47686 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Proposed Rules 

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–P] 

RIN 0938–AT23 

Medicare and Medicaid Programs; 

Regulatory Provisions To Promote 

Program Efficiency, Transparency, and 

Burden Reduction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

reform Medicare regulations that are 

identified as unnecessary, obsolete, or 

excessively burdensome on health care 

providers and suppliers. This proposed 

rule would increase 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. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on November 19, 2018. 

ADDRESSES: In commenting, please refer 

to file code CMS–3346–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3346–P, P.O. Box 8010, Baltimore, 

MD 21244–1810. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3346–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Alpha-Banu Wilson, (410) 786–8687. 

We have also included a subject matter 

expert under the ‘‘Provisions of the 

Proposed Rule’’ section for each 

provision set out in the proposed rule. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. 

Table of Contents 

To assist readers in referencing 

sections contained in this preamble, we 

are providing a Table of Contents. 

I. Executive Summary and Background 

A. Purpose 

B. Summary of Major Provisions 

C. Summary of Costs and Benefits 

II. Provisions of the Proposed Regulations 

A. Religious Nonmedical Health Care 

Institutions (RNHCIs)—Discharge 

Planning (§ 403.736(a) and (b)) 

B. Ambulatory Surgical Centers 

C. Hospice 

D. Hospitals 

E. Transplant Centers 

F. Home Health Agencies 

G. Comprehensive Outpatient 

Rehabilitation Facility (CORF)— 

Utilization Review Plan (§ 485.66) 

H. Critical Access Hospitals 

I. Community Mental Health Center 

(§ 485.914(d)) 

J. Portable X-Ray Services (§ 486.104(a) and 

486.106(a)) 

K. Rural Health Clinics (RHCs) and 

Federally Qualified Health Centers 

(FQHCs) 

L. Emergency Preparedness for Providers 

and Suppliers 

III. Collection of Information Requirements 

IV. Response to Comments 

V. Regulatory Impact Analysis 

A. Statement of Need 

B. Overall Impact 

C. Sources of Data Used in Estimates of 

Burden Hours and Cost Estimates 

D. Anticipated Effects 

E. Alternatives Considered 

F. Uncertainty 

G. Accounting Statement and Table 

H. Reducing Regulation and Controlling 

Regulatory Costs 

I. Conclusion 

I. Executive Summary and Background 

A. Purpose 

Over the past several years, we have 

revised the Conditions of Participation 

(CoPs) and Conditions for Coverage 

(CfCs) to reduce the regulatory burden 

on providers and suppliers while 

preserving 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 patient 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 


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Burden Reduction; Part II’’, published 

May 12, 2014 (79 FR 27105). 

This proposed 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 propose changes to the 

current requirements, CoPs, and 

Conditions for Coverage (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 proposed 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. Ultimately, these 

proposals balance patient safety and 

quality, while also providing broad 

regulatory relief for providers and 

suppliers. 

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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction in future rulemaking. 

Specifically, we are seeking public 

comment on additional proposals or 

modifications to the proposals set forth 

in this rule 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. Consistent with our 

‘‘Patients Over Paperwork’’ Initiative, 

we are particularly interested in any 

suggestions to improve existing 

requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note 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. We refer readers to the public 

comments that were submitted in 

response to the RFI for the following 

2017 payment regulations: 

• End-Stage Renal Disease 

Prospective Payment System and 

Payment for Renal Dialysis Services 

Furnished to Individuals with Acute 

Kidney Injury, and End-Stage Renal 

Disease Quality Incentive Program 

found at https://www.regulations.gov/ 

docket?D=CMS-2017-0084. 

• CY 2018 Home Health Prospective 

Payment System Rate Update; ValueBased Purchasing Model; and Quality 

Reporting Requirements found at 

https://www.regulations.gov/ 

docket?D=CMS-2017-0100. 

• FY 2018 Hospice Wage Index and 

Payment Rate Update and Hospice 

Quality found at https://

www.regulations.gov/ 

document?D=CMS-2017-0062-0001. 

• FY 2018 Hospital Inpatient 

Prospective Payment System for Acute 

Care Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

RFI, found at https://

www.regulations.gov/docket?D=CMS2017-0055. 

• CY 2018 Hospital Outpatient PPS 

Policy Changes and Payment Rates and 

Ambulatory Surgical Center Payment 

System Policy Changes and Payment 

Rates found at https://

www.regulations.gov/docket?D=CMS2017-0091. 

• FY 2018 Inpatient Rehabilitation 

Facility Prospective Payment System 

found at https://www.regulations.gov/ 

document?D=CMS-2017-0059-0002. 

• FY 2018 Inpatient Psychiatric 

Facilities Prospective Payment System 

found at https://www.regulations.gov/ 

document?D=CMS-2018-0053-0002. 

• CY 2018 Revisions to Payment 

Policies under the Physician Fee 

Schedule and Other Revisions to Part B 

found at https://www.regulations.gov/ 

docket?D=CMS-2017-0092. 

• FY 2018 Prospective Payment 

System and Consolidated Billing for 

Skilled Nursing Facilities found at 

https://www.regulations.gov/ 

document?D=CMS-2017-0060-0002. 

Public comments on the RFIs can be 

found by searching for the terms ‘‘RFI’’ 

or ‘‘request for information’’ in the 

aforementioned 2017 payment 

regulation dockets on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

B. Summary of Major Provisions 

We propose to reduce regulatory 

burden on providers and suppliers by 

modifying, removing, or streamlining 

current regulations that we now believe 

are excessively burdensome. The 

proposals fall under three categories: (1) 

Proposals that simplify and streamline 

processes, (2) proposals that reduce the 

frequency of activities and revise 

timelines, and (3) proposals that are 

obsolete, duplicative, or that contain 

unnecessary requirements, as follows. 

1. Proposals That Simplify and 

Streamline Processes 

a. Discharge Planning in Religious 

Nonmedical Health Care Institutions 

(RNHCIs) 

We have concluded that a more 

condensed and flexible process for 

discharge planning for RNHCIs would 

reduce burden and simplify the 

discharge process for patients. 

Specifically, we propose to revise the 

requirements at 42 CFR 403.736(a), 

requiring an evaluation, and 

§ 403.736(b), requiring a discharge plan. 

Instead of specifying detailed discharge 

processes, we would simply require 

RNHCIs to assess the need for a 

discharge plan for any patient identified 

as likely to suffer adverse consequences 

if there is no 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 propose to remove the 

requirements at 42 CFR 416.41(b)(3), 

‘‘Standard: Hospitalization.’’ This 

would address the competition barriers 

that currently exist in some situations 

where hospitals providing outpatient 

surgical services refuse to sign written 

transfer agreements or grant admitting 

privileges to physicians performing 

surgery in an ambulatory surgical center 

(ASC). The Emergency Medical 

Treatment and Labor Act emergency 

response regulations would continue to 

address emergency transfer of a patient 

from an ASC to a nearby hospital. 

c. ASC Requirements for 

Comprehensive Medical History and 

Physical Assessment 

We propose to remove the current 

requirements at § 416.52(a) and replace 

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 would 

require the operating physician to 

document any pre-existing medical 

conditions and appropriate test results, 

in the medical record, which would 

have to be considered before, during 

and after surgery. In addition, we have 

retained the requirement that all presurgical assessments include 

documentation regarding any allergies 

to drugs and biologicals, and that the 

medical history and physical 

examination (H&P), if completed, be 


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placed in the patient’s medical record 

prior to the surgical procedure. 

d. Hospice Requirements for Medication 

Management 

We have concluded that the 

requirements at 42 CFR 418.106(a)(1), 

related to having on the hospice staff, an 

individual with specialty knowledge of 

hospice medications, is no longer 

necessary for various reasons. Therefore, 

we propose to remove these 

requirements. 

In addition, we propose to replace the 

requirement that hospices provide a 

copy of medication policies and 

procedures to patients, families and 

caregivers with a requirement that 

hospices provide information regarding 

the use, storage, and disposal of 

controlled drugs to the patient or patient 

representative, and family. This 

information would be provided in a 

more user-friendly manner, as 

determined by each hospice. We believe 

this could improve patients’ and 

caregivers’ comprehension and 

maximize the effectiveness of the 

education effort. 

e. Hospice Requirements: Orientation of 

Skilled Nursing Facility (SNF) and 

Intermediate Care Facilities for 

Individuals With Intellectual 

Disabilities (ICF/IID) Staff 

We propose to move the requirements 

at § 418.112(f) to the ‘‘Written 

agreement’’ standard at new 

§ 418.112(c)(10). Moving the 

requirement for facility staff orientation 

from a standalone requirement that 

places responsibility solely on hospices 

to the section of the rule related to the 

written agreement established between 

hospices and skilled nursing facilities 

(SNFs) and intermediate care facilities 

for individuals with intellectual 

disabilities (ICFs/IID) will allow both 

entities to negotiate the terms for 

assuring orientation of facility staff. This 

will give hospices more freedom to 

develop innovative approaches and 

avoid effort duplication with other 

hospices that are orienting the same 

facility staff. 

f. Hospital Quality Assessment and 

Performance Improvement Program 

(QAPI Program) 

We propose a new standard at 42 CFR 

482.21(f), ‘‘Unified and integrated QAPI 

program for multi-hospital systems.’’ 

We would allow a hospital that was part 

of a hospital system consisting of 

multiple separately certified hospitals 

using a system governing body that was 

legally responsible for the conduct of 

two or more hospitals, the system 

governing body could elect to have a 

unified and integrated Quality 

Assessment and Performance 

Improvement (QAPI) 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 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 would have to demonstrate that: 

The unified and integrated QAPI 

program was 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 the unified and integrated 

QAPI program would 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, were 

given due consideration, and that the 

unified and integrated QAPI program 

would have mechanisms in place to 

ensure that issues localized to particular 

hospitals were duly considered and 

addressed. 

g. Hospital Requirements for 

Comprehensive Medical History and 

Physical Examinations (§§ 482.22, 

482.24, and 482.51) 

We propose to allow hospitals the 

flexibility to establish a medical staff 

policy describing the circumstances 

under which such hospitals could 

utilize a pre-surgery/pre-procedure 

assessment for an outpatient, instead of 

a comprehensive medical history and 

physical examination (H&P). We believe 

that the burden on the hospital, the 

practitioner, and the patient could be 

greatly reduced by allowing this option. 

In order to exercise this option, a 

hospital would need to document the 

assessment in a patient’s medical 

record. The hospital’s policy would 

have to 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 propose a new standard at 

§ 482.42(c), ‘‘Unified and integrated 

infection control program for multihospital systems.’’ Like the proposed 

requirements for a unified and 

integrated QAPI program, the proposed 

standard for infection control would 

allow 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 infection control 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 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 

We propose at § 482.61(d) to clarify 

the scope of authority for non-physician 

practitioners or Doctor of Medicine 

Doctor 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 proposing a nomenclature 

change at part 482 and the transplant 

center regulations at §§ 482.68, 482.70, 

482.72 through 482.104, and at § 488.61. 

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, thereby reducing 

provider confusion. 


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k. Data Submission, Clinical Experience, 

and Outcome Requirements for ReApproval of Transplant Centers 

We propose to remove the 

requirements at § 482.82 that require 

transplant centers to submit clinical 

experience, outcomes, and other data in 

order to obtain Medicare re-approval. 

Transplant centers will still be required 

to comply with the CoPs at §§ 482.72 

through 482.104 and the data 

submission, clinical experience, and 

outcome requirements for initial 

Medicare approval under § 482.80. 

l. Special Procedures for Approval and 

Re-Approval of Organ Transplant 

Centers 

We propose to remove the 

requirements at § 488.61(f) through (h) 

with respect to the re-approval process 

for transplant centers. This change 

corresponds to the proposed removal of 

the provisions § 482.82. 

m. HHA Requirements for Verbal 

Notification of Patient Rights and 

Responsibilities 

We propose to remove the 

requirements for verbal (meaning 

spoken) notification of patient rights to 

those patient rights elements for which 

the Social Security Act (the Act) 

requires such verbal notification. 

Specifically, we propose to only require 

verbal notice for those rights related to 

payments made by Medicare, Medicaid, 

and other federally funded programs, 

and potential patient financial 

liabilities. 

n. Personnel Requirements for Portable 

X-Ray Technologists 

We propose to revise § 486.104, 

‘‘Condition for coverage: Qualifications, 

orientation and health of technical 

personnel’’, to align the current 

requirements at § 486.104(a)(1), (2), (3), 

(4) with § 482.26(c)(2), which refers to 

qualifications of radiologic technologists 

in hospitals and is focused on the 

qualifications of the individual 

performing services. 

o. Portable X-Ray Requirements for 

Orders 

We propose to revise the requirements 

for portable x-ray orders at 

§ 486.106(a)(2). We propose to remove 

the requirement that physician or nonphysician practitioner’s orders for 

portable x-ray services must be written 

and signed. We also propose 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 proposed changes would simplify 

the ordering process for portable x-rays 

and promote the use of more efficient 

ordering methods, such as electronic 

orders. 

p. Emergency Preparedness 

Requirements: Requirements for 

Emergency Plans 

We propose to eliminate part of the 

requirement from § 482.15(a)(4) for 

hospitals and other parallel provisions 

for other affected Medicare and 

Medicaid providers and suppliers 

(referred to collectively as ‘‘facilities,’’ 

throughout the remainder of this 

proposed rule where applicable), 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. In 

accordance with the remaining 

requirement at § 482.15(a)(4), facilities 

would 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. Only 

the documentation requirements would 

be eliminated. 

2. Proposals That Reduce the Frequency 

of Activities and Revise Timelines 

a. Home Health Agency (HHA) 

Requirements for Providing Patients 

With Copies of Clinical Records 

We propose to remove the 

requirement that Home Health Agencies 

(HHAs) provide a copy of the clinical 

record to a patient, upon request, by the 

next home visit. We propose to retain 

the requirement that the copy of the 

clinical record must be provided, upon 

request, within 4 business days. 

b. CAH Annual Review of Policies and 

Procedures 

We propose to change the 

requirement at § 485.635(a)(4) to reflect 

the current medical practice where 

providers are expected to update their 

policies and procedures as needed in 

response to regulatory changes, changes 

in the standard of care, or nationally 

recognized guidelines. The current CoP 

at § 485.635(a)(4) requires a CAH’s 

professional personnel to review its 

policies at least annually and the CAH 

to review as necessary. We propose to 

reduce burden and provide flexibility by 

requiring the CAH’s, professional 

personnel, at a minimum, to conduct a 

biennial review of its policies and 

procedures instead of an annual review. 

c. Comprehensive Outpatient 

Rehabilitation Facility (CORF) 

Utilization Review Plans 

We propose to amend the utilization 

review plan requirements at § 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. 

d. Community Mental Health Center 

(CMHC) Requirements for Updating the 

Client Assessment 

We propose to remove the 

requirement that all Community Mental 

Health Center (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 propose to 

retain the 30 day assessment update 

time frame in accordance with existing 

Medicare payment requirements for 

partial hospitalization services. 

e. RHC and FQHC Review of Patient 

Care Policies 

We propose to revise the requirement 

at § 491.9(b)(4) that RHC and FQHC 

patient care policies are reviewed at 

least annually by a group of professional 

personnel to review every other year to 

reduce the frequency of policy reviews. 

f. RHC and FQHC Program Evaluation 

We propose to revise the requirement 

at § 491.11(a) by changing the frequency 

of the required RHC or FQHC evaluation 

from annually to every other year. 

g. Emergency Preparedness 

Requirements: Requirements for Annual 

Review of Emergency Program 

On September 16, 2016, we finalized 

a rule imposing emergency 

preparedness requirements on most 

Medicare and Medicaid facilities 

(Emergency Preparedness Requirements 

for Medicare and Medicaid Participating 

Providers and Suppliers, 81 FR 63860). 

Facilities participating in Medicare and/ 

or Medicaid are now required, among 

other things, to review their emergency 

preparedness programs annually. This 

includes a review of their emergency 

plans, policies and procedures, 

communication plans, and training and 

testing programs. We propose to revise 

these requirements, so that applicable 

providers and suppliers have increased 

flexibility with compliance. 


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h. Emergency Preparedness 

Requirements: Requirements for 

Training 

As with the review of the emergency 

plan previously discussed, we propose 

to revise the requirement that facilities 

develop and maintain a training 

program based on the facility’s 

emergency plan annually. Instead, we 

would require that facilities provide 

training biennially (every 2 years) after 

facilities conduct initial training for 

their emergency program. In addition, 

we propose to require additional 

training when the emergency plan is 

significantly updated. 

i. Emergency Preparedness 

Requirements: Requirements for Testing 

For inpatient providers, we propose to 

expand the types of acceptable testing 

exercises that may be conducted such 

that one of the two annually required 

testing exercises may be an exercise of 

their choice, which may include one 

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. For 

outpatient providers, we propose to 

revise 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 chose the testing exercise of their 

choice which may include 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. 

3. Proposals That Are Obsolete, 

Duplicative, or That Contain 

Unnecessary Requirements 

a. Hospice Aide Training and 

Competency Requirements 

We propose to revise § 418.76(a)(1)(iv) 

to remove the requirement that a State 

licensure program meet the specific 

training and competency requirements 

set forth in § 418.76(b) and (c) in order 

for such licensure to qualify a hospice 

aide to work at a Medicare-participating 

hospice. We would defer to State 

licensure requirements regardless of 

their content or format, and would 

allow states to set forth training and 

competency requirements that meet the 

needs of their populations. We believe 

that this change would streamline the 

hiring process for most hospices. 

b. Medical Staff: Autopsies 

We propose to remove the 

requirement for hospitals at § 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 propose to instead defer to State law 

regarding such medical-legal 

requirements. 

c. Hospital and CAH Swing-Bed 

Requirements 

We propose to remove the cross 

reference to § 483.10(f)(9) at 

§ 482.58(b)(1) (for hospital swing-bed 

providers) and § 485.645(d)(1) (for CAH 

swing-bed providers). The crossreference gives a resident the right to 

choose to, or refuse to, perform services 

for the facility if they so choose. If the 

resident works, the facility must 

document it in the resident’s plan of 

care, noting whether the services are 

voluntary or paid, and, if paid, 

providing wages for the work being 

performed, at prevailing rates. 

We propose to remove the crossreference to § 483.24(c) at § 482.58(b)(4) 

(for hospital swing-bed providers) and 

§ 485.645(d)(4) (for CAH swing-bed 

providers). This cross reference requires 

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 propose to remove the crossreference to § 483.70(p) at § 482.58(b)(5) 

(for hospital swing-bed providers) and 

§ 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 propose to remove the crossreference to § 483.55(a)(1) at 

§ 482.58(b)(8) (for hospital swing-bed 

providers) and § 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 Supervision Requirements 

We propose to revise the requirement 

at § 418.76(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 

and a competency evaluation directly 

related to the deficient skills. 

e. CAH Disclosure Requirements 

We propose to remove § 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). The 

provider agreement rules note that the 

basis for termination of the provider 

agreement includes failure of the 

provider to furnish ownership 

information as required in § 420.206, 

making this CAH CoP requirement 

duplicative of those regulations. 

C. Summary of Costs and Benefits 

1. Overall Impact 

This proposed rule would create 

savings and reduce burden in many 

areas. Several of the proposed changes 

would create measurable monetary 

savings for providers and suppliers, 

while others would create less 

quantifiable savings of time and 

administrative burden. We estimate a 

total annual savings of $1,123 million 

using the midpoints of estimated ranges. 

We also estimate a one-time 

implementation cost of $64 million. 

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 proposed rule): 


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TABLE 1—SUMMARY OF COSTS AND BENEFITS

Provider or supplier type and description of proposed provisions Frequency 

Number of 

affected 

entities 

Estimated 

annual 

savings 

or benefits 

($millions) 

Religious Nonmedical Health Care Institution: 

• Discharge Planning ......................................................................... As patients are discharged (Estimated 619 annual discharges).18 (*) 

Ambulatory Surgical Center: 

• Governing Body and Management ................................................. Upon failed hospital transfer agreement attempts.5,557 (*) 

• Patient Admission, Assessment and Discharge (History and 

Physical) **.

Every patient admission to an ASC 

or hospital outpatient.

1 5,557 

2 5,031 

454 

• Medical Records ............................................................................. Recurring annually .......................... 5,557 0 

Hospices: 

• Drugs and Biologicals, Medical Supplies, and Durable Medical 

Equipment.

Recurring annually .......................... 1,151 80 

• Hospices That Provide Hospice Care to residents of a SNF/NF or 

ICF/IID.

Recurring annually .......................... 4,602 (*) 

• Hospice Aide and Homemaker Services ........................................ Recurring annually .......................... 3,498 2 

Hospitals: 

• Quality Assessment and Performance Improvement Program ...... Recurring annually .......................... 5,031 28 

• Medical staff: Autopsies .................................................................. Recurring annually .......................... 5,031 0 

• Infection Control .............................................................................. Recurring annually .......................... 5,031 105 

• Special requirements for hospital providers of long-term care 

services (‘‘swing-beds’’).

Recurring annually .......................... 5,031 30 

• Special Requirements for Psychiatric Hospitals ............................. Recurring annually .......................... 574 62 

Transplant Programs: 

• Various provisions related to performance *** ................................ Recurring annually .......................... 750 (3) 

Home Health Agencies: 

• Patient rights ................................................................................... Recurring annually .......................... 12,624 55 

• Home health aide services ............................................................. Recurring annually .......................... 12,624 0 

• Clinical records ............................................................................... Recurring annually .......................... 12,624 0 

Critical Access Hospitals: 

• Provision of Services ...................................................................... Recurring biennially ......................... 1,343 2 

• Organizational structure .................................................................. Recurring annually .......................... 1,343 (*) 

• Special requirements for hospital providers of long-term care 

services (‘‘swing-beds’’).

Recurring annually .......................... 1,246 86 

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 technicians *** ............................................. Annual ............................................. 500 31 

• Removing written orders ................................................................. Annual ............................................. 500 29 

RHC (4,160 clinics) & FQHC (7,874 center locations): 

• Provision of Services ...................................................................... Recurring biennially ......................... 12,034 7 

• Program Evaluation ........................................................................ Recurring biennially ......................... 12,034 9 

Emergency Preparedness for Providers and Suppliers: 

• Annual Review of Emergency Preparedness Program .................. Recurring annually .......................... 72,844 94 

• Emergency Plan .............................................................................. Recurring annually .......................... 68,254 7 

• Training and Testing-Training Program .......................................... Recurring annually .......................... 69,196 33 

• Training and Testing-Testing .......................................................... Recurring annually .......................... 36,971 9 

Total Annual Savings .................................................................. .......................................................... ........................ 1,123 

Life-extending benefits for transplant patients ** ......................... .......................................................... ........................ (3) 

* Amount is less than 1 million dollars. 

** 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 increase in future years. 

1 (ACSs). 

2 (Hospitals). 

3 Not Quantified. 


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II. Provisions of the Proposed 

Regulations 

A. Religious Nonmedical Health Care 

Institutions (RNHCIs)—Discharge 

Planning (§ 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. 

We have implemented these provisions 

in 42 CFR part 403, subpart G, 

‘‘Religious Nonmedical Health Care 

Institutions Benefits, Conditions of 

Participation, and Payment.’’ Currently 

there are 18 Medicare-certified RNHCIs 

that are subject to the RNHCI 

regulations. 

A RNHCI provides only non-medical 

items and services through non-medical 

nursing personnel on a 24-hour basis. 

These services are provided to 

beneficiaries who choose to rely solely 

upon a religious method of healing and 

for whom the acceptance of medical 

services would be inconsistent with 

their religious beliefs. ‘‘Religious nonmedical care’’ or ‘‘religious method of 

healing’’ means care provided under 

established religious tenets that prohibit 

conventional or unconventional medical 

care for the treatment of the patient, and 

exclusive reliance on religious activity 

to fulfill a patient’s total healthcare 

needs. The RNHCI does not furnish 

medical screening, examination, 

diagnosis, prognosis, treatment, or the 

administration of drugs or biologicals to 

its patients. 

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. 

We reviewed the current CoPs and 

payment for RNHCIs at 42 CFR part 403, 

subpart G, in an effort to reduce burden 

and provide flexibility as feasible. As a 

result of the review, we identified 

discharge planning as one area where 

we could reduce burden. The current 

discharge planning requirements at 

§ 403.736(a) and (b) require RNHCIs to 

have a discharge planning process that 

applies to all patients, and to assure that 

appropriate post-institution services are 

obtained for each patient, as necessary. 

Currently, § 403.736(a)(1) requires 

RNHCIs to assess the need for a 

discharge plan for any patient identified 

as likely to suffer adverse consequences 

if there is no planning and for any other 

patient upon his or her request or at the 

request of his or her legal representative. 

In accordance with § 403.736, this 

discharge planning evaluation must be 

initiated at admission and must include 

the following: 

• An assessment of the possibility of 

a patient needing post-RNHCI services 

and of the availability of those services. 

• An assessment of the probability of 

a patient’s capacity for self-care or of the 

possibility of the patient being cared for 

in the environment from which he or 

she entered the RNHCI. 

• The staff must complete the 

assessment on a timely basis so that 

arrangements for post-RNHCI care are 

made before discharge and so that 

unnecessary delays in discharge are 

avoided. 

• The discharge planning evaluation 

must be included in the patient’s care 

record for use in establishing an 

appropriate discharge plan. Staff must 

discuss the results of the discharge 

planning evaluation with the patient or 

a legal representative acting on his or 

her behalf. 

• If the discharge planning evaluation 

indicates a need for a discharge plan, 

qualified and experienced personnel 

must develop or supervise the 

development of the plan. 

• In the absence of a finding by the 

RNHCI that the beneficiary needs 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. 

• The RNHCI must arrange for the 

initial implementation of the 

beneficiary’s discharge plan. 

• If there are factors that may affect 

continuing care needs or the 

appropriateness of the discharge plan, 

the RNHCI must reevaluate the 

beneficiary’s discharge plan. The RNHCI 

must inform the beneficiary or legal 

representative about the beneficiary’s 

post-RNHCI care requirements. 

• The discharge plan must inform the 

beneficiary or his or her legal 

representative about the freedom to 

choose among providers of care when a 

variety of providers is available that are 

willing to respect the discharge 

preferences of the beneficiary or legal 

representative. 

Since the RNHCI’s religious tenets 

prohibit conventional or 

unconventional medical treatment of a 

beneficiary, we believe that the 

extensive requirements previously 

discussed are unnecessarily 

burdensome, because medical postinstitution services are not utilized by 

RNHCI patients. 

Based on our experience with 

RNHCIs, patients are routinely 

discharged to home and not to an acute 

or post-acute care medical provider or 

supplier. We do not see a need for 

RNHCIs to develop a discharge plan that 

includes medical care once a patient 

leaves the RNHCI, because doing so is 

not in keeping with the religious tenets 

and goals of the facility. However, we 

believe that it is important to discuss 

with the caregiver at home about a safe 

and healing environment at home and to 

monitor the individual to access any 

changes in the patient’s well-being and 

the need to seek additional care. We 

would expect RNHCIs to have policies 

and procedures that address their 

discharge processes. If the RNHCI 

determines that a patient either does or 

does not require discharge instructions, 

this decision must be made based on the 

RNHCI’s existing policies. Surveyors 

would be expected to review the RNHCI 

policies and confirm that either the 

existence or lack of discharge 

instructions is consistent with policies 

established by the RNHCI. 

We propose a more condensed and 

flexible process for discharge planning 

and instructions for RNHCIs. 

Specifically, we propose to remove the 

requirements at § 403.736(a) and (b), 

proposing instead to require RNHCIs to 

provide discharge instructions to the 

patient and/or the patient’s caregiver 

when the patient is discharged home. 

We also propose that paragraphs (c) and 

(d) be redesignated as paragraphs (b) 

and (c). 

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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction for future rulemaking. 

Specifically, we are seeking public 

comment on additional proposals or 

modifications to the proposals set forth 

in this rule that would further reduce 

burden on RNHCIs and create cost 

savings, while also preserving quality of 

care and patient health and safety. 

Consistent with our ‘‘Patients Over 

Paperwork’’ Initiative, we are 

particularly interested in any 

suggestions to improve existing 

requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note that such suggestions 

could include or expand upon 

comments submitted in response to the 

FY 2018 Hospital Inpatient Prospective 

Payment System for Acute Care 

Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

RFI, found at https://

www.regulations.gov/docket?D=CMS2017-0055. Public comments on the RFI 

can be found by searching for the terms 

‘‘RFI’’ or ‘‘request for information’’ in 

the aforementioned 2017 payment 


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regulation docket on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

Contact: Mary Collins, (410) 786– 

3189. 

B. Ambulatory Surgical Centers 

Section 416.2 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. Currently, 

there are 5,591 Medicare certified ASCs 

in the United States. 

Section 1832(a)(2)(F)(i) of the Act 

specifies that ASCs must meet health, 

safety, and other requirements specified 

by the Secretary in regulation in order 

to participate in Medicare. The 

Secretary of the Department of Health 

and Human Services (the Secretary) is 

responsible for ensuring that the CfCs 

protect the health and safety of all 

individuals treated by ASCs, whether 

they are Medicare beneficiaries or other 

patients. 

The ASC regulations were first 

published on August 5, 1982 (47 FR 

34082) and have since been amended 

several times. On November 18, 2008, 

we published a final rule, entitled 

‘‘Medicare Program: Changes to the 

Ambulatory Surgical Center Conditions 

for Coverage’’, (73 FR 68502) revising 

four existing health and safety CfCs and 

created three new health and safety 

CfCs. In addition, several other small 

changes have been made in the past 

several years to amend the emergency 

equipment requirements (77 FR 29002) 

and radiologic services requirements 

required in the ASCs (79 FR 27106). 

1. Governing Body and Management 

(§ 416.41(b)(3)(i) and (ii)) 

Hospitalization Requirements 

Section 416.41(b) outlines the patient 

hospitalization procedures that ASCs 

must have in place to participate in 

Medicare. Section 416.41(b)(1) states the 

ASC must have an effective procedure 

for the immediate transfer, to a hospital, 

of patients requiring emergency medical 

care that surpass the capabilities of the 

ASC. Additionally, there are two 

requirements that also pertain to ASC 

patient hospital transfers. Section 

416.41(b)(3)(i) and (ii) requires ASCs to 

have a written transfer agreement with 

a hospital that meets certain Medicare 

requirements or ensure all physicians 

performing surgery in the ASC have 

admitting privileges in a hospital that 

meets certain Medicare requirements. A 

written transfer agreement and 

physician admitting privileges is 

intended to make sure there is a 

relationship between the ASC and local 

hospital that would serve the patient in 

the event of a medical emergency. Over 

the past 5 years, we have heard from the 

largest ASC trade association and 

multiple ASCs that we need to address 

the widespread issue of the growing 

number of hospitals that are declining to 

work with ASCs (either by declining to 

sign a transfer agreement or by declining 

to allow admitting privileges to the 

hospital by physicians who work in 

ASCs) due to competition between 

hospital outpatient surgery departments 

and ASCs. CMS has continually worked 

with the ASCs and hospitals directly to 

resolve this requirement issue, however, 

several facilities have not been able to 

reach a positive outcome. Furthermore, 

we have seen no evidence of negative 

patient outcomes due to a lack of such 

transfer agreements and admitting 

privileges. Research reports published 

by the ASC Quality Collaborative 

indicate the national hospital transfer 

rate from an ASC to a hospital for care 

is about 1.25 per 1,000 ASC admissions 

(https://www.cms.gov/Medicare/ 

Quality-Initiatives-Patient-AssessmentInstruments/ASC-Quality-Reporting/ 

index.html). ASCs are already required 

to have personnel trained and available 

for emergency response when there is a 

patient in the ASC. In addition, the ASC 

is expected to provide initial stabilizing 

treatment until the patient is 

transferred. Finally, the current 

requirement dates back to 1982, when 

ASCs were a newly emerging medical 

care option and there was reasonable 

concern as to needed emergency care 

being available. 

EMTALA was enacted in 1986 and as 

its enforcement evolved over time this 

effectively has rendered such transfer 

agreements unnecessary, since 

EMTALA imposed requirements on all 

hospitals to provide emergency care 

without regard to prior arrangements 

until a patient could be stabilized and, 

as appropriate, either discharged 

because further care was not necessary, 

or transferred to another facility or care 

arrangement. Therefore, we conclude 

that these requirements are creating an 

administrative barrier to efficient ASC 

operations without any improvement in 

patient care or safety. In the absence of 

a transfer agreement or admitting 

privileges, ASCs would continue to 

have access to local emergency services 

to transfer patients to the nearest 

appropriate hospital for continued care. 

Hospitals are required to provide 

appropriate screening and stabilizing 

treatment for patients experiencing 

emergency medical conditions in 

accordance with the regulations set 

forth at § 489.24. 

In light of these factors, we propose to 

remove the requirement for a written 

hospital transfer agreement or hospital 

physician admitting privileges at 

§ 416.41(b)(3). We believe the proposed 

changes to the ASC hospitalization 

standard requirements would streamline 

ASC administrative operations and still 

assure the safety of these services while 

being less burdensome for Medicarecertified ASC facilities. The 

requirements in § 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 § 482.2. 

As part of this effective procedure, ASCs 

are not precluded from obtaining a 

hospital transfer agreements or hospital 

physician admitting privileges when 

possible. We would also like to solicit 

comments on burden that may result 

from the absence of a transfer agreement 

between ASCs and hospitals. 

