REGULATORY UPDATE: TELEMEDICINE

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1 REGULATORY UPDATE: TELEMEDICINE Collaborative Technology Solutions: The Future of Healthcare June 13, 2013 Jennifer Breuer, Esq. Drinker Biddle & Reath 312/

2 Agenda > Review legal and regulatory issues facing telehealth practitioners in the following areas: Licensure Credentialing and Privileging Prescribing of medication Reimbursement Fraud & Abuse Privacy 2

3 Definitions > Telemedicine: use of medical information exchanged from one site to another via electronic communications Includes, at a minimum, audio and video equipment permitting two-way, real time interactive communication between the patient, and the physician or practitioner at the distant site (Source: CMS) > Originating Site: location of patient during telemedicine encounters > Distant Site: location of specialist providing services during telemedicine encounters

4 Licensure > Telemedicine practitioners must meet licensing requirements in the state in which services are provided Telemedicine services are deemed provided where is the patient located > Licensure requirements are different in each state

5 Illinois Medical Practice Act > Illinois Medical Practice Act requires telemedicine providers to be licensed under the Act > For licensure purposes, telemedicine" means: The performance of any of the activities listed in [the Act], including but not limited to rendering written or oral opinions concerning diagnosis or treatment of a patient in Illinois by a person located outside Illinois as a result of transmission of individual patient data by telephonic, electronic, or other means of communication from within this State > "Telemedicine" does not include: Periodic consultations between a person licensed under the Act and a person outside the State of Illinois A second opinion provided to a person licensed under the Act; and Diagnosis or treatment services provided to a patient in Illinois following care or treatment originally provided to the patient in the state in which the provider is licensed to practice medicine 5

6 Credentialing and Privileging > CMS policy used to require Originating Site hospital to fully credential and privilege all practitioners, including telehealth practitioners > But, Joint Commission allowed credentialing and privileging by proxy > Now, CMS permits Originating Site hospital to rely on Distant Site for credentialing and privileging Distant Site can either be: Medicare Participating Hospital Telemedicine Entity Requires written agreement between Originating Site hospital and Distant Site

7 Credentialing and Privileging > Hospitals choosing to use proxy credentialing or privileging must assure that: Distant Site hospital participates in Medicare Distant Site practitioner is privileged at Distant Site hospital Distant Site hospital provides current list of practitioner s privileges to Originating Site hospital Distant Site practitioner holds a license issued or recognized by the state in which Originating Site hospital is located Originating Site hospital performs an internal review of the Distant Site practitioner s performance and provides this information to Distant Site hospital Information sent from Originating Site to Distant Site must include all adverse events and complaints from telemedicine services provided by Distant Site practitioner to Originating Site hospital s patients

8 Internet/Telemedicine Prescribing: Scope of Practice > Illinois does not have a specific statute prohibiting prescriptions over the internet, but: May, 1999, Department of Professional Regulation suspended license of physician prescribing Viagra over Internet without personal interview October, 2002, Board of Medical Examiners issued a cease and desist order against Internet pharmacy due to its diagnosing and prescribing without prior physician-patient relationship or physical exam, and operating in IL without a license October, 2003, Board revoked license of physician for prescribing via the Internet based on an online questionnaire and without a prior examination November, 2004, Board indefinitely suspended the license of a physician for Internet prescribing violations > Must consider appropriate standard of care when writing a prescription outside the traditional, in-person visit context

9 Reimbursement > Medicare Reimburses for telehealth services only if presented from Originating Site in rural HPSA or outside of MSA Distant Site provider submits claims with GT modifier Originating Sites are paid separate, Part B facility fee > Medicaid Reimburses for telehealth services provided by physician, podiatrist or APN Also reimburses for telepsychiatry services provided by physician who completed approved psych residency program Distant Site Provider submits claims with GT modifier Originating Site paid $25 facility fee (Q3014) Physician or other licensed provider must be present with patient at Originating Site Physician office, podiatrist office, local health department, community mental health center, outpatient hospitals qualify as Originating Site

10 Anti-Kickback Statute > Whoever anyone hospital, physician, agent > Knowingly and willfully - One purpose test - need not be the sole or primary purpose > Offers or pays Both sides to the arrangement > Any remuneration (in cash or in kind) Cash, cash equivalents Free equipment Technical support > To induce or reward the referral of items or services reimbursed by a federal health care program > Has committed a felony > Need to think about Originating Site/Distant Site referrals when providing telemedicine equipment outside of employment context Lease FMV Arm s length transaction terms 10

11 Stark Law (Physician Self-Referral Law) > Physician may not refer: Medicare or Medicaid patients for designated health services To an entity with which the physician or an immediate family member Has a financial relationship Unless an exception applies > DHS entity prohibited from billing for services provided as a result of prohibited referral > Need to think about Originating Site/Distant Site referrals when providing telemedicine equipment outside of employment context Lease FMV Arm s length transaction terms 11

12 Privacy HIPAA Privacy Rule > Use and disclosure of PHI permitted for treatment, payment and operations purposes > Minimum necessary > Notice of Privacy Practices > Access to and review of Designated Record Sets > Incidental use and disclosure of PHI permissible under certain circumstances > Verification of requestor > Sanctions > Business Associate agreements HIPAA Security Rule > Access control > Authentication > Network Controls > Training > Reasonable safeguards > Workstation controls (physical and technical) > Authentication/ Authorization > Audit trails > Chain-of-Trust Agreements 12

13 HIPAA Issues Unique to Telemedicine Services > Security of technology used to provide telemedicine services > Distribution of Notice of Privacy Practice to patient, if Distant Site provider is not a member of the Originating Site s workforce > HIPAA privacy training/education if the Distant Site provider is a member of the patient site workforce > Business associate agreements with technical providers (non-covered entities) who assist with the delivery of healthcare by telemedicine > Telemedicine consultations may require additional nonclinical personnel, such as technicians and camera operators, who do not participate in traditional medical care 13

14 QUESTIONS? Jennifer Breuer, Esq. Drinker, Biddle & Reath, LLP 312/

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