20564 Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 488 and 489 

[CMS–3255–P] 

RIN 0938–AQ33 

Medicare and Medicaid Programs; 

Survey, Certification and Enforcement 

Procedures 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

revise the survey, certification, and 

enforcement procedures related to CMS 

oversight of national accreditation 

organizations (AOs). These revisions 

would implement certain provisions 

under the Medicare Improvements for 

Patients and Providers Act of 2008 

(MIPPA). The proposed revisions would 

also clarify and strengthen our oversight 

of AOs that apply for, and are granted, 

recognition and approval of an 

accreditation program in accordance 

with the Social Security Act. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on June 4, 2013. 

ADDRESSES: In commenting, please refer 

to file code CMS–3255–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

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

the instructions under the ‘‘More Search 

Options’’ tab. 

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–3255–P, P.O. Box 8016, Baltimore, 

MD 21244–8016. 

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–3255–P, Mail 

Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–8016. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

7195 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Melanson, (410) 786–0310; 

Patricia Chmielewski, (410) 786–6899; 

or Marilyn Dahl, (410) 786–8665. 

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 Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

Acronyms 

ADI—Advanced Diagnostic Imaging Services 

AO—Accrediting Organization 

ASC—Ambulatory Surgical Center 

CAH—Critical Access Hospital 

CfC—Condition for coverage 

CFR—Code of Federal Regulations 

CMHC—Community Mental Health Center 

CMS—Center for Medicare & Medicaid 

Services 

CoP—Condition of Participation 

CORF—Comprehensive Outpatient 

Rehabilitation Facility 

EMTALA—Emergency Medical Treatment 

and Labor Act 

GAO—Government Accountability Office 

HHA—Home Health Agency 

HHS—Department of Health and Human 

Services 

MIPPA—Medicare Improvements for Patients 

and Providers Act of 2008 

NF—Nursing Facility 

OIG—Office of the Inspector General 

OPT—Provider of outpatient physical 

therapy and speech language pathology 

services 

RHC—Rural Health Clinic 

Social Security Act—the Act 

SNF—Skilled Nursing Facility 

TJC—The Joint Commission 

I. Background 

To participate in the Medicare 

program, providers and suppliers of 

health care services, must be 

substantially in compliance with 

specified statutory requirements of the 

Social Security Act (the Act), as well as 

any additional regulatory requirements 

related to the health and safety of 

patients specified by the Secretary of the 

Department of Health and Human 

Services (HHS). These health and safety 

requirements are generally called 

conditions of participation (CoPs) for 

most providers, requirements for skilled 

nursing facilities (SNFs), conditions for 

coverage (CfCs) for ambulatory surgical 

centers (ASCs) and other suppliers, and 

conditions for certification for rural 

health clinics (RHCs). A provider or 

supplier that does not substantially 

comply with the applicable health and 

safety requirements risks having its 

participation in the Medicare program 

terminated. 

In accordance with section 1864 of 

the Act, state health departments or 

similar agencies, under an agreement 

with CMS, survey health care providers 

and suppliers to ascertain compliance 

with the applicable CoPs, CfCs, 

conditions of certification, or 

requirements, and certify their findings 

to us. Based on these state survey 

agency certifications, we determine 

whether the provider or supplier 

qualifies, or continues to qualify, for 

participation in the Medicare program. 

Section 1865(a) of the Act allows 

health care facilities, except kidney 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 20565 

1HCFA’s Approval and Oversight of Private 

Accreditation Organizations (HEHS–99–197R), 

September 30, 1999. http://www.gao.gov/products/ 

HEHS–99–197R 

CMS Needs Additional Authority to Adequately 

Oversee Patient Safety in Hospitals (GAO–04–850) 

July 20, 2004. http://www.gao.gov/new.items/ 

d04850.pdf 

Hospital Oversight in Medicare: Accreditation 

and Deeming Authority. May 6, 2005 http:// 

www.nhpf.org/library/issue-briefs/ 

IB802_Accreditation_05–06–05.pdf 

Moffett, M. & Bohara, A. Hospital Quality 

Oversight by the Joint Commission on Accreditation 

of Healthcare Organizations. Vol 31, No. 4 (Fall 

2005) pp 629–647. 

transplant centers, end stage renal 

dialysis facilities, and suppliers of 

medical equipment and supplies, to 

demonstrate compliance with Medicare 

CoPs, requirements, CfCs, or conditions 

for certification through accreditation by 

a CMS-approved program of a national 

accreditation body. If an accrediting 

organization (AO) is recognized by the 

Secretary as having standards for 

accreditation that meet or exceed 

Medicare requirements, any provider or 

supplier accredited by the AO’s CMSapproved accreditation program may be 

deemed by us to meet the Medicare 

conditions or requirements. 

We are responsible for the review, 

approval and subsequent oversight of 

national AOs’ Medicare accreditation 

programs, and for ensuring providers or 

suppliers accredited by the AO meet the 

quality and patient safety standards 

required by the Medicare CoPs, 

requirements, CfCs, and conditions for 

certification. Any national AO seeking 

approval of an accreditation program in 

accordance with section 1865(a) of the 

Act must apply for and be approved by 

CMS for a period not to exceed 6 years. 

The AO must reapply for renewed CMS 

approval of an accreditation program 

before the date its approval period 

expires. This allows providers or 

suppliers accredited under the program 

to continue to be deemed to be in 

compliance with the applicable 

Medicare CoPs, requirements, CfCs, and 

conditions for certification. Regulations 

implementing these provisions are 

found at 42 CFR 488.1 through 488.9. 

In accordance with § 488.8(f), if we 

determine that an AO’s accreditation 

program requirements are no longer 

comparable to Medicare requirements 

we may open a deeming authority 

review and give the AO up to 180 days 

to adopt comparable requirements. If at 

the end of the deeming authority review 

period, the AO’s accreditation program 

has failed to adopt comparable 

requirements, we may give the AO 

conditional approval with a 

probationary period for up to one year. 

Within 60 days after the end of any 

probationary period, we will make a 

final determination as to whether or not 

an accreditation program continues to 

meet the Medicare requirements and 

will issue an appropriate notice 

(including reasons for the 

determination) to the AO and affected 

providers or suppliers. 

Section 1834(e) of the Act requires 

that, beginning January 1, 2012, 

Medicare payment may only be made 

for the technical component of 

advanced diagnostic imaging (ADI) 

services for which payment is made 

under the fee schedule established in 

section 1848(b) of the Act to a supplier 

who is accredited by an accrediting 

organization designated by the 

Secretary. Currently, oversight of these 

accrediting organizations is limited to 

requirements at § 414.68, and these 

accrediting organizations are not subject 

to the more expansive oversight 

requirements at 488, subpart A. 

II. Provisions of the Proposed Rule 

Section 125 of the Medicare 

Improvement for Patients and Providers 

Act of 2008 (MIPPA) (Pub. L. 110–275, 

enacted on July 15, 2008) removed legal 

distinctions between the Joint 

Commission (TJC) hospital accreditation 

program and all other accreditation 

programs approved by CMS in 

accordance with section 1865 of the Act. 

In this proposed rule, we are proposing 

corresponding changes to the 

regulations in part 488, subpart A, 

which implement section 1865 of the 

Act. 

The Secretary has endorsed the 

recommendations of the HHS Office of 

Inspector General (OIG), and the 

Government Accountability Office 

(GAO) to strengthen our oversight and 

ensure greater accountability of AOs 

and instructed CMS to respond 

appropriately 1. AOs and their CMSapproved accreditation programs 

significantly impact the health and 

safety of patients and the quality of care 

provided in Medicare-participating 

facilities across the country. We 

currently have 19 approved 

accreditation programs offered by seven 

national AOs. In fiscal year 2011, 

accredited facilities deemed to meet 

Medicare standards accounted for over 

11,000 Medicare-participating facilities 

(not including accredited clinical 

laboratories. 

All 19 CMS-approved AO 

accreditation programs received an 

extensive review in accordance with the 

application and reapplication process 

described at part 488 in recent years. 

The application and reapplication 

review process provides us the 

opportunity to conduct a 

comprehensive evaluation of an AO’s 

performance and ability to assure that 

providers or suppliers meet or exceed 

the applicable Medicare standards. The 

review process also provides the 

opportunity to evaluate compliance 

with the other requirements of subpart 

A of part 488. 

The high volume of comprehensive 

AO application and reapplication 

reviews that we have conducted has 

provided us with an abundance of 

opportunities to apply the existing AO 

approval regulations in a variety of 

circumstances. Throughout each review, 

we worked closely with the AOs, 

provided education and extensive 

feedback, and clarified expectations for 

the AOs. This experience has helped us 

to identify areas of our regulations in 

need of revision to more clearly 

articulate the requirements for all AOs 

with a CMS-approved accreditation 

program, as well as new AOs seeking 

initial CMS approval. 

Furthermore, as we have taken actions 

to exercise more oversight of existing 

CMS-approved AO programs, we have 

become aware of the need to clarify, 

reorganize, and amend our regulations 

to support a more efficient and effective 

oversight process. In several situations 

involving serious and pervasive areas of 

non-compliance identified in CMSapproved AO accreditation programs, 

we found it necessary to invoke our 

oversight authorities under the existing 

regulations. In each case, we required 

the AO to implement corrective 

action(s) to ensure comparability with 

the Medicare requirements. Actions that 

we normally take include opening a 

deeming review outside the normal 

reapplication process, and issuing a 

conditional approval with a 

probationary period. In the course of 

taking these actions, we identify the 

need to revise and expand our 

enforcement tools to strengthen our 

ability to address serious and pervasive 

areas of AO non-compliance with the 

Medicare requirements; ensure that the 

AO takes the necessary corrective 

actions to address the area(s) of noncompliance; and ensure continuing 

compliance and comparability with 

Medicare requirements. 

We propose expanding the scope of 

the accrediting organizations’ oversight 

regulations at § 488, subpart A to 

include accrediting organizations with 

CMS-approved accreditation programs 

for ADI services. The current oversight 

regulations for accrediting organizations 

for the technical component of ADI 

services at § 414.68 would remain 

unchanged. This proposed expansion is 

part of our initiative to broaden our 

quality oversight of both the CMSapproved accrediting organizations as 


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20566 Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 

well as the suppliers of ADI services. As 

part of this effort, we anticipate future 

rule making to develop and implement 

Medicare health and safety standards for 

suppliers of these services. Prior to 

embarking upon this rule making 

process, we anticipate consulting with 

key stakeholders to shape the notice of 

proposed rulemaking. We note that, 

under section 135 of MIPPA, state 

survey agencies do not play a role in the 

oversight of suppliers of the technical 

component of ADI services, and we do 

not have the statutory authority to create 

such a role. 

We propose to clarify that, when a 

state survey agency substantial 

allegation validation survey, that is, a 

complaint survey, of an accredited 

provider or supplier finds substantial 

non-compliance with one or more of 

Medicare’s conditions or requirements, 

we have the flexibility in terms of its 

next steps. Currently we may either 

proceed immediately to enforcement 

action based on that complaint survey, 

or may instead require the state survey 

agency to conduct another, full survey 

which assesses compliance with all of 

the CoPs or CfCs for that type of 

provider or supplier. We are proposing 

not only to retain this flexibility but also 

to expand it, so that we could require 

the state survey agency to conduct 

another, more comprehensive survey, 

but not a full survey assessing 

compliance with all the CoPs or CfCs. 

This clarification supports the ability for 

us to make efficient use of survey 

resources while maintaining an effective 

enforcement process that is appropriate 

for each specific case. 

A. Definitions (§ 488.1) 

Section 488.1 sets forth definitions for 

terms used in part 488. We are 

proposing revisions at § 488.1 as 

follows: 

• We propose deleting the definition 

of ‘‘accredited provider or supplier.’’ 

Use of this language has caused 

confusion both internally and 

externally. National AOs offer a variety 

of accreditation programs. However, not 

all programs are CMS-approved 

accreditation programs for the purpose 

of Medicare participation. 

• We propose deleting the language, 

‘‘AOA stands for the American 

Osteopathic Association.’’ The proposed 

revisions to subpart A would no longer 

refer to any specific AO. The proposed 

revisions instead are broader, 

referencing national AOs generically. 

• We propose expanding the 

definition of ‘‘certification’’ to include 

the RHC conditions; clarify that each 

provider or supplier must meet its 

respective conditions or requirements to 

be certified; and deleting the language 

‘‘for SNFs and NFs’’ to eliminate 

redundancy. 

• We propose revising the definition 

of ‘‘conditions for coverage’’ for 

increased clarity and specificity. 

• We propose adding a definition of 

‘‘conditions for certification’’ to include 

the terminology for standards that RHCs 

must meet to participate in the Medicare 

program. 

• We propose adding a definition of 

‘‘deemed status’’ to increase clarity and 

reduce ambiguity when referring to the 

status of providers and suppliers 

accredited under a CMS-approved 

accreditation program and who are 

participating in Medicare via this 

accreditation. 

• We propose revising the definition 

of ‘‘full review’’ to clarify that the 

regulations at part 488 apply to all 

providers and suppliers, not just 

hospitals. 

• We propose adding a definition of 

‘‘immediate jeopardy’’ at § 488.1 that 

would apply generically to all providers 

and suppliers subject to the certification 

requirements at part 488. 

• We propose deleting the language, 

‘‘JCAHO stands for the Joint 

Commission on Accreditation of 

Healthcare Organizations,’’ since the 

proposed revisions to subpart A do not 

refer to any specific AO. 

• We propose adding a definition of 

‘‘national accreditation organization’’ to 

specify that CMS requires a program 

seeking initial approval to already be 

fully implemented and operational 

nationally. 

• We propose expanding the 

definition of ‘‘provider of services or 

provider’’ to include a clinic, 

rehabilitation agency or public health 

agency that furnishes outpatient 

physical therapy or speech language 

pathology services. This proposed 

change is consistent with the language 

at section 1861(p)(4) of the Act. 

• We propose revising the definition 

of ‘‘reasonable assurance by deleting the 

language ‘‘taken as a whole.’’ This 

proposed change would clarify the 

requirement that an AO’s CMSapproved accreditation program has 

standards that meet or exceed the 

applicable Medicare conditions or 

requirements consistent with language 

at section 1865(a)(1) of the Act. 