2. Patient Admission, Assessment and 

Discharge (§ 416.52(a)(1), (2), (3) and (4)) 

The current regulations at § 416.52 

require ASCs to ensure that a physician 

or other qualified practitioner provide a 

comprehensive medical history and 

physical assessment completed not 

more than 30 days before the date of the 

scheduled surgery. We have received 

feedback from stakeholders that the 

current requirement is overly 

burdensome for a large majority of 

healthy patients, specifically those 

patients who are receiving minimally 

invasive surgical procedures that are 

performed under minimal sedation or 

local anesthesia alone. For example, 

cataract surgery is the most commonly 

performed ASC surgical procedure 

among Medicare beneficiaries. Modern 

cataract surgery is a short procedure 

using mild sedation and local 

anesthesia. Medical complications for 

cataract surgery before, during and after 

surgery are extremely rare. Other 

ophthalmic procedures, such as 

Yttrium-Aluminum Garnet (YAG) laser 

capsulotomy, does not require a local 


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anesthetic and is a painless 60 second 

procedure that can be completed during 

a routine patient visit. However, when 

it is performed in an ASC, which 

enables one laser to be utilized by 

multiple surgeons for procedures, the 

requirement for a history and physical 

is burdensome to the patient and 

medical staff without any additional 

benefits. One study published in the 

New England Journal of Medicine 

concluded that routine preoperative 

medical testing (blood counts, clotting 

studies, chemistry panels, 

electrocardiograms, chest x-ray, etc.) 

conferred no measurable value in 

reducing adverse medical events on the 

day of surgery or up to one week 

postoperatively (Schein OD, Katz J, Bass 

EB, et al. Study of Medical Testing for 

Cataract Surgery. The value of routine 

preoperative medical testing before 

cataract surgery. New England Journal 

of Medicine. 2000; 342(3): 168–75). 

Another article on this issue from the 

Cochrane Database of Systematic 

Reviews reviewed three randomized 

clinical trials and also found that 

routine preoperative testing did not 

increase the safety of cataract surgery 

(Keay L, Lindsley K, Tielsch J, Katz J, 

and Schein O. Routine preoperative 

medical testing for cataract surgery, 

2012;3:CD007293). These results are 

consistently found for other ambulatory 

surgeries. For example, one study tested 

over one thousand patients over a wide 

range of surgeries and found no increase 

in adverse events as a result of no 

preoperative testing (Chung F, Yuan H, 

Yin L, Vairavanathan S, and Wong DT. 

Elimination of preoperative testing in 

ambulatory surgery. Anaesth Analg. 

2009 Feb: 108(s):467–75). Another and 

much larger study reviewed the 

literature on a broad range of 

ambulatory surgeries and examined 

records of results for over 73,000 

patients who underwent various hernia 

surgeries and found that preoperative 

testing was not associated with rates of 

postoperative complications. 

The vast majority of outpatient 

surgeries are performed on an outpatient 

or ‘‘ambulatory’’ basis precisely because 

they involve extremely low risk of 

complications due either to preexisting 

conditions or to the risk of the surgical 

procedure itself. Most such procedures 

are among those that are also routinely 

performed in physician offices. We 

further note that the specification of any 

short time period for the acceptability of 

pre-surgical evaluations (in other words, 

within 30 days) is inherently arbitrary 

and burdensome for the ASC patient 

population. For example, in the case of 

a cataract patient who needs a 

procedure in both eyes, a 31-day delay 

between the two operations would 

trigger the need for another physical 

examination and, possibly, another set 

of laboratory tests. Likewise, if an 

unanticipated event such as a death in 

the family required delaying a 

procedure by more than the 30th day 

after the examination, a duplicative 

examination and any necessary tests 

would be required. Moreover, if the 

examination and tests had been 

performed timely, but the results not 

transmitted in time, the duplicative 

examination and tests would be 

required. 

We propose to remove the current 

requirements at § 416.52(a) and replace 

them with requirements that defer to the 

facility’s established policies for presurgical medical histories and physical 

examinations (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 propose to require each 

ASC to establish and implement a 

policy that identifies patients who 

require an H&P prior to surgery. We 

propose that the policy would include 

the time frame for the H&P to be 

completed prior to surgery. ASCs may 

choose to continue the 30 day policy 

that has existed in regulation since 

2008, or may choose a different time 

frame based on available evidence and 

standards of practice. We propose 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 propose 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. 

Particular subgroups of patients may 

benefit from more extensive and 

complete medical history and physical 

assessments prior to surgery. Those 

subgroups, for example, might include 

patients who cannot lie supine, have 

chest pain or shortness of breath, have 

pacemakers, have had a recent heart 

attack, on dialysis, or take insulin 

(Schein OD, Pronovost PJ. A 

Preoperative Medical History and 

Physical Should Not Be a Requirement 

for All Cataract Patients. DOI: 10.1007/ 

s11606–017–4043–9, March 20, 2017.) 

We would retain the requirement that 

the physician performing the surgery or 

other qualified practitioner perform a 

pre-surgical assessment for each ASC 

patient, including documentation 

regarding any allergies to drugs and 

biologicals. We would also retain the 

requirement that any documentation 

related to the H&P that may have been 

performed would be placed in the 

patient’s medical record prior to the 

surgical procedure. 

Our proposed change would simply 

eliminate the requirement for a preoperative H&P, while allowing patientspecific physician decisions and ASCwide policy decisions to determine 

what examinations and tests are 

necessary for each patient. Such 

decisions could be informed by 

specialty societies, medical literature, 

past experience, or other factors. We 

believe the proposed changes will 

reduce burden and provide flexibility 

for patients while maintaining a balance 

of health and safety requirements for 

providers. 

In reading the discussion that follows, 

it is important to understand that the 

requirement for making a patient 

assessment at the ASC, on the day of 

surgery and before surgery commences, 

remains unchanged. This assessment 

addresses any new surgical risks for the 

patient with procedure-specific or 

patient-specific questions (for example, 

has the patient had a fever in the last 24 

hours or, for a patient with diabetes, 

have there been any recent changes to 

random blood glucose levels with athome monitoring?). The questions focus 

on any recent changes or updates to the 

patient’s condition since the last H&P 

that might adversely impact the 

outcome of the procedure for the 

patient. This assessment must occur 

before proceeding with the procedure. 

Furthermore, we are not proposing to 

eliminate or discourage comprehensive 

pre-surgical H&Ps where warranted. To 

replace the current arbitrary 30-day rule 

applying to all patients, regardless of 

procedure or risk, we propose that each 

facility make an independent 

determination as to which procedures 

and which patient profiles would 

dictate requiring a pre-operative history 

and examination, taken before (but not 

necessarily 30 days before and possibly 

many months before) the day of surgery. 

We request comment on whether we 

should make exceptions, such as for 

particular patient conditions or surgical 

procedures, that should not be entitled 

to such broad discretion, and for any 

evidence that would support such 

exceptions. We would also be interested 

in knowing if particular examinations or 

tests should be normal for those 


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conditions or procedures, and whether 

such standards would need be imposed 

by regulation or could rely on physician 

and facility judgment and practices. 

3. Medical Records (§ 416.47) 

The current regulations at § 416.47 

require ASCs to maintain complete, 

comprehensive, and accurate medical 

records to ensure adequate patient care. 

Section 416.47(b) sets out the form and 

content of the record, including specific 

items that must be included in the 

medical record. To conform to the 

proposed changes to the medical history 

and physical examination requirements 

at § 416.52(a), we propose to revise the 

requirement at § 416.47(b)(2) that states 

‘‘Significant medical history and results 

of physical examination’’, by adding ‘‘as 

applicable.’’ This proposed revision 

would reflect the fact that, in 

accordance with our proposed changes 

to § 416.52(a), not all ASC patients may 

have a medical history and physical 

examination report that would be 

included in the medical record. 

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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction in future rulemaking. 

Specifically, we are seeking public 

comment on additional proposals or 

modifications to the proposals set forth 

in this rule that would further reduce 

burden on ASCs and create cost savings, 

while also preserving quality of care and 

patient health and safety. Consistent 

with our ‘‘Patients Over Paperwork’’ 

Initiative, we are particularly interested 

in any suggestions to improve existing 

requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note that such suggestions 

could include or expand upon 

comments submitted in response to the 

RFI that was included in the CY 2018 

OPPS/ASC proposed rule. Public 

comments in response to this RFI can be 

found at the following link: https://

www.regulations.gov/docket?D=CMS2017-0091. Public comments on the RFI 

can be found by searching for the terms 

‘‘RFI’’ or ‘‘request for information’’ in 

the aforementioned 2017 payment 

regulation docket on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

Contact: CAPT Jacqueline Leach, 

USPHS, 410–786–4282. 

C. Hospice 

1. Hospice Aide and Homemaker 

Services (§ 418.76) 

Under the current hospice CoP 

requirements at § 418.76, all hospice 

aides are required to meet specific, 

federally-established, training and 

education requirements. The 

requirements are based on the training 

and education requirements for home 

health aides as set forth at section 

1891(a)(3)(D) and 1861(m)(4) of the Act. 

Specifically, the current CoPs 

(§ 418.76(a)) require that a hospice aide 

must be a person who has completed 

one of the following: A training program 

and competency evaluation as specified 

in the regulations; a competency 

evaluation program that meets the 

requirements specified in the regulation; 

a nurse aide training and competency 

evaluation program in accordance with 

the requirements set forth in the long 

term care requirements; or a State 

licensure program that meets the 

requirements at § 418.76(b) (training) 

and (c) (competency evaluation). At 

§ 418.76(b) and (c) of the hospice CoPs, 

we specifically detail the content and 

format of aide education, training, and 

of competency evaluations, including 

the number of classroom and practical 

training hours that must be completed, 

the skills that must be addressed, and 

the general method (exam or practical 

observation) used for assessing 

competency in those various skills. 

We initially proposed and finalized 

these requirements in order to be 

consistent with the requirements that 

apply to home health aides (§ 484.80). 

Historically, a significant number of 

hospice agencies were HHA-based, 

meaning that the same entity provides 

both hospice and home health care 

services, often utilizing the same pool of 

staff to furnish both services. Using 

similar requirements for both hospices 

and home health agencies streamlines 

operations for hospices that are home 

health agency based. Due to the 

evolution of the hospice industry as a 

whole, the proportion of HHA-based 

hospices has significantly declined, 

reducing the streamlining benefits that 

occur by having the same requirements 

for aides in both hospice and home 

health settings. 

As the streamlining benefits for the 

hospice industry as a whole have 

reduced, the burden/benefit ratio related 

to meeting the prescriptive home health 

aide qualification requirements, which 

are required to be set forth in regulation 

by section 1891(a) of the Act, has 

shifted. While section 1891(a) of the Act 

requires CMS to establish prescriptive 

requirements for aides who provide 

services on behalf of home health 

agencies, the Act does not establish 

similarly prescriptive requirements for 

aides who provide services on behalf of 

hospices. In addition to the hospice aide 

qualifications that are established in the 

hospice CoPs, hospice aides must also 

be licensed, certified, or registered by 

the State in which they are practicing (if 

available), in accordance with the 

requirements at § 418.116(a). A hospice 

industry association conducted an 

informal survey of all 50 states and 

found that 76 percent of those states 

currently have their own hospice aide 

qualifications for licensure, 

certification, or registration. Therefore, 

we assume that in 76 percent of states, 

hospice aides are required to meet two 

different qualification standards (one for 

state licensure, certification, or 

registration; and one for compliance 

with the Federal CoPs). 

This regulatory approach has created 

unintentional burden during the hiring 

process for all of the non HHA-based 

hospices, as well as those HHA-based 

hospices that do not share staff with the 

home health agency portion of their 

organization. The unintentional burden 

is the result of hospices having to verify 

during the aide hiring process that the 

applicant meets both the state licensure, 

certification, or registration 

requirements, and also meets the 

specific training and competency 

requirements set forth in the CoPs. State 

requirements may change at any time 

and hospices may receive employment 

applications from aides that have been 

trained in another setting such as nurse 

aide training in the long term care 

environment or private duty aide 

training not subject to Federal 

regulations, so hospices are burdened 

with the need to review, in detail, each 

employment applicant’s training and 

competency content and format each 

time they need to make a new hire. For 

example, State requirements may 

specify a different number of training 

hours to be completed, a different 

format for assessing competency in a 

specific skill, or even a different set of 

mandatory skills in accordance with 

State scope of practice requirements. We 

believe that this is an unnecessary and 

inefficient use of hospice staff time that 

does not serve to improve patient care 

and safety. 

To address these concerns, we 

propose to revise § 418.76(a)(1)(iv) to 

remove the requirement that a State 

licensure program must meet the 

specific training and competency 

requirements set forth in § 418.76(b) and 


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(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, regardless of their 

content or format, and would allow 

states to set forth training and 

competency requirements that meet the 

needs of their populations. We do not 

believe that it is necessary for the 

Federal government to oversee the 

qualifications established by states 

because these states have already 

demonstrated their willingness and 

ability to regulate this area along with 

federally established requirements. This 

change would also streamline the hiring 

process for most hospices. We would 

continue to require that hospice aides 

may only perform those skills that are 

consistent with the training that the aide 

has received (§ 418.76(g)(2)(iv)), and 

would continue to require 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 § 418.76(c) and 

(h)(1)(iii). We believe that these 

requirements will ensure that aides only 

perform duties for which they are 

trained and that they perform such 

duties in a safe and effective manner. 

Furthermore, we would continue to 

require that hospices must 

comprehensively assess patients on a 

regular schedule and on an as needed 

basis (§ 418.54(a), (b) and (d)), 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 (§ 418.56(b) 

through (d)), assure that the plan of care 

reflects patient and family goals 

(§ 418.56(b) and includes all services 

(including aide services) necessary to 

manage pain and symptoms 

(§ 418.56(c)), and ensure that hospice 

care and services are provided in 

accordance with the plan of care and are 

based on all assessments of the patient 

and family needs (§ 418.56(e)). 

Furthermore, hospices would continue 

to be required to provide hospice care 

that optimizes comfort and dignity, and 

is consistent with patient and family 

needs and goals (§ 418.100(a)). Finally, 

hospices would continue to be required 

to maintain an effective, ongoing, 

hospice-wide data-driven quality 

assessment and performance 

improvement program that involves all 

hospice services, including aide 

services, that focuses on indicators 

related to improved patient outcomes, 

and takes actions to demonstrate 

improvement in hospice performance 

(§ 418.58). While deferring to state 

requirements for hospice aide 

qualifications would likely introduce a 

new level of variability in the aide 

hiring process, we believe that the 

remaining hospice CoPs would continue 

to assure that hospice aide services meet 

the needs of patients and families, and 

are delivered in a safe and effective 

manner. 

2. Drugs and Biologicals, Medical 

Supplies, and Durable Medical 

Equipment (§ 418.106(a)(1) and (e)(2)(i)) 

The June 5, 2008 Hospice CoP final 

rule (73 FR 32088) 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 (§ 418.106(a)(1)). This 

requirement was implemented as a 

direct result of public comments that 

were submitted in regards to the May 

2005 Hospice CoP proposed rule (70 FR 

30840). The May 2005 Hospice CoP 

proposed rule proposed to retain 

longstanding requirements for 

pharmacist involvement in the planning 

and delivery of drugs and biologicals for 

patients that receive care in the hospice 

inpatient setting. Commenters suggested 

that we broaden our proposal and apply 

it to patients receiving care in all 

settings. The commenters stated that, 

since drugs are prescribed to virtually 

all hospice patients, these patients 

should benefit from the expertise of a 

pharmacist and the additional level of 

drug oversight required by the 

regulatory standards. We agreed with 

the commenters that it would be 

beneficial to patients to broaden the 

scope of the pharmacy requirements. 

For this reason, we finalized a 

requirement at paragraph (a), ‘‘Managing 

drugs and biologicals,’’ to require that 

each hospice ensures 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. Hospices have the 

option of using a licensed pharmacist or 

an individual who has an extensive and 

up-to-date knowledge of drugs, to fulfill 

this role. 

At the time when this requirement 

was finalized in 2008, we estimated that 

1,600 hospices (56 percent of all 

hospices) were already contracting with 

pharmacy benefit management 

companies to provide drugs and 

pharmacist services to each of their 

patients at a single bundled service rate. 

These hospices were already realizing 

the benefits of specialized drug 

management expertise in the absence of 

Federal regulations. Since 2008, the use 

of pharmacy benefit management 

companies, including their built-in 

pharmacy experts, has continued to 

grow at a rapid pace. Although there 

have been no formal studies on the 

proliferation of pharmacy benefit 

management company use in hospice, 

conversations with industry experts 

lead us to estimate that, at minimum, 75 

percent of existing hospices use such 

services. Experts estimate that the more 

likely number is between 90 and 95 

percent of hospices due to various 

factors that hospices find to be 

desirable, such as predictable capitated 

medication fees and direct to the patient 

door medication delivery services. Since 

the use of pharmacology experts has 

become routine due to the proliferation 

of pharmacy benefit management 

companies that provide pharmacist 

services for each patient bundled with 

drug and biologics supply services, we 

believe that it is no longer necessary to 

include a regulatory requirement 

specifically related to the use of a 

pharmacology expert. As pharmacy 

benefit management services bundle 

drug and biologics supply services with 

expert advice, and since industry 

experts estimate that at least 75 percent 

and as many as 95 percent of hospices 

use pharmacy benefit management 

services for reasons primarily unrelated 

to this specific regulatory requirement, 

we conclude that the vast majority of 

hospices, and thus the vast majority of 

hospice patients, will continue to 

receive such advice and guidance in the 

absence of regulation. This proposed 

change would allow hospices to more 

seamlessly integrate the information 

provided by the drug management 

expert into routine interdisciplinary 

group meetings rather than having to 

use burdensome formulaic approaches 

that hospices currently implement in 

order to demonstrate compliance with 

the regulation. 

In addition to changes in the 

pharmacy benefit management 

landscape, there have also been 

significant changes in the hospice and 

palliative care nursing and physician 

landscapes. Since publication of the 

2008 Hospice CoP final rule (73 FR 

32088), the number of hospice and 

palliative care nursing and physician 

specialty training and certification 

programs has rapidly expanded. As 

more hospice and palliative care 


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nursing and physician specialists have 

entered the job market, more hospices 

are employing these clinicians with 

advanced skill sets. In hospices that do 

not use a pharmacy benefit management 

service, these clinicians typically fill the 

role of the required individual with 

education and training in drug 

management in addition to being the 

regular physician or nurse member of 

the interdisciplinary group. As these 

clinicians are already members of the 

core interdisciplinary group in 

accordance with the requirements at 

§ 418.56(a), we believe that hospices 

will continue to benefit from their 

expertise in the absence of Federal 

regulations. For these reasons, we 

conclude that the requirements at 

§ 418.106(a)(1) are no longer necessary 

to assure patient safety and the 

effectiveness of hospice care. 

Furthermore, we believe that hospices 

may achieve a cost savings upon 

removal of this requirement because 

they will no longer need to assure a 

dedicated time in each interdisciplinary 

group meeting in order to be able to 

document that a specific conversation 

occurred among group members, and 

thus document compliance with the 

regulation. Therefore, we propose to 

delete the requirements at 

§ 418.106(a)(1). 

Hospices would continue to be 

required to comprehensively assess 

patients on a regular schedule and on an 

as needed basis (§ 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 

(§ 418.56(b) through (d)). To the extent 

that a hospice needs additional expert 

information or expertise beyond what is 

provided by hospice employees and the 

pharmacy expertise of any pharmacy 

benefit manager that a hospice may 

choose to use in order to meet a given 

patient’s assessment, care planning, and 

care delivery medication-related needs, 

we would continue to require that it 

secure such information and expertise. 

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. 

The 2008 Hospice CoP final rule (73 

FR 32088) also required hospices, at 

§ 418.106(e)(2)), to: (1) Provide a copy of 

the hospice written policies and 

procedures on the management and 

disposal of controlled drugs to the 

patient or patient representative and 

family; (2) discuss the hospice policies 

and procedures for managing the safe 

use and disposal of controlled drugs 

with the patient or representative and 

the family in a language and manner 

that they understand to ensure that 

these parties are educated regarding the 

safe use and disposal of controlled 

drugs; and (3) document in the patient’s 

clinical record that the written policies 

and procedures for managing controlled 

drugs was provided and discussed. We 

believe that the hospice, as well as the 

patient, family, and caregivers share the 

responsibility and accountability for 

maintaining controlled substances in 

the home. We believe that hospices 

must assume responsibility to educate 

the patient and family about the proper 

use and disposal of controlled drugs and 

biologicals that are maintained in the 

home environment. The drug policies 

and procedures also help the hospice 

explain its own role in controlled drug 

management. 

We believe that this requirement 

continues to be relevant, particularly in 

relationship to implementing proper 

storage and security precautions that 

can prevent theft and other drug 

diversion in the home, and proper 

disposal when a drug is no longer 

needed to prevent inappropriate access 

and environmental damage. Therefore, 

we continue to expect that hospices 

would have such policies and 

procedures for their own internal use as 

part of routine business practice. 

However, hospice policies and 

procedures are typically written in ways 

that are not easily understood by the 

general public. Hospice clinicians spend 

more time than expected explaining 

technical terms and otherwise 

translating the policies and procedures 

into layperson’s terms. We do not 

believe that this process of explaining 

complex documents in a manner that is 

meaningful to patients and families is 

beneficial to patients, families, 

caregivers, or hospices. 

We propose to replace the 

requirement 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 and 

families. This information would be 

provided in a more user-friendly 

manner, as decided by each hospice, 

which we believe can improve 

comprehension and maximize the 

effectiveness of the education effort. 

Furthermore, by providing information 

in a more user-friendly manner, 

hospices would be able to eliminate 

time spent explaining technical terms 

and other otherwise translating the 

policies and procedures into layperson’s 

terms. This would create more 

efficiency while simultaneously 

improving hospice-patient 

communications. Hospices would be 

free to choose the content and format(s) 

that best suits their needs and the needs 

of their patient population. We propose 

to require that, regardless of the format 

chosen, this information must be 

provided to patients and families in a 

manner that allows for continual access 

to the information on an as-needed basis 

in order to assure that patients and 

families have information available 

when they need it. CMS is soliciting 

input concerning what a standardized 

educational format should entail, 

including whether the format should be 

paper or electronic; in writing, pictorial, 

video, or audio; what general subjects 

should be addressed in regards to 

storage, disposal, use, and risks; and 

what specific content should be 

included to minimize opioid diversion 

and maximize safety. 

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, 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/forindividuals/special-topics/limitedenglish-proficiency/guidance-Federalfinancial-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. 

3. Hospices That Provide Hospice Care 

to Residents of a SNF/NF or ICF/IID 

(§ 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 


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hospice patients. This orientation is 

required to include information 

concerning 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. 

The intent of this standard is to ensure 

that facility staff who furnish care to 

residents who are hospice patients are 

provided information on the hospice 

philosophy and approach to care, much 

in the same way that home caregivers 

are routinely provided information on 

the hospice philosophy and approach to 

care. It is the hospice’s responsibility to 

coordinate the trainings with 

representatives of the facility. It is also 

the hospice’s responsibility to 

determine how frequently training 

needs to be offered in order to ensure 

that the staff furnishing care to hospice 

patients are oriented to the philosophy 

of hospice care. 

We believe that the intent of the 

requirement to educate facility staff 

about hospice care continues to be an 

appropriate regulatory requirement. 

However, we believe that, as currently 

written and implemented, this 

requirement may create duplication 

when multiple hospices provide care to 

the residents of a single facility. 

Furthermore, by assigning sole 

responsibility for this effort to hospice 

providers, this requirement may impede 

joint hospice-facility collaboration and 

training innovations. Creating 

duplicative efforts and impeding 

collaboration may increase hospice 

burden without improving the care of 

hospice patients. Therefore, we believe 

that it is appropriate to revise the 

current requirement. 

Specifically, we propose to remove 

§ 418.112(f) and add a new requirement 

at § 418.112(c)(10), ‘‘Written 

agreement,’’ to address this issue. 

Moving the requirement for facility staff 

orientation to the standard related to the 

written agreement established between 

hospices and facilities would ensure 

that both entities negotiate the 

mechanism and schedule for assuring 

orientation of facility staff. Additionally, 

enabling hospices and facilities to 

negotiate their now shared role would 

encourage collaboration between both 

entities, avoid duplication of efforts 

with other hospices that are orienting 

the same facility staff, and provide 

incentives to facilities to become more 

engaged in the hospice orientation 

process for facility staff. 

We are seeking public comment on all 

of the proposed hospice changes. In 

addition, we note 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 are soliciting 

public comments on additional 

regulatory reforms for burden reduction 

in future rulemaking. Specifically, we 

are seeking public comment on 

additional proposals or modifications to 

the proposals set forth in this rule that 

would further reduce burden on 

hospices and create cost savings, while 

also preserving quality of care and 

patient health and safety. Consistent 

with our ‘‘Patients Over Paperwork’’ 

Initiative, we are particularly interested 

in any suggestions to improve existing 

requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note that such suggestions 

could include or expand upon 

comments submitted in response to the 

RFI that was included in the FY 2018 

Hospice Wage Index and Payment Rate 

Update and Hospice Quality Reporting 

Requirements. Public comments in 

response to this RFI can be found at the 

following link: https://

www.regulations.gov/ 

document?D=CMS-2017-0062-0001. 

Public comments on the RFI can be 

found by searching for the terms ‘‘RFI’’ 

or ‘‘request for information’’ in the 

aforementioned 2017 payment 

regulation docket on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

Contact: Danielle Shearer, 410–786– 

6617. 

D. Hospitals 

1. Quality Assessment and Performance 

Improvement Program (§ 482.21) 

On May 16, 2012, we published a 

final rule, entitled ‘‘Reform of Hospital 

and Critical Access Hospital Conditions 

of Participation’’ (77 FR 29034). In that 

rule, we finalized changes to the 

requirements of the ‘‘Governing body’’ 

CoP, § 482.12, and adopted a policy to 

allow one governing body to oversee 

multiple hospitals in a multi-hospital 

system. We noted in this rule that the 

regulations, as finalized, were intended 

to provide systems that own two or 

more hospitals with an option, but not 

a requirement, to use a system 

governing body for two or more 

hospitals. In those instances where a 

system believes that its interests are best 

served by using a system governing 

body legally responsible for two or more 

hospitals, under the CMS regulations, 

that system will have the flexibility to 

do so, just as system that owns two or 

more hospitals will have the flexibility 

to continue with the model of a separate 

governing body for each hospital in its 

system if it determines that course 

would best serve its interests. 

After publication of the May 2012 

final rule, we received a considerable 

amount of feedback regarding our 

responses in the rule (77 FR 29061) 

where we discussed our interpretation 

of the Medical staff CoP at § 482.22 as 

requiring that each hospital have its 

own independent medical staff despite 

the arguable ambiguity of the regulatory 

language. It was brought to our attention 

that, over the years, this apparently 

ambiguous language might have led 

some stakeholders to interpret § 482.22 

as allowing for separately certified 

hospitals, as members of a multihospital system, to share a unified and 

integrated medical staff. This eventually 

led to us proposing a requirement in a 

February 7, 2013 proposed rule, entitled 

‘‘Regulatory Provisions To Promote 

Program Efficiency, Transparency, and 

Burden Reduction—Part II’’ (78 FR 

9216), which proposed to prohibit the 

use of a unified and integrated medical 

staff subject to a system governing body. 

In the May 12, 2014 final rule, 

Medicare and Medicaid Programs; 

Regulatory Provisions To Promote 

Program Efficiency, Transparency, and 

Burden Reduction (79 FR 27105) that 

followed, and after carefully considering 

all of the arguments for and against 

allowing a system that owns two or 

more hospitals to use a unified and 

integrated medical staff structure for its 

member hospitals that are subject to a 

common system governing body, we 

came to the conclusion that it was in the 

best interest of hospitals, medical staff 

members, and patients for us to modify 

the proposed prohibition on the use of 

a unified and integrated medical staff 

for a multi-hospital system and its 

member hospitals so as to enable the 

medical staff of each hospital that is 

subject to a common system governing 

body to voluntarily integrate itself into 

a larger system medical staff. 

The fact that many hospital systems 

had been using a unified medical staff 

model for a number of years, without 

evidence showing that such a model 

was detrimental to patients or decreased 

the quality of care delivered, was a 

major factor in our decision to allow 

hospitals and their respective medical 

staffs the flexibility to decide which 

medical staff framework worked best for 


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their particular situations. We received 

a large number of comments from 

individual physicians as well as 

national and State physician 

organizations that supported our 

proposed changes to reaffirm and make 

more explicit the requirement that each 

hospital to have its own medical staff, 

specifically those hospitals that are part 

of a multi-hospital system. These 

commenters stated they believe that 

allowing a multi-hospital system to have 

a unified and integrated medical staff 

instead of separate medical staffs for 

each hospital would destroy the concept 

of medical staff self-governance that is 

‘‘a basic requirement’’ for TJC hospital 

accreditation and which is ‘‘mandated 

by some states.’’ Additionally, there 

were some comments from individuals 

as well as hospital leaders that stated 

that while they support the proposed 

requirement overall, they believe that 

there should be some allowance for 

hospitals within a system to share 

medical staff bylaws, rules, and 

regulations. 

However, these arguments against 

allowing this flexibility through the 

CoPs did not provide any evidence that 

having a single and separate medical 

staff for each hospital within a system 

was inherently superior, particularly in 

the areas of patient safety and quality of 

care, to the unified and integrated 

medical staff model for two or more 

hospitals subject to a system governing 

body. We weighed this argument against 

the comments from the physician 

leaders and members of unified and 

integrated medical staffs who provided 

testimony and anecdotal evidence for 

the benefits of this type of structure. 

Additionally, we considered 

preliminary evidence that appeared to 

show that hospitals using a unified 

medical staff might be achieving some 

success in reducing Hospital-Acquired 

Conditions (HACs), HealthcareAssociated Infections (HAIs), and 

readmissions, and in improving patient 

safety and outcomes. During our 

preliminary development of this rule, 

we carefully considered any additional 

areas where we could provide further 

flexibility and reduce regulatory burden 

for hospitals. We were particularly 

interested in those areas that we had not 

considered or proposed in the previous 

rulemaking efforts discussed. As we 

noted with regard to the use of a unified 

medical staff model under a system 

governing body, much of the evidence 

and testimony provided to us at that 

time focused on observed improvements 

in patient safety, quality of care, and 

overall patient outcomes. In the May 

2014 final rule previously referenced, 

one public commenter, writing on 

behalf of a multi-hospital system that 

the commenter references as the largest 

in their State, stated that ‘‘we believe 

the concept of a single medical staff has 

substantially contributed to our success 

as an integrated delivery system and has 

accelerated our quality, safety and 

efficiency performance.’’ The 

commenter also cited the system’s 

achievements, which the commenter 

stated that they believe were a result of 

this single and integrated medical staff 

model: Core measures in the top quartile 

with excellent value-based purchasing 

scores according to CMS; lower inhospital mortality rates that are 

statistically significant, that is, 17 

percent lower than expected; lower 

hospital readmission rates that are 

statistically significant, that is, 15 

percent lower than expected; and the 

second lowest congestive heart failure 

readmission rate in the nation, 

according to published CMS data. 

Since those rules were published, we 

have not received any negative feedback 

on the regulatory changes or any 

evidence that the use of a unified 

medical staff model is detrimental to 

patients and their care. And because the 

potential benefits to using such a system 

appear to point to patient safety and 

quality of care specifically, we began to 

look at two areas in the CoPs for 

possible revision along these lines, two 

areas that we believe have the most 

direct impact on ensuring and 

promoting a culture of safety in 

hospitals—QAPI and infection control. 

We believe that applying the unified 

model to a hospital’s QAPI program 

and/or a hospital’s infection control 

program would be a natural progression 

for a multi-hospital system currently 

using a system governing body and a 

unified medical staff. By allowing a 

system governing body the option of 

unifying and integrating its various 

member hospital QAPI programs and/or 

infection control programs into unified 

programs incorporating each individual 

hospital’s QAPI program and/or 

infection control program (and thus 

applying the greater resources of the 

system to each hospital’s QAPI program 

and/or infection control program), we 

believe a system might be able to more 

efficiently and effectively disseminate 

innovations, solutions, and best 

practices for patient care to each of its 

member hospitals through these 

respective unified programs. The Health 

Research and Educational Trust, in 

partnership with the American Hospital 

Association in a March 2010 publication 

entitled, ‘‘A Guide to Achieving High 

Performance in Multi-Hospital Health 

Systems,’’ identified specific best 

practices associated with health systems 

(http://www.hpoe.org/Reports-HPOE/ 

highperformance3.2010.pdf). The 

publication stated that ‘‘due to the size 

and breadth of their organizations, 

multi-hospital health system leaders 

have significant impact on the quality of 

health care in the United States. More 

than half of all U.S. hospitals belong to 

multi-hospital health systems, and 

about 60 percent of all hospital 

admissions occurs in system hospitals. 

While a wide range of quality 

improvement mechanisms can be 

applied in individual hospitals, there 

has been a lack of actionable 

information that leaders of multihospital systems can leverage to 

improve quality across their systems.’’ 

