Medicare Program; Approval of Application by the Accreditation Commission for Healthcare for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program, 23046-23047 [2020-08718]

Download as PDF 23046 Federal Register / Vol. 85, No. 80 / Friday, April 24, 2020 / Notices [FR Doc. 2020–08719 Filed 4–23–20; 8:45 am] BILLING CODE 4120–01–C DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–3390–FN] Medicare Program; Approval of Application by the Accreditation Commission for Healthcare for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program Centers for Medicare and Medicaid Services, HHS. ACTION: Final notice. AGENCY: This final notice announces our decision to approve the Accreditation Commission for Healthcare for initial recognition as a national accrediting organization for home infusion therapy suppliers that wish to participate in the Medicare program. A home infusion therapy supplier that participates must meet the Medicare conditions for coverage (CfCs). DATES: The approval announced in this final notice is effective April 23, 2020 through April 23, 2024. FOR FURTHER INFORMATION CONTACT: Christina Mister-Ward, (410) 786–2441. Lillian Williams, (410) 786–8636. SUPPLEMENTARY INFORMATION: khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: 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 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. VerDate Sep<11>2014 17:03 Apr 23, 2020 Jkt 250001 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 ‘‘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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 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 November 25, 2019 Federal Register (84 FR 64904), we published a proposed notice announcing Accreditation Commission for Health Care’s (ACHC’s) request for initial approval of its Medicare HIT accreditation program. In the November 25, 2019 proposed notice, we detailed our evaluation criteria. Under section 1834(u)(5) the Act and in our regulations at § 488.1010, we conducted a review of ACHC Medicare home infusion accreditation application in accordance with the criteria specified by our regulations, which included, but are not limited to the following: • An onsite administrative review of ACHC’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 an ACHC to conduct timely review of accreditation applications. • The ability of an ACHC to take into account the capacities of suppliers located in a rural area. • The comparison of an ACHC’s Medicare home infusion therapy accreditation program standards to our current Medicare home infusion therapy conditions for coverage (CfCs). • ACHC’s survey process to determine the following: ++ The composition of the survey team, surveyor qualifications, and ACHC’s ability to provide continuing surveyor training. ++ ACHC’s processes, including periodic resurvey and the ability to investigate and respond appropriately to complaints against accredited home infusion therapies. ++ Evaluate ACHC’s procedures for monitoring home infusion therapies it has found to be out of compliance with ACHC’s program requirements. E:\FR\FM\24APN1.SGM 24APN1 Federal Register / Vol. 85, No. 80 / Friday, April 24, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES ++ Assess ACHC’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 ACHC’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 ACHC’s staff and other resources. ++ Confirm ACHC’s ability to provide adequate funding for performing required surveys. ++ Confirm ACHC’s policies with respect to surveys being unannounced. ++ Review ACHC’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 ACHC’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 November 25, 2019 proposed notice also solicited public comments regarding whether ACHC’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 ACHC’s Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements We compared ACHC’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 ACHC’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, ACHC has completed revising its standards and certification processes in order to meet the condition at: • § 486.520(c), to address the requirement of the plan of care must be periodically reviewed by the physician. • § 486.525(a)(3), to address the requirement of remote monitoring for the provision of home infusion therapy. • § 488.1010(a)(6)(iv), to revise ACHC’s survey procedures for surveys. • § 488.1010(a)(6)(v), to revise ACHC’s procedures and timelines for notifying a surveyed or audited home infusion therapy supplier of noncompliance with the home infusion VerDate Sep<11>2014 17:03 Apr 23, 2020 Jkt 250001 therapy accreditation program’s standards. • § 488.1010(a)(6)(vi), to revise ACHC’s procedures and timelines for monitoring the home infusion therapy supplier’s correction of identified noncompliance with the accreditation program’s standards. B. Term of Approval Based on the review and observations described in section III. of this final notice, we have determined that ACHC’s requirements for HITs meet or exceed our requirements. Therefore, we approve ACHC as a national accreditation organization for HITs that request participation in the Medicare program, effective April 23, 2020 through April 23, 2024. IV. Collection of Information Requirements This document does not impose information collection and requirements, that is, reporting, recordkeeping or third party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, having reviewed and approved this document, authorizes Evell J. Barco Holland, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register. Dated: April 14, 2020. Evell J. Barco Holland, Federal Register Liaison, Department of Health and Human Services. [FR Doc. 2020–08718 Filed 4–23–20; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1987–P–0074] Canned Pacific Salmon Deviating From Identity Standard; Amendment of Temporary Marketing Permit AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is amending Bumble Bee Seafoods Inc.’s temporary permit to market test canned skinless and boneless chunk salmon packed in water that contains sodium SUMMARY: PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 23047 tripolyphosphate to inhibit protein curd formation during retorting. The temporary permit is amended to allow for the canned skinless and boneless chunk salmon packed in water with or without sodium tripolyphosphate and to update the manufacturing location. This amendment will allow the applicant to continue to test market the test product and collect data on consumer acceptance of the test product. FOR FURTHER INFORMATION CONTACT: Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2371. SUPPLEMENTARY INFORMATION: In the Federal Register of July 13, 1987 (52 FR 26186), we issued a notice announcing that we had issued a temporary permit to Bumble Bee Seafoods, Inc., San Diego, CA 92123, to market test products identified as canned skinless and boneless chunk salmon packed in water and containing added sodium tripolyphosphate to inhibit protein curd formation during retorting. The permit allowed for the test product to be manufactured at a plant located in Petersburg, AK. We issued the permit to facilitate market testing of products that deviate from the requirements of the standard of identity for canned Pacific salmon in 21 CFR 161.170, which were issued under section 401 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341). In the Federal Register of April 8, 1988 (53 FR 11710), we issued a notice announcing that we had amended the temporary permit to permit the test product be manufactured at one additional plant, Chugach Alaska Fisheries, Inc., Ocean Dock Rd., Cordova, AK 99574. In the Federal Register of September 6, 1988 (53 FR 34354), we issued another notice announcing that we were extending the expiration date of the permit to either the effective date of a final rule for any proposal to amend the standard of identity for canned Pacific salmon that may result from the National Food Processors Association’s petition, submitted on behalf of Bumble Bee Seafoods, Inc., and other salmon packers holding temporary permits, or 30 days after termination of such proposal. Under our regulations at 21 CFR 130.17(f), we are amending the temporary permit issued to Bumble Bee Seafoods, Inc., to allow for the canned skinless and boneless chunk salmon packed in water with or without sodium tripolyphosphate and to allow the test product to be manufactured only at one E:\FR\FM\24APN1.SGM 24APN1

