40350 Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Proposed Rules 

1Rural Health Research Gateway. (2018). Rural 

Communities: Age, Income, and Health Status. 

https://www.ruralhealthresearch.org/assets/2200- 

8536/rural-communities-age-income-health-statusrecap.pdf. 

2Health Resources & Services Administration 

(2021). Rural Hospital Programs. https://

www.hrsa.gov/rural-health/rural-hospitals/. 

3UNC: Cecil G. Sheps Center for Health Services 

Research. (2022). Rural Hospital Closures. https:// 

www.shepscenter.unc.edu/programs-projects/ruralhealth/rural-hospital-closures/. 

4Healthy People 2020 (n.d.) Access to Health 

Services. https://www.healthypeople.gov/2020/ 

topics-objectives/topic/Access-to-Health-Services. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 485 and 489 

[CMS–3419–P] 

RIN 0938–AU92 

Medicare and Medicaid Programs; 

Conditions of Participation (CoPs) for 

Rural Emergency Hospitals (REH) and 

Critical Access Hospital CoP Updates 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

establish conditions of participation that 

Rural Emergency Hospitals (REH) must 

meet to participate in the Medicare and 

Medicaid programs. These requirements 

are intended to ensure that a high 

quality of care is furnished by REHs. 

This proposed rule also includes 

changes to the requirements Critical 

Access Hospital would have to meet to 

participate in the Medicare and 

Medicaid programs. Proposed payment 

policies and enrollment policies for 

REHs will be developed under separate 

rulemaking. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below by August 

29, 2022. 

ADDRESSES: In commenting, please refer 

to file code CMS–3419–P. 

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 https://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–3419–P, P.O. Box 8016, Baltimore, 

MD 21244–8010. 

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–3419–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:

Kianna Banks, (410) 786–3498. 

Capt. Scott Cooper, U.S. Public Health 

Service (USPHS), (410) 786–9465. 

Kristin Shifflett, (410) 786–4133. 

Lela Strong, (410) 786–3213. 

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: https://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. CMS will not post on 

Regulations.gov public comments that 

make threats to individuals or 

institutions or suggest that the 

individual will take actions to harm the 

individual. CMS continues to encourage 

individuals not to submit duplicative 

comments. We will post acceptable 

comments from multiple unique 

commenters even if the content is 

identical or nearly identical to other 

comments. 

I. Background 

A. Introduction 

Americans who live in rural areas of 

the nation make up about 20 percent of 

the United States (U.S.) population, and 

they often experience shorter life 

expectancy, higher all-cause mortality, 

higher rates of poverty, fewer local 

doctors, and greater distances to travel 

to see health care providers, compared 

to their urban and suburban 

counterparts.1 In addition, one in five 

rural residents identifies as Black, 

Hispanic, American Indian/Alaska 

Native (AI/AN), Asian American/Pacific 

Islander (AA/PI), or a combination of 

ethnic backgrounds. Compared to the 

non-Hispanic White rural population, 

these rural minority groups often and 

regularly experience several 

disadvantageous social determinants of 

health.2

The health care inequities that many 

rural Americans face raise serious 

concerns that the trend for poor health 

care access and worse outcomes overall 

in rural areas will continue unless the 

potential causes of such health care 

inequities are addressed. 

There have been growing concerns 

over the closures of rural hospitals and 

critical access hospitals (CAHs). 

Between 2010 and February 2022, 138 

rural hospitals stopped providing 

inpatient services, 44 of which were 

Critical Access Hospitals. There were 75 

complete hospital closures where all 

services ended and 63 hospital 

conversions where inpatient services 

ended but some type of health care 

service continued.3 Rural hospitals 

report they continue to face the threat of 

closure because they lack sufficient 

patient volume to offer traditional 

hospital inpatient acute care services 

required for Medicare payment; 

however, the demand still exists for 

emergency and outpatient services in 

areas served by these hospitals. Rural 

hospitals are essential to providing 

health care to their communities and the 

closure of these hospitals limits access 

to care for the communities they once 

served and reduces employment 

opportunities, further impacting local 

economies. Barriers such as workforce 

shortages, can impact health care access 

in rural communities and can lead to 

unmet health needs, delays in receiving 

appropriate care, inability to get 

preventive services, financial burdens, 

and preventable hospitalizations.4

The Consolidated Appropriations Act 

(CAA) of 2021 (Pub. L. 116–260), was 

signed into law on December 27, 2020. 

In this legislation, Congress established 

a new rural Medicare provider type: 

Rural Emergency Hospitals (REHs). 

These providers will furnish emergency 

department and observation care, and 

other specified outpatient medical and 

health services, if elected by the REH, 

that do not exceed an annual per patient 

average of 24 hours. Hospitals that were 

CAHs or rural hospitals with not more 

than 50 beds, participating in Medicare, 

as of the date of enactment of the CAA, 

may submit an application to convert to 

and enroll in Medicare as an REH. An 

REH will receive Medicare payment for 

REH services furnished on or after 

January 1, 2023. 

REHs are expected to help address the 

barriers in access to health care, 

particularly emergency services and 

other outpatient services that result 


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5 86 FR 7009 (Jan. 25, 2021). The White House. 

(2021). Briefing Room: Executive Order on 

Advancing Racial Equity and Support for 

Underserved Communities Through the Federal 

Government. https://www.whitehouse.gov/briefingroom/presidential-actions/2021/01/20/executiveorder-advancing-racial-equity-andsupport-forunderserved-communities-through-thefederalgovernment/. 

6 86 FR 7023 (Jan. 25, 2021). The White House. 

(2021). Briefing Room: Executive Order on 

Preventing and Combating Discrimination on the 

Basis of Gender Identity or Sexual Orientation. 

https://www.whitehouse.gov/briefing-room/ 

presidential-actions/2021/01/20/executive-orderpreventing-and-combatingdiscrimination-on-basisof-gender-identity-orsexual-orientation/. 

7 86 FR 7193 (Jan. 26, 2021). The White House. 

(2021). Briefing Room: Executive Order on Ensuring 

an Equitable Pandemic Response and Recovery. 

https://www.whitehouse.gov/briefing-room/ 

presidentialactions/2021/01/21/executive-orderensuring-anequitable-pandemic-response-andrecovery/. 

8Congress.gov. (2020). H.R.133—Consolidated 

Appropriations Act, 2021. https://

www.congress.gov/116/bills/hr133/BILLS116hr133enr.pdf. 

from rural hospital closures, and by 

doing so, may help address observed 

inequities in health care in rural areas. 

On January 20 and 21, 2021, President 

Biden issued three Executive orders 

related to issues of health equity: 

Executive Order 13985 ‘‘Advancing 

Racial Equity and Support for 

Underserved Communities Through the 

Federal Government;’’ 5 Executive Order 

13988, ‘‘Preventing and Combating 

Discrimination on the Basis of Gender 

Identity or Sexual Orientation;’’ 6 and 

Executive Order 13995 ‘‘Ensuring an 

Equitable Pandemic Response and 

Recovery.’’ 7

Executive Order 13985, ‘‘Advancing 

Racial Equity and Support for 

Underserved Communities Through the 

Federal Government,’’ requires the 

Federal Government to pursue a 

comprehensive approach to advancing 

equity for all, including people of color 

and others who have been historically 

underserved, marginalized, and 

adversely affected by persistent poverty 

and inequality by recognizing and 

working to redress inequities in its 

policies and programs that serve as 

barriers to equal opportunity. In 

accordance with this Executive order, 

persons who live in rural areas are 

identified as belonging to underserved 

communities that have been adversely 

affected by inequality. 

Executive Order 13988, ‘‘Preventing 

and Combating Discrimination on the 

Basis of Gender Identity or Sexual 

Orientation,’’ requires the Federal 

Government to prevent and combat 

discrimination, including when 

accessing health care, on the basis of 

gender identity or sexual orientation, 

and to fully enforce Title VII of the Civil 

Rights Act. This Executive order also 

requires the Federal Government to 

fully enforce other laws that prohibit 

discrimination on the basis of gender 

identity or sexual orientation, all of 

which impact all persons, including 

those in rural communities. 

In accordance with Executive Order 

13995, ‘‘Ensuring an Equitable 

Pandemic Response and Recovery,’’ the 

Federal Government must identify and 

eliminate health and social inequities 

resulting in disproportionately higher 

rates of exposure, illness, and death 

related to COVID–19 and take swift 

action to prevent and remedy 

differences in COVID–19 care and 

outcomes within communities of color 

and other underserved populations. The 

Executive order highlights the observed 

inequities in rural and Tribal 

communities, territories, and other 

geographically isolated communities. 

We believe the services furnished by 

REHs, could be one means of addressing 

some of the issues raised in these 

orders, particularly, barriers to access 

health care in rural communities. 

Consistent with these Executive 

orders, in implementing the new REH 

provider type, we are committed to 

advancing equity for all, including 

racial and ethnic minorities, members of 

the lesbian, gay, bisexual, transgender, 

and queer/questioning (LGBTQ) 

community, people with limited English 

proficiency, people with disabilities, 

rural populations, and people otherwise 

adversely affected by persistent poverty 

or inequality. 

We are proposing at this time to 

establish conditions of participation 

(CoPs) for REHs as a new Medicare 

provider type, consistent with the 

provisions of section 125 of the CAA. In 

developing the proposed CoPs for REHs, 

we have considered the role that we 

believe REHs can play in helping to 

advance equity and ensure access to 

available services and quality health 

care in rural communities. Proposed 

payment and enrollment policies for 

REHs will be developed in separate 

rulemaking. 

B. Statutory Authority and 

Establishment of Rural Emergency 

Hospitals as a Medicare Provider Type 

Section 125 of Division CC of the 

CAA was signed into law on December 

27, 2020 and establishes REHs as a new 

Medicare provider type that will receive 

Medicare payment for services 

furnished on or after January 1, 2023. 

Section 125 of the CAA added section 

1861(kkk) to the Social Security Act (the 

Act), which sets forth the requirements 

for REHs. Section 1861(kkk)(2) of the 

Act defines an REH as a facility that is 

enrolled in the Medicare program as an 

REH; does not provide any acute care 

inpatient services (other than post-REH, 

that is after discharge from an REH, or 

post-hospital extended care services 

furnished in a distinct part unit licensed 

as a skilled nursing facility (SNF)); has 

a transfer agreement in effect with a 

level I or level II trauma center; meets 

certain licensure requirements; meets 

requirements of a staffed emergency 

department; meets staff training and 

certification requirements established 

by the Secretary of the Department of 

Health and Human Services (the 

Secretary); and meets certain CoPs 

applicable to hospital emergency 

departments and CAHs with respect to 

emergency services. 

Additionally, section 125(a)(1) of the 

CAA added section 1861(kkk)(1) of the 

Act, which requires that REHs provide 

emergency department services and 

observation care, and, at the election of 

the REH, other medical and health 

services furnished on an outpatient 

basis, as specified by the Secretary 

through rulemaking. The REH must also 

have a staffed emergency department 24 

hours a day, 7 days a week, have a 

physician, nurse practitioner, clinical 

nurse specialist, or physician assistant 

available to furnish rural emergency 

hospital services in the facility 24 hours 

a day, and meet applicable staffing 

requirements similar to those for CAHs.8

In order to become an REH, section 

1861(kkk)(3) of the Act requires that the 

facility, on the date of enactment of the 

CAA, 2021 (December 27, 2020), was a 

CAH or a rural hospital with not more 

than 50 beds. For the purpose of REH 

designation, the statute defines rural as 

a county (or equivalent unit of local 

government) considered rural (as 

defined in section 1886(d)(2)(D) of the 

Act), or treated as being located in a 

rural area pursuant to section 

1886(d)(8)(E) of the Act. To be treated as 

being located in a rural area for the 

purpose of REH eligibility, we are 

proposing as part of this proposed rule 

that a hospital located in a metropolitan 

county must have had an active 

reclassification from urban to rural 

status as specified in 42 CFR 412.103 as 

of December 27, 2020. In addition, the 

REH must meet certain other 

requirements under section 1861(kkk) of 

the Act, including, but not limited to the 

following: 

• An annual per patient average of 24 

hours or less in the REH; 

• Staff training and certification 

requirements established by the 

Secretary; 

• Emergency services CoPs applicable 

to CAHs; 


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• Hospital emergency department 

CoPs determined applicable by the 

Secretary; 

• The applicable SNF requirements 

(if the REH includes a distinct part 

SNF); 

• A transfer agreement with a level I 

or level II trauma center; and 

• Any other requirements the 

Secretary finds necessary in the interest 

of the health and safety of individuals 

who are furnished services in an REH. 

Starting on January 1, 2023, an REH 

that provides rural emergency hospital 

services (as defined in section 

1861(kkk)(1) of the Act) will receive a 

Medicare payment for those services 

pursuant to section 1834(x)(1) of the 

Act, as added by section 125 of the 

CAA, that is equal to the amount of 

payment that would otherwise apply 

under the Medicare Hospital Outpatient 

Prospective Payment System (OPPS) for 

covered outpatient department services 

increased by 5 percent. The beneficiary 

co-payments for these services will be 

calculated the same way as under the 

OPPS for the service, excluding the 5 

percent payment increase. In addition, 

section 1834(x)(2) of the Act provides an 

additional monthly facility payment to 

an REH. The details of the payment 

policies for REHs will be developed in 

separate notice and comment 

rulemaking. 

To participate in the Medicare 

program and receive payment for 

services furnished to Medicare 

beneficiaries, providers of services such 

as hospitals, home-health agencies, 

hospices, SNFs, and now REHs must 

enter into a provider agreement with 

Centers for Medicare & Medicaid 

Services (CMS), in accordance with 

section 1866 of the Act. Medicaid 

providers (every person or institution 

providing services under the state plan), 

likewise, must enter into agreements 

with state Medicaid agencies to be 

eligible for participation in that program 

as described in section 1902(a)(27) of 

the Act. By entering into a provider 

agreement, a facility agrees that it will 

comply with the applicable 

requirements of the Medicare and 

Medicaid statutes and the regulations 

that the Secretary issues under the 

respective statute. 

Section 1861(kkk)(7) of the Act 

requires the Secretary to establish 

quality measurement reporting 

requirements for REHs, which may 

include claims-based outcome measures 

and/or patient experience surveys. An 

REH is required to submit quality 

measure data to the Secretary with 

respect to each year beginning in 2023 

(or each year beginning on or after the 

date that is one year after one or more 

measures are first specified), and the 

Secretary is required to establish 

procedures to make the data available to 

the public on the CMS website. Quality 

measure specifications and quality 

reporting requirements for REHs will be 

developed in future rulemaking. 

The Quality Improvement 

Organization requirements of the Act 

shall apply to REHs in the same manner 

that they apply to hospitals and CAHs, 

in accordance with section 1866(a) of 

the Act (as amended by section 

125(b)(1) of the CAA). In addition, the 

requirements established at section 1864 

of the Act for hospitals and CAHs to be 

surveyed for compliance with the CoPs 

shall apply to REHs in the same manner 

as other hospitals and CAHs, in 

accordance with section 125(d)(2) of the 

CAA. 

Under section 1864 of the Act, CMS 

uses state surveyors to determine 

whether a provider or supplier subject 

to certification qualifies for an 

agreement to participate in Medicare. 

Additionally, under section 1865 of the 

Act, some providers or suppliers subject 

to certification have the option to 

instead elect to be accredited by private 

accrediting organizations (AOs) whose 

Medicare accreditation programs have 

been approved by CMS as having 

standards and survey procedures that 

meet or exceed all applicable Medicare 

requirements and be deemed to meet 

Federal requirements. The survey 

process for Medicare- and Medicaidparticipating providers and suppliers 

provides an opportunity for these 

providers and suppliers to demonstrate 

compliance with all of the applicable 

CoPs, conditions for coverage (CfCs), 

conditions for certification, or 

requirements. The methods used by 

CMS to determine compliance with the 

regulations include surveys conducted 

by a state survey agency, surveys 

conducted by AOs that have deeming 

authority for Medicare providers and 

suppliers, and self-attestation. CMS 

would require REHs participating in 

Medicare to demonstrate and maintain 

compliance with the provisions 

included in the final rule. 

C. Summary of Comments by Interested 

Parties in Response to REH Request for 

Information 

In preparation for developing these 

proposed standards and to gain a clear 

understanding of the challenges faced 

by facilities providing health care 

services in rural communities, we 

published a Request for Information 

(RFI) on REHs in the proposed rule, 

‘‘Medicare Program: Hospital Outpatient 

Prospective Payment and Ambulatory 

Surgical Center Payment Systems and 

Quality Reporting Programs; Price 

Transparency of Hospital Standard 

Charges; Radiation Oncology Model; 

Request for Information on Rural 

Emergency Hospitals’’ (86 FR 42018) on 

August 4, 2021. CMS sought public 

input on a broad range of issues to 

inform our policymaking in establishing 

this new provider type. The RFI 

solicited public input on the concerns of 

rural providers, including in the areas of 

health and safety standards, health 

equity, payment policies, quality 

measures and quality reporting, and 

additional considerations and 

unintended consequences that should 

be considered during the development 

of standards for REHs. As previously 

noted in section I.B of this proposed 

rule, the details of the payment policy 

and quality measures and quality 

reporting requirements for REHs will be 

developed via future rulemaking. 

Commenters on the RFI generally 

noted that CMS should remain flexible 

in the development of standards for 

REHs and take into consideration the 

challenges associated with the 

provisi0on of health care services in 

rural communities. Specific themes 

from the comments received centered 

on suggested CoPs including 

requirements for staffing, transfers, and 

supervision, services that should be 

offered by REHs, and the health equity 

implications for REHs. Several 

commenters stated that the CoPs 

currently in place for CAHs would be 

sufficient for REHs and that the CoPs for 

REHs should not be more rigorous than 

those for CAHs. Commenters also 

recommended that REHs should provide 

maternal health, behavioral/mental 

health services, and telehealth services 

to further support the communities that 

they will serve. With regard to health 

equity, several interested parties 

commented that REHs could have 

significant value for underserved, rural 

populations by maintaining local access 

to care, reducing travel times for care, 

and serving as leaders for community 

health improvement efforts including 

efforts to address the social 

determinants of health. We note that 

CMS is committed to reducing 

inequities in rural communities and we 

are considering the best approach to 

address health equity in the standards 

for all Medicare-and Medicaidparticipating providers and suppliers, 

including REHs. 

The REH RFI public comments are 

available for review at https://

www.regulations.gov/document/CMS2021-0124-0002/comment. We have 

reviewed all comments from interested 

parties and have taken them into 

consideration while drafting this 


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proposed rule. We appreciate the 

interested parties’ input and responses 

to our outreach efforts thus far. 

During the development of the 

policies to implement this new provider 

type, we reviewed the public comments 

received on the REH RFI, and held 

public listening sessions with national 

organizations representing interested 

parties as well as tribal communities. 

We also gave presentations at CMS’ 

hospital, rural health, and SNF open 

door forums and sought public 

feedback. We carefully reviewed the 

hospital and CAH requirements to 

determine which requirements would 

be appropriate (as is or based on 

modification) for REHs. 

II. Provisions of the Proposed 

Regulation 

A. Rural Emergency Hospital Conditions 

for Participation (Proposed Part 485, 

Subpart E) 

We propose to add a new subpart E 

in 42 CFR part 485, to incorporate the 

REH CoPs. Proposed subpart E which 

would include all the health and safety 

standards for REHs. Overall, the 

proposed requirements are modeled 

closely after the CoPs for CAHs. In some 

instances, we have also proposed 

requirements that are similar to the 

CoPs for hospitals and CfCs for 

Ambulatory Surgical Centers (ASCs). In 

each of the sections below, we specify 

the existing requirements for CAHs, 

hospitals, or ASCs that we used to guide 

the proposed requirements. 

1. Basis and Scope (Proposed § 485.500) 

We propose to set forth the basis and 

scope of part 485, subpart E, at 

§ 485.500. As previously noted, 

proposed part 485, subpart E, would 

implement section 1861(kkk) of the Act, 

which establishes the requirements that 

an REH must meet in order to 

participate in the Medicare program. 

Section 1833(a) of the Act serves as the 

basis for the establishment of payment 

of benefits covered under Medicare for 

REHs. 

2. Definitions (Proposed § 485.502) 

At § 485.502, we propose to define 

certain terms that would be used 

throughout the REH CoPs. We propose 

to define the term ‘‘Rural Emergency 

Hospital or REH’’ in accordance with 

the definition set forth in section 

1861(kkk) of the Act. In accordance with 

the Act, we propose to define Rural 

Emergency Hospital or REH as an entity 

that operates for the purpose of 

providing emergency department 

services, observation care, and other 

outpatient medical and health services 

specified by the Secretary in which the 

annual per patient average length of stay 

does not exceed 24 hours. The REH 

must not provide inpatient services, 

except those furnished in a unit that is 

a distinct part licensed as a skilled 

nursing facility to furnish post-REH or 

post-hospital extended care services. 

We received several comments on the 

REH RFI indicating that the average 

length of stay should be increased in 

certain instances, such as when the REH 

is providing services to a patient who is 

need of inpatient psychiatric or 

inpatient rehabilitation services. The 

commenters stated that placement of 

these patients in an inpatient facility 

could be difficult with some patients 

potentially remaining in the REH for 

observation services for weeks. 

Commenters noted further that these 

patients may produce an average length 

of stay that exceeds the proposed 24- 

hour annual per patient average length 

of stay. Other commenters requested 

that CMS be flexible in recognizing bed 

capacity issues for those patients 

awaiting placement in an inpatient 

facility and practice enforcement 

discretion related to the proposed length 

of stay requirement. 

However, in accordance with section 

1861(kkk)(1)(A) of the Act, services 

furnished by the REH must not exceed 

an annual per patient average of 24 

hours in the REH. We would expect an 

REH to transfer patients whom the REH 

determines require a higher level of care 

as soon as possible. We do understand 

that there may be occasional 

circumstances in which a facility is not 

immediately available to provide a 

higher level of care, resulting in patients 

receiving services at the REH for more 

than 24 hours. However, we believe that 

this will occur at a frequency that will 

not seriously affect the REH’s average 

length of stay. As a result, we do not 

anticipate that the REH would be at risk 

for exceeding the statutory annual per 

patient average length of stay of 24 

hours or less. 

3. Basic Requirements (Proposed 

§ 485.504) 

At § 485.504 we propose to set forth 

the basic requirements for REHs in 

accordance with section 1861(kkk) of 

the Act. Participating REHs would be 

limited to those facilities that meet the 

definition in proposed § 485.502 and 

have in effect a provider agreement as 

defined at 42 CFR 489.3. We would add 

REHs to the list of providers required to 

obtain a provider agreement at 

§ 489.2(b) in the ‘‘Conforming 

Amendments’’ section of this proposed 

rule. 

4. Designation and Certification of REHs 

(Proposed § 485.506) 

At § 485.506 we propose to set forth 

the criteria for CMS certification of an 

REH in accordance with section 

1861(kkk) of the Act. We propose to 

establish that CMS would certify a 

facility as an REH if the facility was, as 

of the date of enactment of the CAA, a 

CAH, or a hospital as defined in section 

1886(d)(1)(B) of the Act with not more 

than 50 beds located in a county (or 

equivalent unit of local government) 

considered rural (as defined in section 

1886(d)(2)(D) of the Act), or treated as 

being located in a rural area pursuant to 

section 1886(d)(8)(E) of the Act. In 

addition, to be treated as being located 

in a rural area for the purpose of REH 

eligibility, we are proposing as part of 

this proposed rule that a hospital 

located in a metropolitan county must 

have had an active reclassification from 

urban to rural status as specified in 

section 42 CFR 412.103 as of December 

27, 2020. 

5. Compliance With Federal, State, and 

Local Laws and Regulations (Proposed 

§ 485.508) 

Consistent with the requirements for 

all Medicare- and Medicaidparticipating providers and suppliers, 

we propose to require REHs to comply 

with Federal, state, and local laws and 

regulations. 

At § 485.508(a) we propose to require 

the REH to be in compliance with 

applicable Federal laws, state, and local 

laws and regulations. In accordance 

with section 1861(kkk)(5) of the Act, we 

also propose to require at § 485.508(b) 

that the REH is located in a state that 

provides for the licensing of such 

hospitals under state or applicable local 

law. In addition, under § 485.508(b)(1) 

and (2), we propose that the REH be 

licensed in the state as an REH or be 

approved as meeting standards for 

licensing by the agency in the state or 

locality responsible for licensing 

hospitals. We note that in many 

instances, states and localities, have 

more stringent laws and regulations 

than the Federal requirements. In cases 

in which state law or regulations are 

more stringent, the REH would need to 

comply with the more stringent state or 

local requirements to meet the proposed 

requirements at § 485.508(a). 

At § 485.508(c), we propose to require 

that the REH ensure that personnel are 

licensed or meet other applicable 

standards required by state or local laws 

to provide services within the 

applicable scope of practice. Some 

commenters on the REH RFI 

recommended that CMS encourage 


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licensure portability among health care 

practitioners. Commenters indicated 

that allowing practitioners to practice in 

multiple states would greatly support 

both in-person and virtual care models 

in rural areas where the closest health 

care provider may be across the state 

line. This proposed standard does not 

prohibit a practitioner that is licensed in 

a different state than where the REH is 

located from providing care at the REH; 

state laws govern whether this is 

permissible. 

6. Condition of Participation: Governing 

Body and Organizational Structure of 

the REH (Proposed § 485.510) 

To ensure appropriate oversight of the 

REH, we propose at § 485.510 to require 

the REH to have an effective governing 

body, or responsible individual or 

individuals, that is legally responsible 

for the conduct of the REH. This aligns 

with the CAH CoP for organizational 

structure at § 485.627(a). In addition to 

oversight, we expect the responsibilities 

of the governing body or responsible 

individual to include ensuring that the 

REH is effectively executing its policies 

and decision-making about the REH’s 

vision, mission, and strategies. If an 

REH does not have an organized 

governing body, we propose to require 

that the person or persons legally 

responsible for the conduct of the REH 

carry out the functions specified in this 

part that pertain to the governing body. 

Consistent with the hospital 

governing body CoPs at § 482.12, we 

propose at § 485.510(a)(1) to require the 

governing body, in accordance with 

state law, to determine which categories 

of practitioners are eligible candidates 

for appointment to the medical staff. 

Additionally, consistent with the 

interpretive guidelines for CAHs in 

Appendix W of the State Operations 

Manual for the standard for Governing 

Body or Responsible Individual at 

§ 485.627(a), we propose to require that 

the governing body of the REH appoint 

members of the medical staff after 

considering the recommendations of the 

existing members of the medical staff. 

The role of the medical staff is the 

promotion of patient safety and the 

quality of care. This proposal would 

give maximum flexibility to an REH in 

determining and granting staff privileges 

and organizing its medical staff, and it 

would allow the REH to grant specific 

privileges related to patient care to 

various other types of licensed 

practitioners as it needed, in addition to 

the privileges it would choose to grant 

to doctors of medicine or osteopathy. 

For example, an REH could choose to 

grant medical staff privileges to nurse 

practitioners and physician assistants if 

this is allowable under state law. We 

also propose to require that the REH’s 

governing body must ensure that its 

medical staff is accountable to the 

governing body for the quality of patient 

care provided by the REH; organizes 

itself under bylaws; and ensures that the 

criteria for selection to the medical staff 

are individual character, competence, 

training, experience, and judgment. 

Many rural populations suffer from 

limited access to care due to a shortage 

of health care professionals, especially 

physicians. Often times, clinicians other 

than physicians provide important care 

services to rural communities with 

physicians providing oversight. This 

may occur in many different ways, 

including via the use of mobile health, 

video and audio technologies, digital 

photography and remote patient 

monitoring. With the development of 

technology that facilitates 

‘‘telemedicine,’’ a physician could 

utilize a variety of methods to provide 

health care services, including being onsite at a facility or at a distant site 

furnishing services remotely to a patient 

located at an originating site. 

Commenters on the REH RFI noted 

that REHs should be able to be an 

originating site (that is, the location 

where a Medicare patient receives 

medical services from a physician or 

other clinician through a 

telecommunications system) for the 

provision of telehealth services. As 

noted in the CY 2022 Medicare 

Physician Fee Schedule final rule (86 

FR 65057), section 125(c) of the CAA 

amended section 1834(m)(4)(C)(ii) of the 

Act to add REHs to the list of 

permissible telehealth originating sites. 

In accordance with section 

1834(m)(4)(C)(ii)(XI) of the Act, as 

added by section 125(c) of the CAA, we 

finalized a revision to § 410.78(b)(3) of 

our regulations to add REH, as defined 

in section 1861(kkk)(2) of the Act, as a 

permissible originating site for 

telehealth services furnished on or after 

January 1, 2023. 

For the purposes of this rule, similar 

to our interpretation in the policy set 

out in our final rule, ‘‘Medicare and 

Medicaid Programs; Changes Affecting 

Hospital and Critical Access Hospital 

Conditions of Participation: 

Telemedicine Credentialing and 

Privileging’’ (76 FR 25550 through 

25556), we see telemedicine as 

encompassing the overall delivery of 

health care to the patient through the 

practice of patient assessment, 

diagnosis, treatment, consultation, 

transfer and interpretation of medical 

data, and patient education all via a 

telemedicine link (for example, audio, 

video, and data telecommunications as 

may be utilized by distant-site 

physicians and practitioners). Therefore, 

in order to make clear that the 

credentialing and privileging provisions 

proposed for REHs are not limited to the 

narrower subset of services and sites 

eligible for Medicare telehealth 

payment, we chose to use the term, 

‘‘telemedicine,’’ throughout this rule 

instead of ‘‘telehealth.’’ As noted 

previously, payment policies for REHs, 

including for services furnished via 

telehealth/telemedicine, will be 

addressed in separate notice and 

comment rulemaking. 

In recognition of the important role 

that telemedicine can play in the 

provision of care in rural communities, 

we believe it is necessary to establish a 

more efficient process for REHs to 

credential and privilege clinicians who 

provide telemedicine services for the 

REH’s patients. We are proposing 

requirements similar to the telemedicine 

credentialing and privileging process 

requirements established for hospitals 

and CAHs that would allow for an 

optional and more streamlined 

credentialing and privileging process 

that REHs may use for practitioners 

providing telemedicine services for their 

patients. We believe that like small 

hospitals and CAHs seeking to provide 

enhanced access to care through the use 

of telemedicine services for their 

patients, REHs might lack the resources 

to fully carry out the traditional 

credentialing and privileging process for 

all of the physicians and practitioners 

that may be available to provide 

telemedicine services. In addition to the 

costs and administrative staff needed for 

this process, REHs would also most 

likely not have in-house medical staff 

with the clinical expertise to adequately 

evaluate and privilege the wide range of 

specialty physicians that larger 

hospitals can provide their patients 

through the use of telemedicine 

services. Therefore, at § 485.510(a)(8) we 

are proposing that REH’s governing 

body ensure that when telemedicine 

services are furnished to the REH’s 

patients through an agreement with a 

Medicare-participating hospital (the 

‘‘distant-site’’—the site at which the 

physician or practitioner is located at 

the time the service is provided via a 

communications system, as defined at 

section 1834(m)(4)(A) of the Act), the 

agreement must specify that it is the 

responsibility of the governing body of 

the distant-site hospital providing the 

telemedicine services to meet the 

requirements in § 485.510(a)(1) through 

(7) with regard to its physicians and 

practitioners who are providing 

telemedicine services. These provisions 


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cover the distant-site hospital’s 

governing body responsibilities for its 

medical staff that all Medicareparticipating hospitals must currently 

meet and that REHs would be required 

to meet when this rule is finalized. The 

proposed requirements at 

§ 485.510(a)(8) would allow the 

governing body of the REH whose 

patients are receiving the telemedicine 

services to grant privileges based on the 

recommendations of its medical staff, 

who would rely on information 

provided by the distant-site hospital, as 

a more efficient means of privileging the 

individual distant-site physicians and 

practitioners. This provision would be 

accompanied by the proposed 

requirement in the ‘‘Medical staff’’ CoP 

at § 485.510(a), which would provide 

the basis on which the REH’s governing 

body, through its agreement as noted 

above, can choose to have its medical 

staff rely upon information furnished by 

the distant-site hospital when making 

recommendations on privileges for the 

individual physicians and practitioners 

providing such services. This option 

would not prohibit an REH’s medical 

staff from continuing to perform its own 

periodic appraisals of telemedicine 

members of its staff, nor would it bar 

them from continuing to use the 

proposed traditional credentialing and 

privileging process proposed at 

§ 485.512(a)(2). The intent of this 

proposed requirement is to relieve 

burden for REHs by providing for a less 

duplicative and more efficient 

privileging scheme with regard to 

physicians and practitioners providing 

telemedicine services. However, in an 

effort to ensure accountability to the 

process, we are proposing within this 

same provision (§ 485.512(a)(3)) that the 

REH, in order to choose this less 

burdensome option for privileging, must 

ensure that (1) the distant-site hospital 

providing the telemedicine services is a 

Medicare-participating hospital; (2) the 

individual distant-site physician or 

practitioner is privileged at the distantsite hospital providing telemedicine 

services, and that this distant-site 

hospital provides a current list of the 

physician’s or practitioner’s privileges; 

(3) the individual distant-site physician 

or practitioner holds a license issued or 

recognized by the state in which the 

REH, whose patients are receiving the 

telemedicine services, is located; and (4) 

with respect to a distant-site physician 

or practitioner granted privileges by the 

REH, the REH has evidence of an 

internal review of the distant-site 

physician’s or practitioner’s 

performance of these privileges and 

sends the distant-site hospital this 

information for use in its periodic 

appraisal of the individual distant-site 

physician or practitioner. We are also 

proposing, at a minimum, the 

information sent for use in the periodic 

appraisal would have to include all 

adverse events that may result from 

telemedicine services provided by the 

distant-site physician or practitioner to 

the REH’s patients and all complaints 

the REH has received about the distantsite physician or practitioner. We are 

also proposing at § 485.512(c)(5) to 

require that REH’s medical staff bylaws 

include criteria for determining 

privileges and a procedure for applying 

the criteria to individuals requesting 

privileges. We are proposing to add 

language to stipulate that in cases where 

distant-site physicians and practitioners 

are requesting privileges to furnish 

telemedicine services through an 

agreement with an REH, the criteria for 

determining those privileges and the 

procedure for applying the criteria 

would be subject to the proposed 

requirements at §§ 485.510(a)(8) and (9) 

and 485.512(a)(3) and (4). 

Similar to the revisions we made in 

the ‘‘Changes Affecting Hospital and 

Critical Access Hospital Conditions of 

Participation’’ final rule (76 FR 25556), 

we have also concluded that it is 

important that the medical staff of a 

distant-site telemedicine entity, which 

may not be a Medicare-participating 

hospital, be included in an optional and 

streamlined credentialing and 

privileging process for those REHs 

electing to enter into agreements for 

telemedicine services with such entities. 

However, similar to the situation we 

faced for hospitals and CAHs in the May 

2011 final rule (that is, the inclusion of 

distant-site telemedicine entities into 

this streamlined process without CMS 

having any regulatory or oversight 

authority over these entities), we 

realized that the proposed requirements 

for REHs would need to hold distantsite telemedicine entities accountable to 

the originating-site REH for meeting 

CMS practitioner credentialing and 

privileging standards. And like the 

current requirements for hospitals and 

CAHs using telemedicine services, REHs 

would need to provide, upon request 

when surveyed, the most current 

telemedicine services agreement 

showing that the distant-site entities 

providing the services are required to 

comply with the CMS standards (even 

though CMS has no direct authority 

over those entities) in order for the REH 

to make use of the more streamlined 

process when credentialing and 

privileging practitioners from these 

distant-site telemedicine entities. 

Similar to our regulations proposed for 

REHs using the telemedicine services of 

distant-site Medicare-participating 

hospitals, the written agreement 

between the REH and the distant-site 

telemedicine entity would be the 

foundation for ensuring accountability 

on both sides. However, due to the 

differences already discussed between 

Medicare-participating distant-site 

hospitals providing telemedicine 

services and distant-site practitioners 

under section 1834(m) of the Act 

providing similar services, there must 

also be differences in the way the 

regulations are written. 

Therefore, we are also proposing 

requirements that would apply to the 

credentialing and privileging process 

and the agreements between REHs and 

distant-site telemedicine entities 

(§§ 485.510(a)(9) and 485.512(a)(4)). 

These provisions would require the 

governing body of the REH (or 

responsible individual), through its 

written agreement with the distant-site 

telemedicine entity, to ensure that the 

distant-site telemedicine entity, acting 

as a contractor of services, furnishes its 

services in a manner that enables the 

REH to comply with all applicable CoPs 

and standards. For the contracted 

services, the applicable CoPs and 

standards would include, but are not 

limited to, the credentialing and 

privileging requirements for distant-site 

physicians and practitioners furnishing 

telemedicine services. 

7. Condition of Participation: Provision 

of Services (Proposed § 485.514) 

Several commenters on the REH RFI 

indicated that CMS should remain 

flexible in the development of the 

standards for REHs and that the 

standards should closely mirror the 

CAH requirements, where appropriate. 

Consistent with the CAH CoPs at 

§ 485.635(a)(1), we propose at 

§ 485.514(a) to require that the REH’s 

health care services must be furnished 

in accordance with appropriate written 

policies that are consistent with 

applicable state law and at § 485.514(b) 

that the REH must have policies that are 

developed with the advice of members 

of the REH’s professional health care 

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. This requirement aligns with 

the CAH CoPs at § 485.635(a)(2). 

At § 485.514(c) we propose 

requirements for the written policies to 

include a description of the services the 

REH furnishes (including those 

furnished through agreement or 

arrangement), policies and procedures 


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9Ali S. Raja, Ivan K. Ip, Aaron D. Sodickson, Ron 

M. Walls, Steven E. Seltzer, Joshua M. Kosowsky, 

and Ramin Khorasani (2014). American Journal of 

for emergency medical services, 

guidelines for the medical management 

of health problems, and policies and 

procedures that address the post-acute 

care needs of all patients receiving 

services furnished by an REH. Because 

the statute prohibits REHs from the 

provision of inpatient services (with the 

exception of patients receiving SNF 

services in a distinct part SNF), postacute care for an REH patient is any care 

the REH patient receives once they are 

discharged from the REH. Lastly, at 

§ 485.514(d), we propose to require the 

policies to be reviewed at least 

biennially by the group of professional 

personnel required at § 485.514(b) and 

updated as necessary by the REH. These 

requirements align with the CAH CoPs 

at § 485.635(a)(3). 

8. Condition of Participation: 

Emergency Services (Proposed 

§ 485.516) 

In accordance with section 

1861(kkk)(2)(D)(iv) of the Act, as added 

by section 125(a)(1)(B) of the CAA, 

REHs must comply with the CAH 

emergency services requirements at 

§ 485.618 as well as the hospital 

emergency services requirements, which 

are located at § 482.55, as determined to 

be applicable. We note that at § 482.12(f) 

if emergency services are not provided 

at the hospital, the governing body must 

assure that the medical staff has written 

policies and procedures for appraisal of 

emergencies, initial treatment, and 

referral when appropriate. Conversely, 

CAHs are required by the CoPs to 

provide emergency services, resulting in 

different emergency services 

requirements for each of these provider 

types. However, one similarity in the 

hospital and CAH emergency services 

requirements is that CAHs and hospitals 

(should they choose to provide 

emergency services) are required to have 

emergency services that meet the needs 

of their respective patients presenting at 

the individual facility. We believe that 

it is important that the REH emergency 

services also meet the needs of its 

patients. As such, at § 485.516 we 

propose to require that the REH must 

provide the emergency care necessary to 

meet the needs of its patients in 

accordance with acceptable standards of 

practice. 

Additionally, because the primary 

function of an REH is to provide 

emergency services, similar to the 

requirements for hospitals, we propose 

at § 485.516(a) that the REH must have 

emergency services that are organized 

under the direction of a qualified 

member of the medical staff and are 

integrated with other departments of the 

REH. We anticipate that there will be 

instances in which a patient is receiving 

outpatient services other than 

emergency services and may 

unexpectedly require care in the 

emergency department. In this instance, 

having emergency services that are 

integrated with the other departments of 

the REH will facilitate care coordination 

and promote patient-centered care. 

At § 485.516(b), we propose that there 

be adequate medical and nursing 

personnel qualified in emergency care 

to meet the needs of the facility. To 

comply with this requirement, we 

would expect the REH to conduct an 

analysis based on the anticipated 

staffing needs and once the REH begins 

to provide services, the analysis would 

include actual staffing needs. Lastly, at 

§ 485.516(c), we propose to require the 

REH to provide emergency services that 

meet the CAH requirements specified at 

§ 485.618(a) through (e), as required by 

section 1861(kkk)(2)(D)(iv)(I) of the Act. 

We are seeking comment on the 

proposed staffing requirements for the 

provision of emergency services in an 

REH to gain insight on the 

appropriateness of not requiring a 

practitioner to be on-site at the REH at 

all times. 

