LEGAL ISSUES FOR FQHCs IN TELEHEALTH

LEGAL ISSUES FOR FQHCs IN TELEHEALTH SOUTH CAROLINA PRIMARY HEALTH CARE ASSOCIATION SOUTH CAROLINA PRIMARY HEALTH CARE ASSOCIATION 32 ND ANNUAL CONFERENCE AND CHC BOARD GOVERNANCE RETREAT Jeanne M. Born, RN, JD OCTOBER 30, 2015 Jborn@nexsenpruet.com

ISSUES FOR FQHCS TO CONSIDER IN TELEMEDICINE Licensure Federal Tort Claims Act Coverage Credentialing/Privileging Physician Patient Relationship Standard of Care/Malpractice Informed Consent Patient Confidentiality HIPAA: Information Privacy and Security Reimbursement Fraud and Abuse Etc. 2

LICENSURE REQUIRED IF PRACTICING MEDICINE Any physician who practices medicine in South Carolina must be licensed in South Carolina. Practice of Medicine includes: (e) rendering a written or otherwise documented medical opinion concerning the diagnosis or treatment of a patient or the actual rendering of treatment to a patient within this State by a physician located outside the State as a result of transmission of individual patient data by electronic or other means from within a state to such physician or his or her agent; S.C. Code Ann. 40-47-20(36). 3

LICENSURE: SCBOME GUIDANCE August 4, 2015 the SCBoME approved two new guidance documents on telemedicine (TBD at the November 2 SCBoME meeting). 1 st one is entitled Telemedicine and is at: http://www.llr.state.sc.us/pol/medical/pdf/telemedicine%20ad visory%20opinon.pdf Provides general guidance on telemedicine practice. Defined telemedicine: the practice of medicine using electronic communication, information technology or other means between a licensee in one location and a patient in another location with or without an intervening health care provider. 4

LICENSURE: SCBOME GUIDANCE PRACTICE TIP: FOLLOW SCBOME GUIDANCE The Board recognizes that technological advances have made it possible for licensees to provide medical care to patients who are separated by some geographical distance. As a result, telemedicine is a potentially useful tool that, if employed appropriately, can provide important benefits to patients, including: increased access to health care, expanded utilization of specialty expertise, rapid availability of patient records, and the reduced cost of patient care. The Board giveth and the board taketh away.... The Board cautions, however, that licensees practicing via telemedicine will be held to the same standard of care as licensees employing more traditional in-person medical care. A failure to conform to the appropriate standard of care, whether that care is rendered in-person or via telemedicine, may subject the licensee to discipline by this Board. 5

LICENSURE: SCBOME GUIDANCE STANDARD OF CARE FOR TELEMEDICINE There is not a separate standard of care for telemedicine. Telemedicine providers will be evaluated according to the standard of care applicable to their area of specialty. Standard of care: The generally recognized practices and procedures that would be exercised by competent practitioners in a practitioner s field under the same or similar circumstances. 6

STANDARD OF CARE/MALPRACTICE Local v. National standard of care In South Carolina, [t]he degree of care which must be observed is... that of an average, competent practitioner acting in the same or similar circumstances. King v. Williams, 279 S.E.2d 618 (S.C. 1981). Abandoned the locality rule. What is the standard of care for telemedicine/telehealth? Varies: From state to state; By type of medical practice; The best philosophy and approach to telemedicine is that the same standards of care and protocols applicable to more traditional forms of medicine exist with telemedicine. The physician-patient relationship and interaction are the same. The process should be the same as if the patient were in the room with the doctor. U.S. v. Rodriguez, 532 F.Supp. 2 nd 316, 327 (2007). 7

STANDARD OF CARE/MALPRACTICE To establish a cause of action for medical malpractice, the plaintiff must prove the following facts by a preponderance of the evidence: (1) The presence of a doctor-patient relationship between the parties; (2) If there is a doctor-patient relationship, then the standard of care is the recognized and generally accepted standards, practices, and procedures which are exercised by competent physicians in the same branch of medicine under similar circumstances; (3) The medical or health professional's negligence, deviating from generally accepted standards, practices, and procedures being the cause in fact and a proximate cause of the plaintiff's injury; and (4) An injury to the plaintiff. Brouwer v. Sisters of Charity Providence Hospitals, 736 S.E.2d 200 (S.C. 2014). 8

