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1 Presenting a live 90-minute webinar with interactive Q&A Telemedicine Credentialing and Privileging: Complying With the New CMS Rule Protecting Patient Privacy, Avoiding Fraud and Abuse Liability, Ensuring Quality of Care THURSDAY, JULY 28, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Mark A. Kadzielski, Partner, Fulbright & Jaworski, Los Angeles Sarah E. Swank, Principal, Ober Kaler, Washington, D.C. Kristina Pervi Ayers, Attorney, Fulbright & Jaworski L.L.P., Los Angeles The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

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5 Telemedicine Credentialing and Privileging: Complying with the New CMS Rule Protecting Patient Privacy, Avoiding Fraud and Abuse Liability, Ensuring Quality of Care MARK A. KADZIELSKI, ESQ. (213) SARAH E. SWANK, ESQ. (202) KRISTINA AYERS, ESQ. (213)

6 OUTLINE OF PRESENTATION I. CMS Final Rule and Associated Regulations II. Impact on Healthcare Facilities and Practitioners III. Complying with the New Rule 6

7 I. CMS FINAL RULE AND ASSOCIATED REGULATIONS Reliance on Credentialing and Privileging decisions is A-OK! Summary of New Rule: Both hhospitals and Critical Access Hospitals ( CAH ) are permitted to rely upon the credentialing and privileging decisions made by the distant-site hospitals or telemedicine entity Effective Date: July 5,

8 WHAT IS TELEMEDICINE? CMS Definition: Telemedicine is the provision of clinical services to patients by practitioners from a distance via electronic communications. i Definition by the American Telemedicine Association: Telemedicine is the use of medical information exchanged from one site to another via electronic communications to improve patients' health status. 8

9 WHAT IS TELEMEDICINE? Closely associated with telemedicine is the term "telehealth," which is often used to encompass a broader definition of remote healthcare that does not always involve clinical services. 9

10 WHAT IS TELEMEDICINE? Examples of Telemedicine: Videoconferencing Transmission of still images E-health including patient t portals Remote monitoring of vital signs Nursing call centers 10

11 WHAT IS TELEMEDICINE? Types of Telemedicine: Non-simultaneous: involve after-the-fact interpretation or assessment, such as teleradiology services Simultaneous: involve real-time interpretation or assessment, such as teleicu services NOT Telemedicine: informal consultations between practitioners 11

12 WHAT PROMPTED THE INITIAL DEVELOPMENT OF TELEMEDICINE? Renowned academic and research institutions with different specialties are not centrally located Advances in technology Aging patient population and an increase of patients with chronic diseases 12

13 DEMAND FOR PROVIDING MEDICAL SERVICES THROUGH TELEMEDICINE 1. Rural or Underserved Communities that often suffer from a shortage of both primary and specialty healthcare practitioners 2. Facing a Physician Shortage as the patient population increases and the average age of an American increases, thus exposing more people to more medical issues 13

14 OUT WITH THE OLD & IN WITH THE NEW: CMS PRIOR TELEMEDICINE RULE Prior CMS Telemedicine Rule: Required the governing body of the hospital or CAH to make all privileging decisions based upon the recommendations of its own medical staff after its medical staff had thoroughly examined and verified the credentials of every single practitioner applying for privileges irrespective of whether that practitioner was providing services in person and onsite at the hospital or remotely through a telecommunications system 14

15 OUT WITH THE OLD & IN WITH THE NEW: REASONS FOR A NEW CMS RULE 1. Duplicative Credentialing: required each hospital seeking to use telemedicine services to credential practitioners, who were already credentialed at their home institutions 2. Burdensome Credentialing: required hospitals, which often lacked adequate resources to fully carry out traditional credentialing, to take on the financial burden of providing much needed care to its patients 15

16 OUT WITH THE OLD & IN WITH THE NEW: REASONS FOR A NEW CMS RULE 3. Conflicting Requirement with TJC: TJC was permitting privileging by proxy for all TJCaccredited hospitals. Privileging by Proxy allowed for one TJC-accredited facility to accept the privileging decisions of another TJC-accredited facility utilizing a streamlined independent determination process, rather than making an individualized decision based on the practitioner s credentials and record. 16