9. Condition of Participation: Laboratory 

Services (Proposed § 485.518) 

We believe that like hospitals, REHs 

should provide laboratory services that 

are determined to be appropriate and 

necessary based on the level of services 

provided at the REH. This portion of the 

provision aligns with the hospital CoP 

at § 482.27. Efficient laboratory support 

is a crucial to providing quality 

emergency services, especially given the 

continued rise in emergency department 

visits. Efficient laboratory support 

positively impacts emergency services 

by contributing to the assessments used 

to determine diagnosis and treatment 

and whether a patient should be 

discharged home or transferred to a 

higher level of care. Emergency 

departments generally provide 

laboratory services by utilizing point of 

care testing, a laboratory technician 

based in the emergency department, or 

an emergency department stat 

(‘‘Statim’’, Latin for ‘‘immediately’’) 

laboratory either directly or through a 

contractual agreement with a laboratory. 

Overall, the ability to provide quality 

laboratory services in the emergency 

department decreases the overall length 

of stay for patients, therefore we are 

proposing at § 485.518 that REHs, 

similar to CAHs (§ 485.635(b)(2)), must 

provide basic laboratory services that 

are essential to the immediate diagnosis 

and treatment of the patient. The CAH 

requirements cite specific laboratory 

services that should be provided by the 

CAH, such as chemical examination of 

urine, hemoglobin or hematocrit, blood 

glucose, examination of stool specimens 

for occult blood, pregnancy tests, and 

primary culturing for transmittal to a 

certified laboratory. However, we 

believe that given the REH’s nature of 

primarily providing emergency services, 

it is appropriate that REHs provide 

laboratory services that are consistent 

with nationally recognized standards of 

care for emergency services. In addition 

to the laboratory services identified in 

the CAH CoPs, we encourage the REH 

to provide laboratory services that 

include a complete blood count, basic 

metabolic panel (also known as a ‘‘chem 

7’’), magnesium, phosphorus, liver 

function tests, amylase, lipase, 

cardiopulmonary tests (troponin, brain 

natriuretic peptide, and d-dimer), 

lactate, coagulation studies 

(prothrombin time, partial 

thromboplastin time, and international 

normalized ratio), arterial blood gas, 

venous blood gas, quantitative human 

chorionic gonadotropin, and urine 

toxicology. In accordance with the 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA), at 

§ 485.518(a), we are proposing to require 

that the REH must ensure that all 

laboratory services provided to its 

patients are performed in a facility 

certified in accordance with the CLIA 

requirements at 42 CFR part 493. 

Furthermore, at § 485.518(b) we are also 

proposing that REHs must have 

emergency laboratory services available 

that would be essential to the immediate 

diagnosis of the patient, 24 hours a day. 

This proposal is appropriate given the 

provision that REHs must provide 

emergency services 24 hours a day. In 

addition, this proposal is consistent 

with comments received on the REH RFI 

noting that laboratory services should be 

required for REHs. 

10. Condition of Participation: 

Radiologic Services (Proposed 

§ 485.520) 

Radiologic services play an integral 

role in the provision of emergency 

services. Commenters on the REH RFI 

noted that radiologic services, also 

referred to as imaging services, should 

be provided at REHs. A study in the 

American Journal of Roentgenology 

noted that, ‘‘The use of imaging in the 

emergency department (ED) has 

increased over time, and by 2010 nearly 

half of all ED visits in the U.S. included 

at least one imaging test.’’ 9 These 


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Roentgenology, (203)2, 355–360. https://doi.org/ 

10.2214/AJR.13.11892. 

10Farmer, B.M., Hayes, B.D., Rao, R., Farrell, N., 

& Nelson, L. (2018). The Role of Clinical 

Pharmacists in the Emergency Department. Journal 

of medical toxicology: official journal of the 

American College of Medical Toxicology, 14(1), 

114–116. https://doi.org/10.1007/s13181-017-0634- 

4. 

11American Society of Health-System 

Pharmacists (2021). ASHP guidelines on emergency 

medicine pharmacist services. Am J Health-Syst 

Pharm, 78(3):261–275. https://doi.org/10.1093/ 

ajhp/zxaa378. 

imaging tests include computed 

tomography (CT), also known as a 

computerized axial tomography (CAT) 

scan, magnetic resonance imaging 

(MRI), and ultrasound. These tests can 

be used to diagnose bone fractures, 

infections, arthritis, injuries from 

trauma, tumors and cancers. They can 

also be used to monitor and evaluate the 

growth and development of a fetus, and 

offer a way to examine many of the 

body’s internal organs such as the liver, 

gallbladder, kidneys, and bladder. 

We expect that REHs will need to 

provide radiologic services given their 

focus on emergency services and given 

the number of emergency department 

patients who receive imaging services. 

Therefore, we propose that the REH 

radiologic requirements mirror the 

hospital radiologic requirements found 

at § 482.26, which is consistent with the 

current CAH standard at § 485.635(b)(3) 

and interpretative guidelines for CAHs 

in Appendix W of the State Operations 

Manual (SOM). 

The CAH standard for radiology 

services found at § 485.635(b)(3) 

requires and that these services are 

furnished by personnel qualified under 

state law and do not expose patients or 

staff to radiation hazards. In addition, 

we note that the interpretative 

guidelines for § 485.635(b)(3) in 

Appendix W of the SOM provides 

guidance for designating qualified 

radiologic personnel, developing 

policies and procedures that ensure 

safety from radiation hazards, 

inspecting and maintaining radiologic 

equipment, and maintaining CAH 

radiology records. 

We are proposing to align the REH 

requirements with the hospital 

requirements for radiologic services and 

propose additional standards related to 

safety, personnel responsibilities, and 

record keeping. We believe that 

facilities that may transition to an REH 

would presently be performing these 

activities to support the delivery of 

radiology services. We also believe that 

these proposed requirements are in 

accordance with the interpretative 

guidelines that CAHs currently follow 

for the provision radiological services. 

We do not expect these proposed 

requirements to create additional 

burden for REHs over those applicable 

to CAHs. 

As such, at § 485.520, we propose to 

require that the REH must provide 

diagnostic radiologic services. We 

propose to require that all radiologic 

services furnished by the REH must be 

provided by qualified personnel in 

accordance with state law and do not 

expose REH patients or personnel to 

radiation hazards at § 485.520(a). Like 

hospitals, we are also proposing to 

require that the REH must have 

radiologic services that meet the needs 

of their patients. For example, we 

expect an REH that is located in a 

mining community to offer x-ray 

services due to the effects of mining on 

one’s lungs or an REH being able to 

furnish ultrasounds to evaluate the 

growth and health of a fetus. 

At § 485.520(b), we are proposing 

basic factors relating to safety hazard 

standards for patients and personnel by 

specifying that the REH must institute 

proper safety precautions, perform 

periodic inspections of equipment, 

periodically check radiation workers for 

exposure, and only provide radiologic 

services based on the order of 

practitioners with clinical privileges or 

authorization by the medical staff and 

governing body. We propose the 

personnel standard at § 485.520(c) to 

require that a qualified radiologist, or 

other personnel qualified under state 

law either full-time, part-time, or on a 

consulting basis interpret radiologic 

tests that require specialized knowledge. 

This requirement can be fulfilled 

through arrangements with off-site 

providers via telehealth. Like hospitals, 

we propose that the radiologist in an 

REH must sign reports only of their 

interpretations. We propose to allow the 

medical staff and the individual 

responsible for radiological services to 

designate who is qualified to use 

radiological equipment. Lastly, at 

§ 485.520(d), we also propose to require 

that records of departmental activities 

be maintained and that radiological 

reports and films be preserved for 5 

years, consistent with the proposed 

requirements for the maintenance and 

retention of the REH medical records. 

11. Condition of Participation: 

Pharmaceutical Services (Proposed 

§ 485.522) 

Pharmaceutical services are another 

integral part of the provision of health 

care services in an emergency 

department. The Journal of Medical 

Toxicology cited in a 2018 article that, 

‘‘Clinical pharmacists are integral to the 

care and safety of patients in the 

hospital, particularly in specialty and 

high-risk settings. Emergency 

departments (EDs) represent care 

environments that carry unique 

risks.’’ 10 The article continues to note, 

‘‘Adult and pediatric patients present 

with undifferentiated medical, 

neurological, traumatic, psychiatric, and 

surgical complaints 24 [hours] a day, 7 

days a week. Patients are generally 

unfamiliar to the emergency care 

providers, may be unable to 

communicate relevant medical 

information, and may require timesensitive interventions. When present, 

ED crowding is associated with 

increased risk for medication errors.’’ 10

Given these identified risks, we believe 

that the REH should have standards for 

pharmaceutical services. 

While the current CAH requirements 

do not have a separate CoP for 

pharmaceutical services, there are 

standards throughout the CAH CoPs for 

the oversight, storage, and 

administration of drugs and biologicals. 

Regulations at § 485.623(b)(3) requires 

the CAH to store drugs and biologicals 

properly, and § 485.635(a)(3)(iv) 

requires the CAH to develop rules for 

the storage, handling, dispensation, and 

administration of drugs and biologicals 

including a drug storage area 

administered in accordance with 

accepted principles. In addition, there 

are standards throughout the CAH CoPs 

regarding provisions for infection 

prevention and control and antibiotic 

stewardship programs that reference 

pharmacy leadership and pharmacy 

services. Therefore, we believe that 

providers that may transition to an REH 

would currently be performing the 

proposed REH requirements to support 

the delivery of pharmaceutical services; 

we do not expect these proposed 

requirements to create additional 

burden for REHs. 

We are proposing to require that the 

REH’s pharmaceutical services meet the 

needs of the patients at proposed 

§ 485.522. According to the American 

Society of Health-System Pharmacists 

Guidelines on Emergency Medicine 

Pharmacy Services, some factors that an 

ED is expected to consider when 

determining how the pharmaceutical 

services can best meet the needs of the 

patients include the type and setting of 

the ED (for example, academic, 

community, urban, or rural), the size of 

the ED, the number of annual visits, the 

patient population served, and any 

specialty services available.11 At 

§ 485.522(a), we propose to require the 

REH to have a pharmacy or drug storage 


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12Centers for Medicare and Medicaid Services 

(2019). Improving Access to Maternal Health Care 

in Rural Communities—Issue Brief. https://

www.cms.gov/About-CMS/Agency-Information/ 

OMH/equity-initiatives/rural-health/09032019- 

Maternal-Health-Care-in-Rural-Communities.pdf. 

area that is administered in accordance 

with accepted professional principles 

and in accordance with state and 

Federal laws. Additionally, we propose 

to require at § 485.522(a)(1) that a 

registered pharmacist or other qualified 

individual in accordance with state 

scope of practice laws direct the 

pharmaceutical services or, when 

appropriate, have a drug storage area 

that is supervised by an individual who 

is competent to do so. Rural 

communities are often challenged by the 

lack of pharmacists willing to move to 

rural areas and for this reason, we 

recognize that there may be REHs that 

can provide pharmaceutical services 

only by having a drug storage area that 

is under the supervision of a qualified 

individual. In these instances, the 

facility must establish qualifications for 

the individual with oversight of the 

drug storage area for competency 

purposes and ensure that someone is 

fulfilling the role who meets those 

requirements. This is consistent with 

the interpretive guidelines for the CAH 

CoPs contained in Appendix W of the 

SOM for § 485.635(a)(3). We are 

proposing that this individual be 

available for a sufficient time to provide 

such oversight based on the scope and 

complexity of the services offered at the 

REH. This individual would not be 

required to be a full-time pharmacist. 

We believe sufficient time provides the 

REH with the flexibility to determine 

how frequently the pharmacist or other 

qualified individual is available. 

Furthermore, the CAH interpretive 

guidelines for § 485.635(a)(3) states that 

the compounding, packaging, and 

dispensing of drugs be consistent with 

accepted professional principles. In 

accordance with the Food and Drug 

Administration, accepted professional 

principles for compounding, packaging, 

and dispensing of drugs include having 

a licensed pharmacist, or in some cases 

a physician, perform these activities (or 

having them performed under the 

supervision of a licensed pharmacist, 

when appropriate). As such, we propose 

at § 485.522(b) that all compounding, 

packaging, and dispensing of drugs 

must be done by a licensed pharmacist 

or a licensed physician, or under the 

supervision of a pharmacist or other 

qualified individual in accordance with 

state scope of practice laws and be 

performed consistent with state and 

Federal laws. In addition, we propose 

that all drugs and biologicals must be 

kept in secure areas, and locked when 

appropriate. All drugs listed in 

Schedules II, III, IV, and V as outlined 

in the Comprehensive Drug Abuse 

Prevention and Control Act of 1970 

(Pub. L. 91–513, as amended), must be 

locked within a secure area and only 

authorized personnel may have access 

to locked areas. We propose that 

outdated, mislabeled, or otherwise 

unusable drugs and biologicals must not 

be available for patient use and drugs 

and biologicals can only be removed 

from the pharmacy or storage area by 

personnel designated in the policies of 

the medical staff and pharmaceutical 

service, in accordance with Federal and 

state law. These proposed requirements 

are also consistent with the CAH 

interpretive guidelines for 

§ 485.635(a)(3). 

Lastly, at § 485.522(c) we propose to 

set forth the standards for the 

administration of drugs. We note that 

the existing CAH CoP at 

§ 485.635(a)(3)(iv) requires that the CAH 

have written policies that include the 

rules for the storage, handling, 

dispensation, and administration of 

drugs and biologicals. The CAH CoPs 

continue to require that these rules 

provide that there is a drug storage area 

that is administrated in accordance with 

accepted professional principles. 

Similarly, we propose to require that 

drugs be prepared and administered in 

an REH according to established 

policies and acceptable standards of 

practice and consistent with the CAH 

requirement at § 485.635(a)(3)(v), we 

propose to require that any adverse 

reactions be reported to the physician 

responsible for the patient and 

documented in the record. While the 

CAH CoPs require that the CAH have 

procedures for reporting adverse drug 

reactions and errors in the 

administration of drugs, we recognize 

that a nationally recognized standard of 

practice is to report adverse drug 

reactions to the physician responsible 

for the care of the patient. We propose 

at § 485.522(c)(2) and (3) respectively, 

that the REH must administer blood 

transfusions, blood products and 

intravenous medications in accordance 

with state law and approved medical 

staff policies and procedures, and that 

orders given orally for drugs and 

biologicals must be followed by a 

written order, signed by the prescribing 

physician or other authorized 

prescriber. We also propose at 

§ 485.522(c)(4) to require that the REH 

have a procedure for reporting 

transfusion reactions, adverse drug 

reactions, and errors in administration 

of drugs. 

12. Condition of Participation: 

Additional Outpatient Medical and 

Health Services (Proposed § 485.524) 

In addition to the provision of 

emergency services and observation 

care, section 1861(kkk)(1)(A)(ii) of the 

Act allows REHs to provide additional 

outpatient medical and health services 

as specified by the Secretary through 

rulemaking. We received comments on 

the REH RFI recommending that CMS 

allow REHs to provide additional 

outpatient services that include 

radiology, laboratory, outpatient 

rehabilitation, surgical, maternal health, 

and behavioral health services. We are 

proposing at § 485.524 that REHs be 

allowed to provide additional medical 

and health outpatient services that 

include, but are not limited, to those 

identified by commenters. We note that 

the REH may provide additional 

outpatient medical and health care 

services beyond those specified; 

however, we expect that the REH would 

be able to demonstrate that the service 

is needed based on an assessment of its 

community as required by proposed 

§ 485.524(a). The decision should be 

based on a health needs assessment that 

is achieved by taking a systematic 

approach to ensuring that the services 

furnished by an REH are appropriate 

and meet the needs of the community. 

Commenters on the REH RFI 

highlighted that providing rehabilitation 

services to rural communities requires 

overcoming the challenges of the 

landscape, limited referral options, and 

a shortage of therapists. 

In addition, one of the health care 

needs in many rural communities is 

improving access to maternal health 

care services. As noted in CMS’ Issue 

Brief Improving Access to Maternal 

Health Care in Rural Communities: 12

A lack of access to high quality maternal 

health services in rural communities is the 

result of many factors including hospital and 

obstetric department closures, workforce 

shortages, and access to care challenges 

arising from the social determinants of health 

which have contributed to disparities in 

maternal health care for rural women and 

their babies. These access challenges can 

result in a number of negative maternal 

health outcomes including premature birth, 

low-birth weight, maternal mortality, severe 

maternal morbidity, and increased risk of 

postpartum depression. These health 

disparities affect American Indian and 

Alaska Native and women of color 

disproportionately. Since one in five 

Americans live in a rural community, 

including approximately 18 million women 

of reproductive age, it is critical that federal, 

regional, state, local agencies and 

communities work together to improve 

access to high quality maternal health 

services in rural communities. 


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13Federspiel, J.J., Suresh, S.C., Darwin, K.C., & 

Szymanski, L.M. (2020). Hospitalization Duration 

Following Uncomplicated Cesarean Delivery: 

Predictors, Facility Variation, and Outcomes. AJP 

reports, 10(2), e187–e197. https://doi.org/10.1055/s0040-1709681. 

14Rural Health Information Hub (2021). Rural 

Mental Health. https://www.ruralhealthinfo.org/ 

topics/mental-health. 

15Center for Disease Control and Prevention 

(2017). Rural Health—Drug Overdose. https://

www.cdc.gov/ruralhealth/drug-overdose/. 

The issue brief, which was published 

in 2019, highlights the role hospitals 

closures have played in the access 

issues to maternal health services in 

rural communities, noting that between 

2004 and 2014, 179 rural counties lost 

or closed their hospitals obstetric 

services, contributing to the fact that 

fewer than 50 percent of rural women 

have access to perinatal services within 

a 30-mile radius.12

Additionally, the Biden-Harris 

Administration has made it their highest 

priority to improve access to maternal 

health care services. The Administration 

published a fact sheet on April 13, 2022, 

announcing actions to be taken to 

address the maternal health crisis in the 

United States (Fact Sheet: Biden-Harris 

Administration Announces Additional 

Actions in Response to Vice President 

Harris’s Call to Action on Maternal 

Health, https://www.whitehouse.gov/ 

briefing-room/statements-releases/2022/ 

04/13/fact-sheet-biden-harrisadministration-announces-additionalactions-in-response-to-vice-presidentharriss-call-to-action-on-maternalhealth/). These actions include: 

• Calling on states to expand their 

postpartum Medicaid and Children’s 

Health Insurance Program coverage; 

• Proposing the ‘‘Birthing-Friendly’’ 

hospital designation to drive 

improvements in maternal health 

outcomes and maternal health equity; 

• Engaging the health care industry to 

improve health outcomes; 

• Strengthening Maternal, Infant, and 

Early Childhood Home Visiting 

(MIECHV) Programs; 

• New funding for the State Maternal 

Health Innovation and Implementation 

(State MHI) Program; 

• Publication of a new Maternal 

Health Best Practice Guide for providers 

to incorporate telehealth for prenatal 

and postpartum care, and monitoring 

within high-risk pregnancy; 

• Investing in doulas; 

• Restoring access to Title X family 

planning services nationwide to fill 

service gaps caused by the withdrawal 

of Title X providers from the program; 

and 

• Including in the proposed FY 2023 

budget a proposed $470 million to be 

used to reduce maternal mortality and 

morbidity rates; expand maternal health 

initiatives in rural communities; 

implement implicit bias training for 

healthcare providers; create pregnancy 

medical home demonstration projects; 

and address the highest rates of 

perinatal health disparities, including 

by supporting the perinatal health 

workforce. 

Given the highlighted challenges 

faced by those living in rural 

communities of accessing maternal 

health services and consistent with the 

Administration’s priorities in improving 

access to these services, we believe it 

would be beneficial that REHs provide 

maternal health services that include 

prenatal care, low-risk labor and 

delivery and postnatal care. We are 

seeking input on the issue of whether 

REHs should be permitted to provide 

low-risk labor and delivery, and 

whether or not we should require that 

the REH also provide outpatient surgical 

services in the event surgical labor and 

delivery intervention is necessary. REHs 

should base their determination on what 

is considered a ‘‘low-risk’’ delivery on 

nationally recognized standards and 

guidelines. If a laboring patient presents 

to the REH for labor and delivery 

services and subsequently requires 

emergency surgical intervention, the 

REH would be responsible for providing 

the emergency and stabilizing treatment 

prior to transfer, including any 

emergency surgical procedures 

including but not limited to c-sections. 

Once the patient is stabilized, they may 

be transferred to an appropriate level of 

care for mother and baby given that the 

average length of inpatient stay for an 

uncomplicated c-section is 2.7 days.13

In such cases, we would encourage the 

REH to provide the patient’s follow-up 

and postpartum care so long as the 

patient’s needs are within the scope of 

practice of the practitioners providing 

services at the REH. We would expect 

that the REH would leverage clinicians 

other than only physicians so that a 

variety of trained professionals or 

support persons could help to address 

barriers to access to care and the 

maternal health workforce shortage in 

rural areas by utilizing nurse 

practitioners, nurse midwives, and 

doulas as allowed by state law. 

The provision of behavioral health 

services is also a challenge in rural 

communities. According to the Rural 

Health Information Hub, ‘‘. . . 

approximately 7.7 million 

nonmetropolitan adults reported having 

any mental illness (AMI) in 2020, 

accounting for 20.5% of 

nonmetropolitan adults. In addition, 1.8 

million, or 4.8%, of adults in 

nonmetropolitan areas reported having 

serious thoughts of suicide during the 

year.’’ 14 The Rural Health Information 

Hub also presents specific challenges in 

this area, including the following: 15

• Accessibility—Rural residents often 

travel long distances to receive services, 

are less likely to be insured for mental 

health services, and providers are less 

likely to recognize a mental illness. 

• Availability—Chronic shortages of 

mental health professionals exist and 

mental health providers are more likely 

to practice in urban centers. 

• Affordability—Some rural residents 

may not be able to afford the cost of 

health insurance or the cost of out-ofpocket care if they lack health 

insurance. 

• Acceptability—Rural residents may 

be more susceptible to the stigma of 

needing or receiving mental health care 

in small communities where everyone 

knows each other and fewer choices of 

trained professionals can lead to a lack 

of faith in confidentiality, as well as a 

reliance on the informal care of family 

members, close friends, and religious 

leaders. 

Several commenters on the REH RFI 

indicated that REHs should provide 

behavioral health services that include 

substance use disorder treatment. 

According to the Centers for Disease 

Control and Prevention, ‘‘Rates of drug 

overdose deaths are rising in rural areas, 

surpassing rates in urban areas.’’ 15

Additionally, treatment for alcohol and 

illicit drug use was generally the same 

or higher in nonmetropolitan counties 

compared to metropolitan counties, 

according to data from the 2018 

National Survey on Drug Use and 

Health (Substance Abuse and Mental 

Health Services Administration, https:// 

www.samhsa.gov/data/sites/default/ 

files/cbhsq-reports/ 

NSDUHDetailedTabs2018R2/ 

NSDUHDetTabsSect5pe2018.htm#tab5- 

9a). The survey highlighted substance 

use disorders related to alcohol, 

methamphetamines, and opioids, 

particularly noting that rural counties 

exhibited a higher rate of opioid 

overdoses than urban counties and that 

opioid misuse is high in states with 

large rural populations. There are 

several factors that contribute to 

substance use disorder in rural 

communities, including high rates of 

poverty and unemployment, increased 

availability of prescription opioids, and 

barriers to treatment. These barriers 

include the level of complexity related 

to treatment of substance use disorders, 

which includes individual and group 

counseling, inpatient and outpatient 

treatment, case management, and 


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16American College of Emergency Physicians— 

ACEP Now (2019). Latest Data Reveal the ED’s Role 

as Hospital Admission Gatekeeper. https://

www.acepnow.com/article/latest-data-reveal-theeds-role-as-hospital-admission-gatekeeper/. 

17Rural Policy Research Initiative Rural Health 

Center for Rural Health Policy Analysis—Rural 

Policy Brief (2011). Surgical Services in Critical 

Access Hospitals, 2011. https://rupri.publichealth.uiowa.edu/publications/policybriefs/2015/ 

Surgical%20Services%20in%20CAHs.pdf. 

18Centers for Disease Control and Prevention 

(2020). Data Portal. https://www.cdc.gov/hai/data/ 

portal/index.html. 

medication, as well as additional 

services and programs. Difficulties 

associated with navigating these 

treatment modalities may, and often 

does lead to delays in treatment. This 

adds to existing access to care issues in 

rural communities where there are 

shortages of providers, ultimately 

resulting in delays in treatment. This 

further illustrates the need for 

behavioral health services in rural areas, 

given the access to care issues which are 

more prevalent in rural areas when 

compared to non-rural areas. 

Additionally, given the data provided 

related to substance use in rural 

communities, we would expect that 

some REHs may be interested in being 

opioid treatment providers. We note 

that providing these services is not 

prohibited by the statute at 1866(kkk) so 

long as the treatment remains an 

outpatient service, given that the statute 

does prohibit REHs from providing 

inpatient services (except those services 

provided in a distinct part SNF of the 

REH). 

If the REH chooses to provide 

additional outpatient medical and 

health services, we propose at 

§ 485.524(a)(1) to require that the 

provision of the additional service be 

based on nationally recognized 

guidelines and standards of practice, 

aligning the proposed requirement with 

the hospital CoPs for outpatient services 

at § 482.54. Given that the REH does not 

provide inpatient services, patients 

requiring a higher level of care would be 

required to be transferred to an acute 

care hospital or CAH. As a result of this, 

and based on comments received on the 

REH RFI, we further propose to require 

that the REH have a system in place for 

referral from the REH to different levels 

of care, including follow-up care, as 

appropriate. Some of the REH RFI 

comments also indicated that REHs 

should be required to have established 

relationships with hospitals that have 

the resources and capacity available to 

deliver care that is beyond the scope of 

care delivered at the REH. Hospital 

admissions and transfers account for 

roughly 20 percent of all patient 

dispositions from the emergency 

department across the U.S.16 As a result, 

we can expect that REHs will transfer at 

least 20 percent of their patients so we 

agree with commenters and are 

therefore proposing to require that REHs 

have established relationships with 

hospitals that have the resources and 

capacity available to deliver care that is 

beyond the scope of care delivered at 

the REH. 

Ensuring effective communication 

between providers of health care 

services and patients and their family is 

a critical element in the provision of 

care and the discharge or transfer of 

patients. We are proposing to require 

that the REH have effective 

communication systems in place 

between the REH and patients (or 

responsible individuals) and their 

family, ensuring that the REH is 

responsive to their needs and 

preferences. We believe this would 

assist with effective care coordination as 

well as improved patient outcomes. 

At § 485.524(b), we propose personnel 

requirements for REHs who choose to 

provide additional outpatient medical 

and health services. These requirements 

ensure that the additional services 

provided by the REH are overseen by at 

least one responsible individual, have 

appropriate professional and 

nonprofessional personnel available at 

each location where outpatient services 

are offered, and are provided by a 

physician or other clinician with 

experience and training in the specialty 

service area. 

At § 485.524(c) we propose to specify 

standards that REHs must have for 

ordering outpatient medical and health 

services that are consistent with the 

hospital requirements at 42 CFR 

482.54(c). Specifically, we propose to 

require outpatient medical and health 

services to only be ordered by a 

practitioner who: (1) is responsible for 

the care of the patient; (2) is licensed in 

the state where they provide care to the 

patient; (3) is acting within their scope 

of practice under state law; and (4) is 

authorized in accordance with state law 

and policies adopted by the medical 

staff, and approved by the governing 

body, to order the applicable outpatient 

services. We also propose that these 

requirements would apply to those 

practitioners who are appointed to the 

REH’s medical staff and who have been 

granted privileges to order the 

applicable outpatient services; and 

those practitioners not appointed to the 

medical staff, but who satisfy the above 

criteria for authorization by the REH for 

ordering the applicable outpatient 

services and for referring patients for 

such services. 

Lastly, the importance of allowing 

REHs to provide outpatient surgical 

services was especially noted by 

commenters in response to the REH RFI. 

A 2011 rural policy brief by the Rural 

Policy Research Institute (RUPRI) Center 

for Rural Health Policy Analysis states 

that, ‘‘Like residents of any community, 

rural residents have surgical needs that 

range from the predictable (e.g., cataract 

procedures) to the emergent (e.g., 

appendectomy). Innovations in surgery 

over the past several decades have made 

possible the provision of many surgical 

procedures on an outpatient basis, 

reducing inpatient admissions.’’ 17 The 

policy brief found that across four states 

(Colorado, North Carolina, Vermont, 

and Wisconsin) in 2011, surgeries were 

performed across 107 CAHs with an 

average of 522 outpatient procedures 

performed per year. This is 75 to 80 

percent of the total surgical procedure 

volume in the state for that year and 

demonstrates that there will be a need 

for outpatient surgical services in 

communities in which CAHs convert to 

an REH. Therefore, we propose at 

§ 485.524(d) to set forth standards for an 

REH performing outpatient surgical 

services that are consistent with the 

CAH requirements for surgical services 

at § 485.639. These include proposed 

standards for ensuring that the services 

are conducted in a safe manner by 

qualified practitioners with specific 

protocols for administering anesthesia. 

Given that in accordance with the 

statutory provision at 

section1861(kkk)(1)(A) of the Act 

services furnished by the REH must not 

exceed an annual per patient average of 

24 hours in the REH, we expect REHs, 

like ASCs, to provide surgical services 

to patients not requiring hospitalization 

and in which the expected duration of 

services would not exceed 24 hours 

following an admission. 

13. Condition of Participation: Infection 

Prevention and Control and Antibiotic 

Stewardship Programs (Proposed 

§ 485.526) 

The Department of Health and Human 

Services (HHS) is particularly 

concerned about health care associated 

infections (HAIs), as they are a 

significant cause of morbidity and 

mortality in the U.S. In 2015, there were 

an estimated 687,000 cases of HAIs in 

U.S hospitals with 72,000 inpatients 

with HAIs that died during that same 

time period.18 Additionally, HHS is 

concerned about the growing threat to 

patient safety posed by organisms that 

are resistant to antibiotics, referred to as 

‘‘multi-drug resistant organisms 

(MDROs).’’ Options for treating patients 


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with MDRO infections are very limited, 

resulting in increased mortality, as well 

as increased hospital lengths of stay and 

costs. In response, HHS launched an 

Action Plan in April 2009 with updates 

in 2013 and 2018 toward the prevention 

and elimination of HAIs. (HHS. ‘‘HHS 

Action Plan to Prevent HealthcareAssociated Infections.’’ Accessed 5 

March 2014 https://www.hhs.gov/ash/ 

initiatives/hai/actionplan/index.html.) 

The HHS Action Plan identifies policy 

changes, some addressed here in this 

proposed rule, in an effort to provide 

better, more efficient care. 

We are proposing a CoP for infection 

prevention and control and antibiotic 

stewardship programs for REHs at 

§ 482.526 in an effort to mirror similar 

infection prevention and control 

requirements for hospitals and CAHs (at 

§§ 482.42 and 485.640, respectively) 

that reflect state-of-the-art practices and 

terminology. We are also proposing a 

standard that would require an REH to 

develop and maintain an antibiotic 

stewardship program as an effective 

means to improve REH antibioticprescribing practices and curb patient 

risk for possibly deadly Clostridium 

difficile infections (CDIs), as well as 

other future, and potentially lifethreatening, antibiotic-resistant 

infections. We would promote better 

alignment of an REH’s infection control 

and antibiotic stewardship efforts with 

nationally recognized guidelines and 

emphasize the role and accountability of 

an REH’s governing body in program 

implementation and oversight. We 

believe that these requirements, 

together, would promote a more patientcentered culture of safety focused on 

infection prevention and control as well 

as appropriate antibiotic use (consistent 

with the requirements for hospitals and 

CAHs), while allowing REHs the 

flexibility to align their programs with 

the guidelines best suited to them. 

Therefore, similar to the requirements 

that we finalized with regard to 

infection prevention and control and 

antibiotic stewardship programs for 

hospitals and CAHs in the September 

30, 2019 final rule ‘‘Medicare and 

Medicaid Programs; Regulatory 

Provisions To Promote Program 

Efficiency, Transparency, and Burden 

Reduction; Fire Safety Requirements for 

Certain Dialysis Facilities; Hospital and 

Critical Access Hospital (CAH) Changes 

To Promote Innovation, Flexibility, and 

Improvement in Patient Care’’ (84 FR 

51732), we are proposing in this rule 

that each REH has facility-wide 

infection prevention and control and 

antibiotic stewardship programs that are 

coordinated with the REH quality 

assessment and performance 

improvement (QAPI) program, for the 

surveillance, prevention, and control of 

HAIs and other infectious diseases and 

for the optimization of antibiotic use 

through stewardship. Further, we are 

proposing in this rule at § 485.526(a)(1) 

that the REH ensure that an individual 

(or individuals), who are qualified 

through education, training, experience, 

or certified in infection, prevention and 

control, are appointed by the governing 

body, or responsible individual, as the 

infection preventionist(s)/infection 

control professional(s) responsible for 

the infection prevention and control 

program at the REH and that the 

appointment is based on the 

recommendations of medical staff and 

nursing leadership. 

At § 485.526(a)(2) we propose that the 

infection prevention and control 

program, as documented in its policies 

and procedures, employ methods for 

preventing and controlling the 

transmission of infections within the 

REH and between the REH and other 

health care settings. The program, as 

documented in its policies and 

procedures, would have to employ 

methods for preventing and controlling 

the transmission of infection within the 

REH setting (for example, among 

patients, personnel, and visitors) as well 

as between the REH (including 

outpatient services) and other 

institutions and health care settings. At 

§ 485.526(a)(3) we are proposing that the 

infection prevention and control 

program include surveillance, 

prevention, and control of HAIs, 

including maintaining a clean and 

sanitary environment to avoid sources 

and transmission of infection, and that 

the program also address any infection 

control issues identified by public 

health authorities. We are proposing at 

§ 485.526(a)(4) that the infection 

prevention and control program reflect 

the scope and complexity of the services 

provided by the REH. 

At § 485.526(b)(1) we propose to set 

standards for the organization and 

policies of the antibiotic stewardship 

program. Specifically, we propose to 

require that the REH’s governing body 

ensure that an individual, who is 

qualified through education, training, or 

experience in infectious diseases and/or 

antibiotic stewardship is appointed as 

the leader of the antibiotic stewardship 

program and that the appointment is 

based on the recommendations of 

medical staff and pharmacy leadership. 

The proposed requirements at 

§ 485.526(b)(2)(i) through (iii) would 

ensure that certain goals for an 

antibiotic stewardship program are met. 

These include demonstrating 

coordination among all components of 

the REH responsible for antibiotic use 

and resistance, including, but not 

limited to, the infection prevention and 

control program, the QAPI program, the 

medical staff, and nursing and 

pharmacy services; documenting the 

evidence-based use of antibiotics in all 

departments and services of the REH; 

and documenting improvements, 

including sustained improvements, in 

proper antibiotic use. We believe that 

these three components are essential for 

an effective program. 

The provisions at § 485.526(b)(3) and 

(4) would require the REH to ensure that 

the antibiotic stewardship program 

adheres to nationally recognized 

guidelines, as well as best practices, for 

improving antibiotic use, and that the 

REH’s stewardship program reflects the 

scope and complexity of services 

offered. We believe these proposed 

requirements are necessary to promote a 

facility-wide culture of quality 

improvement. 

We would require that the governing 

body or responsible individual ensure 

that the infection prevention and 

control issues identified by the infection 

prevention and control professionals be 

addressed in collaboration with REH 

leadership. Therefore, at 

§ 485.526(c)(1)(i) and (ii), we propose 

certain requirements that the governing 

body or responsible individual must 

adhere to including— 

• Ensuring systems are in place and 

operational for the tracking of all 

infection surveillance, prevention, and 

control, and antibiotic use activities to 

demonstrate the implementation, 

success, and sustainability of such 

activities; and 

• Ensuring all HAIs and other 

infectious diseases identified by the 

infection prevention and control 

program and antibiotic use issues 

identified by the antibiotic stewardship 

program are addressed in collaboration 

with REH QAPI leadership. 

At § 485.526(c)(2)(i) through (vi), we 

propose that the responsibilities of the 

infection prevention and control 

professionals would include the 

development and implementation of 

facility-wide infection surveillance, 

prevention, and control policies and 

procedures that adhere to nationally 

recognized guidelines. The infection 

preventionist(s)/infection control 

professional(s) would be responsible for 

all documentation, written or electronic, 

of the infection prevention and control 

program and its surveillance, 

prevention, and control activities. 


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Additionally, the infection 

preventionist(s)/infection control 

professional(s) would be responsible for 

the following— 

• Communication and collaboration 

with the REH’s QAPI program on 

infection prevention and control issues; 

• Competency-based training and 

education of REH personnel and staff 

including professional health care staff 

and, as applicable, personnel providing 

services in the REH under agreement or 

arrangement, on the practical 

applications of infection prevention and 

control guidelines, policies and 

procedures; 

• Prevention and control of HAIs, 

including auditing of adherence to 

infection prevention and control 

policies and procedures by REH 

personnel; and 

• Communication and collaboration 

with the antibiotic stewardship 

program. 

At § 485.526(c)(3), we propose 

requirements for the leader(s) of the 

antibiotic stewardship program that are 

similar, but not identical, to the 

proposed responsibilities for the REH’s 

designated infection preventionist(s)/ 

infection control professional(s) at 

proposed § 485.526(c)(2). We believe 

that an REH’s antibiotic stewardship 

program is the most effective means for 

ensuring appropriate antibiotic use. We 

also believe that such a program would 

require a leader who is responsible and 

accountable for its success. Therefore, 

we propose that the leader of the 

antibiotic stewardship program would 

be responsible for the development and 

implementation of a facility-wide 

antibiotic stewardship program, based 

on nationally recognized guidelines, to 

monitor and improve the use of 

antibiotics. We do not expect that each 

new leader would develop a new 

antibiotic stewardship program, unless 

it is determined that a new program is 

necessary. We also propose that the 

leader of the antibiotic stewardship 

program would be responsible for all 

documentation, written or electronic, of 

antibiotic stewardship program 

activities. The leader would also be 

responsible for communicating and 

collaborating with medical and nursing 

staff, pharmacy leadership, and the 

REH’s infection prevention and control 

and QAPI programs, on antibiotic use 

issues. 

We also propose that the leader would 

be responsible for the competency-based 

training and education of REH 

personnel and staff, including medical 

staff, and, as applicable, personnel 

providing contracted services in the 

REH, on the practical applications of 

antibiotic stewardship guidelines, 

policies, and procedures. 

Similar to a standard in the hospital 

CoPs, we propose a standard at 

§ 485.526(d) for REHs that would allow 

for the governing body of an REH that 

is part of a system consisting of 

multiple, separately certified hospitals, 

CAHs, and/or REHs using a single 

system governing body that is legally 

responsible for the conduct of two or 

more hospitals, CAHs, and/or REHs, to 

elect to have unified and integrated 

infection prevention and control and 

antibiotic stewardship programs for all 

of its member facilities, including any 

REHs, after determining that such a 

decision is in accordance with all 

applicable state and local laws. We are 

proposing a similar standard for CAHs 

at § 485.640(g), which is discussed in 

section B.3 of this proposed rule. The 

system’s single governing body would 

be responsible for ensuring that each of 

its separately certified REHs met the 

requirements of this section. We note 

that each separately certified REH 

subject to the system’s single governing 

body would need to demonstrate that 

the unified and integrated infection 

prevention and control and antibiotic 

stewardship programs: 

• Were established in a manner that 

takes into account each member REH’s 

unique circumstances and any 

significant differences in patient 

populations and services offered in each 

REH; 

• Established and implemented 

policies and procedures to ensure that 

the needs and concerns of each of its 

separately certified REHs, regardless of 

practice or location, are given due 

consideration; and 

• Had mechanisms in place to ensure 

that issues localized to particular REHs 

were duly considered and addressed. 

The REH would also need to 

demonstrate that it had designated a 

qualified individual (or individuals) 

with expertise in infection prevention 

and control and in antibiotic 

stewardship at the REH to be 

responsible for: 

• Communicating with the system’s 

unified infection prevention and control 

and antibiotic stewardship programs; 

• Implementing and maintaining the 

policies and procedures governing 

infection prevention and control and 

antibiotic stewardship as directed by the 

unified infection prevention and control 

and antibiotic stewardship programs; 

and 

• Providing education and training on 

the practical applications of infection 

prevention and control and antibiotic 

stewardship to REH staff. 

Finally, in response to the COVID–19 

pandemic, on September 2, 2020, CMS 

published an interim final rule with 

comment period to track the incidence 

and impact of COVID–19 to assist public 

health officials in detecting outbreaks 

and saving lives (85 FR 54820). CMS 

then published a final rule with 

comment containing reporting 

requirements for hospitals and CAHs to 

report acute respiratory illness during 

the public health emergency (PHE) for 

COVID–19 (85 FR 86304) on December 

4, 2020. Lastly, on November 5, 2021, 

CMS published an interim final rule 

with comment establishing COVID–19 

vaccination requirements for most 

Medicare- and Medicaid-certified 

providers and suppliers (86 FR 61623). 

Consistent with the recent changes we 

made to the hospital and CAH infection 

control CoPs related to COVID–19 (87 

FR 28108) and the declared PHE, we are 

proposing the following three standards 

in this proposed rule for REHs: 

• Reporting of data related to viral 

and bacterial pathogens and infectious 

diseases of pandemic or epidemic 

potential, which would require an REH 

to electronically report information on 

Acute Respiratory Illness (including, but 

not limited to, Seasonal Influenza Virus, 

Influenza-like Illness, and Severe Acute 

Respiratory Infection), SARS–CoV–2/ 

COVID–19, and other viral and bacterial 

pathogens and infectious diseases of 

pandemic or epidemic potential only 

when the Secretary has declared a 

Public Health Emergency, directly 

related to such specific pathogens and 

infectious diseases. 