STANDARD OF CARE/MALPRACTICE April 26, 2014: Federation of State Medical Boards adopted policy guidelines for safe practice of telemedicine. Key provisions: Standards of care that protect patients during in-person medical interactions apply equally to medical care delivered electronically. Providers using telemedicine should establish a credible patient-physician relationship and ensure that their patients are properly evaluated and treated. Providers should adhere to well-established principles guiding privacy and security of records, informed consent, safe prescribing and other key areas of medical practice. Advise that you review the guidelines at: http://www.fsmb.org/media/default/pdf/fsmb/advocacy/fsmb_teleme dicine_policy.pdf 9

STANDARD OF CARE/MALPRACTICE Recommendations: Understand the standard of care for your type of practice; Consult your specific professional board; Consult your certification boards; Consult your national associations; Consult AHRQ standards: http://www.innovations.ahrq.gov/content.aspx?id=2847 Consult your accreditation bodies (TJC; DNV; AAAHC; BPHC; HRSA; etc.); Consult the American Telemedicine Association: http://www.americantelemed.org/resources/standards/ata-standards-guidelines 10

LICENSURE: SCBOME GUIDANCE STANDARD OF CARE FOR TELEMEDICINE [T]elemedicine providers are expected to adhere to current standards for practice improvement and monitoring of outcomes and provide reports containing this information upon request. FQHC Practice tip: Be sure to structure performance improvement/outcome monitoring to include/be able to segregate telemedicine practices from face-to-face practice. 11

LICENSURE: SCBOME GUIDANCE FOLLOW SCBOME TELEMEDICINE GUIDANCE Training of Staff; Use of telemedicine equipment; and Competence in its operation. Evaluations and Examinations: Must provide an appropriate evaluation prior to diagnosing &/or treating the patient; The evaluation need not be in person if the licensee employs technology sufficient to accurately diagnose and treat the patient in conformity with the applicable standard of care; Other examinations of licensed health care professionals may also be considered in conjunction with the examination of the telemedicine provider; A simple questionnaire without an appropriate evaluation may be a violation of law and/or subject the licensee to discipline by the Board. 12

LICENSURE: SCBOME GUIDANCE RISK MANAGEMENT TIP: FOLLOW SCBOME TELEMEDICINE GUIDANCE Licensee-Patient Relationship: Must verify the patient s identity; Must verify the patient s location; Must inform the patient of the practitioner s name, location and professional credentials; Diagnosis must be established through the employment of accepted medical practices including: history, mental status evaluation, physical examination and appropriate diagnostic and laboratory testing; Ensure the availability of follow-up care including the availability of medical records related to the telemedicine encounter. 13

LICENSURE: SCBOME GUIDANCE FOLLOW SCBOME TELEMEDICINE GUIDANCE Medical Records: Licensee treating the patient via telemedicine must create and maintain a complete record in accord with prevailing medical record standards. It must reflect an appropriate evaluation of the patient s presenting symptoms, and relevant components of the electronic professional interaction must be documented as with any other encounter. Must maintain the confidentiality of the record and disclose the record in accord with state and federal law. If the patient has a primary care provider and a telemedicine provider for the same ailment, then the primary care provider s medical record and the telemedicine provider s record constitute one complete patient record. Licensees using telemedicine will be held to the same standards of professionalism concerning medical records transfer and communication with the primary care provider and medical home as those licensees practicing via traditional means. 14

LICENSURE: SCBOME GUIDANCE FOLLOW SCBOME TELEMEDICINE GUIDANCE Licensure: The practice of medicine is deemed to occur in the state in which the patient is located; Accordingly, the practitioner must be licensed to practice in the state where the patient is located; Licensees diagnosing and treating patients in other states must check with the state licensing boards in the state where the patient is located; Questions about other states laws: Federation of State Medical Boards: http://www.fsmb.org/directory_smb.html. 15

LICENSURE: SCBOME GUIDANCE FOLLOW SCBOME TELEMEDICINE GUIDANCE Prescribing: Follow the Board s Advisory Opinion: Establishment of Physician- Patient Relationship as Prerequisite to Prescribing Drugs. later. It is the position of the Board that prescribing controlled substances for the treatment of pain by means of telemedicine is not consistent with the standards of care. Licensees prescribing controlled substances by means of telemedicine for other conditions must obey all relevant federal and state laws and are expected to participate in the South Carolina Prescription Monitoring Program. 16

