Medicare Program; Application by the National Association of Boards of Pharmacy (NABP) for Continued CMS Approval of Its Home Infusion Therapy (HIT) Accreditation Program, 76839-76841 [2024-21409]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
• Agenda item and application
number;
• Email address;
• Any special assistance requests
(will be considered if the registration is
submitted by 5 p.m. ET, October 25,
2024);
• Whether the registrant is a primary
speaker or a 5-minute speaker for an
agenda item; and
• Whether the primary speaker will
use a PowerPoint presentation.
B. Speakers and Attendees
lotter on DSK11XQN23PROD with NOTICES1
1. Primary Speakers
Each applicant that submitted a
HCPCS Level II code application that
will be discussed at the virtual public
meetings is permitted to designate a
primary speaker. Fifteen minutes is the
total time interval for a primary speaker
per agenda item. Any unused time from
the primary speaker will be forfeited
and cannot be delegated to another
speaker. The deadline for primary
speakers to register and submit any
supporting PowerPoint presentation is 5
p.m. ET, October 25, 2024. CMS will
accept PowerPoint presentations if those
materials are emailed to HCPCS@
cms.hhs.gov by the stated deadline. Due
to the timeframe needed for the
planning and coordination of the
HCPCS virtual public meetings,
materials that are not submitted in
accordance with this deadline cannot be
accommodated.
All PowerPoint presentation materials
must not exceed 10 slides and should be
in PowerPoint presentation format, not
PDF. We will not play videos,
transitions, or animations during the
public meeting sessions and request that
the speakers exclude these materials
from their PowerPoint presentation and
instead submit any relevant video or
animation materials along with their
written comments. We request that
speakers ensure the presentation does
not include any inappropriate content
before submission.
Every primary speaker must declare at
the beginning of their presentation at
the meeting, as well as in their written
summary, whether they have any
financial involvement with the
manufacturer of the item that is the
subject of the HCPCS Level II
application that the primary speaker
presented, or any competitors of that
manufacturer with respect to the item.
This includes any payment, salary,
remuneration, or benefit provided to
that speaker by the applicant.
2. 5-Minute Speakers
Any individual related to the public
meeting agenda item, including but not
VerDate Sep<11>2014
16:59 Sep 18, 2024
Jkt 262001
limited to, an employee, interested
parties, competitor, insurer, public
consumer, etc., may register and speak
as a 5-minute speaker. The deadline for
registering to be a 5-minute speaker is
5 p.m. ET, October 25, 2024.
Every 5-minute speaker must declare
at the beginning of their presentation at
the meeting, as well as in their written
summary, whether they have any
financial involvement with the
manufacturer of the item that is the
subject of the HCPCS Level II code
application or agenda item that the 5minute speaker presented, or with any
competitors of that manufacturer with
respect to the item. This includes any
payment, salary, remuneration, or
benefit provided to that speaker by the
applicant. We will not accept any other
written materials, outside of the written
comments, from a 5-minute speaker.
3. All Other Attendees
All individuals who plan to attend the
virtual public meetings to listen and do
not plan to speak, may access the virtual
public meeting using the Zoom link
posted on the HCPCS Level II website at
https://www.cms.gov/medicare/codingbilling/healthcare-common-proceduresystem as well as the guidelines
document.
Individuals who require special
assistance must register and request
special assistance services by 5 p.m. ET,
October 25, 2024.
IV. Written Comments
The primary and 5-minute speaker(s)
must email a brief, written summary
(one paragraph) of their comments and
conclusions. Written comments from
anyone, including the primary and 5minute speaker(s), will only be accepted
when emailed to: HCPCS@cms.hhs.gov
before 5 p.m. ET on the date of the
virtual public meeting at which the
HCPCS Level II code application that is
the subject of the comments is
discussed.
V. Additional Information
The HCPCS section of the CMS
website also includes details regarding
the public meeting process for new
revisions to the HCPCS Level II code set,
including information on how to join
the meeting remotely, and guidelines for
an effective presentation. The HCPCS
section of the CMS website also
contains a document titled ‘‘Healthcare
Common Procedure Coding System
(HCPCS) Level II Coding Procedures
(PDF),’’ which is a description of the
HCPCS Level II coding process,
including a detailed explanation of the
procedures CMS uses to make HCPCS
Level II coding determinations.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
76839
When CMS refers to a HCPCS code or
HCPCS Level II coding application
above, CMS may also be referring to
circumstances when a HCPCS code has
already been issued, but a Medicare
benefit category and/or payment has not
been determined. CMS is working
diligently to address Medicare benefit
category and payment determinations
for new items and services that may be
DME, prosthetic devices, orthotics and
prosthetics, therapeutic shoes and
inserts, surgical dressings, or splints,
casts, and other devices used for
reductions of fractures and dislocations
under Medicare Part B. Please check the
CMS website listed above for the final
agenda.
