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Telemedicine/Telehealth Implementation: Do’s and Don’tsLEGAL & OPERATIONAL ISSUES
Ka i t l in Rosentha l (Ka i t l in .Rosentha l@jefferson .edu)Rene Quash ie ( rquash ie@cozen .com)
Getting Started –What Type of Telehealth Program Do Want to Implement?
2
Legal/Regulatory Overview
3
Regulatory Overview
Center for Connected Health Policy Report (Fall 2017)
Email, telephone, and fax are rarely
acceptable forms of delivery unless used with other type of
system
States either are silent or explicitly
exclude these forms, sometimes even
within the definition of telehealth and/or
telemedicine
Live, interactive video communication fits within definition of “telemedicine” or
“telehealth” in every state where terms
defined
4
Progress in the States
Most states now allow initial patient evaluations to occur via telemedicine
Rise of parity laws
Rise of licensure compacts
Little enforcement
activity
Little malpractice activity
5
State Bills
Hundreds of telehealth‐related bills have been introduced in the last 2 years.
Trends include:
Defining “telehealth” or “telemedicine”
Expanding covered providers
Allowing physical exams to occur by
telehealthCoverage parity Pilot programs
6
Pennsylvania Bill
Senate Bill 780 introduced in June 2017
Telemedicine practitioner must: • Must establish a practitioner‐patient relationship• Must provide an appropriate virtual examination through telemedicine technologies• Must have an emergency plan for medical emergencies and referrals when needed• May use interactive audio without video if practitioner determines that he/she can meet the standard of care
• Insurance coverage parity
7
Telemedicine Programs
8
Types of ProgramsHospital ED and pre‐admission testing telehealth programs
On‐demand and scheduled appointment physician office visits
Provider‐to‐provider programs (such as stroke patient neurology consults from one hospital to another)
Remote second opinion programs
9
Initial Issues to Consider
Are institutional providers involved?
Where is the patient located?
Who will be providing the telehealth
service?
10
Getting a Telehealth Program Off‐the‐Ground –Legal & Regulatory Issues
11
Licensure
12
Physician Licensure
A physician must be licensed by, or under the jurisdiction of,
the medical board of the state where the patient is located
The practice of medicine occurs where the patient is located at the time telemedicine technologies are
used
Physicians who treat or prescribe via telehealth are practicing medicine
and must possess appropriate licensure in all jurisdictions where patients receive care
13
Physician LicensureRegular License
• Some states require telemedicine providers to obtain the relevant professional license required by the state
Special Telemedicine License
• Some states issue special licenses/certificates for telemedicine services allowing out‐of‐state providers holding such licenses to render services provided certain conditions are met, such as not opening an office in the state
14
Consultation ExceptionAllows a physician who is not licensed in the state
to practice medicine “in consultation” with a referring physician who is licensed in the state
Available in many states but scope varies widely state to state
Unclear whether applicable to routine, ongoing consultations with telemedicine providers
15
Physician Compact
16
• 22 states are part of the Compact• Expedited pathway to state licensure for
experienced physicians who have outstanding practice histories
• Complements existing licensing and regulatory authority of state medical boards• Must still become fully licensed in each
state• Must still pay fees
• Passed in PA• Implementation delayed
Non‐Physician CompactsNurse Licensure Compact• Allows a nurse (RN and LPN/VN) to have one compact license in the nurse’s primary state of residence (the home state) and to practice in other compact states (remote states)
• Nurse must follow the nurse practice act of each state• Permits practice (physically and telephonically/electronically) across state lines in Compact states
• Advanced practice registered nurses not included in this compact• Enhanced Compact
APRN Compact (National Council of State Boards of Nursing)
17
Physician‐Patient Relationship/Prescribing
18
Establishing the Physician‐Patient RelationshipTraditionally, establishing a physician‐patient relationship has required at least an initial in‐person encounter between a physician and a patient
Increased use of telehealth technologies raises questions regarding this traditional view of physician‐patient relationships
19
Example
Most states allow the physician‐patient relationship to be established by virtual means
New Hampshire
• Physician‐patient relationship means a medical connection between a licensed physician and a patient that includes an in‐person or face‐to‐face two‐way real‐time interactive communication exam, a history, a diagnosis, a treatment plan