LICENSURE REQUIRED IF PRACTICING MEDICINE Practice of Medicine v. Consulting PracticeTip: Beware of the risks inherent in the curbside consult between a distant site physician and a physician practicing medicine in South Carolina. Exception to the definition of the practice of medicine: consulting at S.C. Code Ann. 40-47-30(A)(10). Be careful: Could be construed as the distant site physician practicing medicine and the South Carolina physician aiding the unauthorized practice of medicine. Misconduct: knowingly performed an act that in any way assists an unlicensed person to practice. S.C. Code Ann. 40-47-110(B)(7). 17

FEDERAL TORT CLAIMS ACT PROTECTIONS 42 U.S.C. 233 Public Health Services Act ( PHSA ) & the Federally Supported Health Centers Assistance Act ( FTCA ): Extends FTCA coverage for entities that qualify as Public Health Services (CHCs receiving funds under Section 330); Also provides FTCA coverage for employees working for government entities or other qualified entities (CHCs) protects from suits brought by 3 rd parties for actions taken within the scope of their employment. Administrative claims must be filed before filing suit and suits must be brought against the U.S. government; Damages are capped at certain amounts; No need for such employees to individually obtain malpractice coverage. CHCs must apply annually to the Secretary of DHHS for FTCA protection. 18

FEDERAL TORT CLAIMS ACT PROTECTIONS Ordinarily independent contractors are exempt from FTCA coverage. But, the PHSA creates an exception for deemed Public Health Services. Adds that contractors (physicians and other licensed or certified health care practitioners) qualify for FTCA protections; The remedy against the U.S. is the exclusive remedy for the third party against such contractor. To be determined a contractor: Performs on average at least 32.5 hours of service/week for the period of the contract; If performs < 32.5 hours, the individual must be a licensed or certified provider of services in family practice; general internal medicine; general pediatrics or OB/Gyn; Does not include psychology/psychiatry A SIGNIFICANT GAP IN PROTECTIONS. 19

FEDERAL TORT CLAIMS ACT PROTECTIONS ISSUES WITH TELEMEDICINE FTCA guidance: States that the physician patient relationship exists only when patients come to the health center site. FTCA guidance does not address telemedicine. If the FQHC is the distant site telemedicine provider and the patient is not at the health center, the FTCA may not cover. Feds have promised to update guidance for telemedicine (not since 2002). Recommend: Tread lightly; Obtain gap malpractice insurance coverage. 20

FEDERAL TORT CLAIMS ACT PROTECTIONS ISSUES WITH TELEMEDICINE If you need for distant providers to be covered under FTCA: Must meet the definition of contractor: Must meet the 32.5 hour requirement OR be one of the listed providers; Family Practice; General Internal Medicine; General Pediatrics; or OB/Gyn. If the distant provider provides psychiatric/psychological services, then other malpractice coverage must be obtained. 21

CREDENTIALING/PRIVILEGING FOLLOW CREDENTIALING REQUIREMENTS: PIN 2001-16 FTCA Guidance (not statute or regulation) requires that CHCs credential their licensed providers. PIN 2001-16: Applies to all health center practitioners, employed or contracted, volunteers and locum tenens. Credentialing: The process of assessing and confirming the qualifications of a licensed or certified health care practitioner. Requires that the provider is licensed in the state, commonwealth or territory in with the health center is located. 22

CREDENTIALING FOLLOW CREDENTIALING REQUIREMENTS: PIN 2001-16 Divides practitioners into two categories: Licensed Independent Practitioners ( LIPs ) Other Licensed or Certified Health Care Practitioners. LIPs: Primary Source Verification: Current License; Relevant education, training or experience; current competence; & health fitness/the ability to perform the requested privileges. Secondary Source Verification: Government issued picture ID; DEA; hospital admitting privileges; immunization & PPD; & life support training. 23

CREDENTIALING FOLLOW CREDENTIALING REQUIREMENTS: 2001-16 Other Licensed or Certified Health Care Practitioners. Primary Source Verification: Current License or certification only. Secondary Source Verification: Relevant education, training or experience; current competence; & health fitness/the ability to perform the requested privileges; government issued picture ID; DEA; hospital admitting privileges; immunization & PPD; & life support training. Must also be privileged to provide specific services initially and reviewed every two years: Ultimate approval authority by the CHC Board; The Board may review recommendations from the Clinical Director; other members of the CHC medical staff; and the CEO of the CHC. 24