• We propose updating the definition 

of ‘‘state survey agency’’ for added 

clarity and precision. 

• We propose revising the definition 

of ‘‘substantial allegation of noncompliance’’ to correct a previous error. 

• We propose modifying the 

definition of ‘‘supplier’’ to make it 

consistent with the definition of 

supplier as amended by section 901 of 

the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (Pub. L. 108–173). 

• We propose deleting the definition 

of ‘‘validation review period.’’ The 

concept of a fixed review period would 

not be used in the proposed revisions at 

§ 488.8. 

B. Statutory Basis (§ 488.2) 

Section 488.2 sets forth the statutory 

basis for provider and supplier 

requirements. We propose revising this 

section by adding pertinent statutory 

citations and revising the statutory 

citation at section 1883 of the Act by 

replacing the title ‘‘Requirements for 

hospitals that provide SNF care’’ with 

‘‘Requirements for hospitals that 

provide extended care services’’ to be 

consistent with the statutory language. 

C. Conditions of Participation; 

Conditions for Coverage; Conditions for 

Certification; and Long-Term Care 

Requirements (§ 488.3) 

Section 488.3 sets forth the conditions 

or requirements that a prospective 

provider or supplier must meet to be 

approved for participation in or 

coverage under the Medicare program. 

We propose revising § 488.3 to include 

the requirements RHCs must meet to 

participate in Medicare; the statutory 

citations for CAHs, RHCs, hospitals that 

provide extended care services, 

hospices, comprehensive outpatient 

rehabilitation facilities (CORFs), 

community mental health centers 

(CMHCs), providers of outpatient 

physical therapy and speech language 

pathology services (OPTs), and 

advanced diagnostic imaging services 

(ADIs); and the regulatory references for 

RHCs, CORFs, CMHCs, CAHs, OPTs, 

and ADIs. In addition, we propose to 

revise § 488.3(b) to address all providers 

or suppliers of services subject to 

certification. This proposal would also 

authorize the Secretary to consult with 

state survey agencies and other 

organizations, which would include all 

AOs and other national standard-setting 

organizations to develop Conditions of 

Participation. We are not proposing any 

policy changes to this program. 

D. CMS-Approved National 

Accreditation Programs for Providers 

and Suppliers (§ 488.4) 

We propose to revise § 488.4 as part 

of our effort to reorganize the 

application and reapplication process, 

delete redundancy, and reorganize the 

accreditation requirements in a more 

logical sequence. We are proposing 

revisions at § 488.4 as follows: 


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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 20567 

• Proposed § 488.4(a) would replace 

the requirements currently set out at 

§ 488.6(a), with some modifications. The 

current regulation specifically lists the 

eligible provider and supplier 

accreditation programs under which 

AOs may provide us with reasonable 

assurance that the AO’s requirements 

are at least as stringent as the Medicare 

conditions or requirements. We propose 

eliminating references to specific types 

of provider and supplier accreditation 

programs by simply stating that CMSapproved accreditation program for 

providers and suppliers with the 

exception of kidney transplant centers, 

end stage renal dialysis facilities, and 

suppliers of medical equipment and 

supplies may provide reasonable 

assurance to CMS that it requires 

providers and suppliers it accredits to 

meet the requirements that are at least 

as stringent as the Medicare conditions 

or requirements. Also, this section 

addresses national accreditation 

programs for hospitals other than those 

offered by TJC and AOA, as well as 

accreditation programs for other types of 

providers and suppliers. We propose 

deleting the reference to ‘‘requirements 

concerning hospitals accredited by the 

JCAHO or AOA’’ since the proposed 

changes are broader and would not 

specify any particular AO. 

• Proposed § 488.4(b) would be a new 

provision, making it explicit that an 

AO’s CMS-approved accreditation 

program would be approved in its 

entirety. Under this provision, an AO 

would not be permitted to make a 

recommendation to us for deemed status 

for a provider or supplier unless that 

provider or supplier satisfied all of the 

AO’s requirements for accreditation. 

This would include both the AO 

accreditation program standards that 

may exceed the Medicare standards, as 

well as those that meet the Medicare 

standards. 

E. Application and Reapplication 

Procedures for National Accreditation 

Organizations (§ 488.5) 

We propose to revise § 488.5 to clarify 

the requirement that a prospective AO 

and its accreditation program be 

national in scope. We also propose 

moving the regulatory language 

currently at § 488.4 to § 488.5 with 

modifications as part of our effort to 

reorganize the accreditation 

requirements in a more logical 

sequence. 

Specifically, we propose the following 

revisions: 

• Proposed § 488.5(a) would replace 

the requirement currently set out at 

§ 488.4(a). It would be revised to clarify 

that these provisions would apply to 

both initial applications for a new 

accreditation program, as well as reapproval of an existing CMS-approved 

accreditation program. The proposed 

revision further would clarify that each 

application for approval would pertain 

to a single provider/supplier-specific 

accreditation program. 

• Proposed § 488.5(a)(1) would 

replace the requirement currently set 

out at § 488.4(a)(1), concerning the AO’s 

identification in its application of the 

type of provider or supplier for which 

it is seeking approval. We propose 

revising this requirement to clarify that 

each application for our approval would 

be separate and distinct from 

applications for our approval of 

accreditation programs for other types of 

providers or suppliers. 

• Proposed § 488.5(a)(2) would 

require an AO seeking initial CMS 

approval of a new accreditation program 

or renewed approval of an existing 

program to demonstrate that the 

program met the definition of a 

‘‘national accrediting organization.’’ 

Section 1865 of the Act applies only to 

programs of national accreditation 

bodies. Demonstration must be specific 

to each accrediting program for which 

new or renewed CMS approval is 

sought. For example, an AO which has 

one or more existing CMS-approved 

programs that seek our initial approval 

of a new accreditation program must 

also demonstrate that the new program 

has been implemented nationally. This 

proposal implements the ‘‘national’’ 

requirement in the statute and sets forth 

a methodology for determining how an 

AO would meet the ‘‘national’’ 

qualification in the regulations. 

• Proposed § 488.5(a)(3) would 

replace the requirement currently set 

out at § 488.4(a)(2), concerning the 

requirement that an AO submit a 

detailed comparison of its standards to 

Medicare requirements, and clarify the 

components of an acceptable crosswalk. 

• Proposed § 488.5(a)(4) would 

replace the requirement currently set 

out at § 488.4(a)(3), which addresses the 

requirement that the AO must provide 

a detailed description of its survey 

process in its application for our 

approval of an accreditation program. 

The language of this provision would 

remain unchanged. 

• Proposed § 488.5(a)(4)(i), would 

replace the requirement currently set 

out at § 488.4(a)(3)(i), concerning the 

frequency of surveys. The proposed 

revisions reflect existing CMS policy 

and would not impose any new 

requirements on AOs, but would be 

added to clarify the requirement. 

• Proposed § 488.5(a)(4)(ii) is a new 

provision that would ensure surveys 

conducted by AOs were comparable to 

the Medicare requirements, and would 

implement section 1865(a)(2) of the Act. 

• Proposed § 488.5(a)(4)(iii) would 

replace the requirement currently set 

out at § 488.4(a)(3)(ii). The language of 

this requirement would be unchanged 

and addresses the content and 

frequency of survey personnel training. 

• Proposed § 488.5(a)(4)(iv) would 

replace the requirement currently set 

out at § 488.8(a)(2)(ii), requiring an AO 

to crosswalk its survey deficiency 

citations to the comparable Medicare 

requirements. This proposed provision 

is being modified for clarity to ensure 

consistency with existing policy and to 

ensure that our oversight of the AOs is 

effective. In addition, we are proposing 

that the language, ‘‘and the ability to 

investigate and respond appropriately to 

accredited facilities,’’ be redesignated to 

proposed § 488.5(a)(7). 

• Proposed § 488.5(a)(4)(v) would 

replace the requirement currently set 

out at § 488.4(a)(3)(iii), concerning the 

survey review and accreditation 

decision-making process. We would 

delete language that would be 

redundant with language being 

incorporated into the proposed revised 

regulatory language at § 488.5(a)(8). 

• Proposed § 488.5(a)(4)(vi), currently 

set out at § 488.4(a)(3)(iv), would specify 

that the AO’s provider or supplier 

notification procedures meet or exceed 

those required for state survey agencies. 

This language represents existing CMS 

policy and would not impose any new 

requirements on AOs, but would be 

added to clarify the requirement and 

provide more specific and precise 

language. 

• Proposed § 488.5(a)(4)(vii) is a new 

proposed provision regarding the AOs 

timeline and procedures for monitoring 

the facilities found to be out of 

compliance. This language reflects 

existing CMS policy and would not 

impose any new requirements on AOs, 

but would be added to clarify the 

requirement and provide more specific 

and precise language. Further, the 

proposed provision would be consistent 

with the requirement at section 

1865(a)(2) of the Act. 

• Proposed § 488.5(a)(4)(viii) would 

replace the requirement currently set 

out at § 488.8(a)(3), which requires the 

AO to provide a copy of its most recent 

accreditation survey for a specified 

provider or supplier, together with any 

other information related to the survey 

that we may require. We propose 

modifying this provision for consistency 

and clarity. 

• Proposed § 488.5(a)(4)(ix) is a new 

proposed provision regarding AO 

notification to us when the AO 


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20568 Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 

identifies an immediate threat to the 

health and safety of patients, that is, a 

situation that constitutes an immediate 

jeopardy as that term is defined in 

§ 489.3. This provision would ensure 

that we are notified of situations that 

may put the health and safety of 

patients receiving care in Medicareparticipating facilities at serious risk of 

harm, and would require us to take 

immediate action to enforce these 

provisions. 

• Proposed § 488.5(a)(5) would 

replace the requirement currently set 

out at § 488.4(a)(4)(i). The language of 

this provision is unchanged and 

addresses the requirement that the AO 

provide us with detailed information 

about its surveyors. 

• Proposed § 488.5(a)(6) would 

replace the requirement currently set 

out at § 488.4(a)(4)(i). This provision 

addresses the requirement for the AO to 

furnish information about the size and 

composition of its survey teams. The 

proposed expanded provisions would 

recognize that, within a given 

accreditation program, there can be 

great variation in the size and 

complexity of individual health care 

facilities. We believe that a uniform size 

and composition for the AO’s survey 

teams would not be appropriate. 

• Proposed § 488.5(a)(6) is a new 

proposed provision that would help 

ensure that an AO maintained an 

adequate number of trained surveyors to 

meet the demand for surveys, both 

initial and re-accreditation surveys. 

There have been instances where an AO 

could not maintain the required reaccreditation survey schedule interval 

for its existing accredited deemed status 

facilities because it was focusing its 

resources on meeting the demand of 

new customers for initial Medicare 

accreditation surveys. These AOs lacked 

sufficient personnel resources to handle 

both existing and new workloads. 

• Proposed § 488.5(a)(7) would 

replace the requirement currently set 

out at § 488.4(a)(4)(ii) concerning the 

AO’s education and experience 

requirements for its surveyors. The 

proposed revisions would explicitly 

require documentation of these surveyor 

requirements. 

• Proposed § 488.5(a)(8) would 

replace the requirement currently set 

out at § 488.4(a)(iii) concerning inservice training of AO survey personnel. 

The language of this provision would be 

revised to explicitly state that the AO 

must provide documentation describing 

the content and frequency of this inservice training. 

• Proposed § 488.5(a)(9) would 

replace the requirement currently set 

out at § 488.4(a)(4)(iv) concerning 

evaluation systems used by the AO to 

monitor the performance of individual 

surveyors and survey teams. This 

provision would be revised to explicitly 

state that an AO must provide 

documentation describing these 

evaluation systems. 

• Proposed § 488.5(a)(10) would 

replace the requirement currently set 

out at § 488.4(a)(4)(v), concerning the 

AO’s policies on the involvement of 

personnel in the survey or accreditation 

decision process who have a financial or 

professional affiliation with the 

provider or supplier. The provision 

would be modified to ensure that the 

AO has policies to avoid such potential 

conflicts of interest that could 

undermine the integrity of its 

accreditation program. 

• Proposed § 488.5(a)(11) would 

replace the requirement currently set 

out at § 488.4(a)(5). This provision 

addresses the requirement that the AO 

provide information on its data 

management system in its application. 

We would reorganize the regulatory text 

to contain the provisions currently set 

out at § 488.5(a)(6)(i) and 

§ 488.5(a)(6)(ii). In proposed 

§ 488.5(a)(6), we would retain existing 

language requiring an AO to submit a 

description of its data management and 

analysis system regarding its surveys 

and accreditation decisions. The 

description would have to include the 

submission of the information set out at 

proposed § 488.5(a)(11)(i) and 

§ 488.5(a)(11)(ii), which includes 

provider or supplier and survey 

information, and accreditation 

decisions. 

• Proposed § 488.5(a)(11)(i) would 

require submission of a detailed 

description of how the AO uses its data 

system to assure compliance with the 

Medicare requirements. This new 

proposed language would replace 

existing language, which is being 

deleted. The existing language proposed 

for deletion is both too specific and too 

limiting in elaborating on what 

information would adequately convey 

how the AO uses its data management 

system for compliance purposes. The 

proposed language would make clear 

that we are seeking information on how 

the AO uses its data management 

systems to meet the various 

requirements of this subpart. 

• Proposed § 488.5(a)(11)(ii) would 

modify the regulatory text currently at 

§ 488.4(b)(1), which requires an AO to 

include in its application a written 

presentation of its ability to submit 

information electronically ‘‘in ASCII 

comparable code.’’ The reference to 

ASCII comparable code is outdated and 

insufficient. The proposed 

modifications are necessary to ensure 

that we have the required data to 

provide effective oversight of an 

approved accreditation program. We are 

also proposing to delete § 488.8(a)(2)(v), 

which is a redundant requirement 

related to electronic data submission in 

ASCII-comparable code. 

• Proposed § 488.5(a)(12) would 

replace the requirement currently set 

out at § 488.4(a)(6). The language of this 

provision would remain unchanged and 

addresses the AO’s procedures for 

responding to and investigating 

complaints. 