• COVID–19 reporting, which would 

require an REH to electronically report 

information about COVID–19 and 

seasonal influenza in a standardized 

format specified by the Secretary, 

including the REH’s current inventory 

supplies of any COVID–19-related 

therapeutics that have been distributed 

and delivered to the REH and the 

current usage rate for those therapeutics 

beginning at the conclusion of the 

COVID–19 PHE, and continuing until 

April 30, 2024, unless the Secretary 

specifies an earlier end date. 

• COVID–19 Vaccination of REH staff, 

which would require the REH to 

develop and implement policies and 

procedures to ensure that all staff, with 

the exception of those with valid 

exemptions, are fully vaccinated for 

COVID–19 until November 4, 2024, 

unless the Secretary specifies an earlier 

end date for the requirements of this 

paragraph. Section 902 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 establishes a 

general 3-year timeline for publishing a 

Medicare final regulation after a 


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proposed regulation or an interim final 

regulation has been published. The 

referenced November 4, 2024 date aligns 

with the statutory 3-year ‘‘Section 902’’ 

deadline for the IFC that implemented 

the COVID–19 staff vaccination 

requirements for the provider and 

supplier types covered under that rule. 

14. Condition of Participation: Staffing 

and Staff Responsibilities (Proposed 

§ 485.528) 

Sections 1861(kkk)(1)(B)(i) and (ii) of 

the Act require that the emergency 

department of the REH be staffed 24 

hours a day, 7 days a week. We propose 

to implement this requirement at 

§ 485.528(a). The statute does not speak 

to the type of staff at the REH that is 

required to fulfill this role. As such, we 

believe that REHs should have the 

flexibility to determine how to staff the 

emergency department at the REH 24 

hours, 7 days a week. We expect that the 

individual(s) staffing the emergency 

department is competent to receive 

patients and activate the appropriate 

medical resources for the treatment of 

the patient. This includes, but is not 

limited to notifying a practitioner of the 

patient’s arrival in the emergency 

department. Such staff may include a 

nurse, nursing assistant, clinical 

technician, or an emergency medical 

technician, (EMT). 

Furthermore, in accordance with 

section 1861(kkk)(1)(B)(iii) of the Act, 

we propose for REHs to meet the 

applicable CAH requirements at 

§ 485.631 for staffing and staff 

responsibilities. We believe that many 

of the CAH staffing requirements are 

appropriate for application to REHs and 

as a result, at § 485.528(b) through (e), 

we set for the proposed standards for 

staffing, responsibilities of the doctor of 

medicine or osteopathy, physician 

assistant, nurse practitioner, and 

clinical nurse specialist responsibilities 

similar to CAHs. For instance, the CAH 

CoPs require at § 485.631(a)(5) that a 

registered nurse, clinical nurse 

specialist, or licensed practical nurse is 

on duty whenever the CAH has one or 

more inpatients. Since REHs are 

required to furnish emergency services 

and observation care, we are proposing 

a similar requirement as CAHs to 

require that a registered nurse, clinical 

nurse specialist, or licensed practical 

nurse be on duty whenever the REH has 

one or more patients receiving 

emergency services or observation care. 

We also propose to require standards 

for the periodic review of clinical 

privileges and performance that are also 

identical to the CAH standards at 

§ 485.631, with the exception of the 

CAH standard at § 485.631(b)(1)(iv), 

which requires that the CAH 

periodically review and sign the records 

of all inpatients cared for by nurse 

practitioners, clinical nurse specialists, 

certified nurse midwives, or physician 

assistants. We are not proposing this 

standard for REHs given that the REH 

would provide outpatient services 

exclusively. 

We do not believe that it is necessary 

to apply the CAH requirement that a 

doctor of medicine or osteopathy, nurse 

practitioner, clinical nurse specialist, or 

physician assistant is available to 

furnish patient care services at all times 

the CAH operates (§ 485.631(a)(4)) to 

REHs. Instead, we are proposing to 

require that the REH standards align 

with the CAH emergency services 

requirements at § 485.618. The CAH 

provision at § 485.618(d) requires that 

there be a doctor of medicine or 

osteopathy, a physician assistant, a 

nurse practitioner, or a clinical nurse 

specialist, with training or experience in 

emergency care, on call and 

immediately available by telephone or 

radio contact, and available on site 

within specified timeframes. This 

allows for the alignment of the REH 

proposed provisions with the CAH 

emergency services standards, as 

required by the statute. 

In response to the REH RFI, 

commenters indicated that CMS should 

require board-certified emergency 

physicians to serve as medical directors 

of the REH. While we agree that having 

a board-certified emergency physician 

serving as the medical director of the 

REH would benefit patients by ensuring 

that the REH is overseen by a highly 

qualified physician with a high level of 

expertise in emergency medicine, we 

believe that requiring this of REHs 

would be unduly burdensome due to 

the challenges faced by rural 

communities in obtaining and retaining 

medical professionals to provide health 

care services. While we are not 

proposing to require that REHs have a 

board-certified emergency physician 

serve as the medical director, we would 

encourage REHs to have such a 

physician serve in the capacity of 

medical director if possible. 

15. Condition of Participation: Nursing 

Services (Proposed § 485.530) 

The CoPs for hospitals and CAHs 

include a provision for nursing services. 

However, given that each of these 

providers offers acute care inpatient 

services, we do not believe that all of 

the nursing services requirements for 

hospitals and CAHs would be 

appropriate for REHs, which is an 

outpatient-only provider. In evaluating 

the appropriateness of nursing services 

requirements for REHs, we also took 

into consideration the CfCs for 

ambulatory surgery centers at 42 CFR 

part 416 since they only offer outpatient 

services. 

Consistent with the hospital 

requirements, we propose to require that 

REHs have an organized nursing service 

that is available to provide 24-hour 

nursing services at § 485.530 for the 

provision of patient care. We believe 

that the REH should have a sufficient 

number of nurses available to provide 

services, based on the number of 

patients receiving services in the REH 

and the level of care required to be 

provided to those patients. 

Similar to the standard hospitals at 

§ 482.23(a), we propose at § 485.530(a) 

to require that patient care 

responsibilities must be delineated for 

all nursing service personnel and that 

nursing services must be provided in 

accordance with recognized standards 

of practice. Also consistent with the 

hospital standards for nursing services, 

we propose to require at § 485.530(b) 

that the REH have a director of nursing 

who is a licensed registered nurse and 

who is responsible for the operation of 

the nursing services. 

16. Condition of Participation: 

Discharge Planning (Proposed 

§ 485.532) 

Hospitals and CAHs have very similar 

discharge planning requirements at 

§§ 482.43 and 485.642, respectively. 

These requirements were revised in the 

final rule entitled ‘‘Medicare and 

Medicaid Programs; Revisions to 

Requirements for Discharge Planning for 

Hospitals, Critical Access Hospitals, and 

Home Health Agencies, and Hospital 

and Critical Access Hospital Changes to 

Promote Innovation, Flexibility, and 

Improvement in Patient Care’’ (84 FR 

51836). Many commenters on the REH 

RFI noted the importance of having indepth discharge planning requirements 

for REHs, highlighting the need for REH 

patients to have safe, well-coordinated 

discharge processes due to the 

availability of fewer health care 

resources in rural environments. As a 

result, we propose to closely align the 

proposed discharge planning 

requirements for REHs with the 

requirements for hospitals and CAHs. 

Specifically, we are proposing at 

§ 485.532 to require that the patient’s 

discharge plan address the patient’s 

goals of care and treatment preferences. 

During the discharge planning process, 

we would expect that the appropriate 

medical staff would discuss the 

patient’s post-acute care goals and 

treatment preferences with the patient, 

the patient’s family or their caregiver/ 


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19Administration of Community Living (2021). 

Long-Term Care Ombudsman Program. https://

acl.gov/programs/Protecting-Rights-and-PreventingAbuse/Long-term-Care-Ombudsman-Program. 

support persons (or both) and 

subsequently document these goals and 

preferences in the medical record. We 

would expect these documented goals 

and treatment preferences to be taken 

into account throughout the entire 

discharge planning process. We note 

that as a provider of emergency services, 

the REH may receive patients from 

nursing homes who require emergency 

care. Having a robust discharge 

planning process in place is imperative 

for this patient population. There may 

be instances in which a patient comes 

to the REH from a nursing home and the 

nursing home expresses an intent not to 

accept the patient or delays the patient’s 

return back to the nursing home after 

the completion of emergency care by the 

REH. Under these circumstances, we 

would encourage the REH to contact 

their State’s long-term care ombudsman 

or State Survey Agency. We also 

encourage the REH to inform patients 

who arrive from or are discharged to a 

long-term care facility about how to 

contact the Ombudsman and State 

Survey Agency, as there may be quality 

of care or quality of life concerns to be 

reported. The Administration of 

Community Living’s Long-Term Care 

Ombudsman Programs, ‘‘. . . work to 

resolve problems related to the health, 

safety, welfare, and rights of individuals 

who live in LTC facilities, such as 

nursing homes, board and care and 

assisted living facilities, and other 

residential care communities. 

Ombudsman programs promote policies 

and consumer protections to improve 

long-term services and supports at the 

facility, local, state, and national 

levels.’’ 19

At § 485.532(a) introductory text and 

(a)(1), we propose to require that REHs 

implement a discharge planning process 

to begin identifying, early in the 

provision of services, the anticipated 

post-discharge goals, preferences, and 

needs of the patient and begin to 

develop an appropriate discharge plan 

for patients who are likely to suffer 

adverse health consequences upon 

discharge in the absence of adequate 

discharge planning. Timely 

identification of the patient’s goals, 

preferences, and needs and 

development of the discharge plan 

would reduce delays in the overall 

discharge process. Patient referrals to or 

consultation with community care 

organizations will be a key step, for 

some, in assuring successful patient 

outcomes. Therefore, we believe that 

discharge planning for patients is a 

process that involves the consideration 

of the patient’s unique circumstances, 

treatment preferences, and goals of care, 

and is not solely a documentation 

process. 

In addition, in order to encourage 

patient engagement and understanding 

of their discharge plan or instructions, 

we recommend that providers follow 

the National Standards for Culturally 

and Linguistically Appropriate Services 

(CLAS) in Health and Health Care 

(https://www.thinkculturalhealth.

hhs.gov/clas/standards), which provide 

guidance on providing instructions in a 

culturally and linguistically appropriate 

manner. We remind providers of their 

obligations to take reasonable steps to 

provide meaningful access to 

individuals with limited English 

proficiency in accordance with Title VI 

of the Civil Rights Act of 1964 and 

section 1557 of the Patient Protection 

and Affordable Care Act (the Affordable 

Care Act). In addition, providers are 

reminded to take appropriate steps to 

ensure effective communication with 

individuals with disabilities, including 

the provision of auxiliary aids and 

services, in accordance with section 504 

of the Rehabilitation Act, the Americans 

with Disabilities Act, and section 1557 

of the Affordable Care Act (see, https:// 

www.hhs.gov/civil-rights and https://

www.ada.gov for more information on 

these requirements). Discharge planning 

would be of little value to patients who 

cannot understand or appropriately 

follow the discharge plans discussed in 

this proposed rule. Without appropriate 

language assistance or auxiliary aids 

and services, discharge planners would 

not be able to fully involve the patient 

and caregiver/support person in the 

development of the discharge plan. 

Furthermore, the discharge planner 

would not be fully aware of the patient’s 

goals for discharge. 

Additionally, effective discharge 

planning would assist REHs in 

complying with the U.S. Supreme 

Court’s holding in Olmstead v. L.C. (527 

U.S. 581 (1999)), which found that the 

unjustified segregation of people with 

disabilities is a form of unlawful 

discrimination under the ADA. We note 

that effective discharge planning may 

assist REHs in ensuring that individuals 

being discharged who would otherwise 

be entitled to institutional services, have 

access to community-based services 

when—(1) such placement is 

appropriate; (2) the affected person does 

not oppose such treatment; and (3) the 

placement can be reasonably 

accommodated. As noted by comments 

received in response to the REH RFI, 

discharge planning should focus on 

returning the patient to a home or 

community-based setting to the fullest 

extent possible with necessary supports 

and service. These proposed discharge 

planning standards are aimed at 

achieving this goal. 

At § 485.532(a)(2), we propose to 

require an REH to perform a discharge 

planning evaluation that must include 

an evaluation of a patient’s likely need 

for appropriate services following care 

that has been furnished by an REH, 

including, but not limited to, hospice 

care services, post-REH extended care 

services, home health services, and nonhealth care services and communitybased care providers, and must also 

include a determination of the 

availability of the appropriate services 

as well as of the patient’s access to those 

services. 

At § 485.532(a)(3) we propose to 

require that the patient’s discharge 

needs evaluation and discharge plan 

must be documented and completed on 

a timely basis, based on the patient’s 

goals, preferences, strengths, and needs, 

so that appropriate arrangements for 

post-REH care are made before 

discharge. This requirement would 

prevent the patient’s discharge or 

transfer from being unduly delayed. We 

expect that in response to this 

requirement, REHs would establish 

more specific time frames for 

completing the evaluation and discharge 

plans based on the needs of their 

patients and their own operations. All 

relevant patient information would be 

incorporated into the discharge plan to 

facilitate its implementation and the 

discharge plan must be included in the 

patient’s medical record. The results of 

the evaluation must also be discussed 

with the patient or patient’s 

representative. Furthermore, we believe 

that REHs will use their evaluation of 

the discharge planning process, with 

solicitation of feedback from other 

providers and suppliers in the 

community, as well as from patients and 

caregivers, to revise their timeframes, as 

needed. We encourage REHs to make 

use of available health information 

technology, such as electronic health 

records, as well as entities that can 

facilitate exchange, such as health 

information exchanges, to enhance the 

efficiency and effectiveness of their 

discharge process. 

At § 485.532(a)(4), we propose to 

require the REH to arrange for the 

development and initial implementation 

of a discharge plan for those patients so 

identified as well as for other patients 

upon the request of the patient’s 

physician. We propose at § 485.532(a)(5) 

to require that a registered nurse, social 

worker, or other personnel qualified in 


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20 Johns Hopkins University, Armstrong Institute 

for Patient Safety and Quality (2014). Improving the 

emergency department discharge process: 

environmental scan report. (Prepared by Johns 

Hopkins University, Baltimore, MD, under Contract 

No. HHSA 2902010000271.). Agency for Healthcare 

Research and Quality; Publication No. 14(15)– 

0067–E. https://www.ahrq.gov/sites/default/files/ 

wysiwyg/professionals/systems/hospital/ 

edenvironmentalscan/edenvironmentalscan.pdf. 

accordance with the REH’s discharge 

planning policy coordinate the 

discharge needs evaluation and the 

development of the discharge plan. 

At § 485.532(a)(6) we propose to 

require that the REH’s discharge 

planning process must ensure an 

ongoing patient evaluation throughout 

the patient’s REH stay or visit to identify 

any changes in the patient’s condition 

that would require modifications to the 

discharge plan. The evaluation to 

determine a patients continued stays at 

the REH (or in other words, their 

readiness for discharge or transfer), is a 

current standard of medical practice. 

We propose to require at 

§ 485.532(a)(7) that the hospital assess 

its discharge planning process on a 

regular basis and include, as part of the 

assessment, an ongoing review of a 

representative sample of discharge 

plans. We expect that this would 

include patients who were emergency 

department revisits, or presented to the 

emergency department within 30 days 

of a previous visit, to ensure that the 

REH is responsive to the discharge 

needs of patients. 

In addition to standards for evaluating 

the discharge needs of patients and the 

development of discharge plans, the 

hospital and CAH discharge planning 

provisions also require that the hospital 

and CAH assist patients, their families, 

or the patient’s representative in 

selecting a post-acute care provider by 

using and sharing data that includes, 

but is not limited to, home health 

agency (HHA), SNF, inpatient 

rehabilitation facility (IRF), or long-term 

care hospital (LTCH) data on quality 

measures and data on resource use 

measures. Furthermore, the CoPs 

require the hospital and CAH to ensure 

that the post-acute care data on quality 

measures and data on resource use 

measures is relevant and applicable to 

the patient’s goals of care and treatment 

preferences. We believe these 

requirements are applicable to REHs 

given that we expect some patients of 

the REH to be discharged to a post-acute 

care provider. As result, we propose at 

§ 485.532(a)(8) to require REHs to share 

data on quality measures and resource 

use measures of local post-acute care 

providers with patients to assist them in 

selecting a post-acute care provider. 

We propose at § 485.532(b) to require 

that the REH must discharge the patient, 

and also transfer or refer the patient 

where applicable, along with all 

necessary medical information 

pertaining to the patient’s current 

course of illness and treatment, postdischarge goals of care, and treatment 

preferences, at the time of discharge, to 

the appropriate post-acute care service 

providers and suppliers, facilities, 

agencies, and other outpatient service 

providers and practitioners responsible 

for the patient’s follow-up or ancillary 

care. 

The Agency for Healthcare Research 

and Quality released an environmental 

scan report on Improving the Emergency 

Department Discharge Process, that 

evaluated the state of the emergency 

department discharge process and ways 

in which it can be improved.20 The 

report found that a high-quality 

emergency department discharge 

incorporates the following: 

• Informs and educates patients on 

their diagnosis, prognosis, treatment 

plan, and expected course of illness. 

This includes informing patients of the 

details of their visit (treatments, tests, 

procedures). 

• Supports patients in receiving postemergency department discharge care. 

This might include medications, home 

care of injuries, use of medical devices/ 

equipment, further diagnostic testing, 

and further health care provider 

evaluation. 

• Coordinates emergency department 

care within the context of the health 

care system (other health care providers, 

social services, etc.). 

We believe discharge planning 

requirements proposed for REHs 

address the goals identified in the 

report. 

17. Condition of Participation: Patient’s 

Rights (Proposed § 485.534) 

It is imperative for patients to have 

the ability to exercise certain rights and 

protections while seeking and receiving 

necessary care and services at an REH. 

As previously mentioned, the 

appropriate provision of behavioral 

health is very important in the treatment 

and safety of patients and staff. 

Behavioral health is a challenge in rural 

areas, due to the accessibility, 

affordability, acceptability and 

availability of these services. We 

anticipate beneficiaries may rely on 

REH’s to access behavioral health care 

services, therefore we believe it is 

important to have policies and 

procedures in place for REHs and CAHs 

(discussed later in this rule) in the event 

of a mental health crisis and the need 

for the use of restraints and seclusions. 

We propose to establish a CoP for 

patient’s rights at § 485.534 that would 

set forth the rights of all patients to 

receive care in a safe setting and provide 

protection for a patient’s emotional 

health and safety as well as their 

physical safety. Furthermore, we 

propose to establish the patient’s rights 

CoP for REHs closely to the patient’s 

rights CoP for hospitals at § 482.13. This 

would include proposed requirements 

for the REH to inform patients of and 

exercise their rights, address privacy 

and safety, adhere to the confidentiality 

of patient records, responsibilities for 

the use of restraint and seclusion, and 

adherence to patient visitation rights. 

We propose to add these same patient’s 

rights CoPs for CAHs, as well. Some of 

these requirements are currently in the 

SOM for CAHs while some are not 

explicitly required. We believe that 

these patient rights provisions are 

important for hospitals, CAHs, and 

REHs. However, we note that some of 

the provisions proposed in this section 

for REHs and, also for CAHs as 

discussed later, are less prescriptive 

than those for hospitals because we are 

proposing to allow for these providers to 

develop policies and procedures based 

on the scope of services they provide 

and patient populations that they serve. 

For example, we believe that REHs, like 

CAHs, will have a lower volume of 

patients than hospitals and the use of 

restraints and seclusion would not be as 

frequent as other providers. REHs would 

not be providing inpatient services and 

if a patient presents at the REH in crisis 

or needing a level of care so acute that 

restraints or seclusions may become 

necessary, we would expect the REH to 

arrange for the transfer of the patient to 

a higher level of care. We are 

specifically soliciting comments on the 

appropriateness of the patient’s rights 

requirements proposed for restraint and 

seclusion, the potential need to require 

standards that are more stringent to 

address patient protections, and the 

feasibility of implementing such 

requirements in rural communities. 

Notice of Rights 

At § 485.534(a), we propose that an 

REH must inform each patient, or when 

appropriate, the patient’s representative 

(as allowed under state law), of the 

patient’s rights, in advance of furnishing 

or discontinuing patient care whenever 

possible. This includes a proposal to 

require the REH to establish a process 

for the oversight and prompt resolution 

of patient grievances and for informing 

each patient whom to contact to file a 

grievance. 


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Exercise of Rights 

At § 485.534(b), we propose to specify 

those rights a patient has regarding their 

medical care, which includes the right 

to make informed decisions regarding 

their care, to be fully informed about 

such care, and the right to request or 

refuse treatment. We note that this right 

must not be construed as a mechanism 

to demand the provision of treatment or 

services deemed medically unnecessary 

or inappropriate. In addition, we 

propose to specify that the patient also 

has the right to formulate advance 

directives and to have REH staff and 

practitioners who provide care in the 

REH comply with these directives. 

Privacy, Safety, and Confidentiality of 

Patient Records 

At § 485.534(c), we propose to specify 

that the patient has the right to personal 

privacy, receive care in a safe setting, 

and be free from all forms of abuse or 

harassment. At § 485.534(d), we propose 

to specify that the patient has the right 

to the confidentiality of their medical 

records and the right to access their 

medical records. When requested, we 

propose that the REH must provide the 

patient with their records in a form and 

format requested by the requestor and 

within a reasonable timeframe, as not to 

frustrate the legitimate efforts of 

individuals to gain access to their own 

medical records. 

Use of Restraints and Seclusion 

At § 485.534(e), we propose those 

patient’s rights relating to the use of 

restraints and seclusion. We are 

proposing requirements that are less 

burdensome than those existing 

restraint and seclusion requirements for 

hospitals because given the level of 

services provided by REHs and the 

anticipated patient volume, we expect 

the likelihood of their need to utilize 

restraints and seclusion to be relatively 

low. In addition, in the event that there 

are patients requiring restraint and 

seclusion we would expect them to be 

transferred to a higher level of care. We 

note that we have similar expectations 

for CAHs and are proposing similar 

requirements for CAHs in this rule. 

Specifically, we propose to specify that 

all patients have the right to be free from 

physical or mental abuse, from corporal 

punishment, and from restraint or 

seclusion, of any form, imposed as a 

means of coercion, discipline, 

convenience, or retaliation by staff. We 

propose that restraint or seclusion may 

only be imposed to ensure the 

immediate physical safety of the patient, 

a staff member, or others and must be 

discontinued at the earliest possible 

time. We propose to define restraint as 

any manual method, physical or 

mechanical device, material, or 

equipment that immobilizes or reduces 

the ability of a patient to move their 

arms, legs, body, or head freely; or a 

drug or medication when it is used as 

a restriction to manage the patient’s 

behavior or restrict the patient’s 

freedom of movement and is not a 

standard treatment or dosage for the 

patient’s condition. A restraint does not 

include devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, off of a 

stretcher, or out of a chair, or to permit 

the patient to participate in activities 

without the risk of physical harm (this 

does not include a physical escort). We 

propose to define seclusion as the 

involuntary confinement of a patient 

alone in a room or area from which the 

patient is physically prevented from 

leaving. Seclusion may only be used for 

the management of violent or selfdestructive behavior. 

At § 485.534(e)(2), we propose to 

require that the restraint or seclusion 

may only be used when less restrictive 

interventions have been determined to 

be ineffective to protect the patient, a 

staff member, or others from harm, and 

at § 485.534(e)(3) that the type or 

technique of restraint or seclusion used 

must be the least restrictive intervention 

that will be effective to protect the 

patient, staff member, or others from 

harm. At § 485.534(e)(4), we propose 

that the REH must have written policies 

and procedures regarding the use of 

restraint and seclusion that are 

consistent with current standards of 

practice. These requirements allow for 

the REH to use restraints and seclusion 

in the event that it is necessary and as 

a last resort to respond to immediate 

safety concerns, but lessens the burden 

and allows for more flexibility than the 

existing hospital CoPs. We believe that 

allowing the REH the flexibility to 

develop their own policies and 

procedures for restraints and seclusion 

based on the scope of services they 

provide is necessary given their patient 

volumes, populations, and access to 

resources. We propose to require that 

the policies and procedures that are 

developed be consistent with current 

standards of practice. As noted, we are 

soliciting comments on the 

appropriateness of the patient’s rights 

requirements proposed for restraint and 

seclusion, the potential need to require 

standards that are more stringent to 

address patient protections, and the 

feasibility of implementing such 

requirements in rural communities. 

Staff Training Requirements for the Use 

of Restraints or Seclusion 

The following staff training 

requirements are not as prescriptive as 

the existing hospital requirements, and 

we are proposing these same 

requirements for CAHs in this rule. At 

§ 485.534(f) we propose to establish staff 

training requirements for the use of 

restraints and seclusion. Specifically, 

we propose that the patient has the right 

to safe implementation of restraint or 

seclusion by trained staff. We propose at 

§ 485.534(f)(1) that the REH must 

provide competency-based training and 

education of REH personnel and staff, 

including medical staff, and, as 

applicable, personnel providing 

contracted services in the REH, on the 

use of restraint and seclusion. To ensure 

that the use of restraint and seclusion 

for patients receiving services in an REH 

is respectful of, and responsive to, 

individual patient preferences, needs 

and values, we propose to require that 

the training be patient-centered. 

Additionally, to ensure that staff are 

educated and trained on using the least 

restrictive intervention necessary for the 

safety of the patients and REH staff, we 

propose at § 485.534(f)(2) to require that 

the REH staff train their staff in 

alternatives to the use of restraint and 

seclusion. For example, staff should 

have trauma-informed knowledge 

competencies and be aware of effective 

de-escalation techniques that can be 

used to avoid the use of restraint and 

seclusion and the trauma that may be 

associated with their use. Trained peer 

workers (people who share similar 

experiences of being diagnosed with 

mental health conditions, substance use 

disorders, or both) and community 

health workers (CHWs) may also serve 

a useful role in assisting patients and 

other staff. This could include helping 

to monitor use of restraint and 

seclusion, deescalating interactions with 

patients and contributing to a positive 

and supportive environment for 

patients, family members, and REH 

staff. REHs are encouraged to consider 

the use of peer workers and CHWs in 

their staffing plans. For further 

information, please see the 2007 

guidance on use of peers in the 

Medicaid program (https://

www.medicaid.gov/federal-policyguidance/downloads/SMD081507A.pdf) 

and resources from the Substance Abuse 

and Mental Health Services 

Administration (https://

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21 Institute of Medicine (US) Committee on 

Quality of Health Care in America. Crossing the 

Quality Chasm: A New Health System for the 21st 

Century. Washington (DC): National Academies 

Press (US); 2001. Available from: https://

www.ncbi.nlm.nih.gov/books/NBK222274/ doi: 

10.17226/10027. 

22United States Department of Health and Human 

Services, Office of Inspector General & American 

Health Lawyers Association. (2004). Corporate 

Responsibility and Health Care Quality: A Resource 

for Health Care Boards of Directors. https://

oig.hhs.gov/documents/compliance-guidance/813/ 

CorporateResponsibilityFinal_9-4-07.pdf. 

23Association of American Medical Colleges. 

(2014). Teaching for Quality: Integrating Quality 

Improvement and Patient Safety across the 

Continuum of Medical Education. https://

www.aamc.org/media/26316/ 

download?attachment. 

24Agency for Healthcare and Research Quality. 

(2020, July) AHRQ National Scorecard on HospitalAcquired Conditions: Final Results for 2014 

through 2017. https://www.ahrq.gov/hai/pfp/ 

index.html. 

25 Dupree, E., Fritz-Campiz, A., Musheno, D. 

(2014). A New Approach to Preventing Falls with 

Injuries. Journal of Nursing Care Quality, 29(2), p. 

99–102. 

26Starmer, A.J. et al. (2014). Changes in Medical 

Errors after Implementation of a Handoff Program. 

New England Journal of Medicine, 371, p. 1803– 

1812. DOI: 10.1056/NEJMsa1405556. 

27Centers for Disease Control and Prevention. 

(2018, October 5). Healthcare-Associated Infections 

Continued 

support-tools/peers). In addition, 

facilities are encouraged to consider any 

nutritional needs while a patient is 

restrained, such as a need to provide 

food and water. 

Death Reporting Requirements 

The following requirements are 

similar to the hospital requirements at 

§ 482.13. At § 485.534(g), we propose to 

establish requirements that REHs must 

follow when reporting deaths associated 

with the use of seclusion or restraint. 

Specifically, we propose to require that 

the REH must report to CMS, by 

telephone, facsimile, or electronically, 

as determined by CMS, no later than the 

close of business on the next business 

day the following information—(1) Each 

death that occurs while a patient is in 

restraint or seclusion; (2) Each death 

that occurs within 24 hours after the 

patient has been removed from restraint 

or seclusion; (3) Each death known to 

the REH that occurs within 1 week after 

restraint or seclusion where it is 

reasonable to assume that use of 

restraint or placement in seclusion 

contributed directly or indirectly to a 

patient’s death, regardless of the type(s) 

of restraint used on the patient during 

this time. We note that ‘‘reasonable to 

assume’’ in this context would include, 

but is not limited to, deaths related to 

restrictions of movement for prolonged 

periods of time, or death related to chest 

compression, restriction of breathing, or 

asphyxiation. 

For instances when no seclusion has 

been used and when the only restraints 

used on the patient are those applied 

exclusively to the patient’s wrist(s), and 

which are composed solely of soft, nonrigid, cloth-like materials, the REH staff 

must record in an internal log or other 

system, the following information—(1) 

Any death that occurs while a patient is 

in such restraints; (2) Any death that 

occurs within 24 hours after a patient 

has been removed from such restraints. 

Furthermore, we propose that staff must 

also document in the patient’s medical 

record the date and time the death was 

reported to CMS or recorded in the 

internal log or other system. Also, for 

instances when no seclusion has been 

used and when the only restraints used 

on the patient are those applied 

exclusively to the patient’s wrist(s),we 

propose to require that entries into the 

internal log or other system must be 

documented no later than seven days 

after the date of death of the patient, 

include the patient’s name, date of birth, 

date of death, name of attending 

physician or other licensed practitioner 

who is responsible for the care of the 

patient, medical record number, and 

primary diagnosis(es), and to be made 

available in either written or electronic 

form to CMS immediately upon request. 

Patient Visitation Rights 

At § 485.534(h), we propose to 

establish requirements related to a 

patient’s visitation rights. These 

requirements are consistent with the 

current hospital and CAH regulations. 

Specifically, we propose to require that 

an REH must have written policies and 

procedures regarding the visitation 

rights of patients, including those 

setting forth any clinically necessary or 

reasonable restriction or limitation that 

the REH may need to place on such 

rights and the reasons for the clinical 

restriction or limitation. An REH must 

inform patients (or support persons, 

where appropriate) of their visitation 

rights, including any clinical restriction 

or limitation on such rights, when they 

are informed of their other rights. Each 

patient should be informed (or support 

persons, where appropriate) of the right, 

subject to their consent, to receive the 

visitors whom they designate, 

including, but not limited to, a spouse, 

a domestic partner (including a samesex domestic partner), another family 

member, or a friend. The patient also 

has the right to withdraw or deny such 

consent at any time, not restrict, limit, 

or otherwise deny visitation privileges 

on the basis of race, color, national 

origin, religion, sex, gender identity, 

sexual orientation, or disability, and 

ensure that all visitors enjoy full and 

equal visitation privileges consistent 

with patient preferences. 

18. Condition of Participation: Quality 

Assessment and Performance 

Improvement Program (QAPI program) 

(Proposed § 485.536) 

Patient safety and quality 

improvement remains a challenge in our 

nation’s hospitals. In 2001, the Institute 

of Medicine (IOM) released a pivotal 

report, ‘‘Crossing the Quality Chasm’’ in 

which it stated that ‘‘the American 

healthcare delivery system is in need of 

fundamental change’’ and recognized 

that ‘‘quality problems are everywhere 

affecting many patients.’’ 21 In a 2004 

educational publication co-sponsored 

by the Office of Inspector General (OIG) 

of the U.S. Department of Health and 

Human Services and the American 

Health Lawyers Association (AHLA), 

Corporate Responsibility and Health 

Care Quality: A Resource for Health 

Care Boards of Directors, the authors 

discuss the IOM report and state that the 

oversight of quality and patient safety is 

becoming clearly recognized as a core 

fiduciary responsibility of health care 

organizations.22 They further note that 

promoting quality of care and 

preserving patient safety are at the core 

of the health care industry and the 

reputation of each health care 

organization and suggest that 

‘‘contemporary health care quality, 

patient safety and cost efficiency 

initiatives provide an opportunity for 

health care organizations to make a 

positive difference to society while 

promoting their missions and enhancing 

their financial success.’’ In their 2013 

expert panel report, the Association of 

American Medical Colleges describes 

the work of the competent health 

professional as not only delivering 

health care, but also working to improve 

it, including identifying problems in 

care delivery and working with others to 

enhance performance.23

While progress has been made 

towards the goal of increased patient 

safety since the publication of the 2001 

IOM report, including a reduction in 

hospital-acquired conditions (HACs) 

and hospital fall-related injuries and 

improvements in patient handoffs, the 

mitigation of medical errors and adverse 

events and protection of patient safety 

remain serious concerns.24 25 26

According to 2018 data from the Centers 

for Disease Control (CDC), 

approximately 1 in 31 hospital patients 

develops an HAI, such as a surgical site 

infections or catheter-related 

bloodstream infections (CRBIs) and the 

effects can be painful, costly, and even 

deadly.27


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(HAIs). HAI Data. https://www.cdc.gov/hai/data/ 

index.html. 

An effective QAPI program that is 

engaged in continuous improvement 

efforts is essential to a provider’s ability 

to deliver high quality and safe care to 

its patients, while reducing the 

incidence of medical errors and adverse 

events. Therefore, we believe the QAPI 

programs for REHs should conform to 

the current health care industry 

standards that require providers to 

proactively design quality improvement 

into each program at the outset, monitor 

data (indicators, measures and reports of 

staff/residents/families), determine root 

causes of problems, develop and 

implement plans that affect system 

improvement, and monitor the success 

of this systematic approach to 

improving quality. 

At § 485.536, we propose to require 

that every REH develop, implement, and 

maintain an effective, ongoing, REHwide, data-driven QAPI program. This 

requirement would ensure that the REH 

systematically reviews its operating 

systems and processes of care to identify 

and implement opportunities to deliver 

effective care to its patients focusing on 

improving health outcomes and 

preventing and reducing medical errors. 

In the development of the proposed 

requirements for the REH QAPI 

program, we reviewed the CAH QAPI 

requirements at § 485.641, which we 

note are also closely aligned with the 

hospital QAPI requirements at § 482.21. 

We also took into account the comments 

on the REH RFI and input from other 

interested parties who requested that 

CMS consider the clinical and 

administrative limitations that rural 

providers experience and, where 

appropriate, we have proposed 

requirements that minimize burden 

while maintaining the ability of the REH 

to proactively maximize quality 

improvement activities and programs. 

The proposed QAPI program contains 

the following five parts: (a) Program and 

scope; (b) Program data collection and 

analysis; (c) Program activities; (d) 

Executive responsibilities; and (e) 

Unified and integrated QAPI program 

for an REH in a multi-hospital system. 

Similar to the program scope standard 

for hospitals at § 482.21(a)(1) and (2), at 

§ 485.536(a)(1), we propose to require 

the REH to have an ongoing QAPI 

program that reflects improvement in 

quality indicators related to health 

outcomes and reductions in medical 

errors. In proposed paragraph 

§ 485.536(a)(2) we would require REHs 

to measure, analyze, and track these 

quality indicators. At § 485.536(b), we 

propose to mirror the program data 

collection and analysis standard for 

CAHs at § 485.641(b) and require that 

the REH’s QAPI program incorporate 

quality indicator data including patient 

care data, quality measures data, and 

other relevant data in order to attain 

quality improvement. 

Similar to the program activities 

standard for hospitals at § 482.21(c), at 

§ 485.536(c)(1), we propose to require 

the REH to set priorities for its 

performance improvement activities and 

that these activities are focused on highrisk, high-volume, or problem-prone 

areas. We also propose to require the 

REH to consider the incidence, 

prevalence, and severity of problems in 

those identified areas and that the set 

priority areas affect health outcomes, 

patient safety, and quality of care. At 

§ 485.536(c)(2) and (3), we propose to 

require the REH’s performance 

improvement activities to track medical 

errors and adverse events, analyze their 

cause, and implement preventive 

actions. We would expect the REH to 

conduct analyses at regular intervals to 

track performance and ensure that 

improvements are sustained. 

We propose at § 485.536(d), similar to 

the standard for executive 

responsibilities for hospitals at 

§ 482.21(e) that the responsibilities for 

the REH’s governing body (or organized 

group or individual who assumes full 

legal authority and responsibility for 

operations of the REH), medical staff, 

and administrative officials include 

ensuring that the QAPI program is 

implemented and maintained, properly 

evaluated, and appropriately resourced. 

Lastly, consistent with the standard 

included at § 482.21(f) in the hospital 

CoPs for QAPI programs, we are 

proposing at § 485.536(e) to allow REHs 

that are part of a multi-facility system 

consisting of multiple separately 

certified hospitals, CAHs, and/or REHs 

to elect to have a unified and integrated 

QAPI program if in accordance with all 

applicable state and local laws. 

Specifically, we propose to specify that 

the system’s governing body would be 

responsible and accountable for 

ensuring that each of its separately 

certified REHs met the proposed QAPI 

program requirements. We expect this 

allowance, if finalized, would be 

beneficial to REHs that may lack time, 

resources or staff to implement an REHspecific QAPI program. The REH would 

be able to benefit from the resources and 

expertise of a multi-hospital system in 

implementing their QAPI program, as 

well as potentially reducing the time 

and labor investments required to enact 

and maintain the program. 

We are interested in input from the 

public regarding possible unintended 

consequences that could occur as a 

result of allowing REHs to participate in 

a unified and integrated QAPI program. 

We are interested in feedback regarding 

how the integrated health system’s 

governing body will ensure that they 

consider the REH’s unique 

circumstances and any significant 

differences in patient populations and 

services offered at the REH. We also 

seek comments regarding how the 

integrated health system’s governing 

body would ensure that an REH 

participating in a unified and integrated 

QAPI program provided the appropriate 

level of care to patients being treated in 

the REH, including being appropriately 

transferred to another facility when 

necessary. 

19. Condition of Participation: 

Agreements (Proposed § 485.538) 

Section 1861(kkk)(2)(C) of the Act, as 

added by the CAA, requires an REH to 

have in effect a transfer agreement with 

a level I or level II trauma center. In 

accordance with section 1861(kkk)(2)(C) 

of the Act, at § 485.538 we propose to 

require that REHs must have in effect an 

agreement with at least one Medicarecertified hospital that is a level I or level 

II trauma center for the referral and 

transfer of patients requiring emergency 

medical care beyond the capabilities of 

the REH. We would require that the 

level I or level II trauma center meets 

certain licensure requirements 

including being licensed as a hospital in 

a state that provides for the licensing of 

hospitals under state or applicable local 

law or approved by the agency of such 

state or locality responsible for licensing 

hospitals, as meeting standards 

established for licensing established by 

the agency of the state. It is also 

acceptable for the level I or II trauma 

center to be located in a state other than 

the state where the REH is located. In 

addition, we propose to require that the 

level I or level II trauma center must 

also be licensed or designated by the 

state or local government authority as 

level I or level II trauma center or is 

verified by the American College of 

Surgeons as a level I or level II trauma 

center. 

We received several comments to the 

REH RFI regarding transfer agreements 

between REHs and hospitals that are not 

designated as a level I or II trauma 

center. Specifically, commenters stated 

that due to distance, or the possibility 

that level I or level II trauma centers 

may not have available beds, many rural 

CAHs currently transfer patients to level 

III or level IV trauma centers based on 

the patient’s specific needs. 

Commenters requested that CMS allow 

these facilities to retain these 


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agreements, should they convert to 

REHs. We would expect REHs to 

comply with the CoP detailed at 

§ 485.538 and to have a transfer 

agreement in place with a level I or II 

trauma center. However, we do not 

believe that the statute precludes an 

REH from also having a transfer 

agreement with a hospital that is not 

designated as a level I or II trauma 

center. An REH may have pre-existing 

relationships with hospitals that are not 

designated as level I or level II trauma 

centers. In these instances, the proposed 

requirement would not preclude them 

from maintaining those relationships 

and leveraging resources and capacity 

that may be available to deliver care that 

is beyond the scope of care delivered at 

the REH. 

We note that section 125(b)(2) of the 

CAA also amended subparagraphs (I) 

and (N) of section 1866(a)(1) of the Act, 

to apply the Emergency Medical 

Treatment and Labor Act (EMTALA) 

requirements under section 1867 of the 

Act, to REHs. One commenter on the 

REH RFI recommended EMTALA 

waivers for REHs to divert patients to 

other hospitals if they require a higher 

level of care than the REH is able to 

provide. However, the statutory 

requirements for REHs do not allow an 

EMTALA waiver. 

