[Federal Register Volume 84, Number 41 (Friday, March 1, 2019)]
[Notices]
[Pages 7057-7061]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03621]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3376-N]


Medicare Program; Solicitation of Independent Accrediting 
Organizations To Participate in the Home Infusion Therapy Supplier 
Accreditation Program

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

ACTION: Notice.

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SUMMARY: This notice informs national accrediting organizations that 
accredit home infusion therapy suppliers of an opportunity to submit 
applications to participate in the home infusion therapy supplier 
accreditation program. This notice contains information on how to apply 
for CMS approval.

DATES: Complete applications will be considered for the January 1, 2021 
designation deadline if received at the address, provided in the 
ADDRESSES section of this notice, by 5 p.m. eastern daylight time 
(e.d.t.) on February 1, 2020.

ADDRESSES: Applications should be sent to: Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244. 
Mail stop C2-21-16, Attention: Christina Mister-Ward.

FOR FURTHER INFORMATION CONTACT: Christina Mister-Ward (410) 786-2441.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 1861(iii)(1) of the Social Security Act (``the Act'') 
defines ``home infusion therapy'' as the items and services described 
furnished by a qualified home infusion therapy supplier which are 
furnished in the individual's home. The individual must be--
     Under the care of an applicable provider; and
     With respect to whom a plan prescribing the type, amount, 
and duration of infusion therapy services that are to be furnished such 
individual has been established by a physician and is periodically 
reviewed by a physician in coordination with the furnishing of home 
infusion drugs under part B.
    According to section 1861(iii)(3)(A) of the Act, ``Applicable 
provider'' means a physician, a nurse practitioner, or a physician 
assistant. In accordance with section 1834(u)(5) of the Act, we defined 
``National accrediting organization'' at 42 CFR 488.1005 as an 
organization that accredits provider or supplier entities under a 
specific program and whose accredited provider or supplier entities 
under each program are widely dispersed geographically across the 
United States. In addition, the specific program is active, fully 
implemented, and operational.
    In the November 13, 2018 Federal Register (83 FR 56406),we 
published a final rule titled, ``Medicare and Medicaid Programs; CY 
2019 Home Health Prospective Payment System Rate Update and CY 2020 
Case-Mix Adjustment Methodology Refinements; Home Health Value-Based 
Purchasing Model; Home Health Quality Reporting Requirements; Home 
Infusion Therapy Requirements; and Training Requirements for Surveyors 
of National Accrediting Organizations.'' The November 2018 final rule 
implemented health and safety standards that home infusion therapy 
suppliers must meet; the temporary transitional payments for home 
infusion therapy services for CYs 2019; and an approval and oversight 
process for accrediting organizations (AOs) that accredit home infusion 
therapy suppliers. For more detailed information on the home therapy 
organization accreditation requirements see the November 2018 final 
rule (83 FR 56563 through 56584).
    Section 1861(iii)(3)(D)(i)(III) of the Act, as added by section 
5012(b) of the 21st Century Cures Act, requires that a home infusion 
therapy supplier be accredited by an 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 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 home infusion therapy suppliers furnishing 
home infusion therapy not later than January 1, 2021.

II. Provisions of the Notice

    This notice solicits applications from AOs with the ability to 
accredit home infusion therapy suppliers.

A. Eligible Organizations

    An accreditation organization that can show evidence of the ability 
to accredit qualified home infusion therapy suppliers as defined in 
section 1861(iii)(3)(D)(i) of the Act are eligible to apply for 
approval as a designated accreditation organization.
    To be considered for approval as a Medicare-designated home 
infusion therapy AO under 42 CFR part 488, subpart L (Sec. Sec.  
488.1000 through 488.1050), an accrediting organization must meet the 
following requirements:
     The AO must have a home infusion therapy accreditation 
program that it separates and distinguishes from any of its other 
accreditation programs (if applicable).
     The AO must have home infusion therapy accreditation 
standards that meet or exceed the Medicare home infusion therapy health 
and safety standards codified at Sec. Sec.  486.500 through 486.525 of 
our regulations.

