U N C H E A L T H C A R E S Y S T E M Telemedicine Sarah Fotheringham, JD Associate General Counsel, UNC Health Care

Agenda What is telemedicine? Is it different from telehealth? Telemedicine terminology CMS Telemedicine Credentialing Requirements Originating Site is a Hospital Originating Site is a CAH Applicable TJC Standards DNV Telemedicine Standard 2

What is Telemedicine? Is it different from Telehealth? 3

From the Final Rule on Telemedicine Credentialing and Privileging: “[W]e consider telemedicine…to be the provision of clinical services to patients by practitioners from a distance via electronic communications…. Generally, payment for telehealth services under [the Social Security] Act [is] distinguished from ‘telemedicine services’.” 76 FR

Telemedicine Terminology 5

Originating site (also referred to as the spoke site) – the site where the patient is located Distant site (also referred to as the hub site) – the site where the physician is located Simultaneous – services provided to the patient in “real time” by the telemedicine practitioner (such as videoconferencing) Non-simultaneous or Asynchronous store and forward – transmission of a patient’s medical information to a provider on a not real-time basis for the purpose of diagnostic and therapeutic assistance (common in specialties such as radiology, pathology, and dermatology) 6

CMS Telemedicine Credentialing Requirements 7

In the past, CMS required an originating site hospital or CAH to follow the same credentialing procedures with providers at the distant site as it did with its own on-site providers Effective July 2011, CMS began to permit (but does not require) an originating site hospital’s medical staff, or a CAH’s governing body or responsible individual, to rely on the credentialing and privileging decisions of a distant site if certain requirements are met. 8

CMS Telemedicine Credentialing Requirements – Originating Site is a Hospital 9

First, the originating site hospital’s governing body may choose to have its medical staff rely on the distant site’s credentialing and privileging decisions when making recommendations on privileges (42 CFR (a)(3), (4)) Second, there must be a written contract between the originating site hospital and the distant site that includes certain provisions (42 CFR (a)(8), (9)) 10

Contract Requirements – What kind of entity is the Distant Site? The contract requirements differ slightly depending on whether the distant site is a hospital or a telemedicine entity A “telemedicine entity” is an entity that: 1.provides telemedicine services; 2.is not a Medicare-participating hospital (so it could be a non- Medicare-participating hospital); and 3.provides contracted services in a manner that enables a hospital using those services to comply with all applicable Conditions of Participation. 76 FR

Contract Requirements – Distant Site Hospital If the distant site is a hospital, the written contract must specify that it is the responsibility of the distant site hospital’s governing body to meet the medical staff requirements of the hospital Conditions of Participation relating to the governing body’s oversight of the medical staff (42 CFR (a)(1)-(7), “The 7 COPs”) with regard to the physicians and practitioners providing telemedicine services. This must be in the contract regardless of whether the originating site hospital decides to rely on the distant site’s credentialing/privileging decision 42 CFR (a)(8) 12

The 7 COPs The 7 COPs state that he governing body must: 1.Determine, in accordance with State law, which categories of practitioners are eligible for appointment to the medical staff; 2.Appoint members of the medical staff after considering the recommendations of the existing members of the medical staff; 3.Assure that the medical staff has bylaws; 4.Approve medical staff bylaws and other medical staff rules and regulations; 5.Ensure that the medical staff is accountable to the governing body for the quality of care provided to patients; 6.Ensure the criteria for selection are individual character, competence, training, experience and judgment; and 7.Ensure that under no circumstances is the accordance of staff membership or professional privileges in the hospital dependent solely upon certification, fellowship, or membership in a specialty body or society. 42 CFR (a)(1)-(7) 42 CFR (a)(8) 13

Contract Requirements – Distant Site Hospital – Relying on Credentialing/Privileging Decisions If the governing board of the originating site hospital wants to have its medical staff rely on the credentialing and privileging decisions of the distant site hospital when making its recommendations, the contract must also provide that: The distant site is a Medicare-participating hospital; The provider at the distant site hospital is privileged at the distant site and the distant site provides a current list of the provider’s privileges at the distant site; The provider is licensed in the originating site hospital’s state; and The originating site hospital does an internal review of the provider’s performance and sends such performance information to the distant site hospital for its use in its appraisal of the provider. At a minimum, this must include all adverse events that result from the telemedicine services and all complaints the originating site hospital receives about the provider. 42 CFR (a)(3) 14

