Medicare Program; Approval of Application by National Association of Boards of Pharmacy for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program, 60793-60795 [2020-21261]

Download as PDF Federal Register / Vol. 85, No. 188 / Monday, September 28, 2020 / Notices written summary of their comments and conclusions to HCPCS_Level_II_Code_ Applications@cms.hhs.gov or to CMS’ HCPCS staff listed in the FOR FURTHER INFORMATION CONTACT section of this notice. C. Additional Virtual Meeting/ Registration Information Prior to registering to attend a virtual public meeting, all participants are advised to review the public meeting agendas at https://www.cms.gov/ Medicare/Coding/MedHCPCSGenInfo/ HCPCSPublicMeetings which identify our preliminary coding recommendations, and the dates each item will be discussed. All participants and other stakeholders are encouraged to begin in early October to regularly check CMS’ official HCPCS website at https://www.cms.gov/Medicare/Coding/ MedHCPCSGenInfo/ HCPCSPublicMeetings for publication of draft agendas, including a summary of each request and our preliminary recommendations. All participants and other interested stakeholders are also encouraged to regularly check CMS’ official HCPCS website at https://www.cms.gov/ Medicare/Coding/MedHCPCSGenInfo/ HCPCSPublicMeetings for additional details regarding the public meeting process for new public requests for revisions to the HCPCS, including information on how to join the meeting remotely, and guidelines for an effective presentation. In particular, please review the document titled ‘‘Guidelines for Participation in Public Meetings for New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS)’’. Individuals who intend to provide a presentation at a virtual public meeting are encouraged to familiarize themselves with the HCPCS website and the valuable information it provides to prospective registrants. The HCPCS website also contains a document titled ‘‘Healthcare Common Procedure Coding System (HCPCS) Level II Coding Procedures,’’ which is a description of the HCPCS coding process, including a detailed explanation of the procedures CMS uses to make coding determinations for the items and services that are coded in the HCPCS. The HCPCS website also contains a document titled ‘‘HCPCS Decision Tree & Definitions,’’ which illustrates, in flow diagram format, HCPCS coding standards as described in our Coding Procedures document. VerDate Sep<11>2014 18:25 Sep 25, 2020 Jkt 250001 III. Written Comments From Meeting Attendees As part of CMS’ response to the COVID–19 public health emergency, there is a limited presence at the CMS headquarters for receiving paper packages. Therefore, written comments from the general public and meeting registrants will only be accepted when emailed to HCPCS_Level_II_Code_ Applications@cms.hhs.gov or to staff listed in the FOR FURTHER INFORMATION CONTACT section of this notice any time up to 5:00 p.m. on the date of the virtual public meeting at which a request is discussed. Due to the close timing of the virtual public meetings, subsequent workgroup review, and final decisions, we are able to consider only those written submissions received by the close of business (5:00 p.m.) on the date of the virtual public meeting at which the request is discussed. The Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Dated: September 22, 2020. Lynette Wilson, Federal Register Liaison, Centers for Medicare & Medicaid. [FR Doc. 2020–21257 Filed 9–25–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3396–FN] Medicare Program; Approval of Application by National Association of Boards of Pharmacy for Initial CMSApproval of Its Home Infusion Therapy Accreditation Program Centers for Medicare and Medicaid Services, HHS. AGENCY: ACTION: Final notice. This final notice announces our decision to approve the National Association of Boards of Pharmacy 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. SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 60793 The approval announced in this final notice is effective September 26, 2020 through September 26, 2024. FOR FURTHER INFORMATION CONTACT: Christina Mister-Ward, (410) 786–2441. Shannon Freeland, (410) 786–4348. Lillian Williams, (410) 786–8636. SUPPLEMENTARY INFORMATION: DATES: I. Background Home Infusion therapy (HIT) is a treatment option for Medicare beneficiaries with a wide range of acute and chronic conditions. Section 5012 of the 21st Century Cures Act (Pub. L. 114– 255, enacted December 13, 2016) added sections 1861(iii) and 1834(u) to the Social Security Act (the Act), establishing a new Medicare benefit for 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. Home infusion therapy 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 • Have 