SA Identification of Potential Providers and Suppliers

2003 - SA Identification of Potential Providers and Suppliers (Rev. 1, 05-21-04) Often, first indications of interest in program participation by potential participants will be contacts with State licensing agencies. These contacts make the SA aware that a provider or supplier wishes to participate. The SA identifies, surveys, and makes certification recommendations to CMS or the SMA about providers and suppliers that are potential program participants. 2003A - Assisting Applicant Providers and Suppliers (Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14) Pre-certification assistance to prospective providers and suppliers is a proper certification- related activity. It may take the form of providing them with a copy of the applicable regulations. The objective is to provide the party with information about the requirements of the certification component of the process for enrolling and participating in Medicare, including compliance with the requirements for SNFs and NFs, Conditions of Participation, Conditions for Coverage, or Conditions for Certification, as applicable. The effective date of Medicare participation in accordance with 42 CFR 489.13 may not be earlier than the date on which the applicant meets all the federal requirements. 2003B - Initial Certification “Kits” (Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14) When an entity seeks to participate in Medicare, it must first complete and submit an enrollment application. Information on enrollment as well as applicable forms and instructions may be found at http://www.cms.gov/Medicare/Provider-Enrollment-and- Certification/MedicareProviderSupEnroll/index.html. Entities subject to survey and certification file either a CMS Form 855A -- Medicare Enrollment Application for Institutional Providers, or a CMS Form 855B--Medicare Enrollment Application for Clinics, Group Practices, and Certain Other Suppliers, or, in some cases, both. Prospective providers and suppliers should be aware that the initial review of the Form CMS-855A or Form CMS-855B by the Medicare Administrative Contractor (MAC) and its recommendation for approval must occur before the on-site initial certification survey is conducted and action is taken by the RO. CMS has established Internet-based Provider Enrollment, Chain and Ownership System (PECOS) as an alternative to the paper enrollment process. Internet-based PECOS allows provider and supplier organizations to enroll, make a change in their Medicare enrollment, view their Medicare enrollment information on file with Medicare, or check on the status of a Medicare enrollment application via the Internet. When the MAC completes its review of the application, it either: 1) sends the SA and the RO its recommendation to approve the applicant; or 2) denies the application. The SA must not perform a survey of an initial applicant until it has received notice from the MAC that the information provided on the enrollment application has been verified and that the MAC is recommending approval of the application. A SA may, however, start planning for an unannounced survey upon initial contact from an applicant. (NOTE: SA surveys of initial applicants must be consistent with the priorities for Federal survey work, established by CMS each fiscal year. Depending upon available resources, initial surveys are typically a lower priority and SAs generally should not perform such work unless all higher priority Federal work will be completed. SAs may consult with the CMS Regional Office (RO) to determine whether a specific initial applicant would address an access to care issue and thus warrants an exception.) The prospective provider/supplier must contact the SA for Medicare and/or Medicaid certification materials for their provider/supplier type. The SA mails the initial certification materials under cover of the appropriate form letter. (See Exhibits 1A-1F and Exhibit 63.) If the applicant has not contacted the SA before the SA receives the MAC’s recommendation for approval, then the SA contacts the applicant using the phone number listed on the application. Upon receipt of the completed certification materials from the prospective applicant, the SA reviews the materials to see that they are properly completed and secures any necessary changes or additional information. It makes sure any required SNF transfer agreements are received. If a distinct part of an organization is being considered for program participation, the SA reviews the diagram (or floor plan) submitted to make sure the size and location of the distinct part are clearly shown. The SA works in conjunction with the RO and the MAC to gather the appropriate documentation from the entity that supports its position of being a distinct part before forwarding the package to the RO, in order to make a recommendation to the RO. Both copies of the signed provider agreement or supplier approval are sent to the RO, along with the Title VI Assurance of Compliance with Civil Rights (Form HHS-690). In title XIX-only cases, the SA sends the Form HHS- 690 or comparable form to the SMA. If the entity indicates that it is requesting a provider-based determination under the Medicare program, the SA must notify the RO immediately. Distinct Part and Provider- Based are not synonymous terms. Determinations concerning provider-based status are made by RO Financial Management personnel. The SA refers questions about