
    Comment: Most commenters supported the proposal to allow hospitals 
that are part of a multi-hospital system to have a unified and 
integrated infection control program. The proposed rule included a 
specific request for public comment on whether there are any other 
programs currently required under the CoPs for each separately 
certified hospital, beyond the QAPI and Infection control programs 
proposed here, that stakeholders believe would likewise be better 
managed under a system governing body legally

[[Page 51746]]

responsible for the conduct of each separately certified hospital. In 
response, we received comments asking CMS for further revisions to the 
CoPs, like those proposed for QAPI and infection control programs here 
(and with specific mention of revising the Nursing services CoP in this 
way), to allow for similar departmental and operational integration 
among hospitals within a multi-hosptial system with a single governing 
body. The commenters stated that expansion of this flexibility for 
other hospital services, departments, units, and programs would reduce 
operational burden for individual hospitals, ensure the proper level of 
staff expertise for member hospitals, and improve the quality and 
continuity of care for all patients served within the system. A few 
commenters also expressed appreciation for the expanded flexibility 
that this proposal would afford hospitals by reducing burden, 
increasing efficiencies, and eliminating the duplication of efforts.
    One commenter encouraged CMS to apply this approach to situations 
when a multi-hospital system's providers have to fulfill additional 
requirements stemming from Medicaid or Medicare managed care plans or 
other external regulatory entities. The commenter suggested the 
mandated training related to the special needs plan models of care (42 
CFR 422.101(f)(2)(ii)) as an example of how this could be applied. The 
commenter stated that a multihospital system with a unified infection 
control program as allowed under the requirements finalized in this 
rule, and that is also potentially participating in an ACO, would most 
certainly meet the Model of Care training requirement. This commenter 
also suggested an alternative approach where ACO participants would be 
deemed as meeting the Model of Care requirement for all other external 
regulatory entities by meeting the unified infection control program 
requirements finalized here.
    Response: We thank the commenters for their support. We believe 
that a hospital's governing body should be afforded the option of 
unifying and integrating the various member hospitals within their 
multi-hospital system into a unified infection control program. As we 
discussed for unified and integrated QAPI programs, such a model would 
incorporate each individual hospital's infection control program, which 
would enable increased efficiencies, innovations, provider flexibility, 
and allow for the dissemination of best practices for patient care 
while also potentially improving patient safety and outcomes. We also 
believe that a unified infection control model is a natural progression 
for a multi-hospital system that utilizes a system governing body (as 
allowed at Sec.  482.12), a unified medical staff (as allowed at Sec.  
482.22), and a unified QAPI program (as finalized in this rule at Sec.  
482.12).
    The comments and recommendations regarding the application of the 
unified infection control model and its CoP requirements to any 
additional requirements mandated by Medicare and Medicaid managed care 
plans or other external regulatory entities are outside the scope of 
the CoPs and this rule.
    Final Rule Action: We are finalizing the proposed requirements in 
Sec.  482.42. Moreover, in addition to revisions proposed and finalized 
for the Hospital/CAH Innovation Rule regarding Antibiotic Stewardship 
Programs (ASPs) (now part of the Infection Prevention and Control CoP 
discussed in Section III.B.6. of this final rule and finalized here at 
Sec.  482.42), we are finalizing changes to Sec.  482.42 that will now 
address the designated and qualified individual(s) at the hospital 
responsible for communicating with the unified infection control 
program, for implementing and maintaining the policies and procedures 
governing infection control, and for providing infection prevention 
education and training to hospital staff with regard to the ASP as 
well. We are also making other minor modifications to this section to 
finalize changes proposed in the Hospital/CAH Innovation Proposed Rule. 
All of these changes are discussed later in Section III.B.6. of this 
final rule.
    Contact: CAPT Scott Cooper, USPHS, 410-786-9465.
e. Special Requirements for Hospital Providers of Long-Term Care 
Services (``Swing-Beds'') (Sec.  482.58(b)(1), (4), (5), and (8), and 
Identical CAH Requirements: Sec.  485.645(d)(1), (4), (5), (6), and 
(7))
    Hospitals providing swing-bed services must meet all of the 
requirements at 42 CFR part 482, which includes the swing-bed 
requirements at Sec.  482.58 for patients receiving swing-bed services, 
and CAHs providing swing-bed services must meet all of the requirements 
at 42 CFR part 485, subpart F, which includes the swing-bed 
requirements at Sec.  485.645 for patients receiving swing-bed 
services. The swing-bed requirements within the hospital and CAH CoPs 
include a subset of cross-referenced long-term care requirements 
contained in 42 CFR part 483, subpart B, for which hospital and CAH 
swing-bed providers are surveyed as they are for all of the CoPs in 
their respective programs. We have determined that some of the cross-
referenced long-term care requirements for hospitals and CAH swing-bed 
providers are unnecessary and unduly burdensome, given their focus on 
``residents'' and longer length of stays, which we believe are not 
relevant to swing-bed patients. Thus, we proposed to remove the 
following requirements: Sec. Sec.  482.58(b)(1) and (c) and 
485.645(d)(1) (incorporating long-term care facility requirements at 
Sec.  483.10(f)(9)). Under our current regulations at Sec.  
483.10(f)(9), the resident has a right to choose to, or refuse to, 
perform services for the facility, and the facility must not require a 
resident to perform services for the facility. Regulations at 
Sec. Sec.  482.58(b)(1) and 485.645(d)(1) incorporate this resident 
right by reference.
    We expect hospital and CAH swing-bed providers who do offer 
patients the option of providing services for the facility to have 
current policies and procedures that reflect this policy that includes 
protocol for establishing an agreement between the two parties.
    Comment: Commenters universally supported the proposal to remove 
the provision requiring hospitals and CAH swing-bed providers to 
provide residents with the right to choose to, or refuse to, perform 
services for the facility, and not requiring a resident to perform 
services for the facility. As with the majority of the hospital and CAH 
swing-bed proposals, commenters noted that this requirement is 
unnecessary, the source of confusion, or is unduly burdensome.
    Response: We appreciate the comments received and continue to 
believe that this change is appropriate.
    Final Rule Action: We are finalizing this proposed change without 
revisions.
    Sec. Sec.  482.58(b)(4) and 485.645(d)(4) (incorporating long-term 
care facility requirements at Sec.  483.24(c)): The facility must 
provide, based on the comprehensive assessment and care plan and the 
preferences of each resident, an ongoing program to support residents 
in their choice of activities and the activities program must be 
directed by a qualified professional who is a qualified therapeutic 
recreation specialist or an activities professional. Patients receiving 
swing-bed services in a hospital or CAH are not long term residents of 
the facility and generally only receive swing-bed services for a brief 
period of time for transition after the provision of acute care 
services. We expect that for those patients who receive swing-bed 
services for an extended period of time, their nursing care plan--as 
required under Sec.  482.23(b)(4) for hospitals and

[[Page 51747]]

Sec.  485.635(d)(4) for CAHs--is based on assessing the patient's 
nursing care needs and will support care that holistically meets the 
needs of the patient, taking into consideration physiological and 
psychosocial factors.
    Comment: The majority of commenters were supportive of the proposed 
removal of the requirement for hospital and CAH swing-bed providers to 
provide an ongoing program to support residents in their choice of 
activities and have an activities program that is directed by a 
qualified professional. As with the majority of the hospital and CAH 
swing-bed proposals, commenters noted that this requirement is 
unnecessary, the source of confusion, or is unduly burdensome due to 
the limited length of stay for most patients receiving swing-bed 
services. Commenters generally agreed that the activity needs of those 
patients who receive swing-bed services for an extended period of time 
would be met via the hospital and CAH nursing care plan requirements.
    However, one commenter noted that in the event a swing-bed patient 
receives care for an extended period of time, the nursing care plan 
will not include interest-based group and individual activities that 
support the patient's physical, mental and psychosocial well-being. The 
commenter noted that therapeutic or recreational activities differ 
significantly from the goals that normally would be identified in a 
nursing care plan.
    Response: We appreciate the comments received and continue to 
believe that this change is appropriate. It is expected that hospitals 
and CAHs, using an interdisciplinary approach, are providing services 
that meet the needs of all of their patients, including those receiving 
swing-bed services, regardless of their length of stay. In addition, 
nursing care plans are intended to provide direction on the type of 
nursing care the needed by the patient, stemming from the patient's 
diagnoses, that is organized based on the specific needs of the 
patient. The care plan is dynamic and should change as the needs of the 
patient change. As a result, if the needs of the patient include 
interest-based group and individual activities that support the 
patient's physical, mental and psychosocial well-being, we expect that 
the hospital or CAH will provide these services to the patient.
    Final Rule Action: We are finalizing this proposed change without 
revision.
    Sec. Sec.  482.58(b)(5) and 485.645(d)(5) (incorporating long-term 
care facility requirements at Sec.  483.70(p)): Any facility with more 
than 120 beds must employ a qualified social worker on a full-time 
basis.
    In accordance with the hospital and CAH swing-bed requirements, 
hospital swing-bed providers are not permitted to have more than 100 
beds while CAH swing-bed providers are not permitted to have more than 
25 beds for the provision of inpatient or swing-bed services. Based on 
feedback from stakeholders, removing this requirement would eliminate 
confusion for providers and accreditation organizations.
    Comment: Commenters universally supported the proposal to remove 
the provision requiring hospitals and CAH swing-bed providers with more 
than 120 beds to employ a full-time social worker. As with the majority 
of the hospital and CAH swing-bed proposals, commenters noted that this 
requirement is unnecessary, the source of confusion, or is unduly 
burdensome.
    Response: We appreciate the comments received and continue to 
believe that this change is appropriate.
    Final Rule Action: We are finalizing this proposed change as 
proposed.
    Sec. Sec.  482.58(b)(7) and 485.645(d)(7) (incorporating the long-
term care facility requirement at Sec.  483.55(a)(1)): Under our long-
term care facility requirements, the facility, must provide routine and 
emergency dental services to meet the needs of each resident, or obtain 
them from an outside resource, in accordance with Sec.  483.70(g).
    Hospitals and CAHs are required to provide care in accordance with 
the needs of the patient that have been identified in such patients' 
plans of care; this could include non-emergency dental care. We expect 
that hospital swing-bed providers are currently addressing the emergent 
dental care needs of their patients under the existing hospital CoP at 
Sec.  482.12(f)(2), which requires that hospitals have written policies 
and procedures for appraisal of emergencies, initial treatment, and 
referral when appropriate. Similarly, we expect that CAH swing-bed 
providers are currently addressing the emergent dental care needs of 
their patients under the existing emergency services CoP at Sec.  
485.618, which requires CAHs to provide emergency care necessary to 
meet the needs of its inpatients and outpatients. As a result, we 
believe that this portion of the requirement is duplicative, given the 
current CoP requirements.
    Comment: Commenters universally supported the proposal to remove 
the provision requiring hospitals and CAH swing-bed providers provide 
or obtain from an outside resource routine and emergency dental 
services to meet the needs of each resident. As with the majority of 
the hospital and CAH swing-bed proposals, commenters noted that this 
requirement is unnecessary, the source of confusion, or is unduly 
burdensome.
    In addition, the most recent guidelines from the American Dental 
Association note that patients should have regular dental visits, with 
the frequency determined by their dentist to accommodate for the 
patients' current oral health status and health history (American 
Dental Association, https://www.ada.org/en/press-room/news-releases/2013-archive/june/american-dental-association-statement-on-regular-dental-visits).
    Response: We appreciate the comments received and continue to 
believe that this change is appropriate.
    Final Rule Action: We are finalizing this proposed change as 
proposed.
    Contact: Kianna Banks, 410-786-3498.
f. Special Requirements for Psychiatric Hospitals (Sec.  482.61(d))
    We believe that as currently written and implemented, this 
requirement requires clarification regarding the language that progress 
notes ``must be recorded by the doctor of medicine or osteopathy 
responsible for the care of the patient as specified in Sec.  
482.12(c), nurse, social worker and, when appropriate, others 
significantly involved in active treatment modalities.'' We believe 
that non-physician practitioners, including physician assistants, nurse 
practitioners, psychologists, and clinical nurse specialists, when 
acting in accordance with State law, their scope of practice, and 
hospital policy, should have the authority to record progress notes of 
psychiatric patients for whom they are responsible. Therefore, we 
proposed to allow the use of non-physician practitioners or MD/DOs to 
document progress notes of patients receiving services in psychiatric 
hospitals.
    Comment: Commenters were mostly supportive of the proposal to 
clarify the documentation requirements for recording progress notes in 
the patient's medical records for patients receiving services in 
psychiatric hospitals. Commenters noted that the proposed change would 
reduce barriers for care providers and will give non-physician 
practitioners expanded access to document the provision of the health 
care to patients, resulting in improved continuity of care.
    Response: We appreciate the comments received and continue to 
believe that this change is appropriate.

[[Page 51748]]

    Comment: One commenter opposed the proposed change, noting that the 
existing regulatory language already permits non-physician 
practitioners to document progress notes in the patient's medical 
records for patients receiving services in psychiatric hospitals; 
therefore, the change would be unlikely to produce costs savings from 
incorporating psychologists or other licensed practitioners in this 
requirement. Another commenter opposed the inclusion in the proposed 
rule of psychologists in the list of non-physician practitioners 
allowed to document the patient's progress notes. The commenter notes 
that the current regulations permit psychologists to document the 
services they provide (psychotherapy, psychological/neuropsychological 
testing notes), but they should not be granted the authority to write 
medical progress notes due to the current Medicare regulations under 
Sec.  482.12(c)(1)(vi).
    Response: While we agree with the commenter regarding the intent of 
the current regulatory language, we believe that there is a need to 
clarify the intent of the language and ensure that the healthcare 
providers with the authority to document the progress reports are 
clearly identified. The majority of commenters supported the need for 
clarification due to the failure of the regulatory text to specify the 
non-physician practitioners who could document progress reports.
    Additionally, we believe psychologists are appropriately included 
in the list of non-physician practitioners who have the authority to 
document in progress notes for patients receiving services in 
psychiatric hospitals. The regulation at Sec.  482.12(c)(1)(vi), 
referenced by the commenter, states that a clinical psychologist, as 
defined in Sec.  410.71, has the authority to admit patients and 
oversee the care of Medicare patients (but only with respect to 
clinical psychologist services as defined in Sec.  410.71 of this 
chapter and only to the extent permitted by State law). Furthermore, 
non-physician practitioners currently document in the progress notes of 
patients in acute care hospitals to the extent of their scope of 
practice and hospital policy.
    We believe that the revised language in this final rule will 
clarify our original intent in the proposed rule (as understood by 
readers as evidenced by the comments discussed here that request and 
support such clarification on this issue) that non-physician 
practitioners, including physician assistants, nurse practitioners, 
psychologists, and clinical nurse specialists, when acting in 
accordance with applicable State scope of practice laws, and hospital 
policies, should have the authority to record progress notes for all 
psychiatric and medical problems, which are present upon patient 
admission or which develop during hospitalization, for any psychiatric 
patient for whom these licensed practitioners are responsible as long 
as such patient problems fall within the bounds of a licensed 
practitioner's specific State scope of practice laws and hospital 
policies.
    Comment: One commenter requested that clarification be provided 
regarding the use of the phrase ``hospital policy'' as it relates to 
the requirement that non-physician practitioners act in accordance with 
hospital policy.
    Response: Psychiatric hospitals must comply with the hospital CoPs 
under 42 CFR part 482, which includes the requirements for psychiatric 
hospitals. The hospital CoPs require that the hospital's governing body 
approve all hospital policies, and in accordance with Sec.  
482.12(a)(4), the governing body must determine (in accordance with 
State law) which categories of practitioners are eligible candidates 
for appointment to the medical staff. The governing body is required to 
appoint members of the medical staff after considering the 
recommendations of the existing members of the medical staff and 
approve medical staff bylaws and other medical staff rules and 
regulations. Non-physician practitioners, whether employees or 
contractors, would be subject to all rules, regulations, and policy 
manuals utilized by the hospital.
    Final Rule Action: We are finalizing the changes as proposed.
     Contact: Kianna Banks, 410-786-3498.
5. Transplant Centers
a. Special Requirement for Transplant Centers (Sec. Sec.  482.68 and 
482.70)
    We proposed to update the terminology within the hospital 
regulation at part 482 and the transplant regulations at Sec. Sec.  
482.68, 482.70, 482.72 through 482.104, and at Sec.  488.61, for 
clarification and consistency. Specifically, we proposed a nomenclature 
change which would:
     Replace the term transplant ``center'' in the regulation 
language with transplant ``program'' (each organ type would be a 
transplant program). A transplant program is located within a 
transplant hospital that provides transplantation services for a 
particular type of organ. Since individual transplant programs are 
surveyed for compliance with the CoPs, using the term transplant 
program throughout the regulation better aligns with current surveyor 
practice and will reduce provider confusion. In order to provide 
further clarity, we also proposed to update the definitions at Sec.  
482.70.
     Consistently use Independent Living Donor Advocate (ILDA) 
throughout the regulation.
     Change ``beneficiaries'' to ``recipients''.
    Comment: All comments we received expressed support for the 
proposed nomenclature change, which would make the terminology used in 
the regulations consistent with the terminology used by the Organ 
Procurement and Transplantation Network (OPTN) and the transplant 
community.
    Response: We thank the commenters for their support. We are 
finalizing this proposal without modification.
b. Data Submission, Clinical Experience, and Outcome Requirements for 
Re-Approval of Transplant Centers (Sec.  482.82)
    We proposed to remove the requirements at Sec.  482.82 that require 
transplant centers to submit data (including, but not limited to, 
submission of the appropriate OPTN forms for transplant candidate 
registration, transplant beneficiary registration and follow-up, and 
living donor registration and follow-up), clinical experience, and 
outcome requirements for Medicare re-approval, and make conforming 
changes to Sec.  482.102(a)(5) ``Condition of participation, Patient 
and living donor rights'' and Sec.  488.61 ``Special Procedures for 
Approval and Re-Approval of Organ Transplant Centers.''
    Comment: Most commenters, including several major organizations 
which represent the interests of transplant surgeons and other 
professionals, transplant patients, individual transplant programs, 
members of the transplant community, and the OPTN, strongly supported 
the proposal to remove the provision that requires transplant centers 
that are applying for Medicare re-approval to meet all data submission, 
clinical experience, and outcome requirements in order to be re-
approved. These commenters agreed with our analysis of the unintended 
consequences that have occurred because of the Medicare re-approval 
requirements and many agreed that eliminating this requirement would 
improve transplantation in the United States. Many of these commenters 
also stated their belief that the proposal would reduce administrative 
burdens. A

[[Page 51749]]

few commenters also supported maintaining the requirements for initial 
Medicare approval for transplant centers.
    Several commenters, including members of the transplant community 
and interested individuals, objected to the removal of this proposal. 
These commenters as a whole were concerned that removing this proposal 
would affect quality of care and patient outcomes. Specifically, 
commenters were concerned as to whether information on transplant 
centers outcomes would continue to be available to the public, and 
whether CMS would still be able to identify underperforming transplant 
programs, in order to ensure patient safety and continued positive 
outcomes. Other commenters stated that, absent these requirements, CMS 
would rely upon transplant programs notifying CMS of changes rather 
than having a process in place that would monitor such changes. A few 
commenters expressed concerns regarding how CMS would identify 
underperforming transplant programs and requested guidance as to how 
CMS plans to ensure patient safety and positive outcomes by using the 
QAPI program instead of the current re-approval process. Others 
requested clarification as to how CMS would continue to monitor 
outcomes absent this requirement.
    Response: We appreciate the commenters' support. CMS is committed 
to ensuring that our regulations support a patient's access to 
lifesaving organs. We also strive to protect the quality of care that 
the transplant recipient and donor receives while in the transplant 
facility and we agree with commenters that the removal of this 
requirement will work towards achieving these goals. We appreciate the 
numerous studies and professional opinions that were submitted by the 
public that further bolstered our understanding of the unintended 
consequences that have occurred as a result of the Medicare re-approval 
requirements for transplant centers and we therefore are finalizing our 
proposal to remove these requirements at Sec.  482.82. We believe that 
the removal of these requirements will lead to improved patient 
outcomes, increased transplantation opportunities for patients on the 
waitlist, improved organ procurement for transplantation, greater organ 
utilization, and reduced burden on transplant programs. We note that 
the removal of these requirements directly aligns with our goal to 
increase access to kidney transplants by increasing the utilization of 
available organs from deceased donors and reducing the organ discard 
rate, which we outline in the Advancing American Kidney Health Paper, 
which can be found on the Office of the Assistant Secretary for 
Planning and Evaluation website at https://aspe.hhs.gov/pdf-report/advancing-american-kidney-health.
    We understand the concerns that commenters raised regarding the 
availability of transplant program outcome data and we remind 
commenters that transplant outcomes will still be available to the 
public every six months on the Scientific Registry for Transplant 
Recipients (SRTR) website at https://www.srtr.org/. In addition, CMS 
will continue to survey the program's QAPI program to make sure the 
program is tracking adverse events, performing thorough analysis of 
each adverse event, and that performance improvement projects ensure 
adverse events do not recur. CMS will also do complaint investigations 
based on public or confidential reports about outcomes or adverse 
events.
    It is our expectation that transplant programs will use their QAPI 
programs to continue to monitor quality of care, evaluate 
transplantation activities and outcomes, and conduct performance 
improvements when necessary. We believe that these efforts and the 
survey of the CoPs provides sufficient oversight to ensure that 
transplant programs will continue to achieve and maintain high 
standards of care.
    Comment: A few commenters, who were generally supportive of the 
proposals, had additional clarifying questions for CMS about the survey 
process. One commenter asked whether additional reporting on the part 
of the hospital and transplant based QAPI programs would be required. A 
few commenters asked whether CMS would monitor hospital and QAPI based 
programs through a different mechanism, while one comment asked whether 
CMS will be providing published information regarding these reviews. 
One commenter also expressed their opposition to a change to the 
transplant QAPI regulations, and they expressed concern that changing 
these regulations will have unintended negative consequences on 
transplant survival outcomes, safety issues, and an increased focused 
on transplant volume by programs. Another commenter asked the following 
questions:
     Whether the monitoring schedule for CMS surveys of 
transplant programs will remain the same;
     What circumstances will trigger a review from CMS outside 
of routine recertification surveys; and
     What options will be available to a transplant program 
with condition level deficiencies on recertification surveys once the 
mitigating factors and SIAs are removed.
    Response: We did not propose changes to the transplant program QAPI 
requirements and, consistent with other provider types, there is no 
public reporting for the hospital and transplant QAPI programs. 
Transplant programs must continue to abide by the hospital and 
transplant program QAPI CoPs at Sec. Sec.  482.21 and 482.96, 
respectively. On survey, documentation of communication between these 
QAPI entities is expected and the hospital QAPI program should report 
to the Governing Body any issues with transplant outcomes.
    In response to the questions about the survey process, we note that 
the survey interval will not change, and that public or confidential 
reports may trigger a complaint survey. Mitigating factors and systems 
improvement agreements were for outcomes non-compliance only and are 
therefore unnecessary with the removal of the outcomes re-approval 
requirement at Sec.  482.82.
    Comment: A few commenters were generally supportive of CMS's goals 
to improve organ transplantation by removing provider disincentives, 
but the commenters suggested that this could be achieved through 
improvements to the quality and outcomes measures. Specifically, the 
commenters suggested that reported outcomes focus on long term outcomes 
instead of short term outcomes, data on waitlist survival, donor 
utilization, total volume of organs transplanted, transplant rate 
utilization, cost-effectiveness, and other quality of care measures.
    Response: We believe that the wide variety of data and studies 
presented in the proposed rule regarding the unintended consequences of 
the re-approval requirements sufficiently demonstrates that it is no 
longer appropriate to include specific outcome measures as a 
requirement for Medicare re-approval. Transplant programs, however, 
will still need to abide by these outcome measures for initial Medicare 
approval.
    Comment: One commenter opposed the transplant center proposals and 
suggested that CMS look at Organ Procurement Organization (OPO) 
performance in producing quality organs.
    Response: We thank the commenters for their feedback regarding OPO 
performance measures. However, we note that comments regarding OPOs are 
outside the scope of this final rule.

[[Page 51750]]

c. Special Procedures for Approval and Re-Approval of Organ Transplant 
Centers (Sec.  488.61(f) Through (h))
    We proposed to remove the requirements at Sec.  488.61(f) through 
(h) for mitigating factors and transplant systems improvement 
agreements for the re-approval process for transplant centers. This 
change is complementary to the proposed removal of Sec.  482.82, 
described previously.
    Comment: The majority of commenters were supportive of the proposal 
to remove the mitigating factors and systems improvement agreements 
requirement for the re-approval process for transplant centers. These 
commenters stated that the removal of this requirement will relieve 
undue burden on transplant programs. However, a few commenters opposed 
the removal of this provision. The commenters were concerned that the 
removal of this provision would negatively impact programs and they 
noted that programs that failed to meet the re-approval requirements 
would be terminated, which would limit patient access. The commenter 
suggested that, if this proposal is finalized, CMS should monitor the 
number of programs that have been decertified or that will face 
decertification based on conditions.
    Response: The proposed change to remove the mitigating factors and 
systems improvement agreements afforded to transplant centers for 
Medicare re-approval is a complementary change to the removal of the 
Medicare re-approval requirements in Sec.  482.82. We are finalizing 
the removal of Sec.  482.82, making the existence of the mitigating 
factors and systems improvement agreement requirements obsolete. 
However, we note that transplant programs are still afforded the 
opportunity to submit mitigating factors or enter into systems 
improvement agreements for the initial Medicare approval, and that we 
are not making additional changes to the current processes other than 
the provisions regarding mitigating factors and systems improvement 
agreements.
    Final Rule Action:
    1. We are finalizing the proposal to make nomenclature changes 
throughout the transplant center regulations at Sec. Sec.  482.68, 
482.70, 482.72 through 482.104, and at Sec.  488.61, without 
modification.
    2. We are finalizing the proposal to remove Sec.  482.82, without 
modification.
    3. We are finalizing the proposal to remove the mitigating factor 
and systems improvement agreement requirements for Medicare re-approval 
at Sec.  488.61(f) through (h), without modification.
    Contact: Alpha-Banu Wilson, 410-786-8687.
6. Home Health Agencies
    We received 27 timely public comments on our proposed changes to 
the HHA requirements. Commenters included industry associations, 
healthcare systems, individual HHAs, consumer advocacy organizations, 
and clinicians. Overall, the majority of commenters were supportive of 
the goal of the proposed changes. Those comments are discussed below.
a. Patient Rights (Sec.  484.50(a)(3) and (c)(7))
    We proposed to delete the requirement at Sec.  484.50(a)(3) that 
HHAs must provide verbal notification of all patient rights. We 
proposed to limit the verbal notification requirements to those 
requirements set out in section 1891(a)(1)(E) of the Act for which 
verbal notification is mandatory. We proposed to revise Sec.  
484.50(c)(7) to implement this more limited verbal notification 
requirement. Revised Sec.  484.50(c)(7) would require HHAs to verbally 
discuss HHA payment and patient financial liability information with 
each HHA patient as described above.
    Comment: The majority of comments submitted regarding this topic 
expressed support for the proposed change to require written notice of 
patient rights for all enumerated rights, and oral notice only for 
those rights specifically set forth in the Act as requiring such oral 
notice. However, a small number of comments did not support this 
change, stating that oral notice of all rights, rather than only those 
set forth in the Act, has value to patients and caregivers. One 
commenter stated that oral notice is particularly important for 
individuals with lower literacy levels due to disabilities.
    Response: Consistent with the notice of patient rights requirements 
for other outpatient provider types, such as hospices, ambulatory 
surgery centers, and community mental health centers, for which written 
notice of patient rights is the only requirement, and in light of the 
support for this proposed change expressed by the majority of 
commenters, we are finalizing this change. We are sensitive to concerns 
related to those individuals with lower literacy levels due to 
disabilities that may impact understanding of the notice of patient 
rights. We remind all HHAs that, as part of their Medicare provider 
agreements, and in accordance with the other requirements of Sec.  
484.50, they are responsible for complying with the provisions of the 
Americans with Disabilities Act and Section 504 of the Rehabilitation 
Act when communicating with all patients regarding all subjects, 
including the notice of patient rights. HHAs must provide equal access 
to individuals with disabilities, including the provision of auxiliary 
aids and alternate formats, including, but not limited to, the 
provision of qualified interpreters, large print documents, Braille, 
digital versions of documents, and audio recordings.
b. Home Health Aide Services (Sec.  484.80(h)(3))
    We proposed to eliminate the requirement at Sec.  484.80(h)(3) that 
HHAs conduct a full competency evaluation of home health aides, and 
replace it with a requirement to retrain the aide regarding the 
identified deficient skill(s) and require the aide to complete a 
competency evaluation related only to those skills.
    Comment: Comments overwhelmingly supported the proposed change to 
remove the requirement that a home health aide must complete a full 
competency evaluation whenever a skill deficiency is noted during the 
aide supervision process.
    Response: We continue to believe that this change is appropriate, 
and are finalizing it as proposed.
c. Clinical Records (Sec.  484.110(e))
    We proposed to remove the requirement at Sec.  484.110(e) that the 
requested clinical record copy must be provided at the next home visit, 
while retaining the requirement that the information must be provided 
within 4 business days.
    Comments: Comments universally supported the proposal to remove the 
requirement that HHAs must provide to patients a copy of information 
contained in the clinical record by the time of the next HHA visit. A 
few comments explicitly supported maintaining the requirement to 
provide the requested information to patients within 4 days. However, 
other comments stated that the proposed change did not provide enough 
burden relief, and suggested that the requirement to provide a copy of 
such information within 4 days should also be revised to allow HHAs up 
to 30 calendar days to provide such information. Commenters stated that 
4 business days was insufficient time to access records, which may be 
archived offsite, make copies, and send those copies in the mail to 
arrive within 4 business days at the patient's home. One comment stated 
that the regulations should not include any requirements for HHAs to 
provide patients with

[[Page 51751]]

information from their own clinical records. Other commenters suggested 
that a shorter timeframe for providing information could be limited to 
only the information from the current 60 day episode of care, rather 
than to all certification periods from the episode of care or the 
patient's entire record of care that may cross several different 
episodes of care. Additionally, some commenters stated that HHAs should 
be permitted to charge patients a fee for providing information from 
the patient's own clinical record. However, other commenters 
specifically supported the prohibition on charging patients a fee to 
receive information from their own records.
    Response: We appreciate the commenters' support for our proposed 
revisions, and for their suggestions for further changes regarding the 
HHA clinical records provisions. Addressing the evolving need for the 
electronic exchange of health information amongst health care providers 
and also between patients and their health care providers is an 
Administration priority. As such, we will consider the issues raised by 
commenters in the broader context of interoperability and health 
information exchange, and will use these comments to inform future 
rulemaking. We are not finalizing the changes to Sec.  484.110(e) at 
this time.
d. Additional Comments
    Summaries of the additional suggestions that we received that are 
not directly related to our proposals and our responses are set forth 
below.
    Comment: Several commenters suggested that the requirement for HHAs 
to provide certain specified information, such as the upcoming HHA 
visit schedule and information about the treatments being furnished by 
HHA clinicians (Sec.  484.60(e)) in writing to patients, should be 
completely removed or significantly revised to remove most of the 
specified information from the list. Commenters specifically cited the 
requirement to provide patients with a visit schedule, contact 
information for a hospice clinical manager, and information about the 
treatments being provided as being overly burdensome requirements.
    Response: While we understand the concerns expressed by commenters, 
we continue to believe that providing patient-centered, patient-
directed care necessitates the provision of this crucial information to 
all patients. Patients cannot be active participants in their own care 
and advocates for their own interests without having essential 
information about when care will be provided to them, what treatments 
are being (or are supposed to be) administered during their care, and 
information for how to contact a clinical member of the HHA care team 
to discuss their questions and concerns. While it may be challenging 
for HHAs to keep patients abreast of their own care, such efforts form 
the basis of patient-centered care and cannot be ignored.
    Comment: A commenter suggested that the CoP for the comprehensive 
assessment should be revised to permit a registered nurse or a 
therapist to perform the comprehensive assessment in all cases where 
both services are ordered. A few commenters suggested that HHAs should 
not be required to provide any clinical services by their own 
employees, per the requirements of Sec.  484.105(f), and should instead 
be allowed to provide all clinical services under arrangement.
    Response: Changes of this magnitude would mark a significant 
departure from longstanding CMS policy. As such, we believe that it 
would be most appropriate to use the traditional notice and comment 
rulemaking process to allow all interested parties the opportunity to 
comment on the concepts. We will take these suggestions under 
consideration for future rulemaking efforts.
    Comment: Several commenters stated that nurse practitioners, in 
addition to physicians, should be allowed to write orders for the home 
health plan of care and provide care plan oversight.
    Response: Section 1861(m) of the Act requires the HHA plan of care 
to be under the direction of a physician. Section 1861(r) of the Act 
defines ``physician'' in a manner that does not include other licensed 
practitioners, such as nurse practitioners and physician assistants. 
Therefore, pursuant to statute, other licensed practitioners may not 
establish and maintain the home health plan of care, including 
reviewing, signing, and ordering services on the home health plan of 
care.
    Comment: A few commenters submitted comments related to physician 
signatures and communication with physicians regarding orders and the 
plan of care. Some comments stated that a physician signature should 
not be required for therapy orders. The commenters stated that 
requiring a physician signature on such orders delays the initiation of 
therapy services. Another comment stated that HHAs should not be 
required to communicate with all physicians who write orders for the 
plan of care when there is a change in the plan of care.
    Response: In order to maintain appropriate oversight of the HHA 
plan of care, all HHA services, including therapy services, must be 
ordered by a physician (Sec.  484.60(b)(1)). The CoPs allow for verbal 
orders in order to facilitate a timely initiation of care, requiring 
that verbal orders be authenticated and dated by the physician in 
accordance with applicable state laws and regulations, and consistent 
with the HHA's own internal policies. Typically, a physician writes 
orders for a therapist to evaluate and treat the patient. The 
requirement for the physician order and subsequent signature in 
accordance with State law and HHA policy would not delay therapy 
services after the therapist's evaluation and recommended treatment 
plan has been communicated to the physician for approval. It is not 
necessary to withhold therapy services while waiting for the physician 
confirmation of the therapy plan.
    We agree with the commenter that communicating with all involved 
physician(s) is not necessary for every single change in the plan of 
care. Section 484.60(c)(3) requires such communication only when the 
change to the plan of care is due to a change in the patient's health 
status (for example, initiating a new medication) or a change in the 
plan for the patient's discharge from the HHA. The communication of 
other changes that do not fall into one of these categories (for 
example, adjusting the dose of a current medication) is left to the 
discretion of HHA clinical staff and the clinical manager(s) 
responsible for the patient's care.
    Comment: Numerous commenters submitted suggestions for changes to 
HHA payment policies, such as the face to face requirement and the 
homebound requirement, which they believe should be addressed as part 
of CMS burden reduction efforts. A single commenter suggested a 
revision to the Home Health Consumer Assessment of Healthcare Providers 
and Systems (HHCAHPS). A small number of commenters submitted comments 
regarding information in the HHA interpretive guidelines.
    Response: Comments not related to the HHA CoPs are outside of the 
scope of this rule. Individuals wishing to submit comments regarding 
CMS payment policies may submit those comments as part of the annual 
HHA payment policy proposed rule. We have shared these unrelated 
comments with the appropriate components within CMS.
    Final Rule Action:
    1. We are finalizing the proposal to delete the requirement at 
Sec.  484.50(a)(3)

[[Page 51752]]

that HHAs must provide verbal notification of all patient rights.
    2. We are finalizing the proposal to revise Sec.  484.50(c)(7), 
requiring HHAs to verbally discuss HHA payment and patient financial 
liability information with each HHA patient.
    3. We are finalizing the proposal to eliminate the requirement at 
Sec.  484.80(h)(3) to conduct a full competency evaluation, and replace 
it with a requirement to retrain the aide regarding the identified 
deficient skill(s), and require the aide to complete a competency 
evaluation related only to those skills.
    4. We are not finalizing the proposal to remove the requirement at 
Sec.  484.110(e) that the requested clinical record copy must be 
provided at the next home visit.
    Contact: Danielle Shearer, 410-786-6617.
7. Comprehensive Outpatient Rehabilitation Facilities (CORFs)--
Utilization Review Plan (Sec.  485.66)
    We proposed to amend the utilization review plan requirements at 
Sec.  485.66 to reduce the frequency of utilization reviews from a 
quarterly basis to an annual requirement.
    We received two timely public comments on our proposed changes to 
the CORF requirements. Both comments expressed strong support for the 
proposed changes; therefore we are finalizing those changes as proposed 
in this final rule.
    1. Final Rule Action: We are finalizing the proposal to revise 
Sec.  485.66, requiring the facility to have a written utilization 
review plan that is implemented annually, without modification.
    Contact: CAPT Jacqueline Leach, USPHS, 410-786-4282.
8. Critical Access Hospitals
a. Organizational Structure (Sec.  485.627(b)(1))
    We proposed to remove the requirement for CAHs to disclose the 
names and addresses of their owners, those with a controlling interest 
in the CAH or in any subcontractor in which the CAH directly or 
indirectly has a 5 percent or more ownership interest, in accordance 
with 42 CFR part 420, subpart C. This requirement is duplicative, as it 
is also a requirement for the provider agreement for Medicare 
participation. This proposal was also included in the Medicare and 
Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes 
To Promote Innovation, Flexibility, and Improvement in Patient Care; 
Proposed Rule (81 FR 39447) for the same reason.
    Comment: Commenters universally supported the proposal to remove 
the CAH disclosure requirement, noting that the requirement duplicates 
a provision found elsewhere in our regulations. Comments received 
regarding this provision in the Medicare and Medicaid Programs; 
Hospital and Critical Access Hospital (CAH) Changes To Promote 
Innovation, Flexibility, and Improvement in Patient Care; Proposed Rule 
(81 FR 39447, 39460, June 16, 2016) were consistent with those received 
for this proposed rule, with commenters also universally supporting the 
proposal.
    Response: We appreciate the comments received and continue to 
believe that this change is appropriate.
    Final Rule Action: We are finalizing the proposed changes without 
modification.
    Contact: Kianna Banks, 410-786-3498.
b. Provision of Services (Sec.  485.635(a)(4))
    Current regulations at Sec.  485.635 require a CAH's professional 
healthcare staff to review policies and procedures annually; the review 
group must include one or more doctors of medicine or osteopathy and 
one or more physician assistants, nurse practitioners, or clinical 
nurse specialists. Based on our experience with other providers, we 
proposed a flexible approach that would allow CAHs to maintain their 
health and safety policies in such a manner as to achieve the intended 
outcomes for all patients. Thus, we proposed to change the requirement 
at Sec.  485.635(a)(4) from ``annual'' to ``biennial''.
    We received 20 public comments on our proposed changes to this CAH 
requirement. Commenters included hospital industry associations, 
individual providers, and national accrediting organizations. Overall 
the commenters were supportive of the proposed changes.
    Summaries of the comments and our responses are set forth below.
    Comment: All of the commenters agreed with the effort to reduce 
burden. However, a few of commenters suggested moving to a 3-year 
timeframe for reviews and several other commenters suggested aligning 
with hospital requirements and removing the timeframe and allow CAHs to 
determine when reviews are done.
    Response: CAHs are rural providers with separate Conditions of 
Participation from hospitals and they do not have the range or number 
of personnel, among other requirements we require for hospitals.
    We believe that the approach of requiring a biennial review reduces 
burden while maintaining the appropriate safeguards for healthy 
outcomes for CAH patients. Therefore, we are finalizing this 
requirement without modification.
    Final Rule Action: We are finalizing the proposed changes to Sec.  
485.635(a)(4).
    Contact: Mary Collins, 410-786-3189.
c. Special Requirements for CAH Providers of Long-Term Care Services 
(``Swing-Beds'') (Sec.  485.645(d)(1), (4), (5) and (8))
    The special requirements for CAH swing-bed providers are nearly 
identical to the requirements for hospital providers of swing-bed 
services. As a result, please refer to the discussion on the special 
requirements for hospital providers of swing-bed services under section 
II.D.3 for the details of the proposed changes for these requirements 
for both hospitals and CAHs. We proposed the following revisions to the 
CAH swing-bed requirements:
     Revision of Sec.  485.645(d)(1) to remove the cross-
referenced long-term care requirement in Sec.  483.10(f)(9), which 
requires that CAH swing-bed providers to offer residents the right to 
choose to or refuse to perform services for the facility and prohibits 
a facility from requiring a resident to perform services for the 
facility;
     Removal of Sec.  485.645(d)(4), which requires CAH swing-
bed providers to provide an ongoing activity program that is directed 
by a qualified therapeutic recreation specialist or an activities 
professional who meets certain requirements (cross-referenced long-term 
care requirement Sec.  483.24(c));
     Revision of Sec.  485.645(d)(4) (as redesignated) to 
remove the cross-referenced long-term care requirement Sec.  483.70(p), 
which requires that CAH swing-bed providers with more than 120 beds to 
employ a qualified social worker on a full-time basis; and
     Revision of Sec.  485.645(d)(7) (as redesignated) to 
remove the cross-referenced long-term care requirement Sec.  
483.55(a)(1), which requires CAH swing-bed providers to assist in 
obtaining routine and 24-hour emergency dental care to its residents.
    Contact: Kianna Banks, 410-786-3498.
9. Community Mental Health Centers (Sec.  485.914(d))
    We require CMHCs, at Sec.  485.914(d)(1), to update clients' 
comprehensive assessments every 30 days. We proposed to revise Sec.  
485.914(d)(1) to require that the CMHC update each client's 
comprehensive assessment via the CMHC interdisciplinary treatment

[[Page 51753]]

team, in consultation with the client's primary health care provider 
(if any), when changes in the client's status, responses to treatment, 
or goal achievement have occurred, and in accordance with current 
standards of practice. Additionally, at Sec.  485.914(d)(2), we 
proposed to retain the minimum 30-day assessment update time frame for 
those clients who receive PHP services. We believe this proposed change 
will allow for the provider and client to choose a visit schedule that 
is appropriate for the client's condition and not cause extra work or 
time for documentation that is unnecessary. Ultimately, this proposed 
change may allow for greater flexibility for the provider and client, 
saving time for both.
    We received 4 timely public comments on our proposed changes to the 
requirements at Sec.  485.914(d). Commenters included physicians, 
associations and health networks. Overall, the majority of commenters 
were supportive of the goal of the proposed changes. Summaries of the 
major issues and our responses are set forth below.
    All of the comments expressed strong support for the proposed 
changes to Sec.  485.914(d); therefore, we are incorporating those 
changes as proposed in this final rule.
    Comment: We received several comments in support of the proposed 
change to the CMHC update to the comprehensive assessment requirement. 
Most commenters agreed that, for patients admitted for non-PHP 
services, it made sense to allow patients care needs, responses to 
treatment and care goals to drive decisions about when a patient needs 
to have an updated assessment. Commenters also agreed that it was 
appropriate to keep the requirement to update to the comprehensive 
assessment every 30 days for PHP patients. One commenter raised a 
concern regarding the proposed update to the comprehensive assessment 
requirement changes as it relates to patients needing to transfer to 
the hospital emergency department. The commenter stated that some 
emergency departments receive patients directly from CMHCs for 
emergency mental health treatment, and that it is important for the 
treating physician in the ED to know what medications the patient is 
taking. A commenter agreed with the proposed change to the 
comprehensive assessment update requirement, and asked for CMS to 
consider making similar burden reducing changes to all the requirements 
for the ''Persons centered active treatment plan'' under Sec.  485.916.
    Response: We appreciate all of the positive feedback on the 
proposed changes to remove the 30-day updated assessment timeframe for 
non-PHP patients, and are finalizing this proposal without change. We 
understand the concerns raised related to how this assessment change 
would impact CMHC patients who must be transferred to a hospital 
emergency room. In the CMHC CoPs under Sec.  485.914(e)(5)(v)(A)-(E), 
we state that when a client becomes an immediate threat to the physical 
safety of themselves, staff or other individuals, the CMHC must 
document a description of the client's behavior and the intervention(s) 
used (including medications), alternatives or other less restrictive 
interventions attempted, the client's condition or symptom(s) that 
warranted the use of the restraint or seclusion, and the client's 
response to the intervention(s) used. Typically, patient transfers from 
a CMHC to an emergency room include a transfer note summarizing the 
above information, including all current medications and any PRN 
medications that were given prior to the transfer to the emergency 
room. Furthermore, we agree with the suggestion that conforming changes 
should be made to Sec.  485.916, because the requirements of Sec.  
485.914 and 485.916 constitute a cycle of care, with assessment and 
care planning feeding into one another. However, because we did not 
propose any changes to the client centered active treatment plan CoP 
(Sec.  485.916), we are legally not permitted to make any changes in a 
final rule without proposing the change to the public in a proposed 
rule. Therefore we will not be amending the regulatory language in 
Sec.  485.916 but will consider proposing a change to the requirements 
at a future date.
    Final Rule Action: We are finalizing the proposal to revise Sec.  
485.914(d) that the CMHC must update each client's comprehensive 
assessment via the CMHC interdisciplinary treatment team, in 
consultation with the client's primary health care provider (if any), 
when changes in the client's status, responses to treatment, or goal 
achievement have occurred and in accordance with current standards of 
practice. For clients that receive PHP services, the assessment must be 
updated no less frequently than every 30 days.
    Contact: CAPT Mary Rossi-Coajou, USPHS, 410-786-6051.
10. Portable X-Ray Services (Sec. Sec.  486.104(a) and 486.106(a))
    We proposed to revise the personnel qualification requirements at 
Sec.  486.104(a)(1), (2), (3), or (4) by removing school accreditation 
requirements and simplifying the structure of the requirements. We 
proposed that all operators of portable X-ray equipment would meet one 
of the following:
    (1) Successful completion of a program of formal training in X-ray 
technology at which the operator received appropriate training and 
demonstrated competence in the use of equipment and administration of 
portable x-ray procedures; or
    (2) Successful completion of 24 full months of training and 
experience under the direct supervision of a physician who is certified 
in radiology or who possesses qualifications which are equivalent to 
those required for such certification.
    We proposed to update Sec.  486.106(a)(2) (specific to portable x-
ray services) to cross reference the requirements at Sec.  410.32 
instead of setting forth specific order requirements. We proposed to 
retain the requirement that the portable x-ray order must include a 
statement on why it is necessary to perform a portable x-ray as opposed 
to performing the study in a facility where x-rays are more typically 
performed.
    We received 9 timely public comments on our proposed changes to the 
portable x-ray requirements. Commenters included long-term care 
facility associations, portable x-ray associations, portable x-ray 
suppliers, and health care systems. Overall, the majority of commenters 
were supportive of the goal of the proposed changes. Summaries of the 
major issues and our responses are set forth below.
    Comment: All of the comments received regarding our proposal to 
revise the personnel requirements for individuals who perform portable 
x-ray services supported the proposed revision. A single commenter 
suggested that option 2, related to 24 full months of training and 
experience under the direct supervision of a physician, and should not 
be included because these training programs are no longer offered.
    Response: We agree with the comments that it is appropriate to 
revise the personnel requirements for individuals who perform portable 
x-ray services in a manner that focuses on the skills of the individual 
rather than the accreditation of the institution that provided the 
training, and we are finalizing this change. We do not agree that it is 
appropriate to eliminate the qualification option related to 24 full 
months of training and experience under the direct supervision of a 
physician. The fact that such programs are no longer offered does not 
mean that those individuals who completed such programs are no longer 
qualified to

[[Page 51754]]

perform portable x-ray services, and thus excluded from performing 
their job duties. Excluding those individuals would not benefit patient 
health and safety or patient access to portable x-ray services; and 
may, in fact, reduce the number of qualified portable x-ray technicians 
and negatively impact access to care.
    Comment: All of the comments received regarding our proposal to 
revise the requirements for portable x-ray orders supported the 
proposed revision. One commenter specifically supported, while another 
specifically disagreed with, the proposal to retain the requirement 
that each order must specify the reason that portable x-ray services 
are necessary.
    Response: We agree with the comments that it is necessary and 
appropriate to revise the requirements for portable x-ray orders to 
align with the separate payment requirements for diagnostic imaging 
orders that also apply to portable x-ray services at Sec.  410.32, and 
are finalizing this change. We believe that it is appropriate to 
require documentation regarding why this unique service is necessary in 
place of the more traditional facility-based x-ray service, and are 
continuing this longstanding element as part of the revised 
requirements for portable x-ray orders.
    Comment: We received several comments related to Medicare payment 
policies and Medicare payment manuals related to portable x-ray 
services. We also received a comment related to the 2018 Crosswalk for 
Medicare Provider/Supplier to Healthcare Provider Taxonomy, and the 
Medicare provider and supplier enrollment process.
    Response: These comments are outside of the scope of this rule, and 
have been shared with the CMS components that are responsible for these 
subject matter areas.
    Final Rule Action: We are finalizing the changes to Sec. Sec.  
486.104(a) and 486.106(a)(2).
    Contact: Sonia Swancy, 410-786-8445.
11. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)
a. Provision of Services (Sec.  491.9(b)(4))
    We proposed to change the requirement at Sec.  491.9(b)(4), related 
to reviewing patient care policies, from an ``annual'' review to a 
``biennial'' review.
b. Program Evaluation (Sec.  491.11(a))
    We proposed to revise the current requirement at Sec.  491.11(a) by 
changing the frequency of the RHC or FQHC evaluation from annually to 
every other year.
    We received 30 timely public comments on our proposed changes to 
the RHC and FQHC requirements. Commenters included industry 
associations, healthcare systems, individual RHCs and FQHCs and 
clinicians. Overall, the majority of commenters were supportive of the 
goal of the proposed changes. Summaries of the major issues and our 
responses are set forth below.
    Comment: Overall, the majority of comments submitted regarding this 
topic expressed support for both of the proposed changes to require 
biennial provision of services policy reviews and clinic or center 
total program evaluation. Some of the commenters were completely 
supportive of the proposed biennial change, while some of the 
commenters stated they were unsure whether it will provide meaningful 
burden reduction. Other commenters were appreciative of the CMS goal to 
reduce burden on the RHC or FQHC and stated that the flexibility and 
opportunity to allow the clinic or center to decide how to most 
appropriately use their staff time and resources is critical to 
maintaining the highest standard of care for their patients. One 
commenter suggested that, in addition to revising the time frame for 
review, CMS should also reduce the burden of this regulation by 
removing the requirement that someone in the group of professional 
personnel that reviews the policies must be from outside the clinic or 
center's staff.
    Response: We continue to believe these two changes are appropriate, 
and are finalizing them as proposed.
    We agree that the requirement to have someone in the group of 
professional personnel that reviews the policies be from outside of the 
clinic or center's own staff can be difficult to meet in medically 
underserved areas or those where there are health professional 
shortages. Administrative burden would be decreased by the time often 
spent trying to find a qualified professional who is not on payroll, 
but is willing to come in and review RHC policies. We will consider 
this change for future rulemaking.
    Final Rule Action:
    1. We are finalizing the proposal to revise the requirement at 
Sec.  491.9(b)(4) requiring RHCs and FQHCs to review their patient care 
policies at least biennially by a group of professional personnel and 
RHC or FQHC staff.
    2. We are finalizing the proposal to revise the requirement at 
Sec.  491.11(a) that requires the clinic or center to carry out or 
arrange for, a biennial evaluation of its total program.
    Contact: CAPT Jacqueline Leach, USPHS, 410-786-4282.
12. Emergency Preparedness for Providers and Suppliers
    On September 16, 2016, we published a final rule entitled, 
``Medicare and Medicaid Programs; Emergency Preparedness Requirements 
for Medicare and Medicaid Participating Providers and Suppliers'' (81 
FR 63860), which established national emergency preparedness 
requirements for Medicare and Medicaid participating providers and 
suppliers (referred to collectively as ``facilities'' in the subsequent 
section) to plan adequately for both natural and man-made disasters and 
coordinate with Federal, State, tribal, regional, and local emergency 
preparedness systems. In that final rule, we emphasized the need for 
facilities to maintain access to healthcare services during 
emergencies, safeguard human resources, and maintain business 
continuity and protect physical resources. A facility's emergency 
preparedness program must include the following elements:

 Risk assessment and emergency planning
 Policies and procedures
 Communication plan
 Training and testing

    We received over 300 comments centered around the proposed 
revisions to the Emergency preparedness requirements. Some of the 
comments were supportive of one or more of the proposed provisions, 
others were not supportive of the proposed revisions and expressed the 
commenters concerns. We have organized our responses to the comments as 
follows: (1) General Comments; (2) Annual Review of Emergency 
Preparedness Program; (3) Documentation of Cooperation Efforts; (4) 
Annual Emergency Preparedness Training Program; (5) Annual Emergency 
Preparedness Testing.
General Comments
    Comment: One commenter suggested that we delay any changes to 
emergency preparedness for 5 years. The commenter states that revisions 
set forth in the September 2016 Emergency Preparedness final rule (81 
FR 63860) just went into effect within the past year and some 
facilities are still working to come into compliance with those 
changes. Commenters assert that implementing additional revisions at 
this time would be burdensome.
    Response: The September 2016 Emergency Preparedness final rule (81

[[Page 51755]]

FR 63860) was a comprehensive change in our requirements for all 
provider types. Therefore, we allowed additional time for providers and 
suppliers to come into compliance. We do not agree that it is necessary 
to extend the effective date because (1) the original compliance date 
was 2017, so providers and suppliers should be complete with 
implementation; (2) the proposed changes in this rule decrease burden, 
so implementation should not impose a hardship on providers and 
suppliers to come into compliance. Therefore, we are not delaying the 
implementation of this requirement. Once this rule is published, 
providers/suppliers will have 60 days from the publication date to be 
in compliance with the finalized changes.
    Comment: One commenter requested that we leave the emergency 
preparedness regulations as they are and work instead on strengthening 
standards as proposed in Sheltering in Danger, a report written by 
Minority Staff of the Senate Finance Committee. The report discusses 
efforts to improve nursing home quality by calling attention to 
specific issues such as heat index/temperature/humidity, sheltering and 
evacuations and community engagement.
    Response: We appreciate the Committee's work on the Sheltering in 
Danger report. We updated Appendix Z of the State Operations Manual in 
February 2019 to clarify the emergency preparedness requirements. This 
includes adding emerging infectious diseases to the definition of all-
hazards approach; clarifications and additional guidance on the use of 
portable generators and alternate source power and a cross reference to 
the nursing home requirements for safe temperatures; and technical 
changes to the home health citations. We are always looking for ways to 
improve quality and safety oversight efforts in nursing homes, and are 
continuing to consider the report's recommendations as we move forward.
    Comment: A few commenters stated that the current emergency 
preparedness requirements are overly burdensome for outpatient 
providers/suppliers and the requirements should be different for 
outpatient versus inpatient providers and suppliers. The commenters 
expressed that providers/suppliers that provide inpatient services 
should have stronger requirements as the patients or residents may be 
incapable of self-preservation in the event of an emergency. Whereas, 
outpatient providers and suppliers generally have patients that are 
capable of self-preservation in the event of an emergency.
    Response: We understand that for many smaller, rural providers and 
suppliers and for outpatient facilities that do not have full-time 
patients the emergency preparedness requirements may seem excessive. 
Many of the requirements are similar for inpatient and outpatient 
providers and suppliers. We believe these emergency preparedness 
requirements are important for all providers and suppliers. However, we 
recognize that there are some differences in inpatient and outpatient 
facilities with regard to emergency preparedness and have made changes 
in this rule that recognize these differences. In addition, we note 
that LTC facilities have some changes in requirements for the emergency 
plan updates and training that are discussed in detail below. We will 
take your recommendation and consider it for future rulemaking.
a. Annual Review of Emergency Preparedness Program (Sec. Sec.  403.748, 
416.54, 418.113, 441.184, 460.84, 482.15, 483.73, 483.475, 484.102, 
485.68, 485.625, 485.727, 485.920, 486.360, 491.12, and 494.62 (a), 
(b), (c), and (d))
    We proposed to change the requirement for facilities to review 
their emergency preparedness program at least every 2 years. This would 
increase the facility's flexibility to review their programs as they 
determine best fits their needs. We are finalizing this proposal with 
modifications to LTC facilities only.
    The comments received in response to the proposed revision were 
mostly supportive and the comments that were not supportive were mostly 
centered around LTC facilities. Below is a summary of the comments we 
received and our responses.
    Comment: Many commenters supported the emergency preparedness 
updates for biennially revisions to the emergency plan. One commenter 
stated that annual revisions are not always necessary, as urgent 
changes are made as needed; otherwise, facilities are reviewing 
procedures that have not changed. The proposed revisions to emergency 
preparedness requirements would increase facilities' flexibility to 
build, train, test and review an effective program that meets the needs 
of each facility and community in which the facility is located.
    Response: We agree that requiring facilities to review their 
emergency preparedness plan biennially allows for more flexibility for 
providers and suppliers. We expect that facilities would routinely 
revise and update their policies and operational procedures to ensure 
that they are operating based on best practices. In addition, 
facilities should update their emergency preparedness program more 
frequently than every 2 years as needed (for example, if staff changes 
occur or lessons-learned are acquired from a real-life event or 
exercise). Therefore, we are finalizing this proposal for all 
providers/suppliers to update their emergency preparedness plan 
biennially. As discussed in greater detail below, due to the 
vulnerability of residents in LTC facilities, we are not finalizing the 
proposal for those facilities only and will require them to update 
their emergency plan annually, as is currently required. This will 
allow the staff and residents to be fully aware of the emergency 
preparedness program and any changes made.
    Comment: As noted above, we received many comments that asked us to 
not finalize the proposed emergency preparedness requirements for LTC 
facilities. One commenter stated that ongoing communication and 
collaboration are very important. The current regulations sensibly 
require annual updates to emergency plans, policies and procedures, 
communications plan, training and testing. The success of a 
preparedness plan often depends on frequent updates. Significant 
changes can occur in a 2 year period, the resident population, as well 
as local health care providers, transportation companies, staff, 
facilities, patient population and other vendors. The LTC facility 
should know about changes in their community. Staff turnover is a 
concern and for that reason emergency preparedness plans need to be 
revisited yearly to be sure everyone is prepared. Many commenters 
stated that changing the requirements to biennial updates creates 
additional opportunities for errors and for facility residents and 
staff to be unprepared, lack appropriate response and endanger more 
residents' lives. Residents depend heavily on the staff and rely on 
their preparedness during an emergency. The effort and expense of 
annual updating is far outweighed by the benefit of a LTC facility 
being prepared for an emergency. Moving to biennial review could 
exacerbate the issue of emergency preparedness in LTC facilities more 
than already exists.
    Response: We recognize that LTC facility residents are generally a 
very vulnerable population that rely on the staff to be knowledgeable 
and prepared in the event of an emergency. For that reason, we are not 
finalizing the proposal for biennial updates to the

[[Page 51756]]

emergency plan for LTC facilities only. All other providers and 
suppliers will be required to update their emergency preparedness plan 
biennially. We would like to point out that this is the minimum 
requirement for non-LTC facility providers and suppliers and that non-
LTC facility providers and suppliers are encouraged to review and 
update their facilities plan more frequently if providers and suppliers 
feel the need to.
b. Documentation of Cooperation Efforts (Sec. Sec.  403.748(a)(4), 
416.54(a)(4), 418.113(a)(4), 441.184(a)(4), 460.84(a)(4), 482.15(a)(4), 
483.73(a)(4), 483.475(a)(4), 484.102(a)(4), 485.68(a)(4), 
485.625(a)(4), 485.920(a)(4), 486.360(a)(4), 491.12(a)(4), and 
494.62(a)(4))
    We proposed to eliminate the requirement that facilities document 
efforts to contact local, tribal, regional, State, and Federal 
emergency preparedness officials and facilities' participation in 
collaborative and cooperative planning efforts. Facilities will still 
be required to include a process for cooperation and collaboration with 
local, tribal, regional, State and Federal emergency preparedness 
officials' efforts to maintain an integrated response during a disaster 
or emergency situation.
    The comments received regarding this proposal were mostly 
supportive. Below we have summarized the comments received and our 
responses.
    Comment: Many commenters support the elimination of documentation 
of efforts to contact local, tribal, regional, State and Federal 
emergency preparedness officials and, when applicable, document the 
facility's participation in collaborative and cooperative planning 
efforts. Commenters state that documenting efforts to contact emergency 
preparedness officials are overly burdensome. The commenters also 
stated that eliminating this requirement allows for smaller facilities 
to focus on patient care.
    Response: We agree that the documentation requirement can be overly 
burdensome, as some comments have raised, and are finalizing the 
proposal to remove the requirement. We believe that eliminating this 
documentation requirement would reduce burden by not requiring 
facilities to demonstrate that they have contacted local, tribal, 
regional, State, and Federal emergency preparedness officials or 
participated in collaborative and cooperative planning in the 
community, while still requiring facilities to have a process for 
cooperation and collaboration. Therefore, we are finalizing this 
requirement as proposed and eliminating the documentation requirement 
for collaboration with emergency preparedness officials. Providers and 
suppliers would still be required to have a process for cooperation and 
collaboration as part of the emergency plan.
    Comment: Commenters stated that removing documentation requirements 
will reduce transparency of cooperation efforts, increasing the 
likelihood of disjointed responses and weakening accountability. 
Documentation proves that the facility has actually contacted and 
collaborated with EP officials, is the only way a state survey agency 
can verify that efforts have been made for compliance, and is 
invaluable to incoming staff.
    Response: We would like to point out that providers would still be 
required at the respective emergency preparedness requirements for each 
provider and supplier to include a process for collaboration/
cooperation with officials; however, they would not be required to 
document efforts to contact these officials. Therefore, this maintains 
the existence of a process for collaboration with officials without 
posing additional documentation burdens. Therefore, we are finalizing 
this requirement as proposed and eliminating the documentation 
requirement for collaboration with emergency preparedness officials.
c. Annual Emergency Preparedness Training Program (Sec. Sec.  
403.748(d)(1)(ii), 416.54(d)(1)(ii), 418.113(d)(1)(ii), 
441.184(d)(1)(ii), 460.84(d)(1)(ii), 482.15(d)(1)(ii), 
483.73(d)(1)(ii), 483.475(d)(1)(ii), 484.102(d)(1)(ii), 
485.68(d)(1)(ii), 485.625(d)(1)(ii), 485.727(d)(1)(ii), 
485.920(d)(1)(ii), 486.360(d)(1)(ii), 491.12(d)(1)(ii), and 
494.62(d)(1)(ii))
    Facilities are required to develop and maintain a training program 
that is based on the facility's emergency plan. This emergency 
preparedness training must be provided at least annually and a well-
organized effective training program must include initial training in 
emergency preparedness policies and procedures. We revisited the public 
comments received on the Emergency Preparedness proposed rule (81 FR 
63890 through 63891) and determined that requiring facilities to 
provide annual training may be unduly burdensome. Therefore, we 
proposed to require facilities to provide training biennially or every 
2 years, after facilities conduct initial training on their emergency 
program. In addition, we proposed to require additional training when 
the emergency plan is significantly updated.
    Overall, the majority of commenters opposed our proposal to require 
emergency preparedness training biennially. We received a significant 
number of comments on this proposal from nursing home resident 
advocates. We received a few supportive and negative comments from 
other stakeholders, including Congressional representatives and 
emergency management professionals. A summary of the major issues and 
our responses are set forth below:
    Comment: Nursing home resident advocates overwhelmingly opposed our 
proposal to require emergency preparedness training biennially. These 
commenters noted that training every 2 years is not sufficient to 
maintain readiness in the event of an emergency. Commenters noted that 
nursing homes specifically experience high staff turnover, changes in 
ownership, and changes in resident conditions/needs, and cited these 
conditions as reasons to support annual training. Commenters also noted 
recent emergency events and the lack of readiness displayed by nursing 
homes as an indication that more emergency preparedness training, not 
less, is needed.
    In addition to the large number of comments from nursing home 
resident advocates, we also received a few comments opposed to the 
proposal from non-LTC facility providers. These commenters also noted 
high staff turnover, changes in community resources, closure of 
receiving providers, changes in patient/resident census, and the need 
to incorporate recent best practices and lessons learned as the main 
reasons to support annual training. Commenters indicated that the 
effort and expense of annual training would be outweighed by the 
benefit of being prepared in the case of an emergency or natural 
disaster.
    Response: We appreciate the feedback and thoughtful comments 
provided on this proposal. We especially appreciate the comments that 
provided a very detailed analysis of the lack of emergency response in 
nursing homes following recent emergency events. We believe that these 
comments have provided compelling evidence to revise our proposal 
specific to LTC facilities. Therefore, for LTC facilities only, we are 
not finalizing our proposal to revise the annual training requirement 
to biennial training. LTC facilities will be required to continue to 
meet the current requirement for annual training.

