Telemedicine: Strength, Weaknesses, Opportunities and Treats March 21, 2012 Steven R. Smith & Sarah E. Swank

1. Telemedicine: Strength, Weaknesses, Opportunities and Treats March 21, 2012 Steven R. Smith & Sarah E. Swank

2. Meet Today’s Speakers Steven R. Smith Principal, Ober|Kaler ssmith@ober.com | 202.326.5006 Speaker Sarah E. Swank Principal, Ober|Kaler seswank@ober.com | 202.326.5003 Speaker Steve and Sarah are cofounders of the Ober|Kaler Health Care General Counsel Institute. Join us on LinkedIn: Ober|Kaler Health Care General Counsel Institute Group

3. Welcome • Upcoming Ober|Kaler Health Care General Counsel webinars • Webinar housekeeping • Overview of the topic • Discussion • Questions

4. Upcoming Webinars • Survival Tactics for General Counsel: Best Practices When the Government is Investigating Your Organization – May 16, 2012 from 12:00 pm to 1:30 pm (EST) • Coming soon – A career focused webinar on internal networking Visit www.healthcaregcinstitute.com for slides and recordings.

5. Webinar Housekeeping • Slides are located in the left hand corner to download • Type your questions into the question window at any time. We will answer them at the end of the program • Webinar slides and audio replay are available at www.healthcaregcinstitute.com and posted on LinkedIn for members • Brief evaluation (6 questions) will be emailed to you after this program

6. Today’s Discussion • Telemedicine NOT just another service • Telemedicine a modality to deliver many types of services • Strategic because: • A tool to determine where and how to provide services • An alternative to brick and mortar • Full service delivery or used to supplement services already in place

7. Today’s Discussion • Strategic planning requires: • Assessment of relevant markets and environment • Understanding of competition • SWOT analysis • Important for counsel to “be at the table” early in the planning process • Requires an understanding of strategic elements of telemedicine AND the underlying legal issues • Consider Exit Strategies

8. Definition of Telemedicine • CMS Definition: The provision of clinical services to patients by practitioners from a distance via electronic communications • Definition by the American Telemedicine Association: Use of medical information exchanged from one site to another via electronic communications to improve patients’ health status • Medicaid: Seeks to improve a patient’s health by permitting two-way, real time interactive communication between the patient, and the physician or practitioner at the distant site. This electronic communication means the use of interactive telecommunications equipment that includes, at a minimum, audio and video equipment.

9. Definition of Telemedicine • Are the following “telemedicine”? • Telehealth • Virtual Care • mHealth • Social Media

10. Definition 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

11. Definition of Telemedicine • Examples of Telemedicine: • Videoconferencing • Transmission of still images • E-health including patient portals • Remote monitoring of vital signs • Nursing call centers • Tele________ [Fill in the blank]

12. Definition of Telemedicine • Variety of practice settings • Academic medical centers (AMCs) • Health care clinics • Ambulatory Surgery Centers (ASCs) • Home • Global

13. Definition of Telemedicine • Example from CMS Telemedicine Rule: • 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. • NOTE: Not a defined term in the CMS Telemedicine Rule

14. Reasons for the Growth of Telemedicine • Advances in technology • Aging patient population and an increase of patients with chronic diseases • Current regulatory environment with an emphasis on care coordination and shifting care settings • Rural health • Physician shortage • Academic and research institutions with highly specialized services are not always centrally located

15. Benefits of Telemedicine • Enable patients to receive care in a more timely manner • Patient safety reasons - no need to move the patient • Enhance patient follow-up in the management of chronic disease conditions • Provide more flexibility to small hospitals and rural hospital with a limited supply of primary care and specialized providers • More cost-effective • Improve patient outcomes and satisfaction • Maintain or expand existing relationships

16. Downsides to Telemedicine • Lack of reimbursement • Difficult to oversee and regulate with expanding technology • Patient safety issues – not in person • Decrease patient satisfaction

17. The Joint Commission (TJC) • “Privileging by proxy” for all TJC-accredited hospitals and CAHs • Standards: LD.04.03.09, MS.13.01.01 and MS.01.01.01 • Goals of TJC Standard • Eliminate duplicative credentialing • Concerns over impeding patient access to health care services • Many agreements already in place under the TJC standards

18. Prior CMS Telemedicine Rule • Prior CMS Telemedicine Rule: Required the governing body of the hospital or Critical Access Hospitals (“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

19. CMS Telemedicine Rule • Hospital Condition of Participation: Both Hospitals and CAH are permitted to rely upon the credentialing and privileging Decisions made by the distant-site hospitals or distant-site telemedicine entity • Effective Date: July 5, 2011

20. The Joint Commission’s Reaction “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, 2011

21. Is It Streamlined?

22. Medicare Conditions of Participation (“CoPs”) • Amended on May 5, 2011 for telemedicine • Effective date July 5, 2011 • Added new paragraphs (a)(8) and (a)(9) to 42 CFR 482.12 • Added new paragraphs (a)(3) and (a)(4) to 42 CFR 482.22

23. Medicare CoPs • 42 CFR 482.12 (a)(8) and (a)(9) are standards for the Governing Body • Allows the Governing Body of the hospital to rely on the GB of the distant site hospital to meet requirements of (a)(1) – (a)(7) of 42 CFR 482.12 • 42 CFR 482.22 (a)(3) and (a)(4) are standards for the Medical Staff • Allows the Medical Staff to rely upon the credentialing and privileging decisions made by the distant site hospital for physicians providing telemedicine services at the distant site hospital

