ATA TELEHEALTH AND REMOTE MONITORING

1. ATA TELEHEALTH AND REMOTE MONITORING Deborah Randall JD, Aging Services and Telehealth Consulting law@deborahrandallconsulting.com

2. Background • Community-centered care • Services to aged, frail, mentally ill, disabled, diminished in capacity, dying • Medicare; Medicaid; CMS; FDA; Privacy law enforcement agencies • The “dark side” : fraud and abuse and compliance concerns for health industry

3. I. Policy Issues • When and how will government payers see benefit from telemonitoring and telehealth, and be prepared to pay for the services, the equipment, the internet connections, or any of the above? => A few Medicaid programs, to date. • Effects of the Medicare Health Support Pilot • Is it “Magical Thinking” that technology can transform a broken health delivery system?

4. Policy Issues • Are electronic health records [EHRs] issues connected to, or distinct from, remote monitoring and home telehealth? • Will the USA ever have a blended health/social care approach like other nations, and is that essential to a robust and vibrant community based-telehealth or telecare activity?

5. Policy and Legislation MIPPA called for Chronic Care Research HITECH: No direct funding of remote monitoring in home; Study as aging services technology as a focal point SERIOUS budget challenges to home health and hospice due to growth/profits

6. HITECH – Policy Committee of the Office of the National Coordinator 2d Line of Focus • Technologies for “vulnerable” populations • Self-service technologies that facilitate use and exchange of patient information • Telemedicine technologies • Facilitate home health care • Reduce medical errors • Facilitate continuity of care

7. Home as Site of Care Concerns • Congress is Traditional: medico-centric rather than nursing-controlled or behavioral-focused; appeal of “medical home” • Abuse in device and equipment industries: Florida outliers, power vehicles, inhalation therapy • Concerns with Medicaid personal care in home= recent legislative expansion in homecare and patient-driven

8. II. Legal Issues in Telehealth • No “due care” standard of care for distanced health delivery • Consents and risk descriptions difficult • Co-managed care fragments the risks • Diminished capacity of many patients, but greater responsibility and involvement of that person at home • Software contracts in the past denied liability; claimed “learned intermediary”

9. Legal Issues, cont. • Interaction or interference of users, family • Multiple relationships within the remote monitoring connected parties • If remote monitoring is performed by or connected to certified home health, long term care or hospice entities, they must provide care with an eye to the Medicare conditions of participation [all patients]

10. III. Licensure and Authority to Practice • What kind of company is “telehealth”? • Barriers to participating: states, prof’l licensure boards, malpractice carriers • What is in-state “doing business” when a consultation “comes into the state” through the internet? From another country? • What training standard • Pre-emption: to permit universal access?

11. IV. Privacy • Just when you thought you knew HIPAA….there’s HITECH • Recent proposed guidance regulations FTC: comments due June 1st on “Notice of Breach”, for those which are not “covered entities” HHS: comments due May 21st on expanded obligations for “unsecured” data

12. Monetary Penalties TIERS OF PENALTIES DESCRIBED.— • Unknowing: $100 for each violation, not to exceed $25,000 in a calendar year; • Not willful neglect: $1,000 for each violation, not to exceed $100,000 per year; • Willful neglect, corrected: $10,000 for each violation, not exceed $250,000 per year; Willful neglect, uncorrected: $50,000 for each violation, not to exceed $1,500,000 per year.

13. V. Know the Fraud Risks • Questionable referrals within the Medicare/Medicaid system • Illegal inducements to patients • State laws on fee splitting, corporate practice of medicine => illegal claims • Investigations and penalties for poor quality care including for under-serving patients. Could include exclusion from the federally funded programs.

14. VI. FDA and Device Regulations • What level of regulation affects your remote monitoring system? • Developing status of software in the FDA regulatory structure • FDA working with industry but also under new leadership; Congress questioning some of the collaborative attitude of FDA in past

15. QUESTIONS? DEBORAH A. RANDALL, ESQ. law@deborahrandallconsulting.com www.deborahrandallconsulting.com 202-257-7073