Medicare Program; Approval of Application by the Utilization Review Accreditation Commission for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program, 18243-18245 [2020-06795]

Download as PDF Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Notices insurance issuers. Nominations should be sent to the email or mailing address listed below. Acknowledgement of submissions will be provided within a week of submission. DATES: Letters of nomination and re´sume´s should be submitted no later than May 13, 2020, to ensure adequate opportunity for review and consideration of nominees prior to appointment. ADDRESSES: Submit letters of nomination and re´sume´s by either of the following methods: Email: PCORI@gao.gov. Include PCORI Nominations in the subject line of the message, or Mail: U.S. GAO, Attn: PCORI Nominations, 441 G Street NW, Washington, DC 20548. FOR FURTHER INFORMATION CONTACT: Ray Sendejas at (202) 512–7113 or sendejasr@gao.gov if you do not receive an acknowledgement or need additional information. For general information, contact GAO’s Office of Public Affairs, (202) 512–4800. Authority: Sec. 6301 and Sec. 10602, Pub. L. 111–148, 124 Stat. 119, 727, 1005 (2010); Div. N, Sec. 104, Pub. L. 116–94, 133 Stat. 2534 (2019). Gene L. Dodaro, Comptroller General of the United States. [FR Doc. 2020–06313 Filed 3–31–20; 8:45 am] BILLING CODE 1610–02–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention jbell on DSKJLSW7X2PROD with NOTICES 18:31 Mar 31, 2020 Jkt 250001 which was published in the Federal Register on March 4, 2020, Volume 85, Number 43, pages 12786–12787. The meeting is being amended to a virtual meeting with a meeting time of 9:30 a.m.–5:30 p.m., EDT. The meeting is closed to the public. FOR FURTHER INFORMATION CONTACT: Kimberly Leeks, Ph.D., M.P.H., Scientific Review Official, NCIPC, CDC, 4770 Buford Highway NE, Building 106, MS S106–9, Atlanta, Georgia 30341, telephone: (770) 488–6562; KLeeks@ cdc.gov. 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Centers for Medicare & Medicaid Services BILLING CODE 4163–18–P Notice is hereby given of a change in the meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)—GH20– 001, Develop, Implement, and Evaluate Evidence-Based, Innovative Approaches to Prevent, Find, and Cure Tuberculosis in High-Burden Settings; GH20–002, VerDate Sep<11>2014 Malaria Operations Research to Improve Malaria Control and Reduce Morbidity and Mortality in Western Kenya; GH20– 003, Conducting Public Health Research in Colombia; GH20–004, Conducting Public Health Research in Georgia; and GH20–005, Conducting Public Health Research in South America; April 14– 16, 2020, 9:00 a.m.– 2:00 p.m., EDT, in the original FRN. Teleconference, which was published in the Federal Register on March 16, 2020, Vol. 85, No. 51, page 14946. The meeting is being amended to change the meeting dates and times to: April 14–15, 2020, from 9:00 a.m.–2:00 p.m., EDT; and April 16, 2020, from 9:30 a.m.–2:30 p.m., EDT. The meeting is closed to the public. FOR FURTHER INFORMATION CONTACT: Hylan Shoob, Ph.D., Scientific Review Officer, Center for Global Health, CDC, 1600 Clifton Road NE, Atlanta, Georgia 30329–4027, Telephone (404) 639–4796; HShoob@cdc.gov. The Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. [FR Doc. 2020–06780 Filed 3–31–20; 8:45 am] Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP) GH20–001, Develop, Implement, and Evaluate Evidence-Based, Innovative Approaches To Prevent, Find, and Cure Tuberculosis in High-Burden Settings; GH20–002, Malaria Operations Research To Improve Malaria Control and Reduce Morbidity and Mortality in Western Kenya; GH20– 003, Conducting Public Health Research in Colombia; GH20–004, Conducting Public Health Research in Georgia; and GH20–005, Conducting Public Health Research in South America; Amended Notice of Meeting 18243 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)—TS–20–001, Identify and Evaluate Potential Risk Factors for Amyotrophic Lateral Sclerosis; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)—RFA– TS–20–001, Identify and Evaluate Potential Risk Factors for Amyotrophic Lateral Sclerosis; May 13, 2020, 1:00 p.m.–5:30 p.m., EDT, in the original FRN. Teleconference, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Atlanta, Georgia 30341, PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Kalwant Smagh, Director, Strategic Business Initiatives Unit, Office of the Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2020–06781 Filed 3–31–20; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [CMS–3389–FN] Medicare Program; Approval of Application by the Utilization Review Accreditation Commission for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program Centers for Medicare and Medicaid Services, HHS. ACTION: Final notice. AGENCY: This final notice announces our decision to approve the Utilization Review Accreditation Commission (URAC) for initial recognition as a national accrediting organization for home infusion therapy suppliers that wish to participate in the Medicare program. A home infusion therapy supplier that participates must meet the Medicare conditions for coverage (CfCs). DATES: The approval announced in this final notice is effective March 27, 2020 through March 27, 2024. FOR FURTHER INFORMATION CONTACT: