ACC Health Law Committee Webcast. Telemedicine and TeleHealth: Who s Doing What; What You Should Know. Alan Einhorn, Esq. Foley & Lardner, LLP

Transcription

1 ACC Health Law Committee Webcast Telemedicine and TeleHealth: Who s Doing What; What You Should Know. Alan Einhorn, Esq. Foley & Lardner, LLP Keith L. Henderson, Esq. Chief Compliance Officer Morehouse School of Medicine May 9, 2018

2 Telemedicine Overview What is Telehealth & Telemedicine Telehealth Reimbursement Telehealth Business Models Legal Considerations

3 What is Telehealth? A collec'on of means or methods for enhancing health care, public health, and health educa'on delivery and support using telecommunica'ons technologies

4 State vs Federal Defini4ons Federal Law Health Resources and Services Administra5on (HRSA) defines telehealth as: The use of electronic informa'on and telecommunica'ons technologies to support long-distance clinical health care, pa'ent and professional healthrelated educa'on, public health and health administra'on. California law defines telehealth as: The mode of delivering health care services and public health via informa'on and communica'on technologies to facilitate the diagnosis, consulta'on, treatment, educa'on, care management, and self-management of a pa'ent's health care while the pa'ent is at the origina'ng site and the health care provider is at a distant site. Telehealth facilitates pa'ent selfmanagement and caregiver support for pa'ents and includes synchronous interac'ons and asynchronous store and forward transfers.

5 Challenges to Implemen4ng Telemedicine Source: 2017 Telemedicine and Digital Health Survey Foley & Larder, LLP

6 Modali4es of Telehealth Real-'me Live Video Synchronous Remote Pa'ent Monitoring Modali'es mhealth Store and Forward Asynchronous

7 Trends in Modali4es Real-Time Video - 48 states and District of Columbia allow for Medicaid reimbursement Asynchronous Store-and-Forward 15 states allow for Medicaid reimbursement Remote Pa:ent Monitoring 21 states allow for Medicaid reimbursement 9 states allow for Real-Time Video, Store and Forward, and Remote Pa:ent Monitoring (AK, AZ, IL,MN,MI,MO,OK,VA & WA)

8 Medicaid Reimbursement Requirements Under Medicaid states implementa'on of Telemedicine varies by state. Providers must meet federal requirements under the federal law but also understand the specific state law provisions that govern Telehealth/Telemedicine 8

9 Medicaid Reimbursement Factors Telemedicine qualifying reimbursement considera'ons under Medicaid: Health Services covered Eligible providers (NPs, PAs) Is cross-state medical licensing allowed? Is a pre-exis'ng rela'onship with pa'ent required? Loca'on restric'ons on pa'ent or provider Applicable CPT codes Type of fee reimbursed (transmission, facility, or both)

10 State Telehealth Laws - Medicaid Source: Center for Connected Health Policy (2017)

11 Medicare Telehealth Reimbursement Reqs. Defining the Origina4ng and Distant Sites. Medicare reimburses for telehealth services offered by a healthcare provider at a distant site, to a Medicare beneficiary (the pa'ent) at an Origina'ng Site. The origina'ng site must be in a HPSA (Health Professional Shortage Area). In order to be eligible for Medicare reimbursement, the pa'ent (Medicare beneficiary) needs to be receiving virtual care at 1 of 8 clinical seengs, namely: Physicians or prac''oner offices Hospitals Cri'cal Access Hospitals (CAH) Rural Health Clinics Federally Qualified Health Centers Hospital-based or CAH-based Renal Dialysis Centers (Not Independent Renal Dialysis Facili5es) Skilled Nursing Facili'es (SNF) Community Mental Health Centers (CMHC).

12 Medicare Telehealth Reimbursement Reqs. Facility Fees. In addi'on to reimbursement for the telemedicine service, Medicare will pay the origina'ng site a facility fee. For example, if you re a primary care provider with a pa'ent in your office and you do a telemedicine visit to consult a physician in another loca'on, you could bill for two separate things the telemedicine service, and a facility fee for using your prac'ce to host of the pa'ent visit. Eligible Providers. Under Medicare, the following healthcare providers can use telemedicine: Physicians Nurse Prac''oners Physician Assistants Nurse Midwives Clinical nurse specialists Clinical Psychologists Clinical Social Workers Registered die''ans or nutri'on professionals 12

13 Medicare Telehealth Reimbursement Reqs. Modality Provider must use an interac've audio and video system that ensures real-'me live communica'on with provider, the distant site and the beneficiary. CPT/HCPCS. (Current Procedural Terminology/ Healthcare Common Procedure Coding Systems) is listed as a covered telehealth service. 13