CREDENTIALING FOLLOW CREDENTIALING REQUIREMENTS: PIN 2001-16 PIN 2001-16 does not address credentialing/privileging distant site providers. Typically required to be credentialed at the referring/originating site (where the patient is located) as well as the distant site. PIN 2001-16 references Joint Commission (Now TJC) Accreditation Manual for Ambulatory Care. Could use TJC Standards to credential distant site providers. 25

CREDENTIALING: TELEMEDICINE CoPS CMS recognized the burden related to credentialing distant site telemedicine providers. In 2011 published regulations that permit the originating hospital to rely on the distant site hospital or telemedicine entity s credentialing and privileging decisions related to distant site providers for compliance with the Conditions of Participation for hospitals ( CoPs ) and grant privileges based on those decisions. Requires that the originating hospital s governing body enter into an agreement with the distant site hospital or telemedicine entity that includes: The distant-site hospital is a Medicare participating hospital The individual distant-site physician or practitioner is privileged at the distant-site hospital and provides a current list of the distant-site physician or practitioner s privileges at the distant-site hospital. The individual distant-site physician or practitioner is licensed in the state in which the hospital whose patients are receiving the telemedicine services is located. As to the individual distant-site physician or practitioner, the hospital has evidence of an internal performance review and the distant-site hospital sends the hospital the review for periodic appraisal (must include adverse events and complaints). OR 26

CREDENTIALING: TELEMEDICINE CoPS The distant-site telemedicine entity s medical staff credentialing and privileging process and standards at least meet the standards: Determines, in accordance with State law, which categories of practitioners are eligible candidates for appointment to the medical staff; Appoints members of the medical staff after considering the recommendations of the existing members of the medical staff; Assures that the medical staff has bylaws; Approves medical staff bylaws and other medical staff rules and regulations; Ensures that the medical staff is accountable to the governing body for the quality of care provided to patients; Ensures the criteria for selection are individual character, competence, training, experience, and judgment; Ensures that under no circumstances is the accordance of staff membership or professional privileges in the hospital dependent solely upon certification, fellowship, or membership in a specialty body or society; Periodically conducts appraisals of its members; & Examine the credentials of all eligible candidates for medical staff membership and makes recommendations to the governing body on the appointment of these candidates in accordance with State law. AND 27

CREDENTIALING: TELEMEDICINE CoPS The individual distant-site physician or practitioner is privileged at the distant-site telemedicine entity and provides a current list of the distant-site physician or practitioner s privileges at the distant-site telemedicine entity. The individual distant-site physician or practitioner is licensed in the state in which the hospital whose patients are receiving the telemedicine services is located. As to the individual distant-site physician or practitioner, the hospital has evidence of an internal performance review and the distant-site telemedicine entity sends the hospital the review for periodic appraisal (must include adverse events and complaints) 28

TELEMEDICINE CoPS: TO DO LIST The Medical Staff Bylaws must be amended to include: criteria for determining telemedicine privileges; and a procedure for applying the criteria to individuals requesting privileges. See 482.22(c)(6). Need to develop/enter into agreements with telemedicine providers. 29

CREDENTIALING: TELEMEDICINE CoPS: PRACTICAL QUESTIONS AND OPEN ISSUES FQHC CONSIDERATIONS What if the distant-site has significantly different privileges lists than the hospital? What if there are significantly different Medical Staff privileging requirements? (e.g., Board Certification requirements; malpractice coverage limits) Should you ask for a copy of the distant-site Medical Staff Bylaws? How will exchanging peer review information affect applicable peer review privileges? Consider risk management issues: how would this play in light of an allegation of negligent credentialing? GET ADVICE FROM LEGAL COUNSEL BEFORE CONSIDERING ALTERNATIVE CREDENTIALING AND PRIVILEGING METHODS!! 30

PHYSICIAN PATIENT RELATIONSHIP When is a physician patient relationship established? A physician-patient relationship is generally described as a consensual one wherein the patient knowingly seeks the assistance of a physician and the physician knowingly accepts him as a patient. The courts state whether a physician patient relationship exists is generally a question of fact for a jury to determine. When does the relationship arise: FTCA Guidance: When the patient comes to the center for FTCA purposes. Generally: Over the telephone/internet when an appointment is made? No = Fay v. Grand Strand Medical Center, 771 S.E.2d 639 (S.C. Ct. App. 2015); But left open the question if an appointment + reviewing records = establishment of a relationship. When there is a first encounter? Face-to-Face; Over the Phone; Via Telemedicine? 31