Christina Mister-Ward, (410)786–2441. Lillian Williams, (410)786–8636. SUMMARY: E:\FR\FM\01APN1.SGM 01APN1 18244 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Notices jbell on DSKJLSW7X2PROD with NOTICES I. Background Infusion therapy is a treatment option for Medicare beneficiaries with a wide range of acute and chronic conditions. Section 5012 of the 21st Century Cures Act added section 1861(iii) to the Social Security Act (the Act), establishing a new Medicare benefit for Home Infusion Therapy (HIT) services. Section 1861(iii)(1) of the Act defines HIT as professional services, including nursing services; training and education not otherwise covered under the Durable Medical Equipment (DME) benefit; remote monitoring; and other monitoring services. HIT must be furnished by a qualified HIT supplier and furnished in the individual’s home. The individual must be under— • The care of an applicable provider (that is, physician, nurse practitioner, or physician assistant); and • A plan of care established and periodically reviewed by a physician in coordination with the furnishing of home infusion drugs under Part B, that prescribes the type, amount, and duration of infusion therapy services that are to be furnished. Section 1861(iii)(3)(D)(III) of the Act requires that a qualified HIT supplier be accredited by an accrediting organization (AO) designated by the Secretary in accordance with section 1834(u)(5) of the Act. Section 1834(u)(5)(A) of the Act identifies factors for designating AOs and in reviewing and modifying the list of designated AOs. These statutory factors are as follows: • The ability of the organization to conduct timely reviews of accreditation applications. • The ability of the organization take into account the capacities of suppliers located in a rural area (as defined in section 1886(d)(2)(D) of the Act). • Whether the organization has established reasonable fees to be charged to suppliers applying for accreditation. • Such other factors as the Secretary determines appropriate. Section 1834(u)(5)(B) of the Act requires the Secretary to designate AOs to accredit HIT suppliers furnishing HIT not later than January 1, 2021. Section 1861(iii)(3)(D) of the Act defines ‘‘qualified home infusion therapy suppliers’’ as being accredited by a CMS-approved AO. In the March 1, 2019 Federal Register, we published a solicitation notice entitled, ‘‘Medicare Program; Solicitation of Independent Accrediting Organizations To Participate in the Home Infusion Therapy Supplier Accreditation Program’’ (84 FR 7057). VerDate Sep<11>2014 18:31 Mar 31, 2020 Jkt 250001 This notice informed national AOs that accredit HIT suppliers of an opportunity to submit applications to participate in the HIT supplier accreditation program. Complete applications will be considered for the January 1, 2021 designation deadline if received by February 1, 2020. Regulations for the approval and oversight of AOs for HIT organizations are located at 42 CFR part 488, subpart L. The requirements for HIT suppliers are located at 42 CFR part 486, subpart I. II. Approval of Accreditation Organizations Section 1834(u)(5) of the Act and the regulations at § 488.1010 require that our findings concerning review and approval of a national AO’s requirements consider, among other factors, the applying AO’s requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide CMS with the necessary data. Our regulations at § 488.1020(a) require that we publish, after 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. In accordance with § 488.1010(d), we have 210 days from the receipt of a complete application to publish notice of approval or denial of the application. III. Provisions of the Proposed Notice In the October 24, 2019 Federal Register (84 FR 57021), we published a proposed notice announcing URAC’s request for initial approval of its Medicare HIT accreditation program. In the October 24, 2019 proposed notice, we detailed our evaluation criteria. Under section 1834(u)(5) the Act and in our regulations at § 488.1010, we conducted a review of URAC Medicare home infusion accreditation application in accordance with the criteria specified by our regulations, which included, but are not limited to the following: • An onsite administrative review of URAC’s: (1) Corporate policies; (2) financial and human resources available to accomplish the proposed surveys; (3) procedures for training, monitoring, and evaluation of its home infusion therapy surveyors; (4) ability to investigate and respond appropriately to complaints against accredited home infusion PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 therapies; and (5) survey review and decision-making process for accreditation. • The ability for URAC to conduct timely review of accreditation applications. • The ability of URAC to take into account the capacities of suppliers located in a rural area. • The comparison of URAC’s Medicare home infusion therapy accreditation program standards to our current Medicare home infusion therapy CfCs. • A documentation review of URAC’s survey process to— ++ Determine the composition of the survey team, surveyor qualifications, and URAC’s ability to provide continuing surveyor training. ++ Compare URAC’s processes, including periodic resurvey and the ability to investigate