17 OUT WITH THE OLD & IN WITH THE NEW: PURPOSE FOR NEW CMS RULE 1. Enable patients to receive medically necessary interventions in a more timely manner; 2. Enhance patient follow-up in the management of chronic disease conditions; 3. Provide more flexibility to small hospitals and CAHs in regions with a limited supply of primary care and specialized providers; 17

18 OUT WITH THE OLD & IN WITH THE NEW: PURPOSE FOR NEW CMS RULE 4. Create a more cost-effective alternative to traditional service delivery approaches; 5. Improve patient outcomes and satisfaction; and 6. Consistency with TJC Standards 18

19 TJC REACTION TO CMS NEW RULE ON TELEMEDICINE The Joint Commission is very pleased that CMS has revised its telemedicine requirements to provide more flexibility to hospitals and lessen their regulatory burden. This is an especially positive step for improving access to care for patients in rural areas. Of particular importance is the fact that critical access hospitals will have additional avenues to benefit from the services of particularly skilled physicians and practitioners. Mark Chassin, MD, FACP, MPP, MPH, May 6,

20 OUT WITH THE OLD & IN WITH THE NEW: THE NEW TELEMEDICINE RULE The New Rule: PERMITS RELIANCE permits a governing body of a hospital or CAH to rely on credentialing and privileging decisions made by distant-site hospitals or telemedicine entities when making privileging decisions for practitioners who provide telemedicine services, as long as certain conditions are met. 20

21 OUT WITH THE OLD & IN WITH THE NEW: BREAKING DOWN THE NEW RULE Definitions: Distant-Site Hospital: a Medicare-participating hospital that provides the practitioner Distant-Site Telemedicine Entity: can include a non- Medicare participating hospital or entity that provides contracted services in a manner that enables a hospital or a CAH using telemedicine services to meet all applicable CoPs. These entities often include teleradiology, telepathology, and ASCs. 21

22 OUT WITH THE OLD & IN WITH THE NEW: DISTANT-SITE HOSPITALS To rely on a distant-site hospital s credentialing and privileging decisions, the hospital or CAH must have a written agreement that establishes the following: 1. The distant-site hospital is a Medicare-participating hospital 2. The distant-site practitioner is privileged at the distantsite hospital as evidenced by a current list of the practitioner s privileges provided by the distant-site hospital 22

23 OUT WITH THE OLD & IN WITH THE NEW: DISTANT-SITE HOSPITALS 3. The practitioner holds a license issued or recognized by the state in which the hospital or CAH whose patients are receiving telemedicine services is located 4. The hospital that credentials and privileges the distantsite practitioners shares the practitioner s performance review information with the distant-site hospital 23

24 OUT WITH THE OLD & IN WITH THE NEW: DISTANT-SITE TELEMEDICINE ENTITIES To rely on the credentialing and privileging decisions by a distant-site telemedicine entity, the hospital or CAH must have a written agreement that establishes the following: 1. The entity s process and standards for assessing the qualifications of its practitioners at least meet those standards set forth in the CoPs 24

25 OUT WITH THE OLD & IN WITH THE NEW: DISTANT-SITE TELEMEDICINE ENTITIES 2. The distant-site practitioner has the experience and expertise as represented by the distant-site telemedicine entity 3. The practitioner holds a license issued or recognize by the state in which the hospital or CAH is located 4. The hospital or CAH that credentials and privileges the distant-site practitioner shares the practitioner s performance review information with the entity 25

26 II. IMPACT ON HEALTHCARE FACILITIES AND PRACTITIONERS: THE BOARD Bylaws Approval of Medical Staff Bylaw changes Medical staff recommendations Understanding their role Contractual obligations 26

27 MEDICAL STAFF: MEDICAL STAFF BYLAWS Privilege categories Definition of encounter or case Which category? Changes in Roles Medical Staff departments Credentials Committee Medical Executive Committee 27

28 MEDICAL STAFF: MEDICAL STAFF BYLAWS Sharing of information Add description of process Add description of information relying on Subject Medical Staff policies Physician health Disruptive behavioral policies 28