VI. 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. 3501 et seq.).
The Administrator of CMS, Chiquita
Brooks-LaSure, having reviewed and
approved this document, authorizes
Trenesha Fultz-Mimms, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2024–21297 Filed 9–18–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3464–FN]
Medicare Program; Application by the
National Association of Boards of
Pharmacy (NABP) for Continued CMS
Approval of Its Home Infusion Therapy
(HIT) Accreditation Program
Centers for Medicare &
Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final notice.
AGENCY:
This final notice announces
our decision to approve the National
Association of Boards of Pharmacy
(NABP) for continued recognition as a
national accrediting organization that
accredits suppliers of home infusion
SUMMARY:
E:\FR\FM\19SEN1.SGM
19SEN1
76840
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
therapy (HIT) services that wish to
participate in the Medicare or Medicaid
programs.
DATES: The approval announced in this
final notice is effective September 26,
2024 through September 26, 2030.
FOR FURTHER INFORMATION CONTACT:
Shannon Freeland, (410) 786–4348.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
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
section 1861(iii) to the Social Security
Act (the Act), establishing a new
Medicare benefit for HIT services.
Section 1861(iii)(1) of the Act defines
‘‘home infusion therapy’’ 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.
Sections 1861(iii)(A) and (B) of the Act
require that the individual (patient)
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,
which 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 HIT
AOs and for reviewing and modifying
the list of designated HIT AOs. These
statutory factors are as follows:
• The ability of the accrediting
organization to conduct timely reviews
of HIT accreditation applications.
• The ability of the accrediting
organization to take into account the
capacities of HIT suppliers located in a
rural area (as defined in section
1886(d)(2)(D) of the Act).
• Whether the accrediting
organization has established reasonable
fees to be charged to HIT suppliers
applying for accreditation.
• Such other factors as the Secretary
determines appropriate.
VerDate Sep<11>2014
16:59 Sep 18, 2024
Jkt 262001
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)(i)(III) of the Act requires
a ‘‘qualified home infusion therapy
supplier’’ to be accredited by a CMSapproved AO, pursuant to section
1834(u)(5) of the Act.
The current term of approval for the
National Association of Boards of
Pharmacy (NABP) HIT accreditation
program expires September 26, 2024.
II. Approval of Deeming Organization
Section 1834(u)(5) of the Act and
§ 488.1010 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 CMS with the
necessary data.
Our rules at 42 CFR 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. Pursuant to our rules
at 42 CFR 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 April 26, 2024 Federal Register
(89 FR 32434), we published a proposed
notice announcing NABP’s request for
continued recognition as a national
accrediting organization for suppliers
providing HIT services that wish to
participate in the Medicare or Medicaid
programs. 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
regulations, which include, but are not
limited to, the following:
• An administrative review of
NABP’s:
++ Corporate policies;
++ Financial and human resources
available to accomplish the proposed
surveys;
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
++ Procedures for training,
monitoring, and evaluation of its HIT
surveyors;
++ Ability to investigate and respond
appropriately to complaints against
accredited HITs; and
++ Survey review and decisionmaking process for accreditation.
• The equivalency of NABP’s
standards for HIT as compared with
CMS’ HIT conditions for participation.
• NABP’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 NABP’s to
CMS’ standards and processes,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited facilities;
++ NABP’s processes and procedures
for monitoring a HIT supplier found out
of compliance with NABP’s program
requirements;
++ NABP’s capacity to report
deficiencies to the surveyed HIT
facilities and respond to the facility’s
evidence of standards compliance in a
timely manner;
++ NABP’s capacity to provide CMS
with electronic data and reports
necessary for effective assessment and
interpretation of the organization’s
survey process;
++ NABP’s capacity to adequately
fund required surveys;
++ NABP’s policies with respect to
whether surveys are announced or
unannounced, to ensure that surveys are
unannounced; and
++ 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 CMS may require (including
corrective action plans or NABP’s
evidence of standards compliance).
• The adequacy of NABP’s staff and
other resources, and its financial
viability.
• NABP’s agreement or policies for
voluntary and involuntary termination
of suppliers.
• NABP’s agreement or policies for
voluntary and involuntary termination
of the HIT AO program.
• 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.
IV. Analysis of and Responses to Public
Comments on the Proposed Notice
In accordance with section 1834(u)(5)
of the Act, the April 26, 2024, proposed
E:\FR\FM\19SEN1.SGM
19SEN1
Federal Register / Vol. 89, No. 182 / Thursday, September 19, 2024 / Notices
notice also solicited public comments
regarding whether NABP’s requirements
met or exceeded the Medicare
conditions for participation for HIT. No
comments were received in response to
our proposed notice.