• Proposed § 488.5(a)(13) would 

replace requirements currently set out at 

§ 488.4(a)(7), with modifications. The 

current provision requires AOs to 

submit information to us regarding their 

policies and procedures for 

withholding, or removing accreditation 

status for facilities that fail to meet the 

AOs’ standards or requirements. The 

AO must also report to us any other 

actions taken by the AO in response to 

its determination of non-compliance 

with its standards and requirements. We 

propose to expand this provision to 

require submission of the AOs’ policies 

and procedures related to granting 

accreditation status and assignment of 

less than full accreditation status. Since 

the granting of full or less than full 

accreditation statuses are essential 

components of an AO’s accreditation 

decision process, it is necessary for us 

to receive information on the policies 

and procedures pertaining to these types 

of decisions as well. 

• Proposed § 488.5(a)(13)(i) would 

replace the requirement currently set 

out at § 488.4(a)(8). The current 

regulation addresses the requirement 

that AOs provide us a description of all 

types and categories of accreditation 

offered under its accreditation program. 

We would modify this provision by 

deleting language and terminology 

specific to one particular AO. Further, 

the current provision seems to require 

the AO to submit information on its 

accreditation programs that fall outside 

the parameters of its Medicare 

accreditation programs. Since we do not 

approve accreditation programs 

unrelated to Medicare, we believe that 

there is no reason to require AOs to 

submit such information to us, nor for 

us to have and review this non-relevant 

information. 

• Proposed § 488.5(a)(13)(ii) would 

address the requirement, currently 

found at § 488.4(b)(3)(i), for an AO to 

agree, as a condition of approval, to 

notify us of any provider or supplier 

that has had its accreditation revoked, 

withdrawn, or revised, or has had any 

remedial or adverse action taken against 


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it. The current regulation requires the 

AO to notify us in writing within 30 

days of its action. We propose to reduce 

this timeframe since AOs transmit such 

information to us electronically. The 30- 

day timeframe was based on 

information being sent to us via hard 

copy mail. Given the instantaneous 

nature of the electronic notification, as 

well as our need to learn of such 

adverse actions as soon as possible to 

initiate enforcement action as 

applicable, we believe it would be 

reasonable to require that the AO 

provide notice to us within three 

business days of its having taken the 

adverse action. 

• Proposed § 488.5(a)(14) would 

replace the requirement currently set 

out at § 488.4(a)(9) concerning 

submission of information on currently 

accredited facilities as part of the AO’s 

application. This provision would be 

modified for clarity. Proposed 

§ 488.5(a)(15) would create a new 

requirement for an AO seeking renewed 

approval for a currently CMS-approved 

accreditation program. It would require 

such an AO to demonstrate, as a 

condition of acceptance of its 

application for renewal, that it 

demonstrated growth as evidenced by 

having accredited at least 50 health care 

facilities under its CMS-approved 

accreditation program. We believe that 

an established AO accreditation 

program that has not been able to 

accredit a minimum of 50 health care 

facilities since receiving initial CMS 

approval has failed to demonstrate 

sufficient infrastructure and scale to be 

sustained over a long period of time. 

Although we are willing to be flexible 

in accepting applications for initial 

approval from new national 

accreditation programs that are 

comparatively small, we believe that an 

established CMS-approved program that 

has not been able to accredit at least 50 

healthcare facilities during the four-year 

period since its initial approval would 

have failed to demonstrate long term 

national viability. Further, we have 

limited resources available to conduct 

the detailed, comprehensive review of 

the AO’s application required under 

section 1865(a)(2) of the Act. We believe 

these federal resources are best focused 

on those larger accreditation programs 

responsible for oversight of the quality 

of care provided in hundreds of 

accredited healthcare facilities, serving 

millions of patients, rather than on an 

accreditation program connected with a 

relatively small number of Medicare 

beneficiaries. 

• Proposed § 488.5(a)(16) would 

replace the requirement currently set 

out at § 488.4(a)(10), which addresses 

the requirement for AOs to provide us 

with a list of accreditation surveys 

scheduled to be performed. We propose 

to revise this requirement to limit the 

schedule the AO must provide to 

surveys expected to be conducted 

during the six month period following 

submission of an application for CMS 

approval. Since we must complete the 

entire application review and publish a 

final notice announcing our decision 

within a 210 day statutory timeframe, it 

is not useful for a survey schedule to be 

submitted for a later timeframe. We use 

this survey schedule to plan our survey 

observation as part of our review. This 

requirement applies to both initial and 

renewal applications and is separate 

and apart from the requirement at 

proposed § 488.5(a)(11), regarding an 

approved program, for an AO to submit 

survey schedules as part of the data it 

agrees to provide us for our ongoing 

oversight. 

• Proposed § 488.5(a)(17) would 

replace the requirement currently set 

out at § 488.4(b)(2), which requires an 

AO to provide a resource analysis 

demonstrating that it has the resources 

to support its accreditation program. 

The proposed modifications would 

more clearly identify the type of 

documentation an AO must provide to 

demonstrate the adequacy of its 

resources. 

• Proposed § 488.5(a)(18) is a new 

provision that would address 

requirements related to AO written 

notification and timeframes regarding 

currently deemed providers or suppliers 

when the AO elected to terminate its 

CMS-approved accreditation program 

voluntarily. This provision would be 

necessary so that we could give affected 

state survey agencies and CMS Regional 

Offices adequate advance notice 

regarding the providers or suppliers 

affected by such a termination. In such 

a case, providers or suppliers would 

subsequently need to be surveyed and 

approved by the State survey agency, 

unless the providers or suppliers sought 

and received accreditation from another 

CMS-approved AO. 

• Proposed § 488.5(a)(19) would 

replace the requirement currently set 

out at § 488.4(b)(3)(iii). This provision 

addresses the timeframe for AO 

notification to us regarding proposed 

changes in accreditation requirements. 

We are proposing to modify the 

regulation by expanding the timeframe 

to provide adequate time for us to 

conduct a comprehensive, detailed 

review of the AO’s proposed changes. 

We are also proposing language 

clarifying that any proposed changes in 

a CMS-approved accreditation program 

may not be implemented by the AO 

before we approve such changes. This 

would ensure that the accreditation 

program continued to meet or exceed 

the Medicare requirements. 

• Proposed § 488.5(a)(20) would 

replace the requirement currently set 

out at § 488.4(b)(3)(iv), concerning AO 

submission of changes to its standards 

within 30 days of a change in our 

requirements. We propose modifying 

the regulation text by deleting 

references to specific timeframes. This 

would provide us the flexibility to 

consider other factors when determining 

an appropriate timeframe for AOs to 

revise their program and submit the 

changes to us. These factors may 

include: the effective date of the 

applicable final rule, the effective date 

of our revised interpretive guidance or 

survey process, and the scope and 

magnitude of our changes that require 

corresponding AO changes. AOs would 

benefit from our having the flexibility to 

provide them longer timeframes for 

response, when appropriate. In 

addition, we propose adding language to 

ensure the AO program continues to 

meet or exceed the Medicare 

requirements, and specify the 

consequences for an AO’s failure to 

submit timely comparable changes. 

• Proposed § 488.5(a)(21) would 

replace the requirement currently set 

out at § 488.4(b)(3)(v), which concerns 

the requirement for the AO to permit its 

surveyors to serve as witnesses if CMS 

takes an adverse action based on 

accreditation findings. We propose 

modifying the regulation by adding 

language to clarify the scope of the 

requirement. 

• Proposed § 488.5(b) would replace 

the requirement currently set out at 

§ 488.4(c). The language of this 

provision addresses the requirement 

that if we determine additional 

information is necessary to make a 

determination for approval or denial of 

an AO’s application for deeming 

authority, the AO will be afforded the 

opportunity to provide the additional 

information. We propose deleting the 

language ‘‘deeming authority.’’ This 

language has been a source of confusion 

both internally and externally. It has led 

healthcare facilities and others to think 

that the AO awards deemed status and 

participation in Medicare. This 

proposed change clarifies that we have 

the authority to grant ‘‘deemed status,’’ 

not the AO. 

• Proposed § 488.5(c)(1) would 

replace the requirement currently set 

out at § 488.4(f), which addresses the 

provision that an AO may withdraw its 

application at any time before the final 

notice is published in the Federal 

Register. We propose to modify this 


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provision by adding language clarifying 

that only an initial application can be 

withdrawn. 

• Proposed § 488.5(c)(2) is a new 

requirement that addresses situations 

where an AO wishes to voluntary 

terminate its CMS-approved 

accreditation program. If an AO decides 

to voluntarily terminate its CMSapproved accreditation program, it must 

notify us of its decision and provide an 

effective date of termination. We will 

publish in the Federal Register a notice 

that includes the reason for the 

termination and the effective date. In 

accordance with the requirements at 

proposed § 488.8(e), the AOs must 

notify, in writing each of its providers 

or suppliers of its decision no later than 

30 calendar days after the notice is 

published in the Federal Register. 

Proposed § 488.5(d) would replace the 

requirement currently set out at 

§ 488.4(h), which addresses the ability 

of an AO whose request for approval of 

an accreditation program has been 

denied to resubmit its application if 

certain requirements are met. We would 

modify this provision by redesignating 

paragraph (i) to paragraph (e). 

• Proposed § 488.5(d)(1) through 

§ 488.5(d)(3), and § 488.5(e) would 

replace the requirement currently set 

out at § 488.4(h)(1) through 

§ 488.4(h)(3)(i). The language of these 

provisions would be unchanged and 

addresses the requirements that an AO 

must meet to resubmit its application 

for CMS approval of an accreditation 

program after an initial request has been 

denied. 

• Proposed § 488.5(f) is a new 

proposed provision, titled ‘‘Notice and 

Comment,’’ that would incorporate the 

timeframes for review of an AO request 

for CMS approval of an accreditation 

program that are set forth in section 

1865(b) of the Act. The text currently at 

§ 488.5 is being proposed for deletion 

because section 125 of MIPPA requires 

us to eliminate the separate provisions 

for TJC hospital accreditation. 

• Proposed § 488.5(f)(1) would 

replace the requirement currently set 

out at § 488.8(b)(1), concerning 

publication of a proposed notice 

announcing our receipt of an AO 

application in the Federal Register. To 

better capture the purpose of a proposed 

versus a final notice, this provision 

would be revised by deleting language 

describing how the AO’s accreditation 

program provides reasonable assurance 

that entities accredited by the 

organization meet the Medicare 

requirements, and moving it to the 

provision concerning the final notice at 

proposed § 488.5(f)(2)(i). In addition, 

language would be added related to the 

timeframe for public comment 

consistent with section 1865 of the Act. 

• Proposed § 488.5(f)(2) would 

replace the requirement currently set 

out at § 488.8(b)(2), which requires us to 

publish a final notice announcing our 

decision to approve or disapprove an 

AO’s accreditation program in the 

Federal Register. In accordance with 

section 1865(a)(3)(A) of the Act, the 

final notice must be published no later 

than 210 days after our receipt of a 

complete application. The language of 

the regulations would be streamlined 

and simplified to more clearly 

communicate existing requirements. 

• Proposed § 488.5(f)(2)(i) would 

replace the requirement currently set 

out at § 488.8(b)(1), § 488.8(b)(2), and 

§ 488.8(c), which address the contents of 

the final notice. We propose modifying 

the current timeframe requirement to be 

consistent with the provisions of section 

1865(a)(3)(A) of the Act. Once a national 

AO’s accreditation program is approved 

by us and this decision is published in 

the Federal Register, we may approve 

any provider or supplier that is 

surveyed or accredited for Medicare 

participation on or after the effective 

date of the final Notice (assuming that 

all other federal requirements have been 

met). 

F. Providers or Suppliers That 

Participate in the Medicaid Program 

Under a CMS-Approved Accreditation 

Program (§ 488.6) 

We propose to broaden and revise the 

standard’s title as a conforming change 

consistent with section 125 of MIPPA. 

Proposed regulations at § 488.6 would 

replace the requirement currently set 

out at § 488.5(b), which states that 

eligibility for Medicaid participation 

can be established through Medicare 

deemed status for providers and 

suppliers that are not required under 

Medicaid regulations to comply with 

any requirements other than Medicare 

participation requirements. 

G. Release and Use of Accreditation 

Surveys (§ 488.7) 

We propose revising this standard’s 

title to be more reflective of the 

standard’s content. Proposed § 488.7 

would replace the requirement currently 

set out at § 488.6(c)(1), which states that 

an accredited provider or supplier must 

authorize its AO to release a copy of its 

most current accreditation survey, 

together with any information related to 

the survey that CMS may require 

(including corrective action plans) to us 

and the state survey agency. The 

proposed revised requirement would be 

for the deemed provider to authorize 

release of a copy of its most recent 

accreditation survey to us. We are also 

taking this opportunity to clarify that we 

recognize that, in accordance with the 

Patient Safety Act and Quality 

Improvement Act (PSQIA) (Pub. L. 109– 

41) and implementing regulations at 42 

CFR § 3.206(b)(8)(i) and (ii), an AO may 

not further disclose patient safety work 

product it receives when such work 

product complies with the requirements 

for patient safety work product 

protected under the PSQIA. Other 

proposed changes are part of our effort 

to reorganize and clarify the regulations, 

as follows: 

• Proposed § 488.7(a) would replace 

the requirement currently set out at 

§ 488.6(c)(2). The language of this 

requirement remains unchanged and 

addresses the requirement that we may 

determine that a provider or supplier 

does not meet the Medicare conditions 

on the basis of our own analysis of the 

accreditation survey or any other 

information related to the survey. 

• Proposed § 488.7(b) would replace 

the requirement currently set out at 

§ 488.5(c)(3) regarding our authority and 

discretion to disclose an AO survey and 

information related to the survey when 

the accreditation survey is related to an 

enforcement action taken by CMS. All 

other disclosures of AO survey 

information are prohibited under 

section 1865(b), with the exception of 

surveys of HHAs. This provision would 

be revised to clarify requirements for 

release of survey information. 

H. On-Going Review of Accreditation 

Organizations (§ 488.8) 

We propose modifying the title of this 

standard with language that is more 

specific and clarifies that our oversight 

of accreditation programs is continuous. 