29 MEDICAL STAFF: CREDENTIALING Credentials Committee Decisions based on other hospital s information Decisions based on telemedicine entity information Comfort level Case Study: IRBs 29

30 MEDICAL STAFF: PEER REVIEW Telemedicine standards Information shared Reliance on another hospital/entity tit Privilege problem Easier in an integrated system 30

31 MEDICAL STAFF: QUALITY Difference from peer review Information needed Reports 31

32 MEDICAL STAFF: POLICIES AND PROCEDURES Clinical protocols Compliance policies HIPAA policies Billing policies Any policy that discusses the physical presence of the physician 32

33 REIMBURSEMENT Medicare Definition of Telemedicine Medical homes Third Party Payors Check your contracts NOTE: Compliance with telemedicine CoPs does not automatically mean $ 33

34 EDUCATION AND TRAINING Board Medical Staff Clinical Staff Patient Accounting Staff IT Staff 34

35 INSURANCE ISSUES Coverage D&O General Liability Malpractice Indemnification 35

36 NON-HOSPITAL TELEMEDICINE ENTITIES Lack of clear definition Goal Health Care Reform Care settings Examples: Neurohealth Radiology Clinics 36

37 TELEMEDICINE VENDORS Selection process Due diligence RFPs Contracts HIPAA issues Cyber insurance Support levels Warranties Intellectual property More expensive is not always better 37

38 MEDICAL RECORD ACCESS HIPAA Physician Portals Confidentiality agreement Good old ldfashion - faxing 38

39 LICENSING REQUIREMENTS State licensing requirements Compact licensing National licensing requirements 39

40 COMMUNITY STANDARD Current Standard Geographical separation Separate telemedicine standards 40

41 COSTS Who pays for the costs? Fraud and abuse issues FMV analysis 41

42 IS IT STREAMLINED? 42

43 III. COMPLYING WITH THE NEW RULE: WRITTEN AGREEMENTS Hospitals must have detailed written agreements with a distant-site hospital or telemedicine entity to rely on the distant site s credentialing and privileging decisions. Written agreements must include: Specific responsibilities of telemedicine provider s governing body or other responsible decisionmakers All provisions required by the Conditions of Participation 43

44 COMPLYING WITH THE NEW RULE: WRITTEN AGREEMENTS A Comparison Credentialing Practitioners from Distant-Site Hospitals Agreements Must Specify: Credentialing Practitioners from Distant-Site Telemedicine Entities Agreements Must Specify: Distant-site hospital governing body responsible for meeting CoPs with regard to its practitioners providing telemedicine services Distant-site telemedicine entity is a contractor of services to hospital & furnishes contracted services in a manner that permits hospital to comply with all applicable CoPs 44

45 COMPLYING WITH THE NEW RULE: WRITTEN AGREEMENTS- A Comparison Credentialing Practitioners from Distant-Site Hospitals Agreements Must Specify: Credentialing Practitioners from Distant-Site Telemedicine Entities Agreements Must Specify: Distant-site hospital is a Medicare participating hospital Entity s process and standards for assessing the qualifications of its practitioners at least meet those set forth in the CoPs 45

46 COMPLYING WITH THE NEW RULE: WRITTEN AGREEMENTS A Comparison Credentialing Practitioners from Distant-Site Hospitals Agreements Must Specify: Credentialing Practitioners from Distant-Site Telemedicine Entities Agreements Must Specify: Distant-site i practitioner i is privileged at distant-site hospital Distant-site i practitioner i holds license issued/recognized by state where hospital is located 46

47 COMPLYING WITH THE NEW RULE: WRITTEN AGREEMENTS- A Comparison Credentialing Practitioners from Distant-Site Hospitals Agreements Must Specify: Credentialing Practitioners from Distant-Site Telemedicine Entities Agreements Must Specify: Distant-site practitioner hld holds license issued/recognized by state where hospital is located Hospital must share distantsite practitioner s performance review information with distant-site hospital. Hospital must share distant- site practitioner s performance review information 47