PHYSICIAN PATIENT RELATIONSHIP: IN THE CONTEXT OF PRESCRIBING DRUGS It is unprofessional conduct for a licensee initially to prescribe drugs to an individual without first establishing a proper physician-patient relationship. S.C. Code Ann. 40-47-113(A) A proper relationship, at a minimum, requires that the licensee make an informed medical judgment based on the circumstances of the situation and on the licensee s training and experience and that the licensee: (1) personally perform and document an appropriate history and physical examination, make a diagnosis, and formulate a therapeutic plan; (2) discuss with the patient the diagnosis and the evidence for it, and the risks and benefits of various treatment options; and (3) ensure the availability of the licensee or coverage for the patient for appropriate follow-up care. S.C. Code Ann. 40-47-113(A) 32

PHYSICIAN PATIENT RELATIONSHIP (B) Notwithstanding subsection (A), a licensee may prescribe for a patient whom the licensee has not personally examined under certain circumstances including, but not limited to, writing admission orders for a newly hospitalized patient, prescribing for a patient of another licensee for whom the prescriber is taking call, prescribing for a patient examined by a licensed advanced practice registered nurse, a physician assistant, or other physician extender authorized by law and supervised by the physician, or continuing medication on a short-term basis for a new patient prior to the patient's first appointment. S.C. Code Ann. 40-47-113(B) (C) Prescribing drugs to individuals the licensee has never personally examined based solely on answers to a set of questions is unprofessional. S.C. Code Ann. 40-47-113(C) 33

PHYSICIAN PATIENT RELATIONSHIP PRACTICE TIP: FOLLOW SCBOME GUIDANCE On August 4, 2015 the SCBoME updated the Establishment of Physician-Patient Relationship as Prerequisite to Prescribing Drugs. http://www.llr.state.sc.us/pol/medical/pdf/establishment%20of%20physician- Patient%20Relationship%20as%20Prerequisite%20to%20Prescribing%20Drugs.pdf. In addition to the exceptions listed in the previous slide added: prescribing an appropriate prescription in a telemedicine encounter offered within a practice setting previously approved by the South Carolina Board of Medical Examiners and during which the threshold information necessary to make an accurate diagnosis has been obtained in a medical history interview conducted by the prescribing physician. BUT, S.C. Code Ann. 40-47-113(B) does not include this exception... What is the process for approval of a practice setting? How do you know if you have met the standard of obtaining sufficient threshold information necessary to make an accurate diagnosis? What is an appropriate prescription... 34

PHYSICIAN PATIENT RELATIONSHIP PRACTICE TIP: FOLLOW SCBOME GUIDANCE Guidance outlines two groups of prohibited prescriptions via telemedicine: Lifestyle medications: hormone replacement therapies, birth control or erectile dysfunction therapies. Controlled substances (does not exclude if not prescribed for pain). Guidance further provides: [T]elemedicine providers are expected to adhere to current standards for practice improvement and monitoring of outcomes and provide reports containing this information upon request. Have performance improvement/monitoring of outcomes processes in place where you can segregate telemedicine services. 35

PHYSICIAN PATIENT RELATIONSHIP PRACTICE TIP: FOLLOW SCBOME GUIDANCE A provider that prescribes drugs for a patient with whom s/he has only had telephonic/electronic communication and for whom s/he has not assumed responsibility with the acknowledgment of the patient s primary provider of care has engaged in unprofessional conduct UNLESS s/he: is writing admission orders for a newly hospitalized patient; prescribing for a patient examined by a licensed advanced practice registered nurse, a physician assistant, or other physician extender authorized by law and supervised by the physician; continuing medication on a short-term basis for a new patient prior to the patient's first appointment; or prescribing an appropriate prescription in a telemedicine encounter offered within a practice setting previously approved by the South Carolina Board of Medical Examiners and during which the threshold information necessary to make an accurate diagnosis has been obtained in a medical history interview conducted by the prescribing physician. 36

PHYSICIAN PATIENT RELATIONSHIP PRACTICE TIP: FOLLOW SCBOME GUIDANCE What does only had telephonic/electronic communication and for whom s/he has not assumed responsibility with the acknowledgment of the patient s primary provider of care mean? What is appropriate documentation of the method of communication with the patient? How do you document the acknowledgment of the patient s primary provider of care? appears to be the key to prescribing via telemedicine. Stay tuned! 37

