1. TELEHEALTH: Strategic and Legal Issues for Community-Based Delivery Deborah A. Randall, JD & Consultant Catherine T. Randall, JD 202-257-7073 www.deborahrandallconsulting.com 1

2. Moving Forward with Telehealth The key is to define and expand strategic relationships, including those with government. Some relationships will be problematic. Regulatory review will increase despite the widely-held desire to keep health information technology open and innovative. 2

3. Where We are Now: Medicare Office of a physician or practitioner Hospitals; Critical Access Hospitals Hospital or CAH-based Renal Dialysis Centers (including satellites) Community Mental Health Centers Rural Health Clinics; Skilled Nursing Facilities ;Federally Qualified Health Centers (FQHC); 3

4. Practitioners,Physicians plus: Nurse practitioners NP Physician assistants PA Nurse midwives; Clinical nurse specialists Clinical psychologists & social workers (but not billing psychotherapy that includes medical and management services under Medicare) Registered dieticians; nutrition professionals 4

5. Medicare Coverage Expansion Telehealth consultations, emergency department or initial inpatient Follow-up inpatient telehealth consultations furnished to beneficiaries in hospitals or SNFs Office or other outpatient visits Subsequent hospital care services, limited to 1 telehealth visit q 3 days 5

6. Medicare Coverage Expansion Individual and group health and behavior assessment and intervention Individual psychotherapy, Pharmacologic management, and Psychiatric diagnostic interview examination 6

7. Medicare Coverage Expansion Individual and group Kidney Disease Education (KDE) services; Individual and group Diabetes Self- Management Training (DSMT) services; Group Medical Nutrition Therapy (MNT) services; Smoking cessation 7

8. How We Got There HITECH ACT 2009 – Stimulus Bill HIT Policy Committee; Aging Services Tech. Study; Infrastructure funding PPACA – Health Reform Act 2010 Independence@Home; Medicaid Medical Home; Chronic Care; Innovation Center; Legislation pushing a reluctant CMS and HHS 8

9. Focus: Strategic Opportunities Relationships: horizontal and vertical Relationships with private insurers, governmental grantors, networks Mining the available relationships Not getting shut out “Demanding” entry Patients: participants not data points 9

10. PPACA Post-hospitalization bundling pilot Independence at Home demonstration Innovation Center’s strong telehealth focus ACOs Medical Home-Medicaid and Pilots 10

11. Where We Are Going: Community/Home Expansion Care coordination and Chronic Disease Patient self-management Ambulatory care and safety Palliative care Rehabilitative services Behavioral and mental health services 11

12. Care Coordination: BEACON: $16+Million Buffalo; San Diego Western NY Info.Exchange Clinical decision support – registries + point-of-care alerts/reminders Innovative telemedicine = improve primary/specialty care for diabetics, ↓ preventable ER visits, hospitalizations re-admissions for diabetes, CHF, pneumonia; ↑immunization of diabetics 12

13. Scope & Payers Home-based telehealth mostly chronic care management => avoid ER & re- hospitalizations. Provider funded; grants Medicaid paying telehealth visits Home as “originating site” NOT reimbursed by Medicare. Skilled nursing home = live consultations in rural or medically underserved area 13

14. CMS Comprehensive Primary Care Initiative 4 yr program represents > 2000 primary care doctors and nurse practitioners in seven markets Care management fee supports enhanced, coordinated bene services Participating commercial, state, other federal insurance plans offering enhanced payment 14

15. CMS Comprehensive Primary Care Initiative Designed to test a model of improved access to quality health care at lower costs. The 500 practices were selected through a competitive application process and will start delivering enhanced health care services this fall. 15

16. CMS Community-based Care Transitions Program Advanced Care Transitions (ACT), Marin County, California Los Angeles Mid-City Integrated Care Collaborative San Francisco Transitional Care Program (SFTCP) 16

17. Aligning with the VA Innovator Soundly funded Committed to results Demanding constituency “Controls” physicians Requires RFP process, outcomes Conservative on privacy 17