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)(i)(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 E:\FR\FM\28SEN1.SGM 28SEN1 60794 Federal Register / Vol. 85, No. 188 / Monday, September 28, 2020 / Notices ‘‘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 § 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. Section 488.1020(a) requires 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 approve or deny the application. III. Provisions of the Proposed Notice In the April 28, 2020 Federal Register (85 FR 23519), we published a proposed notice announcing National Association of Boards of Pharmacy’s (NABP’s) request for initial approval of its Medicare HIT accreditation program. In that 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 NABP’s Medicare HIT accreditation application in accordance with the criteria specified by our VerDate Sep<11>2014 18:25 Sep 25, 2020 Jkt 250001 regulations, which included, but are not limited to the following: • An administrative review of NABP’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 NABP to conduct timely review of accreditation applications. • The ability of NABP to take into account the capacities of suppliers located in a rural area. • The comparison of NABP’s Medicare home infusion therapy accreditation program standards to our current Medicare home infusion therapy conditions for coverage (CfCs). • NABP’s survey process to determine the following: ++ The composition of the survey team, surveyor qualifications, and NABP’s ability to provide continuing surveyor training. ++ NABP’s processes, including periodic resurvey and the ability to investigate and respond appropriately to complaints against accredited home infusion therapies. ++ Evaluate NABP’s procedures for monitoring home infusion therapies it has found to be out of compliance with NABP’s program requirements. ++ Assess NABP’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 NABP’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 NABP’s staff and other resources. ++ Confirm NABP’s ability to provide adequate funding for performing required surveys. ++ Confirm NABP’s policies with respect to surveys being unannounced. ++ Review NABP’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 NABP’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. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 The April 28, 2020 proposed notice also solicited public comments regarding whether NABP’s requirements met or exceeded the Medicare CfCs for home infusion therapy. No comments were received in response to our proposed notice. IV. Provisions of the Final Notice A. Differences Between NABP’s Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements We compared NABP’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 NABP’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, NABP has completed revising its standards and certification processes in order to meet the condition at: • § 486.520, to include the term ‘‘qualified’’ to meet the requirement for home infusion suppliers. • § 486.525(a), to include the language ‘‘qualified’’ to meet the requirement for home infusion suppliers. • § 486.525(b), to revise standard language removing the word ‘‘shall’’ from the home infusion standards. • § 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)(i), to revise survey procedures for information gathering and investigation. • § 488.1010(a)(6)(v), to revise 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. • § 488.1010(a)(6)(vi), to revise NABP’s procedures and timelines for monitoring the home infusion therapy supplier’s correction of identified noncompliance with the accreditation program’s standards. • § 488.1010(6)(ix), to revise procedures for immediate jeopardy. • § 489.13, to reflect our policies regarding when the effective period of an accreditation begins and ends. B. Term of Approval As authorized under § 488.1040(a), we reserve the right to conduct onsite observations of accrediting organization operations at any time as part of the E:\FR\FM\28SEN1.SGM 28SEN1 Federal Register / Vol. 85, No. 188 / Monday, September 28, 2020 / Notices ongoing review and continuing oversight of an accrediting organization’s performance. Based on the review and observations described in section III. of this final notice, we have determined that NABP’s requirements for HIT meet or exceed our requirements. Therefore, we approve NABP as a national accreditation organization for HITs that request participation in the Medicare program, effective September 26, 2020 through September 26, 2024. V. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Dated: September 22, 2020. Lynette Wilson, Federal Register Liaison, Centers for Medicare & Medicaid. [FR Doc. 2020–21261 Filed 9–25–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–4191–N] Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2021 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2021. The calendar year 2021 AIC threshold SUMMARY: VerDate Sep<11>2014 18:25 Sep 25, 2020 Jkt 250001 amounts are $180 for ALJ hearings and $1,760 for judicial review. DATES: This annual adjustment takes effect on January 1, 2021. FOR FURTHER INFORMATION CONTACT: Liz Hosna (Katherine.Hosna@cms.hhs.gov), (410) 786–4993. SUPPLEMENTARY INFORMATION: I. Background Section 1869(b)(1)(E) of the Social Security Act (the Act), as amended by section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), established the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review at $100 and $1,000, respectively, for Medicare Part A and Part B appeals. Section 940 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), amended section 1869(b)(1)(E) of the Act to require the AIC threshold amounts for ALJ hearings and judicial review to be adjusted annually. Beginning in January 2005, the AIC threshold amounts are to be adjusted by the percentage increase in the medical care component of the consumer price index (CPI) for all urban consumers (U.S. city average) for July 2003 to the July preceding the year involved and rounded to the nearest multiple of $10. Section 940(b)(2) of the MMA provided conforming amendments to apply the AIC adjustment requirement to Medicare Part C/Medicare Advantage (MA) appeals and certain health maintenance organization and competitive health plan appeals. Health care prepayment plans are also subject to MA appeals rules, including the AIC adjustment requirement. Section 101 of the MMA provides for the application of the AIC adjustment requirement to Medicare Part D appeals. A. Medicare Part A and Part B Appeals The statutory formula for the annual adjustment to the AIC threshold amounts for ALJ hearings and judicial review of Medicare Part A and Part B appeals, set forth at section 1869(b)(1)(E) of the Act, is included in the applicable implementing regulations, 42 CFR 405.1006(b) and (c). The regulations at § 405.1006(b)(2) require the Secretary of Health and Human Services (the Secretary) to publish changes to the AIC threshold amounts in the Federal Register. In order to be entitled to a hearing before an ALJ, a party to a proceeding must meet the AIC requirements at § 405.1006(b). Similarly, a party must PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 60795 meet the AIC requirements at § 405.1006(c) at the time judicial review is requested for the court to have jurisdiction over the appeal (§ 405.1136(a)). B. Medicare Part C/MA Appeals Section 940(b)(2) of the MMA applies the AIC adjustment requirement to Medicare Part C appeals by amending section 1852(g)(5) of the Act. The implementing regulations for Medicare Part C appeals are found at 42 CFR 422, subpart M. Specifically, sections 422.600 and 422.612 discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 422.600 grants any party to the reconsideration (except the MA organization) who is dissatisfied with the reconsideration determination a right to an ALJ hearing as long as the amount remaining in controversy after reconsideration meets the threshold requirement established annually by the Secretary. Section 422.612 states, in part, that any party, including the MA organization, may request judicial review if the AIC meets the threshold requirement established annually by the Secretary. C. Health Maintenance Organizations, Competitive Medical Plans, and Health Care Prepayment Plans Section 1876(c)(5)(B) of the Act states that the annual adjustment to the AIC dollar amounts set forth in section 1869(b)(1)(E)(iii) of the Act applies to certain beneficiary appeals within the context of health maintenance organizations and competitive medical plans. The applicable implementing regulations for Medicare Part C appeals are set forth in 42 CFR 422, subpart M and apply to these appeals in accordance with 42 CFR 417.600(b). The Medicare Part C appeals rules also apply to health care prepayment plan appeals in accordance with 42 CFR 417.840. D. Medicare Part D (Prescription Drug Plan) Appeals The annually adjusted AIC threshold amounts for ALJ hearings and judicial review that apply to Medicare Parts A, B, and C appeals also apply to Medicare Part D appeals. Section 101 of the MMA added section 1860D–4(h)(1) of the Act regarding Part D appeals. This statutory provision requires a prescription drug plan sponsor to meet the requirements set forth in sections 1852(g)(4) and (g)(5) of the Act, in a similar manner as MA organizations. As noted previously, the annually adjusted AIC threshold requirement was added to section 1852(g)(5) of the Act by section 940(b)(2)(A) of the MMA. The implementing regulations for Medicare E:\FR\FM\28SEN1.SGM 28SEN1

