Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Proposed Rules 65331 

invoice payment submitted by the 

Contractor under this contract. 

(2) (i) Except as provided in paragraph 

(c) of this clause, the Contractor shall 

submit invoices using the electronic 

invoicing program Invoice Processing 

Platform (IPP), which is a secure webbased service provided by the U.S. 

Treasury that more efficiently manages 

government invoicing. 

(ii) Under this contract, the following 

documents are required to be submitted 

as an attachment to the IPP invoice: 

(This is a fill-in for acceptable types of 

required documentation, such as an SF 

1034 and 1035, or an invoice/selfdesigned form on company letterhead 

that contains the required information.) 

(iii) The Contractor’s Government 

Business Point of Contact (as listed in 

System for Award Management (SAM)) 

will receive enrollment instructions via 

email from the IPP. The Contractor must 

register within 3 to 5 days of receipt of 

such email from IPP. 

(iv) Contractor assistance with 

enrollment can be obtained by 

contacting the IPP Production Helpdesk 

via email at IPPCustomerSupport@

fiscal.treasury.gov or by telephone at 

(866) 973–3131. 

(3) If the Contractor is unable to 

comply with the requirement to use IPP 

for submitting invoices for payment, the 

Contractor shall submit a waiver request 

in writing to the Contracting Officer. 

The Contractor may submit an invoice 

using other than IPP only when— 

(i) The Contracting Officer 

administering the contract for payment 

has determined, in writing, that 

electronic submission would be unduly 

burdensome to the Contractor; and in 

such cases, the Contracting Officer shall 

modify the contract to include a copy of 

the Determination; or 

(ii) When the Governmentwide 

commercial purchase card is used as the 

method of payment. 

(4) The Contractor shall submit any 

non-electronic payment requests using 

the method or methods specified in 

Section G of the contract. 

(5) In addition to the requirements of 

this clause, the Contractor shall meet 

the requirements of the appropriate 

payment clauses in this contract when 

submitting payment requests. 

(6) Invoices submitted through IPP 

will be either rejected, or accepted and 

paid, in their entirety, and will not be 

paid on a partial basis. 

(b) The Contractor shall prepare its 

invoice or request for contract financing 

payment in accordance with FAR 

32.905 on the prescribed Government 

forms, or the Contractor may submit 

self-designed forms which contain the 

required information. Standard Form 

1034, Public Voucher for Purchases and 

Services other than Personal, is 

prescribed for used by contractors to 

show the amount claimed for 

reimbursement. Standard Form 1035, 

Public Voucher for Purchases and 

Services other than Personal— 

Continuation Sheet, is prescribed for 

use to furnish the necessary supporting 

detail or additional information 

required by the Contracting Officer. 

* * * * * 

(g) * * * 

(5) Voucher Number—Insert the 

appropriate serial number of the 

voucher. A separate series of 

consecutive numbers, beginning with 

Number 1, shall be used by the 

contractor for each new contract. For an 

adjustment invoice, write ‘‘[invoice 

number] #Adj’’ at the voucher number. 

For a final invoice, put invoice number 

F. For a completion invoice, put invoice 

number #C. 

* * * * * 

Note to paragraph (i)—Any costs 

requiring advance consent by the Contracting 

Officer will be considered improper and will 

be disallowed, if claimed prior to receipt of 

Contracting Officer consent. Include the total 

cost claimed for the current and cumulativeto-date periods. After the total amount 

claimed, provide summary dollar amounts 

disallowed on the contract as of the date of 

the invoice. Also include an explanation of 

the changes in cumulative costs disallowed 

by addressing each adjustment in terms of: 

Voucher number, date, dollar amount, 

source, and reason for the adjustment. 

Disallowed costs should be identified in 

unallowable accounts in the contractor’s 

accounting system. 