20. Condition of Participation: Medical 

Records (Proposed § 485.540) 

The maintenance of a medical records 

system is a longstanding requirement in 

both the hospital and CAH CoPs. In the 

development of proposed requirements 

for medical records for REHs, we 

reviewed the CoPs for medical records 

for CAHs established at § 485.638, 

including the requirements finalized in 

the May 2020 final rule, ‘‘Medicare and 

Medicaid Programs; Patient Protection 

and Affordable Care Act; 

Interoperability and Patient Access’’ (85 

FR 25510 through 25585), focused on 

electronic patient event notifications of 

a patient’s admission, discharge, and/or 

transfer to another health care facility or 

to another community provider. We also 

considered the comments from the REH 

RFI that encouraged CMS to closely 

align the CoPs for REHs with currently 

established requirements for CAHs. 

After reviewing the CoPs for medical 

records for CAHs at § 485.638, we 

believe that the requirements 

established for medical records for 

CAHs are also appropriate for REHs. We 

also would expect that many facilities 

that may elect to convert to an REH 

would presently have these systems in 

place, which may minimize 

administrative burden. Therefore, at 

§ 485.540(a), we propose to require that 

the REH must maintain a medical 

records system in accordance with 

written policies and procedures, that the 

records must be legible, complete, 

accurately documented, readily 

accessible, and systematically organized 

and that a designated member of the 

professional staff is responsible for 

maintaining the records. We also 

propose to require that for each patient 

receiving health care services, the REH 

maintains a record that includes, as 

applicable, identification and social 

data, evidence of properly executed 

informed consent forms, pertinent 

medical history, assessment of the 

health status and health care needs of 

the patient, and a brief summary of the 

episode, disposition, and instructions to 

the patient. We propose that the record 

requirements include reports of physical 

examinations, diagnostic and laboratory 

test results, including clinical laboratory 

services, and consultative findings and 

all orders of doctors of medicine or 

osteopathy or other practitioners, 

reports of treatments and medications, 

nursing notes and documentation of 

complications, and other pertinent 

information necessary to monitor the 

patient’s progress, such as temperature 

graphics or progress notes describing 

the patient’s response to treatment. 

Lastly, we propose that the record 

include dated signatures of the doctor of 

medicine or osteopathy or other health 

care professional. 

At § 485.540(b) and (c), we propose to 

require the REH to maintain the 

confidentiality of record information 

and to ensure records are retained for at 

least 5 years from date of last entry, and 

longer if required by state statute, or if 

the records may be needed in any 

pending proceeding. 

Lastly, at § 485.540(d), we propose a 

standard for electronic notifications if 

the REH utilizes an electronic medical 

records system or other electronic 

administrative system that conforms 

with the content exchange standard at 

45 CFR 170.205(d)(2). This requirement 

is intended to limit the applicability of 

this CoP to those REHs which currently 

possess an EHR or other electronic 

administrative system with the 

technical capacity to generate 

information for electronic patient event 

notifications. As discussed in the CMS 

Interoperability and Patient Access final 

rule (85 FR 25585), electronic patient 

event notifications can be an effective 

tool for improving care coordination 

across settings, especially for patients at 

discharge. We propose to require the 

REH to demonstrate that the system’s 

notification capacity is fully operational 

and sends notifications with at least 

specified patient information, as 

appropriate, and facilitates the exchange 

of health information when the patient 

is registered, discharged, or transferred 

from the REH’s emergency department. 

Finally, we propose to require that the 

REH make a reasonable effort to ensure 

that the system sends the notifications 

to certain recipients including, the 

patient’s applicable post-acute care and 

primary care services providers. 

21. Condition of Participation: 

Emergency Preparedness (Proposed 

§ 485.542) 

Over the past several years, the U.S. 

has been challenged by several natural 

and man-made disasters. As a result of 

the September 11, 2001 terrorist attacks, 

the subsequent anthrax attacks, the 

catastrophic hurricanes in the Gulf 

Coast states in 2005, flooding in the 

Midwestern states in 2008, tornadoes 

and floods in the spring of 2011, the 

2009 H1N1 influenza pandemic, and 

Hurricane Sandy in 2012 and most 

recently, the COVID–19 pandemic, 

readiness for public health emergencies 

has been put on the national agenda. On 

September 16, 2016, we published a 

final rule, ‘‘Medicare and Medicaid 

Programs; Emergency Preparedness 

Requirements for Medicare and 

Medicaid Participating Providers and 

Suppliers’’ (81 FR 63860), to establish 

emergency preparedness requirements 

for Medicare and Medicaid participating 

providers and suppliers to plan 

adequately for both natural and manmade disasters, and coordinate with 

Federal, state, tribal, regional, and local 

emergency preparedness systems. 

Disasters can disrupt the health care 

environment and change the demand for 

health care services. This makes it 

essential that health care providers and 

suppliers ensure that emergency 

management is integrated into their 

daily functions and values. 

Thus, we are proposing emergency 

preparedness requirements to establish 

a comprehensive, consistent, flexible, 

and dynamic regulatory approach to 

emergency preparedness for REHs that 

aligns with the existing emergency 

preparedness standards for Medicare 

and Medicaid participating providers 

and suppliers. These proposed 

requirements mirror the existing CAH 

emergency preparedness requirements. 

The emergency preparedness 

requirements for all Medicareparticipating providers and suppliers 

are consistent, with some differences 

based on the provider type (such as 

inpatient versus outpatient). 

Consistent with the standards for all 

Medicare and Medicaid participating 

providers and suppliers, we propose to 

require REHs to comply with all 


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applicable Federal, state, and local 

emergency preparedness requirements. 

In addition, we propose to require that 

the REH establish and maintain an 

emergency preparedness program that 

addresses four core elements that we 

believe are central to an effective 

emergency preparedness system. The 

four elements are: (1) risk assessment 

and planning; (2) policies and 

procedures; (3) communication; and (4) 

training and testing. 

At § 485.542(a), we propose to require 

that REHs develop and maintain an 

emergency preparedness plan that must 

be reviewed and updated at least every 

2 years. Specifically, we propose to 

require that the REHs emergency plan 

must—(1) Be based on and include a 

documented, facility-based and 

community-based risk assessment, 

utilizing an all-hazards approach, (2) 

Include strategies for addressing 

emergency events identified by the risk 

assessment, (3) Address the patient 

population, including, but not limited 

to, the type of services the REH has the 

ability to provide in an emergency; and 

continuity of operations, including 

delegations of authority and succession 

plans, and (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. 

At § 485.542(b), we propose to require 

REHs to develop and implement 

policies and procedures, that are based 

on the emergency plan, risk assessment, 

and communication plan, and must be 

reviewed and updated at least every 2 

years. Specifically, we propose to 

require that the policies and procedures 

must address the following: 

• Provision of subsistence needs for 

staff and patients, whether they 

evacuate or shelter in place, including, 

but not limited to food, water, medical 

and pharmaceutical supplies, other 

sources of energy to maintain 

temperatures, emergency lighting, fire 

detection and sewage and waste 

disposal; 

• A system to track the location of onduty staff and sheltered patients in the 

REH’s care during an emergency, and if 

staff are being relocated the REH must 

document the specific name and 

location of the receiving facility or other 

location; 

• Safe evacuation from the REH, to 

include consideration of care and 

treatment needs of the evacuees, staff 

responsibilities and transportation and 

identification of the evacuation 

location(s); 

• A means to shelter in place for any 

patients, staff and volunteers that 

remain at the REH; 

• A system of medical documentation 

that preserves patient information, 

protects confidentiality of all patient 

information and secures and maintains 

the availability of the records; 

• The use of volunteers in an 

emergency and other staffing strategies, 

including the process and role for 

integration of state and federally 

designated health care professionals to 

address surge needs during an 

emergency; and 

• The role of the REH under a waiver 

declared by the Secretary, in accordance 

with section 1135 of the Act, in the 

provision of care and treatment at an 

alternate care site identified by 

emergency management officials. 

We believe that small and rural REHs 

would be able to develop an appropriate 

emergency preparedness plan and 

develop policies and procedures in 

accordance with our proposed 

requirements with the assistance of 

resources in their state and local 

community guidance. 

At § 485.542(c), we propose to require 

REHs to develop and maintain an 

emergency preparedness 

communication plan that complies with 

both Federal and state law and must be 

reviewed and updated at least every 2 

years. The communication plan must 

include the following: 

• Names and contact information for 

staff, entities providing services under 

agreement, patients’ physicians and 

volunteers; 

• Contact information for Federal, 

state, tribal, regional, and local 

emergency preparedness staff and other 

sources of assistance; 

• Primary and alternate means for 

communicating with the REH’s staff and 

Federal, state, tribal, regional, and local 

emergency management agencies; 

• A method for sharing information 

and medical documentation for patients 

under the REH’s care, as necessary, with 

other health care providers to maintain 

the continuity of care; 

• A means, in the event of an 

evacuation, to release patient 

information; 

• A means of providing information 

about the general condition and location 

of patients under the facility’s care; and 

• A means of providing information 

about the REH’s needs, and its ability to 

provide assistance, to the authority 

having jurisdiction, the Incident 

Command Center, or designee. 

We would expect patient care to be 

well-coordinated within the REH, across 

healthcare providers, and with state and 

local public health departments and 

emergency management agencies and 

systems to protect patient health and 

safety in the event of a disaster. The 

following link is to FEMA’s 

comprehensive preparedness guide to 

develop and maintain emergency 

operations plans: https://www.fema.gov/ 

sites/default/files/2020-05/CPG_101_

V2_30NOV2010_FINAL_508.pdf. During 

an emergency, it is critical that REHs, 

have a system to contact appropriate 

staff, patients’ treating physicians, and 

other necessary persons in a timely 

manner to ensure continuation of 

patient care functions throughout the 

facilities and to ensure that these 

functions are carried out in a safe and 

effective manner. 

At § 485.542(d), we propose to require 

the REH to develop and maintain an 

emergency preparedness training and 

testing program that is based on the 

emergency plan, policies and 

procedures and communication plan, 

and reviewed and updated at least every 

2 years. We propose to require at 

§ 485.542(d)(1) that the training program 

include initial training in the emergency 

preparedness policies and procedures 

for new and existing staff, individuals 

providing on-site services under 

arrangement, and volunteers, consistent 

with their expected roles. We also 

propose to require the facility to provide 

emergency preparedness training at 

least every 2 years, maintain 

documentation of all emergency 

preparedness training, demonstrate staff 

knowledge of emergency procedures, 

and if the emergency preparedness 

policies and procedures are significantly 

updated, conduct training on the 

updated policies and procedures. The 

Homeland Security Exercise and 

Evaluation Program (HSEEP), developed 

by FEMA, includes a section on the 

establishment of a Training and Exercise 

Planning Workshop (TEPW). The TEPW 

section provides guidance to 

organizations in conducting an annual 

TEPW and developing a Multi-year 

Training and Exercise Plan (TEP) in line 

with the HSEEP (https://www.fema.gov/ 

sites/default/files/2020-04/HomelandSecurity-Exercise-and-EvaluationProgram-Doctrine-2020-Revision-2-2- 

25.pdf). 

We propose at § 485.542(d)(2) to 

require that the REH conduct exercises 

to test the emergency plan at least 

annually. Specifically, we propose to 

require that the REH conduct two 

testing exercises, a full-scale or 

functional exercise and an additional 

exercise of its choice, every 2 years. 

First, the REH must participate in a fullscale exercise that is community-based. 

When a community-based exercise is 

not accessible, we propose that the REH 


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must conduct a facility-based functional 

exercise or if the REH experiences an 

actual natural or man-made emergency 

that requires activation of the 

emergency plan, the REH is exempt 

from engaging in its next required 

community-based or individual, facilitybased functional exercise following the 

onset of the emergency event. Second, 

the REH must conduct an additional 

exercise, opposite the year the full-scale 

or functional exercise is conducted, that 

may include, but is not limited to a 

second full-scale exercise that is 

community-based, or an individual, 

facility-based functional exercise, a 

mock disaster drill, or a tabletop 

exercise or workshop that is led by a 

facilitator and includes a group 

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

of problem statements, directed 

messages, or prepared questions 

designed to challenge an emergency 

plan. Lastly, we propose to require that 

the REH must analyze its response to 

and maintain documentation of all 

drills, tabletop exercises, and emergency 

events and revise the REH’s emergency 

plan, as needed. 

We propose at § 485.625(e)(1)(i) that 

REHs must store emergency fuel and 

associated equipment and systems as 

required by the 2000 edition of the Life 

Safety Code (LSC) of the NFPA®. In 

addition to the emergency power system 

inspection and testing requirements 

found in NFPA® 99 and NFPA® 110 and 

NFPA® 101, we proposed that REHs test 

their emergency and stand-by-power 

systems for a minimum of 4 continuous 

hours every 12 months at 100 percent of 

the power load the REH anticipates it 

will require during an emergency. 

Finally, at § 485.542(f), we propose to 

specify that if an REH is part of a 

healthcare system consisting of multiple 

separately certified healthcare facilities 

that elects to have a unified and 

integrated emergency preparedness 

program, the REH may choose to 

participate in the healthcare system’s 

coordinated emergency preparedness 

program. If elected, we propose that the 

unified and integrated emergency 

preparedness program must 

demonstrate that each separately 

certified facility within the system 

actively participated in the development 

of the unified and integrated emergency 

preparedness program and be developed 

and maintained in a manner that takes 

into account each separately certified 

facility’s unique circumstances, patient 

populations, and services offered. 

In addition, we propose that each 

separately certified REH in the system 

must be capable of actively using the 

unified and integrated emergency 

preparedness program and is in 

compliance. We also propose that the 

unified and integrated emergency 

preparedness program must include a 

unified and integrated emergency plan 

that is based on a documented 

community-based risk assessment, 

utilizing an all-hazards approach and a 

documented individual facility-based 

risk assessment for each separately 

certified REH within the health system, 

utilizing an all-hazards approach. 

Lastly, we propose that the unified and 

integrated emergency preparedness 

program must have integrated policies 

and procedures, a coordinated 

communication plan, and training and 

testing programs. 

22. Condition of Participation: Physical 

Environment (Proposed § 485.544) 

The LSC is a compilation of fire safety 

requirements for new and existing 

buildings, and is updated and published 

every 3 years by the National Fire 

Protection Association (NFPA), a 

private, nonprofit organization 

dedicated to reducing loss of life due to 

fire. The Medicare and Medicaid 

regulations have historically 

incorporated these requirements by 

reference, along with Secretarial waiver 

authority. The statutory basis for 

incorporating NFPA’s LSC into the 

regulations we apply to Medicare and, 

as applicable, Medicaid providers and 

suppliers is the Secretary’s facilityspecific authority to stipulate health and 

safety regulations for each type of 

Medicare and (if applicable) Medicaidparticipating facility. For REHs, that 

statutory authority is set out at new 

section 1861(kkk)(2)(D)(v) of the Act. 

The following provisions we have 

proposed are similar to the Hospital, 

CAH, and ASC LSC and Health Care 

Facilities Code requirements. 

The 2012 Edition of the Life Safety Code 

As stated previously, the LSC is a 

compilation of fire safety requirements 

for new and existing buildings, and is 

updated and published every 3 years by 

the NFPA. The NFPA 101®2012 edition 

of the LSC (including the technical 

interim amendments (TIAs)) provides 

minimum requirements, with due 

regard to function, for the design, 

operation and maintenance of buildings 

and structures for safety to life from fire. 

Its provisions also aid life safety in 

similar emergencies. The NFPA 99®

2012 edition of the Health Care 

Facilities Code (including the TIAs) 

provides minimum requirements for 

health care facilities for the installation, 

inspection, testing, maintenance, 

performance, and safe practices for 

facilities, material, equipment, and 

appliances, including other hazards 

associated with the primary hazards. 

We review each new edition of the 

NFPA 101 and NFPA 99 every 3 years 

to see if there are any significant 

provisions that we need to adopt, but 

there is no requirement to use the most 

recent version. We will continue to 

review these documents every 3 years to 

see if there are relevant or updated 

provisions that we need to adopt. The 

2012 edition of the LSC includes 

provisions that we believe are vital to 

the health and safety of all patients and 

staff. Our intention is to ensure that 

patients and staff continue to experience 

the highest degree of fire safety possible. 

All Medicare and Medicaid 

participating providers and suppliers 

are currently subject to the requirements 

of the 2012 edition of the LSC and the 

2012 edition of the Health Care 

Facilities Code as adopted by CMS. 

Therefore, in this rule we propose to 

incorporate by reference the NFPA 101®

2012 edition of the LSC, issued August 

11, 2011, and all Technical Interim 

Amendments issued (TIA) April 16, 

2014; and the NFPA 99®2012 edition of 

the Health Care Facilities Code, issued 

August 11, 2011, and all TIA issued 

prior to April 16, 2014. (1) NFPA 101, 

LSC, 2012 edition, issued August 11, 

2011; (i) TIA 12–1 to NFPA 101, issued 

August 11, 2011. (ii) TIA 12–2 to NFPA 

101, issued October 30, 2012. (iii) TIA 

12–3 to NFPA 101, issued October 22, 

2013. (iv) TIA 12–4 to NFPA 101, issued 

October 22, 2013. (2) NFPA 99, 

Standards for Health Care Facilities 

Code of the NFPA 99, 2012 edition, 

issued August 11, 2011. (i) TIA 12–2 to 

NFPA 99, issued August 11, 2011. (ii) 

TIA 12–3 to NFPA 99, issued August 9, 

2012. (iii) TIA 12–4 to NFPA 99, issued 

March 7, 2013. (iv) TIA 12–5 to NFPA 

99, issued August 1, 2013. (v) TIA 12– 

6 to NFPA 99, issued March 3, 2014. 

The materials that are incorporated by 

reference are available to interested 

parties and can be inspected at the CMS 

Information Resource Center, 7500 

Security Boulevard, Baltimore, MD. 

Copies may be obtained from the 

National Fire Protection Association, 1 

Batterymarch Park, Quincy, MA 02169, 

www.nfpa.org, 1 (617) 770–3000. If any 

changes in this edition of the Code are 

incorporated by reference, CMS will 

publish a document in the Federal 

Register to announce the changes. 

The 2012 Edition of the Health Care 

Facilities Code 

The 2012 edition of the NFPA 99, 

‘‘Health Care Facilities Code,’’ addresses 

requirements for both health care 

occupancies and ambulatory care 

occupancies and serves as a resource for 


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28RUPRI Center for Rural Health Policy Analysis. 

(2021). Trends in Nursing Home Closures in 

Nonmetropolitan and Metropolitan Counties in the 

United States, 2008–2018. https://rupri.publichealth.uiowa.edu/publications/policybriefs/2021/ 

Rural%20NH%20Closure.pdf. 

those who are responsible for protecting 

health care facilities from fire and 

associated hazards. The purpose of this 

Code is to provide minimum 

requirements for the installation, 

inspection, testing, maintenance, 

performance, and safe practices for 

health care facility materials, equipment 

and appliances. This Code is a 

compilation of documents that have 

been developed over a 40-year period by 

NFPA, and is intended to be used by 

those persons involved in the design, 

construction, inspection, and operation 

of health care facilities, and in the 

design, manufacture, and testing of 

appliances and equipment used in 

patient care areas of health care 

facilities. It provides information on 

subjects, for example, medical gas and 

vacuum systems, electrical systems, 

electrical equipment, and gas 

equipment. The NFPA 99 applies 

specific requirements in accordance 

with the results of a risk-based 

assessment methodology. A risk-based 

approach allows for the application of 

requirements based upon the types of 

treatment and services being provided 

to patients or residents rather than the 

type of facility in which they are being 

performed. In order to ensure the 

minimum level of protection afforded 

by NFPA 99 is applicable to all patient 

and resident care areas within a health 

care facility, we are proposing to adopt 

the 2012 edition of NFPA 99, with the 

exception of chapters 7—Information 

Technology and Communications 

Systems for Health Care Facilities; 8— 

Plumbing; 12—Emergency Management; 

and 13—Security Management. 

REH Proposed Requirements 

At § 485.544(a) we propose that the 

REH be constructed, arranged, and 

maintained to ensure the safety of the 

patient and to provide facilities for 

diagnosis and treatment and for special 

hospital services appropriate to the 

needs of the community. Specifically, 

we propose that the condition of the 

physical plant and the overall REH 

environment must be developed and 

maintained in such a manner that the 

safety and well-being of patients are 

assured. This would include emergency 

power and lighting in at least all areas 

serviced by the emergency supply 

source, including but not limited to, the 

operating, recovery, and emergency 

rooms, and stairwells. In all other areas 

not serviced by the emergency supply 

source the REH would be required to 

have battery lamps and flashlights 

available. In addition, we propose to 

require the REH to have facilities for 

emergency gas and water supply and a 

safe and sanitary environment, that is 

properly constructed, equipped and 

maintained to protect the health and 

safety of all patients. 

At § 485.544(b), we propose that the 

REH be required to maintain adequate 

facilities for its services that includes 

diagnostic and therapeutic facilities that 

are located in a manner that ensures the 

safety of patients. We also would 

require the REH to maintain facilities, 

supplies, and equipment in a manner 

that ensures an acceptable level of safety 

and quality. We propose further that the 

facility be designed and maintained to 

reflect the scope and complexity of the 

services it offers in accordance with 

accepted standards of practice and that 

there must be proper ventilation, light, 

and temperature controls in 

pharmaceutical, food preparation, and 

other appropriate areas. 

At § 485.544(c), we propose that REHs 

meet the provisions applicable to 

Ambulatory Health Care Occupancies in 

the 2012 edition of the LSC, regardless 

of the number of patients the facility 

serves. We believe the protection 

provided in the Ambulatory Health Care 

Occupancies chapter is necessary to 

protect the health and safety of patients 

who are incapable of caring for 

themselves at any point in time. We 

propose at § 485.544(c)(2) to implement 

requirements related to the Secretary’s 

waiver authority for periods deemed 

appropriate, which would result in 

unreasonable hardship, but only if the 

waiver will not adversely affect the 

health and safety of patients. We 

propose at § 485.544(c)(3) that the 

provisions of the LSC would not apply 

in a state if CMS finds that a fire and 

safety code imposed by state law 

adequately protects patients. We also 

propose at § 485.544(c)(4) requirements 

related to protection against 

inappropriate access for alcohol-based 

hand rub dispensers. At § 485.544(c)(5), 

we propose to require that a REH with 

a sprinkler system that is out of service 

for more than 10 hours in a 24-hour 

period to evacuate the building or 

portion of the building affected by the 

system outage, or establish a fire watch 

until the system is back in service, 

notwithstanding the lower standard of 

the 2012 LSC. 

Lastly, at § 485.544(d) we propose to 

require REHs to comply with the 2012 

edition of the NFPA 99. We propose that 

chapters 7, 8, 12, and 13 would not 

apply to REHs. We also propose to allow 

for waivers of these provisions under 

the same conditions and procedures that 

we currently use for waivers of 

applicable provisions of the LSC. 

23. Condition of Participation: Skilled 

Nursing Facility Distinct Part Unit 

(Proposed § 485.546) 

Section 1861(kkk)(2)(D)(vi) of the Act 

allows REHs to establish a unit that is 

a distinct part licensed as a SNF to 

furnish post-REH or post-hospital (in 

the event the services were provided at 

a hospital or a CAH) extended care 

services (or SNF services). A distinct 

part SNF is an area that is separately 

licensed and certified to provide SNF 

services at all times. A distinct part SNF 

must be physically distinguishable from 

the REH, must be fiscally separate for 

cost reporting purposes, and the beds in 

the certified distinct part SNF unit of an 

REH must meet the requirements 

applicable to distinct part SNFs at 42 

CFR part 483, subpart B. Medicare 

payment for SNF services furnished in 

these distinct part SNFs of an REH 

would be under the SNF prospective 

payment system as required under 

section 1834(x)(4) of the Act. We note 

that a distinct part SNF of an REH is not 

subject to the REH’s length of stay limits 

of less than an annual per patient 

average of 24 hours. 

According to a policy brief published 

by RUPRI Center for Rural Health Policy 

Analysis, there were 472 nursing home 

closures between 2008 and 2018 in 

nonmetropolitan counties in the U.S.28

The policy brief noted that 10.1 percent 

of the country’s nonmetropolitan 

counties had no nursing homes. Given 

the closures of rural nursing homes and 

the lack of nursing homes in rural 

communities, residents living in rural 

areas may not have adequate access to 

SNF services. The provision of these 

services in distinct part units of REHs 

may help address this access issue. 

We highlight that a distinct part SNF 

unit is not the same as a CAH or 

hospital utilizing swing-beds. CAHs and 

hospitals may provide swing-bed 

services, allowing them to use their beds 

for acute inpatient care or for posthospital or CAH SNF care. These 

facilities must be certified by CMS to 

provide swing-bed services. CAHs or 

hospitals utilizing swing-beds are not 

required to have their swing-beds in a 

special unit or area within the facility. 

To implement that statutory provision 

allowing REHs to establish distinct part 

SNFs, we are proposing at § 485.546 to 

require REHs choosing to establish such 

a distinct part unit to meet the 


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requirements for long-term care 

facilities at 42 CFR part 483, subpart B. 

B. Proposed Changes for Critical Access 

Hospital Conditions of Participation 

1. Condition of Participation: Status and 

Location (§ 485.610(c)) 

a. Adding the Definition of ‘‘Primary 

Roads’’ 

Generally, a CAH must meet certain 

criteria for designation, as outlined in 

section 1820(c)(2)(B) of the Act. These 

criteria specify certain ‘‘distance 

requirements’’ relative to other hospitals 

or CAHs, and specifically require that a 

CAH be (1) ‘‘located more than a 35- 

mile drive (or, in the case of 

mountainous terrain or in areas with 

only secondary roads available, a 15- 

mile drive) from a hospital’’ or (2) 

‘‘certified before January 1, 2006, by the 

State as being a necessary provider of 

health care services to residents in the 

area’’. The current regulatory 

requirement at § 485.610(c) sets forth 

the distance requirements for CAHs 

relative to other CAHs and hospitals, 

and specific definitions as related to the 

distance requirements are found in the 

SOM, Chapter 2, Section 2256A. 

In 2013, the HHS OIG released a 

report entitled Most Critical Access 

Hospitals Would Not Meet the Location 

Requirements If Required to Re-Enroll in 

Medicare (OEI–05–12–00080) which 

found that approximately 63 percent of 

CAHs would not meet the distance 

requirement if required to re-enroll in 

Medicare. The report also found that 

CMS does not have the authority to 

decertify most of these CAHs based on 

failure to meet the distance requirement, 

as a majority of these CAHs are 

‘‘necessary provider’’ CAHs and 

therefore exempt from the distance 

requirement as noted in section 

1820(h)(3) of the Act. The report also 

included a recommendation for CMS to 

ensure that CAHs’ compliance with the 

location-related CoPs is periodically 

reassessed. In response, CMS began 

evaluating its policies concerning the 

definitions of several key concepts used 

in enforcing the CAH regulations at 

§ 485.610, which are further described 

in the SOM, Chapter 2, Section 2256A 

for enforcement of the distance 

requirements. The COVID–19 PHE put a 

hold on CAH certifications, and CMS 

has used this opportunity to work with 

interested parties to continue to review 

how it applies the distance 

requirements for CAH eligibility. In this 

proposed rule, CMS outlines how it will 

apply the CAH distance requirements as 

a result of its review. We recognize the 

impact of these criteria on rural 

communities and we aim to minimize 

any disruption to CAHs based on these 

requirements. 

The distance requirements are 

uniquely important to CAH 

designations, as they must continually 

be met to maintain status as a CAH, by 

statutory design. As such, CMS 

anticipates certain facilities may lose or 

gain eligibility for CAH designation 

depending on the locations of hospitals 

and CAHs established within relevant 

distance of the CAH. Thus, CMS must 

continually verify the CAH distance 

requirements periodically to ensure that 

they are still met. CMS generally 

recertifies the distance requirements of 

CAHs every three years or upon a 

change of ownership as a component of 

initial certification or a recertification. If 

there is a change in distance and 

location that does not meet the 

requirements, CMS notifies the provider 

of its options for continued enrollment 

in the Medicare program. 

CMS publishes guidance related to 

the distance requirements in the SOM, 

Chapter 2, Section 2256A. One of the 

distance criteria, as described in section 

1820(c)(2)(B)(i) of the Act and set forth 

in § 485. 610(c), requires CMS to 

determine what constitutes a secondary 

road, and by extension a primary road. 

In 2015, CMS refined the definition of 

‘‘primary road’’ in the SOM. The 

purpose of this refinement was, first, to 

make the definition of what constitutes 

a ‘‘primary road’’ more consistent across 

regions of the U.S., and, second, to make 

measuring the distances between 

facilities more consistent. It was not 

anticipated that this refinement in the 

definition of primary road would have 

any significant impact on the eligibility 

of existing CAHs to maintain their 

certification, but certain providers and 

interested parties raised concern in 

anticipation of their re-certification. 

Specifically, they were concerned about 

certain aspects of the 2015 refinements 

from the previous SOM update that 

would no longer afford them eligibility 

as a CAH, even though the existing CAH 

did not change location and there were 

no other CAHs or hospitals that moved 

within a relevant distance. Thus, CMS 

is further refining and codifying the 

definition to offer maximum flexibility 

to providers in meeting these distance 

criteria. 

Presently, primary roads are defined 

as any U.S. highway, including; (1) any 

road in the National Highway System, 

as codified at 23 U.S.C. 103(b); or (2) in 

the Interstate System, as defined at 23 

U.S.C. 103(c); or (3) which is a USNumbered Highway (also called ‘‘US 

Routes’’ or ‘‘US Highways’’) as 

designated by the American Association 

of the State Highway and Transportation 

Officials (AASHTO), regardless of 

whether it is also part of the National 

Highway System. Currently, there is no 

regulatory language that references 

primary roads or outlines the definition 

of this term. 

We propose to incorporate the 

definition of primary road in the CAH 

distance requirement regulations, both 

as part of the 35-mile drive requirement, 

and as applicable through the secondary 

roads definition for the 15-mile drive 

requirement. Specifically, we propose to 

revise § 485.610(c) to clarify that the 

location distance for a CAH is one for 

more than a 35-mile drive on primary 

roads (or, in the case of mountainous 

terrain or in areas with only secondary 

roads available, a 15-mile drive) from a 

hospital or another CAH. In addition, at 

§ 485.610(c)(2), we propose to specify 

that primary road of travel for 

determining the driving distance of a 

CAH and its proximity to other 

providers as a numbered Federal 

highway, including interstates, 

intrastates, expressways or any other 

numbered Federal highway; or a 

numbered state highway with two or 

more lanes each way. We are also 

soliciting comments regarding the 

description of a numbered Federal 

highway in this proposed definition. 

Specifically, we are interested in 

feedback on whether the definition of 

primary roads should include numbered 

Federal highways with two or more 

lanes, similar to the description of 

numbered state highways, and exclude 

numbered Federal highways with only 

one lane in each direction. 

We believe that codifying the 

definition of primary roads in the 

regulations will provide clarity and 

consistency regarding the distance 

requirements. 

Furthermore, if finalized, to support 

these proposed regulatory changes we 

are planning to establish a centralized, 

data-driven review procedure that 

focuses on hospitals being certified in 

proximity to a CAH, rather than 

focusing specifically on road 

classifications. CMS would review all 

hospitals and CAHs within a 50-mile 

radius of the CAH during each review 

of eligibility, and then subsequently on 

a 3-year cycle. Following the initial 

review of distance and location, further 

investigations would focus primarily on 

expanded healthcare capacity and 

access to care within the 35-mile radius 

of the CAH being examined and less on 

the actual roadway designations used in 

making the calculations. Those CAHs 

with no new hospitals within 50 miles 

would be immediately recertified. Those 

CAHs with new hospitals within 50 

miles will receive additional review 


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based on the distance from the new 

hospital and the definitions for Primary 

Roads and Mountainous Terrain. To 

facilitate this review, the CAH Distance 

Analysis Committee and the CMS 

Survey Operations Group (SOG) 

Locations will utilize the geocoding of 

hospitals to identify those CAHs that are 

located within 50 miles of another 

certified hospital. Those CAHs that do 

not meet the regulatory distance and 

location requirements at the time of 

review would be identified as noncompliant and may face enforcement 

actions. We believe this change would 

help surveyors to make evidence-based 

and objective determinations of 

continued CAH eligibility. We expect 

the new distance review procedure, 

coupled with regulatory clarity on the 

proposed primary roads definition, 

would provide greater consistency in 

evaluating if CAHs meet the statutory 35 

or 15-mile distance requirements from 

other acute care hospitals and CAHs as 

well greater adherence to statutory 

language by ensuring that CAHs operate 

under the CAH designation until, or 

unless, a hospital moves within 35 

miles or 15 miles of the existing CAH. 

2. Condition of Participation: Patient’s 

Rights (§ 485.614) 

We believe that it is imperative for 

patients to have the ability to exercise 

certain rights and protections while 

seeking and receiving necessary care 

and services at a CAH. Ensuring that 

patients and family members are aware 

of their rights and how to exercise them 

are vital components of improving 

overall CAH quality and patient 

satisfaction. We believe that having 

patient’s rights requirements for CAHs 

creates transparency between the 

provider and patient. In addition, 

adding patient’s rights requirements for 

CAHs is consistent with other providers 

and suppliers similar to CAHs, 

including those proposed in this rule for 

REHs. As previously mentioned, 

behavioral health is very important in 

the treatment and safety of patients and 

staff. Behavioral health is a challenge in 

rural areas, due to the accessibility, 

affordability, acceptability and 

availability of these services, therefore 

we believe it is important to have 

policies and procedures in place for 

CAHs and REHs in the event of a mental 

health crisis and the need for the use of 

restraints and seclusions. 

We have received feedback from 

interested parties stating that CAHs 

should have patient rights requirements 

in place to protect the patient. 

Therefore, we are mirroring these 

proposed requirements for CAHs after 

the hospital patient’s rights 

requirements found at § 482.13. 

However, we note that some of the 

provisions in this section for CAHs, and 

also for REHs (as discussed earlier) have 

requirements that are less prescriptive 

than those for hospitals because are 

proposing to allow for these providers to 

develop policies and procedures based 

on the scope of services they provide 

and patient populations they serve. 

For example, we believe that CAHs 

will have a lower volume of patients 

than hospitals and the use of restraints 

and seclusion would not be as frequent 

as other providers. CAHs do not 

currently have any patient rights CoPs 

so our proposed requirements aim to 

increase accountability and provide 

patient protections in the event 

restraints and seclusion are used. We 

are specifically soliciting comments on 

the appropriateness of the patient’s 

rights requirements proposed for 

restraint and seclusion, the potential 

need to require standards that are more 

stringent to address patient protections, 

and the feasibility of implementing such 

requirements in rural communities. 

Specifically, we propose to establish a 

CoP for patient’s rights at § 485.614 that 

would set forth the rights of all patients 

to receive care in a safe setting and 

provide protection for a patient’s 

emotional health and safety as well as 

their physical safety. This would 

include proposed requirements for the 

CAH to inform patients of and exercise 

their rights; address privacy and safety; 

adhere to the confidentiality of patient 

records; responsibilities for the use of 

restraint and seclusion; and adherence 

to patient visitation rights. 

Notice of Rights 

At § 485.614(a), we propose that a 

CAH must inform each patient, or when 

appropriate, the patient’s representative 

(as allowed under state law), of the 

patient’s rights, in advance of furnishing 

or discontinuing patient care whenever 

possible. This includes a proposal to 

require the CAH to establish a process 

for the oversight and prompt resolution 

of patient grievances and for informing 

each patient whom to contact to file a 

grievance. 

Exercise of Rights 

At § 485.614(b), we propose to specify 

those rights a patient has regarding their 

medical care, which includes the right 

to participate in the development and 

implementation of their plan of care, to 

make informed decisions regarding their 

care, to be fully informed about such 

care, and the right to request or refuse 

treatment, and finally the right to have 

a family member or representative of 

their choice and their own physician 

notified promptly of their admission to 

the hospital. We note that this right 

must not be construed as a mechanism 

to demand the provision of treatment or 

services deemed medically unnecessary 

or inappropriate. In addition, we 

propose to specify that the patient also 

has the right to formulate advance 

directives and to have CAH staff and 

practitioners who provide care in the 

CAH comply with these directives. 

Privacy, Safety, and Confidentiality of 

Patient Records 

At § 485.614(c), we propose to specify 

that the patient has the right to personal 

privacy, receive care in a safe setting, 

and be free from all forms of abuse or 

harassment. At § 485.614(d), we propose 

to specify that patients have the right to 

the confidentiality of their medical 

records and the right to access their 

medical records. When requested, we 

propose that the CAH must provide the 

patients with their records in a form and 

format requested by the requestor and 

within a reasonable timeframe, as not to 

frustrate the legitimate efforts of 

individuals to gain access to their own 

medical records. 

Use of Restraints and Seclusion 

At § 485.614(e), we propose those 

patient’s rights relating to the use of 

restraints and seclusion. We are 

proposing requirements that are less 

burdensome than those existing 

restraint and seclusion requirements for 

hospitals because given the level of 

services provided by CAHs and their 

patient volume, we expect the 

likelihood of their need to utilize 

restraints and seclusion to be relatively 

low. 

Specifically, we propose to specify 

that all patients have the right to be free 

from physical or mental abuse, and from 

corporal punishment and from restraint 

or seclusion, of any form, imposed as a 

means of coercion, discipline, 

convenience, or retaliation by staff. We 

propose that restraint or seclusion may 

only be imposed to ensure the 

immediate physical safety of the patient, 

a staff member, or others and must be 

discontinued at the earliest possible 

time. We propose to define restraint as 

any manual method, physical or 

mechanical device, material, or 

equipment that immobilizes or reduces 

the ability of a patient to move their 

arms, legs, body, or head freely; or a 

drug or medication when it is used as 

a restriction to manage the patient’s 

behavior or restrict the patient’s 

freedom of movement and is not a 

standard treatment or dosage for the 

patient’s condition. A restraint does not 

include devices, such as orthopedically 


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prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, off of a 

stretcher, or out of a chair, or to permit 

the patient to participate in activities 

without the risk of physical harm (this 

does not include a physical escort). We 

propose to define seclusion as the 

involuntary confinement of a patient 

alone in a room or area from which the 

patient is physically prevented from 

leaving. Seclusion may only be used for 

the management of violent or selfdestructive behavior. 

At § 485.614(e)(2), we propose to 

require that the restraint or seclusion 

may only be used when less restrictive 

interventions have been determined to 

be ineffective to protect the patient a 

staff member or others from harm, and 

at § 485.614(e)(3) that the type or 

technique of restraint or seclusion used 

must be the least restrictive intervention 

that will be effective to protect the 

patient, a staff member, or others from 

harm. At § 485.614(e)(4) we propose that 

the CAH must have written policies and 

procedures regarding the use of restraint 

and seclusion that are consistent with 

current standards of practice. These 

proposed requirements would allow for 

the CAH to use restraints and seclusion 

in the event that it is necessary and as 

a last resort to respond to immediate 

safety concerns, but lessens the burden 

and allows for more flexibility than the 

current hospital CoPs. We believe that 

allowing the CAH the flexibility to 

develop their own policies and 

procedures for restraints and seclusion 

based on the scope of services they 

provide is necessary given their patient 

volumes, populations, and access to 

resources. The policies and procedures 

that are developed need to be consistent 

with current standards of practice. As 

noted, we are soliciting comments on 

the appropriateness of the patient’s 

rights requirements proposed for 

restraint and seclusion, the potential 

need to require standards that are more 

stringent to address patient protections, 

and the feasibility of implementing such 

requirements in rural communities. 

Staff Training Requirements for the Use 

of Restraints or Seclusion 

The following staff training 

requirements are not as prescriptive as 

the existing hospital requirements, and 

we are proposing these same 

requirements for REHs in this rule. At 

§ 485.614(f) we propose to establish staff 

training requirements for the use of 

restraints and seclusion. Specifically, 

we propose that the patient has the right 

to safe implementation of restraint or 

seclusion by trained staff. We propose 

that the CAH must provide competencybased training and education of CAH 

personnel and staff, including medical 

staff, and, as applicable, personnel 

providing contracted services in the 

CAH, on the use of restraint and 

seclusion. To ensure that the use of 

restraint and seclusion for patients 

receiving services in a CAH is respectful 

of, and responsive to, individual patient 

preferences, needs and values, we 

propose to require that the training be 

patient-centered. Additionally, to 

ensure that staff are educated and 

trained on using the least restrictive 

intervention necessary for the safety of 

the patients and CAH staff, we propose 

at § 485.614(f)(2) to require that the CAH 

train their staff in alternatives to the use 

of restraint and seclusion. For example, 

we believe that staff should have 

trauma-informed knowledge 

competencies and be aware of effective 

de-escalation techniques that can be 

used to avoid the use of restraint and 

seclusion so not to trigger any previous 

mental health issues because of the use 

of restraints and seclusion. Trained peer 

workers (people who share similar 

experiences of being diagnosed with 

mental health conditions, substance use 

disorders, or both) and CHWs may also 

serve a useful role in assisting patients 

and other staff. This could include 

helping to monitor use of restraint and 

seclusion, deescalating interactions with 

patients and contributing to a positive 

and supportive environment for 

patients, family members, and CAH 

staff. CAHs are encouraged to consider 

the use of peer workers and CHWs in 

their staffing plans. For further 

information, please see the 2007 

guidance on use of peers in the 

Medicaid program (https://

www.medicaid.gov/federal-policyguidance/downloads/SMD081507A.pdf) 

and resources from the Substance Abuse 

and Mental Health Services 

Administration (https://

www.samhsa.gov/brss-tacs/recoverysupport-tools/peers). In addition, 

facilities are encouraged to consider any 

nutritional needs while a patient is 

restrained, such as a need to provide 

food and water. 

