Medicare and Medicaid Programs; Application From the Joint Commission (TJC) for Continued Approval of its Home Health Agency Accreditation Program, 57026-57028 [2019-23185]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 57026 Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment: 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Annual Eligibility Redetermination, Product Discontinuation and Renewal Notices; Use: Section 1411(f)(1)(B) of the Affordable Care Act directs the Secretary of Health and Human Services (the Secretary) to establish procedures to redetermine the eligibility of individuals on a periodic basis in appropriate circumstances. Section 1321(a) of the Affordable Care Act provides authority for the Secretary to establish standards and regulations to implement the statutory requirements related to Exchanges, qualified health plans (QHPs) and other components of title I of the Affordable Care Act. Under section 2703 of the Public Health Service Act (PHS Act), as added by the Affordable Care Act, and former section 2712 and section 2741 of the PHS Act, enacted by the Health Insurance Portability and Accountability Act of 1996, health insurance issuers in the group and individual markets must guarantee the renewability of coverage unless an exception applies. The final rule ‘‘Patient Protection and Affordable Care Act; Annual Eligibility Redeterminations for Exchange Participation and Insurance Affordability Programs; Health Insurance Issuer Standards Under the Affordable Care Act, Including Standards Related to Exchanges’’ (79 FR 52994), provides that an Exchange may choose to conduct the annual redetermination process for a plan year (1) in accordance with the existing procedures described in 45 CFR 155.335; (2) in accordance with procedures described in guidance issued by the Secretary for the coverage year; or (3) using an alternative proposed by the Exchange and approved by the Secretary. The final rule also amends the requirements for product renewal and re-enrollment (or nonrenewal) notices to be sent by QHP issuers in the Exchanges and specifies content for these notices. Form Number: CMS–10527 (OMB control number 0938–1254); Frequency: Annually; Affected Public: Private Sector, State Governments; Number of Respondents: 1,805; Total Annual Responses: 7,420; Total Annual Hours: 90,331. (For policy VerDate Sep<11>2014 17:34 Oct 23, 2019 Jkt 250001 questions regarding this collection contact Usree Bandyopadhyay at 410– 786–6650.) Dated: October 18, 2019. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2019–23143 Filed 10–23–19; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3384–PN] Medicare and Medicaid Programs; Application From the Joint Commission (TJC) for Continued Approval of its Home Health Agency Accreditation Program Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed notice. AGENCY: This proposed notice acknowledges the receipt of an application from The Joint Commission (TJC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization’s complete application, the Centers for Medicare and Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on November 25, 2019. ADDRESSES: In commenting, please refer to file code CMS–3384–PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to https://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–3384–PN, P.O. Box 8016, Baltimore, MD 21244–8010. SUMMARY: PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 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–3384–PN, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. 4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses: a. For delivery in Washington, DC— Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) b. For delivery in Baltimore, MD— Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244–1850. If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786– 7195 in advance to schedule your arrival with one of our staff members. Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Sharon Lash (410) 786–9457. Caecilia Blondiaux (410) 786–2190. 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: https:// www.regulations.gov. Follow the search instructions on that website to view public comments. E:\FR\FM\24OCN1.SGM 24OCN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices 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 an entity 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 facilities 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 the conditions or requirements set forth in 42 CFR 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 body’s approved program would 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 § 488.5. The regulations at § 488.5(e)(2)(i) require accrediting organizations to reapply for continued approval of their accreditation program every 6 years or sooner as determined by CMS. VerDate Sep<11>2014 17:34 Oct 23, 2019 Jkt 250001 The Joint Commission’s (TJC’s) term of approval for their HHA accreditation program expires March 31, 2020. II. Approval of Deeming Organizations Section 1865(a)(2) of the Act and our regulations at § 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 us 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 TJC’s request for continued approval for its HHA accreditation program. This notice also solicits public comment on whether TJC’s requirements meet or exceed the Medicare conditions of participation (CoPs) for HHAs. III. Evaluation of Deeming Authority Request TJC submitted all the necessary materials to enable us to make a determination concerning its request for continued approval of its HHA accreditation program. This application was determined to be complete on July 15, 2019. Under section 1865(a)(2) of the Act and our regulations at § 488.5 (Application and re-application procedures for national accrediting organizations), our review and evaluation of TJC will be conducted in accordance with, but not necessarily limited to, the following factors: • The equivalency of TJC’s standards for HHAs as compared with CMS’ HHA CoPs. • TJC’s survey process to determine the following: ++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training. ++ The comparability of TJC’s processes to those of state agencies, including survey frequency, and the PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 57027 ability to investigate and respond appropriately to complaints against accredited HHAs. ++ TJC’s processes and procedures for monitoring HHAs found out of compliance with TJC’s program requirements. These monitoring procedures are used only when TJC identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the state survey agency monitors corrections as specified at § 488.9(c). ++ TJC’s capacity to report deficiencies to the surveyed HHAs and respond to the HHA’s plan of correction in a timely manner. ++ TJC’s capacity to provide us with electronic data and reports necessary for effective validation and assessment of the organization’s survey process. ++ The adequacy of TJC’s staff and other resources, and its financial viability. ++ TJC’s capacity to adequately fund required surveys. ++ TJC’s policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced. ++ TJC’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. ++ TJC’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). IV. Collection of Information Requirements This document does not impose information collection requirements, that is reporting, recordkeeping or thirdparty disclosure requirements. Consequently, there is no need for review by the Office 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 notice. Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the Federal E:\FR\FM\24OCN1.SGM 24OCN1 57028 Federal Register / Vol. 84, No. 206 / Thursday, October 24, 2019 / Notices Register summarizing our response to comments and announcing the result of our evaluation. Dated: September 26, 2019. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2019–23185 Filed 10–23–19; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–4467] Breast Implants—Certain Labeling Recommendations To Improve Patient Communication; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Breast Implants— Certain Labeling Recommendations to Improve Patient Communication.’’ This draft guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gelfilled breast implants. FDA is seeking comments on all aspects of the draft guidance, including the respective benefits and risks of smooth and textured breast implants and applicability of the recommendations to both types. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by December 23, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a VerDate Sep<11>2014 17:34 Oct 23, 2019 Jkt 250001 third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2019–D–4467 for ‘‘Breast Implants— Certain Labeling Recommendations to Improve Patient Communication.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Breast Implants— Certain Labeling Recommendations to Improve Patient Communication’’ to the Office of Policy, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Cynthia Chang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4646, Silver Spring, MD 20993–0002, 301–796–6891. SUPPLEMENTARY INFORMATION: I. Background Over the past few years, FDA has received new information pertaining to risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma and systemic symptoms commonly referred to as breast implant illness that some patients attribute to their implants. FDA has taken several steps to better understand and address risks associated with breast implants, including convening the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on March E:\FR\FM\24OCN1.SGM 24OCN1

