Telehealth: Implementation Challenges in an Evolving Dynamic

Transcription

1 Telehealth: Implementation Challenges in an Evolving Dynamic Katharine Conklin Struck, Rush University Medical Center Ross K. Friedberg, Doctor on Demand Julia B. Jacobson, McDermott Will & Emery LLP Lisa Schmitz Mazur, McDermott Will & Emery LLP Moderator: Dale C. Van Demark, McDermott Will & Emery LLP April 14, Boston Brussels Chicago Dallas Düsseldorf Frankfurt Houston London Los Angeles Miami Milan Munich New York Orange County Paris Rome Seoul Silicon Valley Washington, D.C. Strategic alliance with MWE China Law Offices (Shanghai) 2015 McDermott Will & Emery. The following legal entities are collectively referred to as "McDermott Will & Emery," "McDermott" or "the Firm": McDermott Will & Emery LLP, McDermott Will & Emery AARPI, McDermott Will & Emery Belgium LLP, McDermott Will & Emery Rechtsanwälte Steuerberater LLP, McDermott Will & Emery Studio Legale Associato and McDermott Will & Emery UK LLP. These entities coordinate their activities through service agreements. McDermott has a strategic alliance with MWE China Law Offices, a separate law firm. This communication may be considered attorney advertising. Prior results do not guarantee a similar outcome.

2 Introduction: The Spur of Innovation Provider Interest New and Innovative Players Consumers Keeping up with patients Quality Population health management demands Building the brand Software and hardware entrepreneurs Consumer facing and provider facing technology developers Attracted to the massive health care market Ease of use Quality Next great thing Payors Lower cost Consumer demand Population health management demands 2

3 Introduction: And Where Does it All Lead? Multiplicity of Catalysts for Change Multiplicity of Connected Health Models Evolution of an Accepting Infrastructure???? 3

4 Introduction: The Policy Balancing Act The Reward Access Quality Cost Reduction Consumer Engagement Free-Flow of Information Etc. The Risk Over-Utilization Quality Just another pricey toy? Doctor-Patient Relationship Free-Flow of Information Etc. 4

5 Introduction: Our Unfortunate Operating Environment 5

6 Introduction: Our Panel Katharine Conklin Struck, Senior Associate Counsel, Rush University Medical Center Ross K. Friedberg, General Counsel, Doctor on Demand Julia Jacobson, Partner, McDermott Will & Emery LLP Lisa Schmitz Mazur, Partner, McDermott Will & Emery LLP Moderator: Dale C. Van Demark, Partner, McDermott Will & Emery LLP 6

7 Reimbursement 7

8 Billing & Reimbursement No two states are the same Medicaid biggest player Medicare limited geographically and by service Commercial payors driven by state legislation Self-pay models patients willing to pay for convenience Investing in the future pay now as early adopter or pay later when payment models catch up 8

9 Billing & Reimbursement - Medicaid Forty-six states have some form of public reimbursement for telehealth services States are developing telemedicine programs and expanding coverage in response to specific needs Live Video most predominantly reimbursed form of telehealth Asynchronous services reimbursed in a handful of states Thirteen states have some form of reimbursement for Remote Patient Monitoring (RPM) 9

10 Billing & Reimbursement Medicaid cont. Majority of states do not have geographical restrictions patients do not need to be located in rural or underserved areas However, reimbursement limited by facility and provider originating site providers and distant site providers Most states exclude the home as a reimbursable site Depending on state, eligible providers may include physicians, physician assistants, podiatrists, APNs, and psychologists 10

11 Billing & Reimbursement Medicaid Example Illinois Medicaid will reimburse for live video under the following conditions: A physician or other licensed health care professional must be present with the patient at the originating site The distant site provider must be a physician, physician assistant, podiatrist or advanced practice nurse who is licensed by Illinois or the state where the patient is located (see next slide) The originating and distant site provider must not be terminated, suspended or barred from IDHFS medical programs Medical data may be exchanged through a telecommunication system The interactive telecommunication system must have the capability of allowing the consulting distant site provider to examine the patient sufficiently to allow proper diagnosis of the involved body system 11

12 Billing & Reimbursement Medicaid Illinois Medicaid Example cont. Permissible Providers: 12

13 Billing & Reimbursement Medicare Medicare Beneficiaries are eligible for telehealth services only if they are presented from an originating site located in: A rural Health Professional Shortage Area, either located outside of a Metropolitan Statistical Area (MSA) or in a rural census tract, as determined by the Office of Rural Health Policy within the Health Resources and Services Administration (HRSA); or A county outside of a MSA. New CPT code to cover remote chronic care management not considered by CMS as rural-only telehealth visits. Under the Bundled Payments for Care Improvement Initiative (models 2 and 3), CMS offers a waiver of the geographic area requirement as long as the services are furnished in accordance with all other Medicare coverage and payment criteria 13