14 Top Telemedicine Special4es A few of the most popular telemedicine special'es are: Radiology offer providers at one loca'on to send a pa'ent s x-rays and records securely to a qualified radiologist at another loca'on, and get a quick consult on the pa'ent s condi'on. Psychiatry allows qualified psychiatrists to provide treatment to pa'ents remotely, expanding access to behavioral health services. Dermatology solu'on are usually store-and-forward technologies that allow a general healthcare provider to send a pa'ent photo of a rash, a mole, or another skin anomaly, for remote diagnosis. As frontline providers of care, primary care prac''oners are oken the first medical professionals to spot a poten'al problem. It allows PCPs con'nue to coordinate a pa'ent s care, and offer a quick answer on whether further examina'on is needed from a dermatologist. Ophthalmology solu'ons allow ophthalmologists to examine pa'ents eyes, or check-in about treatments from a distance. A common example is an ophthalmologist diagnosing and trea'ng an eye infec'on. These solu'ons are usually either live or store-and-forward telemedicine. Nephrology solu'ons are most commonly used interprofessionally, when a family physician needs to consult a nephrologist about a pa'ent with kidney disease. Obstetrics allow obstetricians to provide prenatal care from afar. This could mean, for example, recording a baby s heart at one loca'on and forwarding it to an obstetrician for diagnosis at another facility. Oncology provide more accessible and convenient care to pa'ents with cancer. Some solu'ons offer storeand-forward tools to forward images for diagnosis, others are live video plalorms to allow pa'ent consults with the oncologist. Pathology pathologists share pathology at a distance for diagnosis, research, and educa'on. Most telemedicine tools in this area are store-and-forward solu'ons, allowing pathologists to share and forward high-resolu'on images and videos. Rehabilita:on allow medical professionals to deliver rehab services (such as physical therapy) remotely.

15 Common Condi4ons Treated Allergies Arthri'c Pain Asthma Bronchi's Diabetes Hypertension Behavioral Health/ Mental Illness Insect Bites Sinusi's Conjunc'vi's Skin Inflamma'ons Celluli's Sore Throats Rashes Bladder Infec'ons UTIs Sprains & Strains 15

16 Restric4ons on Services Medicare reimburses generally for very specific health services provided via telemedicine, oken with strict requirements. Although, Medicare has expanded the list of reimbursable telemedicine services it s'll imposes many restric'ons on how the service is provided in order to be covered.

17 Revenue Cycle - Billing Only certain CPT and HCPCS codes are eligible for telemedicine reimbursement. Medicare has a specific list of CPT and HCPCS codes that are covered under telemedicine services. Be sure to check the CMS website for the most up-to-date codes. When billing, use the Place of Service POS 02 modifier. When billing for telemedicine visits, you need to include the POS O2 modifier with the relevant CPT code to indicate the service was provided virtually, except in Alaska and Hawaii where the GT or GQ modifier is required.

18 Private Payers Private payers con'nue to grow in allowing for reimbursement of some telehealth services but they are not consistent across payers as to what is covered and there are no federal requirements to provide coverage for telehealth services 36 states and DC have laws that affect telehealth reimbursement by private payer plans. (2017)

19 OIG Medicare Telehealth Project Health and Human Services, Office of the Inspector General (OIG), audit uncovered 31% of a sample claims did not meet Medicare reimbursement requirements. Audit revealed that 191,118 Medicare claims totaling $13.8 million did not have origina'ng site claims.

20 OIG Medicare Telehealth Project OIG will be reviewing Medicare claims paid for telehealth services provided at distant sites that do not have corresponding claims from origina'ng sites to determine whether those services met Medicare requirements. OIG will also determine whether states Medicaid payments for services delivered via telehealth were allowable. Telehealth services must have been delivered through a range of interac've video, audio or data transmissions. 20

21 New Telehealth Law Changes Bipar4san Budget Act of 2018 Key changes to the law under Medicare for telehealth include: (1) expanding stroke telemedicine coverage; (2019) (2) improving access to telehealth-enabled home dialysis oversight; (2019) (3) enabling pa'ents to be provided with free at-home telehealth dialysis technology without the provider viola'ng the Civil Monetary Penal'es Law; (2019) (4) allowing Medicare Advantage (MA) plans to include delivery of telehealth services in a plan s basic benefits; (2020) and (5) giving Accountable Care Organiza'ons (ACOs) the ability to expand the use of telehealth services to include pa'ent homes as an origina'ng site and eliminates rural restric'ons. (2020)

22 New Telehealth Law Expansion Cont d Medicare Advantage Plans are allowed to include Telehealth Services as a Basic Benefit Medicare Advantage plans will be allowed to offer addi'onal, clinically appropriate telehealth benefits in their annual bid amounts beyond the services that currently receive payment under Medicare Part B. The law provides MA plans the ability to offer telehealth services as part of their basic benefit package (i.e., as if the telehealth services were benefits under the original Medicare fee-for-service program op'on). The type of telemedicine service that qualifies as a basic benefit is s'll being defined with a comment period through November 18, 2018.

