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Pillsbury Winthrop Shaw Pittman LLP
Legal Developments for Telehealth
Amid COVID-19, April, 2020
Allen Briskin
Senior Counsel
Pillsbury Winthrop Shaw Pittman LLP
Los Angeles, California
Overview
▪ Temporary expansions of coverage for telehealth, and relaxed
enforcement of related requirements for
� Medicare
� Medicaid (Medi-Cal)
� Health Plans and Insurers
� Self-Funded ERISA Plans
▪ Temporary relaxations of federal anti-fraud, waste, and abuse rules
relating to cost-sharing for telehealth
▪ Temporary relaxation of rules regarding practice across state lines
▪ Additional opportunities from Federal funding
▪ Temporary relaxation of certain HIPAA requirements for telehealth
▪ Challenges and opportunities after the emergency ends
1 | Legal Developments for Telehealth Amid COVID-19, April 2020
Changes to Medicare Coverage - Policy
▪ CMS March 17, 2020 statement describes an “urgency to expand the
use of technology to help people who need routine care, and keep
vulnerable beneficiaries and beneficiaries with mild symptoms in their
homes while maintaining access to the care they need. . . . It is
imperative during this public health emergency that patients avoid
travel, when possible, to physicians’ offices, hospitals, and other
health care facilities where they could risk their own or others’
exposure to further illness.”
▪ Some changes to rules; other changes to enforcement choices.
▪ All are described as temporary, but does that make sense for all?
2 | Legal Developments for Telehealth Amid COVID-19, April 2020
Changes to Medicare Coverage - 1
▪ Medicare will pay for professional office, hospital, and other visits
furnished via telehealth, including services provided to a patient who
is in any health care facility or at home
▪ Require use of interactive audio and video telecommunications
system that permits real-time communication between the distant site
and the patient (at home or elsewhere)
▪ Telehealth visits are considered for purposes of payment the same as
in-person visits and shall be paid at the same rate as in-person visits.
▪ Expanded coverage not limited to COVID-19 testing, diagnosis, or
treatment
▪ Expanded coverage applies in addition to existing coverage for virtual
check-ins and e-visits
3 | Legal Developments in Telehealth Amid COVID-19, April 2020
Changes to Medicare Coverage - 2
▪ Services may be provided by physicians, nurse practitioners,
physician assistants, nurse midwives, certified nurse anesthetists,
clinical psychologists, clinical social workers, registered dietitians, and
nutrition professionals
▪ Requirement that telehealth patient have a prior established
relationship with the practitioner remains, but HHS will not conduct
audits to ensure that such a relationship existed for Medicare claims
submitted during the current public health emergency
▪ Medicare coinsurance and deductibles still apply, and routine waivers
of cost-sharing remains generally prohibited under rules regarding
fraud, waste, and abuse, but Office of Inspector General will exercise
enforcement discretion for providers who reduce or waive cost-
sharing for telehealth visits, but . . . .
4 | Legal Developments for Telehealth Amid COVID-19, April 2020
Changes to Medicare Coverage - 3
▪ That flexibility does not extend to virtual check-ins and e-visits
▪ Changes took effect as of March 6, 2020, and are to remain in effect
through the end of the Public Health Emergency declared by the
Secretary of HHS on January 30, 2020 (“COVID-19 Public Health
Emergency”)
▪ Common telehealth services will include
� 99201-99215 (Office and other outpatient visits)
� G0425-G0427 (Telehealth consultations, emergency department or initial
treatment)
� G0406-G0408 (Follow-up inpatient telehealth consultations furnished to
beneficiaries in hospitals or SNFs)
▪ Complete list: https://www.cms.gov/Medicare/Medicare-General-
Information/Telehealth/Telehealth-Codes
5 | Legal Developments for Telehealth Amid COVID-19, April 2020
Changes to Medicare Coverage - 4
▪ On April 9, 2020, CMS announced temporary suspension of a number
of supervision, licensure, and certification requirements that permit
doctors to directly care for patients in specified settings through
telehealth (i.e., via telephone, radio, or online communication) across
state lines (e.g., without being licensed in the state in which the
patient is located)
▪ Flexibility is limited to settings such as critical access hospitals, rural
health clinics, federally qualified health centers, skilled nursing
facilities, home health agencies, and hospice.
