The Georgia Partnership for Telehealth

The Doctor Will “See” You Now: Industry Perspectives on Telehealth and

Its Legal and Regulatory Implications

Greg Billings, Executive DirectorCenter for Telehealth and e-Health Law

March 20, 2014

Slides may not be duplicated without consent by CTeL. Copyright 2014

Objectives

• Review legal and regulatory issues facing telehealth practitioners:– Licensure– Prescribing of medication– Credentialing and Privileging– Reimbursement

CTeL’s History

• CTeL was founded in 1995 to address the legal and regulatory barriers impacting the utilization of telehealth and related e-health services.

• CTeL, formerly known as the Center for Telemedicine Law, was created under the vision and leadership of:

– Mayo Foundation – Cleveland Clinic – Midwest Rural Telemedicine Consortium– Texas Children’s Hospital – Robert J. Waters

Where are the Hurdles?

• Licensure• Credentialing and Privileging• Diagnosing/Prescribing of medication

without an in-person/face-to-face physical exam

• Reimbursement– Medicare– Medicaid– Private payers

Licensure for Telehealth

• Where is the patient located?• Telehealth practitioners must meet

licensing requirements in the state in which they provide services.

• That is—the location of the patient.• Licensure requirements are different in

each state.

Physician Licensure

• All states require medical licensure.• 10 States have a telemedicine or special

licensure process.• 46 States require licensure in another locality

in order to practice across state lines.

Note: Following 2014 state legislative action, CTeL is completing a comprehensive review of all state licensure laws. Numbers subject to change based on final research.

Licensure: State ExceptionsCommon Thread

• Physician to physician consultation• Resident in training• Border states• U.S. Military/VA physicians• Public health services• Medical emergencies/natural disasters

Licensure: Exceptions

• “Infrequent” or “occasional” consultations permitted.– All states allow this exception– 7 states specifically define “occasional” or

“infrequent”• Delaware: fewer than 12 consults per year.• New Mexico: no more than 10 patients per year.• Wyoming: not more than 12 days in any 52 week

period.

Special Telemedicine License /Special Purpose License

1. Alabama2. Louisiana3. Minnesota4. Montana 5. Nevada 6. New Mexico 7. Ohio8. Oregon9. Tennessee 10.Texas

Special Telemedicine License /Special Purpose License

• May require other conditions for special license:– Maintain a full medical license in another

state– No ethics violations– Must not have an in-state office

Licensure Consultation Requirements

• Georgia• For special cases, the board may approve a

consultation by a regularly licensed physician from another state or territory.

• Licensed physicians from another state or country may be permitted to provide consultative services for a Georgia licensed physician provided the out-of-state physician does not establish offices in the state of Georgia.

Licensure Consultation Requirements

• Alabama• A physician licensed in another state is permitted to conduct an informal

consultation with an Alabama licensed physician provided that neither physician receives compensation and the consultation does not result in the formal rendering of a written or documented medical opinion concerning the diagnosis or treatment of the patient by the out-of-state practitioner.

• Out- of- state practitioners may practice in Alabama in a medical emergency or on an irregular basis.

• The irregular practice of medicine is defined as the practice of medicine across state lines that occurs less than 10 times per calendar year or involves fewer than 10 patients in a calendar year or comprises less than one percent of the physician’s diagnostic or therapeutic practice

• Practice exceeding these limits requires a special purpose license.

Licensure Consultation Requirements

•South Carolina• An out-of-state physician may provide

consultative services to a physician licensed in South Carolina regarding the treatment of a patient located in South Carolina.

• The consulting physician is not permitted to prescribe, treat, operate on, or in any other way, manage the health care of a specific patient.

Licensure Consultation Requirements

• Florida• Out-of-state physicians are permitted to provide

consultative services at the request of a Florida licensed physician.

• Out-of-state physicians providing consultative services are permitted to examine the patient, take a history and physical, review laboratory tests and x-rays, and make recommendations to a physician licensed in Florida with regard to diagnosis and treatment of the patient.

• Out-of-state physicians are prohibited from performing any medical procedure or rendering treatment to a patient.

Consultation versus Practicing?

• Can the lines be blurred between consultation and practicing?– Is the relationship between the consulting practitioner

and the primary practitioner at or near the same “level”?– Or is the consulting practitioner at a significantly

different level than the primary practitioner?

• Can the lines be crossed so a consultation is actually practicing medicine without being properly licensed at the originating site?

Credentialing and Privileging

• July 5, 2011 – credentialing and privileging “by proxy” is permitted through CMS Final Regulation.

• Originating Site Hospital can rely on Distant Site for Credentialing and Privileging.

• Distant Site can either be:– Medicare Participating Hospital– Telemedicine Entity

• Written agreement between Hospital and Distant Site.

Credentialing and Privileging

• Guidelines: – The distant-site hospital is a Medicare-

participating hospital.

– The distant-site practitioner is privileged at

the distant-site hospital. – The distant-site hospital provides a current

list of the practitioner’s privileges.