and respond appropriately to complaints against accredited home infusion therapies. ++ Evaluate URAC’s procedures for monitoring home infusion therapies it has found to be out of compliance with URAC’s program requirements. ++ Assess URAC’s ability to report deficiencies to the surveyed home infusion therapy and respond to the home infusion therapy’s plan of correction in a timely manner. ++ Establish URAC’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 URAC’s staff and other resources. ++ Confirm URAC’s ability to provide adequate funding for performing required surveys. ++ Confirm URAC’s policies with respect to surveys being unannounced. ++ URAC’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. ++ Obtain URAC’s agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as we may require, including corrective action plans. The October 24, 2019 proposed notice also solicited public comments regarding whether URAC’s requirements met or exceeded the Medicare CfCs for home infusion therapy. No comments were received in response to our proposed notice. E:\FR\FM\01APN1.SGM 01APN1 Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Notices IV. Provisions of the Final Notice A. Differences Between URAC’s Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements We compared URAC’s HIT accreditation requirements and survey process with the Medicare CfCs of part 486, subpart I and the survey and certification process requirements of part 488, subpart L. Our review and evaluation of URAC’s HIT application, which was conducted as described in section III. of this final notice, yielded the following areas where, as of the date of this notice, URAC has completed revising its standards and certification processes in order to meet the condition at: • § 486.520(a), to address the requirement stating all patients must be under the care of an applicable provider. • § 488.1010(a)(5), to provide a detailed crosswalk identifying the exact language of the organization’s comparable accreditation requirements and standards. • § 488.1010(a)(6)(ix), to revise URAC’s procedures for ‘‘immediate jeopardy’’ situations. • § 488.1010(a)(6)(iv), to revise URAC’s survey procedures for surveys. • § 488.1010(a)(6)(v), to revise URAC’s procedures and timelines for notifying a surveyed or audited home infusion therapy supplier of noncompliance with the home infusion therapy accreditation program’s standards. • § 488.1010(a)(6)(vi), to revise URAC’s procedures and timelines for monitoring the home infusion therapy supplier’s correction of identified noncompliance with the accreditation program’s standards. • § 489.13, to reflect our policies regarding when the effective period of an accreditation begins and ends jbell on DSKJLSW7X2PROD with NOTICES B. Term of Approval Based on the review and observations described in section III. of this final notice, we have determined that URAC’s requirements for HITs meet or exceed our requirements. Therefore, we approve URAC as a national accreditation organization for HITs that request participation in the Medicare program, effective March 27, 2020 through March 27, 2024. IV. Collection of Information Requirements This document does not impose information collection and requirements, that is, reporting, recordkeeping or third party disclosure VerDate Sep<11>2014 18:31 Mar 31, 2020 Jkt 250001 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. Chapter 35). The Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, having reviewed and approved this document, is delegating the authority to electronically sign this document to Evell J. Barco Holland, who is the Federal Register Liaison, for purposes of publication in the Federal Register. Dated: March 26, 2020. Evell J. Barco Holland, Federal Register Liaison, Department of Health and Human Services. [FR Doc. 2020–06795 Filed 3–31–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3384–FN] 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: Final notice. AGENCY: This final notice announces our decision to approve 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. A HHA that participates in Medicaid must also meet the Medicare conditions of participation (CoPs). DATES: The decision announced in this final notice is effective March 31, 2020 through March 31, 2026. FOR FURTHER INFORMATION CONTACT: Sharon Lash (410) 786–9457. Caecilia Blondiaux (410) 786–2190. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Under the Medicare program, eligible beneficiaries may receive covered services from a home health agency (HHA), provided that 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 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 18245 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 certification surveys by state agencies. Accreditation by a nationally recognized Medicare accreditation program approved by CMS may substitute for both initial and ongoing state review. 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 our 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. 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 Joint Commission’s (TJC’s) term of approval for their HHA accreditation program expires March 31, 2020. II. Application Approval Process Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS- E:\FR\FM\01APN1.SGM 01APN1