* * * * * 

Note to paragraph (j)—Any costs 

requiring advance consent by the Contracting 

Officer will be considered improper and will 

be disallowed, if claimed prior to receipt of 

Contracting Officer consent. Include the total 

cost claimed for the current and cumulativeto-date periods. After the total amount 

claimed, provide summary dollar amounts 

disallowed on the contract as of the date of 

the invoice. Also include an explanation of 

the changes in cumulative costs disallowed 

by addressing each adjustment in terms of: 

Voucher number, date, dollar amount, 

source, and reason for the adjustment. 

Disallowed costs should be identified in 

unallowable accounts in the contractor’s 

accounting system. 

* * * * * 

[FR Doc. 2018–27478 Filed 12–19–18; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 488 

[CMS–3367–NC] 

RIN 0938–AT84 

Medicare Program: Accrediting 

Organizations Conflict of Interest and 

Consulting Services; Request for 

Information 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Request for information. 

SUMMARY: This request for information 

(RFI) seeks public comment regarding 

the appropriateness of the practices of 

some Medicare-approved Accrediting 

Organizations (AOs) to provide feebased consultative services for 

Medicare-participating providers and 

suppliers as part of their business 

model. We wish to determine whether 

AO practices of consulting with the 

same facilities which they accredit 

under their CMS approval could create 

actual or perceived conflicts of interest 

between the accreditation and 

consultative entities. We intend to 

consider information received in 

response to this RFI to assist in future 

rulemaking. 

DATES: 

Comments: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

February 19, 2019. 

ADDRESSES: In commenting, refer to file 

code CMS–3367–NC. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

Comments, including mass comment 

submissions, must be submitted in one 

of the following three ways (please 

choose only one of the ways listed): 

1. Electronically. You may submit 

electronic comments on this RFI to 

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

‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3367–NC, P.O. Box 8016, 

Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 


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following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3367–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

FOR FURTHER INFORMATION CONTACT: 

Monda Shaver, 410–786–3410 or 

Caroline Gallagher, 410–786–8705. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period will be made 

available for viewing by the public, 

including any personally identifiable or 

confidential business information that is 

included in a comment. We will post all 

comments received before the close of 

the comment period on the following 

website as soon as possible after they 

have been received: http://

www.regulations.gov. Follow the search 

instructions on that website to view 

public comments. 

I. Background 

To participate in the Medicare 

program, providers and suppliers of 

health care services must be in 

substantial 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 (the Secretary). These health 

and safety requirements are generally 

called conditions of participation (CoPs) 

for most providers, requirements for 

skilled nursing facilities (SNFs), and 

conditions for coverage or certification 

(CfCs) for other suppliers. Medicare 

certified providers and suppliers 

participate in the Medicare program by 

entering into an agreement with 

Medicare in which, among other things, 

they agree to comply with the CoPs or 

other applicable health and safety 

requirements. The providers and 

suppliers subject to these requirements 

include hospitals, skilled nursing 

facilities, home health agencies, hospice 

programs, rural health clinics, critical 

access hospitals, comprehensive 

outpatient rehabilitation facilities, 

laboratories, clinics, rehabilitation 

agencies, public health agencies, and 

ambulatory surgical centers. A 

Medicare-certified 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 agencies or other 

appropriate local agencies, under an 

agreement with CMS, survey health care 

providers and suppliers for compliance 

with the applicable CoPs, CfCs, 

conditions of certification, or 

requirements. Based on these State 

Survey Agency (SA) certifications, CMS 

determines whether the provider or 

supplier qualifies, or continues to 

qualify, for participation in the 

Medicare program. Additionally, section 

1865(a) of the Act allows most health 

care facilities to demonstrate 

compliance with Medicare CoPs, 

requirements, CfCs, or conditions for 

certification through accreditation by a 

CMS-approved program of a national 

accreditation organization (AO), in lieu 

of being surveyed by SAs for 

certification. Accreditation by an AO is 

generally voluntary and is not required 

for Medicare certification or 

participation in the Medicare Program. 

Section 1865(a)(1) of the Act provides 

that if the Secretary finds that 

accreditation of a provider entity (which 

includes a provider of services, 

supplier, facility, clinic, agency, or 

laboratory) by a national accreditation 

body demonstrates that all applicable 

conditions are met or exceeded, the 

Secretary may deem those requirements 

as being met by the provider entity. We 

are ultimately 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 accreditation program 

approval in accordance with § 488.5 and 

may be approved by CMS for a period 

not to exceed 6 years. 