▪ This is part of a relaxation of a number of rules that do not affect
telehealth, and still must be reconciled with state regulation of
interstate practice
6 | Legal Developments for Telehealth Amid COVID-19, April 2020
Changes to Medicaid Coverage - 1
▪ Each state Medicaid program may expand its coverage for services
provided through telehealth
▪ CMS announced that states wishing to expand telehealth need not file
an amendment to their State Medicaid Plans to do so
▪ California Department of Health Care Services announced on March
24, 2020 that the general rule is that services provided by telehealth
will be payable, if properly coded, if the treating health care
practitioner at the distant site believes that the Medi-Cal benefits or
services being provided are clinically appropriate based upon
evidence-based medicine and/or best practices to be delivered via
telehealth, subject to oral or written consent by the beneficiary.
7 | Legal Developments for Telehealth Amid COVID-19, April 2020
Changes to Medicaid Coverage - 2
▪ What’s not OK:
� Benefits or services that are performed in an operating room or
while the patient is under anesthesia
� Benefits or services that require direct visualization or
instrumentation of bodily structures
� Benefits or services that involve sampling of tissue or
insertion/removal of medical devices
� Benefits or services that otherwise require the in-person presence
of the patient for any reason
8 | Legal Developments for Telehealth Amid COVID-19, April 2020
Changes to Medicaid Coverage - 3
▪ General Rule: Unless otherwise agreed to by the Managed Care
Plans (“MCP”) and provider, DHCS and MCPs must reimburse Medi-
Cal providers at the same rate, whether a service is provided in-
person or through telehealth, if the service is the same regardless of
the modality of delivery, as determined by the provider’s description of
the service on the claim. DHCS and MCPs must provide the same
amount of reimbursement for a service rendered via telephone or
virtual communication, as they would if the service is rendered via
video, provided the modality by which the service is rendered
(telephone versus video) is medically appropriate for the member
9 | Legal Developments for Telehealth Amid COVID-19, April 2020
Changes to Commercial Payment – California Health
Plans
▪ On April 7, 2020, California Department of Managed Health Care
expanded period order to all Knox-Keene plans to pay health care
providers the same rate, whether a service is provided in-person or
through telehealth, “if the service is the same regardless of the
modality of delivery, as determined by the provider’s description of the
service on the claim.”
▪ Note limit upon plan’s ability to re-classify the service
▪ Services provided by telehealth may not have higher cost-sharing
than services provided in-person
▪ Payment is to be the same for service provided by telephone as if
provided by video, if the modality used is medically appropriate
▪ Applies to all services, not only those related to testing, diagnosis, or
treatment of COVID-19
10 | Legal Developments for Telehealth Amid COVID-19, April 2020
Changes to Commercial Payment – California
Insurance
▪ On March 30, 2020, California Department of Insurance ordered
insurers to provide increased access to medically necessary health
care without requiring patients to visit providers in person, when
clinically appropriate
▪ Not limited to COVID-19 related services
▪ All network providers should be allowed to use “all available and
appropriate modes of telehealth delivery.”
▪ Payment rates are to “mirror” payment rates for equivalent office visit.
▪ DOI calls upon insurers to encourage telehealth, i.e., “Telehealth
services delivered by in-network providers should replace in-person
visits whenever possible and clinically appropriate.”
