TELEMEDICINE AND TELEHEALTH – COMPLIANCE CHALLENGES© Deborah A. Randall, JD & Consultant

Electronically Enabled Care Delivery in 2012 HIT = Health Information Technology HIE = Health Information Exchange EHR = Electronic Health Record EMR = Electronic Medical Record PHR = Personal Health Record ONC = Office of the National Coordinator for HIT [DHHS]

American Telemedicine Assn Extensive materials on-line and training. Creating standards for practice in telemedicine and telehealth. Lobbying for expansion. Working groups in new areas. I chair palliative care and end-of-life.

Survey 2010: eHealth Initiative 61% of respondents agree or strongly agree that significant progress has been made in the successful adoption and use of HIT since BUT 54.9% disagree or strongly disagree the value of HIE is clearly understood & 66.6% disagree or strongly disagree outreach on value of EHR/HIE is effective

eHealth Survey, cont. 55.5% of respondents disagree or strongly disagree that differences between federal and state privacy laws are not a barrier to consumer’s rights to healthcare privacy. 56% agree or strongly agree that HIT and HIE have had a positive effects on care delivery.

Evolving Definitions Telemedicine vs. telehealth Doctor to doctor d2d Doctor to patient d2p Distance learning Remote monitoring eCare eHealth mHealth “Smart” homes

Developments & Trends New Medicare Reimbursement Possibilities: Reviewed annually; patient must be in a rural or underserved area. Devices as diagnosis-enhancers Infrastructure for Telemedicine and Telehealth Legislation

“Originating Sites” 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);

Medicare Coverage Expansion In 2011 HCPCS codes added for: Individual and group Kidney Disease Education (KDE) services; Individual and group Diabetes Self- Management Training (DSMT) services; Group Medical Nutrition Therapy (MNT) services;

Medicare Coverage Expansion Group Health and Behavior Assessment and Intervention (HBAI) services; and Subsequent hospital care and nursing facility care services.

LEGISLATION HITECH ACT Stimulus Bill HIT Policy Committee of ONC Infrastructure got first funding Aging Services Technology Study PPACA – Health Reform Act 2010 Medicaid Medical Home; Chronic Care; Innovation Cntr

HighTech Telehealth Impact A.$2 billion Office of the National Coordinator – Regional health information exchange efforts and state-based “extension centers" – Health information enterprise integration - Big grants B.Medicare and Medicaid provider and hospital incentive to adopt and use health IT through “meaningful use”

HIGHTECH, cont. – Indian Health Service health IT – Community health centers for health IT acquisition – Social Security – $1.1 billion for comparative effectiveness research

BEACON: $16+Million Buffalo 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

Patient Protection and Accountable Care Act of 2010 “PPACA” --This is where the expansion will continue to be. PPACA drives the process towards management of chronic disease. Health information technology is finally showing, with reliable data, that telehealth can integrate with traditional care and use staffing innovations.

PPACA Post-hospitalization bundling pilot Independence at Home demonstration Innovation Center at DHHS; policy includes strong telehealth focus ACOs Medical Home-Medicaid and Pilots

Blue Cross/Blue Shield WNY Blue Cross/Blue Shield Western New York in May 2010 initiated online physician-patient communication as a compensated service; encouraging telehealth communications and webcam visits; measuring quality of care and patient compliance factors Hawai’I HMO doing major telehealth

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

Technology-enabled Community Care Satellite health facilities In situ care w medical devices Remote monitoring and sensors Awareness and acceptance European efforts in ambient care The VA system –the Vanguard

Telehealth Expansion Care coordination and Chronic Disease Patient self-management Ambulatory care and safety Palliative care Rehabilitative services Behavioral & mental health services

VA Chronic Care Coordination Telehealth Report 12/08 CONDITION # % DECREASE UTILIZATION Diabetes 8, Hypertension 7, CHF 4, [congestive heart failure] COPD 1, [chronic pulmonary obstruction]

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 “ “ 6,140 patients;26.0% Interventions “just in time”; “air traffic control”

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

Telehealth: Dementia Patients Residential facilities designed to allow movement of individuals through facility and grounds; Families can track on computer/internet based systems Sensoring systems; Intel research; TRILL; diagnostic sensoring for fall prevention yielding data on Alzheimer specific movement differentials

Telehealth:Dementia Patients AlarmTouch GPS is a personal safety phone with GPS location in Europe. The telecare device includes a ‘Geofencing’ feature, enabling accurate location of users in need. When the wearer wanders outside a specified zone – such as home or school area - the system can send a short message (SMS) alert to a monitoring centre or to a relative or caregiver.