[[Page 51757]]

d. Annual Emergency Preparedness Testing (Sec. Sec.  403.748(d)(2), 
416.54(d)(2), 418.113(d)(2), 441.184(d)(2), 460.84(d)(2), 482.15(d)(2), 
483.73(d)(2), 483.475(d)(2), 484.102(d)(2), 485.68(d)(2), 
485.625(d)(2), 485.727(d)(2), 485.920(d)(2), 486.360(d)(2), 
491.12(d)(2), and 494.62(d)(2))
    Facilities are currently required to conduct exercises to test the 
emergency plan at least annually. The facility must conduct two 
emergency preparedness testing exercises every year. Specifically, 
facilities must:
     Participate in a full-scale exercise that is community-
based or when a community-based exercise is not accessible, an 
individual, facility-based. If the facility experiences an actual 
natural or-man made emergency that requires activation of the emergency 
plan (including their communication plan and revision of the plan as 
needed), the facility is exempt from engaging in a community-based or 
individual, facility based full-scale exercise for 1 year following the 
onset of the actual event;
     Conduct an additional exercise that may include either a 
second full-scale exercise that is community-based or individual, 
facility-based or a tabletop exercise that includes a group discussion 
led by a facilitator.
    Upon further analysis of this requirement, and taking into account 
stakeholder feedback, we determined that there was a need to clarify 
and revise some of the requirements included in the Emergency 
Preparedness final rule (81 FR 63860). Therefore, for all provider and 
supplier types, we proposed to clarify our intent with regard to the 
types of testing exercises, specifically full-scale exercises and 
functional exercises.
    For providers of inpatient services (inpatient hospice facilities, 
Psychiatric Residential Treatment Facilities (PRTFs), hospitals, long-
term care facilities (LTCFs), ICFs/IIDs, and CAHs), we proposed to 
retain the existing requirement for these provider and supplier types 
to conduct two emergency preparedness testing exercises annually. We 
proposed to expand the testing requirement options, such that one of 
the two annually required testing exercises could be an exercise of 
their choice, which could include one community-based full-scale 
exercise (if available), an individual facility-based functional 
exercise, a drill, or a tabletop exercise or workshop that included a 
group discussion led by a facilitator. We noted that although RNHCIs 
provide inpatient services, we determined that changing their existing 
requirements to make them consistent with this proposed provision would 
be unduly burdensome, as they are currently only required to conduct a 
paper-based, tabletop exercise at least annually.
    For providers of outpatient services (ASCs, freestanding/home-based 
hospice, Program for the All-Inclusive Care for the Elderly (PACE), 
HHAs, CORFs, Organizations (which include Clinics, Rehabilitation 
Agencies, and Public Health Agencies as Providers of Outpatient 
Physical Therapy and Speech-Language Pathology Services), CMHCs, Organ 
Procurement Organizations (OPOs), RHCs, FQHCs, and ESRD facilities), we 
proposed to require that providers of outpatient services conduct only 
one testing exercise per year. Furthermore, we proposed to require that 
these providers participate in either a community-based full-scale 
exercise (if available) or conduct an individual facility-based 
functional exercise every other year. In the opposite years, we 
proposed to allow these providers to conduct the testing exercise of 
their choice, which may include either a community-based full-scale 
exercise (if available), an individual, facility-based functional 
exercise, a drill, or a tabletop exercise or workshop that includes a 
group discussion led by a facilitator. We noted that due to the nature 
of services provided by OPOs, we proposed to require that they have the 
option of providing either a tabletop exercise or workshop every year.
    Lastly, we proposed to clarify the testing requirement exemption by 
noting that if a provider experiences an actual natural or man-made 
emergency that requires activation of their emergency plan, inpatient 
and outpatient providers will be exempt from their next required full-
scale community-based exercise or individual, facility-based functional 
exercise following the onset of the actual event.
    The majority of the comments received were supportive of our 
proposal to differentiate the emergency preparedness testing 
requirements between inpatient and outpatient providers and to clarify 
the types of testing exercises that will satisfy the proposal. A 
summary of the major comments and our responses are below:
    Comment: While many commenters supported our requirement to 
differentiate the emergency preparedness testing requirements between 
inpatient and outpatient providers, one commenter noted that the 
varying requirements may discourage coordination and collaboration 
amongst providers within a community.
    Response: We appreciate the feedback in support of our proposal. It 
is not our intention to discourage coordination among providers, but 
rather to provide facilities with a requirement for emergency 
preparedness testing that is realistic and attainable, without 
impacting the health and safety of the patients that they serve. We 
believe that differentiating the testing requirements by inpatient and 
outpatient provider and supplier types takes into consideration the 
unique characteristics of not only the provider type, but also the 
population that they serve. We expect that facilities will continue to 
make best efforts to collaborate with providers within their community 
to not only maximize efforts and resources, but to also meet the many 
other emergency preparedness requirements for coordination and 
collaboration. We note that all provider and supplier types are 
required to develop an emergency preparedness communication plan that, 
among other things, includes information for other providers; and to 
develop a method for sharing information and medical documentation for 
individuals under the provider's care with other health care providers, 
as necessary to maintain the continuity of care.
    Comment: Commenters supported the clarification of the types of 
testing exercises that would satisfy the testing requirements. However 
some commenters indicated that the proposal, and terminology we used, 
remain confusing. These commenters urged us to follow the principles of 
exercise programs established under the Homeland Security Exercise and 
Evaluation Program (HSEEP). One commenter indicated that we use 
functional exercise and full-scale exercise interchangeably, when the 
two exercises are vastly different types of exercises. This commenter 
suggested further that we use a more broad definition of the types of 
testing exercises to align with HSEEP. Specifically, the commenter 
recommended that we require facilities to participate in an annual 
operations-based exercise in conjunction with local, county, or other 
state stakeholders (if available) or conduct an operations-based 
exercise at the facility level. The commenter noted that, as defined by 
HSEEP, an ``operations-based exercise'' could include any of the 
following types of exercises: Drill, functional exercise, or full-scale 
exercise. Furthermore, the commenter indicated that as a choice of 
testing exercises we should specify that

[[Page 51758]]

facilities may choose a ``discussion based exercise'' that, as defined 
by HSEEP, would include a tabletop exercise or workshop.
    Response: We appreciate the feedback and want to ensure that the 
language used in our regulations and the intent behind our regulations 
are as clear as possible. As indicated in the proposed rule and as well 
in the 2016 Emergency Preparedness final rule (81 FR 63860), we have 
attempted to align our terminology with that used by HSEEP. We note 
that functional exercise and full-scale exercise are specific testing 
exercise types as defined by HSEEP. Furthermore, in the proposed rule 
(83 FR 47714) we provided definitions for both functional and full-
scale exercises, as defined by HSEEP. Therefore, we disagree with the 
commenters who suggested that we have not aligned our proposal with the 
guiding principles of HSEEP.
    It is our intent that providers and suppliers make an attempt to 
conduct a full-scale exercise within their community, while 
understanding that this may not always be feasible. Therefore, we 
provide that when a full-scale exercise is not available, facilities 
must conduct a functional exercise at the individual facility level in 
order to satisfy our requirement. The commenter's suggestion to broaden 
the language to ``operations-based exercise'' would mean that a drill 
could also satisfy our requirement, and that is not our intention. We 
specifically refer to a full-scale exercise and functional exercise 
because those are the two testing exercises that would satisfy the 
requirement. We encourage readers to refer to the proposed rule (83 FR 
47714) and the HSEEP guidelines located at https://preptoolkit.fema.gov/documents/1269813/1269861/HSEEP_Revision_Apr13_Final.pdf/65bc7843-1d10-47b7-bc0d-45118a4d21da for 
additional details regarding the definition of these types of 
exercises.
    While we have not made any modifications to the terminology used to 
highlight the testing types, we have reviewed the regulatory text for 
opportunities to improve readability and have made minor revisions to 
the regulatory language in hopes of providing clarity about what is 
required.
    Final Rule Action:
     We are not finalizing our proposal to require biennial 
updates to the emergency preparedness program for LTC facilities only. 
All other affected providers are required to update the emergency 
preparedness program biennially.
     We are finalizing our proposal to eliminate the 
requirement that facilities document efforts to contact local, tribal, 
regional, State, and Federal emergency preparedness officials and 
facilities' participation in collaborative and cooperative planning 
efforts.
     We are not finalizing our proposal to require biennial 
emergency preparedness training for LTC facilities only. All other 
affected providers are required to provide emergency preparedness 
training biennially.
     We are finalizing our proposal to require inpatient 
providers to conduct two testing exercises annually and outpatient 
providers to conduct one testing exercise annually with only minor 
modification to improve the readability and clarity of the requirement.
    Contact: Kristin Shifflett, 410-786-4133, Ronisha Blackstone, 410-
786-6882.
13. Technical Corrections
    In response to public comments, we are revising that language used 
to reference doctors of dental surgery that appear in the regulatory 
text for hospitals. The hospital CoPs reference these physicians in the 
Medical Staff CoP (Sec. Sec.  482.22(c)(5)(1) and 482.22(c)(6)) as 
oromaxillofacial surgeons. The accurate and current terminology to use 
for these physicians is oral and maxillofacial surgeons. We are 
revising the regulatory text for these provisions.
    Although we did not propose this in the proposed rule, in response 
to public comments regarding home health aide competency training, we 
are revising the language used to describe the process for conducting 
home health aide competency evaluations to restore longstanding 
official CMS policy. In the July 18, 1991 (56 FR 32967) final rule, 
``Medicare Program; Home Health Agencies: Conditions of 
Participation,'' issued by CMS, we explicitly permitted the use of 
pseudo-patients and laboratory environments for purposes of home health 
aide competence evaluations, even though the regulatory text did not 
specifically mention ``pseudo-patients.'' We stated, ``[W]e believe 
that it is acceptable to conduct aide training with a mannequin and to 
conduct competency evaluations in a laboratory setting using `pseudo 
patients' such as another aide or volunteer. We do not believe it is 
necessary to revise the regulations to clarify this point.'' (56 FR 
32972). We agree with commenters that it is necessary to make a 
technical correction to the HHA CoPs as finalized on January 13, 2017 
(82 FR 4584) to explicitly permit the use of pseudo-patients for 
purposes of home health aide competency evaluations in order to assure 
that the home health agency regulations and Interpretive Guidelines are 
consistent with the policy originally set forth in 1991.
    This technical correction restores longstanding CMS policy, as 
stated in the 1991 rule, that permitted the use of pseudo-patients, and 
is consistent with the original intent of the January 2017 HHA CoPs 
final rule. We are making conforming changes to the definitions section 
of the HHA CoPs at Sec.  484.2 to define the terms ``pseudo-patient'' 
and ``simulation'' as follows:
     ``Pseudo patient means a person trained to participate in 
a role-play situation, or a computer-based mannequin device. A pseudo-
patient must be capable of responding to and interacting with the home 
health aide trainee, and must demonstrate the general characteristic to 
the primary patient population served by the HHA in key areas such as 
age, frailty, functional status, and cognitive status.''
     ``Simulation means a training and assessment technique 
that mimics the reality of the homecare environment, including 
environmental distractions and constraints that evoke or replicate 
substantial aspects of the real world in a fully interactive fashion, 
in order to teach and assess proficiency in performing skills, and to 
promote decision making and critical thinking.''
    Because this is a clarification of an already-existing rule to 
codify longstanding policy, we do not believe that notice and comment 
rulemaking is necessary; we are therefore waiving notice and comment as 
indicated in Section I.C.14 below.
General Comments
    Comment: We received many comments regarding issues that are out of 
scope of this rule, such as payment and reimbursement, Medicare 
advantage, prior authorization, physical therapy requirements and more. 
Some of these issues were for specific providers or suppliers and some 
were blanket comments.
    Response: We have read and received all of the comments that are 
out of the scope of this rule. We will not be addressing them in this 
rule; however, we will consider them for future rulemaking.
14. Waiver of Proposed Rulemaking
    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule. The 
notice of proposed rulemaking includes a reference to the legal 
authority under which the rule is proposed, and the terms and 
substances of the proposed

[[Page 51759]]

rule or a description of the subjects and issues involved. This 
procedure can be waived, however, if an agency finds good cause that a 
notice-and-comment procedure is impracticable, unnecessary, or contrary 
to the public interest and incorporates a statement of the finding and 
its reasons in the rule issued.
    A notice-and-comment rulemaking procedure is unnecessary for the 
change related to adding the phrase ``or with a pseudo-patient as part 
of a simulation'' to the HHA aide competency evaluation requirement at 
Sec.  484.80(c)(1) because this regulatory revision simply restores 
official CMS policy as stated in rulemaking dating back to 1991, and 
does not constitute a change in CMS policy. We are adding conforming 
changes to the definitions section at Sec.  484.2 for the terms 
``pseudo-patient'' and ``simulation.'' These changes are technical in 
nature. These changes to restore longstanding CMS policies are in the 
public interest, in order to assure that HHAs are adequately staffed 
with aides that have proven their competency to serve HHA patients. 
Home health aides may not provide services to patients until they have 
demonstrated their skill competencies. Allowing HHAs to use pseudo-
patients as part of a simulation in order to demonstrate skill 
competencies facilitates timely placement of properly trained and 
evaluated aides in patient homes to provide much needed services in 
accordance with each patient's individualized plan of care. In the 
absence of this regulatory change to conform to longstanding CMS 
policy, in a survey conducted by the National Home Care Association 45 
percent of responding HHAs reported being unable to provide full 
competency examinations for newly hired home health aides, creating a 
delay in delivering physician-ordered aide services to HHA patients. 
This delay in direct patient care services may be harmful to patients, 
and the technical change will resolve the underlying aide competency 
evaluation backlog problem that is creating the delay.
    Therefore, we find good cause to waive the notice of proposed 
rulemaking and to issue these provisions on an interim basis. We are 
providing a 60-day public comment period.

C. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we 
solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We solicited public comment on each of the section 3506(c)(2)(A)-
required issues for the following information collection requirements 
(ICRs).
1. Wage Costs
    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2017 National Occupational Employment and Wage 
Estimates for all salary estimates (https://www.bls.gov/oes/2017/may/oes_nat.htm). In this regard, the following table presents the mean 
hourly wage, the cost of fringe benefits and overhead costs (calculated 
at 100 percent of salary), and the adjusted hourly wage cost.

                          Table 2--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                    Occupation      Mean hourly    Benefits and      Adjusted
                Occupation title                       code        wage ($/hour)   overhead cost    hourly wage
                                                                                     ($/hour)      cost ($/hour)
----------------------------------------------------------------------------------------------------------------
Healthcare Support Worker.......................         31-9099          $18.56          $18.56             $37
Physicians and Surgeons.........................         29-1060          103.22          103.22             206
Physicians and Surgeons, All Other..............         29-1069          101.63          101.63             203
Physicians, Psychiatrists.......................         29-1066          103.89          103.89             208
Surgeons........................................         29-1067          121.10          121.10             242
Registered Nurse--(RN-Quality Improvement, Home          29-1141           35.36           35.36              71
 Care Coordinator, HealthCare Trainer, Quality
 Assurance Nurse, QAPI Nurse Coordinator,
 Infection Control Nurse Coordinator,
 Psychiatric RN)................................
Medical Secretary (Clerical, Administrative              43-6013           17.25           17.25              35
 Assistant).....................................
Administrative Services Manager (Facility                11-3011           49.70           49.70              99
 Director)......................................
Management Occupations (Director, Community              11-0000           57.65           57.65             115
 Relations Manager, Administrator)..............
Pharmacist......................................         29-1051           58.52           58.52             117
Medical and Health Services Manager                      11-9111           53.69           53.69             107
 (Administrator, Transplant Program Senior
 Administrator/Hospital Administrator/Medical
 and Health Services Managers, Program Director,
 Risk Management Director. QAPI Director, Organ
 Procurement Coordinator, Nurse manager,
 Director of Nursing, Nursing care facilities/
 skilled nursing facilities)....................
Managers, All Others (Administrator)............         11-9199           54.41           54.41             109
*Activities Specialist (Recreational Therapists,         29-1125           20.64           20.64              41
 Nursing Care Facilities/SNFs)..................
Internists (Medical Director, General Physician)         29-1063           95.37           95.37             191
Family and General Practitioner (Medical                 29-1062          100.27          100.27             201
 Director)......................................
Physical Therapist (Director of Rehab)..........         29-1123           42.34           42.34              85
Healthcare Social Worker (Social Worker)........         21-1022           27.31           27.31              55
Mental Health and Substance Abuse Social Worker          21-1023           22.99           22.99              46
 (Social Worker)................................
Nurse Practitioner (Clinician, Nurse                     29-1171           51.68           51.68             103
 Practitioner Outpatient Care Center)...........
Mental Health Counselor.........................         21-1018           22.38           22.38              45
Physician Assistant.............................         29-1071           50.37           50.37             101

[[Page 51760]]

 
Licensed Practical and Licensed Vocational               29-2061           21.98           21.98              44
 Nurses (Director of Nursing)...................
First Line Supervisors of Office and                     43-1011           28.14           28.14              56
 Administrative Support Workers (Office Manager)
Office Clerks, General (Clerical staff).........         43-9061           16.30           16.30              33
Secretaries and Administrative Assistants                43-6010           19.74           19.74              39
 (Clerical staff)...............................
Chief Executive.................................         11-1011           94.25           94.25             189
----------------------------------------------------------------------------------------------------------------
* Salary information used is for Nursing Care Facility/SNF industry.

2. ICRs Regarding RNHCI Discharge Planning (Sec.  403.736(a) and (b))
    It was discovered during review that the burden for existing 
requirements at 42 CFR 403.724(a), 403.730(a), 403.732, 403.736(a)(b), 
and 403.736(d) was erroneously not accounted for nor approved under the 
PRA prior to this rulemaking. Accordingly, the burden associated with 
these requirements is currently pending OMB approval (OMB control 
number 0938-NEW). Section 403.736 will reduce the extensive 
requirements for an RNHCI to coordinate with other medical providers 
for post-RNHCI care. Based on recent claims data, there was a combined 
annual total of 619 beneficiaries that stayed in the 18 facilities.
    We estimate that the time currently required to develop and 
document discharge plans and activities is 1,238 burden hours (2 hours 
for each of the 619 beneficiaries discharged) and that it would be 
reduced by half. Of the approximately 619 annual discharges, we 
estimate that a RNHCIs burden would be reduced to one hour for each 
discharged individual. A RNHCI would not need to develop a discharge 
plan that includes medical care once a patient leaves the RNHCI because 
doing so would not be in keeping with the religious tenets of the 
patients they serve. We estimate that the healthcare support worker 
responsible for a patients discharge plan costs $37 an hour, including 
hourly wage and an estimated 100 percent add-on for fringe benefit 
costs and overhead costs (this is an HHS standard calculation). Based 
on our experience with RNHCIs, we estimate that it would take 1 hour to 
develop the proposed discharge instructions and discuss them with the 
patient or caregiver. We estimate a total of 619 annual discharges from 
RNHCIs at a savings of $37 per discharge for a total savings of $22,903 
($37 x 619 hours).
3. ICRs Regarding ASC Governing Body and Management (Sec.  
416.41(b)(3)(i) and (ii))
    We are finalizing our proposal with changes to eliminate the 
requirements at Sec.  416.41(b)(3) that states the ASC must have a 
written transfer agreement with a hospital or ensure all physicians 
performing surgery in the ASC have admitting privileges at a local 
hospital that meets CMS hospitalization requirements. However, we will 
require that the ASCs have a notice requirement with hospitals and 
encourage a transfer agreement when possible. All ASCs easily meet this 
requirement and have established a relationship with their local 
hospital and obtained an agreement as usual and customary practice for 
running an ASC, with the exception of approximately twenty ASCs that 
have difficult relationships with their local hospitals. The savings 
would not be significant, however, it does affect the 20 ASCs by 
removing the requirement. The current information collection request 
for the ASC rules (OMB control number 0938-1071) does not address any 
potential burden associated with this requirement. We believe that 
having and maintaining written agreements is standard practice. 
Therefore, removing this requirement would not alter the current 
information collection burden for ASCs.
4. ICR Regarding ASC Medical Records (Sec.  416.47(b)(2))
    We are finalizing our proposal to revise Sec.  416.47(b)(2) by 
adding the phrase ``(as applicable)'' to the significant medical 
history and results of physical examination requirement of documents 
that must be included in the medical record in order to conform to the 
changes that we proposed to the mandatory medical history and physical 
examination requirement. There are no collection of information 
requirements associated with this proposed change because maintaining a 
medical record for each patient is a usual and customary practice in 
accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2).
5. ICRs Regarding ASC Patient Admission, Assessment and Discharge 
(Sec.  416.52(a)(1), (2), (3) and (4))
    At Sec.  416.52 we are finalizing our proposal to replace the 
requirement that every patient have a comprehensive medical history and 
physical examination (H&P) within 30 days prior to surgery in an ASC 
with a requirement that allows the operating physician and ASC to 
determine which patients would require more extensive testing and 
assessment prior to surgery. The burden associated with this 
requirement would be the time and effort necessary to create new 
policies for when, and whether, to require some form of history and 
physical that would require pre-operative examination and testing, and 
on what time schedule. The current information collection request for 
the ASC rules (OMB control number 0938-1071) does not account for any 
information collection related burden associated with the comprehensive 
H&P requirement. We assume that creating these policies (which could 
leave such decisions to the surgeon's discretion in most or all cases) 
would require 10 hours of physician time, 10 hours of RN time, and 10 
hours of clerical time, at the preceding hourly rates, for a total of 
30 hours per facility. This would be a one-time cost of $3,460 per 
facility ([10 x $242] + [10 x $71] + [10 x $33]), and $19.2 million for 
all 5,557 facilities. Therefore, this proposed requirement would 
increase the information collection related burden by $19.2 million and 
166,710 hours (30 hours x 5,557 facilities) on a one-time basis for all 
ASCs.
6. ICRs Regarding Hospice Aide and Homemaker Services (Sec.  418.76)
    At Sec.  418.76(a) we are finalizing our proposal to defer to State 
training and competency requirements, where they exist, for hospice 
aides. The information

[[Page 51761]]

collection request for the hospice requirements (OMB control number 
0938-1067) estimates that a hospice would spend 5 minutes per newly 
hired hospice aide to document verification that an aide meets the 
required training and competency requirements, for a total of 372 
annual burden hours for all hospices at a cost of $11,540. This change 
to the actual training and competency requirements would not alter the 
requirement to document the fact that a hospice aide meets one of the 
training and competency requirements set forth in the rule; therefore 
there would be no change to the existing collection of information 
estimates because the estimates relate to the unchanged documentation 
requirements rather than the actual training and competency 
requirements that would be revised by this change.
7. ICRs Regarding Drugs and Biologicals, Medical Supplies, and Durable 
Medical Equipment (Sec.  418.106(a))
    At Sec.  418.106(a) we are finalizing our proposal to remove the 
requirement that a hospice ensure that the interdisciplinary group 
confers with an individual with education and training in drug 
management as defined in hospice policies and procedures and State law, 
who is an employee of or under contract with the hospice to ensure that 
drugs and biologicals meet each patient's needs. The information 
collection request for the hospice requirements (OMB control number 
0938-1067) states that the burden associated with this requirement is 
the time necessary to document the results of this consultation in each 
patient's clinical record. In the information collection request we 
assumed that an average hospice would confer with a pharmacist, and 
that the pharmacist would document the results of his or her 
consultation. We estimated that it requires 5 minutes to document the 
initial review of a patient's drug and biologicals. Additionally, we 
estimated that it requires 5 minutes of the pharmacist's time to 
document a review of updates to the patient's drug profile. Based on a 
17 day median length of service, we assumed that each patient would 
likely receive one update to their plans of care. At an average hourly 
rate of $117 for a pharmacist, we estimated that it would cost a 
hospice $19.50 per patient ($117 x [5 minutes for initial + 5 minutes 
for 1 update]) and an annual cost of $6,942 ($19.50 x 356 patients). 
The total annual burden hours for all hospices was estimated to be 
264,588 hours (1,587,527 patients x .1666 hour per patient), and the 
total annual burden cost for all hospices (taking into account new wage 
data) is estimated to be $30,956,777 ($19.50 per patient x 1,587,527 
patients). Therefore, removing the requirement that a hospice must 
ensure that the interdisciplinary group confers with an individual with 
education and training in drug management would result in a burden 
reduction of 264,588 hours and $30,956,777.
    The information collection request will be revised and sent to OMB.
H. ICRs Regarding Hospices That Provide Hospice Care to Residents of a 
SNF/NF or ICF/IID (Sec.  418.112(c)(10) and (f))
    At Sec.  418.112(f) we are finalizing a requirement to allow 
hospices and long term care facilities the additional flexibility to 
negotiate the format and schedule for orienting long term care facility 
staff regarding certain hospice-specific information. This change does 
not effect the existing hospice information collection request (OMB 
control number 0938-1067).
9. ICRs Regarding Hospital Quality Assessment and Performance 
Improvement (QAPI) Program (Sec.  482.21)
    We are finalizing the proposed new standard at Sec.  482.21(f), 
``Unified and integrated QAPI program for multi-hospital systems''. We 
would allow that for a hospital that is part of a hospital system 
consisting of two or more separately certified hospitals subject to a 
system governing body legally responsible for the conduct of each 
hospital, the system governing body could elect to have a unified and 
integrated QAPI program for all of its member hospitals after 
determining that such a decision is in accordance with all applicable 
State and local laws.
    As stated in the information collection request for the hospital 
requirements (expired OMB control number 0938-0328), we estimate that 
the burden associated with updating and, in some instances, writing new 
hospital policies directly related to patient care would be an average 
of eight (8) hours annually for each member of hospital staff involved 
in the specific patient care policies addressed.
    Patient care policy development (and revision) by hospital medical 
staff is essential to patient health and safety because it provides the 
framework within which all patient care services are furnished. Thus, 
we have included the involvement of a physician at approximately $1,624 
annually (8 burden hours x $203), a QAPI nurse coordinator at $568 
annually (8 burden hours x $71), and a medical secretary at $280 
annually (8 burden hours x $35).
    We estimate the necessary policy changes needed to comply with the 
requirements proposed in this rule would cost $2,472 per year ($1,624 + 
$568 + $280) for each of the 424 hospital systems that would be 
eligible to do so and that would choose to exercise this option. 
Therefore, the total annual cost for all eligible hospital systems to 
meet these information collection requirements would be approximately 
$1 million.
10. ICRs Regarding Hospital Medical Staff, Medical Records Services, 
and Surgical Services (Sec. Sec.  482.22, 482.24, and 482.51)
    At Sec.  416.52, we are finalizing our proposal to replace the 
requirement that every patient have a comprehensive H&P within 30 days 
prior to surgery in an ASC with a requirement that allows the operating 
physician and ASC to determine which patients would require more 
extensive testing and assessment prior to surgery. As discussed in 
``Provisions of the Proposed Regulations,'' section II.D.2 of the 
proposed rule, there is a similar regulatory requirement for hospital 
outpatient surgery. Based on the substantial similarity between these 
two service settings, we proposed, through the revisions to Sec. Sec.  
482.22, 482.24, and 482.51 discussed in section II.D.2, to provide an 
exception to these requirements for outpatient surgery in hospitals.
    As stated in the information collection request for the hospital 
requirements (expired OMB control number 0938-0328), which is in the 
process of being reinstated, we estimate that the burden associated 
with updating and, in some instances, writing new hospital policies 
directly related to patient care would be an average of eight (8) hours 
annually for each member of hospital staff involved in the specific 
patient care policies addressed.
    Patient care policy development (and revision) by hospital medical 
staff is essential to patient health and safety because it provides the 
framework within which all patient care services are furnished. Thus, 
we have included the involvement of a physician at approximately $1,624 
annually (8 burden hours x $203), a nurse coordinator at $568 annually 
(8 burden hours x $71), and a medical secretary at $280 annually (8 
burden hours x $35).
    We estimate that the necessary policy changes needed to comply with 
the requirements in this rule would cost $2,472 per year ($1,624 + $568 
+ $280) for each of the 4,823 hospitals that might choose to exercise 
this option.

[[Page 51762]]

Therefore, the total annual cost for all hospitals to meet these 
information collection requirements would be approximately $11.9 
million.
11. ICRs Regarding Hospital Medical Staff: Autopsies (Sec.  482.22)(d))
    We are finalizing our proposal to remove the requirement at Sec.  
482.22(d), which states that a hospital's medical staff should attempt 
to secure autopsies in all cases of unusual deaths and of medical-legal 
and educational interest. Hospitals are further required to define a 
mechanism for documenting permission to perform an autopsy, and they 
must have a system for notifying the medical staff, and specifically 
the attending practitioner, when an autopsy is being performed. Since 
more detailed, specific requirements regarding medical-legal 
investigations and autopsies for hospitals are covered by the 
individual State laws in which the hospital is located, there are no 
collection of information requirements associated with this proposed 
change.
12. ICRs Regarding Hospital Infection Control (Sec.  482.42)
    We are finalizing the proposed new standard at Sec.  482.42(d), 
``Unified and integrated infection control program for multi-hospital 
systems.'' Like the proposed requirements for a unified and integrated 
QAPI program, the proposed standard for infection control would allow 
that for a hospital that is part of a hospital system consisting of 
multiple separately certified hospitals subject to a system governing 
body legally responsible for the conduct of each hospital, such system 
governing body could elect to have a unified and integrated infection 
control program for all of its member hospitals after determining that 
such a decision was in accordance with all applicable State and local 
laws.
    As stated in the information collection request for the hospital 
requirements (OMB control number 0938-0328), which is in the process of 
being reinstated, we estimate that the burden associated with updating 
and, in some instances, writing new hospital policies directly related 
to patient care would be an average of eight (8) hours annually for 
each member of hospital staff involved in the specific patient care 
policies addressed.
    Patient care policy development (and revision) by hospital medical 
staff is essential to patient health and safety because it provides the 
framework within which all patient care services are furnished. Thus, 
we have included the involvement of a physician at approximately $1,624 
annually (8 burden hours x $203), an infection control nurse 
coordinator at $568 annually (8 burden hours x $71), and a medical 
secretary at $280 annually (8 burden hours x $35).
    We estimate the necessary policy changes needed to comply with the 
requirements proposed in this rule would cost $2,472 per year ($1,624 + 
$568 + $280) for each of the 424 hospital systems that would be 
eligible to do so and that would elect to exercise this option. 
Therefore, the total annual cost for all eligible hospital systems to 
meet these information collection requirements would be approximately 
$1 million.
13. ICRs Regarding Special Requirements for Hospital Providers of Long-
Term Care Services (``Swing-Beds'') (Sec.  482.58(b)(1), (4), (5), and 
(8), and Parallel CAH Requirements: Sec.  485.645(d)(1), (4), (5), and 
(8))
    At Sec. Sec.  482.58(b)(1) and 485.645(d)(1) (cross-referenced 
long-term care requirement at Sec.  483.10(f)(9)) we are finalizing our 
proposal to remove the requirement for hospital and CAH swing-bed 
providers to provide the right for patients to choose to or refuse to 
perform services for the facility and if they so choose; (a) document 
in the resident's plan of care, (b) noting whether the services are 
voluntary or paid and (c) provide wages for the work being performed 
given the location quality, and quantity of work requiring comparable 
skills.
    We assume that each of the hospital swing-bed providers (478 
hospitals) and CAH swing-bed providers (1,246 CAHs) has an activities 
specialist employed at $41 per hour who would oversee the residents who 
have chosen to perform services for the facility, and document and 
update the plan of care accordingly. We believe that given the limited 
budget of most rural providers, services are being provided to the CAH 
on a voluntary basis and that these providers are not compensating 
patients for providing these services. The current regulatory burden 
for compliance with this requirement is approximately $29.4 million for 
all hospital and CAH swing-bed providers, or $17,056 per hospital or 
CAH swing-bed provider (1,724 hospital and CAH swing-bed providers x 
$41 an hour for an activities specialist x 8 hours per week x 52 weeks 
per year), which are the cost savings to the providers as a result of 
the removal of this requirement.
    At Sec.  482.58(b)(4) (and Sec.  485.645(d)(4)) (cross-referenced 
long-term care requirement at Sec.  483.24(c)), we are finalizing our 
proposal to remove the requirement for hospital and CAH swing-bed 
providers to provide an ongoing activity program that is directed by a 
qualified therapeutic recreation specialist or an activities 
professional who meets certain requirements as listed at Sec.  
483.24(c)(2). We assume that each of the hospital swing-bed providers 
(478 hospitals) and CAH swing-bed providers (1,246 CAHs) has an 
activities specialist employed at least part time at $41 per hour. The 
current regulatory burden for compliance with this requirement is based 
on the activities specialist organizing, overseeing, and scheduling the 
activity. The cost savings as a result of the removal of this 
requirement are approximately $73.5 million for all hospital and CAH 
swing-bed providers, or $42,640 per hospital or CAH swing-bed provider 
(1,724 hospital and CAH swing-bed providers x $41 an hour for an 
activities specialist x 1,040 hours per year) which are the cost 
savings to the providers.
    We are finalizing our proposal to remove the requirement at 
Sec. Sec.  482.58(b)(5) and 485.645(d)(5) (cross-referenced long-term 
care requirement at Sec.  483.70(p) for hospital and CAH swing-bed 
providers to employ a qualified social worker on a full-time basis if 
the facility has more than 120 beds. Given that this provision is not 
applicable to either provider type due to the regulatory requirements 
for each, it does not impose a burden upon hospitals and as such, its 
removal would not result in a savings of economic burden hours or 
dollars.
    At Sec. Sec.  482.58(b)(8) and 485.645(d)(8) (cross-referenced 
long-term care requirement at Sec.  483.55(a)(1)) we are finalizing our 
proposal to remove the requirement for hospital and CAH swing-bed 
providers to assist in obtaining routine and 24-hour emergency dental 
care to its residents.
    Under the current CoPs, hospitals and CAHs are currently required 
to address the emergent dental care needs of their patients at Sec.  
482.12(f)(2) for hospitals, and at Sec.  485.618 (emergency services) 
for CAHs. As a result, we have calculated the burden associated with 
the provision of routine dental care for hospital and swing-bed 
patients. The American Dental Association recommends annual dental 
checkups for routine dental care for adults over 60 years of age. With 
an average length of stay in a hospital or CAH swing-bed of 1-2 weeks 
and an average daily census of 2 patients, we assume that 1 patient 
receiving swing-bed services will require routine dental services per 
month. While a dentist and dental hygienist provide the dental 
services, Medicare is billed for the provision of these services. The 
costs to the provider

[[Page 51763]]

are related to the nursing activities associated with the patient 
receiving the dental services. The current regulatory burden for 
compliance with this requirement is approximately $2.9 million for all 
hospital and CAH swing-bed providers, or $1,704 per hospital or CAH 
swing-bed provider (1,724 hospital and CAH swing-bed providers x $71 an 
hour for a RN x 24 hours per year), which are the cost savings to the 
providers as a result of the removal of this requirement. The 
information collection requests will be revised and sent to OMB for 
approval (OMB control number 0938-0328 for hospitals and 0938-1043 for 
CAHs).
14. ICRs Regarding Special Requirements for Psychiatric Hospitals 
(Sec.  482.61(d))
    At Sec.  482.61(d) we are finalizing our proposal to clarify the 
requirement allowing non-physician practitioners to document progress 
notes in accordance with State laws and scope of practice requirements. 
In accordance with the information collection request for the hospital 
requirements, which includes the special requirements for psychiatric 
hospitals (OMB control number 0938-0328), no burden is associated with 
recordkeeping, as the documentation and maintenance of medical records 
is usual and customary. However, since we believe that clarification of 
the intent of the regulation is necessary and will result in non-
physician practitioners (specifically physician assistants, nurse 
practitioners, psychologists, and clinical nurse specialists) 
documenting in the progress notes for patients receiving services in 
psychiatric hospitals, we have calculated savings for this provision in 
the RIA which are essentially identical to those we would estimate 
under the PRA.
15. ICRs Regarding Special Requirement for Transplant Centers and 
Definitions (Sec. Sec.  482.68 and 482.70)
    We are finalizing the proposed nomenclature change at part 482 and 
the transplant center regulations at Sec. Sec.  482.68, 482.70, 482.72 
through 482.104, and at Sec.  488.61. Because this change would update 
the terminology used in the regulations to conform to the terminology 
that is widely used and understood within the transplant community, 
there are no collection of information requirements associated with 
this proposal.
16. ICRs Regarding Data Submission, Clinical Experience, and Outcome 
Requirements for Re-Approval of Transplant Centers (Sec.  482.82)
    Section 482.82 requires that, except as specified in Sec.  488.61, 
transplant centers must meet all the data submission, clinical 
experience, and outcome requirements to be re-approved for Medicare 
participation. Section 482.82(a) requires that no later than 90 days 
after the due date established by the OPTN, a transplant center must 
submit to the OPTN at least 95 percent of the required data submissions 
on all transplants (deceased and living donors) it has performed over 
the 3 year approval period. Furthermore, Sec.  482.82(b) requires 
transplant centers to perform an average of 10 transplants per year 
during the prior 3 years and Sec.  482.82(c) requires transplant 
centers to meet the outcome requirements for Medicare re-approval. The 
burden associated with this requirement would be the time it would take 
a transplant program to submit the required information (OMB control 
number 0938-1069). However, as required by Sec. Sec.  482.72 and 
482.45(b), a hospital in which a transplant program is located, must 
belong to the OPTN, and the OPTN requires that these hospitals submit 
this data to the OPTN. Therefore, we believe that the requirements 
under Sec.  482.82 do not impose an additional burden on transplant 
programs because all Medicare participating transplant programs are 
already submitting this information to the OPTN. Removing these 
requirements will have no effect on the collection of information 
burden on transplant programs.
17. ICRs Regarding Special Procedures for Approval and Re-Approval of 
Organ Transplant Centers (Sec.  488.61(f) Through (h))
    Section 488.61(f) through (h) sets out the process for our 
consideration of a transplant center's mitigating factors in initial 
approval and re-approval surveys, certifications, and enforcement 
actions for transplant centers. The provisions also set out definitions 
and rules for transplant systems improvement agreements. We are 
finalizing our proposal to remove the requirements at Sec.  488.61(f) 
through (h) for mitigating factors and transplant systems improvement 
agreements for the re-approval process for transplant centers. This 
change is complementary to the removal of Sec.  482.82, described 
previously. The information collection request (OMB control number 
0938-1069) does not account for any information collection related 
burden associated with the requirements in Sec.  488.61(f) through (h) 
for the re-approval process. Therefore, we estimate that the 
requirements under Sec.  488.61(f) would require a transplant program 
to write and submit the initial formal notice of the program's intent 
to seek mitigating factors re-approval, and write and submit a request 
for consideration of mitigating factors (which would include all of the 
content listed in Sec.  488.61(f)(2)). We estimate that this would take 
a medical director, a transplant center senior administrator, and a 
hospital administrator approximately 5 hours, or 2 hours for the 
medical director and the transplant program senior administrator and 1 
hour for the hospital administrator, to complete and submit these 
mitigating factors for re-approval, as described in Table 3.

   Table 3--Annual Burden Hours and Cost for Transplant Programs To Submit Mitigating Factors for Re-Approval
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                            Position                                  Hourly      Hours required     estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................            $191               2            $382
Transplant Program Senior Administrator.........................             107               2             214
Hospital Administrator..........................................             107               1             107
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Totals......................................................  ..............               5             703
----------------------------------------------------------------------------------------------------------------

    In total, we estimate that an average of 14 programs would submit 
mitigating factors annually. Thus, for those 14 programs we estimate 
that it would require 70 burden hours (5 burden hours x 14 programs) at 
a cost of $9,842

[[Page 51764]]

($703 x 14 programs). Removing this requirement would yield an 
estimated savings to transplant programs of 5 burden hours each and a 
total of 70 burden hours for all 14 programs, with a total cost savings 
of $9,842.
    In addition, we estimate that the transplant hospital in 
conjunction with the transplant program that is located in the 
hospital, would submit mitigating factors and then would also enter 
into systems improvement agreements, as described under Sec.  488.61(h) 
annually. This would require the hospital to enter into a binding 
agreement with CMS to allow the program additional time to achieve 
compliance with the CoPs. We estimate that this would take a medical 
director, a transplant program senior administrator, a hospital 
administrator, and an administrative assistant approximately 14 hours, 
or 4 hours for the medical director, transplant program senior 
administrator, and an administrative assistant, and 2 hours for the 
hospital administrator to complete these activities (including 
notifying patients about the degree of noncompliance by mail and 
organizing and completing the other tasks listed in Sec.  488.61(h)(1) 
as required by the terms in the systems improvement agreement), as 
described in Table 4.

 Table 4--Annual Burden Hours and Cost for Transplant Programs To Enter Into a Systems Improvement Agreement for
                                                   Re-Approval
----------------------------------------------------------------------------------------------------------------
                                                                                                    Total cost
                            Position                                  Hourly      Hours required     estimate
----------------------------------------------------------------------------------------------------------------
Medical Director................................................            $191               4            $764
Transplant Program Senior Administrator.........................             107               4             428
Hospital Administrator..........................................             107               2             214
Administrative Assistant........................................              35               4             140
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Totals......................................................  ..............              14           1,546
----------------------------------------------------------------------------------------------------------------

    In total, we estimate that an average of 14 programs will submit 
mitigating factors annually. Thus, for those 14 programs we estimate 
that it would require 196 burden hours (14 burden hours x 14 programs) 
at a cost of $21,644 ($1,546 x 14 transplant programs). In the context 
of the proposed rule, removing this requirement would yield an 
estimated savings to transplant programs of 14 burden hours each and a 
total of 196 burden hours for all 14 programs, with a total cost 
savings of $21,644.
18. ICRs Regarding HHA Home Health Aide Services (Sec.  484.80(h)(3))
    We are finalizing the proposal to eliminate the requirement at 
Sec.  484.80(h)(3) that the HHA conduct a full competency evaluation of 
deficient home health aides, and replace it with a requirement to 
retrain the aide regarding the identified deficient skill(s) and 
require the aide to complete a competency evaluation related only to 
those skills. We are also finalizing a change to permit HHAs to use 
either patients or pseudo-patients when conducting competency 
evaluations for home health aides. The content of an aide competency 
examination and whether patients or pseudo-patients are used in the 
process do not have an associated collection of information 
requirement. Therefore, this proposed change would neither impose nor 
remove any collection of information burdens.
19. ICRs Regarding HHA Clinical Records (Sec.  484.110(e))
    As discussed in section I.B.6.c. of this final rule, we are not 
finalizing the proposal to allow HHAs 4 business days to provide 
patients with information from their clinical records upon request. 
Consequently, there are no new information collection requirements.
20. ICRs Regarding CORF Utilization Review Plan (Sec.  485.66)
    We are finalizing the proposal to reduce the required frequency in 
which CORFs would be required to complete a ``utilization review plan'' 
from quarterly to annually. Changing from a quarterly implementation of 
the utilization review plan to an annual implementation would reduce 
the current documentation requirements (OMB control number 0938-1091) 
on CORFs by 75 percent each year. For the purposes of our analysis, we 
estimate that it would take a CORF approximately 8 hours for 
administrative, clinical and clerical staff to review and evaluate the 
necessary and efficient use of services provided by the facility on a 
quarterly basis, for a total of 32 hours per year per CORF and 6,016 
hours for all 188 CORFs. In a 1-year period, we estimate a savings of 
$1,680 per facility ($560 x 3 quarters), and a combined total savings 
of $315,840 for all CORFs ($1,680 x 188 CORFs). We will submit the 
revised information collection request to OMB for approval.

                                  Table 5--CORF--Hourly Costs and Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                   Hourly costs    Burden hours    Cost estimate
                            Position                                 per CORF        per CORF        per CORF
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $107               2            $214
Clerical Staff..................................................              33               2              66
Physical Therapist..............................................              85               2             170
Social Worker...................................................              55               2             110
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................................................  ..............               8             560
----------------------------------------------------------------------------------------------------------------


[[Page 51765]]

21. ICRs Regarding CAH Organizational Structure (Sec.  485.627(b)(1))
    As of 2017, there were approximately 1,353 CAHs that were certified 
by Medicare. We are finalizing our proposal for revision of the CAH 
disclosure requirements imposed on CAHs removes the requirement for 
CAHs to disclose to CMS its owners, or those with a controlling 
interest in the CAH or in any subcontractor in which the CAH directly 
or indirectly has a 5 percent or more ownership interest, in accordance 
with 42 CFR part 420, subpart C (OMB control number 0938-1043). While 
we estimate that these changes occur at 2 CAHs per year on average 
between all 1,353 CAHs, with the vast majority not experiencing any 
such changes throughout the lifetime of the CAH, each CAH is still 
required to review the duplicative documentation. As discussed in our 
rule, Medicare Program; Criteria and Standards for Evaluating Regional 
Durable Medical Equipment, Prosthetics, Orthotics and Supplies 
(DMEPOS); Final Rule and Request for Comments (57 FR 2790, June 18, 
1992), the burden associated with this requirement is 1-hour per 
facility. As a result, this will save all CAHs an estimated $144,771 
and will save each CAH $107 (1-burden hour for an administrator at $107 
per hour x 1,353 CAHs).
22. ICRs Regarding CAH Provision of Services (Sec.  485.635(a)(4))
    Section 485.635(a)(4) requires CAHs to conduct an annual review of 
all its policies and procedures (OMB control number 0938-1043). We are 
finalizing our proposal for revision of the patient care policies 
requirements imposed on CAHs would reduce the frequency that is 
currently required for CAHs to perform a review of all their policies 
and procedures. We anticipate that a change from an annual review to a 
biennial review would reduce the burden on CAHs by half in a given 
period of time. For the purposes of our analysis, we estimate that it 
would take a CAH approximately 16 hours for administrative and clinical 
staff to review and make changes to policies and procedures annually. 
In a 2-year period, we estimate a savings of $1,968 per facility, and a 
combined total savings of $2.7 million for CAHs ($1,968 x 1,353 CAHs), 
or annualized savings of approximately $1.3 million.
    We estimate that the CAH staff time and associated costs would be 
assigned to a biennial review as shown in Table 6.

                                     Table 6--Hourly Costs and Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                    Hourly cost    Burden hours    Cost estimate
                            Position                                  per CAH         per CAH         per CAH
----------------------------------------------------------------------------------------------------------------
Administrator...................................................            $189               4            $756
Clerical staff..................................................              39               3             117
Registered Nurse................................................              71               3             213
Nurse practitioner..............................................             103               3             309
Physician.......................................................             191               3             573
                                                                 -----------------------------------------------
    Totals......................................................  ..............              16           1,968
----------------------------------------------------------------------------------------------------------------

23. ICRs Regarding Special Requirements for CAH Providers of Long-Term 
Care Services (``Swing-Beds'') (Sec.  485.645(d)(1), (4), (5) and (8))
    We have included the discussion of the ICRs regarding special 
requirements for CAH providers of long-term care services in the 
discussion of the ICRs regarding special requirements for hospital 
providers of long-term care services, which can be found in section 
I.C.13 of this rule (ICRs Regarding Special Requirements for Hospital 
Providers of Long-Term Care Services (``Swing Beds'') (Sec.  
482.58(b)(1), (4), (5), and (8), and Parallel CAH requirements: Sec.  
485.645(d)(1), (4), (5), and (8))).
24. ICRs Regarding CMHCs (Sec.  485.914(d))
    Section 485.914(d)(1) requires each CMHC to update each client's 
comprehensive assessment via the CMHC interdisciplinary treatment team, 
in consultation with the client's primary health care provider (if 
any), no less frequently than every 30 days. We are modifying the 
requirement at Sec.  485.914(d) to remove the 30-day assessment update 
timeframe for those clients who do not receive PHP services. Under the 
current 30-day time frame requirement, each client receives an updated 
assessment 12 times per year (OMB control number 0938-1245). We 
estimate that, in accordance with the proposed need-based assessment 
update requirements, each non-PHP client would receive 2 assessment 
updates in a year. Therefore, we estimate that this change would reduce 
the burden of 10 assessments per client, per year.
    As of August 2017 there are 161 Medicare participating CMHCs 
serving 3,122 Medicare beneficiaries and an estimated 2,080 non-
Medicare clients, for an average of 32 clients per CMHC. In order to 
develop the estimated number of non-Medicare clients we divided the 
total number of Medicare beneficiaries who received partial 
hospitalization services by the total number of Medicare-participating 
CMHCs to establish the average number of Medicare beneficiaries per 
CMHC. This resulted in 19 beneficiaries per CMHC. We then assumed that, 
in order to comply with the 40 percent requirement (Sec.  
485.918(b)(1)(v)), those 19 beneficiaries only accounted for 60 percent 
of an average CMHC's total patient population. This means that an 
average CMHC also treated another 13 clients who did not have Medicare 
as a payer source, for a total of 32 clients (Medicare + non-Medicare) 
in an average CMHC. Therefore, all CMHCs combined would have 
approximately 2,093 non-PHP clients per year (13 per CMHC), and 
approximately 20,930 assessments would be reduced nationwide per year 
(2,093 patients x 10 assessments per patient). We estimate that 
documenting each assessment update requires 10 minutes of a CMHC 
clinician's time, for a total savings of 3,487 hours nationwide (0.1666 
hours x 20,930 assessment updates). At a cost of $7.50 for a mental 
health counselor to document each assessment, the total cost savings 
would be $156,975 ($7.50 x 20,930 assessments).
25. ICRs Regarding Portable X-Ray Services (Sec. Sec.  486.104(a) and 
486.106(a))
    We are finalizing our proposal to revise the requirements for 
portable x-ray technologist personnel qualifications at Sec.  486.104 
to align the current requirements at Sec.  486.104(a)(1), (2), (3), and 
(4) with those for hospital radiologic technologists at Sec.  
482.26(c)(2) which are focused on the qualifications of the individual 
performing services as permitted by State law. Although changing the 
qualifications would

[[Page 51766]]

require management time, with the associated cost of those hours, in 
order to revise the internal personnel descriptions and qualifications, 
we believe that this proposed change would impose no burden because 
maintaining internal personnel descriptions and qualifications is a 
standard business practice. Therefore, this burden would not be subject 
to the PRA in accordance with the implementing regulations of the PRA 
at 5 CFR 1320.3(b)(2).
    We are finalizing our proposal to revise the requirements for 
portable x-ray orders at Sec.  486.106(a)(2). We proposed to remove the 
requirement that physician or non-physician practitioner's orders for 
portable x-ray services must be written and signed. We also proposed to 
replace the specific requirements related to the content of each 
portable x-ray order with a cross-reference to the requirements at 42 
CFR 410.32, which also apply to portable x-ray services. These changes 
would simplify the ordering process for portable x-rays and promote the 
use of more efficient ordering methods, such as electronic orders.
    In the information collection request (OMB control number 0938-
0338) we estimate that the current order requirements would impose the 
following burdens:
     3 minutes to write an order x 3,986,000 portable x-rays 
exams ordered = 199,300 hours x $71/hour for a nurse = $14,150,300.
     $1 for printing and faxing verbal orders to physician 
offices for signature x 2,500,000 verbal orders = $2,500,000.
     2,000,000 follow-up calls regarding the status of faxes x 
10 minutes of time for clerical staff (5 minutes for portable x-ray 
clerical staff + 5 minutes for ordering physician clerical staff) = 
333,333 hours x $33/hour = $10,999,989.
    All of these burdens would be eliminated by revising the current 
ordering standards. Therefore, we estimate a proposed information 
collection savings of $27.7 million from this proposed change.
26. ICRs Regarding RHC and FQHC Provision of Services (Sec.  
491.9(b)(4))
    There are currently more than 4,100 RHCs and approximately 1,400 
FQHC organizations furnishing services at approximately 12,000 or more 
total locations. Many FQHC organizations have multiple delivery sites, 
and as of May 2017 there were 4,160 RHC and 7,874 FQHC delivery sites. 
All CMS-certified sites are subject to our requirements and we are 
therefore utilizing the total number of current sites in our burden 
reduction calculations.
    We are finalizing our proposal to revise Sec.  491.9(b)(4) to 
reduce the number of times that RHCs and FQHCs perform a review of all 
their policies and procedures. Changing from an annual review to a 
review every other year would reduce the burden on RHCs and FQHCs by 
half in a given period of time. In the currently approved information 
collection request (OMB control number 0938-0334), we only included 
burden estimates for RHCs. However, we recognize that the information 
collection applies to FQHCs as well. Therefore, we estimate that it 
would take a RHC or FQHC approximately 4 hours for clinical staff to 
review and make changes to policies and procedures annually, for a 
total of 48,136 hours for all 12,034 RHC and FQHC locations. In a 2-
year period, RHCs and FQHCs would use 96,272 total hours to comply with 
the requirements to annually review all of their policies and 
procedures. Under the proposed change to review policies every other 
year, we estimate that in a 2-year period, it will take a total of 
48,136 hours, for a savings of 48,136 hours per year. We estimate a 
savings of $608 per facility (see Table 7) for a combined total savings 
of $7.3 million biennially for 12,034 RHCs or FQHCs ($608 x 12,034 RHCs 
and FQHCs), or annualized savings of half these amounts. We will submit 
a revised information collection request to OMB for approval.

