31
Telehealth – Core Legal Requirements (including current COVID 19 flexibilities) Emily H. Wein, Of Counsel Foley & Lardner LLP May 2020
Telehealth –Core Legal Requirements(including current COVID 19 flexibilities)
Emily H. Wein, Of Counsel
Foley & Lardner LLP
May 2020
Medicare Telehealth Coverage –The Perfect Storm
1
DISTANT SITE PROVIDER
ORIGINATINGSITE
COVERED SERVICES (CCPT
CODE)
GEOGRAPHIC LOCATIONS
PROPER TECHNOLOGY PLATFORM
Medicare Telehealth Reimbursement
2
GEOGRAPHIC LOCATIONS
Telehealth Medicare Coverage/Payment
Geographic Location– Originating site (where the patient is) must be in either:
A rural Health Professional Shortage Area (HPSA) in a rural census tract; or
A county outside of a Metropolitan Statistical Area (MSA)
– Entities participating in a federal telehealth demonstration project qualify regardless of location
– U.S. Health Resources and Services Administration (HRSA) makes geographic designations
– Location analyzer
– https://data.hrsa.gov/tools/medicare/telehealth
During COVID 19 PHE: Patient geographic location requirements do not apply.
3
Medicare Telehealth Reimbursement
4
GEOGRAPHIC LOCATIONS
ORIGINATINGSITE
Medicare – Originating Site Location of the Patient (Originating Site)
– Physician/practitioner office
– Hospitals
– Critical Access Hospitals
– Rural Health Clinics
– Federally Qualified Health Centers
– Hospital-based or CAH-based Renal Dialysis Centers (including satellites)
– Skilled Nursing Facilities
– Community Mental Health Centers
5
Medicare – Originating Site
Recent Changes (pre COVID 19)
Renal Dialysis Facilities (Jan. 2019) *
Homes of beneficiaries with ESRD receiving home dialysis or SUD and/or co-occurring mental health issues (Jul. 2019)*
Mobile Stroke Unit (Jan. 2019)*
• Geographic limitations do not apply to the above
• During COVID 19 PHE: Originating site requirements do not apply
6
Medicare Telehealth Reimbursement
7
DISTANT SITE PROVIDER
ORIGINATINGSITE
GEOGRAPHIC LOCATIONS
Medicare Distant Site Practitioner Physicians
Nurse practitioners
Physician assistants
Nurse-midwives
Clinical nurse specialists
Certified registered nurse anesthetists
Clinical psychologists
Clinical social workers
Registered dietitians or nutrition professionals* Check for conflicts under state law, e.g., Medicaid
During COVID 19 PHE: All Medicare billing providers are eligible
8
Medicare Telehealth Reimbursement
9
DISTANT SITE PROVIDER
ORIGINATINGSITE
GEOGRAPHIC LOCATIONS
PROPER TECHNOLOGY PLATFORM
Telehealth Medicare Technology
Must be “synchronous.” Communication must be live interactive audio and video connection that allows for “real time” communication
No coverage for “asynchronous” or “store and forward” technology outside of federal demonstration program
During COVID 19 PHE: Clarification that phones with audio and video capabilities may be used. More recently audio-only services have been classified as telehealth.
10
Medicare Telehealth Reimbursement –The Perfect Storm
11
DISTANT SITE PROVIDER
ORIGINATINGSITE
COVERED SERVICES (CCPT
CODE)
GEOGRAPHIC LOCATIONS
PROPER TECHNOLOGY PLATFORM
Medicare Telehealth Covered Services
Published each year by November 1 in final Physician Fee Schedule List available here:
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes Additional codes may be requested and added Category 1 requests. Granted if similar to the
types of telehealth services already covered Category 2 requests. Granted if not similar to the
currently approved telehealth services; code is accurate and use of telehealth provides a demonstrated benefit – evidence required
12
Medicare Telehealth Covered Services
COVID 19 1135 Waivers - For duration of PHE – Numerous additional services added to the
approved list – Frequency limits lifted in hospital, SNF and ESRD
settings– Certain face to face (in-person) services
permitted via telehealth– FQHC and RHC services as distant sites– Audio-only services now on telehealth services– Process to add new codes is expedited– Will it stick?
13
Medicare Telehealth Payment
Telehealth Payment
– Originating site receives a facility fee, approximately $25 but can vary based on facility type; Code Q3014
– Distant site practitioner receives PFS rate; Place of Service Code 02
– CAH billing under Method II and billing for reassigned distant site claims, use GT modifier
– GQ modifier used in demonstration programs.