11 | Legal Developments for Telehealth Amid COVID-19, April 2020
Changes to Commercial Payment – Self-Funded
Plans
▪ No regulatory framework equivalent to state regulation of health plans
and insurance
▪ Therefore, a narrower approach
▪ Families First Coronavirus Response Act requires all employer-
sponsored health plans (commonly referred to as “ERISA plans”) to
cover all costs for diagnostic testing services related to COVID-19,
including but not limited to telehealth services
▪ “All costs” means no cost-sharing, but the reach of this rule is
narrower
▪ “All costs” does not include costs of treatment for COVID-19 related
conditions
▪ Does not apply to non-COVID-19 related services
12 | Legal Developments for Telehealth Amid COVID-19, April 2020
Additional Opportunities – CARES Act
Reimbursement
▪ The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act
appropriates $100 billion to the “Public Health and Social Services
Emergency Fund” to reimburse “eligible health care providers” for
COVID-19 related health care expenses and lost revenues
▪ Secretary of HHS has broad discretion
▪ Funds are not to be used to reimburse expenses or losses that have
been or are eligible for reimbursement by other sources (e.g.,
Medicare payments)
▪ First $30 billion took form of distributions to hospitals based upon prior
Medicare payments; consider all those left out
▪ Consider developing case for reimbursement of unusual expense
associated with developing and implementing telehealth capacity
13 | Legal Developments for Telehealth Amid COVID-19, April 2020
Additional Opportunities – FCC Telehealth Program
▪ The CARES Act also appropriated $200 million to the COVID-19
Telehealth Program, under which health care providers may apply for
funding to pay for:
� Telecommunications services and broadband connectivity services
� Information services, i.e., remote patient monitoring platforms, store & forward
systems, platforms and services for synchronous video consultation
� Internet connected devices & equipment
▪ Program requires registration with Federal Communications
Commission
▪ Limited eligibility pool includes post-secondary educational institutions
offering health care instruction, teaching hospitals, and medical
schools; local government agencies; community health centers;
nonprofit hospitals, rural health clinics, and skilled nursing facilities
14 | Legal Developments for Telehealth Amid COVID-19, April 2020
HIPAA Enforcement Discretion - 1
▪ HHS Office of Civil Rights will exercise enforcement discretion not to
impose penalties for HIPAA violations against health care providers in
connection with good faith provision of communications technologies
that do not fully comply with the HIPAA Security Rule
▪ HIPAA Security Rule generally requires covered entities to provide
secure means of electronic transmission
▪ Under temporary rules, health care providers may use any “non-public
facing remote [audio or video] communication product that is available
to communicate with patients.”
▪ Applies to all communications, not only those related to the testing,
diagnosis, or treatment of conditions related to COVID-19.
15 | Legal Developments for Telehealth Amid COVID-19, April 2020
HIPAA Enforcement Discretion - 2
▪ What’s OK, i.e., non-public facing: Apple FaceTime, Facebook
Messenger video chat, Google Hangouts video, Zoom, or Skype
▪ What’s NOT OK, i.e., public facing: Facebook Live, Twitch, TikTok, or
similar
▪ Providers are nevertheless encouraged to seek telecommunications
technology vendors that do comply with HIPAA, i.e., can enter into a
business associate agreement (“BAA”)
▪ OCR will not seek penalties against covered entities that do not obtain
BAAs with vendors consistent with this guidance
▪ Changes took effect when announced on March 20, 2020 and are to
remain in effect thorough the end of the COVID-19 Public Health
Emergency
16 | Legal Developments for Telehealth Amid COVID-19, April 2020
Challenges and Opportunities After the Emergency
Ends
▪ By their terms, most regulatory and enforcement changes will end
with the end of the COVID-19 Public Health Emergency
▪ Which of these changes will demonstrate the case for lasting
changes?
� Showing the convenience and efficacy of telehealth
� Addressing continuing needs emphasized during the emergency
� Acting to improve access and address inequalities
▪ Good candidates for extension should include payment rules, and
perhaps rules limiting practice across state lines
▪ Less persuasive candidates include relaxation of HIPAA security
requirements and continuing federal grants and/or subsidies
▪ Rate parity and cost-sharing waivers present significant political &
policy issues
17 | Legal Developments for Telehealth Amid COVID-19, April 2020
18 | I Legal Developments for Telehealth Amid COVID-19, April 2020 e
The purpose of this presentation is to inform and comment
upon recent developments in health law. It is not intended,
nor should it be used, as a substitute for specific legal
advice – legal counsel may only be given in response to
inquiries regarding particular situations.