B. Application Requirements

    To be considered for approval by Medicare as a home infusion 
therapy accrediting organization, an accrediting organization must 
submit an application to CMS requesting approval of its home infusion 
therapy accreditation program. The home infusion therapy accrediting 
organization's application must contain all of the following 
information to demonstrate that the AO's home infusion therapy 
accreditation program meets or exceeds the applicable Medicare 
requirements:
     Documentation to demonstrate that they meet the definition 
of a ``national

[[Page 7058]]

accrediting organization'' as required by 42 CFR 488.1010(a)(1).
     The Medicare provider or supplier type for which the 
organization is requesting approval or re-approval (Sec.  
488.1010(a)(2)).
     Documentation that demonstrates the home infusion therapy 
accrediting organization's ability to take into account the capacities 
of rural home infusion therapy suppliers (as required by section 
1834(u)(5)(A)(ii) of the Act and 42 CFR 488.1010(a)(3)).
     Information that demonstrates the home infusion therapy 
accrediting organization's knowledge, expertise, and experience in home 
infusion therapy (see Sec.  488.1010(a)(4)).
     A detailed crosswalk (in table format) that identifies, 
for each of the applicable Medicare requirements, the exact language of 
the organization's comparable accreditation requirements and standards 
(see Sec.  488.1010(a)(5)).
     A detailed description of the home infusion therapy 
accrediting organization's survey processes to confirm that a home 
infusion therapy supplier's processes are comparable to those of 
Medicare (see Sec.  488.1010(a)(6)). This description must include all 
of the following:
    ++ The types and frequency of surveys performed, and a rationale 
for which accreditation requirements will be evaluated via onsite 
surveys and which will be evaluated via offsite audits, or other 
strategies for ensuring accredited home infusion therapy suppliers 
maintain adherence to the home infusion therapy accreditation program 
requirements, including an explanation of how the accrediting 
organization will maintain the schedule it proposes (Sec.  
488.1010(a)(6)(i)).
    ++ Copies of the home infusion therapy accrediting organizations 
survey and audit forms, guidelines, and instructions to surveyors 
(Sec.  488.1010(a)(6)(ii)).
    ++ Documentation demonstrating that the home infusion therapy 
accrediting organization's onsite survey or offsite audit reports 
identify, for each finding of non-compliance with accreditation 
standards, the comparable Medicare home infusion therapy accreditation 
requirements, as applicable (Sec.  488.1010(a)(6)(iii)).
    ++ A description of the home infusion therapy accrediting 
organization's accreditation survey review process (Sec.  
488.1010(a)(6)(iv)).
    ++ A description of the home infusion therapy accrediting 
organization'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)(v)).
    ++ A description of the home infusion therapy accrediting 
organization'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(a)(6)(vi)).
    ++ The ability of the home infusion therapy accrediting 
organization to conduct timely reviews of accreditation applications 
(Sec.  488.1010(a)(6)(vii)).
    ++ A statement acknowledging that, as a condition for CMS approval 
of a national accrediting organization's accreditation program, the 
home infusion therapy accrediting organization agrees to provide CMS 
with information extracted from each home infusion therapy 
accreditation onsite survey, offsite audit or other evaluation 
strategies as part of its data submissions required under Sec.  
488.1010(a)(19), and, upon request from CMS, a copy of the most recent 
accreditation onsite survey, offsite audit, or other evaluation 
