Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [CMS-3457-FN]

# AGENCY:

Centers for Medicare & Medicaid Services, HHS.

# ACTION:

Notice.

# SUMMARY:

This notice acknowledges the approval of an application by Community Health Accreditation Partner Inc., for continued CMS-approval as a national accrediting organization for its hospice programs that wish to participate in the Medicare or Medicaid programs.

# DATES:

The decision announced in this notice is applicable November 20, 2024 through November 20, 2029.

# FOR FURTHER INFORMATION CONTACT:

Lillian Williams, (410) 786-8636.

Erin Imhoff, (410) 786-2337.

# SUPPLEMENTARY INFORMATION:

## I. Background

Under the Medicare program, eligible beneficiaries may receive covered services in a hospice provided certain requirements are met by the hospice. Section 1861(dd) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as a hospice. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 418 specify the conditions that a hospice must meet in order to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for hospices.

                    Generally, to enter into an agreement, a hospice must first be certified as complying with the conditions set forth in part 418 and recommended to the Centers for Medicare & Medicaid (CMS) for participation by a state survey agency. Thereafter, the hospice is                           ( print page 89016)                        subject to periodic surveys by a state survey agency to determine whether it continues to meet these conditions. 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 the Secretary of the Department of Health and Human Services (the Secretary) finds that accreditation of a provider entity by an approved national accrediting organization (AO) meets or exceeds all applicable Medicare conditions, we may treat the provider entity as having met those conditions; that is, we may “deem” the provider entity to be in compliance. Accreditation by an AO is voluntary and is not required for Medicare participation.

If an AO is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national AO's approved program may be deemed to meet the Medicare conditions. A national AO applying for CMS approval of their accreditation program under 42 CFR part 488, subpart A, must provide CMS with reasonable assurance that the AO requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of AOs are set forth at § 488.5. Section 488.5(e)(2)(i) requires AOs to reapply for continued approval of its Medicare accreditation program every 6 years or sooner as determined by CMS. The Community Health Accreditation Partner's (CHAP'S) term of approval as a recognized accreditation program for its hospice accreditation program expires November 20, 2024.

## 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-approval 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 June 7, 2024,                     **Federal Register**                     (89 FR 48646), we published a proposed notice announcing CHAP's request for continued approval of its Medicare hospice accreditation program. In the June 7, 2024, 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 CHAP's Medicare hospice accreditation application in accordance with the criteria specified by our regulations, which include, but are not limited to the following:                
    - A virtual administrative review of CHAP's: (1) corporate policies; (2) financial and human resources available to accomplish the proposed surveys; (3) procedures for training, monitoring, and evaluation of its hospice surveyors; (4) ability to investigate and respond appropriately to complaints against accredited hospices; and (5) survey review and decision-making process for accreditation.
    - The comparison of CHAP's Medicare hospice accreditation program standards to our current Medicare hospice CoPs.
    - A documentation review of CHAP's survey process to—

++ Determine the composition of the survey team, surveyor qualifications, and CHAP's ability to provide continuing surveyor training.

++ Compare CHAP'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 hospices.

++ Evaluate CHAP's procedures for monitoring hospices it has found to be out of compliance with CHAP's program requirements. (This pertains only to monitoring procedures when CHAP 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 CHAP's ability to report deficiencies to the surveyed hospice and respond to the hospice's plan of correction in a timely manner.

++ Establish CHAP'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 CHAP's staff and other resources.

++ Confirm CHAP's ability to provide adequate funding for performing required surveys.

++ Confirm CHAP's policies with respect to surveys being unannounced.

++ Confirm CHAP'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 CHAP'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.

In accordance with section 1865(a)(3)(A) of the Act, the June 7, 2024 proposed notice also solicited public comments regarding whether CHAP's requirements met or exceeded the Medicare CoPs for hospices. We received one comment, which was out of the scope of the proposed notice.