19 | Legal Developments for Telehealth Amid COVID-19, April 2020
e
Wrap Up and Questions
20 | Legal Developments for Telehealth Amid COVID-19, April 2020
THANK YOU
Allen Briskin
Pillsbury Winthrop Shaw Pittman LLP
725 South Figueroa Street, Suite 2800
Los Angeles, CA 90017
allen.briskin@pillsburylaw.com
© 2020, Pillsbury Winthrop Shaw Pittman LLP

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Legal developments for telehealth amid covid 19

  • 1. Pillsbury Winthrop Shaw Pittman LLP Legal Developments for Telehealth Amid COVID-19, April, 2020 Allen Briskin Senior Counsel Pillsbury Winthrop Shaw Pittman LLP Los Angeles, California
  • 2. Overview ▪ Temporary expansions of coverage for telehealth, and relaxed enforcement of related requirements for � Medicare � Medicaid (Medi-Cal) � Health Plans and Insurers � Self-Funded ERISA Plans ▪ Temporary relaxations of federal anti-fraud, waste, and abuse rules relating to cost-sharing for telehealth ▪ Temporary relaxation of rules regarding practice across state lines ▪ Additional opportunities from Federal funding ▪ Temporary relaxation of certain HIPAA requirements for telehealth ▪ Challenges and opportunities after the emergency ends 1 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 3. Changes to Medicare Coverage - Policy ▪ CMS March 17, 2020 statement describes an “urgency to expand the use of technology to help people who need routine care, and keep vulnerable beneficiaries and beneficiaries with mild symptoms in their homes while maintaining access to the care they need. . . . It is imperative during this public health emergency that patients avoid travel, when possible, to physicians’ offices, hospitals, and other health care facilities where they could risk their own or others’ exposure to further illness.” ▪ Some changes to rules; other changes to enforcement choices. ▪ All are described as temporary, but does that make sense for all? 2 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 4. Changes to Medicare Coverage - 1 ▪ Medicare will pay for professional office, hospital, and other visits furnished via telehealth, including services provided to a patient who is in any health care facility or at home ▪ Require use of interactive audio and video telecommunications system that permits real-time communication between the distant site and the patient (at home or elsewhere) ▪ Telehealth visits are considered for purposes of payment the same as in-person visits and shall be paid at the same rate as in-person visits. ▪ Expanded coverage not limited to COVID-19 testing, diagnosis, or treatment ▪ Expanded coverage applies in addition to existing coverage for virtual check-ins and e-visits 3 | Legal Developments in Telehealth Amid COVID-19, April 2020
  • 5. Changes to Medicare Coverage - 2 ▪ Services may be provided by physicians, nurse practitioners, physician assistants, nurse midwives, certified nurse anesthetists, clinical psychologists, clinical social workers, registered dietitians, and nutrition professionals ▪ Requirement that telehealth patient have a prior established relationship with the practitioner remains, but HHS will not conduct audits to ensure that such a relationship existed for Medicare claims submitted during the current public health emergency ▪ Medicare coinsurance and deductibles still apply, and routine waivers of cost-sharing remains generally prohibited under rules regarding fraud, waste, and abuse, but Office of Inspector General will exercise enforcement discretion for providers who reduce or waive cost- sharing for telehealth visits, but . . . . 4 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 6. Changes to Medicare Coverage - 3 ▪ That flexibility does not extend to virtual check-ins and e-visits ▪ Changes took effect as of March 6, 2020, and are to remain in effect through the end of the Public Health Emergency declared by the Secretary of HHS on January 30, 2020 (“COVID-19 Public Health Emergency”) ▪ Common telehealth services will include � 99201-99215 (Office and other outpatient visits) � G0425-G0427 (Telehealth consultations, emergency department or initial treatment) � G0406-G0408 (Follow-up inpatient telehealth consultations furnished to beneficiaries in hospitals or SNFs) ▪ Complete list: https://www.cms.gov/Medicare/Medicare-General- Information/Telehealth/Telehealth-Codes 5 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 7. Changes to Medicare Coverage - 4 ▪ On April 9, 2020, CMS announced temporary suspension of a number of supervision, licensure, and certification requirements that permit doctors to directly care for patients in specified settings through telehealth (i.e., via telephone, radio, or online communication) across state lines (e.g., without