strategy together with any other information related to the survey as 
CMS may require (including corrective action plans) (Sec.  
488.1010(a)(6)(viii)).
    ++ A statement acknowledging that the home infusion therapy 
accrediting organization will provide timely notification to CMS when 
an accreditation survey or complaint investigation identifies an 
immediate jeopardy as that term is defined at Sec.  488.1005. Using the 
format specified by CMS, the home infusion therapy accrediting 
organization must notify CMS within 2 business days from the date the 
accrediting organization identifies the immediate jeopardy (Sec.  
488.1010(a)(6)(ix)).
     Procedures to ensure either of the following:
    ++ Unannounced onsite surveys, as appropriate, will be conducted 
periodically, including procedures that protect against unannounced 
surveys becoming known to the provider or supplier in advance of the 
visit (Sec.  488.1010(a)(7)(i)).
    ++ Offsite survey audits are performed to evaluate the quality of 
services provided which may be followed up with periodic onsite visits 
(Sec.  488.1010(a)(7)(ii)).
     The criteria for determining the size and composition of 
the home infusion therapy accrediting organization's survey, audit and 
other evaluation strategy teams for individual supplier onsite surveys. 
The home infusion therapy accrediting organization's criteria should 
include, but not be limited to the following information:
    ++ The expected number of individual home infusion therapy supplier 
locations to be surveyed using an onsite survey (Sec.  
488.1010(a)(8)(i)).
    ++ The number of home infusion therapy suppliers to be surveyed 
using off-site audits (Sec.  488.1010(a)(8)(ii)).
    ++ A description of other types of home infusion therapy 
accreditation review activities to be used (Sec.  488.1010(a)(8)(iii)).
    ++ The reasons for each type of survey (that is, initial 
accreditation survey, reaccreditation survey, and complaint survey) 
(Sec.  488.1010(a)(8)(iv)).
     The overall adequacy of the number of the home infusion 
therapy accrediting organization's surveyors, auditors, and other staff 
available to perform survey related activities, including how the 
organization will increase the size of the survey, audit, and other 
evaluation staff to match growth in the number of accredited facilities 
or programs while maintaining re-accreditation intervals for existing 
accredited facilities or programs (Sec.  488.1010(a)(9)).
     Detailed information about the individuals who perform 
onsite surveys, offsite audits or other strategies for ensuring 
accredited home infusion therapy suppliers maintain adherence to the 
home infusion therapy accreditation program requirements, including all 
of the following information:
    ++ The number and types of professional and technical staff 
available for conducting onsite surveys, offsite audits, or other 
strategies for ensuring accredited home infusion therapy suppliers 
maintain adherence to the home infusion therapy accreditation program 
requirements. (Sec.  488.1010(a)(10)(i)).
    ++ The education, employment, and experience requirements surveyors 
an auditors must meet (Sec.  488.1010(a)(10)(ii)).
    ++ The content and length of the orientation program (Sec.  
488.1010(a)(10)(iii)).
     The content, frequency and types of in-service training 
provided to survey and audit personnel (Sec.  488.1010(a)(11)).
     The evaluation systems used to monitor the performance of 
individual surveyors, auditors and survey teams (Sec.  
488.1010(a)(12)).
     The home infusion therapy accrediting organization's 
policies and procedures to avoid conflicts of interest, including the 
appearance of conflicts of interest, involving individuals who conduct 
surveys, audits or participate in accreditation decisions (Sec.  
488.1010(a)(13)).