enrollment, MACs, payment rules, financial solvency, or title VI clearance to the RO or the State Medicaid agency, as appropriate. For questions concerning the downloading, completion, and submission of the Form CMS-855A or CMS-855B, the provider/supplier should be directed to the CMS Web site or the appropriate MAC. Initial Certifications Involving New Owners who Reject Assignment of the Existing Medicare Agreement In the case of a prospective applicant that is planning to acquire an existing Medicare- participating provider or supplier, the RO should provide pre-certification assistance to the prospective applicant which includes making the prospective applicant aware of the consequences of accepting or rejecting assignment of the existing provider’s/supplier’s Medicare agreement. The RO should be consulted if the prospective applicant is considering rejecting assignment of the agreement so that the RO can provide detailed information on the consequences of such action before the prospective applicant makes a final decision and submits an application. In the case of an applicant that has acquired an existing Medicare-participating provider or supplier and has rejected assignment of that entity’s Medicare agreement, that applicant is considered a new applicant seeking initial certification and the SA must prioritize scheduling an initial survey for that applicant accordingly. This includes adhering to workload priorities identified by CMS for surveys of initial applicants to enroll in Medicare. Unless specifically directed by the RO to do so, SAs must not conduct initial surveys unless they are able to complete their higher priority workload. For initial applicants that have an accreditation option, initial certification surveys are the lowest SA priority. When an SA conducts an initial certification survey of an applicant that acquired a provider/supplier but rejected assignment, the RO must review the facts of the case carefully to determine whether the SA deviated from CMS workload priorities as well as the SA’s typical practice for initial applicants. Such deviation may raise reasonable doubt that the survey was unannounced. Section 2700A of the SOM requires all surveys of providers and suppliers (other than clinical laboratories) to be unannounced. This requirement applies to AO as well as SA surveys. An unannounced survey provides an opportunity to assess how the provider or supplier typically operates. On the other hand, if a provider or supplier knows the exact or approximate date of a survey, it may temporarily adjust its typical practices to enhance its compliance at the time of the survey. In doing so, it presents an unrepresentative picture to surveyors of the quality of care typically provided to its patients or residents. It is therefore in the best interest of patients and residents that surveys be unannounced. Given the lead time normally required to schedule and prepare for a full survey, if an initial survey takes place shortly after the acquisition date, such timing suggests discussion with the new owner prior to the acquisition date to arrange the timing of the survey to occur shortly thereafter, compromising the requirement that the survey be unannounced. While the new owner, like any other initial applicant to the Medicare program, will be expecting to be surveyed at some point, there must be some degree of uncertainty about just when that survey will occur, in order to permit an assessment of compliance when the facility is operating in a typical manner. The RO may refuse to accept a SA survey certifying compliance or an AO recommendation for deemed status if the survey timing creates reasonable doubt that the survey was unannounced. Each case must be assessed based on the facts specific to it; however, any survey that takes place within fourteen days after the effective date of an acquisition that involves rejection of assignment of the provider agreement may warrant closer review by the RO of the circumstances of the case and the timing of the survey. However, it is also possible that the facts of a specific case may indicate that an initial certification survey taking place at a later date was announced. See Section 3210 for more information about policies and procedures related to acquisitions of Medicare-participating providers or suppliers. 2003C – Deemed Status Providers/Suppliers, Excluding CLIA (Rev. 123, Issued: 10-03-14, Effective: 10-03-14, Implementation: 10-03-14) 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 of a national accrediting organization 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, and those programs are only for 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. The enrollment and certification requirements also apply to providers/suppliers seeking deemed status through their accreditation by a CMS-approved Medicare accreditation program. AOs with approved Medicare accreditation programs are also required by CMS not to survey initial applicants until they provide evidence that the MAC has reviewed their application and recommended approval. The prospective provider/supplier seeking deemed status through accreditation must still contact the SA for Medicare and/or Medicaid certification materials for their provider/supplier type. The SA mails the initial certification materials under cover of the appropriate form letter. (See Exhibits 1A-1F and Exhibit 63.) If the applicant has not contacted the SA before the SA receives the MAC’s