48 COMPLYING WITH THE NEW RULE: WRITTEN AGREEMENTS Written agreements should include: Any additional standard with which a distant site s credentialing and privileging process should comply Adequate representations and warranties regarding the quality of services and credentialing/privileging processes provided by the distant-site telemedicine provider 48

49 COMPLYING WITH THE NEW RULE: WRITTEN AGREEMENTS Written agreements should include: Adequate representations and warranties regarding the quality of services and credentialing/privileging processes provided by any entity with which the distant-site subcontracts Tight, protective indemnification and risk-sharing provisions Requirement that distant-site telemedicine entity has liability insurance 49

50 COMPLYING WITH THE NEW RULE: WRITTEN AGREEMENTS Additional Considerations: Address greater oversight concerns that arise when contracting with a distant-site telemedicine entity rather than a licensed, distant-site hospital. 50

51 COMPLYING WITH THE NEW RULE: WRITTEN AGREEMENTS Additional Considerations: Require additional assurances if a distant site subcontracts with a telemedicine entity. Avoid relying solely on representations and warranties. Consider requiring separate written agreements. Review agreements between distant site and its subcontractors. 51

52 COMPLYING WITH THE NEW RULE: MONITORING PRACTITIONERS Hospitals must monitor distant-site telemedicine practitioners. THE RULE: Hospital using telemedicine services of distant-site site practitioners must maintain evidence of an internal review of the distant-site practitioner s performance of privileges and send information to the distant site for use in the periodic appraisal of the practitioner. 52

53 COMPLYING WITH THE NEW RULE: MONITORING PRACTITIONERS At minimum, monitored and shared information must include: (1) All adverse events that result from telemedicine services provided by practitioner to patients, and (2) All complaints the hospital has received about the practitioner 53

54 COMPLYING WITH THE NEW RULE: MONITORING PRACTITIONERS Additional Considerations: Determine what additional information, if any, to collect as part of monitoring process. Determine how to use and act on collected information. Identify telemedicine practitioner s procedural rights. 54

55 COMPLYING WITH THE NEW RULE: SHARING PROTECTING INFORMATION Compliance with the new rule requires sharing of peer review and internal review information between hospitals and distant sites. Develop procedures and policies for sharing information to ensure the privacy of physician peer review and patient information is appropriately protected. 55

56 COMPLYING WITH THE NEW RULE: SHARING PROTECTING INFORMATION Additional Considerations: Develop and implement policies and procedures to comply with federal privacy laws and each state ss peer review and patient privacy laws. Determine what information to share no need to share too much. Determine who should have access to confidential, shared information. 56

57 COMPLYING WITH THE NEW RULE: SHARING PROTECTING INFORMATION Additional Considerations: Only disclose information in a manner that preserves all peer review privileges under state law. Note: A telemedicine entity may not be a recognized peer review body under state law and thus not subject to any peer review privilege. 57

58 COMPLYING WITH THE NEW RULE: OPEN QUESTIONS Fair Hearing Rights: What happens if the hospital no longer wants to use a provider from the telemedicine site because of quality issues? 58

59 COMPLYING WITH THE NEW RULE: OPEN QUESTIONS Subcontractor Issues: What happens if a medical group at the hospital subcontracts with another entity to provide telemedicine services; does the hospital need a written agreement with that subcontractor? 59

60 COMPLYING WITH THE NEW RULE: OPEN QUESTIONS Monitoring of Technology: How does a hospital realistically keep track of all the telemedicine that is occurring with its four-walls? Is it even possible? 60

61 QUESTIONS? 61

62 Telemedicine Credentialing and Privileging: Complying with the New CMS Rule Protecting Patient Privacy, Avoiding Fraud and Abuse Liability, Ensuring Quality of Care MARK A. KADZIELSKI, ESQ. (213) SARAH E. SWANK, ESQ. (202) KRISTINA AYERS, ESQ. (213)

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65 Thanks. Please join us for our next legal conference, ZPIC Medicare Audits: Lessons Learned From CMS Scrutiny - Navigating the Complex Audit and Appeals Processes, scheduled on Thursday, August 11, 2011 starting at 1pm EDT. Strafford Publications, Inc