[[Page 7059]]

     The policies and procedures used when a home infusion 
therapy supplier has a dispute regarding survey or audit findings, or 
an adverse decision (Sec.  488.1010(a)(14)).
     Procedures for the home infusion therapy supplier to use 
to notify the home infusion therapy accrediting organization when the 
accredited home infusion therapy supplier does the either of the 
following (Sec.  488.1010(a)(15)):
    ++ Removes or ceases furnishing services for which they are 
accredited.
    ++ Adds services for which they are not accredited.
     The home infusion therapy accrediting organization's 
procedures for responding to, and investigating complaints against 
accredited facilities, including policies and procedures regarding 
referrals, when applicable, to appropriate licensing bodies, ombudsmen 
offices, and CMS (Sec.  488.1010(a)(16)).
     A description of the home infusion therapy accrediting 
organization's accreditation status decision-making process. The home 
infusion therapy accrediting organization must furnish the following 
(Sec.  488.1010(a)(17)):
    ++ Its process for addressing deficiencies identified with 
accreditation program requirements, and the procedures used to monitor 
the correction of deficiencies identified during an accreditation 
survey and audit process.
    ++ A description of all types and categories of accreditation 
decisions associated with the program, including the duration of each 
of the organization's accreditation decisions.
    ++ Its policies and procedures for the granting, withholding or 
removal of accreditation status for facilities that fail to meet the 
accrediting organization's standards or requirements, assignment of 
less than full accreditation status or other actions taken by the 
organization in response to non-compliance with its standards and 
requirements.
    ++ A statement acknowledging that the home infusion therapy 
accrediting organization agrees to notify CMS (in a manner CMS 
specifies) of any decision to revoke, terminate, or revise the 
accreditation status of a home infusion therapy supplier, within 3 
business days from the date the organization takes an action.
     A list of all currently accredited home infusion therapy 
suppliers, the type and category of accreditation, currently held by 
each, and the expiration date for each home infusion therapy supplier's 
current accreditation (Sec.  488.1010(a)(18)).
     A schedule of all survey activity (such as onsite surveys, 
offsite audits and other types if survey strategies) expected to be 
conducted by the organization during the 6-month period following 
submission of an initial or renewal application (Sec.  
488.1010(a)(19)).
     A written presentation that demonstrates the 
organization's ability to furnish CMS with electronic data (Sec.  
488.1010(a)(20)).
     A description of the home infusion therapy accrediting 
organization's data management and analysis system with respect to its 
surveys and accreditation decisions, including all of the following 
(Sec.  488.1010(a)(21)):
    ++ A detailed description of how the home infusion therapy 
accrediting organization uses its data to assure the compliance of its 
home infusion therapy accreditation program with the Medicare home 
infusion therapy accreditation program requirements.
    ++ A written statement acknowledging that the home infusion therapy 
accrediting organization agrees to submit timely, accurate, and 
complete data that CMS has determined is both necessary to evaluate the 
accrediting organization's performance and is not unduly burdensome for 
the accrediting organization to submit.
    ++ The organization must submit necessary data according to the 
instructions and timeframes CMS specifies.
    ++ Data to be submitted includes the following:
    --Accredited home infusion therapy supplier identifying 
information.
    --Survey findings.
    --Quality measures.
    --Notices of accreditation decisions.
     The three most recent annual audited financial statements 
of the home infusion therapy accrediting organization that demonstrate 
that the organization's staffing, funding, and other resources are 
adequate to perform the required surveys, audits, and related 
activities to maintain the accreditation program (Sec.  
488.1010(a)(22)).
     A written statement acknowledging that, as a condition for 
approval, the home infusion therapy accrediting organization agrees to 
the following (Sec.  488.1010(a)(23)):
    ++ Voluntary termination. Provide written notification to CMS and 
all home infusion therapy suppliers accredited under its CMS-approved 
home infusion therapy accreditation program at least 180 calendar days 
in advance of the effective date of a decision by the home infusion 
therapy accrediting organization to voluntarily terminate its CMS-
approved home infusion therapy accreditation program and the 
implications for the suppliers' payment status once their current term 
of accreditation expires in accordance with the requirements at Sec.  
488.1045(a).
    ++ Involuntary termination. Provide written notification to all 
accredited home infusion therapy suppliers accredited under its CMS-
approved home infusion therapy accreditation program no later than 30 
calendar days after the notice is published in the Federal Register 
announcing that CMS is withdrawing its approval of its accreditation 
program and the implications for the home infusion therapy supplier's 
payment status in accordance with the requirements at Sec.  488.1045(b) 
once their current term of accreditation expires.
    --For both voluntary and involuntary terminations, provide a second 
written notification to all accredited home infusion therapy suppliers 
10 calendar days prior to the organization's accreditation program 
effective date of termination.
    --Notify CMS, in writing (electronically or hard copy), within 2 
business days of a deficiency identified in any accredited home 
infusion therapy supplier from any source where the deficiency poses an 
immediate jeopardy to the home infusion therapy supplier's 
beneficiaries or a hazard to the general public.
    ++ Summary accreditation activity data and trends. Provide, on an 
annual basis, summary accreditation activity data and trends including 
the following:
    --Deficiencies.
    --Complaints.
    --Terminations.
    --Withdrawals.
    --Denials.
    --Accreditation decisions.
    --Other survey-related activities as specified by CMS.
    ++ Termination of an accreditation organization. If CMS terminates 
a home infusion therapy accrediting organization's approved status, the 
home infusion therapy accrediting organization must work 
collaboratively with CMS to direct its accredited home infusion therapy 
suppliers to the remaining CMS-approved accrediting organizations 
within a reasonable period of time.
    ++ Notification of proposed changes. Notify CMS at least 60 days in 
advance of the implementation date of any significant proposed changes 
in its CMS-approved home infusion therapy accreditation program and 
that it agrees not to implement the proposed changes without prior 
written notice of continued program approval from CMS, except as 
provided for at Sec.  488.1040(b)(2).

[[Page 7060]]