Death Reporting Requirements 

The following requirements are 

similar to the hospital requirements at 

§ 482.13. At § 485.614(g), we propose to 

establish requirements that CAHs must 

follow when reporting deaths associated 

with the use of seclusion or restraint. 

Specifically, we propose to require that 

the CAH must report to CMS, by 

telephone, facsimile, or electronically, 

as determined by CMS, no later than the 

close of business on the next business 

day the following information— (1) 

Each death that occurs while a patient 

is in restraint or seclusion; (2) Each 

death that occurs within 24 hours after 

the patient has been removed from 

restraint or seclusion; (3) Each death 

known to the CAH that occurs within 1 

week after restraint or seclusion where 

it is reasonable to assume that use of 

restraint or placement in seclusion 

contributed directly or indirectly to a 

patient’s death, regardless of the type(s) 

of restraint used on the patient during 

this time. We note that ‘‘reasonable to 

assume’’ in this context would include, 

but is not limited to, deaths related to 

restrictions of movement for prolonged 

periods of time, or death related to chest 

compression, restriction of breathing, or 

asphyxiation. 

For instances when no seclusion has 

been used and when the only restraints 

used on the patient are those applied 

exclusively to the patient’s wrist(s), and 

which are composed solely of soft, nonrigid, cloth-like materials, the CAH staff 

must record in an internal log or other 

system, the following information—(1) 

Any death that occurs while a patient is 

in such restraints; (2) Any death that 

occurs within 24 hours after a patient 

has been removed from such restraints. 

Furthermore, we propose that staff must 

also document in the patient’s medical 

record the date and time the death was 

reported to CMS or recorded in the 

internal log or other system. Also, for 

instances when no seclusion has been 

used and when the only restraints used 

on the patient are those applied 

exclusively to the patient’s wrist(s),we 

propose to require that entries into the 

internal log or other system must be 

documented no later than seven days 

after the date of death of the patient, 

include the patient’s name, date of birth, 

date of death, name of attending 

physician or other licensed practitioner 

who is responsible for the care of the 

patient, medical record number, and 

primary diagnosis(es), and to be made 

available in either written or electronic 

form to CMS immediately upon request. 

Patient Visitation Rights 

We propose to redesignate 

§ 485.635(f) as § 485.614(h). At 

§ 485.614(h), we propose to establish 

requirements related to a patient’s 

visitation rights. Specifically, we 

propose to require that a CAH must 

have written policies and procedures 

regarding the visitation rights of 

patients, including those setting forth 

any clinically necessary or reasonable 

restriction or limitation that the CAH 


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may need to place on such rights and 

the reasons for the clinical restriction or 

limitation. A CAH must inform each 

patient (or support person, where 

appropriate) of their visitation rights, 

including any clinical restriction or 

limitation on such rights, when they are 

informed of their other rights, inform 

each patient (or support person, where 

appropriate) of the right, subject to their 

consent, to receive the visitors whom 

they designates, including, but not 

limited to, a spouse, a domestic partner 

(including a same-sex domestic partner), 

another family member, or a friend, and 

their right to withdraw or deny such 

consent at any time, not restrict, limit, 

or otherwise deny visitation privileges 

on the basis of race, color, national 

origin, religion, sex, gender identity, 

sexual orientation, or disability, and 

ensure that all visitors enjoy full and 

equal visitation privileges consistent 

with patient preferences. 

3. Condition of Participation: Staffing 

and Staff Responsibilities (§ 485.631) 

Unified and Integrated Medical Staff for 

a CAH in a Multi-Facility System 

In alignment the current standards for 

hospitals, we are proposing at 

§ 485.631(e) to allow for either a unique 

medical staff for each CAH or for a 

unified and integrated medical staff 

shared by multiple hospitals, CAHs, and 

REHs within a health care system. We 

propose to hold a CAH responsible for 

showing that it actively addresses its 

use of a system unified and integrated 

medical staff model. We are also 

proposing to require that the medical 

staff members holding privileges at each 

separately certified CAH in the system 

have voted either to participate in a 

unified and integrated medical staff 

structure or to opt out of such a 

structure, and to maintain a CAHspecific separate and distinct medical 

staff for their respective CAH. 

In addition, we propose to require 

that the unified and integrated medical 

staff has bylaws, rules, and 

requirements that describe its processes 

for self-governance, appointment, 

credentialing, privileging, and oversight, 

as well as its peer review policies and 

due process rights guarantees, and 

which include a process for the 

members of the medical staff of each 

separately certified CAH (that is, all 

medical staff members who hold 

specific privileges to practice at that 

CAH) to be advised of their rights to opt 

out of the unified and integrated 

medical staff structure after a majority 

vote by the members to maintain a 

separate and distinct medical staff for 

their CAH. We propose that the unified 

and integrated medical staff must be 

established in a manner that takes into 

account each CAH’s unique 

circumstances, and any significant 

differences in patient populations and 

services offered in each CAH. Lastly, we 

propose that the unified and integrated 

medical staff give due consideration to 

the needs and concerns of members of 

the medical staff, regardless of practice 

or location, and the CAH has 

mechanisms in place to ensure that 

issues localized to particular CAHs are 

duly considered and addressed. 

In proposing this allowance for CAHs 

in the requirements here, we considered 

this past rulemaking experience with 

those multi-hospital systems using the 

single governing body and unified and 

integrated medical staff model for 

separately certified hospitals within 

their systems, as well as our decision to 

also propose this flexibility for REHs (as 

discussed in section II.A.7. of this rule), 

and applied the same model to CAHs 

within single governing body systems. 

As we continue to do with hospitals, we 

believe that it is in the best interest of 

CAHs, medical staff members, and 

patients to propose this requirement 

allowing for the use of a unified and 

integrated medical staff for a multifacility system and its member CAHs, in 

order to enable the medical staff of each 

CAH to voluntarily integrate itself into 

a larger system medical staff. We 

welcome comments on the proposed 

applicability of these changes for CAHs. 

4. Condition of Participation: Infection 

Prevention and Control and Antibiotic 

Stewardship Programs (§ 485.640) 

Unified and Integrated Infection 

Prevention and Control and Antibiotic 

Stewardship Programs for a CAH in a 

Multi-Facility System 

Similar to a standard in the hospital 

CoPs, we propose a standard at 

§ 485.649(h) for CAHs that would allow 

for the governing body of a CAH that is 

part of a system consisting of multiple 

separately certified hospitals, CAHs, 

and/or REHs using a single system 

governing body that is legally 

responsible for the conduct of two or 

more hospitals, CAHs, and/or REHs, to 

elect to have unified and integrated 

infection prevention and control and 

antibiotic stewardship programs for all 

of its member facilities, including any 

CAHs, after determining that such a 

decision is in accordance with all 

applicable state and local laws. The 

system’s single governing body would 

be responsible for ensuring that each of 

its separately certified CAHs meets all of 

the requirements of this section. We 

note that each separately certified CAH 

subject to the system’s single governing 

body would need to demonstrate that 

the unified and integrated infection 

prevention and control and antibiotic 

stewardship programs: 

• Are established in a manner that 

takes into account each member CAH’s 

unique circumstances and any 

significant differences in patient 

populations and services offered in each 

CAH; 

• Establish and implement policies 

and procedures to ensure that the needs 

and concerns of each of its separately 

certified CAHs, regardless of practice or 

location, are given due consideration; 

and 

• Have mechanisms in place to 

ensure that issues localized to particular 

CAHs are duly considered and 

addressed. 

The CAH would also need to 

demonstrate that it has designated a 

qualified individual (or individuals) 

with expertise in infection prevention 

and control and in antibiotic 

stewardship at the CAH to be 

responsible for: 

• Communicating with the system’s 

unified infection prevention and control 

and antibiotic stewardship programs; 

• Implementing and maintaining the 

policies and procedures governing 

infection prevention and control and 

antibiotic stewardship as directed by the 

unified infection prevention and control 

and antibiotic stewardship programs; 

and 

• Providing education and training on 

the practical applications of infection 

prevention and control and antibiotic 

stewardship to CAH staff. 

5. Condition of Participation: Quality 

Assessment and Performance 

Improvement Program (§ 485.641) 

Unified and Integrated QAPI Program 

for a CAH in a Multi-Facility System 

Consistent with the standard included 

at § 482.21(f) in the hospital CoPs for 

QAPI programs, we are proposing at 

§ 485.641(f) to allow CAHs that are part 

of a multi-facility system consisting of 

multiple separately certified hospitals, 

CAHs, and/or REHs to elect to have a 

unified and integrated QAPI program 

after determining that such a decision is 

in accordance with all applicable state 

and local laws. Specifically, we propose 

to specify that the system’s governing 

body is responsible and accountable for 

ensuring that each of its separately 

certified CAHs meets the proposed 

QAPI program requirements. We expect 

this allowance, if finalized, would be 

beneficial to CAHs that may lack time, 

resources, or staff to implement a QAPI 

program. The CAH would be able to 


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29This study can be accessed here: https://

www.shepscenter.unc.edu/product/how-manyhospitals-might-convert-to-a-rural-emergencyhospital-reh/. 

30CLA, ‘‘A Path Forward: CLA’s Simulations on 

Rural Emergency Hospital Designation’’, 2/8/22, at 

https://www.claconnect.com/resources/articles/ 

2022/a-path-forward-clas-simulations-on-ruralemergency-hospital-designation. 

benefit from the resources and expertise 

of a multi-hospital system in 

implementing their QAPI program, as 

well as potentially reducing the time 

and labor investments required to enact 

and maintain the program. 

We are interested in input from the 

public regarding unintended 

consequences that could occur as a 

result of allowing CAHs to participate in 

a unified and integrated QAPI program. 

We are interested in feedback regarding 

how the integrated health system’s 

governing body will ensure that they 

take into account the CAH’s unique 

circumstances and any significant 

differences in patient populations and 

services offered at the CAH. We also 

seek comments regarding how the 

integrated health system’s governing 

body will ensure that a CAH 

participating in a unified and integrated 

QAPI program provides the appropriate 

level of care to patients being treated in 

the CAH, including being appropriately 

transferred to another facility when 

necessary. 

C. Conforming Amendments and 

Technical Corrections 

1. Technical Correction to 

§ 485.635(b)(2) 

We are proposing to make a technical 

correction to the laboratory services 

CAH CoP at § 485.635(b)(2). In the 

September 1, 1994, final rule entitled 

‘‘Medicare Program; Changes to the 

Hospital Inpatient Prospective Payment 

Systems and Fiscal Year 1995 Rates’’ (59 

FR 45403), we revised the CAH 

laboratory services requirement to 

require the CAH laboratory services to 

meet the standards imposed under 

section 353 of the Public Health Service 

Act (42 U.S.C. 236a). We inadvertently 

included an error in the referenced 

Public Health Service Act standard. The 

referenced standard at § 485.635(b)(2) 

should read, ‘‘. . .353 of the Public 

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

2. Conforming Amendments §§ 489.2(b) 

and 489.24(b) 

The provider agreement and supplier 

approval requirements for Medicareparticipating providers and suppliers 

are located at 42 CFR part 489. Section 

489.2 sets forth the basic requirements 

for submittal and acceptance of a 

provider agreement under Medicare, 

with the providers that are subject to the 

provisions of this part listed at 

§ 489.2(b). We are proposing to add 

REHs to the list of applicable providers 

at § 489.2(b) and therefore require REHs 

to adhere to the requirements for 

submittal and acceptance of provider 

agreements under Medicare as defined 

by § 489.3. 

The requirements at 42 CFR part 489 

also set forth requirements for Medicare 

hospitals in emergency cases. These 

provisions apply to hospitals that have 

emergency departments. Under this 

section, a hospital includes a critical 

access hospital as defined in section 

1861(mm)(1) of the Act. The CAA 

amends Section 1867(e)(5) of the Act by 

including REHs, as defined in 

1861(kkk)(2), as hospitals that have 

emergency departments. As a result, we 

are proposing to add REHs to the 

definitions at § 489.24(b) for Medicare 

hospitals in emergency cases under the 

hospital definition and to the definition 

of a participation hospital. 

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 (ICR) is submitted to the 

Office of Management and Budget 

(OMB) for review and approval. 

In order to fairly evaluate whether an 

information collection should be 

approved by OMB, section 3506(c)(2)(A) 

of the Paperwork Reduction Act of 1995 

requires that we solicit comment on the 

following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

affected public, including automated 

collection techniques. 

We are soliciting public comment on 

each of these issues for the following 

sections of this document that contain 

information collection requirements 

(ICRs): 

A. Factors Influencing ICR Burden 

Estimates 

Under this proposed rule, an REH’s 

ICR may differ from that of a hospital or 

CAH, given that REHs would be 

providers of outpatient services and 

would not provide inpatient services. 

We based the ICRs for REHs on the ICRs 

for hospitals and CAHs in some cases 

because, in accordance with section 

1861(kkk) of the Act, REHs must convert 

from either a rural hospital with not 

more than 50 beds or a CAH. In the 

discussion that follows, we rely heavily 

on the study of the North Carolina Rural 

Health Research Program’s (NC RHRP’s) 

study titled, ‘‘How Many Hospitals 

Might Convert to a Rural Emergency 

Hospital (REH)?’’ 29 This study 

examined data on existing rural 

hospitals (Medicare-funded through 

both the prospective payment system 

and cost-reimbursements to CAHs) to 

determine how many might meet three 

key criteria (1) three years of negative 

total financial margins; (2) average daily 

census of acute and swing beds of less 

than three persons; and (3) net patient 

revenue of less than $20 million 

annually. The study further assumed 

that all the statutory and regulatory 

requirements would be met by every 

REH. The NC RHRP study assumes that 

hospitals and CAHs meeting the 

necessary requirements would apply for 

election of coverage under the new REH 

program. The study did not address the 

potential caseload, cost, or revenue 

changes from electing conversion and 

implicitly assumed that the net effects 

would be positive. 

We note that another study from 

consulting firm CLA also examines the 

number of facilities likely to convert to 

REHs titled, ‘‘A Path Forward: CLA’s 

Simulations on Rural Emergency 

Hospital Designation.’’ 30 The CLA 

study estimated that between 11 and 

600 CAHs would benefit from 

conversion to REH status—based on 

estimated REH reimbursement and 

several financial assumptions (estimated 

average facility payment, estimated 

outpatient fee schedule payment, 

estimated average skilled nursing 

facility payment rates by state, presence 

or loss of swing bed payments, and 

continuance or cessation of 340B 

eligibility) and four simulation methods. 

A key takeaway from both studies is that 

available data support a possible wide 

range of conversion decisions. In 

addition, we note that these results and 

the calculations on which they rely are 

subject to a wide range of uncertainty as 

illustratively shown in the CLA study’s 

summary estimate and the NC RHRP 

study makes the same point in 

describing its central estimate set of 

results. In the analysis that follows, we 

use for simplicity of exposition the NC 

RHRP study results, which depend on 

data and calculations presented in the 

study at a level of detail that allows 

reader analysis and present our 


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31BLS. May 2020 National Occupational 

Employment and Wage Estimates United States. 

United States Department of Labor. Accessed at https://www.bls.gov/oes/current/oes_nat.htm. 

Accessed on August 25, 2021. 

summary estimates based on the NC 

RHRP study’s central estimate. 

In total, the NC RHRP study estimated 

that there are 1,673 hospitals (mostly 

CAHs) eligible to convert to an REH and 

of these, 68 would convert to REH 

status. The reasons why some would 

convert are presented in the NC RHRP 

study and include low levels of 

inpatient revenue, low levels of swing 

bed nursing care revenue, and negative 

financial margins over a period of years. 

The finances of individual rural 

hospitals and CAHs vary widely, as do 

the local economic and demographic 

circumstances of the communities 

served by these facilities (for example 

some rural areas are gaining population 

even as most face declining 

populations). Competition from other 

hospitals either in the rural area or in 

nearby cities also varies widely, with 

the only certainty in forecasting REH 

conversion is that seemingly similar 

hospitals and CAHs will make widely 

different decisions. What the NC RHRP 

did, in essence, was predict that the 

hospitals and CAHs facing the most 

severe financial difficulties would be 

the most likely to convert. 

For purposes of our analysis, we use 

the NC RHRP estimate of 68 conversions 

though acknowledge that the number of 

conversions could be less than or 

significantly greater than this estimate. 

In addition, when considering the PRA 

burden for REHs, given that the 

proposed CoPs align closely with 

existing standards, we considered both 

the existing burden estimates for CAHs 

and hospitals, as well as our ongoing 

experience with these provider types. 

We also considered that REHs would 

only be furnishing outpatient services, 

which would lessen their burden. We 

request comments on our estimates, 

particularly the conversion assumption. 

The final rule could utilize different 

estimates based on these comments. 

B. Sources of Data Used in Estimates of 

Burden Hours and Cost Estimates 

For the estimated costs contained in 

the analysis below, we used data from 

the U.S. Bureau of Labor Statistics (BLS) 

to determine the mean hourly wage for 

the positions used in this analysis.31 For 

the total hourly cost, we doubled the 

mean hourly wage for a 100 percent 

increase to cover overhead and fringe 

benefits, according to standard HHS 

estimating procedures. If the total cost 

after doubling resulted in 0.50 or more, 

the cost was rounded up to the next 

dollar. If it was 0.49 or below, the total 

cost was rounded down to the next 

dollar. The total costs used in this 

analysis are indicated in Table 1. 

BILLING CODE 4120–01–P 


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BILLING CODE 4120–01–C 

C. Rural Emergency Hospitals 

1. ICRs Regarding Condition of 

Participation: Provision of Services 

(§ 485.514) 

Proposed § 485.514(a) would require 

REHs to furnish health care services in 

accordance with appropriate written 

policies that are consistent with 

applicable state law. In addition, 

proposed § 485.514(b) would require 

REHs to develop the policies with the 

advice of members of the REH’s 

professional health care staff, while 

§ 485.514(d) would require REHs to 

conduct a biennial review of all its 

policies and procedures. We have not 

designated any specific process or 

format for REHs to use in developing 

their policies or conducting a review of 

their policies because we believe they 

need the flexibility to determine how 

best to accomplish these tasks. 

In accordance with the section 

1861(kkk)(3) of the Act, REHs must have 

been either a CAH or a rural hospital 

with not more than 50 beds as of the 

date of enactment of the CAA, December 

27, 2020, to convert to an REH. We 

estimate that 68 facilities will convert to 

an REH and we believe that they will be 

developing REH-specific policies that 

are based on policies that were utilized 

when the facility was a rural hospital or 

CAH. As a result, we estimate that it 

would take an REH approximately 80 

hours for administrative and clinical 

staff to develop policies. If there are 68 

REHs to comply with the policy 

development requirement and each REH 

uses 80 hours to comply: (16 hours for 

a physician + 16 hours for an 

administrator + 16 hours for a mid-level 

practitioner + 16 hours for a nurse + 16 

hours for a clerical staff person), then 

the burden hours are 5,440 (68 REHs × 

80 hours). The cost is $8,800 per REH 

($3,360 for a physician (16 hours × 

$210) + $1,952 for an administrator (16 

hours × $122) + $1,616 for a mid-level 

practitioner (16 hours × $101) + $1,264 

for a nurse (16 hours × $79) + $608 for 

a clerical staff person (16 hours × $38)). 

The total cost is 598,400 (68 REHs × 

$8,800). We estimate that it would take 

an REH’s professional personnel 16 

hours to review and make changes to 

policies and procedures biennially. 

Therefore, for all 68 REHs to comply 

with the policy review requirement it 

would require an estimated 16 burden 

hours biennially, or 8 hours annually 

(1.5 hours for a physician + 2 hours for 

an administrator + 1.5 hours for a midlevel practitioner + 1.5 hours for a nurse 

+ 1.5 hours for a clerical staff person). 

The burden hours are 544 (8 hours × 68 

REHs). The cost per REH is $886 ($315 

for a physician (1.5 hours × $210) + 

$244 for an administrator (2 hours × 

$122) + $151.50 for a mid-level 

practitioner (1.5 hours × $101) + 

$118.50 for a nurse (1.5 hours × $79) + 

$57 for a clerical staff person (1.5 hours 

× $38)). The total cost is $60,248 ($886 

× 68 REHs). Therefore, the total cost for 

each REH to comply with these 

requirements would be $658,648 

annually and 5,984 burden hours. 

2. ICRs Regarding Condition of 

Participation: Infection Prevention and 

Control and Antibiotic Stewardship 

Programs (§ 485.526) 

COVID–19 and Seasonal Influenza 

Reporting 

Consistent with the recent changes we 

made to the hospital and CAH infection 

control CoPs related to COVID–19 and 

the declared public health emergency 

(PHE), we are proposing to require 

REHs, after the conclusion of the current 

COVID–19 PHE, to report COVID–19 

and seasonal influenza-related 

reporting. The proposed requirements 

would apply upon conclusion of the 

COVID–19 PHE and would continue 

until April 30, 2024, unless the 

Secretary establishes an earlier ending 

date. The proposed data elements align 

closely with those COVID–19 reporting 

requirements for long-term care (LTC) 

facilities that were finalized on 

November 9, 2021 (86 FR 62421), and 

are representative of the guidance 

provided to hospitals and CAHs for 

reporting. Therefore, we do not expect 

that these categories of data elements 

would require REHs to report any 

information beyond that which they 

have already been reporting as existing 

rural hospitals or CAHs. Furthermore, 

similar to the requirements for LTC 

facilities, this proposal would also allow 

for the scope and frequency of data 

collection to be reduced and limited 

responsive to the evolving clinical and 

epidemiological circumstances. 

Based on our experience with those 

existing hospitals and CAHs and the 

current COVID–19 and related reporting 

requirements, we believe that this will 

primarily be the responsibility of a 

registered nurse and we have used this 

position in this analysis at an average 

hourly salary of $79. According to the 

most recent COVID–19 hospital 

reporting guidance (available at https:// 

www.hhs.gov/sites/default/files/covid19-faqs-hospitals-hospital-laboratoryacute-care-facility-data-reporting.pdf), 

hospitals are reporting COVID–19 and 

influenza-related data on a daily basis, 

with backdating permitted for weekends 

and holidays, except psychiatric and 

rehabilitation hospitals who report 

weekly. Some data element reporting 

fields are inactive for data collection, 

and therefore, hospitals can optionally 

report data for these fields. The inactive 

fields and active fields together reflect 

what is listed in this proposed rule for 

COVID–19 and influenza-related 

reporting as well as future reporting in 

the event of a declared PHE, which we 

discuss next. We do not expect, nor 

have we proposed, daily reporting for 

COVID–19 or influenza outside of a 

declared PHE. 

If we were to assume a weekly 

reporting frequency, we would 

anticipate that there are reduced cases 

and fewer data elements (with no line 

level patient data) being reported. Based 

on these assumptions, we estimate that 

total annual burden hours for REHs to 

comply with these requirements would 

be 5,304 hours based on weekly 

reporting of the required information by 

68 REHs × 52 weeks per year and at an 

average weekly response time of 1.5 

hours for a registered nurse with an 

average hourly salary of $79. Therefore, 

the estimate for total annual costs for all 

hospitals and CAHs to comply with the 

required reporting provisions weekly 

would be $419,016 or approximately 

$6,162 per facility annually. We 

acknowledge that the data elements and 

reporting frequency could increase or 

decrease over the next two years, and 

those changes would impact this burden 

estimate. 

We note that this estimate is assumed 

to be a one-day snapshot of reporting 

information as opposed to a cumulative 

weekly report accounting for 

information based on each day of that 

week. If we assumed a cumulative 

weekly account, we can assume reduced 

burden related to the actual reporting 

time, but anticipate that the estimate 

would be slightly higher to account for 

the need to track closely to daily 

reporting. We also acknowledge that 

respondents may have to track and 

invest in infrastructure in order to 

timely and accurately report on the 

specified frequency. Thus, respondents 

may face ongoing burdens associated 

with this collection even in the case of 

reduced frequency of submissions. We 

solicit comment on this potentiality. 

Furthermore, we note that this 

estimate likely overestimates the costs 

associated with reporting because it 

assumes that all REHs will report 

manually. Efforts are underway to 

automate reporting that have the 

potential to significantly decrease 

reporting burden and improve 

reliability. 


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Future Reporting in the Event of a 

Future PHE Declaration 

In addition, we are proposing to 

establish reporting requirements for 

future PHEs related to epidemics and 

pandemics by requiring REHs to 

electronically report information on 

Acute Respiratory Illness (including, but 

not limited to, Seasonal Influenza Virus, 

Influenza-like Illness, and Severe Acute 

Respiratory Infection), SARS–CoV–2/ 

COVID–19, and other viral and bacterial 

pathogens or infectious diseases of 

pandemic or epidemic potential only 

when the Secretary has declared a PHE 

directly related to such specific 

pathogens and infectious diseases. 

Specifically, when the Secretary has 

declared a PHE, we propose to require 

REHs to report specific data elements to 

the CDC’s National Health Safety 

Network (NHSN), or other CDCsupported surveillance systems, as 

determined by the Secretary. The 

proposed requirements of this section 

would apply to local, state, and national 

PHEs as declared by the Secretary. 

Relevant to the declared PHE, the 

categories of data elements that this 

report would include are as follows: 

suspected and confirmed infections of 

the relevant infectious disease pathogen 

among patients and staff; total deaths 

attributed to the relevant infectious 

disease pathogen among patients and 

staff; personal protective equipment and 

other relevant supplies in the facility; 

capacity and supplies in the facility 

relevant to the immediate and long term 

treatment of the relevant infectious 

disease pathogen, such as ventilator and 

dialysis/continuous renal replacement 

therapy capacity and supplies; total 

REH bed and intensive care unit bed 

census, capacity, and capability; staffing 

shortages; vaccine administration status 

of patients and staff for conditions 

monitored under this section and where 

a specific vaccine is applicable; relevant 

therapeutic inventories and/or usage; 

isolation capacity, including airborne 

isolation capacity; and key comorbidities and/or exposure risk factors 

of patients being treated for the 

pathogen or disease of interest in this 

section that are captured with 

interoperable data standards and 

elements. 

We are also proposing to require that, 

unless the Secretary specifies an 

alternative format by which a REH must 

report each applicable infection 

(confirmed and suspected) and the 

applicable vaccination data in a format 

that provides person-level information, 

to include medical record identifier, 

race, ethnicity, age, sex, residential 

county and zip code, and relevant 

comorbidities for affected patients, 

unless the Secretary specifies an 

alternative format by which the REH 

would be required report these data 

elements. We are also proposing in this 

provision to limit any person-level, 

directly or potentially individually 

identifiable, information for affected 

patients and staff to items outlined in 

this section or otherwise specified by 

the Secretary. We note that the provided 

information obtained in this 

surveillance system that would permit 

identification of any individual or 

institution is collected with a guarantee 

that it will be held in strict confidence, 

will be used only for the purposes 

stated, and will not otherwise be 

disclosed or released without the 

consent of the individual, or the 

institution in accordance with sections 

304, 306, and 308(d) of the Public 

Health Service Act (42 U.S.C. 242b, 

242k, and 242m(d)). Lastly, we are 

proposing that a REH would provide the 

information specified on a daily basis, 

unless the Secretary specifies a lesser 

frequency, to the Centers for Disease 

Control and Prevention’s National 

Healthcare Safety Network (NHSN) or 

other CDC-supported surveillance 

systems as determined by the Secretary. 

For purposes of this burden 

collection, we acknowledge the 

unknown and the ongoing burdens that 

may exist even if CMS is not collecting 

information outside of a declared PHE. 

We recognize that considerations such 

as building and maintaining the 

infrastructure to support readiness are 

necessary to ensure compliance with 

this requirement. Therefore, we are 

soliciting comment on the burden 

associated with these proposed 

requirements given the intended 

flexibility provided in reducing or 

limiting the scope and frequency of 

reporting based on the state of the PHE 

and ongoing circumstances. We are 

specifically asking for comment on the 

potential burden associated with the 

proposed reporting requirements as they 

might relate to any differences in the 

public health response to one specific 

pathogen or infectious disease versus 

another that would be directly related to 

the declared PHE. We are also interested 

in public comments addressing burden 

estimates (and the potential differences 

in those estimates) for variations in the 

required reporting response for a local 

PHE versus a regional PHE versus a 

national PHE that might be declared by 

the Secretary based on the specific 

circumstances at the time of the 

declaration. 

CMS will pursue an emergency 

collection of information in the case of 

a declared PHE and use such burden 

estimate to inform its approach at that 

time. CMS will also publish an 

accompanying Federal Register Notice 

concurrent with its submission of a 

request to collect information, in 

addition to all other actions consistent 

with 5 CFR 1320.13. CMS commits to 

ensuring that respondents are well 

aware in advance of the intention to 

collect such information and solicits 

comment on the appropriate timeline 

and notification process for such 

actions. 

3. ICRs Regarding Condition of 

Participation: Staffing and Staff 

Responsibilities (§ 485.528) 

We proposed that the emergency 

department of the REH be staffed 24 

hours a day, 7 days a week, and we 

propose this requirement at 

§ 485.6528(a) and that a doctor of 

medicine or osteopathy, nurse 

practitioner, clinical nurse specialist, or 

physician assistant must be available to 

furnish services in the REH in the 

facility 24 hours a day. The burden 

associated with this requirement is the 

time it takes to review the REH’s written 

policies and make appropriate changes 

or updates regarding its staffing and 

staff responsibilities for the services it 

furnishes. In conjunction with a midlevel practitioner, the physician 

develops, executes, and periodically 

reviews the REH’s written policies 

governing the services it furnishes. We 

estimate that it will take the physician 

and mid-level practitioner 1 hour each 

to review the REH written policies and 

make the appropriate changes. We also 

estimate that a REH will utilize the 

services of one clerical person for half 

an hour to process any changes or 

updates, for a total of 2.5 burden hours 

and an estimated cost per REH of $ 330 

((1 hour × $210 for a physician) + (1 

hour × $101 for a mid-level practitioner) 

+ (0.5 hours × $38 for clerical staff)). 

Therefore, the burden associated with 

this requirement is an estimated 170 

burden hours (2.5 hours × 68 REHs) at 

an estimated cost of $22,440 ($330 × 68 

REHs). 

4. ICRs Regarding Condition of 

Participation: Patient’s Rights 

(§ 485.534) Standard: Notice of Rights: 

§ 485.534(a)(1) and (2) 

Proposed § 485.534(a) would require 

REHs to notify a patient of their rights 

and of whom to contact to file a 

grievance. We allow REHs the flexibility 

to use different approaches to meet this 

CoP. We have set forth general elements 

that should be common to all grievance 

processes, but have not delineated 

strategies and policies for implementing 

this system. We believe that in large 


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32https://oig.hhs.gov/oei/reports/oei-05-12- 

00081.pdf. 

measure, REHs would be able to use 

existing systems for providing patients 

with information and handling 

complaints, and the elements listed in 

the regulation only serve to give basic 

assurance that these systems are 

responsive to patient grievances and act 

effectively. A less specific approach 

would permit a nominal, non-functional 

system that in essence did not serve the 

very purpose intended by the 

regulation. Costs associated with 

formalizing a process and modifying 

any existing notices or processes will 

most likely be partially offset by a 

reduction in patient-initiated lawsuits 

regarding care, and should provide a 

valuable tool for targeting internal 

quality assurance mechanisms. 

We asked that the patient be provided 

with written notice containing a contact 

person’s name, the steps taken on behalf 

of the patient to investigate the 

grievance, the results of the grievance 

process, and the date of completion. 

Steps taken on behalf of the patient 

need not include a detailed description 

of who was spoken to and when. It 

might merely be that the appropriate 

staff were interviewed and that records 

were reviewed to investigate the 

grievance, and that the investigation 

found the grievance to be either 

unsubstantiated or substantiated. 

Second, the figures represented are 

estimates. We know of no existing 

system that tracks how many 

complaints are lodged in aggregate in 

hospitals or CAHs each year; however, 

for REHs, we believe that the grievance 

response can largely rely on 

standardized language with only 

relevant information filled in, or could 

be created in a check-sheet format, or in 

many other ways. 

Thus, the burden associated with this 

requirement is the time and effort 

necessary to modify any existing notices 

to include the proposed grievance 

process requirements. We believe that 

an office assistant may be tasked with 

drafting or updating the notices and 

distributing or posting, as appropriate, 

the information. We estimate that this 

would require no more than two hours 

of the clerical staff time. Based on this 

we estimate that this will create a onetime cost of $5,168 (68 REHs × 2 hours 

× $38 clerical staff hourly wage). In 

addition, we estimate that it will require 

the office assistant 2 minutes (.0333 

hours) to provide the notice per REH 

patient on an annual basis. The number 

of notices required will depend on the 

number of patients received at the REH. 

Therefore, the per facility burden 

associated with providing the notice 

will vary based on the unique factors of 

the REH. According to an OIG report, 

there were 2,316,675 outpatient visits in 

2011 at CAHs.32 Based on this estimate, 

we assume that the REH will have an 

average of 1,743 outpatient/emergency 

department visits per year that would 

require informing each patient of their 

rights which would take 58 hours (.0333 

hours × 1,743 notices). The cost is 

$149,872 ($38 clerical staff wage × 58 

hours × 68 REHs). 

In its resolution of a grievance, a REH 

must provide the patient with written 

notice of its decision that contains the 

name of the REH contact person, the 

steps taken on behalf of the patient to 

investigate the grievance, the results of 

the grievance process, and the date of 

completion. 

The burden associated with this 

requirement is the time and effort 

necessary to disclose the written notice 

to each patient who filed a grievance. 

We estimate that on average it will take 

each REH 15 minutes to develop and 

disseminate the required notice and 

estimate that an REH may have to 

provide 50 notices on an annual basis 

for a total annual burden. The burden 

hours would be 13 hours (0.25 hours × 

50 notices). The total burden hours 

would be 884 hours (13 hours × 68 

REHs) at the cost of $33,592 ($38 × 884 

hours). Therefore, the total burden 

associated with this requirement is 

$188,632 ($5,168 to update notices, 

$149,872 to provide the notices, and 

$33,592 to provide the results of a 

grievance investigation). 

Standard: Confidentiality of Patient 

Records (§ 485.534(d)) 

Proposed § 485.534(d), which sets 

forth the patient’s right to access 

information in their records, will 

involve minimal burden as many states’ 

existing laws cover this point. We have 

not proposed to require disclosure of all 

records, inasmuch as we recognize that 

there are situations where such a release 

could be harmful to the patient or 

another individual. Furthermore, we 

have not taken a prescriptive approach 

in specifying how quickly this 

information must be provided to the 

patient, or by setting a rate that the REH 

can charge. In the absence of state law, 

the REH should charge whatever is 

reasonable and customary in its 

community for duplication services 

(based on rates at local commercial copy 

centers, post offices, or other venues in 

which one could make photocopies). 

Therefore, while this requirement is 

subject to the PRA, we believe that the 

burden associated with this requirement 

is exempt from the PRA, as defined in 

5 CFR 1320.3(b)(2) and (3) because this 

requirement is considered standard 

industry practice and/or is required 

under state or local law. 

Standard: Restraint and Seclusion 

(§ 485.534(e)) 

Section 485.534(e) requires that REH 

must have written policies and 

procedures regarding the use of restraint 

and seclusion that are consistent with 

current standards of practice. While the 

requirement is subject to the PRA, we 

believe the associated burden is exempt 

in accordance with 5 CFR 1320.3(b)(2) 

because the time, and effort, and 

financial resources necessary to comply 

with this requirement would be 

incurred by persons in the normal 

course of their activities. These are 

reasonable and customary state 

practices based on current standards of 

practice and the state would impose this 

standard for efficient utilization of 

Medicare or Medicaid services in the 

absence of a Federal requirement. 

However, we are soliciting comment on 

whether this is a customary business 

practice or whether this would impose 

an additional burden on those providers 

eligible to convert to an REH. 

Standard: Restraint and Seclusion: Staff 

Training Requirements (§ 485.534(f)) 

Section 485.534(f) requires facilities 

to establish staff training requirements 

for the use of restraints and seclusion. 

The REH must provide competencybased training and education of REH 

personnel and staff, including medical 

staff, and, as applicable, personnel 

providing contracted services in the 

REH, on the use of restraint and 

seclusion. While these information 

collection requirements are subject to 

the PRA, we believe the burden 

associated with them are exempt as 

defined in 5 CFR 1320.3(b)(2) because 

the time, effort, and financial resources 

necessary to comply with the 

requirement are incurred by persons in 

the normal course of their activities. 

However, we are soliciting comment on 

whether this is a customary business 

practice or whether this would impose 

an additional burden on those providers 

eligible to convert to an REH. 

Standard: Death Reporting 

Requirements (§ 485.534(g)) 

Section 485.534(g) requires the 

facility to report the death of a resident 

associated with restraint or seclusion to 

the CMS regional office. A report must 

include the name of the resident 

involved in the serious occurrence, a 

description of the occurrence, and the 

name, street address, and telephone 

number of the facility. 


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We estimate it will take 5 minutes to 

report each death to the CMS regional 

office and to document that report. We 

estimate fewer than 10 deaths annually 

for all 68 facilities. Five (5) minutes × 

10 deaths annually would equate to a 

national burden of 50 minutes per year. 

The hourly adjusted rate for a Medical 

and Health Service Manager responsible 

for notifying the CMS regional office of 

a death a documenting the report is 

$122/hour. Multiplying the total burden 

of 0.83 hours by the hourly wage yields 

an associated cost of about $101.67. 

Standard: Patient Visitation Rights 

(§ 485.534(h)) 

Section 485.534(h) requires a REH to 

have written policies and procedures 

regarding the visitation rights of 

patients, including any clinically 

necessary or reasonable restriction or 

limitation that the REH may need to 

place on such rights and the reasons for 

the clinical restriction or limitation. 

Specifically, the written policies and 

procedures must contain the 

information listed in § 485.534(h)(1) 

through (4). Given that the statute 

requires a REH to have been either a 

CAH or rural hospital as of the date of 

enactment of the CAA, we expect these 

facilities to already have a visitation 

policy in accordance with the CAH and 

hospital CoPs at §§ 485.635(f) and 

482.13(h), respectively. Therefore, the 

ICR burden associated with this 

requirement would be the time and 

effort necessary for a REH to review and 

make any necessary updates given its 

conversion to an REH and to distribute 

that information to patients. We expect 

that an office secretary or other clerical 

staff would update and distribute, or 

post as appropriate, the information and 

could accomplish this task in 15 

minutes for an estimated one-time 

burden total of 17 hours (0.25 hours × 

68 REHs) and at the cost of $646 ($38 

× 17 hours). 

5. ICRs Regarding Condition of 

Participation: Transfer Agreements 

(Proposed § 485.538) 

At § 485.538, we propose that each 

REH must have a transfer agreement in 

effect with at least one certified hospital 

that is a level I or level II trauma center 

for the referral and transfer of patients 

requiring emergency medical care 

beyond the capabilities of the REH. We 

estimate that it would require an REH 

administrator and a clerical person 2 

hours each to develop the initial 

agreement and obtain the appropriate 

approvals. According to Table 1, the 

REH administrator’s total hourly cost is 

$122 per hour. The clerical staff 

person’s total hourly cost is $38. We 

estimate that for each REH to comply 

with the requirements in this section it 

would require 4 burden hours which 

would be a total of 272 hours (4 hours 

× 68 REHs). The cost is $320 ($244 (2 

hours × $122 for an administrator) + $76 

(2 hours × $38 for a clerical staff 

person)) for each REH. The total cost is 

$21,760 ($320 × 68 REHs). This is a onetime cost. 

6. ICRs Regarding Condition of 

Participation: Medical Records 

(Proposed § 485.540) 

There is no burden attributed to this 

task. The REH’s health care services are 

furnished in accordance with 

appropriate written policies that are 

consistent with applicable state law. 

The policies include a description of the 

services the REH furnishes directly and 

those furnished through agreement or 

arrangement; policies and procedures 

for emergency medical services and 

guidelines for medical management of 

health problems that include the 

conditions requiring medical 

consultation and/or patient referral and 

the maintenance of health care records. 

We are not including burden 

associated with certain patient related 

activities such as health care plans, 

patient records, medical records, etc., 

because prudent institutions already 

incur this burden in the course of doing 

everyday business. As stated in 5 CFR 

1320.3(b)(2), the burden associated with 

usual and customary business practices 

is exempt from the PRA. However, we 

are soliciting comment on whether this 

is a customary business practice or 

whether this would impose an 

additional burden on those providers 

eligible to convert to an REH. Further, 

state laws require providers to maintain 

patient records. (For example, the 

annotated Code of Maryland 

(¶ 10.11.03.13) requires a provider to be 

responsible for maintaining patient 

records for services that it provides.) 

State law requires record information 

that should include: documentation of 

personal interviews; diagnosis and 

treatment recommendations; records of 

professional visits and consultations; 

and consultant notes which shall be 

appropriately initialed or signed. 