23 Reimbursement for Telemedicine Source: 2017 Telemedicine and Digital Health Survey Foley & Larder, LLP

24 OFFICE OF COMPLIANCE & CORPORATE INTEGRITY Keith L. Henderson, JD, LL.M. Chief Compliance Officer Morehouse School of Medicine Atlanta, Georgia May 9, 2018

25 Telemedicine Business Models 25

26 Institution to Institution One institution (and its providers) provides clinical care/assistance to the patients (or providers) of another institution E.g. Hospital to hospital specialty services consults and/or direct patient care Telestroke and E-ICU services Weekend and/or weeknight rounds Urgent care center services (including physician availability, oversight of advanced practice providers) Post-discharge services, including follow-up monitoring 26

27 Institution to Institution (cont d) Also includes, e.g., Acute hospital agreements with SNF s Psychiatric facilities Clinics and other ambulatory care providers For Consults Back-up coverage Patient care services 27

28 Institution to Institution (cont d) Components of Institution to Institution Arrangements Professional Services Agreement Services to be provided, including supervision requirements (as applicable) Fee/payment arrangements Duration and termination Credentialing Agreement (if Credentialing by Proxy) Technology and support Agreement Technology to be Provided or Utilized Responsibility for Integration Responsibility for maintenance and upgrades Fee/payment arrangements 28

29 Non-Institution Provider to Institution Provider or Provider Practice provides clinical and/or consult services to Institutional Provider and/or that Provider s patients E.g., Distant site telemedicine entity to hospital/hospital service line Teleradiology, teleneurology, telepsychiatry, other Distant site telemedicine entity, physician/provider practice, or provider to skilled nursing facilities, clinics, urgent care centers on a consulting or patient care basis Components of Non-Institution Provider to Institution arrangements Similar to institution to institution arrangements, particularly if the institution is a hospital 29

30 Clinician to Clinician Typically, a generalist to specialist arrangement, for specialty consultation services and/or clinical services to patients. E.g., Telepsych Neurology Cardiology Dermatology Ocular medicine Components of Clinician to Clinician Arrangements Professional Services Agreement Technology and support Agreement 30

31 Direct to Patient Enables patients to obtain direct access to care-givers for consultation, monitoring of condition and/or care plan compliance, referral, etc. May include: Online second opinion services Patient navigation/care management Chronic Care Management (Medicare service available to patients with qualifying conditions in practices that satisfy certain status review and communication requirements) Components of Direct to Patient Arrangements Primarily a physician/patient relationship consistent with applicable regulatory requirements, and insurance coverage (or a payment arrangement for non-covered services) 31

32 Other Arrangements The following services/arrangements are frequently components of the foregoing business models: Monitoring- processes/technologies that are intended to enhance the service offerings of the distant site telemedicine provider and offer more comprehensive clinical services to the patient and/or originating site, e.g., monitoring ICU beds and enabling distant site clinicians to serve as care quarterback to direct care or consult with on-site staff. Monitoring chronic care patients vital signs and/or care plan compliance to facilitate ongoing care management Improves quality, creates cost-savings, reduces admissions/readmissions. 32

33 Other Arrangements (cont d) Hardware/Software-to facilitate the delivery of services remotely E.g., kiosks, workstations Allows delivery of direct services where on-demand care is desired or needed Can include -factories -other work sites (even oil rigs) -schools Also allows incorporation of audio-video and asynchronous modalities (e.g., diagnostic peripherals). For work-sites, promotes stay at work opportunities, less time off for, e.g., unnecessary travel, wait time. 33

34 Legal Considerations 34

35 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. 35

36 Telemedicine and Licensing (cont d) Understanding the licensing laws/regulations of the state(s) in which the physician is practicing is critical, because some states: allow unlicensed physicians to perform peer to peer consultations with physicians who are licensed in those states; allow out-of-state physicians who are licensed in border states to practice without a license in the state; have abbreviated license options or registrations for in-state telemedicine only care; allow physicians to provide follow-up care to their own patients (e.g., post-op, or travel) Also, some states have joined or are considering joining the Federation of State Medical Boards Interstate Medical Licensure Compact 36

37 Telemedicine and Licensing (cont d)- Practice Standards Practicing in a state also means adherence to that state s medical practice standards. Apart from the above, one should ask: Can a valid physician-patient relationship be established in the state via telemedicine without an in-person exam? What ARE the minimum requirements for establishing a physicianpatient relationship What modality of telemedicine is required to establish a valid physician-patient relationship? None may be stated. The gold standard is audio-video while the physician has the patient s medical record available. 37