We propose further revisions at § 488.8 

consistent with our effort to reorganize, 

streamline and clarify the regulations, as 

follows: 

• Proposed § 488.8(a) would replace 

the requirement currently set out at 

§ 488.8(d), which address the 

continuing federal oversight of 

equivalency of an AO and removal of 

deeming authority. The proposed 

revisions would ensure consistency 

with section 1875(b) of the Act, which 

authorizes continuing Secretarial 

oversight of accreditation organization 

activities with respect to Medicare 

participating entities and yearly reports 

to Congress concerning such activities. 

The proposed revisions would replace 

the concept of a ‘‘validation’’ review 

with the broader concept of an ongoing 

AO ‘‘performance’’ review. We also 

propose to remove reference to a ‘‘20 

percent’’ rate of disparity at current 

§ 488.8(d)(2)(i) as a threshold for 


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triggering a validation review that could 

result in termination of an AO’s 

program approval. Our experience over 

the past few years has demonstrated 

that, although the rate of disparity 

between AO and State survey agency 

surveys of the same facility within a 60 

day time period may be one reliable 

measure of some aspects of AO 

performance, a single measure used in 

isolation does not provide a complete 

and accurate picture of AO 

performance. As described in the CMS 

annual report to Congress, ‘‘Review of 

Medicare’s Program for Oversight of 

Accreditation Organizations,’’ we 

employ a multi-faceted approach that 

utilizes not only the disparity rate, but 

a number of other quantitative measures 

of AO performance, as well as the 

results of our periodic qualitative 

reviews of AO standards or of AO 

renewal applications to develop a 

comprehensive assessment of an AO’s 

performance. We believe it is not 

appropriate to include in the regulation 

a requirement, based on only one data 

point, which would trigger an 

automatic, formal review of an AO’s 

accreditation program’s continuing 

approval. Likewise, we believe our 

ability to open a formal review of an AO 

program should not be limited by tying 

such review to one data point. As a 

result, we propose deleting the specific 

reference in the regulation to a 20 

percent disparity rate triggering a formal 

validation review. We propose instead 

to provide at § 488.8(a) for an ongoing 

performance review of approved AO 

programs, and identify at proposed 

§ 488.8(a)(2) the disparity rate as only 

one of several components that may 

trigger a performance review. Further, 

we propose in § 488.8(c) to provide for 

a formal accreditation program review 

when a performance review reveals 

evidence of substantial non-compliance. 

We believe that the proposed revision 

will enable us to continue to make use 

of the disparity rate in our ongoing 

assessment of AO performance, but to 

also make use of other performance 

indicators that enable us to reach a more 

comprehensive assessment of the 

quality of an AO’s program. This 

revision would also make clearer that a 

formal accreditation program review 

could be opened as the result of a 

variety of serious compliance concerns. 

• Proposed § 488.8(a)(1) through 

§ 488.8(a)(3) are new proposed 

provisions which would be added to 

clarify that we evaluate AO performance 

by looking at various aspects of their 

practices. 

• Proposed § 488.8(b) would revise 

the requirement currently set out at 

§ 488.8(d)(1), which addresses CMS 

comparability reviews. The proposed 

revisions would clarify our current 

practice. 

• Proposed § 488.8(b)(1) would revise 

the requirement currently set out at 

§ 488.8(d)(1)(i), which address the need 

for a comparability review when we 

impose new requirements or change our 

survey process. We propose adding 

language which would provide us the 

flexibility to consider multiple factors 

when determining an appropriate 

timeframe for AOs to revise their 

accreditation program and submit 

revisions to CMS. These factors may 

include: the effective date of any final 

rule which would affect the substantive 

standards which are applied to various 

providers and suppliers; the effective 

date of any revised interpretive 

guidance or survey process affecting 

accredited providers or suppliers; and 

the scope and magnitude of such 

changes. In addition, the proposed new 

language would set out the 

consequences if an AO failed to submit 

comparable changes in a timely manner. 

These provisions would parallel 

proposed revisions at § 488.5(a)(12)(ii). 

• Proposed § 488.8(b)(2) would revise 

the requirement currently set out at 

§ 488.8(d)(1)(ii) concerning 

circumstances in which an AO proposes 

to adopt new requirements or changes 

its survey process. Under the current 

regulations, an AO must provide written 

notification to CMS at least 30 days in 

advance of the effective date of any 

proposed changes in its accreditation 

requirements or survey process. We 

propose expanding the timeframes to 

allow adequate time for us to conduct a 

comprehensive, detailed review of the 

AO’s proposed changes. In addition, we 

propose adding language to clarify that 

the AO may not implement any changes 

to its CMS-approved accreditation 

program prior to receiving CMS 

approval. The purpose of the proposed 

new language would be to ensure 

continuing comparability of the AO’s 

accreditation program with the 

Medicare requirements. These changes 

would parallel comparable changes at 

proposed § 488.5(a)(12)(i). 

• Proposed § 488.8(c) and 

§ 488.8(c)(1) would revise the 

requirement currently set out at 

§ 488.8(e), which states that if a 

comparability or validation review 

indicates that an AO is not meeting the 

Medicare requirements, we will provide 

written notice to the AO indicating that 

its accreditation program approval may 

be in jeopardy and that an accreditation 

program review is being initiated. We 

propose revising the standard’s title to 

more accurately reflect the language of 

the standard that follows and deleting 

redundant language. We would also add 

language to broaden the regulation and 

allow us to consider other aspects of AO 

performance that may warrant the 

opening of a review of a CMS-approved 

accreditation program. For example, if 

during a validation review, a question 

arose as to the ability of an AO to 

conduct re-accreditation surveys in a 

timely manner, or to provide us with 

timely and accurate data regarding 

deemed facilities, we would add this 

matter to the review. We further propose 

separating the one standard into two 

separate standards to more clearly 

articulate the circumstances that may 

trigger the opening of a review of a 

CMS-approved accreditation program 

and the written notice CMS must 

provide the AO upon opening such a 

review. 

• Proposed § 488.8(c)(1)(i) would 

relocate the requirement currently set 

out at § 488.8(e)(1), which requires that 

our notice include a statement of the 

requirements, instances, rates or 

patterns of discrepancies that were 

found in the course of a comparability 

or validation review, as well as other 

related documentation associated with 

the review. We propose deleting 

language and replacing it with broader 

language that more clearly describes 

current practices related to an 

accreditation program review. The 

proposed revisions would address the 

information that we would be required 

to include in the written notice that we 

send the AO indicating that an 

accreditation program review is being 

initiated. 

• Proposed § 488.8 (c)(1)(ii) would 

revise the requirement currently set out 

at § 488.8(e)(3), which requires that the 

notice of our comparability or validation 

review include a description of the 

process available if the AO wishes an 

opportunity to explain or justify the 

findings made during such review. The 

proposed language would clarify that 

the AO would not be limited to only one 

opportunity to offer factual information 

and documentation. Instead, such 

opportunities would be available 

throughout the accreditation program 

review process. 

• Proposed § 488.8(c)(1)(iii) would 

revise the requirement currently set out 

at § 488.8(e)(4), which describes the 

possible enforcement actions that we 

may take based on findings from a 

validation review. We propose deleting 

the language, ‘‘from the validation 

review,’’ and replacing it with the 

conforming language, ‘‘based on the 

findings of the accreditation program 

review.’’ 

• Proposed § 488.8(c)(1)(iv) would 

revise the requirement currently set out 


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at § 488.8(f)(2). The current provision 

states that if CMS determines, following 

the accreditation program review, that 

the AO failed to adopt requirements 

comparable to CMS’s, or to submit new 

requirements in a timely manner, the 

AO may be given conditional CMS 

approval of its accreditation program 

with a probationary period of up to 180 

days to adopt comparable requirements. 

To clarify the existing requirements, we 

propose revising this provision to 

include the actions an AO would have 

to take to address the identified 

deficiencies, including a timeline for 

implementation not to exceed 180 

calendar days from the date of issuance 

of the electronic version of the CMS 

letter, indicating that an accreditation 

program review is being initiated. 

• Proposed § 488.8(c)(2) would revise 

the requirement currently set out at 

§ 488.8(f)(1). The current provision 

requires CMS to conduct a review of an 

AO’s accreditation program if the 

comparability or validation reviews 

produce findings that an AO has failed 

to adopt requirements comparable to 

Medicare. The language of this 

provision would be modified for 

increased clarity by utilizing current 

terminology. 

• Proposed § 488.8(c)(3) would 

replace the requirement currently set 

out at § 488.8(f)(2). The current 

provision provides us authority to grant 

conditional approval of deeming 

authority with a probationary period of 

up to 180 days to adopt comparable 

requirements when the AO has failed to 

adopt requirements comparable to 

CMS’s, or has failed to submit new 

requirements in a timely manner during 

a deeming review. We propose 

expanding the language to clarify that 

the probationary period of up to 180 

calendar days would apply only when 

an AO has not adopted the necessary 

comparable changes to its existing CMSapproved accreditation program by the 

end of the 180-calendar-day 

accreditation program review. It further 

would clarify that an accreditation 

program review probationary period 

could not extend beyond the AO’s term 

of approval. Finally, it would clarify the 

differences between an accreditation 

program review and renewal application 

review related to a probationary period, 

versus a conditional approval with a 

probationary period. 

• Proposed § 488.8(c)(3)(i) would 

revise the requirement currently set out 

at § 488.8(f)(4), which states that within 

60 days after the end of any 

probationary period, we will make a 

final determination as to whether or not 

an accreditation program continues to 

meet the Medicare requirements and 

will issue an appropriate notice to the 

AO and affected providers or suppliers. 

We propose clarifying this provision by 

deleting the language, ‘‘make a final 

determination’’ and replacing it with, 

‘‘issue a written determination.’’ We 

further propose deleting the language, 

‘‘criteria described at paragraph (a)(1) of 

this section,’’ and replacing it with, 

‘‘requirements of this subpart.’’ 

• Proposed § 488.8(c)(3)(ii) would 

revise the requirement currently set out 

at § 488.8(f)(5) concerning the 

requirement that if the AO has not made 

improvements acceptable to us by the 

end of the probationary period, we will 

remove its approval effective 30 days 

from the date that it provides written 

notice to the AO. We propose modifying 

this provision by expanding the 

timeframe to account for the process 

required in order to publish a notice in 

the Federal Register. 

• Proposed § 488.8(c)(3)(iii) would 

revise the requirement currently set out 

at § 488.8(f)(7), which instructs us to 

publish a notice in the Federal Register 

when necessary, withdrawing its 

approval of an AO’s accreditation 

program, including a justification for its 

decision. We propose clarifying this 

provision by specifying the timeframe 

for publication of this notice. 

• Proposed § 488.8(d) would revise 

the requirement currently set out at 

§ 488.8(g), which state that when we 

determine that continued approval of an 

AO’s accreditation program poses an 

immediate jeopardy to the patients of 

the entities accredited by that 

organization, or such continued 

approval otherwise constitutes a 

significant hazard to the public health, 

we may immediately withdraw approval 

of that AO’s accreditation program. We 

propose clarifying this provision by 

deleting the language, ‘‘deeming 

authority’’ and replacing it with the 

conforming change, ‘‘CMS-approved 

accreditation program.’’ 

• Proposed § 488.8(e) is a new 

provision that would address an AO’s 

responsibility to notify its providers or 

suppliers in the event that CMS 

withdraws approval of its accreditation 

program or the AO voluntarily 

terminates its program. This new, 

proposed provision would be necessary 

to ensure that providers or suppliers 

affected by an AO’s loss of CMS 

approval for an accreditation program 

would be informed that they were no 

longer deemed to meet the Medicare 

requirements. Notification would afford 

affected providers or suppliers an 

opportunity to seek accreditation 

through another CMS-approved AO 

accreditation program, or participate in 

Medicare under the state survey 

agency’s jurisdiction. 

• Proposed § 488.8(f) would revise 

the requirement currently set out at 

§ 488.8(h), which provides an AO that is 

not satisfied with CMS’s determination 

to withdraw approval of its 

accreditation program the opportunity 

to request a reconsideration of that 

determination in accordance with 

subpart D of this part. We propose 

clarifying this provision by deleting the 

language, ‘‘deeming authority’’ and 

replacing it with the conforming change, 

‘‘CMS-approved accreditation program.’’ 

• Proposed § 488.8(g) would revise 

the requirement currently set out at 

§ 488.8(f)(8). The current requirement 

states that after we remove approval of 

an AO’s accreditation program, an 

affected provider’s or supplier’s deemed 

status continues in effect for 60 days 

after removal of approval. It further 

states that we may extend the period for 

an additional 60 days if it determines 

that the provider or supplier submitted 

an application within the 60 day 

timeframe to another approved AO or to 

us so that compliance with Medicare 

conditions can be determined. We 

propose revising this provision by 

expanding the timeframe for continued 

deemed status of an affected provider or 

supplier if certain criteria are met, and 

the provider or supplier provides notice 

to the state survey agency to avoid 

duplication of services by the state 

survey agency and the AO. 

• Proposed § 488.8(h) would replace 

the requirement currently set out at 

§ 488.8(f)(9), which states that a 

provider’s or supplier’s failure to 

comply with the timeframes set forth 

will jeopardize its participation in the 

Medicare program and, where 

applicable, the Medicaid program. The 

language of this proposed provision 

would remain unchanged. 

• Proposed § 488.8(i) would revise 

the requirement currently set out at 

§ 488.9. This provision addresses the 

onsite observation of an AO’s 

operations. We propose modifying this 

provision and adding language that 

provides greater specificity and clarity. 

In addition, we propose expanding the 

provision to give us greater flexibility in 

the timing of onsite visits to improve 

our oversight of approved AO 

accreditation programs. 

I. Validation Surveys (§ 488.9) 

We propose revising the title of this 

section because proposed § 488.9 sets 

out the language currently at § 488.7 

that addresses validation surveys. The 

regulatory language would remain 

unchanged with the exception of: 

deleting language related to a plan of 


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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 20573 

correction that no longer reflects current 

state survey agency practice; and 

deleting language regarding compliance 

with the Life Safety Code that would be 

duplicative of proposed language at 

§ 488.12(a)(2). In addition, we are 

proposing minor changes to conform 

this section to the rest of the proposed 

rule. 

