Telehealth Secrets 2019: Consumer initiated health care business models - Charles Dunham, JD, Greenberg Traurig, LLP

1. VSee Telehealth Secrets
Annual Conference 2019
Legal Panel Discussion
OCTOBER 02, 2019 www.gtlaw.com
Charles C. Dunham | duhamc@gtlaw.com | +1 713.374.3555

2. Government
Driving Change
2

3. © 2019 Greenberg Traurig, LLP
• “Over several decades, government has concocted a complex
system of rules – a time-sucking morass that has
contributed to obscene administrative costs and stifled
innovation and competition.”
• “Our administration is upending the status quo to empower
patients to be informed consumers of healthcare, seeking
out high value providers…those that deliver the highest
quality of care at the lowest price.”
CMS Administrator Seema Verma at AHA (09/10/2019)
3
“Patients Over Paperwork”

4. © 2019 Greenberg Traurig, LLP
Medicare Telehealth
Waivers and Carveouts
 Congressional Program Expansion
 CHRONIC Care Act
 Bipartisan Budget Act of 2018: End Stage Renal Disease and Acute Stroke
 Opioid Crisis Response Act (Substance Abuse – At Home)
 CMS Telehealth Waivers and Demonstration Projects
 Chronic Care management
 Tele-Stroke and Tele-Behavior programs
 Substance Abuse
 Telecommunication Technology-Based Services (not “Telehealth Services”)
 Virtual Check-In (E/M Services) codes
 Remote Patient Monitoring (RPM) codes
 Value-Based Care
 Medicare Shared Savings Program (Next Generation ACOs)
 Medicare Advantage Plans

5. © 2019 Greenberg Traurig, LLP
Medicare Advantage (MA) Plans
 Basic Benefits Package (subject to section 1834(m)
limitations)
 Medicare Expansion of Basic Benefits –
Additional Telehealth Services
 MA Supplemental Benefits

6. © 2019 Greenberg Traurig, LLP
MA Plan Benefits
Additional Telehealth Services
(1) services for which benefits are available under
Medicare Part B, but are not payable under
section 1834(m) of the Act,
(2) and services that have been identified for the
applicable year as clinically appropriate to be
furnished through telehealth
E.g. primary care visits, routine and/or specialty
consultations, dermatological examinations

7. © 2019 Greenberg Traurig, LLP
MA Plan Benefits
Coverage Requirements
 Must be delivered by network providers
 Beneficiary’s right of choice to receive in-person visit or
through electronic exchange
Determination of “clinically appropriate” in advance
Notice to beneficiaries in advance

8. FRAUD AND ABUSE
8

9. © 2019 Greenberg Traurig, LLP
• Advisory Opinions (99-14, 04-07 and 11-12)
• Advisory Opinion No. 19-02 (2019) OIG approved a
pharmaceutical manufacturer’s proposal to loan a limited-
functionality smartphone to financially needy patients who
do not have the technology necessary to receive adherence
data from a sensor embedded in their prescribed
antipsychotic medication
• Advisory Opinion No. 18-03 (2018) OIG allowed a
private health care center to equip a county clinic with IT-
related equipment and services to facilitate Telemedicine
encounters for HIV prevention that directly results in a
service performed by donor payable by FHCP
9
OIG Advisory Opinions
Telehealth Arrangements

10. © 2019 Greenberg Traurig, LLP 10
OIG Advisory Opinions
Telehealth Arrangements
Referral between originating
and distant site providers
Provision of free telehealth
technology and equipment;
but donor retains ownership
Increased access to
treatment with no
increased cost to FHCPs
Prioritize “health benefit”
to the community
Some common
themes . . .

11. © 2019 Greenberg Traurig, LLP
• “OPERATION BRACE YOURSELF” – DOJ Investigation
• “One of the Largest Medicare Fraud Schemes in History”
• $1.2 Billion Fraud Scheme -- DME/Pharma
• International Shell Companies
• DOJ Prosecutions:
• Owner Of Telemarketing Company Plead Guilty To Conspiracy
Charges to Defraud and Launder Money -- $200 Million
Restitution
• “Four Men and Seven Companies Indicted” (EDTN)
• “Tampa Resident Sentenced to 20 Years” (SDFL)
Telemedicine doctors providing the
keys to unlock the doors
11
Headline News

12. © 2019 Greenberg Traurig, LLP
• OIG Fraud Alerts:
• Genetic Testing Scam -- Solicitation of Medicare
Beneficiaries Telemarketing Calls, Public Events, Health
Fairs, Nursing Homes and Door-to-Door Canvassing
• “Operation Double Helix” – DOJ Investigation
• “One of the Largest Medicare Fraud Schemes in History”
• $2.1 Billion Fraud Scheme – Genetic Testing
• International Shell Companies
• Closely Held Laboratories Across the Country
12
Fraud and Abuse