83_FR_12826 83 FR 12769 - Medicare and Medicaid Programs; Approval of the Community Health Accreditation Partner for Continued CMS Approval of Its Home Health Agency Program

83 FR 12769 - Medicare and Medicaid Programs; Approval of the Community Health Accreditation Partner for Continued CMS Approval of Its Home Health Agency Program

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

Federal Register Volume 83, Issue 57 (March 23, 2018)

Page Range12769-12770
FR Document2018-05891

This notice announces our decision to approve the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs.

Federal Register, Volume 83 Issue 57 (Friday, March 23, 2018)
[Federal Register Volume 83, Number 57 (Friday, March 23, 2018)]
[Notices]
[Pages 12769-12770]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05891]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3349-FN]


Medicare and Medicaid Programs; Approval of the Community Health 
Accreditation Partner for Continued CMS Approval of Its Home Health 
Agency Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice announces our decision to approve the Community 
Health Accreditation Partner (CHAP) for continued recognition as a 
national accrediting organization for home health agencies (HHAs) that 
wish to participate in the Medicare or Medicaid programs.

DATES: This notice is applicable March 31, 2018 through March 31, 2024.

FOR FURTHER INFORMATION CONTACT: Lillian Williams (410) 786-8636, Monda 
Shaver, (410) 786-3410, or Patricia Chmielewski (410) 786-6899.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under the Medicare program, eligible beneficiaries may receive 
covered services from a home health agency (HHA) provided certain 
requirements are met. Sections 1861(m) and (o), 1891, and 1895 of the 
Social Security Act (the Act) establish distinct criteria for entities 
seeking designation as an HHA. Regulations concerning provider 
agreements are at 42 CFR part 489 and those pertaining to activities 
relating to the survey and certification of agencies and other entities 
are at 42 CFR part 488. The regulations at 42 CFR parts 409 and 484 
specify the conditions that an HHA must meet to participate in the 
Medicare program, the scope of covered services and the conditions for 
Medicare payment for home health care.
    Generally, to enter into a provider agreement with the Medicare 
program, an HHA must first be certified by a state survey agency as 
complying with conditions or requirements set forth in part 484 of our 
regulations. Thereafter, the HHA 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 
Health and Human Services as having standards for accreditation that 
meet or exceed Medicare requirements, any provider entity accredited by 
the national accrediting organization's approved program may be deemed 
to meet the Medicare conditions. A national accrediting organization 
applying for CMS approval of their accreditation program under 42 CFR 
part 488, subpart A, must provide CMS with reasonable assurance that 
the accrediting organization requires the accredited provider entities 
to meet requirements that are at least as stringent as the Medicare 
conditions. Our regulations concerning the approval of accrediting 
organizations are set forth at Sec.  488.5. Section 488.5(e)(2)(i) 
requires accrediting organizations to reapply for continued approval of 
its Medicare accreditation program every 6 years or sooner as 
determined by CMS. The Community Health Accreditation Partner's 
(CHAP'S) term of approval as a recognized accreditation program for 
HHAs expires March 31, 2018.

II. Approval of Accreditation Organizations

    Section 1865(a)(3)(A) of the Act provides a statutory timetable to 
ensure that our review of applications for CMS-approval of an 
accreditation program is conducted in a timely manner. The Act provides 
us 210 days after the date of receipt of a complete application, with 
any documentation necessary to make the determination, to complete our 
survey activities and application process. Within 60 days of receiving 
a completed application, we must publish a notice in the Federal 
Register that identifies the national accrediting body making the 
request, describes the request, and provides no less than a 30-day 
public comment period. At the end of the 210-day period, we must 
publish a notice in the Federal Register approving or denying the 
application.

III. Proposed Notice

    On October 20, 2017, we published a proposed notice in the Federal 
Register (82 FR 48817) announcing CHAP's request for continued approval 
of its Medicare HHA accreditation program. In the proposed notice, we 
detailed our evaluation criteria. Under section 1865(a)(2) of the Act 
and Sec.  488.5, we

