Collapse to view only § 488.1100 - Basis and scope.

§ 488.1100 - Basis and scope.

Sections 1812, 1814, 1822, 1861, 1864, and 1865 of the Act establish requirements for Hospice programs and to authorize surveys to determine whether they meet the Medicare conditions of participation.

§ 488.1105 - Definitions.

As used in this subpart—

Abbreviated standard survey means a focused survey other than a standard survey that gathers information on hospice program's compliance with specific standards or conditions of participation. An abbreviated standard survey may be based on complaints received or other indicators of specific concern.

Complaint survey means a survey that is conducted to investigate substantial allegations of noncompliance as defined in § 488.1.

Condition-level deficiency means noncompliance as described in § 488.24.

Deficiency is a violation of the Act and regulations contained in part 418, subparts C and D, of this chapter, is determined as part of a survey, and can be either standard or condition-level.

Hospice Special Focus Program (SFP) means a program conducted by CMS to identify hospices as poor performers, based on defined quality indicators, in which CMS selects hospices for increased oversight to ensure that they meet Medicare requirements. Selected hospices either successfully complete the SFP program or are terminated from the Medicare program.

IDR stands for informal dispute resolution.

Noncompliance means any deficiency found at the condition-level or standard-level.

SFP status means the status of a hospice provider in the SFP with respect to the provider's progress in the SFP, which is indicated by one of the following status levels:

(1) Level 1—in progress.

(2) Level 2—completed successfully.

(3) Level 3—terminated from the Medicare program.

SFP survey means a standard survey as defined in this section and is performed after a hospice is selected for the SFP and is conducted every 6 months, up to 3 occurrences.

Standard-level deficiency means noncompliance with one or more of the standards that make up each condition of participation for hospice programs.

Standard survey means a survey conducted in which the surveyor reviews the hospice program's compliance with a select number of standards or conditions of participation or both to determine the quality of care and services furnished by a hospice program.

Substantial compliance means compliance with all condition-level requirements, as determined by CMS or the State.

[86 FR 62425, Nov. 9, 2021, as amended at 88 FR 77879, Nov. 13, 2023]

§ 488.1110 - Hospice program: surveys and hotline.

(a) Basic period. Each hospice program as defined in section 1861(dd) of the Act is subject to a standard survey by an appropriate State or local survey agency, or an approved accreditation agency, as determined by the Secretary, not less frequently than once every 36 months. Additionally, a survey may be conducted as frequently as necessary to -

(1) Assure the delivery of quality hospice program services by determining whether a hospice program complies with the Act and conditions of participation; and

(2) Confirm that the hospice program has corrected deficiencies that were previously cited.

(b) Complaints. A standard survey, or abbreviated standard survey-

(1) Must be conducted of a hospice program when complaints against the hospice program are reported to CMS, the State, or local agency.

(2) The State, or local agency is responsible for maintaining a toll-free hotline to collect, maintain, and continually update information on Medicare-participating hospice programs including significant deficiencies found regarding patient care, corrective actions, and remedy activity during its most recent survey, and to receive complaints and answer questions about hospice programs. The State or local agency is also responsible for maintaining a unit for investigating such complaints.

§ 488.1115 - Surveyor qualifications and prohibition of conflicts of interest.

(a) Minimum qualifications. Surveyors must meet minimum qualifications prescribed by CMS. Before any accrediting organization, State or Federal surveyor may serve on a hospice survey team (except as a trainee), he/she must have successfully completed the relevant CMS-sponsored Basic Hospice Surveyor Training Course, and additional training as specified by CMS.

(b) Disqualifications. Surveyor(s) must disclose actual or perceived conflicts of interest prior to participating in a hospice program survey and be provided the opportunity to recuse themselves as necessary. Any of the following circumstances disqualifies a surveyor from surveying a particular hospice program:

(1) The surveyor currently serves, or, within the previous 2 years has served, with the hospice program to be surveyed as one of the following:

(i) A direct employee.

(ii) An employment agency staff at the hospice program.

