Benefits and Liability of Health IT for Homecare and Hospice

1. Benefits and Liability of Health IT for Homecare and Hospice Deborah Randall, Esq. Law Office of Deborah Randall law@deborahrandallconsulting.com

2. Overview • Telephonic, wireless and mHealth developments for home health and hospice • HIT studies on chronic disease management, aging services and diagnostics • Working home HIT into medical homes and RHIOs • Efforts in the EU, Ireland, UK in home telehealth • Quality of care, patient access, control and ethics • Reimbursement, licensure and risk management

3. Concerning Medicare and Telehealth • "A recent xxxxxx came to visit and was impressed by [telehealth] technology but even though [he] may want it, no one in the health department was incentivised to take it on because their seats are more carefully retained if they do more of the same -- they see disruptive technology as too risky," Cellar said.

4. Legislation under Review • S. 2741, the Rural Telemedicine Enhancing Community Health (TECH) Act of 2009 • Telehealth pilot projects to analyze clinical outcomes and cost effectiveness associated with telehealth services in a variety of geographic areas; • “Originating sites" = urban areas; telestroke coverage  • Expanded access = store-and-forward and video conferencing technologies. • Centers for Medicare and Medicaid Services (CMS) required to allow credentialing and privileging on multi-provider-site basis, reducing costs/duplication.

5. Health Reform Legislation • HHS Center for Innovation • Demonstration for bundled care • Medical Home • Mental Health Parity for Private Insurers • Reduction in Home Health Reimbursement; quality outcomes factor • Direction for new Hospice payment review

6. National Pilot on Patient Bundling • Pilot for integrated care during an episode of care around a hospitalization and post-acute care services • Looking at factors, to include • a mix of acute and chronic conditions • evidence for need of quality of care improvement • significant variation in readmissions • significant variation in post-acute care spending • Common assessment instrument [again] • Combo of hosp/MD/SNF/HHA may apply

7. Independence at Home Demo. • Physician/NP or group[s] of same, and support team with experience providing home-based primary care • In-home visits, access for care 24/7 • 200+High-cost chronically ill beneficiaries • ‘uses electronic health information systems, remote monitoring and mobile diagnostic technology’ • Per capita spending targets& -5% bonus

8. Fate of the ‘Innovation Center’ • Given the unknowns in any health care reform progress after Mass. election, what room is there for additional HHS infrastructure • Re-organization of HRSA has disconnected portions of the grant-making apparatus, appearing to emphasize rural settings and ‘traditional’ telehealth

9. Unsafe at Home - Drugs • A new national survey of people ages 65 and older who use medications reports that 51% take at least five different prescription drugs regularly. Of these: • One in four take between 10 and 19 pills each day 35% are not sure they can name all the medications they use………17% worry about drug interactionsSource: "New Survey Shows Seniors Struggle Under the Weight of Multiple Medication Use," Medco Health Solutions press release, December 29, 2009, http://medco.mediaroom.com/index.php?s=43&item=417

10. Unsafe at Home - Falls • GE QuietCare, a remote passive activity and behavioural monitoring system for the elderly, alerts caregivers to subtle changes = potential health issues, emergency, fall or emerging health problem. • Initially in assisted living facilities but now aimed at clinical decision support at home. • Alzheimer’s Ass’n funded research.

11. UK National Health Service • 2009 /10 National Health Operating Framework: Primary Care Trusts have as a “first priority” a new prevention package for older people that will ‘initially improve falls and fracture services, foot care, intermediate care, telecare and audiology services, with the aim of enabling older people to live longer, healthier and more independent lives’

12. UK PROJECTS • NHS Efforts with Whole System Demonstrator; lessons learned about assumptions of social supports • Pilot in No.East Essex w Intel and Turnstall and County installing 400 units for individuals with COPD and other chronic illnesses

13. 6000 Persons –WSD telehealth • Recent NHS publication on ‘Improving the life of health and well-being of people with long-term conditions’ http://www.dh.gov.uk/dr_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_111187.pdf

14. EU/UK Furthest Ahead? • Clinical trials in Newham,Kent and Cornwall, United Kingdom, involve 400 patients in each county suffering from illnesses such as diabetes, high blood pressure, and heart disease. • monitored at home via diagnostic equipment linked by broadband internet connections to local hospitals and clinics. Savings = “millions of pounds,” per Britain’s Department of Health (DoH), because > 14.5 million have chronic conditions that require monitoring.

15. UK PROJECTS • 25 units in private homes; 15 in community settings such as long term care residences • Measuring: Physical: blood glucose, ECG, blood pressure, pulse rate, weight, oxygen saturation levels, and temperature. Behavioral/symptom: questionnaires on symptoms; programmable questions on coughs, inflammation, medication adherence and healthy eating.