18. VA Chronic Care Coordination Telehealth Report 12/08 CONDITION # % DECREASE UTILIZATION Diabetes 8,954 20.4 Hypertension 7,447 30.3 CHF 4,089 25.9 [congestive heart failure] COPD 1,963 20.7 [chronic pulmonary obstruction] 18

19. VA Chronic Care Coordination via Telehealth Study, cont. Posttraumatic stress disorder: 45.1% Depression: 56.4% Other mental health condition: 40.9% Single condition 10,885 patients: 24.8% Multiple condition 6,140 patients: 26.0% Interventions “just in time”; “air traffic control” 19

20. VA Chronic Care Coordination via Telehealth Study, cont. The cost ($1,600.24 pp/yr compares favorably) direct cost of VHA’s home-based primary care services of $13,121.25 per annum and market nursing home care rates that average $77,745.26 per patient per annum”. Conclusion: a flexible and cost-effective adjunct to VHA’s existing services. Darkins et al., Telemedicine & EHealth, 12/2008. 20

21. VA Rapidly Expanding Health Outreach By end 2013, 825,000 on telehealth PTSD; mental and behavioral concerns of wounded warriors. Local centers & distanced specialists. Internet-based programs along with Skype-type live sessions Increased home-based video consults, e-consults and teleradiology programs 21

22. Dignity Health Home Care 12% reduction in hospitalization within 30 days as compared to control group 59% reduction in post-intervention re- admissions at six months as compared to prior 6 months* 58% reduction in cost of care (ACF and E.D.) post intervention at six months as compared to prior 6 months* * Test group

23. What are the New Directions? Tele-rehabilitation; falls prevention Tele-mental and behavioral health Continuous monitoring: diabetes; cardiac Impaired: Alzheimer’s & dementias Ambient assisted living; www.aal- europe.eu 23

24. New or Altered Relationships The partially or marginally competent The resistant or resilient, aging or younger person The shared relationship with family The non-compliant, managed care member confronted with “discipline” Incurable, declining, chronic care customers 24

25. Telehealth: Dementia Patients Residential facilities allow movement of individuals through facility and grounds; families can track Geo-fencing in Europe Sensoring systems; Intel research; TRILL; diagnostic sensoring for fall prevention yielding data on Alzheimer specific movement differentials 25

26. Palliative Care Pain and symptom management Outreach and crisis management Triage without transporting to facility Psychological pain and suffering Diagnostic opportunities; family interactions Ethical principles: autonomy enhanced 26

27. Advanced Illness: Is there a Role for Telehealth? Using an existing model: Kaiser’s Advanced Illness Coordinated Care Program (AICCP) & health counseling Developed for patients with advanced illness (congestive heart failure, end- stage pulmonary disease, end-stage renal disease, and cancer) in 3 settings of a multistate health plan. 27

28. Telehealth & Compliance Evolution and innovation are good things The legal implications of rapid, technology- based change can seem overwhelming, and they do warrant careful evaluation and monitoring BUT privacy, reimbursement, and other compliance concerns are not unfamiliar issues. They are not insurmountable obstacles! 28

29. Compliance Concerns Licensure and Credentialing Under-serving patients; Liability Consent Reimbursement and Documentation Management of the Case Privacy and Confidentiality Security of Communication Fraud and Abuse 29

30. Telehealth is People-Centered Telehealth is not just about technology Requires employee/patient engagement and confidence  “Champion” the teleheath cause  Demonstrate telehealth’s role as a helpful, cost-saving addition to clinical practice, as opposed to an impersonal replacement  Address concerns and how to manage them  Confident practitioners = confident patients 30

31. Educate Employees Education and Training  Clear compliance guidelines  Educate employees about telehealth’s current strengths and limitations (clinical, technical, legal)  Train employees to use, configure, and troubleshoot technical problems on their own – minimize the time/expense of technical errors, avoid relying on outside IT (availability problems, $) 31