INFORMED CONSENT ISSUED IN TELEMEDICINE Basis of doctrine of informed consent is patient's right to exercise control over his or her body by deciding intelligently for himself or herself whether or not to submit to a particular procedure. The patient consent to treat is typically obtained at the first encounter. Specific informed consent is typically required for specialized procedures and services. The doctrine of informed consent: A physician has a duty to disclose (1) the diagnosis, (2) the general nature of the contemplated procedure, (3) the material risks involved in the procedure, (4) the probability of success associated with the procedure, (5) the prognosis if the procedure is not carried out, and (6) the existence of any alternatives to the procedure. Hook v. Rothstein, 281 S.C. 541, 547, 316 S.E.2d 690, 694 95 (Ct.App.1984). 38

INFORMED CONSENT ISSUED IN TELEMEDICINE PRACTICE TIP: OBTAIN INFORMED CONSENT Practice Tips: Document the consent process; Use clear and understandable language; Clearly define the telehealth service to be provided; Clearly state the patient s right to revoke consent (subject to the providers reliance on the consent prior to revocation); Clearly state the alternatives; Clearly describe the benefits; But also... 39

INFORMED CONSENT ISSUED IN TELEMEDICINE Be comprehensive in describing the potential risks: Risks in the use of telemedicine technology: Equipment/technology failure resulting in errors in diagnosis; Security failures (will get to HIPAA!); Potential for poor data quality; Limited ability to for the distant provider to examine and provide emergent treatment; Limited access to information. Always ask yourself if the patient has the information the patient needs to make an informed decision; Obtain the written informed consent of the patient. 40

PATIENT CONFIDENTIALITY/HIPAA Every State and Federal law that protects the confidentiality, privacy and security of protected health information that is created in a face-to-face encounter apply to virtual encounters. Most notable: Privacy Rule: A Covered Entity is required to provide administrative, physical and technical safeguards to protect the privacy of PHI. 45 C.F.R. 164.530 Security Rule: A Covered Entity is required to implement policies and procedures to protect the integrity, confidentiality, and availability of e-phi. 45 C.F.R. Part 164, Subpart C. 41

PATIENT CONFIDENTIALITY/HIPAA Examples of issues with Telemedicine/Telehealth can create increased risk exposure: Interoperability in cooperating locations' systems could increase risks (breach; medical errors); Interruptions in connectivity mid-examination/procedure; Differences in operational procedures and technology implementations could increase risk exposure Treatment could be viewed by unauthorized individuals without patient knowledge or permission Electronic communications could be intercepted by unauthorized individuals Locally stored PHI could be accessed or altered by people with system-level privileges. 42

PATIENT CONFIDENTIALITY/HIPAA Recommendations: Foster a strong culture related to the privacy & security of PHI; Be sure your cooperative providers also have similar cultures; Encrypt (in transmission and at rest) Work with your cooperative providers to address interoperability issues up front; Coordinate operational policies and procedures with your cooperative providers; Conduct a thorough risk assessment to identify vulnerabilities, both internal and external threats to the system; Conduct a review of your HIPAA Privacy and Security Standards to address new issues; Be sure your insurance carriers (GL & Cyber) cover telemedicine/telehealth. 43

REIMBURSEMENT: MEDICARE The Secretary shall pay for telehealth services that are furnished via a telecommunications system by a physician (as defined in section 1395x(r) of this title) or a practitioner (described in section 1395u(b)(18)(C) of this title) to an eligible telehealth individual enrolled under this part notwithstanding that the individual physician or practitioner providing the telehealth service is not at the same location as the beneficiary. 42 U.S.C.A. 1395m(m) Payment: Distant site: The Secretary shall pay to a physician or practitioner located at a distant site that furnishes a telehealth service to an eligible telehealth individual an amount equal to the amount that such physician or practitioner would have been paid under this subchapter had such service been furnished without the use of a telecommunications system. 44

REIMBURSEMENT: MEDICARE Payment: Facility fee for the originating site: $24.83 for 2015 With respect to a telehealth service, subject to section 1395l(a)(1)(U) of this title, [be 80 percent of the lesser of the actual charge or the amounts specified in such section] there shall be paid to the originating site a facility fee equal to after 2002, the facility fee for the preceding year increased by the percentage increase in the MEI (as defined in section 1395u(i)(3) of this title) [%age increase in the Medicare economic index applicable for that year] for such year. No requirement for there to be a physician at the originating site. 45