Therefore, we propose to apply this 

same level of flexibility and regulatory 

burden reduction to a hospital’s QAPI 

program as an option for system 

governing bodies that directly control 

and are legally responsible for two or 

more separately certified hospitals. As 

with our allowances for system 

governing bodies and unified medical 

staffs noted previously, we believe that 

system governing bodies that are legally 

responsible for two or more separately 

certified hospitals should be given the 

flexibility to determine which model of 

a QAPI program works best for their 

individual member and separately 

certified hospitals. We also believe that, 

in addition to the efficiencies that might 

be gained in the management and 

administration of QAPI programs 

through the increased resources of the 

hospital system, there might also be 

significant improvements in patient 

safety and outcomes to be achieved 

through such resources. Allowing for a 

unified and integrated QAPI program for 

its member hospitals would provide a 

system governing body with the needed 

flexibility and ease of administration to 

more readily apply the best practices 

and innovations learned and developed 

at one hospital to other hospitals subject 

to the same system governing body that 

might be facing the same problem-prone 

areas of patient care. We believe that by 

allowing system governing bodies this 

regulatory option, greater 

communication between member 

hospitals would be fostered so that a 

culture of patient safety and quality care 

could then be more fully integrated 

throughout the system. Given this 

flexibility and opportunity for 

integration, we believe that member 

hospitals subject to the same system 

governing body would replace the 

approach of each hospital operating 

within its own ‘‘silo,’’ a still all-tooVerDate Sep<11>2014 18:26 Sep 19, 2018 Jkt 244001 PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 E:\FR\FM\20SEP2.SGM 20SEP2

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common operating standard, even 

within multi-hospital systems, that 

thwarts advances and innovations in 

improving patient care across the 

system. 

We propose a new standard at 

§ 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. Our 

expectation is that the focus on quality 

assessment, performance improvement, 

and patient safety within a certified 

hospital that is part of a unified and 

integrated QAPI program would be 

maintained and enhanced through the 

benefits of such integration. 

2. Medical Staff, Medical Records 

Services, and Surgical Services 

(§§ 482.22, 482.24, and 482.51) 

Hospital Medical History and Physical 

Examination Requirements 

The current CoP at § 482.22, ‘‘Medical 

Staff,’’ requires that a hospital have an 

organized medical staff that operates 

under bylaws approved by the 

governing body, and which is 

responsible for the quality of medical 

care provided to patients by the 

hospital. At § 482.22(c)(5), the hospital 

medical staff bylaws must include a 

requirement that a H&P 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. The bylaws must 

also include a requirement that 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 H&P are 

completed within 30 days before 

admission or registration. These medical 

staff bylaws requirements addressing 

patient H&Ps form the basis for similar 

requirements in the hospital CoPs at 

§ 482.24, ‘‘Medical Record Services,’’ 

and § 482.51, ‘‘Surgical Services.’’ 

Current hospital H&P requirements 

were proposed and finalized between 

2005 and 2007, and similar ASC 

requirements were finalized 1 year later. 

According to a February 28, 2017, 

Centers for Disease Control and 

Prevention (CDC) National Health 

Statistics Report (Hall MJ, Schwartzman 

A, Zhang J, Liu X. Ambulatory surgery 

data from hospitals and ambulatory 

surgery centers: United States, 2010. 

National health statistics reports; no. 

102. Hyattsville, MD: National Center 

for Health Statistics. 2017), in 2010, 28.6 

million ambulatory surgery visits to 

hospitals and ASCs occurred, with an 

estimated 48.3 million surgical and 

nonsurgical procedures performed. The 

report also states that an estimated 25.7 

million (53 percent) ambulatory surgery 

procedures were performed in hospitals 

and 22.5 million (47 percent) were 

performed in ASCs during this time. 

Further, the report found that the most 

frequently performed procedures (for 

both ASCs and hospital outpatient/ 

ambulatory surgery departments) 

included endoscopy of large intestine 

(4.0 million), endoscopy of small 

intestine (2.2 million), extraction of lens 

(2.9 million), insertion of prosthetic lens 

(2.6 million), and injection of agent into 

spinal canal (2.9 million). These 

statistics, which also show similarities 

between the characteristics of patients 

seen by ASCs and hospital outpatient/ 

ambulatory surgery departments, 

combined with the evidence already 

discussed in section II.B.2, ‘‘Patient 

Admission, Assessment and Discharge’’ 

(§ 416.52(a)(1), (2), (3) and (4)) have led 

us to conclude that we should propose 

a less burdensome option for the 

assessment of a patient prior to a 

hospital outpatient/ambulatory surgery 

or procedure for specific patients and 

procedures. 

Because the hospital H&P 

requirements apply to all hospital 

patients (not just ambulatory surgery 

patients, as in ASCs) and because these 

requirements are contained under three 

separate CoPs, any proposed hospital 

requirements for pre-surgical 

assessments in lieu of the current 

requirements for a comprehensive H&P 

would need to be structured somewhat 

differently than those proposed for 

ASCs. However, we are basing certain 

aspects of the proposed hospital 

requirements on those proposed for 

ASCs in order to take into account some 

of the similarities of the two provider 

types. 

We would revise the current 

requirements at § 482.22(c)(5)(i) and (ii) 

with respect to medical staff bylaws 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 oromaxillofacial surgeon, 

or other qualified licensed individual in 

accordance with State law and hospital 

policy. We propose to include this same 

language regarding who can complete 

and document the assessment in the 

proposed provision at § 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 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 are also proposing 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 


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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 propose 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 §§ 482.22, 

482.24, and 482.51) would continue to 

apply and the proposed requirements 

for this CoP, as well as those proposed 

for §§ 482.24 and 482.51, would not 

apply. 

For the current CoP at § 482.24, 

‘‘Medical Record Services,’’ we would 

revise the provisions at 

§ 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 are proposing 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. 

The current CoP at § 482.51, ‘‘Surgical 

Services,’’ contains provisions at 

§ 482.51(b)(1)(i) and (ii) that require, 

prior to surgery or a procedure requiring 

anesthesia services and except in the 

case of emergencies that a medical 

history and physical examination must 

be completed and documented no more 

than 30 days before or 24 hours after 

admission or registration 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. We are revising these 

requirements to allow for an exception 

to them under proposed paragraph 

(b)(1)(iii), where we propose 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 § 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. 

As we did in the ASC section’s 

discussion of these proposed changes to 

the H&P requirements, we request 

comment on whether there are any 

evidence-based exceptions or specific 

guidelines, such as for particular patient 

conditions or surgical procedures, that 

would prohibit this level of discretion 

for determining those hospital 

outpatient surgery patients who would 

not require a comprehensive H&P prior 

to outpatient surgeries or procedures. 

Contact: CDR Scott Cooper, USPHS, 

410–786–9465. 

3. Medical Staff: Autopsies (§ 482.22(d)) 

In the June 1986 final rule, Medicare 

and Medicaid Programs, Conditions of 

Participation for Hospitals (51 FR 

22010), we finalized a regulation to 

recommend that a hospital’s medical 

staff attempt to secure autopsies in all 

cases of unusual deaths and of medicallegal 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. In that final rule, we stated 

that autopsies were an essential 

educational tool which contributed to 

the quality of care furnished by a 

hospital. Medical-legal investigative 

autopsies are conducted by a coroner’s 

or medical examiner’s office to 

determine the circumstances under 

which someone died and combine a 

scientific inquiry into a death under a 

coroner’s or medical examiner’s legal 

jurisdiction (https://www.cdc.gov/phlp/ 

publications/topic/coroner.html). 

Although the regulations specify that 

hospitals should attempt to secure 

permission to perform autopsies in 

certain cases, each state has established 

specific standards, laws, and regulations 

regarding the performance of autopsies 

for medical-legal investigative purposes 

for hospital patients. According to 

CDC’s Public Health Law Program, each 

State sets its own standards for what 

kinds of deaths require investigation 

and its own professional and continuing 

education requirements for individuals 

carrying out these investigations. For 

example, the Medicolegal Death 

Investigation system for the state of New 

York specifies the use of coroners and 

medical examiners, who have specific 

medical and residency qualifications. 

Maine’s Medicolegal Death Investigation 

system only specifies the role of a 

medical examiner. Unlike the 

regulations of the individual States, 

§ 482.22(d) does not provide specifics 

on who should perform an autopsy, nor 

does it delve into the specifics of the 

medical-legal investigation process. As 

with all other CoPs, our intention was 

not to be overly prescriptive or overly 

burdensome in our requirements. In this 

case, the individual States have more 

specific requirements than the CoPs. 

After reexamining this CoP, and in an 

effort to reduce duplicative or 

redundant requirements for hospitals, 

we believe that it is appropriate to 

remove the requirement at § 482.22(d). 

We believe that more detailed, specific 

requirements regarding medical-legal 

investigations and autopsies for 

hospitals are more appropriately and 

more effectively covered by the 

individual State laws in which the 

hospital is located. Therefore, we 

propose to remove the requirement at 

§ 482.22(d). However, we continue to 

believe that the performance of 

autopsies further advances medical 

knowledge. 

Contact: Alpha-Banu Wilson, 410– 

786–8687. 

4. Infection Control (§ 482.42) 

Similar to our proposal for a unified 

and integrated QAPI program for multihospital systems previously discussed, 

we believe that the same level of 

flexibility and regulatory burden 

reduction can be applied to a hospital’s 

infection control program. We firmly 

believe that the same efficiency of 

administration, and improved patient 

outcomes, patient safety, and quality of 

care would be achieved in the infection 

control realm through a consistent 

system-wide approach as would be 


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allowed by this proposed rule. Our 

expectation is that the focus on 

infection control within a certified 

hospital that is part of a unified and 

integrated infection control program 

would be maintained and enhanced 

through the benefits of such integration, 

and that the trajectory toward continued 

reductions in infections would be 

continued. 

Therefore, we propose a new standard 

at § 482.42(c), ‘‘Unified and integrated 

infection control program for multihospital 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. 

We are specifically seeking 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 responsible for 

the conduct of each separately certified 

hospital. 

Contact: CDR Scott Cooper, USPHS, 

410–786–9465. 

5. Special Requirements for Hospital 

Providers of Long-Term Care Services 

(‘‘Swing-Beds’’) (§ 482.58(b)(1), (4), (5), 

and (8), and Identical CAH 

Requirements: § 485.645(d)(1), (4), (5), 

(6), and (7)) 

Section 1883 of the Act permits 

certain small, rural hospitals to enter 

into a swing-bed agreement, under 

which a hospital or CAH can use its 

beds as needed, to provide either acute 

or SNF care. Swing-beds are beneficial 

when a patient is ready to leave the 

acute care level of a hospital stay, but 

still requires further skilled nursing 

care. They are often the only option in 

rural areas to provide this level of care. 

As defined in our regulations, a swingbed hospital is a hospital or CAH 

participating in Medicare that has CMS 

approval to provide post-hospital SNF 

care and meets certain requirements. 

Hospitals providing swing-bed services 

must meet all of the requirements at 42 

CFR part 482, which includes the 

swing-bed requirements at § 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 § 485.645 

for patients receiving swing-bed 

services. 

The hospital CoPs at § 482.58(a)(1) 

and (2) specify that hospitals providing 

swing-bed services must be located in a 

rural area and have less than 100 beds. 

Section 482.58(a)(1) excludes from the 

count beds for newborns and beds in 

intensive care type inpatient units, and 

§ 482.58(a)(2) requires that the hospital 

be located in rural area, which includes 

all areas not delineated as ‘‘urbanized’’ 

areas by the Census Bureau, based on 

the most recent census. 

The CAH CoPs at § 485.645(a)(2) state 

that a CAH must not maintain more 

than 25 inpatient beds that may be used 

for the provision of inpatient or swingbed services, and as required at 

§ 485.635(b)(1)(ii), the CAH must 

furnish acute care inpatient services to 

patients who present to the CAH for 

treatment, so long as the CAH has an 

available inpatient bed and the 

treatment required to appropriately care 

for the patient is within the scope of 

services offered by the CAH (State 

Operations Manual, Appendix W). 

Hospitals and CAHs must both meet 

eligibility requirements to be granted 

approval from CMS to provide swingbed services. The swing-bed 

requirements within the hospital and 

CAH CoPs include a subset of crossreferenced long-term care requirements 

contained in 42 CFR part 483, subpart 

B, for which hospital and CAH swingbed providers are surveyed as they are 

for all of the CoPs in their respective 

programs. 

The long-term care requirements 

under 42 CFR part 483 frequently 

reference residents given the average 

length of stay in long-term care facilities 

(28 days for skilled nursing facilities 

and 835 days for nursing homes) 

(Medicare Skilled Nursing Facility 

(SNF) Transparency Data (CY2013), 

https://www.cms.gov/Newsroom/ 

MediaReleaseDatabase/Fact-sheets/ 

2016-Fact-sheets-items/2016-03- 

09.html#; Centers for Disease Control 

and Prevention, Nursing Home Care 

FastStats, https://www.cdc.gov/nchs/ 

data/series/sr_03/sr03_038.pdf). 

However, individuals receiving swingbed services in a hospital or CAH are 

receiving SNF services and generally 

have shorter length of stays, with an the 

average length of stay of 11.4 days 

(Centers for Medicare & Medicaid 

Services, Office of Enterprise Data and 

Analytics, 2016). Note that this is still 

less than the average 28-day length of 

stay in a SNF. While we understand that 

some patients receiving swing-bed 

services in a hospital or CAH may have 

longer than average length of stays, we 

have determined that some of the crossreferenced 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. 

Thus, we propose to remove the 

following requirements: 

• §§ 482.58(b)(1) and (c) and 

485.645(d)(1) (incorporating long-term 

care facility requirements at 

§ 483.10(f)(9): Under our current 

regulations at § 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 §§ 482.58(b)(1) and 

485.645(d)(1) incorporate this resident 

right by reference. The resident may 

perform services for the facility, if he or 

she chooses. 

The current requirement for LTCFs 

also states that residents of these 

providers who are receiving swing-bed 

services who choose to perform services 

for the facility may do so when the 

facility has documented the need or 

desire for the resident to work in the 

plan of care; the plan specifies the 

nature of the services performed and 

whether the services are voluntary or 

paid; compensation for paid services is 


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at or above prevailing rates; and the 

resident agrees to the work arrangement 

described in the plan of care. Provided 

that those receiving hospital and CAH 

swing-bed services are not residents and 

spend a limited amount of time 

receiving swing-bed services, we have 

determined that this is an unduly 

burdensome requirement. Swing-bed 

services are transitional SNF-level 

services provided on a temporary basis. 

As a result, only a limited number of the 

SNF requirements are applicable to 

these patients. Therefore, we believe 

that it is unlikely that patients receiving 

hospital and CAH swing-bed services 

would be assigned a job and given an 

opportunity to provide services at the 

hospital or CAH due to their relatively 

short length of stay. With the proposed 

removal of this requirement, a hospital 

or CAH may permit patients receiving 

swing-bed services to provide services 

at the facility upon mutual agreement 

between the patient and the facility; 

thus, we believe that this requirement is 

unnecessary. 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. 

In addition, in the absence of these 

requirements, we believe patients’ rights 

requirements for hospitals at § 482.13 

and CAHs providing swing-bed services 

at § 485.645(d)(3) (which incorporates 

the long-term care requirements that 

patients be free from abuse, neglect and 

exploitation) would address such 

situations. We would monitor for any 

unintended consequences, as well as 

through evaluation of complaints that 

might be submitted regarding 

involuntary work performed by patients 

receiving swing-bed services in 

hospitals and CAHs. We would also 

ensure patient protections were 

maintained via the survey process and 

the process used to determine 

allegations of non-compliance with 

Federal or State requirements. 

• §§ 482.58(b)(4) and 485.645(d)(4) 

(incorporating long-term care facility 

requirements at § 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. 

Similar to the requirements noted 

previously, we believe that this 

requirement is also unnecessary and 

burdensome for hospitals and CAHs, as 

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 

§ 482.23(b)(4) for hospitals and 

§ 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. 

• §§ 482.58(b)(5) and 485.645(d)(5) 

(incorporating long-term care facility 

requirements at § 483.70(p)): Any 

facility with more than 120 beds must 

employ a qualified social worker on a 

full-time basis. 

We propose to revise the requirements 

at §§ 482.58(b)(5) and 485.645(d)(5) for 

hospitals and CAHs. The requirement 

that hospital and CAH swing-bed 

providers with more than 120 beds 

employ a full-time social worker is not 

applicable to either provider type. In 

accordance with the hospital and CAH 

swing-bed requirements, hospital swingbed providers are not permitted to have 

more than 100 beds while CAH swingbed 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. 

• §§ 482.58(b)(7) and 485.645(d)(7) 

(incorporating the long-term care facility 

requirement at § 483.55(a)(1)): Under 

our long-term care facility requirements, 

the facility, must provide or obtain from 

an outside resource, in accordance with 

§ 483.70(g), routine and emergency 

dental services to meet the needs of 

each resident. We believe that this 

requirement is unnecessary and unduly 

burdensome for hospital and CAH 

swing-bed providers, as patients 

receiving swing-bed services in a 

hospitals or CAHs are not ‘‘generally 

long term residents’’ of the facility and 

are meant to receive swing-bed services 

for a brief period of time for transition 

after the provision of acute care 

services. The American Dental 

Association recommends regular dental 

checkups at least once a year 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 11.4 days 

and an average daily swing-bed census 

of 2 patients, we believe that it is 

unlikely that there is a need for routine 

dental services that cannot be provided 

on an outpatient basis. We expect that 

any required dental services that 

necessitate immediate treatment would 

be considered an emergency and would 

be addressed accordingly. In addition, 

the American Dental Association 

recommends that routine dental care be 

obtained at least every 6 months, which 

greatly exceeds that average length of 

stay in a hospital or CAH swing-bed. 

However, 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 nonemergency 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 

§ 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 

§ 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. 

Contact: Kianna Banks, 410–786– 

3498. 

6. Special Requirements for Psychiatric 

Hospitals (§ 482.61(d)) 

Section 482.61(d) of our regulations, 

as finalized in the June 1986 final rule 

(51 FR 22050), requires that progress 

notes be documented by the doctor of 

medicine (MD) or doctor of osteopathy 

(DO) responsible for the care of the 

patient and, when appropriate, others 

significantly involved in active 

treatment modalities. ‘‘Others 

significantly involved in active 

treatment modalities’’ has been 

interpreted as staff from other 

disciplines, such as rehabilitative 

therapy and psychology, which are 

significantly involved in active 

treatment modalities and interventions. 

The intent of this requirement is to 

assure that the patient’s medical record 

contains documentation of the patient’s 

response to treatment planning and 

course of treatment. This documentation 

also serves to apprise all staff about 

patient’s progress and any new 

problems or regression. We believe that 

the intent of the requirement to record 

progress notes in the patient’s medical 

record continues to be an appropriate 

regulatory requirement. However, we 


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believe that as currently written and 

implemented, this requirement requires 

clarification. We believe that nonphysician 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 propose to 

allow the use of non-physician 

practitioners or MD/DOs to document 

progress notes of patient receiving 

services in psychiatric hospitals. 

Contact: Kianna Banks, 410–786– 

3498. 

We are seeking public comment on all 

of the proposed hospital changes. In 

addition, we note 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 are soliciting 

public comments on additional 

regulatory reforms for burden reduction 

in future rulemaking. Specifically, we 

are seeking public comment on 

additional proposals or modifications to 

the proposals set forth in this rule that 

would further reduce burden on 

hospitals and create cost savings, while 

also preserving quality of care and 

patient health and safety. Consistent 

with our ‘‘Patients Over Paperwork 

Initiative,’’ we are particularly 

interested in any suggestions to improve 

existing requirements, within our 

statutory authority, where they make 

providing quality care difficult or less 

effective. We also note that such 

suggestions could include or expand 

upon comments submitted in response 

to RFIs that were included in the 

following 2017 prospective payment 

regulations for hospitals: 

• FY 2018 Hospital Inpatient 

Prospective Payment System for Acute 

Care Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

found at https://www.regulations.gov/ 

docket?D=CMS-2017-0055. 

• CY 2018 Outpatient Prospective 

Payment System/Ambulatory Surgical 

Center proposed rule (https://

www.regulations.gov/docket?D=CMS2017-0091). 

• FY 2018 Inpatient Rehabilitation 

Facility Prospective Payment System 

(https://www.regulations.gov/ 

document?D=CMS-2017-0059-0002). 

• FY 2018 Inpatient Psychiatric 

Facilities Prospective Payment System 

(https://www.regulations.gov/ 

document?D=CMS-2018-0053-0002). 

Public comments on the RFIs can be 

found by searching for the terms ‘‘RFI’’ 

or ‘‘request for information’’ in the 

aforementioned 2017 payment 

regulation dockets on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

E. Transplant Centers 

Transplant programs, located within a 

transplant hospital that has a Medicare 

provider agreement, provide 

transplantation services for a particular 

organ type. Transplant programs must 

comply with the transplant center CoPs, 

located at §§ 482.72 through 482.104, 

and with the hospital CoPs. There are 

several types of transplant programs 

including heart, lung, liver, and kidney. 

Intestine, pancreas, and multi-organ 

transplants are performed within 

existing transplant programs. For the 

purposes of this discussion, we define a 

transplant center as a group of 

transplant programs that are located in 

a transplant hospital. A transplant 

program is a component of the 

transplant center, within a transplant 

hospital, that provides transplantation 

for a particular type of organ. Transplant 

programs are surveyed for compliance 

with the CoPs. 

This proposed rule uses the term 

‘‘transplant center’’ when discussing the 

current requirements and language used 

in the regulations. In accordance with 

our proposed nomenclature change, 

discussed later in this proposed rule, 

the term ‘‘transplant program’’ is widely 

used throughout the preamble and in 

the proposed regulation text. 

Section 1881(b)(1) of the Act sets out 

our authority for the Secretary to 

prescribe regulations for facilities 

furnishing end stage renal disease care 

to beneficiaries, including renal 

transplant centers. Section 1861(e)(9) of 

the Act permits the Secretary to issue 

regulations for the health and safety of 

individuals furnished services in 

hospitals. 

In response to the relative scarcity of 

donated organs compared to the number 

of people on transplant waitlists and the 

critical need to use these limited 

resources efficiently, we published a 

final rule that established CoPs for 

transplant centers on March 30, 2007, 

(Medicare Program; Hospital Conditions 

of Participation: Requirements for 

Approval and Re-Approval of 

Transplant Centers To Perform Organ 

Transplants) which codified 

requirements for approval and reapproval of transplant centers. We also 

placed Medicare-approved transplant 

centers under the survey and 

certification enforcement process we 

use for all other providers and suppliers 

of Medicare items and services (72 FR 

15198). The transplant center CoPs 

include data submission, clinical 

experience, outcome, and process 

requirements for approval and reapproval of transplant centers. The 

requirements focus on an organ 

transplant program’s ability to perform 

successful transplants and deliver 

quality patient care, as evidenced by 

outcomes as well as sound policies and 

procedures. The CoPs include 

requirements to protect the health and 

safety of both transplant recipients and 

living donors. 

We have continued to review and 

analyze the effectiveness of the 

transplant center CoPs, the effects of 

interpretive guidance, and the data 

derived from surveys of transplant 

programs. We also received comments 

from various stakeholders within the 

transplant center community that 

detailed the impacts of the 

implementation of the CoPs on 

transplant programs and transplant 

recipients. Upon further review, and 

taking into account input from various 

stakeholders, we believe that it is 

appropriate and necessary to revise the 

transplant center CoPs in order to 

reduce provider burden, increase longterm savings to the Medicare program, 

and eliminate obsolete or unnecessary 

requirements, while also continuing to 

protect the health and safety of 

transplant recipients and living donors. 

Furthermore, we believe that revising 

the transplant center CoPs will 

positively impact organ donation and 

transplantation in the United States by 

increasing the number of transplants 

performed each year and increasing the 

organ utilization rate, for reasons we 

discuss in further detail below. 

According to the Organ Procurement 

and Transplantation Network (OPTN) 

33,610, organ transplants were 

performed and 15,948 donors (both 

living and deceased) provided organs in 

the United States in 2016. However, as 

of the writing of this proposed rule, 

117,104 people still need a lifesaving 

organ transplant in 2017 (number 

represents total waiting list candidates, 

https://optn.transplant.hrsa.gov/, July 

2017). While strides are being made to 

improve organ donation and increase 

the number of organ transplants in the 

United States, there continues to be a 

shortage of organs. 

Therefore, we propose to revise the 

transplant center CoPs, as follows: 


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1. Special Requirement for Transplant 

Centers (§§ 482.68 and 482.70) 

Section 482.68 generally describes the 

requirements that a transplant center 

must meet in order to participate in the 

Medicare program; section § 482.70 sets 

out definitions of terms used in the 

regulations. Specifically, in addition to 

meeting all the CoPs as a hospital, a 

transplant center must meet the CoPs 

specified in §§ 482.72 through 482.104 

in order to be granted approval from 

CMS to provide transplant services. 

Throughout the regulation, we use 

terminology relevant to transplantation 

and organ procurement to describe 

transplant centers, programs, living 

donors, and transplant center recipients. 

Because the terminology currently used 

in the regulation is not consistent with 

current nomenclature used throughout 

the transplant community and by the 

OPTN, Scientific Registry of Transplant 

Recipients (SRTR), and the Department 

of Health and Human Services (HHS), 

we propose to update the terminology 

within the hospital regulation at part 

482 and the transplant regulations at 

§§ 482.68, 482.70, 482.72 through 

482.104, and at § 488.61, for 

clarification and consistency. 

Specifically, we propose 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 are also proposing to 

update the definitions at § 482.70. 

• Consistently use Independent 

Living Donor Advocate (ILDA) 

throughout the regulation. 

• Change ‘‘beneficiaries’’ to 

‘‘recipients’’. 

Since these changes would make our 

terms consistent with the terminology 

utilized by the OPTN and the transplant 

community, we believe these proposed 

changes would reduce provider 

confusion. 

2. Data Submission, Clinical Experience, 

and Outcome Requirements for ReApproval of Transplant Centers 

(§ 482.82) 

Section 482.82 requires that 

transplant centers that are applying for 

Medicare re-approval meet all data 

submission, clinical experience, and 

outcome requirements in order to be reapproved. In the March 2007 final rule 

(72 FR 15198), we also finalized these 

requirements for initial Medicare 

approval of transplant centers, as 

described in § 482.80. Since the 

publication of the final rule, several 

studies have been published that 

examine the impact of these 

requirements on transplantation and 

organ utilization in the United States. A 

2016 article published in the American 

Medical Association Journal of Ethics 

concluded that ‘‘using measured 

outcomes for punitive purposes may 

have resulted in significant unintended 

consequences’’ and that ‘‘transplant 

professionals will, by necessity, adapt 

practice to minimize the risk of 

regulatory citation and loss of transplant 

volume’’ which contributes to ‘‘lower 

transplant rates (typically among higherrisk candidates)’’ and increased organ 

discard of marginal organs. (Adler, Joel 

T. and Axelrod, David A. Regulations’ 

Impact on Donor and Recipient 

Selection for Liver Transplantation: 

How Should Outcomes be Measured 

and MELD Exception Scores be 

Considered, AMA Journal of Ethics, Vol. 

Volume 18, Number 2: 133–142. Doi: 

10.1001/journalofethics.2016.18.02. 

pfor1–1602, February 2016.). 

Another study linked performance 

evaluations to transplant volume in 

kidney transplant centers. The authors 

observed that centers that had low 

performance evaluations were more 

likely to have fewer kidney transplants 

than other kidney transplant centers. 

The study stated that kidney transplant 

centers that were identified with poor 

outcomes ‘‘may be more likely to have 

staff turnover which may lead to 

declines in transplant volume’’ and 

‘‘[c]enters that have been evaluated with 

lower performance may generally 

become more conservative in overall 

acceptance rates of candidates and 

donor organs’’ (Schold, JD, et al. The 

Association of Center Performance 

Evaluations and Kidney Transplant 

Volume in the United States. American 

Journal of Transplantation 2013; 13: 67– 

75. doi: 10.1111/j.1600– 

6143.2012.04345, 2013.). 

Another study covering over 90,000 

liver transplant candidates concluded 

that the transplant center regulations 

that were finalized in the March 2007 

final rule (72 FR 15198) increased the 

likelihood that liver transplant 

candidates would be removed from the 

liver transplant candidate waitlist and 

that this policy change led to the sickest 

patients being increasingly ‘‘denied this 

lifesaving procedure while transplant 

mortality risks remain unaffected.’’ The 

study found that the 2007 regulations 

had the effect of altering waitlist 

management and clinical decision 

making, thereby increasing the removal 

of the sickest patients from the waitlist. 

The impacts were seen through a 16 

percent increase in delisting of patients 

due to the severity of their illness after 

the implementation of the 2007 

regulation, and likelihood of being 

delisted continued to increase 

thereafter. The authors concluded that 

the 2007 regulation, which aimed to 

improve patient outcomes, had the 

consequence of instead failing to show 

any benefit to liver transplant patients. 

The authors suggested that future 

national policy decisions consider 

rebalance of the waitlist and transplant 

outcomes scale (Dolgin, Natasha H. et al. 

Decade-Long Trends in Liver Transplant 

Waitlist Removal Due to Illness 

Severity: The Impact of Centers for 

Medicare and Medicaid Services Policy. 

Journal of the American College of 

Surgeons. Volume 222, Issue 6, Pages 

1054–1065. DOI: http://dx.doi.org/ 

10.1016/j.jamcollsurg.2016.03.021, June 

2016.). 

Another study of kidney 

transplantation found that most of the 

increases in the discard rate from 1988 

to 2009 could be explained by recovery 

of organs from an increasing donor pool 

and changes in ‘‘pumping’’ or perfusion 

practices. ‘‘However, the presence of an 

unexplained, residual increase suggests 

behavioral factors (e.g., increased risk 

aversion) . . . may have played a role.’’ 

(Darren E. Stewart, et al. Diagnosing the 

Decades-Long Rise in the Deceased 

Donor Kidney Discard Rate in the 

United States. Transplantation. 2017; 

101: 575–587.). 

A different approach was taken in a 

recent study using data from 2000 to 

2015. This study found that by 

comparing donors from whom one only 

one kidney was discarded and the other 

was transplanted reasons for discard 

could be better assessed. In this study ‘‘a 

large number of discarded kidneys were 

procured from donors whose 

contralateral kidneys were transplanted 

with good post-transplant outcomes.’’ It 

found that when two kidneys were 

retrieved from a deceased donor, and 

one of the two was discarded and the 

other used in a transplant, it was often 

the case that these ‘‘discarded organs 

could have possibly demonstrated 

excellent performance if transplanted’’ 

and ‘‘the use of even a fraction of them 

could substantially reduce the number 

of patients who never receive an organ.’’ 

As for the cause of these discards, the 

authors analyzed several factors and 

stated that ‘‘the current report card 

system for transplant centers in the 


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United States . . . creates a disincentive 

to broader organ acceptance for centers 

concerned about payment penalties’’ 

and that ‘‘realignment of [these] 

incentives to promote more appropriate 

utilization is a key factor in reducing 

discards.’’ (Syed Ali Husain, et al. 

Characteristics and Performance of 

Unilateral Kidney Transplants from 

Deceased Donors. Clinical Journal 

American Society of Nephrology 13: 

2018.) 

We also received comments and 

feedback from pertinent stakeholders in 

the transplant community that align 

with the conclusions of these studies. 

For instance, UNOS has presented at 

public meetings that up to 1⁄3 of kidneys 

that are discarded could be successfully 

transplanted. Furthermore, the 

transplant community has noted that 

transplant programs may not use these 

kidneys due to the perception that they 

are of higher risk and that the utilization 

of these kidneys may lead to outcomes 

non-compliance under § 482.82. These 

programs have avoided using these 

kidneys for fear of non-compliance with 

the CoPs and potential Medicare 

termination of the program, despite 

evidence to the contrary that 

demonstrates that the use of these 

kidneys would not pose a problem for 

transplant recipients. The transplant 

community has therefore concluded that 

the regulations have led to behavioral 

changes in organ selection and 

transplantation on patients with fewer 

comorbidities and lower risk. This has 

resulted in transplant programs 

potentially avoiding performing 

transplant procedures on certain 

patients and many organs going unused. 

While it was our intent to ensure 

quality of care in transplant programs 

with the implementation of the 

regulations in § 482.82, we acknowledge 

that the final regulation may have 

caused unintended consequences that 

impact transplantation and transplant 

programs in the U.S. Given the findings 

of published studies and articles, and 

the public feedback we have received, 

we believe that it is appropriate to 

remove these requirements for reapproval of transplant programs in the 

Medicare program. 

Therefore, we propose to remove the 

requirements at § 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 

§ 482.102(a)(5) ‘‘Condition of 

participation, Patient and living donor 

rights’’ and § 488.61 ‘‘Special 

Procedures for Approval and ReApproval of Organ Transplant Centers.’’ 