32. Licensure Many states bar physicians from practicing via telehealth without a full or partial new license => quality; control as issues Some states license the entity which arranges for/participates in telehealth Therapy associations are “waking up” 32

33. Credentialing in Telehealth HHS concessions: No need for hospital physicians and other health professionals to have admitting privileges at “receiving” institution where patient is located But hospitals must play ball with this 33

34. AMA – Conservative Stand AMA has issued practice code guidance suggesting all physicians must see a patient in-person to establish a physician relationship AMA has raised ethical issues AMA is opposed to Rx on-line Self-interest? 34

35. Licensure & Credentialing Compliance Adhere to all requirements required by CMS rules, including for hospitals:  Written agreements  Revisions of bylaws and policies  Process for monitoring off-site providers Address risk-sharing and indemnification in agreements with off- site providers 35

36. AB 415: Telehealth Advancement Act of 2011 Expands definition of telehealth Expands provider types – all professionals licensed under CA’s healing arts statute Specifically allows use of telehealth regardless of setting Medi-Cal: no sunset date on store- and-forward, no requirement to document barrier to care 36

37. AB 415, cont. Aligns CA with CMS credentialing rules, allowing but not requiring “privileging by proxy” Removes requirement for written consent to telehealth – oral OK (but this may change soon) But does NOT require payment for telehealth services by public or private payors 37

38. Monitoring Telehealth Off-Site Implement reliable monitoring system  How many providers (credentials, contracts) can you track? 10? 100? 1000? Make realistic assessment of capacity  Designate party responsible for data, Q/Cing and regulatory deadlines  Test methodology before going “live” Keep lines of communication open with off- site telehealth providers 38

39. Patient Screening & Education Pre-screening: telehealth is not appropriate for all patients, types of clinical practice Educate patients about use of technology before starting treatment  Provide information about potential risks of data breaches, technical mishaps, etc.  Security required on patient’s end  Instructions in case of problems 39

40. Patient Consent in CA Before beginning treatment, obtain consent to use telehealth; currently, oral consent OK in many States. No mention of consent in some. Do the types of potential harms that could arise from a breach of privacy or flawed data require more protective consent procedures?  Privacy/confidentiality: health info > financial info?  Data loss/errors could lead to mistakes in treatment and harm to patients 40

41. “Under-Serving” a Patient in Need? Patient Inducement? Civil Money Penalties Act = concerns when less care than needed is given. If telehealth is not Medicare covered, is it still a visit, an encounter, a service or an accessory? Is it a patient inducement to provide telehealth for free? – OIG Advisory Opinion (2000) suggests no if not advertised... 41

42. Technology & Liability Inadequate, unreliable technology = lost profits, lost efficiency, lost confidence and support by patients and practitioners; potential for privacy breaches and malpractice issues Liability for lost/damaged data: for example, a practitioner makes a wrong diagnosis, or takes the wrong action, based on missing/partial data Liability for patient harmed by misuse of technology: for example, a psychotic patient is traumatized by sound or video distortion during video-conference 42

43. Technology & Liability Be Prepared:  Purchase sufficient internet bandwidth and reliable technology to handle the volume and types of data being stored and transmitted  Use technology that allows accurate observations and diagnoses, e.g. large, high- definition monitors  Have clear steps for employees/patients to follow in event of technical problems  Implement backup plans – on-site/at-home  Q/C and run test cases prior to implementing 43

44. Confidentiality, Privacy & Data Protection Confidentiality, privacy and data theft are old concerns, but new technology requires new safeguards Benefit of storing and transmitting electronic health records (EHRs) = improved cost efficiency, quality and coordination of care, reduced communication errors Risk = breach of an entire database of patient information is a big event 44

45. Confidentiality, Privacy & Data Protection Telehealth expands the potential number of people who can access patient information: identify how data will stay protected Patients and practitioners cannot be too hasty to connect and use unsecured video- conferencing software  No guaranteed confidentiality for Skype  Patient’s home computer setup unlikely as secure as hospital/clinic’s technology  What if patients cannot afford to purchase or have access to a secure system? 45