Agencies

[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18243-18245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3389-FN]


Medicare Program; Approval of Application by the Utilization 
Review Accreditation Commission for Initial CMS-Approval of Its Home 
Infusion Therapy Accreditation Program

AGENCY: Centers for Medicare and Medicaid Services, HHS.

ACTION: Final notice.

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

SUMMARY: This final notice announces our decision to approve the 
Utilization Review Accreditation Commission (URAC) for initial 
recognition as a national accrediting organization for home infusion 
therapy suppliers that wish to participate in the Medicare program. A 
home infusion therapy supplier that participates must meet the Medicare 
conditions for coverage (CfCs).

DATES: The approval announced in this final notice is effective March 
27, 2020 through March 27, 2024.

FOR FURTHER INFORMATION CONTACT: 
Christina Mister-Ward, (410)786-2441.
Lillian Williams, (410)786-8636.

[[Page 18244]]

I. Background

    Infusion therapy is a treatment option for Medicare beneficiaries 
with a wide range of acute and chronic conditions. Section 5012 of the 
21st Century Cures Act added section 1861(iii) to the Social Security 
Act (the Act), establishing a new Medicare benefit for Home Infusion 
Therapy (HIT) services. Section 1861(iii)(1) of the Act defines HIT as 
professional services, including nursing services; training and 
education not otherwise covered under the Durable Medical Equipment 
(DME) benefit; remote monitoring; and other monitoring services. HIT 
must be furnished by a qualified HIT supplier and furnished in the 
individual's home. The individual must be under--
     The care of an applicable provider (that is, physician, 
nurse practitioner, or physician assistant); and
     A plan of care established and periodically reviewed by a 
physician in coordination with the furnishing of home infusion drugs 
under Part B, that prescribes the type, amount, and duration of 
infusion therapy services that are to be furnished.
    Section 1861(iii)(3)(D)(III) of the Act requires that a qualified 
HIT supplier be accredited by an accrediting organization (AO) 
designated by the Secretary in accordance with section 1834(u)(5) of 
the Act. Section 1834(u)(5)(A) of the Act identifies factors for 
designating AOs and in reviewing and modifying the list of designated 
AOs. These statutory factors are as follows:
     The ability of the organization to conduct timely reviews 
of accreditation applications.
     The ability of the organization take into account the 
capacities of suppliers located in a rural area (as defined in section 
1886(d)(2)(D) of the Act).
     Whether the organization has established reasonable fees 
to be charged to suppliers applying for accreditation.
     Such other factors as the Secretary determines 
appropriate.
    Section 1834(u)(5)(B) of the Act requires the Secretary to 
designate AOs to accredit HIT suppliers furnishing HIT not later than 
January 1, 2021. Section 1861(iii)(3)(D) of the Act defines ``qualified 
home infusion therapy suppliers'' as being accredited by a CMS-approved 
AO.
    In the March 1, 2019 Federal Register, we published a solicitation 
notice entitled, ``Medicare Program; Solicitation of Independent 
Accrediting Organizations To Participate in the Home Infusion Therapy 
Supplier Accreditation Program'' (84 FR 7057). This notice informed 
national AOs that accredit HIT suppliers of an opportunity to submit 
applications to participate in the HIT supplier accreditation program. 
Complete applications will be considered for the January 1, 2021 
designation deadline if received by February 1, 2020.
    Regulations for the approval and oversight of AOs for HIT 
organizations are located at 42 CFR part 488, subpart L. The 
requirements for HIT suppliers are located at 42 CFR part 486, subpart 
I.

II. Approval of Accreditation Organizations

    Section 1834(u)(5) of the Act and the regulations at Sec.  488.1010 
require that our findings concerning review and approval of a national 
AO's requirements consider, among other factors, the applying AO's 
requirements for accreditation; survey procedures; resources for 
conducting required surveys; capacity to furnish information for use in 
enforcement activities; monitoring procedures for provider entities 
found not in compliance with the conditions or requirements; and 
ability to provide CMS with the necessary data.
    Our regulations at Sec.  488.1020(a) require that we publish, after 
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. 
In accordance with Sec.  488.1010(d), we have 210 days from the receipt 
of a complete application to publish notice of approval or denial of 
the application.