In addition, section 353 of the Public 

Health Service Act (PHS Act), as 

amended by the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578), requires any 

laboratory that performs testing on 

human specimens for health purposes to 

meet the requirements established by 

CLIA and regulations issued under its 

authority, and have in effect an 

applicable CLIA certificate. Pursuant to 

section 353(e) of the PHS Act, a 

laboratory covered by CLIA may receive 

a certificate if, among other things, it is 

accredited by a laboratory AO approved 

by CMS under paragraph 353(e)(2) of 

the PHS Act. Any proposed or future 

regulation made regarding AOs’ practice 

of providing fee-based consulting 

services to Medicare-participating 

providers and suppliers would also 

apply to AOs that accredit laboratories 

pursuant to CLIA. 

While accreditation by an AO is 

generally voluntary, suppliers of the 

technical component of Advanced 

Diagnostic Imaging (ADI) services (as 

described at 42 CFR 414.68); Diabetes 

Self-Management Training (DSMT) 

services (as described at 42 CFR 

410.141); and Durable Medical 

Equipment (DME) (as described at 42 

CFR 424.58) are subject to accreditation 

required in order to receive 

reimbursement from Medicare for the 

services they furnish to Medicare 

beneficiaries. We also recently finalized 

regulations, at 42 CFR part 488, subpart 

L, for the approval and oversight of AOs 

that accredit Home Infusion Therapy 

suppliers, because section 1834(u)(5) of 

the Act requires suppliers of Home 

Infusion Therapy services (HIT) to be 

accredited (CY 2019 Home Health 

Prospective Payment System Rate 

Update final rule, 83 FR 56406, 

November 13, 2018). 

Pursuant to their respective 

authorizing statutes, these four supplier 

types cannot participate in Medicare 

using a state survey option. One AO 

provides accreditation for several 

provider and supplier types, some 

under accreditation that is required in 

order for the provider or supplier to 

receive payment from Medicare for 

services furnished to Medicare 

beneficiaries, and some under the 

voluntary accreditation programs 

authorized under section 1865 of the 

Act. Therefore, our RFI also seeks 

comment on potential conflicts of 

interest related to this category of AOs 

that certify the four supplier types 

subject to accreditation that is required 

for a provider or supplier to receive 

payment from Medicare for services 

furnished to Medicare beneficiaries as 

well as laboratories accredited by an AO 

under CLIA. 

AOs charge fees to facilities that seek 

their accreditation and generally offer 

facilities at least two accreditation 

options: Accreditation alone, or 

accreditation under a CMS-approved 

program for the purpose of participating 

in Medicare. Accreditation alone may be 

provided for purposes other than 

participation in Medicare. Accreditation 

under a CMS-approved program is 

provided for the purpose of obtaining 

and maintaining a Medicare provider 

agreement. Existing regulations at 

§ 488.4 sets forth the general provisions 

for CMS-approved accreditation 

programs for providers and suppliers 

and § 488.5 outlines the application and 

re-application procedures for national 

AOs that seek to obtain CMS approval 


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Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Proposed Rules 65333 

1Report to Congress: https://www.cms.gov/ 

Medicare/Provider-Enrollment-and-Certification/ 

SurveyCertificationGenInfo/Policy-and-Memos-toStates-and-Regions.htm. 

2The Wall Street Journal, ‘‘Watchdog Awards 

Hospitals Seal of Approval Even After Problems 

Emerge’’ Stephanie Armour (September 8, 2018) 

https://www.wsj.com/articles/watchdog-awardshospitals-seal-of-approval-even-after-problemsemerge-1504889146. 

of their accreditation programs, often 

called ‘‘deeming authority.’’ 

