Ohio Hospital Association Telemedicine & Delegated Credentialing: Who is Responsible for What and Why Presented by: Catherine M. Ballard, Esq. 614-227-8806 cballard@bricker.com Kimberly S. Parks, Esq. 614-227-8801 ksparks@bricker.com Bricker & Eckler, LLP 100 South Third Street Columbus, Ohio 43215 www.bricker.com Copyright 2015 Bricker and Eckler LLP 8947153v2 1
Terminology Distant Site Hospital or Distant Site Telemedicine Entity = Provider of the telemedicine services Hospital or Critical Access Hospital (CAH) = Receiver of the telemedicine services (i.e., the place where the patient is located). 2
Telehealth The definition of telehealth varies. Telemedicine is included under the broader scope of telehealth. 3
Telemedicine The provision of clinical services to patients by practitioners from a distance via electronic communications. Applies to all Medicare-participating Hospitals and CAH inpatients and outpatients. 4
Types of Telemedicine Arrangements Simultaneous The distant site telemedicine practitioner provides clinical services to the Hospital or CAH patient simultaneously. Clinical services provided to the patient in real time. Examples: telestroke/teleneurology, teleicu, telenicu, etc. 5
Types of Telemedicine Arrangements Non-simultaneous Services may involve after-the fact interpretation of diagnostic tests in order to provide an assessment of the patient s condition. Do not require real time assessments. Examples: teleradiology, telepatholgy, etc. 6
OSMB Telemedicine Position Statement Practice of Telemedicine Practice of medicine in Ohio through oral, written, or electronic communication by a physician located outside of Ohio. Physicians licensed in Ohio may examine and diagnose patients through the use of any communication (including oral, written, or electronic) without obtaining a telemedicine certificate. 7
OSMB Expectations OSMB position statement sets forth expectations in the following areas with respect to licensees treating patients via telemedicine: Licensee-patient relationship Training Examination Medical records Licensure Prescribing 8
OAC 4731-11-09 Generally requires a physician/other authorized prescriber to personally physically examine and diagnose a person prior to initially prescribing, dispensing, otherwise providing or causing to be provided any controlled substance or non-controlled substance. Exceptions 9
OSMB Interpretative Guidelines to OAC 4731-11-09 Apply solely to cases that involve prescribing or personally furnishing noncontrolled substances. Do not address prescribing for controlled substances. 10
OSMB Interpretative Guidelines Address ability to personally physically examine a patient who is located at a remote location based upon technological advances. Outline steps the physician/authorized prescriber should take prior to prescribing non-controlled substances. 11
OSMB Interpretive Guidelines Obtain a reliable medical history Perform a physical examination of the patient 12
OSMB Interpretive Guidelines Valid provider-patient relationship Appropriate diagnostic medical equipment capable of transmitting the patient s vital signs and other physical data real-time. Appropriate diagnostic medical equipment capable of transmitting real-time images of the patient s symptoms. 13
OSMB Interpretive Guidelines Sufficient dialogue with the patient. Follow up with the patient as appropriate. Contemporaneous medical record. 14
Credentialing by Proxy Goals of CMS Telemedicine Hospital/CAH Conditions of Participation (CoP): Increase patient access to specialty services. Reduce burden on small hospitals and CAHs 15
Credentialing and Privileging Options Traditional credentialing and privileging procedure Credentialing by Proxy Between Hospital or CAH and distant site Medicare-participating hospital Between a Hospital or CAH and a distant site telemedicine entity 16
Credentialing by Proxy Distant Site Telemedicine Entity Provides telemedicine services. Is not a Medicare-participating hospital. Provides contracted services in a manner that enables a Hospital/CAH using its services to meet all applicable CoPs particularly those requirements related to credentialing and privileging of practitioners providing telemedicine services to the patients of a Hospital/CAH. 17
Legal Requirements for Credentialing by Proxy Written agreement Content must meet applicable CMS Hospital or CAH CoP Content must meet applicable Hospital or CAH accreditation standards 18
Legal Requirements for Credentialing by Proxy (con t.) Differences between Hospital and CAH CoPs and accreditation standards Differences between distant site Medicare participating hospital and distant site telemedicine entity requirements 19
Legal Requirements for Credentialing by Proxy When the distant site is a Medicare participating hospital, the written agreement specifies that it is the responsibility of the distant site hospital to meet the credentialing requirements of 42 C.F.R. 482.12 (a)(1)-(a)(7), as that provision may be amended from time to time, with regard to the distant site hospital practitioners providing telemedicine services. 20
Legal Requirements When the distant site is a distant site telemedicine entity the written agreement shall specify that the distant site telemedicine entity is a contractor of services to the Hospital and, as such, furnishes the contracted services in a manner that permits the Hospital to comply with all applicable conditions of participation for the contracted services including, but not limited to, 42 C.F.R. 482.12 (a)(1)-(a)(7) with regard to the distant site telemedicine entity practitioners providing telemedicine services. 21