J. State Survey Agency Review: Statutory 

Provisions (§ 488.10) 

We propose to revise § 488.10 to 

implement section 125 of MIPPA 

(revising section 1865(a) of the Act) to 

clarify that our proposed regulations 

apply to several types of providers and 

suppliers, not just hospitals. The 

regulation currently at § 488.10(c) 

addresses the authority of the Secretary 

to enter into agreements with state 

survey agencies for the purpose of 

conducting validation surveys. It further 

states, ‘‘Section 1865(d) provides that an 

accredited hospital which is found after 

a validation survey to have significant 

deficiencies related to the health and 

safety of patients will no longer be 

deemed to meet the conditions of 

participation.’’ We propose revising this 

provision by separating it into two 

separate provisions, § 488.10(c) and 

§ 488.10(d). We propose modifying this 

provision by updating the regulatory 

citation to implement changes 

associated with section 125 of MIPPA. 

We further propose modifying this 

provision by adding broader language to 

make it clear that the regulations would 

apply to all national AOs with CMSapproved accreditation programs, and 

all provider or supplier types. 

K. State Survey Agency Functions 

(§ 488.11) 

We propose to revise § 488.11(b) by 

deleting the word, ‘‘accredited,’’ and 

replacing it with ‘‘deemed’’ as a 

conforming change for increased clarity. 

We also propose deleting the citation, 

‘‘§ 488.7,’’ and replacing it with 

‘‘§ 488.9.’’ This change would be 

consistent with the proposed 

reorganization of the requirements. 

L. Effect of Survey Agency Certification 

(§ 488.12) 

Section 488.12 addresses provider or 

supplier certification recommendations 

made by the state survey agency to 

CMS. Section 488.12(a)(2) addresses 

whether an accredited hospital is 

deemed to meet the Medicare CoPs or is 

subject to a full review by the state 

survey agency. We propose modifying 

this provision by inserting broader 

language to make it clear that the 

revised regulations not only pertain to 

hospitals exclusively, but to all deemed 

providers and suppliers. We further 

propose modifying this provision for 

clarity and conforming changes. 

M. Loss of Accredited Status (§ 488.13) 

Section 488.13 is a new proposed 

section entitled, ‘‘Loss of 

Accreditation.’’ We believe that this 

proposed section is necessary to address 

the consequences of a provider’s or 

supplier’s loss of accreditation, either 

voluntary or involuntary, from an AO’s 

CMS-approved accreditation program. 

Voluntary loss of accreditation occurs 

when a provider or supplier chooses to 

withdraw from a CMS-approved 

accreditation program. Involuntary loss 

of accreditation occurs when an AO 

terminates a provider’s or supplier’s 

accreditation due to non-compliance 

with the AO’s CMS-approved 

accreditation program requirements, or 

the provider’s or supplier’s nonpayment of AO fees. The proposed 

additions address the timing of a state 

survey agency survey in such 

circumstances. 

N. Providers or Suppliers, Other Than 

SNFs and NFs, With Deficiencies 

(§ 488.28) 

We propose to revise § 488.28(a) to 

state that in immediate jeopardy 

situations involving providers or 

suppliers other than nursing homes or 

SNFs, the Secretary may require a 

shorter timeframe for a provider or 

supplier to come into compliance. This 

is consistent with our longstanding 

enforcement policy regarding immediate 

jeopardy situations with respect to 

provider types other than long term care 

facilities. We believe it would be 

beneficial to make this practice explicit 

in this proposed rule. 

O. Statutory Basis (§ 489.1) 

We propose to revise § 489.1(b), 

which addresses the scope of part 489. 

This proposed revision would expand 

the scope of these provisions to indicate 

that suppliers are subject to 

certification, as well as providers. 

Currently § 489.1(b) indicates that the 

regulations at § 489.13, governing the 

effective date of the provider agreement 

or supplier approval, are applicable not 

only to providers but also to suppliers 

that require certification in accordance 

with § 488.3 and § 488.12 to participate 

in Medicare. Various supplier-specific 

rules in this chapter that require 

certification also establish requirements 

related to termination of the supplier’s 

participation agreement with the 

Medicare program. However, only some 

of these rules provide for termination of 

the agreement where the supplier places 

restrictions on the persons it will accept 

for treatment and fails to either exempt 

Medicare beneficiaries or apply the 

restrictions in the same way for 

Medicare beneficiaries as all other 

persons seeking care in the supplier 

facility. We believe that this nondiscrimination provision should also 

apply as a basis for termination of all 

Medicare-certified suppliers. 

Likewise, neither the certified 

supplier-specific rules governing 

termination of their agreements, nor the 

current termination of provider 

agreement rules at § 489.53 provide for 

termination of the supplier agreement 

where the certified supplier denies 

immediate access to state surveyors or 

other authorized entities or refuses to 

allow photocopying of its records. 

Currently, the only enforcement remedy 

in the face of such denial or refusal by 

a certified supplier would be exclusion 

of the certified supplier from Medicare 

by the OIG pursuant to 42 CFR 

§ 1001.1301(a). It would be quicker and 

more efficient for us to handle such a 

denial or refusal of access to the 

certified supplier facility or 

photocopying of its records in the same 

manner as is currently used for 

providers, that is, CMS termination of 

the Medicare agreement. 

Accordingly, we propose amending 

§ 489.1(b) to expand the enumeration of 

provisions of part 489 that apply to 

certain suppliers, as well as providers. 

Because these provisions would apply 

only to those types of suppliers that 

require certification and not to all 

suppliers, we are including language in 

the proposed revised § 489.1(b) 

describing which types of suppliers 

would be affected, using the same 

language currently found at § 489.13. 

This language would indicate that the 

affected types of suppliers participate in 

Medicare based on surveys conducted 

by the state survey agency or CMS 

surveyors, or on the basis of 

accreditation by CMS-approved AO. 

We propose redesignating the current 

language in § 489.1(b), which makes the 

effective date rules at § 489.13 

applicable to suppliers as well as 

providers, as new paragraph 

§ 489.1(b)(1). Further, we propose 

adding a new paragraph at § 489.1(b)(2) 

indicating that the termination 

provisions at § 489.53(a), § 489.53(a)(2), 

and § 489.53(a)(13) and proposed new 

§ 489.53(a)(18) (discussed below) would 

apply to suppliers as well as providers. 

P. Definitions (§ 489.3) 

The regulations at § 489.3 define the 

term ‘‘immediate jeopardy’’ as a 

situation in which the provider’s noncompliance with one or more 

requirements of participation has 


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20574 Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 

caused, or is likely to cause, serious 

injury, harm, impairment, or death to a 

resident. This definition is identical to 

the one at § 488.301, which, in that 

context, applies only to long term care 

facilities, that is, nursing facilities (NFs) 

and SNFs. However, the regulation at 

§ 489.53(d) addresses exceptions 

permitted for the required notice of 

termination which we must provide to 

the provider or supplier. This regulation 

permits exceptions in the case of 

immediate jeopardy situations in 

hospitals that have violated the 

Emergency Medical Treatment and 

Labor Act (EMTALA) requirements at 

§ 489.24(a) through (e), as well as to 

immediate jeopardy situations in SNFs. 

We propose to revise the definition of 

immediate jeopardy at § 489.3 to clarify 

that it has the meaning found in 

proposed new § 488.1, which applies to 

all types of providers and suppliers 

subject to certification. 

Q. Termination by CMS (§ 489.53) 

We propose to revise § 489.53(a), 

which addresses the basis for us to 

terminate a Medicare provider 

agreement. We propose deleting the 

language ‘‘with any provider’’ from the 

heading for this provision since we are 

proposing that several of the 

termination provisions apply to 

suppliers, as well as providers. We 

propose retaining language stating that 

we may terminate the agreement with 

any provider if we find that any of the 

failings enumerated in § 489.53(a) is 

attributable to that provider. We further 

propose adding language indicating that 

we may, in addition to applying the 

various provisions in this chapter 

governing the termination of agreements 

with suppliers, terminate agreements 

with those suppliers that fail to comply 

with the requirements set out in 

§ 489.53(a)(13) and proposed new 

§ 489.53(a)(18). 

We propose adding language in 

§ 489.53(a)(2) to indicate that when a 

provider or supplier places restrictions 

on the persons accepted for treatment 

services without either exempting 

Medicare beneficiaries from such 

restrictions, or applying the restrictions 

to Medicare beneficiaries in the same 

manner as to all other persons seeking 

care, this may be grounds for 

termination of the Medicare agreement. 

The current language at § 489.53(a)(2) 

applies only to providers. 

We propose adding language at 

§ 489.53(a)(13) to indicate that failure by 

a provider or supplier to permit 

photocopying of any records or other 

information by, or on behalf of us, as 

necessary, to determine or verify 

compliance with participation 

requirements, may be grounds for 

terminating the Medicare agreement. 

The current language at § 489.53(a)(13) 

applies only to providers. 

Further, we propose adding a new 

§ 489.53(a)(18) to state explicitly that 

denial of immediate access to a state 

survey agency or other authorized entity 

for the purpose of determining, in 

accordance with § 488.3, whether the 

provider or supplier meets the 

applicable requirements, conditions of 

participation, conditions for coverage, 

or conditions for certification, may be 

grounds for termination of the provider 

agreement or supplier approval. 

Consistent with the definition at 42 CFR 

1001.1301(a)(2), we interpret ‘‘failure to 

grant immediate access’’ to mean the 

failure to grant access at the time of a 

reasonable request or to provide a 

compelling reason why access may not 

be granted. 

Finally, we propose a technical 

correction to § 489.53(d)(2)(i). Section 

489.53(d) governs the timeframe for 

provision of a minimum 15-day advance 

notice of termination of a provider 

agreement by us to the affected 

provider, while subsection (d)(2) 

governs exceptions to the general 

timeframe in situations involving 

immediate jeopardy. The first exception, 

at § 489.53(d)(2)(i), applies to hospitals 

that have been determined by us to have 

an EMTALA violation which poses an 

immediate jeopardy. In these cases, we 

are required to give the hospital a 

preliminary notice of termination in 23 

days if the hospital does not correct its 

identified deficiencies or refute the 

finding, and a final notice of 

termination at least 2, but not more than 

4, days before the effective date of 

termination. We are proposing clarifying 

that this exception to the timing notice 

provision applies to a hospital that has 

been found to be in violation of any of 

the EMTALA requirements found at 

§ 489.24, paragraphs (a) through (f). The 

current regulation refers to hospitals 

with emergency departments found in 

violation of § 489.24, paragraphs (a) 

through (e). This proposed clarification 

would not change current EMTALA 

citation or enforcement practices. 

R. Table of Current Location and 

Proposed Location of Regulations Text 

Table 1 identifies the current location, 

as well as the proposed location of the 

regulations text associated with this 

proposed rule. 

TABLE 1—CURRENT LOCATION AND

PROPOSED LOCATION OF REGULATIONS TEXT

Current location Proposed location 

§ 488.3(b)(1) .............. § 488.3(b). 

§ 488.4(b) .................. § 488.5(a). 

§§ 488.4(b)(3) and 

488.4(b)(3)(i).

§ 488.5(a)(8)(ii). 

§ 488.4(b)(3)(vii) ........ § 488.5(a)(4)(ix). 

§ 488.4(b)(3)(viii) ....... § 488.5(a)(12)(ii). 

§ 488.4(d) .................. § 488.9. 

§ 488.4(e) .................. § 488.5(f)(1). 

§ 488.6(a) .................. § 488.4(a). 

§ 488.4 ....................... § 488.5. 

§ 488.4(a) .................. § 488.5(a). 

§ 488.4(a)(1) .............. § 488.5(a)(1). 

§ 488.4(a)(2) .............. § 488.5(a)(3). 

§ 488.4(a)(3) .............. § 488.5(a)(4). 

§ 488.4(a)(3)(i) ........... § 488.5(a)(4)(i). 

§ 488.(a)(3)(ii) ............ § 488.5(a)(4)(iii). 

§ 488.8(a)(2)(ii) .......... § 488.5(a)(4)(iv). 

§ 488.4(a)(3)(iii) ......... § 488.5(a)(4)(v). 

§ 488.4(a)(3)(iv) ......... § 488.5(a)(4)(vi). 

§ 488.8(a)(3) .............. § 488.5(a)(4)(viii). 

§ 488.4(a)(4)(i) ........... § 488.5(a)(5). 

§ 488.4(a)(4)(i) ........... § 488.5(a)(6). 

§ 488.4(a)(4)(ii) .......... § 488.5(a)(7). 

§ 488.4(a)(4)(iii) ......... § 488.5(a)(8). 

§ 488.4(a)(4)(iv) ......... § 488.5(a)(9). 

§ 488.4(a)(4)(v) .......... § 488.5(a)(10). 

§ 488.4(a)(5) .............. § 488.5(a)(11). 

§ 488.4(b)(1) .............. § 488.5(a)(11)(ii). 

§ 488.4(a)(6) .............. § 488.5(a)(12). 

§ 488.4(a)(7) .............. § 488.5(a)(13). 

§ 488.4(a)(8) .............. § 488.5(a)(13)(i). 

§ 488.4(b)(3)(i) ........... § 488.5(a)(13)(ii). 

§ 488.4(a)(9) .............. § 488.5(a)(14). 

§ 488.4(a)(10) ............ § 488.5(a)(16). 

§ 488.4(b)(2) .............. § 488.5(a)(17). 

§ 488.4(b)(3)(iii) ......... § 488.5(a)(19). 

§ 488.4(b)(3)(iv) ......... § 488.5(a)(20). 

§ 488.4(b)(3)(v) .......... § 488.5(a)(21). 

§ 488.4(c) .................. § 488.5(b). 

§ 488.4(f) ................... § 488.5(c). 

§ 488.4(h) .................. § 488.5(d). 

§ 488.4(h)(1)- 

§ 488.4(h)(3)(i).

§ 488.5(d)(1)- 

§ 488.5(d)(3), 

§ 488.5(e). 