Additionally, AO application and reapplication procedures are set forth at 

§ 414.68(c) for accreditors of ADI 

suppliers, § 410.142 for accreditors of 

DSMT suppliers, and § 424.57(c) for 

accreditors of DME suppliers. Pursuant 

to the above regulations CMS has 

responsibility for oversight and 

approval of AO accreditation programs 

used for Medicare participation 

purposes and for ensuring that 

providers and suppliers that are 

accredited under a CMS-approved AO 

accreditation program meet or exceed 

the quality and patient safety standards 

required by the Medicare regulations. A 

thorough review of each accreditation 

program voluntarily submitted by an 

AO seeking CMS approval is conducted 

by CMS, including a review of the 

equivalency to the Medicare standards 

of its accreditation requirements, survey 

processes and procedures, surveyor 

training, and oversight and enforcement 

of provider entities. In addition, we also 

review the qualifications of the 

surveyors, staff, and the AO’s financial 

status. 

Under the application and reapplication requirement procedures in 

§ 488.5 for ‘‘voluntary’’ accreditation 

programs, under § 488.5(a)(10), an AO 

submitting an application must include 

a copy of the AO’s ‘‘organization’s 

policies and procedures to avoid 

conflicts of interest, including the 

appearance of conflicts of interest, 

involving individuals who conduct 

surveys or participate in accreditation 

decisions.’’ This provision is 

implemented by CMS’s review of 

submitted documentation to determine 

that no conflicts of interest exist. 

Section 488.5(e) requires that we 

publish a notice in the Federal Register 

when we receive a complete application 

or reapplication from a national AO 

which is voluntarily seeking approval of 

its voluntary accreditation program. The 

notice identifies the organization and 

the type of providers or suppliers to be 

covered by the voluntary accreditation 

program and provides a 30-day public 

comment period. We have 210 days 

from the receipt of a complete 

application to publish notice of 

approval or denial of the application. 

Upon approval, any provider or supplier 

subsequently accredited by the AO’s 

approved program(s) would be deemed 

by CMS to have met the applicable 

Medicare conditions and would be 

referred to as having ‘‘deemed status.’’ 

Similar rules regarding CMS’s approval 

process also apply to the accreditation 

required to receive payment from 

Medicare for the services furnished by 

the provider or supplier to Medicare 

beneficiaries by ADI, DSMT, DME and 

HIT suppliers, as discussed above. 

In addition to the general 

accreditation application process, we 

are also required by statute to submit an 

annual Report to Congress 1 on our 

oversight of the national AOs. This 

report contains information related to 

the AO activities in a given fiscal year 

and compares these activities to the 

previous years. Within this report, we 

also measure the ‘‘disparity rate’’, which 

is a comparison rate based on AO 

findings of non-compliance during an 

AO survey and the SA findings of noncompliance for the same facilities found 

during a state validation survey. When 

the state survey agency cites a 

condition-level deficiency for which the 

AO has not cited a comparable 

deficiency, the deficiency is considered 

by CMS to have been ‘‘missed’’ and is 

factored into the AO’s disparity rate for 

each facility type. The identification of 

only one missed condition level finding 

in any survey results in the entire 

survey being counted as disparate. The 

number of disparate surveys is divided 

by the number of validation surveys to 

determine the AO’s disparity rate. 

According to the most recently 

published Report to Congress, disparity 

rates for all CMS-approved AO 

programs for the following facility types 

for the most recent year in the report 

(FY 2017) are: Hospital rates (46 

percent); Psychiatric hospitals (57 

percent); Critical Access Hospitals (44 

percent); Home Health Agencies (18 

percent); Hospices (18 percent); 

Ambulatory Surgery Centers (35 

percent). 

As part of our ongoing efforts to 

enhance transparency and oversight of 

the AOs, in 2018 CMS began a pilot for 

integrated validation surveys for 

accredited hospitals. Rather than the SA 

performing a separate second survey of 

an accredited facility within 60-days of 

the AO having completed its survey (of 

the same facility), state survey teams 

accompanied the AO survey team to 

evaluate AO competency and 

effectiveness during the same survey. 

