83 FR 27992 - Medicare and Medicaid Programs: Application From the Community Health Accreditation Partner for Continued CMS Approval of Its Hospice Accreditation Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services

Federal Register Volume 83, Issue 116 (June 15, 2018)

Page Range		27992-27993
FR Document		2018-12840

This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.

Federal Register, Volume 83 Issue 116 (Friday, June 15, 2018)

[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 27992-27993]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[CMS-3360-PN]


Medicare and Medicaid Programs: Application From the Community 
Health Accreditation Partner for Continued CMS Approval of Its Hospice 
Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Proposed notice.

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SUMMARY: This proposed notice acknowledges the receipt of an 
application from the Community Health Accreditation Partner (CHAP) for 
continued recognition as a national accrediting organization for 
hospices that wish to participate in the Medicare or Medicaid programs.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on July 16, 2018.

ADDRESSES: In commenting, please refer to file code CMS-3360-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-3360-PN, P.O. Box 8010, 
Baltimore, MD 21244-8010.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3360-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Lillian Williams, (410) 786-8636, 
Monda Shaver, (410) 786-3410, or Marie Vasbinder, (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 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

    Under the Medicare program, eligible beneficiaries may receive 
covered services in a hospice provided certain requirements are met by 
the hospice. Sections 1861(dd) of the Social Security Act (the Act) 
establishes distinct criteria for facilities seeking designation as a 
hospice. Regulations concerning provider agreements are at 42 CFR part 
489 and those pertaining to activities relating to the survey and 
certification of facilities are at 42 CFR part 488. The regulations at 
42 CFR part 418, specify the conditions that a hospice must meet in 
order to participate in the Medicare program, the scope of covered 
services and the conditions for Medicare payment for hospices.
    Generally, to enter into an agreement, a hospice must first be 
certified by a State survey agency as complying with the conditions or 
requirements set forth in part 418. Thereafter, the hospice is subject 
to regular surveys by a State survey agency to determine whether it 
continues to meet these requirements.
    However, there is an alternative to surveys by state agencies. 
Section 1865(a)(1) of the Act provides that, if a provider entity 
demonstrates through accreditation by an approved national accrediting 
organization that all applicable Medicare conditions are met or 
exceeded, we will deem those provider entities as having met the 
requirements. Accreditation by an accrediting organization is voluntary 
and is not required for Medicare participation.
    If an accrediting organization is recognized by the Secretary of 
the Department of Health and Human Services as having standards for 
accreditation that meet or exceed Medicare requirements, any provider 
entity accredited by the national accrediting body's approved program 
would be deemed to meet the Medicare conditions. A national accrediting 
organization applying for deeming authority under part 488, subpart A, 
must provide the Centers for Medicare & Medicaid Services (CMS) with 
reasonable assurance that the

[[Page 27993]]

accrediting organization requires the accredited provider entities to 
meet requirements that are at least as stringent as the Medicare 
conditions. Our regulations concerning the reapproval of accrediting 
organizations are set forth at Sec.  488.5. The regulations at Sec.  
488.5(e)(2)(i) require accrediting organizations to reapply for 
continued deeming authority every 6 years or sooner as we determine.
    The Community Health Accreditation Partner's (CHAP's) term of 
approval for its hospice accreditation program expires November 20, 
2018.

II. Approval of Deeming Organizations

    Section 1865(a)(2) of the Act and our regulations at Sec.  488.5 
require that our findings concerning review and approval of a national 
accrediting organization's requirements consider, among other factors, 
the applying accrediting organization's requirements for accreditation; 
survey procedures; resources for conducting required surveys; capacity 
to furnish information for use in enforcement activities; monitoring 
procedures for provider entities found not in compliance with the 
conditions or requirements; and ability to provide CMS with the 
necessary data for validation.
    Section 1865(a)(3)(A) of the Act further requires that we publish 
within 60 days of receipt of an organization's complete application, a 
notice identifying the national accrediting body making the request, 
describing the nature of the request, and providing at least 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.
    The purpose of this proposed notice is to inform the public of 
CHAP's request for continued CMS approval of its hospice accreditation 
program. This notice also solicits public comment on whether CHAP's 
requirements meet or exceed the Medicare conditions for participation 
for hospices.

