Category: Telemedicine

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OIG to Audit Medicare Telehealth Services: What You Need to Know

medicare telehealth

For what may be the first time, the Office of Inspector General (OIG) at the Department of Health & Human Services (HHS) recently announced a new project to review Medicare payments for telehealth services. Accordingly, providers who bill the Medicare program for telehealth services may expect to have those claims reviewed to confirm the patient was at an eligible originating site and that the statutory conditions for coverage were met. The audit is a new project added as a supplement to the OIG’s 2017 Work Plan.

OIG Work Plan

Historically, at the beginning of each new fiscal year, the OIG issued its Work Plan, setting forth the compliance and enforcement projects and priorities OIG intends to pursue in the coming year. Beginning in June 2017, OIG will update the annual Work Plan on a monthly basis.  The Work Plan contains dozens of projects affecting Medicare and Medicaid providers, suppliers and payors, as well as public health reviews and Department-specific reviews.

The Work Plan reflects (in large part) two aspects of the work of OIG:

1) Projects originating within the Office of Audit Services (OAS), which conducts financial, billing, and performance audits of HHS programs; and

2) Projects originating within the Office of Evaluations and Inspections (OEI), which provides management reviews and evaluations of HHS program operations.

Except by providing general statistics, the Work Plan itself does not detail the work of the Office of Investigations or the Office of Counsel to the Inspector General in investigating and enforcing matters involving specific individual providers and suppliers.  The new telehealth project will be run by the OAS.

Review of Medicare Payments for Telehealth Services

OIG describes its new telehealth review project as follows:

“Medicare Part B covers expenses for telehealth services on the telehealth list when those services are delivered via an interactive telecommunications system, provided certain conditions are met (42 CFR § 410.78(b)). To support rural access to care, Medicare pays for telehealth services provided through live, interactive videoconferencing between a beneficiary located at a rural originating site and a practitioner located at a distant site. An eligible originating site must be the practitioner’s office or a specified medical facility, not a beneficiary’s home or office. We will review Medicare claims paid for telehealth services provided at distant sites that do not have corresponding claims from originating sites to determine whether those services met Medicare requirements.”

The expected issue date of the OIG report is 2017, so presumably the review will commence shortly (although OIG Work Plan projects are sometimes continued or extended from year-to-year).

Medicare 2014 Telehealth Claims Data

The new OIG project is not the first time Medicare claims data has identified a potential mismatch regarding the conditions for coverage for telehealth services. A July 2016, Medicare Payment Advisory Commission (MEDPAC) Report to Congress: Medicare and the Health Care Delivery System contained a detailed chapter on telehealth services and the Medicare program.  In it, MEDPAC analyzed Medicare claims data from 2014 for preliminary qualitative assessments on the state of telehealth services under Medicare. The report included a paragraph on telehealth distant site claims without a corresponding originating site claim, stating:

“Among the 175,000 telehealth claims from distant sites, 95,000 (55 percent) were without an originating site claim.  This discrepancy could be due to providers not bothering to bill for the $25 facility fee, or it could be that some services inappropriately originated from a patient’s home, as other research has suggested (Gilman and Stensland 2013).  Among the distant site telehealth claims without an originating site claim, 56 percent (53,000 visits) were associated with rural beneficiaries and 44 percent (41,000 visits) were associated with urban beneficiaries.  Both claims groups suggest that beneficiaries could be inappropriately receiving telehealth services from home or another unapproved location that did not file an originating site claim.  The urban claims are also potentially problematic because they could be occurring in urban originating sites, which is inconsistent with Medicare statute.”

Medicare Coverage of Telehealth Services

Current coverage of telehealth services under Medicare is limited, with the coverage restrictions established via statute under the Social Security Act.  Any notable expansion of telehealth coverage under Medicare would require legislation by Congress.  There are several bills pending in Congress to remove these limitations, but until such time, there are five main conditions for coverage for telehealth services under Medicare.