Although we propose to remove these 

requirements, we continue to strongly 

believe that transplant programs should 

focus on maintaining high standards 

that protect patient health and safety 

and produce positive outcomes for 

transplant recipients. Therefore, we will 

continue to monitor and assess 

outcomes, after initial Medicare 

approval, through the transplant and 

hospital QAPI programs. In addition, 

quality of care will be monitored by 

assessing the other transplant program 

CoPs, including §§ 482.72 through 

482.104. We also encourage transplant 

programs and their respective hospitals’ 

QAPI programs to conduct thorough 

analyses of adverse events, document 

such events, and implement 

improvement activities to prevent 

recurrences. We further note that 

transplant programs must continue to 

comply with the CoPs at §§ 482.72 

through 482.104 and the data 

submission, clinical experience, and 

outcome requirements for initial 

Medicare approval under § 482.80. We 

believe this proposal will eliminate 

provider disincentives for performing 

transplantations and will lead to 

increased transplantation opportunities 

for patients on the waitlist; improved 

organ procurement for transplantation; 

greater organ utilization; lifesaving 

effects, reduced burden on transplant 

programs; and reductions in costs to 

both public and private insurance. 

We are seeking public comment on 

the removal of this requirement. 

3. Special Procedures for Approval and 

Re-Approval of Organ Transplant 

Centers (§ 488.61(f) Through (h)) 

Section 488.61 describes the survey, 

certification, and enforcement 

procedures for transplant centers, 

including the periodic review of 

compliance and approval as set out at 

§ 488.20. Section 488.61(f) through (h) 

set out the process for our consideration 

of a transplant center’s mitigating 

factors in initial approval and reapproval surveys, certifications, and 

enforcement actions for transplant 

centers. The provisions also set out 

definitions and rules for transplant 

systems improvement agreements. We 

propose to remove the requirements at 

§ 488.61(f) through (h) for mitigating 

factors and transplant systems 

improvement agreements for the reapproval process for transplant centers. 

This change is complementary to the 

proposed removal of § 482.82, described 

previously. We believe that repeal of 

these paragraphs would significantly 

reduce transplant programs’ regulatory 

burden by no longer requiring them to 

submit mitigating factors applications or 

enter into systems improvement 

agreements for outcomes noncompliance (for re-approval surveys, 

certifications, and enforcement actions 

for transplant programs). Transplant 

programs will continue to be afforded 

the opportunity to submit mitigating 

factors or to enter into transplant 

systems improvement agreements 

during the initial application process to 

the Medicare program under § 488.61 (f) 

through (h). 

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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction in future rulemaking. 

Specifically, we are seeking public 

comment on additional proposals or 

modifications to the proposals set forth 

in this rule that would further reduce 

burden on transplant programs and 

create cost savings, while also 

preserving quality of care and patient 

health and safety. Consistent with our 

‘‘Patients Over Paperwork Initiative,’’ 

we are particularly interested in any 

suggestions to improve existing 

requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note that such suggestions 

could include or expand upon 

comments submitted in response to the 

RFI that was included in the FY 2018 

Hospital Inpatient Prospective Payment 

System for Acute Care Hospitals and the 

Long-Term Care Hospital Prospective 

Payment System proposed rule. Public 

comments in response to this RFI can be 

found at the following link: https://

www.regulations.gov/docket?D=CMS2017-0055. Public comments on the RFI 

can be found by searching for the terms 

‘‘RFI’’ or ‘‘request for information’’ in 

the aforementioned 2017 payment 

regulation docket on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

Contact: Alpha-Banu Wilson, 410– 

786–8687. 

F. Home Health Agencies 

Home health services are covered for 

the elderly and disabled under the 


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Hospital Insurance (Part A) and 

Supplemental Medical Insurance (Part 

B) benefits of the Medicare program, 

and are described in section 1861(m) of 

the Social Security Act (the Act). These 

services, provided under a plan of care 

established and periodically reviewed 

by a physician, must be furnished by, or 

under arrangement with, a home health 

agency (HHA) that participates in the 

Medicare or Medicaid programs. 

Services are provided on a visiting basis 

in the beneficiary’s home, and may 

include the following: 

• Part-time or intermittent skilled 

nursing care furnished by or under the 

supervision of a registered professional 

nurse. 

• Physical therapy, speech-language 

pathology, and occupational therapy. 

• Medical social services under the 

direction of a physician. 

• Part-time or intermittent home 

health aide services. 

• Medical supplies (other than drugs 

and biologicals) and durable medical 

equipment. 

• Services of interns and residents if 

the HHA is owned by or affiliated with 

a hospital that has an approved medical 

residency training program. 

• Services at hospitals, skilled 

nursing facilities, or rehabilitation 

centers when the services involve 

equipment too cumbersome to bring to 

the home. 

Under the authority of sections 

1861(o) and 1891 of the Act, the 

Secretary has established in regulations 

the requirements that an HHA must 

meet to participate in the Medicare 

program. These requirements are set 

forth in regulations at 42 CFR part 484, 

Home Health Services. 

1. Patient Rights (§ 484.50(a)(3) and 

(c)(7)) 

Section 484.50(a)(3) of the January 

2017 HHA CoP final rule (82 FR 4504), 

effective January 13, 2018, requires 

HHAs to provide verbal (meaning 

spoken) notice of the patient’s rights 

and responsibilities in addition to the 

requirement to provide such notice in 

writing. Section 1891(a)(1)(E) of the Act 

requires additional oral notice of rights 

for specified information as follows: 

• All items and services furnished by 

(or under arrangements with) the agency 

for which payment may be made under 

Medicare, 

• The coverage available for such 

items and services under Medicare, 

Medicaid, and any other Federal 

program of which the agency is 

reasonably aware, 

• Any charges for items and services 

not covered under Medicare and any 

charges the individual may have to pay 

with respect to items and services 

furnished by (or under arrangements 

with) the agency, and 

• Any changes to the charges or items 

and services set forth in the previous 

bullets. 

Section 1891(a)(1)(F) of the Act 

requires that HHAs provide the notice of 

patient rights in writing. 

The requirements at § 484.50(a)(3) 

implement these statutory requirements, 

and require spoken notice of all patient 

rights, rather than limiting such notice 

to those rights specified in the Act. On 

July 28, 2017, we published a proposed 

rule entitled ‘‘CY 2018 Home Health 

Prospective Payment System Rate 

Update; Home Health Value Based 

Purchasing Model; and Home Health 

Quality Reporting Requirements’’ (82 FR 

35270) that solicited public comments 

on ways to reduce regulatory burden. In 

response to this solicitation, we 

received feedback from HHA 

stakeholders that the requirement to 

provide verbal notice of all rights to 

patients and their representatives was 

overly burdensome to the HHA 

clinicians that would be required to 

discuss the notice with patients when 

they could be furnishing hands-on 

patient care during that time, and lacked 

evidence that such explanations would 

result in improvements to patient safety 

or care. Furthermore, comments 

received encouraged us to reexamine all 

burdens in the January 2017 HHA CoP 

final rule to weigh potential benefits 

against estimated costs. 

We believe that the concerns 

expressed by commenters have merit. In 

light of this information, we believe that 

any benefits of this requirement are 

outweighed by the burdens imposed by 

this requirement. For this reason, we 

propose to delete the requirement that 

HHAs must provide verbal notification 

of all patient rights. This change would 

be 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. We propose 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 propose to revise 

§ 484.50(c)(7) to implement this more 

limited verbal notification requirement. 

Revised § 484.50(c)(7) would require 

HHAs to verbally discuss HHA payment 

and patient financial liability 

information with each HHA patient as 

described above. 

This change would not prevent states 

or Accrediting Organizations (AOs) from 

independently establishing and 

enforcing verbal notification 

requirements for all patient rights for 

purposes other than the HHA CoPs, nor 

would it prohibit HHAs from providing 

such verbal notification of all patient 

rights in the absence of Federal 

regulation. Furthermore, this change 

would not alter the other requirements 

at § 484.50(a), which requires HHAs to 

provide the notice of patient rights in 

writing, nor would it alter the 

requirements at § 484.50(f), 

Accessibility, which requires HHAs to 

provide information to patients in plain 

language and in a manner that is both 

accessible and timely to: (1) Persons 

with disabilities in accordance with the 

Americans with Disabilities Act and 

Section 504 of the Rehabilitation Act, 

and (2) persons with limited English 

proficiency. While HHAs would no 

longer be required to provide a verbal 

notification of all patient rights, we 

would continue to expect that HHAs 

answer any questions from patients or 

their representatives regarding the 

content of the written notice of rights. 

We believe that this proposed change 

would continue to provide adequate 

notice to patients while reducing 

burden on HHAs. 

2. Home Health Aide Services 

(§ 484.80(h)(3)) 

Section 484.80(h)(3) of the January 

2017 HHA CoP final rule (82 FR 4504) 

requires that, when a supervisory visit 

identifies a deficiency in a home health 

aide’s skills, the HHA must conduct, 

and the aide must complete, a full 

competency evaluation to assess all aide 

skills and identify any other skill 

deficiencies that were not identified 

while observing the aide performing 

care with a patient. In public comments 

submitted for the July 2017 proposed 

rule ‘‘CY 2018 Home Health Prospective 

Payment System Rate Update’’ (82 FR 

35270), a commenter suggested that 

completing a full competency 

evaluation was overly burdensome for 

HHAs and aides. Although this 

comment was not submitted during the 

proposed rule public comment period 

for the HHA CoP proposed rule, we 

believe that the concern expressed by 

the commenter has merit. In light of this 

new comment, we reconsidered the 

requirement, and concluded that a full 

competency evaluation is unnecessary 

and overly burdensome when only 

certain skills have been identified as 

deficient. We propose to eliminate the 

requirement 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 


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competency evaluation related only to 

those skills. This targeted retraining and 

competency evaluation requirement 

would reduce the time spent completing 

competency evaluations and retraining 

efforts. 

3. Clinical Records (§ 484.110(e)) 

In the January 2017 HHA CoPs final 

rule (82 FR 4504), effective January 13, 

2018, we finalized a requirement, 

codified at § 484.110(e), that an HHA 

must make available, upon request, a 

copy of the patient’s clinical record at 

the next home visit, or within 4 

business days (whichever comes first). 

In response to the July 2017 proposed 

rule solicitation of public comment on 

burden reduction via the CY 2018 Home 

Health Prospective Payment System 

Rate Update (82 FR 35270), we received 

feedback from HHA stakeholders that 

this requirement was impractical for 

HHAs to comply with because 

providing the record at the next visit 

may not allow enough time for HHAs to 

create a physical or electronic copy of 

the clinical record content, provide that 

copy to the next visiting clinician who 

may not be scheduled to come into the 

HHA office prior to the visit due to the 

nature of home based care and the 

significant travel that HHA clinicians 

must do in order to make patient visits, 

and successfully deliver the copy to the 

patient. The comments suggested that 

the 4 business day timeline was more 

practical and is an appropriate 

regulatory requirement. We agree that 

providing the record at the next visit is 

not practical or even possible in some 

cases. Furthermore, we agree that 

retaining the 4 business day timeframe 

is an appropriate regulatory 

requirement. Therefore, we propose to 

remove the requirement that the 

requested clinical record copy must be 

provided at the next home visit. 

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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction. Specifically, we are seeking 

public comment on additional proposals 

or modifications to the proposals set 

forth in this rule that would further 

reduce burden on HHAs and create cost 

savings, while also preserving quality of 

care and patient health and safety. 

Consistent with our ‘‘Patients Over 

Paperwork Initiative,’’ we are 

particularly interested in any 

suggestions to improve existing 

requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note that such suggestions 

could include or expand upon 

comments submitted in response to the 

RFI that was included in the CY 2018 

Home Health Prospective Payment 

System Rate Update; Value-Based 

Purchasing Model; and Quality 

Reporting Requirements. Public 

comments in response to this RFI can be 

found at the following link: https://

www.regulations.gov/docket?D=CMS2017-0100. Public comments on the RFI 

can be found by searching for the terms 

‘‘RFI’’ or ‘‘request for information’’ in 

the aforementioned 2017 payment 

regulation docket on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

Contact: Danielle Shearer, 410–786– 

6617. 

G. Comprehensive Outpatient 

Rehabilitation Facilities (CORFs)— 

Utilization Review Plan (§ 485.66) 

Section 485.51 of our rules defines a 

Comprehensive Outpatient 

Rehabilitation Facility (CORF) as a 

nonresidential facility that is 

established and operated exclusively for 

the purpose of providing diagnostic, 

therapeutic, and restorative services to 

outpatients for the rehabilitation of 

injured, disabled, or sick persons, at a 

single fixed location, by or under the 

supervision of a physician. As of May 

2017, there were 188 Medicare-certified 

CORFs in the United States. Section 

1861(cc)(2)(G) of the Act requires 

CORFs to maintain utilization review 

programs. Under this authority, the 

Secretary has established requirements 

at § 485.66 with respect to such 

programs. Currently, § 485.66 requires 

the CORF to have in effect a written 

utilization review plan that is 

implemented at least each quarter, to 

assess the necessity of services and 

promotes the most efficient use of 

services provided by the facility. 

We propose to amend the utilization 

review plan requirements at § 485.66 to 

reduce the frequency of utilization 

reviews. We believe the requirement to 

implement a utilization review plan 4 

times a year is overly burdensome and 

diverts staff from providing patient care. 

We propose to require the utilization 

review plan be implemented annually 

by the facility, which would allow an 

entire year to collect and analyze data 

to inform changes to the facility and the 

services provided. Changing the 

requirement from a quarterly to an 

annual review would not preclude the 

CORF from implementing their 

utilization review plan more frequently, 

if required by facility policy. We believe 

that an annual utilization review plan 

will serve as a useful measurement tool 

for the facility, and that the change from 

quarterly to annual would not 

negatively affect patient health and 

safety. 

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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction in future rulemaking. 

Specifically, we are seeking public 

comment on additional proposals or 

modifications to the proposals set forth 

in this rule that would further reduce 

burden on CORFs and create cost 

savings, while also preserving quality of 

care and patient health and safety. 

Consistent with our ‘‘Patients Over 

Paperwork’’ Initiative, we are 

particularly interested in any 

suggestions to improve existing 

requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note that such suggestions 

could include or expand upon 

comments submitted in response to RFIs 

that were included in the 2017 payment 

regulations. We refer readers to the 

public comments that were submitted in 

response to the RFI for the following 

2017 payment regulations: 

• End-Stage Renal Disease 

Prospective Payment System and 

Payment for Renal Dialysis Services 

Furnished to Individuals with Acute 

Kidney Injury, and End-Stage Renal 

Disease Quality Incentive Program 

found at https://www.regulations.gov/ 

docket?D=CMS-2017-0084. 

• CY 2018 Home Health Prospective 

Payment System Rate Update; ValueBased Purchasing Model; and Quality 

Reporting Requirements found at 

https://www.regulations.gov/ 

docket?D=CMS-2017-0100. 

• FY 2018 Hospice Wage Index and 

Payment Rate Update and Hospice 

Quality found at https://

www.regulations.gov/ 

document?D=CMS-2017-0062-0001. 

• FY 2018 Hospital Inpatient 

Prospective Payment System for Acute 

Care Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

RFI, found at https://

www.regulations.gov/docket?D=CMS2017-0055. 


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• CY 2018 Hospital Outpatient PPS 

Policy Changes and Payment Rates and 

Ambulatory Surgical Center Payment 

System Policy Changes and Payment 

Rates found at https://

www.regulations.gov/docket?D=CMS2017-0091. 

• FY 2018 Inpatient Rehabilitation 

Facility Prospective Payment System 

found at https://www.regulations.gov/ 

document?D=CMS-2017-0059-0002. 

• FY 2018 Inpatient Psychiatric 

Facilities Prospective Payment System 

found at https://www.regulations.gov/ 

document?D=CMS-2018-0053-0002. 

• CY 2018 Revisions to Payment 

Policies under the Physician Fee 

Schedule and Other Revisions to Part B 

found at https://www.regulations.gov/ 

docket?D=CMS-2017-0092. 

• FY 2018 Prospective Payment 

System and Consolidated Billing for 

Skilled Nursing Facilities found at 

https://www.regulations.gov/ 

document?D=CMS-2017-0060-0002. 

Public comments on the RFIs can be 

found by searching for the terms ‘‘RFI’’ 

or ‘‘request for information’’ in the 

aforementioned 2017 payment 

regulation dockets on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

Contact: CAPT Jacqueline Leach, 

USPHS, 410–786–4282. 

H. Critical Access Hospitals 

1. Organizational Structure 

(§ 485.627(b)(1)) 

Current regulations at § 485.627 

require CAHs to disclose the names and 

addresses of its 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. 

Section 42 CFR part 420, subpart C, sets 

forth requirements for providers, Part B 

suppliers, intermediaries, and carriers to 

disclose ownership and control 

information and sets forth requirements 

for disclosure of information about a 

provider’s or Part B supplier’s owners 

and those with a controlling interest. 

The disclosure of ownership 

provisions at 42 CFR part 420, subpart 

C, are also required under the provider 

agreement rules under 42 CFR part 489. 

The term ‘‘provider agreement’’ is 

defined in § 489.3 as an agreement 

between CMS and a provider or supplier 

to provide services to Medicare 

beneficiaries and to comply with the 

requirements of section 1866 of the Act 

(Agreements with Providers of Services; 

Enrollment Processes). Providers must 

meet the terms of the agreement to be 

qualified to participate in the Medicare 

program. 

We propose to remove this disclosure 

requirement from the CAH CoPs as it is 

duplicative of requirements for the 

provider agreement. Specifically, 

disclosure of individuals with a 

financial interest in the CAH is a 

requirement under the provider 

agreement rules in § 489.12(a)(2) and 

must be completed during the provider 

enrollment process. This information 

must be disclosed on the provider’s 

Medicare enrollment application (Form 

CMS–855A for CAHs) and the 

enrollment application must be updated 

with any changes, such as address 

changes, practice name or change of 

ownership of information and must be 

submitted to CMS. Also note that this is 

not a requirement in the hospital CoPs 

under 42 CFR part 482 because it is 

already a requirement in the provider 

agreement rules under § 498.12(a)(2). 

Contact: Kianna Banks, 410–786– 

3498. 

2. Provision of Services (§ 485.635(a)(4)) 

Current regulations at § 485.635 

require CAHs to review policies and 

procedures annually. We believe that 

medical practice has evolved such that 

we can provide flexibility for facilities 

to review, correct, or change their 

policies and procedures. Based on our 

experience with medical care providers 

and information from organizations 

such as the Brookings Institution 

(https://www.brookings.edu/ 

testimonies/improving-health-carequality-the-path-forward/), the 

expanded use of Web-based information 

and resources has fundamentally 

changed patient care, medical practice, 

and education. It has enabled providers 

to easily adjust policies and procedures 

on an as-needed basis. We believe that 

a prescriptive requirement to review 

policies and procedures annually could 

be eliminated to allow providers to 

review biennially and update as 

necessary, or more frequently if needed. 

For example, we expect providers to 

update their policies and procedures as 

needed in response to regulatory 

changes, changes in the standard of 

care, or nationally recognized 

guidelines. 

The current CoP at § 485.635(a)(4) 

requires a CAH to review its policies at 

least annually by the CAH’s professional 

healthcare staff, including one or more 

doctors of medicine or osteopathy and 

one or more physician assistants, nurse 

practitioners, or clinical nurse 

specialists, if they are on staff under the 

provisions of § 485.631(a)(1). The 

policies that are reviewed must include 

the following: 

• A description of the services the 

CAH furnishes, including those 

furnished through agreement or 

arrangement; 

• Policies and procedures for 

emergency medical services; 

• Guidelines for the medical 

management of health problems that 

include the conditions requiring 

medical consultation and/or patient 

referral, the maintenance of health care 

records; 

• Rules for the storage, handling, 

dispensation, and administration of 

drugs and biologicals; 

• Procedures for reporting adverse 

drug reactions and errors in the 

administration of drugs; and 

• A system for identifying, reporting, 

investigating and controlling infections 

and communicable diseases of patients 

and personnel. 

• Procedures that ensure that the 

nutritional needs of post-hospital SNF 

inpatients are met in accordance with 

recognized dietary practices. 

Based on feedback from stakeholders, 

the prescriptive annual schedule can be 

burdensome or, in some situations, 

ineffective. Providers stated that they 

make annual, monthly and biannual 

changes to their policies. Some have 

stated that they make changes as needed 

or infrequently. They also stated that the 

time that it took to review the policies 

varied. Some stated it would take as 

little as 2 hours while a few stated a 

much longer period time such as a 

month, depending on what was being 

changed. We believe that taking a month 

would represent a new facility or a 

facility that is experiencing major 

restructuring. After a careful review of 

the varied responses, we propose to 

provide flexibility and reduce burden by 

revising the requirement at 

§ 485.635(a)(4) to, at a minimum, only 

require a biennial review of policies and 

procedures. The 2-year review would 

not preclude a facility from conducting 

a review more frequently if needed or 

organizing the review such that it would 

be completed over a 2-year period. 

Based on our experience with other 

providers, we believe that this approach 

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 

propose to change the requirement at 

§ 485.635(a)(4) from ‘‘annual’’ to 

‘‘biennial’’. 

Contact: Mary Collins, 410–786–3189. 


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3. Special Requirements for CAH 

Providers of Long-Term Care Services 

(‘‘Swing-Beds’’) (§ 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. We propose the following 

revisions to the CAH swing-bed 

requirements: 

• Revision of § 485.645(d)(1) to 

remove the cross-referenced long-term 

care requirement in § 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 § 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 § 483.24(c)); 

• Redesignation of paragraphs (d)(5) 

through (9) as (d)(4) through (8), 

respectively; 

• Revision of § 485.645(d)(4) (as 

redesignated) to remove the crossreferenced long-term care requirement 

§ 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 § 485.645(d)(7) (as 

redesignated) to remove the crossreferenced long-term care requirement 

§ 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. 

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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction in future rulemaking. 

Specifically, we are seeking public 

comment on additional proposals or 

modifications to the proposals set forth 

in this rule that would further reduce 

burden on CAHs and create cost 

savings, while also preserving quality of 

care and patient health and safety. 

Consistent with our ‘‘Patients Over 

Paperwork’’ Initiative’’ we are 

particularly interested in any 

suggestions to improve existing 

requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note that such suggestions 

could include or expand upon 

comments submitted in response to the 

FY 2018 Hospital Inpatient Prospective 

Payment System for Acute Care 

Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

RFI, found at https://

www.regulations.gov/docket?D=CMS2017-0055. Public comments on the RFI 

can be found by searching for the terms 

‘‘RFI’’ or ‘‘request for information’’ in 

the aforementioned 2017 payment 

regulation docket on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

I. Community Mental Health Center 

(§ 485.914(d)) 

On October 29, 2013, we published a 

final rule (78 FR 209) that established, 

for the first time, a set of requirements 

that Medicare-certified CMHCs must 

meet in order to participate in the 

Medicare program. These CoPs ensure 

the quality and safety of CMHC care for 

all clients served by the CMHC, 

regardless of payment source. These 

requirements focus on a personcentered, outcome-oriented process that 

promotes quality client care. These CoPs 

are set forth at 42 CFR part 485 and 

apply to all Medicare participating 

CMHCs. 

Medicare certified CMHCs provide 

services to a wide range of clients, from 

those needing partial hospitalization 

program (PHP) services to clients 

needing routine counseling. Partial 

hospitalization services are an intense 

level of services needed ‘‘to improve or 

maintain the individual’s condition and 

functional level and to prevent relapse 

or hospitalization. . . .’’ (section 

1861(ff)(2) of the Act). As written, the 

current standard at § 485.914(d) requires 

the CMHC to update the client 

comprehensive assessment every 30 

days regardless of the client’s needs or 

treatment schedule. This 30 day update 

of the comprehensive assessment 

correlates with the CMS PHP payment 

regulations, requiring PHP clients to 

receive an updated active treatment 

plan every 30 days. Clients receiving 

PHP are more acute and typically 

receive care in the CMHC multiple days 

a week for several hours a day. The PHP 

client will have changing needs as they 

progress through their treatment plan; 

therefore, updating the assessment every 

30 days or sooner if the client’s 

condition changes continues to be an 

important requirement for the PHP 

client. 

While the minimum 30 day update 

time fame at § 485.914(d) is needed for 

clients receiving PHP services, we do 

not believe that this time frame 

requirement supports the needs of all 

CMHC clients. Clients that do not 

receive PHP services may be seen 

weekly or every 2 weeks, while others 

are only seen every 2–6 months for a 

medication follow up. Requiring an 

updated assessment every 30 days may 

not be practical for the non-PHP client, 

causing either additional visits or phone 

calls from the CMHC to the client to 

document ‘‘no changes in the client’s 

assessment’’. This is not an efficient use 

of CMHC clinician or client time. 

Therefore, we propose to modify this 

standard at § 485.914(d)(1) to require 

that the CMHC 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. 

Additionally at § 485.914(d)(3), we 

propose 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 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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction in future rulemaking. 

Specifically, we are seeking public 

comment on additional proposals or 

modifications to the proposals set forth 

in this rule that would further reduce 

burden on CMHCs and create cost 

savings, while also preserving quality of 

care and patient health and safety. 

Consistent with our ‘‘Patients Over 

Paperwork Initiative,’’ we are 

particularly interested in any 

suggestions to improve existing 


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requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note that such suggestions 

could include or expand upon 

comments submitted in response to the 

RFI that was included in the CY 2018 

OPPS/ASC proposed rule. Public 

comments in response to this RFI can be 

found at the following link: https://

www.regulations.gov/docket?D=CMS2017-0091. Public comments on the RFI 

can be found by searching for the terms 

‘‘RFI’’ or ‘‘request for information’’ in 

the aforementioned 2017 payment 

regulation docket on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

Contact: CAPT Mary Rossi-Coajou, 

USPHS, 410–786–6051. 

J. Portable X-Ray Services (§§ 486.104(a) 

and 486.106(a)) 

Portable x-rays are basic radiology 

studies (predominately chest and 

extremity x-rays) performed on patients 

in skilled nursing facilities, residents of 

long term care facilities and homebound 

patients. Under the authority of section 

1861(s)(3) of the Act, the Secretary has 

established the CfCs that the supplier of 

portable x-ray services must meet to 

participate in Medicare and Medicaid, 

and these conditions are set forth at 

§§ 486.100 through 486.110. The 

portable x-ray CfCs set forth at § 486.104 

were originally published on January 

10, 1969 (34 FR 388) and were 

redesignated on September 30, 1977 (42 

FR 528260), and amended on April 12, 

1988 (53 FR 12015), August 30, 1995 (60 

FR 45086), and November 19, 2008 (73 

FR 69942). The portable x-ray CfCs set 

forth at § 486.106 were originally 

published on January 10, 1969 (34 FR 

388) and were redesignated on 

September 30, 1977 (42 FR 52826) and 

further redesignated and amended 

January 9, 1995 (60 FR 2326), August 

30, 1995 (60 FR 45086), and November 

16, 2012 (77 FR 69372). The November 

2012 revision to the portable x-ray 

requirements allowed nurse 

practitioners and non-physician 

providers acting within their scope of 

practice to order portable x-ray studies. 

The current regulations are inconsistent 

with other rules governing diagnostic 

studies, as described later in this section 

of this proposed rule. In order to 

improve consistency, we propose 

changes to both § 486.104, Condition for 

coverage: Qualifications, orientation and 

health of technical personnel and 

§ 486.106, Condition for coverage: 

Referral for service and preservation of 

records. 

At § 486.104, Condition for coverage: 

Qualifications, orientation and health of 

technical personnel, the portable x-ray 

technologist must meet any one of four 

training and education requirements in 

§ 486.104(a)(1), (2), (3), or (4). The 

requirement focuses on the 

accreditation of the school rather than 

the competency of the individual. In 

contrast, § 482.26(c)(2), referring to 

qualifications of radiologic technologists 

in hospitals, is focused on the 

qualifications of the individual 

performing services as permitted by 

State law. Additionally, § 410.33(c), 

which sets forth the personnel 

requirements for non-physician 

personnel used by an independent 

testing facility to perform tests, requires 

that testing personnel, including x-ray 

technologists, must demonstrate the 

basic qualifications to perform the tests 

in question and have training and 

proficiency as evidenced by licensure or 

certification by the appropriate State 

health or education department. These 

two other regulatory requirements that 

govern the same type of technologists do 

not have any accreditation 

requirements. Based on our survey 

findings in hospitals, which have not 

identified widespread patient safety or 

quality of care concerns related to the 

training and education levels of 

technologists, we do not believe that 

removing the school accreditation 

requirement from the portable x-ray 

personnel requirements would 

negatively impact portable x-ray patient 

health and safety. 

We propose to remove the four 

training and education requirements for 

two reasons. First, paragraph (a)(1), and 

to some extent paragraph (a)(4), focus on 

the accreditation of the school where 

the technologist received training, 

instead of focusing on the qualifications 

of the technologist performing the 

diagnostic test. Radiologic technicians 

who practice in a hospital, and for 

whom there are no requirements to 

receive education and training by an 

accredited program, are legally allowed 

to perform any diagnostic imaging 

procedure, including computed 

topography scans, mammograms, 

sonograms, and many other procedures 

that are more complex and require more 

expertise than portable x-rays. In 

contrast, portable x-ray radiologic 

technicians typically perform basic xrays of the limbs (hand, foot) and chest, 

and are limited in their duties by State 

scope of practice rules. For this reason 

we are aligning the current requirements 

at § 486.104(a)(1), (2), (3), and (4) with 

§ 482.26(c)(2), which refers to 

qualifications of radiologic technologists 

in hospitals, and is focused on the 

qualifications of the individual 

performing services as permitted by 

State law. This change would not 

preclude state licensure entities and 

portable x-ray suppliers from 

establishing personnel requirements 

that are more stringent that the 

proposed Federal requirements. 

Second, paragraphs (a)(2), (3), and (4) 

establish different personnel 

qualifications based on the date that a 

technologist received his or her 

education and training. We do not 

believe that it is efficient or necessary to 

have varying qualifications based 

simply on the date that such training 

was received. We propose to replace 

these four different qualifications with a 

single, streamlined qualification that 

focuses on the skills and abilities of the 

technologist. We believe that removing 

school accreditation requirements and 

simplifying the requirements will 

reduce regulatory burden, streamline 

the hiring process, and widen the pool 

of individuals who may be employed by 

portable x-ray suppliers to perform 

portable x-ray services, particularly 

those individuals who received training 

through the military for performing 

portable x-rays, as military training 

programs are not accredited. 

Section 486.106(a)(2) contains 

specific requirements for the content of 

the order for portable x-ray services, and 

requires that physician or non-physician 

practitioners orders for portable x-ray 

services must be written and signed. 

The requirements at § 486.106(a)(2) are 

inconsistent with the order 

requirements at § 410.32, which also 

apply to portable x-ray suppliers, in two 

ways. First, the requirements at 

§ 486.106(a)(2) have different order 

content requirements. Second, the 

requirements at § 486.106(a)(2) have the 

effect of limiting or precluding 

telephonic and electronic orders, which 

are often more efficient ordering 

methods. Section 410.32 allows for the 

diagnostic service to be ordered in 

writing, by telephone, or by secure 

electronic methods. Although, § 410.32 

does not prescribe the form of an order. 

The Medicare Benefit Policy Manual 

(Pub. 100–02), chapter 15, section 80.6 

provides additional guidance on 

§ 410.32, and states: 

‘‘An order may be delivered via the 

following forms of communication: 

• A written document signed by the 

treating physician/practitioner, which is 

hand delivered, mailed, or faxed to the 

testing facility; NOTE: No signature is 

required on orders for clinical 

diagnostic tests paid on the basis of the 


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clinical laboratory fee schedule, the 

physician fee schedule, or for physician 

pathology services; 

• A telephone call by the treating 

physician/practitioner or his or her 

office to the testing facility; and 

• An electronic mail by the treating 

physician/practitioner or his or her 

office to the testing facility. 

If the order is communicated via 

telephone, both the treating physician/ 

practitioner or his or her office, and the 

testing facility must document the 

telephone call in their respective copies 

of the beneficiary’s medical records. 

While a physician order is not required 

to be signed, the physician must clearly 

document, in the medical record, his or 

her intent that the test be performed. 

We propose to update § 486.106 

(specific to portable x-ray services) to 

cross reference the requirements at 

§ 410.32. We propose to retain the 

requirement that the portable x-ray 

order must include a statement on why 

it is necessary to perform a portable xray as opposed to performing the study 

in a facility where x-rays are more 

typically performed. This change would 

allow for portable x-ray services to be 

ordered in writing, by telephone, or by 

electronic methods. The change would 

also streamline the ordering process by 

avoiding the need to write two separate 

orders for the same study, one to meet 

the Medicare payment requirements in 

accordance with § 410.32 and its 

associated Manual guidance, and 

another to meet the content 

requirements of the regulation set forth 

at § 486.106. We believe the proposed 

change would allow for additional 

ordering flexibility to streamline 

ordering practices while maintaining 

ordering and documentation 

requirements consistent with all other 

diagnostic testing. 

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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction in future rulemaking. 

Specifically, we are seeking public 

comment on additional proposals or 

modifications to the proposals set forth 

in this rule that would further reduce 

burden on suppliers of portable x-ray 

services and create cost savings, while 

also preserving quality of care and 

patient health and safety. Consistent 

with our ‘‘Patients Over Paperwork 

Initiative,’’ we are particularly 

interested in any suggestions to improve 

existing requirements, within our 

statutory authority, where they make 

providing quality care difficult or less 

effective. We also note that such 

suggestions could include or expand 

upon comments submitted in response 

to the RFI that was included in the CY 

2018 Revisions to Payment Policies 

under the Physician Fee Schedule and 

Other Revisions to Part B. Public 

comments in response to this RFI can be 

found at the following link: https://

www.regulations.gov/docket?D=CMS2017-0092. Public comments on the RFI 

can be found by searching for the terms 

‘‘RFI’’ or ‘‘request for information’’ in 

the aforementioned 2017 payment 

regulation docket on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

Contact: Sonia Swancy, 410–786– 

8445. 