REIMBURSEMENT: MEDICARE Limits on: Location of the patient (rural primarily); Type of provider (physician or practitioner [PA, NP, CNS, CRNA, CNMW, Clinical SW, Clinical Psychologist; RD]; Type of facility (Physician office; CAH; RHC; FQHC; Hospital; Hospital based renal dialysis center; SNF; Community Mental Health Center); Type of services (updated annually). See also: 42 C.F.R. 410.78 Telehealth services 42 C.F.R. 414.65 Payment for telehealth services 46

REIMBURSEMENT: MEDICAID South Carolina Medicaid reimburses for telemedicine: Telemedicine includes consultation, diagnostic, and treatment services. Telemedicine as a service delivery option, in some cases, can provide beneficiaries with increased access to specialists, better continuity of care, and eliminate the hardship of traveling extended distances. Covered referring sites (where the patient is located) The office of a physician or practitioner; Hospital (Inpatient and Outpatient); RHC; FQHC; Community Mental Health Centers. Providers: Physicians and NPs. Covered services include consultation, office visits, individual psychotherapy, pharmacologic management, and psychiatric diagnostic interview examinations and testing, delivered via a telecommunication system. A licensed physician and/or nurse practitioner are the only providers of telepsychiatry services. 47

REIMBURSEMENT: MEDICAID Services not covered: Telephone conversations E-mail messages Video cell phone interactions Facsimile transmissions Services provided by other allied health professionals Referring site fee (RHCs & FQHCs): $14.96 per encounter Hospital Providers: Receive a facility fee only when operating as a referring site. 48

REIMBURSEMENT: PRIVATE Varies from payor to payor. May require prior approval. 49

REIMBURSEMENT RISK MANAGEMENT CONSIDERATIONS As you consider what services to provide, carefully review your payors to determine what telemedicine services are reimbursable. Learn about Medicare/Medicaid reimbursement for telemedicine. Review your private insurers reimbursement requirements for telemedicine services. Bill only for those specific services that are provided by a qualified provider that are medically necessary. Code appropriately. 50

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Anti-Kickback (AKS): Prohibits a person from knowingly and willingly soliciting or receiving any remuneration in return for referring an individual for medical care if that individual pays for the service by way of any federal health care program (42 USC 1320a-7b) Penalties Imprisonment for up to 5 years, $25,000 fine, or both; Exclusion from participation in government programs; Civil monetary penalties up to $50,000 per.violation 51

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS AKS Safe harbors set forth standards that, if met, create the presumption that the arrangement will not subject the parties to civil or criminal sanctions under the Anti- Kickback Statute, even if the arrangement could be technically covered by the broad provisions of the Anti- Kickback Statute 52

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Safe harbors that may apply to telemedicine: Space Rental Safe Harbor; Equipment Rental Safe Harbor; Personal Services and Management Contracts Safe Harbor; Bona Fide Employees Safe Harbor; Electronic Prescribing Arrangements Safe Harbor; or Electronic Health Records Safe Harbor. 53

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Failure to meet each element of a safe harbor does not necessarily mean that you violate the AKS; it means the arrangement could be investigated to determine if it does. Failure to comply could mean the arrangement: (1) is not within the AKS; (2) clearly violates AKS; or (3) may violate the AKS in a less serious way. The degree of risk depends on the evaluation of several factors: Does the activity comply with accepted medical practices and is it a reasonable and legitimate medical activity? (want to be yes); Does the activity increase the cost of the Medicare or Medicaid Programs by allowing the provider to bill the programs tice for the same treatment? (want to be no); And Does payment for the activity depend on a percentage arrangement or on the number Medicare patient seen? (want to be no) 54

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS OIG Advisory Opinions telemedicine: 11-12: Health System installing neuro imaging telemedicine equipment at the originating site hospital ED free of charge; 12-19: Pharmacy company providing pre-populated medication administration records, physician order forms, and treatment sheets to community homes for free in paper or electronic format or via a web-based software program & web-based software program to community homes to perform certain administrative functions and to maintain EHRs for free or below value; 12-20: Providing free access to an electronic record interface to community physicians and physician practices that would allow the physician to transmit orders and receive diagnostic results. 55

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Stark Law If a Physician (or family member) has a financial relationship with the entity, the Physician may not refer Medicare/Medicaid patients to the entity for Designated Health Service (DHS). Entity may not bill for that DHS service, unless an applicable exception exists. 56

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Designated Health Services includes: Clinical laboratory services Physical therapy services Occupational therapy services Radiology services (including MRIs) Radiation therapy services and supplies Durable medical equipment and supplies Inpatient and outpatient hospital services Designated Health Services also determined by CPT codes. 57

