2019-15127. Medicare Program; Application From The Joint Commission (TJC) for Initial CMS-Approval of Its Home Infusion Therapy (HIT) Accreditation Program

AGENCY:

Centers for Medicare and Medicaid Services, HHS.

ACTION:

Proposed notice with request for comment.

SUMMARY:

This proposed notice acknowledges the receipt of an application from The Joint Commission (TJC) for initial recognition as a national accrediting organization providing home infusion therapy (HIT) services that wish to participate in the Medicare program. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 15, 2019.

ADDRESSES:

In commenting, please refer to file code CMS-3381-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.

2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3381-PN, P.O. Box 8016, Baltimore, MD 21244-8010.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3381-PN, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Christina Mister-Ward, [phone]

Shannon Freeland, [phone]

Lillian Williams, [phone]

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov . Follow the search instructions on that website to view public comments.

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 added section 1861(iii) to the Social Security Act (the Act) establishing a new Medicare benefit for home infusion therapy services. Section 1861(iii)(1) of 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
• Have a plan of care prescribing the type, amount, and duration of infusion therapy services that are to be furnished/established for him/her and periodically reviewed by a physician, in coordination with the furnishing of home infusion drugs under Part B.
• An “applicable provider” would mean a physician, a nurse practitioner, and a physician assistant.

Section 1861(iii)(3)(D)(III) of the Act, requires that a qualified 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 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 home infusion therapy suppliers furnishing home infusion therapy not later than January 1, 2021. Section 1861(iii)(3)(D) of the Act defines “qualified home infusion therapy suppliers” as being accredited by a CMS-approved AO.

On March 1, 2019, 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 accrediting organizations that accredit home infusion therapy suppliers of an opportunity to submit applications to participate in the home infusion therapy 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 accrediting organizations for home infusion therapy organizations are located at 42 CFR part 488, subpart L. The requirements for home infusion therapy suppliers are located at 42 CFR part 486, subpart I.

II. Approval of Accreditation Organizations

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 regulations at 42 CFR 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 publish notice of approval or denial of the application.

The purpose of this proposed notice is to inform the public of The Joint Commission's (TJC's) initial request for CMS approval of its HIT accreditation program. This notice also solicits public comment on whether TJC's requirements meet or exceed the Medicare conditions of participation for HIT services.

III. Evaluation of Deeming Authority Request

TJC submitted all the necessary materials to enable us to make a determination concerning its request for initial approval of its HIT accreditation program. This application was determined to be complete on May 19, 2019. Under section 1834(u)(5) of the Act and § 488.1010 (Application and re-application procedures for national home infusion therapy accrediting organizations), our review and evaluation of TJC will be conducted in accordance with, but not necessarily limited to, the following factors:

• The equivalency of TJC's standards for HIT as compared with CMS' HIT conditions for certification.
• TJC's survey process to determine the following:

++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.

++ The comparability of TJC's to CMS standards and processes, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.

++ TJC's processes and procedures for monitoring a HIT found out of compliance with TJC's program requirements.

++ TJC's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.

++ TJC's capacity to provide CMS with electronic data and reports necessary for effective assessment and interpretation of the organization's survey process.

++ The adequacy of TJC's staff and other resources, and its financial viability.

++ TJC's capacity to adequately fund required surveys.

++ TJC's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.

++ TJC's 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).

• TJC's agreement or policies for voluntary and involuntary termination of suppliers.
• TJC agreement or policies for voluntary and involuntary termination of the HIT AO program.

IV. Collection of Information Requirements

This document does not impose information collection and requirements, that is, reporting, recordkeeping or third party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

V. Response to Public Comments

Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.

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

Dated: July 3, 2019.

Seema Verma,

Administrator, Centers for Medicare & Medicaid Services.