K. Rural Health Clinics (RHCs) and 

Federally Qualified Health Centers 

(FQHCs) 

1. Provision of Services (§ 491.9(b)(4)) 

Currently, § 491.9(b)(4) requires RHCs 

and FQHCs to have their patient care 

policies reviewed at least annually by 

the designated group of professional 

personnel who advise the RHC or FQHC 

in developing these policies (described 

at § 491.9(b)(2)), and reviewed as 

necessary by the RHC or FQHC. We 

propose to reduce the frequency of 

policy reviews. We believe the 

requirement to review patient care 

policies annually is burdensome and 

diverts staff from providing patient care. 

We propose to require the patient care 

policies be reviewed on a biennial basis 

by the group of professional personnel. 

Changing the review requirement from 

annually to every other year would not 

preclude the RHC or FQHC from 

maintaining their current annual 

review, if they believe it is necessary or 

if it is required by facility policy. We 

believe that this approach would allow 

RHCs and FQHCs to maintain their 

health and safety policies in such a 

manner as to achieve the intended 

outcomes for all patients. Thus, we 

propose to change the requirement at 

§ 491.9(b)(4) from ‘‘annual’’ to 

‘‘biennial’’. 

2. Program Evaluation (§ 491.11(a)) 

The current requirement at § 491.11(a) 

requires that the RHC or FQHC carries 

out, or arranges for, an annual 

evaluation of its total program. Some 

RHCs and FQHCs have reported to us 

that this requirement is burdensome and 

utilizes costly staff resources. We 

propose to revise the current 

requirement at § 491.11(a) by changing 

the frequency of the RHC or FQHC 

evaluation from annually to every other 

year. The revised requirement would 

then require a biennial evaluation of its 

total program. Changing the program 

evaluation requirement from annually to 

every other year would not preclude the 

RHC or FQHC from conducting an 

evaluation more frequently or 

maintaining their current annual 

evaluation, if they believe it is necessary 

or if it is required by facility policy. 

Furthermore, the proposed changes 

would give the RHC or FQHC the 

flexibility to focus only on certain 

program areas, if they choose to do so, 

for the off year in-between required 

program evaluations. The proposed 

change would reduce the paperwork 

burden of the RHC or FQHC and allow 

clinicians to focus more on patient care. 

We believe that an evaluation of the 

RHC or FQHC’s total program every 

other year is sufficient to ensure 

consistent quality of care, and that the 

change from annual to biennial would 

not negatively affect patient health and 

safety. We welcome the public’s 

comments on these proposed changes. 

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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction in future rulemaking. 

Specifically, we are seeking public 

comment on additional proposals or 

modifications to the proposals set forth 

in this rule that would further reduce 

burden on RHCs and FQHCs and create 

cost savings, while also preserving 

quality of care and patient health and 

safety. Consistent with our ‘‘Patients 

Over Paperwork’’ Initiative, we are 

particularly interested in any 

suggestions to improve existing 

requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note that such suggestions 

could include or expand upon 

comments submitted in response to RFIs 

that were included in the 2017 

prospective payment regulations for 

most provider types. We refer readers to 

the public comments that were 

submitted in response to the RFI for the 

following 2017 payment regulations: 

• End-Stage Renal Disease 

Prospective Payment System and 

Payment for Renal Dialysis Services 

Furnished to Individuals with Acute 

Kidney Injury, and End-Stage Renal 


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Disease Quality Incentive Program 

found at https://www.regulations.gov/ 

docket?D=CMS-2017-0084. 

• CY 2018 Home Health Prospective 

Payment System Rate Update; ValueBased Purchasing Model; and Quality 

Reporting Requirements found at 

https://www.regulations.gov/ 

docket?D=CMS-2017-0100. 

• FY 2018 Hospice Wage Index and 

Payment Rate Update and Hospice 

Quality found at https://

www.regulations.gov/ 

document?D=CMS-2017-0062-0001. 

• FY 2018 Hospital Inpatient 

Prospective Payment System for Acute 

Care Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

RFI, found at https://

www.regulations.gov/docket?D=CMS2017-0055. 

• CY 2018 Hospital Outpatient PPS 

Policy Changes and Payment Rates and 

Ambulatory Surgical Center Payment 

System Policy Changes and Payment 

Rates found at https://

www.regulations.gov/docket?D=CMS2017-0091. 

• FY 2018 Inpatient Rehabilitation 

Facility Prospective Payment System 

found at https://www.regulations.gov/ 

document?D=CMS-2017-0059-0002. 

• FY 2018 Inpatient Psychiatric 

Facilities Prospective Payment System 

found at https://www.regulations.gov/ 

document?D=CMS-2017-0105-0002. 

• CY 2018 Revisions to Payment 

Policies under the Physician Fee 

Schedule and Other Revisions to Part B 

found at https://www.regulations.gov/ 

docket?D=CMS-2017-0092. 

• FY 2018 Prospective Payment 

System and Consolidated Billing for 

Skilled Nursing Facilities found at 

https://www.regulations.gov/ 

document?D=CMS-2017-0060-0002. 

Public comments on the RFIs can be 

found by searching for the terms ‘‘RFI’’ 

or ‘‘request for information’’ in the 

aforementioned 2017 payment 

regulation dockets on 

www.regulations.gov. 

The most useful comments will be 

those that include data or evidence to 

support the position, offer suggestions 

to amend specific sections of the 

existing regulations, or offer particular 

additions. 

Contact: CAPT Jacqueline Leach, 

USPHS, 410–786–4282. 

L. 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 

After the publication of that final rule, 

we continued to review and analyze the 

final emergency preparedness 

requirements and pertinent stakeholder 

feedback. Upon further review, we 

believe that some emergency 

preparedness requirements could be 

modified or eliminated to reduce 

provider and supplier burden while 

continuing to maintain essential 

emergency preparedness requirements 

that preserve the health and safety of 

patients in the United States. The 

following proposals would simplify the 

emergency preparedness requirements, 

eliminate duplicative requirements, 

and/or reduce the frequency with which 

providers and suppliers would need to 

perform certain required activities. We 

note that the current emergency 

preparedness standards are similar 

amongst all provider and supplier types, 

with a few variations to account for 

differences in health care settings. For 

clarity in the discussion later in this 

section of this proposed rule, we often 

refer to the hospital regulatory citation 

and we include specific references to 

other provider or supplier types when 

necessary. 

1. Annual Review of Emergency 

Preparedness Program (§§ 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)) 

Facilities are currently required to 

annually review their emergency 

preparedness program, which includes a 

review of their emergency plan, policies 

and procedures, communication plan, 

and training and testing program. 

However, pertinent stakeholders 

continue to question whether an annual 

review of the emergency program is 

necessary or beneficial to the facility. In 

response to their comments, we are 

therefore proposing to change this 

requirement to require facilities to 

review their program at least every 2 

years. This will increase the facility’s 

flexibility to review their programs as 

they determine best fits their needs. 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). 

As noted in the Emergency 

Preparedness final rule (81 FR 63860), 

‘‘. . . there are various infections and 

diseases, such as the Ebola outbreak in 

October, 2014, that required updates in 

facility assessments, policies and 

procedures and training of staff beyond 

the directly affected hospitals. The final 

rule requires that if a facility 

experiences an emergency, an analysis 

of the response and any revisions to the 

emergency plan will be made and gaps 

and areas for improvement should be 

addressed in their plans to improve the 

response to similar challenges for any 

future emergencies.’’ 

The Assistant Secretary for 

Preparedness and Response (ASPR) 

Technical Resources, Assistance Center, 

and Information Exchange (TRACIE) 

located at: https://asprtracie.hhs.gov/, is 

an excellent resource for the various 

CMS providers and suppliers as they 

seek to implement the emergency 

preparedness requirements. TRACIE is 

designed to provide resources and 

technical assistance to healthcare 

system preparedness stakeholders in 

building a resilient healthcare system. 

There are numerous products and 

resources located within the TRACIE 

website that target specific provider 

types affected by the emergency 

preparedness aspects of this proposed 

rule. While TRACIE does not focus 

specifically on the requirements 

implemented in this proposed 

regulation, this is a valuable resource to 

aid a wide spectrum of partners with 

their health system emergency 

preparedness activities. We strongly 

encourage providers and suppliers to 

utilize TRACIE and leverage the 

information provided by ASPR. 


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2. Documentation of Cooperation Efforts 

(§§ 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)) 

Facilities are currently required to 

develop and maintain an emergency 

preparedness plan that includes 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, 

including documentation of the 

facilities’ efforts to contact such officials 

and, when applicable, of its 

participation in collaborative and 

cooperative planning efforts. Upon 

further review of this requirement, we 

believe that elements of this 

requirement are unduly burdensome on 

facilities. Therefore, we propose 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. We 

believe that eliminating this 

documentation requirement will reduce 

provider and supplier 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 at least include a process for 

cooperation and collaboration. We 

continue to encourage facilities to 

participate, when available, in 

community cooperative and 

collaborative planning efforts and 

execute the training and testing 

requirements in § 482.15 (d) for 

hospitals and similar parallel citations 

for other facilities. 

3. Annual Emergency Preparedness 

Training Program (§§ 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. We are therefore proposing 

to change this requirement to require 

that facilities provide training biennially 

or every 2 years, after facilities conduct 

initial training on their emergency 

program. In addition, we propose to 

require additional training when the 

emergency plan is significantly updated. 

For example, when a facility makes 

substantial changes to the procedures or 

protocols within the emergency plan, 

we would require additional training on 

the updated emergency plan. Other nonsignificant updates, such as revisions to 

the communication plan regarding 

contact information for staff, could be 

sent in company memorandum or 

provided to the facility’s staff through 

other means. These proposed changes 

give facilities additional flexibility to 

determine what is appropriate for their 

facility’s or staff’s needs while 

maintaining adequate readiness. 

4. Annual Emergency Preparedness 

Testing (§§ 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 have 

determined that there is also a need to 

clarify and revise some of the 

requirements included in the 

Emergency Preparedness final rule (81 

FR 63860). We propose to clarify our 

intent with regard to the types of testing 

exercises, specifically full-scale 

exercises and functional exercises. As 

noted in the Emergency Preparedness 

proposed rule (78 FR 79101), a full-scale 

exercise is a multi-agency, 

multijurisdictional, multi-discipline 

exercise involving functional (for 

example, joint field office, emergency 

operation centers, etc.) and ‘‘boots on 

the ground’’ responses (for example, 

firefighters decontaminating mock 

victims). We expect facilities to engage 

in such comprehensive exercises with 

coordination across the public health 

system and local geographic area, if 

possible. Moreover, a functional 

exercise examines or validates the 

coordination, command, and control 

between various multiagency 

coordination centers (for example, 

emergency operation center, joint field 

office, etc.). A functional exercise does 

not involve any ‘‘boots on the ground’’ 

(that is, first responders or emergency 

officials responding to an incident in 

real time). The term ‘‘functional 

exercise’’ more accurately reflects our 

intentions for the testing requirement in 

the Emergency Preparedness final rule 

(81 FR 63860). We believe that there are 

opportunities to reduce the burden for 

inpatient and outpatient providers to 

meet the testing requirement. 

For providers of inpatient services, we 

propose to expand the testing 

requirement options such that one of the 

two annually required testing exercises 

may be an exercise of their choice, 

which may include one communitybased 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. As 

indicated in the Emergency 


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Preparedness proposed rule, ‘‘A 

workshop resembles a seminar, but is 

employed to build specific products, 

such as a draft plan or policy (for 

example, a Training and Exercise Plan 

Workshop is used to develop a 

Multiyear Training and Exercise Plan)’’ 

(78 FR 79101). Providers of inpatient 

services include RNHCIs, inpatient 

hospice facilities, Psychiatric 

Residential Treatment Facilities 

(PRTFs), hospitals, long-term care 

facilities (LTCFs), ICFs/IIDs, and CAHs. 

We believe this will allow greater 

flexibility for inpatient providers to 

meet this requirement. We note that 

although RNHCIs provide inpatient 

services, we have determined that 

changing their existing requirements to 

make them consistent with this 

proposed provision will be unduly 

burdensome as they are currently 

required to conduct a paper-based, 

tabletop exercise at least annually. 

For providers of outpatient services, 

we believe that conducting two testing 

exercises per year is overly burdensome 

as these providers do not provide the 

same level of acuity or inpatient 

services for their patients. Therefore, we 

propose to require that providers of 

outpatient services conduct only one 

testing exercise per year. Furthermore, 

we propose 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 

propose 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. 

Providers of outpatient services include 

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. Due to the nature of 

services provided by OPOs we propose 

to require that they have the option of 

providing either a tabletop exercise or 

workshop every year. 

Lastly, we propose 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. A facility’s communication 

plan is part of their emergency plan, as 

is coordination with other community 

emergency preparedness officials (for 

example, emergency management and 

public health), and we expect that these 

elements, along with the completion of 

a corrective action plan, are part of the 

activation of their emergency plan. 

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 are soliciting public comments on 

additional regulatory reforms for burden 

reduction in future rulemaking. 

Specifically, we are seeking public 

comment on additional proposals or 

modifications to the proposals set forth 

in this rule that would further reduce 

burden on all Medicare and Medicaid 

participating providers and suppliers 

mentioned in this section and create 

cost savings, while also preserving 

quality of care and patient health and 

safety. Consistent with our ‘‘Patients 

Over Paperwork’’ Initiative, we are 

particularly interested in any 

suggestions to improve existing 

requirements, within our statutory 

authority, where they make providing 

quality care difficult or less effective. 

We also note that such suggestions 

could include or expand upon 

comments submitted in response to RFIs 

that were included in the following 

2017 payment regulations: 

• End-Stage Renal Disease 

Prospective Payment System and 

Payment for Renal Dialysis Services 

Furnished to Individuals with Acute 

Kidney Injury, and End-Stage Renal 

Disease Quality Incentive Program 

found at https://www.regulations.gov/ 

docket?D=CMS-2017-0084. 

• CY 2018 Home Health Prospective 

Payment System Rate Update; ValueBased Purchasing Model; and Quality 

Reporting Requirements found at 

https://www.regulations.gov/ 

docket?D=CMS-2017-0100. 

• FY 2018 Hospice Wage Index and 

Payment Rate Update and Hospice 

Quality found at https://

www.regulations.gov/ 

document?D=CMS-2017-0062-000. 

• FY 2018 Hospital Inpatient 

Prospective Payment System for Acute 

Care Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

RFI, found at https://

www.regulations.gov/docket?D=CMS2017-0055. 

• CY 2018 Hospital Outpatient PPS 

Policy Changes and Payment Rates and 

Ambulatory Surgical Center Payment 

System Policy Changes and Payment 

Rates found at https://

www.regulations.gov/docket?D=CMS2017-0091. 

• FY 2018 Inpatient Rehabilitation 

Facility Prospective Payment System 

found at https://www.regulations.gov/ 

document?D=CMS-2017-0059-0002. 

• FY 2018 Inpatient Psychiatric 

Facilities Prospective Payment System 

found at https://www.regulations.gov/ 

document?D=CMS-2017-0105-0002. 

• CY 2018 Revisions to Payment 

Policies under the Physician Fee 

Schedule and Other Revisions to Part B 

found at https://www.regulations.gov/ 

docket?D=CMS-2017-0092. 

• FY 2018 Prospective Payment 

System and Consolidated Billing for 

Skilled Nursing Facilities found at 

https://www.regulations.gov/ 

document?D=CMS-2017-0060-0002. 

Public comments on the RFIs can be 

found by searching for the terms ‘‘RFI’’ 

or ‘‘request for information’’ in the 

aforementioned 2017 payment 

regulation dockets on 

www.regulations.gov. The most useful 

comments will be those that include 

data or evidence to support the position, 

offer suggestions to amend specific 

sections of the existing regulations, or 

offer particular additions. 

Contact: Kianna Banks, 410–786– 

3498. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995 (PRA), we are required to 

provide 60-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 are soliciting public comment on 

each of the section 3506(c)(2)(A)- 


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47716 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Proposed Rules 

required issues for the following 

information collection requirements 

(ICRs). 

A. Wages 

To derive average costs, we used data 

from the U.S. Bureau of Labor Statistics’ 

May 2016 National Occupational 

Employment and Wage Estimates for all 

salary estimates (https://www.bls.gov/ 

oes/2016/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. 

NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES

Occupation title Occupation 

code 

Mean hourly 

wage 

($/hour) 

Fringe 

benefit 

($/hour) 

Adjusted 

hourly wage 

($/hour) 

Healthcare Support Worker ............................................................................. 31–9099 $18.13 $18.13 $36

Physicians and Surgeons ................................................................................ 29–1060 101.04 101.04 202 

Physicians and Surgeons, All Other ................................................................ 29–1069 98.83 98.83 198 

Physicians, Psychiatrists ................................................................................. 29–1066 94.26 94.26 189 

Surgeons .......................................................................................................... 29–1067 121.59 121.59 243 

Registered Nurse (RN—Quality Improvement, Home Care Coordinator, 

HealthCare Trainer, Quality Assurance Nurse, QAPI Nurse Coordinator, 

Infection Control Nurse Coordinator, Psychiatric RN) ................................. 29–1141 34.70 34.70 69 

Medical Secretary (Clerical, Administrative Assistant) .................................... 43–6013 16.85 16.85 34 

Administrative Services Manager (Facility Director) ........................................ 11–3011 47.56 47.56 96 

Management Occupations (Director, Community Relations Manager, Administrator) ......................................................................................................... 11–0000 56.74 56.74 114 

Pharmacist ....................................................................................................... 29–1051 57.82 57.82 115 

Medical and Health Services Manager (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) ............................................ 11–9111 52.58 52.58 105 

Managers, All Others(Administrator) ............................................................... 11–9199 53.92 53.92 108 

* Activities Specialist (Recreational Therapists, Nursing Care Facilities/ 

SNFs) ........................................................................................................... 29–1125 19.92 19.92 40 

Internists (Medical Director, General Physician .............................................. 29–1063 97.04 97.04 194 

Family and General Practitioner (Medical Director) ........................................ 29–1062 96.54 96.54 194 

Physical Therapist (Director of Rehab) ........................................................... 29–1123 41.93 41.93 84 

Healthcare Social Worker (Social Worker) ...................................................... 21–1022 26.69 26.69 53 

Mental Health and Substance Abuse Social Worker (Social Worker) ............ 21–1023 23.02 23.02 46 

Nurse Practitioner (Clinician, Nurse Practitioner Outpatient Care Center) ..... 29–1171 50.30 50.30 101 

Mental Health Counselor ................................................................................. 21–1014 22.14 22.14 44 

Physician Assistant .......................................................................................... 29–1071 49.08 49.08 98 

Licensed Practical and Licensed Vocational Nurses (Director of Nursing) .... 29–2061 21.56 21.56 44 

First Line Supervisors of Office and Administrative Support Workers (Office 

Manager) ...................................................................................................... 43–1011 27.83 27.83 56 

Office Clerks, General (Clerical staff) .............................................................. 43–9061 15.87 15.87 32 

Secretaries and Administrative Assistants (Clerical staff) ............................... 43–6010 19.39 19.39 38 

Chief Executive ................................................................................................ 11–1011 93.44 93.44 186 

* Salary information used is for Nursing Care Facility/SNF industry. As indicated, we are adjusting our employee hourly wage estimates by a 

factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer 

to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and 

we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method. 

B. ICRs Regarding RNHCI Discharge 

Planning (§ 403.736(a) and (b)) 

Section 403.736 will reduce the 

extensive requirements for an RNHCI to 

coordinate with other medical providers 

for post-RNHCI care. The discharge 

evaluation must include an assessment 

of a patient’s capacity for self-care and 

information regarding the care once the 

patient leaves the facility. The nursing 

staff would need to prepare the patient 

and/or their caregiver for discharge. 

Most patients are discharged to home or 

to another facility that adheres to the 

same religious tenets. Although all 

patients must have a discharge planning 

evaluation, not all patients require a 

discharge plan. 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 is paid at mean 

wage of $36, including 100 percent for 

fringe and overhead costs. 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 and/or 

caregiver. We estimate a total of 619 

annual discharges from RNHCIs at a 

savings of $36 per discharge for a total 

savings of $22,284 ($36 × 619 hours). 


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C. ICRs Regarding ASC Governing Body 

and Management (§ 416.41(b)(3)(i) and 

(ii)) 

We propose to eliminate the 

requirements at § 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. 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. 

D. ICR Regarding ASC Medical Records 

(§ 416.47(b)(2)) 

We propose to revise § 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 are 

proposing 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). 

E. ICRs Regarding ASC Patient 

Admission, Assessment and Discharge 

(§ 416.52(a)(1), (2), (3) and (4)) 

At § 416.52 we propose 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 $3,440 per facility ([10 

× $243] + [10 × $69] + [10 × $32]), and 

$19.1 million for all 5,557 facilities. 

Therefore, this proposed requirement 

would increase the information 

collection related burden by $19.1 

million and 166,710 hours (30 hours × 

5,557 facilities) on a one-time basis for 

all ASCs. The information collection 

request will be revised to account for 

the additional burden. 

F. ICRs Regarding Hospice Aide and 

Homemaker Services (§ 418.76) 

At § 418.76(a) we propose to defer to 

State training and competency 

requirements, where they exist, for 

hospice aides. The information 

collection request for the hospice 

requirements (OMB control number 

0938–1067) is currently under review at 

OMB. It 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 

proposed 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 proposed 

change. 

G. ICRs Regarding Drugs and 

Biologicals, Medical Supplies, and 

Durable Medical Equipment 

(§ 418.106(a) and (e)(2)(i)) 

At § 418.106(a) we propose 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, currently under review at 

OMB) 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/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 $115 for a pharmacist, we estimated 

that it would cost a hospice $19 per 

patient ($115 × [5 minutes for initial + 

5 minutes for 1 update]) and an annual 

cost of $6,764 ($19 × 356 patients). The 

total annual burden hours for all 

hospices was estimated to be 264,588 

hours (1,587,527 patients × .1666 hour 

per patient), and the total annual burden 

cost for all hospices was estimated to be 

$30,163,013 ($19 per patient × 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 $30,163,013. 

We assume that, upon 

implementation of the proposed change 

to allow hospices to provide 

information regarding the safe 

maintenance and disposal of controlled 

drugs in a more user-friendly manner, 

hospices would develop understandable 

instructions in layperson terms to 

replace the copy of the policies and 

procedures that is currently provided. 

While the instructions could be created 

in any number of formats, such as a 

slide show, video, podcast, or 

pictograph, for purposes of our analysis 

we assume that hospices would create 

written instructions. We estimate that a 

hospice would use 1 hour of 

administrator time to develop a new 

form at $105 per hour. For all 4,602 

hospices, the total initial cost would be 

$483,210. 

The information collection request 

will be revised and sent to OMB. 


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H. ICRs Regarding Hospices That 

Provide Hospice Care to Residents of a 

SNF/NF or ICF/IID (§ 418.112(c)(10) and 

(f)) 

At § 418.112(f) we propose 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. A hospice 

and SNF/NF or ICF/IID must have a 

written agreement that specifies the 

provision of hospice services in the 

facility. The agreement must be signed 

by authorized representatives of the 

hospices and the SNF/NF or ICF/IID 

prior to the provision of hospice care 

services. The burden associated with 

this requirement is the time and effort 

necessary to develop, draft, sign, and 

maintain the written agreement. As 

stated in the hospice information 

collection request (OMB control number 

0938–1067, currently under review at 

OMB), the use of this type of written 

agreement is a usual and customary 

business practice and the associated 

burden is exempt from the PRA under 

the implementing regulations at 5 CFR 

1320.3(b)(2). However, updating the 

written agreement to address this new 

requirement would not constitute a 

usual and customary business practice; 

therefore, we believe that a one-time 

burden to update the written agreement 

would be imposed by this change. For 

purposes of this analysis only, we 

estimate that each hospice would use 8 

hours of administrator time to revise the 

existing written agreement. At a cost of 

$105 per hour for an administrator to 

complete this task, we estimate that the 

onetime cost per hospice would be 

$840. For all hospices the onetime cost 

would be $3,865,680 (4,602 hospices × 

$840) for 36,816 hours (4,602 hospices 

× 8 hours). The information collection 

request will be revised to account for 

this one time increase in burden and 

sent to OMB. 

I. ICRs Regarding Hospital Quality 

Assessment and Performance 

Improvement (QAPI) Program (§ 482.21) 

We propose a new standard at 

§ 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. 

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 $1,584 annually (8 

burden hours × $198), a QAPI nurse 

coordinator at $552 annually (8 burden 

hours × $69), and a medical secretary at 

$272 annually (8 burden hours × $34). 

We estimate the necessary policy 

changes needed to comply with the 

requirements proposed in this rule 

would cost $2,408 per year ($1,584 + 

$552 + $272) 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. 

J. ICRs Regarding Hospital Medical 

Staff, Medical Records Services, and 

Surgical Services (§§ 482.22, 482.24, 

and 482.51) 

At § 416.52 we propose 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 

this proposed rule, there is a similar 

regulatory requirement for hospital 

outpatient surgery. Based on the 

substantial similarity between these two 

service settings, we propose, through 

the revisions to §§ 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 (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 $1,584 annually (8 

burden hours × $198), a nurse 

coordinator at $552 annually (8 burden 

hours × $69), and a medical secretary at 

$272 annually (8 burden hours × $34). 

We estimate that the necessary policy 

changes needed to comply with the 

requirements proposed in this rule 

would cost $2,408 per year ($1,584 + 

$552 + $272) for each of the 5,031 

hospitals that might choose to exercise 

this option. Therefore, the total annual 

cost for all hospitals to meet these 

information collection requirements 

would be approximately $12.1 million. 

K. ICRs Regarding Hospital Medical 

Staff: Autopsies (§ 482.22)(d)) 

We propose to remove the 

requirement at § 482.22(d), which 

recommends that a hospital’s medical 

staff attempt to secure autopsies in all 

cases of unusual deaths and of medicallegal 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 


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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. 

L. ICRs Regarding Hospital Infection 

Control (§ 482.42) 

We propose a new standard at 

§ 482.42(c), ‘‘Unified and integrated 

infection control program for multihospital 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, were 

given due consideration; (3) had 

mechanisms in place to ensure that 

issues localized to particular hospitals 

were duly considered and addressed; 

and (4) has designated a qualified 

individual(s) with expertise in infection 

prevention and control at the hospital 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. 

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 $1,584 annually (8 

burden hours × $198), an infection 

control nurse coordinator at $552 

annually (8 burden hours × $69), and a 

medical secretary at $272 annually (8 

burden hours × $34). 

We estimate the necessary policy 

changes needed to comply with the 

requirements proposed in this rule 

would cost $2,408 per year ($1,584 + 

$552 + $288) 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. 

M. ICRs Regarding Special 

Requirements for Hospital Providers of 

Long-Term Care Services (‘‘SwingBeds’’) (§ 482.58(b)(1), (4), (5), and (8), 

and Identical CAH requirements: 

§ 485.645(d)(1), (4), (5), and (8)) 

At §§ 482.58(b)(1) and 485.645(d)(1) 

(cross-referenced long-term care 

requirement at § 483.10(f)(9)) we 

propose 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 believe 

this requirement is unduly burdensome 

as we do not expect patient’s receiving 

hospital or CAH swing-bed services 

have an average length of stay long 

enough to be positively impacted by 

providing services to the facility. We 

assume that each of the hospital swingbed providers (478 hospitals) and CAH 

swing-bed providers (1,246 CAHs) has 

an activities specialist employed at $40 

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 

million for all hospital and CAH swingbed providers, or $16,821 per hospital 

or CAH swing-bed provider (1,724 

hospital and CAH swing-bed providers 

× $40 an hour for an activities specialist 

× 8 hours per week × 52 weeks per year), 

which are the cost savings to the 

providers as a result of the removal of 

this requirement. 

At § 482.58(b)(4) (and § 485.645(d)(4)) 

(cross-referenced long-term care 

requirement at § 483.24(c)), we propose 

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 

§ 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 $40 per 

hour. CAHs are required to provide 

activity services by either a qualified 

individual who meet the requirements 

of § 483.24(c)(2), or by an individual on 

the facility staff who is designated as the 

activities director and who serves in 

consultation with a therapeutic 

recreation specialist, occupational 

therapist, or other professional with 

experience or education in recreational 

therapy. For the purpose of this 

analysis, we assume that the cost of 

each would be the same due to the rural 

location of CAHs. 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 $72 million for all 

hospital and CAH swing-bed providers, 

or $41,800 per hospital or CAH swingbed provider (1,724 hospital and CAH 

swing-bed providers × $40 an hour for 

an activities specialist × 1,040 hours per 

year) which are the cost savings to the 

providers. Our analysis assumes that the 

reduced staffing is largely for part-time 

work assignment (1,040 hours annually) 

at hospital and CAH swing-bed 

providers. It is likely that many of the 

actual persons holding these positions 

were full-time workers not devoted 

solely to recreational therapy, whose 

hours will simply be reassigned to other 

functions, with providers ultimately 

saving these full-time equivalent hours 

through ripple effects on an even wider 

range of staffing functions through 

turnover over time. 

We propose to remove the 

requirement at §§ 482.58(b)(5) and 

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term care requirement at § 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 §§ 482.58(b)(8) and 485.645(d)(8) 

(cross-referenced long-term care 

requirement at § 483.55(a)(1)) we 

propose 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 § 482.12(f)(2) for hospitals, 

and at § 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 

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 swingbed providers, or $1,682 per hospital or 

CAH swing-bed provider (1,724 hospital 

and CAH swing-bed providers × $69 an 

hour for a RN × 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). 

N. ICRs Regarding Special Requirements 

for Psychiatric Hospitals (§ 482.61(d)) 

At § 482.61(d) we propose to clarify 

the requirement allowing non-physician 

practitioners to document progress 

notes in accordance with State laws and 

scope of practice requirements. We 

believe this would apportion the burden 

associated with having MDs/DOs 

document their progress notes in 

psychiatric hospitals with nonphysician practitioners and will 

decrease costs associated with this 

activity. 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 the 

progress notes for patients receiving 

services in psychiatric hospitals, we are 

attributing ICR burden savings for this 

provision. For purposes of this analysis 

only, we estimate that MDs/DOs spend 

approximately 30 minutes documenting 

progress notes in psychiatric hospitals. 

We estimate that 33 percent of this time 

would be covered by non-physician 

practitioners. Of the 5,031 Medicare 

participating hospitals, 574 (or 11 

percent) are psychiatric hospitals. 

According to AHA, there were 

35,061,292 inpatient hospital stays in 

2015, and an estimated 11 percent of 

these stays were at psychiatric hospitals. 

The proposed change would result in a 

savings of $62.4 million (3,856,742 

psychiatric hospital stays × 0.5 hours of 

physician/psychiatrist time × $98 per 

hourly wage difference between 

physicians/psychiatrists ($198) and 

non-physician practitioners ($100, the 

average wage between nurse 

practitioners and physician assistants) × 

33 percent of physician time spent 

writing progress notes covered by nonphysician practitioners). This savings is 

equivalent to $108,647 per psychiatric 

hospital per year. 

O. ICRs Regarding Special Requirement 

for Transplant Centers and Definitions 

(§§ 482.68 and 482.70) 

We are proposing a nomenclature 

change at part 482 and the transplant 

center regulations at §§ 482.68, 482.70, 

482.72 through 482.104, and at § 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. 

P. ICRs Regarding Data Submission, 

Clinical Experience, and Outcome 

Requirements for Re-Approval of 

Transplant Centers (§ 482.82) 

Section 482.82 requires that, except as 

specified in § 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. The required data 

submissions include, but are not limited 

to, submission of the appropriate OPTN 

forms for transplant candidate 

registration, transplant recipient 

registration and follow up, and living 

donor registration and follow up. 

Furthermore, § 482.82(b) requires 

transplant centers to perform an average 

of 10 transplants per year during the 

prior 3 years and § 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. However, as 

required by §§ 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 § 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 

additional collection of information 

burden on transplant programs. We 

describe additional life-saving benefits 

that result from the removal of this 

proposal in the subsequent RIA section. 

Q. ICRs Regarding Special Procedures 

for Approval and Re-Approval of Organ 

Transplant Centers (§ 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 

proposing to remove the requirements at 

§ 488.61(f) through (h) for mitigating 


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factors and transplant systems 

improvement agreements for the reapproval process for transplant centers. 

This change is complementary to the 

proposed removal of § 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 

§ 488.61(f) through (h) for the reapproval process. Therefore, we 

estimate that the requirements under 

§ 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 § 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 2. 