16. UK – Scotland COPD Project • " …patients love the HomePod as it offers them an unprecedented sense of freedom and also peace of mind that they are taking charge of their own health. • Crucially, it also removes the temptation for self-diagnosis, either through books and magazines or on the Internet, which is all too common but which can also be very dangerous. " www.ehealthnews.eu

17. “Telecare” and Dementia Objective 10: Considering the potential for housing support, housing-related services and telecare to support people with dementia and their carers. The needs of people with dementia and their carers should be included in the development of housing options, assistive technology and telecare. As evidence emerges, commissioners should consider the provision of options to prolong independent living and delay reliance on more intensive services. LIVING WELL WITH DEMENTIA, A NATIONAL DEMENTIA STRATEGY, UK DEPT OF HEALTH, 2/3/09

18. Unsafe at Home – Chronic Symptoms- EU • New Product [VITALSEN] is a disposable electrode patch and a reusable clip-on transmitter for management of chronically ill patients at home and monitoring inpatients and out-patients attending • Data measured include heart rate, ECG, temperature and levels of activity in the chest area, transmitted by Bluetooth to software in a PC or laptop in the patient’s home, or in the hospital ward. HAS CE DESIGNATION IN EUROPE AND IS SEEKING FDA APPROVAL

19. Unstable at Home – Chronic Illness • Blackpool, England [52% predictable long-term health condition for over 65 year olds] Remote monitoring=> 75% reduction in hospital admissions for COPD & Heart Disease, 12mo 85% reduction in GP visits 43% reduction in home visits. Patient response = 80% of respondents strongly agreed ---better understanding of their medical conditions,contributing to management. 70% strongly believed their quality of life had improved. Pilot protocols had alerts as well as trended data. FUTURE – Telehealth in obesity management; workplace BP monitoring

20. Unsafe at Home – Congestive Heart Failure [CHF] • Congestive Heart Failure (CHF) Program.      Meridian Health System and MedApps' products [wi-fi;web-based] pilot generates biometric data for monitoring nurses and attending physicians. The program will:  • Monitor signs and symptoms immediately after discharge from hospital environments and provide comprehensive, individualized education and follow up support; • Promote patient self-management, independence and adherence to prescribed treatments; and  • Help identify early signs / symptoms of worsening conditions in a post acute environment.   • Reduce re-admission rates and ER utilization of patients with CHF.  • DUKE UNIV. study shows use of remote monitoring and nurse calls greatly improves outcomes for cardiac patients

21. New Study in British Columbia • Telemonitoring of CHF shown to improve outcomes but expensive equipment. • Web site study of 20 participants who entered weight and symptoms onto the Web site for 6 months. Seventeen completed the study. • Nurse monitored the Web site for changes in participant health status and telephoned the participants as necessary. • Self-care, quality of life, 6-minute walk test, and N-terminal prohormone brain natriuretic peptide (NT-proBNP). • A significant change in the Self-Care of Heart Failure Index (p = 0.039). • A Web site to facilitate telemonitoring favorably accepted.

22. Ill at Home – Mental Health • American Telemedicine Association [ATA] issued Standards for telemedicine in behavioral health field in 2009. • MSWs, advanced practice psychiatric nurses, psychologist could provide counseling to at-home patients. • Distanced counseling has demonstrated benefits in clinical outcomes studies. • Third party insurers might reimburse.

23. Unstable at Home – Frantic Caregivers • Distanced educational benefits from telemedicine, plus possibilities of grant funding • Family and lay caregivers with chronically ill or terminally ill patients to be guided through intervention steps prior to calling EMS or transporting to emergency room settings.

24. Unstable at Home – Living Alone • Falls prevention = clinical trials on medical devices worn by patients, imbedded in flooring, sensor and movement driven • Information about clients conveyed from ‘Smart Homes’. TRIL laboratory with couples living in experimental housing sensored for multiple dimensions. • Making private homes ‘assisted’ living

25. Ill at Home – Pain Management and Palliation • Palliative care physicians are now able to be Board-certified; specialization and research interests are increasing • Patients can be counseled, educated, advised, offered therapy via social work services, brought into the hospice care plan management with videoconferencing • Studies underway on increased quality of life and decreased unnecessary ER visits

26. Unstable at Home – Diagnosis and Rehabilitation UCLA is initiating the Clinical Movement Assessment System [CMAS] – potential in-home use to assess progress after neurotraumas and as a rehabilitative tool to expand the reach of telemedicine.  Could possibly be used to differentiate and help diagnose diseases states, such as Parkinson's Clinical assessment device and associated software captures current and ongoing muscle and neuromotor functions, yielding quantifiable, real-time data

27. At Home-Avoiding Doctors’ Offices • Maine institutes ‘e-visits’ to reach out of state patients, students; schedule appointments, check on test results. • Anthem Blue Cross and Eastern Maine Healthcare Systems, and primary doctors • Between office visits communications • Specific protocols • No co-pay for participants

28. At Home - Rehabilitation • Grants for seniors’ remote patient monitoring programsThe Center for Technology and Aging (CTA)- Oakland, CA • Up to six one-year grants, totaling $500,000, to organizations with remote health improvement programs for elderly adults. • Must use already-proven technologies that are ready to be used more broadly. • Prior experience with remote patient monitoring technologies and must be able to demonstrate a positive and measurable impact in the near term. LOI March 12; start date July 1. 1  http://www.techandaging.org/grants_home.html