  1. The beneficiary is located in a qualifying rural area (providers can check if the originating site is in a qualifying rural area by using the Medicare Telehealth Payment Eligibility Analyzer);
  2. The beneficiary is located at one of eight qualifying originating sites (i.e., the offices of physicians or practitioners; Hospitals; Critical Access Hospitals; Rural Health Clinics; Federally Qualified Health Centers; Hospital-based or CAH-based Renal Dialysis Centers (including satellites); Skilled Nursing Facilities; and Community Mental Health Centers);
  3. The services are provided by one of ten distant site practitioners eligible to furnish and receive Medicare payment for telehealth services (i.e., physicians; nurse practitioners;™physician assistants;™nurse-midwives;™ clinical nurse specialists;™ certified registered nurse anesthetists; clinical psychologists; clinical social workers; registered dietitians; and nutrition professionals);
  4. The beneficiary and distant site practitioner communicate via an interactive audio and video telecommunications system that permits real-time communication between them (store and forward is covered in Alaska and Hawaii under demonstration programs); and
  5. The CPT/HCPCS (Current Procedural Terminology/Healthcare Common Procedure Coding System) code for the service itself is named on the CY 2017 (or current year) list of covered Medicare telehealth services.

In order to bill Medicare for telehealth services, the distant site practitioner must fully comply with each of these requirements. If the service does not meet each of these above requirements, the Medicare program will not pay for the service.  If, however, the conditions of coverage are met, the use of an interactive telecommunications system substitutes for an in-person encounter (i.e., it satisfies the “face-to-face” element of a service).

Providers ought not fear the new OIG project, or see it as a reason not to offer telehealth services to their patients. Indeed, the project and its eventual report can help shed light on those areas of compliance which the OIG believes important. In the interim, providers should continue to ensure their telehealth programs and claims comply with Medicare requirements, including coverage, coding, and documentation rules.

For more information on telemedicine, telehealth, and virtual care innovations, including the team, publications, and other materials, visit Foley’s Telemedicine Practice.

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Vermont’s New Telemedicine Law Expands Insurance Coverage, Bans Recording

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Vermont health care providers and patients can now enjoy a revamped, and significantly improved, telehealth commercial insurance coverage law. Vermont Governor Phil Scott signed S. 50 into law on June 7, 2017, expanding commercial coverage and payment parity in the Green Mountain State by requiring Vermont Medicaid and private health plans to pay for telemedicine services at any patient originating site location rather than limiting coverage to services provided while the patient is located in a health care facility. The law also imposes some additional telemedicine practice standards, including a unique prohibition on recording telemedicine consultations.

The state’s prior telehealth coverage law required Vermont Medicaid and commercial insurers to cover telemedicine-based services only if the patient was located at a health care facility, such as a hospital. Under the new law, all health insurance plans in Vermont must provide coverage for health care services delivered through telemedicine to a patient at an originating site to the same extent that the plan would cover the services if they were provided through in-person consultation. The law broadly defines originating site as follows:

Originating site means the location of the patient, whether or not accompanied by a health care provider, at the time services are provided by a health care provider through telemedicine, including a health care provider’s office, a hospital, or a health care facility, or the patient’s home or another nonmedical environment such as a school-based health center, a university-based health center, or the patient’s workplace.

The “distant site” is the location of the health care provider delivering services through telemedicine at the time the services are provided. Under the statute, a health insurance plan means “any health insurance policy or health benefit plan offered by a health insurer, as defined in 18 V.S.A. § 9402, as well as Medicaid and any other public health care assistance program offered or administered by the State or by any subdivision or instrumentality of the State.” The term “health insurance plan” does not include policies or plans providing coverage for specified disease or other limited benefit coverage.

Health insurance plans are allowed to limit coverage to providers in the plan’s network, although the new law removes the prior provision that allowed plans to require the originating site provider to document the reason the services are being provided by telemedicine rather than in-person.

The definition of telemedicine remains unchanged, and is as follows:

Telemedicine means the delivery of health care services such as diagnosis, consultation, or treatment through the use of live interactive audio and video over a secure connection that complies with the requirements of [HIPAA]. Telemedicine does not include the use of audio-only telephone, e-mail, or facsimile.

With regard to store and forward modalities, a health insurance plan “may reimburse for teleophthalmology or teledermatology provided by store and forward means and may require the distant site health care provider to document the reason the services are being provided by store and forward means.” The term store and forward means “an asynchronous transmission of medical information to be reviewed at a later date by a health care provider at a distant site who is trained in the relevant specialty and by which the health care provider at the distant site reviews the medical information without the patient present in real time.”

