Telehealth: Implementation Challenges in an Evolving Dynamic

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www.mwe.com

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

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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

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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

(7)

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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

(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)



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)



Illinois Medicaid Example

cont.

(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)



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

(15)



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)

CMS Conditions of Coverage Medicare Reimbursement

Requirements (42 C.F.R. § 410.78)

(17)



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)

(18)



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)



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)

(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

(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

(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

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

Recommend

treatment plan

(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

(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

(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

(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)

(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

(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)

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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)

(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

(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

(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?

(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.

(45)

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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

(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

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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: [email protected]

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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: [email protected]

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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