Agencies

[Federal Register Volume 85, Number 188 (Monday, September 28, 2020)]
[Notices]
[Pages 60793-60795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3396-FN]


Medicare Program; Approval of Application by National Association 
of Boards of Pharmacy 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 
National Association of Boards of Pharmacy 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.

DATES: The approval announced in this final notice is effective 
September 26, 2020 through September 26, 2024.

FOR FURTHER INFORMATION CONTACT: 
Christina Mister-Ward, (410) 786-2441.
Shannon Freeland, (410) 786-4348.
Lillian Williams, (410) 786-8636.

SUPPLEMENTARY INFORMATION:

I. Background

    Home Infusion therapy (HIT) is a treatment option for Medicare 
beneficiaries with a wide range of acute and chronic conditions. 
Section 5012 of the 21st Century Cures Act (Pub. L. 114-255, enacted 
December 13, 2016) added sections 1861(iii) and 1834(u) to the Social 
Security Act (the Act), establishing a new Medicare benefit for 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. Home infusion therapy 
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
     Have 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)(i)(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

[[Page 60794]]

``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.
    Section 488.1020(a) requires 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 approve or deny the application.

III. Provisions of the Proposed Notice

    In the April 28, 2020 Federal Register (85 FR 23519), we published 
a proposed notice announcing National Association of Boards of 
Pharmacy's (NABP's) request for initial approval of its Medicare HIT 
accreditation program. In that 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 NABP's Medicare 
HIT accreditation application in accordance with the criteria specified 
by our regulations, which included, but are not limited to the 
following:
     An administrative review of NABP'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 NABP to conduct timely review of 
accreditation applications.
     The ability of NABP to take into account the capacities of 
suppliers located in a rural area.
     The comparison of NABP's Medicare home infusion therapy 
accreditation program standards to our current Medicare home infusion 
therapy conditions for coverage (CfCs).
     NABP's survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
NABP's ability to provide continuing surveyor training.
    ++ NABP's processes, including periodic resurvey and the ability to 
investigate and respond appropriately to complaints against accredited 
home infusion therapies.
    ++ Evaluate NABP's procedures for monitoring home infusion 
therapies it has found to be out of compliance with NABP's program 
requirements.
    ++ Assess NABP'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 NABP'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 NABP's staff and other resources.
    ++ Confirm NABP's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm NABP's policies with respect to surveys being 
unannounced.
    ++ Review NABP'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 NABP'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 April 28, 2020 proposed notice also solicited public comments 
regarding whether NABP's requirements met or exceeded the Medicare CfCs 
for home infusion therapy. No comments were received in response to our 
proposed notice.

IV. Provisions of the Final Notice

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

    We compared NABP'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 NABP'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, NABP has completed revising 
its standards and certification processes in order to meet the 
condition at:
     Sec.  486.520, to include the term ``qualified'' to meet 
the requirement for home infusion suppliers.
     Sec.  486.525(a), to include the language ``qualified'' to 
meet the requirement for home infusion suppliers.
     Sec.  486.525(b), to revise standard language removing the 
word ``shall'' from the home infusion standards.
     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)(i), to revise survey procedures for 
information gathering and investigation.
     Sec.  488.1010(a)(6)(v), to revise 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 NABP's procedures and 
timelines for monitoring the home infusion therapy supplier's 
correction of identified non-compliance with the accreditation 
program's standards.
     Sec.  488.1010(6)(ix), to revise procedures for immediate 
jeopardy.
     Sec.  489.13, to reflect our policies regarding when the 
effective period of an accreditation begins and ends.

B. Term of Approval

    As authorized under Sec.  488.1040(a), we reserve the right to 
conduct onsite observations of accrediting organization operations at 
any time as part of the

[[Page 60795]]

ongoing review and continuing oversight of an accrediting 
organization's performance. Based on the review and observations 
described in section III. of this final notice, we have determined that 
NABP's requirements for HIT meet or exceed our requirements. Therefore, 
we approve NABP as a national accreditation organization for HITs that 
request participation in the Medicare program, effective September 26, 
2020 through September 26, 2024.

V. Collection of Information Requirements

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

    Dated: September 22, 2020.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid.
[FR Doc. 2020-21261 Filed 9-25-20; 8:45 am]
BILLING CODE 4120-01-P

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