TABLE 2—ANNUAL BURDEN HOURS AND COST FOR TRANSPLANT PROGRAMS TO SUBMIT MITIGATING FACTORS FOR REAPPROVAL

Position Hourly wage Hours required Total 

cost estimate 

Medical Director ........................................................................................................................... $194 2 $388 

Transplant Program Senior Administrator ................................................................................... 105 2 210 

Hospital Administrator .................................................................................................................. 105 1 105 

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 × 14 programs) at a cost of $9,842 

($703 × 14 programs). In the context of 

this proposed rule, 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 § 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. The 

agreement would require hospitals to 

complete certain tasks as listed and 

described in § 488.61(h)(1), which 

include (but are not limited to): Patient 

notification about the degree and type of 

noncompliance by the program, an 

explanation of what the program 

improvement efforts mean for patients 

and financial assistance to defray the 

out-of-pocket costs of copayments and 

testing expenses for any wait-listed 

individual who wishes to be listed with 

another program, an external 

independent peer review team that 

conducts an onsite assessment of the 

program, an action plan that addresses 

systemic quality improvements and is 

updated after the onsite peer review, an 

onsite consultant who provides services 

for 8 days per month on average for the 

duration of the agreement, a 

comparative effectiveness analysis that 

compares policies, procedures, and 

protocols of the transplant program with 

those of other programs in areas of 

endeavor that are relevant to the center’s 

current quality improvement needs, 

amongst other requirements listed in 

§ 488.61(h)(1)(i) through (x). 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 

§ 488.61(h)(1) as required by the terms 

in the systems improvement agreement), 

as described in Table 3. 

TABLE 3—ANNUAL BURDEN HOURS AND COST FOR TRANSPLANT PROGRAMS TO ENTER INTO A SYSTEMS IMPROVEMENT

AGREEMENT FOR RE-APPROVAL

Position Hourly wage Hours required Total 

cost estimate 

Medical Director ........................................................................................................................... $194 4 $776 

Transplant Program Senior Administrator ................................................................................... 105 4 420 

Hospital Administrator .................................................................................................................. 105 2 210 

Administrative Assistant ............................................................................................................... 34 4 136 

Totals .................................................................................................................................... ........................ 14 1,542 

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 × 14 programs) at a cost of 

$21,588 ($1,542 × 14 transplant 

programs). In the context of this 

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 $21,588. 

R. ICRs Regarding HHA Home Health 

Aide Services (§ 484.80(h)(3)) 

We propose to eliminate the 

requirement at § 484.80(h)(3) that the 

HHA conduct a full competency 

evaluation of deficient home health 


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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. 

The content of an aide competency 

examination does not have an 

associated collection of information 

requirement. Therefore, this proposed 

change would neither impose nor 

remove any collection of information 

burdens. 

S. ICRs Regarding HHA Clinical Records 

(§ 484.110(e)) 

We propose to remove the 

requirement at § 484.110(e) related to 

providing a requested copy of 

information contained in the clinical 

record at the next home visit, while 

retaining the requirement to provide the 

record within 4 business days. As stated 

in the January 2017 HHA CoP final rule 

(82 FR 4568 and 4575), we believe that 

providing such information to patients 

is a usual and customary practice that 

does not impose a burden upon HHAs 

and would not be subject to the PRA in 

accordance with the implementing 

regulations of the PRA at 5 CFR 

1320.3(b)(2). As such, removing the 

‘‘next home visit’’ timeframe 

requirement would not result in a 

savings of burden hours or dollars. 

T. ICRs Regarding CORF Utilization 

Review Plan (§ 485.66) 

We propose 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 

$1,644 per facility ($548 × 3 quarters), 

and a combined total savings of 

$309,072 for all CORFs ($1644 × 188 

CORFs). We will submit the revised 

information collection request to OMB 

for approval. 

TABLE 4—CORF—HOURLY WAGES AND BURDEN HOURS

Position Hourly wage 

per CORF * 

Burden hours 

per 

CORF 

Cost estimate 

per CORF 

Administrator ................................................................................................................................ $105 2 $210 

Clerical Staff ................................................................................................................................ 32 2 64 

Physical Therapist ....................................................................................................................... 84 2 168 

Social Worker .............................................................................................................................. 53 2 106 

Total ...................................................................................................................................... 274 8 548 

* Includes 100% fringe benefits & overhead costs. 

U. ICRs Regarding CAH Organizational 

Structure (§ 485.627(b)(1)) 

As of May 2017, there were 1,343 

CAHs that are certified by Medicare. 

Our proposed revision of the CAH 

disclosure requirements imposed on 

CAHs would remove 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. While we estimate that 

these changes occur at 2 CAHs per year 

on average between all 1,343 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. In accordance with 

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 proposal will save all CAHs 

an estimated $141,000 and will save 

each CAH $105 (1-burden hour for an 

administrator at $105 per hour × 1,343 

CAHs). We will submit the revised 

information collection request to OMB 

for approval (OMB control number 

0938–0328). 

V. ICRs Regarding CAH Provision of 

Services (§ 485.635(a)(4)) 

Section 485.635(a)(4) requires CAHs 

to conduct an annual review of all its 

policies and procedures. Based on 

feedback from stakeholders, the 

prescriptive annual schedule is 

burdensome or, in some situations, 

ineffective. Our proposed 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 propose 

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 

$1,956.10 per facility, and a combined 

total savings of $2.6 million for CAHs 

($1,956.10 × 1,343 CAHs). 

We estimate that the CAH staff time 

and associated costs would be assigned 

to a biennial review as shown in Table 

5. 

TABLE 5—HOURLY WAGES AND BURDEN HOURS

Position Hourly wage 

per CAH 

Burden hours 

per CAH 

Cost estimate 

per CAH 

Administrator ................................................................................................................................ $186.88 4 $747.52 

Clerical staff ................................................................................................................................. 38.78 3 116.34 

Registered Nurse ......................................................................................................................... 69.40 3 208.20 


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TABLE 5—HOURLY WAGES AND BURDEN HOURS—Continued 

Position Hourly wage 

per CAH 

Burden hours 

per CAH 

Cost estimate 

per CAH 

Nurse practitioner ........................................................................................................................ 100.60 3 301.80 

Physician ...................................................................................................................................... 194.08 3 582.24 

Totals .................................................................................................................................... 589.74 16 1,956.10 

W. ICRs Regarding Special 

Requirements for CAH Providers of 

Long-Term Care Services (‘‘SwingBeds’’) (§ 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 under 

section L of this part. 

X. ICRs Regarding CMHCs (§ 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 

propose to modify the requirement at 

§ 485.914(d) to remove the 30-day 

assessment update time frame for those 

clients who do not receive PHP services. 

Instead of a fixed 30-day time frame, 

assessment updates would be completed 

when changes in the client’s status, 

responses to treatment, or goal 

achievement have occurred, and in 

accordance with current standards of 

practice. The burden associated with 

these requirements is the time required 

to record an updated assessment. The 

current information collection request 

(OMB Control number 0938–1245) does 

not account for any information 

collected related to the burden 

associated with updating the 

comprehensive assessment requirement. 

While in the past we believed that this 

is considered usual and customary 

practice, recent comments from the 

CMHC provider community, submitted 

in response to CMS’ solicitation for 

public comments pertaining to burden 

reduction suggestions, stated that it is 

not usual and customary to update 

assessments for non-PHP clients on a 30 

day schedule as required by the CMHC 

regulations. The commenters stated that 

the 30 day requirement was overly 

burdensome, and suggested that the 

CMHC assessment update requirement 

should more closely align with the 

patient-oriented approach of other 

entities that govern CMHC operations. 

Upon further consideration, we agreed 

with the commenter that the 30 day 

requirement does, in fact, impose a 

burden and is not usual and customary 

practice. Therefore, removing this 

requirement would reduce information 

collection burden for CMHCs. 

Under the current 30-day time frame 

requirement, each client receives an 

updated assessment 12 times per year. 

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 52 

Medicare participating CMHCs serving 

3,122 Medicare beneficiaries and an 

estimated 2,080 non-Medicare clients, 

for an average of 100 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 60 beneficiaries per 

CMHC. We then assumed that, in order 

to comply with the 40 percent 

requirement (§ 485.918(b)(1)(v)), those 

60 beneficiaries only accounted for 60 

percent of an average CMHC’s total 

patient population. This means that an 

average CMHC also treated another 40 

clients who did not have Medicare as a 

payer source, for a total of 100 clients 

(Medicare + non-Medicare) in an 

average CMHC. Therefore, all CMHCs 

combined would have approximately 

2,080 non-PHP clients per year (40 per 

CMHC), and approximately 20,800 

assessments would be reduced 

nationwide per year (2,080 patients × 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 

3,466 hours nationwide (1,666 hours × 

20,800 assessment updates). At a cost of 

$7.33 for a mental health counselor to 

document each assessment, the total 

cost savings would be $152,464 ($7.33 

× 20,800 assessments). 

Y. ICRs Regarding Portable X-Ray 

Services (§§ 486.104(a) and 486.106(a)) 

We propose to revise the requirements 

for portable x-ray technologist personnel 

qualifications at § 486.104 to align the 

current requirements at § 486.104(a)(1), 

(2), (3), and (4) with those for hospital 

radiologic technologists at § 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 

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 propose to revise the requirements 

for portable x-ray orders at 

§ 486.106(a)(2). We propose to remove 

the requirement that physician or nonphysician practitioner’s orders for 

portable x-ray services must be written 

and signed. We also propose 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 proposed changes would simplify 

the ordering process for portable x-rays 

and promote the use of more efficient 

ordering methods, such as electronic 

orders. 

This change would allow for portable 

x-ray services to be ordered in writing, 

by telephone, or by electronic methods. 

The change would also streamline the 

ordering process by avoiding the need to 

write two separate orders for the same 

study, one to meet the Medicare 

payment requirements in accordance 

with § 410.32 and its associated Manual 

guidance, and another to meet the 

content requirements of the regulation 

set forth at § 486.106. We believe the 

proposed change would allow for 

additional ordering flexibility to 

streamline ordering practices. In the 

information collection request (OMB 

control number 0938–0338) we estimate 


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that the current order requirements 

would impose the following burdens: 

• 3 minutes to write an order × 

3,986,000 portable x-rays exams ordered 

= 199,300 hours × $69/hour for a nurse 

= $13,751,700. 

• $1 for printing and faxing verbal 

orders to physician offices for signature 

× 2,500,000 verbal orders = $2,500,000. 

• 2,000,000 follow-up calls regarding 

the status of faxes × 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 × $32/hour = 

$10,666,656. 

All of these burdens would be 

eliminated by revising the current 

ordering standards. Therefore, we 

estimate a proposed information 

collection savings of $26,918,356 from 

this proposed change. 

Z. ICRs Regarding RHC and FQHC 

Provision of Services (§ 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, so to be as 

accurate as possible, our burden 

reduction calculations are based on the 

most recent data available, which shows 

that as of May 2017, there were 4,160 

RHCs 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 propose to revise § 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 

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 a review 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 $592 per facility (see Table 6) 

for a combined total savings of $7.1 

million for 12,034 RHCs or FQHCs 

($592 × 12,034 RHCs and FQHCs). We 

will submit a revised information 

collection request to OMB for approval. 

TABLE 6—HOURLY WAGES AND BURDEN HOURS

Position 

Hourly wage 

per 

RHC/FQHC 

(Includes 

100% benefit 

package) 

Burden hours 

per 

RHC/FQHC 

Cost estimate 

per 

RHC/FQHC 

Physician ...................................................................................................................................... $198 2 $396 

Mid-Level Provider (PA or NP) .................................................................................................... 98 2 196 

Total ...................................................................................................................................... 296 4 592 

AA. ICRs Regarding RHC and FQHC 

Program Evaluation (§ 491.11(a)) 

We propose to revise § 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 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 a hourly savings of 72,204 total 

hours and a cost savings of $802 per 

facility (see Table 7), for a combined 

total savings of $9.7 million for 12,034 

RHCs or FQHCs ($802 × 12,034 RHC 

and FQHC locations). 

TABLE 7—HOURLY WAGES AND BURDEN HOURS

Position 

Hourly wage 

per 

RHC/FQHC 

(Includes 

100% benefit 

package) 

Burden hours 

per RHC/ 

FQHC 

Cost estimate 

per 

RHC/FQHC 

Administrator/Health Services Manager ...................................................................................... $105 2 $210 

Physician ...................................................................................................................................... 198 2 396 

Mid-Level Provider (PA or NP) .................................................................................................... 98 2 196.00 

Total ...................................................................................................................................... 401 6 802 


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BB. ICRs Regarding Emergency 

Preparedness for Providers and 

Suppliers 

1. Review of the Emergency 

Preparedness Program 

At § 482.15(a), (b), (c), and (d) for 

hospitals and parallel regulatory 

citations for other facilities, we propose 

to allow providers to review their 

program at least every 2 years. As of 

May 2017, there were approximately 

74,246 total 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 2016 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 a total annual cost savings 

of $94,312,719 and 187 burden hours 

saved. We list a detailed calculation for 

each facility below, based on facility 

numbers available as of May 2017: 

• RNHCIs: Combined total savings of 

$9,540 for 18 RNHCIs ((8 burden hours 

for an administrator at $105 plus 5 

burden hours for a director of nursing at 

$44 per hour) × 18 RNHCIs × 50 

percent). 

• ASCs: Combined total savings of 

$6,134,928 for 5,557 ASCs ((8 burden 

hours for an administrator at $108 per 

hour plus 4 burden hours for a 

physician at $198 per hour plus 8 

burden hours for a quality improvement 

RN at $69 per hour) × 5,557 ASCs × 50 

percent). 

• Hospices: Combined total savings of 

$5,781,832 for 4,489 hospice facilities 

((8 burden hours for an administrator at 

an hourly wage of $105 per hour plus 

4 burden hours for a physician at $198 

per hour plus 4 burden hours for a 

counselor at $44 per hour plus 4 burden 

hours for a social worker at $54 per hour 

plus 8 burden hours for a RN at $69 per 

hour) × 4,489 hospices × 50 percent). 

• PRTFs: Combined total savings of 

$556,512 for 374 PRTFs ((8 burden 

hours for an administrator $105 per our 

plus 8 burden hours for a physician at 

$198 per hour plus 8 burden hours for 

a RN at $69 per hour) × 374 PRTFs × 50 

percent). 

• PACE: Combined total savings of 

$226,476 for 233 PACE organizations ((8 

burden hours for an administrator at 

$105 per hour plus 8 burden hours for 

a home care coordinator at $69 per hour 

plus 8 burden hours for a RN at $69 per 

hour) × 233 PACE organizations × 50 

percent). 

• Hospitals: Combined total savings 

of $11,933,532 for 5,031 hospitals ((8 

burden hours for an administrator at 

$108 per hour plus 8 burden hours for 

a physician at $198 per hour plus 8 

burden hours for a risk management 

director at $105 per hour plus 8 burden 

hours for a quality assurance nurse at 

$69 per hour plus 8 burden hours for a 

facility director at $96 per hour plus 4 

burden hours for a medical secretary at 

$34 per hour) × 5,031 hospitals × 50 

percent). 

• LTCF: Combined total savings of 

$25,562,016 for 15,663 LTCF facilities 

((8 burden hours for an administrator at 

$105 per hour plus 8 burden hours for 

a physician at $198 per hour plus 8 

burden hours for a director of nursing at 

$105 per hour) × 15,663 LTCFs × 50 

percent). 

• ICF/IID: Combined total savings 

$3,402,126 for 6,097 ICF/IIDs ((8 burden 

hours for an administrator at $105 per 

hour plus 4 burden hours for a RN $69 

per hour) × 6,097 ICF/IIDs × 50 percent). 

• HHA: Combined total savings of 

$16,259,712 for 12,624 HHAs ((8 burden 

hours for an administrator at $105 per 

hour plus 8 burden hours for a nursing 

director at $105 per hour plus 8 burden 

hours for a director of rehab at $84 per 

hour plus 4 burden hours for an office 

manager at $56 per hour) × 12,624 

HHAs × 50 percent). 

• CORF: Combined total savings of 

$142,128 for 188 CORFs ((8 burden 

hours for an administrator at $105 per 

hour plus 8 burden hours for a physical 

therapist at $84 per hour) × 188 CORFs 

× 50 percent). 

• CAH: Combined total savings of 

$1,643,832 for 1,343 CAHs ((8 burden 

hours for an administrator at $105 per 

hour plus 8 burden hours for a director 

of nursing at $105 per hour plus 8 

burden hours for a facility director at 

$96 per hour) × 1,343 CAHs × 50 

percent). 

• Organizations: Combined total 

savings of $1,220,688 for 2,076 

Organizations ((8 burden hours for an 

administrator at $105 per hour plus 4 

burden hours for a physical therapist at 

$84 per hour) × 2,076 Organizations × 

50 percent). 

• CMHCs: Combined total savings of 

$146,832 for 161 CMHCs ((8 burden 

hours for an administrator at $105 per 

hour plus 8 burden hours for a RN at 

$69 per hour plus 8 burden hours for a 

social worker at $54 per hour) × 161 

CMHCs × 50 percent). 

• OPOs: Combined total savings of 

$119,016 for 58 OPOs ((8 burden hours 

for an OPO director at $105 per hour 

plus 8 burden hours for a physician at 

$198 per hour plus 8 burden hours for 

a QAPI director at $105 per hour plus 

8 burden hours for an organ 

procurement coordinator at $105 per 

hour) × 58 OPOs × 50 percent). 

• RHC/FQHC: Combined total savings 

of $9,916,016 ((8 burden hours for an 

administrator at $105 per hour plus 8 

burden hours for a nurse practitioner/ 

physician assistant at $101 per hour) × 

4,160 RHCs × 50 percent) $3,427,840 + 

((8 burden hours for an administrator at 

$105 per hour plus 8 burden hours for 

a nurse practitioner/physician assistant 

at $101 per hour × 7,874 FQHCs × 50 

percent) $6,488,176). 

• ESRD Facilities: Combined total 

savings of $11,064,392 for 6,898 dialysis 

facilities ((8 burden hours for an 

administrator at $105 per hour plus 8 

burden hour for a medical director/ 

physician at $198 per hour plus 8 

burden hours for a nurse manager at 

$105) × 6,898 dialysis facilities × 50 

percent) as shown in Table 8. 


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TABLE 8—COST SAVINGS FOR ANNUAL REVIEW OF EMERGENCY PREPAREDNESS PLAN

Provider/supplier 

Cost savings 

per provider/ 

supplier 

Combined total savings 

RNHCIs ..................................................... $530 $9,540 for 18 RNHCIs. 

ASCs ......................................................... 1,104 $6,134,928 for 5,557 ASCs. 

Hospices ................................................... 1,288 $5,781,832 for 4,489 hospice facilities both inpatient and freestanding/home based. 

PRTFs ....................................................... 1,488 $556,512 for 374 PRTFs. 

PACEs ...................................................... 972 $226,476 for 233 PACEs. 

Hospitals ................................................... 2,372 $11,933,532 for 5,031 hospitals. 

LTCFs ....................................................... 1,632 $25,562,016 for 15,663 LTCFs. 

ICFs/IIDs ................................................... 558 $3,402,126 for 6,097 ICF/IIDs. 

HHAs ......................................................... 1,288 $16,259,712 for 12,624 HHAs. 

CORFs ...................................................... 756 $142,128 for 188 CORFs. 

CAHs ......................................................... 1,224 $1,643,832 for 1,343 CAHs. 

Organizations ............................................ 588 $1,220,688 for 2,076 Organizations. 

CMHCs ..................................................... 912 $146,832 for 161 CMHCs. 

OPOs ........................................................ 2,052 $119,016 for 58 OPOs. 

RHCs/FQHCs ........................................... 824 $9,916,016 for RHCs and FQHCs ($3,427,840 for 4,160 RHCs and $6,488,176 for 

7,874 FQHCs). 

ESRD Facilities ......................................... 1,6332 $11,257,536 for 6,898 dialysis facilities. 

2. Contents of the Emergency Plan 

At § 482.15(a)(4) for hospitals, and 

other parallel citations for the facilities 

mentioned in section II.J.2 of this 

proposed rule, we propose 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. 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 TJCaccredited 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 

2016 BLS salary data, we calculate an 

hourly mean wage of $105 for an 

administrator, a PACE Program Director, 

or QAPI director and a cost savings of 

$105 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 ($105 

hourly mean wage × 1 burden hour). For 

non-TJC accredited hospitals, we 

estimate an hourly mean wage of $114 

for a community relations manager, and 

a $114 cost per facility ($114 × 1 hour). 

Therefore, we estimate the following for 

each facility affected by the proposed 

change, for a total savings of $7,179,117 

and 18 burden hours. We list a summary 

of the calculation for savings accrued by 

removing this requirement for each 

facility in Table 9, based on facility 

numbers available as of May 2017. 

TABLE 9—COST SAVINGS: DOCUMENTATION OF THE FACILITY’S PARTICIPATION IN COLLABORATIVE AND COOPERATIVE

PLANNING EFFORTS

Provider/supplier 

Cost savings 

per provider/ 

supplier 

Combined total savings 

RNHCIs ..................................................... $105 $1,890 for 18 RNHCIs. 

ASCs (Non-TJC accredited) ..................... 105 $522,375 for 4,975 non-TJC accredited ASCs. 

Hospices ................................................... 105 $471,345 for 4,489 hospice facilities both inpatient and freestanding/home based. 

PRTFs ....................................................... 105 $39,270 for 374 PRTFs. 

PACEs ...................................................... 105 $24,465 for 233 PACEs. 

Hospitals (Non-TJC accredited) ................ 114 $157,662 for 1,383 non-TJC accredited hospitals. 

LTCFs ....................................................... 105 $1,644,615 for 15,663 LTCFs. 

ICFs/IIDs ................................................... 105 $640,185 for 6,097 ICF/IIDs. 

HHAs ......................................................... 105 $1,325,520 for 12,624 HHAs. 

CORFs ...................................................... 105 $19,740 for 188 CORFs. 

CAHs (Non-TJC accredited) ..................... 105 $103,215 for 983 non-TJC accredited CAHs. 

Organizations ............................................ 105 $217,980 for 2,076 Organizations. 

CMHCs ..................................................... 105 $16,905 for 161 CMHCs. 

OPOs ........................................................ 105 6,090 for 58 OPOs. 

RHCs/FQHCs ........................................... 105 $1,263,570 for RHCs and FQHCs ($436,800 for 4,160 RHCs and $826,770 for 

7,874 FQHCs). 


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TABLE 9—COST SAVINGS: DOCUMENTATION OF THE FACILITY’S PARTICIPATION IN COLLABORATIVE AND COOPERATIVE

PLANNING EFFORTS—Continued 

Provider/supplier 

Cost savings 

per provider/ 

supplier 

Combined total savings 

ESRD Facilities ......................................... 105 $724,290 for 6,898 dialysis facilities. 

3. Training 

At § 482.15(d)(1)(ii) for hospitals, and 

other parallel citations for other 

facilities mentioned in section II.J.2 of 

this proposed rule, we propose to 

require that facilities provide training 

biennially, or every 2 years, after 

facilities conduct initial training on 

their emergency program. In addition, 

we propose to require additional 

training when the emergency plan is 

significantly updated. We believe that 

the annual training requirement is too 

prescriptive as annual may not always 

be necessary. We propose to maintain 

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 would 

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. 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 2016 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 a total annual cost savings 

of $33,267,864 and 111 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 10: 

• RNHCIs: Combined total savings of 

$3,870 for 18 RNHCIs ((2 burden hours 

for an administrator at $105 plus 5 

burden hours for a director of nursing at 

$44 per hour) × 18 RNHCIs × 50 

percent). 

• ASCs: Combined total savings of 

$1,258660 for 5,557 ASCs ((1 burden 

hour for an administrator at $108 per 

hour plus 5 burden hours for a quality 

improvement RN at $69 per hour) × 

5,557 ASCs × 50 percent). 

• Hospices: Combined total savings of 

$929,223 for 4,489 hospice facilities (6 

burden hours for a RN at $69 per hour 

× 4,489 hospices × 50 percent). 

• PRTFs: Combined total savings of 

$129,030 for 374 PRTFs (10 burden 

hours for a RN at $69 per hour × 374 

PRTFs × 50 percent). 

• PACE: Combined total savings of 

$96,462 for 233 PACE organizations (3 

burden hours for a home care 

coordinator at $69 per hour plus 9 

burden hours for a RN at $69 per hour 

× 233 PACE organizations × 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 $2,015,031 for 

1,383 non-TJC accredited hospitals (2 

burden hours for an administrator at 

$108 per hour plus 6 burden hours for 

a risk management director at $105 per 

hour plus 28 hours for a healthcare 

trainer (RN) at $69 per hour plus 4 

burden hours for a medical secretary at 

$34 per hour × 1,383 hospitals × 50 

percent). 

• LTCF: Combined total savings of 

$8,223,075 for 15,663 LTCFs (2 burden 

hours for an administrator at $105 per 

hour plus 8 burden hours for a director 

of nursing at $105 per hour × 15,663 

LTCFs × 50 percent). 

• ICF/IID: Combined total savings 

$1,691,918 for 6,097 ICF/IIDs (2 burden 

hours for an administrator at $105 per 

hour plus 5 burden hours for a RN $69 

per hour × 6,097 ICF/IIDs × 50 percent). 

• HHA: Combined total savings of 

$7,902,624 for 12,624 HHAs (2 burden 

hours for an administrator at $105 per 

hour plus 2 burden hours for a nursing 

director at $105 per hour plus 2 burden 

hours for a director of rehab at $84 per 

hour plus 2 burden hours for an office 

manager at $56 per hour plus 8 burden 

hours for a director of training at $69 × 

12,624 HHAs × 50 percent). 

• CORF: Combined total savings of 

$73,038 for 188 CORFs (5 burden hours 

for an administrator at $105 per hour 

plus 3 burden hours for a physical 

therapist at $84 per hour × 188 CORFs 

× 50 percent). 

• CAH: Combined total savings of 

$968,974 for 1,343 CAHs (2 burden 

hours for an administrator at $105 per 

hour plus 9 burden hours for a director 

of nursing at $105 per hour plus 3 

burden hours for a facility director at 

$96 per hour × 1,343 CAHs × 50 

percent). 

• Organizations: Combined total 

savings of $828,324 for 2,076 

Organizations (6 burden hours for an 

administrator at $105 per hour plus 2 

burden hours for a physical therapist at 

$84 per hour × 2,076 Organizations × 50 

percent). 

• CMHCs: Combined total savings of 

$55,545 for 161 CMHCs (10 burden 

hours for a psychiatric RN at $69 per 

hour × 161 CMHCs × 50 percent). 

• OPOs: Combined total savings of 

$111,012 for 58 OPOs (2 burden hours 

for a director at $114 per hour plus 2 

burden hours for a medical director/ 

physician at $198 per hour plus 12 

burden hours for a QAPI director at 

$105 per hour plus 8 hours for an organ 

procurement coordinator at $105 per 

hour plus 16 burden hours for an 

education coordinator at $69 per hour × 

58 OPOs × 50 percent). 

• RHC/FQHC: Combined total savings 

of $6,125,306 ((2 burden hours for an 


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administrator at $105 per hour plus 8 

burden hours for a nurse practitioner/ 

physician assistant at $101 per hour × 

4,160 RHCs × 50 percent) $2,117,440 + 

(2 burden hours for an administrator at 

$105 per hour plus 8 burden hours for 

a nurse practitioner/physician assistant 

at $101 per hour × 7,874 FQHCs × 50 

percent) $4,007,866). 

• ESRD Facilities: Combined total 

savings of $2,855,772 for 6,898 dialysis 

facilities (3 burden hours for an 

administrator at $105 per hour plus 1 

burden hour for a medical director/ 

physician at $198 per hour plus 3 

burden hours for a nurse manager at 

$105 × 6,898 dialysis facilities × 50 

percent). 

TABLE 10—COST SAVINGS: TRAINING

Provider/supplier 

Cost savings 

per provider/ 

supplier 

Combined total savings 

RNHCIs ..................................................... $215 $3,870 for 18 RNHCIs. 

ASCs ......................................................... 226 $1,258,660 for 5,557 ASCs. 

Hospices ................................................... 207 $929,223 for 4,489 hospice facilities both inpatient and freestanding/home based. 

PRTFs ....................................................... 345 $129,030 for 374 PRTFs. 

PACEs ...................................................... 414 $96,462 for 233 PACE organizations. 

Hospitals (Non-TJC accredited) ................ 1,457 $2,015,031 for 1,383 non-TJC accredited hospitals. 

LTCFs ....................................................... 525 $8,223,075 for 15,663 LTCFs. 

ICFs/IIDs ................................................... 278 $1,691,918 for 6,097 ICF/IIDs. 

HHAs ......................................................... 626 $ 7,902,624 for 12,624 HHAs. 

CORFs ...................................................... 389 $73,038 for 188 CORFs. 

Organizations ............................................ 399 $828,324 for 2,076 Organizations. 

CAHs ......................................................... 721 $968,974 for 1,343 CAHs. 

CMHCs ..................................................... 345 $55,545 for 161 CMHCs. 

OPOs ........................................................ 1,914 $1111,012 for 58 OPOs. 

RHCs/FQHCs ........................................... 509 $6,125,306 for RHCs and FQHCs ($2,117,440 for 4,160 RHCs and $4,007,866 for 

7,874 FQHCs). 

ESRD Facilities ......................................... 414 $2,855,772 for 6,898 dialysis facilities. 

4. Testing 

Finally, at § 482.15(d)(2), we propose 

to require that providers of inpatient 

services mentioned in section II.J.2 of 

this proposed 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 estimate that revising 

this requirement to include additional 

options for the types testing exercises 

that may be conducted for one of the 

two annually required exercises will 

provide greater flexibility for these 

providers. 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 would not result in a savings of 

burden hours or dollars. 

We propose to require that providers 

of outpatient services mentioned in 

section II.J.2 of this proposed rule 

conduct one testing exercise annually 

which must be either a communitybased 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 2016 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 $9,117,425 and 25 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 11: 

• ASCs: Combined total savings of 

$1,066,944 for 5,557 ASCs ((1 burden 

hour for an administrator at $108 per 

hour plus 4 burden hours for a quality 

improvement RN at $69 per hour) × 

5,557 ASCs × 50 percent). 

• Freestanding/home-based hospices: 

Combined total savings of $557,520 for 

4,040 hospice facilities (4 burden hours 

for a RN at $69 per hour × 4,040 

hospices × 50 percent). 

• PACE: Combined total savings of 

$40,193 for 233 PACE organizations (4 

burden hours for a home care 

coordinator at $69 per hour plus 1 

burden hours for a RN at $69 per hour 

× 233 PACE organizations × 50 percent). 

• HHA: Combined total savings of 

$3,970,248 for 12,624 HHAs (1 burden 

hour for an administrator at $105 per 

hour plus 3 burden hours for a nursing 

director at $105 per hour plus 1 burden 

hours for a director of rehab at $84 per 

hour plus 1 burden hour for an office 

manager at $56 per hour plus 1 burden 

hours for a director of training at $69 × 

12,624 HHAs × 50 percent). 

• CORF: Combined total savings of 

$55,272 for 188 CORFs (4 burden hours 

for an administrator at $105 per hour 

plus 2 burden hours for a physical 

therapist at $84 per hour × 188 CORFs 

× 50 percent). 

• Organizations: Combined total 

savings of $305,172 for 2,076 

organizations (2 burden hours for an 

administrator at $105 per hour plus 1 


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burden hour for a physical therapist at 

$84 per hour × 2,076 organizations × 50 

percent). 

• CMHCs: Combined total savings of 

$22,218 for 161 CMHCs (4 burden hours 

for a psychiatric RN at $69 per hour × 

161 CMHCs × 50 percent). 

• OPOs: Combined total savings of 

$12,673 for 58 OPOs (3 burden hours for 

a QAPI director at $105 per hour plus 

2 burden hours for an education 

coordinator at $69 per hour × 58 OPOs 

× 50 percent). 

• RHC/FQHC: Combined total savings 

of $3,086,721 ((2 burden hours for an 

administrator at $105 per hour plus 3 

burden hours for a nurse practitioner/ 

physician assistant at $101 per hour × 

4,160 RHCs × 50 percent) + (2 burden 

hours for an administrator at $105 per 

hour plus 3 burden hours for a nurse 

practitioner/physician assistant at $101 

per hour × 7,874 FQHCs × 50 percent)). 

• 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 (§ 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, ESRDs are not 

included in the burden calculation. 

TABLE 11—COST SAVINGS: TESTING

Provider/supplier 

Cost savings 

per provider/ 

supplier 

Combined total savings 

ASCs ......................................................... $192 $1,066,944 for 5,557 ASCs. 

Hospices (freestanding/home-based) ....... 138 $557,520 for 4,040 hospices. 

PACEs ...................................................... 173 $40,193 for 233 PACE organizations. 

HHAs ......................................................... 314 $3,970,248 for 12,624 HHAs. 

CORFs ...................................................... 294 $55,272 for 188 CORFs. 

Organizations ............................................ 147 $305,172 for 2,076 Organizations. 

CMHCs ..................................................... 138 $22,218 for 161 CMHCs. 

OPOs ........................................................ 226 $13,137 for 58 OPOs. 

RHCs/FQHCs ........................................... 256 $3,086,721 ($1,067,040 for 4,160 RHCs and $2,019,681 for 7,874 FQHCs).

We will submit a revised information 

collection request to OMB to account for 

the burden hour and cost savings. 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

V. Regulatory Impact Analysis 

A. 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 reflect current 

knowledge as to 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. 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 patient 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). 

These reforms, however, did not 

exhaust the potential for burdenreducing reforms. We have continued to 

consult with regulated entities, have 

reviewed new research findings, have 

reviewed comments on previous 

rulemakings, and in these and other 

ways have identified additional reforms. 

These reforms are addressed in this 

proposed rule. 