§ 488.8(b)(1) .............. § 488.5(f)(1). 

§ 488.8(b)(2) .............. § 488.5(f)(2). 

§ 488.8(b)(1), 

§ 488.8(b)(2), 

§ 488.8(c).

§ 488.5(f)(2)(i). 

§ 488.5(b) .................. § 488.6. 

§ 488.6(c)(1) .............. § 488.7. 

§ 488.6(c)(2) .............. § 488.7(a). 

§ 488.5(c)(3) .............. § 488.7(b). 

§ 488.8(d) .................. § 488.8(a). 

§ 488.8(d)(1) .............. § 488.8(b). 

§ 488.8(d)(1)(i) ........... § 488.8(b)(1). 

§ 488.8(d)(1)(ii) .......... § 488.8(b)(2). 

§ 488.8(e) .................. § 488.8(c)– 

§ 488.8(c)(1). 

§ 488.8(e)(1) .............. § 488.8(c)(1)(i). 

§ 488.8(e)(3) .............. § 488.8(c)(1)(ii). 

§ 488.8(e)(4) .............. § 488.8(c)(1)(iii). 

§ 488.8(f)(2) ............... § 488.8(c)(1)(iv). 

§ 488.8(f)(1) ............... § 488.8(c)(2). 

§ 488.8(f)(2) ............... § 488.8(c)(3). 

§ 488.8(f)(4) ............... § 488.8(c)(3)(i). 

§ 488.8(f)(5) ............... § 488.8(c)(3)(ii). 

§ 488.8(f)(7) ............... § 488.8(c)(3)(iii). 

§ 488.8(h) .................. § 488.8(d). 

§ 488.8(g) .................. § 488.8(e). 


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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 20575 

TABLE 1—CURRENT LOCATION AND

PROPOSED LOCATION OF REGULATIONS TEXT—Continued 

Current location Proposed location 

§ 488.8(f)(8) ............... § 488.8(f). 

§ 488.8(f)(9) ............... § 488.8(f)(1). 

§ 488.9 ....................... § 488.8(g). 

§ 488.7 ....................... § 488.9. 

§ 488.10(d) ................ § 488.10(b). 

III. Collection of Information 

Requirements 

While this rule does contain 

information collection requirements, we 

believe they are exempt under 5 CFR 

1320.3(c)(4). The requirements would 

affect less than 10 entities in a 12-month 

period. The requirements in the 

document have been in existence since 

September 2008. Since implementation, 

there have only been a total of seven 

entities that meet the criteria necessary 

to become accrediting organizations, 

with the seventh having just been added 

as recently as September 2008. Should 

the number of eligible entities approach 

or exceed 10, we will prepare an 

information collection request for OMB 

approval. As required by the Paperwork 

Reduction Act of 1995, we will 

announce the information collection 

request via the required Federal 

Register notices and allow the public 

ample time to review the request and 

submit comments. 

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 (or 

Analysis) 

We have examined the impact of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (January 18, 

2011), the Regulatory Flexibility Act 

(RFA) (September 19, 1980, Pub. L. 96– 

354), section 1102(b) of the Social 

Security Act, section 202 of the 

Unfunded Mandates Reform Act of 1995 

(March 22, 1995; Pub. L. 104–4), 

Executive Order 13132 on Federalism 

(August 4, 1999) 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 rule does not reach the economic 

threshold and thus is not considered a 

major rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $7.0 million to $35.5 million in any 

1 year. Individuals and states are not 

included in the definition of a small 

entity. We are not preparing an analysis 

for the RFA because we have 

determined, and the Secretary certifies, 

that this proposed rule will not have a 

significant economic impact on a 

substantial number of small entities. 

In addition, section 1102(b) of the 

Social Security Act requires us to 

prepare a regulatory impact analysis if 

a rule may have a significant impact on 

the operations of a substantial number 

of small rural hospitals. This analysis 

must conform to the provisions of 

section 603 of the RFA. For purposes of 

section 1102(b) of the Act, we define a 

small rural hospital as a hospital that is 

located outside of a Metropolitan 

Statistical Area 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 will not 

have a significant impact on the 

operations of a substantial number of 

small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

In 2013, that threshold level is currently 

approximately $141 million. This 

proposed rule has no consequential 

effect on state, local, or tribal 

governments or on the private sector. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects 

42 CFR Part 488 

Administrative practice and 

procedure, Health facilities, Medicare, 

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 488—SURVEY, CERTIFICATION, 

AND ENFORCEMENT PROCEDURES 

■ 1. The authority citation for part 488 

continues to read as follows: 

Authority: Secs. 1102, and 1871 of the 

Social Security Act, unless otherwise noted 

(42 U.S.C 1302 and 1395(hh)); Section 6111 

of the Patient Protection and Affordable Care 

Act (Pub. L. 111–148). 

■ 2. Section 488.1 is amended by— 

■ A. Revising the definitions of 

‘‘Certification,’’ ‘‘Full review,’’ 

‘‘Provider of services or provider,’’ 

‘‘Reasonable assurance,’’ ‘‘State survey 

agency,’’ ‘‘Substantial allegation of noncompliance,’’ and ‘‘Supplier.’’ 

■ B. Removing the definitions of 

‘‘Accredited provider or supplier,’’ 

‘‘AOA,’’ ‘‘JCAHO,’’ and ‘‘Validation 

review period.’’ 

■ C. Adding the definitions of 

‘‘Conditions for certification,’’ ‘‘Deemed 

status,’’ ‘‘Immediate jeopardy,’’ and 

‘‘National accrediting organization.’’ 

The revisions and additions read as 

follows: 

§ 488.1 Definitions. 

* * * * * 

Certification means a determination 

made by the state survey agency that 

providers and suppliers are in 

compliance with the applicable 

conditions of participation, conditions 

for coverage, conditions for certification, 

or requirements. 

* * * * * 

Conditions for certification means the 

health and safety standards RHCs must 

meet to participate in the Medicare 

program. 

Deemed status is awarded by CMS 

when a provider or supplier has 

voluntarily applied for, and received, 

accreditation from a CMS-approved 

national accrediting organization; been 

recommended by the national 

accrediting organization for Medicare 

participation; has met all other 


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requirements for participation in the 

Medicare program as determined by 

CMS; and, is participating in the 

Medicare program on the basis of CMS’s 

acceptance of the accrediting 

organization’s recommendation. 

Deemed status is an alternative to 

regular surveys by the state survey 

agency to determine whether or not it 

continues to meet the Medicare 

requirements. 

Full review means a survey of a 

provider or supplier for compliance 

with all of the Medicare conditions or 

requirements applicable to that provider 

or supplier type. 

Immediate jeopardy means a situation 

in which the provider’s or supplier’s 

non-compliance with one or more 

Medicare requirements, conditions of 

participation, conditions for coverage or 

certification has caused, or is likely to 

cause, serious injury, harm, impairment, 

or death to a resident or patient. 

* * * * * 

National accrediting organization 

means an organization that accredits 

health care facilities under a specific 

program and whose accredited 

healthcare facilities under each program 

are widely located geographically across 

the United States. 

Provider of services or provider refers 

to a hospital, critical access hospital, 

skilled nursing facility, nursing facility, 

home health agency, hospice, 

comprehensive outpatient rehabilitation 

facility, or a clinic, rehabilitation agency 

or public health agency that furnishes 

outpatient physical therapy or speech 

pathology services. 

* * * * * 

Reasonable assurance means that an 

accrediting organization has 

demonstrated to CMS’s satisfaction that 

its accreditation program requirements 

meet or exceed the Medicare program 

requirements. 

* * * * * 

State survey agency refers to the state 

health agency or other appropriate state 

or local agency CMS uses to perform 

survey and review functions provided 

for in sections 1864, 1819(g), and 

1919(g) of the Act. 

Substantial allegation of noncompliance means a complaint from any 

of a variety of sources (that is, patient, 

relative, or third party), including 

complaints submitted in person, by 

telephone, through written 

correspondence, or in newspaper or 

magazine articles, that, if substantiated, 

could or may affect the health and safety 

of patients or raise doubts as to a 

provider’s or supplier’s compliance 

with any Medicare condition of 

participation, condition for coverage, 

condition for certification, or other 

requirements. 

Supplier means unless the context 

otherwise requires, a physician or other 

practitioner, a facility, or other entity 

(other than a provider of services) that 

furnishes items or services. For the 

purposes of this part, the term does not 

include suppliers of durable medical 

equipment and supplies, kidney 

transplant centers, or end stage renal 

dialysis facilities. 

■ 3. Section 488.2 is amended by— 

■ A. Adding the following statutory 

provisions in numerical order. 

■ B. Revising the description of section 

1883 of the Social Security Act. 

The additions and revisions read as 

follows: 

§ 488.2 Statutory basis. 

* * * * * 

1138(b)—Requirements for organ 

procurement organizations and organ 

procurement agencies. 

* * * * * 

1820—Requirements for CAHs. 

1832(a)(2)(C)—Requirements for 

Organizations that provide outpatient 

physical therapy and speech language 

pathology services. 

1832(a)(2)(F)—Requirements for 

ASCs. 

1832(a)(2)(J)—Requirements for 

partial hospitalization for CMHCs. 

1843(e)—Requirements for Advanced 

Diagnostic Imaging (ADI) services. 

1861(e)—Requirements for hospitals. 

* * * * * 

1861(p)(4)—Requirements for 

rehabilitation agencies. 

* * * * * 

1861(aa)—Requirements for RHCs and 

FQHCs. 

1861(cc)(2)—Requirements for 

CORFs. 

1861(dd)—Requirements for hospices. 

1861(ff)(3)(A)—Requirements for 

CMHCs. 

* * * * * 

1863—Consultation with state 

agencies, accrediting bodies, and other 

organizations to develop conditions of 

participation, conditions for coverage, 

conditions for certification, and 

requirements for providers or suppliers. 

* * * * * 

1875(b)—Requirements for 

performance review of CMS-approved 

accreditation programs. 

1881—Requirements for ESRDs. 

1883—Requirements for hospitals that 

furnish extended care services. 

* * * * * 

■ 4. Section 488.3 is revised to read as 

follows: 

§ 488.3 Conditions of participation, 

conditions for coverage, conditions for 

certification and long term care 

requirements. 

(a) Basic rules. To be approved for 

participation in, or coverage under, the 

Medicare program, a prospective 

provider or supplier must meet the 

following: 

(1) Meet the applicable statutory 

definitions in section 1138(b), 1819, 

1820, 1832(a)(2)(C), 1832(a)(2)(F), 

1832(a)(2)(J), 1834(e), 1861, 1881, 1883, 

1891, 1913 or 1919 of the Act. 

(2) Be in compliance with the 

applicable conditions, certification 

requirements, or long term care 

requirements prescribed in part 405 

subparts U or X, part 410 subpart E, 

§ 410.33, § 414.68, part 416, part 418 

subpart C, parts 482 through 485, part 

491 subpart A, or part 494 of this 

chapter. 

(b) Special conditions—The Secretary 

may consult with state agencies and 

other organizations to develop 

conditions of participation, conditions 

for coverage, conditions for certification, 

and long term care requirements. 

(1) The Secretary may, at a state’s 

request, approve health and safety 

requirements for providers or suppliers 

in the state that exceed Medicare 

program requirements. 

(2) If a state or political subdivision 

imposes requirements on institutions 

(that exceed the Medicare program 

requirements) as a condition for the 

purchase of health services under a state 

Medicaid plan approved under title XIX 

of the Act, (or if Guam, Puerto Rico, or 

the Virgin Islands does so under a state 

plan for Old Age Assistance under title 

I of the Act, or for Aid to the Aged, 

Blind, and Disabled under the original 

title XVI of the Act), the Secretary 

imposes similar requirements as a 

condition for payment under Medicare 

in that state or political subdivision. 

■ 5. Section 488.4 is revised to read as 

follows: 

§ 488.4 General rules for a CMS-approved 

accreditation programs for providers and 

suppliers. 

(a) A national accrediting organization 

can apply to CMS for approval to 

accredit providers and suppliers (except 

for kidney transplant centers, ESRD 

facilities, and suppliers of medical 

equipment and supplies) as meeting or 

exceeding the Medicare conditions or 

requirements. The following 

requirements apply when a national 

accrediting organization approved by 

CMS provides reasonable assurance to 

CMS that it requires providers or 

suppliers (except for kidney transplant 

centers, ESRD facilities, and suppliers of 


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medical equipment and supplies) it 

accredits to meet requirements that meet 

or exceed the Medicare conditions or 

requirements: 

(1) When a provider or supplier 

demonstrates full compliance with all of 

the accreditation program requirements 

of the national accrediting 

organization’s CMS-approved 

accreditation program, the national 

accrediting organization may 

recommend to CMS to grant deemed 

status to the provider or supplier. 

(2) CMS may deem the provider or 

supplier to be in compliance with the 

applicable Medicare conditions or 

requirements. The provider or supplier 

is subject to validation surveys under 

§ 488.9. 

(b) [Reserved] 

■ 6. Section 488.5 is revised to read as 

follows: 

§ 488.5 Application and re-application 

procedures for national accrediting 

organizations. 

(a) Information submitted with 

application. A national accrediting 

organization applying to CMS for 

approval or re-approval of an 

accreditation program under § 488.4 

must furnish CMS with all of the 

following information and materials to 

demonstrate that the program provides 

reasonable assurance that the entities 

accredited under the program meet or 

exceed the applicable Medicare 

conditions or requirements. This 

information must include the following: 

(1) Documentation that demonstrates 

the organization meets the definition of 

a ‘‘national accrediting organization’’ 

under § 488.1 as it relates to the 

accreditation program. 

(2) The type of provider or supplier 

accreditation program for which the 

organization is requesting approval or 

re-approval. 

(3) A detailed crosswalk (in table 

format) that identifies, for each of the 

applicable Medicare conditions or 

requirements, the exact language of the 

organization’s comparable accreditation 

requirements and standards. 