CMS plans to refine this process over 

the next several years in an effort to 

enhance AO oversight, and to ensure 

that facilities under deemed status are 

in compliance with CMS conditions. 

Additionally, to ensure transparency 

both in the performance of AOs with 

CMS-approved accreditation programs 

and the quality of care provided by 

those deemed facilities, we are also 

working to create a CMS.gov web page 

that will provide AO performance data, 

as well as the latest quality of care 

findings based on complaint surveys of 

facilities accredited by these 

organizations. 

As we noted above, section 1865(a)(2) 

of the Act states that the Secretary shall 

consider, among other factors with 

respect to a national accreditation body, 

its requirements for accreditation, its 

survey procedures, its ability to provide 

adequate resources for conducting 

required surveys and supplying 

information for use in enforcement 

activities, its monitoring procedures for 

provider entities found out of 

compliance with the conditions or 

requirements, and its ability to provide 

the Secretary with necessary data for 

validation. CMS determines whether 

accreditation standards and procedures 

are comparable to those of CMS. 

CMS has been aware for some time 

that some AOs with CMS-approved 

accreditation programs are also 

providing fee-based consultative 

services to Medicare-participating 

health care facilities. Typical 

consultative services include, but are 

not limited to the following: 

• Assistance for clinical and nonclinical leaders, including 

administrators in understanding the AO 

and CMS standards for compliance; 

• Review of facility standards and 

promised early intervention and action 

through simulation of a real survey, 

similar to a mock survey to include 

comprehensive written reports of 

findings; 

• Review of a facility’s processes, 

policies and functions; 

• Identification of and technical 

assistance for changing and sustaining 

areas in need of improvement; and, 

• Educational consultative services. 

These activities are not prohibited by 

law or regulation, and the training 

provided by the AOs may be useful for 

entities to learn to comply with the 

requirements and identify gaps in 

compliance. 

This RFI is in response to increasing 

concern about potential conflicts of 

interest created by the accreditation and 

consultative activities of the AOs. In 

September 2017, an article 2 in the Wall 

Street Journal raised concerns regarding 

the performance, transparency, and 

potential conflicts of interest between 

an AO’s accreditation services and its 


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65334 Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Proposed Rules 

3https://energycommerce.house.gov/news/pressrelease/ec-leaders-request-information-hospitalaccreditation-processes/. 

consulting services, which brought 

heightened attention to this issue in the 

public and the Congress. This article 

also discussed CMS’s oversight of the 

AOs. Members of Congress subsequently 

sent letters to CMS 3 regarding the 

agency’s oversight of AOs, which 

encouraged CMS to consider whether 

the agency should continue to recognize 

or approve AOs that seek to provide 

consultative services to the entities they 

accredit for CMS participation in light 

of the potential for actual or perceived 

conflict of interest. 

After consideration of these issues, we 

are seeking comment to determine 

whether offering consultative services to 

the same entities an AO accredits may 

create actual or perceived conflicts of 

interest between the AOs accreditation 

program and its consultative program. 

We have concerns that this dual 

function may undermine, or appear to 

undermine, the integrity of the 

accreditation programs and could erode 

the public trust in the safety of CMSaccredited providers and suppliers. We 

recognize and acknowledge that certain 

consulting services offered by some of 

the AOs, such as quality improvement 

work and training of facility staff, may 

be beneficial to some facilities and 

result in improvements in operations or 

the quality of care furnished and may be 

provided with the best of intentions. 

However, it has been brought to our 

attention that this dual role played by 

some AOs may create, a minimum, the 

perception of conflicts of interest or 

actual conflicts of interest, which are 

rooted in the intersection of the AO’s 

accreditation program with the AO’s 

consulting services. We are concerned 

that circumstances could arise where an 

AO has recommended deemed status 

through accreditation that a client 

facility was in compliance with the 

Medicare regulations, while the 

consultancy service of the AO was 

generating revenue assisting the same 

facility in passing the AO’s own 

accreditation surveys. While the 

consultancy arm may or may not have 

used surveyors which were conducting 

the on-site AO accreditation surveys, 

the consultants are advertised as experts 

on compliance standards. Some AOs 

have indicated that they establish 

firewalls between the arms of their 

businesses, but we are concerned that 

these firewalls may not be sufficient to 

ensure that no conflicts of interest result 

from these activities. 