V. Provisions of the Final Notice
lotter on DSK11XQN23PROD with NOTICES1
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 Conditions
for Coverage of 42 CFR part 486, and the
survey and certification process
requirements of part 488. Our review
and evaluation of NABP’s HIT
application, which were conducted as
described in section III of this final
notice, yielded the following areas
where, as of the date of this notice,
NABP has completed revising its
standards and certification processes to
meet the conditions at §§ 486.500 to
486.525.
• Section 486.520(a), to address the
requirement that all patients must be
under the care of an applicable
provider.
• Section 486.520(b), to address the
requirement that the plan of care must
be established by a physician and that
it prescribes the type, amount, and
duration of the home infusion therapy
services that are to be furnished.
• Section 486.520(c), to address the
requirement that the plan of care for
each patient must be periodically
reviewed by the physician.
• Section 486.525(a), to address the
requirement that the HIT supplier must
provide the following services on a 7day a week, 24 hour-a-day basis in
accordance with the plan of care:
++ Section 486.525(a)(1), to provide
professional services, including nursing
services.
++ Section 486.525(a)(2), to address
the requirement for patient training and
education and not otherwise paid for as
durable medical equipment.
++ Section 486.525(a)(3), to address
the requirement of remote monitoring
services for the provision of HIT
services and home infusion drugs.
Section 486.525(b), to address the
requirement that all home infusion
therapy suppliers must provide HIT
services in accordance with nationally
recognized standards of practice, and in
accordance with all applicable state and
federal laws and regulations.
B. Term of Approval
Based on the review and observations
described in section III. of this final
VerDate Sep<11>2014
16:59 Sep 18, 2024
Jkt 262001
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, 2024 through
September 26, 2030.
VI. 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),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Trenesha Fultz-Mimms, who
is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2024–21409 Filed 9–18–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3462–FN]
Medicare Program; Application by The
Compliance Team (TCT) for Continued
CMS Approval of Its Home Infusion
Therapy (HIT) Accreditation Program
Centers for Medicare &
Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final notice.
AGENCY:
This final notice announces
our decision to approve The
Compliance Team (TCT) for continued
recognition as a national accrediting
organization that accredits suppliers of
home infusion therapy (HIT) services
that wish to participate in the Medicare
or Medicaid programs.
DATES: The approval announced in this
final notice is effective September 28,
2024, through September 28, 2030.
FOR FURTHER INFORMATION CONTACT:
Shannon Freeland, (410) 786–4348.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
76841
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
section 1861(iii) to the Social Security
Act (the Act), establishing a new
Medicare benefit for HIT services.
Section 1861(iii)(1) of the Act defines
‘‘home infusion therapy’’ 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.
Sections 1861(iii)(A) and (B) of the Act
require that the individual (patient)
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,
which 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 HIT
AOs and for reviewing and modifying
the list of designated HIT AOs. These
statutory factors are as follows:
• The ability of the accrediting
organization to conduct timely reviews
of HIT accreditation applications.
• The ability of the accrediting
organization to take into account the
capacities HIT suppliers located in a
rural area (as defined in section
1886(d)(2)(D) of the Act).
• Whether the accrediting
organization has established reasonable
fees to be charged to HIT 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)(i)(III) of the Act requires
a ‘‘qualified home infusion therapy
supplier’’ to be accredited by a CMSapproved AO, pursuant to section
1834(u)(5) of the Act.
The current term of approval for The
Compliance Team (TCT) HIT
E:\FR\FM\19SEN1.SGM
19SEN1
]]>Agencies
[Federal Register Volume 89, Number 182 (Thursday, September 19, 2024)]
[Notices]
[Pages 76839-76841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21409]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3464-FN]
Medicare Program; Application by the National Association of
Boards of Pharmacy (NABP) for Continued CMS Approval of Its Home
Infusion Therapy (HIT) Accreditation Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and
Human Services (HHS).
ACTION: Final notice.
-----------------------------------------------------------------------
SUMMARY: This final notice announces our decision to approve the
National Association of Boards of Pharmacy (NABP) for continued
recognition as a national accrediting organization that accredits
suppliers of home infusion
[[Page 76840]]
therapy (HIT) services that wish to participate in the Medicare or
Medicaid programs.
DATES: The approval announced in this final notice is effective
September 26, 2024 through September 26, 2030.
FOR FURTHER INFORMATION CONTACT: Shannon Freeland, (410) 786-4348.
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 section 1861(iii) to the Social Security Act
(the Act), establishing a new Medicare benefit for HIT services.