                                     Table 7--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                   Hourly cost per RHC/
                                                   FQHC (includes 100%    Burden hours per    Cost estimate per
                     Position                        for benefits and         RHC/FQHC             RHC/FQHC
                                                        overhead)
----------------------------------------------------------------------------------------------------------------
Physician........................................                 $203                    2                 $406
Mid-Level Provider (PA or NP)....................                  101                    2                  202
                                                  --------------------------------------------------------------
    Total........................................  ...................                    4                  608
----------------------------------------------------------------------------------------------------------------

27. ICRs Regarding RHC and FQHC Program Evaluation (Sec.  491.11(a))
    We are finalizing the proposal to revise Sec.  491.11(a) to reduce 
the number of times that RHCs and FQHCs carry out or arrange for an 
annual evaluation of the total program. Changing from an annual 
evaluation to an evaluation every other year would reduce the burden on 
RHCs and FQHCs by half in a given period of time. In the currently 
approved information collection request (OMB control number 0938-0334), 
we only included burden estimates for RHCs, however we recognize that 
the information collection applies to FQHCs as well. Therefore, we 
estimate that it would take a RHC or FQHC approximately 6 hours for 
administrative and clinical staff to perform an evaluation of its total 
program annually for a total of 72,204 hours for all 12,034 RHC and 
FQHC locations. In a 2-year period, RHCs and FQHCs would use 144,408 
total hours to comply with the requirement for an evaluation of the 
total program. Under the proposed change to evaluate the total program 
every other year, we estimate an hourly savings of 72,204 total hours 
and a cost savings of $822 per facility (see Table 8), for a combined 
total savings of $9.9 million biennially for 12,034 RHCs or FQHCs ($822 
x 12,034 RHC and FQHC locations), or annualized savings of half these 
amounts.

[[Page 51767]]



                                     Table 8--Hourly Wages and Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                   Hourly cost per RHC/
                                                   FQHC (includes 100%    Burden hours per    Cost estimate per
                     Position                        for benefits and         RHC/FQHC             RHC/FQHC
                                                        overhead)
----------------------------------------------------------------------------------------------------------------
Administrator/Health Services Manager............                 $107                    2                 $214
Physician........................................                  203                    2                  406
Mid-Level Provider (PA or NP)....................                  101                    2                  202
                                                  --------------------------------------------------------------
    Total........................................  ...................                    6                  822
----------------------------------------------------------------------------------------------------------------

28. ICRs Regarding Emergency Preparedness for Providers and Suppliers
a. Review of the Emergency Preparedness Program
    At Sec.  482.15(a), (b), (c), and (d) for hospitals and parallel 
regulatory citations for other facilities, we are finalizing our 
proposal to allow providers to review their program at least every 2 
years. However, we are withdrawing the proposal for LTC facilities. As 
of May 2017, there were approximately 72,646 total facilities, or 
56,983 excluding LTC facilities. All are required to review their 
emergency preparedness program annually, which includes a review of 
their emergency plan, policies and procedures, communication plan, and 
training and testing program.
    For our analysis, we estimate that reducing this requirement from 
annually to biennially would reduce compliance costs related to review 
of the emergency plan by 50 percent. The methodology used for our cost 
estimate analysis generally mirrors the methodology used for the annual 
review of the emergency plan Emergency Preparedness final rule (81 FR 
63930) with a 50 percent reduction in the cost estimate calculation; 
however, after receiving additional feedback from stakeholders, we have 
determined that we underestimated the amount of time it would take to 
review the emergency plan. As a result, we have presented current 
burden hours associated with reviewing the emergency plan that reflects 
the increased associated burden hours relative to the information 
collection request for this provision (OMB control number 0938-1325). 
As in the Emergency Preparedness final rule (81 FR 63930), we assume 
that the individuals involved in the review of the emergency plan 
include an administrator, director of nursing, a RN, a physician, a 
social worker, a counselor, and an office manager, depending on the 
facility type. Based on May 2017 BLS salary data, we calculated the 
hourly mean wage for each position for this requirement identified in 
the Emergency Preparedness final rule (81 FR 63930).
    We estimate that the finalized change will accrue total annualized 
cost savings of $69,639,324 and 657,345 burden hours saved, or biennial 
savings of double these amounts. We list a detailed calculation for 
each facility below, based on facility numbers available as of 2017:
     RNHCIs: Combined total savings of $9,684 for 18 RNHCIs ((8 
burden hours for an administrator at $107 plus 5 burden hours for a 
director of nursing at $44 per hour) x 18 RNHCIs x 50 percent).
     ASCs: Combined total savings of $6,257,182 for 5,557 ASCs 
((8 burden hours for an administrator at $109 per hour plus 4 burden 
hours for a physician at $203 per hour plus 8 burden hours for a 
quality improvement RN at $71 per hour) x 5,557 ASCs x 50 percent).
     Hospices: Combined total savings of $5,916,502 for 4,489 
hospice facilities ((8 burden hours for an administrator at an hourly 
wage of $107 per hour plus 4 burden hours for a physician at $203 per 
hour plus 4 burden hours for a counselor at $45 per hour plus 4 burden 
hours for a social worker at $55 per hour plus 8 burden hours for a RN 
at $71 per hour) x 4,489 hospices x 50 percent).
     PRTFs: Combined total savings of $569,976 for 374 PRTFs 
((8 burden hours for an administrator $107 per our plus 8 burden hours 
for a physician at $203 per hour plus 8 burden hours for a RN at $71 
per hour) x 374 PRTFs x 50 percent).
     PACE: Combined total savings of $232,068 for 233 PACE 
organizations ((8 burden hours for an administrator at $107 per hour 
plus 8 burden hours for a home care coordinator at $71 per hour plus 8 
burden hours for a RN at $71 per hour) x 233 PACE organizations x 50 
percent).
     Hospitals: Combined total savings of $11,700,598 for 4,823 
hospitals ((8 burden hours for an administrator at $109 per hour plus 8 
burden hours for a physician at $203 per hour plus 8 burden hours for a 
risk management director at $107 per hour plus 8 burden hours for a 
quality assurance nurse at $71 per hour plus 8 burden hours for a 
facility director at $99 per hour plus 4 burden hours for a medical 
secretary at $35 per hour) x 4,823 hospitals x 50 percent).
     ICF/IID: Combined total savings $3,475,290 for 6,097 ICF/
IIDs ((8 burden hours for an administrator at $107 per hour plus 4 
burden hours for a RN $71 per hour) x 6,097 ICF/IIDs x 50 percent).
     HHA: Combined total savings of $16,512,192 for 12,624 HHAs 
((8 burden hours for an administrator at $107 per hour plus 8 burden 
hours for a nursing director at $107 per hour plus 8 burden hours for a 
director of rehab at $85 per hour plus 4 burden hours for an office 
manager at $56 per hour) x 12,624 HHAs x 50 percent).
     CORF: Combined total savings of $144,384 for 188 CORFs ((8 
burden hours for an administrator at $107 per hour plus 8 burden hours 
for a physical therapist at $85 per hour) x 188 CORFs x 50 percent).
     CAH: Combined total savings of $1,693,956 for 1,353 CAHs 
((8 burden hours for an administrator at $107 per hour plus 8 burden 
hours for a director of nursing at $107 per hour plus 8 burden hours 
for a facility director at $99 per hour) x 1,353 CAHs x 50 percent).
     Organizations: Combined total savings of $1,241,448 for 
2,076 Organizations ((8 burden hours for an administrator at $107 per 
hour plus 4 burden hours for a physical therapist at $85 per hour) x 
2,076 Organizations x 50 percent).
     CMHCs: Combined total savings of $150,052 for 161 CMHCs 
((8 burden hours for an administrator at $107 per hour plus 8 burden 
hours for a RN at $71 per hour plus 8 burden hours for a social worker 
at $55 per hour) x 161 CMHCs x 50 percent).
     OPOs: Combined total savings of $121,568 for 58 OPOs ((8 
burden hours for an OPO director at $107 per hour plus 8 burden hours 
for a physician at $203 per hour plus 8 burden hours for

[[Page 51768]]

a QAPI director at $107 per hour plus 8 burden hours for an organ 
procurement coordinator at $107 per hour) x 58 OPOs x 50 percent).
     RHC/FQHC: Combined total savings of $10,108,560 ((8 burden 
hours for an administrator at $107 per hour plus 8 burden hours for a 
nurse practitioner/physician assistant at $103 per hour) x 4,160 RHCs x 
50 percent) $3,494,400 + ((8 burden hours for an administrator at $107 
per hour plus 8 burden hours for a nurse practitioner/physician 
assistant at $103 per hour x 7,874 FQHCs x 50 percent) $6,614,160).
     ESRD Facilities: Combined total savings of $11,505,864 for 
6,898 dialysis facilities ((8 burden hours for an administrator at $107 
per hour plus 8 burden hour for a medical director/physician at $203 
per hour plus 8 burden hours for a nurse manager at $107) x 6,898 
dialysis facilities x 50 percent) as shown in Table 9.

 Table 9--Cost Savings for Annual Review of Emergency Preparedness Plan
------------------------------------------------------------------------
                                 Cost savings per      Combined total
       Provider/supplier        provider/supplier         savings
------------------------------------------------------------------------
RNHCIs........................               $538  $9,684 for 18 RNHCIs.
ASCs..........................              1,126  $6,257,182 for 5,557
                                                    ASCs.
Hospices......................              1,318  $5,916,502 for 4,489
                                                    hospice facilities
                                                    both inpatient and
                                                    freestanding/home
                                                    based.
PRTFs.........................              1,524  $569,976 for 374
                                                    PRTFs.
PACEs.........................                996  $232,068 for 233
                                                    PACEs.
Hospitals.....................              2,426  $11,700,598 for 4,823
                                                    hospitals.
ICFs/IIDs.....................                570  $3,475,290 for 6,097
                                                    ICF/IIDs.
HHAs..........................              1,308  $16,512,192 for
                                                    12,624 HHAs.
CORFs.........................                768  $144,384 for 188
                                                    CORFs.
CAHs..........................              1,252  $1,693,956 for 1,353
                                                    CAHs.
Organizations.................                598  $1,241,448 for 2,076
                                                    Organizations.
CMHCs.........................                932  $150,052 for 161
                                                    CMHCs.
OPOs..........................              2,096  $121,568 for 58 OPOs.
RHCs/FQHCs....................                840  $10,108,560 for RHCs
                                                    and FQHCs
                                                    ($3,494,400 for
                                                    4,160 RHCs and
                                                    $6,614,160 for 7,874
                                                    FQHCs).
ESRD Facilities...............              1,668  $11,505,864 for 6,898
                                                    dialysis facilities.
------------------------------------------------------------------------

b. Contents of the Emergency Plan
    At Sec.  482.15(a)(4) for hospitals, and other parallel citations 
for the facilities mentioned in section II.J.2 of the rule, we are 
finalizing our proposal to eliminate the requirement that facilities 
document efforts to contact local, tribal, regional, State, and Federal 
emergency preparedness officials and that facilities document 
participation in collaborative and cooperative planning efforts (OMB 
control number 0938-1325). We estimate that an administrator, or in the 
case of a hospital a community relations manager, a program director 
for a PACE, or a QAPI director for OPOs, would take 1 hour to document 
efforts to contact local, tribal, regional, State and Federal emergency 
preparedness officials and, when applicable, document the facility's 
participation in collaborative and cooperative planning efforts. We 
note that The Joint Commission (TJC)-accredited ASCs, TJC-accredited 
CAHs, and TJC-accredited hospitals have emergency preparedness 
requirements for developing an emergency preparedness plan that are 
comparable to the current emergency preparedness CoPs (81 FR 63937, 
63954, and 63978 through 63979). Utilizing the same assumptions we used 
in the Emergency Preparedness final rule (81 FR 63937, 63954, and 63978 
through 63979), we estimate that cost savings will accumulate from non-
TJC accredited ASC, CAHs, and hospitals, since TJC-accredited ASCs, 
CAHs and hospitals are already required by the TJC to develop emergency 
preparedness plans. As a result, these facilities are excluded from the 
analysis given the requirements of their accreditation organization 
standards. Based on May 2017 BLS salary data, we calculate an hourly 
mean wage of $107 for an administrator, a PACE Program Director, or 
QAPI director and a cost savings of $107 per facility for RNHCIs, non-
TJC accredited ASCs, hospices (both inpatient and freestanding), PRTFs, 
PACEs, LTCFs, ICF/IIDs, HHAs, CORFs, non-TJC accredited CAHs, 
Organizations, CMHCs, OPOs, RHC/FQHCs, and dialysis facilities ($107 
hourly mean wage x 1 burden hour). For non-TJC accredited hospitals, we 
estimate an hourly mean wage of $115 for a community relations manager, 
and a $115 cost per facility ($115 x 1 hour). Therefore, we estimate 
the following for each facility affected by the proposed change, for a 
total savings of $7,316,489 and 68,275 burden hours. We list a summary 
of the calculation for savings accrued by removing this requirement for 
each facility in Table 10, based on facility numbers available as of 
May 2017.

Table 10--Cost Savings: Documentation of the Facility's Participation in
             Collaborative and Cooperative Planning Efforts
------------------------------------------------------------------------
                                 Cost savings per      Combined total
       Provider/supplier        provider/supplier         savings
------------------------------------------------------------------------
RNHCIs........................               $107  $1,926 for 18 RNHCIs.
ASCs (Non-TJC accredited).....                107  $532,325 for 4,975
                                                    non-TJC accredited
                                                    ASCs.
Hospices......................                107  $480,323 for 4,489
                                                    hospice facilities
                                                    both inpatient and
                                                    freestanding/home
                                                    based.
PRTFs.........................                107  $40,018 for 374
                                                    PRTFs.
PACEs.........................                107  $24,931 for 233
                                                    PACEs.
Hospitals (Non-TJC accredited)                115  $159,045 for 1,383
                                                    non-TJC accredited
                                                    hospitals.

[[Page 51769]]

 
LTCFs.........................                107  $1,675,941 for 15,663
                                                    LTCFs.
ICFs/IIDs.....................                107  $652,379 for 6,097
                                                    ICF/IIDs.
HHAs..........................                107  $1,350,768 for 12,624
                                                    HHAs.
CORFs.........................                107  $20,116 for 188
                                                    CORFs.
CAHs (Non-TJC accredited).....                107  $107,428 for 1,004
                                                    non-TJC accredited
                                                    CAHs.
Organizations.................                107  $222,132 for 2,076
                                                    Organizations.
CMHCs.........................                107  $17,227 for 161
                                                    CMHCs.
OPOs..........................                107  $6,206 for 58 OPOs.
RHCs/FQHCs....................                107  $1,287,638 for RHCs
                                                    and FQHCs ($445,120
                                                    for 4,160 RHCs and
                                                    $842,518 for 7,874
                                                    FQHCs).
ESRD Facilities...............                107  $738,086 for 6,898
                                                    dialysis facilities.
------------------------------------------------------------------------

c. Training
    At Sec.  482.15(d)(1)(ii) for hospitals, and other parallel 
citations for other facilities mentioned in section II.J.2 of the rule, 
we are finalizing our proposal to require that facilities provide 
training biennially, or every 2 years, after facilities conduct initial 
training on their emergency program, as well as requiring additional 
training when the emergency plan is significantly updated. However, we 
are withdrawing this proposal for LTC facilities only. We are 
maintaining the requirement that providers and suppliers develop a 
well-organized, effective training program that includes initial 
training for new and existing staff in emergency preparedness policies 
and procedures and would require training when the emergency plan is 
significantly updated. Facilities will have the flexibility to 
determine what is considered a significant update to the emergency 
plan.
    For our analysis, we estimate that reducing this requirement from 
annually to biennially will reduce compliance costs related to 
providing emergency preparedness training by 50 percent (OMB control 
number 0938-1325). The methodology used for our cost estimate analysis 
mirrors the methodology used for the annual training requirement in the 
Emergency Preparedness final rule (81 FR 63930) with a 50 percent 
reduction in the cost estimate calculation. As in the Emergency 
Preparedness final rule (81 FR 63930), we assume that the individuals 
involved in the development and provision of training include an 
administrator, director of nursing, a RN, and an office manager, 
depending on the facility type. Providers and suppliers are expected to 
provide initial training in emergency preparedness policies and 
procedures to all new and existing staff, individuals providing 
services under arrangement, and volunteers, consistent with their 
expected roles, and maintain documentation of the training. Based on 
May 2017 BLS salary data, we calculated the hourly mean wage for each 
position for this requirement identified in the Emergency Preparedness 
final rule (81 FR 63930). We estimate that the proposed change will 
accrue annualized cost savings of $25,593,781 and 288,266 burden hours, 
or biennial savings of double these amounts. We list a detailed 
calculation for each facility below, based on facility numbers 
available as of May 2017 with a summary of these calculations provided 
in Table 11:
     RNHCIs: Combined total savings of $3,906 for 18 RNHCIs ((2 
burden hours for an administrator at $107 plus 5 burden hours for a 
director of nursing at $44 per hour) x 18 RNHCIs x 50 percent).
     ASCs: Combined total savings of $1,289,224 for 5,557 ASCs 
((1 burden hour for an administrator at $109 per hour plus 5 burden 
hours for a quality improvement RN at $71 per hour) x 5,557 ASCs x 50 
percent).
     Hospices: Combined total savings of $956,157 for 4,489 
hospice facilities (6 burden hours for a RN at $71 per hour x 4,489 
hospices x 50 percent).
     PRTFs: Combined total savings of $132,770 for 374 PRTFs 
(10 burden hours for a RN at $71 per hour x 374 PRTFs x 50 percent).
     PACE: Combined total savings of $99,258 for 233 PACE 
organizations (3 burden hours for a home care coordinator at $71 per 
hour plus 9 burden hours for a RN at $71 per hour x 233 PACE 
organizations x 50 percent).
     Hospitals: As we stated in the Emergency Preparedness 
final rule (81 FR 63958), TJC-accredited hospitals are required to 
train their staff for their assigned roles during emergencies (CAMH, 
Standard EC.4.16, Eps 1-2, p. EC-13e). In addition, the TJC-accredited 
hospitals also must provide on-going training to their staff, including 
training on specific job-related safety (CAMH, Standard HR-2.30, EP 4, 
CAMH Refreshed Core, January 2008, p. HR-11), and we expect that 
emergency preparedness is part of such on-going training. As a result, 
we estimate a combined total savings of $2,066,202 for 1,383 non-TJC 
accredited hospitals (2 burden hours for an administrator at $109 per 
hour plus 6 burden hours for a risk management director at $107 per 
hour plus 28 hours for a healthcare trainer (RN) at $71 per hour plus 4 
burden hours for a medical secretary at $35 per hour x 1,383 hospitals 
x 50 percent).
     ICF/IID: Combined total savings $1,734,597 for 6,097 ICF/
IIDs (2 burden hours for an administrator at $107 per hour plus 5 
burden hours for a RN $71 per hour x 6,097 ICF/IIDs x 50 percent).
     HHA: Combined total savings of $8,066,736 for 12,624 HHAs 
(2 burden hours for an administrator at $107 per hour plus 2 burden 
hours for a nursing director at $107 per hour plus 2 burden hours for a 
director of rehab at $85 per hour plus 2 burden hours for an office 
manager at $56 per hour plus 8 burden hours for a director of training 
at $71 x 12,624 HHAs x 50 percent).
     CORF: Combined total savings of $74,260 for 188 CORFs (5 
burden hours for an administrator at $107 per hour plus 3 burden hours 
for a physical therapist at $85 per hour x 188 CORFs x 50 percent).
     CAH: Combined total savings of $997,161 for 1,353 CAHs (2 
burden hours for an administrator at $107 per hour plus 9 burden hours 
for a director of nursing at $107 per hour plus 3 burden hours for a 
facility director at $99 per hour x 1,353 CAHs x 50 percent).
     Organizations: Combined total savings of $842,856 for 
2,076 Organizations (6 burden hours for an administrator at $107 per 
hour plus 2 burden hours for a physical therapist at

[[Page 51770]]

$85 per hour x 2,076 Organizations x 50 percent).
     CMHCs: Combined total savings of $57,155 for 161 CMHCs (10 
burden hours for a psychiatric RN at $71 per hour x 161 CMHCs x 50 
percent).
     OPOs: Combined total savings of $113,448 for 58 OPOs (2 
burden hours for a director at $115 per hour plus 2 burden hours for a 
medical director/physician at $203 per hour plus 12 burden hours for a 
QAPI director at $107 per hour plus 8 hours for an organ procurement 
coordinator at $107 per hour plus 16 burden hours for an education 
coordinator at $71 per hour x 58 OPOs x 50 percent).
     RHC/FQHC: Combined total savings of $6,245,646 ((2 burden 
hours for an administrator at $107 per hour plus 8 burden hours for a 
nurse practitioner/physician assistant at $103 per hour x 4,160 RHCs x 
50 percent) $2,159,040 + (2 burden hours for an administrator at $107 
per hour plus 8 burden hours for a nurse practitioner/physician 
assistant at $103 per hour x 7,874 FQHCs x 50 percent) $4,086,606).
     ESRD Facilities: Combined total savings of $2,914,405 for 
6,898 dialysis facilities (3 burden hours for an administrator at $107 
per hour plus 1 burden hour for a medical director/physician at $203 
per hour plus 3 burden hours for a nurse manager at $107 x 6,898 
dialysis facilities x 50 percent).

                    Table 11--Cost Savings: Training
------------------------------------------------------------------------
                                 Cost savings per
      Provider/ supplier            provider/          Combined total
                                     supplier             savings
------------------------------------------------------------------------
RNHCIs........................               $217  $3,906 for 18 RNHCIs.
ASCs..........................                232  $1,289,224 for 5,557
                                                    ASCs.
Hospices......................                213  $956,157 for 4,489
                                                    hospice facilities
                                                    both inpatient and
                                                    freestanding/home
                                                    based.
PRTFs.........................                355  $132,770 for 374
                                                    PRTFs.
PACEs.........................                426  $99,258 for 233 PACE
                                                    organizations.
Hospitals (Non-TJC accredited)              1,494  $2,066,202 for 1,383
                                                    non-TJC accredited
                                                    hospitals.
ICFs/IIDs.....................                285  $1,734,597 for 6,097
                                                    ICF/IIDs.
HHAs..........................                639  $8,066,736 for 12,624
                                                    HHAs.
CORFs.........................                395  $74,260 for 188
                                                    CORFs.
CAHs..........................                737  $997,161 for 1,353
                                                    CAHs.
Organizations.................                406  $842,856 for 2,076
                                                    Organizations.
CMHCs.........................                355  $57,155 for 161
                                                    CMHCs.
OPOs..........................              1,956  $113,448 for 58 OPOs.
RHCs/FQHCs....................                519  $6,245,646 for RHCs
                                                    and FQHCs
                                                    ($2,159,040 for
                                                    4,160 RHCs and
                                                    $4,086,606 for 7,874
                                                    FQHCs).
ESRD Facilities...............                423  $2,914,405 for 6,898
                                                    dialysis facilities.
------------------------------------------------------------------------

d. Testing
    Finally, at Sec.  482.15(d)(2), we are finalizing our proposal to 
require that providers of inpatient services mentioned in section 
II.J.2 of the rule conduct two testing exercises annually, one of which 
may be an exercise of their choice that must be either a community-
based full-scale exercise (if available), an individual facility-based 
functional exercise, a drill, a tabletop exercise or workshop that 
includes a group discussion led by a facilitator. Given that these 
providers are currently required to conduct two testing exercises 
annually, and because they may choose to conduct the same types of 
testing exercises, we do not anticipate that this requirement will 
impose a burden upon providers of inpatient services and as such, this 
revision will not result in a savings of burden hours or dollars (OMB 
control number 0938-1325).
    We are also finalizing our proposal to require that providers of 
outpatient services mentioned in section II.J.2 of the rule conduct one 
testing exercise annually which must be either a community-based full-
scale exercise (if available) or an individual facility-based 
functional exercise every other year, and in the opposite years, may be 
either a community-based full-scale exercise (if available), a 
facility-based functional exercise, a drill, or a tabletop exercise or 
workshop that includes a group discussion led by a facilitator.
    For our analysis, we estimate that reducing this requirement from 
biannually to annually for outpatient providers will reduce compliance 
costs related to conducting emergency preparedness testing by 50 
percent. The methodology used for our cost estimate analysis mirrors 
the methodology used for the biannual testing requirement in the 
Emergency Preparedness final rule (81 FR 63930) with a 50 percent 
reduction in the cost estimate calculation. As in the Emergency 
Preparedness final rule (81 FR 63930), we will assume that the same 
individuals involved with developing training would typically also 
develop the scenarios, materials, as well as any accompanying 
documentation associated with testing exercises. Based on May 2017 BLS 
salary data, we calculated the hourly mean wage for each position for 
this requirement identified in the Emergency Preparedness final rule 
(81 FR 63930) and decreased the cost by 50 percent due to the 50 
percent reduction in the frequency requirement.
    We estimate that the proposed change will accrue a total annual 
cost savings of $9,296,423 and 100,969 burden hours. We list a detailed 
calculation for each facility below, based on facility numbers 
available as of May 2017 with a summary of these calculations provided 
in Table 12:
     ASCs: Combined total savings of $1,091,951 for 5,557 ASCs 
((1 burden hour for an administrator at $109 per hour plus 4 burden 
hours for a quality improvement RN at $71 per hour) x 5,557 ASCs x 50 
percent).
     Freestanding/home-based hospices: Combined total savings 
of $573,680 for 4,040 hospice facilities (4 burden hours for a RN at 
$71 per hour x 4,040 hospices x 50 percent).
     PACE: Combined total savings of $41,358 for 233 PACE 
organizations (4 burden hours for a home care coordinator at $71 per 
hour plus 1 burden hours for a RN at $71 per hour x 233 PACE 
organizations x 50 percent).
     HHA: Combined total savings of $4,039,680 for 12,624 HHAs 
(1 burden hour for an administrator at $107 per hour plus 3 burden 
hours for a nursing

[[Page 51771]]

director at $107 per hour plus 1 burden hours for a director of rehab 
at $85 per hour plus 1 burden hour for an office manager at $56 per 
hour plus 1 burden hours for a director of training at $71 x 12,624 
HHAs x 50 percent).
     CORF: Combined total savings of $56,212 for 188 CORFs (4 
burden hours for an administrator at $107 per hour plus 2 burden hours 
for a physical therapist at $85 per hour x 188 CORFs x 50 percent).
     Organizations: Combined total savings of $310,362 for 
2,076 organizations (2 burden hours for an administrator at $107 per 
hour plus 1 burden hour for a physical therapist at $85 per hour x 
2,076 organizations x 50 percent).
     CMHCs: Combined total savings of $22,862 for 161 CMHCs (4 
burden hours for a psychiatric RN at $71 per hour x 161 CMHCs x 50 
percent).
     OPOs: Combined total savings of $13,427 for 58 OPOs (3 
burden hours for a QAPI director at $107 per hour plus 2 burden hours 
for an education coordinator at $71 per hour x 58 OPOs x 50 percent).
     RHC/FQHC: Combined total savings of $3,146,891 ((2 burden 
hours for an administrator at $107 per hour plus 3 burden hours for a 
nurse practitioner/physician assistant at $103 per hour x 4,160 RHCs x 
50 percent) $1,087,840 + (2 burden hours for an administrator at $107 
per hour plus 3 burden hours for a nurse practitioner/physician 
assistant at $103 per hour x 7,874 FQHCs x 50 percent) $2,059,051).
     ESRD: As identified in the Emergency Preparedness final 
rule (81 FR 64006), the current CFCs already require dialysis 
facilities to evaluate their emergency preparedness plan at least 
annually (Sec.  494.60(d)(4)(ii)); thus, we expect that all dialysis 
facilities are already conducting some type of tests to evaluate their 
emergency preparedness plans. As a result, Dialysis facilities are not 
included in the burden calculation.

                     Table 12--Cost Savings: Testing
------------------------------------------------------------------------
                                 Cost savings per      Combined total
      Provider/ supplier        provider/supplier         savings
------------------------------------------------------------------------
ASCs..........................               $197  $1,091,951 for 5,557
                                                    ASCs.
Hospices (freestanding/home-                  142  $573,680 for 4,040
 based).                                            hospices.
PACEs.........................                178  $41,358 for 233 PACE
                                                    organizations.
HHAs..........................                320  $4,039,680 for 12,624
                                                    HHAs.
CORFs.........................                299  $56,212 for 188
                                                    CORFs.
Organizations.................                150  $310,362 for 2,076
                                                    Organizations.
CMHCs.........................                142  $22,862 for 161
                                                    CMHCs.
OPOs..........................                232  $13,427 for 58 OPOs.
RHCs/FQHCs....................                262  $3,146,891
                                                    ($1,087,840 for
                                                    4,160 RHCs and
                                                    $2,059,051 for 7,874
                                                    FQHCs).
------------------------------------------------------------------------

    We received few comments specifically addressing our information 
collection cost and burden estimates. Many comments, as previously 
discussed, did address specific regulatory changes and with only a few 
exceptions, mainly related to long term care facilities, endorsed those 
proposals to reduce information collection burdens.
    We will submit a revised information collection request to OMB to 
account for the burden hour and cost savings.

II. Final Rule: Fire Safety Requirements for Certain Dialysis 
Facilities

A. Background

1. Overview
    The Life Safety Code (LSC) is a compilation of fire safety 
requirements for new and existing buildings, and is updated and 
published every 3 years by the National Fire Protection Association 
(NFPA), a private, nonprofit organization dedicated to reducing loss of 
life due to fire. The Medicare and Medicaid regulations have 
historically incorporated these requirements by reference, along with 
Secretarial waiver authority. The statutory basis for incorporating 
NFPA's LSC into the regulations we apply to Medicare and, as 
applicable, Medicaid providers and suppliers is the Secretary of the 
Department of Health and Human Services' (the Secretary) authority to 
stipulate health, safety and other regulations for each type of 
Medicare and (if applicable) Medicaid-participating facility. 
Specifically, section 1881(b)(1)(A) of the Social Security Act (the 
Act) provides for payments for ``providers of services and renal 
dialysis facilities which meet such requirements as the Secretary shall 
by regulation prescribe for institutional dialysis services and 
supplies. . . .'' Under this statutory authority, the Secretary has set 
out ``Conditions for Coverage,'' including LSC compliance requirements, 
at 42 CFR part 494, subpart B. Our current LSC provisions are set out 
at Sec.  494.60(d).
    In implementing the LSC provisions, we have given ourselves the 
discretion to waive specific provisions of the LSC for facilities if 
application of our rules would result in unreasonable hardship for the 
facility, and if the health and safety of its patients would not be 
compromised by such waiver. For dialysis facilities, that authority is 
set out at Sec.  494.60(d)(4). In addition, the Secretary may accept a 
State's fire and safety code instead of the LSC if the Centers for 
Medicare & Medicaid Services (CMS) determines that the protections of 
the State's fire and safety code are equivalent to, or more stringent 
than, the protections offered by the LSC; dialysis facility provisions 
to that effect are set out at Sec.  494.60(d)(3). These flexibilities 
mitigate the potential unnecessary burdens of applying the requirements 
of the LSC to all affected health care facilities.
    On May 12, 2012, we published a final rule in the Federal Register, 
entitled ``Medicare and Medicaid Program; Regulatory Provisions to 
Promote Program Efficiency, Transparency, and Burden Reduction'' (77 FR 
29002). In that final rule, we limited the application of LSC 
requirements to dialysis facilities either located adjacent to 
industrial high hazard areas, and those that did not provide one or 
more exits to the outside at grade level from the patient treatment 
area level. Subsequently, we proposed to update Life Safety Code 
provisions for CMS providers and suppliers, ``Medicare and Medicaid 
Programs; Fire Safety Requirements for Certain Health Care Facilities; 
Proposed Rule'' (79 FR 21552, April 16, 2014). However, we 
inadvertently neglected to include dialysis facilities in this 
proposal. Therefore, we issued a proposal specifically for dialysis 
facilities, ``Medicare and Medicaid Programs; Fire Safety Requirements 
for Certain Dialysis

[[Page 51772]]

Facilities'' (81 FR 76899, November 4, 2016). We are finalizing these 
provisions now, with some modifications to the terms of the LSC to 
address the unique needs of dialysis facilities. The finalized update 
would apply only to dialysis facilities that do not provide one or more 
exits to the outside at grade level from the treatment area level (for 
instance, in upper floors of a mid-rise or high-rise building). We 
would not require other dialysis facilities to comply with NFPA 
99[supreg] 2012 edition of the Health Care Facilities Code (NFPA 99) 
and NFPA 101[supreg] 2012 edition of the Life Safety Code (NFPA 101) 
because we believe that patients in dialysis facilities are generally 
capable of unhooking themselves from dialysis machines and self-
evacuating without additional assistance in the event of an emergency. 
We believe that in all facilities with at-grade exits, patients would 
be able to evacuate the building in a timely fashion. Consequently, we 
believe that state and local requirements are sufficient to protect 
these patients and staff in the event of an emergency. In accordance 
with NFPA 101 sections 20.1.3.7 and 21.1.3.7, we would prohibit 
Medicare-approved dialysis facilities from being located adjacent to 
industrial high hazard facilities. ``Adjacent to'' is defined as 
sharing a wall, ceiling or floor, with a facility.
Defining ``Exit to the Outside at Grade Level From the Patient 
Treatment Area Level''
    The phrase ``exit to the outside at grade level from the patient 
treatment area level'' applies to dialysis facilities that are on the 
ground or grade level of a building where patients do not have to 
traverse up or down stairways within the building to evacuate to the 
outside. Accessibility ramps in the exit area that provide an ease of 
access between the patient treatment level and the outside ground level 
are not considered stairways.
    A dialysis facility which provides one or more exits to the outside 
at grade level from patient treatment level and which has a patient 
exit path to the outside (which may include an accessibility ramp that 
is compliant with NFPA and the Americans with Disabilities Act (ADA)) 
would be exempt from compliance with the applicable provisions of NFPA 
99 and NFPA 101.

B. Provisions of the Proposed Rule and Analysis and Response to Public 
Comments

    On November 4, 2016 we published a proposed rule to update the 
requirements for certain dialysis facilities (81 FR 76899) that do not 
provide one or more exits to the outside at grade level from the 
patient treatment area to comply with the 2012 edition of the NFPA 101 
and NFPA 99.
    We are finalizing those requirements for dialysis facilities that 
do not provide one or more exits to the outside at grade level from the 
patient treatment area level, by incorporating a reference to the 2012 
edition of NFPA 101 and NFPA 99. Certified dialysis facilities without 
one or more exits to the outside at grade level from the patient 
treatment area level are already required to meet the 2000 edition of 
the LSC, while other provider and supplier types are required to comply 
with the 2012 edition of the NFPA 101 and the NFPA 99 (LSC final rule 
published May 4, 2016 at 81 FR 26872).
    The NFPA 101[supreg] 2012 edition of the LSC provides minimum 
requirements, with due regard to function, for the design, operation 
and maintenance of buildings and structures for safety to life from 
fire. Its provisions also aid life safety in similar emergencies.
    The NFPA 99[supreg] 2012 edition of the Health Care Facilities Code 
provides minimum requirements for health care facilities for the 
installation, inspection, testing, maintenance, performance, and safe 
practices for facilities, material, equipment, and appliances.
1. 2012 Edition of the Life Safety Code
    The 2012 edition of the LSC includes new provisions that we believe 
are vital to the health and safety of all patients and staff. Our 
intention is to ensure that patients and staff continue to experience 
the highest degree of fire safety possible. We do review each edition 
of the NFPA 101 and NFPA 99 every 3 years to see if there are any 
significant provisions that we need to adopt. CMS will continue to 
review revisions to ensure we meet proper standards for patient safety. 
We have reviewed the 2015 and 2018 edition of the NFPA 101 and NFPA 99 
and do not believe that there are any significant provisions that need 
to be addressed at this time. Newer buildings are typically built to 
comply with the newer versions of the LSC because state and local 
jurisdictions often adopt and enforce newer versions of the LSC as they 
become available.
    We must emphasize that the LSC is not an accessibility code, and 
compliance with the LSC does not ensure compliance with the 
requirements of the ADA. State and local government programs and 
services, including health care facilities, are required to comply with 
Title II of the ADA. Private entities that operate public 
accommodations such as nursing homes, hospitals, and social service 
center establishments are required to comply with Title III of the ADA. 
Entities that receive federal financial assistance from the Department 
of Health and Human Services, including Medicare and Medicaid, are also 
required to comply with section 504 of the Rehabilitation Act of 1973. 
The same accessibility standards apply regardless of whether health 
care facilities are covered under Title II or Title III of the ADA or 
section 504 of the Rehabilitation Act of 1973.\1\ For more information 
about the ADA's requirements, see the Department of Justice's website 
at http://www.ada.gov or call 1-800-514-0301 (voice) or 1-800-514-0383 
(TTY).
---------------------------------------------------------------------------

    \1\ Facilities newly constructed or altered after March 15, 2012 
must comply with the 2010 Standards for Accessible Design (2010 
Standards). Facilities newly constructed or altered between 
September 15, 2010 and March 15, 2012 had the option of complying 
with either the 1991 Standards for Accessible Design (1991 
Standards) or the 2010 Standards. Facilities newly constructed 
between January 26, 1993 and September 15, 2010, or altered between 
January 26, 1992 and September 15, 2010 were required to comply with 
the 1991 Standards under Title III and either the 1991 Standards or 
the Uniform Federal Accessibility Standards under Title II.
---------------------------------------------------------------------------

2. Incorporation by Reference
    This final rule will incorporate by reference the NFPA 101[supreg] 
2012 edition of the LSC, issued August 11, 2011, and Tentative Interim 
Amendments (TIAs) issued prior to April 16, 2014; and the NFPA 
99[supreg]2012 edition of the Health Care Facilities Code, issued 
August 11, 2011, and TIAs issued prior to April 16, 2014 in Sec.  
494.60(f).
    (1) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011;
    (i) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ii) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (iii) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (iv) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (2) NFPA 99, Standards for Health Care Facilities Code of the 
National Fire Protection Association 99, 2012 edition, issued August 
11, 2011.
    (i) TIA 12-2 to NFPA 99, issued August 11, 2011.
    (ii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iii) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (iv) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (v) TIA 12-6 to NFPA 99, issued March 3, 2014.
    These materials have been previously incorporated by reference for 
other

[[Page 51773]]

provider and supplier types by the final rule, ``Medicare and Medicaid 
Programs; Fire Safety Requirements for Certain Health Care Facilities'' 
published on May 4, 2016 (81 FR 26872).
    The materials that are incorporated by reference can be found for 
interested parties and are available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD 
21244, or from the National Fire Protection Association, 1 Batterymarch 
Park, Quincy, MA 02269. If any changes to these editions of the Codes 
are incorporated by reference, CMS will publish a document in the 
Federal Register to announce those changes.
    The 2012 edition of the NFPA 101 (including the TIAs) provides 
minimum requirements, with due regard to function, for the design, 
operation and maintenance of buildings and structures for safety to 
life from fire. Its provisions also aid life safety in similar 
emergencies.
    The 2012 edition of the NFPA 99 (including the TIAs) provides 
minimum requirements for health care facilities for the installation, 
inspection, testing, maintenance, performance, and safe practices for 
facilities, material, equipment, and appliances, including other 
hazards associated with the primary hazards.
3. Ambulatory Health Care Occupancies
    According to our memorandum, ``Survey & Certification: 13-47-LSC/
ESRD,'' issued July 12, 2013, dialysis facilities that are subject to 
the LSC provisions must meet the requirements of the Ambulatory Health 
Care Occupancy chapters 20 and 21 of the LSC. Dialysis facilities that 
are not subject to our LSC regulations must continue to meet State and 
local fire codes. (See https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-47.pdf.)
    The following are key provisions in the 2012 edition of the LSC 
from Chapter 20, ``New Ambulatory Health Care Occupancies'' and Chapter 
21, ``Existing Ambulatory Health Care Occupancies.'' We have provided 
the LSC citation and a description of the requirement.
    The 2012 edition of the LSC defines an ``Ambulatory Health Care 
Occupancy'' as a facility capable of treating 4 or more patients 
simultaneously on an outpatient basis. We believe that dialysis 
facilities that do not provide one or more exits to the outside at 
grade level from the patient treatment area should also be required to 
meet the provisions applicable to Ambulatory Health Care Occupancy 
Chapters, regardless of the number of patients served, as a matter of 
health and safety of patients receiving services in these facilities. 
In the burden reduction final rule, published in the Federal Register 
on May 12, 2012 entitled, ``Medicare and Medicaid Program; Regulatory 
Provisions to Promote Program Efficiency, Transparency, and Burden 
Reduction'' (77 FR 29002), we removed the provision's applicability to 
dialysis facilities with at-grade exits directly from the treatment 
area because, in our view, there was, and continues to be, an extremely 
low risk of fire in dialysis facilities. Medicare-approved dialysis 
facilities that provide exits to the outside at grade level would 
continue to be required to follow State and local fire codes, which we 
believe provide for sufficient patient protection in the event of an 
emergency. If a facility's exits were located above or below grade, 
patients would require more time to evacuate. Consequently, we believe 
that the LSC would still be required due to the additional risk 
entailed in longer exit times.
Sections 20.3.2.1 and 21.3.2.1--Doors
    This provision requires all doors to hazardous areas be self-
closing or close automatically.
Sections 20.3.2.6 and 21.3.2.6--Alcohol Based Hand Rubs
    This provision explicitly allows aerosol dispensers, in addition to 
gel hand rub dispensers. The aerosol dispensers are subject to 
limitations on size, quantity, and location, just as gel dispensers are 
limited. Automatic dispensers are also now permitted in ambulatory care 
facilities, provided, among other things, that--(1) they do not release 
contents unless they are activated; (2) the activation occurs only when 
an object is within 4 inches of the sensing device; (3) any object 
placed in the activation zone and left in place must not cause more 
than one activation; (4) the dispenser must not dispense more than the 
amount required for hand hygiene consistent with the label 
instructions; (5) the dispenser is designed, constructed and operated 
in a way to minimize accidental or malicious dispensing; and (6) all 
dispensers are tested in accordance with the manufacturer's care and 
use instructions each time a new refill is installed. The provision 
further defines prior language regarding ``above or adjacent to an 
ignition source'' as being ``within 1 inch'' of the ignition source.
Sections 20.3.5 and 21.3.5--Extinguishment Requirements
    This provision is related to sprinkler system requirements and 
requires the evacuation of a building or the instituting of an approved 
fire watch when a sprinkler system is out of service for more than 10 
hours in a 24-hour period until the system has been returned to 
service. A facility must evacuate the building or portion of the 
building affected by the system outage until the system is back in 
service, or establish a fire watch until the system is back in service.
4. 2012 Edition of the Health Care Facilities Code
    The 2012 edition of the NFPA 99, ``Health Care Facilities Code,'' 
addresses requirements for both health care occupancies and ambulatory 
care occupancies, and serves as a resource for those who are 
responsible for protecting health care facilities from fire and 
associated hazards. The purpose of this Code is to provide minimum 
requirements for the installation, inspection, testing, maintenance, 
performance, and safe practices for health care facility materials, 
equipment and appliances. This Code is a compilation of documents that 
have been developed over a 40-year period by NFPA, and is intended to 
be used by those persons involved in the design, construction, 
inspection, and operation of health care facilities, and in the design, 
manufacture, and testing of appliances and equipment used in patient 
care areas of health care facilities. It provides information on 
subjects, for example, medical gas and vacuum systems, electrical 
systems, electrical equipment, and gas equipment. The NFPA 99 applies 
specific requirements in accordance with the results of a risk-based 
assessment methodology. A risk-based approach allows for the 
application of requirements based upon the types of treatment and 
services being provided to patients or residents rather than the type 
of facility in which they are being performed. In order to ensure the 
minimum level of protection afforded by NFPA 99 is applicable to all 
patient and resident care areas within a health care facility, we 
proposed adoption of the 2012 edition of NFPA 99, with the exception of 
chapters 7--``Information Technology and Communications Systems for 
Health Care Facilities''; 8--``Plumbing''; 12--``Emergency 
Management''; and 13--``Security Management''. The first three chapters 
of the NFPA 99 address the administration of the NFPA 99, the

[[Page 51774]]

referenced publications, and definitions. Short descriptions of some of 
the more important provisions of NFPA 99 follow:
Chapter 4--Fundamentals
    Chapter 4 provides guidance on how to apply NFPA 99 requirements to 
health care facilities based upon ``categories'' determined when using 
a risk-based methodology.
    There are four categories utilized in the risk assessment 
methodology, depending on the types of treatment and services being 
provided to patients or residents. Section 4.1.1 of NFPA 99 describes 
Category 1 as, ``Facility systems in which failure of such equipment or 
system is likely to cause major injury or death of patients or 
caregivers. . . .'' Section A.4.1.1 provides examples of what a major 
injury could include, such as amputation or a burn to the eye. Section 
4.1.2 describes Category 2 as, ``Facility systems in which failure of 
such equipment is likely to cause minor injury to patients or 
caregivers. . . .'' Section A.4.1.2 describes a minor injury as one 
that is not serious or involving risk of life. Section 4.1.3 describes 
Category 3 as, ``Facility systems in which failure of such equipment is 
not likely to cause injury to patients or caregivers, but can cause 
patient discomfort. . . .'' Section 4.1.4 describes Category 4 as, 
``Facility systems in which failure of such equipment would have no 
impact on patient care. . . .''
    Section 4.2 requires that each facility that is a health care or 
ambulatory occupancy define its risk assessment methodology, implement 
the methodology, and document the results. We did not propose to 
require the use of any particular risk assessment procedure. However, 
if future situations indicate the need to define a particular risk 
assessment procedure, we would pursue that through a separate notice 
and comment rulemaking.
Chapter 5--Gas and Vacuum Systems
    The hazards addressed in Chapter 5 include the ability of oxygen 
and nitrous oxide to exacerbate fires, safety concerns from the storage 
and use of pressurized gas, and the reliance upon medical gas and 
vacuum systems for patient care. Chapter 5 does not mandate the 
installation of any systems; rather, if they are installed or are 
required to be installed, the systems will be required to comply with 
NFPA 99. Chapter 5 covers the performance, maintenance, installation, 
and testing of the following:
     Non-flammable medical gas systems with operating pressure 
below a gauge pressure of 300 psi;
     Vacuum systems in health care facilities;
     Waste anesthetic gas disposal systems (WAGD); and
     Manufactured assemblies that are intended for connection 
to the medical gas, vacuum, or WAGD systems.
Chapter 6--Electrical Systems
    The hazards addressed in Chapter 6 are related to the electrical 
power distribution systems in health care facilities, and address 
issues such as electrical shock, power continuity, fire, electrocution, 
and explosions that might be caused by faults in the electrical system. 
Chapter 6 also covers the performance, maintenance, and testing of the 
electrical systems in health care facilities.
Chapter 9--Heating, Ventilation, and Air Conditioning (HVAC)
    Chapter 9 requires HVAC systems serving spaces or providing health 
care functions to be in accordance with the American Society of 
Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE) Standard 
170--Ventilation of Health Care Facilities (2008 edition) (http://www.ashrae.org).
    Chapter 9 does not apply to existing HVAC systems, but applies to 
the construction of new health care facilities, and the altered, 
renovated, or modernized portions of existing systems or individual 
components. Chapter 9 ensures minimum levels of heating, ventilation 
and air conditioning performance in patient and resident care areas. 
Some of the issues discussed in Chapter 9 are as follows:
     HVAC system energy conservation;
     Commissioning;
     Piping;
     Ductwork;
     Acoustics;
     Requirements for the ventilation of medical gas storage 
and trans-filling areas;
     Waste anesthetic gases;
     Plumes from medical procedures;
     Emergency power system rooms; and
     Ventilation during construction.
Chapter 10--Electrical Equipment
    Chapter 10 covers the performance, maintenance, and testing of 
electrical equipment in health care facilities. Much of this chapter 
applies to requirements for portable electrical equipment in health 
care facilities, but there are also requirements for fixed-equipment 
and information on administrative issues.
Chapter 11--Gas Equipment
    The hazards addressed in Chapter 11 relate to general fire, 
explosions, and mechanical issues associated with gas equipment, 
including compressed gas cylinders.
Chapter 14--Hyperbaric Facilities
    Chapter 14 addresses the hazards associated with hyperbaric 
facilities in health care facilities, including electrical, explosive, 
implosive, as well as fire hazards. Chapter 14 sets forth minimum 
safeguards for the protection of patients and personnel administering 
hyperbaric therapy and procedures. Chapter 14 contains requirements for 
hyperbaric chamber manufacturers, hyperbaric facility designers, and 
personnel operating hyperbaric facilities. It also contains 
requirements related to construction of the hyperbaric chamber itself 
and the equipment used for supporting the hyperbaric chamber, as well 
as administration and maintenance. Many requirements in this chapter 
are applicable only to new construction and new facilities.
Chapter 15--Features of Fire Protection
    Chapter 15 covers the performance, maintenance, and testing of fire 
protection equipment in health care facilities. Issues addressed in 
this chapter range from the use of flammable liquids in an operating 
room to special sprinkler protection. These fire protection 
requirements are independent of the risk-based approach, as they are 
applicable to all patient care areas in both new and existing 
facilities.
    Chapter 15 has several sections taken directly from the NFPA 101, 
including requirements for the following:
     Construction and compartmentalization of health care 
facilities.
     Laboratories.
     Utilities.
     Heating, ventilation and air conditioning systems.
     Elevators.
     Escalators.
     Conveyors.
     Rubbish Chutes.
     Incinerators.
     Laundry Chutes.
     Fire detection, alarm and communication systems.
     Automatic sprinklers and other extinguishing equipment.
     Compact storage including mobile storage and maintenance.
     Testing of water based fire protection systems.
    These sections have requirements for inspection, testing and 
maintenance which apply to all facilities, as well as

[[Page 51775]]

specific requirements for existing systems and equipment that also 
apply to all facilities.
     The prospective timeline for applicability of these 
requirements would be 60 days after the publication of the final rule 
in the Federal Register. We solicited comments on the proposal of the 
adoption of the 2012 NFPA 101 and the 2012 NFPA 99 for dialysis 
facilities that do not provide one or more exits to the outside at 
grade level from the treatment area level in the proposed rule ``Fire 
Safety Requirements for Certain Dialysis Facilities,'' published 
November, 4, 2016 (81 FR 76899).
    We received 4 comments and all commenters were in support of the 
proposal. Therefore, we are finalizing the adoption of the 2012 NFPA 
101 and the 2012 NFPA 99 for dialysis facilities that do not provide 
one or more exits to the outside at grade level from the treatment area 
level.
Technical Correction
    We inadvertently left out the update of Sec.  494.60(d)(2) from the 
2000 edition of the Life Safety Code to the 2012 edition of the Life 
Safety Code. This update goes along with the overall adoption of the 
2012 edition of the Life Safety Code. This will have no impact on 
facilities as they are all already meeting the 2012 edition of the Life 
Safety Code in accordance with state and local requirements.

C. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501 et seq.).

III. Final Rule: Hospital and Critical Access Hospital (CAH) Changes To 
Promote Innovation, Flexibility, and Improvement in Patient Care

A. Background

    On June 16, 2016, we published a proposed rule in the Federal 
Register, ``Medicare and Medicaid Programs; Hospital and Critical 
Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and 
Improvement in Patient Care'' (81 FR 39447), to revise a number of 
hospital and CAH requirements, including those focused on infection 
control, antibiotic use, and antidiscrimination. We are now finalizing 
several of the proposed changes in order to modernize the hospital and 
critical access hospital (CAH) requirements, improve quality of care, 
and support HHS and CMS priorities. We believe that benefits of these 
finalized requirements will include: Reduced incidence of hospital-
acquired conditions (HACs), including reduced incidence of healthcare-
associated infections (HAIs); reduced inappropriate antibiotic use; 
reduced regulatory burden and increased cost savings for hospitals, 
CAHs, and insurers; and strengthened patient protections overall. 
Specifically, we proposed to revise the conditions of participation 
(CoPs) for hospitals and CAHs to address:
     Discriminatory behavior by healthcare providers that may 
create real or perceived barriers to care;
     A requirement regarding a patient's right to access his or 
her own medical records, including in an electronic format;
     Continued use of the term ``Licensed Independent 
Practitioners'' (LIPs), which might inadvertently exacerbate workforce 
shortage concerns, might unnecessarily impose regulatory burden on 
hospitals by restricting a hospital's ability to allow non-physician 
practitioners such as physician assistants (PAs) to operate within the 
scope of practice allowed by state law, and does not recognize the 
benefits to patient care that might be derived from fully utilizing PAs 
and their clinical skills to the highest levels of their training, 
education, and experience as allowed by hospital policy in accordance 
with state law;
     The use of quality reporting program data by hospital 
Quality Assessment and Performance Improvement (QAPI) programs;
     Requirements in the Nursing services CoP to improve 
clarity and provide some regulatory flexibility and burden relief;
     Requirements in the Medical records services CoP to 
improve clarity regarding the distinctions between a patient's 
inpatient and outpatient status and the subtle differences between 
certain aspects of medical record documentation related to each status;
     Requirements that do not fully conform to current 
standards for infection control for both hospitals and CAHs;
     Requirements for antibiotic stewardship programs to help 
reduce inappropriate antibiotic use and antimicrobial resistance for 
both hospitals and CAHs;
     A requirement for CAHs that would allow a patient's 
nutritional needs to 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; and
     Requirements for CAHs to establish a quality assessment 
and performance improvement program (QAPI).