[[Page 12770]]

conducted a review of CHAP's Medicare HHA application in accordance 
with the criteria specified by our regulations, which include, but are 
not limited to the following:
     An onsite administrative review of CHAP's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its surveyors; (4) ability to investigate and respond 
appropriately to complaints against HHAs; and (5) survey review and 
decision-making process for accreditation;
     A comparison of CHAP's HHA accreditation standards to our 
current Medicare HHA conditions for participation (CoPs);
     A documentation review of CHAP's survey processes to:
    ++ Determine the composition of the survey team, surveyor 
qualifications, and CHAP's ability to provide continuing surveyor 
training.
    ++ Compare CHAP's processes to those we require of state survey 
agencies, including periodic resurvey and the ability to investigate 
and respond appropriately to complaints against accredited HHAs.
    ++ Evaluate CHAP's procedures for monitoring HHAs found to be out 
of compliance with CHAP program requirements. This pertains only to 
monitoring procedures when CHAP identifies non-compliance. If non-
compliance is identified by a state survey agency through a validation 
survey, the state survey agency monitors corrections as specified at 
Sec.  488.9(c)[rtarr8]
    ++ Assess CHAP's ability to report deficiencies to the surveyed 
HHAs and respond to the HHA's plan of correction in a timely manner.
    ++ Establish CHAP's ability to provide CMS with electronic data and 
reports necessary for effective validation and assessment of the 
organization's survey process.
    ++ Determine the adequacy of CHAP's staff and other resources.
    ++ Confirm CHAP's ability to provide adequate funding for the 
completion of required surveys.
    ++ Confirm CHAP's policies for surveys being unannounced.
    ++ Obtain CHAP's agreement to provide us 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.
    In accordance with section 1865(a)(3)(A) of the Act, the October 
20, 2017 proposed notice (82 FR 48817) also solicited public comments 
regarding whether CHAP's requirements met or exceeded the Medicare CoPs 
for HHAs. There were no comments submitted.

IV. Provisions of the Final Notice

A. Differences Between CHAP's Standards and Requirements for 
Accreditation and Medicare Conditions of Participation and Survey 
Requirements

    We compared CHAP's accreditation requirements for HHAs and its 
survey process with the Medicare CoPs at 42 CFR part 484, and the 
survey and certification process requirements of 42 CFR parts 488 and 
489. CHAP's standards crosswalk, which crosswalks CHAP standards to the 
corresponding Medicare requirements and regulations, was also examined 
to ensure that the appropriate CMS regulation would be included in 
citations as appropriate. Our review and evaluation of CHAP's HHA 
application, which were conducted as described in section III. of this 
final notice, yielded the following areas where, as of the date of this 
notice, CHAP has revised its survey processes so that its processes are 
comparable to CMS requirements:
     Sec.  488.5(a)(4)(vii), to ensure plans of corrections 
(PoCs) address all non-compliant practices and include policy changes 
required to correct the deficient practice.
     Sec.  488.5(a)(7) through (9), to ensure surveyors 
maintain current licensure, that new surveyors receive the minimum 
number of mentored surveys prior to surveying independently, and that 
all new surveyors receive a 90-day evaluation of performance.
     Sec.  488.5(a)(12), to ensure the appropriate number of 
medical records are reviewed during complaint investigations.
     Sec.  488.26(b), to ensure that survey documentation 
includes a detailed deficiency statement that clearly outlines the 
number of medical records reviewed, describes the manner and degree of 
non-compliance, and supports the appropriate level of deficiency 
citation.

B. Term of Approval

    Based on the review and observations described in section III. of 
this final notice, we have determined that CHAP's requirements for HHAs 
meet or exceed our requirements. Therefore, we approve CHAP as a 
national accreditation organization for HHAs that request participation 
in the Medicare program, effective March 31, 2018 through March 31, 
2024.

V. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, record keeping 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. 35).

    Dated: March 8, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-05891 Filed 3-22-18; 8:45 am]
 BILLING CODE 4120-01-P



                                                                               Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Notices                                                          12769

                                             police departments, sheriff’s                              the study over three years, with a study                           than 63 minutes (total) to complete.
                                             departments, or similar governmental                       goal of obtaining complete                                         Participation is voluntary and there are
                                             organizations throughout the                               anthropometric assessment of 1,000                                 no costs to the respondents other than
                                             continental United States. One thousand                    LEOs. Information collection for each                              their time. The total estimated
                                             five LEO volunteers will participate in                    respondent is expected to take no longer                           annualized burden hours are 353.