recommendation, then the SA contacts the applicant using the phone number listed on the application. In the case of a “deemed” provider or supplier, the SA does not conduct a survey to initially certify or recertify compliance with the applicable Medicare CoPs, CfCs, or requirements. Rather, such providers or suppliers are under the jurisdiction of the AO, not the SA, for oversight of their ongoing compliance, unless the SA conducts a validation survey (either a representative sample or substantial allegation validation survey) at the direction of CMS and CMS determines as a result of such validation survey that the provider or supplier fails to comply with one or more CoPs, CfCs, Conditions for Certification or requirements. Note that some AOs offer multiple accreditation programs for a given type of provider or supplier, but for each provider/supplier type an AO may offer no more than one CMS- approved Medicare accreditation program. 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 healthcare entity to be “accredited” without being “deemed” for Medicare participation. For certification purposes, CMS considers only accreditation under a CMS-approved Medicare accreditation program where the AO has recommended deemed status. SAs must enter information on the Deemed tab within the certification kit in ASPEN only for those initial applicants that are seeking deemed status on the basis of accreditation under a CMS-approved Medicare accreditation program. CMS has established a process for AOs to provide notice to the applicable CMS Regional Office (RO) when it has accredited a provider or supplier under its CMS-approved Medicare accreditation program and is recommending the provider or supplier for deemed status. The RO forwards these notices to the applicable SA for inclusion in the certification kit that the SA subsequently forwards to the RO. In initial certification cases where there is no AO notice of accreditation under a CMS-approved Medicare accreditation program for the applicant, SAs must not use other sources of information about the applicant being “accredited” to conclude that the applicant is “deemed” and must not enter deemed status for the applicant in ASPEN. An AO may not conduct an initial certification survey of a prospective provider or supplier for Medicare certification purposes until the MAC has completed its initial review of the enrollment application and has made a recommendation for approval to CMS. CMS requires AOs subject to its oversight to employ a survey process that is comparable to the process required for an SA, which may not conduct an initial survey until it receives notice from the MAC recommending approval of the applicant (see Section 2003B). Accordingly, an AO must also wait until the MAC has made its recommendation before it conducts an initial survey. The MAC gives the applicant written notice when its review has been completed. Therefore, AOs must inform providers or suppliers seeking to participate in Medicare via the AO’s CMS-approved Medicare accreditation program that an initial, unannounced survey will not take place until after the applicant has received notice from the MAC that it has completed its review of the enrollment application and that the MAC is recommending approval. If the MAC denies approval of the application, the AO must not proceed with a survey. Notices that the MAC provides to the SA and RO are internal communications among CMS and its contractors. AOs are not entitled to receive copies of the MAC notice from the MAC, SA, or RO, but are expected to obtain copies of the MAC notice that was provided to the applicant. In the case of an applicant that is planning to acquire an existing Medicare-participating provider or supplier and that is considering rejecting assignment of the prior Medicare agreement, the AO must refer the applicant to the RO, so that the RO can provide detailed information on the consequences of acceptance or rejection of assignment. In the case of an applicant that has acquired an existing Medicare-participating provider or supplier and has rejected assignment, the applicant is considered an initial applicant. Generally, it is not acceptable for the AO to schedule an initial survey to minimize the period of time between the termination of the prior Medicare agreement and the effective date of the new agreement. Surveys conducted either on the date an acquisition is effective or within days thereafter do not qualify as unannounced surveys and also are inconsistent with CMS regulations and policy that require such applicants to be treated in the same way as any other initial applicant. See Section 3210 for more information about policies and procedures related to acquisitions of Medicare-participating providers or suppliers. The AO is required to notify CMS whenever it newly accredits and recommends Medicare deemed status for a provider or supplier seeking Medicare participation. This notice must be sent to both CO and the applicable RO via a designated email box (See Section 1022). However, the prospective provider or supplier must also provide the SA with documentation of the AO’s accreditation decision and recommendation for deemed status. This documentation is included in and becomes part of the certification packet the SA submits to the RO. Therefore, AOs must instruct the prospective provider or supplier to furnish a copy of this documentation to the SA for inclusion in the applicant’s certification packet.