    ++ Response to a written notice from CMS. A statement acknowledging 
that, in response to a written notice from CMS to the home infusion 
therapy accrediting organization of a change in the applicable home 
infusion therapy accreditation requirements or survey process, the 
organization will provide CMS with proposed corresponding changes in 
the accrediting organization's home infusion therapy accreditation 
requirements for its CMS-approved home infusion therapy accreditation 
program to ensure that its accreditation standards continue to meet or 
exceed those of Medicare, or survey process remains comparable with 
that of Medicare. The home infusion therapy accrediting organization 
must comply with the following requirements:
    --The proposed changes must be submitted within 30 calendar days of 
the date of the written CMS notice to the home infusion therapy 
accrediting organization or by a date specified in the notice, 
whichever is later. CMS gives due consideration to a home infusion 
therapy accrediting organization's request for an extension of the 
deadline as long as it is submitted prior to the due date.
    --The proposed changes are not to be implemented without prior 
written notice of continued program approval from CMS, except as 
provided for at Sec.  488.1040(b)(2)(ii).
     The organization's proposed fees for accreditation, 
including any plans for reducing the burden and cost of accreditation 
to small and rural suppliers (Sec.  488.1010(a)(2)).
     Acknowledgement agreeing to release of accreditation 
surveys. The home infusion accreditation organization must include a 
statement within its accreditation application and accreditation 
agreement with each home infusion therapy supplier, agreeing to release 
its most current accreditation survey and any information related to 
the survey that CMS may require, including the home infusion therapy 
supplier's corrective action plans (Sec.  488.1025).
     Acknowledgement of Onsite Observation of 
Accrediting Organizations. The home infusion accreditation organization 
must include a statement its accreditation application to permit CMS to 
conduct an onsite inspection of the home infusion therapy accreditation 
organizations operations and offices at any time to verify the 
organization's representation and to assess the organizations 
compliance with its own policies and procedures (Sec.  488.1040).
     Acknowledgement of Reconsideration Process. The 
home infusion therapy accreditation organization must include a 
statement acknowledging understanding of the reconsideration process. 
The home infusion therapy accreditation organization may request 
reconsideration of an unfavorable decision made by CMS, as stated at 
(Sec.  488.1050).

C. Requests for Additional Information by CMS (Sec.  488.1010(b))

    If CMS determines that additional information is necessary to make 
a determination for approval or denial of the home infusion therapy 
accrediting organization's initial application (or reapplication) for 
CMS-approval of an accreditation program, CMS may require that the home 
infusion therapy accrediting organization submit any additional 
documentation and attestations necessary as a condition of approval of 
accreditation. If such additional information is required, CMS will 
notify the home infusion therapy accrediting organization and afford it 
an opportunity to provide the additional information.

D. Withdrawal of an Application (Sec.  488.1010(c))

    A home infusion therapy accrediting organization may withdraw its 
initial application seeking CMS' approval of its home infusion therapy 
accreditation program at any time before CMS publishes the final notice 
as provided in Sec.  488.1020(b).

E. Evaluation of Applications

    An application review team will evaluate all applications submitted 
by accrediting organizations seeking designation as CMS-approved home 
infusion therapy accrediting organizations under section 1834(u)(5)(B) 
of the Act using the processes for consideration set forth in part 488, 
subpart L.

F. Notice of Approval or Disapproval of Application (Sec.  488.1010(d))

    We are required to send a notice of its decision to approve or 
disapprove the home infusion therapy accrediting organization's 
application within 210 calendar days from the date CMS determines the 
home infusion therapy accrediting organization's application is 
complete. The final notice will specify the following:
     The basis for the decision.
     The effective date.
     The term of the approval (not exceed 6 years).

G. Public Notice and Comment (Sec.  488.1020)

    We are required to publish a notice in the Federal Register when 
the following conditions are met:
     Proposed notice. CMS publishes a notice after 
the receipt of a completed application from a national home infusion 
therapy accrediting organization seeking CMS's approval of a home 
infusion therapy accreditation program. The notice identifies the home 
infusion therapy accrediting organization, the type of suppliers 
covered by the home infusion therapy accreditation program, and 
provides at least a 30-day public comment period (beginning on the date 
of publication) (Sec.  488.1020(a)).
     Final notice. The final notice announces CMS 
decision to approve or deny a national accrediting organization 
application. The notice specifies the basis for the CMS decision (Sec.  
488.1020(b)).
    ++ Approval or re-approval. If CMS approves or re-approves the home 
infusion therapy accrediting organization's home infusion therapy 
accreditation program, the final notice at a minimum includes the 
following information:
    ++ A description of how the home infusion therapy accreditation 
program meets or exceeds Medicare home infusion therapy accreditation 
program requirements.
    ++ The effective date of approval (no later than the publication 
date of the notice).
    ++ The term of the approval (6 years or less).
     Denial. If CMS does not approve the home infusion therapy 
accrediting organization's accreditation program, the final notice 
describes the following:
    ++ How the home infusion therapy accrediting organization fails to 
meet Medicare home infusion therapy accreditation program requirements.
    ++ The effective date of the decision.

III. 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.).


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    Dated: February 19, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-03621 Filed 2-27-19; 11:15 am]
 BILLING CODE 4120-01-P