7. ICRs Regarding Condition of 

Participation: Quality Assessment and 

Performance Improvement Program 

(QAPI) (Proposed § 485.536) 

At proposed § 485.536, we require 

REHs to develop, implement, and 

maintain an effective, ongoing, REHwide, data-driven quality assessment 

and performance improvement (QAPI) 

program. The REH’s governing body 

must ensure that the program reflects 

the complexity of the REH’s 

organization and services; involves all 

REH departments and services 

(including those services furnished 

under contract or arrangement); and 

focuses on indicators related to 

improved health outcomes and the 

prevention and reduction of medical 

errors. The REH must maintain and 

demonstrate evidence of its QAPI 

program for review by CMS. In addition, 

REHs must comply with all of the 

requirements set forth in proposed 

§ 485.536(a) through (e). We believe that 

the REH QAPI leadership (consisting of 

a physician, and/or administrator, midlevel practitioner, and a nurse) would 

need to have at least one and potentially 

two meetings to ensure that the current 

QAPI program that the provider has 

established is in accordance with the 

proposed requirements at § 485.536. The 

first meeting would be to discuss the 

current QAPI program and what, if 

anything, needs to be revised based on 

the proposed QAPI requirements at 

§ 485.536. The second meeting, if 

needed, would be to discuss strategies 

to update the current policies, and then 

to discuss the process for incorporating 

those changes. We believe that these 

meetings would take approximately 2 

hours each. We estimate that the 

physician would have a limited amount 

of time, approximately 1 hour to devote 

to the QAPI activities. Additionally, we 

estimate these activities would require 4 

hours of an administrator’s time, 4 

hours of a mid-level practitioner’s time, 

8 hours of a nurse’s time, and 2 hours 

of a clerical staff person’s time for a total 

of 19 burden hours. We believe that the 

REH’s QAPI leadership would need to 

meet periodically to review and discuss 

the changes that would need to be made 

to their program. We also believe that a 

nurse would likely spend more time 

developing the program with the midlevel practitioner. The physician would 

likely review and approve the program. 

The clerical staff member would 

probably assist with the program’s 

development and ensure that the 

program was disseminated to all of the 

necessary parties in the REH. 

Based on these factors, we estimate 

that for each REH to comply with the 

requirements in this section it would 

require annually 19 burden hours (1 

hour for a physician + 4 hours for an 

administrator + 4 hours for a mid-level 

practitioner + 8 hours for a nurse + 2 

hours for a clerical staff person) at a cost 

of $1,810 ($210 for a physician (1 hour 

× $210) + $488 for an administrator (4 

hours × $122) + $404 for a mid-level 

practitioner (4 hours × $101) + $632 for 

a nurse (8 hours × $79) + $76 for a 


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clerical staff person (2 hours × $38)). 

Therefore, for all 68 REHs to comply 

with these requirements, it would 

require 1,292 burden hours (19 hours × 

68 REHs) at a cost of approximately 

$123,080 ($1,810 × 68 REHs). 

8. ICRs Regarding Condition of 

Participation: Emergency Preparedness 

(§ 485.542) 

Section 485.542 sets forth the 

proposed emergency preparedness 

requirements for REHs. We note that 

these emergency preparedness 

standards are consistent national 

parameters that all Medicare and 

Medicaid participating providers and 

suppliers must meet. This includes both 

rural hospitals and CAHs and therefore 

facility that converts to an REH would 

have already incurred the costs to 

develop and implement their emergency 

preparedness plan. Based on this, the 

burden associated with these 

requirements would be the on-going 

costs to review, maintain and 

implement the emergency preparedness 

program to ensure ongoing compliance 

with the requirements and as such we 

have developed this collection of 

information (COI) section based largely 

on the existing COI burden for CAHs 

and hospitals. 

Standard: Risk Assessment and 

Planning (§ 485.542(a)) 

We propose to require REHs to 

develop and maintain an emergency 

preparedness plan that must be 

reviewed and updated at least 

biennially. We expect that each REH 

facilities director ($104 per hour) would 

conduct a thorough risk assessment that 

will consider its location and 

geographical area; patient population, 

including those with special needs; and 

the type of services they have the ability 

to provide in an emergency (12 hours 

biennially or 6 hours annually) based on 

the services that they are now providing 

as an REH. They each would also need 

to review the measures needed to ensure 

continuity of its operation, including 

delegations and succession plans. We 

estimate that ongoing compliance with 

this requirement would require 6 

burden hours annually (12 biennially) 

from the REH facilities director. 

Therefore, for all 68 REHs to comply 

with this requirement, it would require 

408 burden hours (6 × 68 REHs) at a cost 

of approximately $42,432 (408 hours × 

$104). 

Standard: Policies and Procedures 

(§ 485.542(b)) 

REHs are required to maintain 

emergency preparedness policies and 

procedures in accordance with their 

emergency plan, risk assessment, and 

communication plan. Each needs to 

review their emergency preparedness 

policies and procedures and revise, or 

in some cases, develop new policies and 

procedures that would ensure that the 

emergency preparedness plans address 

the specific requirements of the 

regulations. 

We believe that the requirement for 

REHs to review and update their 

policies and procedures annually 

constitutes a usual and customary 

business practice and is not subject to 

the PRA in accordance with 5 CFR 

1320.3(b)(2). However, we are soliciting 

comment on whether this is a customary 

business practice or whether this would 

impose an additional burden on those 

providers eligible to convert to an REH. 

Standard: Communication Plan 

(§ 485.542(c)) 

REHs are required to develop and 

maintain an emergency preparedness 

communication plan that complies with 

both Federal and state law and must be 

reviewed and updated at least annually. 

The burden associated with this 

requirement would be the time and 

effort necessary to review, revise, and if 

necessary, develop a new 

communications plan to ensure that it 

complies with the requirements of this 

regulation. However, we believe that 

most REHs have some type of 

emergency preparedness 

communication plan based on their 

prior status as a CAH or rural hospital. 

It is standard practice in the health care 

industry to have and maintain contact 

information for both staff and outside 

sources of assistance; alternate means of 

communications in case there is an 

interruption in phone service to the 

facility, such as cell phones; and a 

method for sharing information and 

medical documentation with other 

health care providers to ensure 

continuity of care for their patients. 

If any revisions or additions are 

necessary to satisfy the requirements as 

an REH, we expect the revisions or 

additions would be those incurred 

during the course of normal business 

and thereby impose no additional 

burden. Thus, the ICRs related to the 

communication plan would constitute a 

usual and customary business practice 

as stated in the implementing 

regulations of the PRA at 5 CFR 

1320.3(b)(2) and we did not include this 

activity in the burden analysis. We are 

soliciting comment on whether this is a 

customary business practice or whether 

this would impose an additional burden 

on those providers eligible to convert to 

an REH. 

Standard: Training and Testing 

(§ 485.542(d)) 

REHs are required to develop and 

maintain an emergency preparedness 

training and testing program. The 

training program must include initial 

training in emergency preparedness 

policies and procedures for all new and 

existing staff, individuals providing 

services under arrangement, and 

volunteers, consistent with their 

expected roles and must be 

documented. The testing program must 

include participation in a full-scale 

exercise that is community-based or 

when a community-based exercise is not 

accessible, an individual, facility-based. 

If an actual natural or man-made 

emergency that requires activation of 

the emergency plan is experienced, then 

this requirement is exempt for 1 year 

following the onset of the actual event. 

In addition, the testing program must 

include one additional testing exercise, 

which may be determined by the REH. 

The training must be provided 

biennially and two testing exercises 

must be conducted annually. 

We expect that all REHs will review 

their current training programs in their 

current capacity as hospitals or CAHs, 

and compare them to their risk 

assessments and emergency 

preparedness plans, emergency policies 

and procedures, and emergency 

communication plans. The CAHs will 

need to revise and, if necessary, develop 

new sections or materials to ensure their 

training and testing programs complied 

with our requirements. We anticipate 

that ongoing compliance with this 

requirement will require the 

involvement of an administrator, the 

mid-level practitioner, the facilities 

director, and clerical staff. We expect 

that a mid-level practitioner will 

perform the initial review of the training 

program (4 hours), brief the 

administrator and the director of 

facilities (2 hours), and clerical staff to 

revise or develop new sections for the 

training program (1 hour), based on the 

group’s decisions, if necessary. This will 

result in a cost of $894 ($404 for a midlevel practitioner (4 hours × $101) + 

$244 for an administrator (2 hours × 

$122) + $208 for a director of facilities 

(2 hours × $104) + $38 for a clerical staff 

person (1 hour × $38)) for each REH. 

Therefore, for all REHs to comply with 

this requirement it will require an 

estimated 476 burden hours (7 hours × 

68 REHs) at a cost of $60,792 ($894 × 68 

REHs). 


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9. ICRs Regarding Conditions of 

Participation: Physical Environment 

(§ 485.544) 

Standard: Life Safety Code (§ 485.544) 

The REH must meet the applicable 

provisions of the 2012 edition of the 

Life Safety Code (LSC) of the National 

Fire Protection Association. If CMS 

finds that the state has a fire and safety 

code imposed by the state law that 

adequately protects patients, CMS may 

allow the state survey agency to apply 

the state’s fire and safety code instead 

of the LSC if waiving the provisions of 

the LSC does not adversely affect the 

health and safety of patients. This 

regulation requires a REH to maintain 

written evidence of regular inspections 

and approval by state fire control 

agencies. We estimate that the burden 

associated with maintaining written 

evidence of state inspections and 

approval would be an average of 30 

minutes for clerical personnel to file the 

documentation, for a total of 34 burden 

hours (0.5 hours × 68 REHs) and a cost 

of $1,292 (34 hours × $38). The burden 

will be accounted for in the Information 

Collection Request under OMB control 

number 0938–XXXX. 

The table that follows summarizes our 

estimates of burden hours and costs for 

REHs. We emphasize that these 

estimates assume 68 conversions and 

that the number actually converting 

could be a fraction of this figure, or 

much higher, which as discussed earlier 

is an uncertainty addressed in both the 

NC RHRP and CLA study that estimated 

likely conversions. Our estimates of the 

cost per entity, however, would not be 

affected by the number of conversions. 

BILLING CODE 4120–01–P 

BILLING CODE 4120–01–C D. Critical Access Hospitals 

1. ICRs Regarding Condition of 

Participation: Patient’s Rights 

(§ 485.614) 

Standard: Notice of Rights: 

§ 485.614(a)(1) and (2) 

Proposed § 485.614(a) proposes to 

require CAHs to notify the patient of 

their rights and of whom to contact to 

file a grievance. We allow REHs the 

flexibility to use different approaches to 

meet this CoP. We have set forth general 

elements that should be common to all 

grievance processes, but have not 

delineated strategies and policies for 

implementing this system. We believe 

that in large measure, CAHs would be 


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33https://oig.hhs.gov/oei/reports/oei-05-12- 

00081.pdf. 

able to use existing systems for 

providing patients with information and 

handling complaints, and the elements 

listed in the regulation only serve to 

give basic assurance that these systems 

are responsive to patient grievances and 

act effectively. A less specific approach 

would permit a nominal, non-functional 

system that in essence did not serve the 

very purpose intended by the 

regulation. Costs associated with 

formalizing a process and modifying 

any existing notices or processes will 

most likely be offset by a reduction in 

patient-initiated lawsuits regarding care, 

and should provide a valuable tool for 

targeting internal quality assurance 

mechanisms. 

We propose that the patient be 

provided with written notice containing 

a contact person’s name, the steps taken 

on behalf of the patient to investigate 

the grievance, the results of the 

grievance process, and the date of 

completion. Steps taken on behalf of the 

patient need not include a detailed 

description of who was spoken to and 

when. It might merely be that the 

appropriate staff were interviewed and 

that records were reviewed to 

investigate the grievance, and that the 

investigation found the grievance to be 

either unsubstantiated or substantiated. 

Second, the figures represented are 

estimates. We know of no existing 

system that tracks how many 

complaints are lodged in aggregate in 

CAHs each year; however, we believe 

that the grievance response can largely 

rely on standardized language with only 

relevant information filled in, or could 

be created in a check-sheet format, or in 

many other ways. 

Thus, the burden associated with this 

requirement is the time and effort 

necessary to modify any existing notices 

to include the proposed grievance 

process requirements. We believe that 

an office assistant may be tasked with 

drafting or updating the notices and 

distributing or posting, as appropriate, 

the information. We estimate that this 

would require no more than two hours 

of the clerical staff time. The burden 

hours are 2,720 (2 hours × 1,360). Based 

on this we estimate that this will create 

a one-time cost of $103,360 (2,720 hours 

× $38). In addition, we estimate that it 

will require the office assistant 2 

minutes (.0333 hours) to provide the 

notice per CAH patient on an annual 

basis. The number of notices required 

will depend on the number of patients 

received at the CAH. Therefore, the per 

facility burden associated with 

providing the notice will vary based on 

the unique factors of the CAH. 

According to a 2013 OIG report, there 

were approximately 1,753 patient visits 

per CAH in 2011.33 Based on this 

estimate, the burden hours would be 58 

hours (.0333 hours × 1,753 notices). The 

total burden hours would be 78,880 

hours (58 hours × 1,360 CAHs). 

Therefore, we estimate that the CAH 

would have had to inform each of these 

patient of their rights at a cost of 

$2,997,440 ($38 × 78,880 hours). 

In its resolution of a grievance, a CAH 

must provide the patient with written 

notice of its decision that contains the 

name of the CAH contact person, the 

steps taken on behalf of the patient to 

investigate the grievance, the results of 

the grievance process, and the date of 

completion. 

The burden associated with this 

requirement is the time and effort 

necessary to disclose the written notice 

to each patient who filed a grievance. 

We estimate that on average it will take 

each REH 15 minutes to develop and 

disseminate the required notice and 

estimate that a CAH may have to 

provide 50 notices on an annual basis. 

The burden hours for each CAH will be 

12.5 (0.25 hour × 50 notices) for a total 

of 17,000 burden hours (12.5 hours × 

1,360 CAHs). The total annual burden 

cost is $646,000 ($38 × 17,000). 

Therefore, the total burden hours are 

98,600 (78,880 + 17,000 + 2,720) and the 

total cost associated with this 

requirement is $3,746,800 ($103,360 to 

update notices, $2,997,440 to provide 

the notices, and $646,000 to provide the 

results of a grievance investigation). 

Standard: Confidentiality of Patient 

Records (§ 485.614(d)) 

Proposed § 485.614(d), which sets 

forth the patient’s right to access 

information in their records, will 

involve minimal burden as many states’ 

existing laws cover this point. We have 

not proposed to require disclosure of all 

records, inasmuch as we recognize that 

there are situations where such a release 

could be harmful to the patient or 

another individual. Furthermore, we 

have not taken a prescriptive approach 

in specifying how quickly this 

information must be provided to the 

patient, or by setting a rate that the CAH 

can charge. In the absence of state law, 

the REH should charge whatever is 

reasonable and customary in its 

community for duplication services 

(based on rates at local commercial copy 

centers, post offices, or other venues in 

which one could make photocopies). 

Therefore, while this requirement is 

subject to the PRA, we believe that the 

burden associated with this requirement 

is exempt from the PRA, as defined in 

5 CFR 1320.3(b)(2) and (3) because this 

requirement is considered standard 

industry practice and/or is required 

under state or local law. 

Standard: Restraint and Seclusion 

(§ 485.614(e)) 

Proposed § 485.614(e) requires that 

each CAH have written policies and 

procedures regarding the use of restraint 

and seclusion that are consistent with 

current standards of practice. While the 

requirement is subject to the PRA, we 

believe the associated burden is exempt 

in accordance with 5 CFR 1320.3(b)(2) 

because the time, and effort, and 

financial resources necessary to comply 

with this requirement would be 

incurred by persons in the normal 

course of their activities. These are 

reasonable and customary state 

practices and the state would impose 

this standard for efficient utilization of 

Medicare and Medicaid services in the 

absence of a Federal requirement. 

However, we are soliciting comment on 

whether this is a customary business 

practice or whether this would impose 

an additional burden. 

Standard: Restraint and Seclusion: Staff 

Training Requirements (§ 485.614(f)) 

Proposed § 485.614(f) requires 

facilities to establish staff training 

requirements for the use of restraints 

and seclusion. The CAH must provide 

competency-based training and 

education of CAH personnel and staff, 

including medical staff, and, as 

applicable, personnel providing 

contracted services in the CAH, on the 

use of restraint and seclusion. While 

these information collection 

requirements are subject to the PRA, we 

believe the burden associated with them 

are exempt as defined in 5 CFR 

1320.3(b)(2) because the time, effort, 

and financial resources necessary to 

comply with the requirement are 

incurred by persons in the normal 

course of their activities. However, we 

are soliciting comment on whether this 

is a customary business practice or 

whether this would impose an 

additional burden. 

Standard: Death Reporting 

Requirements (§ 485.614(g)) 

Proposed § 485.614(g) requires the 

facility to report the death of a resident 

associated with seclusion or restraint to 

the CMS regional office. A report must 

include the name of the resident 

involved in the serious occurrence, a 

description of the occurrence, and the 

name, street address, and telephone 

number of the facility. 

We estimate it will take 5 minutes to 

report each death to the CMS regional 


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office and to document that report. We 

estimate fewer than 10 deaths annually 

for all 1,360 facilities. Five (5) minutes 

× 10 deaths annually would equate to a 

national burden of 50 minutes per year. 

The hourly adjusted rate for a Medical 

and Health Service Manager responsible 

for notifying the CMS regional office of 

a death a documenting the report is 

$122/hour. Multiplying the total burden 

of 0.83 hours by the hourly wage yields 

an associated cost of about $101.26. 

The burden for the proposed CAH 

provisions will be accounted for in the 

Information Collection Request under 

OMB control number 0938–XXXX. 

If you comment on these information 

collection requirements, that is, 

reporting, recordkeeping or third-party 

disclosure requirements, please submit 

your comments electronically as 

specified in the ADDRESSES section of 

this proposed rule. 

Comments must be received by 

August 29, 2022. 

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 Statement 

We have examined the impact of this 

proposed rule as required by Executive 

Order 12866 on Regulatory Planning 

and Review (September 30, 1993), 

Executive Order 13563 on Improving 

Regulation and Regulatory Review 

(January 18, 2011), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, section 202 of 

the Unfunded Mandates Reform Act of 

1995 (March 22, 1995; Pub. L. 104–4), 

Executive Order 13132 on Federalism 

(August 4, 1999), and the Congressional 

Review Act (5 U.S.C. 804(2)). 

Executive Orders 12866 and 13563 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A Regulatory Impact Analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). 

This proposed rule addresses the CoPs 

required for REH designation, which in 

accordance with the statute, may be 

sought by CAHs and small rural 

hospitals. It also proposes several new 

CAH requirements that we believe are 

appropriate under the existing program 

as well as to REHs. However, note that 

the costs of these CAH proposals are not 

attributable to the new REH program 

(except where such costs are 

experienced by entities that remain 

open due to the REH option but would 

have closed otherwise). The baseline for 

the estimates of REH costs is the status 

quo had the new program had not been 

created. Because the proposed CoPs for 

the new REH provider type are similar 

to those already met by the facilities that 

will potentially convert to REH status, 

and assuming that the estimated number 

of hospitals converting to the new 

program is approximately correct, the 

provisions of this proposed rule do not 

reach the economic threshold and thus 

it is not considered a major rule. This 

would remain the case if the number 

converting were to be significantly 

higher or lower. This is also an upper 

bound for these costs on a per facility 

basis, since for collection of information 

purposes we did not subtract offsetting 

savings from providers who would 

already meet these standards and who 

decide to make little change when 

updating their status. Payment policies 

for REHs will be developed under 

separately proposed rulemaking, and we 

expect that the total economic impact of 

the new program including both 

Conditions of Participation and 

payment costs will exceed the threshold 

for an economically significant impact, 

and will be addressed at that time. 

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, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other healthcare 

providers and suppliers are small 

entities, either by nonprofit status or by 

having revenues of less than $8.0 

million to $41.5 million in any 1 year. 

Individuals and states are not included 

in the definition of a small entity. We 

estimate that almost all of the new REH 

facilities, and the great majority of 

CAHs, are or would be small entities on 

the basis of legal status, revenues, or 

both. The North American Industry 

Classification System Code for the 

converting hospitals is 622110 (General 

Medical and Surgical Hospitals), and for 

the REHs to which they convert the 

closest Code is 621493 (Freestanding 

Ambulatory Surgical and Emergency 

Centers). 

HHS uses an increase in costs or 

decrease in revenues of more than 3 


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percent as its threshold for ‘‘significant 

economic impact’’. Our collection of 

information estimates are that the 68 

facilities converting to REH status (as 

estimated by the NC RHRP study 

referenced in the COI section) would 

face average annual costs of about 

$22,600 each (68 × $22,600 = $1,537,000 

(COI burden estimate)). The North 

Carolina Rural Health Research Program 

estimated that the 68 hospitals it 

thought most likely to convert to REH 

status had average patient revenues of 

$7.3 million. For these facilities, the 3 

percent threshold would be about 

$219,000, almost ten times our 

estimated cost of information collection. 

The CLA study does not present average 

facility revenues. However, we note that 

while it reaches a broad range of 

conversion estimates, we do not believe 

that it would have reached different 

conclusions had it presented such 

calculations. These relationships 

between revenues and costs would not 

be substantially different if the number 

of conversions was substantially fewer 

or substantially greater in number. More 

importantly, these facilities would be 

converting voluntarily to the new 

program. We expect that the costs any 

facility faces would be less than the 

anticipated gains of conversion, or it 

would not convert. This positive 

relationship of expected gains from 

conversion compared to current costs 

and revenues is explicit in the CLA 

modeling. 

The effects of the proposed policy 

changes on CAHs are even smaller. The 

average annual cost per CAH for the 

new Conditions of Participation would 

be about $2,755 each (1,360 facilities × 

$2,755 = the $3,747,000 COI estimate), 

a tiny fraction of 1 percent of annual 

patient revenues estimated in the NC 

RHRP study at about $24 million a year. 

Moreover, the proposed change in the 

definition of primary roads could 

prevent the loss of the CAH designation 

for 3 to 4 CAHs. We note that we 

propose no change in rural hospital 

standards, so they are not directly 

regulated by this proposed rule. 

For these reasons, an Initial 

Regulatory Flexibility Analysis (IRFA) is 

not required. Furthermore, as described 

provision by provision earlier in this 

preamble, we carefully sought to keep 

regulatory burdens on REH providers to 

a reasonable minimum, taking into 

account our obligation to reduce health 

care inequities, their small size, and the 

statutory and practical limitations on 

their status as providers. For example, 

we propose to allow systems composed 

of multiple and separately certified 

hospitals, CAHs, and/or REHs to have 

unified or integrated governing bodies, 

unified infection prevention and control 

and antibiotic stewardship programs, 

and unified and integrated medical staff. 

Taking all these factors into account, 

this analysis and the preamble as a 

whole meet the scope and content 

required for IRFAs. 

Accordingly, we are not preparing an 

analysis under the RFA because we 

have determined, and the Secretary 

certifies, that this proposed rule would 

not have a significant economic impact 

on a substantial number of small 

entities. We do, however, request 

comments on our estimates and 

analysis, and on any alternatives that 

would reduce unnecessarily costly 

effects. 

In addition, section 1102(b) of the Act 

requires us to prepare an RIA 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 for Medicare payment 

regulations and has fewer than 100 

beds. We are not preparing an analysis 

for section 1102(b) of the Act because 

we have determined, and the Secretary 

certifies, that this proposed rule would 

not have a significant impact on the 

operations of a substantial number of 

small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

In 2022, that threshold is approximately 

$165 million. This proposed rule would 

not impose a mandate that will result in 

the expenditure by state, local, and 

Tribal Governments, in the aggregate, or 

by the private sector, of more than $165 

million in any 1 year. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on state and local 

governments, preempts state law, or 

otherwise has Federalism implications. 

Since this regulation does not impose 

any costs on state or local governments, 

the requirements of Executive Order 

13132 are not applicable. 

In accordance with the provisions of 

Executive Order 12866, this proposed 

rule was reviewed by the Office of 

Management and Budget. 

Chiquita Brooks-LaSure, 

Administrator of the Centers for 

Medicare & Medicaid Services, 

approved this document on June 9, 

2022. 

List of Subjects 

42 CFR Part 485 

Grant programs—health, Health 

facilities, Incorporation by reference, 

Medicaid, Privacy, Reporting and 

recordkeeping requirements. 

42 CFR Part 489 

Health facilities, 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 485—CONDITIONS OF 

PARTICIPATION: SPECIALIZED 

PROVIDERS 

■ 1. The authority citation for part 485 

continues to read as follows: 

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

■ 2. Subpart E is added to read as 

follows: 

Subpart E—Conditions of Participation: 

Rural Emergency Hospitals (REHs) 

Sec. 

485.500 Basis and scope. 

485.502 Definitions. 

485.504 Basic requirements. 

485.506 Designation and certification of 

REHs. 

485.508 Condition of participation: 

Compliance with Federal, state, and 

local laws and regulations. 

485.510 Condition of participation: 

Governing body and organizational 

structure of the REH. 

485.512 Condition of participation: Medical 

staff. 

485.514 Condition of participation: 

Provision of services. 

485.516 Condition of participation: 

Emergency services. 

485.518 Condition of participation: 

Laboratory services. 

485.520 Condition of participation: 

Radiologic services. 

485.522 Condition of participation: 

Pharmaceutical services. 

485.524 Condition of participation: 

Additional outpatient medical and 

health services. 

485.526 Condition of participation: 

Infection prevention and control and 

antibiotic stewardship programs. 

485.528 Condition of participation: Staffing 

and staff responsibilities. 

485.530 Condition of participation: Nursing 

services. 

485.532 Condition of participation: 

Discharge planning. 

485.534 Condition of participation: 

Patient’s rights. 

485.536 Condition of participation: Quality 

assessment and performance 

improvement program. 


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485.538 Condition of participation: 

Agreements. 

485.540 Condition of participation: Medical 

records. 

485.542 Condition of participation: 

Emergency preparedness. 

485.544 Condition of participation: 

Physical environment. 

485.546 Condition of participation: Skilled 

nursing facility distinct part unit. 

Subpart E—Conditions of 

Participation: Rural Emergency 

Hospitals (REHs) 

§ 485.500 Basis and scope. 

Section 1861(kkk) of the Act requires 

the Secretary to establish the conditions 

REHs must meet in order to participate 

in the Medicare program and which are 

considered necessary to ensure the 

health and safety of patients receiving 

services at these entities. 

§ 485.502 Definitions. 

As used in this subpart, Rural 

Emergency Hospital or REH means an 

entity that operates for the purpose of 

providing emergency department 

services, observation care, and other 

outpatient medical and health services 

specified by the Secretary in which the 

annual per patient average length of stay 

does not exceed 24 hours. The entity 

must not provide inpatient services, 

except those furnished in a unit that is 

a distinct part licensed as a skilled 

nursing facility to furnish post-REH or 

post-hospital extended care services. 

§ 485.504 Basic requirements. 

Participation as an REH is limited to 

facilities that— 

(a) Meet the definition in § 485.502. 

(b) Have in effect a provider 

agreement as defined at § 489.3 of this 

chapter to provide services. 

(c) Meet the conditions of 

participation set out in this subpart. 

§ 485.506 Designation and certification of 

REHs. 

CMS certifies a facility as an REH if 

the facility was, as of December 27, 

2020— 

(a) A critical access hospital; or 

(b) A hospital as defined in section 

1886(d)(1)(B) of the Act with not more 

than 50 beds located in a county (or 

equivalent unit of local government) 

that is considered rural (as defined in 

section 1886(d)(2)(D) of the Act); or 

(c) A hospital as defined in section 

1886(d)(1)(B) of the Act with not more 

than 50 beds that was treated as being 

located in a rural area that has had an 

active reclassification from urban to 

rural status as specified in § 412.103 of 

this chapter as of December 27, 2020. 

§ 485.508 Condition of participation: 

Compliance with Federal, state, and local 

laws and regulations. 

(a) The REH must be in compliance 

with applicable Federal laws related to 

the health and safety of patients. 

(b) The REH must be located in a state 

that provides for the licensing of such 

hospitals under state or applicable local 

law; and is 

(1) Licensed in the state as an REH; or 

(2) Approved as meeting standards for 

licensing established by the agency of 

the state or locality responsible for 

licensing hospitals. 

(c) The REH must assure that 

personnel are licensed or meet other 

applicable standards that are required 

by state or local laws to provide services 

within the applicable scope of practice. 

§ 485.510 Condition of participation: 

Governing body and organizational 

structure of the REH. 

There must be an effective governing 

body, or responsible individual or 

individuals, that is legally responsible 

for the conduct of the REH. If an REH 

does not have an organized governing 

body, the person or persons legally 

responsible for the conduct of the REH 

must carry out the functions specified in 

this subpart that pertain to the 

governing body. 

(a) Standard: Medical staff. The 

governing body must: 

(1) Determine, in accordance with 

state law, which categories of 

practitioners are eligible candidates for 

appointment to the medical staff. 

(2) Appoint members of the medical 

staff after considering the 

recommendations of the existing 

members of the medical staff. 

(3) Ensure that the medical staff has 

bylaws. 

(4) Approve medical staff bylaws and 

other medical staff rules and 

regulations. 

(5) Ensure that the medical staff is 

accountable to the governing body for 

the quality of care provided to patients. 

(6) Ensure the criteria for selection are 

individual character, competence, 

training, experience, and judgment. 

(i) Members of the medical staff must 

be legally and professionally qualified 

for the positions to which they are 

appointed and for the performance of 

privileges granted. The REH grants 

privileges in accordance with 

recommendations from qualified 

medical personnel. 

(ii) Medical staff privileges must be 

periodically reappraised by the REH. 

The scope of procedures performed in 

the REH must be periodically reviewed 

and amended as appropriate. 

(iii) If the REH assigns patient care 

responsibilities to practitioners other 

than physicians, it must have 

established policies and procedures, 

approved by the governing body, for 

overseeing and evaluating their clinical 

activities. 

(7) Ensure that under no 

circumstances is the accordance of staff 

membership or professional privileges 

in the REH dependent solely upon 

certification, fellowship, or membership 

in a specialty body or society. 

(8) Ensure that, when telemedicine 

services are furnished to the REH’s 

patients through an agreement with a 

distant-site hospital, the agreement is 

written and that it specifies that it is the 

responsibility of the governing body of 

the distant-site hospital to meet the 

requirements in paragraphs (a)(1) 

through (7) of this section with regard 

to the distant-site hospital’s physicians 

and practitioners providing 

telemedicine services. The governing 

body of the REH whose patients are 

receiving the telemedicine services may, 

in accordance with § 485.512(a)(3), grant 

privileges based on its medical staff 

recommendations that rely on 

information provided by the distant-site 

hospital. 

(9) Ensure that when telemedicine 

services are furnished to the REH’s 

patients through an agreement with a 

distant-site telemedicine entity, the 

written agreement specifies that the 

distant-site telemedicine entity is a 

contractor of services to the REH and as 

such, in accordance with paragraph (b) 

of this section, furnishes the contracted 

services in a manner that permits the 

REH to comply with all applicable 

conditions of participation for the 

contracted services, including, but not 

limited to, the requirements in 

paragraphs (a)(1) through (7) of this 

section with regard to the distant-site 

telemedicine entity’s physicians and 

practitioners providing telemedicine 

services. The governing body of the REH 

whose patients are receiving the 

telemedicine services may, in 

accordance with § 485.512(a)(4), grant 

privileges to physicians and 

practitioners employed by the distantsite telemedicine entity based on such 

REH’s medical staff recommendations; 

such staff recommendations may rely on 

information provided by the distant-site 

telemedicine entity. 

(10) Consult directly with the 

individual assigned the responsibility 

for the organization and conduct of the 

REH’s medical staff, or their designee. 

At a minimum, this direct consultation 

must occur periodically throughout the 

fiscal or calendar year and include 

discussion of matters related to the 

quality of medical care provided to 

patients of the REH. For a multi-facility 


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system, including a multi-hospital or 

multi-REH system, using a single 

governing body, the single multi-facility 

or multi-REH system governing body 

must consult directly with the 

individual responsible for the organized 

medical staff (or their designee) of each 

hospital or REH within its system in 

addition to the other requirements of 

this paragraph (a). 

(b) Standard: Contracted services. The 

governing body must be responsible for 

services furnished in the REH whether 

or not they are furnished under 

contracts. The governing body must 

ensure that a contractor of services 

(including one for shared services and 

joint ventures) furnishes services that 

permit the REH to comply with all 

applicable conditions of participation 

and standards for the contracted 

services. 

(1) The governing body must ensure 

that the services performed under a 

contract are provided in a safe and 

effective manner. 

(2) The REH must maintain a list of 

all contracted services, including the 

scope and nature of the services 

provided. 

§ 485.512 Condition of participation: 

Medical staff. 

The REH must 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 

REH. 

(a) Standard: Eligibility and process 

for appointment to medical staff. The 

medical staff must be composed of 

doctors of medicine or osteopathy. In 

accordance with state law, including 

scope-of-practice laws, the medical staff 

may also include other categories of 

physicians (as listed at paragraph (c)(1) 

of this section) and non-physician 

practitioners who are determined to be 

eligible for appointment by the 

governing body. 

(1) The medical staff must 

periodically conduct appraisals of its 

members. 

(2) The medical staff must examine 

the credentials of all eligible candidates 

for medical staff membership and make 

recommendations to the governing body 

on the appointment of these candidates 

in accordance with state law, including 

scope-of-practice laws, and the medical 

staff bylaws, rules, and regulations. A 

candidate who has been recommended 

by the medical staff and who has been 

appointed by the governing body is 

subject to all medical staff bylaws, rules, 

and regulations, in addition to the 

requirements contained in this section. 

(3) When telemedicine services are 

furnished to the REH’s patients through 

an agreement with a distant-site 

hospital, the governing body of the REH 

whose patients are receiving the 

telemedicine services may choose, in 

lieu of the requirements in paragraphs 

(a)(1) and (2) of this section, to have its 

medical staff rely upon the credentialing 

and privileging decisions made by the 

distant-site hospital when making 

recommendations on privileges for the 

individual distant-site physicians and 

practitioners providing such services, if 

the REH’s governing body ensures, 

through its written agreement with the 

distant-site hospital, that all of the 

following provisions are met: 

(i) The distant-site hospital providing 

the telemedicine services is a Medicareparticipating hospital. 

(ii) The individual distant-site 

physician or practitioner is privileged at 

the distant-site hospital providing the 

telemedicine services, which provides a 

current list of the distant-site 

physician’s or practitioner’s privileges 

at the distant-site hospital. 

(iii) The individual distant-site 

physician or practitioner holds a license 

issued or recognized by the state in 

which the REH whose patients are 

receiving the telemedicine services is 

located. 

(iv) With respect to a distant-site 

physician or practitioner, who holds 

current privileges at the REH whose 

patients are receiving the telemedicine 

services, the REH has evidence of an 

internal review of the distant-site 

physician’s or practitioner’s 

performance of these privileges and 

sends the distant-site hospital such 

performance information for use in the 

periodic appraisal of the distant-site 

physician or practitioner. At a 

minimum, this information must 

include all adverse events that result 

from the telemedicine services provided 

by the distant-site physician or 

practitioner to the REH’s patients and 

all complaints the REH has received 

about the distant-site physician or 

practitioner. 

(4) When telemedicine services are 

furnished to the REH’s patients through 

an agreement with a distant-site 

telemedicine entity, the governing body 

of the REH whose patients are receiving 

the telemedicine services may choose, 

in lieu of the requirements in 

paragraphs (a)(1) and (2) of this section, 

to have its medical staff rely upon the 

credentialing and privileging decisions 

made by the distant-site telemedicine 

entity when making recommendations 

on privileges for the individual distantsite physicians and practitioners 

providing such services, if the REH’s 

governing body ensures, through its 

written agreement with the distant-site 

telemedicine entity, that the distant-site 

telemedicine entity furnishes services 

that, in accordance with paragraph (d) 

of this section, permit the REH to 

comply with all applicable conditions of 

participation for the contracted services. 

The REH’s governing body must also 

ensure, through its written agreement 

with the distant-site telemedicine entity, 

that all of the following provisions are 

met: 

(i) The distant-site telemedicine 

entity’s medical staff credentialing and 

privileging process and standards at 

least meet the standards at 

§ 485.510(a)(1) through (7) and 

paragraphs (a)(1) and (2) of this section. 

(ii) The individual distant-site 

physician or practitioner is privileged at 

the distant-site telemedicine entity 

providing the telemedicine services, 

which provides the REH with a current 

list of the distant-site physician’s or 

practitioner’s privileges at the distantsite telemedicine entity. 

(iii) The individual distant-site 

physician or practitioner holds a license 

issued or recognized by the state in 

which the REH whose patients are 

receiving such telemedicine services is 

located. 

(iv) With respect to a distant-site 

physician or practitioner, who holds 

current privileges at the REH whose 

patients are receiving the telemedicine 

services, the REH has evidence of an 

internal review of the distant-site 

physician’s or practitioner’s 

performance of these privileges and 

sends the distant-site telemedicine 

entity such performance information for 

use in the periodic appraisal of the 

distant-site physician or practitioner. At 

a minimum, this information must 

include all adverse events that result 

from the telemedicine services provided 

by the distant-site physician or 

practitioner to the REH’s patients, and 

all complaints the REH has received 

about the distant-site physician or 

practitioner. 

(b) Standard: Medical staff 

organization and accountability. The 

medical staff must be well organized 

and accountable to the governing body 

for the quality of the medical care 

provided to patients. 

(1) The medical staff must be 

organized in a manner approved by the 

governing body. 

(2) If the medical staff has an 

executive committee, a majority of the 

members of the committee must be 

doctors of medicine or osteopathy. 

(3) The responsibility for organization 

and conduct of the medical staff must be 

assigned only to one of the following: 


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(i) An individual doctor of medicine 

or osteopathy. 

(ii) A doctor of dental surgery or 

dental medicine, when permitted by 

state law of the state in which the 

hospital is located. 

(iii) A doctor of podiatric medicine, 

when permitted by state law of the state 

in which the hospital is located. 

(4) If an REH is part of a system 

consisting of multiple separately 

certified hospitals, critical access 

hospitals, and/or REHs, and the system 

elects to have a unified and integrated 

medical staff for its member hospitals, 

critical access hospitals, and/or REHs 

after determining that such a decision is 

in accordance with all applicable state 

and local laws, each separately certified 

REH must demonstrate that: 

(i) The medical staff members of each 

separately certified REH in the system 

(that is, all medical staff members who 

hold specific privileges to practice at 

that REH) have voted by majority, in 

accordance with medical staff bylaws, 

either to accept a unified and integrated 

medical staff structure or to opt out of 

such a structure and to maintain a 

separate and distinct medical staff for 

their respective REH; 

(ii) The unified and integrated 

medical staff has bylaws, rules, and 

requirements that describe its processes 

for self-governance, appointment, 

credentialing, privileging, and oversight, 

as well as its peer review policies and 

due process rights guarantees, and 

which include a process for the 

members of the medical staff of each 

separately certified REH (that is, all 

medical staff members who hold 

specific privileges to practice at that 

REH) to be advised of their rights to opt 

out of the unified and integrated 

medical staff structure after a majority 

vote by the members to maintain a 

separate and distinct medical staff for 

their REH; 

(iii) The unified and integrated 

medical staff is established in a manner 

that takes into account each member 

REH’s unique circumstances and any 

significant differences in patient 

populations and services offered in each 

hospital, CAH, and REH; and 

(iv) The unified and integrated 

medical staff establishes and 

implements policies and procedures to 

ensure that the needs and concerns 

expressed by members of the medical 

staff, at each of its separately certified 

hospitals, CAHs, and REHs, regardless 

of practice or location, are given due 

consideration, and that the unified and 

integrated medical staff has mechanisms 

in place to ensure that issues localized 

to particular hospitals, CAHs, and REHs 

are duly considered and addressed. 

(c) Standard: Medical staff bylaws. 

The medical staff must adopt and 

enforce bylaws to carry out its 

responsibilities. The bylaws must: 

(1) Be approved by the governing 

body. 

(2) Include a statement of the duties 

and privileges of each category of 

medical staff (for example, active, 

courtesy, etc.). 

(3) Describe the organization of the 

medical staff. 

(4) Describe the qualifications to be 

met by a candidate in order for the 

medical staff to recommend that the 

candidate be appointed by the 

governing body. 

(5) Include criteria for determining 

the privileges to be granted to 

individual practitioners and a procedure 

for applying the criteria to individuals 

requesting privileges. For distant-site 

physicians and practitioners requesting 

privileges to furnish telemedicine 

services under an agreement with the 

REH, the criteria for determining 

privileges and the procedure for 

applying the criteria are also subject to 

the requirements in § 485.510(a)(8) and 

(9) and paragraphs (a)(3) and (4) of this 

section. 

§ 485.514 Condition of participation: 

Provision of services. 

(a) The REH’s health care services 

must be furnished in accordance with 

appropriate written policies that are 

consistent with applicable state law. 

(b) The policies must be developed 

with the advice of members of the REH’s 

professional health care 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 

§ 485.528(b)(1). 

(c) The policies must include the 

following: 

(1) A description of the services the 

REH furnishes, including those 

furnished through agreement or 

arrangement. 

(2) Policies and procedures for 

emergency medical services. 

(3) 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, and procedures for the periodic 

review and evaluation of the services 

furnished by the REH. 

(4) Policies and procedures that 

address the post-acute care needs of 

patients receiving services in the REH. 

(d) The policies must be reviewed at 

least biennially by the group of 

professional personnel required under 

paragraph (b) of this section and 

updated as necessary by the REH. 