(4) A detailed description of the 

organization’s survey process to confirm 

that a provider or supplier meets or 

exceeds the Medicare program 

requirements. This description must 

include all of the following information: 

(i) Frequency of surveys performed 

and agreement by the organization to resurvey every accredited provider or 

supplier, through unannounced surveys, 

no later than 36 months after the 

previous accreditation survey, including 

an explanation of how the accrediting 

organization will maintain the schedule 

it proposes. If there is a statutorilymandated survey interval of less than 36 

months, the organization must indicate 

how it will adhere to the statutory 

schedule. 

(ii) Documentation demonstrating the 

comparability of the organization’s 

survey process and surveyor guidance to 

those required for state survey agencies 

conducting federal Medicare surveys for 

the same provider or supplier type, as 

specified in the CMS State Operations 

Manual (Pub. No. 100–07). 

(iii) Copies of the organization’s 

survey forms, guidelines, and 

instructions to surveyors. 

(iv) Documentation demonstrating 

that the organization’s survey reports 

identify, for each finding of noncompliance with accreditation 

standards, the comparable Medicare 

conditions of participation, conditions 

for coverage, conditions for certification, 

or requirements. 

(v) Description of the organization’s 

accreditation survey review process. 

(vi) Description of the organization’s 

procedures and timelines for notifying 

surveyed facilities of non-compliance 

with the accreditation program’s 

standards. 

(vii) Description of the organization’s 

procedures and timelines for monitoring 

the provider’s or supplier’s correction of 

identified non-compliance with the 

accreditation program’s standards. 

(viii) A statement acknowledging that, 

as a condition for CMS approval of a 

national accrediting organization’s 

accreditation program, the organization 

agrees to provide CMS with a copy of 

the most recent accreditation survey for 

a specified provider or supplier, 

together with any other information 

related to the survey as CMS may 

require (including corrective action 

plans). 

(ix) A statement acknowledging that 

the accrediting organization will 

provide timely notification to CMS 

when an accreditation survey or 

complaint investigation identifies an 

immediate jeopardy as that term is 

defined at § 489.3 of this chapter. Using 

the format specified by CMS, the 

accrediting organization must notify 

CMS within 1 business day from the 

date the accrediting organization 

identifies the immediate jeopardy. 

(5) The criteria for determining the 

size and composition of the 

organization’s survey teams for the type 

of provider or supplier to be accredited, 

including variations in team size and 

composition for individual provider or 

supplier surveys. 

(6) The overall adequacy of the 

number of the organization’s surveyors, 

including how the organization will 

increase the size of the survey staff to 

match growth in the number of 

accredited facilities while maintaining 

re-accreditation intervals for existing 

accredited facilities. 

(7) A description of the education and 

experience requirements surveyors must 

meet. 

(8) A description of the content and 

frequency of the organization’s inservice training it provides to survey 

personnel. 

(9) A description of the organization’s 

evaluation systems used to monitor the 

performance of individual surveyors 

and survey teams. 

(10) The organization’s policies and 

procedures for avoiding potential 

conflicts of interest by precluding 

individuals who are professionally or 

financially affiliated with a provider or 

supplier from participating in the 

survey or accreditation decision process 

with respect to that provider or 

supplier. 

(11) A description of the 

organization’s data management and 

analysis system with respect to its 

surveys and accreditation decisions, 

including all of the following: 

(i) A detailed description of how the 

organization uses its data to assure the 

compliance of its accreditation program 

with the Medicare program 

requirements. 

(ii) A statement acknowledging that 

the organization agrees to submit timely, 

accurate, and complete data to support 

CMS’s evaluation of the accrediting 

organization’s performance. The 

organization must submit to CMS the 

data according to the instructions and 

timeframes CMS specifies. Data 

submissions include, but are not limited 

to, accredited provider or supplier 

demographic information, survey 

schedules, survey findings, and notices 

of accreditation decisions. 

(12) The organization’s procedures for 

responding to, and investigating, 

complaints against accredited facilities, 

including policies and procedures 

regarding coordination of these 

activities with appropriate licensing 

bodies and ombudsmen programs. 

(13) The organization’s accreditation 

status decision-making process, 

including its policies and procedures for 

granting, withholding, or removing 

accreditation status for facilities that fail 

to meet the accrediting organization’s 

standards or requirements, assignment 

of less than full accreditation status or 

other actions taken by the organization 

in response to non-compliance with its 

standards and requirements. The 

organization must furnish the following: 

(i) A description of all types and 

categories of accreditation decisions 

associated with the program for which 


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approval is sought, including the 

duration of each. 

(ii) A statement acknowledging that 

the organization agrees to notify CMS 

(in a manner CMS specifies) of any 

provider or supplier-specific 

accreditation decisions, including but 

not limited to the following: 

accreditation revoked, withdrawn, or 

revised; or has had any remedial or 

adverse action taken against it, within 3 

business days from the date the 

organization takes an action. 

(14) A list of all facilities currently 

accredited by the organization under the 

program for which CMS approval is 

sought, including the type and category 

of accreditation currently held by each 

provider or supplier, and the expiration 

date of each provider’s or supplier’s 

current accreditation. 

(15) CMS considers applications for 

re-approval of a national accrediting 

organizations accreditation program if 

the accrediting organization 

demonstrates it has accredited at least 

50 providers or suppliers under its 

current CMS-approved accreditation 

program. 

(16) A schedule of all accreditation 

surveys expected to be conducted by the 

organization during the 6-month period 

following submission of the application. 

(17) The three most recent audited 

financial statements of the organization 

that demonstrate that the organization’s 

staffing, funding, and other resources 

are adequate to perform the required 

surveys and related activities. 

(18) A statement that it will provide 

written notification to all providers or 

suppliers accredited under a CMSapproved accreditation program at least 

90 calendar days in advance of the 

effective date of a decision by the 

organization to voluntarily terminate its 

CMS-approved accreditation program. 

(19) A statement that it will provide 

written notification to CMS at least 60 

calendar days in advance of the effective 

date of any proposed changes in the 

organization’s CMS-approved 

accreditation program requirements, 

including an agreement not to 

implement the changes before receiving 

CMS’s approval. 

(20) A statement that, in response to 

a notice from CMS of a change in the 

applicable conditions or requirements 

or in the survey process, the 

organization will provide CMS with 

proposed corresponding changes in the 

organization’s requirements for its CMSapproved accreditation program to 

ensure continued comparability with 

the CMS conditions or requirements or 

survey process. The organization must 

comply with the following 

requirements: 

(i) The proposed changes must be 

submitted within 30 calendar days or by 

the date specified in the CMS notice, 

whichever is later. 

(ii) The organization may not 

implement the proposed changes before 

receiving CMS’s approval. 

(21) A statement acknowledging that, 

as a condition for CMS’s approval of an 

accreditation program, the organization 

will agree to require its surveyors to 

serve as witnesses in a legal proceeding 

if CMS takes an adverse action against 

a provider or supplier on the basis of the 

organization’s accreditation survey 

findings. 

(b) Additional information needed. If 

CMS determines that additional 

information is necessary to make a 

determination for approval or denial of 

the organization’s initial application or 

re-application for CMS’s approval of an 

accreditation program, CMS will notify 

the organization and afford it an 

opportunity to provide the additional 

information. 

(c)(1) Withdrawing an application. An 

accrediting organization may withdraw 

its initial application for CMS’sapproval of its accreditation program at 

any time before CMS publishes the final 

notice described in paragraph (f)(2) of 

this section. 

(2) Voluntary termination of a CMSapproved accreditation program. An 

accrediting organization may 

voluntarily terminate its CMS-approved 

accreditation program at any time. The 

AO must notify CMS of its decision to 

voluntarily terminate its approved 

accreditation program and provide an 

effective date of termination. CMS will 

publish in the Federal Register a notice 

that includes the reasons for the 

termination and the effective date. In 

accordance with the requirements at 

§ 488.8(e), the AOs must notify, in 

writing each of its providers or 

suppliers of its decision. 

(d) Requesting reconsideration of a 

disapproval. If an accrediting 

organization has requested, in 

accordance with subpart D of this part, 

a reconsideration of CMS’s 

determination that its request for 

approval of an accreditation program is 

denied, it may not submit an initial 

application for approval of an 

accreditation program for another type 

of provider or supplier until the hearing 

officer’s final decision is rendered. 

(e) Re-submitting a request. Except as 

provided in paragraph (d) of this 

section, an organization whose request 

for CMS’s approval or re-approval of an 

accreditation program has been denied 

may resubmit its application if the 

organization completes all of the 

following: 

(1) Revises its accreditation program 

to address the issues related to the 

denial of its previous request. 

(2) Demonstrates that it can provide 

reasonable assurance that its accredited 

facilities meet the applicable Medicare 

program requirements. 

(3) Resubmits the application in its 

entirety. 

(f) Public notice and comment. CMS 

publishes a notice in the Federal 

Register when the following conditions 

are met: 

(1) Proposed notice. When CMS 

receives a complete application from a 

national accrediting organization 

seeking CMS’s approval of an 

accreditation program, it publishes a 

proposed notice. The proposed notice 

identifies the organization and the type 

of providers or suppliers to be covered 

by the accreditation program and 

provides 30 calendar days for the public 

to submit comments to CMS. 

(2) Final notice. When CMS decides to 

approve or disapprove a national 

accrediting organization’s application, it 

publishes a final notice within 210 

calendar days from the date CMS 

determines the accrediting 

organization’s application was 

complete. The final notice specifies the 

basis for the CMS decision. 

(i) Approval or re-approval. If CMS 

approves or re-approves the accrediting 

organization’s accreditation program, 

the final notice describes how the 

accreditation program provides 

reasonable assurance that the providers 

or suppliers accredited by the 

organization under that program meet 

the applicable Medicare requirements. 

The final notice specifies the effective 

date and term of the approval (which 

may not be later than the publication 

date of the notice and which will not 

exceed 6 years). 

(ii) Disapproval. If CMS does not 

approve the accrediting organization’s 

accreditation program, the final notice 

describes how the organization fails to 

provide reasonable assurance that the 

providers or suppliers accredited by the 

organization under that program meet 

the applicable Medicare requirements. 

The final notice specifies the effective 

date of the decision. 

■ 7. Section 488.6 is revised to read as 

follows: 

§ 488.6 Providers or suppliers that 

participate in the Medicaid program under 

a CMS-approved accreditation program. 

A provider or supplier that has been 

granted ‘‘deemed status’’ by CMS by 

virtue of its accreditation from a CMSapproved accreditation program is 

eligible to participate in the Medicaid 

program. 


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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 20579 

§ 488.9 [Removed] 

■ 8. Section 488.9 is removed. 

§ 488.7 [Redesignated as § 488.9] 

■ 9. Section 488.7 is redesignated as 

new § 488.9. 

■ 10. New section 488.7 is added to read 

as follows: 

§ 488.7 Release and use of accreditation 

surveys. 

A Medicare participating provider or 

supplier deemed to meet program 

requirements in accordance with § 488.4 

must authorize its accrediting 

organization to release to CMS a copy of 

its most current accreditation survey 

and any information related to the 

survey that CMS may require 

(including, but not limited to, corrective 

action plans). 

(a) CMS may determine that a 

provider or supplier does not meet the 

applicable Medicare conditions or 

requirements on the basis of its own 

investigation of the accreditation survey 

or any other information related to the 

survey. 

(b) With the exception of home health 

agency surveys, general disclosure of an 

accrediting organization’s survey 

information is prohibited under section 

1865(b) of the Act. CMS may publically 

disclose an accreditation survey and 

information related to the survey, upon 

written request, to the extent that the 

accreditation survey and survey 

information are related to an 

enforcement action taken by CMS. 

■ 11. Section 488.8 is revised to read as 

follows: 

§ 488.8 Ongoing review of accrediting 

organizations. 

(a) Performance review. In accordance 

with section 1875(b) of the Act, CMS 

evaluates the performance of each CMSapproved accreditation program on an 

ongoing basis. This review includes, but 

is not limited to the following: 

(1) Review of the organization’s 

survey activity. 

(2) Analysis of the results of the 

validation surveys under § 488.9(a)(1), 

including the rate of disparity between 

certifications of the accrediting 

organization and certifications of the 

state survey agency. 

(3) Review of the organization’s 

continued fulfillment of the 

requirements in § 488.5(a). 

(b) Comparability review. CMS 

assesses the equivalency of an 

accrediting organization’s CMSapproved program requirements to the 

comparable CMS requirements if the 

following conditions exist: 

(1) CMS imposes new requirements or 

changes its survey process. 

(i) CMS provides timely notice of the 

changes to the affected accrediting 

organization. 

(ii) CMS specifies a timeframe, not 

less than 30 calendar days, for the 

accrediting organization to submit its 

proposed equivalent changes, including 

an implementation timeframe, for CMS 

review and approval. 

(iii) After approval of the proposed 

changes, CMS determines whether the 

changes were implemented within the 

approved timeframe. 

(iv) If an organization fails to submit 

timely comparable changes, CMS may 

open an accreditation program review in 

accordance with paragraph (c) of this 

section. 

(2) An accrediting organization 

proposes to adopt new requirements or 

to change its survey process. 

(i) An accrediting organization must 

provide written notice to CMS at least 

60 calendar days before the proposed 

effective date of any proposed changes 

in its accreditation requirements or 

survey process. 

(ii) The accrediting organization must 

not implement any changes before 

receiving CMS’s approval. 

(c) CMS-approved accreditation 

program review. If a comparability or 

performance review reveals evidence of 

substantial non-compliance of an 

accrediting organization’s CMSapproved accreditation program with 

the requirements of this subpart, CMS 

may initiate an accreditation program 

review. 

(1) If an accreditation program review 

is initiated, CMS provides written 

notice to the organization indicating 

that its CMS-approved accreditation 

program approval may be in jeopardy 

and that an accreditation program 

review is being initiated. The notice 

provides all of the following 

information: 

(i) A statement of the instances, rates 

or patterns of non-compliance 

identified, as well as other related 

information, if applicable. 

(ii) A description of the process to be 

followed during the review, including a 

description of the opportunities for the 

accrediting organization to offer factual 

information related to CMS’s findings. 

(iii) A description of the possible 

actions that may be imposed by CMS 

based on the findings of the 

accreditation program review. 

(iv) The actions the accrediting 

organization must take to address the 

identified deficiencies including a 

timeline for implementation not to 

exceed 180 calendar days after receipt of 

the notice that CMS is initiating an 

accreditation program review. 