We have promulgated regulations and 

other requirements for other programs to 

ensure public trust by, for example, 

taking steps to address potential 

conflicts of interest in the Quality 

Improvement Organizations (QIO) (42 

CFR 475.102 and 475.103) and External 

Quality Review Organization (EQRO) 

(42 CFR 438.354 and 42 CFR 438.358) 

programs. For example, 42 CFR 

475.105(c) prohibits QIOs from 

subcontracting with a healthcare 

facilities to perform any case review 

activities except for the review of the 

quality of care 

Section 1932(c)(2) of the Act and 

§ 438.350 and 438.354, respectively, 

specifies that EQRO programs must be 

independent from the State Medicaid 

agency and the managed care plans it 

reviews. Under these requirements, 

EQRO programs may not conduct 

certain ongoing Medicaid managed care 

program operations related to oversight 

of the quality of managed care plan 

services on the state’s behalf. For 

example, these restrictions preclude an 

EQRO from reviewing any managed care 

plan for which it is conducting or has 

conducted an accreditation review 

within the previous 3 years, or having 

a present, or known future, direct or 

indirect financial relationship with a 

managed care plan that it will review as 

an EQRO. We believe that the 

prohibitions set forth at § 438.354 

ensure the independence of the EQROs 

from the state Medicaid agency and 

other managed care organizations and 

provide an example for how to avoid 

any perceived conflict of interest 

between their consultative services and 

work to deliver healthcare services to 

Medicaid beneficiaries. 

Our consideration of this issue and 

review of how conflicts of interest are 

handled in similar programs suggested a 

need to reexamine our current 

regulations regarding AO conflicts of 

interest. Prior to initiating the 

rulemaking process in this area, we are 

seeking information (for example, 

evidence, research and trends), 

including stakeholder and AO feedback, 

specific to the topics discussed in this 

request for information. We intend to 

consider any such comments when we 

draft proposals for future policy 

development, to better protect public 

health and the safety of patients, and 

ensure our process for approving and 

ongoing monitoring of AOs is 

meaningful and maintains the public 

trust. 

II. Potential Alternatives for Addressing 

Conflicts of Interest 

We believe that, similar to QIO and 

EQRO programs, any AO with a 

Medicare-approved accreditation 

program has assumed a position of 

public trust, and is responsible for 

acting on behalf of the public, because 

the AO is performing a function that 

assists in the federal government’s 

enforcement programs. We also believe 

that AOs voluntarily take on this 

position and responsibility when they 

seek accreditation approval from CMS 

to accredit providers and suppliers on 

behalf of CMS for participation in 

Medicare. Because of the responsibility 

CMS has related to maintaining public 

trust and guarding public health, we are 

compelled to ensure that all entities and 

programs, including AOs and their 

accreditation programs, that require 

CMS approval, be held to the high 

standards of ethical conduct so that 

every citizen can have complete 

confidence in the integrity of the 

Federal Government. In our view, AO 

accreditation determinations must be 

made without regard to any additional 

services that a Medicare provider or 

supplier might obtain through the AO or 

its subsidiaries, in order to ensure and 

maintain public trust in the Medicare 

certification program. 

While we are seeking public comment 

under this RFI to gather information 

which may be used for potential future 

rulemaking, we also believe that 

stakeholders may provide insight on 

other mechanisms to address this 

potential conflict of interest. These areas 

for which we are seeking insight from 

stakeholders are further discussed in 

Section III, ‘‘Solicitation of Comments’’. 

