Exceptions to SA Certification

1018 - Exceptions to SA Certification (Rev. 1, 05-21-04) 1018A - Federal and Indian Health Institutions (Rev. 1, 05-21-04) Because of questions of intergovernmental jurisdiction, the survey and certification of a hospital or SNF that is either owned or operated by the Indian Health Service, and therefore considered to be a Federal provider of services, is handled by the RO. The SA is responsible, however, for determining whether the facility meets Medicaid certification requirements. The SA may accept Medicare certification as sufficient evidence of meeting Medicaid requirements, or the SA may conduct a survey. Since Indian health tribal facilities may or may not be under Federal jurisdiction the RO determines whether the RO or the SA has jurisdiction. 1018B - Religious Nonmedical Health Care Institutions (RNHCIs) (Rev. 1, 05-21-04) Section 1861(e) of the Act includes in the definition of "hospital" a religious nonmedical health care institution that is operated or listed and certified by the First Church of Christ, Scientist, in Boston, Massachusetts, with respect to certain items and hospital services furnished to inpatients. Section 1861(y) includes sanatoria with respect to items and services furnished to inpatients in a long-term care setting. All approvals are handled by the Boston RO. No SA certifications are necessary. The State may also include these services under the State plan for Medicaid. 1018C - Deemed Providers/Suppliers (Excluding CLIA Laboratories) (Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14) In order to enter into a provider or supplier agreement with the Medicare program, or in many cases a provider agreement with the Medicaid program, a health care entity must satisfy all applicable Federal requirements. For Medicare providers and suppliers subject to certification, Federal requirements include demonstrating compliance with the applicable health and safety standards, i.e., SNF requirements, provider CoPs or supplier CfCs. Generally the prospective provider or supplier demonstrates compliance with health and safety standards when it is certified by a SA as being in compliance and recommended to the RO for approval. Thereafter, the provider or supplier is subject to periodic surveys by the SA to determine whether it continues to meet the applicable long term care requirements, CoPs, CfCs or Conditions for Certification. However, there is an alternative to SA surveys, for demonstrating compliance with the applicable CoPs/CfCs/Conditions for Certification. Accreditation based on a survey by a CMS-approved Medicare accreditation program may be used by CMS to “deem” a provider or supplier as complying with the applicable regulatory standards. For certain types of providers/suppliers, for example hospitals or psychiatric hospitals, Medicaid will also accept accreditation under a CMS-approved Medicare accreditation program as evidence of compliance for Medicaid purposes. Section 1865(a) of the Act provides that CMS may recognize and approve national accrediting organization (AO) Medicare accreditation programs which demonstrate that their health and safety standards and survey and oversight processes meet or exceed those used by CMS to determine a health care provider’s or supplier’s compliance with applicable Medicare CoPs, CfCs, Conditions for Certification or requirements. The regulations which govern Medicare survey, certification, and enforcement procedures are generally found in 42 CFR Part 488, Section 488.1 defines an accredited provider or supplier as “a provider or supplier that has voluntarily applied for and has been accredited by a national accreditation program meeting the requirements of, and approved by, CMS in accordance with §488.5 or §488.6.” Accreditation under a CMS- approved Medicare accreditation program is voluntary and is not required for Medicare participation. Consistent with Section 1865 of the Act, 42 CFR §§488.5 and 488.6 permit deemed status certification for ambulatory surgical centers; comprehensive outpatient rehabilitation facilities; critical access hospitals; home health agencies; hospices; hospitals; clinics, rehabilitation agencies or public health agencies providing outpatient physical therapy, occupational therapy or speech pathology services; psychiatric hospitals; religious nonmedical health care institutions; rural health clinics; screening mammography services; skilled nursing facilities; and transplant centers, except for kidney transplant centers. However, at this time only certain AOs have requested CMS approval of Medicare accreditation programs, for only some of these provider/supplier types. A current list of CMS-approved Medicare accreditation programs may be found at https://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/SurveyCertificationGenInfo/Accreditation.html. In the case of a deemed provider or supplier, the SA does not conduct a survey to recertify compliance with the applicable Medicare CoPs, CfCs, or requirements. Rather, such providers or suppliers remain under the jurisdiction of the AO for oversight of their ongoing compliance. The SA may conduct a validation survey (e.g., representative sample or substantial allegation survey) of a deemed provider or supplier when directed to do so by the RO. If the RO determines, based on the findings of such SA validation survey, that the provider or supplier is out of compliance with one or more CoPs, CfCs, Conditions for Certification or requirements, the RO removes the provider’s/supplier’s deemed status and places it under SA jurisdiction for review until it either comes back into compliance or is terminated. Note that some AOs offer multiple accreditation programs for a given type of provider or supplier. However, an AO may offer no more than one Medicare accreditation program per provider/supplier type and that program must be approved in advance by CMS. In addition, some AOs may offer only one program for a provider/supplier type, but they offer this program to their customers with and without the option of the AO recommending Medicare deemed status to CMS. Thus, it is possible for a provider or supplier to be “accredited” without being “deemed” to participate in the Medicare/Medicaid programs. For certification purposes, CMS considers as evidence of a provider’s or supplier’s compliance with the applicable CoPs, CfCs, or requirements only accreditation under a CMS-approved Medicare accreditation program, where the AO has recommended deemed status to CMS. SAs must enter information on the deemed tab within the certification kit in ASPEN only for those providers and suppliers that have been deemed on the basis of accreditation under a CMS-approved Medicare accreditation program. CMS has established a process for an AO to provide notice to the applicable RO when it has accredited a provider or supplier under its CMS-approved Medicare accreditation program and is recommending the provider or supplier for initial or continued deemed status. The RO forwards these notices to the applicable SA for inclusion in the initial certification packet that the SA subsequently forwards to the RO for approval or denial of the application for a provider agreement or supplier approval. 1018H - Deemed CLIA Laboratories (Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14) Because each accrediting organization that has received approval under CLIA is approved for specific laboratory specialties or subspecialties, consult the RO for specific guidance. Refer to Chapter 6 of this manual for additional information on CLIA accrediting organizations. For a current list of accrediting organizations approved for distinct CLIA specialties or subspecialties please go to www.cms.gov/clia/. 1018I - Exemption of Laboratories Licensed by States (Rev. 1, 05-21-04) CLIA will exempt laboratories in States that have been determined to have laws and regulations in effect that are equal to, or more stringent than, CLIA requirements. Exempt laboratories must hold a valid State license within the exempt State. Oregon and Washington States have been granted complete exemption. New York State has been granted a partial exemption. Refer to Chapter 6 for additional information on CLIA exempt laboratories organizations. 1018J - Eligibility for Medicaid Facilities (Rev. 1, 05-21-04) A facility’s eligibility for Medicaid participation can be established through Medicare deemed status for providers and suppliers that are not required under Medicaid regulations to comply with any requirements other than Medicare participation requirements for that provider or supplier type. See 42 CFR 488.6.