being licensed in the state in which the patient is located) ▪ Flexibility is limited to settings such as critical access hospitals, rural health clinics, federally qualified health centers, skilled nursing facilities, home health agencies, and hospice. ▪ This is part of a relaxation of a number of rules that do not affect telehealth, and still must be reconciled with state regulation of interstate practice 6 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 8. Changes to Medicaid Coverage - 1 ▪ Each state Medicaid program may expand its coverage for services provided through telehealth ▪ CMS announced that states wishing to expand telehealth need not file an amendment to their State Medicaid Plans to do so ▪ California Department of Health Care Services announced on March 24, 2020 that the general rule is that services provided by telehealth will be payable, if properly coded, if the treating health care practitioner at the distant site believes that the Medi-Cal benefits or services being provided are clinically appropriate based upon evidence-based medicine and/or best practices to be delivered via telehealth, subject to oral or written consent by the beneficiary. 7 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 9. Changes to Medicaid Coverage - 2 ▪ What’s not OK: � Benefits or services that are performed in an operating room or while the patient is under anesthesia � Benefits or services that require direct visualization or instrumentation of bodily structures � Benefits or services that involve sampling of tissue or insertion/removal of medical devices � Benefits or services that otherwise require the in-person presence of the patient for any reason 8 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 10. Changes to Medicaid Coverage - 3 ▪ General Rule: Unless otherwise agreed to by the Managed Care Plans (“MCP”) and provider, DHCS and MCPs must reimburse Medi- Cal providers at the same rate, whether a service is provided in- person or through telehealth, if the service is the same regardless of the modality of delivery, as determined by the provider’s description of the service on the claim. DHCS and MCPs must provide the same amount of reimbursement for a service rendered via telephone or virtual communication, as they would if the service is rendered via video, provided the modality by which the service is rendered (telephone versus video) is medically appropriate for the member 9 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 11. Changes to Commercial Payment – California Health Plans ▪ On April 7, 2020, California Department of Managed Health Care expanded period order to all Knox-Keene plans to pay health care providers the same rate, whether a service is provided in-person or through telehealth, “if the service is the same regardless of the modality of delivery, as determined by the provider’s description of the service on the claim.” ▪ Note limit upon plan’s ability to re-classify the service ▪ Services provided by telehealth may not have higher cost-sharing than services provided in-person ▪ Payment is to be the same for service provided by telephone as if provided by video, if the modality used is medically appropriate ▪ Applies to all services, not only those related to testing, diagnosis, or treatment of COVID-19 10 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 12. Changes to Commercial Payment – California Insurance ▪ On March 30, 2020, California Department of Insurance ordered insurers to provide increased access to medically necessary health care without requiring patients to visit providers in person, when clinically appropriate ▪ Not limited to COVID-19 related services ▪ All network providers should be allowed to use “all available and appropriate modes of telehealth delivery.” ▪ Payment rates are to “mirror” payment rates for equivalent office visit. ▪ DOI calls upon insurers to encourage telehealth, i.e., “Telehealth services delivered by in-network providers should replace in-person visits whenever possible and clinically appropriate.” 