Other notable highlights of the Vermont law, including changes to telemedicine practice standards, include:

  • The law broadly defines health care provider as “a person, partnership, or corporation, other than a facility or institution, that is licensed, certified, or otherwise authorized by law to provide professional health care services in this State to an individual during that individual’s medical care, treatment, or confinement.”
  • Prescribing. Providers may issue prescriptions via telemedicine, without the need for an in-person exam. Treatment recommendations and prescriptions delivered via telemedicine are held to the same standards of appropriate practice as those of in-person settings.
  • Informed Consent. Providers must obtain and document the patient’s oral or written informed consent before using telemedicine. Details of the informed consent requirement, including certain exceptions where consent is not required, are set forth in the statute.
  • No Recording Allowed. As noted above, the law prohibits recording telemedicine consultations, stating: “neither a health care provider nor a patient shall create or cause to be created a recording of a provider’s telemedicine consultation with a patient.”

With an effective date of October 1, 2017, providers and insurers need to be ready and positioned for the patients who will want to enjoy this new coverage. Those providers who develop their business models, finalize their contractual arrangements, and timely deploy their telehealth offerings will have a strategic advantage come October.

Copyright 2017, American Health Lawyers Association, Washington, DC. Reprint permission granted.

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Is Telemedicine Change Coming to Congress? The Medicare Telehealth Parity Act of 2017 Among Several New Federal Bills

Congress is reconsidering a nationwide telehealth coverage bill, named the Medicare Telehealth Parity Act of 2017, designed to introduce an incremental, though significant, expansion of coverage for telehealth services under the Medicare program. The bipartisan Act is sponsored by Representative Mike Thompson (D-CA), with seven co-sponsors to date (four Republican, three Democrat). If enacted, the Act would modernize the way Medicare reimburses telehealth services by expanding the number of qualifying geographic locations and expanding coverage of telehealth services in a series of three phases.

A previous incarnation of the Act failed to advance, but has been given new life by the recently-formed bipartisan Congressional Telehealth Caucus. The Caucus was founded by Representatives Thompson, Gregg Harper (R-MS), Diane Black (R-TN), and Peter Welch (D-VT), and has garnered additional members in the last couple weeks.

Here is a summary of the key provisions in the Act, aligned according to its three implementation phases.

Phase 1 expands qualifying originating sites to include all federally qualified health centers and all rural health clinics, and the qualifying geographic location also includes counties in Metropolitan Statistical Areas with populations fewer than 50,000. Additionally, Phase 1 expands telehealth coverage to include services provided by certified diabetes educators, respiratory therapists, audiologists, occupational therapists, speech language therapists, and physical therapists. Phase 1 also provides Medicare coverage of asynchronous (store & forward) telehealth services across the country (not just Alaska and Hawaii).

Phase 2 expands qualifying originating sites to include a home telehealth site, and the qualifying originating geographic location include counties in Metropolitan Statistical Areas with populations of 50,000-100,000.

Phase 3 expands qualifying originating geographic locations to include counties in Metropolitan Statistical Areas with populations above 100,000. Additionally, the Act authorizes the Centers for Medicare & Medicaid Services to develop and implement new payment methods for these telehealth services.

The Act also includes provisions for Medicare coverage of remote patient monitoring services (RPM) for covered chronic care conditions, and home dialysis services for those with end stage renal disease.

Several Congressional Telehealth Proposals at Play

The Medicare Telehealth Parity Act of 2017 is just one of a growing number of bills filed this year that seek to remove Medicare coverage restrictions on telehealth services and improve access. Several notable bills are as follows:

  • The Chronic Kidney Disease Improvement in Research and Treatment Act of 2017 (CKDIRT) would, among other things, eliminate restrictions on telemedicine to treat kidney patients in their homes.
  • The Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act (CONNECT Act) seeks to expand the use of telehealth among Medicare beneficiaries.
  • The Helping Expand Access to Rural Telehealth Act (HEART Act) seeks to remove barriers to the adoption of telehealth services in rural areas, expand telehealth services to rural clinics and Metropolitan Statistical Areas of 70,000 people or fewer, and add Medicare coverage for remote patient monitoring of congestive heart failure and chronic obstructive pulmonary disorder.
  • The Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act of 2017 (CHRONIC Act) would seek to reduce Medicare costs by improving chronic disease management services and care coordination at home, shifting the patient site of service.

The introduction of the Medicare Telehealth Parity Act of 2017, coupled with other telehealth related bills and the creation of the Congressional Telehealth Caucus, represents continued progress towards expanded telehealth coverage and hopefully portends increasing support for and understanding of telehealth benefits among federal lawmakers. Health care providers and telemedicine companies should recognize the importance of this progress, as it is an opportunity to contribute their voices and help shape public policy on telehealth and virtual care services.

Copyright 2017, American Health Lawyers Association, Washington, DC. Reprint permission granted.