III. Provisions of the Proposed Notice

    In the October 24, 2019 Federal Register (84 FR 57021), we 
published a proposed notice announcing URAC's request for initial 
approval of its Medicare HIT accreditation program. In the October 24, 
2019 proposed notice, we detailed our evaluation criteria. Under 
section 1834(u)(5) the Act and in our regulations at Sec.  488.1010, we 
conducted a review of URAC Medicare home infusion accreditation 
application in accordance with the criteria specified by our 
regulations, which included, but are not limited to the following:
     An onsite administrative review of URAC's: (1) Corporate 
policies; (2) financial and human resources available to accomplish the 
proposed surveys; (3) procedures for training, monitoring, and 
evaluation of its home infusion therapy surveyors; (4) ability to 
investigate and respond appropriately to complaints against accredited 
home infusion therapies; and (5) survey review and decision-making 
process for accreditation.
     The ability for URAC to conduct timely review of 
accreditation applications.
     The ability of URAC to take into account the capacities of 
suppliers located in a rural area.
     The comparison of URAC's Medicare home infusion therapy 
accreditation program standards to our current Medicare home infusion 
therapy CfCs.
     A documentation review of URAC's survey process to--
    ++ Determine the composition of the survey team, surveyor 
qualifications, and URAC's ability to provide continuing surveyor 
training.
    ++ Compare URAC's processes, including periodic resurvey and the 
ability to investigate and respond appropriately to complaints against 
accredited home infusion therapies.
    ++ Evaluate URAC's procedures for monitoring home infusion 
therapies it has found to be out of compliance with URAC's program 
requirements.
    ++ Assess URAC's ability to report deficiencies to the surveyed 
home infusion therapy and respond to the home infusion therapy's plan 
of correction in a timely manner.
    ++ Establish URAC'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 URAC's staff and other resources.
    ++ Confirm URAC's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm URAC's policies with respect to surveys being 
unannounced.
    ++ URAC'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.
    ++ Obtain URAC's agreement to provide CMS with a copy of the most 
current accreditation survey together with any other information 
related to the survey as we may require, including corrective action 
plans.
    The October 24, 2019 proposed notice also solicited public comments 
regarding whether URAC's requirements met or exceeded the Medicare CfCs 
for home infusion therapy. No comments were received in response to our 
proposed notice.

[[Page 18245]]

IV. Provisions of the Final Notice

A. Differences Between URAC's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements

    We compared URAC's HIT accreditation requirements and survey 
process with the Medicare CfCs of part 486, subpart I and the survey 
and certification process requirements of part 488, subpart L. Our 
review and evaluation of URAC's HIT application, which was conducted as 
described in section III. of this final notice, yielded the following 
areas where, as of the date of this notice, URAC has completed revising 
its standards and certification processes in order to meet the 
condition at:
     Sec.  486.520(a), to address the requirement stating all 
patients must be under the care of an applicable provider.
     Sec.  488.1010(a)(5), to provide a detailed crosswalk 
identifying the exact language of the organization's comparable 
accreditation requirements and standards.
     Sec.  488.1010(a)(6)(ix), to revise URAC's procedures for 
``immediate jeopardy'' situations.
     Sec.  488.1010(a)(6)(iv), to revise URAC's survey 
procedures for surveys.
     Sec.  488.1010(a)(6)(v), to revise URAC's procedures and 
timelines for notifying a surveyed or audited home infusion therapy 
supplier of non-compliance with the home infusion therapy accreditation 
program's standards.
     Sec.  488.1010(a)(6)(vi), to revise URAC's procedures and 
timelines for monitoring the home infusion therapy supplier's 
correction of identified non-compliance with the accreditation 
program's standards.
     Sec.  489.13, to reflect our policies regarding when the 
effective period of an accreditation begins and ends

B. Term of Approval

    Based on the review and observations described in section III. of 
this final notice, we have determined that URAC's requirements for HITs 
meet or exceed our requirements. Therefore, we approve URAC as a 
national accreditation organization for HITs that request participation 
in the Medicare program, effective March 27, 2020 through March 27, 
2024.

IV. Collection of Information Requirements

    This document does not impose information collection and 
requirements, that is, reporting, recordkeeping or third party 
disclosure requirements. Consequently, there is no need for review by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Seema Verma, having reviewed and approved this document, is 
delegating the authority to electronically sign this document to Evell 
J. Barco Holland, who is the Federal Register Liaison, for purposes of 
publication in the Federal Register.

    Dated: March 26, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-06795 Filed 3-31-20; 8:45 am]
 BILLING CODE 4120-01-P

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