11 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 13. Changes to Commercial Payment – Self-Funded Plans ▪ No regulatory framework equivalent to state regulation of health plans and insurance ▪ Therefore, a narrower approach ▪ Families First Coronavirus Response Act requires all employer- sponsored health plans (commonly referred to as “ERISA plans”) to cover all costs for diagnostic testing services related to COVID-19, including but not limited to telehealth services ▪ “All costs” means no cost-sharing, but the reach of this rule is narrower ▪ “All costs” does not include costs of treatment for COVID-19 related conditions ▪ Does not apply to non-COVID-19 related services 12 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 14. Additional Opportunities – CARES Act Reimbursement ▪ The Coronavirus Aid, Relief, and Economic Security (“CARES”) Act appropriates $100 billion to the “Public Health and Social Services Emergency Fund” to reimburse “eligible health care providers” for COVID-19 related health care expenses and lost revenues ▪ Secretary of HHS has broad discretion ▪ Funds are not to be used to reimburse expenses or losses that have been or are eligible for reimbursement by other sources (e.g., Medicare payments) ▪ First $30 billion took form of distributions to hospitals based upon prior Medicare payments; consider all those left out ▪ Consider developing case for reimbursement of unusual expense associated with developing and implementing telehealth capacity 13 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 15. Additional Opportunities – FCC Telehealth Program ▪ The CARES Act also appropriated $200 million to the COVID-19 Telehealth Program, under which health care providers may apply for funding to pay for: � Telecommunications services and broadband connectivity services � Information services, i.e., remote patient monitoring platforms, store & forward systems, platforms and services for synchronous video consultation � Internet connected devices & equipment ▪ Program requires registration with Federal Communications Commission ▪ Limited eligibility pool includes post-secondary educational institutions offering health care instruction, teaching hospitals, and medical schools; local government agencies; community health centers; nonprofit hospitals, rural health clinics, and skilled nursing facilities 14 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 16. HIPAA Enforcement Discretion - 1 ▪ HHS Office of Civil Rights will exercise enforcement discretion not to impose penalties for HIPAA violations against health care providers in connection with good faith provision of communications technologies that do not fully comply with the HIPAA Security Rule ▪ HIPAA Security Rule generally requires covered entities to provide secure means of electronic transmission ▪ Under temporary rules, health care providers may use any “non-public facing remote [audio or video] communication product that is available to communicate with patients.” ▪ Applies to all communications, not only those related to the testing, diagnosis, or treatment of conditions related to COVID-19. 15 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 17. HIPAA Enforcement Discretion - 2 ▪ What’s OK, i.e., non-public facing: Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, Zoom, or Skype ▪ What’s NOT OK, i.e., public facing: Facebook Live, Twitch, TikTok, or similar ▪ Providers are nevertheless encouraged to seek telecommunications technology vendors that do comply with HIPAA, i.e., can enter into a business associate agreement (“BAA”) ▪ OCR will not seek penalties against covered entities that do not obtain BAAs with vendors consistent with this guidance ▪ Changes took effect when announced on March 20, 2020 and are to remain in effect thorough the end of the COVID-19 Public Health Emergency 16 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 18. Challenges and Opportunities After the Emergency Ends ▪ By their terms, most regulatory and enforcement changes will end with the end of the COVID-19 Public Health Emergency ▪ Which of these changes will demonstrate the case for lasting changes? � Showing the convenience and efficacy of telehealth � Addressing continuing needs emphasized during the emergency � Acting to improve access and address inequalities ▪ Good candidates for extension should include payment rules, and perhaps rules limiting practice across state lines ▪ Less persuasive candidates include relaxation of HIPAA security requirements and continuing federal grants and/or subsidies ▪ Rate parity and cost-sharing waivers present significant political & policy issues 17 | Legal Developments for Telehealth Amid COVID-19, April 2020
  • 19. 18 | I Legal Developments for Telehealth Amid COVID-19, April 2020 e The purpose of this presentation is to inform and comment upon recent developments in health law. It is not intended, nor should it be used, as a substitute for specific legal advice – legal counsel may only be given in response to inquiries regarding particular situations.
  • 20. 19 | Legal Developments for Telehealth Amid COVID-19, April 2020 e Wrap Up and Questions
  • 21. 20 | Legal Developments for Telehealth Amid COVID-19, April 2020 THANK YOU Allen Briskin Pillsbury Winthrop Shaw Pittman LLP 725 South Figueroa Street, Suite 2800 Los Angeles, CA 90017 allen.briskin@pillsburylaw.com © 2020, Pillsbury Winthrop Shaw Pittman LLP