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Key Takeaways from Oklahoma’s New Telemedicine Law

Oklahoma

Oklahoma Governor Mary Fallin recently signed into law SB 726, establishing new telemedicine practice standards, including explicitly allowing doctors to create valid physician-patient relationships via telemedicine without an in-person exam. The new law is effective November 1, 2017.

The bill creates a new section in the Oklahoma Code (Sections 478 and 478.1 of Title 59). A summary of the key provisions follows:

  • Telemedicine” is defined as the practice of health care delivery, diagnosis, consultation, evaluation and treatment, transfer of medical data or exchange of medical education information by means of a two-way, real-time interactive communication, not to exclude store and forward technologies, between a patient and a physician with access to and reviewing the patient’s relevant clinical information prior to the telemedicine visit. Note the latter portion of the definition requires the physician to have access to and review the patient’s relevant clinical information prior to the telemedicine visit.
  • “Store and forward technologies” is defined as the transmission of a patient’s medical information from an originating site to the physician or practitioner at the distant site; provided photographs visualized by a telecommunications system shall be specific to the patient’s medical condition and adequate for furnishing or confirming a diagnosis or treatment plan.
  • Audio-Only or Text-Based Communications. The law excludes from the definition of telemedicine consultations provided by telephone audio-only communication, electronic mail, text message, instant messaging conversation, website questionnaire, nonsecure video conference, or facsimile machine.
  • Physician-Patient Relationship. A valid physician-patient relationship may be established via telemedicine if the physician holds an Oklahoma medical license, confirms the patient’s identity and physical location, and provides the physician’s identity and professional credentials to the patient. A physician-patient relationship is not to be created solely based on the receipt of patient health information by a physician. Rather, the physician must affirmatively undertake to diagnose and treat the patient, or participate in the diagnosis and treatment of the patient.
  • Health Insurance Portability and Accountability Act (HIPAA). The telemedicine and store and forward technology encounters must comply with HIPAA and ensure that all patient communications and records are secure and confidential.
  • Telemedicine Prescribing. A physician-patient relationship cannot be established via telemedicine or store and forward technologies for the purpose of prescribing opiates, synthetic opiates, semisynthetic opiates, benzodiazepine or carisprodol, but may be used to prescribe opioid antagonists or partial agonists. The law does not prohibit the use of telemedicine for prescribing other medications, but Oklahoma law does consider it unprofessional conduct to prescribe or administer a drug or treatment without sufficient examination and the establishment of a valid physician-patient relationship.

Oklahoma already has medical board regulations (Okla. Admin. Code r. 435:10-7-13) and a position statement on the practice of telemedicine, and the new law may potentially require the Oklahoma Board of Medicine to rewrite some of its existing guidance to the extent it conflicts with the controlling provisions of the new statute. The new law can serve to streamline and simplify existing Oklahoma rules, and give a greater degree of confidence for accepted telemedicine practices. Industry insiders may recall the 2013 Trow decision, in which a physician was sanctioned by the Oklahoma Medical Board for inappropriate telemedicine prescribing practices, including controlled substances.

Copyright 2017, American Health Lawyers Association, Washington, DC. Reprint permission granted.

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Michigan Telemedicine Prescribing and Controlled Substance Laws

Michigan

Michigan Governor Rick Snyder, recently signed into law SB 213, clarifying that health professionals in Michigan may prescribe controlled substances via telemedicine without an in-person examination. The law reverses a 2016 telehealth bill that prevented providers from prescribing controlled substances via telehealth technologies.

Under the new law, a health care professional treating a patient via telehealth may prescribe a drug if both requirements are met:

  • The health professional is a prescriber acting within the scope of his or her practice in prescribing the drug; and
  • If the health professional is prescribing a controlled substance, he or she meets the requirements applicable to that health professional for prescribing a controlled substance.

The law also requires the prescriber to comply with both the following:

  • If the health professional considers it medically necessary, he or she must provide the patient with a referral for other health care services geographically accessible to the patient, including emergency services; and
  • After providing a telehealth service, the health professional, or a health professional acting under the delegation of another health professional, must make himself or herself available to provide follow-up health care services to the patient or refer the patient to another health professional for follow-up health care services.

The law also requires the Michigan Department of Licensing and Regulatory Affairs, in consultation with its respective professional licensing boards, to promulgate rules to implement the law’s provisions regarding telehealth services.