Legal Requirements The written agreement shall further specify that the distant site telemedicine entity s medical staff credentialing and privileging process and standards will, at minimum, meet the standards at 42 C.F.R. 482.12 (a)(1)-(a)(7) and at 42 C.F.R. 482.22 (a)(1)- (a)(2), as those provisions may be amended from time to time. 22
Legal Requirements The individual distant site practitioner is privileged at the distant site for those services to be provided to Hospital patients via telemedicine link and the Hospital is provided with a current list of his/her privileges at the distant site. 23
Legal Requirements The individual distant site practitioner holds an appropriate license (or telemedicine certificate) issued by the State Medical Board of Ohio or other appropriate licensing entity. 24
Legal Requirements The Hospital maintains documentation of its internal review of the performance of each distant site practitioner and sends the distant site such performance information for use in the distant site s periodic appraisal of the distant site practitioner. 25
Legal Requirements At a minimum, this information must include: All adverse events that result from the telemedicine services provided by the distant site practitioner to Hospital patients; and, All complaints the Hospital receives about the distant site practitioner. 26
Legal Requirements Requirements for credentialing by proxy by CAHs are modeled after the Hospital requirements. See 42 C.F.R. 485.616 (c)(1)(i)-(c)(1)(vii) Other noted differences. 27
Accreditation Requirements TJC Requires the distant site to be TJC accredited. See TJC Hospital standards MS.13.01.01, MS.13.01.03, and LD.04.03.09 See TJC CAH standards MS.13.01.01 and LD.04.03.09 HFAP and DNV Mirror CMS Telemedicine Hospital/CAH CoPs 28
Accreditation Requirements HFAP See Hospital Medical Staff standards 03.00.02, 03.00.08, and 03.00.09 See CAH Administrative (Compliance with Regulations) standards 01.03.06 and 01.03.07 29
Accreditation Standards DNV See Hospital contracted services standard (GB.3) and telemedicine standard (MS.20) See CAH quality management standard (QM.1), agreements standard (GB.4) and telemedicine standard (MS.17) 30
Practical Considerations/Best Practice QUESTION: Should the Hospital/CAH receiving the telemedicine services maintain a credentials file for the telemedicine practitioner? If so, what information should be in it? 31
Practical Considerations/Best Practice QUESTION: Is the distant site hospital or telemedicine entity expected to provide the patient-site Hospital/CAH with detailed information that may be contained in the telemedicine practitioner s credentialing file at the distant site? 32
Practical Considerations/Best Practice QUESTION: Should a Business Associate Agreement be part of the Credentialing by Proxy Agreement? 33
Practical Considerations/Best Practice QUESTION: Can the Hospital/CAH rely upon/have a copy of the results of the NPDB query conducted by the distant site hospital/telemedicine entity? 34
Practical Considerations/Best Practice QUESTION: Does the telemedicine practitioner need to complete an application? Does the distant site hospital or telemedicine entity need to provide the Hospital/CAH with an attestation regarding the telemedicine practitioners privileges at the distant site? 35
Practical Considerations/Best Practice QUESTION: Does the Hospital or CAH need to have a telemedicine delineation of privileges (DoP)? Does the telemedicine Practitioner need to request privileges/sign the Hospital/CAH DoP or is the DoP at the distant site hospital or telemedicine entity sufficient? 36
Practical Considerations/Best Practice QUESTION: Is the telemedicine practitioner granted medical staff appointment and privileges? 37
Practical Considerations/Best Practice QUESTION: Should the telemedicine practitioner s privilege period at the Hospital/CAH match the privilege period at the distance site hospital/telemedicine entity? 38
Practical Considerations/Best Practice QUESTION: Does the Hospital/CAH have to actually grant clinical privileges to the telemedicine practitioner or is the fact that the distant site grants the practitioner a medical staff appointment and privileges sufficient? 39
Practical Considerations/Best Practice Other Questions? 40
Peer Review/Quality Considerations CMS Telemedicine Hospital/CAH CoPs require: Hospitals/CAHs who credential by proxy to provide the distant site hospital or telemedicine entity with (1) all adverse events that result from the telemedicine practitioner s exercise of privileges with respect to the Hospital/CAH patients; and (2) all complaints that the Hospital/CAH receives regarding the telemedicine practitioner. 41
Peer Review/Quality Considerations When you are in Ohio, you should feel safe sharing peer review information as between the distant site and the receiving site Consider letting telemedicine physicians know this is occurring Permission is not required 42
Peer Review/Quality Considerations Be clear as to what is being shared Do not say all peer review information. Does root cause analysis mean the full analysis or the report or the findings? What about a patient complaint? What about an incident report? Anything informal? 43
Peer Review/Quality Considerations When you are not in Ohio You need to know not only the state s statute but, also, how the state s courts are interpreting it If strong, consider credentialing by proxy If weak, consider standard credentialing 44
Practical Considerations/Best Practice QUESTION: Who conducts the Professional Practice Evaluation on telemedicine practitioners? 45
Practical Considerations/Best Practice QUESTION: Should a Sharing of Information Agreement be part of the Credentialing by Proxy Agreement? 46
Practical Considerations QUESTION: Should the Hospital/CAH maintain a quality file on telemedicine practitioners? If so, what information should be in the file? 47