## IV. Provisions of the Final Notice

### A. Differences Between CHAP's Standards and Requirements for Accreditation and Medicare Conditions and Survey Requirements

We compared CHAP's hospice accreditation requirements and survey process with the Medicare CoPs of part 418, and the survey and certification process requirements of parts 488 and 489. Our review and evaluation of CHAP's hospice 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, CHAP has completed revising its standards and certification processes in order to meet the requirements at:
    - Section 418.52(c)(5), to include reference to 45 CFR parts 160  and  164 .
    - Section 418.62(a), to include reference to § 418.114.
    - Section 418.64(b)(2), to address the requirement that state law permits registered nurses to see, treat, and write orders for patients, then registered nurses may provide services to beneficiaries receiving hospice care.
    - Section 418.64(c), to indicate that services are not only provided under the direction of a physician but also by a qualified social worker.
    - Section 418.66(a)(3)(i) through (iv), to include all the requirements that are entailed in “good faith efforts” to hire nurses.
    - Section 418.74(d), to address the requirement that if a hospice wishes to receive a 1-year extension, it must submit a request to CMS before the expiration of the waiver period and certify that conditions under which it originally requested the waiver have not changed since the initial waiver was granted.       ( print page 89017)      
    - Section 418.76(k)(2), to address the requirement for instructions to be prepared by the interdisciplinary group.
    - Section 418.104(c), to include reference to 45 CFR parts 160  and  164 .
    - Section 418.106(b)(1)(iii), to address this requirement to allow a physician assistant to order drugs in accordance with state scope of practice requirements and hospice policy.
    - Section 418.110(d)(2), to address the regulatory Life Safety Code (LSC) waiver requirement.
    - Section 418.110(d)(3), to address the requirement that the provisions of the adopted edition of the LSC do not apply in a State if we find that a fire and safety code imposed by State law adequately protects patients in hospices.
    - Section 418.110(e)(2), to address the Health Care Facilities Code waiver allowance.

In addition to the standards review, we also reviewed CHAP's comparable survey processes, which were conducted as described in section III. of this notice, and yielded the following areas where, as of the date of this notice, CHAP has completed revising its survey processes to demonstrate that it uses survey processes that are comparable to state survey agency processes by:
    - Revising CHAP's surveyor guide to include comparable guidance relating to situations that might require discontinuation or refusal to conduct exit conference activities or share with CMS additional materials that are used by CHAP hospice program surveyors.
    - Revising CHAP's surveyor guidance to be comparable with Appendix M related to inpatient hospice care.
    - Revising CHAP's surveyor guide to include comparable guidance on reviewing personnel records for training requirements.
    - Revising CHAP's Hospice Accreditation Processes and resources to include the applicable sections of the Health Care Facilities Code (HCFC) and National Fire Protection Agency (NFPA 101) in accordance with § 418.110.
    - Ensuring that all Hospice LSC surveyors have received comparable, adequate training or have sufficient experience to make them qualified to survey health care facilities to both the 2012 editions of LSC and HCFC, and 2013 edition of the Fire Safety Evaluation System NFPA 101A Fire Safety for Health Care Occupancies.
    - Revising CHAP's survey process to require pre-survey preparation to include review of the 2012 editions of the LSC and HCFC.
    - Revising CHAP's LSC Survey Checklist and LSC citation documentation process to ensure all applicable regulations, LSC/HCFC sections, and CHAP standards are referenced in the survey report and provide surveyor training, as necessary.

### B. Term of Approval

Based on our review and observations described in section III. of this final notice, we approve CHAP as a national accreditation organization for hospices that request participation in the Medicare program, effective November 20, 2024 through November 20, 2029.

## 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),  Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Vanessa Garcia, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the                     **Federal Register**                    .                

Vanessa Garcia,

Federal Register Liaison, Centers for Medicare & Medicaid Services.

[FR Doc. 2024-26123 Filed 11-8-24; 8:45 am]

BILLING CODE 4120-01-P