III. Evaluation of Deeming Authority Request

    CHAP submitted all the necessary materials to enable us to make a 
determination concerning its request for continued approval of its 
hospice accreditation program. This application was determined to be 
complete on April 24, 2018. Under section 1865(a)(2) of the Act and our 
regulations at Sec.  488.5 (Application and re-application procedures 
for national organizations), our review and evaluation of CHAP will be 
conducted in accordance with, but not necessarily limited to, the 
following factors:
     The equivalency of CHAP's standards for hospices as 
compared with CMS' hospice conditions of participation.
     CHAP's survey process to determine the following:
    ++ CHAP's composition of the survey team, surveyor qualifications, 
and the ability of the organization to provide continuing surveyor 
training.
    ++ CHAP's processes compared to those of State agencies, including 
survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited facilities.
    ++ CHAP's processes and procedures for monitoring a hospice found 
out of compliance with CHAP's program requirements. These monitoring 
procedures are used only when CHAP identifies noncompliance. If 
noncompliance is identified through validation reviews, the State 
survey agency monitors corrections as specified at Sec.  488.9(c).
    ++ CHAP's capacity to report deficiencies to the surveyed 
facilities and respond to the facility's plan of correction in a timely 
manner.
    ++ CHAP's capacity to provide CMS with electronic data, and reports 
necessary for effective validation and assessment of the organization's 
survey process.
    ++ CHAP's staff adequacy and other resources, and its financial 
viability.
    ++ CHAP's capacity to adequately fund required surveys.
    ++ CHAP's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
    ++ CHAP's agreement to provide CMS with a copy of the most current 
accreditation survey together with any other information related to the 
survey as we may require (including corrective action plans).
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this proposed notice, we will publish a final 
notice in the Federal Register announcing the result of our evaluation.

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. 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. 3501 et seq.).

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.

    Dated: May 29, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-12840 Filed 6-14-18; 8:45 am]
 BILLING CODE 4120-01-P

Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 27993

accrediting organization requires the • The equivalency of CHAP’s Federal Register documents, we are not
accredited provider entities to meet standards for hospices as compared able to acknowledge or respond to them
requirements that are at least as with CMS’ hospice conditions of individually. We will consider all
stringent as the Medicare conditions. participation. comments we receive by the date and
Our regulations concerning the • CHAP’s survey process to time specified in the DATES section of
reapproval of accrediting organizations determine the following: this preamble, and, when we proceed
are set forth at § 488.5. The regulations ++ CHAP’s composition of the survey with a subsequent document, we will
at § 488.5(e)(2)(i) require accrediting team, surveyor qualifications, and the respond to the comments in the
organizations to reapply for continued ability of the organization to provide preamble to that document.
deeming authority every 6 years or continuing surveyor training.
++ CHAP’s processes compared to Dated: May 29, 2018.
sooner as we determine.
those of State agencies, including survey Seema Verma,
The Community Health Accreditation
Partner’s (CHAP’s) term of approval for frequency, and the ability to investigate Administrator, Centers for Medicare &
its hospice accreditation program and respond appropriately to Medicaid Services.
expires November 20, 2018. complaints against accredited facilities. [FR Doc. 2018–12840 Filed 6–14–18; 8:45 am]
++ CHAP’s processes and procedures BILLING CODE 4120–01–P
II. Approval of Deeming Organizations for monitoring a hospice found out of
Section 1865(a)(2) of the Act and our compliance with CHAP’s program
regulations at § 488.5 require that our requirements. These monitoring DEPARTMENT OF HEALTH AND
findings concerning review and procedures are used only when CHAP HUMAN SERVICES
approval of a national accrediting identifies noncompliance. If
organization’s requirements consider, noncompliance is identified through Centers for Medicare & Medicaid
among other factors, the applying validation reviews, the State survey Services
accrediting organization’s requirements agency monitors corrections as specified [CMS–3363–N]
for accreditation; survey procedures; at § 488.9(c).
resources for conducting required ++ CHAP’s capacity to report Medicare Program; Meeting of the
surveys; capacity to furnish information deficiencies to the surveyed facilities Medicare Evidence Development and
for use in enforcement activities; and respond to the facility’s plan of Coverage Advisory Committee—
monitoring procedures for provider correction in a timely manner. August 22, 2018
entities found not in compliance with ++ CHAP’s capacity to provide CMS
with electronic data, and reports AGENCY: Centers for Medicare &
the conditions or requirements; and
necessary for effective validation and Medicaid Services (CMS), HHS.
ability to provide CMS with the
necessary data for validation. assessment of the organization’s survey ACTION: Notice of meeting.
Section 1865(a)(3)(A) of the Act process.
++ CHAP’s staff adequacy and other SUMMARY: This notice announces that a
further requires that we publish within
resources, and its financial viability. public meeting of the Medicare
60 days of receipt of an organization’s
++ CHAP’s capacity to adequately Evidence Development & Coverage
complete application, a notice
fund required surveys. Advisory Committee (MEDCAC)
identifying the national accrediting
++ CHAP’s policies with respect to (‘‘Committee’’) will be held on
body making the request, describing the
whether surveys are announced or Wednesday, August 22, 2018. This
nature of the request, and providing at
unannounced, to assure that surveys are meeting will focus on the state of
least a 30-day public comment period.
unannounced. evidence on Chimeric Antigen Receptor
We have 210 days from the receipt of a ++ CHAP’s agreement to provide (CAR) T-cell therapies that are approved
complete application to publish notice CMS with a copy of the most current by the Food and Drug Administration
of approval or denial of the application. accreditation survey together with any
The purpose of this proposed notice (FDA). We are seeking the MEDCAC’s
other information related to the survey recommendations regarding collection
is to inform the public of CHAP’s as we may require (including corrective
request for continued CMS approval of of patient reported outcomes (PRO) in
action plans). cancer clinical studies. The MEDCAC
its hospice accreditation program. This Upon completion of our evaluation,
notice also solicits public comment on will specifically focus on appraisal of
including evaluation of comments evidence-based PRO assessments to
whether CHAP’s requirements meet or received as a result of this proposed
exceed the Medicare conditions for provide information that impacts
notice, we will publish a final notice in patients, their providers, and caregivers
participation for hospices. the Federal Register announcing the after a CAR T-cell therapy intervention
III. Evaluation of Deeming Authority result of our evaluation. for the patient’s cancer. This meeting is
Request III. Collection of Information open to the public in accordance with
CHAP submitted all the necessary Requirements the Federal Advisory Committee Act.
materials to enable us to make a This document does not impose DATES:
determination concerning its request for information collection requirements, Meeting Date: The public meeting will
continued approval of its hospice that is, reporting, recordkeeping or be held on Wednesday, August 22, 2018
accreditation program. This application third-party disclosure requirements. from 7:30 a.m. until 4:30 p.m., Eastern
was determined to be complete on April Consequently, there is no need for Daylight Time (EDT).
24, 2018. Under section 1865(a)(2) of the Deadline for Submission of Written
sradovich on DSK3GMQ082PROD with NOTICES

review by the Office of Management and
Act and our regulations at § 488.5 Budget under the authority of the Comments: Written comments must be
(Application and re-application Paperwork Reduction Act of 1995 (44 received at the address specified in the
procedures for national organizations), U.S.C. 3501 et seq.). ADDRESSES section of this notice by 5:00
our review and evaluation of CHAP will p.m., EDT, Monday, July 16, 2018. Once
be conducted in accordance with, but IV. Response to Comments submitted, all comments are final.
not necessarily limited to, the following Because of the large number of public Deadlines for Speaker Registration
factors: comments we normally receive on and Presentation Materials: The

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Document Created: 2018-11-02 12:01:21
Document Modified: 2018-11-02 12:01:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Proposed notice.
Dates		To be assured consideration, comments must be received at one of
Contact		Lillian Williams, (410) 786-8636, Monda Shaver, (410) 786-3410, or Marie Vasbinder, (410) 786-8665.
FR Citation		83 FR 27992

83 FR 27992 - Medicare and Medicaid Programs: Application From the Community Health Accreditation Partner for Continued CMS Approval of Its Hospice Accreditation Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare and Medicaid Services

Federal Register Volume 83, Issue 116 (June 15, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services