During COVID: Hospitals can bill for originating site when patient is at home if they are serving as provider based location (HWW)
14
Trend of “Technology-Based” Services
CMS: Innately not face-to-face = not “telehealth”
Virtual Check-In (HCPCS G2012)– Established patients
– No E/M in prior 7 days or subsequent24 hours/ “soonest available”
– 5-10 minutes of discussion
Remote Evaluation of Pre-Recorded Data(HCPCS G2010)– Established patient recorded images or videos
– Interpretation and follow-up in 24 hours
– No E/M in prior 7 days or subsequent 24 hours/ “soonest available”
15
Technology – Based Services
Inter-professional Consultations– 6 Codes 4 recently unbundled (99446, 99447,
99448, 99449)
2 new (99451, 99452)
– 5 for consultative physician;1 for treating or requesting physician/QHP
– Telephone, internet, EHR assessment/management
– Verbal and/or written reports required
– Consent required
16
Remote Patient Monitoring
17
18
InterventionRPM Data Co-Pay
review/interpretation, modify care plan as
necessary
RPM Codes
Effective January 1, 2019
Two Practice Expense Codes– CPT 99453: “Remote monitoring of physiologic
parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment.”
– CPT 99454: “Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days.”
19
RPM Codes (continued)
Monitoring Codes– CPT 99457: “Remote physiologic monitoring treatment
management services clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; initial 20 minutes
– CPT 99458: “Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; additional 20 minutes Effective January 1, 2020
20
Remote Patient Monitoring
Certain detailed requirements:– Consent
– Minimum of 16 days
– Co-pay applies
– Device meets FDA definition
Clinical staff allowed:– 2020 CMS clarified “general”
supervision” permitted
21
Medicare Expansion of Digital Health
During COVID19 PHE:– RPM – clarification that it is available for existing and
new patients – Consent need only be obtained annually– At least 2 days of monitoring is required not 16 days– Direct supervision may be provided via interactive
telecommunications– More practitioners can provide Communication
Technology Based Services (CTBS) (e.g., social workers, psychologists, PTs, OTs and SLPTs)
– Will it stick?
22
Medicaid Basics
More flexibility than Medicare
May include limiting factors or not:
– Modality
– Covered services
– Originating Site (sometimes the homes count)
– Distant Site Providers
https://www.cchpca.org/
23
Commercial Insurance
Commercial Payor Rules– What are the restrictions? Location Service Provider
Most states have parity laws– Note: Coverage Parity is not the same as Payment
Parity– Each parity law must be reviewed closely to determine if a
business model is lucrative or a loss leader RPM often specifically covered otherwise it would not be
covered by parity statute
24
Telemedicine and Licensing
Physician offering care via telemedicine is subject to licensure rules of the state in which the patient is physically located at the time of the consult
State law expressly or implicitly requires licensure if the patient is located in the state at the time of the consult
Common exceptions: consultations, border states, follow-up care, intermittent practice
Growth of Interstate Licensing Compacts
26* Questions regarding the current status and extent of these states’ and boards’ participation in the IMLC should be directed to the respective state boards.
State License Waivers – COVID19
49 States plus Guam, Puerto Rico and CNMI have waived licensure requirements to facilitate the provision of telehealth
http://www.fsmb.org/siteassets/advocacy/pdf/states-waiving-licensure-requirements-for-telehealth-in-response-to-covid-19.pdf
Will it stick?
27
State Practice Law Compliance
Fee splitting
Proper physician-patient relationship
Corporate practice of medicine
Prudent marketing practices
Legitimate medically necessary services
Adherence to state practice
(telehealth) standards
28
Fraud and Abuse 2018 OIG Report
– 100 Claims without both originating and distant site claims
– 31% error rate
– Non-compliance with the “perfect storm”
– Fraud? Lack of education? Lack of clarity on rules?
AKS and Stark compliance in all financial arrangements, e.g., compensation, ownership
Increase in utilization will likely result in increased audits/scrutiny
During COVID19 PHE: OIG not enforcing waivers of cost-sharing for telehealth and other digital/remote services
29
ATTORNEY ADVERTISEMENT. The contents of this document, current at the date of publication, are for reference purposes only and do not constitute legal advice. Where previous cases are included, prior results do not guarantee a similar outcome. Images of people may not be Foley personnel.© 2019 Foley & Lardner LLP
Thank you!Emily H. Wein, Of Counsel
Foley & Lardner LLP
Washington Harbour
3000 K Street, N.W.
Suite 600
Washington, D.C. 20007-5109