20
State Law – Prescribing•Require an in‐person evaluation or physical examination before prescribing online •Majority of states now allow examination to occur via telehealth
•Permit physicians to prescribe via telehealth only if there is a preexisting patient relationship even if physician is licensed in the state where patient is physically located
•Almost all states prohibit prescribing based solely on information from an online questionnaire
• Some states regulate online prescribing through pharmacy laws
States have different approaches
21
State Pharmacy LawsCOLORADO• Pharmacist cannot dispense a prescription drug if the pharmacist knows or should have known that the order for such drug was issued on the basis of an Internet‐based questionnaire, an Internet‐based consultation, or a telephonic consultation, all without a valid preexisting patient‐practitioner relationship
DC• Pharmacist cannot “dispense a prescription if the pharmacist knows that the prescription was issued without a valid patient‐practitioner relationship”
22
FSMB Guidelines – PrescribingPrescribing medications, in‐person or via telemedicine, is at the professional discretion of the physician
The indication, appropriateness, and safety considerations for each prescription must be evaluated by the physician keeping in mind current standards of practice
Telemedicine technologies may be used (if patient safety upheld) in the absence of traditional physical examination.
23
Federal Law – Prescribing Controlled Substances
Ryan Haight Act
• No controlled substance may be delivered, distributed or dispensed via the Internet without a valid prescription
• Unless a telemedicine exception applies, a valid prescription may only be obtained by a practitioner who has conducted at least one in‐person medical evaluation of the patient, or by a covering practitioner
• 7 exceptions including a patient being treated via telemedicine when located at a DEA‐registered facility treated by a DEA‐registered practitioner
24
Professional Liability Insurance
25
PIAA Data (July 2015)94,228 total claims in the DSP from 2004‐2013◦ Only 196 claims were linked with telephone treatment◦ Of those 196 reported claims, 56 resulted in some form of claim payment
Total indemnity loss related to telephone treatment was only $17 million◦ Compared to $8 billion for the total of all MPL losses in the DSP (0.21% of all MPL losses)
Average indemnity loss lower for telephone treatment◦ $303,691, compared to $328,815 for all MPL claims within the DSP
26
MPL InsuranceProviders should purchase MPL before patient encounters commence
Coverage to all healthcare providers and the healthcare entity on a shared basis per occurrence and in the aggregate• No need to have each individual healthcare professional carry his or her own individual limits
• Prevents “clash loss” – claim names multiple defendant entities and/or individuals implicating multiple policies and multiple sets of limits
27
MPL Coverage – Incident Reporting
Seek policy allowing for reporting of facts and
circumstances that might lead to a claim –“incident reporting”
Allows insured to report
potential claims or bad outcomes as soon as they become known to the insured
party
Incumbent carrier is then responsible for that claim after proper notice is
given even if insured changes carriers before a written demand for
damages should occur
28
Getting a Telehealth Program Off‐the‐Ground –Operational Considerations
29
Strategic ApproachImplement a targeted and strategic approach when starting a telehealth program:
• Determine whether the desired program has any opportunities to generate revenue or reduce expenses
• Conduct a financial analysis to determine whether it makes business sense to expand to other states
• Consider using contracted networks of providers already operating in other states
30
Understand Operational Requirements
If additional provider licensure is required, do you have systems to track such licensure and maintenance
thereof?
Does your telehealth technology match patient
location to provider licensure?
Will your providers need to be credentialed at another
facility?
31
Understand Operational RequirementsDo you have malpractice coverage in the target state?
Do you understand state‐specific requirements related to informed consent, the standard of care, and prescribing?
Have you trained your providers on any new state‐specific requirements?
Are you equipped to handle patient medical records in accordance with state‐specific requirements?
32
Understand Operational Requirements
Do you understand any applicable state‐specific reporting requirements?
Can you operationalize any state‐specific business entity
requirements?
For example, in a state where a captive PC is required, how will your systems make sure you bill and collect money in the name of the captive?
