Centers for Medicare & Medicaid Services (CMS), HHS.
This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. A HHA that participates in Medicaid must also meet the Medicare conditions of participation (CoPs).
The decision announced in this final notice is effective March 31, 2020 through March 31, 2026.
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FOR FURTHER INFORMATION CONTACT:
Sharon Lash (410) 786-9457.
Caecilia Blondiaux (410) 786-2190.
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Under the Medicare program, eligible beneficiaries may receive covered services from a home health agency (HHA), provided that certain requirements are met. Sections 1861(m) and (o), 1891 and 1895 of the Social Security Act (the Act) establish distinct criteria for an entity seeking designation as an HHA. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities and other entities are at 42 CFR part 488. The regulations at 42 CFR parts 409 and 484 specify the conditions that an HHA must meet to participate in the Medicare program, the scope of covered services and the conditions for Medicare payment for home health care.
Generally, to enter into a provider agreement with the Medicare program, an HHA must first be certified by a state survey agency as complying with the conditions or requirements set forth in 42 CFR part 484 of our regulations. Thereafter, the HHA is subject to regular surveys by a state survey agency to determine whether it continues to meet these requirements. However, there is an alternative to certification surveys by state agencies. Accreditation by a nationally recognized Medicare accreditation program approved by CMS may substitute for both initial and ongoing state review.
Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met our requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary of Health and Human Services as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for CMS approval of their accreditation program under 42 CFR part 488, subpart A must provide CMS with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of accrediting organizations are set forth at § 488.5. Section 488.5(e)(2)(i) requires accrediting organizations to reapply for continued approval of its Medicare accreditation program every 6 years or sooner as determined by CMS.
The Joint Commission's (TJC's) term of approval for their HHA accreditation program expires March 31, 2020.
II. Application Approval Process
Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS-Start Printed Page 18246approval of an accreditation program is conducted in a timely manner. The Act provides us 210 days after the date of receipt of a complete application, with any documentation necessary to make the determination, to complete our survey activities and application process. Within 60 days after receiving a complete application, we must publish a notice in the Federal Register that identifies the national accrediting body making the request, describes the request, and provides no less than a 30-day public comment period. At the end of the 210-day period, we must publish a notice in the Federal Register approving or denying the application.
III. Provisions of the Proposed Notice
In the October 24, 2019 Federal Register (84 FR 57026), we published a proposed notice announcing TJC's request for continued approval of its Medicare HHA accreditation program. In the October 24, 2019 proposed notice, we detailed our evaluation criteria. Under section 1865(a)(2) of the Act and in our regulations at § 488.5, we conducted a review of TJC's Medicare HHA accreditation application in accordance with the criteria specified by our regulations, which include, but are not limited to the following:
- An onsite administrative review of TJC's: (1) Corporate policies; (2) financial and human resources available to accomplish the proposed surveys; (3) procedures for training, monitoring, and evaluation of its HHA surveyors; (4) ability to investigate and respond appropriately to complaints against accredited HHAs; and (5) survey review and decision-making process for accreditation.
- The comparison of TJC's Medicare HHA accreditation program standards to our current Medicare HHA CoPs.
- A documentation review of TJC's survey process to do the following:
++ Determine the composition of the survey team, surveyor qualifications, and TJC's ability to provide continuing surveyor training.
++ Compare TJC's processes to those we require of state survey agencies, including periodic resurvey and the ability to investigate and respond appropriately to complaints against accredited HHAs.
++ Evaluate TJC's procedures for monitoring HHAs it has found to be out of compliance with TJC's program requirements. (This pertains only to monitoring procedures when TJC identifies non-compliance. If noncompliance is identified by a state survey agency through a validation survey, the state survey agency monitors corrections as specified at § 488.9(c)).
++ Assess TJC's ability to report deficiencies to the surveyed HHAs and respond to the HHAs plan of correction in a timely manner.
++ Establish TJC'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 TJC's staff and other resources.
++ Confirm TJC's ability to provide adequate funding for performing required surveys.
++ Confirm TJC's policies with respect to surveys being unannounced.
++ Confirm TJC'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 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 we may require, including corrective action plans.
In accordance with section 1865(a)(3)(A) of the Act, the October 24, 2019 proposed notice also solicited public comments regarding whether TJC's requirements met or exceeded the Medicare CoPs for HHA. No comments were received in response to our proposed notice.
IV. Provisions of the Final Notice
A. Differences Between TJC's Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements
We compared TJC's HHA accreditation requirements and survey process with the Medicare CoPs of parts 409 and 484, and the survey and certification process requirements of parts 488 and 489. Our review and evaluation of TJC's HHA 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, TJC has completed revising its standards and certification processes in order to do all of the following:
- Meet the requirements of all of the following regulations:
++ Section 484.45 to address that HHAs must electronically report all OASIS data collected in accordance with § 484.55.
++ Section 484.50 to include language referencing patient representatives, to be included within the “Patient Rights” condition of participation.
++ Section 484.50(a)(1)(i) to incorporate language related to the right of persons who have limited English proficiency and individuals with disabilities to receive understandable, accessible communications.
++ Section 484.50(c)(11) to include the patient's rights to voice grievances to an outside entity.
++ Section 484.50(d)(1) to address safe and appropriate transfer of patients.
++ Section 484.50(e)(2) to include reporting of injuries of unknown source, or misappropriation of patient property.
++ Section 484.60 to address “individualized” and “patient-specific” plans of care, specifically that the individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including identification of the responsible discipline(s), and the measurable outcomes that the HHA anticipates will occur as a result of implementing and coordinating the plan of care.
++ Section 484.60(b)(4) to address that stamped signatures are not acceptable unless used in a case of an author with a physical disability that can provide proof to a CMS contractor of his/her inability to sign their signature due to their disability (Rehabilitation Act of 1973).
++ Section 484.80(g)(1) to include professions of physical therapist, speech-language pathologist, or occupational therapist professions in any of their standards where “appropriate skilled professional” is found in the regulatory language.
++ Section 484.105(h)(2)(i) and 484.105(h)(2)(ii)(B) to include that transactions that are separated in time, but are components of an overall plan or patient care objective, are viewed in their entirety without regard to their timing and to include section 1122 of the Act (42 U.S.C. 1320a-1) and implementing regulations.
++ Section 484.115(a)(1) to address citable standards to this CoP regarding HHA administrators.
- Provide clarifications and training to surveyors related to the verification of written documentation of the facility's emergency preparedness program as required under § 484.102.
- Provide training to TJC surveyors related to report gathering, specifically the requirements for CASPER and OASIS reports.
- Make changes to the amount of detail provided to the facility during TJC's daily briefing to ensure tracer methodology does not change the integrity of the survey process.
- Remove previous references to the educational and consultative nature of TJC's services when TJC is conducting Start Printed Page 18247surveys, particularly during communications with the facility. Accrediting organization survey processes should emphasize facility compliance with Medicare's health and safety standards, rather than any educational function.
B. Term of Approval
Based on our review and observations described in section III. of this final notice, we approve TJC as a national accreditation organization for HHAs that request participation in the Medicare program. The decision announced in this final notice is effective March 31, 2020 through March 31, 2026.
V. Collection of Information Requirements
This document does not impose information collection requirements, that is, reporting recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
The Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, having reviewed and approved this document, is delegating the authority to electronically sign this document to Evell J. Barco Holland, who is the Federal Register Liaison, for purposes of publication in the Federal Register.
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Dated: March 26, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of Health and Human Services.
[FR Doc. 2020-06792 Filed 3-31-20; 8:45 am]
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