14 Billing & Reimbursement Medicare Individual and group health, and behavior assessment and intervention Psychiatric diagnostic interview examination Individual psychotherapy Psychoanalysis Family psychotherapy (wit h and without patient present) Screening for depression in adults Smoking cessation for services Alcohol and/or substance (other than tobacco) abuse assessment and intervention services, brief face-to-face behavior counseling for alcohol abuse, and annual alcohol misuse screening (w/ limitations) High-intensity behavioral counseling to prevent sexually transmitted infection, and related education and training Annual intensive behavioral therapy for cardiovascular disease. Emergency Department or initial inpatient consultations Follow-up inpatient consultations to patients in hospitals or SNFs Office/outpatient visits Subsequent hospital services or nursing facility care services (w/ limitations) Individual and group diabetes self-management training services (w/ limitations) Individual and group kidney disease education services Pharmacologic management Psychiatric diagnostic interview examinations Counseling for obesity (w/ limitations) Transitional care management services Prolonged services with direct face-to-face patient contact Annual wellness visit 14

15 Billing & Reimbursement Medicare Reimbursement to Distant Provider and Originating Site Reimbursement to the health professional delivering the medical service is the same as the current fee schedule amount for the service provided. Originating Site is eligible to receive a facility fee. In 2015, Medicare increased payments to originating sites by.8% (but would not drop the rural location requirement). Claims for reimbursement should be submitted with the appropriate CPT code for the professional service provided and the telehealth modifier GT via interactive audio and video telecommunications system. 15

16 Billing & Reimbursement Medicare CMS Conditions of Coverage Medicare Reimbursement Requirements (42 C.F.R ) 16

17 Billing & Reimbursement Medicare Permissible Practitioners Distant site providers who may furnish and receive payment for covered telehealth services (subject to State law) are: Physicians Nurse practitioners Physician assistants Nurse-midwives; Clinical nurse specialists Clinical psychologists and clinical social workers (special rules apply) Registered dietitians or nutrition professionals 17

18 Billing & Reimbursement Medicare Delivery Method As a condition of payment, an interactive audio and video telecommunications system must be used that permits realtime communication between the distant site provider and the patient at the originating site 18

19 Billing & Reimbursement Medicare The originating sites authorized by Medicare include: The offices of physicians or practitioners Hospitals Critical Access Hospitals (CAH) Rural Health Clinics Federally Qualified Health Centers Hospital-based or CAH-based Renal Dialysis Centers (including satellites) Skilled Nursing Facilities (SNF) Community Mental Health Centers (CMHC) 19

20 Billing & Reimbursement Commercial Payors Overview of State of Reimbursement by Private Payers Reimbursement policy varies from payer to payer Several major private payers are highly influential in payment policies for telehealth private payers UnitedHealth, WellPoint, Humana Private payers have administrative rules regarding telehealth reimbursement that can be barriers to services and reimbursement 20

21 Billing & Reimbursement Commercial Payors Coverage on the Rise Health care organizations are incorporating telehealth technologies to manage costs, broaden access and improve patient care Examples: WellPoint now offers employer and individual plans remote consultations with physicians using laptop webcams and video-enabled smartphones UnitedHealth offers NowClinic telehealth consultations in over 20 states Blue Cross Blue Shield s Online Care Anywhere is currently available to residents in approximately 30 states A growing number of large businesses (e.g., Home Depot, Westinghouse Electric, EMC) are offering more remote health care consultations in their employee benefits package 21

22 Billing & Reimbursement Commercial Payors Overview of State of Reimbursement by Private Payers Illinois recently passed a law that amends the Illinois Insurance Code to provide that if a policy of accident or health insurance provides coverage for telehealth services, then it must comply with certain prohibitions (e.g., can t require in-person contact for services to be provided through telehealth, require use of telehealth provider has determined not appropriate, etc.) 20 states and D.C. have adopted laws that require private insurers to reimburse for certain telemedicine services Legislation to this effect has been proposed in an additional 15 states (including Illinois) Increase in the number of reimbursable services in recent years Popular reimbursable services include telepsychiatry Increase partly due to state mandates and payers are recognizing opportunities to decrease costs 22

23 Licensure and Scope of Practice/Standard of Care 23

24 Defining Telehealth and Telemedicine Depends on who you ask 24

25 What is Telemedicine? The specific facts and circumstances related to the encounter are often relevant Not patient specific Review patient s medical records Direct patient s care No control over patient s care Incidental consultation More than one consultation Recommend treatment plan No direct contact w/patient Direct interaction with the patient Probably not Depends what definition is applicable? Probably 25

26 State Regulation of Telemedicine States have their own: Licensing laws and requirements Standards of care Scope of practice laws, identifying who may provide healthcare services and the scope of such services Other requirements (e.g., consent) 26