(2) CMS reviews the accrediting 

organization’s plan of correction for 

acceptability. 

(3) If CMS determines as a result of 

the accreditation program review or a 

review of an application for renewal of 

an existing CMS-approved accreditation 

program that the accrediting 

organization has failed to meet any of 

the requirements of this subpart, CMS 

may place the accrediting organization’s 

CMS-approved accreditation program 

on probation for a period up to 180 

calendar days to implement corrective 

actions, not to exceed the accrediting 

organization’s current term of approval. 

In the case of a renewal application 

where CMS has placed the accreditation 

program on probation, CMS indicates 

that any approval of the application is 

conditional while the program is placed 

on probation. 

(i) Within 60 calendar days after the 

end of any probationary period, CMS 

issues a written determination to the 

accrediting organization as to whether 

or not a CMS-approved accreditation 

program continues to meet the 

requirements of this subpart, including 

the reasons for the determination. 

(ii) If CMS has determined that the 

accrediting organization does not meet 

the requirements, CMS withdraws 

approval of the CMS-approved 

accreditation program. The notice of 

determination provided to the 

accrediting organization includes notice 

of the removal of approval, reason for 

the removal, including the effective date 

determined in accordance with 

paragraph (c)(3)(iii) of this section. 

(iii) CMS publishes in the Federal 

Register a notice of its decision to 

withdraw approval of a CMS-approved 

accreditation program, including the 

reasons for the withdrawal, effective 60 

calendar days from the date of 

publication of the notice. 

(d) Immediate jeopardy. If at any time 

CMS determines that the continued 

approval of a CMS-approved 

accreditation program of any accrediting 

organization poses an immediate 

jeopardy to the patients of the entities 

accredited under that program, or the 

continued approval otherwise 

constitutes a significant hazard to the 

public health, CMS may immediately 

withdraw the approval of a CMSapproved accreditation program of that 

accrediting organization and publishes a 

notice of the removal, including the 

reasons for it, in the Federal Register. 

(e) Notification of providers or 

suppliers. An accrediting organization 

whose CMS approval of its accreditation 

program has been withdrawn or the 

organization voluntarily terminates its 

program must notify, in writing, each of 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
20580 Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 

its providers or suppliers of withdrawal 

of deemed status no later than 30 

calendar days after the notices is 

published in the Federal Register. 

(f) Request for reconsideration. Any 

accrediting organization dissatisfied 

with a determination to withdraw CMS 

approval of its accreditation program 

may request a reconsideration of that 

determination in accordance with 

subpart D of this part. 

(g) Continuation of deemed status. 

After CMS removes approval of an 

accrediting organization’s accreditation 

program, an affected provider’s or 

supplier’s deemed status continues in 

effect for 180 calendar days after the 

removal of the approval if the provider 

or supplier submits an application to 

another CMS-approved accreditation 

program within 60 calendar days from 

the date of publication of the removal 

notice in the Federal Register. The 

provider or supplier must provide 

written notice to the state survey agency 

that it has submitted an application for 

accreditation with deemed status with 

another CMS-approved accrediting 

organization within this same 60- 

calendar day timeframe. Failure to 

comply with the timeframe 

requirements specified in this section 

will place the provider or supplier 

under the state survey agency’s 

authority for continued participation in 

Medicare and on-going monitoring. 

(h) Onsite observations of accrediting 

organization operations. As part of the 

application review process, the ongoing 

review process, or the continuing 

oversight of an accrediting 

organization’s performance, CMS may 

conduct at any time an onsite inspection 

of the accrediting organization’s 

operations and offices to verify the 

organization’s representations and to 

assess the organization’s compliance 

with its own policies and procedures. 

The onsite inspection may include, but 

is not limited to, the review of 

documents, auditing meetings 

concerning the accreditation process, 

observation of surveys, the evaluation of 

survey results or the accreditation 

decision-making process, and 

interviews with the organization’s staff. 

■ 12. Newly designated § 488.9 is 

revised to read as follows: 

§ 488.9 Validation surveys. 

(a) Basis for survey. CMS may require 

a survey of an accredited provider or 

supplier to validate the accrediting 

organization’s CMS-approved 

accreditation process. These surveys are 

conducted on a representative sample 

basis, or in response to substantial 

allegations of non-compliance. 

(1) For a representative sample, the 

survey may be comprehensive and 

address all Medicare conditions or 

requirements, or it may be focused on a 

specific condition(s) as determined by 

CMS. 

(2) For a substantial allegation, the 

state survey agency surveys for any 

condition(s) or requirement(s) that CMS 

determines is related to the allegations. 

(b) Selection for survey. (1) A provider 

or supplier selected for a validation 

survey must cooperate with the state 

survey agency that performs the 

validation survey. 

(2) If a provider or supplier selected 

for a validation survey fails to cooperate 

with the state survey agency, it will no 

longer be deemed to meet the Medicare 

conditions or requirements, but will be 

subject to a review by the state survey 

agency in accordance with § 488.10(a), 

and may be subject to termination of its 

provider agreement under § 489.53 of 

this chapter. 

(c) Consequences of a finding of noncompliance. (1) If a CMS validation 

survey results in a finding that the 

provider or supplier is out of 

compliance with one or more Medicare 

conditions or requirements, the provider 

or supplier will no longer be deemed to 

meet the Medicare conditions or 

requirements and will be subject to 

ongoing review by the state survey 

agency in accordance with § 488.10(a) 

until the provider or supplier 

demonstrates compliance. 

(2) CMS may take actions with respect 

to the deficiencies identified in the state 

validation survey in accordance with 

§ 488.24, or may first direct the state 

survey agency to conduct another 

survey of the provider’s or supplier’s 

compliance with specified Medicare 

conditions or requirements before taking 

the enforcement actions provided for at 

§ 488.24. 

(3) If CMS determines that a provider 

or supplier is not in compliance with 

applicable Medicare conditions or 

requirements, the provider or supplier 

may be subject to termination of the 

provider or supplier agreement under 

§ 489.53 of this chapter or of the 

supplier agreement in accordance with 

the applicable supplier conditions and 

any other applicable intermediate 

sanctions and remedies. 

(d) Re-instating deemed status. An 

accredited provider or supplier will be 

deemed to meet the applicable Medicare 

conditions or requirements in 

accordance with this section if all of the 

following requirements are met: 

(1) It withdraws any prior refusal to 

authorize its accrediting organization to 

release a copy of the provider’s or 

supplier’s current accreditation survey. 

(2) It withdraws any prior refusal to 

allow a validation survey, if applicable. 

(3) CMS finds that the provider or 

supplier meets all applicable Medicare 

conditions of participation, conditions 

for coverage, conditions of certification, 

or requirements. 

(e) Impact of adverse actions. The 

existence of any performance review, 

comparability review, deemed status 

review, probationary period, or any 

other action by CMS, does not affect or 

limit conducting any validation survey. 

■ 13. Section 488.10 is amended by 

revising paragraphs (b) through (d) to 

read as follows: 

§ 488.10 State survey agency review: 

Statutory provisions. 

* * * * * 

(b) Section 1865(a) of the Act provides 

that if an institution is accredited by a 

national accrediting organization 

recognized by the Secretary, it may be 

deemed to have met the applicable 

conditions or requirements. 

(c) Section 1864(c) of the Act 

authorizes the Secretary to enter into 

agreements with state survey agencies 

for the purpose of conducting validation 

surveys in institutions accredited by an 

accreditation program recognized by the 

Secretary. 

(d) Section 1865(c) provides that an 

accredited institution that is found after 

a validation survey to have significant 

deficiencies related to health and safety 

of patients will no longer meet the 

applicable conditions or requirements. 

■ 14. Section 488.11 is amended by 

revising paragraph (b) to read as follows: 

§ 488.11 State survey agency functions. 

* * * * * 

(b) Conduct validation surveys of 

deemed facilities as provided in § 488.9. 

* * * * * 

■ 15. Section 488.12 is amended by 

revising paragraph (a)(2) to read as 

follows: 

§ 488.12 Effect of survey agency 

certification. 

* * * * * 

(a) * * * 

(2) A provider or supplier accredited 

under a CMS-approved accreditation 

program remains deemed to meet the 

Medicare conditions or requirements, or 

will be placed under the jurisdiction of 

the state survey agency and subject to 

further enforcement actions in 

accordance with the provisions at 

§ 488.9. 

* * * * * 

■ 16. Section 488.13 is added to read as 

follows: 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Proposed Rules 20581 

§ 488.13 Loss of accreditation. 

If an accrediting organization notifies 

CMS that it is terminating a provider or 

supplier due to non-compliance with its 

CMS-approved accreditation 

requirements, the state survey agency 

will conduct a full review in a timely 

manner. 

■ 17. Section 488.28 is amended by 

revising paragraph (a) to read as follows: 

§ 488.28 Providers or suppliers, other than 

SNFs and NFs, with deficiencies. 

(a) If a provider or supplier is found 

to be deficient in one or more of the 

standards in the conditions of 

participation, conditions for coverage, 

or conditions for certification or 

requirements, it may participate in, or 

be covered under, the Medicare program 

only if the provider or supplier has 

submitted an acceptable plan of 

correction for achieving compliance 

within a reasonable period of time 

acceptable to the Secretary. In the case 

of an immediate jeopardy situation, the 

Secretary may require a shorter time 

period for achieving compliance. 

* * * * * 

PART 489—PROVIDER AGREEMENTS 

AND SUPPLIER APPROVAL 

■ 18. The authority citation for part 489 

is revised to read as follows: 

Authority: Secs. 1102 and 1871 of the 

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

1395(hh). 

■ 19. Section 489.1 is amended by 

revising paragraph (b) to read as follows: 

§ 489.1 Statutory basis. 

* * * * * 

(b) Although section 1866 of the Act 

speaks only to providers and provider 

agreements, the following rules in this 

part also apply to the approval of 

supplier entities that, for participation 

in Medicare, are subject to a 

determination by CMS on the basis of a 

survey conducted by the state survey 

agency or CMS surveyors; or, in lieu of 

a state survey agency or CMS-conducted 

survey, accreditation by an accrediting 

organization whose program has CMS 

approval in accordance with § 488.4 at 

the time of the accreditation survey and 

accreditation decision, in accordance 

with the following: 

(1) The effective date rules specified 

in § 489.13. 

(2) The requirements specified in 

§ 489.53(a)(2), (13), and (18), related to 

termination by CMS of participation in 

Medicare. 

* * * * * 

■ 20. Section 489.3 is amended by 

revising the definition of ‘‘Immediate 

jeopardy’’ to read as follows: 

§ 489.3 Definitions. 

* * * * * 

Immediate jeopardy means a situation 

in which the provider’s or supplier’s 

non-compliance with one or more 

requirements, conditions of 

participation, conditions for coverage, 

or certification has caused, or is likely 

to cause, serious injury, harm, 

impairment, or death to a resident or 

patient. 

* * * * * 

■ 21. Section 489.53 is amended by— 

■ A. Revising paragraphs (a) 

introductory text, (a)(2), (a)(13). 

■ B. Adding reserved paragraph (a)(17). 

■ C. Adding paragraph (a)(18). 

■ D. Revising paragraph (d)(2)(i) 

introductory text. 

The additions and revisions read as 

follows: 

§ 489.53 Termination by CMS. 

(a) Basis for termination of agreement. 

CMS may terminate the agreement with 

any provider if CMS finds that any of 

the following failings is attributable to 

that provider, and may, in addition to 

the applicable requirements in this 

chapter governing the termination of 

agreements with suppliers, terminate 

the agreement with any supplier to 

which the failings in paragraphs (a)(2), 

(a)(13), and (a)(18) of this section are 

attributable: 

* * * * * 

(2) The provider or supplier places 

restrictions on the persons it will accept 

for treatment and it fails either to 

exempt Medicare beneficiaries from 

those restrictions or to apply them to 

Medicare beneficiaries the same as to all 

other persons seeking care. 

* * * * * 

(13) The provider or supplier refuses 

to permit photocopying of any records 

or other information by, or on behalf of, 

CMS, as necessary to determine or 

verify compliance with participation 

requirements. 

* * * * * 

(17) [Reserved] 

(18) The provider or supplier fails to 

grant immediate access upon a 

reasonable request to a state survey 

agency or other authorized entity for the 

purpose of determining, in accordance 

with § 488.3, whether the provider or 

supplier meets the applicable 

requirements, conditions of 

participation, conditions for coverage or 

conditions for certification. 

* * * * * 

(d) * * * 

(2) * * * 

(i) Hospitals. If CMS finds that a 

hospital is in violation of § 489.24 (a) 

through (f), and CMS determines that 

the violation poses immediate jeopardy 

to the health or safety of individuals 

who present themselves to the hospital 

for emergency services, CMS— 

* * * * * 

CMS–3255–P 

Authority: (Catalog of Federal Domestic 

Assistance Program No. 93.778, Medical 

Assistance Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: November 15, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: March 13, 2013. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2013–07950 Filed 4–4–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 155 

[CMS–9955–P] 

RIN 0938–AR75 

Patient Protection and Affordable Care 

Act; Exchange Functions: Standards 

for Navigators and Non-Navigator 

Assistance Personnel 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Proposed rule. 

SUMMARY: The proposed regulations 

would create conflict-of-interest, 

training and certification, and 

meaningful access standards applicable 

to Navigators and non-Navigator 

assistance personnel in Federallyfacilitated Exchanges, including State 

Partnership Exchanges, and to nonNavigator assistance personnel in Statebased Exchanges that are funded 

through federal Exchange Establishment 

grants. These proposed standards would 

help ensure that Navigators and nonNavigator assistance personnel will be 

fair and impartial and will be 

appropriately trained, and that they will 

provide services and information in a 

manner that is accessible. 

The proposed regulations would also 

make two amendments to the existing 

regulation for Navigators that would 

apply to all Navigators in all Affordable 

Insurance Exchanges (Exchanges), 

including State-based Exchanges, 

clarifying that any Navigator licensing, 

certification, or other standards 


TKELLEY on DSK3SPTVN1PROD with PROPOSALS