Agencies

[Federal Register Volume 85, Number 80 (Friday, April 24, 2020)]
[Notices]
[Pages 23046-23047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3390-FN]


Medicare Program; Approval of Application by the Accreditation 
Commission for Healthcare 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 
Accreditation Commission for Healthcare for initial recognition as a 
national accrediting organization for home infusion therapy suppliers 
that wish to participate in the Medicare program. A home infusion 
therapy supplier that participates must meet the Medicare conditions 
for coverage (CfCs).

DATES: The approval announced in this final notice is effective April 
23, 2020 through April 23, 2024.

FOR FURTHER INFORMATION CONTACT: 
Christina Mister-Ward, (410) 786-2441.
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 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 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 ``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 November 25, 2019 Federal Register (84 FR 64904), we 
published a proposed notice announcing Accreditation Commission for 
Health Care's (ACHC's) request for initial approval of its Medicare HIT 
accreditation program. In the November 25, 2019 proposed notice, we 
detailed our evaluation criteria. Under section 1834(u)(5) the Act and 
in our regulations at Sec.  488.1010, we conducted a review of ACHC 
Medicare home infusion accreditation application in accordance with the 
criteria specified by our regulations, which included, but are not 
limited to the following:
     An onsite administrative review of ACHC'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 an ACHC to conduct timely review of 
accreditation applications.
     The ability of an ACHC to take into account the capacities 
of suppliers located in a rural area.
     The comparison of an ACHC's Medicare home infusion therapy 
accreditation program standards to our current Medicare home infusion 
therapy conditions for coverage (CfCs).
     ACHC's survey process to determine the following:
    ++ The composition of the survey team, surveyor qualifications, and 
ACHC's ability to provide continuing surveyor training.
    ++ ACHC's processes, including periodic resurvey and the ability to 
investigate and respond appropriately to complaints against accredited 
home infusion therapies.
    ++ Evaluate ACHC's procedures for monitoring home infusion 
therapies it has found to be out of compliance with ACHC's program 
requirements.

[[Page 23047]]

    ++ Assess ACHC'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 ACHC'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 ACHC's staff and other resources.
    ++ Confirm ACHC's ability to provide adequate funding for 
performing required surveys.
    ++ Confirm ACHC's policies with respect to surveys being 
unannounced.
    ++ Review ACHC'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 ACHC'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 November 25, 2019 proposed notice also solicited public 
comments regarding whether ACHC'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 ACHC's Standards and Requirements for 
Accreditation and Medicare Conditions and Survey Requirements
    We compared ACHC'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 ACHC'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, ACHC has completed revising 
its standards and certification processes in order to meet the 
condition at:
     Sec.  486.520(c), to address the requirement of the plan 
of care must be periodically reviewed by the physician.
     Sec.  486.525(a)(3), to address the requirement of remote 
monitoring for the provision of home infusion therapy.
     Sec.  488.1010(a)(6)(iv), to revise ACHC's survey 
procedures for surveys.
     Sec.  488.1010(a)(6)(v), to revise ACHC's procedures and 
timelines for notifying a surveyed or audited home infusion therapy 
supplier of non-compliance with the home infusion therapy accreditation 
program's standards.
     Sec.  488.1010(a)(6)(vi), to revise ACHC's procedures and 
timelines for monitoring the home infusion therapy supplier's 
correction of identified non-compliance with the accreditation 
program's standards.

B. Term of Approval

    Based on the review and observations described in section III. of 
this final notice, we have determined that ACHC's requirements for HITs 
meet or exceed our requirements. Therefore, we approve ACHC as a 
national accreditation organization for HITs that request participation 
in the Medicare program, effective April 23, 2020 through April 23, 
2024.

IV. Collection of Information Requirements

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

    Dated: April 14, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-08718 Filed 4-23-20; 8:45 am]
 BILLING CODE 4120-01-P

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