B. Provisions of the Proposed Regulations and Responses to Public 
Comments for Hospitals (42 CFR Part 482)

1. General Comments
    In response to the proposed rule, we received 200 public comments. 
Commenters included individuals, healthcare professionals and 
corporations, national associations and coalitions, state health 
departments, patient advocacy organizations, and individual facilities 
that would be impacted by the regulation.
    Generally, most comments expressed support for the regulatory 
changes. We have provided a summary of the public comments, our 
responses to those comments, and any changes made as a result of those 
comments in the proceeding sections. Several commenters expressed 
concern that we underestimated the time and effort required for 
compliance with the antibiotic stewardship and QAPI requirements, 
especially for smaller hospitals, including CAHs. Commenters requested 
a delayed implementation for these requirements.
2. Implementation Timeframe
    Comment: We received several comments stating that we have 
underestimated the time necessary to implement some of the requirements 
contained in this rule. Some commenters stated that the proposed 
hospital and CAH infection control and antibiotic stewardship and QAPI 
provisions required additional time to implement. These commenters 
requested that we grant additional time for the implementation for 
these requirements. Commenters cited challenges associated with 
implementing these requirements, especially for small, rural hospitals 
and CAHs including obtaining and training appropriate staff for the 
required positions.
    Response: We understand the complexities of the required changes in 
this rule for hospitals and CAHs, particularly the effects on CAHs and 
small, rural hospitals. As a result, we are using the following 
implementation schedule for the provisions of this final rule:

[[Page 51776]]

     CAH QAPI requirements--an implementation date that is 18 
months after the effective date of this final rule;
     Hospital and CAH compliance with the antibiotic 
stewardship requirements--an implementation date that is six months 
from the effective date of this final rule; and
     All other requirements, including those for patient's 
rights--an implementation date that is 60 days from the publication of 
this final rule.
3. Non-Discrimination
    We proposed to establish at Sec.  482.13(i) for hospitals and Sec.  
485.635 (g) for CAHs, explicit requirements that a hospital (or CAH) 
not discriminate on the basis of race, color, religion, national 
origin, sex (including gender identity), sexual orientation, age, or 
disability and that the hospital (or CAH) establish and implement a 
written policy prohibiting discrimination on the basis of race, color, 
religion, national origin, sex (including gender identity), sexual 
orientation, age, or disability.
    We proposed to further require that each patient, (and/or support 
person, where appropriate), is informed, in a language he or she can 
understand, of the right to be free from discrimination against them on 
any of these bases when he or she is informed of his or her other 
rights under Sec.  482.13(i) (or Sec.  485.635(g)). In addition, we 
proposed to require that the hospital (or CAH) inform the patient and/
or representative, and/or support person, on how he or she can seek 
assistance if they encounter discrimination.
    Comment: We received numerous comments that expressed support for 
this proposal and also discussed the potential benefits of the proposal 
to patients. In addition, we received comments that expressed concern 
about the consequences of the implementation of this proposal and 
suggested modifications to our proposed requirement. Commenters also 
discussed potential technical difficulties that may exist when 
implementing this proposal and they expressed concern that the proposed 
requirement may be duplicative of other current federal requirements.
    Response: In response to these comments, we are not finalizing the 
proposal to require explicit non-discrimination requirements in the 
CoPs and we are instead deferring to the non-discrimination 
requirements of Section 1557 of the Affordable Care Act.
    Final Action: We are not finalizing proposed Sec.  482.13(i) and 
Sec.  485.635(g).
4. Licensed Independent Practitioner
    We proposed to delete the modifying term ``independent'' from the 
CoPs at Sec.  482.13(e)(5), as well as at Sec.  482.13(e)(8)(ii), and 
also proposed to revise the provision to be in keeping with the 
language of the Children's Health Act of 2000 (Pub. L. 106-310) (CHA) 
regarding restraint and seclusion orders and licensed practitioners. 
Therefore, we proposed that Sec.  482.13(e)(5) read 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. We proposed that Sec.  
482.13(e)(8)(ii) would state that, after 24 hours, before writing a new 
order for the use of restraint or seclusion for the management of 
violent or self-destructive behavior, 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 would have to see and assess the patient.
    We proposed to revise the provisions in sections Sec.  
482.13(e)(10), Sec.  482.13(e)(11), Sec.  482.13(e)(12)(i)(A), Sec.  
482.13(e)(14), and Sec.  482.13(g)(4)(ii) that contain the term 
``licensed independent practitioner'' by changing the term from 
``licensed independent practitioner'' to simply ``licensed 
practitioner.'' We also proposed to remove the term ``physician 
assistant'' from the current provisions at Sec.  482.13(e)(12)(i)(B) 
and Sec.  482.13(e)(14).
    Comment: The majority of commenters were supportive of this change. 
Specifically, commenters noted that the proposed language change will 
remove uncertainty regarding these provisions and clearly demonstrates 
that Physician Assistants (PAs) are authorized to order restraint and 
seclusion, in accordance with state law and facility policy, when 
medically necessary to protect patients and health professionals. One 
commenter did not support the removal of the term ``independent'' from 
this requirement. The commenter stated that removing the term 
``independent'' may make this requirement applicable to other care 
providers, such as registered nurses.
    Response: We thank commenters for their support of this 
requirement. We believe this revision reflects our goal to have health 
professionals operate within the scope of practice allowed by state 
law, and recognizes the need to fully utilize the healthcare workforce. 
We also believe that this change will reduce unnecessary burden for 
hospitals and remove obstacles PAs face when ordering seclusion and 
restraints. We disagree with the commenters who stated that the removal 
of the term ``independent'' will cause confusion over the applicability 
of this requirement. Our proposed removal of the term ``independent'' 
is consistent with the language used in the CHA, which utilizes the 
term ``other licensed practitioner'', without the independent modifying 
term. In addition, the order of restraint or seclusion must be ordered 
by a licensed practitioner who is authorized by hospital policy in 
accordance with State law to do so. This would exclude Registered 
Nurses or other hospital staff, who either through State law or 
hospital policy, would not have the authorization to order the use of 
restraints and seclusion.
    After consideration of the comments we received, we are finalizing 
this proposal, without modification.
    Final Action: We are finalizing the following revisions to Sec.  
482.13:
    1. Remove the modifying term ``independent'' from the CoPs at Sec.  
482.13(e)(5) and Sec.  482.13(e)(8)(ii).
    2. Revise Sec.  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 Sec.  482.13(e)(10), Sec.  
482.13(e)(11), Sec.  482.13(e)(12)(i)(A), Sec.  482.13(e)(14), and 
Sec.  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 Sec.  482.13(e)(12)(i)(B) and Sec.  482.13(e)(14).
5. Quality Assessment and Performance Improvement (QAPI) Program (Sec.  
482.21)
    We proposed a minor change to the program data requirements at 
Sec.  482.21(b), which would require that 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
    Comment: We received mostly positive feedback regarding this 
requirement; however, some commenters asked that we remove the provided 
example of ``data related to hospital readmissions and hospital-
acquired conditions.'' Commenters

[[Page 51777]]

believed that the inclusion of this information makes it unclear to 
hospitals that they should utilize all data available to them. One 
commenter also disagreed with any proposal that would restrict quality 
improvement work to a limited number of areas.
    Response: We thank the commenters for their feedback. We believe 
that this requirement affords hospitals increased flexibility, while 
continuing to promote patient safety and quality of care. As revised by 
this final rule, the regulation at Sec.  482.21(b)(1) now requires that 
the QAPI program ``incorporate quality indicator data including patient 
care data, and other relevant data such as data submitted to or 
received from Medicare quality reporting and quality performance 
programs, including but not limited to data related to hospital 
readmissions and hospital-acquired conditions.'' We believe the intent 
of the regulation is clear as the language states that the data that 
must be incorporated is not limited to data related to hospital 
readmissions and hospital-acquired conditions; however, we will ensure 
that the intent is also clear in the Interpretive Guidelines for this 
requirement. Note that CMS historically releases Interpretive 
Guidelines for new regulations after the final rule has been published. 
Furthermore, we note that these requirements would not restrict 
hospitals to a certain number of quality improvement areas, but they 
are instead minimum requirements that hospitals can choose to exceed as 
they strive to improve the quality of the services that they provide.
    Final Action: We are finalizing Sec.  482.21(b) as proposed.
6. Nursing Services (482.23)
    As a result of our internal review of the CoPs for nursing 
services, we recognized that some of our requirements might be 
ambiguous and confusing due to unnecessary distinctions between 
inpatient and outpatient services, or might fail to account for the 
variety of ways through which a hospital might meet its nurse staffing 
requirements. We proposed to make revisions to the nursing services CoP 
to improve clarity. Specifically, we proposed to revise Sec.  
482.23(b), which currently states that 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. We proposed to 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. We understand that the 
term ``immediate availability'' has been interpreted to mean physically 
present on the unit or in the department. We further understand that 
there are some outpatient services where it might not be necessary to 
have a registered nurse physically present. For example, while it is 
clearly necessary to have an RN present in an outpatient ambulatory 
surgery recovery unit, it might not be necessary to have an RN on-site 
at a hospital MRI facility that is outside the hospital building, but 
still on the hospital campus. We proposed to allow a hospital to 
establish a policy that would specify which, if any, outpatient 
departments would not be required to have an RN physically present as 
well as the alternative staffing plans that would be established under 
such a policy. We would require such a policy to take into account 
factors such as the services delivered, the acuity of patients 
typically served by the facility, and the established standards of 
practice for such services. In addition, we would propose that the 
policy must be approved by the medical staff and be reviewed at least 
once every three years. We solicited comments on the need for, the 
risks of establishing, and the appropriate criteria we should require 
for such an exception.
    We also proposed to clarify in (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. We expect 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.
    Finally, we proposed to 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) to clarify that all licensed nurses who provide services in 
the hospital must adhere to the policies and procedures of the 
hospital. In addition, the director of nursing service 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. We recognize 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. We would expect non-licensed 
personnel to be supervised by a licensed nurse.
    In addition, we proposed to delete inappropriate references to 
Sec.  482.12(c) that are currently in (c)(1) and (3). We discuss these 
technical corrections in detail below.
    Comment: Commenters expressed concern regarding the removal of the 
word ``bedside'' under Sec.  482.23(b), (which stated that 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

[[Page 51778]]

bedside care of any patient). Commenters noted that our proposed 
revision could create confusion in certain inpatient departments and 
asked that CMS clarify that each hospital department or nursing unit 
should ensure that nurse staffing should be immediately available, when 
needed. Commenters also asked that we clarify that policies related to 
nurse staffing are approved by the hospital's medical staff in 
conjunction with nursing leadership. One commenter stated that the 
approval of any policies regarding nursing services would be under the 
authority of the hospital's director of nursing and medical staff 
approval would not be needed as proposed here.
    Response: The nursing service must ensure that patient needs are 
met by continuously assessing the needs of patients and must provide 
nursing staff to meet those needs, regardless of whether the patient is 
an inpatient or an outpatient. There must be sufficient numbers and 
types of supervisory and staff nursing personnel to meet the nursing 
needs and to care for the patient population of each department or 
nursing unit. A registered nurse must be available to care for any 
patient, as determined by the needs of the patient and hospital policy. 
Note that the term ``immediate availability'' has been interpreted to 
mean physically present on the unit or in the department. Also note 
that there are some outpatient services where it might not be necessary 
to have a registered nurse physically present. For example, while it is 
clearly necessary to have an RN present in an outpatient ambulatory 
surgery recovery unit, it might not be necessary to have an RN on-site 
at an off-campus outpatient department where radiology services are 
offered. Hospitals are provided the flexibility to establish a policy 
that would specify which, if any, outpatient departments would not be 
required to have an RN physically present as well as the alternative 
staffing plans that would be established under such a policy. Such a 
policy must take into account factors such as the services delivered, 
the acuity of patients typically served by the facility, and the 
established standards of practice for such services. We agree with the 
comment that stated that the approval of any nursing services policy 
falls under the authority of the hospital's nursing leadership and we 
have modified the proposed requirement at Sec.  482.23(b)(7)(iii) to 
reflect that in this final rule.
    Comment: We received positive comments about the requirement under 
Sec.  482.23(b)(4), which requires that the nursing care plan, which is 
needed for every patient, reflect the needs of the patient and the 
nursing care to be provided to meet those needs. Commenters stated 
these changes help ensure that the clinical team is working together 
with the patient and the patient's family to ensure that the team is 
continuously working towards meeting the established patient goals. 
However, as evidenced by some comments, there appears to exist some 
confusion over whether a nursing care plan is required for both 
inpatients and outpatients or if it is required for inpatients only.
    Response: We appreciate the positive feedback received for this 
requirement. Initiating a nursing care plan for patients that reflects 
the needs of the patient will lead to better patient outcomes and has 
the potential to decrease length of stay.
    Regarding the question of which patients (all patients or only 
inpatients) are required to have a nursing care plan, we must look at 
both the regulatory text and the interpretive guidance contained in the 
SOM, Appendix A, Section A-0396, for this provision. While the actual 
regulatory text has always simply used the term, ``patient,'' implying 
both inpatients and outpatients, other areas of the CoPs specifically 
use the term ``inpatient'' as does the language of the Act 
(specifically with regard to nursing services) as well as other 
instances in the CoPs that refer to patient ``admissions,'' which 
further implies inpatients. Additionally, the interpretive guidance for 
this provision in the SOM, Appendix A, has traditionally held that the 
requirement for a nursing care plan only applies to patients after 
their ``admission,'' (that is, inpatients only) (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/som107ap_a_hospitals.pdf, p. 224).
    While we believe that nursing care plans most appropriately, and in 
most instances, apply only to inpatients, we urge hospitals to review 
their policies and procedures in this area to determine if there are 
outpatients where a nursing care plan would be appropriate and should 
be required for the benefit of the patient's health and safety and for 
improved outcomes. For instance, hospitals should look at the policies 
that they develop for the provisions that we are finalizing here, at 
Sec.  482.23(b)(7), regarding those policies and procedures that must 
be in place to establish which outpatient departments, if any, are not 
required under hospital policy to have a registered nurse present. As 
we discussed previously, that while it is clearly necessary to have an 
RN present in an outpatient ambulatory surgery recovery unit, it might 
not be necessary to have an RN on-site at a hospital MRI facility that 
is outside the hospital building, but still on the hospital campus. In 
exercising this policy flexibility provided in this final rule for 
reviewing the need for establishing which outpatient units must have an 
RN present for patient care and safety, we likewise encourage hospitals 
to exercise a similar regulatory flexibility in reviewing their 
policies for establishing which types of outpatients would require a 
nursing care plan through a similar lens--that is, based on the 
services that a patient is receiving and the location in which he or 
she is receiving those services. We further believe that the example 
provided here regarding the requirement differences in the patient's 
needs for having an RN present, which clearly exist between an 
outpatient undergoing ambulatory surgery and one receiving an MRI or 
other radiologic services, is entirely relevant to the considerations 
for determining which patient needs a nursing care plan.
    Comment: We received positive feedback regarding Sec.  
482.23(b)(6), in which we proposed to clarify that all licensed nurses 
who provide services in the hospital must adhere to the policies and 
procedures of the hospital and addresses the supervision and evaluation 
of the clinical activities of all nursing personnel. Commenters 
appreciated the clarification of the requirements in this in calling 
for adequate supervision and evaluation of all nursing personnel. One 
commenter asked that we clarify that nursing leadership is responsible 
for ensuring that there are clear lines of reporting and supervision.
    Response: We appreciate the comments received on the proposed 
requirement. We expect all nursing personnel to have a clear 
understanding of the reporting and supervisory structure and it is the 
responsibility of nursing leadership to ensure that there are clear 
lines of reporting and supervision. This requirement must be met 
regardless of the employment type or status of the nursing personnel, 
including but not limited to those employed via 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 are obtained, in order to ensure the health and safety 
of patients, all nurses must 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

[[Page 51779]]

that occur within the responsibility of the nursing service. We would 
expect non-licensed personnel to be supervised by a licensed nurse.
    Final Decision: After consideration of the comments we received on 
the proposed rule, we are finalizing Sec.  482.23 as proposed with the 
exception of the proposed requirement at Sec.  482.23(b)(7)(iii), which 
we have revised in response to comments by replacing ``medical staff'' 
with ``director of nursing,'' and which we are finalizing here.
7. Medical Record Services (Sec.  482.24)
    We proposed to revise Sec.  482.24(c) to require that the content 
of the medical record contain 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 patient.
    Similarly, we proposed to revise Sec.  482.24(c)(4)(ii) to include 
``all diagnoses specific to each inpatient stay and outpatient visit,'' 
which would include specifying any admitting diagnoses. At Sec.  
482.24(c)(4)(iv), we proposed to require that the content of the record 
include documentation of complications, hospital-acquired conditions, 
healthcare-associated infections, and adverse reactions to drugs and 
anesthesia. We also propose changes to Sec.  482.24(c)(4)(vi) to add 
``progress notes. . . interventions, responses to interventions . . .'' 
to the required documentation of ``practitioners' orders'' to emphasize 
the necessary documentation for both inpatients and outpatients. We 
also proposed to add the phrase ``to reflect all services provided to 
the patient,'' so that the entire provision would now read that 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.
    We proposed to change Sec.  482.24(c)(4)(vii) to require that all 
patient medical records 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.
    Finally, we proposed to revise Sec.  482.24(c)(4)(viii) so that 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.
    Comment: The comments we received on these proposed changes were 
concerned that the medical records documentation revisions would be 
unduly burdensome and confusing regarding distinctions between the 
requirements for inpatients versus outpatients. Commenters also 
expressed concerns over the ongoing interplay between EHRs and paper-
based records systems and EHR interoperability issues that may arise.
    Response: We appreciate the commenter's feedback regarding these 
proposals. We agree that the proposed changes to the medical records 
documentation requirements would impose an additional undue burden on 
hospitals and we are therefore not finalizing this proposal at this 
time.
    Final Action: Based on the public comments, we are not finalizing 
the proposed changes to the Medical Records requirements at Sec.  
482.24.
8. Infection Prevention and Control and Antibiotic Stewardship Programs 
(Sec.  482.42)
    We proposed 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. Along with these changes, we proposed 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. We would also require that a 
program 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. While these particular changes 
are new to the regulatory text, it is worth noting that these 
requirements, with the exception of the new requirement for an 
antibiotic stewardship program, have been present in the Interpretive 
Guidelines for hospitals since 2008 (See A0747 at Appendix A--Survey 
Protocol, Regulations and Interpretive Guidelines for Hospitals, http://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf).
    We also proposed 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. As has been described in the Interpretive 
Guidelines for this regulation, ``surveillance'' includes infection 
detection, data collection, and analysis; monitoring; and evaluation of 
preventive interventions. (See SOM, Appendix A--Survey Protocol, 
Regulations and Interpretive Guidelines for Hospitals, pp. 361-362, 
http://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf). In 
collaboration with the hospital's QAPI program, the hospital would be 
required to develop and implement appropriate infection prevention and 
control interventions to address issues identified through its 
detection activities.
    We also proposed 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. We realize that, in developing 
the patient health and safety requirements that are the hospital CoPs, 
particular attention must be paid to the ever-evolving nature of 
medicine and patient care. Moreover, a certain degree of latitude must 
be left in the requirements to allow for innovations in medical 
practice that improve the quality of care and move toward the reduction 
of medical errors and patient harm.
    Therefore, we intentionally built flexibility into the revised 
regulations by proposing language that requires hospitals to 
demonstrate adherence to nationally recognized guidelines (and best 
practices where applicable) rather than requiring that all hospitals 
demonstrate adherence to a specific guideline or set of guidelines for 
infection prevention and control and for antibiotic stewardship. While 
the CDC guidelines and guidance (for example, guidelines from the 
Healthcare Infection

[[Page 51780]]

Control Practices Advisory Committee (HICAPC) and Core Elements of 
Hospital Antibiotic Stewardship Programs) represent one set, there are 
other sets of nationally recognized guidelines from which hospitals 
might choose, such as those established by the Association for 
Professionals in Infection Control and Epidemiology (APIC), the Society 
for Healthcare Epidemiology of America (SHEA), and the Association of 
periOperative Registered Nurses (AORN). The U.S. Occupational Health 
and Safety Administration (OSHA) also issues federal regulations 
applicable to infection control practices. We believe this approach 
will provide hospitals the flexibility they need to select and 
integrate those standards that best suit their individual infection 
prevention and control and antibiotic stewardship programs. We also 
believe this approach will allow hospitals the flexibility to adapt 
their policies and procedures in concert with any updates in the 
guidelines they have elected to follow.
    Comment: A few commenters were concerned that the proposed 
requirements for antibiotic stewardship programs would dictate the 
treatment options for patients with conditions such as Lyme disease. 
Some of these commenters were particularly concerned about the proposed 
rule's reference to IDSA antibiotic stewardship program guidelines.
    Response: We proposed to intentionally build flexibility into the 
regulation by proposing language that requires hospitals to demonstrate 
adherence to nationally recognized guidance and guidelines, rather than 
any specific guidance, guideline, or set of guidelines, for best 
practices in infection prevention and control and for implementing 
antibiotic stewardship programs. For infection control best practices, 
CDC guidelines represent a fundamental set of practices, while other 
sets of nationally recognized infection control guidance and guidelines 
provide further setting- and procedure-specific options from which 
hospitals might choose, such as those established by APIC, SHEA, and 
IDSA. For the implementation of antibiotic stewardship programs, 
guidance is available from several organizations, including IDSA, SHEA, 
American Society for Health System Pharmacists, and CDC's Core 
Elements.
    We appreciate the concerns expressed about the inclusion of 
guidelines developed by individual organizations, specifically, the 
Infectious Disease Society of America (IDSA). The intention in the 
proposed rule was to reference guidance for the implementation of 
antibiotic stewardship programs, not treatment guidelines for any 
particular infection. The reference to IDSA guidelines explicitly 
refers to guidelines for implementing stewardship programs and even 
references guidelines from other societies. These guidelines are 
referenced specifically because they are the only guidelines that we 
are aware of that are dedicated solely to the implementation of 
antibiotic stewardship programs in hospitals. We are not requiring that 
hospitals choose the IDSA guidelines for antibiotic stewardship 
programs specifically, but rather that they choose guidance on 
implementing antibiotic stewardship programs from a nationally 
recognized source.
    Comment: One commenter recommended that rather than focusing on the 
explicit roles of two distinct staff, the CoPs instead focus on the 
overall process of clinical care and infection management and permit 
some flexibility in how hospitals establish each of their programs. 
They stated that in their experience, the ASP [antibiotic stewardship 
program] is part of the overall ICP [infection control program], which 
is broader than antibiotics.
    Response: We agree that careful coordination between the infection 
prevention and control and antibiotic stewardship programs is essential 
and this is stated explicitly in the regulatory text. However, we 
believe it is also important to highlight the distinctions between the 
two programs. Infection prevention and control programs are almost 
exclusively staffed by infection preventionists, the overwhelming 
majority of whom do not prescribe or manage antibiotics. Antibiotic 
stewardship programs must be staffed by people who are very familiar 
with antibiotics. Also, though both groups share some common goals of 
reducing antibiotic resistance and C. difficile, the types of 
interventions the two programs seek to implement are also fundamentally 
different. Finally, the ultimate goals of both programs are different; 
infection prevention and control programs seek to eliminate healthcare-
associated infections, while antibiotic stewardship programs seek to 
ensure that all patients get optimal antibiotic therapy.
    Comment: One commenter stated that, given the size and overall 
staff of free-standing IRFs and LTCHs, some facilities may need 
additional time to incorporate these new ASP staffing requirements.
    Response: We agree that these new provisions might require 
additional time to implement beyond the standard 60 days for all 
facilities, not just IRFs and LTCHs. Therefore, as discussed above, the 
provisions regarding antibiotic stewardship will become effective and 
be enforced 6 months after the effective date of this final rule for 
all facilities. IRFs and LTCHs are still required to comply with the 
hospital CoPs, so changes to the hospital CoPs also apply to IRFs and 
LTCHs.
    Comment: One commenter appreciated the flexibility afforded in the 
requirements regarding the leader of the ASP, but believes there is 
value in that position being further defined, and recommend that the 
ASP professional requirements be clarified and explicitly state the 
person must hold either a formal M.D. or Pharm. D. degree in order to 
comply with the regulation.
    Response: While this most likely will be the case in practice, we 
believe that the requirements should remain flexible for hospitals and 
CAHs to make these determinations for themselves. Therefore, we believe 
that the hospital leadership should determine the appropriate 
qualifications for the leader of the ASP. However, we note here that 
the CDC Core Elements of Hospital Antibiotic Stewardship Programs 
(https://www.cdc.gov/antibiotic-use/healthcare/implementation/core-elements.html#lead) recommend including both a physician and a 
pharmacist (especially those with formal training and experience in 
infectious diseases and/or antibiotic stewardship) to co-lead the 
hospital AS program and to be accountable for it. We urge hospitals and 
CAHs to consider these recommendations when they set their ASP 
leadership qualifications and when hiring the appropriate staff to 
develop and lead these programs.
    Comment: One commenter suggested that in smaller facilities CMS 
should give some consideration to flexibility in staffing if the goals 
of the program are met and a single person is capable of handling both 
roles and ensuring that both priorities are met.
    Response: The leaders of the infection prevention and control and 
the antibiotic stewardship programs must have the training required to 
do those jobs effectively. While there are specific types of knowledge 
required to lead each program (that is, knowledge about infection 
prevention and control best practices and knowledge about antibiotic 
prescribing and antimicrobial resistance), there is nothing in the 
regulatory language that would preclude a properly trained person from 
leading both programs.
    Comment: Several commenters urged us to be flexible in the 
implementation of these provisions for all hospitals, but

[[Page 51781]]

especially for smaller hospitals and CAHs, due to the time and effort 
it will take to fill leadership positions and develop their programs.
    Response: We appreciate this comment and agree. We also agree that 
some smaller hospitals and CAHs may need extra technical assistance to 
implement the new provisions in a way that truly improves patient care. 
We are committed to partnering with federal and other partners to 
provide that assistance. For example, the CDC initiated an effort with 
The American Hospital Association, the Federal Office of Rural Health 
Policy, and the Pew Charitable Trusts to work with several CAHs that 
have successful antibiotic stewardship programs to learn best practices 
and implementation suggestions that can be shared with other critical 
access hospitals. The Implementation of Antibiotic Stewardship Core 
Elements at Small and Critical Access Hospitals and related tools 
released in 2017 provides guidance on practical strategies to implement 
antibiotic stewardship programs in small and critical access hospitals 
(https://www.cdc.gov/antibiotic-use/healthcare/implementation/core-elements-small-critical.html).
    Comment: One commenter did not support our proposal to require that 
the leaders of the infection prevention and control and antibiotic 
stewardship programs be specifically appointed by the governing body of 
a hospital or CAH.
    Response: We appreciate this concern. The goal of this proposed 
requirement was to ensure that the infection prevention and antibiotic 
stewardship leaders are vested with authority from the leadership of 
the hospital or CAH. To maintain this concept while allowing more 
flexibility, we have changed these requirements for hospitals and CAHs. 
Specifically, we have revised sections Sec. Sec.  482.42(a)(1) and 
485.640(a)(1) of the final rule to provide that the hospital (or CAH) 
must ensure that an individual (or individuals), who are qualified 
through education, training, experience, or certification in infection 
prevention and control, are 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 and leadership.
    We have also revised Sec. Sec.  482.42(b)(1) and 485.640(b)(1) to 
now provide that the hospital (or CAH) ensure that 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.
    Comment: One commenter urged CMS to modify the proposed standards 
regarding the demonstration of improvements in antibiotic stewardship. 
The commenter does not believe it is appropriate or accurate to solely 
use antibiotic resistance within the hospital to demonstrate antibiotic 
stewardship program success or evaluate a hospital's antibiotic 
stewardship efforts. The commenter states that numerous external 
factors contribute to resistance patterns, including prescribing 
patterns of local practitioners who may not be connected to the 
hospital, community-onset infections, and patient transfers from other 
facilities. The commenter further noted that it can be difficult to 
demonstrate meaningful improvement over a short period of time.
    Response: We appreciate the suggestion and have modified and also 
deleted elements of this language for both hospitals and CAHs at 
Sec. Sec.  482.42(b)(2)(iii) and 485.640(b)(2)(iii), respectively, to 
require that hospital and CAH ASPs must ``document any'' improvements, 
including sustained improvements, in proper antibiotic use. We agree 
that it would not be appropriate to use antibiotic resistance within 
the hospital (or CAH) as the sole criterion to demonstrate antibiotic 
stewardship program success or to evaluate a hospital's (or CAH's) 
antibiotic stewardship efforts. Therefore, we have deleted this portion 
of the regulatory language at Sec. Sec.  482.42(b)(2)(iii) and 
485.640(b)(2)(iii). We believe that this will provide hospitals and 
CAHs the ability to record any category of improvement in proper 
antibiotic use and will not restrict ASPs to demonstrating specific 
types of improvements like decreased antibiotic resistance (though ASPs 
are still encouraged to document any improvements in this area). These 
revisions will also implicitly acknowledge that there often external 
factors, as noted by the commenter, that can negatively contribute to 
antibiotic resistance in the facility and that can also negatively 
impact meaningful improvements in this area in the short term. 
Hospitals and CAHs will still need to ensure that their ASPs are 
following nationally recognized guidelines and best practices while 
documenting the evidence-based use of antibiotics.
    Comment: One commenter recommended that in order to clarify the 
organization of the antibiotic stewardship and infection prevention and 
control programs, the following change be made to the existing language 
in the preamble of the proposed rule: ``Antibiotic Stewardship, as a 
component of controlling infection, has long been recognized as one of 
the special challenges that hospitals must meet in order to address the 
problems of multidrug-resistant organisms and Clostridium difficile 
infections (CDIs) in hospitals and outpatient settings.''
    Response: We appreciate this commenter's recognition of the 
importance of the antibiotic stewardship and infection prevention and 
control programs.
    Final Decision: After consideration of the comments we received on 
the proposed rule, we are finalizing Sec.  482.42 with some minor 
modifications to the overall regulatory language and with the following 
more substantive modifications:
     Revise and finalize the language of Sec. Sec.  
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.''
     Revise and finalize the language of Sec. Sec.  
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.''
     Revise and finalize the language at Sec. Sec.  
482.42(b)(2)(iii) and 485.640(b)(2)(iii) to now require: ``Documents 
any improvements, including sustained improvements, in proper 
antibiotic use.''
9. Technical Corrections
Technical Amendments to Sec.  482.27(b)(7)(ii) and Sec.  482.27(b)(11)
    In the final rule ``Medicare and Medicaid Programs; Hospital 
Conditions of Participation: Laboratory Services,'' amending 42 CFR 
482.27 (72 FR 48562, 48573, Aug. 24, 2007), we stated that

[[Page 51782]]

HCV notification requirements for donors tested before February 20, 
2008, would expire on August 24, 2015, in accordance with 21 CFR 
610.48. Since the notification requirement period has expired, we 
proposed to remove Sec.  482.27(b)(11), ``Applicability'' and the 
corresponding requirements set out at Sec.  482.27(b)(7)(ii).
Corrected Reference in Sec.  482.58
    In our review of the Hospital Conditions of Participation, we found 
an incorrect cross-reference at Sec.  482.58(b)(6), which currently 
reads ``Discharge planning (Sec.  483.20(e))''. Subsection 483.20(e) 
addresses coordination of the preadmission screening and resident 
review program, not discharge planning. SNF requirements for discharge 
plans are set out at Sec.  483.20(l). Therefore, we proposed to correct 
the reference to read ``Discharge summary (Sec.  483.20(l))''.
Removal of Inappropriate References to Sec.  482.12(c)(1)
    Upon our review of the Hospital CoPs for the proposed rule, we 
discovered that there were several provisions that incorrectly 
reference Sec.  482.12(c)(1), which lists the types of physicians and 
applies only to patients who are Medicare beneficiaries. Section 
482.12(c) states that the governing body of the hospital must ensure 
that every Medicare patient is under the care of one of the following 
practitioners:
     A doctor of medicine or osteopathy;
     A doctor of dental surgery or dental medicine who is 
legally authorized to practice dentistry by the State and who is acting 
within the scope of his or her license;
     A doctor of podiatric medicine, but only with respect to 
functions which he or she is legally authorized by the State to 
perform;
     A doctor of optometry who is legally authorized to 
practice optometry by the State in which he or she practices;
     A chiropractor who is licensed by the State or legally 
authorized to perform the services of a chiropractor, but only with 
respect to treatment by means of manual manipulation of the spine to 
correct a subluxation demonstrated by x-ray to exist; and
     A clinical psychologist as defined in Sec.  410.71 of this 
chapter, but only with respect to clinical psychologist services as 
defined in Sec.  410.71 of this chapter and only to the extent 
permitted by State law.
    The reference of this ``Medicare beneficiary-only'' requirement in 
certain other provisions of the hospital CoPs (which we have listed 
below) inappropriately links it to all patients and not Medicare 
beneficiaries exclusively. In fact, the Act at Sec.  1861(e)(4) states 
that ``every patient with respect to whom payment may be made under 
this title must be under the care of a physician except that a patient 
receiving qualified psychologist services (as defined in subsection 
(ii)) may be under the care of a clinical psychologist with respect to 
such services to the extent permitted under State law.'' In accordance 
with that provision, we have chosen to apply Sec.  482.12(c) to 
Medicare patients. With the exception of a few provisions in the CoPs 
such as those directly related to Sec.  482.12(c) described here, the 
remainder of the CoPs apply to all patients, regardless of payment 
source, and not just Medicare beneficiaries. For example, the Nursing 
Services CoP, at Sec.  482.23(c)(1), requires that all ``drugs and 
biologicals must be prepared and administered in accordance with 
Federal and State laws, the orders of the practitioner or practitioners 
responsible for the patient's care as specified under Sec.  482.12(c), 
and accepted standards of practice.'' Since the CoPs clearly allow 
hospitals to determine which categories of practitioners would be 
responsible for the care of other patients, outside the narrow Medicare 
beneficiary restrictions of Sec.  482.12(c), this reference is 
inappropriate and unnecessarily restrictive of hospitals and their 
medical staffs to make these determinations based on State law and 
practitioner scope of practice.
    In order to clarify that these provisions apply to all patients and 
not only Medicare beneficiaries, we proposed to delete any 
inappropriate references to Sec.  482.12(c). Therefore, we proposed to 
delete references to Sec.  482.12(c) found in the following provisions: 
Sec. Sec.  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 Sec. Sec.  
482.23(c)(1) and 482.23(c)(3) in the Nursing Services CoP. 
Additionally, and in the course of finalizing this rule, we discovered 
that we inadvertently failed to propose to delete an inappropriate 
reference to Sec.  482.12(c), which is contained in the current 
provision at Sec.  482.61(d) in the Special Medical Record Requirements 
for Psychiatric Hospitals CoP under the Special Requirements for 
Psychiatric Hospitals (regarding which hospital personnel may complete 
progress notes). Therefore, in the interests of consistency with the 
other revisions here, we are also deleting this reference in this final 
rule. We believe this to be a technical correction, for which notice 
and comment are unnecessary. We have noted this revision in the 
``Waiver of Proposed Rulemaking'' discussion found above at section at 
I.B.14. With respect to all of these provisions, the reference to 
services provided under the order of a physician or other practitioner 
would still apply. We did not receive any comments on these proposed 
changes and are therefore finalizing them without change.

C. Provisions of the Proposed Regulations and Responses to Public 
Comments for Critical Access Hospitals (42 CFR Part 485)

    We identified several priority areas in the CoPs for CAHs (42 CFR 
part 485, subpart F) for updates and revisions. We believe that these 
proposed regulations would benefit the quality of care provided with a 
positive impact on patient satisfaction, length of stay, and, 
ultimately, cost per patient. Additionally, we have proposed the 
following changes to the CAH CoPs, after considering the resource 
restrictions of remote and frontier CAHs.
1. Organizational Structure (Sec.  485.627(b))
    This proposal was also included in the Medicare and Medicaid 
Programs; Regulatory Provisions To Promote Program Efficiency, 
Transparency, and Burden Reduction, Proposed Rule (83 FR 47686). We are 
finalizing this proposal in that final rule. We refer readers to the 
discussion under Section I.B.8.a for further information regarding this 
provision.
2. Periodic Review of Clinical Privileges and Performance (Sec.  
485.631(d)(1) Through (2))
    We proposed to change the current CoP at Sec.  485.641 to reflect 
the current QAPI format used in hospitals. As such, we proposed to 
retain the requirements under paragraphs Sec.  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 Sec.  485.631. We 
are not changing these requirements and believe that they are still 
appropriate for the CAH regulations. Since the current CoP under Sec.  
485.631 discusses staffing requirements and responsibilities, we 
believe that relocating the requirement under a new standard, entitled 
``Periodic Review of Clinical Privileges and Performance'' (Sec.  
485.631(d)) is a more appropriate placement for the current provisions 
requiring a CAH to evaluate the quality of care provided by

[[Page 51783]]

their nurse practitioners, clinical nurse specialists, certified nurse 
midwives, physician assistants, doctors of medicine, or doctors of 
osteopathy.
3. Provision of Services (Sec.  485.635(a)(3)(vii))
    We currently require CAHs at Sec.  485.635(a)(3)(vii) to have 
procedures that ensure that the nutritional needs of inpatients are met 
in accordance with recognized dietary practices and the orders of the 
practitioner responsible for the care of the patients and that the 
requirement of Sec.  483.25(i) of this chapter is met with respect to 
inpatients receiving post-hospital SNF care.
    We proposed revisions to Sec.  485.635(a)(3)(vii) that would 
require that 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, we also proposed that the requirement of 
Sec.  483.25(i) of this chapter is met with respect to inpatients 
receiving post hospital SNF care.
    Comment: Commenters support CMS' efforts to allow clinicians to 
practice to the fullest extent of their credentials. The commenters 
stated that this proposed change at Sec.  485.635 requiring diets to be 
ordered by the practitioner responsible for the patient or a qualified 
dietitian or qualified nutrition professional as authorized by the 
medical staff and in accordance with state law, recognizes the 
specialized knowledge and training of dietitians and the benefit 
available to patients.
    Response: We appreciate the comments and will finalize this change 
as proposed.
4. Provision of Services (485.635(g))
    At Sec.  485.635(g) we proposed 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. We further proposed 
to require 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. After consideration of the comments that we 
received, we are not finalizing our proposal and are instead deferring 
to the non-discrimination requirements of Section 1557 of the 
Affordable Care Act. We refer readers to section III.B.3 of this final 
rule for a more detailed discussion.
5. Infection Prevention and Control and Antibiotic Stewardship Programs 
(Sec.  485.640)
    We proposed to remove the current requirements at Sec.  
485.635(a)(3)(vi) and Sec.  485.641(b)(2) and are adding a new 
infection prevention and control and antibiotic stewardship CoP at 
Sec.  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.
    We are finalizing the proposal that each CAH has 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.
    Comment: Commenters were supportive of the proposal to require each 
CAH to have facility-wide infection prevention and control and 
antibiotic stewardship programs that are coordinated with the CAH QAPI 
program. Commenters recognized that these changes will support a 
culture of antibiotic stewardship that will increase patient safety and 
quality of care.
    Response: We appreciate the comments received on the proposed 
changes for the CAH infection control and antibiotic stewardship 
programs and will finalize the changes as proposed.
    Comment: Commenters noted that CAHs would need time, resources, 
flexibility and support to adapt to the antibiotic stewardship 
requirements, especially given the fact that many do not have staff 
pharmacists available at all times.
    Response: We also appreciate these comments. While we understand 
that CAHs may have less resources available, we encourage CAHs to 
utilize the existing available resources to ensure the antibiotic 
stewardship requirements are met. While small and critical access 
hospitals face special challenges in implementing antibiotic 
stewardship programs, antibiotic stewardship is no less important in 
these settings. Small and critical access hospitals also have some 
factors that can support improvements in care, as they are often tight-
knit communities where collaboration is the norm. The CDC has resources 
available for training and education as well as support for providers 
implementing antibiotic stewardship programs specifically for CAHs. We 
also encourage CAHs to work with other hospitals or CAHs in their 
network (if available) for pharmaceutical support. CAHs should also be 
encouraged to work with their respective quality improvement 
network(s)/organization(s) and health departments for additional 
support and resources. Additionally, we encourage CAHs to use the 
technical assistance available from their State Flex Program. CAHs can 
find contact information for their State Flex Program at https://www.ruralcenter.org/tasc/flexprofile.
    Final Rule Action: We are finalizing the proposed changes without 
revision.
Sec.  485.640(a)(1) Through (2) Infection Control Officer(s); and 
Prevention and Control of Infections Within the CAH and Between the CAH 
and Other Healthcare Settings
    At Sec.  485.640(a)(1) we proposed that the CAH ensure that an 
individual (or individuals), who 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.
    We proposed at Sec.  485.640(a)(2) 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.
    Comment: Commenters were generally supportive of the proposal for 
CAHs to have a qualified individual (or individuals) in the role of the 
infection preventionist(s)/infection control professional(s).

[[Page 51784]]

    Response: We appreciate the comments received on the proposed 
changes for this CAH proposal.
    Final Rule Action: We are finalizing the proposed changes without 
revision.
Sec.  485.640(a)(3) Healthcare-Associated Infections (HAIs)
    We proposed at Sec.  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.
    Comment: Commenters were supportive of the proposal for CAHs to 
have an infection prevention and control program that includes 
surveillance, prevention, and control of HAIs.
    Response: We appreciate the comments received on the proposed 
changes for this CAH proposal.
    Final Rule Action: We are finalizing the proposed changes without 
revision.
Sec.  485.640(a)(4) Scope and Complexity
    We proposed at Sec.  485.640(a)(4) that the infection prevention 
and control program reflects the scope and complexity of the services 
provided by the CAH.
    Comment: Commenters were supportive of the proposal for CAHs to 
have an infection and prevention and control program that reflects the 
scope and complexity of the services provided by the CAH, with one 
commenter requesting that specific language stating that CRNAs and 
other anesthesia professionals should be included in the development 
and leadership of infection prevention and control programs in 
hospitals and CAHs.
    Response: We appreciate the comments received on the proposed 
changes for this CAH proposal. As noted in the preamble, as it relates 
to CAHs, staffing for these programs should be appropriate to the scope 
and complexity of the services offered at the CAH. We believe that CAHs 
should have the flexibility to include the individuals who are deemed 
appropriate by the CAH to be included in the development and leadership 
of these programs.
    Final Rule Action: We are finalizing the proposed changes.
Sec.  485.640(b)(1) Leader of the Antibiotic Stewardship Program
    We proposed at Sec.  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.
    Comment: Commenters were supportive of the proposal for the CAH's 
governing body to ensure that an individual with the appropriate 
experience is appointed as the leader of the antibiotic stewardship 
program. One commenter noted that this role will be fulfilled by a 
nurse who also has other related responsibilities and may not have the 
specialized training necessary for the infection preventionist role. 
The commenter encouraged CMS to ensure that cost effective and 
accessible education and training are available for CAH infection 
preventionists, and that ongoing technical assistance be provided. 
Additionally, the commenter requested infection preventionist expertise 
be available through shared services agreements across CAH networks or 
similar arrangements.
    Response: We appreciate the comments received on the proposed 
changes for this CAH proposal. The proposal requires that the leader of 
the antibiotic stewardship program be qualified through education, 
training, or experience in infectious diseases and/or antibiotic 
stewardship. We encourage CAHs to utilize the infection control 
training available and resources that are available through the CDC 
(https://www.cdc.gov/infectioncontrol/training/index.html). We 
encourage CAHs to reach out to other CAHs (within their network or 
otherwise) to collaboratively meet their needs of ensuring that a 
leader of the antibiotic stewardship program is available to meet the 
needs of the CAH and its patients.
    Final Rule Action: We are finalizing the proposed changes.
Sec.  485.640(b)(2)(i), (ii), and (iii) Goals of the Antibiotic 
Stewardship Program
    The proposed requirements at Sec.  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.
    We did not receive any comments on this proposal.
    Final Rule Action: We are finalizing the proposed changes.
Sec.  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.
    Comments for the identical hospital proposal are discussed with the 
hospital proposal in section II.B.4.
    Final Rule Action: We are finalizing the proposed changes.
Sec.  485.640(c)(1), (2), and (3) Governing Body; Infection Prevention 
and Control Professionals'; and Antibiotic Stewardship Program Leader's 
Responsibilities
    We proposed at Sec.  485.640(c)(1)(i) and (ii) 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 Sec.  485.640(c)(2)(i)-(vi), we proposed 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. Additionally, the infection preventionist(s)/
infection control professional(s) would be responsible for:

[[Page 51785]]

     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.
    Finally in this CoP, at Sec.  485.640(c)(3), we proposed 
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). We believe that a CAH's antibiotic stewardship 
program is the most effective means for ensuring appropriate antibiotic 
use. We also believe that such a program would require a leader 
responsible and accountable for its success. Therefore, we proposed 
that 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. We also 
propose that the leader of the antibiotic stewardship program would be 
responsible for all documentation, written or electronic, of antibiotic 
stewardship program activities. The leader would also 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.
    Finally, we proposed that the leader would 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.
    We did not receive any comments on this proposal.
    Final Rule Action: We are finalizing the proposed changes.
6. Quality Assessment and Performance Improvement (QAPI) Program (Sec.  
485.641)
    Since May 26, 1993 (58 FR 30630), the ``Periodic evaluation and 
quality assurance review'' CoP (Sec.  485.641) has not been updated to 
reflect current industry standards that utilize the QAPI model (Sec.  
482.21) to assess and improve patient care.
    We proposed to revise Sec.  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.
    We believe that much of the work and resources that are currently 
required under the existing periodic evaluation and quality assurance 
CoP would be utilized to adhere to the new QAPI requirement. We 
proposed to retain the requirements under paragraphs Sec.  
485.641(b)(3)-(4) regarding the evaluation of the diagnosis and 
treatment furnished by physicians and non-physician practitioners and 
relocate them to a new standard under the ``Staffing and staff 
responsibilities'' CoP at Sec.  485.631.
    Comment: Commenters generally agree with requiring CAHs to have a 
QAPI program that is integrated with all of the departments within a 
CAH. Commenters also agree with encouraging CAHs to use proven quality 
improvement data to improve the quality and safety of care provided. 
One commenter asked about requiring CAHs to report externally for 
comparative benchmarking and performance improvement activities. A few 
commenters stated that we should require CAHs to make informed choices 
about where they focus improvement work to ensure their efforts have a 
greater benefit to the patients and communities served. Some commenters 
were concerned that we underestimated the time and effort it would take 
CAH's to implement a new QAPI program. Also, commenters requested an 
implementation date that is one year after the publication of this 
final rule and that we provide technical assistance to CAHs for the 
implementation of these requirements.
    Response: We have taken into consideration the comment that we 
underestimated the time and effort it would take CAH's to implement 
these new QAPI requirements. We agree with an extended timeframe for 
implementation to allow CAHs additional time to prepare and ultimately 
comply with the requirements. Therefore, the requirements at Sec.  
485.641 must be implemented by 18 months after the effective date of 
this final rule. We also encourage CAHs to utilize the technical 
assistance and services for CAHs that are available through the State 
Flex Programs, including the Medicare Beneficiary Quality Improvement 
Project (MBQIP), supported by HRSA's Federal Office of Rural Health 
Policy. CAHs can find contact information for their State Flex Program 
on this page, https://www.ruralcenter.org/tasc/flexprofile. We do not 
require external reporting for comparative benchmarking and performance 
improvement activities as a condition of participation; however, we do 
require that CAHs maintain and demonstrate evidence of the 
effectiveness of its QAPI program.
    Finally, we have re-evaluated our proposed requirements to 
eliminate unnecessary prescriptiveness proposed under paragraph (c)(1) 
through (6); paragraph (e); and paragraph (f)(2) through (3) and are 
withdrawing those proposed provisions. These changes to the proposal 
will allow each CAH the flexibility to implement its QAPI program in 
the most efficient manner for its unique circumstances.
    We will require 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 Sec.  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. We noted in our proposal suggesting 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; however, we have removed the language 
referencing national quality reporting and quality performance program 
data from the regulatory text. We will expand on this and other 
examples of relevant data in the subregulatory guidance.
    This data must be used by the CAH to achieve the objectives of the 
QAPI program, including addressing outcome indicators related to 
improved health

[[Page 51786]]

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.
    In addition, since the QAPI requirement will replace the annual 
evaluation requirement, we believe that a large portion of the cost can 
be utilized for the QAPI program because CAHs are conducting many of 
the functions required for an effective QAPI program. CAHs are 
currently required to carry out an annual evaluation of its total 
program. They are to evaluate their health care policies and the 
appropriateness of the services they provide. All patient care services 
and other services affecting patient health must be evaluated. Also, we 
have removed some of the prescriptive requirements under proposed 
485.641(f)(2) through (3) for the QAPI program and recalculated the 
cost for implementation.
    Final Rule Decision: We are finalizing the proposal, but 
eliminating the following proposed requirements:
     Proposed paragraph (c)(1) through (6);
     Proposed paragraph (e); Performance improvement projects
     Revise the proposed requirement under paragraph (e) to 
remove the phrase, ``. . . such as data submitted to or received from 
national quality reporting and quality performance programs . . .'' and
     Proposed paragraph (f)(2 through (f)(3); Program data 
collection and analysis.
7. Technical Corrections
    We proposed to correct a typographical error in the regulations at 
Sec.  485.645 by correcting the word ``provided'' to ``provide'' in the 
lead first sentence. As proposed, the lead sentence would read as 
follows: ``A CAH must meet the following requirements in order to be 
granted an approval from CMS to provide post-hospital SNF care, as 
specified in Sec.  409.30 of this chapter, and to be paid for SNF-level 
services, in accordance with paragraph (c) of this section.'' As noted, 
we are also deleting an obsolete cross-reference to Sec.  482.12(c) in 
our revision of the regulations text at Sec.  482.61(d).

D. Requirements for Issuance of Regulations

    This final rule finalizes provisions set forth in ``Regulatory 
Provisions to Promote Program Efficiency, Transparency, and Burden 
Reduction (CMS-3346-P,'' published September 20, 2018 (83 FR 47686), 
``Hospital and Critical Access Hospital (CAH) Changes to Promote 
Innovation, Flexibility, and Improvement in Patient Care (CMS-3295-
P),'' published June 16, 2016 (81 FR 39448); and ``Fire Safety 
Requirements for Certain Dialysis Facilities (CMS-3334-P),'' published 
November 4, 2016 (81 FR 76899).
    Section 902 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and 
requires the Secretary, in consultation with the Director of the Office 
of Management and Budget, to establish and publish timelines for the 
publication of Medicare final regulations based on the previous 
publication of a Medicare proposed or interim final regulation. Section 
902 of the MMA also states that the timelines for these regulations may 
vary but shall not exceed 3 years after publication of the preceding 
proposed or interim final regulation except under exceptional 
circumstances.
    This final rule has been published within the 3-year time limit 
imposed by section 902 of the MMA for ``Hospital and Critical Access 
Hospital (CAH) Changes to Promote Innovation, Flexibility, and 
Improvement in Patient Care (CMS-3295-P),'' and ``Fire Safety 
Requirements for Certain Dialysis Facilities (CMS-3334-P),'' published 
November, 4, 2016 (81 FR 76899).
    Additionally, a continuation notice for ``Hospital and Critical 
Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and 
Improvement in Patient Care (CMS-3295-P) was published on June 11, 
2019, (84 FR 27069). Therefore, the final rule is in accordance with 
the Congress' intent to ensure timely publication of final regulations.

E. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    We are soliciting public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs).
1. ICRs Regarding Quality Assessment and Performance Improvement (Sec.  
482.21)
    The existing QAPI CoP requires each hospital to:
     Develop, implement, maintain, and evaluate its' own QAPI 
program;
     Establish a QAPI program that reflects the complexity of 
its organization and services;
     Establish a QAPI program that involves all hospital 
departments and services and focuses on improving health outcomes and 
preventing and reducing medical errors; and
     Maintain and demonstrate evidence of its QAPI program for 
review by CMS.
    We are finalizing a minor change to the program data requirements 
at Sec.  482.21(b). Currently, we require that hospitals incorporate 
quality indicator data including patient care data, and other relevant 
data, for example, information submitted to, or received from, the 
hospital's Quality Improvement Organization.
    We are updating this requirement to reflect and capitalize on the 
wealth of important quality data available to hospitals through several 
quality data reporting programs. Specifically, we are requiring that 
the hospital QAPI program must incorporate quality indicator data 
including patient care data, and other relevant data such as 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. Hospitals are likely to 
be participating in one or more existing quality reporting and quality 
performance programs such as the Hospital Inpatient Quality Reporting 
program, the Hospital Value-Based Purchasing Program, the Hospital 
Acquired Condition Reduction program, Hospital Compare, the Medicare 
and Medicaid Electronic Health Record

[[Page 51787]]

Incentive Programs, the Hospital Outpatient Quality Reporting program, 
and the Joint Commission's Quality CheckTM. Since a hospital 
is already collecting and reporting quality measures data for these 
programs, we do not believe that this change would increase the 
information collection burden for hospitals.
2. ICRs Regarding Nursing Services (Sec.  482.23)
    We are finalizing our proposal to revise Sec.  482.23(b), which 
currently states ``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,'' 
to delete the term ``bedside,'' which might imply only inpatient 
services to some readers. The nursing service must ensure that patient 
needs are met by ongoing assessments of patients' needs and must 
provide nursing staff to meet those needs regardless of whether the 
patient is an inpatient or an outpatient. We are allowing a hospital to 
establish a policy that would specify which, if any, outpatient units 
would not be required to have an RN physically present as well as the 
alternative staffing plans that would be established under such a 
policy. The policy must take into account factors such as the services 
delivered; the acuity of patients typically served by the facility; and 
the established standards of practice for such services. In addition, 
the policy must be approved by the director of nursing and be reviewed 
at least once every 3 years.
    TJC-accredited hospitals are already allowed this flexibility in 
nursing services policy. Those hospitals that use their TJC 
accreditation for deeming purposes are required to have ``Leaders [who] 
provide for a sufficient number and mix of individuals to support safe, 
quality care, treatment, and services. (Note: The number and mix of 
individuals is appropriate to the scope and complexity of the services 
offered.)'' (CAMH, Standard LD.03.06.01, EP 3). Further, TJC-accredited 
hospitals also require the ``nurse executive, registered nurses, and 
other designated nursing staff [to] write: Nursing policies and 
procedures.'' (CAMH, Standard NR.02.02.01, EP 3). Therefore, we expect 
that TJC-accredited hospitals already have the policies and procedures 
that satisfy the requirements in this subsection, including medical 
staff approval and regular review. If there are any tasks that a TJC-
accredited hospital may need to complete to satisfy the requirement for 
this subsection, we expect that the burden imposed would be negligible. 
Thus, for the approximately 3,900 TJC-accredited hospitals the 
development of policies and procedures that would satisfy this 
subsection would constitute a usual and customary business practice in 
accordance with 5 CFR 1320.3(b)(2).
    The non TJC-accredited hospitals would need to review their current 
policies and procedures and update them so that they comply with the 
requirements in Sec.  482.23(b). This would be a one-time burden on the 
hospital. We estimate that this would require a physician, a nurse, and 
one administrator. Including fringe benefits and overhead calculated at 
100% of one's hourly wage, we estimate that physicians earn a total 
hourly compensation of $191, administrators earn an average hourly 
compensation of $189, and registered nurses earn an hourly compensation 
of $71 (2017 BLS Wage Data by Area and Occupation at (https://www.bls.gov/oes/2017/may/oes_nat.htm). We estimate that each person 
would spend three hours on this activity for a total of nine hours at a 
cost of $1,353 (3 hours x $71 for a nurse's hourly wage + 3 hours x 
$189 for an administrator's hourly wage + 3 hours x $191 for a 
physician's hourly wage). For all 1,193 non-TJC-accredited hospitals to 
comply with this requirement, we estimate a total one-time cost of 
approximately $1.6 million (1,193 hospitals x $1,353). We estimate that 
review of the policies and procedures once every 3 years would take one 
hour for each individual included for a total cost of $538,043 ((1 hour 
x $71 for a nurse's hourly wage + 1 hour x $189 for an administrator's 
hourly wage + 1 hour x $191 for a physician's hourly wage) x 1,193 
hospitals), or an annualized cost of $179,347. The burden associated 
with these requirements will be captured in an existing information 
collection request (OMB Control No. 0938-0328).
3. ICRs Regarding Condition of Participation: Quality Assessment and 
Performance Improvement Program (Sec.  485.641)
    Sec.  485.641 would require CAHs to develop, implement, and 
maintain an effective, ongoing, CAH-wide, data-driven QAPI program. The 
QAPI program must be appropriate for the complexity of the CAH's 
organization and the services it provides. In addition, CAHs must 
comply with all of the requirements set forth in Sec.  485.641(b) 
through (e).
    The current CAH CoPs at Sec.  485.641 require CAHs to have an 
effective quality assurance program to evaluate the quality and 
appropriateness of the diagnosis and treatment furnished in the CAH and 
the treatment outcomes. CAHs are currently required to conduct a 
periodic evaluation and quality assurance review (42 CFR 485.641(a)). 
They are required to evaluate its total program (for example, policies 
and procedures and services provided) annually. The evaluation must 
include reviewing the utilization of the CAH services using a 
representative sample of both active and closed clinical records, as 
well as reviewing the facility's health care policies. The purpose of 
the evaluation is to determine whether the utilization of services was 
appropriate, the established policies were followed, and if any changes 
are needed. The CAH's staff considers the findings of the evaluation 
and takes corrective action, if necessary (42 CFR 485.641(b)(5)(i)). 
Thus, we believe that all of the CAHs are performing the activities 
that are required to comply with many of the requirements in Sec.  
485.641. However, we also believe that the CAHs would need to review 
their current quality assurance program and revise and, if needed, 
develop new provisions to ensure compliance with the requirements.
    TJC accreditation standards for performance improvement (PI) 
already require that CAHs collect, compile, and analyze to monitor 
their performance (TJC Accreditation Standard PI.01.01.01 and 
PI.02.01.01). These TJC-accredited CAHs must also improve their 
performance on an ongoing basis (TJC Accreditation Standard 
PI.03.01.01). Thus, we believe that the 349 TJC-accredited CAHs are 
already in compliance with the new requirements in Sec.  485.641. 
However, each CAH would need to review their current practice to ensure 
that they are in compliance with all of the requirements under Sec.  
485.641. Any additional tasks those CAHs would need to comply with the 
requirements for this section should result in a negligible burden, if 
any. Thus, the burden for these activities for the 349 TJC-accredited 
CAHs will be excluded from the burden analysis because they constitute 
usual and customary business practices in accordance with 5 CFR 
1320.3(b)(2).
    The 1,004 non TJC-accredited CAHs would need to review their 
current programs and then revise and develop new provisions of their 
programs to ensure compliance with the new requirements. We believe 
that the CAH QAPI leadership (consisting of a physician, and/or 
administrator, mid-level practitioner, and a nurse) would need to have 
at least two meetings to ensure that the current annual evaluation and 
quality assurance (QA)

[[Page 51788]]

program is transitioned into the QAPI format. The first meeting would 
be to discuss the current quality assurance program and what needs to 
be included based on the new QAPI provision. The second meeting would 
be to discuss strategies to update the current policies, and then to 
discuss the process for incorporating those changes. We believe that 
these meetings would take approximately two hours each. We estimate 
that the physician would have a limited amount of time, approximately 1 
hour to devote to the QAPI activities. Additionally, we estimate these 
activities would require 4 hours of an administrator's time, 4 hours of 
a mid-level practitioner's time, 8 hours of a nurse's time, and 2 hours 
of a clerical staff person's time for a total of 19 burden hours. We 
believe that the CAH's QAPI leadership (formerly the periodic 
evaluation and quality assurance leadership) would need to meet 
periodically to review and discuss the changes that would need to be 
made to their program. We also believe that a nurse would likely spend 
more time developing the program with the mid-level practitioner. The 
physician would likely review and approve the program. The clerical 
staff member would probably assist with the program's development and 
ensure that the program was disseminated to all of the necessary 
parties in the CAH. This burden estimate is slightly lower than what 
was published in the proposed rule because we re-evaluated our proposed 
requirements to eliminate unnecessary prescriptiveness. The finalized 
requirements are expected to allow more flexibility, and therefore 
slightly less burden. Since a CAH is currently required to evaluate its 
total program and evaluate the quality and appropriateness of the 
services furnished, take appropriate action to address deficiencies and 
document such activities, we believe that the resources utilized on the 
current QA program would be utilized for the ongoing QAPI activities 
under Sec.  485.641(b)-(e). Thus, we estimate that for each CAH to 
comply with the requirements in this section it would require 19 burden 
hours (1 for a physician + 4 for an administrator + 4 for a mid-level 
practitioner + 8 for a nurse + 2 for a clerical staff person) at a cost 
of $1,657 ($191 for a physician + $428 for an administrator (4 hours x 
$107) + $404 for a mid-level practitioner (4 hours x $101) + $568 (8 
hours x $71 for a nurse) + $66 for a clerical staff person (2 hours x 
$33). Therefore, for all 1,004 non TJC-deemed CAHs to comply with these 
requirements, it would require 19,076 burden hours (19 x 1,004 non TJC-
deemed CAHs) at a cost of approximately $1.7 million ($1,657 for each 
CAH x 1,004 non TJC-deemed CAHs). We note here the difference in hourly 
wage between a hospital CEO/administrator ($189) and a CAH CEO/
administrator ($107). This is estimated to be an additional 15,431 
hours and $1.3 million in cost compared to the existing QA burden. The 
burden associated with these requirements will be captured in an 
existing information collection request (OMB Control No. 0938-1043).