Contract Requirements – Distant Site Telemedicine Entity If the distant site is a telemedicine entity, there must be a written contract between the originating site hospital and the distant site telemedicine entity. That contract must specify that: 1.The distant site telemedicine entity is a contractor of services to the originating site hospital; 2.As a contractor, the distant site telemedicine entity furnishes those contracted services in a manner that permits the originating site hospital to comply with the 7 COPs with regard to the physicians and practitioners providing telemedicine services. This must be in the contract regardless of whether the originating site hospital decides to rely on the distant site’s credentialing/privileging decision 42 CFR (a)(9) 15

Contract Requirements – Distant Site Telemedicine Entity – Relying on Credentialing/Privileging Decisions If the governing board of the originating site hospital wants to have its medical staff rely on the credentialing and privileging decisions of the distant site telemedicine entity when making its recommendations, the contract must also provide that: The distant site’s medical staff credentialing and privileging process must at least meet the standards of the 7 COPs; The provider at the distant site telemedicine entity is privileged at the distant site and the distant site provides a current list of the provider’s privileges at the distant site; The provider is licensed in the originating site’s state; and The originating site hospital does an internal review of the provider’s performance and sends such performance information to the distant site telemedicine entity for its use in its appraisal of the provider. At a minimum, this must include all adverse events that result from the telemedicine services and all complaints the originating site hospital receives about the provider. 42 CFR (a)(4) 16

CMS Telemedicine Credentialing Requirements – Originating Site is a CAH 17

CMS Telemedicine Credentialing Requirements – Originating Site is a CAH First, the originating site CAH’s governing body or responsible individual may choose to have its medical staff rely on the distant site’s credentialing and privileging decisions when making recommendations on privileges (42 CFR (c)(2), (4)) Second, there must be a written contract between the originating site and the distant site that includes certain provisions, depending on whether the distant site is a hospital or a telemedicine entity (42 CFR (c)(1), (3)) 18

Contract Requirements – Distant Site Hospital If the distant site is a hospital, the written contract must specify that it is the responsibility of the distant site hospital’s governing body to meet what is equivalent to the 7 COPs with regard to the physicians and practitioners providing telemedicine services. This must be in the contract regardless of whether the originating site CAH decides to rely on the distant site’s credentialing/privileging decision 45 CFR (c)(1) 19

Contract Requirements – Distant Site Hospital – Relying on Credentialing/Privileging Decisions If the governing board or responsible individual of the originating site CAH wants to rely on the credentialing and privileging decisions of the distant site hospital, the contract must also provide that: The distant site is a Medicare-participating hospital; The provider at the distant site hospital is privileged at the distant site and the distant site provides a current list of the provider’s privileges at the distant site; The provider is licensed in the originating site CAH’s state; and The originating site CAH does an internal review of the provider’s performance and sends such performance information to the distant site hospital for its use in its appraisal of the provider. At a minimum, this must include all adverse events that result from the telemedicine services and all complaints the originating site CAH receives about the provider. 42 CFR (c)(2) 20

Contract Requirements – Distant Site Telemedicine Entity If the distant site is a telemedicine entity, the written contract must specify that: 1.The distant site telemedicine entity is a contractor of services to the originating site CAH; 2.As a contractor, the distant site telemedicine entity furnishes those contracted services in a manner that enables the CAH to comply with all applicable conditions of participation for the contracted services, including, but not limited to, the requirements with regard to physicians and practitioners providing telemedicine services. This must be in the contract regardless of whether the originating site CAH decides to rely on the distant site’s credentialing/privileging decision 42 CFR (c)(3) 21