24. Medicare CoPs • Summary of New Rule: Both Hospitals and Critical Access Hospitals (“CAH”) are permitted to rely upon the credentialing and privileging decisions made by distant-site hospitals or telemedicine entities so long as certain conditions are met

25. Provisions of CoP for Distant Site Hospitals • Permissive rule – Hospitals that want to rely upon traditional methods of credentialing and privileging free to do so

26. Provisions of CoP for Distant Site Hospitals • To rely on the credentialing and privileging decisions of a distant site hospital, the hospital must have a written agreement with the distant site hospital that provides: • The Governing Body of the distant site hospital will meet the requirements of (a)(1) through (a)(7) of 42 CFR 482.12 regard ing the distant site physician providing services • The distant site hospital is Medicare certified • The distant-site practitioner is privileged at the distant-site hospital as evidenced by a current list of the practitioner’s privileges provided by the distant-site hospital

27. Provisions of CoP for Distant Site Hospitals • The distant-site physician holds a license issued or recognized by the State in which the hospital whose patients are receiving the telemedicine services is located • The hospital that credentials and privileges the distant-site practitioners shares the practitioner’s performance review information with the distant-site hospital

28. Provisions of CoP for Distant Site Telemedicine Entities (“DSTE”) • To rely on the credentialing and privileging decisions of a DSTE, the hospital must have a written agreement with the DSTE that provides: • DSTE is a contractor of services to the hospital and furnishes the services so that the hospital can comply with all CoPs for the contracted services

29. Provisions of CoP for DSTEs • The process and standards of the DSTE for assessing the qualifications of its practitioners at least meet those standards set forth in the CoPs • The physician at the DSTE is privileged at the DSTE providing the telemedicine services and the DSTE provides the hospital with a current list of the physician’s privileges at the DSTE

30. Provisions of CoP for DSTEs • The physician at the DSTE holds a license issued or recognized by the state in which the hospital whose patients are receiving telemedicine services are located • The hospital that credentials and privileges the physician at the DSTE shares the physician’s performance review information with the DSTE • Minimum required: All adverse events resulting from the telemedicine services and all complaints received about the DSTE or physician

31. CoPs Governance and Operational Impacts • Governing Body • Medical Staff • Insurance/Liability • Peer Review • Contractual Obligations

32. Governing Body • Board Bylaws • Medical Staff Bylaws • Education for Board on its role and what it is delegating • Provisions and approval of Agreement with distant site hospital or DSTE

33. Medical Staff • Medical Staff Bylaws • Address any aspect of Bylaws or policies that involve the physical presence of a physician • E.g., meeting requirements, definition of patient encounters or contacts, minimum number of contacts or encounters, criteria for new members in departments (sometimes based on “need”), emergency room coverage, etc.

34. Medical Staff • Medical Staff Bylaws • Describe process and information being relied upon • Impact on: • Department chiefs • Credentials Committee • Medical Executive Committee • Required to monitor quality and risk for distant site practitioner • Bylaws, policies or rule changes to describe process • How to effectively do so? • Communications with DSTE

35. Medical Staff • Medical Staff Policies • Physician health • Corrective Action • Fair Hearing • Disruptive behavior

36. Medical Staff • Fair Hearing Rights • If distant site practitioner is on staff then these will apply • How to implement for telemedicine and distant site practitioners? • Exit strategy for convenience and when there is a problem

37. Insurance and Liability • Professional liability coverage for distant site practitioner and hospital or DSTE • Check hospital’s policies • No exclusions or other provisions that could lead to a denial in coverage in working with telemedicine providers • No issues by delegating decisions • D&O coverage

38. Insurance and Liability • Indemnification of hospital • Complete reliance on distant site hospital • Need strong provision • Standard of care – Community vs. local? • Telemedicine quality standards? • Other credentialing concerns of the hospital that should apply to telemedicine arrangements

39. Peer Review • Hospital to review the performance of the distant site practitioner and send performance information to the distant site hospital • Peer review information being communicated from one hospital to another (including adverse events and patient complaints) • Is this protected or is there a risk of loss of the privilege for peer review information?

40. Peer Review • Review state laws in jurisdiction of hospital with patient and distant site hospital • Potential use of Patient Safety and Quality Improvement Act of 2005? • Patient Safety Evaluation System • Reporting of information • Develop policies and procedures to handle these issues

41. Agreement • Credentialing provisions required by Hospital CoP • Insurance/Indemnification • Who pays? • Access to privilege information from distant site • Reps and warranties re quality and credentialing • Other

42. Costs and Marketing OIG Advisory Opinion No. 11-12 • Who pays for the costs? • Marketing • Current or past relationship • Reduction in volume • Analysis hinges on no reimbursement

43. Implementation • Education • Policies • HIPAA/Medical Records • Telemedicine Vendors • State License Requirements • Community Standard

44. Telemedicine Vendors Contracts HIPAA issues Cyber insurance Support levels Warranties Intellectual property • Selection process • Due diligence • RFPs • Can it be done in house? More expensive is not always better

45. State Licensing Requirements State licensing requirements vary • Special Telemedicine licenses Compact licensing is one answer National licensing requirements

46. Community Standard Current standard Geographical separation Separate telemedicine standards

47. Questions

48. More questions? Contact us. Steven R. Smith Principal, Ober|Kaler ssmith@ober.com | 202.326.5006 Sarah E. Swank Principal, Ober|Kaler seswank@ober.com | 202.326.5003 Steve and Sarah are cofounders of the Ober|Kaler Health Care General Counsel Institute. Join us on LinkedIn: Ober|Kaler Health Care General Counsel Institute Group