This proposed rule is not just a 

continuation of our efforts to reduce 

regulatory burden but also directly 

responds to the January 30, 2017 

Executive Order ‘‘Reducing Regulation 

and Controlling Regulatory Costs’’ 

(Executive Order 13771). We propose 

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. This proposed 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. Ultimately, these 

proposals balance patient safety and 

quality, while also providing broad 

regulatory relief for providers and 

suppliers, and reducing the associated 

burden on patients. 

B. 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 


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47730 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Proposed Rules 

(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 RIA that, to the best 

of our ability, presents the costs and 

benefits of the rulemaking. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. This proposed 

rule would create ongoing cost savings 

to providers and suppliers in many 

areas. Other changes we have proposed 

would 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 created by the current 

transplant center regulations to decline 

to transplant patients with slightly 

lower probability of success, and to 

decline to use organs with a slightly 

lower probability of success. 

We welcome public comments on all 

of 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 especially solicit comments on 

either our estimates of likely impacts or 

the specific regulatory changes that 

drive these estimates. 

As stated in the ICR section of this 

proposed rule, we obtained all salary 

information from the May 2016 National 

Occupational Employment and Wage 

Estimates, United States by the Bureau 

of Labor Statistics (BLS) at https://

www.bls.gov/oes/2016/may/oes_nat.htm 

and calculated the added value of 100 

percent for overhead and fringe benefits. 

TABLE 12—SECTION–BY–SECTION ECONOMIC IMPACT ESTIMATES

Provider and supplier type and description 

of proposed provisions Frequency 

Number of 

affected 

entities 

Estimated 

annual 

savings or 

benefits 

($ millions) 

Religious Nonmedical Health Care Institutions: 

• Discharge Planning .............................................................. As patients are discharged (Estimated 619 

annual discharges).

18 * 

Ambulatory Surgical Centers: 

• Governing Body and Management ...................................... Upon failed hospital transfer agreement attempts.5,557 * 

• Patient Admission, Assessment and Discharge (History 

and Physical).

Every patient registration at an ASC or at 

a hospital outpatient/ambulatory surgery 

department.

5,557 (ASCs) 

5,031 

(Hospitals) 

454 

• Medical Records .................................................................. Recurring annually ...................................... 5,557 0 

Hospices: 

• Drugs and Biologicals, Medical Supplies, and Durable 

Medical Equipment.

Recurring annually ...................................... 1,151 80 

• Hospices That Provide Hospice Care to residents of a 

SNF/NF or ICF/IID.

Recurring annually ...................................... 4,602 * 

• Hospice Aide and Homemaker Services ............................. Recurring annually ...................................... 3,498 2

Hospitals: 

• Quality Assessment and Performance Improvement Program.Recurring annually ...................................... 5,031 28 

• Medical staff: Autopsies ....................................................... Recurring annually ...................................... 5,031 0 

• Infection Control ................................................................... Recurring annually ...................................... 5,031 105 

• Special requirements for hospital providers of long-term 

care services (‘‘swing-beds’’).

Recurring annually ...................................... 1,724 30 

• Special Requirements for Psychiatric Hospitals .................. Recurring annually ...................................... 574 62 

Transplant programs: 

• Various provisions related to performance * * ...................... Recurring annually ...................................... 750 Not Quantified 

Home Health Agencies: 

• Patient rights ........................................................................ Recurring annually ...................................... 12,624 55 

• Home health aide services .................................................. Recurring annually ...................................... 12,624 0 

• Clinical records .................................................................... Recurring annually ...................................... 12,624 0 

Critical Access Hospitals: 

• Provision of Services ........................................................... Recurring biennially .................................... 1,343 2 

• Organizational structure ....................................................... Recurring annually ...................................... 1,343 * 


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TABLE 12—SECTION–BY–SECTION ECONOMIC IMPACT ESTIMATES—Continued 

Provider and supplier type and description 

of proposed provisions Frequency 

Number of 

affected 

entities 

Estimated 

annual 

savings or 

benefits 

($ millions) 

• Special requirements for CAH providers of long-term care 

services (‘‘swing-beds’’).

Recurring annually ...................................... 1,246 86 

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 technicians*** ................................ Annual ......................................................... 500 31 

• Removing written orders ...................................................... Annual ......................................................... 500 29 

RHC (4,160 clinics) & FQHC (7,874 center locations): 

• Provision of Services ........................................................... Recurring biennially .................................... 12,034 7 

• Program Evaluation ............................................................. Recurring biennially .................................... 12,034 9 

Emergency Preparedness for Providers and Suppliers: 

• Annual Review of Emergency Preparedness Program ....... Recurring annually ...................................... 72,844 94 

• Emergency Plan .................................................................. Recurring annually ...................................... 68,254 7 

• Training and Testing-Training Program ............................... Recurring annually ...................................... 69,196 33 

• Training and Testing-Testing ............................................... Recurring annually ...................................... 36,971 9 

Total Annual Savings ....................................................... ..................................................................... ........................ 1,123 

Life-extending benefits for transplant patients ................. ..................................................................... ........................ Not Quantified 

* Amount is less than one million dollars. 

** 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 increase in future years. 

C. Anticipated Effects 

1. Effects on Religious Nonmedical 

Health Care Institutions 

As detailed in the Collection of 

Information section of this rule, we 

propose to reduce 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 

$27,013.16. 

2. Effects on Ambulatory Surgical 

Centers and Hospital Outpatient/ 

Ambulatory Surgery Departments 

As of May 2017 there were 5,557 

Medicare-participating ASCs. We 

proposed 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 proposed 

change are described later in this 

section of this proposed rule. At 

§ 416.41(b)(3), we propose to remove the 

requirements related to transfer 

agreements and admitting privileges. 

This change would eliminate 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 already with the transfer 

agreements in place, there would not be 

any more follow-up burden related to 

renewals or updates to the documents. 

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 welcome 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 

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 proposed 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 


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million dollar range. We welcome 

comments on these effects and on the 

preceding analysis of health effects. 

At § 416.52 we propose to replace 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 would 

reduce 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 on the 

day of surgery, but we cannot forecast 

with any precision what medical 

specialty societies, ASC governing 

bodies, hospital governing bodies, or 

accreditation bodies will decide to do in 

replacing the current requirement. 

Therefore, we do not forecast specific 

cost savings at this time, and solicit 

public comments to help us with our 

estimate in the final rule. 

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 

would reduce 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 would 

reduce 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. 

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 13. 

TABLE 13—TWENTY MOST FREQUENT ASC SERVICES IN 2015 

Surgical service Rank Percent of 

volume 

Cataract surgery w/IOL insert .................................................................................................................................. 1 18.60 

Upper GI endoscopy, biopsy ................................................................................................................................... 2 8.2 

Colonoscopy and biopsy ......................................................................................................................................... 3 6.8 

Lesion removal colonoscopy (snare technique) ...................................................................................................... 4 5.6 

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 individual ............................................................................................................... 12 1.9 

Cataract surgery, complex ....................................................................................................................................... 11 1.6 

Injection procedure for sacroiliac joint, anesthetic .................................................................................................. 19 1.3 

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 forceps) .................................................................................................. 14 0.8 

Upper GI endoscopy, insertion of guide wire .......................................................................................................... 18 0.8 

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 had two or more 

services within the 30-day ‘‘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 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 


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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 $32 an hour, the cost per patient 

would average $5 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 $243 an hour) and 

a half hour of registered nurse (RN) time 

(at $69 an hour) is wasted, and that 

clerical time ($32 an hour) to reschedule 

averages 10 minutes, the average cost 

per postponement would be $161. (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 14, could be as much as 

$972 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 current 

regulatory requirement would be 5 

percent less than the preceding 

calculations. Supposing that such 

examination and testing information 

would still be required for 50 percent of 

all patients, the costs of the current 

requirement and hence the potential 

savings from its reform would fall much 

further. Absent more specific 

information, the estimates of potential 

costs and savings in Table 14 are 

suggestive but not robust until or unless 

improved through public comment and 

additional information. In our summary 

estimates, we have assumed a range of 

savings from zero to 50 percent, with a 

midpoint of 25 percent. 

As support for the 50 percent upper 

bound, we note that 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, find that 

approximately 53 percent of Medicare 

cataract patients undergo pre-operative 

testing, none of which is mandated by 

CMS regulation. If these patients’ 

physicians are cautious enough to 

currently pursue more preoperative 

activity (testing, H&P, etc.) than what is 

required, or state or hospital rules are 

driving physician behavior beyond what 

Medicare necessitates, then there is 

little reason to believe that that behavior 

will change with the finalization of this 

rule. Given that other procedures tend 

to be more invasive than cataract 

surgery, pre-operative caution on the 

part of physicians is likely to be even 

greater in the non-cataract context. 

Indeed, Benarroch-Gampel J, Sheffield 

KM, Duncan CB, Brown KM, Han Y, 

Townsend CM and Riall TS, 

Preoperative Laboratory Testing in 

Patients Undergoing Elective, Low-Risk 

Ambulatory Surgery, Annals of Surgery 

256(3):518–528, September 2012, and 

Fischer JP, Shang EK, Nelson JA, Wu 

LC, Serletti JM and Kovach SJ, Patterns 

of Preoperative Laboratory Testing in 

Patients Undergoing Plastic Surgery 

Procedures, Aesthetic Surgery Journal 

1(1):133–141, January 2014, find that 

almost two-thirds of hernia procedures 

are preceded by testing, as are 62 

percent of ambulatory plastic surgeries. 

This leaves an upper bound of 33 to 38 

percent of non-cataract outpatient 

surgery H&P costs that could reasonably 

be expected to be avoided as a result of 

this rulemaking. 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 request 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. 

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. This study covered hernia 

patients but similar results have been 

found in studies of cataract surgery. 

Accordingly, eliminating the testing 

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. Therefore, if H&P is avoided, 

rather than more thoroughly integrated 

into same-day presurgical assessments, 

there could be adverse consequences to 

patients; these impacts have not been 

quantified. 

As discussed in ‘‘Provisions of the 

Proposed Regulations,’’ section II.D. 2. 

of this proposed rule, there is a similar 

regulatory requirement for hospital 

outpatient surgery. Based on the 

substantial similarity between these two 

service settings, we also propose 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. This would depend on 

whether hospital-based outpatient 


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surgery decisions parallel those of 

independent ASCs. 

If, after ASCs and hospitals make 

policy decisions on which types of 

outpatient/ambulatory surgery patients 

would require a comprehensive H&P, it 

is found that only 50 percent of current 

costs were continued, potential total 

annual savings, and hence benefits, for 

both settings taken together could be as 

much as $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 only 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, 

though likely removing the strict 30-day 

rule. Because of the proposed 

requirements, and other uncertainties, 

the potential savings from lifting the 

current requirements encompass at least 

this broad range and quite possibly 

more. Because there is great uncertainty 

in these estimates we have decided not 

to present a predetermined figure in this 

proposed rule. Instead, we are 

requesting public comments on all the 

parameters of our estimates to inform 

the estimates we will make in the final 

rule. We welcome information on likely 

decisions in both ASC and hospital 

outpatient settings, and if possible for 

the most common procedures shown in 

Table 13 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. 

TABLE 14—CURRENT COSTS AND POTENTIAL ANNUAL SAVINGS FROM CREATING AND OBTAINING EXAMINATION AND TEST

RESULTS

Type of cost Unit cost Number 

(M) 

Current 

total cost 

($M) 

Twenty-five 

percent 

retained 

($M) 

Fifty percent 

retained 

($M) 

Seventy-five 

percent 

retained 

($M) 

Physical Examinations ............................. $100 4.56 $456 $114 $228 $342 

Test Batteries ........................................... 100 2.28 228 57 114 171 

Patient Travel Cost .................................. 36 4.56 164 41 82 123 

Administrative Cost to ASC ..................... 5 4.56 23 6 11 17 

Surgery Cancellations * ............................ 161 0.228 37 9 18 28 

Total Cost, ASCs .............................. ........................ ........................ 908 227 454 681 

Total Cost, Hospital Outpatient ** ..... ........................ ........................ 908 227 454 681 

Total Cost ......................................... ........................ ........................ 1,815 454 908 1,362 

Total Savings .................................... ........................ ........................ ........................ 1,362 908 454 

* 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 $243 an 

hour), one half hour of RN time wasted (at $69 an hour), and ten minutes of clerical time (at $32 an hour) to reschedule. 

** Hospital outpatient savings assumed to be equal to ASC savings. 

We assume that the one-time costs of 

developing such policies for hospital 

outpatient surgery in 5,031 Medicareparticipating 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 welcome comments on these 

estimates and on both the proposal and 

any alternatives, and particularly 

welcome 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. 

3. Effects on Hospices 

As of May 2017 there are 4,602 

Medicare participating hospices. We 

proposed to revise 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 § 418.76(a) we propose to defer to 

State training and competency 

requirements, where they exist, for 

hospice aides. Deferring to state 

requirements would 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 


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States have their own training and 

competency requirements, accounting 

for approximately 83,910 aide positions. 

Hospices in these states would benefit 

from the proposed 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 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 $32 per 

hour for a general office clerk to perform 

this check, we estimate that hospices 

will save $2,237,664 annually. 

At § 418.106(a) we propose 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 would 

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 § 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 $299 per hour 

($198 physician + $53 social worker + 

$48 pastoral counselor), we estimate 

that removing this requirement would 

save $47,840,000 annually. 

Additionally, we believe that this 

change would 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 $69 per 

patient for all advisement services 

(updated to 2017 dollars). We estimate 

that this proposed change would reduce 

that time by 50 percent, to 30 minutes 

per patient, resulting in a $35 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 

would occur for 400,000 patients 

nationwide (25 percent of 1.6 million 

hospice patients), for a total annual 

savings of $14,000,000. 

Together with the previously stated 

estimate, total savings would be 

$47,840,000 + $14 million = 

$61,840,000 annually. 

We propose to revise the requirement 

at § 418.106(d) to allow hospices to 

provide information regarding safe 

medication use, storage, and disposal in 

a more understandable manner. Under 

the current requirements, hospices are 

required to provide patients and 

families with a copy of the hospice’s 

policies and procedures, which are not 

written in layperson terms. The 

proposed change would alleviate the 

burden associated with addressing the 

confusion created by the policies and 

procedures document. Following the 

initial cost of $483,210 (described in 

section III.E. of this rule) for developing 

new, more easily understandable 

materials for patient education, we 

believe that hospices would realize a 

savings of 10 minutes per patient 

because it would require less hospice 

staff time to explain the more 

understandable material. Based on an 

assumed 10 minutes of saved nursing 

time per patient, and 1.6 million 

patients, hospices would save 266,667 

hours. At a cost of $69 per hour, the 

total savings would be $18,400,023. 

First year: $18,400,023 

savings¥$483,210 initial year cost = 

$17,916,813 net savings. 

Annually thereafter: $18,400,023 

savings. 

At § 418.112(f) we propose 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 would 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 $69 

per hour, a typical hospice would spend 

$828 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 $166 a year, or $763,932 savings 

annually for all 4,602 hospices. 

Taken together, these proposed 

reforms would generate annual savings 

of approximately $82.8 million ($47.8 

million for reduced interdisciplinary 

group meeting time + $14 million for 

reduced specialty nursing time + $18 

million for streamlined controlled drug 

education practices + $2.2 million for 

streamlined hospice aide qualification 

requirements + $0.8 million for 

streamlined facility staff orientation). 

We welcome public comment regarding 

these burden estimates, and additional 

regulatory reforms to reduce the burden 

of the hospice CoPs. 

4. Effects on Hospitals 

As of May 2017, there were 5,031 

Medicare participating hospitals. We 

propose to revise 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 proposed change are described 

below. 


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At § 482.21, we propose to allow 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 would 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 this 

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 this 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 3,200 of the 5,031 

Medicare-participating hospitals 

participate in a hospital system 

(American Hospital Association (AHA), 

Fast Facts 2017 (https://www.aha.org/ 

system/files/2018-01/fast-facts-ushospitals-2017_0.pdf)). According to the 

2017 AHA Guide, there are 424 multihospital systems. The current regulatory 

burden for compliance with the QAPI 

program requirement is approximately 

$10,000 annually per hospital or $50.3 

million annually for all 5,031 hospitals. 

If we were to allow a unified QAPI 

program for multi-hospital systems, this 

would remove 3,200 hospitals from the 

total 5,031 (replaced by the 424 multihospital systems) for a total of 2,255 

hospitals/multi-hospital systems that 

would still need to comply. The new 

regulatory burden would be a total of 

approximately $22.6 million annually 

(2,255 × $10,000), for an annual total 

savings of approximately $28 million. 

We welcome 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. 

We propose to remove the 

requirement for hospitals at § 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 § 482.42, we propose to allow 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 would 

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 

$191 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 3,200 hospitals from the 

total 5,031 (replaced by the 424 multihospital systems) for a total of 2,255 

hospitals/multi-hospital systems that 

would still need to comply. The new 

regulatory burden would be a total of 

approximately $86 million annually 

(2,255 × $38,000), for an annual total 

savings of approximately $105 million. 

We welcome 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 §§ 482.58(b)(1) and 

485.645(d)(1) (cross-referenced longterm care requirement at § 483.10(f)(9)) 

we propose 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 discuss the 

economic impact for this provision in 

the ICR section of this rule, which is 

estimated to be $32 million. 

At § 482.58(b)(4) (and § 485.645(d)(4)) 

(cross-referenced long-term care 

requirement at § 483.24(c)), we propose 

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 

§ 483.24(c)(2). We discuss the economic 

impact for this provision in the ICR 

section of this rule, which is estimated 

to be $81 million. 

We propose to remove the 

requirement at §§ 482.58(b)(5) and 

485.645(d)(5) (cross-referenced longterm care requirement at § 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 burden 

hours or dollars. 

At §§ 482.58(b)(8) and 485.645(d)(8) 

(cross-referenced long-term care 

requirement at § 483.55(a)(1)) we 

propose 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. 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 § 482.61(d), we propose to allow 

non-physician practitioners to 

document progress notes in accordance 

with State laws and scope of practice 

requirements. We discuss the economic 

impact for this provision in the ICR 

section, which is estimated at $54.7 

million in savings for psychiatric 

hospitals. 


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5. Effects on Transplant Programs and 

Patients 

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/ProviderEnrollment-and-Certification/Survey

CertificationGenInfo/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-deceaseddonors-set-new-records-in-2016/). 

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 

this 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%20


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Stewart%20-%20No%20Organ%20

Left%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 

transplantion. 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 pertransplant 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 (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). 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. 

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 

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 

threaten’s program closure. For recent 

reviews of potential effects of those 

changes see B.L. Kasiske et al., 

‘‘Potential Implications of Recent and 


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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 misidentify 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 propose 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 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 proposed 

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. That said, we 

welcome any additional information 

that might allow a quantitative estimate 

in the final rule. 

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 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 

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 researchbased estimates of the value that people 


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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 

× $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 lifeextending 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 welcome comments on the 

quantitative and non-quantitative 

portions of the preceding discussion 

and seek any empirical evidence that 

would allow robust estimates of 

benefits, and in particular robust 

quantitative estimates of the number of 

patients deprived of transplantation as a 

result of the 2007 rule, as currently 

implemented to reflect the 2016 

guidance, for each organ type. We also 

welcome comments on whether we have 

accurately and reasonably summarized 

the research evidence on the effects of 

the 2007 rules, particularly in the light 

of the many other factors influencing 

transplantation trends and performance. 

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 posttransplant. 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 propose 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 this 

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 proposed 

change to provide substantial net 

benefits, particularly since other 

regulatory and informational incentives 

remain in place. 

We welcome 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. 

6. 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 4149) we estimated 

that compliance with the requirements 

at § 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 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 $91,786,974 burden, 

based on a RN earning $69 per hour. 

We propose 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 (330,246 hours 

originally estimated × 0.6) and 

$55,072,184 ($91,786,974 burden as 

updated to reflect more recent salary 

estimates × 0.6). 

We also propose two changes that do 

not have a savings estimate. First, we 

propose to eliminate the requirement at 

§ 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 


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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 supervision do not impose any 

additional burden. 

Second, we propose to remove the 

requirement at § 484.110(e) related to 

providing a requested copy of the 

clinical record at the next home visit, 

while retaining the requirement to 

provide the record within 4 business 

days. As stated in the January 2017 

HHA CoP final rule (82 FR 4568 and 

4575), we believe that providing such 

information to patients is a usual and 

customary practice that does not impose 

a burden upon HHAs. As such, 

removing the ‘‘next home visit’’ 

timeframe requirement would not result 

in a savings of burden hours or dollars. 

We welcome public comment 

regarding these burden estimates, and 

additional regulatory reforms to reduce 

the burden of the HHA CoPs. 

7. Effects on CAHs 

We propose to remove the 

requirement at § 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 ha 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 $141,000 total for all CAHs. 

We 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 $2.5 million. 

8. 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 

$309,072. 

9. Effects on CMHCs 

We discussed the burden reduction 

for our proposed revision of 

§ 485.914(d)(1) ‘‘update of the 

comprehensive assessment’’ 

requirements imposed on CMHCs in the 

ICR section, which is an estimated 

savings of $152,464. 

10. Effects on Portable X-Ray Services 

At § 486.104 we propose 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 xray 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 welcome public comment 

regarding these burden estimates, and 

additional regulatory reforms to reduce 

the burden of the portable x-ray CfCs. 

11. Effects on RHCs and FQHCs 

We discussed the burden reduction 

for our proposed revision of 

§ 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 $6.8 

million. In addition, the burden 

reduction for our proposed revision of 

§ 491.11(a) ‘‘program evaluation’’ 

requirements imposed on RHCs and 

FQHCs in the ICR section of this rule, 

which is an estimated savings of $9.4 

million. 

12. Effects of Emergency Preparedness 

Requirements on Providers and 

Suppliers 

This proposed rule revises the 

emergency preparedness requirements 

for Medicare and Medicaid participating 

providers and suppliers, as discussed in 

detail in section II.M of this proposed 

rule. The proposed modifications to the 

emergency preparedness requirements 

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 

proposed changes to the emergency 

preparedness requirements would 

accrue an annual cost savings of $155 

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 proposed 

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 § 482.15(a), (b), (c), and (d) for 

hospitals and parallel regulatory 

citations for other facilities, we propose 

to allow 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 $94,312,719 in 

savings. 

At § 482.15(a)(4) for hospitals, and 

other parallel citations for the facilities 

mentioned in section II.J.2 of this 

proposed rule, we propose 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. We 

discuss the economic impact for this 

requirement in the ICR section of this 

rule, which represents $7,179,117 in 

savings. 

At § 482.15(d)(1)(ii) for hospitals, and 

other parallel citations for other 

facilities mentioned in section II.J.2 of 

this proposed rule, we propose to 

require that facilities provide training 

biennially, or every 2 years, after 

facilities conduct initial training on 

their emergency program. In addition, 

we propose to require 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 $33,267,864 in savings. 

Finally, at § 482.15(d)(2), we propose to 

require that providers of inpatient 

services mentioned in section II.J.2 of 

this proposed 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 propose to require that 

providers of outpatient services 

mentioned in section II.J.2 of this 

proposed rule conduct one testing 

exercise annually which must be either 

a community-based full-scale exercise 

(if available) or an individual facilitybased 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 


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discuss the majority of this economic 

impact for this requirement in the ICR 

section, which represents $9,117,425 in 

savings. We do not estimate any 

economic impact for the providers of 

inpatient services as we are not 

proposing 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 $55,272 and 

$305,172, respectively. 

We estimate a total impact savings of 

$10,997,373 for this proposed change. 

With an estimated ICR savings of 

$9,117,425, we estimate that the total 

economic impact of this rule for the 

affected providers will be $20,114,798. 

We list a summary of the calculation for 

the impact savings accrued by removing 

this requirement for each facility in 

Table 15, based on facility numbers 

available as of May 2017. 

• ASCs: Combined total savings of 

$1,967,178 for 5,557 ASCs ((4 hours for 

an administrator at $108 per hour plus 

4 hours for a registered nurse at $69 per 

hour) × 5,557 ASCs × 50 percent). 

• Outpatient Hospice: Combined total 

savings of $1,405,920 ((4 hours for an 

administrator at $105 per hour plus 4 

hours for a registered nurse at $69 per 

hour) × 4,040 outpatient hospices × 50 

percent). 

• PACE: Combined total savings of 

$16,077 ((1 hour home for a care 

coordinator at $69 per hour plus 1 hour 

for a quality improvement nurse at $69) 

× 233 PACEs × 50 percent). 

• HHAs: Combined total savings of 

$2,632,104 ((2 hours for an 

administrator at $105 per hour plus 3 

hours for a director of training at $69 

per hour) × 12,624 HHAs × 50 percent). 

• CMHCs: Combined total savings of 

$58,926 ((5 hours for an administrator at 

$105 per hour plus 3 hours for a nurse 

at $69 per hour) × 161 CMHCs × 50 

percent). 

• OPOs: Combined total savings of 

$5,046 ((1 hour for a QAPI Director at 

$105 per hour plus 1 hour for an 

education coordinator at $69 per hour) 

× 58 OPOs × 50 percent). 

• RHCs/FQHCs: Combined total 

savings of $ 4,187,832 (((4 hours for an 

administrator at $105 per hour plus 4 

hours for a registered nurse at $69 per 

hour) × 4,160 RHCs × 50 percent) plus 

(4 hours for an administrator at $105 per 

hour plus 4 hours for a registered nurse 

at $69 per hour) × 7,874 FQHCs × 50 

percent). 

• ESRDs: Combined total savings of 

$724,290 ((1 hour for an administrator at 

$105 per hour plus 1 hour for a nurse 

manager at $105 per hour) × 6,898 

dialysis facilities × 50 percent). 

TABLE 15—COST SAVINGS FOR EMERGENCY PREPAREDNESS TESTING

Provider/supplier 

Cost savings 

per provider/ 

supplier 

Combined total savings 

ASCs ........................................................................................... $354 $1,967,178 for 5,557 ASCs. 

Hospices (outpatient) .................................................................. 348 $1,405,920 for 4,040 outpatient hospice facilities. 

PACEs ........................................................................................ 69 $16,077 for 233 PACEs. 

HHAs .......................................................................................... 209 $2,632,104 for 12,624 HHAs. 

CMHCs ....................................................................................... 366 $58,926 for 161 CMHCs. 

OPOs .......................................................................................... 87 $5,046 for 58 OPOs. 

RHCs/FQHCs ............................................................................. 348 $4,187,832 for RHCs and FQHCs ($1,447,680 for 4,160 RHCs 

and $2,740,152 for 7,874 FQHCs). 

ESRD Facilities ........................................................................... 105 $724,290 for 6,898 dialysis facilities. 

13. 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 onetime 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 $134 for 

lawyers, $105 for managers, $70 for 

registered nurses, and $198 for 

physicians. These numbers are from 

BLS statistics for 2016, at https://

www.bls.gov/oes/2016/may/oes_

nat.htm. 

The estimated costs for an average 

provider would therefore be 1 hour at 

$134 and in total for the lawyers, 2 

hours at $105 or $210 in total for the 

managers, 2 hours at $69 or $138 in total 

for the other staff, and two-tenths of 1 


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hour at $198 or $40 in total for the 

physicians. These one-time costs add up 

to $522 per provider on average, and in 

total to about $64 million. 

TABLE 16—ONE-TIME IMPLEMENTATION COSTS

Provider type 

Number of 

affected 

providers 

Religious Nonmedical Health Care Institutions ................................................................................................................................... 18 

Ambulatory Surgical Centers and hospital outpatient ......................................................................................................................... 10,587 

Hospices .............................................................................................................................................................................................. 4,602 

Hospitals .............................................................................................................................................................................................. 5,031 

Transplant programs ............................................................................................................................................................................ 750 

Home Health Agencies ........................................................................................................................................................................ 12,624 

Critical Access Hospitals ..................................................................................................................................................................... 1,343 

Comprehensive Outpatient Rehabilitation Facilities ............................................................................................................................ 188 

Community Mental Health Centers ..................................................................................................................................................... 52 

Portable X-Ray Services ..................................................................................................................................................................... 500 

Rural Health Clinics and Federally Qualified Health Centers ............................................................................................................. 12,034 

Emergency Preparedness of Providers and Suppliers ....................................................................................................................... 74,246 

Total Number of Providers .................................................................................................................................................................. 122,180 

Average Cost Per Provider .................................................................................................................................................................. $522 

Total One-Time Cost .................................................................................................................................................................... $63,777,960 

13. 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 $7.5 million to 

$38.5 million in any 1 year, varying by 

type of provider and highest for 

hospitals). Accordingly, almost all of the 

savings that this proposed rule would 

create will benefit 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 proposed 

rule are not relevant to the RFA. 

The RFA requires that a Regulatory 

Flexibility Analysis (RFA) be prepared 

if a proposed 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 this proposed 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 this proposed 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 603 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 this 

proposed 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 2018, that 

threshold is approximately $148 

million. This proposed rule contains 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. 

This proposed 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. 

14. 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 propose 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 


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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. 

In total, we estimate that the 

approximately 40 specific provisions 

summarized in Tables 1 and 2 that are 

not related to reductions in preoperative physical examinations and 

tests in outpatient surgery, or to 

transplantation, will save facilities and 

other providers, insurers, and patients 

about $669 million annually. The 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 

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. 

The following table shows our 

estimates of savings by major burden 

reduction category and by type of payer. 

TABLE 17—SAVINGS BY MAJOR PAYER CATEGORIES

[$ Millions] 

Savings to: Ambulatory 

surgery Transplant programs All other cost reductions Total 

Medicare ......................................................... 123 not estimated .................................................. 141 264 

Medicaid .......................................................... 57 not estimated .................................................. 120 177 

Private Insurance ............................................ 110 not estimated .................................................. 234 344 

Other Payers ................................................... 47 not estimated .................................................. 100 147 

Patients ........................................................... 117 not estimated .................................................. 74 191 

Total ......................................................... 454 not estimated .................................................. 669 1,123 

Note: Calculations based largely on payer percentages in ‘‘National Health Care Spending in 2016,’’ Health Affairs, January 2018, pages 150– 

160. Patient share for ambulatory surgery savings reflects travel time, not medical costs. 

15. Benefits to Patients 

We discussed life-extending and lifesaving 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 propose. 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 do, 

however, welcome public comments on 

these or any other aspects of costs and 

benefits of the proposed rule. 

D. 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 

this proposed rule. For all of the 

proposed provisions, we considered not 

making these changes. Ultimately, we 

saw no good reasons not to propose 

these burden reducing changes. 

We welcome comments on whether 

we properly selected the best candidates 

for change, and welcome suggestions for 

additional reform candidates from the 

entire body of CoPs and other regulatory 

provisions that fall directly on 

providers. 

E. 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. 

F. Accounting Statement and Table 

As required by OMB Circular A–4 

(available at https://

obamawhitehouse.archives.gov/omb/ 

circulars_a004_a-4/), in Table 18, we 

have prepared an accounting statement 

showing the classification of the 

transfers and costs associated with the 

various provisions of this proposed rule. 

While most provisions of the 

proposed 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 


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that apply to a particular provider type). 

Other provisions (notably those related 

to organ transplantation and removal of 

strict H & P requirements before 

ambulatory 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 

lower bound is zero cost reductions and 

our upper bound is a 50% reduction in 

H&P and associated laboratory testing 

costs. 

TABLE 18—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED BENEFITS AND SAVINGS

[$ Millions] 

Category Primary 

estimate 

Lower 

bound 

Upper 

bound 

Units 

Year dollars 

Discount 

rate 

(%) 

Period 

covered 

Life-Extending Benefits (monetized) ......................... Not Quantified 

Medical Cost Reduction Benefits (monetized) ......... Not Quantified 

Other Cost Reductions (monetized) ......................... ¥$1,240 ¥$580 ¥$1,890 2016 7 2018 onward. 

¥$1,250 ¥$590 ¥$1,900 2016 3 2018 onward. 

Costs ......................................................................... None 

Transfers ................................................................... None 

G. Reducing Regulation and Controlling 

Regulatory Costs 

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 proposed rule will, if finalized as 

proposed, be considered an E.O. 13771 

deregulatory action. We estimate that 

this rule generates $1,051 million in 

annualized cost savings, discounted at 7 

percent relative to year 2018, over a 

perpetual time horizon. This estimate is 

based on cost reductions starting at 

$1,123 million, and growing by $31 

million annually due to salary savings 

from X-ray technician turnover, 

partially offset by one-time first-year 

implementation costs of $64 million, all 

in 2016 dollars. Details on the estimated 

cost savings from this rule can be found 

in the preceding analysis. We note that 

public comments and additional 

information may enable us to estimate 

considerably larger savings from 

reforming H & P requirements for 

ambulatory surgery or to narrow the 

uncertainty within the range of the 

preliminary estimates. 

H. Conclusion 

This proposed rule would 

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 

proposed rule does not require an Initial 

Regulatory Flexibility Analysis, this 

regulatory impact analysis, together 

with the remainder of this preamble, 

meets the requirements for such an 

analysis. Furthermore, the analysis in 

this section of the preamble, together 

with the remainder of this preamble, 

provides a complete Regulatory Impact 

Analysis. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

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, 


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47746 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Proposed Rules 

Reporting and recordkeeping 

requirements, Rural and Urban areas. 