                                                                                                       ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                            Average
                                                                                                                                                                                          Number of
                                                                   Type of                                                                                                 Number of                      burden per
                                                                                                                              Form name                                                 responses per
                                                                 respondents                                                                                              respondents                      response
                                                                                                                                                                                          respondent       (in hours)

                                             Law Enforcement Officers ..............................   Biographical Information ................................                  335                1            3/60
                                             Law Enforcement Officers ..............................   Data Sheet .....................................................           335                1           25/60
                                             Law Enforcement Officers ..............................   Assessment of Challenges in Vehicle and                                    335                1            5/60
                                                                                                         with Body Armor.
                                             Law Enforcement Officers ..............................   Two-dimensional Hand Scan and Three-di-                                    335                1           30/60
                                                                                                         mensional Body Scans.



                                             Leroy Richardson,                                          Act) establish distinct criteria for                               with reasonable assurance that the
                                             Chief, Information Collection Review Office,               entities seeking designation as an HHA.                            accrediting organization requires the
                                             Office of Scientific Integrity, Office of the              Regulations concerning provider                                    accredited provider entities to meet
                                             Associate Director for Science, Office of the              agreements are at 42 CFR part 489 and                              requirements that are at least as
                                             Director, Centers for Disease Control and                  those pertaining to activities relating to                         stringent as the Medicare conditions.
                                             Prevention.                                                the survey and certification of agencies                           Our regulations concerning the approval
                                             [FR Doc. 2018–05911 Filed 3–22–18; 8:45 am]                and other entities are at 42 CFR part                              of accrediting organizations are set forth
                                             BILLING CODE 4163–18–P                                     488. The regulations at 42 CFR parts 409                           at § 488.5. Section 488.5(e)(2)(i) requires
                                                                                                        and 484 specify the conditions that an                             accrediting organizations to reapply for
                                                                                                        HHA must meet to participate in the                                continued approval of its Medicare
                                             DEPARTMENT OF HEALTH AND                                   Medicare program, the scope of covered                             accreditation program every 6 years or
                                             HUMAN SERVICES                                             services and the conditions for Medicare                           sooner as determined by CMS. The
                                                                                                        payment for home health care.                                      Community Health Accreditation
                                             Centers for Medicare & Medicaid                               Generally, to enter into a provider                             Partner’s (CHAP’S) term of approval as
                                             Services                                                   agreement with the Medicare program,                               a recognized accreditation program for
                                             [CMS–3349–FN]                                              an HHA must first be certified by a state                          HHAs expires March 31, 2018.
                                                                                                        survey agency as complying with
                                             Medicare and Medicaid Programs;                            conditions or requirements set forth in                            II. Approval of Accreditation
                                             Approval of the Community Health                           part 484 of our regulations. Thereafter,                           Organizations
                                             Accreditation Partner for Continued                        the HHA is subject to regular surveys by                              Section 1865(a)(3)(A) of the Act
                                             CMS Approval of Its Home Health                            a state survey agency to determine                                 provides a statutory timetable to ensure
                                             Agency Program                                             whether it continues to meet these                                 that our review of applications for CMS-
                                                                                                        requirements.                                                      approval of an accreditation program is
                                             AGENCY: Centers for Medicare &                                However, there is an alternative to                             conducted in a timely manner. The Act
                                             Medicaid Services (CMS), HHS.                              surveys by state agencies. Section                                 provides us 210 days after the date of
                                             ACTION: Notice.                                            1865(a)(1) of the Act provides that, if a                          receipt of a complete application, with
                                                                                                        provider entity demonstrates through                               any documentation necessary to make
                                             SUMMARY:  This notice announces our
                                                                                                        accreditation by an approved national                              the determination, to complete our
                                             decision to approve the Community
                                                                                                        accrediting organization that all                                  survey activities and application
                                             Health Accreditation Partner (CHAP) for
                                                                                                        applicable Medicare conditions are met                             process. Within 60 days of receiving a
                                             continued recognition as a national
                                                                                                        or exceeded, we will deem those                                    completed application, we must publish
                                             accrediting organization for home health
                                                                                                        provider entities as having met the                                a notice in the Federal Register that
                                             agencies (HHAs) that wish to participate
                                                                                                        requirements. Accreditation by an                                  identifies the national accrediting body
                                             in the Medicare or Medicaid programs.
                                                                                                        accrediting organization is voluntary                              making the request, describes the
                                             DATES: This notice is applicable March                     and is not required for Medicare                                   request, and provides no less than a 30-
                                             31, 2018 through March 31, 2024.                           participation.                                                     day public comment period. At the end
                                             FOR FURTHER INFORMATION CONTACT:                              If an accrediting organization is                               of the 210-day period, we must publish
                                             Lillian Williams (410) 786–8636, Monda                     recognized by the Secretary of Health                              a notice in the Federal Register
                                             Shaver, (410) 786–3410, or Patricia                        and Human Services as having                                       approving or denying the application.
                                             Chmielewski (410) 786–6899.                                standards for accreditation that meet or
                                             SUPPLEMENTARY INFORMATION:                                 exceed Medicare requirements, any                                  III. Proposed Notice
                                                                                                        provider entity accredited by the                                     On October 20, 2017, we published a
                                             I. Background
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                                                                                                        national accrediting organization’s                                proposed notice in the Federal Register
                                               Under the Medicare program, eligible                     approved program may be deemed to                                  (82 FR 48817) announcing CHAP’s
                                             beneficiaries may receive covered                          meet the Medicare conditions. A                                    request for continued approval of its
                                             services from a home health agency                         national accrediting organization                                  Medicare HHA accreditation program.
                                             (HHA) provided certain requirements                        applying for CMS approval of their                                 In the proposed notice, we detailed our
                                             are met. Sections 1861(m) and (o), 1891,                   accreditation program under 42 CFR                                 evaluation criteria. Under section
                                             and 1895 of the Social Security Act (the                   part 488, subpart A, must provide CMS                              1865(a)(2) of the Act and § 488.5, we