(iii) An officer, consultant, or agent for the hospice program to be surveyed concerning compliance with conditions of participation specified in or in accordance with sections 1861(dd) of the Act.

(2) The surveyor has a financial interest or an ownership interest in the hospice program to be surveyed.

(3) The surveyor has an immediate family member, as defined at § 411.351 of this chapter, who has a financial interest or an ownership interest with the hospice program to be surveyed.

(4) The surveyor has an immediate family member, as defined at § 411.351 of this chapter, who is a patient of the hospice program to be surveyed.

§ 488.1120 - Survey teams.

Standard surveys conducted by more than one surveyor must be conducted by a multidisciplinary team of professionals typically involved in hospice care and identified as professionals providing hospice core services at § 418.64 of this chapter. The multidisciplinary team must include a registered nurse. Surveys conducted by a single surveyor, must be conducted by a registered nurse.

§ 488.1125 - Consistency of survey results.

A survey agency or accrediting organization must provide a corrective action plan to CMS for any disparity rates that are greater than the threshold established by CMS.

§ 488.1130 - Informal dispute resolution (IDR).

(a) Opportunity to refute survey findings. Upon the provider's receipt of an official statement of deficiencies, hospice programs can request an informal opportunity to dispute condition-level survey findings.

(b) Failure to conduct IDR timely. Failure of CMS, the State, or the AO, as appropriate, to complete IDR must not delay the effective date of any enforcement action.

(c) Revised statement of deficiencies as a result of IDR. If any findings are revised or removed by CMS, the State, or the AO based on IDR, the official statement of deficiencies is revised accordingly, and any enforcement actions imposed solely as a result of those cited deficiencies are adjusted accordingly.

(d) Notification. (1) If the survey findings indicate a condition-level deficiency, the hospice program is notified in writing of its opportunity for participating in an IDR process at the time the official statement of deficiencies is issued.

(2) The request for IDR must—

(i) Be submitted in writing;

(ii) Include the specific deficiencies that are disputed; and

(iii) Be made within the same 10 calendar day period that the hospice program has for submitting an acceptable plan of correction.

[88 FR 77879, Nov. 13, 2023]

§ 488.1135 - Hospice Special Focus Program (SFP).

(a) Applicability. (1) The provisions of this section are effective on or after January 1, 2024. ; and

(2) SFP selection begins in CY 2024.

(b) Selection criteria. (1) Selection of hospices for the SFP is made based on the highest aggregate scores based on the algorithm used by CMS.

(2) Hospice programs with accrediting organization deemed status placed in the SFP—

(i) Do not retain deemed status; and

(ii) Are placed under CMS or State survey agency jurisdiction until completion of the SFP or termination.

(c) Survey and enforcement criteria. A hospice in the SFP—

(1) Is surveyed not less than once every 6 months by CMS or the State agency; and

(2) With condition level deficiencies on any survey is subject to standard enforcement actions and may be subject to progressive enforcement remedies at the discretion of CMS.

(d) Completion criteria. A hospice in the SFP that has two SFP surveys within 18 months with no condition-level deficiencies, and that has no pending complaint survey triaged at an immediate jeopardy or condition level, or that has returned to substantial compliance with all requirements may complete the SFP.

(e) Termination criteria. (1) A hospice in the SFP that does not meet the SFP completion requirements in paragraph (d) of this section is considered for termination from the Medicare program in accordance with 42 CFR 489.53.

(2) CMS may consider termination from the Medicare program in accordance with § 488.1225 if any survey results in an immediate jeopardy citation while the hospice is in the SFP.

(f) Public reporting. CMS posts all of the following at least annually on a CMS public-facing website:

(1) A subset of 10 percent of hospice programs based on the highest aggregate scores as determined by the algorithm used by CMS.

(2) Hospice SFP selection from the list in paragraph (f)(1) of this section as determined by CMS.

(3) SFP status as defined in § 488.1105.

[88 FR 77879, Nov. 13, 2023]