Section 488.5(a)(10) of our regulations 

states that the application information 

from the AO include the organization’s 

policies and procedures to avoid 

conflicts of interest, including the 

appearance of conflicts of interest, 

involving individuals who conduct 

surveys or participate in accreditation 

decisions. We implement this by 

reviewing the AOs policies and 

procedures regarding conflict of interest 

to determine that no overt conflicts of 

interest exist regarding such 

individuals. AOs typically include 

provisions in their organization’s 

policies that ban surveyors from 

conducting surveys in the following 

situations: If the surveyor has performed 

any previous consulting services for the 

facility; if the surveyor (or family 

member) has any financial interest in 

the facility; and, if the surveyor was 

previously employed by a facility. 

We are seeking feedback to determine 

whether we should revise our review 

process to identify actual, potential or 

perceived AO conflicts of interest as 

part of the application and renewal 

process for all AOs, including the 

programs that require accreditation in 

order for the provider or supplier to 


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receive payment from Medicare for 

services furnished to Medicare 

beneficiaries, as discussed above. We 

are interested in ways that we could 

potentially modify § 488.5(a), which 

lists the required information to be 

submitted with an application by an AO 

to CMS for review, to also include a 

provision which addresses this conflict 

of interest review process, for which we 

are seeking public comments. As noted, 

§ 488.5(a)(10) of our regulations requires 

that the application information include 

the organization’s policies and 

procedures to avoid conflicts of interest, 

including the appearance of conflicts of 

interest, involving individuals who 

conduct surveys or participate in 

accreditation decisions. Similarly, for 

HIT suppliers, under the CY 2019 Home 

Health final rule (83 FR 56406), at 

§ 488.1010(a)(13), we require AOs for 

home infusion therapy suppliers to 

provide documentation of the AO’s 

policies and procedures for avoiding 

and handling conflicts of interest, 

including the appearance of conflicts of 

interest, involving individuals who 

conduct surveys, audits or participate in 

accreditation decisions. We believe that 

potentially expanding § 488.5(a)(10) by 

adding additional provisions which 

would require the AOs to disclose 

information about any consultative 

services provided by the AO to facilities 

which the AO accredits would further 

enhance oversight of AOs with CMSapproved accreditation programs; this 

would allow CMS to identify 

consultative relationships that create 

real, potential and perceived conflicts of 

interest. We are also considering adding 

similar provisions to the requirements 

for accrediting organizations that 

provide accreditation to providers and 

suppliers that must be accredited in 

order to receive payment from Medicare 

for services they furnish to Medicare 

beneficiaries, including HIT suppliers, 

as set out in the CY 2019 Home Health 

final rule (83 FR 56406) at 

§ 488.1010(a)(13). 

III. Solicitation of Comments 

This is a request for information only. 

Respondents are encouraged to provide 

complete but concise responses to the 

questions listed in the sections outlined 

below. Response to this RFI is 

completely voluntary. This RFI is issued 

solely for information and planning 

purposes; it does not constitute a 

Request for Proposal, applications, 

proposal abstracts, or quotations. This 

RFI does not commit the Government to 

contract for any supplies or services or 

make a grant award. Further, we are not 

seeking proposals through this RFI and 

will not accept unsolicited proposals. 

Responders are advised that the United 

States Government will not pay for any 

information or administrative costs 

incurred in response to this RFI; all 

costs associated with responding to this 

RFI will be solely at the interested 

party’s expense. Not responding to this 

RFI does not preclude participation in 

any future procurement, if conducted. It 

is the responsibility of the potential 

responders to monitor this RFI 

announcement for additional 

information pertaining to this request. 

Also, we note that we will not respond 

to questions about the policy issues 

raised in this RFI. We may or may not 

choose to contact individual responders. 

Such communications would only serve 

to further clarify written responses. 

Contractor support personnel may be 

used to review RFI responses. 

Responses to this notice are not offers 

and cannot be accepted by the 

Government to form a binding contract 

or issue a grant. Information obtained as 

a result of this RFI may be used by the 

Government for program planning on a 

non-attribution basis. Respondents 

should not include any information that 

might be considered proprietary or 

confidential. This RFI should not be 

construed as a commitment or 

authorization to incur cost for which 

reimbursement would be required or 

sought. All submissions become 

Government property and will not be 

returned. We may publically post the 

comments received, or a summary 

thereof. 