Credentialing and Privileging

• Guidelines (continued): – The distant-site practitioner holds a license issued or

recognized by the state in which the originating-site hospital is located.

– The originating-site hospital has an internal review of the distant-site practitioner’s performance and provides to the distant-site hospital.

– Information sent from the originating-site to the distant site must include all adverse events and complaints from telemedicine services provided by the distant-site practitioner to the originating-site hospital’s patients.

Credentialing and Privileging

• We’re setting up a telemedicine program with another

facility? Do we have to credential and privilege those

telemedicine specialists?

• The Guiding Rule: How would the by-laws of your

facility treat those practitioners if they walked through

the front door to see the patients in person rather

through telemedicine?• If not required: Services through telemedicine should be added to the

list of privileges already granted.

• For performance/ peer review purposes, to judge in-person and

telemedicine separately.

Internet/Telemedicine Diagnosing and Prescribing:

Scope of Practice

• Prescribing statutes were written before the widespread use of

telemedicine.

• 42 states/jurisdictions require physical exam or a preexisting

physician-patient relationship before• Diagnosing, treating, or prescribing

• Problem: Statutes use vague language.– Can a “face to face” or “in person” examination occur through

telemedicine?

Note: CTeL has completed a comprehensive review of all state prescribing laws. This research will be reviewed by boards of jurisdiction. Summary numbers subject to change based on research.

Internet/Telemedicine Prescribing: Scope of

Practice• 19 states allow for the physical examination to take place electronically (each

administered differently)

– Arizona - Colorado– Florida - Georgia– Hawaii - Louisiana– Maryland - Nevada– New Mexico - North Carolina**– Ohio - Oklahoma**– Rhode Island - Tennessee– Texas - Utah– Vermont - Virginia– Washington

Note: CTeL has completed a comprehensive review of all state prescribing laws. This research will be reviewed by boards of jurisdiction. Summary numbers subject to change based on research.

Internet/Telemedicine Prescribing: Scope of

Practice

• 30 States require a Patient Medical History before

prescribing.

• 29 States allow for emergency prescribing in specific

situations.

• 36 States specifically prohibit medical questionnaires

and/or patient supplied history as sole basis for

prescription.

Note: CTeL has completed a comprehensive review of all state prescribing laws. This research will be reviewed by boards of jurisdiction. Summary numbers subject to change based on research.

Telemedicine Prescribing Requirements

• Georgia• It is unprofessional conduct for a practitioner to diagnose

and treat a patient without conducting a physical

examination beforehand.

• Georgia does recognize telemedicine as a legitimate

method of conducting that required physical examination.

• It is considered unprofessional conduct to prescribe a

controlled substance for a patient based solely on a

consultation via electronic means with the patient, patient’s

guardian, or patient’s agent.

Telemedicine Prescribing Requirements

• Alabama and South Carolina• A practitioner must establish a bona fide

relationship with the patient through a “personal”

examination before diagnosing and treating.

• An examination via two way, audio video

telemedicine is not recognized as a legitimate

method of conducting the required “personal”

examination before prescribing.

Telemedicine Prescribing Requirements

• Florida• A practitioner must make a documented patient

evaluation, which includes a physical examination, before diagnosing/treating patient.

• Telemedicine, via two-way, audio-video, is recognized as a legitimate method of conducting the required physical examination.

• Prescribing medications based solely on an electronic medical questionnaire constitutes the failure to practice medicine within the accepted standard of care.

How Is the Physician-Patient Relationship Established?

Does the State . . .

• Require “in person” or “face-to-face exam”? (31 states)

• Allow that exam to be conducted through two way, audio-video (conforming to standard of care)? (19 states)

• Stipulate that the telemedicine examination be “equivalent in scope to a face-to-face encounter” and meet all “applicable standards of care”, including the ordering of diagnostic tests?

• Allow that exam to be conducted through a telephone call? Through an email? Through an online portal? Phone app?

• Allow the “on call” privileges to be assumed by a physician not designated by the primary care physician?

How Is the Physician-Patient Relationship Established in this State?

“Unprofessional conduct” includes the following:• providing treatment, rendering a diagnosis, or

prescribing medications based solely on a patient-supplied history that a physician licensed in this state received by telephone, facsimile, or electronic format;

• prescribing, dispensing, or furnishing a prescription medication to a person without first conducting a physical examination of that person, unless the licensee has a patient-physician or patient-physician assistant relationship with the person.

How Is the Physician-Patient Relationship Established in this state?

A. A physician shall perform a patient evaluation adequate to establish diagnoses and identify underlying conditions or contraindications to recommended treatment options before providing treatment or prescribing medication.B. A XXXXX-licensed physician may rely on a patient evaluation performed by another XXXXX-licensed physician if one physician is providing coverage for the other physician.C. If a physician-patient relationship does not include prior in-person, face-to-face interaction with a patient, the physician shall incorporate real-time auditory communications or real-time visual and auditory communications to allow a free exchange of information between the patient and the physician performing the patient evaluation.