IV. Economic Analyses

A. Regulatory Impact Analysis for Regulatory Provisions To Promote 
Program Efficiency, Transparency, and Burden Reduction

1. Statement of Need
    All major and many ostensibly minor government regulations should 
undergo periodic review to ensure that they do not unduly burden 
regulated entities or the American people, and to reflect current 
knowledge as to their regulatory effects. In recent years, we have 
revised the CoPs and CfCs to reduce the regulatory burden on providers 
and suppliers. In doing so, we identified obsolete and burdensome 
regulations that could be eliminated or reformed to improve 
effectiveness or reduce unnecessary reporting requirements and other 
costs, with a particular focus on freeing up resources that health care 
providers, health plans, and States could use to improve or enhance 
patient health and safety. We also examined policies and practices not 
codified in rules that could be changed or streamlined to achieve 
better outcomes for patients while reducing burden on providers of 
care, and we identified non-regulatory changes that would increase 
transparency and allow CMS to become a better business partner.
    These final rule provisions are a continuation of our efforts to 
reduce regulatory burden. We are finalizing changes to the current CoPs 
or CfCs that will simplify and streamline the current regulations and 
thereby increase provider flexibility and reduce excessively burdensome 
regulations, while also allowing providers to focus on providing high-
quality healthcare to their patients. The final rule provisions will 
also reduce the frequency of certain required activities and, where 
appropriate, revise timelines for certain requirements for providers 
and suppliers and remove obsolete, duplicative, or unnecessary 
requirements. Ultimately, these requirements balance patient safety and 
quality, while also providing broad regulatory relief for providers and 
suppliers, and reducing the associated burden on patients.
2. Overall Impact
    We have examined the impacts of the regulatory provisions to 
Promote Program Efficiency, Transparency, and Burden Reduction as 
required by Executive Order 12866 on Regulatory Planning and Review 
(September 30, 1993), Executive Order 13563 on Improving Regulation and 
Regulatory Review (January 18, 2011), the Regulatory Flexibility Act 
(RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the 
Social Security Act, section 202 of the Unfunded Mandates Reform Act of 
1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on 
Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 
804(2)), and Executive Order 13771 on Reducing Regulation and 
Controlling Regulatory Costs (January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). We estimate that this rulemaking is ``economically significant'' 
as measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly,

[[Page 51789]]

we have prepared an RIA that, to the best of our ability, presents the 
costs and benefits of these provisions of the rulemaking.
    This final rule will create ongoing cost savings to providers and 
suppliers in many areas. Other changes we are finalizing will clarify 
existing policy and relieve some administrative burdens. We have 
identified other kinds of savings that providers and patients will 
realize throughout this preamble, and substantial lifesaving benefits. 
These life-saving effects arise by removing the incentives that were 
created by the current transplant center regulations to decline to 
transplant patients with slightly lower probabilities of success, or to 
decline to use organs with slightly lower probabilities of success.
    We sought public comment on our burden assumptions and estimates as 
well as comments identifying additional reforms that should be 
considered for future rulemakings. As discussed later in this 
regulatory impact analysis, substantial uncertainty surrounds these 
estimates and we solicited comments on either our estimates of likely 
impacts or the specific regulatory changes that drive these estimates. 
We received, however, few comments specifically addressing our 
estimates. In the proposed rule, we solicited additional suggestions 
for things to consider that could potentially reduce burden for 
providers/suppliers in the future.
    Comment: We received many submissions related to possible 
additional changes in CoP/CfCs to reduce burden. For example, we 
received a number of suggestions related to additional reforms 
regarding the removal of barriers to the use of nurse anesthetists that 
could be considered for future rulemakings.
    Response: Thank you for all the comments that were submitted with 
suggestions on how we can improve the CoPs/CfCs. Some of the 
suggestions are burden reducing, however some of the suggestions would 
be burdensome. Regardless, we will take all the suggestions in to 
consideration for future rulemaking.
    Comment: Several commenters expressed that costs or savings 
attributed to QAPI, infection prevention, recertification efforts, and 
emergency training may have been underestimated due to the exclusion of 
consideration for technology changes, or other factors, in the proposed 
rule estimates.
    Response: We thank you for your comments and recognize the 
uncertainty involved in our estimates. Some of our estimates have been 
updated to reflect new information to the extent that we are able; 
however, we lack the data that would be necessary to make major 
adjustments to many of the estimates.
    Comment: One commenter inquired about what happens with all the 
savings being estimated for each provider or supplier.
    Response: The estimated savings from reducing burden for the 
providers/suppliers will allow the providers and suppliers to use those 
savings towards other necessary needs. We anticipate that they will 
have more time for patient care, and that the savings represent 
expenses that providers and suppliers will no longer have to incur now 
that we have finalized these proposals or made modifications. Some of 
these savings will be passed on to patients in reduced charges, but 
most will reduce costs charged to insurers, which will over time reduce 
insurance premiums to enrollees, public programs, and employer payers.
    In the analysis that follows, we address the economic effects of 
all the major provisions of the final rule provisions. As pertinent, we 
indicate any significant changes from the proposed rule estimate. The 
analysis generally follows the typology used earlier in the preamble, 
and in the table that follows. As stated in the ICR section of the 
rule, we obtained all salary information from the May 2017 National 
Occupational Employment and Wage Estimates by the Bureau of Labor 
Statistics (BLS) at https://www.bls.gov/oes/2017/may/oes_nat.htm and 
calculated the total cost per hour by adding a cost of 100 percent for 
overhead costs and fringe benefits.

                             Table 13--Section-by-Section Economic Impact Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of
   Provider and supplier type and            Frequency            affected       Estimated savings (annualized,
 description of proposed provisions                               entities                 $millions)
----------------------------------------------------------------------------------------------------------------
Religious Nonmedical Health Care
 Institutions:
     Discharge Planning.....  As patients are                      18  (*)
                                       discharged (Estimated
                                       619 annual discharges).
Ambulatory Surgical Centers:
     Governing Body and       Upon failed hospital              5,557  (*)
     Management.                       transfer agreement
                                       attempts.
     Patient Admission,       Every patient                     5,557  77.
     Assessment and Discharge          registration at an ASC
     (History and Physical).           or at a hospital
                                       outpatient/ambulatory
                                       surgery department.
     Medical Records........  Recurring annually.....           5,557  0.
Hospices:
     Drugs and Biologicals,   Recurring annually.....           4,602  94.
     Medical Supplies, and Durable
     Medical Equipment ***.
     Hospices That Provide    Recurring annually.....           4,602  1.
     Hospice Care to residents of a
     SNF/NF or ICF/IID.
     Hospice Aide and         Recurring annually.....           4,602  2.
     Homemaker Services.
Hospitals:
     Quality Assessment and   Recurring annually.....           4,823  31.
     Performance Improvement Program.
     Medical staff:           Recurring annually.....           4,823  0.
     Autopsies.
     Infection Control......  Recurring annually.....           4,823  115.
     Special requirements     Recurring annually.....             478  30.
     for hospital providers of long-
     term care services (``swing-
     beds'').
     Special Requirements     Recurring annually.....             620  154.
     for Psychiatric Hospitals.
     Patient Admission,       Every patient                     4,823  77.
     Assessment and Discharge          registration at an ASC
     (History and Physical).           or at a hospital
                                       outpatient/ambulatory
                                       surgery department.
Transplant programs:
     Various provisions       Recurring annually.....             750  Not Quantified.
     related to performance **.

[[Page 51790]]

 
Home Health Agencies:
     Patient rights.........  Recurring annually.....          12,624  57.
     Home health aide         Recurring annually.....          12,624  Not Quantified.
     services.
     Clinical records.......  Recurring annually.....          12,624  Not Quantified.
Critical Access Hospitals:
     Provision of Services..  Recurring biennially...           1,353  1.
     Organizational           Recurring annually.....           1,353  (*)
     structure.
     Special requirements     Recurring annually.....           1,246  77.
     for CAH providers of long-term
     care services (``swing-beds'')..
Comprehensive Outpatient
 Rehabilitation Facilities:
     Utilization Review Plan  Recurring annually.....             188  (*)
Community Mental Health Centers:
     Assessment Update......  Recurring annually.....              52  (*)
Portable X-Ray Services:
     Qualifications of X-ray  Recurring annually.....             500  31.
     technicians ***.
     Removing written orders  Recurring annually.....             500  28.
RHC (4,160 clinics) & FQHC (7,874
 center locations):
     Patient Care Policies    Recurring biennially...          12,034  4.
     Review.
     Program Evaluation.....  Recurring biennially...          12,034  5.
Emergency Preparedness for Providers
 and Suppliers:
     Review of Emergency      Recurring biennially...          56,983  70.
     Preparedness Program.
     Emergency Plan.........  Recurring annually.....          68,275  7.
     Training and Testing--   Recurring biennially...          53,543  26.
     Training Program.
     Training and Testing--   Recurring annually.....          36,971  21.
     Testing.
----------------------------------------------------------------------------------------------------------------
* Amount is less than half a million dollars and rounds to zero.
** These include proposed changes to the following requirements: Special Requirements for Transplant Programs;
  Data submission, Clinical Experience, and Outcome Requirement for Re-approval of Transplant Programs; and
  Special Procedures for Approval and Re-Approval of Organ Transplant Programs.
*** This estimate is for first full year savings only and will differ in future years.

3. Anticipated Effects
a. Effects on Religious Nonmedical Health Care Institutions
    As detailed in the Collection of Information section addressing 
these provisions, we reduced the discharge planning requirements for 
RNHCIs because RNHCIs do not provide medical treatment or services. 
Most patients are discharged to home or to another facility that also 
does not provide medical treatment or services. Although all patients 
must have a discharge planning evaluation, not all patients require a 
discharge plan. The discharge planning cost would be reduced by an 
estimated $22,903.
b. Effects on Ambulatory Surgical Centers and Hospital Outpatient/
Ambulatory Surgery Departments
    As of May 2017 there were 5,557 Medicare-participating ASCs. We 
finalized our proposal to revise the ASC CfCs in order to reduce 
unnecessary duplications and streamline processes in order to reduce 
ASC compliance burden while maintaining minimum standards for patient 
safety and care. The specific savings for each change are described 
later in this section of the rule. At Sec.  416.41(b)(3), we are 
removing transfer agreements and admitting privileges requirements and 
replacing it by mandating ASCs must periodically provide the local 
hospital with written notice of its operation and patient population 
served. This change eliminates the administrative burden associated 
with preparing an agreement for signature and going through the 
hospital credentialing process in order to obtain admitting privileges. 
Currently, all Medicare-certified ASCs are meeting the transfer 
agreement or admitting privileges requirement with the exception of 
approximately twenty ASCs that have tenuous relationships with their 
local hospital. We estimate the ASCs that do have difficulty with 
meeting this requirement would appreciate the annual burden savings of 
2 to 4 administrator hours spent on paperwork and documentation. For 
those ASCs that already have transfer agreements with their local 
hospitals, the administrative burden is removed since transfer 
agreements and admitting privileges are eliminated, however, 
administrative burden is then replaced by the preparation and 
completion of the notice of operation requirement. For this reason, we 
have not assigned any additional burden created by the notice to the 
local hospital requirement. We estimate the savings at less than 
$10,000 overall and largely believe this change will not produce 
significant savings, however, it does affect twenty or more ASCs in the 
short term by removing the transfer agreement requirement. We welcomed 
any feedback related to the time and effort for those ASCs that have 
secured an agreement, and if we have underestimated the savings of 
removing this transfer agreement in the future. As previously 
discussed, the enactment of EMTALA and its increasingly effective 
enforcement over time has rendered these transfer and admitting 
privileges obsolete and unnecessary. To put this point in perspective, 
emergencies or other unforeseen adverse events can arise in any 
ambulatory medical or dental setting, or in home settings. Over time, 
``911'' emergency calls and direct ambulance responses have become 
standard operating procedures virtually nationwide, regardless of the 
place in which the problem arose. Under modern procedures, emergency 
responders (and patients themselves) take patients to hospital 
emergency rooms without regard to prior agreements between particular 
physicians and particular

[[Page 51791]]

hospitals. Indeed, the most appropriate emergency treatment setting for 
a particular patient may not be one involving such an agreement, even 
where the agreement exists. Of course, nothing prevents particular 
arrangements where a hospital and ASC agree that this is beneficial for 
a particular type of surgery or patient condition and where patient 
transport can be appropriately arranged to reflect this. Accordingly, 
we estimate that there will be no consequential adverse health effects 
of this change, and therefore estimate no medical costs.
    There will be competitive benefits in those places where an ASC 
will now be allowed to operate and provide care at reduced cost 
compared to inpatient treatment. Nonetheless, we believe that the 
number of affected areas and facilities are few, and that annual 
benefits are unlikely to reach the million dollar range. We sought 
comments on all these effects and on the preceding analysis of health 
effects and the majority of those we received agreed with our proposed 
reform.
    At Sec.  416.52 we are replacing the requirement that every patient 
must have a comprehensive H&P within 30 days prior to surgery in an 
ASC, with a requirement that allows the operating physician and ASC to 
determine which patients would require more extensive testing and 
assessment prior to surgery. We believe that this change reduces 
patient and provider burden in a multitude of ways that includes the 
community-based physician, the ASC, and the patient. We believe that in 
almost all situations ASCs can reasonably rely on existing H&P results 
that are more than 30 days old and then are updated by patient 
responses just prior to surgery.
    For ASCs, we believe this change would reduce administrative burden 
by decreasing the amount of time that ASC personnel spend following up 
on patient visits to obtain the necessary H&P information and that it 
will provide for an increase in scheduling flexibility for the 
facility. We believe these changes may have the effect of improving 
patient satisfaction and increasing positive patient referrals for the 
ASC.
    For community-based healthcare providers, to include primary care 
providers, we believe this change would reduce unnecessary examinations 
that are required to be performed and reduce administrative paperwork 
burden associated with providing ASCs with the necessary H&P 
documentation and additional testing requirements. This change may 
potentially provide an opportunity for increased access to community-
based providers because of available appointments that are not being 
filled by unnecessary patient appointments for H&P requirements for 
surgery in an ASC. Those vacant appointments may also generate more 
revenue.
    For patients, we believe this change reduces the time spent to 
prepare for surgery (time in community-based physician office, travel 
time and costs, time missed from the work place and lost productivity) 
and the cost associated with co-pays and other healthcare cost sharing 
requirements.
    Finally, we believe this change reduces expenses for healthcare 
insurers to include Medicare, Medicaid, and private healthcare 
insurance companies. This change would reduce costs associated with 
reduced pre-operative exams, laboratory testing, chest radiographs, and 
echocardiograms.
    In the proposed rule we stated that it is difficult to estimate the 
savings from this change, because they depend on a number of factors 
previously described, and additional factors for which we do not have 
precise measures, such as the number of patients (both Medicare and 
non-Medicare) who received two or more ASC services within the 30-day 
window allowed for one physical examination. This is a common 
occurrence because, for example, patients often receive cataract 
surgery on one eye and then, a week later, on the other eye. 
Furthermore, there are an immense number of different outpatient 
surgical services. At present, for example, there are about 137 
services that account for about 90 percent of ASC volume, and these 
services are highly diverse, as shown in Table 14.

           Table 14--Twenty Most Frequent ASC Services in 2015
------------------------------------------------------------------------
                                                            Percent of
            Surgical service                   Rank           volume
------------------------------------------------------------------------
Cataract surgery w/IOL insert...........               1            18.6
Upper GI endoscopy, biopsy..............               2             8.2
Colonoscopy and biopsy..................               3             6.8
Lesion removal colonoscopy (snare                      4             5.6
 technique).............................
Inject foramen epidural: Lumbar, sacral.               7             4.8
After cataract laser surgery............               6             4.4
Injection spine: Lumbar, sacral (caudal)               8             3.3
Inject paravertebral: Lumbar, sacral....               9             3.1
Diagnostic colonoscopy..................               5             2.3
Colorectal screen, high-risk individual.              10             2.0
Colorectal screen, not high-risk                      12             1.9
 individual.............................
Cataract surgery, complex...............              11             1.6
Injection procedure for sacroiliac                    19             1.3
 joint, anesthetic......................
Cystoscopy..............................              15             1.2
Upper GI endoscopy, diagnosis...........              13             1.0
Inject spine, cervical or thoracic......              17             1.0
Revision of upper eyelid................              16             0.9
Lesion removal colonoscopy (hot biopsy                14             0.8
 forceps)...............................
Upper GI endoscopy, insertion of guide                18             0.8
 wire...................................
Carpal tunnel surgery...................              20             0.7
                                         -------------------------------
    Total...............................  ..............            70.4
------------------------------------------------------------------------
Source: MEDPAC. Ambulatory surgical center services. 2017, p. 140.

    In total, ASCs provided about 6.4 million services in 2015 (MEDPAC. 
Ambulatory surgical centers services, 2017, p. 139). If we assume that 
25 percent of these patients had two or more services within the 30-day

[[Page 51792]]

``window'' allowed in the current rule, then another H&P with its 
associated battery of tests were required for each of the remaining 4.8 
million individuals. Assuming that 5 percent of these patients would 
otherwise have already had an overall H&P and associated tests within 
30 days of the surgery, 4.56 million persons would then require a new 
H&P and tests before surgery under the current requirements. In the 
great majority of cases involving eye or eyelid surgery of one kind or 
another, the ophthalmology examination preceding the ASC surgery would 
not have involved a comprehensive H&P or battery of tests, and a 
similar situation would be involved for most other surgeries preceded 
by specialist rather than primary care visits.
    Although we are unable to estimate the likely number of cases, one 
way to estimate the costs of these examinations and tests would be as 
follows. First, the H&P itself would cost approximately $100 (the exact 
amount depending on diagnostic details, and not necessarily 
corresponding to any particular payment schedule). The battery of tests 
would cost approximately $100, assuming both urine and blood testing, 
and, in some cases, an electrocardiogram, but only half of physical 
examinations (for example, few or no ophthalmologist exams) would 
include such tests. The travel of the patient to and from the physician 
office to obtain the examination and tests would on average require 1 
hour, which when valued at the average wage rate in the economy of $24 
(increased by 50 percent to include fringe benefits but not overhead) 
would cost about $36. In addition, ASCs incur substantial costs for the 
time and trouble needed to contact physician offices and arrange for 
the results to be delivered. The physician offices themselves would be 
put through the trouble of transferring those medical records. Assuming 
average time spent (the median would be less but a small number of 
difficult cases would bring the average well above the median) would 
reach 10 minutes, and the use of a general office clerk at $33 an hour, 
the cost per patient would average $5.50 per patient. A further cost 
arises because in many cases the examination and test results simply 
cannot be obtained timely, and a scheduled surgery has to be postponed. 
Assuming that in such cases a half hour of surgeon time (at $242 an 
hour) and a half hour of registered nurse (RN) time (at $71 an hour) is 
wasted, and that clerical time ($33 an hour) to reschedule averages 10 
minutes, the average cost per postponement would be $162. (In some of 
these cases patient time would be wasted, as well as the time of family 
members accompanying the patient--we have not estimated these costs.)
    Aggregating these calculations, one estimate of the annual costs of 
the current regulatory requirement, as shown in Table 15, could be as 
much as $908 million for ASCs and a similar amount for hospital 
outpatient surgery. For many and perhaps most cases, however, either 
the surgeon or the facility would decide that H&P information is needed 
for particular patients or particular procedures, whether or not this 
regulatory requirement existed. Of course, it is unlikely that in such 
cases a strict 30-day window would be insisted on. Assuming that such 
examination and testing information would continue to be needed for 10 
percent of all patients, and that in half of these cases the 
information would require a new examination and tests within a 30-day 
window, the net costs of the regulatory reform we proposed would be 95 
percent less than the preceding calculations.
    As support for the proposed rule's 50 percent upper bound, the 
proposed rule preamble (83 FR 47733) noted that Chen et al. found that 
approximately 53 percent of Medicare cataract patients undergo pre-
operative testing, none of which is mandated by CMS regulation.\2\ If 
these patients' physicians are cautious enough to currently pursue more 
preoperative activity (for example, testing and H&P) than what is 
required, or state or hospital rules are driving physician behavior 
beyond what Medicare necessitates, then this study might be interpreted 
to suggest that there is little reason to believe that that behavior 
will change with the finalization of this rule. This study did not, 
however, address the 30-day time frame. We are unaware of any study or 
body of opinion suggesting that 30 days or any such arbitrary time 
limit can be medically justified, or that any providers would adhere to 
such a limit if not a regulatory requirement. The same points apply to 
other procedures performed in outpatient settings, even those such as 
hernia and plastic surgeries. In order to more successfully tailor the 
upper bound of potential cost savings to H&P activity--rather than just 
extrapolating from testing behavior--we requested comment on the 
possibility of building on Chen et al.'s data and methodology to 
estimate the increased frequency of within-30-day office visits 
(presumed to be H&P) when ophthalmologist visits are at least 31 days 
prior to surgery relative to when ophthalmologist visits are no more 
than 30 days prior. We received no comments supporting (or opposing) 
such an estimating procedure. Regardless, laboratory testing and 
physical examinations have no particular dependence on each other in 
terms of time or place. A physician, for example, can order a 
laboratory test for a patient without a physical examination at all, 
relying on a one or two year old examination or other information. 
Hence, the literature on the necessity of testing is not directly 
germane to the question of whether a routine physical examination 
should occur, with or without routine blood and urine tests. To take a 
common example, it is universal practice for highly detailed eye tests 
to be performed in the surgeon's office, a week or so before cataract 
surgery. It is that testing on that highly specialized equipment, not a 
recent physical examination or blood tests ordered by a general 
practitioner, that determines whether, how, and with what techniques 
and lens inserts the cataract surgery will be performed.
---------------------------------------------------------------------------

    \2\ Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, 
Maze M, Gropper MA and Dudley RA, Preoperative Medical Testing in 
Medicare Patients Undergoing Cataract Surgery. New England Journal 
of Medicine 372:1530-1538, April 16, 2015.
---------------------------------------------------------------------------

    As noted in the medical literature previously discussed, Chung F, 
Yuan H, Yin L, Vairavanathan S, and Wong DT. Elimination of 
preoperative testing in ambulatory surgery. Anesth Analg. 2009 Feb, 
108(s):467-75, there are no known consequential medical benefits from 
the testing often performed in association with the current regulatory 
requirements for general physical examinations. This study covered 
hernia patients but similar results have been found in studies of 
cataract surgery. Accordingly, eliminating the testing that occurs 
during or after H&P could in theory produce very substantial annual ASC 
cost savings with no offsetting medical cost increases or harm to 
patients. H&P itself, however, is distinct from testing, and literature 
indicating that testing is wasteful does not necessarily speak to the 
importance of H&P. There are, however, no known studies supporting the 
proposition that H&P procedures should be performed within 30 days of 
surgery to avoid adverse consequences to patients. We received no 
public comments making such a claim and the great majority of those 
addressing this issue recommended removing at least the 30-day rule, 
and usually the entire requirement.

[[Page 51793]]

    In addition, Schein et al. and Bass et al. suggest that regulations 
play a prominent role in the persistence of low-value H&Ps and testing. 
They note that prior research indicates that it may often be the case 
that each member of a care team individually believes there is little 
value in preoperative testing for certain procedures, but those same 
individual physicians may fear that one or more of the other 
specialists or the institution may require certain tests.3 4 
Therefore, the requirement for a preoperative H&P, especially within 30 
days of a surgery, greatly increases the likelihood for 
miscommunication among the care team regarding what tests may or may 
not be required. It follows that the persistence of low-value testing 
may simply be due to our requirement for what are often low-value H&Ps, 
as opposed to an indication that care teams are consciously pursuing 
preoperative care beyond what Medicare requires, or that they would 
continue to do so in the absence of such a requirement.
---------------------------------------------------------------------------

    \3\ Schein OD, Pronovost PJ. A Preoperative Medical History and 
Physical Should Not Be a Requirement for All Cataract Patients. J 
Gen Intern Med. 2017;32(7):813-814. doi:10.1007/s11606-017-4043-9.
    \4\ Bass EB, Steinberg EP, Luthra R, et al. Do Ophthalmologists, 
Anesthesiologists, and Internists Agree About Preoperative Testing 
in Healthy Patients Undergoing Cataract Surgery? Arch Ophthalmol. 
1995;113(10):1248-1256. doi:10.1001/archopht.1995.01100100036025.
---------------------------------------------------------------------------

    As discussed in ``Provisions of the Proposed Regulations,'' section 
II.D. 2. of the proposed rule, there is a similar regulatory 
requirement for hospital outpatient surgery. Based on the substantial 
similarity between these two service settings, we also proposed to 
eliminate these requirements for such surgery. Although we do not have 
detailed data for hospital outpatient surgery, it is widely agree to be 
roughly equal in size and composition to ASC surgery, though spending 
is higher because a higher payment schedule is used by some insurers, 
including Medicare, for most hospital outpatient surgery. Regardless, 
estimates should be based on economic costs, not any particular payment 
schedules. Accordingly, potential total annual savings, and hence 
benefits, for both settings taken together could be as much as $1.7 
billion or more. This would depend on whether hospital-based outpatient 
surgery decisions parallel those of independent ASCs.
    If, after ASCs and hospitals make policy decisions on which types 
of outpatient/ambulatory surgery patients would continue to require a 
comprehensive H&P, and only 50 percent of current costs were continued, 
potential total annual savings, and hence benefits, for both settings 
taken together would be about $908 million, assuming that hospital-
based outpatient surgery H&P policy decisions parallel those of 
independent ASCs. Alternatively, if 75 percent of current costs were 
continued, potential savings would be about $454 million annually. 
While the literature shows that we can be reasonably certain that for 
some procedures, such as cataract surgery, few or possibly even no 
costs would be self-imposed, there may be other procedures where 
ensuing policy decisions would retain all current history and physical 
requirements other than the strict 30-day rule. Because of the new 
requirements, and other uncertainties, the potential savings from 
lifting the current requirements encompass at least this broad range 
and quite possibly more. Because there was great uncertainty in these 
estimates as to future decisions by ASCs and hospital outpatient 
departments, we decided not to present a predetermined figure in the 
proposed rule. Instead, we requested public comments on all the 
parameters of our estimates to inform the estimates we would make in 
the final rule. We welcomed information on likely decisions in both ASC 
and hospital outpatient settings, and if possible for the most common 
procedures shown in Table 14 and for the likelihood and cost saving 
effects for procedure and patient categories where the facility chooses 
to retain an external H&P requirement, but extends the time window to a 
year or some other period that is far longer than 30 days. We did not 
receive any public comments on the dollar estimates but did receive a 
large number of public comments stating that the current H&P 
requirements in their entirety and/or the 30-day limit did not rest on 
any medical evidence of benefits to patients, and should be removed. 
Even those few comments supporting retention provided no medical 
evidence as to the necessity of applying either an H&P requirement or a 
30-day requirement to most outpatient surgeries.

  Table 15--Current Costs and Potential Annual Savings From Creating and Obtaining Examination and Test Results
----------------------------------------------------------------------------------------------------------------
                                                                       Twenty-               Seventy-   Eighty-
                                                            Current      five      Fifty       five       five
            Type of cost                Unit      Number     total     percent    percent    percent    percent
                                        cost       (M)        cost     retained   retained   retained   retained
                                                              ($M)       ($M)       ($M)       ($M)       ($M)
----------------------------------------------------------------------------------------------------------------
Physical Examinations..............       $100       4.56       $456       $114       $228       $342       $388
Test Batteries.....................        100       2.28        228         57        114        171        194
Patient Travel Cost................         36       4.56        164         41         82        123        140
Administrative Cost to ASC.........          5       4.56         23          6         11         17         19
Surgery Cancellations *............        162      0.228         37          9         18         28         31
                                    ----------------------------------------------------------------------------
    Total Cost, ASCs...............  .........  .........        908        227        454        681        772
                                    ----------------------------------------------------------------------------
    Total Cost, Hospital Outpatient  .........  .........        908        227        454        681        772
     **............................
                                    ----------------------------------------------------------------------------
    Total Cost.....................  .........  .........      1,816        454        908      1,362      1,544
                                    ----------------------------------------------------------------------------
    Total Savings..................  .........  .........  .........      1,362        908        454        272
----------------------------------------------------------------------------------------------------------------
* Based on information from a major ambulatory surgery facility, this estimate assumes that 5 percent of
  scheduled cataract operations are cancelled at the last minute since the required H&P information has not
  arrived from the physician office where the examination was performed and the tests ordered or performed.
  Staff salaries must still be paid. Our estimates assume one half hour of surgeon time wasted (at $242 an
  hour), one half hour of RN time wasted (at $71 an hour), and ten minutes of clerical time (at $33 an hour) to
  reschedule.
** Hospital outpatient savings assumed to be equal to ASC savings.


[[Page 51794]]

    We assume that the one-time costs of developing such policies for 
hospital outpatient surgery in 4,823 Medicare-participating hospitals 
would be the same in the aggregate, though the mix of personnel used 
would be somewhat different and the cost at free-standing hospitals 
would likely be several times higher (for example, for involvement of 
the governing body and legal review). About 3,200 of these hospitals 
are in multi-hospital systems that would, however, reap economies of 
scale, and about 574 are psychiatric hospitals that we assume rarely 
perform surgery. In total, we estimate that, first year savings for 
both types of facilities would be $38 million less, regardless of the 
replacement rules that each facility imposed on itself.
    There are possible alternatives, including limiting the regulatory 
reform to the lowest risk procedures, which would probably mean almost 
all procedures, excluding certain procedures from the regulatory 
reform, exempting ASCs, but not hospital outpatient departments, 
changing the 30-day requirement to something much longer in duration 
such as 6 months or a year, and likely others. Absent contrary 
evidence, however, we believe that relying on physician and facility 
judgment maximizes benefits and presents no consequential costs.
    We welcomed comments on these estimates and on both the proposal 
and any alternatives, and particularly welcomed any evidence-based 
information that would inform both our ability to provide cost savings 
estimates and a policy choice between either the proposed reform or an 
alternative. We did not receive any public comments specific to our 
cost estimates or recommending any alternative reform.
    In the proposed rule we stated that we could not forecast with any 
precision what medical specialty societies, ASC governing bodies, 
hospital governing bodies, or accreditation bodies would decide to do 
in replacing the current requirement. For these reasons, we did not 
forecast a specific level of cost savings in the proposed rule, and 
simply presented a range of from 25% to 75% (and possibly even higher 
or lower). The comments we received from a wide range of stakeholders 
suggest that there might be more ASCs than we anticipated that take 
advantage of the new flexibility to reduce either the numbers and types 
of procedures for which H&P would be required, or to expand the 30-day 
limitation to a greater time window, or both. Moreover, the largest 
organization deemed by CMS to provide standards at least equal to those 
of CMS, and allowed to accredit providers based on those standards, 
strongly endorsed replacing the current standard with one allowing 
procedure-specific medical judgment, as did several organizations 
representing professional societies or large provider organizations. 
There are, however, some organizations in some states and some 
providers that indicated they opposed any loosening of current 
restrictions. Our final rule would allow them to self-impose identical 
restrictions, and allow all affected providers to retain current 
restrictions for some categories of surgery.
    As noted previously, in order to more successfully tailor the upper 
bound of potential cost savings, we built on Chen et al.'s methodology 
to estimate the increased frequency of within-30-day office visits 
(presumed to be H&P) when ophthalmologist visits are at least 31 days 
prior to surgery relative to when ophthalmologist visits are no more 
than 30 days prior (and thus aspects of their own medical examinations 
could be used to satisfy time-sensitive regulatory requirements). More 
specifically, we used Medicare fee-for-service claims data for 
procedures performed in hospitals on an outpatient basis or in 
ambulatory surgical centers; following Chen et al., we limited our 2017 
data set to cataract surgeries performed on patients of at least age 66 
and assumed office visits within 30 days prior to surgery were 
associated with H&P if the provider specialty was noted as general 
practice, anesthesiology, cardiology, family practice, internal 
medicine, geriatric medicine, nurse practitioner or physician 
assistant. The dependent variable in our logistic regression took the 
value 1 if an office visit, with a specialty as listed above, had been 
conducted within 30 days prior to cataract surgery and 0 otherwise. The 
key explanatory variable took the value 1 if an ophthalmologist visit 
(identified if the provider specialty was noted as ophthalmology) was 
within 30 days prior to surgery and 0 if it was at least 31 days prior. 
Control variables included patient year of birth, sex and race.
    Using this methodology to model the probability that the dependent 
variable is equal to 1, the odds ratio of the key explanatory variable 
is 0.654 (95 percent confidence interval: 0.633-0.676). There are, 
however, several limitations to this method of analysis. Most notably, 
identifying ophthalmology visits by the physician specialty code proved 
to be unreliable, and it is unclear how many ophthalmology visits may 
have been missed because the physician specialty field was either blank 
or noted as unknown. We removed all beneficiaries from our analysis who 
underwent a cataract surgery in 2017, yet did not have any identifiable 
ophthalmology visits within that same calendar year, which limited our 
data set substantially.
    Our overall estimate is that approximately 28 percent of cataract 
surgeries were preceded, within 30 days, by office visits. In the 
vicinity of a 28-percent rate, a roughly 8- or 9-percentage-point 
difference in rates yields an odds ratio of 0.654. Therefore, 8.5 
percent will be used in the calculation of our primary savings 
estimate, with an upper bound on savings of 17 percent and a lower 
bound of zero.
c. Effects on Hospices
    As of May 2017 there are 4,602 Medicare participating hospices. We 
are finalizing our revisions the hospice CoPs in order to reduce 
unnecessary duplications and streamline processes in order to reduce 
hospice compliance burden while maintaining minimum standards for 
patient safety and care.
    At Sec.  418.76(a) we finalized our proposal to defer to State 
training and competency requirements, where they exist, for hospice 
aides. Deferring to state requirements will streamline the hiring 
process because hospices would not have to verify that a job 
candidate's qualifications meet or exceed the Federal standard in 
addition to verifying that the candidate meets State requirements.
    According to the BLS, 408,920 aides are currently employed in 
``home care''. The term ``home care'' encompasses both home health 
agency and hospice employers. There are 12,624 HHAs and 4,602 hospices, 
meaning that hospices represent 27 percent of the ``home care'' 
employer market. Thus, we conclude that hospices employ 110,408 aides 
(27 percent of all aide positions in ``home care''). Based on an 
informal survey conducted by the largest hospice industry association, 
76 percent of States have their own training and competency 
requirements, accounting for approximately 83,910 aide positions. 
Hospices in these states would benefit from the change because they 
would be permitted to rely on the completion of state mandated training 
and competency programs to assure that a candidate is qualified for 
employment, and would no longer have to take the additional step of 
verifying that each potential job candidate also meet the Federal 
requirements. We assume a 25 percent turnover rate based on discussions 
with industry experts, or 20,978 aide job listings per year. Based on 
an assumed 20 candidates that would require the qualifications 
verification per job

[[Page 51795]]

listing, we estimate that hospices must verify the training and 
competency program content and format for 419,560 candidates per year. 
We assume that it would take 10 minutes per candidate to verify 
compliance with the Federal requirements, for a total of 69,927 hours 
per year nationwide. At a cost of $33 per hour for a general office 
clerk to perform this check, we estimate that hospices will save 
$2,307,591 annually.
    At Sec.  418.106(a) we are finalizing our proposal to delete the 
requirement that a hospice must ensure that the interdisciplinary group 
confers with an individual with education and training in drug 
management as defined in hospice policies and procedures and State law, 
who is an employee of or under contract with the hospice to ensure that 
drugs and biologicals meet each patient's needs. Not requiring the 
specific pharmacy advisement function will allow for more streamlined 
interdisciplinary group meetings. We assume that 25 percent of hospices 
currently use their own staff (employee or contract) for this function, 
and that this staff member is typically the nurse member of the 
interdisciplinary group. The nurse member of the interdisciplinary 
group is also required by Sec.  418.56(a); therefore we believe that 
removing this requirement will not result in removing the expertise 
from the group. Rather, we believe that removing this requirement will 
remove the formulaic approach to interdisciplinary discussions whereby 
the group allots time in each meeting specifically for this discussion 
in order to assure regulatory compliance. In the absence of regulation, 
the interdisciplinary group would have the authority to decide whether 
the discussion is pertinent for a given patient and the information can 
be woven into the discussion at large. This approach has the potential 
to reduce the overall group discussion time, particularly for the 3 
members of the interdisciplinary group that are not charged with being 
the pharmacology expert. Based on 1.6 million hospice patients and an 
assumed 3 interdisciplinary group meetings per patient, there are a 
total of 4,800,000 interdisciplinary group meetings per year. We assume 
that each interdisciplinary group meeting includes 2 minutes of time 
specifically related to discussing the results of the pharmacy 
advisement service for purposes of complying with the regulation, or 
160,000 hours per year nationwide. At a cost of $307 per hour ($203 
physician + $55 social worker + $49 pastoral counselor (BLS Occupation 
code 21-1010)), we estimate that removing this requirement would save 
$49,120,000 annually. There are additional savings detailed in the 
Collection of Information section of $30,956,777 annually due to 
removing this requirement.
    Additionally, we believe that this change will reduce the 
specialist nursing time spent specifically on advisement services. We 
believe that moving away from a regulatory compliance ``check box'' 
approach would allow the specialist nurse to incorporate medication 
management more seamlessly into regular clinical practice. The 2008 
Hospice CoP final rule (73 FR 32088) estimated a 1 hour burden per 
patient for expert pharmacy services (30 minute initial advisement per 
patient + 2 15 minute update advisements) for a total cost of $71 per 
patient for all advisement services (updated to 2017 dollars). We 
estimate that this change will reduce that time by 50 percent, to 30 
minutes per patient, resulting in a $35.50 per patient savings. Based 
on the assumption that 25 percent of hospices use their own employee to 
perform this function, we estimate that this reduction will occur for 
400,000 patients nationwide (25 percent of 1.6 million hospice 
patients), for a total annual savings of $14,200,000.
    Together with the previously stated estimates, total savings would 
be $49,120,000 + $30,956,777 + $14,200,000 million = $94,276,777 
annually.
    At Sec.  418.112(f) we are finalizing our proposal to allow 
hospices and long term care facilities the additional flexibility to 
negotiate the format and schedule for orienting long term care facility 
staff regarding certain hospice-specific information. We believe that 
this will allow for innovation and streamlining, and reduce hospice 
compliance costs related to this requirement by 20 percent. For 
purposes of our analysis only, we assume that a typical hospice 
conducts 6 orientation sessions per year, and that each orientation 
requires 2 hours of time from a hospice nurse. At a cost of $71 per 
hour, a typical hospice would spend $852 each year to orient long term 
care facility staff. Assuming a 20 percent reduction in burden that can 
be achieved through innovation and streamlining, a typical hospice 
would save $170 a year, or $782,340 savings annually for all 4,602 
hospices.
    Taken together, these reforms will generate annual savings of 
approximately $97.4 million ($80.1 million for reduced 
interdisciplinary group meeting time + $14.2 million for reduced 
specialty nursing time + $2.3 million for streamlined hospice aide 
qualification requirements + $0.8 million for streamlined facility 
staff orientation). We requested public comment regarding these burden 
estimates, and additional regulatory reforms to reduce the burden of 
the hospice CoPs, but did not receive any comments specific to our 
solicitation.
d. Effects on Hospitals
    As of 2017, there were 4,823 Medicare participating hospitals. We 
revised the hospital CoPs in order to simplify some requirements and 
streamline processes in order to reduce burden associated with hospital 
compliance with the Medicare CoPs while maintaining minimum health and 
safety standards. The specific savings for each change are described 
below.
    At Sec.  482.21, we are allowing for multi-hospital systems using a 
system governing body, as allowed under the CoPs, and that is legally 
responsible for two or more separately certified member hospitals, to 
have a unified QAPI program for the member hospitals subject to the 
system governing body. This will afford hospitals flexibility and the 
ability to gain efficiencies and achieve significant progress in 
quality by sharing best practices among all hospitals subject to the 
system governing body. This will be similar to current allowances for 
system governing bodies and unified medical staffs.
    While there are no current requirements that explicitly prohibit 
the sharing of best practices across a system, the current requirements 
for each hospital to have its own separate and distinct QAPI program 
and Infection Control program certainly have inhibited and stifled 
sharing of best practices and innovations among individual hospitals 
within a system as we point out in the preamble to the proposed rule, 
and which we support with our reference to the Health Research and 
Educational Trust, in partnership with the American Hospital 
Association March 2010 publication entitled, ``A Guide to Achieving 
High Performance in Multi-Hospital Health Systems.'' This publication, 
along with positive public comments regarding unified medical staffs 
that we discussed in the May 2014 final rule and to which we refer in 
the proposed rule, clearly point to multi-hospitals more efficiently 
and effectively collecting, disseminating, and sharing innovations, 
solutions, and best practices for patient care to each of its member 
hospitals through these unified patient care programs.
    Approximately 3,493 of the 4,823 Medicare-participating hospitals

[[Page 51796]]

participated in a hospital system in 2017 (American Hospital 
Association (AHA), Fast Facts 2019 (https://www.aha.org/statistics/fast-facts-us-hospitals)). According to the 2017 AHA Guide, there are 
424 multi-hospital systems. The current regulatory burden for 
compliance with the QAPI program requirement is approximately $10,000 
annually per hospital or $48.2 million annually for all 4,823 
hospitals. If we were to allow a unified QAPI program for multi-
hospital systems, this would remove 3,493 hospitals from the total 
4,823 (replaced by the 424 multi-hospital systems) for a total of 1,754 
hospitals/multi-hospital systems that would still need to comply. The 
new regulatory burden will be a total of approximately $17.5 million 
annually (1,754 x $10,000), for an annual total savings of 
approximately $31 million. We welcomed comments on the quantitative and 
non-quantitative portions of the preceding discussion and seek any 
empirical evidence that would improve the accuracy and thoroughness of 
the relevant benefits estimation, but did not receive any comments 
specific to our solicitation.
    We are removing the requirement for hospitals at Sec.  482.22(d), 
which states that a hospital's medical staff should attempt to secure 
autopsies in all cases of unusual deaths and of medical-legal and 
educational interest. Because this requirement is redundant and more 
detailed, specific requirements regarding medical-legal investigative 
autopsies are required by individual state law, we do not anticipate 
that hospitals would accrue additional savings from this change. The 
benefit to hospitals from eliminating this requirement is realized 
through a reduction in burden from no longer having to comply with two 
similar requirements of the Federal government and the State 
government. Hospitals would instead be required to follow the more 
detailed, specific regulations of the state in which they are located.
    At Sec.  482.42, we are allowing for multi-hospital systems using a 
system governing body as currently allowed under the CoPs, and that is 
legally responsible for two or more separately certified member 
hospitals, to have a unified infection control program for those member 
hospitals subject to the system governing body. This will allow 
hospitals flexibility and the ability to gain efficiencies and achieve 
significant progress in infection prevention and control. This would 
also be similar to current allowances for system governing bodies and 
unified medical staffs. The current regulatory burden for compliance 
with the Infection Control program requirement is approximately $183 
million annually for all hospitals or $38,000 per hospital. If we were 
to allow a unified Infection Control program for multi-hospital 
systems, this would remove 3,493 hospitals from the total 4,823 
(replaced by the 424 multi-hospital systems) for a total of 1,754 
hospitals/multi-hospital systems that would still need to comply. The 
new regulatory burden would be a total of approximately $66.7 million 
annually (1,754 x $38,000), for an annual total savings of 
approximately $116 million, less the estimated cost of $1 million 
described in the Collection of Information Requirements section, for an 
annual net savings of approximately $115 million. We welcomed comments 
on the quantitative and non-quantitative portions of the preceding 
discussion and seek any empirical evidence that would improve the 
accuracy and thoroughness of the relevant benefits estimation.
    At Sec. Sec.  482.58(b)(1) and 485.645(d)(1) (cross-referenced 
long-term care requirement at Sec.  483.10(f)(9)) we are removing the 
requirement for hospital and CAH swing-bed providers to provide the 
right for patients to choose to or refuse to perform services for the 
facility and if they so choose, (a) document in the resident's plan of 
care, (b) noting whether the services are voluntary or paid and (c) 
provide wages for the work being performed given the location quality, 
and quantity of work requiring comparable skills. We discuss the 
economic impact for this provision in the ICR section of this rule, 
which is estimated to be $29.4 million.
    At Sec.  482.58(b)(4) (and Sec.  485.645(d)(4)) (cross-referenced 
long-term care requirement at Sec.  483.24(c)), we are removing the 
requirement for hospital and CAH swing-bed providers to provide an 
ongoing activity program that is directed by a qualified therapeutic 
recreation specialist or an activities professional who meets certain 
requirements as listed at Sec.  483.24(c)(2). We discuss the economic 
impact for this provision in the ICR section of this rule, which is 
estimated to be a savings of $73.5 million.
    We are finalizing our proposal to remove the requirement at 
Sec. Sec.  482.58(b)(5) and 485.645(d)(5) (cross-referenced long-term 
care requirement at Sec.  483.70(p)) for hospital and CAH swing-bed 
providers to employ a qualified social worker on a full-time basis if 
the facility has more than 120 beds. Given that this provision is not 
applicable to either provider type due to the regulatory requirements 
for each, it does not impose a burden upon hospitals and as such, its 
removal will not result in a savings of burden hours or dollars.
    At Sec. Sec.  482.58(b)(8) and 485.645(d)(8) (cross-referenced 
long-term care requirement at Sec.  483.55(a)(1)) we are removing the 
requirement for hospital and CAH swing-bed providers to assist in 
obtaining routine and 24-hour emergency dental care to its residents. 
We discuss the economic impact for this provision in the ICR section of 
this rule, which is estimated to be $2.9 million for all hospital and 
CAH swing-bed providers.
    At Sec.  482.61(d), we are finalizing our proposal to allow non-
physician practitioners to document progress notes in accordance with 
State laws and scope of practice requirements. We believe that 
clarification of the intent of the regulation is necessary and will 
result in non-physician practitioners (specifically, physician 
assistants, nurse practitioners, psychologists, and clinical nurse 
specialists) documenting in the progress notes for patients receiving 
services in psychiatric hospitals. We estimate that MDs/DOs currently 
spend approximately 30 minutes documenting progress notes in 
psychiatric hospitals, and that 33 percent of this time would be 
covered by non-physician practitioners. Of the 4,823 Medicare 
participating hospitals, approximately 620 (or 13 percent) are 
psychiatric hospitals. According to AHA, there were 36,510,207 
inpatient hospital stays in 2017, and therefore an estimated 13 percent 
of these stays were at psychiatric hospitals. The proposed change would 
result in a savings of $153.5 million (4,746,327 psychiatric hospital 
stays x 2 progress notes per stay x 0.5 hours of physician/psychiatrist 
time x $98 per hourly wage difference between physicians/psychiatrists 
($198) and non-physician practitioners ($100, the average wage between 
nurse practitioners and physician assistants) x 33 percent of physician 
time spent writing progress notes covered by nonphysician 
practitioners). This savings is equivalent to $247,575 per psychiatric 
hospital per year.
    Comment: We received a comment expressing concern over this 
estimate and whether the 30 minutes applies to each note, each patient 
per day, all patients per day, or some other measure; and that in any 
case, the total calculated amount of time spent on progress notes 
appears grossly underestimated.
    Response: We thank you for your feedback and for calling this to 
our attention. We agree that our original estimate was low, and have 
revised our estimates to reflect 30 minutes spent on each note, 
assuming one progress note

[[Page 51797]]

per week during an average length of stay of 12 days per patient.
e. Effects on Transplant Programs and Patients
    We are finalizing the proposed revisions unchanged. For the 
convenience of current readers we are also repeating, essentially 
unchanged, the data and analysis that indicate that the proposed (and 
hence final) rule would have substantial life-extending benefits, 
perhaps in the billion dollar a year range, but that we are unable to 
provide a robust estimate of their overall magnitude.
    There are approximately 750 Medicare approved transplant programs 
in the United States, of which 250 are kidney transplant programs. All 
Medicare approved transplant programs must be a part of a Medicare 
approved hospital, and many hospitals have several types of organ 
programs. Oversight of these programs occurs in two major ways: By the 
Organ Procurement and Transplantation Network (OPTN), which is a non-
profit membership-based organization operated under a Federal contract 
administered by the Health Resources and Services Administration 
(HRSA), and by CMS under the CoPs. The current and long-term OPTN 
contractor is the United Network for Organ Sharing (UNOS), which 
performs many transplantation functions, including matching donated 
organs to waiting lists of patients who have failing organs, and 
reviewing the performance of transplant centers on a variety of 
criteria, including patient and organ survival. There is a third 
mechanism encouraging better transplant program performance, the SRTR 
(accessed at https://www.srtr.org). The SRTR, also operated under a 
HRSA contract, provides detailed data on the performance of all 
transplant programs, and allows the OPTN, individual transplant 
programs, and patients themselves to compare results on such vital 
metrics as patient survival rates after transplant.
    For patients with most types of organ failure, a transplant is the 
only option for long-term survival. In the case of kidney failure, 
however, kidney dialysis is a viable medium-term and sometimes long-
term option for most patients. On average these patients can survive a 
dozen or more years on dialysis; however, without a transplant, they 
suffer increasingly high morbidity and mortality rates. We provide 
Medicare coverage for such patients through the ESRD program. Under the 
ESRD program, patients receive dialysis treatment, usually three times 
a week, through machines that cleanse their blood in much the same way 
as healthy kidneys would do. Since its inception in 1973, more than one 
million patients have received treatment under this program. Kidney 
failure patients are unique in another way: Unlike most other organs, 
with the partial exception of some liver donations, it is possible for 
living individuals to donate ``live'' kidneys, whether the living donor 
is a relative or an unrelated altruistic donor. In the case of ESRD 
patients, the Medicare ESRD program serves almost all kidney failure 
patients, regardless of age, and these patients receive costly dialysis 
for a prolonged period of time. As is the case for all CoPs, our 
regulations for Medicare-approved organ transplant programs have the 
potential to protect all patients, not just Medicare beneficiaries.
    As discussed earlier in this preamble, we have long regulated 
transplant programs, but put in place additional CoPs in the March 2007 
final rule (72 FR 15198) in an effort to increase the quality of care 
by specifying minimal health and safety standards. In addition, outcome 
metrics (1 year graft and patient survival) were included in the 
regulation and mirrored the OPTN outcomes metrics as calculated by the 
SRTR. Over time, increased emphasis on organ and patient survival 
rates, as key metrics of transplant performance, created incentives for 
transplant programs to select organs most likely to survive after 
transplant without rejection, and to select recipients most likely to 
survive after the transplant. In particular, due to the increasing 
patient and organ survival rates over time, the 2007 standards have 
become increasingly stringent over time as an artifact of the 
performance calculation method established in the 2007 rule, an outcome 
that was never intended by CMS. In addition, the 2007 rule created 
performance standards that focused only on organ and patient survival 
rates for those who received a transplant, not on survival rates of 
patients awaiting transplant. We refer readers to a discussion of this 
problem in the following CMS compliance Guidelines that could only 
partially lighten this unintended regulatory burden at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-24.pdf.
    There is extensive literature on these incentives and other 
phenomena in transplant medicine that strongly suggests some unintended 
consequences on organ utilization (decreased use of ``marginal'' organs 
in their patients) and de-selection of some patients who are slightly 
less likely to survive for an extended period post-transplant. These 
unintended consequences have been anecdotal and measuring the extent to 
which they have occurred is difficult. In addition to the studies 
previously cited in the preamble (Adler et al., Schold et al., Dolgin 
et al., Stewart et al., Husain et al.), other studies on this issue 
include Kasiske B, Salkowski N, Wey A, Israni A, and Snyder J, 
``Potential Implications of Recent and Proposed Changes in the 
Regulatory Oversight of Solid Organ Transplantation in the United 
States,'' American Journal of Transplantation, Volume 16, Issue 12, 
December 2016, pages 3371-3377; Howard R, Cornell D, and Schold J, 
``CMS Oversight, OPOs and transplant centers and the law of unintended 
consequences, Clinical Transplantation, Volume 23, Issue 6, November/
December 2009, pages 778-783; and Abecassis M, Burke R, Klintmaim G, 
Matas A, Merion R, Millman D, Olhoff K, and Roberts J, ``American 
Society of Transplant Surgeons Transplant Center Outcome Requirements--
A Threat to Innovation,'' American Journal of Transplantation, Volume 
9, Issue 6, June 2009, pages 1279-1286; and Schold J, Miller C, 
Mitchell H, Buccine L, Flechner S, Goldfarb D, Poggio E, and Andreoni 
K, ``Evaluation of Flagging Criteria of United States Kidney Transplant 
Performance: How to Best Define Outliers,'' Transplantation, June 2017, 
Volume 101, Issue 6, pages 1373-1380. These studies regarding the 
reduced number of transplants that would otherwise have occurred, 
yielded several relevant facts. The number of deceased donor organs 
that are discarded has been increasing over time and for kidneys, is 
above 20 percent. For example, about 33 percent of kidneys recovered 
from donors age 50 to 64 are discarded, as are about 62 percent of 
kidneys recovered from donors age 65 or older (Hart A et al., OPTN/SRTR 
2015 ``Annual Data Report: Kidney.'' Accessed at http://onlinelibrary.wiley.com/doi/10.1111/ajt.14124/full). Officials of the 
UNOS have stated at public meetings that in their judgment up to 1,000 
kidneys of the approximately 3,000 that are discarded each year are of 
good enough quality to be transplanted successfully. The number of 
organ transplantations reached record highs in 2016 (33,500), about 20 
percent more than 5 years earlier, due mainly to increased donation 
rates (OPTN, ``United States organ transplants and deceased donors set 
new records in 2016.'' Accessed at https://optn.transplant.hrsa.gov/news/us-organ-transplants-and-deceased-donors-set-new-records-in-2016/
).