How will you track revenue derived from out‐of‐state for
tax purposes?
33
Privacy/Security Legal Issues
34
Privacy & Security EcosystemHIPAA
• Privacy Rule• Security Rule• Breach Notification• Health Information Technology for Economic and Clinical Health Interim Act (HITECH) – February, 2009
• Omnibus Final Rule –March, 2013
FTC Act
• Section 5
State Privacy/Security & Telemedicine Laws
• Patchwork that varies by state
35
Privacy/Security Issues
Breach notification (verifying breaches)
Complying with privacy laws in multiple states (interstate telehealth)
Web‐based platforms (Skype, etc.) for delivery of treatment
Transmission security
Distribution of Notice of Privacy
Practices to telehealth patients
Sharing data and management responsibility with other providers
Business Associate
Agreements with technical
providers (non‐covered entities)
supporting telehealth services
Presence of non‐clinical personnel
supporting telehealth services
36
Privacy/Security Operational Considerations
37
Considerations
• Does the platform have two‐way audio and video? • The ability to conference in third party? • The ability to send and receive other types of pertinent health information (such as radiology films)?
• How will the platform integrate with your other systems? • For example, will it store medical records and/or perform billing functions?
Understand the technology needs for your
specific telehealth program
38
ConsiderationsSign a contract and (most likely) a business associate agreement with
the vendor
Have your IT Department verify the platform meets your institution’s
security requirements
39
Reimbursement Overview
40
Medicare OverviewEligible provider limitations
Mostly for rural beneficiaries (original site limitations)
Limited number of services covered
Live interactive audio/video (no coverage for asynchronous, store‐and‐forward communication in most cases)
$29 million paid out for telehealth services (2016)
• $615 billion paid out for all Medicare programs/services
41
Alternate Payment Models
Bundled payments
Medical home CMMI MSSP CJR Next‐Gen
ACOs BPCI HCIA
42
Medicaid OverviewStates and DC Medicaid programs cover telemedicine in some form• The most predominantly reimbursed form of telehealth is live video, with almost every state
offering some type of live video reimbursement in their Medicaid program
States have adopted Interstate Medical Licensure Compact
States cover store and forward services
States cover remote patient monitoring
States reimburse a transmission/facility fee
Jurisdictions require informed consent
43
Medicaid Managed CareFederal regulations have
overhauled Medicaid managed care requirements
States required to develop and make publicly available time and
distance network adequacy standards for primary care and several specialties, behavioral
health, dental care, hospital care
Includes factors states should consider in setting standards,
including the use of telemedicine, e‐visits, and/or other evolving and innovative technological
solutions
44
Coverage and Reimbursement – Private PayersMany leading private insurers provide coverage and reimbursement for
telemedicine services, although these policies vary
• Private pay “pioneers” include:• Blue Cross Blue Shield• CIGNA• United Healthcare
A growing number of states (about 30 states and DC) have or are in the process of
enacting so‐called “parity” laws
• Generally require health insurers to cover and provide reimbursement for services provided via telemedicine “in a comparable manner” to how the payer would for the same services provided in person
• Over 30 states and counting (e.g., CA, GA, HI, MD, MI, OR, VA)
45
Reimbursement Considerations
46
Review Contracts with Payers
Do the agreements contain any telemedicine specific rates and/or dictate which codes should be used to bill telemedicine?
Does the payer have a telemedicine coverage policy, such as for primary care services?
If telemedicine services are not covered, does the payer contract contain any patient notice requirements that must be met before charging patients cash?
47
Review Contracts with Payers
When setting a self‐pay cash rate, did you make sure you are not setting your usual
and customary rate too low?
What do payer parity laws really achieve for your
program?
48
Other Considerations• Selling your services to large employers who will include it as an employee benefit
• Selling services to other payers such as TRICARE• Second opinions• Clinical trials
Consider other reimbursement arrangements
• How will you make sure telemedicine services are billed using the codes the payers want?
• How will you provide self‐pay patients with any required notifications?
Program your systems to appropriately bill for telemedicine
services
49