29. At Home – Teenage Patients • Remotely monitored in-home virtual reality video games improved hand function and forearm bone health in teens with hemiplegic cerebral palsy, helping them perform activities of daily living such as eating, dressing, cooking, and other tasks for which two hands are needed, according to a study by researchers at Indiana University School of Medicine (IUSM) and Rutgers University Tele-Rehabilitation Institute. The findings suggest that such games could also benefit other persons with movement-hindering afflictions from strokes, arthritis, multiple sclerosis and orthopedic injuries, according to study lead author Dr. Meredith R. Golomb, associate professor of neurology at IUSM. Each participant was asked to exercise their affected hand 30 minutes per day, five days per week, using a specially fitted sensor glove linked to a remotely monitored video game console in their home. The study appears in the January issue of Archives of Physical Medicine and Rehabilitation.http://newsinfo.iu.edu/news/page/normal/13065.html

30. At Home – Teenage Patients • Type-1 Diabetes Text messaging for blood sugar levels, interactions with physicians, general compliance and maintenance • Compliance enhanced by rewards of text minutes- UK studies over five years

31. Why Isn’t Telehealth Moving Faster? • ARRA monies largely emphasize EHRs, not service delivery..BUT there are ways… • Hospitals and physicians over HHAs, LTC and hospices • HHS attitudes persist in reluctance to acknowledge evidence of positive outcomes in community care setting • The Privacy Paralysis issue

32. Inertia – Regulatory ‘Mazes’ • ‘Maze-like regulatory regimes that differ from federal agency to federal agency and from state to state, as well as hard-to-navigate reimbursement policies on the part of government and private insurers are the challenge of the extraordinary promise of this industry’ ,Hyung Kim, VP Research, Ascension Health [in 20 states].

33. Inertia – Public Trust • Transparency- who has the data and where is it going • Control – by the patient as to what happens to the data and with whom • Security – of the content of data, in balance with the concept that even motionless, paper-based data can be subject to security breach

34. Ethical Considerations • Non-malfeasance = “do no harm”. Are we in danger of doing more harm than good? Example: Is there a risk that a piece of equipment may lead to more confusion or distress. • Beneficence = striving consciously to be “of benefit” to a person. Enabling access to support or help if they fall or helping them take their medication. • Autonomy = respecting the person’s rights to things like self determination, privacy, freedom, and choice. If a device such as a sensor mat helps monitor falls risk, would it be used just to tell the person not to walk or get up, or would the person be offered a companion to walk with safely? • Justice = treating everyone fairly. Equal access to technology, or taking into account diversity and individual differences. Stephen Wey, University College of York St. John / WSDAN

35. National Quality Forum Measures -Home Care =>Telehealth Options? • timely initiation of care; • patient and caregiver education; • preventive services; • pain intervention and assessment; • improvement and assessment of clinical symptoms; • improvement in functional status; • assessment of need for emergency care or hospitalization; • patient experience of care.

36. Where are we on Liability? • JAMA : “HIT Vendor Contracts Shift Liability to Health Care Providers”, Ross Koppel & David Kreda, 3/25/09 • “Hold harmless” clauses in computer software contracts • “Learned intermediary” defense • Providers’ experience: software contracts averse to risk sharing or “partnering”

37. Where are we on Liability? • Physician practice across state lines • Increased number of states with “special” telemedicine licenses/requirements • Prosecution and sentencing of physician who, without speaking with the person, renewed prescription for generic Prozac to college student who committed suicide • CMS/JCAHO on hospital credentialing

38. Limited Research on Liability Telemedicine & E-Prescribing:Evolving Ethical, Licensing & Reimbursement Rules & Realities, ABA 2008 E-Health Hazards, Sharona Hoffman and Andy Podgorski, Case Western Reserve Research Paper Liability Coverage for Regional Health Information Organizations - Lessons from the AHRQ-Funded State and Regional Demonstration Projects in Health Information Technology and Other Community Efforts, AHRQ No. 09-0071-EF

39. Standards in Homecare HIT • American Telemedicine Ass’n [ATA] has a set of Homecare and Remote Monitoring Standards available on their website. www.americantelemed.org • Workgroup on Hospice and Palliative Care of the ATA, which I chair, looking at goals and directions but not yet ‘standards’ given very early adoption.

40. Agency on Aging Grant Chronic Disease Self-Management • Submission window closed Feb. 12th • One grant per state; ceiling one million • Criteria –Tested through randomized controlled trials • i. effective at improving and/or maintaining the health status of older people • ii. suitable for community-based human services organizations and involve non-clinical workers and/or volunteers • iii. research results published in a peer-reviewed scientific journal • iv. translated into practice; ready for national distribution

41. QUESTIONS? THANK YOU Deborah Randall law@deborahrandallconsulting.com 202-257-7073