[[Page 51798]]

    For purposes of this analysis, one approach to estimating effects 
is to isolate the number of kidneys (and other organs) that have been 
discarded as a result of the March 2007 rule; indeed, a reasonable 
assumption would be that the proposed rule's rescission of the 2007 
requirements would have an equal and opposite effect. A slide 
presentation by UNOS researcher Darren Stewart (2017; accessed at 
https://www.myast.org/sites/default/files/ceot2017/AST%20CEOT%2001%20Stewart%20-%20No%20Organ%20Left%20Behind%20-%20S3.pdf), presents an estimate that about 1,110 of about 2,759 
kidneys discarded in 2012 were of transplant quality and that between 
500 and 1,000 of these could have been used in transplants (the most 
recent discard numbers, for 2016, are about 20 percent higher than in 
2012 and one-third higher than in 2007). This presentation cites the 
study previously discussed in this preamble (Stewart et al. (2017)), 
that shows kidney discard rates rising from between 5 and 7 percent in 
the late 1980s to 19.2 percent in 2015. Notably, the discard rate had 
already reached approximately 18 percent by 2007, making the rate of 
increase much lower after the March 2007 rule was implemented than it 
had been in the previous two decades. Although this contrary evidence 
is far from definitive, it suggests that the effect of the March 2007 
rule was too small to be observable in the kidney discard data.
    Unfortunately, these and other studies have had to deal with other 
trends during the last two decades that greatly complicate measuring 
the independent effect of the 2007 rule. These include the increasing 
age of the donor pool and the attendant decline in some dimensions of 
organ quality, and the opposite effects of improved techniques for 
maintaining organ quality between the time of donation and the time of 
transplantation. As a result, the published studies using data on organ 
discards have had to use complicated multivariate statistical 
procedures in attempting to estimate the effects of the 2007 rule, and 
invariably conclude that their findings are subject to considerable 
uncertainty.
    The preceding analysis focuses on discard rates as a tool that 
transplant programs can use to reduce risk of lower patient or organ 
survival rates, and hence risk of closure under the 2007 rule. A second 
tool that a transplant program can use to reduce its risk of lower 
overall patient survival rates is to remove patients who are slightly 
less likely to survive from its waiting list, most commonly by making a 
judgmental decision that the patient is ``too sick for 
transplantation.'' Programs that are on the margin of receiving 
regulatory sanctions, or that have received such sanctions already, are 
particularly likely to exercise such judgments to reduce regulatory 
risk. Several studies have estimated specific numbers of transplant 
reductions due to the 2007 rule by comparing the number of patients 
removed from the waiting list at programs that have received regulatory 
sanctions to those that have not. To provide a baseline, these studies 
make the conservative assumption that those programs with zero 
sanctions have not removed any patients from their transplant waiting 
list in order to avoid sanctions. For kidneys, one study estimated that 
in the seven year period from 2007 to 2014, the lower performing 
programs removed from waiting lists over 2500 patients more than would 
have been expected absent sanctions, an average of over 350 per year 
(J.D. Schold et al., ``Association of Candidate Removals From the 
Kidney Transplant Waiting List and Center Performance Oversight,'' 
American Journal of Transplantation 2016, 1276-1284). The implications, 
for the present time, of wait list changes initiated in 2007 is 
unclear. Increased mortality in 2007 among the very sick patients who 
were dropped from the wait list would have freed up organs for 2007's 
moderately sick patients; these patients otherwise would have declined 
in health so as to be the very sick population in 2008. Thus the 
absolute level of health in 2008 would have been relatively good, in 
which case the phenomenon of patients being dropped from the wait list 
might not have perpetuated into the future, leaving little or no scope 
for benefits to be achieved now as a result of the proposed CoP 
revision. (We note that one year, from 2007 to 2008, may be an 
exaggeration as to the short-term nature of this wait list-related 
effect, but a somewhat longer tapering period could still have reached 
completion now, more than a decade after the implementation of the 2007 
CoP, thus leaving little scope for benefits.) On the other hand, if the 
sickest patients in 2008 were dropped based on their relative health 
levels--in spite of their improved absolute health relative to the 
sickest patients in 2007--there would be potential wait list-related 
benefits from revising this CoP at the present time. The benefits of 
shifting transplants to the sickest patients from relatively less sick 
patients have not been quantified, but because the harm to the less 
sick patients would need to be netted off the benefit to the sickest 
patients, the per-transplant magnitude would be much lower than the 
per-transplant benefits of avoided organ discards.
    Another quantitative study of kidney transplant effects used a 
similar methodology and estimated that as a result of the 2007 rule, in 
2011 sanctioned programs performed 766 fewer kidney transplants than 
would otherwise have been the case.\5\ White et al.'s finding of 
reduced transplant volumes at particular kidney transplant centers does 
not necessarily indicate decreased transplant volumes overall, with the 
authors stating that their aggregate results ``do not indicate that the 
introduction of the [2007] CoPs has systematically reduced 
opportunities for marginal candidates or that there has been a 
systematic shift away from utilization of higher risk deceased donor 
kidneys.'' In other words, regulatory sanctions could have triggered 
behavioral responses by some patients, some transplant surgeons, or 
some health insurance plans to shift patients away from these centers 
(many insurers restrict coverage through ``centers of excellence'' 
programs). Schold et al. (2013) find additional support for this 
phenomenon, describing their empirical result as follows: ``Among 203 
[adult kidney transplant] centers, 46 (23%) were low performing (LP) . 
. . Among LP centers, there was a mean decline in transplant volume of 
22.4 cases compared to a mean increase of 7.8 transplants among other 
centers.'' The estimated decrease per low-performing transplant center 
is roughly three times the increase per other center, but there are 
also roughly three times as many other centers as low-performing 
centers; as such, the most straightforward interpretation of this paper 
is that the same number of transplants is being concentrated in a 
smaller number of transplant centers. This outcome could still have 
real impacts, such as changes in travel time for patients, but although 
these impacts are valid for inclusion in a regulatory impact 
assessment, they would be much smaller in magnitude than the longevity 
benefits emphasized elsewhere in this analysis.
---------------------------------------------------------------------------

    \5\ Sarah L. White et al., ``Patient Selection and Volume in the 
Era Surrounding Implementation of Medicare Conditions of 
Participation for Transplant Programs,'' Health Services Research, 
April 2015, 330-350.
---------------------------------------------------------------------------

    A feature common to most of these studies that is that they use 
data that are already several years old when the study is published, 
both because of the usual publishing lag and because performance data 
such as one-year survival rates necessarily make transplant program 
results less timely. None of these studies covers the last two

[[Page 51799]]

or three years of transplant program performance. As a result, none of 
these studies has been able to use actual data to assess the effects of 
the May 13, 2016 CMS changes that slightly reduced the performance 
level for finding a ``condition-level'' violation that threatens 
program closure. For recent reviews of potential effects of those 
changes see BL Kasiske et al, Potential Implications of Recent and 
Proposed Changes in the Regulatory Oversight of Solid Organ 
Transplantation in the United States,'' Am J Transplant, December 2016, 
16(12), 3371-3377, and Colleen Jay and Jesse Schold, Measuring 
transplant center performance: The goals are not controversial but the 
methods and consequences can be, Curr Transplant Rep, March 2017, 4(1), 
52-58. Using past data to measure potential effects, these studies 
predict little or no positive effect from the revised standards (which 
both studies conclude will still mis-identify lower performing 
programs), but cannot evaluate actual effects because post-issuance 
evidence is not yet available. This may not be relevant policy-wise, 
since we proposed to eliminate those standards, but it is a key 
question for estimating the remaining scope (if any) of CoP-associated 
unnecessary organ discards, and it does flag the pervasive problem of 
timeliness of data and timeliness of study findings.
    There are several studies that make similar estimates for liver 
transplant programs (for example, L.D. Buccini, et al., ``Association 
Between Liver Transplant Center Performance Evaluations and Transplant 
Volume,'' American Journal of Transplantation 2014, 2097-2105). This 
study found a large difference in transplant volume between programs 
rated as lower performing by the SRTR (average decrease of 39.9 
transplants from 2007 to 2012) and those not receiving adverse SRTR 
ratings (average increase of 9.3 transplants over the same period). The 
27 lower performing centers thus reduced their total number of liver 
transplants by over 1,000, and compared to the higher performing 
centers the decrease was even larger. This study did not, however, tie 
its estimates to the performance standards in the 2007 rule (which are 
similar but not identical to SRTR standards), to sanctions under that 
rule, or to specific center decisions, such as removing candidates from 
the wait list. Hence, while it certainly contributes to the body of 
scholarship indicating that since 2007 transplants have been performed 
in a more concentrated set of programs, it does not appear to provide 
direct estimates of the quantitative effects of the 2007 rule on 
overall numbers of liver transplants.
    Taking into account all the various uncertainties involved in these 
studies, we did not and do not believe that we can estimate the effects 
of the 2007 rule on numbers of transplantations for any organ other 
than kidneys, and that even for kidneys there is no clear central 
estimate of likely quantitative effects. The wide variation in 
published results, and the disclaimers as to the various uncertainties 
involved, make a precise as well as reliable estimate all but 
impossible and would render arbitrary any non-zero lower bound estimate 
of health and longevity impacts. (As noted above, however, even in the 
absence of health and longevity effects, there may be other benefits, 
such as reduced travel costs, if the proposed rule reduces 
concentration of transplants in a smaller number of facilities.) 
Therefore, we have shown the effects of the final rule change as ``not 
quantified.'' This is not unusual in regulatory impact analyses that 
address complex phenomena that cannot be measured directly, or whose 
effects are intertwined with other changing circumstances.
    Every transplant quality organ that is used for transplantation 
rather than discarded has a very high probability of substantially 
extending the life of the recipient. There is a particularly extensive 
literature on life expectancy before and after transplant, quality of 
life, and cost savings for kidney patients. A literature synthesis on 
``The Cost-Effectiveness of Renal Transplantation,'' by Elbert S. 
Huang, Nidhi Thakur, and David O. Meltzer, in Sally Satel, When 
Altruism Isn't Enough (AEI Press, 2008) found essentially universal 
agreement that kidney transplants were not only substantially life 
extending, but also cost reducing. The authors performed an extensive 
literature search and found that from 1968 to 2007 seventeen studies 
assessed the cost-effectiveness of renal transplantation. The authors 
concluded that ``Renal transplantation . . . is the most beneficial 
treatment option for patients with end-stage renal disease and is 
highly cost-effective compared to no therapy. In comparison to 
dialysis, renal transplantation has been found to reduce costs by 
nontrivial amounts while improving health both in terms of the number 
of years of life and the quality of those years of life'' (page 31). 
More recent studies have reached similar conclusions, as have other 
syntheses. For example, the ``Systematic Review: Kidney Transplantation 
Compared with Dialysis in Clinically Relevant Outcome'' (M. Tonelli, N. 
Wiebe, G. Knoll, A. Bello, S. Browne, D. Jadhov, S. Klarenbach, and J. 
Gill, American Journal of Transplantation 2011: 2093-2109) focused on 
life expectancy and quality of life. This article reviewed 110 studies, 
and concluded that the vast majority showed major improvement in life 
quality and reductions in mortality among transplant recipients 
compared to those remaining on dialysis. The Annual Data Report of the 
United States Renal Data System utilizes national data on ESRD, and 
reports that deaths per 1,000 patient years are about 180 for dialysis 
patients and about 32 for transplant recipients (see 2016 report, 
volume 2, Figure i.13 and Tables H.4 and H.10); accessed at https://www.usrds.org/adr.aspx). There are similar data on other organs. For 
example, in 1998, HHS published a final rule with comment period that 
established governance procedures for the OPTN (63 FR 16296). In the 
RIA for that rule, the Department estimated that ``the annual benefits 
of organ transplantation include about eleven thousand lives vastly 
improved by kidney transplantation, and another eight thousand lives 
both vastly improved and prolonged by transplantation of other major 
organs'' (63 FR 16323).
    Even without a robust aggregate estimate of likely increases in 
organ utilization as a result of this proposed regulatory change, the 
potential benefits are very substantial. For each new kidney 
transplantation, there would be an average of 10 additional life years 
per transplant patient compared to those on dialysis (see Wolfe A et 
al., ``Comparisons of Mortality in All Patients on Dialysis, Patients 
on Dialysis Awaiting Transplantation, and Recipients of a First 
Cadaveric Transplant,'' NEJM, 1999, 341:1725-30; accessed at http://www.nejm.org/doi/full/10.1056/NEJM199912023412303#t=article). Valuing 
each year of life gained using a ``value of a statistical life year'' 
(VSLY) of $490,000 in 2014 dollars, the total benefits from each 
additional transplantation in 2018 would be $4.9 million before 
discounting and $4.4 million after inflating to 2016 dollars and 
discounting at either 3 or 7 percent over the 10-year period (life-year 
figure for 2014 from Office of the Assistant Secretary for Planning and 
Evaluation, HHS, Guidelines for Regulatory Impact Analysis, 2016, page 
21, accessed at https://aspe.hhs.gov/pdf-report/guidelines-regulatory-impact-analysis). The HHS methodology produces the same result at 
either discount rate in order to reach the same predetermined ``real'' 
value. For an explanation and

[[Page 51800]]

justification of this VSLY approach, see Cass R. Sunstein, ``Lives, 
Life-Years, and Willingness to Pay,'' 104 Columbia Law Review [i] 
(2004).
    Those HHS guidelines also explain in some detail the concept of 
quality adjusted life years. The key point to understand is that these 
are research-based estimates of the value that people are willing to 
pay for life-prolonging and life-improving health care interventions of 
any kind (see sections 3.2 and 3.3 of the HHS Guidelines for a detailed 
explanation). The QALY amount used in any estimate of overall benefits 
is not meant to be a precise estimate, but instead is a rough 
statistical measure that allows an overall estimate of benefits 
expressed in dollars.
    An alternative and more sophisticated analysis would take into 
account that the life-extending effect of a kidney transplant is not 
its first effect, but typically follows a number of years off dialysis, 
until the organ fails and the patient returns to dialysis or is 
retransplanted. Such an analysis can be found in a recent study by P.J. 
Held et al., ``A Cost-Benefit Analysis of Government Compensation of 
Kidney Donors,'' American Journal of Transplantation, 2016, pages 877-
885 (plus 65 pages of supplementary details explaining all assumptions, 
data sources, and calculations). The largest differences between the 
base case estimated in that study and the preceding estimates is that 
this RIA uses the considerably higher value of a statistical year of 
life under HHS guidelines, and this RIA uses the full value of a 
statistical life year without a ``quality'' adjustment for the added 
years of life (we use QALYs only for the improved quality of life 
during years that would otherwise be on kidney dialysis). Under such an 
estimation approach, potential life-extending benefits could be 
somewhat larger. For example, if the proposed reform increased the 
number of life-extending kidney transplants by only 100 a year, and the 
benefits of both additional life years and QALY gains were estimated at 
$5.1 million per patient, its total annual benefits for kidney patients 
would be approximately $510 million a year (100 x $5.1 million).
    There are additional benefits from kidney transplantation. As 
previously discussed, kidney transplants do reduce medical costs, with 
``breakeven'' after about 5 years and net savings of several hundred 
thousand dollars per patient. Other organ transplants create lesser or 
no medical savings because the alternative is not dialysis. Clearly, 
however, these kidney transplant savings are small in relation to the 
life-extending benefits. We have not estimated medical savings or costs 
for kidneys or other organs in this RIA because any such estimates 
would depend on the number of additional transplants that we have not 
estimated.
    We note that life-extending estimates are averages across patients 
who vary widely in age, medical condition, and life expectancy, as well 
as type of organ failure. For example, the sickest patients typically 
have very low life expectancies without transplant, and hence stand to 
gain the most years of life from a transplant. Partly offsetting this, 
these same patients, on average, have slightly lower survival rates 
post-transplant. Organ and patient survival issues are complex and 
dealt with by detailed policies and procedures developed and used by 
the transplant community under the auspices of the OPTN. These policies 
are reviewed and revised frequently based on actual experience and 
changing technology--over time the success rate from previously 
marginal organs, and in older patients, have both increased 
substantially. For purposes of this analysis, the proper measure is the 
average gain across all patients who would receive transplants as a 
result of eliminating the 2007 rule, net of these other factors.
    There could be potential offsets to these calculated and 
uncalculated benefits and cost reductions. However, the particular 
regulatory requirements we proposed to remove are unlikely to drive any 
further significant increases in graft and patient survival. For renal 
transplants, the expected 1-year graft and patient survival rates are 
already at 95 percent or better. Transplant program outcomes will 
continue to be monitored by the OPTN and programs that are not in 
compliance with the OPTN outcomes are referred to their Membership and 
Professional Standards Committee for quality improvement activities. 
The SRTR also publishes detailed data on transplant program performance 
that allows patients and their physicians to compare transplant 
programs and this transparency creates pressures to maintain and 
improve survival rates in order to attract these patients.
    The current regulatory requirements for transplant centers, as 
discussed in section II.E ``Transplant Centers'' of the proposed rule, 
have created both positive and adverse incentives for transplant 
programs, with unanticipated side effects on both utilization of 
donated organs and the ability of the highest risk patients to obtain 
transplants. We expect the changes made by this final rule to provide 
substantial net benefits, particularly since other regulatory and 
informational incentives remain in place.
    We requested comments on this analysis as well as information that 
would enable a more robust quantitative analysis of the impacts of this 
change and on any alternative reforms that might provide even higher 
benefits. We did not, however, receive comments specifically addressing 
these requests.
f. Effects on HHAs
    As of May 2017 there are 12,624 HHAs that participate in Medicare 
and Medicaid. In the January 2017 HHA CoP final rule (82 FR 4504) we 
estimated that compliance with the requirements at Sec.  484.50(a)(3) 
related to providing oral notice of all rights to each patient would 
impose a burden of 5 minutes per patient, or 1,330,246 hours of burden 
nationwide at a cost of $80,030,370, annually. The cost estimate was 
based on a $63 per hour estimate for the services of a RN as derived 
from the BLS Occupational Handbook, 2014-2015 edition, including a 100 
percent benefit and overhead package. Adjusted to reflect more updated 
salary information, as described previously, we estimate that 
compliance with this provision would impose a $94,447,466 burden, based 
on a RN earning $71 per hour.
    We proposed to revise the verbal notification requirements to limit 
them to those that are required by section 1891 of the Act. Limiting 
the amount of information that is required to be provided orally will 
reduce the time per patient that is required to comply with the revised 
requirement. For purposes of this analysis only, we assume that 
providing oral notice regarding financial liability only will require 2 
minutes per patient, reducing burden by 60 percent. Based on this 
assumption, this proposed change would reduce the burden of the patient 
rights notification requirement by 198,148 hours (1,330,246 hours 
originally estimated x 0.6) and $56,668,480 ($94,447,466 burden as 
updated to reflect more recent salary estimates x 0.6).
    We are also finalizing three changes that do not have a savings 
estimate. First, we are eliminating the requirement at Sec.  
484.80(h)(3) that the HHA conduct a full competency evaluation of 
deficient home health aides, and replace it with a requirement to 
retrain the aide regarding the identified deficient skill(s) and 
require the aide to complete a competency evaluation related to those 
skills. As we stated in the January 2017 HHA CoP final rule (82 FR 
4575), it is standard practice within the HHA industry to supervise 
home health aides, and the regulatory requirements for such

[[Page 51801]]

supervision do not impose any additional burden. We are also finalizing 
a change to permit HHAs to use either patients or pseudo-patients when 
conducting home health aide competency evaluations. While this change 
does not have a monetary savings estimate, we believe that this 
additional flexibility will increase the speed for aides completing 
their competency evaluations, thus increasing the pool of aides 
eligible to provide services and reducing patient wait times for aide 
services.
    We requested public comment regarding these burden estimates, and 
additional regulatory reforms to reduce the burden of the HHA CoPs, but 
did not receive any specific to our burden estimates. Comments 
regarding additional regulatory reforms to reduce the burden on HHAs 
are addressed earlier in the preamble.
g. Effects on CAHs
    We proposed to remove the requirement at Sec.  485.627(b)(1) for 
CAHs to disclose to CMS its owners or those with a controlling interest 
in the CAH or any subcontractor in which the CAH directly or indirectly 
has a 5 percent or more ownership interest in accordance with 42 CFR 
part 420, subpart C. We discuss the economic impact of this provision 
in the ICR section, which is estimated at $143,701 in total savings for 
all CAHs. We also discussed the burden reduction for our proposed 
revision of the ``patient care policies'' requirements imposed on CAHs 
in the ICR section of this rule, which is estimated at $2.6 million. 
Finally, the effects of the CAH swing-bed provisions are covered in the 
ICR section of the rule, and estimated to be $76.5 million for all 
CAHs.
h. Effects on CORFs
    We discussed the burden reduction for our proposed revision of the 
``utilization review plan'' requirements imposed on CORFs in the ICR 
section of this rule, which is estimated at $315,840.
i. Effects on CMHCs
    We discussed the burden reduction for our proposed revision of 
Sec.  485.914(d)(1) ``update of the comprehensive assessment'' 
requirements imposed on CMHCs in the ICR section, which is an estimated 
savings of $156,975.
j. Effects on Portable X-Ray Services
    At Sec.  486.104 we proposed to revise the portable x-ray CfCs to 
focus on the qualifications of the technologist performing the 
diagnostic test. As of May 2017 there were approximately 500 Medicare-
participating portable x-ray suppliers employing an estimated 5,000 
portable x-ray technologists. Hiring limited x-ray technologists or 
those with State licensure would allow portable x-ray suppliers to fill 
vacant positions at a lower hourly cost. Assuming a 10 percent annual 
turnover rate, all technologists could be hired at the lower salary 
over a period of 10 years. Limited x-ray technologists can be hired for 
approximately $30 an hour ($62,400 per year), whereas, according to the 
BLS, x-ray technologists with advanced certification (ARRT) are hired 
at a rate of approximately $60 dollars per hour ($124,800 per year). 
This creates a savings opportunity of $30 per hour, or $62,400 per 
year, per technologist position. Based on an assumed 10 percent 
turnover rate, or 500 positions filled in any given year, this change 
would create a savings of $31,200,000 savings in the first year. We 
believe that these savings would be increased every year as more 
positions are filled at the lower salary rate.
    We discuss the economic impact for the requirements regarding 
written orders in the ICR section of this rule, which represents $27.7 
million in savings.
    We requested public comment regarding these burden estimates, and 
additional regulatory reforms to reduce the burden of the portable x-
ray CfCs, but did not receive any comments specific to our 
solicitation.
k. Effects on RHCs and FQHCs
    We discussed the burden reduction for our revision of Sec.  
491.9(b)(4) ``review of patient care policies'' requirements imposed on 
RHCs and FQHCs in the ICR section, which is an estimated savings of 
$7.3 million biennially, or approximately $3.7 million annually.
    In addition, the burden reduction for our revision of Sec.  
491.11(a) ``program evaluation'' requirements imposed on RHCs and FQHCs 
in the ICR section of this rule, which is an estimated savings of $9.9 
million biennially, or approximately $5 million annually.
l. Effects of Emergency Preparedness Requirements on Providers and 
Suppliers
    The revisions to the emergency preparedness requirements for 
Medicare and Medicaid participating providers and suppliers, as 
discussed in section II.M, either simplify the requirements, eliminate 
duplicative requirements, or reduce the frequency in which providers 
would need to comply with the emergency preparedness requirements. We 
estimate that the finalized changes to the emergency preparedness 
requirements would accrue an annual cost savings of $124 million in 
total. The potential, estimated cost savings for each revised emergency 
preparedness requirement is outlined in detail below. The methodology 
used to calculate the economic impact and the costs associated with the 
changes to the emergency preparedness requirements is the same 
methodology used to calculate the economic impact in the Emergency 
Preparedness final rule (81 FR 63860).
    At Sec.  482.15(a), (b), (c), and (d) for hospitals and parallel 
regulatory citations for other facilities, we are finalizing our 
proposal for all providers, except LTC facility providers, to review 
their program at least every 2 years. We discuss the economic impact 
for this requirement in the ICR section of this rule, which represents 
annualized cost savings of $69,639,324, or approximately $139 million 
biennially.
    At Sec.  482.15(a)(4) for hospitals, and other parallel citations 
for the facilities mentioned in section II.J.2 of the rule, we 
eliminated the requirement that facilities document efforts to contact 
local, tribal, regional, State, and Federal emergency preparedness 
officials and that facilities document participation in collaborative 
and cooperative planning efforts. We discuss the economic impact for 
this requirement in the ICR section of this rule, which represents 
$7,319,255 in savings.
    At Sec.  482.15(d)(1)(ii) for hospitals, and other parallel 
citations for other facilities mentioned in section II.J.2 of the rule, 
we are finalizing our proposal for all providers, except LTC 
facilities, to require that facilities provide training biennially, or 
every 2 years, after facilities conduct initial training on their 
emergency program. In addition, we are requiring additional training 
when the emergency plan is significantly updated. We discuss the 
economic impact for this requirement in the ICR section of this rule, 
which represents annualized cost savings of $25,593,781, or 
approximately $51 million biennially.
    Finally, at Sec.  482.15(d)(2), we are finalizing our proposal to 
require that providers of inpatient services mentioned in section 
II.J.2 of the rule conduct two testing exercises annually, one of which 
may be an exercise of their choice that must be either a community-
based full-scale exercise (if available), an individual facility-based 
functional exercise, a drill, a tabletop exercise or workshop that 
includes a group discussion led by a facilitator. We are requiring that 
providers of outpatient services mentioned in section II.J.2 of

[[Page 51802]]

the rule conduct one testing exercise annually which must be either a 
community-based full-scale exercise (if available) or an individual 
facility-based functional exercise every other year, and in the 
opposite years, may be either a community-based full-scale exercise (if 
available), a facility-based functional exercise, a drill, or a 
tabletop exercise or workshop that includes a group discussion led by a 
facilitator. We discuss the other economic impacts for this requirement 
in the ICR section, which represents $9,296,422 in savings. We do not 
estimate any economic impact for the providers of inpatient services as 
we did not propose any changes to the number of testing exercises that 
must be conducted by these providers; however, we estimate an 
additional economic impact for this provision for each outpatient 
provider due to a reduction in the testing requirement from two 
exercises per year to one exercise per year. We would like to note that 
for CORFs and Organizations, consistent with the Emergency Preparedness 
Final Rule (Medicare and Medicaid Programs; Emergency Preparedness 
Requirements for Medicare and Medicaid Participating Providers and 
Suppliers; Final Rule, 81 FR 63860), the CoPs for these providers 
previously required them to have ongoing drills and exercises to test 
their disaster plans. Therefore, we continue to expect, as we did in 
the Emergency Preparedness final rule, that the economic impact to 
comply with this requirement will be minimal, if any. Therefore, the 
total economic impact of this provision for CORFs and Organizations 
will be limited to the estimated ICR burden of $56,212 and $310,362, 
respectively.
    We estimate a total impact savings of $11,238,093 for this change. 
With an estimated ICR savings of $9,296,422, we estimate that the total 
economic impact of this policy for the affected providers will be 
$20,534,515. We list a summary of the calculation for the impact 
savings accrued by removing this requirement for each facility in Table 
16, based on facility numbers available as of May 2017.
     ASCs: Combined total savings of $2,000,520 for 5,557 ASCs 
((4 hours for an administrator at $109 per hour plus 4 hours for a 
registered nurse at $71 per hour) x 5,557 ASCs x 50 percent).
     Outpatient Hospice: Combined total savings of $1,438,240 
((4 hours for an administrator at $107 per hour plus 4 hours for a 
registered nurse at $71 per hour) x 4,040 outpatient hospices x 50 
percent).
     PACE: Combined total savings of $16,543 ((1 hour home for 
a care coordinator at $71 per hour plus 1 hour for a quality 
improvement nurse at $71) x 233 PACEs x 50 percent).
     HHAs: Combined total savings of $2,695,224 ((2 hours for 
an administrator at $107 per hour plus 3 hours for a director of 
training at $71 per hour) x 12,624 HHAs x 50 percent).
     CMHCs: Combined total savings of $60,214 ((5 hours for an 
administrator at $107 per hour plus 3 hours for a nurse at $71 per 
hour) x 161 CMHCs x 50 percent).
     OPOs: Combined total savings of $5,162 ((1 hour for a QAPI 
Director at $107 per hour plus 1 hour for an education coordinator at 
$71 per hour) x 58 OPOs x 50 percent).
     RHCs/FQHCs: Combined total savings of $4,284,104 (((4 
hours for an administrator at $107 per hour plus 4 hours for a 
registered nurse at $71 per hour) x 4,160 RHCs x 50 percent) 
$1,480,960+ (4 hours for an administrator at $107 per hour plus 4 hours 
for a registered nurse at $71 per hour) x 7,874 FQHCs x 50 percent) 
2,803,144.
     ESRDs: Combined total savings of $738,086 ((1 hour for an 
administrator at $107 per hour plus 1 hour for a nurse manager at $107 
per hour) x 6,898 dialysis facilities x 50 percent).

        Table 16--Cost Savings for Emergency Preparedness Testing
------------------------------------------------------------------------
                                 Cost savings per      Combined total
       Provider/supplier        provider/supplier         savings
------------------------------------------------------------------------
ASCs..........................               $360  $2,000,520 for 5,557
                                                    ASCs.
Hospices (outpatient).........                356  $1,438,240 for 4,040
                                                    outpatient hospice
                                                    facilities.
PACEs.........................                 71  $16,543 for 233
                                                    PACEs.
HHAs..........................                214  $2,695,224 for 12,624
                                                    HHAs.
CMHCs.........................                374  $60,214 for 161
                                                    CMHCs.
OPOs..........................                 89  $5,162 for 58 OPOs.
RHCs/FQHCs....................                356  $4,284,104 for RHCs
                                                    and FQHCs
                                                    ($1,480,960 for
                                                    4,160 RHCs and
                                                    $2,803,144 for 7,874
                                                    FQHCs).
ESRD Facilities...............                107  $738,086 for 6,898
                                                    dialysis facilities.
------------------------------------------------------------------------

m. One-Time Implementation Costs
    All of the changes presented above will necessarily have to be 
read, and understood, and implemented by affected providers. This will 
create one-time costs even though the underlying change reduces burden. 
In most cases these costs will be very low, and may be as simple as 
observing that a particular procedure will need only to be performed 
once rather than twice a year, and changing the schedule accordingly. 
In some cases, the facility will need to adjust in response to multiple 
burden reduction changes. In still other cases, time will have to be 
spent deciding how to change existing policy. For example, as discussed 
previously, ASCs and hospital outpatient facilities will need to decide 
whether and in what circumstances medical histories and physical 
examinations will be required or encouraged as a matter of policy. 
Rather than attempt to estimate these situational variables in detail 
for each facility type, we believe it possible to make reasonable 
overall estimates of these one-time costs, recognizing that there will 
be considerable variations among provider types and among individual 
providers.
    In total, there are about 122 thousand affected entities, as shown 
in the Table 17 that follows. We assume that on average there will be 1 
hour of time spent by a lawyer, 2 hours of time by an administrator or 
health services manager, and 2 hours of time by other staff (we assume 
registered nurses or equivalent in wage costs) of each affected 
provider to understand the regulatory change(s) and make the 
appropriate changes in procedures. We further estimate that for one 
tenth of these providers, 2 hours of physician time will be needed to 
consider changes in facility policy. Average hourly costs for these 
professions, with wage rates doubled to account for fringe benefits and 
overhead costs, are $136 for lawyers, $107 for managers, $71 for

[[Page 51803]]

registered nurses, and $203 for physicians based on 2017 BLS data.
    The estimated costs for an average provider would therefore be 1 
hour at $136 and in total for the lawyers, 2 hours at $107 or $214 in 
total for the managers, 2 hours at $71 or $142 in total for the other 
staff, and 0.2 hours at $203 or $41 in total for the physicians. These 
one-time costs add up to $533 per provider on average, and in total to 
about $65 million.

                 Table 17--One-Time Implementation Costs
------------------------------------------------------------------------
                                                             Number of
                      Provider type                          affected
                                                             providers
------------------------------------------------------------------------
Religious Nonmedical Health Care Institutions...........              18
Ambulatory Surgical Centers and hospital outpatient.....          10,587
Hospices................................................           4,602
Hospitals...............................................           4,823
Transplant programs.....................................             750
Home Health Agencies....................................          12,624
Critical Access Hospitals...............................           1,353
Comprehensive Outpatient Rehabilitation Facilities......             188
Community Mental Health Centers.........................              52
Portable X-Ray Services.................................             500
Rural Health Clinics and Federally Qualified Health               12,034
 Centers................................................
Emergency Preparedness of Providers and Suppliers.......          74,246
                                                         ---------------
  Total Number of Providers.............................         121,982
Average Cost Per Provider...............................            $533
                                                         ---------------
  Total One-Time Cost...................................     $65,016,406
------------------------------------------------------------------------

n. Effects on Small Entities, Effects on Small Rural Hospitals, 
Unfunded Mandates, and Federalism
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, we estimate that 
almost all health care providers regulated by CMS are small entities as 
that term is used in the RFA (including small businesses, nonprofit 
organizations, and small governmental jurisdictions). The great 
majority of hospitals and most other health care providers and 
suppliers are small entities, either by being nonprofit organizations 
or by meeting the SBA definition of a small business (having revenues 
of less than $8 million to $41.5 million in any 1 year, varying by type 
of provider and highest for hospitals). Accordingly, almost all of the 
savings that the rule will create benefits small entities. We note that 
individual persons are not small entities for purposes of the RFA, and 
hence the life-extending transplantation benefits of the rule are not 
relevant to the RFA.
    The RFA requires that a final regulatory flexibility analysis 
(FRFA) be prepared if a final rule would have a ``significant impact on 
a substantial number'' of such entities. HHS interprets the statute as 
mandating this analysis only the impact is adverse, though there are 
differing interpretations. Regardless, there is no question that the 
final rule would affect a ``substantial number'' of small entities. As 
shown in Table 17, the total number of affected entities will be about 
122,000, including those affected by more than one provision. The rule 
of thumb used by HHS for determining whether an impact is 
``significant'' is an effect of 3 percent or more of annual revenues. 
These savings do not approach that threshold. Hospitals account for 
about one-third of all health care spending and even if all these 
savings accrued to hospitals this threshold would not be approached. 
Therefore, the Secretary has determined that these provisions of the 
final rule will not have a significant economic impact on a substantial 
number of small entities.
    In addition, section 1102(b) of the Social Security Act requires us 
to prepare a regulatory impact analysis if a rule may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 604 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a metropolitan statistical area and has fewer than 100 beds. For the 
reasons previously given, the Secretary has determined that these 
provisions of the final rule will not have a significant impact on the 
operations of a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2019, that 
threshold is approximately $154 million. These provisions of the final 
rule contain no mandates that will impose spending costs on State, 
local, or tribal governments, or on the private sector. Indeed, it 
substantially reduces existing private sector mandates.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has federalism 
implications. The final rule imposes no such requirements. Importantly, 
it would remove Federal requirements setting qualification standards 
for hospice aides. Setting qualifications for health care workers is 
traditionally a State function, and this change would therefore remove 
an infringement on State prerogatives.
o. Effects on Costs to Facilities, Providers, Medicare, Other 
Insurance, and Patients
    Most of the individual proposals addressed in the preceding 
analysis involve reducing burdensome costs on facilities, health care 
professionals, and patients. Most of those reductions save time and 
effort currently performed on tasks that we proposed to eliminate or 
reform and those reductions will result ultimately in reduced medical 
care costs in these facilities, some of which will result in further 
effects on public and private insurance costs. In this regard, it is 
important to emphasize that the CoPs and CfCs generally apply to all 
patients served by a Medicare and/or Medicaid participating provider or 
supplier, not just Medicare or Medicaid patients, and to the entire 
operations of the provider. Revisions to those requirements apply 
broadly to the entire health care system. We are hopeful that cost 
reductions ultimately flow to reductions in charges, to reductions in 
third party payments, and hence to reductions in insurance costs and to 
those who pay those costs.
    Initial savings will accrue primarily to providers. How much of 
these savings will flow to insurers and patients depends primarily on 
the payment and reimbursement mechanisms in place for each affected 
entity for those particular costs. According to the National Health 
Expenditure Accounts, approximate payer shares in 2016 were 11 percent 
for consumer out of pocket, 35 percent for private health insurance, 21 
percent for Medicare, 18 percent for Medicaid, and 15 percent for other 
public and private payers such as the Department of Veteran Affairs and 
the Department of Defense. We would expect savings to approximate these 
shares. Ultimately, all costs are paid by workers and taxpayers who pay 
for all health care directly or indirectly, quite apart from immediate 
cost subsidies or cost sharing.
    Two provisions directly reduce Medicare and other insurance costs. 
Eliminating unnecessary patient history and physical examinations and 
medical tests for procedures (such as cataract surgery) performed in 
ASCs and in hospital outpatient surgery will disproportionately reduce 
Medicare costs, since use of these services rises with age. Additional 
transplantation of

[[Page 51804]]

kidneys will reduce Medicare's ESRD costs, partially offset by 
increased transplantation costs. Because of the difficulty in finding 
evidence of the volume of such savings, we cannot estimate the likely 
effects on Medicare spending.
    Most of the facility and provider savings will accrue to Medicare 
and other insurers over time as payment rate increases are slightly 
reduced, and the remainder will accrue to other payers and to patients.
p. Benefits to Patients
    We discussed life-extending and life-saving benefits at length in 
the analysis of increases in transplantation. These result from removal 
of disincentives to transplant patients, or to use organs, where this 
could reduce success rates by a few percent and possibly trigger 
closure of transplant centers or programs under current rules. As 
previously explained, we do not have robust estimates. There are 
additional and substantial patient benefits likely to result from the 
cost-reducing reforms that we proposed. Time not wasted by medical care 
providers or facilities on unnecessary tasks is time that can be used 
to focus on better care. While such effects could be measured in 
principal, there is little existing data on magnitudes of such effects. 
We requested but did not receive public comments on these or any other 
aspects of costs and benefits of the proposed rule.
4. Alternatives Considered
    From within the entire body of CoPs and CfCs, we selected what we 
believe to be the most viable candidates for reform as identified by 
stakeholders, by recent research, or by experts as unusually 
burdensome. This subset of the universe of standards is the focus of 
the proposed rule. For all of the proposed provisions, we considered 
not making these changes. Ultimately, we saw no good reasons not to 
finalize these burden reducing changes.
    We welcomed comments on whether we properly selected the best 
candidates for change, and welcomed suggestions for additional reform 
candidates from the entire body of CoPs and other regulatory provisions 
that fall directly on providers. As discussed earlier in this preamble, 
we did receive suggestions for additional reforms and will consider 
those in future reform efforts.
5. Uncertainty
    Our estimates of the effects of this regulation are subject to 
significant uncertainty. While the Department is confident that these 
reforms will provide flexibilities to facilities that will yield major 
cost savings, there are uncertainties about the magnitude of these 
effects. Despite these uncertainties, we are confident that the rule 
will yield substantial overall cost reductions and other benefits. In 
this analysis we have provided estimates to suggest the potential 
savings these reforms could achieve under certain assumptions. We 
appreciate that those assumptions are simplified, and that actual 
results could be substantially higher or lower. Although there is 
uncertainty concerning the magnitude of all of our estimates, we do not 
have the data to provide specific estimates for each reform proposed, 
as to the range of possibilities, or to estimate all categories of 
possible benefits, including health effects.
6. Conclusion
    These provisions of the final rule will substantially reduce 
existing regulatory requirements imposed on health care providers 
through the CoPs and related regulatory provisions that Medicare and 
Medicaid providers must meet. For some provisions, health benefits to 
patients will be substantial and direct. Other provisions will free up 
time and efforts of health care providers to focus on improving health 
care quality and service delivery. Although this rule does not require 
a final regulatory flexibility analysis, we believe the preceding 
analysis meets the requirements for such an analysis as set out in 
Sec.  604 of the Regulatory Flexibility Act. In addition, the analysis 
above, together with the remainder of this preamble, provides a 
regulatory impact analysis.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

B. Regulatory Impact Statement for Fire Safety Requirements for Certain 
Dialysis Facilities

    We have examined the impact of these regulatory provisions as 
required by Executive Order 12866 on Regulatory Planning and Review 
(September 30, 1993), Executive Order 13563 on Improving Regulation and 
Regulatory Review (January 18, 2011), the Regulatory Flexibility Act 
(RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the 
Social Security Act, section 202 of the Unfunded Mandates Reform Act of 
1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on 
Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 
804(2)), and Executive Order 13771 on Reducing Regulation and 
Controlling Regulatory Costs (January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year).
    We do not know how many, if any, dialysis facilities would be 
affected by this adoption of the 2012 editions of the NFPA 101 and NFPA 
99. All States have adopted the 2012 editions, so as a practical 
matter, all dialysis facilities are already following the 2012 
requirements. Therefore, we do not anticipate any impact on the 
applicable dialysis facilities.
    Accordingly, these provisions do not reach the economic threshold 
and thus are neither economically significant under Executive Order 
12866, nor a major rule under the Congressional Review Act.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, and to prepare a final regulatory flexibility 
analysis if a rule is found to have a significant impact on a 
substantial number of small entities. For purposes of the RFA, small 
entities include small businesses, nonprofit organizations, and small 
governmental jurisdictions. Most hospitals and most other providers and 
suppliers are small entities, either by nonprofit status or by having 
revenues of less than $7.5 million to $38.5 million in any 1 year. 
Individuals and States are not included in the definition of a small 
entity. We are not preparing a final regulatory flexibility analysis 
because we have determined, and the Secretary certifies, that these 
provisions of the final rule will not have a significant economic 
impact on a substantial number of small entities.
    In addition, section 1102(b) of the Social Security Act (the Act) 
requires us to prepare a regulatory impact analysis if a rule may have 
a significant impact on the operations of a substantial number of small 
rural hospitals. This analysis must conform to the provisions of 
section 604 of the RFA. For purposes of section 1102(b) of the Act, we 
define a small rural hospital as a hospital that is located outside of 
a Metropolitan Statistical Area for Medicare payment regulations and 
has fewer than 100 beds. We are not preparing an analysis for section 
1102(b) of the Act because

[[Page 51805]]

we have determined, and the Secretary certifies, that these provisions 
of the final rule will not have a significant impact on the operations 
of a substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2019, that 
threshold is approximately $154 million. These provisions will have no 
consequential effect on State, local, or tribal governments or on the 
private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. Since these provisions do not impose any costs on State 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

F. Regulatory Impact Analysis for Hospital and Critical Access Hospital 
Changes To Promote Innovation, Flexibility, and Improvement in Patient 
Care

1. Statement of Need
    CMS is aware, through conversations with stakeholders and federal 
partners, and as a result of internal evaluation and research, of 
outstanding concerns about CoPs for hospitals and CAHs, despite recent 
revisions. We believe that the revisions will alleviate many of those 
concerns. In addition, modernization of the requirements would 
cumulatively result in improved quality of care and improved outcomes 
for all hospital and CAH patients. We believe that benefits would 
include reduced readmissions, reduced incidence of hospital-acquired 
conditions (including healthcare-associated infections), improved use 
of antibiotics at reduced costs (including the potential for reduced 
antibiotic resistance), and improved patient and workforce protections.
    These benefits are consistent with former HHS Quality Initiatives, 
including efforts to prevent HAIs; the national action plan for adverse 
drug event (ADE) prevention; the national strategy for Combating 
Antibiotic-Resistant Bacteria (CARB); and the Department's National 
Quality Strategy (http://www.ahrq.gov/workingforquality/index.html). 
Principles of the National Quality Strategy supported by the proposed 
rule include eliminating disparities in care; improving quality; 
promoting consistent national standards while maintaining support for 
local, community, and State-level activities that are responsive to 
local circumstances; care coordination; and providing patients, 
providers, and payers with the clear information they need to make 
choices that are right for them (http://www.ahrq.gov/workingforquality/nqs/principles.htm). Our proposal to prohibit discrimination would 
support eliminating disparities in care, and we believe our proposals 
about QAPI and infection prevention and control and antibiotic 
stewardship programs will improve quality and promote consistent 
national standards. Our proposals regarding the term licensed 
independent practitioners and establishing policies and protocols for 
when the presence of an RN is needed will support care coordination and 
quality of care. In sum, we believe our proposed changes are necessary, 
timely, and beneficial. We are finalizing most of the aforementioned 
proposals.
2. Overall Impact
    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive 
Order 13771 on Reducing Regulation and Controlling Regulatory Costs 
(January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with economically significant effects ($100 million or more in any 1 
year). We estimate that this rulemaking is ``economically significant'' 
as measured by the $100 million threshold, and hence also a major rule 
under the Congressional Review Act. Accordingly, we have prepared a 
regulatory impact analysis (RIA) that, to the best of our ability, 
presents the costs and benefits of the rulemaking.
    The Congressional Review Act, 5 U.S.C. 801 et. seq., as added by 
the Small Business Regulatory Enforcement Fairness Act of 1996, 
generally provides that before a rule may take effect, the agency 
promulgating the rule must submit a rule report, which includes a copy 
of the rule, to each chamber of the Congress and to the Comptroller 
General of the United States. HHS will submit a report containing this 
rule and other required information to the U.S. Senate, the U.S. House 
of Representatives, and the Comptroller General of the United States 
prior to publication of the rule in the Federal Register.
    The final rule would create ongoing cost savings to hospitals and 
CAHs in many areas. We believe these savings would largely, but not 
necessarily entirely, offset any costs to hospitals and CAHs that would 
be incurred by other changes we are finalizing in this rule. The 
financial savings and costs are summarized in Table 18.
    We sought public comment on our burden assumptions and estimates as 
well as comments identifying additional reforms that should be 
considered for future rulemakings. As is usually the case in impact 
analysis, substantial uncertainty surrounds these estimates and we 
solicited comments on any suggestions or data that would inform our 
estimates for the final rule.
    Comment: We received a comment that was generally in support of the 
changes proposed and the goals of those changes; however, the commenter 
was concerned that the rule dramatically

[[Page 51806]]

underestimates the time and effort required for compliance with the 
antibiotic stewardship and Quality Assessment and Performance 
Improvement (QAPI) programs.
    Response: We note that since the QAPI requirement will replace the 
annual evaluation requirement, we believe many of those resources could 
be reallocated to QAPI activities to minimize burden. In addition, we 
have re-evaluated our proposed requirements and eliminated unnecessary 
prescriptiveness, allowing each CAH the flexibility to implement its 
QAPI program in the most efficient manner for its unique circumstances. 
With regards to the antibiotic stewardship program, we have expanded on 
our cost estimates to account for a more robust intervention, and 
presented a range of estimates to account for uncertainty.
    Comment: We received a comment expressing concern over whether the 
costs of implementing the infection prevention and control program were 
underestimated due to the additional training and technical assistance 
that would be required for the individual fulfilling the infection 
preventionist role in CAHs.
    Response: We thank you for your comment, and we agree that the 
burden for CAHs due to the infection preventionist role was 
underrepresented in the proposed rule. We have revised our estimates to 
account for that error in this final rule.

                             Table 18--Section-by-Section Economic Impact Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of     Estimated net
                   Issue                                  Frequency                  affected        costs ($
                                                                                     entities       millions) *
----------------------------------------------------------------------------------------------------------------
Hospitals..................................  ...................................           4,823  ..............
     Patients' rights (RIA)........  One-time...........................           4,823   Not estimated
     Nursing services (ICR)........  Every 3 years......................           1,193               1
     Nursing services (ICR)........  One-time...........................           1,193               2
     Infection Prevention & Control  One-time...........................           4,823              20
     and Antibiotic Stewardship (RIA)......  Recurring annually.................             482             -23
CAHs.......................................  ...................................           1,353  ..............
     QAPI (ICR)....................  Recurring annually.................           1,004               1
     Food and dietary (RIA)........  Recurring annually.................             677              -5
     Infection Prevention & Control  One-time...........................           1,353               6
                                             Recurring annually.................           1,004             148
     and Antibiotic Stewardship (RIA)......  Recurring annually.................             501             -27
----------------------------------------------------------------------------------------------------------------
Note: This table includes entries only for those proposed reforms that we believe would have a measurable
  economic effect; includes estimates from ICRs and RIA. Negative costs indicate cost savings.
* Amounts rounded to the nearest million.

3. Anticipated Effects
    There are about 4,823 hospitals and 1,353 CAHs that are certified 
by Medicare and/or Medicaid. We use these figures to estimate the 
potential impacts of the final rule. In the estimates that were shown 
in the Collection of Information Requirements section of the preamble 
and in the RIA here, we estimate hourly costs as follows. Using May 
2017 data from the Bureau of Labor Statistics, we have obtained 
estimates of the national average hourly wage for all medical 
professions (https://www.bls.gov/oes/2017/may/oes_nat.htm). We have 
adjusted these rates by adding 100 percent to the hourly wage to 
account for overhead costs and fringe benefit costs. We use the 
following average hourly wages in our estimates:

                  Table 19--Hourly Costs by Profession
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Registered dietitians and nutrition professionals................    $58
Registered nurses................................................     71
Advanced practice registered nurses..............................    103
Physician assistants.............................................    101
Pharmacists......................................................    117
Network data analysts............................................     89
Hospital CEO/administrators......................................    189
CAH CEO/administrators...........................................    107
Clerical staff workers...........................................     33
Physicians.......................................................    191
Clinical Laboratory Technicians..................................     51
------------------------------------------------------------------------

a. Effects on Hospitals
(1) Licensed Independent Practitioners (Patients' Rights Sec.  482.13)
    We are finalizing our proposal to delete the modifying term 
``independent'' from the CoP at Sec.  482.13(e)(5), as well as at Sec.  
482.13(e)(8)(ii). While we believe that hospitals might be able to 
achieve some costs savings through these changes (by having additional 
licensed practitioners such as PAs allowed to write restraint and 
seclusion orders and thus relieve some of the burden from physicians), 
we do not have a reliable means of quantifying these possible cost 
savings. We solicited comments as to whether the assumption of cost 
savings is reasonable and welcomed any data that may help inform the 
costs and benefits of this provision, but did not receive any comments 
specific to our solicitation.
(2) Infection Control and Antibiotic Stewardship (Infection Prevention 
and Control Sec.  482.42)
    We are revising the hospital requirements at 42 CFR 482.42, 
``Infection control,'' which currently require hospitals to provide a 
sanitary environment to avoid sources and transmission of infections 
and communicable diseases. Hospitals are also currently required to 
have a designated infection control officer, or officers, who are 
required to develop a system to identify, report, investigate and 
control infections and communicable diseases of patients and personnel. 
The hospital's CEO, medical staff, and director of nursing services are 
charged with ensuring that the problems identified by the infection 
control officer or officers are addressed in hospital training programs 
and their QAPI program. The CEO, medical staff, and director of nursing 
services are also responsible for the implementation of successful 
corrective action plans in affected problem areas.
    We are finalizing our proposal to 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

[[Page 51807]]

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 could play in 
improving patient care and safety and combatting antimicrobial 
resistance through implementation of a robust stewardship program that 
follows nationally recognized guidelines for appropriate antibiotic 
use. Along with these changes, we proposed 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. We will also require that a program 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, for reducing the development and 
transmission of HAIs and antibiotic-resistant organisms. While these 
particular changes are new to the regulatory text, it is worth noting 
that these requirements, with the exception of the new requirement for 
an antibiotic stewardship program, have been present in the 
Interpretive Guidelines (IGs) for hospitals since 2008 (See A0747 at 
Appendix A--Survey Protocol, Regulations and Interpretive Guidelines 
for Hospitals, http://cms.gov/manuals/Downloads/som107ap_a_hospitals.pdf).
(a) Infection Prevention and Control
    Each hospital will be required to review their current infection 
control program and compare it to the new requirements contained in 
this section. After performing this comparison, each hospital will be 
required to revise their program so that it complies with the 
requirements in this section. Based on our experience with hospitals, 
we believe that a physician and a nurse on the infection control team 
will conduct this review and revision of the program. We believe both 
the physician and the nurse will spend 16 hours each for a total of 32 
hours. According to BLS data, doubled to account for overhead costs and 
fringe benefits, physician time costs an average of $191 an hour, and 
nurses' time costs an average wage of $71 an hour. Thus, to ensure 
their infection control program complied with the requirements in this 
section, we estimate that each hospital will require 32 burden hours 
(16 hours for a physician and 16 hours for a nurse) at a cost of $4,192 
($3,056 ($191 an hour for a physician x 16 burden hours) + $1,136 ($71 
an hour for a nurse x 16 burden hours)). Based on the estimate, for all 
4,823 hospitals, complying with this requirement will require 154,336 
burden hours (32 hours for each hospital x 4,823 hospitals) at a one-
time cost of approximately $20 million ($4,192 for each hospital x 
4,823 hospitals).
    At Sec.  482.42(a)(1), we are finalizing our proposal to require 
the hospital to appoint an infection preventionist(s)/infection control 
professional(s). Within this change we are deleting the outdated term, 
``infection control officer,'' and replacing it with the more current 
and accurate terms, ``infection preventionist/infection control 
professional.'' CDC has defined ``infection control professional 
(ICP)'' as ``a person whose primary training is in either nursing, 
medical technology, microbiology, or epidemiology and who has acquired 
specialized training in infection control.'' In designating infection 
preventionists/ICPs, hospitals should ensure that the individuals so 
designated are qualified through education, training, experience, or 
certification (such as that offered by the CBIC, or by the specialty 
boards in adult or pediatric infectious diseases offered for physicians 
by the American Board of Internal Medicine (for internists) and the 
American Board of Pediatrics (for pediatricians).
    Since this requirement has been present in the IGs since 2008, we 
believe that hospitals have been aware of CMS' expectations for the 
qualifications of infection control officers. The Joint Commission has 
a similar requirement (TJC Accreditation Standard IC.01.01.01). We 
believe that hospitals accredited by TJC (over 75 percent of all 
hospitals (http://www.jointcommission.org/facts_about_hospital_accreditation/)) should already be in compliance, 
or near compliance, with this requirement. The Joint Commission 
requires that a hospital identify the individual(s) responsible for its 
infection prevention and control program, including the individual(s) 
with clinical authority over the infection prevention and control 
program. For these reasons, we do not anticipate any new recurring 
burden to hospitals attributable to appointing an infection 
preventionist.
(b) Antibiotic Stewardship (AS)
    At Sec.  482.42(b), we believe that the finalized requirements for 
a hospital to have an active antibiotic stewardship program, and for 
its organization and policies, would constitute additional regulatory 
burden, as will be discussed in more detail below. However, we believe 
that the estimated costs of an AS program would be greatly offset by 
the savings that a hospital would achieve through such a program. The 
most obvious savings would be from decreased inappropriate antibiotic 
use leading to overall decreased drug costs for a hospital. 
Antimicrobial costs, particularly antibiotic costs, often constitute a 
significant percentage of the pharmacy budget for a hospital, so 
reducing overall antibiotic use would most likely have a substantial 
impact in lowering overall drug costs for a hospital. In fact, our 
review of the literature showed significant savings in this area, with 
annual savings proportional to bed size of the hospital or hospital 
unit. Reported annual savings ranged from $27,917 (Canadian dollars) 
for a 12-bed medical/surgical intensive care unit to $2.1 million for 
an 880-bed academic medical center.6 7
---------------------------------------------------------------------------

    \6\ Leung V., Gill S., Sauve J., Walker K., Stumpo C., Powis J. 
Growing a ``positive culture'' of antimicrobial stewardship in a 
community hospital. The Canadian journal of hospital pharmacy. 2011; 
64(5):314-20.
    \7\ Beardsley J.R., Williamson J.C., Johnson J.W., Luther V.P., 
Wrenn R.H., Ohl C.C. Show me the money: Long-term financial impact 
of an antimicrobial stewardship program. Infection control and 
hospital epidemiology: The official journal of the Society of 
Hospital Epidemiologists of America. 2012; 33(4):398-400.
---------------------------------------------------------------------------

    We specifically note the $177,000 in annual drug cost savings 
achieved by a 120-bed community hospital with its AS program for the 
year of 2000 compared to 1999, and would use that as the average cost 
savings for the average-sized 124-bed hospital discussed above (LaRocco 
2003, CID ``Concurrent antibiotic review programs--a role for 
infectious diseases specialists at small community hospitals''). 
Inflating this number to 2017 dollars using the consumer price index 
yields approximately $258,000. According to NHSN survey data, almost 82 
percent of hospitals were implementing all 7 of CDC's core elements of 
hospital antibiotic stewardship programs in 2017. This is significantly 
higher than the estimate published in the proposed rule, because the 
number of hospitals implementing AS programs has increased dramatically 
in the past several years. This is primarily driven by large 
accrediting organizations announcing and implementing their own 
antimicrobial stewardship standards. Preliminary 2018 data suggest that 
this upward trend of AS programs is likely to continue to some degree; 
however, since the the antimicrobial stewardship standards are already 
in effect for one of the largest

[[Page 51808]]

accrediting bodies as of January 2017, we would expect a sharp decline 
in the marginal rate of AS implementation in 2017 and beyond without 
further intervention. Therefore, for our baseline we have projected 
that approximately 90% of hospitals would have AS programs in 2018 were 
the rate of adoption to decrease by half, and we assume that is 
approximately where the market would level off absent further 
intervention. We have accounted for this uncertainty by providing 
estimates in the accounting statement that are 25 percent higher or 
lower than our primary estimate. Accordingly, we estimate that the 
annual drug cost savings for 10 percent of all 4,823 hospitals under 
the rule would be approximately $124 million (482 hospitals x 
$258,000). While most of the evidence we reviewed showed clear savings 
through reduced hospital pharmacy costs that was a direct result of 
reduced antibiotic use, some studies also demonstrated other financial 
benefits for hospitals with AS programs, such as decreases in patient 
length of stay and readmission rates as well as reductions in CDI rates 
and costs (as we discuss in more detail in the paragraphs to follow).
    Based on the published studies that we previously noted, we 
therefore also believe that the proposed requirement for an AS program 
would assist hospitals in significantly reducing rates of CDI and the 
attendant costs. Based on an AS program model developed by the CDC, a 
hospital combined IC/AS program with an average effectiveness rate of 
50 percent would reduce the number of CDIs among Medicare beneficiaries 
annually by 101,000.\8\ The costs examined in the model were costs for 
patients who developed CDIs while they were in the hospital or had to 
be re-admitted to the hospital for a case of CDI that was a result of a 
recent hospitalization, so the costs are much higher than what would be 
associated with outpatient cases. The 101,000-reduction is an annual 
reduction in the number of cases of CDI among patients who develop the 
infection because of medical care; that is, they were admitted for 
something else and then acquired CDI while getting care. It should be 
noted that the 101,000 number actually comprises two types of CDI--
cases that occur while the patient is in the hospital and cases that 
are directly attributable to a recent hospitalization, but which 
manifest after the patient is discharged and requires a readmission. 
Their study found that the cost for patients who develop the infection 
while they are already in the hospital is between $4,323 and $8,146. 
However, the infections related to a recent hospital stay that require 
readmission are more expensive, on average, because they require an 
entirely new admission; the cost of those cases is between $7,061 and 
$11,601. A more recent CDC study found the attributable patient cost 
savings for health care-associated clostridioides difficile (HCA-CDI) 
to be $6,844 per prevented case, and $12,703 per prevented case of 
recurrent CDI (2015 $).\9\ Inflating these numbers to 2017 dollars 
using the consumer price index returns approximately $7,133 and $13,240 
respectively. Scott et al. built their economic model with a range from 
10 to 50 percent effectiveness, which represents a range of between 
approximately 200,000 and 1.1 million inpatient cases of HCA-CDI 
averted in a 5 year period.
---------------------------------------------------------------------------

    \8\ Rachel B. Slayton, Ph.D., MPH; R. Douglas Scott II, Ph.D.; 
James Baggs, Ph.D.; Fernanda C. Lessa, MD; L. Clifford McDonald, MD; 
John A. Jernigan, MD. ``The Cost-Benefit of Federal Investment in 
Preventing Clostridium difficile Infections through the Use of a 
Multifaceted Infection Control and Antimicrobial Stewardship 
Program,'' Infection Control & Hospital Epidemiology 2015;00(0):1-7.
    \9\ R. Douglas Scott II, Rachel B. Slayton, Fernanda C. Lessa, 
James Baggs, Steven D. Culler, L. Clifford McDonald and John A. 
Jernigan; ``Assessing the social cost and benefits of a national 
requirement establishing antibiotic stewardship programs to prevent 
Clostridioides difficile infection in US hospitals''; Antimicrobial 
Resistance & Infection Control, 2019, 8:17.
---------------------------------------------------------------------------