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                                             12770                           Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Notices

                                             conducted a review of CHAP’s Medicare                   exceeded the Medicare CoPs for HHAs.                  V. Collection of Information
                                             HHA application in accordance with the                  There were no comments submitted.                     Requirements
                                             criteria specified by our regulations,                                                                          This document does not impose
                                             which include, but are not limited to the               IV. Provisions of the Final Notice
                                                                                                                                                           information collection requirements,
                                             following:                                              A. Differences Between CHAP’s                         that is, reporting, record keeping or
                                                • An onsite administrative review of                 Standards and Requirements for                        third-party disclosure requirements.
                                             CHAP’s: (1) Corporate policies; (2)                     Accreditation and Medicare Conditions                 Consequently, there is no need for
                                             financial and human resources available                 of Participation and Survey                           review by the Office of Management and
                                             to accomplish the proposed surveys; (3)                 Requirements                                          Budget under the authority of the
                                             procedures for training, monitoring, and                                                                      Paperwork Reduction Act of 1995 (44
                                             evaluation of its surveyors; (4) ability to                We compared CHAP’s accreditation                   U.S.C. 35).
                                             investigate and respond appropriately to                requirements for HHAs and its survey
                                             complaints against HHAs; and (5)                        process with the Medicare CoPs at 42                    Dated: March 8, 2018.
                                             survey review and decision-making                       CFR part 484, and the survey and                      Seema Verma,
                                             process for accreditation;                              certification process requirements of 42              Administrator, Centers for Medicare &
                                                • A comparison of CHAP’s HHA                         CFR parts 488 and 489. CHAP’s                         Medicaid Services.
                                             accreditation standards to our current                  standards crosswalk, which crosswalks                 [FR Doc. 2018–05891 Filed 3–22–18; 8:45 am]
                                             Medicare HHA conditions for                             CHAP standards to the corresponding                   BILLING CODE 4120–01–P
                                             participation (CoPs);                                   Medicare requirements and regulations,
                                                • A documentation review of CHAP’s                   was also examined to ensure that the
                                             survey processes to:                                    appropriate CMS regulation would be                   DEPARTMENT OF HEALTH AND
                                                ++ Determine the composition of the                  included in citations as appropriate.                 HUMAN SERVICES
                                             survey team, surveyor qualifications,                   Our review and evaluation of CHAP’s
                                             and CHAP’s ability to provide                                                                                 Centers for Medicare & Medicaid
                                                                                                     HHA application, which were                           Services
                                             continuing surveyor training.                           conducted as described in section III. of
                                                ++ Compare CHAP’s processes to                       this final notice, yielded the following              [CMS–2397–FN]
                                             those we require of state survey                        areas where, as of the date of this notice,           RIN–0938–ZB29
                                             agencies, including periodic resurvey                   CHAP has revised its survey processes
                                             and the ability to investigate and                      so that its processes are comparable to               Medicaid Program; Announcement of
                                             respond appropriately to complaints                     CMS requirements:                                     Medicaid Drug Rebate Program
                                             against accredited HHAs.
                                                                                                        • § 488.5(a)(4)(vii), to ensure plans of           National Rebate Agreement
                                                ++ Evaluate CHAP’s procedures for
                                                                                                     corrections (PoCs) address all non-                   AGENCY:  Centers for Medicare &
                                             monitoring HHAs found to be out of
                                                                                                     compliant practices and include policy                Medicaid Services (CMS), HHS.
                                             compliance with CHAP program
                                                                                                     changes required to correct the deficient