38 Telemedicine and Licensing (cont d)- Practice Standards What modality is required/allowed for ongoing telemedicine practice purposes? Does the state impose any originating site restrictions for telemedicine practice purposes? Does the state require a patient-site tele-presenter? Does the state allow telemedicine prescribing of noncontrolled substances without a prior in-person exam? Does the state allow telemedicine prescribing of controlled substances without a prior in-person exam? And are there ongoing visit requirements when prescribing particular schedules of controlled substances? 38

39 Telemedicine and Licensing (cont d)- Practice Standards Are there special medical records guidance/ requirements? Are there state telemedicine consent requirements? Note that some states do have these requirements even though telemedicine is not a medical specialty, is not inherently dangerous, and is not generally associated with unusual risks. 39

40 AKS, Stark, CMP and State Analogs Any time a provider enters into an arrangement with an individual or entity that has the potential to refer, or influence referrals to that provider for clinical services or other business, the provider (and the other party to the transaction) must consider, and address if necessary, a host of federal and state laws, particularly if the services or business that may referred is paid for by Medicare or Medicaid. This includes, e.g.: Institution to institution or institution to provider arrangements, Clinician to clinician arrangements, and even Direct to consumer arrangements 40

41 AKS, Stark, CMP and State Analogs (cont d) Federal Laws Anti-Kickback Statute Physician Self- Referral Civil Monetary Penalty Law State Laws Patient Brokering Acts Self-Referral Laws

42 AKS, Stark, CMP and State Analogs (cont d) Avoidance of the penalties associated with these laws requires compliance with applicable regulatory safe harbors or exceptions, including, generally: Memorializing the arrangements with written agreements Describing the specific services to be provided, including timeframes Paying fair market value compensation Paying compensation that does not vary based on the volume or value of referrals or other business 42

43 Corporate Practice and Fee Splitting Entities that are not owned or controlled solely by practitioners or their clinical practice entities are prohibited from providing medical/clinical services in some states. This prohibition is referred to as the corporate practice of medicine. It applies to businesses that employ physicians and other providers to provide clinical services, but can also apply to hospitals that employ providers and seek to have those providers provide services in states where the hospitals are not licensed. A friendly PC model is often utilized as a solution to corporate practice prohibitions 43

44 Corporate Practice and Fee Splitting (cont d) Non-Physician Owner(s) Physician Owner(s) MSO PC Contracted / Employed Professionals

45 Corporate Practice and Fee Splitting (cont d) State Fee-Splitting Statutes preclude physicians/other practitioners from splitting their earnings from professional services with others who did not play a bona fide role in the delivery of the services. Fee splitting statutes can implicate business arrangements where it appears that, e.g., A provider is being compensated for something other than clinical or related administrative services (e.g., referrals) A manager is receiving a disproportionate payment for services or purported services 45

46 Credentialing Providers of service should seek to ensure that those providing clinical services to their patients including distant site telemedicine providers are qualified to provide those clinical services Credentialing standards are most clearly articulated for hospitals, as a result of explicit CMS COPS, state licensure and accreditation requirements. A hospital that utilizes distant site telemedicine services must credential the distant site providers one-by-one, unless it (i) has Medical Staff Bylaws in place that accommodate credentialing by proxy, a process that allows the hospital to rely, in large part, on the credentialing performed by either a distant site hospital or distant site telemedicine entity, and (ii) has a credentialing agreement with the distant site entity that satisfies both COPS and accreditation standards, and is consistent with state law. 46

47 HIPAA, Security Those providing telemedicine services must comply with applicable federal and state laws relating to privacy and security. This is, in effect, no different than what is required in other clinical situations except that telemedicine services necessarily require the transmission of protected health information between and among sites, thereby arguably elevating associated risks. 47

48 Liability Here, too, the risks associated with telemedicine services are not unlike those faced by other providers. Risks include, but are not limited to Malpractice/negligence in connection with the delivery of services Breach of contract Billing and coding related errors and/or billing fraud or misfeasance Privacy and/or security breaches Additional liability considerations associated with the delivery of telemedicine services may include: -choice of modality/technology -failure to properly obtain or maintain modality/technology -use of practitioners/personnel to deliver services who are unfamiliar to the distant site provider, or not adequately trained on the technology, or not properly supervised (by the distant site provider, and/or the originating site) 48

49 Questions? Alan Einhorn, Esq. Of Counsel Foley & Lardner LLP Co-Chair, Compliance and Operations Work Group One Law Firm. All Your Digital Health Needs. Telemedicine Telehealth Virtual Care mhealth Fraud and Abuse Regulatory Compliance International/Destination Medicine Reimbursement and Payment Contracting and Joint Ventures M&A Licensure and Practice Concierge Medicine Privacy and Security 49

50 Thank you 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 Foley & Lardner LLP