    For our purposes, we have based our central estimate on the middle 
of the aforementioned range, or approximately 30 percent effectiveness, 
resulting in 546,000 inpatient cases of HCA-CDI averted, and 117,000 
recurrent cases averted. It is not clear exactly how many of these 
averted cases would occur in hospitals versus CAHs, but the prevalence 
of existing AS programs (or lack thereof) suggest CAHs may have more 
potential for improvement despite their smaller number of beds; there 
is also a limited amount of research that suggests the rate of CDI may 
be higher in hospitals with fewer beds, possibly due to rates of 
testing or other factors; and it is also possible that CAHs serve an 
older population that is more at risk for healthcare-associated 
infections than patients at non-CAHs.10 11 Therefore, we 
assume an equal number of cases averted per facility, meaning 
approximately 78 percent of these would occur in hospitals and 22 
percent in CAHs. As previously explained, we estimate that 90 percent 
of hospitals already have AS programs, and therefore 10 percent of 
those averted cases would be attributable to this regulation. This 
comes to a total of 42,588 HCA-CDI cases averted, and 9,126 recurrent 
cases averted for hospitals in a 5 year period. Multiplying these 
averted cases by the attributable patient cost savings, and annualizing 
the amount, comes to approximately $85 million in annualized patient 
cost savings. These patient cost savings do not include the cost 
savings attributable to any averted or modified antibiotic regimen, 
which was calculated above.
---------------------------------------------------------------------------

    \10\ Kamboj M, Brite J, Aslam A, et al. Artificial Differences 
in Clostridium difficile Infection Rates Associated with Disparity 
in Testing. Emerging Infectious Diseases. 2018;24(3):584-587.
    \11\ Joynt, K. E., Harris, Y., Orav, E. J., & Jha, A. K. (2011). 
Quality of care and patient outcomes in critical access rural 
hospitals. JAMA, 306(1), 45-52. doi:10.1001/jama.2011.902.
---------------------------------------------------------------------------

    Thus, we estimate that the combined annual drug cost savings and 
patient cost savings will be approximately $209 million. These savings 
will accrue to patients (reduced out-of-pocket costs), hospitals 
(reduced costs and improved balance sheets), as well as healthcare 
insurers, including Medicare (over time, payment rates will be adjusted 
downward as hospital costs fall). However, we are not able to apportion 
the savings that would accrue to each group with any accuracy and it 
will inevitably change over time as insurance rates change. Regardless, 
healthcare-associated infections are known to be expensive to insurers, 
including CMS. Preventing these infections will reduce CMS and other 
insurer expenditures, both on direct hospital costs and through reduced 
re-admissions. The cost-savings estimates for CDI included in the RIA 
provide an example of the savings Medicare and other insurers could 
realize through reductions in just one HAI. Ultimately, of course, 
insurance costs (and the medical care they pay for) are paid by 
taxpayers and workers. Even the employer contribution to insurance 
costs is generally regarded by economists as part of worker 
compensation. We requested comment regarding data that would allow for 
more robust quantification of the rule's impacts on HAIs other than 
CDI, but did not receive any such comments.
    We believe that the burden of implementing and maintaining an AS 
program includes the costs of the qualified personnel needed to 
establish and manage such a hospital program. In the proposed rule, our 
review of the literature, consultations with CDC, and experience with 
hospitals suggested that the establishment and maintenance of a 
hospital antibiotic stewardship program for an average-size hospital 
(approximately 124 beds), would require at least the leadership of a 
physician (preferably one with training in infectious diseases) and a 
clinical pharmacist, and also the services of a

[[Page 51809]]

network data analyst, at the following proportions of full-time 
employee salaries respectively: 0.10, 0.25, and 0.05. However, the 
latest research on the resources required for an effective AS program 
suggest that the minimum full-time equivalent support recommended for a 
hospital of this size may be somewhat more burdensome, due to the 
leadership of a pharmacist and physician at the full time equivalents 
of their salaries of 1.0 and 0.4 respectively.\12\ We also based our 
estimates on the prior assumption that 10 percent of hospitals do not 
yet have programs that implement all of the CDC core elements. Based on 
these assumptions, the minimum annual cost of the essential team 
members for a hospital to establish and maintain an antibiotic 
stewardship program would be $386,800 (($191 x 0.40 x 2,000 hours per 
year = $152,800 for a physician) + ($117 x 1.00 x 2,000 hours per year 
= $234,000 for a clinical pharmacist)). The annual labor cost for 10 
percent of hospitals ($386,800 x 482) would be approximately $186 
million.
---------------------------------------------------------------------------

    \12\ Sarah B Doernberg, Lilian M Abbo, Steven D Burdette, Neil O 
Fishman, Edward L Goodman, Gary R Kravitz, James E Leggett, Rebekah 
W Moehring, Jason G Newland, Philip A Robinson, Emily S Spivak, 
Pranita D Tamma, Henry F Chambers, Essential Resources and 
Strategies for Antibiotic Stewardship Programs in the Acute Care 
Setting, Clinical Infectious Diseases, Volume 67, Issue 8, 15 
October 2018, Pages 1168-1174
---------------------------------------------------------------------------

    We invited public comment regarding the amount by which costs may 
exceed savings in cases of non-voluntary IC/AS program adoption, but 
did not receive comments with specific estimates.
b. Effects on CAHs
(1) Ordering Privileges for Qualified Dietitians (RDs) and Qualified 
Nutrition Professionals (Provision of Services Sec.  485.635)
    We are finalizing our proposal to revise the CAH requirements at 42 
CFR 485.635 (a)(3)(vii), which currently require that the nutritional 
needs of inpatients are met in accordance with recognized dietary 
practices and the orders of the practitioner responsible for the care 
of the patients. Specifically, we proposed revisions that would change 
the CMS requirements to allow for flexibility in this area by requiring 
that all patient diets, including therapeutic diets, must be ordered by 
a practitioner responsible for the care of the patient, or by a 
qualified dietitian or qualified nutrition professional as authorized 
by the medical staff in accordance with State law governing dietitians 
and nutrition professionals.
    With these changes to the current requirements, a CAH will have the 
regulatory flexibility to grant qualified dietitians/nutrition 
professionals specific dietary ordering privileges (including the 
capacity to order specific laboratory tests to monitor nutritional 
interventions and then modify those interventions as needed). We 
believe that this is another area of change to the requirements that 
might produce savings since this will allow physicians to delegate to a 
qualified dietitian or qualified nutrition professional the task of 
prescribing patient diets, including therapeutic diets, to the extent 
allowed by state law. We further believe that dietitians or other 
clinically qualified nutrition professionals are already performing 
patient dietary assessments and making dietary recommendations to the 
physician (or PA or APRN) who then evaluates the recommendations and 
writes orders to implement them. Our analysis does not take into 
account improved quality of life nor improved clinical outcomes for the 
patient. We do not currently have data to more precisely estimate the 
savings that this revision could produce in CAHs. However, we believe 
that it might allow for better use of both physician/PA/APRN and 
dietitian/nutrition professional time and could result in improved 
quality of life and improved clinical outcomes for CAH patients.
    More obviously, dietitians/nutrition professionals with ordering 
privileges will be able to provide dietary/nutritional services at 
lower costs than physicians (as well as APRNs and PAs, two categories 
of non-physician practitioners that have traditionally also devised and 
written patient dietary plans and orders). This cost savings stems in 
some part from significant differences in the average salaries between 
the professions and the time savings achieved by allowing dietitians/
nutrition professionals to autonomously plan, order, monitor, and 
modify services as needed and in a more complete and timely manner than 
they are currently allowed. Savings would be realized by CAHs through 
the physician/APRN/PA time and salaries saved.
    Physicians, APRNs, and PAs often lack the training and educational 
background to manage the nutritional needs of patients with the same 
efficiency and skill as dietitians/nutrition professionals. The 
addition of ordering privileges enhances the ability that dietitians/
nutrition professionals already have to provide timely, cost-effective, 
and evidence-based nutrition services as the recognized nutrition 
experts on a CAH interdisciplinary team.
    It might seem natural to calculate these cost savings for CAHs 
based on the following assumptions:
     There is an average hourly cost difference of $74 between 
dietitians/nutrition professionals on one side ($58 per hour) and the 
hourly cost average for physicians, APRNs, and PAs ($132 per hour) on 
the other;
     There were 282,584 inpatient visits by Medicare 
beneficiaries in 2011 (According to a December 2013 OIG report (http://oig.hhs.gov/oei/reports/oei-05-12-00081.pdf)) with each of these stays 
requiring at least one dietary plan and orders;
     On average, each dietary order, including ordering and 
monitoring of laboratory tests, subsequent modifications to orders, and 
dietary orders for discharge/transfer/outpatient follow-up as needed, 
will take 30 minutes (0.5 hours) of a physician's/APRN's/PA's/
dietitian's/nutrition professional's time per patient during an average 
stay; and
     We estimate that approximately 50 percent of CAHs (or 
approximately 677 CAHs) have not already granted ordering privileges to 
dietitians and nutrition professionals, reducing the number of total 
number of CAH inpatient stays to 141,292.
    The resulting savings would be $7,722 annually on average for each 
CAH (141,292 inpatient hospital stays x 0.50 hours of a physician's/
APRN's/PA's/dietitian's/nutrition professional's time x $74 per hourly 
cost difference / 677 CAHs) for a total annual savings of approximately 
$5.2 million. We note that these estimates exclude some categories of 
cost increases (for example, internal CAH meetings to plan changes and 
the time and other costs of training physicians, dietitians/nutrition 
professionals, and other staff on the new dietary ordering procedures). 
Even more importantly, this estimate does not account for barriers, 
other than federal regulation, to RDs receiving ordering privileges; 
Weil et al. (2008) provide evidence on the existence of such barriers, 
which would likely prevent at least some of these cost savings from 
being realized.\13\ If such barriers are not relevant, then there is 
another adjustment that would need to be made to the calculation. 
Specifically, the dietitian wage estimate would need to be revised 
because the wage data do not account for the increase in demand for 
dietitians we projected would result from the hospital burden reduction 
rule

[[Page 51810]]

finalized that same month. For the savings estimates accompanying that 
rule to be achieved would require at least 6.7 percent of the dietitian 
FTEs in the U.S. to be newly allocated to providing nutrition services 
to hospital patients.\14\ This shift in activity entails a substantial 
movement along the supply curve for dietitian labor, thus raising the 
dietitian wage and reducing the cost savings estimated with the method 
outlined. For these reasons, as well as our lack of data on CAH 
outpatient visits for nutritional services and the impact that the 
proposed regulatory changes might have on hospital costs in this area, 
we present the estimate for discussion purposes only.
---------------------------------------------------------------------------

    \13\ Weil, Sharon D., et al. ``Registered Dietitian Prescriptive 
Practices in Hospitals.'' Journal of the American Dietetic 
Association 108:1688-1692. October 2008.
    \14\ BLS data show employment of 59,490 dietitians, with a mean 
hourly wage of $27.62. Assuming all dietitians are employed full-
time (2,080 hours annually) yields a total sector value of $3.4 
billion, or $6.8 billion when doubled to account for fringe benefits 
and overhead. For the May, 2014, final rule, we estimated $459 
million of loaded wage savings associated with dietary ordering 
switching from physicians, nurse practitioners and physician 
assistants to lower-paid dietitians. Thus the relevant portion of 
the savings estimate equals roughly 6.7 percent (= $459 million / 
$6.8 billion) of the sector as a whole--and would exceed 6.7 
percent, to the extent that some current dietitian positions are 
part-time.
---------------------------------------------------------------------------

(2) Sec.  485.640 Condition of Participation: Infection Prevention and 
Control and Antibiotic Stewardship Programs
    As we finalized for hospitals, we are also finalizing the new 
infection prevention and control and antibiotic stewardship 
requirements for CAHs. The infection control requirements for CAHs have 
remained unchanged since 1997. We are adding a new infection prevention 
and control (as well as antibiotic stewardship) CoP for CAHs because 
the existing standards for infection control do not reflect the current 
nationally recognized practices for the prevention and elimination of 
healthcare-associated infections.
(a) Infection Prevention and Control
    Each CAH will be required to review their current infection control 
program and compare it to the new requirements. After performing this 
comparison, each CAH will be required to revise their program so that 
it complies with the new requirements. Based on our experience with 
CAHs, we believe that a physician and a nurse on the infection control 
team would conduct this review and revision of the program. We believe 
both the physician and the nurse will spend 16 hours each for a total 
of 32 hours. Physicians earn an average of $191 an hour, and nurses 
earn an average wage of $71 an hour, including overhead and fringe 
benefits. Thus, to ensure their infection control program complies with 
the new requirements, we estimate that each CAH would require 32 burden 
hours (16 hours for a physician and 16 hours for a nurse) at a cost of 
$4,192 ($3,056 ($191 an hour for a physician x 16 burden hours) + 
$1,136 ($71 an hour for a nurse x 16 burden hours)). Based on the 
estimate, for all 1,353 CAHs, complying with this requirement will 
require 43,296 burden hours (32 hours for each CAH x 1,353 CAHs) at a 
one-time cost of approximately $5.7 million ($4,192 for each CAH x 
1,353 CAHs).
    CAHs will also incur a recurring cost due to the new requirement 
that they appoint an infection preventionist. The Joint Commission has 
a similar requirement (TJC Accreditation Standard IC.01.01.01), and so 
we believe that the 349 CAHs accredited by TJC should already be in 
compliance, or near compliance, with this requirement. The Joint 
Commission requires that a CAH identify the individual(s) responsible 
for its infection prevention and control program, including the 
individual(s) with clinical authority over the infection prevention and 
control program. For the remaining CAHs not accredited by TJC, we are 
calculating the burden for them to come into compliance with this 
requirement.
    Based on our experience with CAHs, we believe that most ICPs would 
be registered nurses with experience, education, and training in 
infection control. As of 2017, approximately 1,004 CAHs are not 
accredited by TJC. For the purposes of a burden estimate, we assume 
that each CAH will choose to employ one ICP full-time (52 weeks x 40 
hours = 2,080 hours) at $71 per hour, although the regulation does not 
require the hiring of a new individual, and this position and its 
associated burden may overlap with that calculated for antibiotic 
stewardship below. Nonetheless, the cost per facility is estimated to 
be $147,680 annually (2,080 hours x $71), and the total cost for all 
non-TJC-accredited CAHs would be approximately $148 million annually 
(1,004 x $147,680).
(b) Antibiotic Stewardship
    Similarly, we believe that the finalized requirements for a CAH to 
have an active antibiotic stewardship program, and for its organization 
and policies, would constitute additional regulatory burden. We believe 
that the burden of implementing and maintaining an AS program includes 
the costs of the qualified personnel needed to establish and manage 
such a CAH program. In the proposed rule, our review of the literature, 
consultations with CDC, and experience with CAHs suggested that the 
establishment and maintenance of a CAH antibiotic stewardship program 
for a statutorily mandated 25-bed CAH, would require at least the 
leadership of a physician (preferably an infectious disease physician 
or physician with training in antibiotic stewardship) and a clinical 
pharmacist (preferably with training in infectious diseases or 
antibiotic stewardship), and also the services of a network data 
analyst at the following proportions of full-time employee salaries 
respectively: 0.05, 0.10, 0.025. However, the latest research on the 
resources required for an effective AS program suggest that the minimum 
full-time equivalent support needed for a CAH may be somewhat more 
burdensome. Doernberg et al. were unable to make specific 
recommendations for hospitals with fewer than 100 beds, however, the 
average self-reported burden for hospitals under 100 beds was larger 
than we anticipated. Therefore, for our purposes we assume 25-bed CAHs 
will incur half of the average costs that were reported by hospitals 
with fewer than 100 beds. Thus, we estimate each CAH will require the 
leadership of a pharmacist and physician at the full time equivalents 
of their salaries of 0.45 and 0.19 respectively. According to NHSN 
survey data, approximately 58 percent of CAHs reported having an AS 
program that meets all of the CDC's core elements in 2017. As 
previously mentioned, this number is significantly higher than the 
estimate published in the proposed rule because the number of CAHs 
implementing AS programs has increased dramatically in the past several 
years. This is primarily driven by large accrediting organizations 
announcing and implementing their own antimicrobial stewardship 
standards. Preliminary 2018 data suggest that this upward trend of AS 
programs is likely to continue to some degree; however, since the 
antimicrobial stewardship standards are already in effect for one of 
the largest accrediting bodies as of January 2017, we would expect a 
sharp decline in the marginal rate of AS implementation in 2017 and 
beyond without further intervention. Therefore, for our baseline we 
have projected that approximately 63% of CAHs would have AS programs in 
2018 were the rate of adoption to decrease by half, and we assume that 
is approximately where the market would level off absent further 
intervention. We have accounted for this uncertainty by providing 
estimates in the accounting

[[Page 51811]]

statement that are 25 percent higher or lower than our primary 
estimate. Accordingly, we estimate that approximately 501 CAHs (or 37 
percent) have not implemented an AS program. Based on these 
assumptions, the minimum annual cost of the essential team members for 
a CAH to establish and maintain an antibiotic stewardship program would 
be $177,880 (($191 per hour x 0.19 x 2,000 hours per year = $72,580 for 
a physician) + ($117 per hour x 0.45 x 2,000 hours per year = $105,300 
for a clinical pharmacist). The annual labor cost for 37 percent of 
CAHs ($177,880 x 501) would be approximately $89 million.
    However, we believe that the estimated costs of an AS program would 
be somewhat offset by the savings that a CAH would achieve through such 
a program. The most obvious savings would be from decreased 
inappropriate antibiotic use leading to overall decreased drug costs 
for a CAH. Our review of the literature showed significant savings in 
this area, with annual savings proportional to bed size of the 
hospital. Reported annual savings ranged from $27,917 for a 12-bed 
medical/surgical intensive care unit to $2.1 million for an 880-bed 
academic medical center. We specifically note the $177,000 in annual 
drug cost savings achieved by a 120-bed community hospital with its AS 
program for the year of 2000 compared to 1999 (LaRocco 2003, CID 
``Concurrent antibiotic review programs-a role for infectious diseases 
specialists at small community CAHs''), and would use that as the basis 
to calculate average annual cost savings for a 25-bed CAH. Inflating 
this number to 2017 dollars using the consumer price index yields 
approximately $258,000. Therefore, ($258,000 annual savings / 120 beds 
= $2,150 annual cost savings per bed) at $53,750 per CAH ($2,150 annual 
cost savings x 25 beds). Using this assumption, we believe that the 
annual drug cost savings for 37 percent of all 1,353 CAHs under the 
rule will be approximately $27 million (501 CAHs x $53,750 in drug cost 
savings).
    As previously explained, patient cost savings for CAHs has been 
estimated based on data from Scott et al., and we assume approximately 
22% of HCA-CDI and recurrent cases averted would occur in CAHs. Based 
on the estimated 63 percent of CAHs that already have AS programs, 
approximately 37 percent of those averted cases would be attributable 
to this regulation. This comes to a total of 44,444 HCA-CDI cases 
averted, and 9,524 recurrent cases averted for CAHs in a 5 year period. 
Multiplying these averted cases by the attributable patient cost 
savings, and annualizing the amount, comes to approximately $89 million 
in annualized patient cost savings.
    Accordingly, we estimate that the combined annual drug cost savings 
and patient cost savings will be approximately $116 million. These 
savings will accrue to patients (reduced out-of-pocket costs), CAHs 
(reduced costs and improved balance sheets), as well as healthcare 
insurers, including Medicare (over time, payment rates will be adjusted 
downward as CAH costs fall). However, we are not able to apportion the 
savings that would accrue to each group with any accuracy and it will 
inevitably change over time as insurance rates change. Regardless, 
healthcare-associated infections are known to be expensive to insurers, 
including CMS. Preventing these infections will reduce CMS and other 
insurer expenditures, both on direct hospital costs and through reduced 
re-admissions. The cost-savings estimates for CDI included in the RIA 
provide an example of the savings Medicare and other insurers could 
realize through reductions in just one HAI. Ultimately, of course, 
insurance costs (and the medical care they pay for) are paid by 
taxpayers and workers. Even the employer contribution to insurance 
costs is generally regarded by economists as part of worker 
compensation.
c. Effects on Patients
    As previously mentioned, some of the estimated cost savings will 
accrue to patients due to decreased morbidity and associated health 
care costs. Although this RIA has mainly focused on the costs 
associated with CDI, there will be savings associated with other 
infections, such as staphylococcus aureus, that we have not quantified 
here. Nor have we quantified any savings to patients due to averted 
travel costs for medical appointments, reduced absence from work, or 
other miscellaneous costs that would be evaded by patients.
    Antibiotic stewardship and infection control has also been proven 
to significantly reduce morbidity and mortality due to healthcare 
associated infections. Research by Scott et al., which has been 
referenced throughout this RIA, thoroughly explored the social costs 
and benefits of a national requirement establishing antibiotic 
stewardship programs to prevent CDI. The direct applicability of their 
study to this RIA is hindered only by differing methods of counting the 
effects of antimicrobial resistance and infection control. Their study 
quantifies the effects of AS on the entirety of hospitals with the 
argument that without these finalized requirements, there would be 
nothing holding hospitals accountable for maintaining their AS 
programs. However, this RIA takes into account a baseline of the 
current market conditions, which we believe have been strengthened by 
new standards set by large accrediting bodies. Nonetheless, they 
estimate CDI infection prevention alone to avert as many as 1.1 million 
inpatient cases and 44,000 deaths at a 3 percent discount rate over a 5 
year period. Using estimates for quality adjusted life years, their 
central estimate for the value of morbidity risk reduction at a 3 
percent discount rate is as much as $3 billion worth of lost quality 
adjusted life years from HCA-CDI, and their central estimate for the 
benefits of mortality risk reduction is as much as $401 billion 
utilizing estimates for the value of a statistical life.
d. Effects on Small Entities
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, we estimate that the 
great majority of the providers that would be affected by CMS rules are 
small entities as that term is used in the RFA. The great majority of 
hospitals and most other healthcare providers and suppliers are small 
entities, either by being nonprofit organizations or by meeting the SBA 
definition of a small business. Accordingly, the usual practice of HHS 
is to treat all providers and suppliers as small entities in analyzing 
the effects of our rules.
    These provisions of the final rule are anticipated to cost CAHs as 
much as $119 million in the first year. While this is a large amount in 
total, the average cost per affected CAH is approximately $88,000 in 
the first year, and slightly less in future years. Although the overall 
magnitude of the paperwork, staffing, and related cost reductions to 
hospitals and CAHs under this rule is economically significant, the net 
effect is likely to be a fraction of 1 percent of total hospital costs. 
Total national hospital care expenditure are approximately 1,143 
billion dollars a year, or an average of about $185 million per 
hospital, and our primary estimate of the net effect of these proposals 
on hospital costs is approximately $79 million annually.
    Under HHS guidelines for regulatory flexibility analyses, actions 
that do not negatively affect costs or revenues by more than 3 percent 
a year are generally not considered to be significant. We do not 
believe that hospitals of any size will be negatively affected to this

[[Page 51812]]

degree. Accordingly, we have determined that the rule will not have a 
significant economic impact on a substantial number of small entities, 
and certify that a final regulatory flexibility analysis is not 
required. Notwithstanding this conclusion, we believe that this RIA and 
the preamble as a whole meet the requirements of the RFA for a final 
regulatory flexibility analysis.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a metropolitan 
statistical area and has fewer than 100 beds. For the preceding 
reasons, we have determined that these provisions of the final rule 
will not have a significant negative impact on the operations of a 
substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2019, that 
is approximately $154 million. These provisions of the final rule do 
contain private sector mandates, but their costs are generally 
anticipated to be mostly offset by savings. Nevertheless, this RIA and 
the preamble, taken together, would meet the requirements of an 
analysis under section 202.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that would impose substantial direct requirement costs on State 
and local governments, preempts State law, or otherwise has Federalism 
implications. These provisions of the rule will not have a substantial 
direct effect on State or local governments, preempt State law, or 
otherwise have federalism implications.
4. Alternatives Considered
    As we stated, CMS is aware, through conversations with stakeholders 
and federal partners, and as a result of internal evaluation and 
research, of outstanding concerns about the CoPs for hospitals and 
CAHs, despite recent revisions. This subset of the universe of 
standards is the focus of the final rule.
    One alternative we did consider was combining the infection 
prevention and control leader position with that of the antibiotic 
stewardship leader position. While this would certainly reduce the 
costs for hospitals by eliminating one of these positions, we also 
believe that it might reduce the overall effectiveness of the program 
and, thus, the overall societal benefits that might be achieved. The 
skills needed to lead each program are different. Infection prevention 
programs are often led by nursing staff who do not prescribe 
antibiotics. Antibiotic stewardship programs are led by physicians and 
pharmacists who have direct knowledge and experience with antibiotic 
prescribing. For these reasons, we decided to finalize the requirement 
as it is contained in this rule.
    For all of the finalized provisions, we considered not making these 
changes. Ultimately, based on our analysis of these issues and for the 
reasons stated in this preamble, we believe that it is best to propose 
changes at this time. We welcomed comments on whether we properly 
selected the best candidates for change, and welcomed suggestions for 
additional reform candidates from the entire body of CoPs.
5. Conclusion
    The financial impact of these provisions of the final rule will lie 
primarily with the balance between estimated costs and savings for the 
antibiotic stewardship program for hospitals. Nevertheless, the total 
costs of these provisions are anticipated to be mostly offset by 
savings. Moreover, the life-saving benefits of some of these 
provisions, including antibiotic stewardship, have been thoroughly 
studied and substantiated by independent researchers. However, we note 
that although savings and morbidity/mortality risk reductions on 
average are consistent with the literature we've reviewed, the outcomes 
for individual hospitals and CAHs will vary depending on their specific 
implementation strategies for AS.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

D. Accounting Statement and Table

    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf), in Table 20, we have prepared an accounting statement showing 
the classification of the transfers and costs associated with the 
various provisions of the final rule.
    While most provisions of the final rule have clearly predictable 
effects we do not in most cases have detailed empirical information on 
the precise magnitude of efforts involved (for example, time spent in 
meeting paperwork or other administrative tasks that apply to a 
particular provider type). Other provisions (notably those related to 
organ transplantation and removal of strict H&P requirements before 
ambulatory or outpatient surgery) have even more uncertain effect 
sizes. Therefore, we have estimated an upper and lower level for 
benefit and cost reduction estimates that is 25 percent higher or lower 
than our primary estimate for all quantified reforms other than those 
related to ambulatory surgery, and in that area our upper bound for 
costs is zero cost reductions and our lower bound is a 17 percent 
reduction in H&P and associated laboratory testing costs.

                Table 20--Accounting Statement: Classification of Estimated Benefits and Savings
                                                  [$ millions]
----------------------------------------------------------------------------------------------------------------
                                                                                             Units
                                            Primary       Low        High    -----------------------------------
                Category                   estimate    estimate    estimate      Year      Discount     Period
                                                                                dollars      rate       covered
----------------------------------------------------------------------------------------------------------------
Benefits:
----------------------------------------------------------------------------------------------------------------
    Life-Extending Benefits (monetized).                              Not Quantified
----------------------------------------------------------------------------------------------------------------
    Medical Cost Reduction Benefits
     (monetized)........................                              Not Quantified
----------------------------------------------------------------------------------------------------------------

[[Page 51813]]

 
    Qualitative.........................   Potential reductions in morbidity and mortality for hospital and CAH
                                                                         patients
----------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized Costs (+) or           -801      -1,127        -485        2017          7%   2019-2028
     Savings (-) ($million/year)........        -803      -1,128        -487        2017          3%   2019-2028
----------------------------------------------------------------------------------------------------------------
Transfers                                                                  None
----------------------------------------------------------------------------------------------------------------

E. Regulatory Reform Analysis Under E.O. 13771

    Executive Order 13771, titled Reducing Regulation and Controlling 
Regulatory Costs, was issued on January 30, 2017 and requires that the 
costs associated with significant new regulations ``shall, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations.'' This final rule is 
considered an E.O. 13771 deregulatory action. We estimate that this 
rule generates $647 million in annualized cost savings in 2016 dollars, 
discounted at 7 percent relative to year 2016, over a perpetual time 
horizon. Details on the estimated cost savings of this rule can be 
found in the preceding analyses.

List of Subjects

42 CFR Part 403

    Grant programs--health, Health insurance, Hospitals, 
Intergovernmental relations, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 416

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 441

    Aged, Family planning, Grant programs--health, Infants and 
children, Medicaid, Penalties, Reporting and recordkeeping 
requirements.

42 CFR Part 460

    Aged, Health care, Health records, Medicaid, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 482

    Grant program--health, Hospitals, Medicaid, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 483

    Grant programs--health, Health facilities, Health professions, 
Health records, Medicaid, Medicare, Nursing home, Nutrition, Reporting 
and recordkeeping requirements, Safety.

42 CFR Part 484

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 485

    Grant programs--health, Health facilities, Medicaid, Reporting and 
recordkeeping requirements.

42 CFR Part 486

    Grant programs--health, Health facilities, Medicare, Reporting and 
recordkeeping requirements, X-rays.

42 CFR Part 488

    Administrative practice and procedures, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 491

    Grant programs--health, Health facilities, Medicaid, Medicare, 
Reporting and recordkeeping requirements, Rural and urban areas.

42 CFR Part 494

    Diseases, Health facilities, Incorporation by Reference, Medicare, 
Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 403--SPECIAL PROGRAMS AND PROJECTS

0
1. The authority citation for part 403 is revised to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
2. Section 403.736 is amended by--
0
a. Removing the introductory text;
0
b. Revising paragraph (a);
0
c. Removing paragraph (b); and
0
d. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c).
    The revision reads as follows:


Sec.  403.736  Condition of participation: Discharge planning.

    (a) Discharge planning and instructions. The RNHCI must have in 
effect a discharge planning process that applies to all patients. The 
process must assure that appropriate post-institution services are 
obtained for each patient, as necessary. The RNHCI must assess the need 
for a discharge plan for any patient likely to suffer adverse 
consequences if there is no planning.
    (1) Discharge instructions must be provided at the time of 
discharge to the patient or the patient's caregiver as necessary.
    (2) If the patient assessment indicates a need for a discharge 
plan, the discharge plan must include instructions on post-RNHCI care 
to be used by the patient or the caregiver in the patient's home, as 
identified in the discharge plan.
    (3) If the RNHCI's patient assessment does not indicate a need for 
a discharge plan, the beneficiary or his or her legal representative 
may request a discharge plan. In this case, the RNHCI must develop a 
discharge plan for the beneficiary.
* * * * *

0
3. Section 403.748 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii); and
0
b. Adding paragraph (d)(1)(v).

[[Page 51814]]

    The revisions and addition read as follows:


Sec.  403.748  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The RNHCI must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
every 2 years. The plan must do all of the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The RNHCI must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The RNHCI must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The RNHCI must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the RNHCI must conduct training on the updated 
policies and procedures.
* * * * *

PART 416--AMBULATORY SURGICAL SERVICES

0
4. The authority citation for part 416 continues to read as follows:

    Authority: 42 U.S.C. 273, 1302, 1320b-8, and 1395hh.


0
5. Section 416.41 is amended by revising paragraph (b)(3) to read as 
follows:


Sec.  416.41  Condition for coverage--Governing body and management.

* * * * *
    (b) * * *
    (3) The ASC must periodically provide the local hospital with 
written notice of its operations and patient population served.

0
6. Section 416.47 is amended by revising paragraph (b)(2) to read as 
follows:


Sec.  416.47  Condition for coverage--Medical records.

* * * * *
    (b) * * *
    (2) Significant medical history and results of physical examination 
(as applicable).
* * * * *

0
7. Section 416.52 is amended by revising paragraph (a) to read as 
follows:


Sec.  416.52  Condition for coverage--Patient admission, assessment and 
discharge.

* * * * *
    (a) Standard: Patient assessment and admission. (1) The ASC must 
develop and maintain a policy that identifies those patients who 
require a medical history and physical examination prior to surgery. 
The policy must--
    (i) Include the timeframe for medical history and physical 
examination to be completed prior to surgery.
    (ii) Address, but is not limited to, the following factors: Patient 
age, diagnosis, the type and number of procedures scheduled to be 
performed on the same surgery date, known comorbidities, and the 
planned anesthesia level.
    (iii) Be based on any applicable nationally recognized standards of 
practice and guidelines, and any applicable State and local health and 
safety laws.
    (2) Upon admission, each patient must have a pre-surgical 
assessment completed by a physician who will be performing the surgery 
or other qualified practitioner in accordance with applicable State 
health and safety laws, standards of practice, and ASC policy.
    (3) The pre-surgical assessment must include documentation of any 
allergies to drugs and biologicals.
    (4) The patient's medical history and physical examination (if any) 
must be placed in the patient's medical record prior to the surgical 
procedure.
* * * * *

0
8. Section 416.54 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  416.54  Condition for coverage--Emergency preparedness.

* * * * *
    (a) Emergency plan. The ASC must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The ASC must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The ASC must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The ASC must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *

[[Page 51815]]

    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the ASC must conduct training on the updated 
policies and procedures.
    (2) Testing. The ASC must conduct exercises to test the emergency 
plan at least annually. The ASC must do the following:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, conduct a 
facility-based functional exercise every 2 years; or
    (B) If the ASC experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the ASC is exempt from 
engaging in its next required community-based or individual, facility-
based functional exercise following the onset of the emergency event.
    (ii) Conduct an additional exercise at least every 2 years, 
opposite the year the full-scale or functional exercise under paragraph 
(d)(2)(i) of this section is conducted, that may include, but is not 
limited to the following:
    (A) A second full-scale exercise that is community-based, or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the ASC's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
ASC's emergency plan, as needed.
* * * * *

PART 418--HOSPICE CARE

0
9. The authority citation for part 418 is revised to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh.


0
10. Section 418.76 is amended by revising paragraph (a)(1)(iv) to read 
as follows:


Sec.  418.76  Condition of participation: Hospice aide and homemaker 
services.

* * * * *
    (a) * * *
    (1) * * *
    (iv) A State licensure program.
* * * * *


Sec.  418.106  [Amended]

0
11. Section 418.106 is amended by--
0
a. Removing paragraph (a)(1);
0
b. Redesignating paragraph (a)(2) as paragraph (a)(1); and
0
c. Adding a new reserved paragraph (a)(2).

0
12. Section 418.112 is amended by revising paragraph (f) to read as 
follows:


Sec.  418.112  Condition of participation: Hospices that provide 
hospice care to residents of a SNF/NF or ICF/IID.

* * * * *
    (f) Standard: Orientation and training of staff. Hospice staff, in 
coordination with SNF/NF or ICF/IID facility staff, must assure 
orientation of such staff furnishing care to hospice patients in the 
hospice philosophy, including hospice policies and procedures regarding 
methods of comfort, pain control, symptom management, as well as 
principles about death and dying, individual responses to death, 
patient rights, appropriate forms, and record keeping requirements.

0
13. Section 418.113 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(iii);
0
b. Adding paragraph (d)(1)(vi);
0
c. Revising paragraph (d)(2); and
0
d. Adding paragraph (d)(3).
    The revisions and additions read as follows:


Sec.  418.113  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The hospice must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
every 2 years. The plan must do the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, or Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The hospice must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The hospice must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The hospice must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (iii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (vi) If the emergency preparedness policies and procedures are 
significantly updated, the hospice must conduct training on the updated 
policies and procedures.
    (2) Testing for hospices that provide care in the patient's home. 
The hospice must conduct exercises to test the emergency plan at least 
annually. The hospice must do the following:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, conduct an 
individual facility-based functional exercise every 2 years; or
    (B) If the hospice experiences a natural or man-made emergency that 
requires activation of the emergency plan, the hospital is exempt from 
engaging in its next required full-scale community-based exercise or 
individual facility-based functional exercise following the onset of 
the emergency event.
    (ii) Conduct an additional exercise every 2 years, opposite the 
year the full-scale or functional exercise under paragraph (d)(2)(i) of 
this section is conducted, that may include, but is not limited to the 
following:
    (A) A second full-scale exercise that is community-based or a 
facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.

[[Page 51816]]

    (3) Testing for hospices that provide inpatient care directly. The 
hospice must conduct exercises to test the emergency plan twice per 
year. The hospice must do the following:
    (i) Participate in an annual full-scale exercise that is community-
based; or
    (A) When a community-based exercise is not accessible, conduct an 
annual individual facility-based functional exercise; or
    (B) If the hospice experiences a natural or man-made emergency that 
requires activation of the emergency plan, the hospice is exempt from 
engaging in its next required full-scale community-based or facility-
based functional exercise following the onset of the emergency event.
    (ii) Conduct an additional annual exercise that may include, but is 
not limited to the following:
    (A) A second full-scale exercise that is community-based or a 
facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop led by a facilitator that 
includes a group discussion using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the hospice's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events and revise the 
hospice's emergency plan, as needed.
* * * * *

PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC 
SERVICES

0
14. The authority citation for part 441 is revised to read as follows:

    Authority: 42 U.S.C. 1302.


0
15. Section 441.184 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  441.184  Emergency preparedness.

* * * * *
    (a) Emergency plan. The PRTF must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The PRTF must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The PRTF must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The PRTF must develop and maintain an 
emergency preparedness training program that is based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, policies and procedures at paragraph 
(b) of this section, and the communication plan at paragraph (c) of 
this section. The training and testing program must be reviewed and 
updated at least every 2 years.
    (1) * * *
    (ii) After initial training, provide emergency preparedness 
training every 2 years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the PRTF must conduct training on the updated 
policies and procedures.
    (2) Testing. The PRTF must conduct exercises to test the emergency 
plan twice per year. The PRTF must do the following:
    (i) Participate in an annual full-scale exercise that is community-
based; or
    (A) When a community-based exercise is not accessible, conduct an 
annual individual, facility-based functional exercise; or
    (B) If the PRTF experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the PRTF is exempt from 
engaging in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the emergency 
event.
    (ii) Conduct an additional annual exercise that may include, but is 
not limited to the following:
    (A) A second full-scale exercise that is community-based or 
individual, a facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the PRTF's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
PRTF's emergency plan, as needed.
* * * * *

PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)

0
16. The authority citation for part 460 is revised to read as follows:

    Authority: 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).


0
17. Section 460.84 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  460.84  Emergency preparedness.

* * * * *
    (a) Emergency plan. The PACE organization must develop and maintain 
an emergency preparedness plan that must be reviewed, and updated at 
least every 2 years. The plan must do the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The PACE organization must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
address management of medical and nonmedical emergencies, including, 
but not limited to: Fire; equipment, power, or water

[[Page 51817]]

failure; care-related emergencies; and natural disasters likely to 
threaten the health or safety of the participants, staff, or the 
public. Policies and procedures must be reviewed and updated at least 
every 2 years. At a minimum, the policies and procedures must address 
the following:
* * * * *
    (c) Communication plan. The PACE organization must develop and 
maintain an emergency preparedness communication plan that complies 
with Federal, State, and local laws and must be reviewed and updated at 
least every 2 years. The communication plan must include all of the 
following:
* * * * *
    (d) Training and testing. The PACE organization must develop and 
maintain an emergency preparedness training and testing program that is 
based on the emergency plan set forth in paragraph (a) of this section, 
risk assessment at paragraph (a)(1) of this section, policies and 
procedures at paragraph (b) of this section, and the communication plan 
at paragraph (c) of this section. The training and testing program must 
be reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the PACE must conduct training on the updated 
policies and procedures.
    (2) Testing. The PACE organization must conduct exercises to test 
the emergency plan at least annually. The PACE organization must do the 
following:
    (i) Participate in a full-scale exercise that is community-based 
or;
    (A) When a community-based exercise is not accessible, conduct an 
annual individual, facility-based functional exercise every 2 years; or
    (B) If the PACE experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the PACE is exempt from 
engaging in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the emergency 
event.
    (ii) Conduct an additional exercise every 2 years opposite the year 
the full-scale or functional exercise under paragraph (d)(2)(i) of this 
section is conducted that may include, but is not limited to the 
following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the PACE's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events and revise the 
PACE's emergency plan, as needed.
* * * * *

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
18. The authority citation for part 482 is revised to read as follows:

    Authority: 42 U.S.C. 1302, 1395hh, and 1395rr, unless otherwise 
noted.


0
19. Section 482.13 is amended by revising paragraphs (e)(5), 
(e)(8)(ii), (e)(10) and (11), (e)(12)(i), (e)(14), and (g)(4)(ii) to 
read as follows:


Sec.  482.13  Condition of participation: Patient's rights.

* * * * *
    (e) * * *
    (5) 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.
* * * * *
    (8) * * *
    (ii) After 24 hours, before writing a new order for the use of 
restraint or seclusion for the management of violent or self-
destructive behavior, 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 
must see and assess the patient.
* * * * *
    (10) The condition of the patient who is restrained or secluded 
must be monitored by a physician, other licensed practitioner, or 
trained staff that have completed the training criteria specified in 
paragraph (f) of this section at an interval determined by hospital 
policy.
    (11) Physician and other licensed practitioner training 
requirements must be specified in hospital policy. At a minimum, 
physicians and other licensed practitioners authorized to order 
restraint or seclusion by hospital policy in accordance with State law 
must have a working knowledge of hospital policy regarding the use of 
restraint or seclusion.
    (12) * * *
    (i) By a--
    (A) Physician or other licensed practitioner.
    (B) Registered nurse who has been trained in accordance with the 
requirements specified in paragraph (f) of this section.
* * * * *
    (14) If the face-to-face evaluation specified in paragraph (e)(12) 
of this section is conducted by a trained registered nurse, the trained 
registered nurse must consult the attending physician or other licensed 
practitioner who is responsible for the care of the patient as soon as 
possible after the completion of the 1-hour face-to-face evaluation.
* * * * *
    (g) * * *
    (4) * * *
    (ii) Each entry must document the patient's name, date of birth, 
date of death, name of attending physician or other licensed 
practitioner who is responsible for the care of the patient, medical 
record number, and primary diagnosis(es).
* * * * *

0
20. Section 482.15 is amended--
0
a. By revising paragraphs (a) introductory text, (a)(4), (b) 
introductory text, (c) introductory text, (d) introductory text, and 
(d)(1)(ii);
0
b. By adding paragraph (d)(1)(v);
0
c. By revising paragraph (d)(2);
0
d. In paragraph (g) introductory text, by removing the phrase 
``transplant centers'' and adding into its place the phrase 
``transplant programs''; and
0
e. In paragraphs (g)(1) and (2), by removing the phrase ``transplant 
center'' and adding into its place the phrase ``transplant program''.
    The revisions and addition read as follows:


Sec.  482.15  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The hospital must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
every 2 years. The plan must do the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The hospital must develop and 
implement emergency preparedness policies and

[[Page 51818]]

procedures, based on the emergency plan set forth in paragraph (a) of 
this section, risk assessment at paragraph (a)(1) of this section, and 
the communication plan at paragraph (c) of this section. The policies 
and procedures must be reviewed and updated at least every 2 years. At 
a minimum, the policies and procedures must address the following:
* * * * *
    (c) Communication plan. The hospital must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The hospital must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the hospital must conduct training on the 
updated policies and procedures.
    (2) Testing. The hospital must conduct exercises to test the 
emergency plan at least twice per year. The hospital must do all of the 
following:
    (i) Participate in an annual full-scale exercise that is community-
based; or
    (A) When a community-based exercise is not accessible, conduct an 
annual individual, facility-based functional exercise; or.
    (B) If the hospital experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the hospital 
is exempt from engaging in its next required full-scale community-based 
exercise or individual, facility-based functional exercise following 
the onset of the emergency event.
    (ii) Conduct an additional annual exercise that may include, but is 
not limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the hospital's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events, and revise the 
hospital's emergency plan, as needed.
* * * * *

0
21. Section 482.21 is amended by revising paragraph (b)(1) and adding 
paragraph (f) to read as follows:


Sec.  482.21  Condition of participation: Quality assessment and 
performance improvement program.

* * * * *
    (b) * * *
    (1) The program must incorporate quality indicator data including 
patient care data, and other relevant data such as data submitted to or 
received from Medicare quality reporting and quality performance 
programs, including but not limited to data related to hospital 
readmissions and hospital-acquired conditions.
* * * * *
    (f) Standard: Unified and integrated QAPI program for multi-
hospital systems. If a hospital is part of a hospital system consisting 
of multiple separately certified hospitals using a system governing 
body that is legally responsible for the conduct of two or more 
hospitals, the system governing body can elect to have a unified and 
integrated QAPI program for all of its member hospitals after 
determining that such a decision is in accordance with all applicable 
State and local laws. The system governing body is responsible and 
accountable for ensuring that each of its separately certified 
hospitals meets all of the requirements of this section. Each 
separately certified hospital subject to the system governing body must 
demonstrate that:
    (1) The unified and integrated QAPI program is established in a 
manner that takes into account each member hospital's unique 
circumstances and any significant differences in patient populations 
and services offered in each hospital; and
    (2) The unified and integrated QAPI program establishes and 
implements policies and procedures to ensure that the needs and 
concerns of each of its separately certified hospitals, regardless of 
practice or location, are given due consideration, and that the unified 
and integrated QAPI program has mechanisms in place to ensure that 
issues localized to particular hospitals are duly considered and 
addressed.

0
22. Section 482.22 is amended by--
0
a. Revising paragraphs (c)(5)(i) and (ii);
0
b. Adding paragraphs (c)(5)(iii), (iv), and (v); and
0
c. Removing paragraph (d).
    The revisions and additions read as follows:


Sec.  482.22  Condition of participation: Medical staff.

* * * * *
    (c) * * *
    (5) * * *
    (i) A medical history and physical examination be completed and 
documented for each patient no more than 30 days before or 24 hours 
after admission or registration, but prior to surgery or a procedure 
requiring anesthesia services, and except as provided under paragraph 
(c)(5)(iii) of this section. The medical history and physical 
examination must be completed and documented by a physician (as defined 
in section 1861(r) of the Act), an oral and maxillofacial surgeon, or 
other qualified licensed individual in accordance with State law and 
hospital policy.
    (ii) An updated examination of the patient, including any changes 
in the patient's condition, be completed and documented within 24 hours 
after admission or registration, but prior to surgery or a procedure 
requiring anesthesia services, when the medical history and physical 
examination are completed within 30 days before admission or 
registration, and except as provided under paragraph (c)(5)(iii) of 
this section. The updated examination of the patient, including any 
changes in the patient's condition, must be completed and documented by 
a physician (as defined in section 1861(r) of the Act), an oral and 
maxillofacial surgeon, or other qualified licensed individual in 
accordance with State law and hospital policy.
    (iii) An assessment of the patient (in lieu of the requirements of 
paragraphs (c)(5)(i) and (ii) of this section) be completed and 
documented after registration, but prior to surgery or a procedure 
requiring anesthesia services, when the patient is receiving specific 
outpatient surgical or procedural services and when the medical staff 
has chosen to develop and maintain a policy that identifies, in 
accordance with the requirements at paragraph (c)(5)(v) of this 
section, specific patients as not requiring a comprehensive medical 
history and physical examination, or any update to it, prior to 
specific

[[Page 51819]]

outpatient surgical or procedural services. The assessment must be 
completed and documented by a physician (as defined in section 1861(r) 
of the Act), an oral and maxillofacial surgeon, or other qualified 
licensed individual in accordance with State law and hospital policy.
    (iv) The medical staff develop and maintain a policy that 
identifies those patients for whom the assessment requirements of 
paragraph (c)(5)(iii) of this section would apply. The provisions of 
paragraphs (c)(5)(iii), (iv), and (v) of this section do not apply to a 
medical staff that chooses to maintain a policy that adheres to the 
requirements of paragraphs of (c)(5)(i) and (ii) of this section for 
all patients.
    (v) The medical staff, if it chooses to develop and maintain a 
policy for the identification of specific patients to whom the 
assessment requirements in paragraph (c)(5)(iii) of this section would 
apply, must demonstrate evidence that the policy applies only to those 
patients receiving specific outpatient surgical or procedural services 
as well as evidence that the policy is based on:
    (A) Patient age, diagnoses, the type and number of surgeries and 
procedures scheduled to be performed, comorbidities, and the level of 
anesthesia required for the surgery or procedure.
    (B) Nationally recognized guidelines and standards of practice for 
assessment of specific types of patients prior to specific outpatient 
surgeries and procedures.
    (C) Applicable state and local health and safety laws.
* * * * *

0
23. Section 482.23 is amended by
0
a. Revising paragraphs (b) introductory text and (b)(4) and (6);
0
b. Adding paragraph (b)(7); and
0
c. Revising (c)(1) introductory text and (c)(3).
    The revisions and addition read as follows:


Sec.  482.23  Condition of participation: Nursing services.

* * * * *
    (b) Standard: Staffing and delivery of care. The nursing service 
must have adequate numbers of licensed registered nurses, licensed 
practical (vocational) nurses, and other personnel to provide nursing 
care to all patients as needed. 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 the care of any 
patient.
* * * * *
    (4) The hospital must ensure that the nursing staff develops and 
keeps current a nursing care plan for each patient that reflects the 
patient's goals and the nursing care to be provided to meet the 
patient's needs. The nursing care plan may be part of an 
interdisciplinary care plan.
* * * * *
    (6) All licensed nurses who provide services in the hospital must 
adhere to the policies and procedures of the hospital. The director of 
nursing service must provide for the adequate supervision and 
evaluation of the clinical activities of all nursing personnel which 
occur within the responsibility of the nursing service, regardless of 
the mechanism through which those personnel are providing services 
(that is, hospital employee, contract, lease, other agreement, or 
volunteer).
    (7) The hospital must have policies and procedures in place 
establishing which outpatient departments, if any, are not required 
under hospital policy to have a registered nurse present. The policies 
and procedures must:
    (i) Establish the criteria such outpatient departments must meet, 
taking into account the types of services delivered, the general level 
of acuity of patients served by the department, and the established 
standards of practice for the services delivered;
    (ii) Establish alternative staffing plans;
    (iii) Be approved by the director of nursing;
    (iv) Be reviewed at least once every 3 years.
    (c) * * *
    (1) Drugs and biologicals must be prepared and administered in 
accordance with Federal and State laws, the orders of the practitioner 
or practitioners responsible for the patient's care, and accepted 
standards of practice.
* * * * *
    (3) With the exception of influenza and pneumococcal vaccines, 
which may be administered per physician-approved hospital policy after 
an assessment of contraindications, orders for drugs and biologicals 
must be documented and signed by a practitioner who is authorized to 
write orders in accordance with State law and hospital policy, and who 
is responsible for the care of the patient.
    (i) If verbal orders are used, they are to be used infrequently.
    (ii) When verbal orders are used, they must only be accepted by 
persons who are authorized to do so by hospital policy and procedures 
consistent with Federal and State law.
    (iii) Orders for drugs and biologicals may be documented and signed 
by other practitioners only if such practitioners are acting in 
accordance with State law, including scope-of-practice laws, hospital 
policies, and medical staff bylaws, rules, and regulations.
* * * * *

0
24. Section 482.24 is amended by revising paragraphs (c)(4)(i)(A) and 
(B), and adding paragraph (c)(4)(i)(C) to read as follows:


Sec.  482.24  Condition of participation: Medical record services.

* * * * *
    (c) * * *
    (4) * * *
    (i) * * *
    (A) A medical history and physical examination completed and 
documented no more than 30 days before or 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services, and except as provided under paragraph (c)(4)(i)(C) of this 
section. The medical history and physical examination must be placed in 
the patient's medical record within 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services.
    (B) An updated examination of the patient, including any changes in 
the patient's condition, when the medical history and physical 
examination are completed within 30 days before admission or 
registration, and except as provided under paragraph (c)(4)(i)(C) of 
this section. Documentation of the updated examination must be placed 
in the patient's medical record within 24 hours after admission or 
registration, but prior to surgery or a procedure requiring anesthesia 
services.
    (C) An assessment of the patient (in lieu of the requirements of 
paragraphs (c)(4)(i)(A) and (B) of this section) completed and 
documented after registration, but prior to surgery or a procedure 
requiring anesthesia services, when the patient is receiving specific 
outpatient surgical or procedural services and when the medical staff 
has chosen to develop and maintain a policy that identifies, in 
accordance with the requirements at Sec.  482.22(c)(5)(v), specific 
patients as not requiring a comprehensive medical history and physical 
examination, or any update to it, prior to specific outpatient surgical 
or procedural services.
* * * * *

0
25. Section 482.27 is amended by revising paragraph (b)(7) and removing 
paragraph (b)(11).
    The revision reads as follows:

[[Page 51820]]

Sec.  482.27  Condition of participation: Laboratory services.

* * * * *
    (b) * * *
    (7) Timeframe for notification-- For donors tested on or after 
February 20, 2008. For notifications resulting from donors tested on or 
after February 20, 2008 as set forth at 21 CFR 610.46 and 610.47 the 
notification effort begins when the blood collecting establishment 
notifies the hospital that it received potentially HIV or HCV 
infectious blood and blood components. The hospital must make 
reasonable attempts to give notification over a period of 12 weeks 
unless--
    (i) The patient is located and notified; or
    (ii) The hospital is unable to locate the patient and documents in 
the patient's medical record the extenuating circumstances beyond the 
hospital's control that caused the notification timeframe to exceed 12 
weeks.
* * * * *

0
26. Section 482.42 is revised to read as follows:


Sec.  482.42  Condition of participation: Infection prevention and 
control and antibiotic stewardship programs.

    The hospital must have active hospital-wide programs for the 
surveillance, prevention, and control of HAIs and other infectious 
diseases, and for the optimization of antibiotic use through 
stewardship. The programs must demonstrate adherence to nationally 
recognized infection prevention and control guidelines, as well as to 
best practices for improving antibiotic use where applicable, and for 
reducing the development and transmission of HAIs and antibiotic-
resistant organisms. Infection prevention and control problems and 
antibiotic use issues identified in the programs must be addressed in 
collaboration with the hospital-wide quality assessment and performance 
improvement (QAPI) program.
    (a) Standard: Infection prevention and control program organization 
and policies. The hospital must demonstrate that:
    (1) An individual (or individuals), who is qualified through 
education, training, experience, or certification in infection 
prevention and control, is appointed by the governing body as the 
infection preventionist(s)/infection control professional(s) 
responsible for the infection prevention and control program and that 
the appointment is based on the recommendations of medical staff 
leadership and nursing leadership;
    (2) The hospital infection prevention and control program, as 
documented in its policies and procedures, employs methods for 
preventing and controlling the transmission of infections within the 
hospital and between the hospital and other institutions and settings;
    (3) The infection prevention and control program includes 
surveillance, prevention, and control of HAIs, including maintaining a 
clean and sanitary environment to avoid sources and transmission of 
infection, and addresses any infection control issues identified by 
public health authorities; and
    (4) The infection prevention and control program reflects the scope 
and complexity of the hospital services provided.
    (b) Standard: Antibiotic stewardship program organization and 
policies. The hospital must demonstrate that:
    (1) An individual (or individuals), who is qualified through 
education, training, or experience in infectious diseases and/or 
antibiotic stewardship, is appointed by the governing body as the 
leader(s) of the antibiotic stewardship program and that the 
appointment is based on the recommendations of medical staff leadership 
and pharmacy leadership;
    (2) The hospital-wide antibiotic stewardship program:
    (i) Demonstrates coordination among all components of the hospital 
responsible for antibiotic use and resistance, including, but not 
limited to, the infection prevention and control program, the QAPI 
program, the medical staff, nursing services, and pharmacy services;
    (ii) Documents the evidence-based use of antibiotics in all 
departments and services of the hospital; and
    (iii) Documents any improvements, including sustained improvements, 
in proper antibiotic use;
    (3) The antibiotic stewardship program adheres to nationally 
recognized guidelines, as well as best practices, for improving 
antibiotic use; and
    (4) The antibiotic stewardship program reflects the scope and 
complexity of the hospital services provided.
    (c) Standard: Leadership responsibilities. (1) The governing body 
must ensure all of the following:
    (i) 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.
    (ii) All HAIs and other infectious diseases identified by the 
infection prevention and control program as well as antibiotic use 
issues identified by the antibiotic stewardship program are addressed 
in collaboration with hospital QAPI leadership.
    (2) The infection preventionist(s)/infection control 
professional(s) is responsible for:
    (i) The development and implementation of hospital-wide infection 
surveillance, prevention, and control policies and procedures that 
adhere to nationally recognized guidelines.
    (ii) All documentation, written or electronic, of the infection 
prevention and control program and its surveillance, prevention, and 
control activities.
    (iii) Communication and collaboration with the hospital's QAPI 
program on infection prevention and control issues.
    (iv) Competency-based training and education of hospital personnel 
and staff, including medical staff, and, as applicable, personnel 
providing contracted services in the hospital, on the practical 
applications of infection prevention and control guidelines, policies, 
and procedures.
    (v) The prevention and control of HAIs, including auditing of 
adherence to infection prevention and control policies and procedures 
by hospital personnel.
    (vi) Communication and collaboration with the antibiotic 
stewardship program.
    (3) The leader(s) of the antibiotic stewardship program is 
responsible for:
    (i) The development and implementation of a hospital-wide 
antibiotic stewardship program, based on nationally recognized 
guidelines, to monitor and improve the use of antibiotics.
    (ii) All documentation, written or electronic, of antibiotic 
stewardship program activities.
    (iii) Communication and collaboration with medical staff, nursing, 
and pharmacy leadership, as well as with the hospital's infection 
prevention and control and QAPI programs, on antibiotic use issues.
    (iv) Competency-based training and education of hospital personnel 
and staff, including medical staff, and, as applicable, personnel 
providing contracted services in the hospital, on the practical 
applications of antibiotic stewardship guidelines, policies, and 
procedures.
    (d) Standard: Unified and integrated infection prevention and 
control and antibiotic stewardship programs for multi-hospital systems. 
If a hospital is

[[Page 51821]]

part of a hospital system consisting of multiple separately certified 
hospitals using a system governing body that is legally responsible for 
the conduct of two or more hospitals, the system governing body can 
elect to have unified and integrated infection prevention and control 
and antibiotic stewardship programs for all of its member hospitals 
after determining that such a decision is in accordance with all 
applicable State and local laws. The system governing body is 
responsible and accountable for ensuring that each of its separately 
certified hospitals meets all of the requirements of this section. Each 
separately certified hospital subject to the system governing body must 
demonstrate that:
    (1) The unified and integrated infection prevention and control and 
antibiotic stewardship programs are established in a manner that takes 
into account each member hospital's unique circumstances and any 
significant differences in patient populations and services offered in 
each hospital;
    (2) The unified and integrated infection prevention and control and 
antibiotic stewardship programs establish and implement policies and 
procedures to ensure that the needs and concerns of each of its 
separately certified hospitals, regardless of practice or location, are 
given due consideration;
    (3) The unified and integrated infection prevention and control and 
antibiotic stewardship programs have mechanisms in place to ensure that 
issues localized to particular hospitals are duly considered and 
addressed; and
    (4) A qualified individual (or individuals) with expertise in 
infection prevention and control and in antibiotic stewardship has been 
designated at the hospital as responsible for communicating with the 
unified infection prevention and control and antibiotic stewardship 
programs, for implementing and maintaining the policies and procedures 
governing infection prevention and control and antibiotic stewardship 
as directed by the unified infection prevention and control and 
antibiotic stewardship programs, and for providing education and 
training on the practical applications of infection prevention and 
control and antibiotic stewardship to hospital staff.