                                             requirements. This pertains only to                                                                           ACTION: Final notice.
                                             monitoring procedures when CHAP                         practice.
                                             identifies non-compliance. If non-                         • § 488.5(a)(7) through (9), to ensure             SUMMARY:   This final notice announces
                                             compliance is identified by a state                     surveyors maintain current licensure,                 changes to the Medicaid National Drug
                                             survey agency through a validation                      that new surveyors receive the                        Rebate Agreement (NDRA, or
                                             survey, the state survey agency monitors                minimum number of mentored surveys                    Agreement) for use by the Secretary of
                                             corrections as specified at § 488.9(c)➢                 prior to surveying independently, and                 the Department of Health and Human
                                                ++ Assess CHAP’s ability to report                   that all new surveyors receive a 90-day               Services (HHS) and manufacturers
                                             deficiencies to the surveyed HHAs and                   evaluation of performance.                            under the Medicaid Drug Rebate
                                             respond to the HHA’s plan of correction                    • § 488.5(a)(12), to ensure the                    Program (MDRP). We are updating the
                                             in a timely manner.                                     appropriate number of medical records                 NDRA to incorporate legislative and
                                                ++ Establish CHAP’s ability to                       are reviewed during complaint                         regulatory changes that have occurred
                                             provide CMS with electronic data and                    investigations.                                       since the Agreement was published in
                                             reports necessary for effective validation                                                                    the February 21, 1991 Federal Register
                                             and assessment of the organization’s                       • § 488.26(b), to ensure that survey               (56 FR 7049). We are also updating the
                                             survey process.                                         documentation includes a detailed                     NDRA to make editorial and structural
                                                ++ Determine the adequacy of                         deficiency statement that clearly                     revisions, such as references to the
                                             CHAP’s staff and other resources.                       outlines the number of medical records                updated Office of Management and
                                                ++ Confirm CHAP’s ability to provide                 reviewed, describes the manner and                    Budget (OMB)-approved data collection
                                             adequate funding for the completion of                  degree of non-compliance, and supports                forms and electronic data reporting.
                                             required surveys.                                       the appropriate level of deficiency                   DATES:
                                                ++ Confirm CHAP’s policies for                       citation.                                               Applicability Date: The updated
                                             surveys being unannounced.                              B. Term of Approval                                   National Medicaid Drug Rebate
                                                ++ Obtain CHAP’s agreement to                                                                              Agreement (NDRA) provided in the
                                             provide us with a copy of the most                        Based on the review and observations                Addendum to this final notice will be
                                             current accreditation survey together                   described in section III. of this final               applicable on March 23, 2018.
                                             with any other information related to                   notice, we have determined that CHAP’s                  Compliance Date: Publication of
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                                             the survey as we may require, including                 requirements for HHAs meet or exceed                  CMS–2397–FN serves as written notice
                                             corrective action plans.                                our requirements. Therefore, we                       of good cause to terminate all existing
                                                In accordance with section                           approve CHAP as a national                            rebate agreements as of the first day of
                                             1865(a)(3)(A) of the Act, the October 20,               accreditation organization for HHAs that              the full calendar quarter which begins at
                                             2017 proposed notice (82 FR 48817) also                 request participation in the Medicare                 least 6 months after the effective date of
                                             solicited public comments regarding                     program, effective March 31, 2018                     the updated NDRA (October 1, 2018).
                                             whether CHAP’s requirements met or                      through March 31, 2024.                               Manufacturers with an existing active


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Document Created: 2018-11-01 08:54:20
Document Modified: 2018-11-01 08:54:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThis notice is applicable March 31, 2018 through March 31, 2024.
ContactLillian Williams (410) 786-8636, Monda Shaver, (410) 786-3410, or Patricia Chmielewski (410) 786-6899.
FR Citation83 FR 12769 

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