Medicare and Medicaid Programs; Approval of the Community Health Accreditation Partner for Continued CMS Approval of Its Home Health Agency Program, 12769-12770 [2018-05891]

Download as PDF 12769 Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Notices police departments, sheriff’s departments, or similar governmental organizations throughout the continental United States. One thousand five LEO volunteers will participate in the study over three years, with a study goal of obtaining complete anthropometric assessment of 1,000 LEOs. Information collection for each respondent is expected to take no longer than 63 minutes (total) to complete. Participation is voluntary and there are no costs to the respondents other than their time. The total estimated annualized burden hours are 353. ESTIMATED ANNUALIZED BURDEN HOURS Type of respondents Form name Law Enforcement Officers .............................. Law Enforcement Officers .............................. Law Enforcement Officers .............................. Biographical Information ................................ Data Sheet ..................................................... Assessment of Challenges in Vehicle and with Body Armor. Two-dimensional Hand Scan and Three-dimensional Body Scans. Law Enforcement Officers .............................. Leroy Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2018–05911 Filed 3–22–18; 8:45 am] BILLING CODE 4163–18–P 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 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: 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: amozie on DSK30RV082PROD with NOTICES SUMMARY: 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 VerDate Sep<11>2014 21:54 Mar 22, 2018 Jkt 244001 Number of respondents 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Number of responses per respondent Average burden per response (in hours) 335 335 335 1 1 1 3/60 25/60 5/60 335 1 30/60 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 § 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 CMSapproval 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 30day 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 § 488.5, we E:\FR\FM\23MRN1.SGM 23MRN1 amozie on DSK30RV082PROD with NOTICES 12770 Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Notices 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 noncompliance is identified by a state survey agency through a validation survey, the state survey agency monitors corrections as specified at § 488.9(c)➢ ++ 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 VerDate Sep<11>2014 21:54 Mar 22, 2018 Jkt 244001 exceeded the Medicare CoPs for HHAs. There were no comments submitted. V. Collection of Information Requirements IV. Provisions of the Final Notice 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). 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: • § 488.5(a)(4)(vii), to ensure plans of corrections (PoCs) address all noncompliant practices and include policy changes required to correct the deficient practice. • § 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. • § 488.5(a)(12), to ensure the appropriate number of medical records are reviewed during complaint investigations. • § 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. PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–2397–FN] RIN–0938–ZB29 Medicaid Program; Announcement of Medicaid Drug Rebate Program National Rebate Agreement Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final notice. AGENCY: This final notice announces changes to the Medicaid National Drug Rebate Agreement (NDRA, or Agreement) for use by the Secretary of the Department of Health and Human Services (HHS) and manufacturers under the Medicaid Drug Rebate Program (MDRP). We are updating the NDRA to incorporate legislative and regulatory changes that have occurred since the Agreement was published in the February 21, 1991 Federal Register (56 FR 7049). We are also updating the NDRA to make editorial and structural revisions, such as references to the updated Office of Management and Budget (OMB)-approved data collection forms and electronic data reporting. DATES: Applicability Date: The updated National Medicaid Drug Rebate Agreement (NDRA) provided in the Addendum to this final notice will be applicable on March 23, 2018. Compliance Date: Publication of CMS–2397–FN serves as written notice of good cause to terminate all existing rebate agreements as of the first day of the full calendar quarter which begins at least 6 months after the effective date of the updated NDRA (October 1, 2018). Manufacturers with an existing active SUMMARY: E:\FR\FM\23MRN1.SGM 23MRN1

Agencies

[Federal Register Volume 83, Number 57 (Friday, March 23, 2018)]
[Notices]
[Pages 12769-12770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
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