While we are soliciting general 

comments on CMS’s oversight of AOs, 

we are specifically seeking input on the 

following areas: 

A. Public/Stakeholder Feedback 

• We are seeking comment on the 

type of fee-based consultative services 

provided by AOs to the facilities they 

accredit. How are these services 

provided and communicated to the 

facilities? Are potential conflicts of 

interest disclosed? 

• Training providers and suppliers of 

services on the applicable requirements 

for Medicare certification is an 

important function to improve quality of 

care. Are there other entities that could 

provide this training besides the AOs? 

• We are seeking public comment 

related to whether commenters perceive 

a conflict of interest in AOs providing 

fee-based consultative services to the 

facilities they accredit. 

• We are seeking public comment 

related to some stakeholders’ perception 

that the ability of an AO to collect fees 

for consultation services from entities 

they accredit could degrade the public 

trust inherent in an AO’s CMS-approved 

accreditation programs. 

• We are seeking public comment on 

what the appropriate consequences or 

impacts should be, if a conflict does 

exist. 

• We are seeking public comment on 

what firewalls may exist within an AO 

between accreditation and consultation 

services, or what firewalls would be 

prudent, to avoid potential and actual 

conflicts of interest. 

• We are soliciting examples of 

positive and negative effects which may 

be as a result of a conflict of interest. 

• We are seeking public comment 

from existing AOs on what the potential 

impact, financially and overall would be 

if CMS were to finalize rulemaking 

which would restrict certain activities 

that might give rise to a real or 

perceived conflict of interest. 

• We are seeking public comment, 

primarily from stakeholders, by 

requesting specific information on when 

and/or under what circumstances it 

would be appropriate for AOs to 

provide fee-based consultative services 

to the facilities which they accredit. 

• We are seeking public and 

stakeholder feedback on whether, and if 

so, under what specific circumstances 

CMS should review a potential conflict 

of interest, and what factors CMS 

should look at to determine if a conflict 

of interest exists. 

• Specifically, we are seeking 

comments in a list type format 

describing under what circumstances 

the AOs or stakeholders would believe 

there to be a conflict; and under which 

circumstances conflict does not exist. 

• We seek comment on the type of 

information which would be considered 

necessary, useful and/or appropriate in 

proving or refuting our hypothesis of a 

connection between the use of 

consultative services and preferential 

treatment of accredited providers and 

suppliers. 

We are seeking comment on 

alternatives for addressing any conflict 

of interest identified. 

B. Financial Impact and Burden 

• We are seeking public comment 

regarding how an AO’s revenue and 

operations may be affected by a 

prohibition or limitation on AOs’ 

marketing and provision of consultative 

services. 

• We are specifically looking for cost 

impacts, detailed accounting, and 

potential business risks for AOs. 

C. Adding a New CFR Subpart to 

Existing Regulation 

• We are seeking stakeholder 

feedback on the most appropriate area 


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65336 Federal Register / Vol. 83, No. 244 / Thursday, December 20, 2018 / Proposed Rules 

for this potential future rulemaking 

under the existing regulations for AOs 

and whether expanding § 488.5(a)(10) to 

include a provision addressing this 

matter would be the most sensible 

placement. 

IV. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

However, section II of this document 

does contain a general solicitation of 

comments in the form of a request for 

information. In accordance with the 

implementing regulations of the 

Paperwork Reduction Act of 1995 

(PRA), specifically 5 CFR 1320.3(h)(4), 

this general solicitation is exempt from 

the PRA. Facts or opinions submitted in 

response to general solicitations of 

comments from the public, published in 

the Federal Register or other 

publications, regardless of the form or 

format thereof, provided that no person 

is required to supply specific 

information pertaining to the 

commenter, other than that necessary 

for self-identification, as a condition of 

the agency’s full consideration, are not 

generally considered information 

collections and therefore not subject to 

the PRA. Consequently, there is no need 

for review by the Office of Management 

and Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). 

V. 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. 

Dated: November 7, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–27506 Filed 12–18–18; 4:15 pm] 

BILLING CODE P 


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