State Operations Manual (Pub. 100-07), Ch. 5 § 5070

Priority Assignment for Nursing Homes, Deemed and Non-

Last amended: 2026Year: 2026Length: 961 wordsOfficial source
5070 - Priority Assignment for Nursing Homes, Deemed and Non- Deemed Non-Long Term Care Providers/Suppliers, and EMTALA (Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26) This section does not apply to clinical laboratories subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). See Sections 5500 – 5590 for CLIA information. An assessment of each complaint or incident intake must be made by an individual who is professionally qualified to evaluate the nature of the problem based upon his/her knowledge of Federal requirements and his/her knowledge of current clinical standards of practice. From a complainant’s allegation(s) or an allegation from a facility-reported incident, the SA/CMS Location identifies potential concerns where the provider/supplier may not be in compliance with Federal requirements. The SA/CMS Location must review the allegation(s) for all requirements that apply and should be investigated. These requirements will be specific to each health care entity. The surveyor then investigates each of those areas of concern and health care entity type. The role of the surveyor is not to validate whether the events contained in the allegation had occurred, but it is to determine whether the facility is in compliance with the Federal requirements for Medicare/Medicaid-certified providers/suppliers. If CMS or the SA believes that the complaint or facility-reported incident should also be investigated under the jurisdiction of another entity, referrals should be made as appropriate (e.g., law enforcement for criminal activity, State licensing boards for health care practitioners, the Medicare Administrative Contractor (MAC) for billing issues). In the case of nursing homes, in situations where a determination is made that immediate jeopardy may be present and ongoing, the SA must start the on-site investigation within three business days of receipt of the initial complaint or incident report. Receipt of the initial complaint or incident report means when the report is received by the SA, whether it is received by the SA directly, or another State agency under arrangement or contractor that is receiving the report on behalf of the SA from the complainant or facility. Also, if a complaint or facility-reported incident is received after business hours, then it is considered to be received on the next business day, for purposes of calculating the investigation timeframe. For example, if a complaint is received on Saturday and the SA office is closed during the weekend, then the following Monday will be used to calculate the investigation timeframe. For non-long term care providers/suppliers, in situations where a determination is made that immediate jeopardy may be present and ongoing, the SA is required to start the on- site investigation within two business days of receipt of the complaint or incident report, or, in the case of a deemed provider or supplier, within two business days of CMS location authorization for investigation. The same process applies to EMTALA complaints or a survey related to a report of a hospital or CAH Distinct Part Unit patient death associated with the use of restraint or seclusion. The SA’s investigation must be initiated within two business days of CMS location authorization for investigation. Generally, an alleged event occurring more than 12 months prior to the intake date would not require a complaint investigation. However, the SA is not precluded from conducting a Federal investigation (with appropriate CMS location authorization, where required) to determine current compliance status based on the concerns identified in the complaint. For nursing homes, an onsite survey may not be required if there is sufficient evidence that the facility does not have continuing noncompliance and the alleged event occurred before the last standard survey. For all intakes concerning deemed status providers or suppliers where the intake involves allegations of substantial noncompliance (in other words, the allegation would result in a condition-level deficiency citation if found to be true and uncorrected), the SA must submit a request for CMS location approval of a complaint validation survey (i.e., substantial allegation validation survey). The SA must obtain CMS location approval before conducting a substantial allegation validation survey. The CMS location will authorize the SA to conduct the survey by issuing electronically via iQIES a Form CMS- 2802, which will indicate the specific conditions for which the SA must assess compliance. The CMS location must authorize assessment of compliance for a whole condition and not just for particular standards within a condition, unless the Form CMS- 2802 for the applicable provider/supplier type permits selection of a specific standard, e.g., Life Safety Code. All allegations of EMTALA violations related to a hospital (which also includes cancer, children’s, long term care, psychiatric and rehabilitation hospitals) or CAH, regardless of whether the hospital or CAH is deemed, must be referred to the CMS location. The CMS location will determine whether the SA will conduct an EMTALA investigation. In cases where the SA or CMS location has noted a pattern of similar complaints about a specific provider or supplier, each of which on its own merits would be triaged at a medium or low level, the SA or CMS location has the discretion to assign a higher triage level to a current intake based on the noted pattern, in order to ensure timely investigation of the provider’s/supplier’s compliance with the applicable requirements or Conditions. CMS expects SAs to prioritize complaints at the appropriate level that is warranted. The timeframes in Section 5075 below represent maximum timeframes for investigation; the SA is not precluded from investigating complaints and facility-reported incidents within a shorter timeframe. In addition, the SA is not precluded from taking other factors into consideration in its triage decision. For example, the SA may identify a trend in allegations that indicates an increased risk of harm to residents or the SA may receive corroborating information from other complainants regarding the allegation. See also Section 5310.2 for requirements for nursing home facility-reported incidents.
State Operations Manual (Pub. 100-07), Ch. 5 § 5070: Priority Assignment for Nursing Homes, Deemed and Non- | Justis AI