[Federal Register Volume 83, Number 244 (Thursday, December 20, 2018)]
[Proposed Rules]
[Pages 65331-65336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27506]
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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.
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SUMMARY: This request for information (RFI) seeks public comment
regarding the appropriateness of the practices of some Medicare-
approved Accrediting Organizations (AOs) to provide fee-based
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
[[Page 65332]]
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 Sec. 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 Sec. 488.4 sets forth the general provisions for CMS-
approved accreditation programs for providers and suppliers and Sec.
488.5 outlines the application and re-application procedures for
national AOs that seek to obtain CMS approval
[[Page 65333]]
of their accreditation programs, often called ``deeming authority.''
Additionally, AO application and re-application procedures are set
forth at Sec. 414.68(c) for accreditors of ADI suppliers, Sec.
410.142 for accreditors of DSMT suppliers, and Sec. 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 re-application requirement procedures in
Sec. 488.5 for ``voluntary'' accreditation programs, under Sec.
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 non-
compliance 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).
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\1\ Report to Congress: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.htm.
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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 non-clinical 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
[[Page 65334]]
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.
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\2\ The Wall Street Journal, ``Watchdog Awards Hospitals Seal of
Approval Even After Problems Emerge'' Stephanie Armour (September 8,
2018) https://www.wsj.com/articles/watchdog-awards-hospitals-seal-of-approval-even-after-problems-emerge-1504889146.
\3\ https://energycommerce.house.gov/news/press-release/ec-leaders-request-information-hospital-accreditation-processes/.
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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 CMS-accredited 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 Sec. 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 Sec. 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
[[Page 65335]]
receive payment from Medicare for services furnished to Medicare
beneficiaries, as discussed above. We are interested in ways that we
could potentially modify Sec. 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, Sec. 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 Sec.
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 Sec. 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 CMS-approved
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 Sec. 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
[[Page 65336]]
for this potential future rulemaking under the existing regulations for
AOs and whether expanding Sec. 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]
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