§ 485.516 Condition of participation: 

Emergency services. 

The REH must provide the emergency 

care necessary to meet the needs of its 

patients in accordance with acceptable 

standards of practice. 

(a) Standard: Organization and 

direction. The emergency services of the 

REH must be—(1) Organized under the 

direction of a qualified member of the 

medical staff; and 

(2) Integrated with other departments 

of the REH. 

(b) Standard: Personnel. There must 

be adequate medical and nursing 

personnel qualified in emergency care 

to meet the written emergency 

procedures and needs anticipated by the 

facility. 

(c) Standard: Compliance with CAH 

requirements. The REH must meet the 

requirements specified in § 485.618, 

with respect to: 

(1) 24-hour availability of emergency 

services (§ 485.618(a)). 

(2) Equipment, supplies, and 

medication (§ 485.618(b)). 

(3) Blood and blood products 

(§ 485.618(c)). 

(4) Personnel (§ 485.618(d)). 

(5) Coordination with emergency 

response systems (§ 485.618(e)). 

§ 485.518 Condition of participation: 

Laboratory services. 

The REH must provide basic 

laboratory services essential to the 

immediate diagnosis and treatment of 

the patient consistent with nationally 

recognized standards of care for 

emergency services. The REH must 

ensure that— 

(a) Laboratory services are available, 

either directly or through a contractual 

agreement with a certified laboratory 

that meets requirements of part 493 of 

this chapter. 

(b) Emergency laboratory services are 

available 24 hours a day. 

§ 485.520 Condition of participation: 

Radiologic services. 

The REH must maintain, or have 

available, diagnostic radiologic services. 

If therapeutic services are also provided, 

the therapeutic services, as well as the 

diagnostic services, must be furnished 

by the REH and provided by personnel 

qualified under state law. The REH must 

ensure that REH patients or personnel 

are not exposed to radiation hazards. 

(a) Standard: Radiologic services. The 

REH must maintain, or have available, 

radiologic services according to needs of 

the patients. 

(b) Standard: Safety for patients and 

personnel. The radiologic services, 


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particularly ionizing radiology 

procedures, must be free from hazards 

for patients and personnel. 

(1) Proper safety precautions must be 

maintained against radiation hazards. 

This includes adequate shielding for 

patients, personnel, and facilities, as 

well as appropriate storage, use, and 

disposal of radioactive materials. 

(2) Periodic inspection of equipment 

must be made and hazards identified 

must be promptly corrected. 

(3) Radiation workers must be 

checked periodically, by the use of 

exposure meters or badge tests, for 

amount of radiation exposure. 

(4) Radiologic services must be 

provided only on the order of 

practitioners with clinical privileges or, 

consistent with state law, of other 

practitioners authorized by the medical 

staff and the governing body to order the 

services. 

(c) Standard: Personnel. (1) The REH 

must have a full-time, part-time, or 

consulting qualified radiologist, or other 

personnel qualified under State law, to 

interpret only those radiologic tests that 

are determined by the medical staff to 

require specialized knowledge. For 

purposes of this section, a radiologist is 

a doctor of medicine or osteopathy who 

is qualified by education and experience 

in radiology. 

(2) Only personnel designated as 

qualified by the medical staff may use 

the radiologic equipment and 

administer procedures. 

(d) Standard: Records. Records of 

radiologic services must be maintained. 

(1) The radiologist or other 

practitioner who performs radiology 

services must sign reports of their 

interpretations. 

(2) The REH must maintain the 

following for at least 5 years: 

(i) Copies of reports and printouts. 

(ii) Films, scans, and other image 

records, as appropriate. 

§ 485.522 Condition of participation: 

Pharmaceutical services. 

The REH must have pharmaceutical 

services that meet the needs of its 

patients. The REH must have a 

pharmacy or a drug storage area that is 

directed by a registered pharmacist or 

other qualified individual in accordance 

with state scope of practice laws. The 

medical staff is responsible for 

developing policies and procedures that 

minimize drug errors. This function 

may be delegated to the REH’s registered 

pharmacist or other qualified 

individual. 

(a) Standard: Pharmacy management 

and administration. The pharmacy or 

drug storage area must be administered 

in accordance with accepted 

professional principles and in 

accordance with state and Federal laws. 

(1) A pharmacist or competent 

individual in accordance with state 

scope of practice laws must be 

responsible for developing, supervising, 

and coordinating all the activities of the 

pharmacy services. The pharmacist or 

competent individual in accordance 

with state law and scope of practice 

must be available for a sufficient time to 

provide oversight of the REH’s 

pharmacy services based on the scope 

and complexity of the services offered at 

the REH. 

(2) The pharmaceutical service must 

have an adequate number of personnel 

to ensure quality pharmaceutical 

services for the provision of all services 

provided by the REH. 

(3) Current and accurate records must 

be kept of the receipt and disposition of 

all scheduled drugs. 

(b) Standard: Delivery of services. 

Drugs and biologicals must be 

controlled and distributed in 

accordance with applicable standards of 

practice, consistent with Federal and 

state law, to ensure patient safety. 

(1) All compounding, packaging, and 

dispensing of drugs must be done by a 

licensed pharmacist or a licensed 

physician, or under the supervision of a 

pharmacist or competent individual in 

accordance with state law and scope of 

practice and performed consistent with 

state and Federal laws. 

(2) All drugs and biologicals must be 

kept in a secure area, and locked when 

appropriate. 

(i) All drugs listed in Schedules II, III, 

IV, and V of the Comprehensive Drug 

Abuse Prevention and Control Act of 

1970 (21 U.S.C. 801 et seq.) must be 

kept locked within a secure area. 

(ii) Only authorized personnel may 

have access to locked areas. 

(3) Outdated, mislabeled, or otherwise 

unusable drugs and biologicals must not 

be available for patient use. 

(4) Drugs and biologicals must be 

removed from the pharmacy or storage 

area only by personnel designated in the 

policies of the medical staff and 

pharmaceutical service, in accordance 

with Federal and state law. 

(c) Standard: Administration of drugs. 

Drugs must be prepared and 

administered according to established 

policies and acceptable standards of 

practice. 

(1) Adverse reactions must be 

reported to the physician responsible for 

the patient and must be documented in 

the record. 

(2) Blood transfusions, blood 

products, and intravenous medications 

must be administered in accordance 

with state law and approved medical 

staff policies and procedures. 

(3) Orders given orally for drugs and 

biologicals must be followed by a 

written order, signed by the prescribing 

physician or other authorized 

prescriber. 

(4) There must be an REH procedure 

for reporting transfusion reactions, 

adverse drug reactions, and errors in 

administration of drugs. 

§ 485.524 Condition of participation: 

Additional outpatient medical and health 

services. 

If the REH provides outpatient 

medical and health services in addition 

to providing emergency services and 

observation care, the medical and health 

services must be appropriately 

organized and meet the needs of the 

patients in accordance with acceptable 

standards of practice. 

(a) Standard: Patient services. The 

REH may provide outpatient and 

medical health diagnostic and 

therapeutic items and services that are 

commonly furnished in a physician’s 

office or at another entry point into the 

health care delivery system that include, 

but are not limited to, radiology, 

laboratory, outpatient rehabilitation, 

surgical, maternal health, and 

behavioral health services. If the REH 

provides outpatient and medical health 

diagnostic and therapeutic items and 

services, those items and services must 

align with the health needs of the 

community served by the REH. If the 

REH provides outpatient medical and 

health services in addition to providing 

emergency services, the REH must— 

(1) Provide items and services based 

on nationally recognized guidelines and 

standards of practice. 

(2) Have a system in place for referral 

from the REH to different levels of care, 

including follow-up care, as 

appropriate. 

(3) Have effective communication 

systems in place between the REH and 

the patient (or responsible individual) 

and their family, ensuring that the REH 

is responsive to their needs and 

preferences. 

(4) Have established relationships 

with hospitals that have the resources 

and capacity available to deliver care 

that is beyond the scope of care 

delivered at the REH. 

(5) Have personnel providing the 

services in paragraphs (a)(1) through (4) 

of this section who meet the 

requirements in paragraph (b) of this 

section. 

(b) Standard: Personnel for additional 

outpatient and medical health services. 

The REH must— 

(1) Assign one or more individuals to 

be responsible for outpatient services. 


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(2) Have appropriate professional and 

nonprofessional personnel available at 

each location where outpatient services 

are offered, based on the scope and 

complexity of outpatient services. 

(3) For any specialty services offered 

at the REH, have a doctor of medicine 

or osteopathy, nurse practitioner, 

clinical nurse specialist, or physician 

assistant providing services with 

experience and training in the specialty 

service area and in accordance with 

their scope of practice. 

(c) Standard: Orders for outpatient 

medical and health services. Outpatient 

medical and health services must be 

ordered by a practitioner who meets the 

following conditions: 

(1) Is responsible for the care of the 

patient. 

(2) Is licensed in the state where they 

provide care to the patient. 

(3) Is acting within their scope of 

practice under state law. 

(4) Is authorized in accordance with 

state law and policies adopted by the 

medical staff, and approved by the 

governing body, to order the applicable 

outpatient services. This applies to the 

following: 

(i) All practitioners who are 

appointed to the REH’s medical staff 

and who have been granted privileges to 

order the applicable outpatient services. 

(ii) All practitioners not appointed to 

the medical staff, but who satisfy the 

requirements of paragraphs (c)(1) 

through (4) of this section for 

authorization by the medical staff and 

the REH for ordering the applicable 

outpatient services for their patients. 

(d) Standard: Surgical services. If the 

REH provides outpatient surgical 

services, surgical procedures must be 

performed in a safe manner by qualified 

practitioners who have been granted 

clinical privileges by the governing 

body, or responsible individual, of the 

REH in accordance with the designation 

requirements under paragraph (a) of this 

section. 

(1) Designation of qualified 

practitioners. The REH designates the 

practitioners who are allowed to 

perform surgery for REH patients, in 

accordance with its approved policies 

and procedures, and with state scope of 

practice laws. Surgery is performed only 

by— 

(i) A doctor of medicine or 

osteopathy, including an osteopathic 

practitioner recognized under section 

1101(a)(7) of the Act; 

(ii) A doctor of dental surgery or 

dental medicine; or 

(iii) A doctor of podiatric medicine. 

(2) Anesthetic risk and evaluation. (i) 

A qualified practitioner, as specified in 

paragraph (a) of this section, must 

examine the patient immediately before 

surgery to evaluate the risk of the 

procedure to be performed. 

(ii) A qualified practitioner, as 

specified in paragraph (d)(3) of this 

section, must examine each patient 

before surgery to evaluate the risk of 

anesthesia. 

(iii) Before discharge from the REH, 

each patient must be evaluated for 

proper anesthesia recovery by a 

qualified practitioner, as specified in 

paragraph (d)(3) of this section. 

(3) Administration of anesthesia. The 

REH designates the person who is 

allowed to administer anesthesia to REH 

patients in accordance with its 

approved policies and procedures and 

with state scope-of-practice laws. 

(i) Anesthesia must be administered 

by only— 

(A) A qualified anesthesiologist; 

(B) A doctor of medicine or 

osteopathy other than an 

anesthesiologist; including an 

osteopathic practitioner recognized 

under section 1101(a)(7) of the Act; 

(C) A doctor of dental surgery or 

dental medicine; 

(D) A doctor of podiatric medicine; 

(E) A certified registered nurse 

anesthetist (CRNA), as defined in 

§ 410.69(b) of this chapter; 

(F) An anesthesiologist’s assistant, as 

defined in § 410.69(b) of this chapter; or 

(G) A supervised trainee in an 

approved educational program, as 

described in § 413.85 or §§ 413.76 

through 413.83 of this chapter. 

(ii) In those cases in which a CRNA 

administers the anesthesia, the 

anesthetist must be under the 

supervision of the operating practitioner 

except as provided in paragraph (e) of 

this section. An anesthesiologist’s 

assistant who administers anesthesia 

must be under the supervision of an 

anesthesiologist. 

(4) Discharge. All patients are 

discharged in the company of a 

responsible adult, except those 

exempted by the practitioner who 

performed the surgical procedure. 

(5) Standard: State exemption. (i) An 

REH may be exempted from the 

requirement for physician supervision 

of CRNAs as described in paragraph 

(d)(3) of this section, if the state in 

which the REH is located submits a 

letter to CMS signed by the Governor, 

following consultation with the State’s 

Boards of Medicine and Nursing, 

requesting exemption from physician 

supervision for CRNAs. The letter from 

the Governor must attest that they have 

consulted with the State Boards of 

Medicine and Nursing about issues 

related to access to and the quality of 

anesthesia services in the state and has 

concluded that it is in the best interests 

of the state’s citizens to opt-out of the 

current physician supervision 

requirement, and that the opt-out is 

consistent with state law. 

(ii) The request for exemption and 

recognition of state laws and the 

withdrawal of the request may be 

submitted at any time, and are effective 

upon submission. 

§ 485.526 Condition of participation: 

Infection prevention and control and 

antibiotic stewardship programs. 

The REH must have active facilitywide programs for the surveillance, 

prevention, and control of healthcareassociated infections (HAIs) and other 

infectious diseases, and for the 

optimization of antibiotic use through 

stewardship. The programs must 

demonstrate adherence to nationally 

recognized infection prevention and 

control guidelines, as well as to best 

practices for improving antibiotic use 

where applicable, and for reducing the 

development and transmission of HAIs 

and antibiotic-resistant organisms. 

Infection prevention and control 

problems and antibiotic use issues 

identified in the programs must be 

addressed in collaboration with the 

facility-wide quality assessment and 

performance improvement (QAPI) 

program. 

(a) Standard: Infection prevention and 

control program organization and 

policies. The REH must demonstrate 

that: 

(1) An individual (or individuals), 

who is qualified through education, 

training, experience, or certification in 

infection prevention and control, is 

appointed by the governing body, or 

responsible individual, as the infection 

preventionist(s)/infection control 

professional(s) responsible for the 

infection prevention and control 

program and that the appointment is 

based on the recommendations of 

medical staff leadership and nursing 

leadership; 

(2) The infection prevention and 

control program, as documented in its 

policies and procedures, employs 

methods for preventing and controlling 

the transmission of infections within the 

REH and between the REH and other 

health care settings; 

(3) The infection prevention and 

control program include surveillance, 

prevention, and control of HAIs, 

including maintaining a clean and 

sanitary environment to avoid sources 

and transmission of infection, and that 

the program also addresses any 

infection control issues identified by 

public health authorities; and 


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(4) The infection prevention and 

control program reflects the scope and 

complexity of the services furnished by 

the REH. 

(b) Standard: Antibiotic stewardship 

program organization and policies. The 

REH must demonstrate that— 

(1) An individual (or individuals), 

who is qualified through education, 

training, or experience in infectious 

diseases and/or antibiotic stewardship, 

is appointed by the governing body, or 

responsible individual, as the leader(s) 

of the antibiotic stewardship program 

and that the appointment is based on 

the recommendations of medical staff 

leadership and pharmacy leadership; 

(2) The facility-wide antibiotic 

stewardship program: 

(i) Demonstrates coordination among 

all components of the REH responsible 

for antibiotic use and resistance, 

including, but not limited to, the 

infection prevention and control 

program, the QAPI program, the medical 

staff, nursing services, and pharmacy 

services; 

(ii) Documents the evidence-based use 

of antibiotics in all departments and 

services of the REH; and 

(iii) Documents any improvements, 

including sustained improvements, in 

proper antibiotic use; 

(3) The antibiotic stewardship 

program adheres to nationally 

recognized guidelines, as well as best 

practices, for improving antibiotic use; 

and 

(4) The antibiotic stewardship 

program reflects the scope and 

complexity of the services furnished by 

an REH. 

(c) Standard: Leadership 

responsibilities. (1) The governing body, 

or responsible individual, must ensure 

all of the following: 

(i) Systems are in place and 

operational for the tracking of all 

infection surveillance, prevention and 

control, and antibiotic use activities, in 

order to demonstrate the 

implementation, success, and 

sustainability of such activities. 

(ii) All HAIs and other infectious 

diseases identified by the infection 

prevention and control program as well 

as antibiotic use issues identified by the 

antibiotic stewardship program are 

addressed in collaboration with the 

REH’s QAPI leadership. 

(2) The infection prevention and 

control professional(s) are responsible 

for: 

(i) The development and 

implementation of facility-wide 

infection surveillance, prevention, and 

control policies and procedures that 

adhere to nationally recognized 

guidelines. 

(ii) All documentation, written or 

electronic, of the infection prevention 

and control program and its 

surveillance, prevention, and control 

activities. 

(iii) Communication and collaboration 

with the REH’s QAPI program on 

infection prevention and control issues. 

(iv) Competency-based training and 

education of REH personnel and staff, 

including medical staff, and, as 

applicable, personnel providing 

contracted services in the REH, on the 

practical applications of infection 

prevention and control guidelines, 

policies and procedures. 

(v) The prevention and control of 

HAIs, including auditing of adherence 

to infection prevention and control 

policies and procedures by REH 

personnel. 

(vi) Communication and collaboration 

with the antibiotic stewardship 

program. 

(3) The leader(s) of the antibiotic 

stewardship program is responsible for: 

(i) The development and 

implementation of a facility-wide 

antibiotic stewardship program, based 

on nationally recognized guidelines, to 

monitor and improve the use of 

antibiotics. 

(ii) All documentation, written or 

electronic, of antibiotic stewardship 

program activities. 

(iii) Communication and collaboration 

with medical staff, nursing, and 

pharmacy leadership, as well as the 

REH’s infection prevention and control 

and QAPI programs, on antibiotic use 

issues. 

(iv) Competency-based training and 

education of REH personnel and staff, 

including medical staff, and, as 

applicable, personnel providing 

contracted services in the REH, on the 

practical applications of antibiotic 

stewardship guidelines, policies, and 

procedures. 

(d) Standard: Unified and integrated 

infection prevention and control and 

antibiotic stewardship programs for 

multi-facility systems. If a REH is part of 

a system consisting of multiple 

separately certified hospitals, CAHs, 

and/or REHs using a system governing 

body that is legally responsible for the 

conduct of two or more hospitals, CAHs, 

and/or REHs, the system governing body 

can elect to have unified and integrated 

infection prevention and control and 

antibiotic stewardship programs for all 

of its member facilities 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 REHs meets all of the 

requirements of this section. Each 

separately certified REH subject to the 

system governing body must 

demonstrate that: 

(1) The unified and integrated 

infection prevention and control and 

antibiotic stewardship programs are 

established in a manner that takes into 

account each member REH’s unique 

circumstances and any significant 

differences in patient populations and 

services offered in each REH; 

(2) The unified and integrated 

infection prevention and control and 

antibiotic stewardship programs 

establish and implement policies and 

procedures to ensure that the needs and 

concerns of each of its separately 

certified REHs, regardless of practice or 

location, are given due consideration; 

(3) The unified and integrated 

infection prevention and control and 

antibiotic stewardship programs have 

mechanisms in place to ensure that 

issues localized to particular REHs are 

duly considered and addressed; and 

(4) A qualified individual (or 

individuals) with expertise in infection 

prevention and control and in antibiotic 

stewardship has been designated at the 

REH as responsible for communicating 

with the unified infection prevention 

and control and antibiotic stewardship 

programs, for implementing and 

maintaining the policies and procedures 

governing infection prevention and 

control and antibiotic stewardship as 

directed by the unified infection 

prevention and control and antibiotic 

stewardship programs, and for 

providing education and training on the 

practical applications of infection 

prevention and control and antibiotic 

stewardship to REH staff. 

(e) COVID–19 and Seasonal Influenza 

reporting. Beginning at the conclusion 

of the COVID–19 Public Health 

Emergency, as defined in § 400.200 of 

this chapter, and continuing until April 

30, 2024, except when the Secretary 

specifies an earlier end date for the 

requirements of this paragraph (e), the 

REH must electronically report 

information about COVID–19 and 

seasonal influenza in a standardized 

format specified by the Secretary. 

(1) Related to COVID–19, to the extent 

as required by the Secretary, this report 

must include the following data 

elements: 

(i) Suspected and confirmed COVID– 

19 infections among patients and staff. 

(ii) Total COVID–19 deaths among 

patients and staff. 

(iii) Personal protective equipment 

and testing supplies. 

(iv) Ventilator use, capacity, and 

supplies. 

(v) Total patient census and capacity. 


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(vi) Staffing shortages. 

(vii) COVID–19 vaccine 

administration data of patients and staff. 

(viii) Relevant therapeutic inventories 

or usage, or both. 

(2) Related to seasonal influenza, to 

the extent as required by the Secretary, 

this report must include the following 

data elements: 

(i) Confirmed influenza infections 

among patients and staff. 

(ii) Total influenza deaths among 

patients and staff. 

(iii) Confirmed co-morbid influenza 

and COVID–19 infections among 

patients and staff. 

(f) Standard: Reporting of data related 

to viral and bacterial pathogens and 

infectious diseases of pandemic or 

epidemic potential. The REH must 

electronically report information on 

Acute Respiratory Illness (including, but 

not limited to, Seasonal Influenza Virus, 

Influenza-like Illness, and Severe Acute 

Respiratory Infection), SARS–CoV–2/ 

COVID–19, and other viral and bacterial 

pathogens and infectious diseases of 

pandemic or epidemic potential only 

when the Secretary has declared a 

Public Health Emergency (PHE), as 

defined in § 400.200 of this chapter, 

directly related to such specific 

pathogens and infectious diseases. The 

requirements of this paragraph (f) will 

be applicable to local, state, regional, or 

national PHEs as declared by the 

Secretary. 

(1) The REH must electronically 

report information about the infectious 

disease pathogen, relevant to the 

declared PHE, in a standardized format 

specified by the Secretary. To the extent 

as required by the Secretary, this report 

must include, the following: 

(i) Suspected and confirmed 

infections of the relevant infectious 

disease pathogen among patients and 

staff. 

(ii) Total deaths attributed to the 

relevant infectious disease pathogen 

among patients and staff. 

(iii) Personal protective equipment 

and other relevant supplies in the REH. 

(iv) Capacity and supplies in the REH 

relevant to the immediate and long term 

treatment of the relevant infectious 

disease pathogen, such as ventilator and 

dialysis/continuous renal replacement 

therapy capacity and supplies. 

(v) Total patient census, capacity, and 

capability. 

(vi) Staffing shortages. 

(vii) Vaccine administration data of 

patients and staff for conditions 

monitored under this section and where 

a specific vaccine is applicable. 

(viii) Relevant therapeutic inventories 

or usage, or both. 

(ix) Isolation capacity, including 

airborne isolation capacity. 

(x) Key co-morbidities or exposure 

risk factors, or both, of patients being 

treated for the pathogen or disease of 

interest in this section that are captured 

with interoperable data standards and 

elements. 

(2) Unless the Secretary specifies an 

alternative format by which the REH 

must report these data elements, the 

REH must report the applicable 

infection (confirmed and suspected) and 

vaccination data in a format that 

provides person-level information, 

which must include medical record 

identifier, race, ethnicity, age, sex, 

residential county and zip code, and 

relevant comorbidities for affected 

patients. Facilities must not report any 

directly or potentially individuallyidentifiable information for affected 

patients (for example, name, social 

security number) that is not set out in 

this section or otherwise specified by 

the Secretary. 

(3) The REH must provide the 

information specified in this paragraph 

(f) on a daily basis, unless the Secretary 

specifies a lesser frequency, to the 

Centers for Disease Control and 

Prevention’s (CDC) National Healthcare 

Safety Network or other CDC-supported 

surveillance systems as determined by 

the Secretary. 

(g) Standard: COVID–19 Vaccination 

of REH staff. Until November 4, 2024, 

unless the Secretary specifies an earlier 

end date for the requirements of this 

paragraph (g), the REH must develop 

and implement policies and procedures 

to ensure that all staff are fully 

vaccinated for COVID–19. For purposes 

of this section, staff are considered fully 

vaccinated if it has been 2 weeks or 

more since they completed a primary 

vaccination series for COVID–19. The 

completion of a primary vaccination 

series for COVID–19 is defined here as 

the administration of a single-dose 

vaccine, or the administration of all 

required doses of a multi-dose vaccine. 

(1) Regardless of clinical 

responsibility or patient contact, the 

policies and procedures must apply to 

the following REH staff, who provide 

any care, treatment, or other services for 

the REH and/or its patients: 

(i) REH employees; 

(ii) Licensed practitioners; 

(iii) Students, trainees, and 

volunteers; and 

(iv) Individuals who provide care, 

treatment, or other services for the REH 

and/or its patients, under contract or by 

other arrangement. 

(2) The policies and procedures of 

this section do not apply to the 

following REH staff: 

(i) Staff who exclusively provide 

telehealth or telemedicine services 

outside of the REH setting and who do 

not have any direct contact with 

patients and other staff specified in 

paragraph (f)(1) of this section; and 

(ii) Staff who provide support services 

for the REH that are performed 

exclusively outside of the REH setting 

and who do not have any direct contact 

with patients and other staff specified in 

paragraph (f)(1) of this section. 

(3) The policies and procedures must 

include, at a minimum, the following 

components: 

(i) A process for ensuring all staff 

specified in paragraph (f)(1) of this 

section (except for those staff who have 

pending requests for, or who have been 

granted, exemptions to the vaccination 

requirements of this section, or those 

staff for whom COVID–19 vaccination 

must be temporarily delayed, as 

recommended by the CDC, due to 

clinical precautions and considerations) 

have received, at a minimum, a singledose COVID–19 vaccine, or the first 

dose of the primary vaccination series 

for a multi-dose COVID–19 vaccine 

prior to staff providing any care, 

treatment, or other services for the REH 

and/or its patients; 

(ii) A process for ensuring that all staff 

specified in paragraph (f)(1) of this 

section are fully vaccinated for COVID– 

19, except for those staff who have been 

granted exemptions to the vaccination 

requirements of this section, or those 

staff for whom COVID–19 vaccination 

must be temporarily delayed, as 

recommended by the CDC, due to 

clinical precautions and considerations; 

(iii) A process for ensuring the 

implementation of additional 

precautions, intended to mitigate the 

transmission and spread of COVID–19, 

for all staff who are not fully vaccinated 

for COVID–19; 

(iv) A process for tracking and 

securely documenting the COVID–19 

vaccination status of all staff specified 

in paragraph (f)(1) of this section; 

(v) A process for tracking and securely 

documenting the COVID–19 vaccination 

status of any staff who have obtained 

any booster doses as recommended by 

the CDC; 

(vi) A process by which staff may 

request an exemption from the staff 

COVID–19 vaccination requirements 

based on an applicable Federal law; 

(vii) A process for tracking and 

securely documenting information 

provided by those staff who have 

requested, and for whom the REH has 

granted, an exemption from the staff 

COVID–19 vaccination requirements 

based on recognized clinical 

contraindications or applicable Federal 

laws; 


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(viii) A process for ensuring that all 

documentation, which confirms 

recognized clinical contraindications to 

COVID–19 vaccines and which supports 

staff requests for medical exemptions 

from vaccination, has been signed and 

dated by a licensed practitioner, who is 

not the individual requesting the 

exemption, and who is acting within 

their respective scope of practice as 

defined by, and in accordance with, all 

applicable state and local laws, and for 

further ensuring that such 

documentation contains: 

(A) All information specifying which 

of the authorized COVID–19 vaccines 

are clinically contraindicated for the 

staff member to receive and the 

recognized clinical reasons for the 

contraindications; and 

(B) A statement by the authenticating 

practitioner recommending that the staff 

member be exempted from the REH’s 

COVID–19 vaccination requirements for 

staff based on the recognized clinical 

contraindications; 

(ix) A process for ensuring the 

tracking and secure documentation of 

the vaccination status of staff for whom 

COVID–19 vaccination must be 

temporarily delayed, as recommended 

by the CDC, due to clinical precautions 

and considerations, including, but not 

limited to, individuals with acute 

illness secondary to COVID–19, and 

individuals who received monoclonal 

antibodies or convalescent plasma for 

COVID–19 treatment; and 

(x) Contingency plans for staff who 

are not fully vaccinated for COVID–19. 

§ 485.528 Condition of participation: 

Staffing and staff responsibilities. 

(a) Standard: Emergency department 

staffing. The emergency department of 

the REH must be staffed 24 hours a day, 

7 days a week to receive patients and 

activate the appropriate medical 

resources. 

(b) Standard: Staffing. (1) The REH 

must have a professional health care 

staff that includes one or more doctors 

of medicine or osteopathy, and may 

include one or more physician 

assistants, nurse practitioners, or 

clinical nurse specialists. 

(2) Any ancillary personnel are 

supervised by the professional staff. 

(3) The staff is sufficient to provide 

the services essential to the operation of 

the REH. 

(4) A registered nurse, clinical nurse 

specialist, or licensed practical nurse is 

on duty whenever the REH has one or 

more patients receiving emergency care 

or observation care. 

(c) Standard: Responsibilities of the 

doctor of medicine or osteopathy. (1) 

The doctor of medicine or osteopathy 

must— 

(i) Provide medical direction for the 

REH’s health care activities and 

consultation for, and medical 

supervision of, the health care staff. 

(ii) In conjunction with the physician 

assistant and/or nurse practitioner 

member(s), participate in developing, 

executing, and periodically reviewing 

the REH’s written policies governing the 

services it furnishes. 

(iii) In conjunction with the physician 

assistant and/or nurse practitioner 

members, periodically review the REH’s 

patient records, provide medical orders, 

and provide medical care services to the 

patients of the REH. 

(iv) Periodically review and sign a 

sample of outpatient records of patients 

cared for by nurse practitioners, clinical 

nurse specialists, certified nurse 

midwives, or physician assistants only 

to the extent where state law requires 

record reviews or co-signatures, or both, 

by a collaborating physician. 

(2) A doctor of medicine or 

osteopathy must be present for 

sufficient periods of time to provide 

medical direction, consultation, and 

supervision for the services provided in 

the REH, and is available through direct 

radio or telephone communication or 

electronic communication for 

consultation, assistance with medical 

emergencies, or patient referral. 

(d) Standard: Physician assistant, 

nurse practitioner, and clinical nurse 

specialist responsibilities. (1) The 

physician assistant, the nurse 

practitioner, or clinical nurse specialist 

members of the REH’s staff must— 

(i) Participate in the development, 

execution and periodic review of the 

written policies governing the services 

the REH furnishes; and 

(ii) Participate with a doctor of 

medicine or osteopathy in a periodic 

review of the patients’ health records. 

(2) The physician assistant, nurse 

practitioner, or clinical nurse specialist 

performs the following functions to the 

extent they are not being performed by 

a doctor of medicine or osteopathy: 

(i) Provides services in accordance 

with the REH’s policies. 

(ii) Arranges for, or refers patients to, 

needed services that cannot be 

furnished at the REH, and assures that 

adequate patient health records are 

maintained and transferred as required 

when patients are referred. 

(3) Whenever a patient is placed in 

observation care at the REH by a nurse 

practitioner, physician assistant, or 

clinical nurse specialist, a doctor of 

medicine or osteopathy on the staff of 

the REH is notified of the patient’s 

status. 

(e) Standard: Periodic review of 

clinical privileges and performance. The 

REH requires that— 

(1) The quality and appropriateness of 

the diagnosis and treatment furnished 

by nurse practitioners, clinical nurse 

specialists, and physician assistants at 

the REH must be evaluated by a member 

of the REH staff who is a doctor of 

medicine or osteopathy or by another 

doctor of medicine or osteopathy under 

contract with the REH. 

(2) The quality and appropriateness of 

the diagnosis and treatment furnished 

by doctors of medicine or osteopathy at 

the REH must be evaluated by one of the 

following— 

(i) One Quality Improvement 

Organization (QIO) or equivalent entity. 

(ii) In the case of distant-site 

physicians and practitioners providing 

telemedicine services to the REH’s 

patient under an agreement between the 

REH and a distant-site hospital, the 

distant-site hospital; or 

(iii) In the case of distant-site 

physicians and practitioners providing 

telemedicine services to the REH’s 

patients under a written agreement 

between the REH and a distant-site 

telemedicine entity, one Quality 

Improvement Organization (QIO) or 

equivalent entity. 

(3) The REH staff consider the 

findings of the evaluation and make the 

necessary changes as specified in 

paragraphs (b) through (d) of this 

section. 

§ 485.530 Condition of participation: 

Nursing services. 

The REH must have an organized 

nursing service that is available to 

provide 24-hour nursing services for the 

provision of patient care. The nursing 

services must be furnished and 

supervised by a registered nurse. 

Nursing services must meet the needs of 

patients. 

(a) Standard: Organization and 

staffing. Patient care responsibilities 

must be delineated for all nursing 

service personnel. Nursing services 

must be provided in accordance with 

recognized standards of practice. 

(b) Standard: Nursing leadership. The 

director of the nursing service must be 

a licensed registered nurse. The 

individual is responsible for the 

operation of the service, including 

determining the types and numbers of 

nursing personnel and staff necessary to 

provide nursing care for all areas of the 

REH. 

§ 485.532 Condition of participation: 

Discharge planning. 

An REH must have an effective 

discharge planning process that focuses 


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on the patient’s goals and treatment 

preferences and includes the patient 

and their caregivers/support person(s) 

as active partners in the discharge 

planning for post-discharge care. The 

discharge planning process and the 

discharge plan must be consistent with 

the patient’s goals for care and their 

treatment preferences, ensure an 

effective transition of the patient from 

the REH to post-discharge care, and 

reduce the factors leading to preventable 

hospital admissions or readmissions. 

(a) Standard: Discharge planning 

process. The REH’s discharge planning 

process must identify, at an early stage 

of the provision of services, those 

patients who are likely to suffer adverse 

health consequences upon discharge in 

the absence of adequate discharge 

planning and must provide a discharge 

planning evaluation for those patients 

so identified as well as for other patients 

upon the request of the patient, patient’s 

representative, or patient’s physician. 

(1) Any discharge planning evaluation 

must be made on a timely basis to 

ensure that appropriate arrangements 

for post-REH care will be made before 

discharge and to avoid unnecessary 

delays in discharge. 

(2) A discharge planning evaluation 

must include an evaluation of a 

patient’s likely need for appropriate 

services following those furnished by 

the REH, including, but not limited to, 

hospice care services, post-REH 

extended care services, home health 

services, and non-health care services 

and community-based care providers, 

and must also include a determination 

of the availability of the appropriate 

services as well as of the patient’s access 

to those services. 

(3) The discharge planning evaluation 

must be included in the patient’s 

medical record for use in establishing an 

appropriate discharge plan and the 

results of the evaluation must be 

discussed with the patient (or the 

patient’s representative). 

(4) Upon the request of a patient’s 

physician, the REH must arrange for the 

development and initial implementation 

of a discharge plan for the patient. 

(5) Any discharge planning evaluation 

or discharge plan required under this 

paragraph (a) must be developed by, or 

under the supervision of, a registered 

nurse, social worker, or other 

appropriately qualified personnel. 

(6) The REH’s discharge planning 

process must require regular reevaluation of the patient’s condition to 

identify changes that require 

modification of the discharge plan. The 

discharge plan must be updated, as 

needed, to reflect these changes. 

(7) The REH must assess its discharge 

planning process on a regular basis. The 

assessment must include ongoing 

periodic review of a representative 

sample of discharge plans. 

(8) The REH must assist patients, their 

families, or the patient’s representative 

in selecting a post-acute care provider 

by using and sharing data that includes, 

but is not limited to, HHA, skilled 

nursing facility (SNF), inpatient 

rehabilitation facility (IRF), or long-term 

care hospital (LTCH) data on quality 

measures and data on resource use 

measures. The REH must ensure that the 

post-acute care data on quality measures 

and data on resource use measures is 

relevant and applicable to the patient’s 

goals of care and treatment preferences. 

(b) Standard: Discharge of the patient 

and provision and transmission of the 

patient’s necessary medical 

information. The REH must discharge 

the patient, and also transfer or refer the 

patient where applicable, along with all 

necessary medical information 

pertaining to the patient’s current 

course of illness and treatment, postdischarge goals of care, and treatment 

preferences, at the time of discharge, to 

the appropriate post-acute care service 

providers and suppliers, facilities, 

agencies, and other outpatient service 

providers and practitioners responsible 

for the patient’s follow-up or ancillary 

care. 

§ 485.534 Condition of participation: 

Patient’s rights. 

An REH must protect and promote 

each patient’s rights. 

(a) Standard: Notice of rights. (1) An 

REH must inform each patient, or when 

appropriate, the patient’s representative 

(as allowed under state law), of the 

patient’s rights, in advance of furnishing 

or discontinuing patient care whenever 

possible. 

(2) The REH must establish a process 

for prompt resolution of patient 

grievances and must inform each patient 

whom to contact to file a grievance. The 

REH’s governing body or responsible 

individual must approve and be 

responsible for the effective operation of 

the grievance process and must review 

and resolve grievances, unless it 

delegates the responsibility in writing to 

a grievance committee. The grievance 

process must include a mechanism for 

timely referral of patient concerns 

regarding quality of care or premature 

discharge to the appropriate Utilization 

and Quality Control Quality 

Improvement Organization. At a 

minimum: 

(i) The REH must establish a clearly 

explained procedure for the submission 

of a patient’s written or verbal grievance 

to the REH. 

(ii) The grievance process must 

specify time frames for review of the 

grievance and the provision of a 

response. 

(iii) In its resolution of the grievance, 

the REH must provide the patient with 

written notice of its decision that 

contains the name of the REH contact 

person, the steps taken on behalf of the 

patient to investigate the grievance, the 

results of the grievance process, and the 

date of completion. 

(b) Standard: Exercise of rights. The 

patient has the right to— 

(1) Participate in the development and 

implementation of their plan of care. 

(2) Make informed decisions 

regarding their care, including being 

informed of their health status, and 

being able to request or refuse treatment. 

This right must not be construed as a 

mechanism to demand the provision of 

treatment or services deemed medically 

unnecessary or inappropriate. 

(3) Formulate advance directives and 

to have REH staff and practitioners who 

provide care in the REH comply with 

these directives, in accordance with 

§§ 489.100, 489.102, and 489.104 of this 

chapter. 

(c) Standard: Privacy and safety. The 

patient has the right to— 

(1) Personal privacy. 

(2) Receive care in a safe setting. 

(3) Be free from all forms of abuse or 

harassment. 

(d) Standard: Confidentiality of 

patient records. (1) The patient has the 

right to the confidentiality of their 

medical records. 

(2) The patient has the right to access 

their medical records, including current 

medical records, upon an oral or written 

request. 

(i) The records must be provided in 

the form and format requested by the 

individual, if it is readily producible in 

such form and format. This includes in 

an electronic form or format when such 

medical records are maintained 

electronically or if not, in a readable 

hard copy form or such other form and 

format as agreed to by the facility and 

the individual. 

(ii) The records must be provided 

within a reasonable time frame. The 

REH must not frustrate the legitimate 

efforts of individuals to gain access to 

their own medical records and must 

actively seek to meet these requests as 

quickly as its recordkeeping system 

permits. 

(e) Standard: Restraint or seclusion. 

All patients have the right to be free 

from physical or mental abuse, and 

corporal punishment. All patients have 

the right to be free from restraint or 


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seclusion, of any form, imposed as a 

means of coercion, discipline, 

convenience, or retaliation by staff. 

Restraint or seclusion may only be 

imposed to ensure the immediate 

physical safety of the patient, a staff 

member, or others and must be 

discontinued at the earliest possible 

time. 

(1)(i) A restraint is— 

(A) Any manual method, physical or 

mechanical device, material, or 

equipment that immobilizes or reduces 

the ability of a patient to move their 

arms, legs, body, or head freely; or 

(B) A drug or medication when it is 

used as a restriction to manage the 

patient’s behavior or restrict the 

patient’s freedom of movement and is 

not a standard treatment or dosage for 

the patient’s condition. 

(C) A restraint does not include 

devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, off of a 

stretcher, or out of a chair, or to permit 

the patient to participate in activities 

without the risk of physical harm (this 

does not include a physical escort). 

(ii) Seclusion is the involuntary 

confinement of a patient alone in a room 

or area from which the patient is 

physically prevented from leaving. 

Seclusion may only be used for the 

management of violent or selfdestructive behavior. 

(2) Restraint or seclusion may only be 

used when less restrictive interventions 

have been determined to be ineffective 

to protect the patient, a staff member or 

others from harm. 

(3) The type or technique of restraint 

or seclusion used must be the least 

restrictive intervention that will be 

effective to protect the patient, a staff 

member, or others from harm. 

(4) The REH must have written 

policies and procedures regarding the 

use of restraint and seclusion that are 

consistent with current standards of 

practice. 

(f) Standard: Restraint or seclusion: 

Staff training requirements. The patient 

has the right to safe implementation of 

restraint or seclusion by trained staff. 

(1) The REH must provide patientcentered competency-based training and 

education of REH personnel and staff, 

including medical staff, and, as 

applicable, personnel providing 

contracted services in the REH, on the 

use of restraint and seclusion. 

(2) The training must include 

alternatives to the use of restraint/ 

seclusion. 

(g) Standard: Death reporting 

requirements. REHs must report deaths 

associated with the use of seclusion or 

restraint. 

(1) With the exception of deaths 

described under paragraph (g)(2) of this 

section, the REH must report the 

following information to CMS by 

telephone, facsimile, or electronically, 

as determined by CMS, no later than the 

close of business on the next business 

day following knowledge of the 

patient’s death: 

(i) Each death that occurs while a 

patient is in restraint or seclusion. 