Section 1861(iii)(1) of the Act defines ``home infusion therapy'' 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. Sections 1861(iii)(A) and (B) of
the Act require that the individual (patient) 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, which 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
HIT AOs and for reviewing and modifying the list of designated HIT AOs.
These statutory factors are as follows:
The ability of the accrediting organization to conduct
timely reviews of HIT accreditation applications.
The ability of the accrediting organization to take into
account the capacities of HIT suppliers located in a rural area (as
defined in section 1886(d)(2)(D) of the Act).
Whether the accrediting organization has established
reasonable fees to be charged to HIT 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)(i)(III) of the Act requires a
``qualified home infusion therapy supplier'' to be accredited by a CMS-
approved AO, pursuant to section 1834(u)(5) of the Act.
The current term of approval for the National Association of Boards
of Pharmacy (NABP) HIT accreditation program expires September 26,
2024.
II. Approval of Deeming Organization
Section 1834(u)(5) of the Act and Sec. 488.1010 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 CMS with the
necessary data.
Our rules at 42 CFR 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.
Pursuant to our rules at 42 CFR 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 April 26, 2024 Federal Register (89 FR 32434), we published
a proposed notice announcing NABP's request for continued recognition
as a national accrediting organization for suppliers providing HIT
services that wish to participate in the Medicare or Medicaid programs.
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
include, but are not limited to, the following:
An administrative review of NABP's:
++ Corporate policies;
++ Financial and human resources available to accomplish the
proposed surveys;
++ Procedures for training, monitoring, and evaluation of its HIT
surveyors;
++ Ability to investigate and respond appropriately to complaints
against accredited HITs; and
++ Survey review and decision-making process for accreditation.
The equivalency of NABP's standards for HIT as compared
with CMS' HIT conditions for participation.
NABP'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 NABP's to CMS' standards and processes,
including survey frequency, and the ability to investigate and respond
appropriately to complaints against accredited facilities;
++ NABP's processes and procedures for monitoring a HIT supplier
found out of compliance with NABP's program requirements;
++ NABP's capacity to report deficiencies to the surveyed HIT
facilities and respond to the facility's evidence of standards
compliance in a timely manner;
++ NABP's capacity to provide CMS with electronic data and reports
necessary for effective assessment and interpretation of the
organization's survey process;
++ NABP's capacity to adequately fund required surveys;
++ NABP's policies with respect to whether surveys are announced or
unannounced, to ensure that surveys are unannounced; and
++ 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 CMS may require (including corrective action plans or NABP's
evidence of standards compliance).
The adequacy of NABP's staff and other resources, and its
financial viability.
NABP's agreement or policies for voluntary and involuntary
termination of suppliers.
NABP's agreement or policies for voluntary and involuntary
termination of the HIT AO program.
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.
IV. Analysis of and Responses to Public Comments on the Proposed Notice
In accordance with section 1834(u)(5) of the Act, the April 26,
2024, proposed
[[Page 76841]]
notice also solicited public comments regarding whether NABP's
requirements met or exceeded the Medicare conditions for participation
for HIT. No comments were received in response to our proposed notice.
V. 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 Conditions for Coverage of 42 CFR part 486,
and the survey and certification process requirements of part 488. Our
review and evaluation of NABP's HIT application, which were conducted
as described in section III of this final notice, yielded the following
areas where, as of the date of this notice, NABP has completed revising
its standards and certification processes to meet the conditions at
Sec. Sec. 486.500 to 486.525.
Section 486.520(a), to address the requirement that all
patients must be under the care of an applicable provider.
Section 486.520(b), to address the requirement that the
plan of care must be established by a physician and that it prescribes
the type, amount, and duration of the home infusion therapy services
that are to be furnished.
Section 486.520(c), to address the requirement that the
plan of care for each patient must be periodically reviewed by the
physician.
Section 486.525(a), to address the requirement that the
HIT supplier must provide the following services on a 7-day a week, 24
hour-a-day basis in accordance with the plan of care:
++ Section 486.525(a)(1), to provide professional services,
including nursing services.
++ Section 486.525(a)(2), to address the requirement for patient
training and education and not otherwise paid for as durable medical
equipment.
++ Section 486.525(a)(3), to address the requirement of remote
monitoring services for the provision of HIT services and home infusion
drugs.
Section 486.525(b), to address the requirement that all home
infusion therapy suppliers must provide HIT services in accordance with
nationally recognized standards of practice, and in accordance with all
applicable state and federal laws and regulations.
B. Term of Approval
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, 2024 through September
26, 2030.
VI. 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), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Trenesha Fultz-Mimms, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Trenesha Fultz-Mimms,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-21409 Filed 9-18-24; 8:45 am]
BILLING CODE 4120-01-P
