www.mwe.com

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.

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, 2015

Telehealth: Implementation Challenges in an Evolving Dynamic

2

Introduction: The Spur of Innovation

Provider Interest Keeping up with patients Quality Population health management demands Building the brand

New and Innovative Players Software and hardware entrepreneurs Consumer facing and provider facing technology developers Attracted to the “massive” health care market

Consumers Ease of use Quality Next great thing

Payors Lower cost Consumer demand Population health management demands

3

Introduction: And Where Does it All Lead?

? ? ? ?

Evolution of an Accepting Infrastructure

Multiplicity of Catalysts for

Change

Multiplicity of Connected

Health Models

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.

5

Introduction: Our Unfortunate Operating Environment

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

7

Reimbursement

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

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)

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

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

12

Billing & Reimbursement – Medicaid

Illinois Medicaid Example cont. Permissible Providers:

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 99490 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

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

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”.

16

Billing & Reimbursement – Medicare

CMS Conditions of Coverage Medicare Reimbursement Requirements (42 C.F.R. § 410.78)

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

18

Billing & Reimbursement – Medicare

Delivery Method – As a condition of payment, an interactive audio and video

telecommunications system must be used that permits real-time communication between the distant site provider and the patient at the originating site

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)

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

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

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

23

Licensure and Scope of Practice/Standard of Care

24

Defining Telehealth and Telemedicine

Depends on who you ask…

25

What is Telemedicine?

Probably not Probably

Direct interaction with the patient

More than one consultation

Incidental consultation

No direct contact w/patient

Direct patient’s care

No control over patient’s care

Review patient’s medical records

Depends… what definition is applicable?

The specific facts and circumstances related to the encounter are often relevant

Recommend treatment plan

Not patient specific

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)

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

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

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

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. 360-3-.07(f).

Florida ‒ The standard of care is the same for in-person services as with telemedicine services (note: certain restrictions are placed on prescribing). Fla. Admin. Code r. 64B8-9.0141(1).

Texas ‒ Treatment and consultation recommendations made in an online setting will be held to same standards as those applicable to in-person encounters. 22 Tex. Admin. Code § 174.8(b).

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

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 § 174.7.

– 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.

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?

34

Privacy Environment

35

Complicated Privacy Environment

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?

37

Telemedicine Inside the HIPAA Silo

.

If the telemedicine provider is a Covered Entity, does consumer understand that his or her self-generated 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.”

38

“Hidden Issues”

39

State Regulation of Interstate Telemedicine

- 39 -

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

Tech Companies

Pharmacies Patient Directed Collaborations (labs, devices)

Nutritionists Health Systems /

Health Plans / Employers Dietitians

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

- 40 -

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?

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?

43

Discussion

What role can telemedicine play in achieving the triple aim of healthcare reform?

How might telemedicine undercut those goals?

44

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.

Thank You

45

Speaker Biographies

46

Speaker Biography: Katharine Conklin Struck

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.

Senior Associate General Counsel

Associate Vice President

Rush University Medical Center

Chicago

T: +1 312-942-6886

E: katharine_E_Struck@rush.edu

47

Speaker Biography: Ross Friedberg

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).

Attorney & General Counsel

Washington, D.C.

T: +1 202 452 8025

E: rfriedberg@doctorondemand.com

48

Speaker Biography: Julia Jacobson

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 consumer-data-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.

Partner

Boston

T: +1 617 535 3881

E: jjacobson@mwe.com

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. 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.

Partner

Chicago

T: +1 312 984 3275

E: lmazur@mwe.com

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. 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.

Partner

Washington, D.C.

T: +1 202 756 8177

E: dvandemark@mwe.com