27 State Licensure Requirements Generally, licensure also required in the state where the patient is located Full licensure Special license/certificate 10 states Exceptions may exist Consults with existing patients Limited consults Physician to physician consults Efforts to reduce barrier State medical boards Professional Associations Federation of State Medical Boards Interstate Medical License Compact 27

28 State Licensure Requirements: Examples Alabama: Full or special purpose license required California: Full license required Georgia: Full license required Illinois: Full licensed required Indiana: Full licensure required Ohio: Full or telemedicine permit Texas: Full license or out-of-state telemedicine license 28

29 State Standard of Care Requirements General consensus that all treatment provided via telemedicine will be held to the same standard as face-to-face encounters Some states identify the standard in which care is delivered via telemedicine May depend on the context (e.g., online) May be limited to prescribing 29

30 State Standard of Care Requirements: Examples Georgia Licensees practicing by electronic or other means will be held to the same standard of care as licensees employing more traditional in-person medical care. Ga. Comp. R. & Regs. R (f). Florida The standard of care is the same for inperson services as with telemedicine services (note: certain restrictions are placed on prescribing). Fla. Admin. Code r. 64B (1). Texas Treatment and consultation recommendations made in an online setting will be held to same standards as those applicable to inperson encounters. 22 Tex. Admin. Code 174.8(b). 30

31 State Scope of Practice Requirements Scope of practice especially relevant to Direct to patient arrangements Online second opinions Follow-up visits/consults for existing patients (e.g., mental health, chronic disease) Significant variation between states Some states have no additional regulations (above existing standards of care) Others severely restrict when and how telemedicine may be used 31

32 State Scope of Practice Requirement: Example Texas Special requirements for telemedicine encounters that occur outside of an established medical site (e.g., a licensed medical facility), such as in the patient s private home. 22 Texas Administrative Code A physician rendering medical care via telemedicine may not: (1) make an initial diagnosis of a new patient via telemedicine at a patient s home (or other location that is not an established medical site), unless the physician has conducted a prior face-to-face initial consultation or the patient has been referred to the telemedicine provider by a physician who evaluated the patient in-person; or (2) provide ongoing medical treatment to a preexisting patient with a new chronic condition, unless a physician conducts a timely in-person evaluation after the diagnosis of the new condition. 32

33 State Standard of Care and Scope of Practice Considerations Can a physician-patient relationship (not preexisting) be established via telemedicine? When has the relationship been established? Is there any requirement for a face-to-face visit prior to delivering care via telemedicine? In-person exam required to establish valid doctor-patient relationship? In-person exam required for diagnosis and treatment recommendation? In-person exam required to prescribe? All medications or just controlled? New prescription or refills? Online interface in real time count? Exceptions if patient present at health facility? What supervision requirements are applicable for licensed and unlicensed personnel? 33

34 Privacy Environment 34

35 Complicated Privacy Environment 35

36 Telemedicine Outside the HIPAA Silo Telemedicine provider is not a HIPAA-covered entity, e.g., consumers pays by credit card to speak with someone about a rash or nutrition. Does the consumer understand that his or her health information is not protected by HIPAA? 36

37 Telemedicine Inside the HIPAA Silo. If the telemedicine provider is a Covered Entity, does consumer understand that his or her selfgenerated and collected health information is outside the HIPAA silo until provided to the Covered Entity? A Covered Entity is not immune from FTC enforcement. See, e.g., LabMD The case is part of an ongoing effort by the Commission to ensure that companies take reasonable and appropriate measures to protect consumers personal data. 37

38 Hidden Issues 38

39 State Regulation of Interstate Telemedicine Telehealth breaks down geographic barriers to care, but state laws make it very challenging to operate in a multi-state environment Lack of a uniform definition Diverse medical practice rules Lack of uniform coverage and payment rules Restrictions on the interstate practice of medicine Complex state medmal insurance landscape State privacy laws Conflicting rules & guidance across state agencies

40 Telehealth is Spawning a New Web of Relationships within Healthcare Themes Tech distribution channel Provider access to new patients Patient access to new providers Patient directed care Integrated technology Expanded service offering Legal Challenges New referral and marketing relationships Crossing outside the healthcare divide Evolving standards of care Pharmacies Nutritionists Health Systems / Health Plans / Employers Dietitians Patient Directed Collaborations (labs, devices) Tech Companies

41 Discussion What are the key areas of legal and regulatory development you believe would help further the development of telehealth? What are the key areas of legal and regulatory development you see taking place right now? 41

42 Discussion What issues emerge with the advent of wearables, the internet of things and other direct to consumer information communication tools that may be integrated into a telemedicine program? 42