Contract Requirements – Distant Site Telemedicine Entity – Relying on Credentialing/Privileging Decisions If the governing board of the CAH or responsible individual wants to rely on the credentialing and privileging decisions of the distant site telemedicine entity, the contract must also provide that: The distant site’s medical staff credentialing and privileging process and standards at least meet what is equivalent to the 7 COPs*; The provider at the distant site telemedicine entity is privileged at the distant site and the distant site provides a current list of the provider’s privileges at the distant site; The provider is licensed in the originating site CAH’s state; and The originating site CAH does an internal review of the provider’s performance and sends such performance information to the distant site telemedicine entity for its use in its appraisal of the provider. At a minimum, this must include all adverse events that result from the telemedicine services and all complaints the originating site CAH receives about the provider. 42 CFR (c)(4) Found at 42 CFR (c)(1)(i)-(vii) 22

Applicable TJC Standards 23

TJC Standard LD Leaders must oversee contracted services that are related to the provision of care, treatment, and services provided to the hospital’s patients to make sure that they are provided safely and effectively. Therefore, the contract or another written document should include established performance expectations by which leaders can evaluate the contracted service. Examples: Collection of data Staff input Patient satisfaction surveys Incident reports Audits You should also be able to evidence that such performance expectations are actually evaluated and followed up on. 24

TJC Standard MS Medical staff bylaws must have certain provisions, such as: The structure of the medical staff The process for privileging Duties/privileges related to each category of the medical staff What categories of the medical staff are eligible to vote Fair hearing and appeals 25

TJC Standard MS Medical staff bylaws identify the criteria for granting privileges to a practitioner. For example, may want to include language that telemedicine privileges will be granted if there is a contract for telemedicine services and the practitioner meets the privileging/credentialing standards of the bylaws. 26

TJC Standard MS Telemedicine practitioners are subject to the credentialing and privileging processes of the originating site. TJC recognizes three options: 1.The originating site fully privileges and credentials the telemedicine practitioner like all other on-site practitioners; 1.The originating site privileges and credentials the telemedicine practitioner using credentialing information from the distant site, if the distant site is TJC-accredited; or… 27

TJC Standard MS (cont’d) 3.The originating site uses the credentialing and privileging decision from the distant site to make a final decision if all the following requirements are met: a.The distant site is a TJC-accredited hospital or ambulatory care organization; b.The practitioner is privileged at the distant site for the services to be provided at the originating site; c.For hospitals that use TJC for deemed status purposes, the distant site provides the originating site with a current list of the practitioner’s privileges; d.The originating site has evidence of an internal review of the practitioner’s performance of telemedicine privileges and sends the distant site information that is useful to assess the practitioner’s quality of care, treatment, and services for use in privileging and performance improvement. At a minimum, this includes all adverse outcomes related to sentinel events considered reviewable by TJC that result from the telemedicine services provided, and complaints from patients, LIPs or staff at the originating site; and e.The distant site has a license in the state where the patient is receiving telemedicine services. 28

TJC Standard MS The medical staff at both the originating and distant sites recommend the clinical services to be provided through a telemedical link at their respective sites. The structure of the medical staff The process for privileging Duties/privileges related to each category of the medical staff What categories of the medical staff are eligible to vote Fair hearing and appeals 29

DNV Telemedicine Standard 30

DNV Standard MS.20 The originating site may rely on the credentialing and privileging decisions of the distant site if there is a written agreement with the distant site that essentially complies with the CMS requirements. 31

Key Takeaways 32

Anyone providing telemedicine services in a hospital or CAH must be granted privileges there The privileges granted must match up with the services that they are providing at your hospital (for example, a telemedicine provider shouldn’t receive surgical privileges) The standard privileging process can always be used – there is no requirement to rely on the privileging decision of the distant site Be prepared for a surveyor to ask you how you verify that a telemedicine entity employs a credentialing or privileging process that meets or exceeds the 7 COPs Check your telemedicine contracts to make sure they have all the necessary elements, and if they don’t, get them amended If you are going to rely on the credentialing and privileging decisions of a distant site hospital or telemedicine entity, make sure your bylaws contain a provision permitting this Key Takeaways 33

Check your telemedicine contracts to make sure they have all the necessary elements, and if they don’t, get them amended If you are going to receive telemedicine services as the originating site, make sure your bylaws have a staff category that telemedicine providers will fit within If you are going to rely on the credentialing and privileging decisions of a distant site hospital or telemedicine entity, make sure your bylaws contain a provision permitting this Key Takeaways 34

Questions? 35