(ii) Each death that occurs within 24 

hours after the patient has been 

removed from restraint or seclusion. 

(iii) Each death known to the REH 

that occurs within 1 week after restraint 

or seclusion where it is reasonable to 

assume that use of restraint or 

placement in seclusion contributed 

directly or indirectly to a patient’s 

death, regardless of the type(s) of 

restraint used on the patient during this 

time. ‘‘Reasonable to assume’’ in this 

context includes, but is not limited to, 

deaths related to restrictions of 

movement for prolonged periods of 

time, or death related to chest 

compression, restriction of breathing, or 

asphyxiation. 

(2) When no seclusion has been used 

and when the only restraints used on 

the patient are those applied exclusively 

to the patient’s wrist(s), and which are 

composed solely of soft, non-rigid, 

cloth-like materials, the REH staff must 

record in an internal log or other 

system, the following information: 

(i) Any death that occurs while a 

patient is in such restraints. 

(ii) Any death that occurs within 24 

hours after a patient has been removed 

from such restraints. 

(3) The staff must document in the 

patient’s medical record the date and 

time the death was: 

(i) Reported to CMS for deaths 

described in paragraph (g)(1) of this 

section; or 

(ii) Recorded in the internal log or 

other system for deaths described in 

paragraph (g)(2) of this section. 

(4) For deaths described in paragraph 

(g)(2) of this section, entries into the 

internal log or other system must be 

documented as follows: 

(i) Each entry must be made not later 

than seven days after the date of death 

of the patient. 

(ii) Each entry must document the 

patient’s name, date of birth, date of 

death, name of attending physician or 

other licensed practitioner who is 

responsible for the care of the patient, 

medical record number, and primary 

diagnosis(es). 

(iii) The information must be made 

available in either written or electronic 

form to CMS immediately upon request. 

(h) Standard: Patient visitation rights. 

An REH must have written policies and 

procedures regarding the visitation 

rights of patients, including those 

setting forth any clinically necessary or 

reasonable restriction or limitation that 

the REH may need to place on such 

rights and the reasons for the clinical 

restriction or limitation. An REH must 

meet the following requirements: 

(1) Inform each patient (or support 

person, where appropriate) of their 

visitation rights, including any clinical 

restriction or limitation on such rights, 

when they are informed of their other 

rights under this section. 

(2) Inform each patient (or support 

person, where appropriate) of the right, 

subject to their consent, to receive the 

visitors whom they designate, 

including, but not limited to, a spouse, 

a domestic partner (including a samesex domestic partner), another family 

member, or a friend, and their right to 

withdraw or deny such consent at any 

time. 

(3) Not restrict, limit, or otherwise 

deny visitation privileges on the basis of 

race, color, national origin, religion, sex, 

gender identity, sexual orientation, or 

disability. 

(4) Ensure that all visitors enjoy full 

and equal visitation privileges 

consistent with patient preferences. 

§ 485.536 Condition of participation: 

Quality assessment and performance 

improvement program. 

The REH must develop, implement, 

and maintain an effective, ongoing, 

REH-wide, data-driven quality 

assessment and performance 

improvement (QAPI) program. The 

REH’s governing body must ensure that 

the program reflects the complexity of 

the REH’s organization and services; 

involves all REH departments and 

services (including those services 

furnished under contract or 

arrangement); and focuses on indicators 

related to improved health outcomes 

and the prevention and reduction of 

medical errors. The REH must maintain 

and demonstrate evidence of its QAPI 

program for review by CMS. 

(a) Standard: Program scope. (1) The 

program must include, but not be 

limited to, an ongoing program that 

shows measurable improvement in 

indicators for which there is evidence 

that it will improve health outcomes 

and identify and reduce medical errors. 


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(2) The REH must measure, analyze, 

and track quality indicators, including 

adverse patient events, and other 

aspects of performance that assess 

processes of care, REH service and 

operations. 

(b) Standard: Program data collection 

and analysis. The program must 

incorporate quality indicator data 

including patient care data, and other 

relevant data, in order to achieve the 

goals of the QAPI program. 

(c) Standard: Program activities. (1) 

The REH must set priorities for its 

performance improvement activities 

that— 

(i) Focus on high-risk, high-volume, 

or problem-prone areas; 

(ii) Consider the incidence, 

prevalence, and severity of problems in 

those areas; and 

(iii) Affect health outcomes, patient 

safety, and quality of care. 

(2) Performance improvement 

activities must track medical errors and 

adverse patient events, analyze their 

causes, and implement preventive 

actions and mechanisms that include 

feedback and learning throughout the 

REH. An adverse patient event means an 

untoward, undesirable, and usually 

unanticipated event that causes death or 

serious injury or the risk thereof. 

Medical error means an error that occurs 

in the delivery of health care services. 

(3) The REH must take actions aimed 

at performance improvement and, after 

implementing those actions, the REH 

must measure its success, and track 

performance to ensure that 

improvements are sustained. 

(d) Standard: Executive 

responsibilities. The REH’s governing 

body (or organized group or individual 

who assumes full legal authority and 

responsibility for operations of the 

REH), medical staff, and administrative 

officials are responsible and accountable 

for ensuring the following: 

(1) That an ongoing program for 

quality improvement and patient safety, 

including the reduction of medical 

errors, is defined, implemented, and 

maintained. 

(2) That the REH-wide quality 

assessment and performance 

improvement efforts address priorities 

for improved quality of care and patient 

safety; and that all improvement actions 

are evaluated. 

(3) That clear expectations for safety 

are established. 

(4) That adequate resources are 

allocated for measuring, assessing, 

improving, and sustaining the REH’s 

performance and reducing risk to 

patients. 

(e) Standard: Unified and integrated 

QAPI program for an REH in a multifacility system. If an REH is part of a 

system consisting of multiple separately 

certified hospitals, CAHs, and/or REHs 

using a system governing body that is 

legally responsible for the conduct of 

two or more hospitals, CAHs, and/or 

REHs, the system governing body can 

elect to have a unified and integrated 

QAPI program for all of its member 

facilities 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 REHs meets all 

of the requirements of this section. Each 

separately certified REH 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 REH’s 

unique circumstances and any 

significant differences in patient 

populations and services offered in each 

REH; 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 REHs, 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 REHs are 

duly considered and addressed. 

§ 485.538 Condition of participation: 

Agreements. 

The REH must have in effect an 

agreement with at least one certified 

hospital that is a level I or level II 

trauma center for the referral and 

transfer of patients requiring emergency 

medical care beyond the capabilities of 

the REH that is— 

(a) Licensed as a hospital in a state 

that provides for the licensing of 

hospitals under state or applicable local 

law or approved by the agency of such 

state or locality responsible for licensing 

hospitals, as meeting standards 

established for licensing established by 

the agency of the state; and 

(b) Licensed or designated by the state 

or local government authority as level I 

or level II trauma center or is verified by 

the American College of Surgeons as a 

level I or level II trauma center. 

§ 485.540 Condition of participation: 

Medical records. 

(a) Standard: Records system. (1) The 

REH must maintain a medical records 

system in accordance with written 

policies and procedures. 

(2) The records must be legible, 

complete, accurately documented, 

readily accessible, and systematically 

organized. 

(3) A designated member of the 

professional staff is responsible for 

maintaining the records and for 

ensuring that they are completely and 

accurately documented, readily 

accessible, and systematically 

organized. 

(4) For each patient receiving health 

care services, the REH must maintain a 

record that includes, as applicable— 

(i) Identification and social data, 

evidence of properly executed informed 

consent forms, pertinent medical 

history, assessment of the health status 

and health care needs of the patient, and 

a brief summary of the episode, 

disposition, and instructions to the 

patient; 

(ii) Reports of physical examinations, 

diagnostic and laboratory test results, 

including clinical laboratory services, 

and consultative findings; 

(iii) All orders of doctors of medicine 

or osteopathy or other practitioners, 

reports of treatments and medications, 

nursing notes and documentation of 

complications, and other pertinent 

information necessary to monitor the 

patient’s progress, such as temperature 

graphics, progress notes describing the 

patient’s response to treatment; and 

(iv) Dated signatures of the doctor of 

medicine or osteopathy or other health 

care professional. 

(b) Standard: Protection of record 

information. (1) The REH must maintain 

the confidentiality of record information 

and provides safeguards against loss, 

destruction, or unauthorized use. 

(2) The REH must have written 

policies and procedures that govern the 

use and removal of records from the 

REH and the conditions for the release 

of information. 

(3) The patient’s written consent is 

required for release of information not 

required by law. 

(c) Standard: Retention of records. 

The records must be retained for at least 

5 years from date of last entry, and 

longer if required by state statute, or if 

the records may be needed in any 

pending proceeding. 

(d) Standard: Electronic notifications. 

If the REH utilizes an electronic medical 

records system or other electronic 

administrative system, which is 

conformant with the content exchange 

standard at 45 CFR 170.205(d)(2), then 

the REH must demonstrate that— 

(1) The system’s notification capacity 

is fully operational and the REH uses it 

in accordance with all state and Federal 

statutes and regulations applicable to 

the REH’s exchange of patient health 

information. 


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(2) The system sends notifications 

that must include at least patient name, 

treating practitioner name, and sending 

institution name. 

(3) To the extent permissible under 

applicable Federal and state law and 

regulations, and not inconsistent with 

the patient’s expressed privacy 

preferences, the system sends 

notifications directly, or through an 

intermediary that facilitates exchange of 

health information, at the time of the 

patient’s registration in the REH’s 

emergency department. 

(4) To the extent permissible under 

applicable Federal and state law and 

regulations, and not inconsistent with 

the patient’s expressed privacy 

preferences, the system sends 

notifications directly, or through an 

intermediary that facilitates exchange of 

health information, either immediately 

prior to, or at the time the patient’s 

discharge or transfer from the REH’s 

emergency department. 

(5) The REH has made a reasonable 

effort to ensure that the system sends 

the notifications to all applicable postacute care services providers and 

suppliers, as well as to any of the 

following practitioners and entities, 

which need to receive notification of the 

patient’s status for treatment, care 

coordination, or quality improvement 

purposes: 

(i) The patient’s established primary 

care practitioner; 

(ii) The patient’s established primary 

care practice group or entity; or 

(iii) Other practitioner, or other 

practice group or entity, identified by 

the patient as the practitioner, or 

practice group or entity, primarily 

responsible for their care. 

§ 485.542 Condition of participation: 

Emergency preparedness. 

The REH must comply with all 

applicable Federal, state, and local 

emergency preparedness requirements. 

The REH must establish and maintain 

an emergency preparedness program 

that meets the requirements of this 

section. The emergency preparedness 

program must include, but not be 

limited to, the following elements: 

(a) Emergency plan. The REH 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: 

(1) Be based on and include a 

documented, facility-based and 

community-based risk assessment, 

utilizing an all-hazards approach. 

(2) Include strategies for addressing 

emergency events identified by the risk 

assessment. 

(3) Address patient population, 

including, but not limited to, the type of 

services the REH has the ability to 

provide in an emergency; and 

continuity of operations, including 

delegations of authority and succession 

plans. 

(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 REH 

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: 

(1) The provision of subsistence needs 

for staff and patients, whether they 

evacuate or shelter in place, include, but 

are not limited to— 

(i) Food, water, medical, and 

pharmaceutical supplies; and 

(ii) Alternate sources of energy to 

maintain: 

(A) Temperatures to protect patient 

health and safety and for the safe and 

sanitary storage of provisions; 

(B) Emergency lighting; 

(C) Fire detection, extinguishing, and 

alarm systems; and 

(D) Sewage and waste disposal. 

(2) A system to track the location of 

on-duty staff and sheltered patients in 

the REH’s care during an emergency. If 

on-duty staff or sheltered patients are 

relocated during the emergency, the 

REH must document the specific name 

and location of the receiving facility or 

other location. 

(3) Safe evacuation from the REH, 

which includes the following: 

(i) Consideration of care and 

treatment needs of evacuees. 

(ii) Staff responsibilities. 

(iii) Transportation. 

(iv) Identification of evacuation 

location(s). 

(v) Primary and alternate means of 

communication with external sources of 

assistance. 

(4) A means to shelter in place for 

patients, staff, and volunteers who 

remain in the REH. 

(5) A system of medical 

documentation that does the following: 

(i) Preserves patient information. 

(ii) Protects confidentiality of patient 

information. 

(iii) Secures and maintains the 

availability of records. 

(6) The use of volunteers in an 

emergency and other staffing strategies, 

including the process and role for 

integration of state and federally 

designated health care professionals to 

address surge needs during an 

emergency. 

(7) The role of the REH under a 

waiver declared by the Secretary, in 

accordance with section 1135 of the Act, 

in the provision of care and treatment at 

an alternate care site identified by 

emergency management officials. 

(c) Communication plan. The REH 

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: 

(1) Names and contact information for 

the following: 

(i) Staff. 

(ii) Entities providing services under 

arrangement. 

(iii) Patients’ physicians. 

(iv) Volunteers. 

(2) Contact information for the 

following: 

(i) Federal, state, tribal, regional, and 

local emergency preparedness staff. 

(ii) Other sources of assistance. 

(3) Primary and alternate means for 

communicating with the following: 

(i) REH’s staff. 

(ii) Federal, state, tribal, regional, and 

local emergency management agencies. 

(4) A method for sharing information 

and medical documentation for patients 

under the REH’s care, as necessary, with 

other health care providers to maintain 

the continuity of care. 

(5) A means, in the event of an 

evacuation, to release patient 

information as permitted under 45 CFR 

164.510(b)(1)(ii). 

(6) A means of providing information 

about the general condition and location 

of patients under the facility’s care as 

permitted under 45 CFR 164.510(b)(4). 

(7) A means of providing information 

about the REH’s needs, and its ability to 

provide assistance, to the authority 

having jurisdiction, the Incident 

Command Center, or designee. 

(d) Training and testing. The REH 

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. 


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(1) Training program. The REH must 

do all of the following: 

(i) Provide initial training in 

emergency preparedness policies and 

procedures to all new and existing staff, 

individuals providing on-site services 

under arrangement, and volunteers, 

consistent with their expected roles. 

(ii) Provide emergency preparedness 

training at least every 2 years. 

(iii) Maintain documentation of all 

emergency preparedness training. 

(iv) Demonstrate staff knowledge of 

emergency procedures. 

(v) If the emergency preparedness 

policies and procedures are significantly 

updated, the REH must conduct training 

on the updated policies and procedures. 

(2) Testing. The REH must conduct 

exercises to test the emergency plan at 

least annually. The REH must do the 

following: 

(i) Participate in a full-scale exercise 

that is community-based every 2 years. 

(A) When a community-based 

exercise is not accessible, conduct a 

facility-based functional exercise every 

2 years; or 

(B) If the REH experiences an actual 

natural or man-made emergency that 

requires activation of the emergency 

plan, the REH is exempt from engaging 

in its next required community-based or 

individual, facility-based functional 

exercise following the onset of the 

emergency event. 

(ii) Conduct an additional exercise at 

least every 2 years, opposite the year the 

full-scale or functional exercise under 

paragraph (d)(2)(i) of this section is 

conducted, that may include, but is not 

limited to the following: 

(A) A second full-scale exercise that is 

community-based, or an individual, 

facility-based functional exercise; or 

(B) A mock disaster drill; or 

(C) A tabletop exercise or workshop 

that is led by a facilitator and includes 

a group discussion using a narrated, 

clinically-relevant emergency scenario, 

and a set of problem statements, 

directed messages, or prepared 

questions designed to challenge an 

emergency plan. 

(iii) Analyze the REH’s response to 

and maintain documentation of all 

drills, tabletop exercises, and emergency 

events and revise the REH’s emergency 

plan, as needed. 

(e) Emergency and standby power 

systems. The CAH must implement 

emergency and standby power systems 

based on the emergency plan set forth 

in paragraph (a) of this section. 

(1) Emergency generator location. The 

generator must be located in accordance 

with the location requirements found in 

the Health Care Facilities Code 

(National Fire Protection Association 

(NFPA) 99 and Technical Interim 

Amendments (TIA) 12–2, TIA 12–3, TIA 

12–4, TIA 12–5, and TIA 12–6), Life 

Safety Code (NFPA 101 and TIA 12–1, 

TIA 12–2, TIA 12–3, and TIA 12–4), and 

NFPA 110, when a new structure is 

built or when an existing structure or 

building is renovated. 

(2) Emergency generator inspection 

and testing. The CAH must implement 

emergency power system inspection and 

testing requirements found in the Health 

Care Facilities Code, NFPA 110, and the 

Life Safety Code. 

(3) Emergency generator fuel. CAHs 

that maintain an onsite fuel source to 

power emergency generators must have 

a plan for how it will keep emergency 

power systems operational during the 

emergency, unless it evacuates. 

(f) Integrated healthcare systems. If an 

REH is part of a healthcare system 

consisting of multiple separately 

certified healthcare facilities that elects 

to have a unified and integrated 

emergency preparedness program, the 

REH may choose to participate in the 

healthcare system’s coordinated 

emergency preparedness program. If 

elected, the unified and integrated 

emergency preparedness program 

must— 

(1) Demonstrate that each separately 

certified facility within the system 

actively participated in the development 

of the unified and integrated emergency 

preparedness program. 

(2) Be developed and maintained in a 

manner that takes into account each 

separately certified facility’s unique 

circumstances, patient populations, and 

services offered. 

(3) Demonstrate that each separately 

certified facility is capable of actively 

using the unified and integrated 

emergency preparedness program and is 

in compliance. 

(4) Include a unified and integrated 

emergency plan that meets the 

requirements of paragraphs (a)(2) 

through (4) of this section. The unified 

and integrated emergency plan must 

also be based on and include the 

following: 

(i) A documented community-based 

risk assessment, utilizing an all-hazards 

approach. 

(ii) A documented individual facilitybased risk assessment for each 

separately certified facility within the 

health system, utilizing an all-hazards 

approach. 

(5) Include integrated policies and 

procedures that meet the requirements 

set forth in paragraph (b) of this section, 

a coordinated communication plan and 

training and testing programs that meet 

the requirements of paragraphs (c) and 

(d) of this section, respectively. 

(g) Incorporation by reference. The 

material listed in this paragraph (g) is 

approved for incorporation by reference 

by the Director of the Office of the 

Federal Register in accordance with 5 

U.S.C. 552(a) and 1 CFR part 51. To 

enforce any edition other than that 

specified in this section, the CMS must 

publish a document in the Federal 

Register and the material must be 

available to the public. All approved 

material is available for inspection at 

CMS and at the National Archives and 

Records Administration (NARA). 

Contact CMS at: CMS Information 

Resource Center, 7500 Security 

Boulevard, Baltimore, MD 21244. For 

information on the availability of this 

material at NARA, email: fr.inspection@

nara.gov, or go to: www.archives.gov/ 

federal-register/cfr/ibr-locations.html. 

The material may be obtained from: 

National Fire Protection Association 

(NFPA), 1 Batterymarch Park, Quincy, 

MA 02169; phone: (617) 770–3000; 

www.nfpa.org. 

(1) NFPA 99, Health Care Facilities 

Code, 2012 edition, issued August 11, 

2011. 

(2) Technical interim amendment 

(TIA) 12–2 to NFPA 99, issued August 

11, 2011. 

(3) TIA 12–3 to NFPA 99, issued 

August 9, 2012. 

(4) TIA 12–4 to NFPA 99, issued 

March 7, 2013. 

(5) TIA 12–5 to NFPA 99, issued 

August 1, 2013. 

(6) TIA 12–6 to NFPA 99, issued 

March 3, 2014. 

(7) NFPA 101, Life Safety Code, 2012 

edition, issued August 11, 2011. 

(8) TIA 12–1 to NFPA 101, issued 

August 11, 2011. 

(9) TIA 12–2 to NFPA 101, issued 

October 30, 2012. 

(10) TIA 12–3 to NFPA 101, issued 

October 22, 2013. 

(11) TIA 12–4 to NFPA 101, issued 

October 22, 2013. 

(12) NFPA 110, Standard for 

Emergency and Standby Power Systems, 

2010 edition, including TIAs to chapter 

7, issued August 6, 2009. 

§ 485.544 Condition of participation: 

Physical environment. 

The REH must be constructed, 

arranged, and maintained to ensure the 

safety of the patient, and to provide 

facilities for diagnosis and treatment 

and for special services appropriate to 

the needs of the community. 

(a) Standard: Buildings. The 

condition of the physical plant and the 

overall REH environment must be 

developed and maintained in such a 

manner that the safety and well-being of 

patients are ensured. 


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(1) There must be emergency power 

and lighting in at least the operating, 

recovery, and emergency rooms, and 

stairwells. In all other areas not serviced 

by the emergency supply source, battery 

lamps and flashlights must be available. 

(2) There must be facilities for 

emergency gas and water supply. 

(3) The REH must have a safe and 

sanitary environment, properly 

constructed, equipped, and maintained 

to protect the health and safety of 

patients. 

(b) Standard: Facilities. The REH 

must maintain adequate facilities for its 

services. 

(1) Diagnostic and therapeutic 

facilities must be located for the safety 

of patients. 

(2) Facilities, supplies, and equipment 

must be maintained to ensure an 

acceptable level of safety and quality. 

(3) The extent and complexity of 

facilities must be determined by the 

services offered. 

(4) There must be proper ventilation, 

light, and temperature controls in 

patient care, pharmaceutical, food 

preparation, and other appropriate 

areas. 

(c) Standard: Safety from fire. (1) 

Except as otherwise provided in this 

section, the REH must meet the 

provisions applicable to Ambulatory 

Health Care Occupancies, regardless of 

the number of patients served, and must 

proceed in accordance with the Life 

Safety Code (NFPA 101 and TIA 12–1, 

TIA 12–2, TIA 12–3, and TIA 12–4). 

(2) In consideration of a 

recommendation by the state survey 

agency or Accrediting Organization or at 

the discretion of the Secretary, may 

waive, for periods deemed appropriate, 

specific provisions of the Life Safety 

Code, which would result in 

unreasonable hardship upon an REH, 

but only if the waiver will not adversely 

affect the health and safety of the 

patients. 

(3) The provisions of the Life Safety 

Code do not apply in a state if CMS 

finds that a fire and safety code imposed 

by state law adequately protects patients 

in an REH. 

(4) An REH may place alcohol-based 

hand rub dispensers in its facility if the 

dispensers are installed in a manner that 

adequately protects against 

inappropriate access. 

(5) When a sprinkler system is shut 

down for more than 10 hours, the REH 

must: 

(i) Evacuate the building or portion of 

the building affected by the system 

outage until the system is back in 

service; or 

(ii) Establish a fire watch until the 

system is back in service. 

(d) Standard: Building safety. Except 

as otherwise provided in this section, 

the REH must meet the applicable 

provisions and must proceed in 

accordance with the 2012 edition of the 

Health Care Facilities Code (NFPA 99 

and TIA 12–2, TIA 12–3, TIA 12–4, TIA 

12–5, and TIA 12–6). 

(1) Chapters 7, 8, 12, and 13 of the 

adopted Health Care Facilities Code do 

not apply to an REH. 

(2) If application of the Health Care 

Facilities Code required under 

paragraph (d) of this section would 

result in unreasonable hardship for the 

REH, CMS may waive specific 

provisions of the Health Care Facilities 

Code, but only if the waiver does not 

adversely affect the health and safety of 

patients. 

(e) Incorporation by reference. The 

material listed in this paragraph (e) is 

approved for incorporation by reference 

by the Director of the Office of the 

Federal Register in accordance with 5 

U.S.C. 552(a) and 1 CFR part 51. To 

enforce any edition other than that 

specified in this section, the CMS must 

publish a document in the Federal 

Register and the material must be 

available to the public. All approved 

material is available for inspection at 

CMS and at the National Archives and 

Records Administration (NARA). 

Contact CMS at: CMS Information 

Resource Center, 7500 Security 

Boulevard, Baltimore, MD 21244. For 

information on the availability of this 

material at NARA, email: fr.inspection@

nara.gov, or go to: www.archives.gov/ 

federal-register/cfr/ibr-locations.html. 

The material may be obtained from: 

National Fire Protection Association 

(NFPA), 1 Batterymarch Park, Quincy, 

MA 02169; phone: (617) 770–3000; 

www.nfpa.org. 

(1) NFPA 99, Standards for Health 

Care Facilities Code of the National Fire 

Protection Association 99, 2012 edition, 

issued August 11, 2011. 

(2) TIA 12–2 to NFPA 99, issued 

August 11, 2011. 

(3) TIA 12–3 to NFPA 99, issued 

August 9, 2012. 

(4) TIA 12–4 to NFPA 99, issued 

March 7, 2013. 

(5) TIA 12–5 to NFPA 99, issued 

August 1, 2013. 

(6) TIA 12–6 to NFPA 99, issued 

March 3, 2014. 

(7) NFPA 101, Life Safety Code, 2012 

edition, issued August 11, 2011; 

(8) TIA 12–1 to NFPA 101, issued 

August 11, 2011. 

(9) TIA 12–2 to NFPA 101, issued 

October 30, 2012. 

(10) TIA 12–3 to NFPA 101, issued 

October 22, 2013. 

(11) TIA 12–4 to NFPA 101, issued 

October 22, 2013. 

§ 485.546 Condition of participation: 

Skilled nursing facility distinct part unit. 

If the REH provides skilled nursing 

facility services in a distinct part unit, 

the services furnished by the distinct 

part unit must comply with the 

requirements of participation for longterm care facilities specified in part 483, 

subpart B, of this subchapter. 

Subpart F—Conditions of 

Participation: Critical Access Hospitals 

(CAHs) 

■ 3. Section 485.610 is amended by 

revising paragraph (c) to read as follows: 

§ 485.610 Condition of participation: 

Status and location. 

* * * * * 

(c) Standard: Location relative to 

other facilities or necessary provider 

certification. (1) The CAH is located 

more than a 35-mile drive on primary 

roads (or, in the case of mountainous 

terrain or in areas with only secondary 

roads available, a 15-mile drive) from a 

hospital or another CAH, or before 

January 1, 2006, the CAH is certified by 

the State as being a necessary provider 

of health care services to residents in 

the area. A CAH that is designated as a 

necessary provider on or before 

December 31, 2005, will maintain its 

necessary provider designation after 

January 1, 2006. 

(2) Primary roads of travel for 

determining the driving distance of a 

CAH and its proximity to other 

providers is defined as: 

(i) A numbered Federal highway, 

including interstates, intrastates, 

expressways, or any other numbered 

Federal highway; or 

(ii) A numbered State highway with 2 

or more lanes each way. 

* * * * * 

■ 4. Section 485.614 is added to read as 

follows: 

§ 485.614 Condition of participation: 

Patient’s rights. 

A CAH must protect and promote 

each patient’s rights. 

(a) Standard: Notice of rights. (1) A 

hospital must inform each patient, or 

when appropriate, the patient’s 

representative (as allowed under State 

law), of the patient’s rights, in advance 

of furnishing or discontinuing patient 

care whenever possible. 

(2) The hospital must establish a 

process for prompt resolution of patient 

grievances and must inform each patient 

whom to contact to file a grievance. The 

hospital’s governing body must approve 

and be responsible for the effective 


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operation of the grievance process and 

must review and resolve grievances, 

unless it delegates the responsibility in 

writing to a grievance committee. The 

grievance process must include a 

mechanism for timely referral of patient 

concerns regarding quality of care or 

premature discharge to the appropriate 

Utilization and Quality Control Quality 

Improvement Organization. At a 

minimum: 

(i) The hospital must establish a 

clearly explained procedure for the 

submission of a patient’s written or 

verbal grievance to the hospital. 

(ii) The grievance process must 

specify time frames for review of the 

grievance and the provision of a 

response. 

(iii) In its resolution of the grievance, 

the hospital must provide the patient 

with written notice of its decision that 

contains the name of the hospital 

contact person, the steps taken on behalf 

of the patient to investigate the 

grievance, the results of the grievance 

process, and the date of completion. 

(b) Standard: Exercise of rights. (1) 

The patient has the right to participate 

in the development and implementation 

of their plan of care. 

(2) The patient or their representative 

(as allowed under State law) has the 

right to make informed decisions 

regarding their care. The patient’s rights 

include being informed of their health 

status, being involved in care planning 

and treatment, and being able to request 

or refuse treatment. This right must not 

be construed as a mechanism to demand 

the provision of treatment or services 

deemed medically unnecessary or 

inappropriate. 

(3) The patient has the right to 

formulate advance directives and to 

have hospital staff and practitioners 

who provide care in the hospital comply 

with these directives, in accordance 

with §§ 489.100, 489.102, and 489.104 

of this chapter. 

(4) The patient has the right to have 

a family member or representative of 

their choice and their own physician 

notified promptly of their admission to 

the hospital. 

(c) Standard: Privacy and safety. (1) 

The patient has the right to personal 

privacy. 

(2) The patient has the right to receive 

care in a safe setting. 

(3) The patient has the right to be free 

from all forms of abuse or harassment. 

(d) Standard: Confidentiality of 

patient records. (1) The patient has the 

right to the confidentiality of their 

clinical records. 

(2) The patient has the right to access 

their medical records, including current 

medical records, upon an oral or written 

request, in the form and format 

requested by the individual, if it is 

readily producible in such form and 

format (including in an electronic form 

or format when such medical records 

are maintained electronically); or, if not, 

in a readable hard copy form or such 

other form and format as agreed to by 

the facility and the individual, and 

within a reasonable time frame. The 

hospital must not frustrate the 

legitimate efforts of individuals to gain 

access to their own medical records and 

must actively seek to meet these 

requests as quickly as its record keeping 

system permits. 

(e) Standard: Restraint or seclusion. 

All patients have the right to be free 

from physical or mental abuse, and 

corporal punishment. All patients have 

the right to be free from restraint or 

seclusion, of any form, imposed as a 

means of coercion, discipline, 

convenience, or retaliation by staff. 

Restraint or seclusion may only be 

imposed to ensure the immediate 

physical safety of the patient, a staff 

member, or others and must be 

discontinued at the earliest possible 

time. 

(1)(i) A restraint is— 

(A) Any manual method, physical or 

mechanical device, material, or 

equipment that immobilizes or reduces 

the ability of a patient to move their 

arms, legs, body, or head freely; or 

(B) A drug or medication when it is 

used as a restriction to manage the 

patient’s behavior or restrict the 

patient’s freedom of movement and is 

not a standard treatment or dosage for 

the patient’s condition. 

(C) A restraint does not include 

devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, or to 

permit the patient to participate in 

activities without the risk of physical 

harm (this does not include a physical 

escort). 

(ii) Seclusion is the involuntary 

confinement of a patient alone in a room 

or area from which the patient is 

physically prevented from leaving. 

Seclusion may only be used for the 

management of violent or selfdestructive behavior. 

(2) Restraint or seclusion may only be 

used when less restrictive interventions 

have been determined to be ineffective 

to protect the patient a staff member or 

others from harm. 

(3) The type or technique of restraint 

or seclusion used must be the least 

restrictive intervention that will be 

effective to protect the patient, a staff 

member, or others from harm. 

(4) The CAH must have written 

policies and procedures regarding the 

use of restraint and seclusion that are 

consistent with current standards of 

practice. 

(f) Standard: Restraint or seclusion: 

Staff training requirements. The patient 

has the right to safe implementation of 

restraint or seclusion by trained staff. 

(1) The CAH must provide patientcentered, trauma informed competencybased training and education of CAH 

personnel and staff, including medical 

staff, and, as applicable, personnel 

providing contracted services in the 

CAH, on the use of restraint and 

seclusion. 

(2) The training must include 

alternatives to the use of restraint/ 

seclusion. 

(g) Standard: Death reporting 

requirements. Hospitals must report 

deaths associated with the use of 

seclusion or restraint. 

(1) With the exception of deaths 

described under paragraph (g)(2) of this 

section, the hospital must report the 

following information to CMS by 

telephone, facsimile, or electronically, 

as determined by CMS, no later than the 

close of business on the next business 

day following knowledge of the 

patient’s death: 

(i) Each death that occurs while a 

patient is in restraint or seclusion. 

(ii) Each death that occurs within 24 

hours after the patient has been 

removed from restraint or seclusion. 

(iii) Each death known to the hospital 

that occurs within 1 week after restraint 

or seclusion where it is reasonable to 

assume that use of restraint or 

placement in seclusion contributed 

directly or indirectly to a patient’s 

death, regardless of the type(s) of 

restraint used on the patient during this 

time. ‘‘Reasonable to assume’’ in this 

context includes, but is not limited to, 

deaths related to restrictions of 

movement for prolonged periods of 

time, or death related to chest 

compression, restriction of breathing, or 

asphyxiation. 

(2) When no seclusion has been used 

and when the only restraints used on 

the patient are those applied exclusively 

to the patient’s wrist(s), and which are 

composed solely of soft, non-rigid, 

cloth-like materials, the hospital staff 

must record in an internal log or other 

system, the following information: 

(i) Any death that occurs while a 

patient is in such restraints. 

(ii) Any death that occurs within 24 

hours after a patient has been removed 

from such restraints. 


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(3) The staff must document in the 

patient’s medical record the date and 

time the death was: 

(i) Reported to CMS for deaths 

described in paragraph (g)(1) of this 

section; or 

(ii) Recorded in the internal log or 

other system for deaths described in 

paragraph (g)(2) of this section. 

(4) For deaths described in paragraph 

(g)(2) of this section, entries into the 

internal log or other system must be 

documented as follows: 

(i) Each entry must be made not later 

than seven days after the date of death 

of the patient. 

(ii) Each entry must document the 

patient’s name, date of birth, date of 

death, name of attending physician or 

other licensed practitioner who is 

responsible for the care of the patient, 

medical record number, and primary 

diagnosis(es). 

(iii) The information must be made 

available in either written or electronic 

form to CMS immediately upon request. 

(h) Standard: Patient visitation rights. 

A CAH must have written policies and 

procedures regarding the visitation 

rights of patients, including those 

setting forth any clinically necessary or 

reasonable restriction or limitation that 

the CAH may need to place on such 

rights and the reasons for the clinical 

restriction or limitation. A CAH must 

meet the following requirements: 

(1) Inform each patient (or support 

person, where appropriate) of his or her 

visitation rights, including any clinical 

restriction or limitation on such rights, 

in advance of furnishing patient care 

whenever possible. 

(2) Inform each patient (or support 

person, where appropriate) of the right, 

subject to his or her consent, to receive 

the visitors whom he or she designates, 

including, but not limited to, a spouse, 

a domestic partner (including a samesex domestic partner), another family 

member, or a friend, and his or her right 

to withdraw or deny such consent at 

any time. 

(3) Not restrict, limit, or otherwise 

deny visitation privileges on the basis of 

race, color, national origin, religion, sex, 

gender identity, sexual orientation, or 

disability. 

(4) Ensure that all visitors enjoy full 

and equal visitation privileges 

consistent with patient preferences. 

■ 5. Section 485.631 is amended by 

adding paragraph (e) to read as follows: 

§ 485.631 Condition of participation: 

Staffing and staff responsibilities. 

* * * * * 

(e) Standard: Unified and integrated 

medical staff for a CAH in a multifacility system. If a CAH is part of a 

system consisting of multiple separately 

certified hospitals, CAHs, and/or REHs, 

and the system elects to have a unified 

and integrated medical staff for its 

member hospitals, CAHs, and/or REHs 

after determining that such a decision is 

in accordance with all applicable State 

and local laws, each separately certified 

CAH must demonstrate that: 

(1) The medical staff members of each 

separately certified CAH in the system 

(that is, all medical staff members who 

hold specific privileges to practice at 

that CAH) have voted by majority, in 

accordance with medical staff bylaws, 

either to accept a unified and integrated 

medical staff structure or to opt out of 

such a structure and to maintain a 

separate and distinct medical staff for 

their respective CAH; 

(2) The unified and integrated 

medical staff has bylaws, rules, and 

requirements that describe its processes 

for self-governance, appointment, 

credentialing, privileging, and oversight, 

as well as its peer review policies and 

due process rights guarantees, and 

which include a process for the 

members of the medical staff of each 

separately certified CAH (that is, all 

medical staff members who hold 

specific privileges to practice at that 

CAH) to be advised of their rights to opt 

out of the unified and integrated 

medical staff structure after a majority 

vote by the members to maintain a 

separate and distinct medical staff for 

their CAH; 

(3) The unified and integrated 

medical staff is established in a manner 

that takes into account each member 

CAH’s unique circumstances and any 

significant differences in patient 

populations and services offered in each 

hospital, CAH, and REH; and 

(4) The unified and integrated 

medical staff establishes and 

implements policies and procedures to 

ensure that the needs and concerns 

expressed by members of the medical 

staff, at each of its separately certified 

hospitals, CAHs, and REHs, regardless 

of practice or location, are given due 

consideration, and that the unified and 

integrated medical staff has mechanisms 

in place to ensure that issues localized 

to particular hospitals, CAHs, and REHs 

are duly considered and addressed. 

§ 485.635 [Amended] 

■ 6. Section 485.635 is amended— 

■ a. In paragraph (b)(2) introductory text 

by removing the reference ‘‘42 U.S.C. 

236a’’ and adding in its place the 

reference ‘‘42 U.S.C. 263a’’; and 

■ b. By removing paragraph (f). 

■ 7. Section 485.640 is amended by 

adding paragraph (g) to read as follows: 

§ 485.640 Condition of participation: 

Infection prevention and control and 

antibiotic stewardship programs. 

* * * * * 

(g) Standard: Unified and integrated 

infection prevention and control and 

antibiotic stewardship programs for a 

CAH in a multi-facility system. If a CAH 

is part of a system consisting of multiple 

separately certified hospitals, CAHs, 

and/or REHs using a system governing 

body that is legally responsible for the 

conduct of two or more hospitals, CAHs, 

and/or REHs, the system governing body 

can elect to have unified and integrated 

infection prevention and control and 

antibiotic stewardship programs for all 

of its member facilities 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 CAHs meets all of the 

requirements of this section. Each 

separately certified CAH subject to the 

system governing body must 

demonstrate that: 

(1) The unified and integrated 

infection prevention and control and 

antibiotic stewardship programs are 

established in a manner that takes into 

account each member CAH’s unique 

circumstances and any significant 

differences in patient populations and 

services offered in each CAH; 

(2) The unified and integrated 

infection prevention and control and 

antibiotic stewardship programs 

establish and implement policies and 

procedures to ensure that the needs and 

concerns of each of its separately 

certified CAHs, regardless of practice or 

location, are given due consideration; 

(3) The unified and integrated 

infection prevention and control and 

antibiotic stewardship programs have 

mechanisms in place to ensure that 

issues localized to particular CAHs are 

duly considered and addressed; and 

(4) A qualified individual (or 

individuals) with expertise in infection 

prevention and control and in antibiotic 

stewardship has been designated at the 

CAH as responsible for communicating 

with the unified infection prevention 

and control and antibiotic stewardship 

programs, for implementing and 

maintaining the policies and procedures 

governing infection prevention and 

control and antibiotic stewardship as 

directed by the unified infection 

prevention and control and antibiotic 

stewardship programs, and for 

providing education and training on the 

practical applications of infection 

prevention and control and antibiotic 

stewardship to CAH staff. 


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■ 8. Section 485.641 is amended by 

adding paragraph (f) to read as follows: 

§ 485.641 Condition of participation: 

Quality assessment and performance 

improvement program. 

* * * * * 

(f) Standard: Unified and integrated 

QAPI program for a CAH in a multifacility system. If a CAH is part of a 

system consisting of multiple separately 

certified hospitals, CAHs, and/or REHs 

using a system governing body that is 

legally responsible for the conduct of 

two or more hospitals, CAHs, and/or 

REHs, the system governing body can 

elect to have a unified and integrated 

QAPI program for all of its member 

facilities 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 CAHs meets all 

of the requirements of this section. Each 

separately certified CAH 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 CAH’s 

unique circumstances and any 

significant differences in patient 

populations and services offered in each 

CAH; 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 CAHs, 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 CAHs are 

duly considered and addressed. 

PART 489—PROVIDER AGREEMENTS 

AND SUPPLIER APPROVAL 

■ 9. The authority citation for part 489 

continues to read as follows: 

Authority: 42 U.S.C. 1302, 1395i–3, 1395x, 

1395aa(m), 1395cc, 1395ff, and 1395hh. 

■ 10. Section 489.2 is amended by 

adding paragraph (b)(11) to read as 

follows: 

§ 489.2 Scope of part. 

* * * * * 

(b) * * * 

(11) Rural emergency hospitals 

(REHs). 

* * * * * 

■ 11. Section 489.24 is amended in 

paragraph (b) by revising the definitions 

of ‘‘Hospital’’ and ‘‘Participating 

hospital’’ to read as follows: 

§ 489.24 Special responsibilities of 

Medicare hospitals in emergency cases. 

* * * * * 

(b) * * * 

Hospital includes a critical access 

hospital as defined in section 

1861(mm)(1) of the Act and a rural 

emergency hospital as defined in 

section 1861(kkk)(2). 

* * * * * 

Participating hospital means: 

(1) A hospital; 

(2) A critical access hospital as 

defined in section 1861(mm)(1) of the 

Act that has entered into a Medicare 

provider agreement under section 1866 

of the Act; or 

(3) A rural emergency hospital as 

defined in section 1861(kkk)(2) of the 

Act. 

* * * * * 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2022–14153 Filed 6–30–22; 4:15 pm] 

BILLING CODE 4120–01–P 


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