Ambient Assisted Living Programme - EU 23 EU member states with support of European Community [EC] -Enhance quality of life of older people -Strengthen industrial base by use of Information and Communication Technologies [ICT] -Aging well at home, community and work -Coherent framework for research into solutions which are compatible with varying social preferences

What are the New Directions? Tele-rehabilitation; Falls prevention Tele-mental and behavioral health Continuous monitoring: diabetes; cardiac Impaired; Alzheimer’s & dementias “Wellness”

Telehealth and Rehabilitation Distanced assessments Robots in SNFs Telestroke => telerehab Wii units in senior living facilities Remote monitoring for falls anticipation Traumatic brain injury;wounded warrior

Behavioral & Mental telehealth On-going research Post traumatic stress disorder Tele-psychiatry Distanced mental health services under new Medicare reimbursement provisions for community mental health centers

VA Rapidly Expanding Behavioral Health Outreach Major projects to help with PTSD and other mental and behavioral concerns of wounded warriors Use of local centers and distanced mental health specialists Use of internet-based programs along with Skype-type live sessions

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

Advanced Illness –Is there a Role for Telehealth Using an existing model. Kaiser’s Advanced Illness Coordinated Care Program (AICCP) included 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.

Expanding a model, cont’d. Improved communication about discomfort, support for decision making; Advance directives (5.5 mo.);problem resolution; attention to caregiver needs. more agreement to do-not-resuscitate or intubate orders; <inpatient admits with no difference in survival.

Opportunities and Challenges Medical Director and other physicians Demonstrating cost savings, &/or quality of care/life improvements- to justify expense of equipment and staff Training and staffing. Maintenance of depth of field/bench so turnover is not a problem. Need for a "champion". Leading nurses to embrace technology

Telehealth: Impediments Medicare Reimbursement and Coding Medicaid Grants Outcomes, cost savings and Disease Management concerns Licensure and interstate barriers Standards; Interoperability among devices/software/infrastructure

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

Licensure Many states –New York is one--bar physicians from practicing via telehealth without a full or partial new license => quality; control as issues Some states now licensing the entity which arranges for and participates in telehealth services Nurses more sane but States [NY] not

Credentialing HHS concessions on no need for physicians and other health professionals to have admitting privileges at “receiving” institution where patient is located who gets telehealth. Next steps for Compliance Officer

HHS Concessions in Rules 76 Fed Reg 65891,65893 (10/24/11) c HHS wants to “provide hospitals the clarity and flexibility they need under federal law to maximize their staffing opportunities for all practitioners,.. particularly for non-physician [s].. under..States’ laws.” Final Rule due soon.

Liability-Consent-Management Medical device or simply a conduit of information Manufacturer; Software vendors will seek total immunity from exposure Patients need to hear from physicians and health entity about conditions, errors and backup response Malpractice Insurers reluctant or ignorant

“Under-Serving” Patient Need? Not likely but..... Civil Money Penalties Act concerns Loss of Provider Arrangement If telehealth is not covered by Medicare in the home, is it a “visit”, an “encounter”, a service or an accessory? Is it a patient inducement? –OIG Advisory Opinion from 2000 suggests not (when not advertised.....)

Impediments to Data Exchange State privacy laws HIPAA Congressional focus HITECH and other HIT bills resulted in Strong language extending privacy protections including business associates. Telemedicine and telehealth raise HIPAA issues on transmission, storage, security, “use” and authorizations grounds, at least

Meaningful Use Regulations The developments around electronic health records have concentrated on privacy and encryption. First stages will be ePharmacy transmissions; see MLN Matters Number: SE1107 and version 5010 coding [began Jan 2012, with enforcement delay.]

Texting? mHealth? The UK’s NHS on tablet/iPad security: “We have developed interim guidance 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.”

Texting? Joint Commission: Not acceptable for physicians or licensed independent practitioners to text orders for patients to the hospital or other healthcare setting...provides 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.

Contracting Issues When private pay, family members are the contracting parties When you are subcontracted to another organization When the HIT vendor writes the contract….Indemnification concerns and insurance issues When the State intervenes

Fraud and 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 interests - ACO guidances HHS and FTC

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

OIG Advisory Opinion 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

Discussion – Are you involved Audience experience in telehealth Reluctance….and reasons Board reactions…have they been educated about telemedicine and telehealth? Can our society afford not to bring telehealth into our healthcare management situations?

Thank You! Deborah Randall, JD Health Law Attorney Telehealth Consultant ©2012 deborahrandall