42 CFR Part 494 

Health facilities, Diseases, Medicare, 

Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services proposes to amend 

42 CFR chapter IV as set forth below: 

PART 403—SPECIAL PROGRAMS AND 

PROJECTS 

■ 1. The authority citation for part 403 

continues to read as follows: 

Authority: 42 U.S.C. 1395b-3 and Secs. 

1102 and 1871 of the Social Security Act (42 

U.S.C. 1302 and 1395hh). 

■ 2. Section 403.736 is amended by— 

■ a. Removing the introductory text; 

■ b. Revising paragraph (a); 

■ c. Removing paragraph (b); and 

■ d. Redesignating paragraphs (c) and 

(d) as paragraphs (b) and (c). 

The revision reads as follows: 

§ 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. 

* * * * * 

■ 3. Section 403.748 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); and 

■ b. Adding paragraph (d)(1)(v). 

The revisions and addition read as 

follows: 

§ 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 

■ 4. The authority citation for part 416 

continues to read as follows: 

Authority: Secs. 1102, 1138, and 1871 of 

the Social Security Act (42 U.S.C. 1302, 

1320–8, and 1395hh) and section 371 of the 

Public Health Service Act (42 U.S.C. 273)). 

§ 416.41 [Amended] 

■ 5. Section 416.41 is amended by 

removing paragraph (b)(3). 

■ 6. Section 416.47 is amended by 

revising paragraph (b)(2) to read as 

follows: 

§ 416.47 Condition for coverage—Medical 

records. 

* * * * * 

(b) * * * 

(2) Significant medical history and 

results of physical examination (as 

applicable). 

* * * * * 

■ 7. Section 416.52 is amended by 

revising the section heading and 

paragraph (a) to read as follows: 

§ 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) Follow nationally recognized 

standards of practice and guidelines, 

and 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. 

* * * * * 

■ 8. Section 416.54 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(v); and 

■ c. Revising paragraph (d)(2). 


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The revisions and addition read as 

follows: 

§ 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) * * * 

(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 or when a 

community-based exercise is not 

accessible, individual, a facility-based 

functional exercise every 2 years. 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 

actual 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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 

■ 9. The authority citation for part 418 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

■ 10. Section 418.76 is amended by 

revising paragraph (a)(1)(iv) to read as 

follows: 

§ 418.76 Condition of participation: 

Hospice aide and homemaker services. 

* * * * * 

(a) * * * 

(1) * * * 

(iv) A State licensure program. 

* * * * * 

■ 11. Section 418.106 is amended by— 

■ a. Removing paragraph (a)(1); 

■ b. Redesignating paragraph (a)(2) as 

paragraph (a)(1); 

■ c. Adding a new reserved paragraph 

(a)(2); and 

■ d. Revising paragraph (e)(2)(i). 

The revision reads as follows: 

§ 418.106 Condition of participation: Drugs 

and biologicals, medical supplies, and 

durable medical equipment. 

* * * * * 

(a) * * * 

(2) [Reserved] 

* * * * * 

(e) * * * 

(2) * * * 

(i) Safe use and disposal of controlled 

drugs in the patient’s home. The 

hospice must have written policies and 

procedures for the management, use, 

storage, and disposal of controlled drugs 

in the patient’s home. At the time when 

controlled drugs are first ordered the 

hospice must: 

(A) Provide information regarding the 

use, storage, and disposal of controlled 

drugs to the patient or patient 

representative and family in a format 

that is available on a continual basis; 

(B) Discuss the information regarding 

the safe use, storage and disposal of 

controlled drugs with the patient or 

representative, and the family, in a 

language and manner that they 

understand to ensure that these parties 

are effectively educated; and 

(C) Document in the patient’s clinical 

record that the information was 

provided and discussed. 

* * * * * 

■ 12. Section 418.112 is amended by 

adding paragraph (c)(10) and removing 

paragraph (f) to read as follows: 

§ 418.112 Condition of participation: 

Hospices that provide hospice care to 

residents of a SNF/NF or ICF/IID. 

* * * * * 

(c) * * * 

(10) A delineation of responsibilities 

for assuring orientation of SNF/NF or 

ICF/IID staff furnishing care to hospice 

patients, to include information 

regarding the hospice philosophy; 

hospice policies and procedures 

regarding methods of comfort, pain 

control, and symptom management; 

principles about death, dying, and 

individual responses to death; patient 

rights; appropriate forms; and record 

keeping requirements. 

* * * * * 

■ 13. Section 418.113 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(iii); 

■ b. Adding paragraph (d)(1)(vi); 

■ c. Revising paragraph (d)(2); and 

■ d. Adding paragraph (d)(3). 

The revisions and addition to read as 

follows: 

§ 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, 


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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 or when a 

community-based exercise is not 

accessible, an individual, facility-based 

functional exercise every 2 years. If the 

hospice 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 communitybased or individual, facility-based 

functional exercise following the onset 

of the actual 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant emergency scenario, and a set 

of problem statements, directed 

messages, or prepared questions 

designed to challenge an emergency 

plan. 

(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 a full-scale exercise 

that is community-based or when a 

community-based exercise is not 

accessible, an individual, facility-based 

functional exercise annually. If the 

hospice experiences an actual natural or 

man-made emergency that requires 

activation of the emergency plan, the 

hospice is exempt from engaging in its 

next required full-scale communitybased or individual, facility-based 

functional exercise following the onset 

of the actual event. 

(ii) Conduct an additional exercise at 

least annually 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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 

■ 14. The authority citation for part 441 

continues to read as follows: 

Authority: Secs. 1102, 1902, and 1928 of 

the Social Security Act (42 U.S.C. 1302). 

■ 15. Section 441.184 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(v); and 

■ c. Revising paragraph (d)(2). 

The revisions and addition read as 

follows: 

§ 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 


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twice per year. The PRTF must do the 

following: 

(i) Participate in a full-scale exercise 

annually that is community-based or 

when a community-based exercise is not 

accessible, an individual, facility-based 

functional exercise annually. 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 communitybased or individual, facility-based 

functional exercise following the onset 

of the actual event. 

(ii) Conduct an additional exercise at 

least annually 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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 ALLINCLUSIVE CARE FOR THE ELDERLY 

(PACE) 

■ 16. The authority citation for part 460 

continues to read as follows: 

Authority: Secs: 1102, 1871, 1894(f), and 

1934(f) of the Social Security Act (42 U.S.C. 

1302, 1395, 1395eee(f), and 1396u–4(f)). 

■ 17. Section 460.84 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(v); and 

■ c. Revising paragraph (d)(2). 

The revisions and addition read as 

follows: 

§ 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 

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 lease 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 when a 

community-based exercise is not 

accessible, an individual, facility-based 

functional exercise every 2 years. 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 communitybased or individual, facility-based 

functional exercise following the onset 

of the actual 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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 

■ 18. The authority citation for part 482 

continues to read as follows: 

Authority: Secs. 1102, 1871, and 1881 of 

the Social Security Act (42 U.S.C. 1302, 

1395hh, and 1395rr), unless otherwise noted. 

■ 19. Section 482.15 is amended— 

■ a. By revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. By adding paragraph (d)(1)(v); 

■ c. By revising paragraph (d)(2); 

■ d. In paragraph (g) introductory text, 

by removing the phrase ‘‘transplant 

centers’’ and adding into its place the 

phrase ‘‘transplant programs’’; and 

■ 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: 

§ 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 


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maintain an integrated response during 

a disaster or emergency situation. 

(b) Policies and procedures. The 

hospital 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 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 

when a community-based exercise is not 

accessible, an individual, facility-based 

functional exercise annually. 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 communitybased exercise or individual, facilitybased functional exercise following the 

onset of the actual event. 

(ii) Conduct an additional exercise at 

least annually 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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. 

* * * * * 

■ 20. Section 482.21 is amended by 

adding paragraph (f) to read as follows: 

§ 482.21 Condition of participation: Quality 

assessment and performance improvement 

program. 

* * * * * 

(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. 

■ 21. Section 482.22 is amended by— 

■ a. Revising paragraphs (c)(5)(i) and 

(ii); 

■ b. Adding paragraphs (c)(5)(iii), (iv), 

and (v); and 

■ c. Removing paragraph (d). 

The revisions and additions read as 

follows: 

§ 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 oromaxillofacial 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 oromaxillofacial 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 

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 oromaxillofacial surgeon, 

or other qualified licensed individual in 

accordance with State law and hospital 

policy. 


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(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. 

* * * * * 

■ 22. 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: 

§ 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 § 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. 

* * * * * 

■ 23. Section 482.42 is amended by 

adding paragraph (c) to read as follows: 

§ 482.42 Condition of participation: 

Infection control. 

* * * * * 

(c) Standard: Unified and integrated 

infection control program for multihospital 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 infection control 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 

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; 

(2) 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; 

(3) 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 

(4) A qualified individual (or 

individuals) with expertise in infection 

prevention and control has been 

designated at the hospital as responsible 

for communicating with the unified 

infection control program, for 

implementing and maintaining the 

policies and procedures governing 

infection control as directed by the 

unified infection control program, and 

for providing infection prevention 

education and training to hospital staff. 

■ 24. Section 482.51 is amended by 

revising paragraphs (b)(1)(i) and (ii) and 

adding paragraph (b)(1)(iii) to read as 

follows: 

§ 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 

§ 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. 

* * * * * 

■ 25. Section 482.58 is amended by— 

■ a. Revising paragraph (b)(1); 

■ b. Removing paragraph (b)(4); 

■ c. Redesignating paragraphs (b)(5) 

through (8) as paragraphs (b)(4) through 

(7); and 

■ d. Revising newly redesignated 

paragraphs (b)(4) and (7). 

The revisions read as follows: 

§ 482.58 Special requirements for hospital 

providers of long-term care services 

(‘‘swing-beds’’). 

* * * * * 


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(b) * * * 

(1) Resident rights (§ 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 (§ 483.40(d) of this 

chapter). 

* * * * * 

(7) Dental services (§ 483.55(a)(2), (3), 

(4), and (5) and (b) of this chapter). 

■ 26. Section 482.61 is amended by 

revising paragraph (d) to read as 

follows: 

§ 482.61 Condition of participation: 

Special medical record requirements for 

psychiatric hospitals. 

* * * * * 

(d) Standard: Recording progress. 

Progress notes must be recorded by the 

physician(s), psychologists, or other 

licensed independent practitioner(s) 

responsible for the care of the patient as 

specified in § 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. 

* * * * * 

§ 482.68 [Amended] 

■ 27. Section 482.68 is amended— 

■ a. In the section heading by removing 

the phrase ‘‘transplant centers’’ and 

adding in its place the phrase 

‘‘transplant programs’’; and 

■ b. In the introductory text and in 

paragraph (b) by removing the phrase 

‘‘transplant center’’ and adding in its 

place the phrase ‘‘transplant program’’. 

■ 28. Section 482.70 is amended— 

■ a. In the definition of ‘‘Adverse event’’ 

by removing the phrase ‘‘transplant 

centers’’ and adding in its place the 

phrase ‘‘transplant programs’’; 

■ b. By removing the definitions of 

‘‘Heart-Lung transplant center’’ and 

‘‘Intestine transplant center’’; 

■ c. By adding the definitions of ‘‘HeartLung transplant program’’ and 

‘‘Intestine transplant program’’ in 

alphabetical order; 

■ d. By removing the definitions of 

‘‘Pancreas transplant center’’ and 

‘‘Transplant center’’; 

■ e. By adding the definition of 

‘‘Pancreas transplant program’’ in 

alphabetical order; and 

■ f. By revising the definition of 

‘‘Transplant program’’. 

The additions and revision read as 

follows: 

§ 482.70 Definitions. 

* * * * * 

Heart-Lung transplant program means 

a transplant program that is located in 

a hospital with an existing Medicareapproved heart transplant program and 

an existing Medicare-approved lung 

program that performs combined heartlung transplants. 

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 kidneypancreas transplants. 

* * * * * 

Transplant program means an organspecific transplant program within a 

transplant hospital (as defined in this 

section). 

§§ 482.72, 482.74, 482.78, and 482.80 

[Amended] 

■ 29. 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 

§ 482.72 ................... ............................................................... transplant center .................................. transplant program. 

§ 482.74 ................... (a) introductory text .............................. transplant center .................................. transplant program. 

§ 482.74 ................... (a) introductory text .............................. center’s ................................................. hospital’s. 

§ 482.74 ................... (a)(1) ..................................................... transplant center .................................. transplant program. 

§ 482.74 ................... (a)(1) ..................................................... center’s ................................................. program’s. 

§ 482.74 ................... (a)(2) ..................................................... transplant center .................................. transplant program. 

§ 482.74 ................... (a)(3) ..................................................... transplant center .................................. transplant program. 

§ 482.74 ................... (b) introductory text .............................. transplant center .................................. transplant program. 

§ 482.78 ................... Section heading ................................... transplant centers ................................. transplant programs. 

§ 482.78 ................... Introductory text ................................... transplant center .................................. transplant program. 

§ 482.78 ................... (a) ......................................................... transplant center .................................. transplant program. 

§ 482.78 ................... (b) ......................................................... transplant center .................................. transplant program. 

§ 482.80 ................... Section heading ................................... transplant centers ................................. transplant programs. 

§ 482.80 ................... Introductory text ................................... transplant centers ................................. transplant programs. 

§ 482.80 ................... (a) ......................................................... transplant center .................................. transplant program. 

§ 482.80 ................... (a) ......................................................... beneficiary ............................................ recipient. 

§ 482.80 ................... (b) ......................................................... transplant center .................................. transplant program. 

§ 482.80 ................... (c) introductory text .............................. center ................................................... program. 

§ 482.80 ................... (c)(1) ..................................................... transplant center’s ................................ transplant program’s. 

§ 482.80 ................... (c)(1) ..................................................... center-specific report ............................ program-specific report. 

§ 482.80 ................... (c)(1) ..................................................... Beneficiaries ......................................... Recipients. 

§ 482.80 ................... (c)(2) ..................................................... center’s ................................................. program’s. 

§ 482.80 ................... (d)(1) ..................................................... transplant center .................................. transplant program. 

§ 482.80 ................... (d)(2) ..................................................... transplant center .................................. transplant program. 

§ 482.80 ................... (d)(3) ..................................................... transplant center .................................. transplant program. 

§ 482.80 ................... (d)(4) ..................................................... transplant center .................................. transplant program. 

§ 482.80 ................... (d)(5) ..................................................... transplant center .................................. transplant program. 


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§ 482.82 [Removed] 

■ 30. Section 482.82 is removed. 

§§ 482.90, 482.92, 482.94, 482.96, 482.98, 

482.100, and 482.102 [Amended] 

■ 31. 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 

§ 482.90 ................... Introductory text ................................... transplant center .................................. transplant program. 

§ 482.90 ................... Introductory text ................................... center ................................................... program. 

§ 482.90 ................... (a)(2) ..................................................... transplant center .................................. transplant program. 

§ 482.90 ................... (a)(4) ..................................................... transplant center .................................. transplant program. 

§ 482.90 ................... (b) introductory text .............................. Transplant centers ............................... Transplant programs. 

§ 482.92 ................... Introductory text ................................... donor-beneficiary .................................. donor-recipient. 

§ 482.92 ................... Introductory text ................................... beneficiary ............................................ recipient. 

§ 482.92 ................... Introductory text ................................... Transplant centers ............................... Transplant programs. 

§ 482.92 ................... Introductory text ................................... transplant center .................................. transplant program. 

§ 482.92 ................... (a) ......................................................... transplant center .................................. transplant program. 

§ 482.92 ................... (a) ......................................................... beneficiary ............................................ recipient. 

§ 482.92 ................... (b) ......................................................... beneficiary ............................................ recipient. 

§ 482.92 ................... (b) ......................................................... beneficiary’s ......................................... recipient’s. 

§ 482.94 ................... Introductory text ................................... Transplant centers ............................... Transplant programs. 

§ 482.94 ................... Introductory text ................................... transplant center .................................. transplant programs. 

§ 482.94 ................... Introductory text ................................... the center also ..................................... the program also. 

§ 482.94 ................... (a) introductory text .............................. transplant center’s ................................ transplant program’s. 

§ 482.94 ................... (a)(2) ..................................................... center ................................................... program. 

§ 482.94 ................... (b) introductory text .............................. Transplant centers ............................... Transplant programs. 

§ 482.94 ................... (b)(2) ..................................................... center’s ................................................. program’s. 

§ 482.94 ................... (b)(3) ..................................................... center’s ................................................. program’s. 

§ 482.94 ................... (c) introductory text .............................. Transplant centers ............................... Transplant programs. 

§ 482.94 ................... (c) introductory text .............................. center’s waiting list ............................... program’s waiting list. 

§ 482.94 ................... (c)(2) ..................................................... transplant center .................................. transplant program. 

§ 482.94 ................... (c)(3) introductory text .......................... transplant centers ................................. transplant programs. 

§ 482.94 ................... (d) introductory text .............................. transplant center .................................. transplant program. 

§ 482.94 ................... (d)(2) ..................................................... transplant center .................................. transplant program. 

§ 482.94 ................... (e) ......................................................... Transplant centers ............................... Transplant programs. 

§ 482.96 ................... Introductory text ................................... Transplant centers ............................... Transplant programs. 

§ 482.96 ................... (a) ......................................................... transplant center’s ................................ transplant program’s. 

§ 482.96 ................... (a) ......................................................... beneficiary ............................................ recipient. 

§ 482.96 ................... (a) ......................................................... transplant center .................................. transplant program. 

§ 482.96 ................... (b) introductory text .............................. transplant center .................................. transplant program. 

§ 482.96 ................... (b)(2) ..................................................... transplant center .................................. transplant program. 

§ 482.96 ................... (b)(2) ..................................................... transplant center’s ................................ transplant program’s. 

§ 482.98 ................... Introductory text ................................... transplant center .................................. transplant program. 

§ 482.98 ................... Introductory text ................................... the center ............................................. the program. 

§ 482.98 ................... (a) (a) heading and introductory text ... transplant center .................................. transplant program. 

§ 482.98 ................... (a)(1) ..................................................... transplant center .................................. transplant program. 

§ 482.98 ................... (b) introductory text .............................. transplant center .................................. transplant program. 

§ 482.98 ................... (c) introductory text .............................. transplant center .................................. transplant program. 

§ 482.98 ................... (c)(2) ..................................................... transplant center .................................. transplant program. 

§ 482.98 ................... (d) introductory text .............................. transplant center .................................. transplant program. 

§ 482.98 ................... (d) heading ........................................... living donor advocate team .................. independent living donor advocate 

team. 

§ 482.98 ................... (d)(1) ..................................................... living donor advocate ........................... independent living donor advocate. 

§ 482.98 ................... (d)(2) introductory text .......................... living donor advocate team .................. independent living donor advocate 

team. 

§ 482.98 ................... (d)(3) introductory text .......................... living donor advocate team .................. independent living donor advocate 

team. 

§ 482.98 ................... (e) ......................................................... transplant center .................................. transplant program. 

§ 482.98 ................... (f) .......................................................... transplant center .................................. transplant program. 

§ 482.100 ................. ............................................................... transplant center .................................. transplant program. 

§ 482.102 ................. Introductory text ................................... transplant center .................................. transplant program. 

§ 482.102 ................. (a) introductory text .............................. Transplant centers ............................... Transplant programs. 

§ 482.102 ................. (a)(8) ..................................................... transplant center .................................. transplant program. 

§ 482.102 ................. (a)(8) ..................................................... beneficiary’s ......................................... recipient’s. 

§ 482.102 ................. (b) introductory text .............................. Transplant centers ............................... Transplant programs. 

§ 482.102 ................. (b)(1) ..................................................... transplant center .................................. transplant program. 

§ 482.102 ................. (b)(4) ..................................................... beneficiary ............................................ recipient. 

§ 482.102 ................. (b)(6) ..................................................... transplant center-specific ..................... transplant program-specific. 

§ 482.102 ................. (b)(6) ..................................................... beneficiaries ......................................... receipients. 

§ 482.102 ................. (b)(6) ..................................................... center-specific outcomes ..................... transplant-specific outcomes. 

§ 482.102 ................. (b)(9) ..................................................... transplant center .................................. transplant program. 

§ 482.102 ................. (b)(9) ..................................................... beneficiary’s ......................................... recipient’s. 

§ 482.102 ................. (c) introductory text .............................. Transplant centers ............................... Transplant programs. 

§ 482.102 ................. (c) introductory text .............................. center’s ................................................. program’s. 

§ 482.102 ................. (c) introductory text .............................. center ................................................... program. 

§ 482.102 ................. (c)(1) introductory text .......................... transplant center .................................. transplant program. 


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Section Paragraphs Remove Add 

§ 482.102 ................. (c)(1) introductory text .......................... center’s waiting list ............................... program’s waiting list. 

§ 482.102 ................. (c)(2)(i) .................................................. center’s waiting list ............................... program’s waiting list. 

§ 482.102 ................. (c)(2)(i) .................................................. transplant center .................................. transplant program. 

§ 482.102 ................. (c)(2)(ii) ................................................. beneficiaries ......................................... recipients. 

§ 482.102 ................. (c)(2)(ii) ................................................. center’s waiting list ............................... program’s waiting list. 

§ 482.102 ................. (c)(2)(ii) ................................................. the center ............................................. the program. 

§ 482.102 ................. (c)(2)(ii) ................................................. center’s termination of approval ........... program’s termination of approval. 

§ 482.102 ................. (c)(3) ..................................................... transplant center’s ................................ transplant program’s. 

§ 482.102 ................. (c)(3) ..................................................... the center ............................................. the program. 

§ 482.102 ................. (c)(3) ..................................................... center’s waiting list ............................... program’s waiting list. 

§ 482.102 ................. (c)(3) ..................................................... transplant center .................................. transplant program. 

■ 32. Section 482.102 is further 

amended by revising paragraph (a)(5) to 

read as follows: 

§ 482.102 Condition of participation: 

Patient and living donor rights. 

* * * * * 

(a) * * * 

(5) National and transplant programspecific 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; 

* * * * * 

§ 482.104 [Amended] 

■ 33. For § 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 

■ 34. The authority citation for part 483 

continues to read as follows: 

Authority: Secs. 1102, 1128I, 1819, 1871 

and 1919 of the Social Security Act (42 

U.S.C. 1302, 1320a–7, 1395i, 1395hh and 

1396r). 

■ 35. Section 483.73 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(v); and 

■ c. Revising paragraph (d)(2). 

The revisions and addition read as 

follows: 

§ 483.73 Emergency preparedness. 

* * * * * 

(a) Emergency plan. The LTC facility 

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, or Federal emergency 

preparedness officials’ efforts to 

maintain an integrated response during 

a disaster or emergency situation. 

(b) Policies and procedures. The LTC 

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. At a 

minimum, the policies and procedures 

must address the following: 

* * * * * 

(c) Communication plan. The LTC 

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 and testing. The LTC 

facility 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 LTC facility must conduct 

training on the updated policies and 

procedures. 

(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 

when a community-based exercise is not 

accessible, an individual, facility-based 

functional exercise annually. 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 communitybased or individual, facility-based 

functional exercise following the onset 

of the actual event. 

(ii) Conduct an additional exercise at 

least annually 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 includes a group discussion led by 


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a facilitator, using a narrated, clinicallyrelevant 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. 

* * * * * 

■ 36. Section 483.475 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(v); and 

■ c. Revising paragraph (d)(2). 

The revisions and addition read as 

follows: 

§ 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 § 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 

when a community-based exercise is not 

accessible, an individual, facility-based 

functional exercise annually. If the ICF/ 

IID experiences an actual natural or 

man-made emergency that requires 

activation of the emergency plan, the 

ICF/IID is exempt from engaging in its 

next required full-scale communitybased or individual, facility-based 

functional exercise following the onset 

of the actual event. 

(ii) Conduct an additional exercise at 

least annually 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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 

■ 37. The authority citation for part 484 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh)) unless otherwise indicated. 

■ 38. Section 484.50 is amended by 

removing and reserving paragraph (a)(3) 

and revising paragraph (c)(7) 

introductory text to read as follows: 

§ 484.50 Condition of participation: Patient 

rights. 

* * * * * 

(c) * * * 

(7) Be advised, orally and in writing, 

of— 

* * * * * 

■ 39. Section 484.80 is amended by 

revising paragraph (h)(3) to read as 

follows: 

§ 484.80 Condition of participation: Home 

health aide services. 

* * * * * 

(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). 

* * * * * 

■ 40. Section 484.102 is amended by— 

■ 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); 

■ b. Redesignating the second paragraph 

(d)(1)(ii) as paragraph (d)(1)(iv); 

■ c. Adding paragraph (d)(1)(v); and 

■ d. Revising paragraph (d)(2). 

The revisions and addition read as 

follows: 

§ 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 


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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 when a 

community-based exercise is not 

accessible, an individual, facility-based 

functional exercise every 2 years. 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 communitybased or individual, facility-based 

functional exercise following the onset 

of the actual 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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. 

* * * * * 

■ 41. Section 484.110 is amended by 

revising paragraph (e) to read as follows: 

§ 484.110 Condition of participation: 

Clinical records. 

* * * * * 

(e) Standard: Retrieval of clinical 

records. A patient’s clinical record 

(whether hardcopy or electronic form) 

must be made available to a patient, free 

of charge, upon request within 4 

business days. 

PART 485—CONDITIONS OF 

PARTICIPATION: SPECIALIZED 

PROVIDERS 

■ 42. The authority citation for part 485 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh)). 

■ 43. Section 485.66 is amended by 

revising the introductory text to read as 

follows: 

§ 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. 

* * * * * 

■ 44. Section 485.68 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(v); and 

■ c. Revising paragraph (d)(2). 

The revisions and addition read as 

follows: 

§ 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 or when a 

community-based exercise is not 

accessible, an individual, facility-based 

functional exercise every 2 years. 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 

actual 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 


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(C) A tabletop exercise or workshop 

that includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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. 

* * * * * 

■ 45. Section 485.625 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(v); and 

■ c. Revising paragraph (d)(2). 

The revisions and addition read as 

follows: 

§ 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 

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 a full-scale exercise 

that is community-based or when a 

community-based exercise is not 

accessible, an individual, facility-based 

functional exercise once per year. 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 

actual event. 

(ii) Conduct an additional exercise at 

least annually, 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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. 

* * * * * 

§ 485.627 [Amended] 

■ 46. Section 485.627 is amended by 

removing and reserving paragraph 

(b)(1). 

■ 47. Section 485.635 is amended by 

revising paragraph (a)(4) to read as 

follows: 

§ 485.635 Condition of participation: 

Provision of services. 

(a) * * * 

(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. 

* * * * * 

■ 48. Section 485.645 is amended by— 

■ a. Revising paragraph (d)(1); 

■ b. Removing paragraph (d)(4); 

■ c. Redesignating paragraphs (d)(5) 

through (9) as paragraphs (d)(4) through 

(8), respectively; and 

■ d. Revising newly redesignated 

paragraphs (d)(4) and (7). 

The revisions read as follows: 

§ 485.645 Special requirements for CAH 

providers of long-term care services 

(‘‘swing-beds’’). 

* * * * * 

(d) * * * 

(1) Resident rights (§ 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 (§ 483.40(d) of this 

chapter). 

* * * * * 

(7) Dental services (§ 483.55(a)(2), (3), 

(4), and (5) and (b) of this chapter). 

* * * * * 

■ 49. Section 485.727 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(5), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(v); and 

■ c. Revising paragraph (d)(2). 

The revisions and addition read as 

follows: 

§ 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 


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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 or when a 

community-based exercise is not 

accessible, an individual, facility-based 

functional exercise every 2 years. 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, facilitybased functional exercise following the 

onset of the actual 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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. 

* * * * * 

■ 50. Section 485.914 is amended by 

revising paragraphs (d)(1) and (3) to 

read as follows: 

§ 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. 

* * * * * 

(3) For clients that receive PHP 

services, the assessment must be 

updated no less frequently than every 

30 days. 

* * * * * 

■ 51. 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: 

§ 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 

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 or when a 

community-based exercise is not 

accessible, an individual, facility-based 

every 2 years. 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 

actual 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 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 


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(C) A tabletop exercise or workshop 

that includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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 

■ 52. The authority citation for part 486 

continues to read as follows: 

Authority: Secs. 1102, 1138, and 1871 of 

the Social Security Act (42 U.S.C. 1302, 

1320b–8, and 1395hh) and section 371 of the 

Public Health Service Act (42 U.S.C 273). 

■ 53. Section 486.104 is amended by 

revising paragraph (a) to read as follows: 

§ 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. 

* * * * * 

■ 54. Section 486.106 is amended by 

revising paragraph (a)(2) to read as 

follows: 

§ 486.106 Conditions for coverage: 

Referral for service and preservation of 

records. 

* * * * * 

(a) * * * 

(2) Such physician or nonphysician 

practitioner’s order meets the 

requirements at § 410.32 of this chapter, 

and includes a statement concerning the 

condition of the patient which indicates 

why portable X-ray services are 

necessary. 

* * * * * 

■ 55. Section 486.360 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(v); and 

■ c. Revising paragraph (d)(2)(i). 

The revisions and addition read as 

follows: 

§ 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) * * * 

(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 a group 

discussion led by a facilitator, 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 actual event. 

* * * * * 

PART 488—SURVEY, CERTIFICATION, 

AND ENFORCEMENT PROCEDURES 

■ 56. The authority citation for part 488 

continues to read as follows: 

Authority: Secs. 1102, 1128l, 1864, 1865, 

1871 and 1875 of the Social Security Act, 

unless otherwise noted (42 U.S.C 1302, 

1320a–7j, 1395aa, 1395bb, 1395hh and 

1395ll). 

§ 488.30 [Amended] 

■ 57. Section 488.30(a) is amended in 

the definition for ‘‘Provider of services, 

provider, or supplier’’ by removing the 

phrase ‘‘transplant centers’’ and adding 

in its place the phrase ‘‘transplant 

programs’’. 

■ 58. Section 488.61 is amended— 

■ a. By revising the section heading; 

■ b. In the introductory text by 

removing the phrase ‘‘transplant 

centers’’ and adding in its place the 

phrase ‘‘transplant programs’’; 

■ c. In paragraph (a) by removing the 

phrases ‘‘centers’’ and ‘‘center’’ each 

time they appear and adding in their 

place the phrases ‘‘programs’’ and 

‘‘program,’’ respectively; 

■ d. In paragraph (a)(2) by removing the 

phrases ‘‘Scientific Registry of 

Transplant Beneficiary (SRTR) centerspecific’’ and ‘‘Scientific Registry of 

Transplant Recipient (SRTR) programspecific’’ and adding in its place the 

phrase ‘‘Scientific Registry of 

Transplant Recipient (SRTR) programspecific’’; 

■ e. By revising paragraph (a)(5); 

■ f. By removing paragraph (c); 

■ g. By redesignating paragraphs (d) 

through (h) as paragraphs (c) through 

(g), respectively; 

■ h. By revising newly redesignated 

paragraphs (c), (d), (e) introductory text, 

(e)(1) introductory text, (e)(1)(iv), (e)(3), 

and (f)(1)(i), (ii), and (iii). 

The revisions read as follows: 


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§ 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 

§§ 482.72 through 482.76 and §§ 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 §§ 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 §§ 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 § 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 § 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 

§ 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 

§ 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 

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 

■ 59. The authority citation for part 491 

continues to read as follows: 

Authority: Sec. 1102 of the Social Security 

Act (42 U.S.C. 1302); and sec. 353 of the 

Public Health Service Act (42 U.S.C. 263a). 

■ 60. Section 491.9 is amended by 

revising paragraph (b)(4) to read as 

follows: 

§ 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. 

* * * * * 

■ 61. Section 491.11 is amended by 

revising paragraph (a) to read as follows: 

§ 491.11 Program evaluation. 

(a) The clinic or center carries out, or 

arranges for, a biennial evaluation of its 

total program. 

* * * * * 

■ 62. Section 491.12 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(v); and 

■ c. Revising paragraph (d)(2). 

The revisions and addition read as 

follows: 

§ 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 


amozie on DSK3GDR082PROD with PROPOSALS2
Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Proposed Rules 47761 

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 or when a 

community-based exercise is not 

accessible, an individual, facility-based 

functional exercise every 2 years. 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, facilitybased functional exercise following the 

onset of the actual 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 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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 

■ 63. The authority citation for part 494 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. l302 and 

l395hh). 

■ 64. Section 494.62 is amended by— 

■ a. Revising paragraphs (a) 

introductory text, (a)(4), (b) introductory 

text, (c) introductory text, (d) 

introductory text, and (d)(1)(ii); 

■ b. Adding paragraph (d)(1)(vii); and 

■ c. Revising paragraph (d)(2). 

The revisions and addition read as 

follows: 

§ 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 or when a 

community-based exercise is not 

accessible, an individual, a facilitybased functional exercise every 2 years. 

If the dialysis facility experiences an 

actual natural or man-made emergency 

that requires activation of the 

emergency plan, the ESRD is exempt 

from engaging in its next required fullscale community-based or individual, 

facility-based functional exercise 

following the onset of the actual 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 includes a group discussion led by 

a facilitator, using a narrated, clinicallyrelevant 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. 

* * * * * 


amozie on DSK3GDR082PROD with PROPOSALS2
47762 Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Proposed Rules 

Dated: August 6, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: August 9, 2018. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2018–19599 Filed 9–17–18; 11:15 am] 

BILLING CODE 4120–01–P 


amozie on DSK3GDR082PROD with PROPOSALS2