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Exceptions that may apply to telemedicine: Lease arrangements (rental of office space) Lease arrangements (rental of equipment) Bona fide employment relationship Personal services arrangements Electronic prescribing arrangements Electronic health records arrangements Must meet all of the elements to qualify for the exception. 58

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Sanctions for Stark violations: Denial of payment (expectation of refund) $15,000 per occurrence $100,000 per arrangement or scheme Governmental health care program exclusion 59

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Stark and AKS violations can implicate the False Claims Act. Anti-kickback and Stark violations can, and many times do, lead to violations of the False Claims Act Theory Since claim based on referral in violation of Anti- Kickback or Stark, the claim should never have been submitted Claim based on improper referral = false claim Creates enforcement through whistleblower claims 60

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Criminal penalties: Imposes felony penalties of up to five (5) years imprisonment and/or fines up to $250,000 for an individual and $500,000 for an organization. Civil penalties: Imposes civil money penalties up to $11,000 per violation plus up to treble the amount found to be false claims. 61

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Obtain legal advice regarding the potential for fraud and abuse implications BEFORE you negotiate your agreements with other providers/suppliers to assure that you are meeting applicable AKS Safe Harbors and Stark Exceptions and any remuneration received is the fair market value for the service provided and that the overall transaction is commercially reasonable. Have a legal compliance program in place with appropriate policies/procedures AND FOLLOW THEM; Audit and monitor agreements/compensation arrangements and billing practices; 62

FRAUD AND ABUSE CONSIDERATIONS RISK MANAGEMENT CONSIDERATIONS Educate, educate, educate; Document, document, document; Use form/template agreements that are drafted for fraud and abuse compliance; Develop a policy for establishing fair market value and commercial reasonableness of financial arrangements subject to AKS and Stark AND FOLLOW IT! 63

TELEMEDICINE ISSUES IN LIABILITY INSURANCE THINK ABOUT Do you have sufficient coverage for telemedicine providers and functions? Does your current coverage anticipate acts and omissions of distant site providers? Potentially out-of-state distant site providers? What type/amount of liability/cyber coverage does the distant site provider have for telemedicine services? Do you know what liability insurance your subcontractors have? Would your current coverage cover negligent credentialing? Does your current coverage cover 2 nd and 3 rd party losses? 64

TELEMEDICINE ISSUES IN LIABILITY INSURANCE THINK ABOUT Does your current coverage cover business interruption if there is a security incident or breach of your system that would affect/interrupt telemedicine services? Does your cyber insurance policy cover telemedicine? Does your insurance policy indemnify you for the cost of defense? Does your insurance policy cover regulatory penalties? 65

TELEMEDICINE GENERAL RISK MANAGEMENT CONSIDERATIONS How do we assure that all of these issues are addressed? Identify key stakeholders in your organization that will be needed to implement legally compliant telemedicine services in a manner that manages the relevant risks: physicians; nurse practitioners; other allied health providers; department heads; risk manager; compliance officials; information technology; performance improvement; marketing; finance; accounting; legal; insurance carrier; etc.; Gather information and concerns from the identified group of stakeholders and organize identified risks; 66

TELEMEDICINE GENERAL RISK MANAGEMENT CONSIDERATIONS How do we assure that all of these issues are addressed? Conduct a risk assessment/gap analysis to identify what processes you have in place and where you need remediation; Organize and prioritize the results of the analysis and assign responsibility for recommending resolutions for the identified gaps in light of the resources available; Summarize the recommendations and provide to the organization s decision-makers; and Implement the appropriate solutions; Re-evaluate periodically and as new risks are identified. 67

TELEMEDICINE ISSUES IN LIABILITY INSURANCE RISK MANAGEMENT CONSIDERATIONS: THINK ABOUT Recall that there were three (3) telemedicine-related bills in the previous legislative session. S.290: Teleconsulting model: Requires a referring health care provider and a consulting health care provider; H.3779: Similar to S.290 as it requires a referring health care provider and a consulting health care provider; and H.4901: Allows the practice of medicine via telemedicine without the need for a referring or consulting health care provider. None pending now. Stay tuned! 68

RISK MANAGEMENT OF TELEMEDICINE Questions? 69

Jeanne M. Born Member 1230 Main Street, Suite 700, Columbia, SC 29201 803.540.2038 Jborn@nexsenpruet.com CHC Board Governance Retreat