46. Privacy & Data Exchange HITECH and other HIT bills extending privacy protections including business associates HIPAA issues on transmission, storage, security, “use” and authorizations grounds Risk management assessments 46

47. HIPAA Case: $1 million fine... Massachusetts Eye and Ear “failed to take necessary steps to comply with certain” Security Rule requirements: ensuring data maintained on portable devices, such as laptops computers, were protected and procedures were in place for identifying and reporting data security incidents. 47

48. Accountability Draft policies and procedures to comply with federal and state privacy protections Standards: ATA and others, still evolving Best Practices  IT tools: encryption, authentication, proxies, “electronic trails”, no unsecured technologies  Employee training: privacy rules and standards of care  Risk management assessments  Do test cases before going “live” 48

49. Texting? mHealth? UK’s NHS on tablet/iPad security: “....these devices are currently not as secure as more traditional IT equipment. They should therefore not be used to store sensitive patient data and should, as with all mobile devices, be encrypted as necessary.” 49

50. Texting? Joint Commission: Not acceptable for physicians or licensed independent practitioners to text orders for patients to the hospital or other healthcare setting... no ability to verify the identity of the person sending the text... no way to keep the original message as validation of what is entered into the medical record. 50

51. Billing & Reimbursement Covered services and reimbursement  As telehealth expands, who and what is covered by Medicare, Medicaid, Med-Cal, and private payers will change  If in doubt about covered services, communicate with private payers ahead of time Know how to bill in case of technical problems, data distortion and/or loss 51

52. Liability & Case Management Potential problem areas  Monitoring performance of equipment and quality of patient care when patient and telehealth technology is at least partially off-site, not immediately accessible  Liability for adverse events: technical and/or human error  Manufacturers/vendors will seek total immunity from exposure  Malpractice insurers still ignorant? Telehealth transmission as Medical Device or a conduit for information Patients need guidance from physicians & health entity: conditions, errors and backup response 52

53. Fraud & Abuse Concerns with how to monitor whether practitioners are:  Billing accurately for services  Providing adequate patient care  Acting within their scope of practice Patient over-use of telehealth services, “doctor-shopping” – is this a real concern, or part of an unlikely “parade of horribles”? 53

54. Fraud & Abuse Coordination of telehealth services vs. Impermissible incentive to referral source, including patient herself. - Limited OIG safe harbor - OIG advisory opinions - Stark law: physician financial interest - ACO guidances HHS and FTC 54

55. OIG Advisory Opinion 11-12 Advisory opinion regarding a health system’s proposal to enter into arrangements to provide neuro emergency clinical protocols and immediate consultations with stroke neurologists via telemedicine technology to certain community hospitals – Approved with caveats 55

56. Resources Final ACO regulations 76 Federal Register 67802 November 2, 2011 Final OIG waivers for ACOs, same Fed Reg, at page 67992. OIG Advisory Opn 11-12, oig.hhs.gov/compliance/advisory- opinion and OIG e-prescribing safe harbor oig.hhs.gov/authorities/docs/06 56

57. Educational Websites American Telemedicine Association, www.americantelemed.org/ www.americantelemed.org/ Center for Connected Health Policy, http://connectedhealthca.org/ http://connectedhealthca.org/ CA Telehealth Resource Center (CTEC), http://www.caltrc.org/ http://www.caltrc.org/ CA Telehealth Network, http://www.caltelehealth.org/ http://www.caltelehealth.org/ HIPAA Security Rule Toolkit, http://www.ohii.ca.gov/calohi/ http://www.ohii.ca.gov/calohi/ 57

58. Thank You! Deborah Randall, JD Health Law Attorney Telehealth Consultant 202-257-7073 law@deborahrandallconsulting.com www.deborahrandallconsulting.com © 2013 Deborah Randall 58