Agencies

[Federal Register Volume 84, Number 206 (Thursday, October 24, 2019)]
[Notices]
[Pages 57026-57028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23185]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3384-PN]


Medicare and Medicaid Programs; Application From the Joint 
Commission (TJC) for Continued Approval of its Home Health Agency 
Accreditation Program

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

ACTION: Proposed notice.

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

SUMMARY: This proposed notice acknowledges the receipt of an 
application from The Joint Commission (TJC) for continued recognition 
as a national accrediting organization for home health agencies (HHAs) 
that wish to participate in the Medicare or Medicaid programs. The 
statute requires that within 60 days of receipt of an organization's 
complete application, the Centers for Medicare and Medicaid Services 
(CMS) publish a notice that identifies the national accrediting body 
making the request, describes the nature of the request, and provides 
at least a 30-day public comment period.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on November 25, 
2019.

ADDRESSES: In commenting, please refer to file code CMS-3384-PN. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://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-3384-PN, 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 following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-3384-PN, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments before the close of the comment period 
to either of the following addresses:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-7195 in advance to schedule your 
arrival with one of our staff members.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Sharon Lash (410) 786-9457.
    Caecilia Blondiaux (410) 786-2190.

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: https://www.regulations.gov. Follow the search instructions on that website to 
view public comments.

[[Page 57027]]

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 an entity 
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 facilities 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 the conditions or requirements set forth in 42 CFR 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 body's approved program would 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. The regulations at Sec.  
488.5(e)(2)(i) require accrediting organizations to reapply for 
continued approval of their accreditation program every 6 years or 
sooner as determined by CMS.
    The Joint Commission's (TJC's) term of approval for their HHA 
accreditation program expires March 31, 2020.

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 us 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 
TJC's request for continued approval for its HHA accreditation program. 
This notice also solicits public comment on whether TJC's requirements 
meet or exceed the Medicare conditions of participation (CoPs) for 
HHAs.

III. Evaluation of Deeming Authority Request

    TJC submitted all the necessary materials to enable us to make a 
determination concerning its request for continued approval of its HHA 
accreditation program. This application was determined to be complete 
on July 15, 2019. Under section 1865(a)(2) of the Act and our 
regulations at Sec.  488.5 (Application and re-application procedures 
for national accrediting organizations), our review and evaluation of 
TJC will be conducted in accordance with, but not necessarily limited 
to, the following factors:
     The equivalency of TJC's standards for HHAs as compared 
with CMS' HHA CoPs.
     TJC's survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
the ability of the organization to provide continuing surveyor 
training.
    ++ The comparability of TJC's processes to those of state agencies, 
including survey frequency, and the ability to investigate and respond 
appropriately to complaints against accredited HHAs.
    ++ TJC's processes and procedures for monitoring HHAs found out of 
compliance with TJC's program requirements. These monitoring procedures 
are used only when TJC identifies noncompliance. If noncompliance is 
identified through validation reviews or complaint surveys, the state 
survey agency monitors corrections as specified at Sec.  488.9(c).
    ++ TJC's capacity to report deficiencies to the surveyed HHAs and 
respond to the HHA's plan of correction in a timely manner.
    ++ TJC's capacity to provide us with electronic data and reports 
necessary for effective validation and assessment of the organization's 
survey process.
    ++ The adequacy of TJC's staff and other resources, and its 
financial viability.
    ++ TJC's capacity to adequately fund required surveys.
    ++ TJC's policies with respect to whether surveys are announced or 
unannounced, to assure that surveys are unannounced.
    ++ TJC'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.
    ++ TJC'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).

IV. 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 
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 notice.
    Upon completion of our evaluation, including evaluation of comments 
received as a result of this notice, we will publish a final notice in 
the Federal

[[Page 57028]]

Register summarizing our response to comments and announcing the result 
of our evaluation.

    Dated: September 26, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-23185 Filed 10-23-19; 8:45 am]
BILLING CODE 4120-01-P
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