Confusion Reins

Statutes and regulations are not always clear . . . Enforcement is a question . . . • Why the confusion? The landscape . . .

• What is the “standard of care” for “minor” issues?• Providers in programs offer care directly to patients they never have met

in person and are not seeing through traditional “on-call” relationship.• Provider companies use a telephone encounter. Or interact through a

web portal. Or email. Or phone app.• Provider companies join with insurance companies, major corporations,

and hospital systems.• People often read these developments in the news media and assume “it

must be legal if XYZ is involved.”

Confusion Reins:“The Wild Wild West”

"If you can think of it, someone is doing it" (or will be soon).

(senior medical official at a state medical board)

• News “sexy” on “telehealth”• Low cost• Ease of care

Scope of the Issue?

• Web Search . . . • “telemedicine physician”• “telemedicine doctor”• “find a telemedicine doctor”• “see a telemedicine doctor”

Example #1:

Problem: Urinate too frequently• Describe symptoms in an email• Few minutes later, you get a doctor’s response • Answer questions. “Probably a UTI”• “Antibiotic is prescribed and you are done.”

Example #2:

• Offers you instant and direct access to doctors. • Necessary care provided by using telephone.• What can be treated?

• doctors can diagnose, recommend treatment and prescribe medication for many medical issues.

• Over 60% of in-person doctor appointments are purely informational.

• Alternative that is every bit as effective as an in-office visit.

Example #3:

Problems Treated by this Service:• Sexually transmitted diseases• Allergy, cold, and cough• Breast infection, breast pain• Bladder infection• Interaction with Nurse Practitioner through a

web portal

Confusion Reins:“The Wild Wild West”

“One night last fall, XXXXX’s 9-year-old son came home with a swollen throat and fever. It was after dinner, so she flipped open her laptop and dialed into XYZ.com, a service offered by her insurer, XXXXXX, that connects patients with doctors via video calls. Fifteen minutes later, XXXXX says, “we were on with a doctor.”

“After a quick diagnosis of an infection (the doctor, XXXXXX says, treated it as strep, though couldn’t diagnose that without a test), a prescription for an antibiotic was called in to a pharmacy near XXXXXX’s home in XXXXXX, Ohio. “By 10 p.m., I was back home,” she says. “It was quick and easy.” Her other options would have been to see a doctor in the morning or risk a long wait at an urgent care facility. The video call was faster and cheaper—it cost $40 instead of the $100 a pediatrician would charge, she says.”

Faster, Cheaper . . . But no mention of quality of care.

Confusion Reins:“The Wild Wild West”

Why Should This Be Of Concern?Overprescribing and Antibiotic Resistance: The Problem

• More that 2 million antibiotic resistant infections in the US annually• At least 23,000 deaths• Most important factor for antibiotic resistance--antibiotic use• Inappropriate use most common for acute respiratory tract infections• Over half of all outpatient antibiotic use unnecessary • JAMA Study on e-Visits: For UTIs, 99 percent of e-visits resulted in an antibiotic,

compared to 49 percent of office visits• Antibiotics are responsible for almost 1 out of every 5 visits to emergency

departments for drug-related adverse events

Centers for Disease Control and Prevention (CTeL Webinar, January 2014)

Confusion Reins:“The Wild Wild West”

If you see a news story describing a practitioner diagnosing a first time patient’s “minor” issue over a web cam, telephone, phone app, or email, don’t assume the encounter is compliant with state law/regulation.

Telehealth Reimbursement

• Medicare Statute (2001)– Originating sites in certain locations (rural)– Specific practitioners eligible– Covered procedures specified with codes– In 2011, Medicare reimbursed approximately

$6.4 million under the Medicare Physician Fee Schedule

• Medicaid – Approximately 45 states cover certain

telehealth services.

Telehealth Reimbursement

• 20 States and District of Columbia mandate private payer telehealth coverage.– California - Colorado - District of– Georgia - Hawaii Columbia– Kentucky - Louisiana– Maine - Maryland– Massachusetts - Michigan– New Hampshire - Oklahoma– Oregon - Texas– Vermont - New Mexico– Montana - Virginia– Mississippi - Arizona

So, Now You Know About the Hurdles . . .

• The concrete “black and white” answers may not exist.

• You may think the statute or rule is “stupid”– Your opinion doesn’t count! Just kidding . . . – Your input on what it should say and your professional

expertise does count!• Incorporate the legal and regulatory questions into

your business model at the beginning, not the end.– Seek telehealth-experienced counsel early.– The legal and regulatory problems won’t just go away if you

don’t address them. – They only get worse.

Contact Information

Greg Billings

Executive Director

Robert J. Waters Center for Telehealth and e-Health Law

P.O. Box 15850

Washington, D.C. 20003

202.499.6970

Greg@ctel.org

www.ctel.org