43 Discussion What role can telemedicine play in achieving the triple aim of healthcare reform? How might telemedicine undercut those goals? 43

44 Thank You The panelists would like to extend a special thanks to Drew McCormick, Assistant General Counsel of Rush University Medical Center, for her assistance in preparing for this presentation. 44

45 Speaker Biographies 45

46 Speaker Biography: Katharine Conklin Struck Senior Associate General Counsel Associate Vice President Rush University Medical Center Chicago T: E: Katie Struck has been working in Rush s legal department since graduating from law school in 2007 and is currently Senior Associate General Counsel and Associate Vice President of Legal Affairs. Her primary areas of practice include analysis of complex regulatory issues, physician arrangements, conflicts of interest, corporate transactions and governance issues. Prior to law school, Katie worked as a lobbyist and served in many roles on various political campaigns in Illinois. 46

47 Speaker Biography: Ross Friedberg Attorney & General Counsel Washington, D.C. T: E: Ross Friedberg is an attorney based in Washington DC who serves as General Counsel for Doctor on Demand, a health care service and technology company that provides individuals with access to licensed health care professionals through a secure video-based mobile and desktop application. Prior to joining Doctor on Demand, Ross practiced healthcare law at the law firm Epstein Becker and Green. Ross is the co-author of the Bloomberg-BNA Portfolio Series on telehealth, "Navigating the Telehealth Landscape: Legal and Regulatory Issues" (BNA Health Law and Business Series). 47

48 Speaker Biography: Julia Jacobson Partner Boston T: E: Julia Jacobson is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm s Boston office. Julia focuses her practice on Privacy & Data Protection Law, counseling clients on data privacy issues, with a focus on the digital ecosystem (online, mobile, social media), including privacy audits, design, development and implementation of websites, mobile applications, social media and other digital services, processes for managing consumer data in consumerdata-driven businesses and draft and negotiate a variety of privacy-related contracts. She advises businesses on electronic contracting issues (browse-wrap and click-wrap contracts of adhesion, E-SIGN Act). She also develops internal and externally-facing privacy-sensitive policies, including privacy statements/policies, social media use and access management. Julia also focuses her practice on technology licensing and agreements, counseling emerging growth through mature technology companies in connection with legal and business issues related to technology agreements. She negotiates and drafts licenses and joint development, alpha/beta testing, SaaS, software, end-user, enterprise, hosting and mobile application agreements. 48

49 Speaker Biography: Lisa Schmitz Mazur Lisa Schmitz Mazur is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm s Chicago office. Lisa maintains a general health industry practice, focusing on the representation of hospitals and health systems and other health industry providers. Partner Chicago T: E: lmazur@mwe.com Lisa s representation of hospitals and health systems includes providing guidance on not-for-profit corporate governance matters, tax-exemption issues, conflict of interest compliance and overall corporate compliance effectiveness. In addition, Lisa regularly assists hospital and health system clients to develop and negotiate physician compensation programs, and prepare agreements with physicians and helps to guide governing boards and committees in the review and approval of such arrangements. Lisa also has experience assisting clients in the development and implementation of accountable care strategies and hospital/physician integration initiatives and the operation of accountable care organizations and clinically integrated networks. In addition, Lisa dedicates a significant portion of her practice to advising clients on state and federal laws affecting telehealth, including issues related to physician licensure, prescribing, scope of practice, and reimbursement, and compliance issues related to the use of technology to deliver care. She has assisted numerous clients to develop and implement telemedicine programs, including drafting provider participation agreements and telemedicine policies and procedures. 49

50 Speaker Biography: Dale Van Demark Dale C. Van Demark is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm s Washington, D.C., office. He focuses his practice on a broad array of merger, acquisition, investment, and strategic structuring transactions, with clients in the health industry. He has extensive experience in health system affiliation and restructuring transactions and regularly represents for-profit and tax-exempt clients in a variety of transactions, including strategic transactions with physicians and hospitals. He regularly advises clients regarding the opportunities and challenges that exist as the result of the passage of the Patient Protection and Affordable Care Act (PPACA) and the continuing trend toward greater collaboration among providers, including hospitals, community health centers and physicians. Partner Washington, D.C. T: E: dvandemark@mwe.com Dale also provides tax-exempt counseling to both tax-exempt organizations and those seeking business relationships with tax-exempt organizations. He regularly advises clients on matters related to tax-exemption qualification and compliance, including issues related to private inurement, intermediate sanctions, joint ventures and governance. More recently, he has been counseling clients on exemption requirements in the context of the new accountable care dynamic brought about in part with the passage the PPACA. Dale has been at the forefront of advising clients with respect to the globalization of the U.S. health care industry. He advises foreign and domestic enterprises with respect to the formation of medical centers in developing countries, international patient programs, telemedicine and the many issues associated with the delivery of health care over national borders. 50