0
27. Section 482.51 is amended by revising paragraphs (b)(1)(i) and (ii) 
and adding paragraph (b)(1)(iii) to read as follows:


Sec.  482.51  Condition of participation: Surgical services.

* * * * *
    (b) * * *
    (1) * * *
    (i) A medical history and physical examination must be completed 
and documented no more than 30 days before or 24 hours after admission 
or registration, and except as provided under paragraph (b)(1)(iii) of 
this section.
    (ii) An updated examination of the patient, including any changes 
in the patient's condition, must be completed and documented within 24 
hours after admission or registration when the medical history and 
physical examination are completed within 30 days before admission or 
registration, and except as provided under paragraph (b)(1)(iii) of 
this section.
    (iii) An assessment of the patient must be completed and documented 
after registration (in lieu of the requirements of paragraphs (b)(1)(i) 
and (ii) of this section) when the patient is receiving specific 
outpatient surgical or procedural services and when the medical staff 
has chosen to develop and maintain a policy that identifies, in 
accordance with the requirements at Sec.  482.22(c)(5)(v), specific 
patients as not requiring a comprehensive medical history and physical 
examination, or any update to it, prior to specific outpatient surgical 
or procedural services.
* * * * *

0
28. Section 482.58 is amended by--
0
a. Revising paragraph (b)(1);
0
b. Removing paragraph (b)(4);
0
c. Redesignating paragraphs (b)(5) through (8) as paragraphs (b)(4) 
through (7); and
0
d. Revising newly redesignated paragraphs (b)(4), (5), and (7).
    The revisions read as follows:


Sec.  482.58  Special requirements for hospital providers of long-term 
care services (``swing-beds'').

* * * * *
    (b) * * *
    (1) Resident rights (Sec.  483.10(b)(7), (c)(1), (c)(2)(iii), 
(c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (h), (g)(8) and 
(17), and (g)(18) introductory text of this chapter).
* * * * *
    (4) Social services (Sec.  483.40(d) of this chapter).
    (5) Discharge summary (Sec.  483.20(l)).
* * * * *
    (7) Dental services (Sec.  483.55(a)(2), (3), (4), and (5) and (b) 
of this chapter).

0
29. Section 482.61 is amended by revising paragraph (d) to read as 
follows:


Sec.  482.61  Condition of participation: Special medical record 
requirements for psychiatric hospitals.

* * * * *
    (d) Standard: Recording progress. Progress notes must be recorded 
by the physicians(s), psychologists, or other licensed independent 
practitioner(s) responsible for the care of the patient as specified in 
Sec.  482.12(c); nurse, social worker and, when appropriate, others 
significantly involved in active treatment modalities. The frequency of 
progress notes is determined by the condition of the patient but must 
be recorded at least weekly for the first 2 months and at least once a 
month thereafter and must contain recommendations for revisions in the 
treatment plan as indicated as well as precise assessment of the 
patient's progress in accordance with the original or revised treatment 
plan.
* * * * *


Sec.  482.68   [Amended]

0
30. Section 482.68 is amended--
0
a. In the section heading by removing the phrase ``transplant centers'' 
and adding in its place the phrase ``transplant programs''; and
0
b. In the introductory text and in paragraph (b) by removing the phrase 
``transplant center'' and adding in its place the phrase ``transplant 
program''.

0
31. Section 482.70 is amended--
0
a. In the definition of ``Adverse event'' by removing the phrase 
``transplant centers'' and adding in its place the phrase ``transplant 
programs'';
0
b. By removing the definition of ``Heart-Lung transplant center'';
0
c. By adding definitions for ``Heart-Lung transplant program'' and 
``Intestine transplant program'' in alphabetical order;
0
d. By removing the definition of ``Intestine transplant center'';
0
e. By adding a definition for ``Intestine transplant program'' in 
alphabetical order;
0
f. By removing the definition of ``Pancreas transplant center'';
0
g. By adding a definition for ``Pancreas transplant program'' in 
alphabetical order;
0
h. By removing the definition of ``Transplant center''; and
0
i. By revising the definition of ``Transplant program''.
    The additions and revision read as follows:


Sec.  482.70  Definitions.

* * * * *
    Heart-Lung transplant program means a transplant program that is 
located in a hospital with an existing Medicare-approved heart 
transplant program and an existing Medicare-approved lung program that 
performs combined heart-lung transplants.

[[Page 51822]]

    Intestine transplant program means a Medicare-approved liver 
transplant program that performs intestine transplants, combined liver-
intestine transplants, or multivisceral transplants.
* * * * *
    Pancreas transplant program means a Medicare-approved kidney 
transplant program that performs pancreas transplants alone or 
subsequent to a kidney transplant as well as kidney-pancreas 
transplants.
* * * * *
    Transplant program means an organ-specific transplant program 
within a transplant hospital (as defined in this section).


Sec. Sec.  482.72, 482.74, 482.78, and 482.80   [Amended]

0
32. In the following table, for each section and paragraph indicated in 
the first two columns, remove the phrase indicated in the third column 
each time it appears and add the reference indicated in the fourth 
column:

------------------------------------------------------------------------
      Section           Paragraphs          Remove             Add
------------------------------------------------------------------------
Sec.   482.72......  ................  transplant        transplant
                                        center.           program.
Sec.   482.74......  (a) introductory  transplant        transplant
                      text.             center.           program.
Sec.   482.74......  (a) introductory  center's........  hospital's.
                      text.
Sec.   482.74......  (a)(1)..........  transplant        transplant
                                        center.           program.
Sec.   482.74......  (a)(1)..........  center's........  program's.
Sec.   482.74......  (a)(2)..........  transplant        transplant
                                        center.           program.
Sec.   482.74......  (a)(3)..........  transplant        transplant
                                        center.           program.
Sec.   482.74......  (b) introductory  transplant        transplant
                      text.             center.           program.
Sec.   482.78......  Section heading.  transplant        transplant
                                        centers.          programs.
Sec.   482.78......  Introductory      transplant        transplant
                      text.             center.           program.
Sec.   482.78......  (a).............  transplant        transplant
                                        center.           program.
Sec.   482.78......  (b).............  transplant        transplant
                                        center.           program.
Sec.   482.80......  Section heading.  transplant        transplant
                                        centers.          programs.
Sec.   482.80......  Introductory      transplant        transplant
                      text.             centers.          programs.
Sec.   482.80......  (a).............  transplant        transplant
                                        center.           program.
Sec.   482.80......  (a).............  beneficiary.....  recipient.
Sec.   482.80......  (b).............  transplant        transplant
                                        center.           program.
Sec.   482.80......  (c) introductory  center..........  program.
                      text.
Sec.   482.80......  (c)(1)..........  transplant        transplant
                                        center's.         program's.
Sec.   482.80......  (c)(1)..........  center-specific   program-
                                        report.           specific
                                                          report.
Sec.   482.80......  (c)(1)..........  beneficiaries...  recipients.
Sec.   482.80......  (c)(2)..........  center's........  program's.
Sec.   482.80......  (d)(1)..........  transplant        transplant
                                        center.           program.
Sec.   482.80......  (d)(1)..........  center..........  program.
Sec.   482.80......  (d)(2)..........  transplant        transplant
                                        center.           program.
Sec.   482.80......  (d)(2)..........  center..........  program.
Sec.   482.80......  (d)(3)..........  transplant        transplant
                                        center.           program.
Sec.   482.80......  (d)(3)..........  center..........  program.
Sec.   482.80......  (d)(4)..........  transplant        transplant
                                        center.           program.
Sec.   482.80......  (d)(4)..........  center..........  program.
Sec.   482.80......  (d)(5)..........  transplant        transplant
                                        center.           program.
------------------------------------------------------------------------

Sec.  482.82   [Removed]

0
33. Section 482.82 is removed.

0
34. The undesignated center heading preceding Sec.  482.90 is revised 
to read ``Transplant Program Process Requirements''.


Sec. Sec.  482.90, 482.92, 482.94, 482.96, 482.98, 482.100, and 
482.102   [Amended]

0
35. In the following table, for each section and paragraph indicated in 
the first two columns, remove the phrase indicated in the third column 
each time it appears and add the reference indicated in the fourth 
column:

------------------------------------------------------------------------
      Section           Paragraphs          Remove             Add
------------------------------------------------------------------------
Sec.   482.90......  Introductory      transplant        transplant
                      text.             center.           program.
Sec.   482.90......  Introductory      center..........  program.
                      text.
Sec.   482.90......  (a)(1)..........  center's waiting  program's
                                        list.             waiting list.
Sec.   482.90......  (a)(2)..........  transplant        transplant
                                        center.           program.
Sec.   482.90......  (a)(3)..........  center's waiting  program's
                                        list.             waiting list.
Sec.   482.90......  (a)(4)..........  transplant        transplant
                                        center.           program.
Sec.   482.90......  (b) introductory  Transplant        Transplant
                      text.             centers.          programs.
Sec.   482.92......  Introductory      donor-            donor-
                      text.             beneficiary.      recipient.
Sec.   482.92......  Introductory      beneficiary.....  recipient.
                      text.
Sec.   482.92......  Introductory      Transplant        Transplant
                      text.             centers.          programs.
Sec.   482.92......  Introductory      transplant        transplant
                      text.             center.           program.
Sec.   482.92......  (a).............  transplant        transplant
                                        center.           program.
Sec.   482.92......  (a).............  beneficiary.....  recipient.
Sec.   482.92......  (b).............  center..........  program.
Sec.   482.92......  (b).............  beneficiary.....  recipient.
Sec.   482.92......  (b).............  beneficiary's...  recipient's.
Sec.   482.94......  Introductory      Transplant        Transplant
                      text.             centers.          programs.
Sec.   482.94......  Introductory      transplant        transplant
                      text.             center.           programs.
Sec.   482.94......  Introductory      the center also.  the program
                      text.                               also.

[[Page 51823]]

 
Sec.   482.94......  (a) introductory  transplant        transplant
                      text.             center's.         program's.
Sec.   482.94......  (a)(2)..........  center..........  program.
Sec.   482.94......  (b) introductory  Transplant        Transplant
                      text.             centers.          programs.
Sec.   482.94......  (b)(2)..........  center's........  program's.
Sec.   482.94......  (b)(3)..........  center's........  program's.
Sec.   482.94......  (c) introductory  Transplant        Transplant
                      text.             centers.          programs.
Sec.   482.94......  (c) introductory  center's waiting  program's
                      text.             list.             waiting list.
Sec.   482.94......  (c)(1)introducto  center's waiting  program's
                      ry text.          list.             waiting list.
Sec.   482.94......  (c)(1)introducto  center..........  program.
                      ry text.
Sec.   482.94......  (c)(1)(i).......  center's waiting  program's
                                        list.             waiting list.
Sec.   482.94......  (c)(1)(ii)......  center's........  progam's.
Sec.   482.94......  (c)(1)(iii).....  center's........  progam's.
Sec.   482.94......  (c)(2)..........  transplant        transplant
                                        center.           program.
Sec.   482.94......  (c)(3)            transplant        transplant
                      introductory      centers.          programs.
                      text.
Sec.   482.94......  (d) introductory  transplant        transplant
                      text.             center.           program.
Sec.   482.94......  (d)(2)..........  transplant        transplant
                                        center.           program.
Sec.   482.94......  (e).............  Transplant        Transplant
                                        centers.          programs.
Sec.   482.96......  Introductory      Transplant        Transplant
                      text.             centers.          programs.
Sec.   482.96......  (a).............  transplant        transplant
                                        center's.         program's.
Sec.   482.96......  (a).............  beneficiary.....  recipient.
Sec.   482.96......  (a).............  transplant        transplant
                                        center.           program.
Sec.   482.96......  (b) introductory  transplant        transplant
                      text.             center.           program.
Sec.   482.96......  (b)(2)..........  transplant        transplant
                                        center.           program.
Sec.   482.96......  (b)(2)..........  transplant        transplant
                                        center's.         program's.
Sec.   482.98......  Introductory      transplant        transplant
                      text.             center.           program.
Sec.   482.98......  Introductory      the center......  the program.
                      text.
Sec.   482.98......  (a) heading and   transplant        transplant
                      introductory      center.           program.
                      text.
Sec.   482.98......  (a) introductory  center's........  program's.
                      text.
Sec.   482.98......  (a)(1)..........  transplant        transplant
                                        center.           program.
Sec.   482.98......  (b) introductory  transplant        transplant
                      text.             center.           program.
Sec.   482.98......  (c) introductory  transplant        transplant
                      text.             center.           program.
Sec.   482.98......  (c)(2)..........  transplant        transplant
                                        center.           program.
Sec.   482.98......  (d) introductory  transplant        transplant
                      text.             center.           program.
Sec.   482.98......  (d) heading.....  living donor      independent
                                        advocate team.    living donor
                                                          advocate team.
Sec.   482.98......  (d)(1)..........  living donor      independent
                                        advocate.         living donor
                                                          advocate.
Sec.   482.98......  (d)(2)            living donor      independent
                      introductory      advocate team.    living donor
                      text.                               advocate team.
Sec.   482.98......  (d)(3)            living donor      independent
                      introductory      advocate team.    living donor
                      text.                               advocate team.
Sec.   482.98......  (e).............  transplant        transplant
                                        center.           program.
Sec.   482.98......  (f).............  transplant        transplant
                                        center.           program.
Sec.   482.100.....  ................  transplant        transplant
                                        center.           program.
Sec.   482.102.....  Introductory      transplant        transplant
                      text.             center.           program.
Sec.   482.102.....  (a) introductory  Transplant        Transplant
                      text.             centers.          programs.
Sec.   482.102.....  (a)(8)..........  transplant        transplant
                                        center.           program.
Sec.   482.102.....  (a)(8)..........  beneficiary's...  recipient's.
Sec.   482.102.....  (b) introductory  Transplant        Transplant
                      text.             centers.          programs.
Sec.   482.102.....  (b)(1)..........  transplant        transplant
                                        center.           program.
Sec.   482.102.....  (b)(4)..........  beneficiary.....  recipient.
Sec.   482.102.....  (b)(6)..........  transplant        transplant
                                        center-specific.  program-
                                                          specific.
Sec.   482.102.....  (b)(6)..........  beneficiaries...  recipients.
Sec.   482.102.....  (b)(6)..........  center-specific   transplant-
                                        outcomes.         specific
                                                          outcomes.
Sec.   482.102.....  (b)(9)..........  transplant        transplant
                                        center.           program.
Sec.   482.102.....  (b)(9)..........  beneficiary's...  recipient's.
Sec.   482.102.....  (c) introductory  Transplant        Transplant
                      text.             centers.          programs.
Sec.   482.102.....  (c) introductory  center's........  program's.
                      text.
Sec.   482.102.....  (c) introductory  center..........  program.
                      text.
Sec.   482.102.....  (c)(1)            transplant        transplant
                      introductory      center.           program.
                      text.
Sec.   482.102.....  (c)(1)            center's waiting  program's
                      introductory      list.             waiting list.
                      text.
Sec.   482.102.....  (c)(2)            center's          program's
                      introductory      Medicare          Medicare
                      text.             approval.         approval.
Sec.   482.102.....  (c)(2)(i).......  center's waiting  program's
                                        list.             waiting list.
Sec.   482.102.....  (c)(2)(i).......  transplant        transplant
                                        center.           program.
Sec.   482.102.....  (c)(2)(ii)......  beneficiaries...  recipients.
Sec.   482.102.....  (c)(2)(ii)......  center's waiting  program's
                                        list.             waiting list.
Sec.   482.102.....  (c)(2)(ii)......  the center......  the program.
Sec.   482.102.....  (c)(2)(ii)......  center's          program's
                                        termination of    termination of
                                        approval.         approval.
Sec.   482.102.....  (c)(3)..........  transplant        transplant
                                        center's.         program's.
Sec.   482.102.....  (c)(3)..........  the center......  the program.
Sec.   482.102.....  (c)(3)..........  center's waiting  program's
                                        list.             waiting list.
Sec.   482.102.....  (c)(3)..........  transplant        transplant
                                        center.           program.
------------------------------------------------------------------------


[[Page 51824]]


0
36. Section 482.102 is further amended by revising paragraph (a)(5) to 
read as follows:


Sec.  482.102  Condition of participation: Patient and living donor 
rights.

* * * * *
    (a) * * *
    (5) National and transplant program-specific outcomes, from the 
most recent SRTR program-specific report, including (but not limited 
to) the transplant program's observed and expected 1-year patient and 
graft survival, and national 1-year patient and graft survival;
* * * * *


Sec.  482.104   [Amended]

0
37. For Sec.  482.104, in the following table, for the heading and each 
paragraph indicated in the first column, remove the phrase indicated in 
the second column each time it appears and add the reference indicated 
in the third column:

------------------------------------------------------------------------
           Paragraphs                   Remove                Add
------------------------------------------------------------------------
Section heading.................  transplant centers  transplant
                                                       programs.
(a).............................  transplant centers  transplant
                                                       programs.
(a).............................  transplant center.  transplant
                                                       program.
(b).............................  transplant centers  transplant
                                                       programs.
(c).............................  transplant centers  transplant
                                                       programs.
------------------------------------------------------------------------

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

0
38. The authority citation for part 483 is revised to read as follows:

    Authority:  42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.


0
39. Section 483.73 is amended by revising paragraphs (a)(4) and (d)(2) 
to read as follows:


Sec.  483.73  Emergency preparedness.

* * * * *
    (a) * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, or Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
* * * * *
    (d) * * *
    (2) Testing. The LTC facility must conduct exercises to test the 
emergency plan at least twice per year, including unannounced staff 
drills using the emergency procedures. The LTC facility must do the 
following:
    (i) Participate in an annual full-scale exercise that is community-
based; or
    (A) When a community-based exercise is not accessible, conduct an 
annual individual, facility-based functional exercise.
    (B) If the LTC facility experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the LTC 
facility is exempt from engaging its next required a full-scale 
community-based or individual, facility-based functional exercise 
following the onset of the emergency event.
    (ii) Conduct an additional annual exercise that may include, but is 
not limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the LTC facility's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the LTC facility's emergency plan, as needed.
* * * * *

0
40. Section 483.475 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  483.475  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The ICF/IID must develop and maintain an 
emergency preparedness plan that must be reviewed, and updated at least 
every 2 years The plan must do all of the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The ICF/IID must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The ICF/IID must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include the following:
* * * * *
    (d) Training and testing. The ICF/IID must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years. The ICF/IID must meet the 
requirements for evacuation drills and training at Sec.  483.470(i).
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the ICF/IID must conduct training on the updated 
policies and procedures.
    (2) Testing. The ICF/IID must conduct exercises to test the 
emergency plan at least twice per year. The ICF/IID must do the 
following:
    (i) Participate in an annual full-scale exercise that is community-
based; or
    (A) When a community-based exercise is not accessible, conduct an 
annual individual, facility-based functional exercise; or.
    (B) If the ICF/IID experiences an actual natural or man-made 
emergency

[[Page 51825]]

that requires activation of the emergency plan, the ICF/IID is exempt 
from engaging in its next required full-scale community-based or 
individual, facility-based functional exercise following the onset of 
the emergency event.
    (ii) Conduct an additional annual exercise that may include, but is 
not limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the ICF/IID's response to and maintain documentation 
of all drills, tabletop exercises, and emergency events, and revise the 
ICF/IID's emergency plan, as needed
* * * * *

PART 484--HOME HEALTH SERVICES

0
41. The authority citation for part 484 continues to read as follows:

    Authority: 42 U.S.C. 1302 and 1395hh unless otherwise indicated.


0
42. Section 484.2 is amended by adding definitions for ``Pseudo-
patient'' and ``Simulation'' in alphabetical order to read as follows:


Sec.  484.2  Definitions.

* * * * *
    Pseudo-patient means a person trained to participate in a role-play 
situation, or a computer-based mannequin device. A pseudo-patient must 
be capable of responding to and interacting with the home health aide 
trainee, and must demonstrate the general characteristics of the 
primary patient population served by the HHA in key areas such as age, 
frailty, functional status, and cognitive status.
* * * * *
    Simulation means a training and assessment technique that mimics 
the reality of the homecare environment, including environmental 
distractions and constraints that evoke or replicate substantial 
aspects of the real world in a fully interactive fashion, in order to 
teach and assess proficiency in performing skills, and to promote 
decision making and critical thinking.
* * * * *

0
43. Section 484.50 is amended by removing and reserving paragraph 
(a)(3) and revising paragraph (c)(7) introductory text.
    The revision reads as follows:


Sec.  484.50  Condition of participation: Patient rights.

* * * * *
    (c) * * *
    (7) Be advised, orally and in writing, of--
* * * * *

0
44. Section 484.80 is amended by revising paragraphs (c)(1) and (h)(3) 
to read as follows:


Sec.  484.80  Condition of participation: Home health aide services.

* * * * *
    (c) * * *
    (1) The competency evaluation must address each of the subjects 
listed in paragraph (b)(3) of this section. Subject areas specified 
under paragraphs (b)(3)(i), (iii), (ix), (x), and (xi) of this section 
must be evaluated by observing an aide's performance of the task with a 
patient or pseudo-patient. The remaining subject areas may be evaluated 
through written examination, oral examination, or after observation of 
a home health aide with a patient, or with a pseudo-patient as part of 
a simulation.
* * * * *
    (h) * * *
    (3) If a deficiency in aide services is verified by the registered 
nurse or other appropriate skilled professional during an on-site 
visit, then the agency must conduct, and the home health aide must 
complete, retraining and a competency evaluation related to the 
deficient skill(s).
* * * * *

0
45. Section 484.102 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, and (d) introductory text and the first 
paragraph (d)(1)(ii);
0
b. Redesignating the second paragraph (d)(1)(ii) as paragraph 
(d)(1)(iv);
0
c. Adding paragraph (d)(1)(v); and
0
d. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  484.102  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The HHA must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do all of the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The HHA must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The HHA must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The HHA must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the HHA must conduct training on the updated 
policies and procedures.
    (2) Testing. The HHA must conduct exercises to test the emergency 
plan at least annually. The HHA must do the following:
    (i) Participate in a full-scale exercise that is community-based; 
or
    (A) When a community-based exercise is not accessible, conduct an 
annual individual, facility-based functional exercise every 2 years; 
or.
    (B) If the HHA experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the HHA is exempt from 
engaging in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the emergency 
event.
    (ii) Conduct an additional exercise every 2 years, opposite the 
year the full-

[[Page 51826]]

scale or functional exercise under paragraph (d)(2)(i) of this section 
is conducted, that may include, but is not limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the HHA's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
HHA's emergency plan, as needed
* * * * *

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
46. The authority citation for part 485 is revised to read as follows:

    Authority: 42 U.S.C. 1302 and 1395(hh).


0
47. Section 485.66 is amended by revising the introductory text to read 
as follows:


Sec.  485.66  Condition of participation: Utilization review plan.

    The facility must have in effect a written utilization review plan 
that is implemented annually, to assess the necessity of services and 
promotes the most efficient use of services provided by the facility.
* * * * *

0
48. Section 485.68 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  485.68  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The CORF must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least every 2 
years. The plan must do all of the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
* * * * *
    (b) Policies and procedures. The CORF must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The CORF must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The CORF must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the CORF must conduct training on the updated 
policies and procedures.
    (2) Testing. The CORF must conduct exercises to test the emergency 
plan at least annually. The CORF must do the following:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, conduct an 
individual, facility-based functional exercise every 2 years; or
    (B) If the CORF experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the CORF is exempt from 
engaging in its next required community-based or individual, facility-
based functional exercise following the onset of the emergency event.
    (ii) Conduct an additional exercise every 2 years, opposite the 
year the full-scale or functional exercise under paragraph (d)(2)(i) of 
this section is conducted, that may include, but is not limited to the 
following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the CORF's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CORF's emergency plan, as needed.
* * * * *

0
49. Section 485.625 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  485.625  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The CAH must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least every 2 
years. The plan must do all of the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The CAH must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The CAH must develop and maintain an 
emergency preparedness communication plan that complies with

[[Page 51827]]

Federal, State, and local laws and must be reviewed and updated at 
least every 2 years. The communication plan must include all of the 
following:
* * * * *
    (d) Training and testing. The CAH must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the CAH must conduct training on the updated 
policies and procedures.
    (2) Testing. The CAH must conduct exercises to test the emergency 
plan at least twice per year. The CAH must do the following:
    (i) Participate in an annual full-scale exercise that is community-
based; or
    (A) When a community-based exercise is not accessible, conduct an 
annual individual, facility-based functional exercise; or.
    (B) If the CAH experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the CAH is exempt from 
engaging in its next required full-scale community-based or individual, 
facility-based functional exercise following the onset of the emergency 
event.
    (ii) Conduct an annual additional exercise, that may include, but 
is not limited to the following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the CAH's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CAH's emergency plan, as needed.
* * * * *


Sec.  485.627   [Amended]

0
50. Section 485.627 is amended by removing paragraph (b)(1) and 
redesignating paragraphs (b)(2) and (3) as paragraphs (b)(1) and (2), 
respectively.

0
51. Section 485.631 is amended by adding paragraph (d) to read as 
follows:


Sec.  485.631  Condition of participation: Staffing and staff 
responsibilities.

* * * * *
    (d) Standard: Periodic review of clinical privileges and 
performance. The CAH requires that--
    (1) The quality and appropriateness of the diagnosis and treatment 
furnished by nurse practitioners, clinical nurse specialist, and 
physician assistants at the CAH are evaluated by a member of the CAH 
staff who is a doctor of medicine or osteopathy or by another doctor of 
medicine or osteopathy under contract with the CAH.
    (2) The quality and appropriateness of the diagnosis and treatment 
furnished by doctors of medicine or osteopathy at the CAH are evaluated 
by--
    (i) One hospital that is a member of the network, when applicable;
    (ii) One Quality Improvement Organization (QIO) or equivalent 
entity;
    (iii) One other appropriate and qualified entity identified in the 
State rural health care plan;
    (iv) In the case of distant-site physicians and practitioners 
providing telemedicine services to the CAH's patient under an agreement 
between the CAH and a distant-site hospital, the distant-site hospital; 
or
    (v) In the case of distant-site physicians and practitioners 
providing telemedicine services to the CAH's patients under a written 
agreement between the CAH and a distant-site telemedicine entity, one 
of the entities listed in paragraphs (d)(2)(i) through (iii) of this 
section.
    (3) The CAH staff consider the findings of the evaluation and make 
the necessary changes as specified in paragraphs (b) through (d) of 
this section.

0
52. Section 485.635 is amended by--
0
a. Removing paragraph (a)(3)(vi);
0
b. Redesignating paragraph (a)(3)(vii) as paragraph (a)(3)(vi); and
0
c. Revising newly designated paragraph (a)(3)(vi) and paragraph (a)(4).
    The revisions read as follows:


Sec.  485.635  Condition of participation: Provision of services.

    (a) * * *
    (3) * * *
    (vi) Procedures that ensure that the nutritional needs of 
inpatients are met in accordance with recognized dietary practices. All 
patient diets, including therapeutic diets, must be ordered by the 
practitioner responsible for the care of the patients or by a qualified 
dietitian or qualified nutrition professional as authorized by the 
medical staff in accordance with State law governing dietitians and 
nutrition professionals and that the requirement of Sec.  483.25(i) of 
this chapter is met with respect to inpatients receiving post CAH SNF 
care.
    (4) These policies are reviewed at least biennially by the group of 
professional personnel required under paragraph (a)(2) of this section 
and updated as necessary by the CAH.
* * * * *

0
53. Section 485.640 is added to read as follows:


Sec.  485.640  Condition of participation: Infection prevention and 
control and antibiotic stewardship programs.

    The CAH must have active facility-wide programs, for the 
surveillance, prevention, and control of HAIs and other infectious 
diseases and for the optimization of antibiotic use through 
stewardship. The programs must demonstrate adherence to nationally 
recognized infection prevention and control guidelines, as well as to 
best practices for improving antibiotic use where applicable, and for 
reducing the development and transmission of HAIs and antibiotic-
resistant organisms. Infection prevention and control problems and 
antibiotic use issues identified in the programs must be addressed in 
coordination with the facility-wide quality assessment and performance 
improvement (QAPI) program.
    (a) Standard: Infection prevention and control program organization 
and policies. The CAH must demonstrate that:
    (1) An individual (or individuals), who is qualified through 
education, training, experience, or certification in infection 
prevention and control, is 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 and that the appointment is based on the 
recommendations of medical staff leadership and nursing leadership;
    (2) The infection prevention and control program, as documented in 
its policies and procedures, employs methods for preventing and 
controlling the transmission of infections within the CAH and between 
the CAH and other healthcare settings;
    (3) The infection prevention and control includes surveillance,

[[Page 51828]]

prevention, and control of HAIs, including maintaining a clean and 
sanitary environment to avoid sources and transmission of infection, 
and that the program also addresses any infection control issues 
identified by public health authorities; and
    (4) The infection prevention and control program reflects the scope 
and complexity of the CAH services provided.
    (b) Standard: Antibiotic stewardship program organization and 
policies. The CAH must demonstrate that:
    (1) An individual (or individuals), who is qualified through 
education, training, or experience in infectious diseases and/or 
antibiotic stewardship, is appointed by the governing body, or 
responsible individual, as the leader(s) of the antibiotic stewardship 
program and that the appointment is based on the recommendations of 
medical staff leadership and pharmacy leadership;
    (2) The facility-wide antibiotic stewardship program:
    (i) Demonstrates 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, nursing services, and pharmacy services;
    (ii) Documents the evidence-based use of antibiotics in all 
departments and services of the CAH; and
    (iii) Documents any improvements, including sustained improvements, 
in proper antibiotic use;
    (3) The antibiotic stewardship program adheres to nationally 
recognized guidelines, as well as best practices, for improving 
antibiotic use; and
    (4) The antibiotic stewardship program reflects the scope and 
complexity of the CAH services provided.
    (c) Standard: Leadership responsibilities. (1) The governing body, 
or responsible individual, must ensure all of the following:
    (i) 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.
    (ii) All HAIs and other infectious diseases identified by the 
infection prevention and control program as well as antibiotic use 
issues identified by the antibiotic stewardship program are addressed 
in collaboration with the CAH's QAPI leadership.
    (2) The infection prevention and control professional(s) is 
responsible for:
    (i) The development and implementation of facility-wide infection 
surveillance, prevention, and control policies and procedures that 
adhere to nationally recognized guidelines.
    (ii) All documentation, written or electronic, of the infection 
prevention and control program and its surveillance, prevention, and 
control activities.
    (iii) Communication and collaboration with the CAH's QAPI program 
on infection prevention and control issues.
    (iv) Competency-based training and education of CAH personnel and 
staff, including medical staff, and, as applicable, personnel providing 
contracted services in the CAH, on the practical applications of 
infection prevention and control guidelines, policies and procedures.
    (v) The prevention and control of HAIs, including auditing of 
adherence to infection prevention and control policies and procedures 
by CAH personnel.
    (vi) Communication and collaboration with the antibiotic 
stewardship program.
    (3) The leader(s) of the antibiotic stewardship program is 
responsible for:
    (i) The development and implementation of a facility-wide 
antibiotic stewardship program, based on nationally recognized 
guidelines, to monitor and improve the use of antibiotics.
    (ii) All documentation, written or electronic, of antibiotic 
stewardship program activities.
    (iii) Communication and collaboration with medical staff, nursing, 
and pharmacy leadership, as well as the CAH's infection prevention and 
control and QAPI programs, on antibiotic use issues.
    (iv) 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.

0
54. Section 485.641 is revised to read as follows:


Sec.  485.641  Condition of participation: Quality assessment and 
performance improvement program.

    The CAH must develop, implement, and maintain an effective, 
ongoing, CAH-wide, data-driven quality assessment and performance 
improvement (QAPI) program. The CAH must maintain and demonstrate 
evidence of the effectiveness of its QAPI program.
    (a) Definitions. For the purposes of this section--
    Adverse event means an untoward, undesirable, and usually 
unanticipated event that causes death or serious injury or the risk 
thereof.
    Error means the failure of a planned action to be completed as 
intended or the use of a wrong plan to achieve an aim. Errors can 
include problems in practice, products, procedures, and systems; and
    Medical error means an error that occurs in the delivery of 
healthcare services.
    (b) Standard: QAPI Program Design and scope. The CAH's QAPI program 
must:
    (1) Be appropriate for the complexity of the CAH's organization and 
services provided.
    (2) Be ongoing and comprehensive.
    (3) Involve all departments of the CAH and services (including 
those services furnished under contract or arrangement).
    (4) Use objective measures to evaluate its organizational 
processes, functions and services.
    (5) Address 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.
    (c) Standard: Governance and leadership. The CAH's governing body 
or responsible individual is ultimately responsible for the CAH's QAPI 
program and is responsible and accountable for ensuring that the QAPI 
program meets the requirements of paragraph (b) of this section.
    (d) Standard: Program activities. For each of the areas listed in 
paragraph (b) of this section, the CAH must:
    (1) Focus on measures related to improved health outcomes that are 
shown to be predictive of desired patient outcomes.
    (2) Use the measures to analyze and track its performance.
    (3) Set priorities for performance improvement, considering either 
high-volume, high-risk services, or problem-prone areas.
    (e) Standard: Program data collection and analysis. The program 
must incorporate quality indicator data including patient care data, 
and other relevant data, in order to achieve the goals of the QAPI 
program.

0
55. Section 485.645 is amended by--
0
a. Revising the introductory text;
0
b. Revising paragraph (d)(1);

[[Page 51829]]

0
c. Removing paragraph (d)(4);
0
d. Redesignating paragraphs (d)(5) through (9) as paragraphs (d)(4) 
through (8), respectively; and
0
e. Revising newly redesignated paragraphs (d)(4) and (7).
    The revisions read as follows:


Sec.  485.645  Special requirements for CAH providers of long-term care 
services (``swing-beds'')

    A CAH must meet the following requirements in order to be granted 
an approval from CMS to provide post-CAH SNF care, as specified in 
Sec.  409.30 of this chapter, and to be paid for SNF-level services, in 
accordance with paragraph (c) of this section.
* * * * *
    (d) * * *
    (1) Resident rights (Sec.  483.10(b)(7), (c)(1), (c)(2)(iii), 
(c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (g)(8) and (17), 
(g)(18) introductory text, and (h) of this chapter).
* * * * *
    (4) Social services (Sec.  483.40(d) of this chapter).
* * * * *
    (7) Dental services (Sec.  483.55(a)(2), (3), (4), and (5) and (b) 
of this chapter).
* * * * *

0
56. Section 485.727 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(5), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  485.727  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The Organizations must develop and maintain an 
emergency preparedness plan that must be reviewed and updated at least 
every 2 years. The plan must do all of the following:
* * * * *
    (5) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
* * * * *
    (b) Policies and procedures. The Organizations must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least every 2 years. At a minimum, the 
policies and procedures must address the following:
* * * * *
    (c) Communication plan. The Organizations must develop and maintain 
an emergency preparedness communication plan that complies with 
Federal, State, and local laws and must be reviewed and updated at 
least every 2 years. The communication plan must include all of the 
following:
* * * * *
    (d) Training and testing. The Organizations must develop and 
maintain an emergency preparedness training and testing program that is 
based on the emergency plan set forth in paragraph (a) of this section, 
risk assessment at paragraph (a)(1) of this section, policies and 
procedures at paragraph (b) of this section, and the communication plan 
at paragraph (c) of this section. The training and testing program must 
be reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the Organizations must conduct training on the 
updated policies and procedures.
    (2) Testing. The Organizations must conduct exercises to test the 
emergency plan at least annually. The Organizations must do the 
following:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, an 
individual, facility-based functional exercise every 2 years; or.
    (B) If the Organizations experience an actual natural or man-made 
emergency that requires activation of the emergency plan, the 
organization is exempt from engaging in its next required full-scale 
community-based or individual, facility-based functional exercise 
following the onset of the emergency event.
    (ii) Conduct an additional exercise every 2 years, opposite the 
year the full-scale or functional exercise under paragraph (d)(2)(i) of 
this section is conducted, that may include, but is not limited to the 
following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the Organization's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise their emergency plan, as needed.
* * * * *

0
57. Section 485.914 is amended by revising paragraphs (d)(1) and (2) to 
read as follows:


Sec.  485.914  Condition of participation: Admission, initial 
evaluation, comprehensive assessment, and discharge or transfer of the 
client.

* * * * *
    (d) * * *
    (1) The CMHC must update each client's comprehensive assessment via 
the CMHC interdisciplinary treatment team, in consultation with the 
client's primary health care provider (if any), when changes in the 
client's status, responses to treatment, or goal achievement have 
occurred and in accordance with current standards of practice.
    (2) For clients that receive PHP services, the assessment must be 
updated no less frequently than every 30 days.
* * * * *

0
58. Section 485.920 is amended by revising paragraphs (a) introductory 
text, (a)(4), (b) introductory text, (c) introductory text, and (d) to 
read as follows:


Sec.  485.920  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The CMHC must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 
years. The plan must do all of the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The CMHC must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and the communication plan at 
paragraph (c) of this section. The policies and

[[Page 51830]]

procedures must be reviewed and updated at least every 2 years. At a 
minimum, the policies and procedures must address the following:
* * * * *
    (c) Communication plan. The CMHC must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The CMHC must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years. If the emergency 
preparedness policies and procedures are significantly updated, the 
CMHC must conduct training on the updated policies and procedures.
    (1) Training. The CMHC must provide initial training in emergency 
preparedness policies and procedures to all new and existing staff, 
individuals providing services under arrangement, and volunteers, 
consistent with their expected roles, and maintain documentation of the 
training. The CMHC must demonstrate staff knowledge of emergency 
procedures. Thereafter, the CMHC must provide emergency preparedness 
training at least every 2 years.
    (2) Testing. The CMHC must conduct exercises to test the emergency 
plan at least annually. The CMHC must:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, conduct an 
individual, facility-based every 2 years; or.
    (B) If the CMHC experiences an actual natural or man-made emergency 
that requires activation of the emergency plan, the CMHC is exempt from 
engaging in its next required community-based or individual, facility-
based functional exercise following the onset of the emergency event.
    (ii) Conduct an additional exercise every 2 years, opposite the 
year the full-scale or functional exercise under paragraph (d)(2)(i) of 
this section is conducted, that may include, but is not limited to 
following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the CMHC's response to and maintain documentation of 
all drills, tabletop exercises, and emergency events, and revise the 
CMHC's emergency plan, as needed.
* * * * *

PART 486--CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED 
BY SUPPLIERS


0
59. The authority citation for part 486 continues to read as follows:

    Authority:  42 U.S.C. 1302, and 1395hh.


0
60. Section 486.104 is amended by revising paragraph (a) to read as 
follows:


Sec.  486.104  Condition for coverage: Qualifications, orientation and 
health of technical personnel.

* * * * *
    (a) Standard: Qualifications of technologists. All operators of the 
portable X-ray equipment meet the requirements of paragraph (a)(1) or 
(2) of this section.
    (1) Successful completion of a program of formal training in X-ray 
technology at which the operator received appropriate training and 
demonstrated competence in the use of equipment and administration of 
portable x-ray procedures; or
    (2) Successful completion of 24 full months of training and 
experience under the direct supervision of a physician who is certified 
in radiology or who possesses qualifications which are equivalent to 
those required for such certification.
* * * * *

0
61. Section 486.106 is amended by revising paragraph (a)(2) to read as 
follows:


Sec.  486.106  Conditions for coverage: Referral for service and 
preservation of records.

* * * * *
    (a) * * *
    (2) Such physician or non-physician practitioner's order meets the 
requirements at Sec.  410.32 of this chapter, and includes a statement 
concerning the condition of the patient which indicates why portable X-
ray services are necessary.
* * * * *

0
62. Section 486.360 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2)(i).
    The revisions and addition read as follows:


Sec.  486.360  Condition for Coverage: Emergency preparedness.

* * * * *
    (a) Emergency plan. The OPO must develop and maintain an emergency 
preparedness plan that must be reviewed and updated at least every 2 
years. The plan must do all of the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The OPO must develop and implement 
emergency preparedness policies and procedures, based on the emergency 
plan set forth in paragraph (a) of this section, risk assessment at 
paragraph (a)(1) of this section, and, the communication plan at 
paragraph (c) of this section. The policies and procedures must be 
reviewed and updated at least every 2 years. At a minimum, the policies 
and procedures must address the following:
* * * * *
    (c) Communication plan. The OPO must develop and maintain an 
emergency preparedness communication plan that complies with Federal, 
State, and local laws and must be reviewed and updated at least every 2 
years. The communication plan must include all of the following:
* * * * *
    (d) Training and testing. The OPO must develop and maintain an 
emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *

[[Page 51831]]

    (ii) Provide emergency preparedness training at every 2 years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the OPO must conduct training on the updated 
policies and procedures.
    (2) * * *
    (i) Conduct a paper-based, tabletop exercise or workshop at least 
annually. A tabletop exercise is led by a facilitator and includes a 
group discussion, using a narrated, clinically-relevant emergency 
scenario, and a set of problem statements, directed messages, or 
prepared questions designed to challenge an emergency plan. If the OPO 
experiences an actual natural or man-made emergency that requires 
activation of the emergency plan, the OPO is exempt from engaging in 
its next required testing exercise following the onset of the emergency 
event.
* * * * *

PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES

0
63. The authority citation for part 488 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


Sec.  488.30   [Amended]

0
64. Section 488.30(a) is amended in the definition of ``Provider of 
services, provider, or supplier'' by removing the phrase ``transplant 
centers'' and adding in its place the phrase ``transplant programs''.

0
65. Section 488.61 is amended--
0
a. By revising the section heading;
0
b. In the introductory text by removing the phrase ``transplant 
centers'' and adding in its place the phrase ``transplant programs'';
0
c. In paragraph (a) introductory text by removing the words ``centers'' 
and ``center'' each time they appear and adding in their place the 
words ``programs'' and ``program,'' respectively;
0
d. In paragraph (a)(2) by removing the phrase ``Scientific Registry of 
Transplant Beneficiary (SRTR) center-specific'' and adding in its place 
the phrase ``Scientific Registry of Transplant Recipient (SRTR) 
program-specific'';
0
e. By revising paragraph (a)(5);
0
f. By removing paragraph (c);
0
g. By redesignating paragraphs (d) through (h) as paragraphs (c) 
through (g), respectively;
0
h. By revising newly redesignated paragraphs (c) and (d), the newly 
redesignated paragraph (e) subject heading, and newly redesignated 
paragraphs (e)(1) introductory text, (e)(1)(iv), (e)(3), and (f)(1)(i) 
through (iii); and
0
i. In newly redesignated paragraph (g)(1)(x) by removing the reference 
``paragraphs (h)(1)(v), (h)(1)(vi), (h)(1)(vii) or (h)(1)(viii)'' and 
adding in its place the reference ``paragraph (g)(1)(v), (vi), (vii) or 
(viii)'' .
    The revisions read as follows:


Sec.  488.61  Special procedures for approval and re-approval of organ 
transplant programs.

* * * * *
    (a) * * *
    (5) If CMS determines that a transplant program has met the data 
submission, clinical experience, and outcome requirements, CMS will 
review the program's compliance with the conditions of participation 
contained at Sec. Sec.  482.72 through 482.76 and Sec. Sec.  482.90 
through 482.104 of this chapter using the procedures described in 
subpart A of this part. If the transplant program is found to be in 
compliance with all the conditions of participation at Sec. Sec.  
482.72 through 482.104 of this chapter, CMS will notify the transplant 
program in writing of the effective date of its Medicare-approval. CMS 
will notify the transplant program in writing if it is not Medicare-
approved.
* * * * *
    (c) Loss of Medicare approval. Programs that have lost their 
Medicare approval may seek re-entry into the Medicare program at any 
time. A program that has lost its Medicare approval must:
    (1) Request initial approval using the procedures described in 
paragraph (a) of this section;
    (2) Be in compliance with Sec. Sec.  482.72 through 482.104 of this 
chapter at the time of the request for Medicare approval; and
    (3) Submit a report to CMS documenting any changes or corrective 
actions taken by the program as a result of the loss of its Medicare 
approval status.
    (d) Transplant program inactivity. A transplant program may remain 
inactive and retain its Medicare approval for a period not to exceed 12 
months. A transplant program must notify CMS upon its voluntary 
inactivation as required by Sec.  482.74(a)(3) of this chapter.
    (e) Consideration of mitigating factors in initial approval survey, 
certification, and enforcement actions for transplant programs--(1) 
Factors. Except for situations of immediate jeopardy or deficiencies 
other than failure to meet requirements at Sec.  482.80 of this 
chapter, CMS will consider such mitigating factors as may be 
appropriate in light of the nature of the deficiency and circumstances, 
including (but not limited to) the following, in making a decision of 
initial approval of a transplant program that does not meet the data 
submission, clinical experience, or outcome requirements:
* * * * *
    (iv) Program improvements that substantially address root causes of 
graft failures or patient deaths, that have been implemented and 
institutionalized on a sustainable basis, and that are supported by 
outcomes more recent than the latest available SRTR report, for which 
there is a sufficient post-transplant patient and graft survival period 
and a sufficient number of transplants such that CMS finds that the 
program demonstrates present-day compliance with the requirements at 
Sec.  482.80(c)(2)(ii)(C) of this chapter;
* * * * *
    (3) Timing. Within 14 calendar days after CMS has issued formal 
written notice of a condition-level deficiency to the program, CMS must 
receive notification of the program's intent to seek mitigating factors 
approval, and receive all information for consideration of mitigating 
factors within 120 calendar days of the CMS written notification for a 
deficiency due to data submission, clinical experience or outcomes at 
Sec.  482.80 of this chapter. Failure to meet these timeframes may be 
the basis for denial of mitigating factors. CMS may permit an extension 
of the timeline for good cause, such as a declared public health 
emergency.
    (f) * * *
    (1) * * *
    (i) Approve initial approval of a program's Medicare participation 
based upon approval of mitigating factors.
    (ii) Deny the program's request for Medicare approval based on 
mitigating factors.
    (iii) Offer a time-limited Systems Improvement Agreement, in 
accordance with paragraph (g) of this section, when a transplant 
program has waived its appeal rights, has implemented substantial 
program improvements that address root causes and are institutionally 
supported by the hospital's governing body on a sustainable basis, and 
has requested more time to design or implement additional improvements 
or demonstrate compliance with CMS outcome requirements. Upon 
completion of the Systems Improvement Agreement or a CMS finding that 
the hospital has failed to meet the terms of the Agreement, CMS makes a 
final determination of whether to approve or deny a program's request 
for Medicare

[[Page 51832]]

approval based on mitigating factors. A Systems Improvement Agreement 
follows the process specified in paragraph (g) of this section.
* * * * *

PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES

0
66. The authority citation for part 491 is revised to read as follows:

    Authority:  42 U.S.C. 263a and 1302.


0
67. Section 491.9 is amended by revising paragraph (b)(4) to read as 
follows:


Sec.  491.9  Provision of services.

* * * * *
    (b) * * *
    (4) These policies are reviewed at least biennially by the group of 
professional personnel required under paragraph (b)(2) of this section 
and reviewed as necessary by the RHC or FQHC.
* * * * *

0
68. Section 491.11 is amended by revising paragraph (a) to read as 
follows:


Sec.  491.11  Program evaluation.

    (a) The clinic or center carries out, or arranges for, a biennial 
evaluation of its total program.
* * * * *

0
69. Section 491.12 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(v); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  491.12  Emergency preparedness.

* * * * *
    (a) Emergency plan. The RHC or FQHC must develop and maintain an 
emergency preparedness plan that must be reviewed and updated at least 
every 2 years. The plan must do all of the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation.
    (b) Policies and procedures. The RHC or FQHC must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least every 2 years. At a minimum, the 
policies and procedures must address the following:
* * * * *
    (c) Communication plan. The RHC or FQHC must develop and maintain 
an emergency preparedness communication plan that complies with 
Federal, State, and local laws and must be reviewed and updated at 
least every 2 years. The communication plan must include all of the 
following:
* * * * *
    (d) Training and testing. The RHC or FQHC must develop and maintain 
an emergency preparedness training and testing program that is based on 
the emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, policies and procedures 
at paragraph (b) of this section, and the communication plan at 
paragraph (c) of this section. The training and testing program must be 
reviewed and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (v) If the emergency preparedness policies and procedures are 
significantly updated, the RHC/FQHC must conduct training on the 
updated policies and procedures.
    (2) Testing. The RHC or FQHC must conduct exercises to test the 
emergency plan at least annually. The RHC or FQHC must do the 
following:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, an 
individual, facility-based functional exercise every 2 years; or.
    (B) If the RHC or FQHC experiences an actual natural or man-made 
emergency that requires activation of the emergency plan, the RHC or 
FQHC is exempt from engaging in its next required full-scale community-
based or individual, facility-based functional exercise following the 
onset of the emergency event.
    (ii) Conduct an additional exercise every 2 years, opposite the 
year the full-scale or functional exercise under paragraph (d)(2)(i) of 
this section is conducted, that may include, but is not limited to 
following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the RHC or FQHC's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the RHC or FQHC's emergency plan, as needed.
* * * * *

PART 494--CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE 
FACILITIES

0
70. The authority citation for part 494 is revised to read as follows:

    Authority:  42 U.S.C. l302 and l395hh.


0
71. Section 494.60 is amended by revising paragraphs (d)(1), (2), and 
(4) and adding paragraphs (d)(5), (e), and (f) to read as follows:


Sec.  494.60  Condition: Physical environment.

* * * * *
    (d) * * *
    (1) Except as provided in paragraph (d)(2) of this section, 
dialysis facilities that do not provide one or more exits to the 
outside at grade level from the patient treatment area level must 
comply with provisions of the Life Safety Code (NFPA 101 and its 
Tentative Interim Amendments TIA 12-1, TIA 12-2, TIA 12-3, and TIA 12-
4) applicable to Ambulatory Health Care Occupancies, regardless of the 
number of patients served.
    (2) Notwithstanding paragraph (d)(1) of this section, dialysis 
facilities participating in Medicare as of October 14, 2008 that 
require sprinkler systems are those housed in multi-story buildings 
construction Types II(000), III(200), or V(000), as defined in the Life 
Safety Code, section 21.1.6.1, which were constructed after January 1, 
2008, and those housed in high rise buildings over 75 feet in height, 
which were constructed after January 1, 2008.
* * * * *
    (4) In consideration of a recommendation by the State survey agency 
or at the discretion of the Secretary, the Secretary may waive, for 
periods deemed appropriate, specific provisions of the Life Safety 
Code, which would result in unreasonable hardship upon an ESRD 
facility, but only if the waiver will not adversely affect the health 
and safety of the patients.
    (5) No dialysis facility may operate in a building that is adjacent 
to an industrial high hazard area, as described

[[Page 51833]]

in sections 20.1.3.7 and 21.1.3.7 of the Health Care Facilities Code 
(NFPA 99 and its Tentative Interim Amendments TIA 12-2, TIA 12-3, TIA 
12-4, TIA 12-5, and TIA 12-6).
    (e) Standard: Building safety. (1) Dialysis facilities that do not 
provide one or more exits to the outside at grade level from the 
patient treatment area level must meet the applicable provisions of the 
Health Care Facilities Code, regardless of the number of patients 
served.
    (2) Chapters 7, 8, 12, and 13 of the Health Care Facilities Code do 
not apply to a dialysis facility.
    (3) If application of the Health Care Facilities Code would result 
in unreasonable hardship for the dialysis facility, CMS may waive 
specific provisions of the Health Care Facilities Code for such 
facility, but only if the waiver does not adversely affect the health 
and safety of patients.
    (f) Incorporation by reference. The standards incorporated by 
reference in this section are approved for incorporation by reference 
by the Director of the Office of the Federal Register in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain the material 
from the sources listed below. You may inspect a copy at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD or 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, email 
[email protected], or go to: www.archives.gov/federal_register/cfr/ibr-locations.html. If any changes in the editions of the Codes are 
incorporated by reference, CMS will publish a document in the Federal 
Register to announce the changes.
    (1) National Fire Protection Association, 1 Batterymarch Park, 
Quincy, MA 02169, www.nfpa.org, 1-617-770-3000.
    (i) NFPA 99, Health Care Facilities Code, 2012 edition, issued 
August 11 2011.
    (ii) TIA 12-2 to NFPA 99, issued August 11, 2011.
    (iii) TIA 12-3 to NFPA 99, issued August 9, 2012.
    (iv) TIA 12-4 to NFPA 99, issued March 7, 2013.
    (v) TIA 12-5 to NFPA 99, issued August 1, 2013.
    (vi) TIA 12-6 to NFPA 99, issued March 3, 2014.
    (vii) NFPA 101, Life Safety Code, 2012 edition, issued August 11, 
2011.
    (viii) TIA 12-1 to NFPA 101, issued August 11, 2011.
    (ix) TIA 12-2 to NFPA 101, issued October 30, 2012.
    (x) TIA 12-3 to NFPA 101, issued October 22, 2013.
    (xi) TIA 12-4 to NFPA 101, issued October 22, 2013.
    (2) [Reserved]

0
72. Section 494.62 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(4), (b) introductory 
text, (c) introductory text, (d) introductory text, and (d)(1)(ii);
0
b. Adding paragraph (d)(1)(vii); and
0
c. Revising paragraph (d)(2).
    The revisions and addition read as follows:


Sec.  494.62  Condition of participation: Emergency preparedness.

* * * * *
    (a) Emergency plan. The dialysis facility must develop and maintain 
an emergency preparedness plan that must be evaluated and updated at 
least every 2 years. The plan must do all of the following:
* * * * *
    (4) Include a process for cooperation and collaboration with local, 
tribal, regional, State, and Federal emergency preparedness officials' 
efforts to maintain an integrated response during a disaster or 
emergency situation. The dialysis facility must contact the local 
emergency preparedness agency at least annually to confirm that the 
agency is aware of the dialysis facility's needs in the event of an 
emergency.
    (b) Policies and procedures. The dialysis facility must develop and 
implement emergency preparedness policies and procedures, based on the 
emergency plan set forth in paragraph (a) of this section, risk 
assessment at paragraph (a)(1) of this section, and the communication 
plan at paragraph (c) of this section. The policies and procedures must 
be reviewed and updated at least every 2 years. These emergencies 
include, but are not limited to, fire, equipment or power failures, 
care-related emergencies, water supply interruption, and natural 
disasters likely to occur in the facility's geographic area. At a 
minimum, the policies and procedures must address the following:
* * * * *
    (c) Communication plan. The dialysis facility must develop and 
maintain an emergency preparedness communication plan that complies 
with Federal, State, and local laws and must be reviewed and updated at 
least every 2 years. The communication plan must include all of the 
following:
* * * * *
    (d) Training, testing, and orientation. The dialysis facility must 
develop and maintain an emergency preparedness training, testing and 
patient orientation program that is based on the emergency plan set 
forth in paragraph (a) of this section, risk assessment at paragraph 
(a)(1) of this section, policies and procedures at paragraph (b) of 
this section, and the communication plan at paragraph (c) of this 
section. The training, testing, and patient orientation program must be 
evaluated and updated at least every 2 years.
    (1) * * *
    (ii) Provide emergency preparedness training at least every 2 
years.
* * * * *
    (vii) If the emergency preparedness policies and procedures are 
significantly updated, the dialysis facility must conduct training on 
the updated policies and procedures.
    (2) Testing. The dialysis facility must conduct exercises to test 
the emergency plan at least annually. The dialysis facility must do all 
of the following:
    (i) Participate in a full-scale exercise that is community-based 
every 2 years; or
    (A) When a community-based exercise is not accessible, an 
individual, and a facility-based functional exercise every 2 years; or
    (B) If the dialysis facility experiences an actual natural or man-
made emergency that requires activation of the emergency plan, the 
dialysis facility is exempt from engaging in its next required full-
scale community-based or individual, facility-based functional exercise 
following the onset of the emergency event.
    (ii) Conduct an additional exercise every 2 years, opposite the 
year the full-scale or functional exercise under paragraph (d)(2)(i) of 
this section is conducted, that may include, but is not limited to the 
following:
    (A) A second full-scale exercise that is community-based or an 
individual, facility-based functional exercise; or
    (B) A mock disaster drill; or
    (C) A tabletop exercise or workshop that is led by a facilitator 
and includes a group discussion, using a narrated, clinically-relevant 
emergency scenario, and a set of problem statements, directed messages, 
or prepared questions designed to challenge an emergency plan.
    (iii) Analyze the dialysis facility's response to and maintain 
documentation of all drills, tabletop exercises, and emergency events, 
and revise the dialysis facility's emergency plan, as needed.
* * * * *


[[Page 51834]]


    Dated: September 6, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: September 17, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-20736 Filed 9-25-19; 11:15 am]
 BILLING CODE 4120-01-P