Michigan now joins a growing number of other states (e.g., Delaware, Florida, New Hampshire, Ohio, and West Virginia) that have enacted laws expressly allowing telemedicine prescribing of controlled substances. This is encouraging news for providers using telemedicine in their practice, as controlled substances are an important and clinically significant component of certain specialties, including telepsychiatry, endocrinology, and hospitalists/emergency medicine.

Telemedicine prescribers should continue to also be mindful of prescribing requirements under federal laws, as remote prescribing of controlled substances is governed by the Ryan Haight Act. Providers must understand and navigate many intersecting state and federal laws on telemedicine, medical practice, fraud and abuse, and controlled substances.

© 2017 American Health Lawyers Association. Washington, DC. Reprinted with permission.

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Indiana Reverses Course on Telemedicine Prescribing and Controlled Substances Laws

Indiana has taken another step towards expanding the meaningful use of telemedicine in connection with clinical services and prescribing. HB 1337, signed by Governor Eric Holcomb and effective July 1, 2017, will allow providers to prescribe controlled substances via telemedicine without an in-person examination, albeit with some notable limitations and restrictions. The law reverses Indiana’s 2016 telehealth law that prevented providers from prescribing controlled substances via telehealth technologies.

Prescribing Drugs via Telemedicine

Under the new law an Indiana provider may prescribe non-controlled substances via telemedicine, without an in-person exam, if the following conditions are met:

  • The provider has satisfied the applicable standard of care in the treatment of the patient.
  • The issuance of the prescription by the provider is within the provider’s scope of practice and certification.
  • The prescription is not for a controlled substance.
  • The prescription is not for an abortion inducing drug.
  • The prescription is not for an ophthalmic device, including: (1) glasses; (2) contact lenses; or (3) low vision devices.

Prescribing Controlled Substances via Telemedicine

Under the new law an Indiana provider may prescribe controlled substances via telemedicine, without an in-person exam, if the prescriber satisfies the conditions outlined above and the following conditions are met:

  • The prescription is not for an opioid, unless the opioid is a partial antagonist that is used to treat or manage opioid dependence.
  • The prescriber maintains a valid controlled substance registration.
  • The prescriber meets the conditions set forth in the federal Ryan Haight Act.
  • The patient has been examined in-person by a licensed Indiana health care provider and the licensed health care provider has established a treatment plan to assist the prescriber in the diagnosis of the patient.
  • The prescriber has reviewed and approved that treatment plan and is prescribing for the patient pursuant to that treatment plan.
  • The prescriber complies with Indiana’s INSPECT prescription drug monitoring program.
  • The prescription for a controlled substance is prescribed and dispensed in accordance with Indiana Code 35-48-7.

While Indiana’s new law removes its prior blanket ban on telemedicine prescribing of controlled substances, it still requires the patient to undergo an in-person exam conducted by an Indiana health care provider, although not necessarily by the prescriber herself. This renders Indiana law more restrictive than many states, and even more restrictive than the federal Ryan Haight Act. The new law follows a growing trend among states to amend and eliminate prior statutory prohibitions on telemedicine prescribing of controlled substances. Michigan, for example, recently enacted a law to eliminate its previous ban, and now allows health professionals to prescribe controlled substances via telemedicine without an in-person examination.

This is encouraging news for providers using telemedicine in their practice, as controlled substances are an important and clinically significant component of certain specialties, including telepsychiatry, endocrinology, and hospitalists/emergency medicine.

Telemedicine prescribers should continue to be mindful of prescribing requirements under federal laws, as remote prescribing of controlled substances is governed by the Ryan Haight Act. Providers must understand and navigate many intersecting state and federal laws on telemedicine, medical practice, fraud and abuse, and controlled substances.

© 2017 American Health Lawyers Association. Washington, DC. Reprinted with permission.

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Florida’s New Medical Marijuana Law: What Physicians and Entrepreneurs Need to Know

florida

The Legislation implementing the medical marijuana amendment Florida voters approved last fall is on its way to the Governor.  On June 9, 2017,  during a special session, the Florida Legislature passed SB 8A and SB 6A, implementing Article X, section 29 of the Florida Constitution.  Florida Governor Rick Scott is expected to sign both bills into law and new laws will become effective immediately upon signature.

The following are among the key provisions in Florida’s new medical marijuana use law:

  • Qualifying Medical Conditions. To qualify for medical marijuana, a patient must be certified by a licensed Florida physician as having at least one of the following qualifying conditions:
    • Cancer
    • Epilepsy
    • Glaucoma
    • HIV/AIDS
    • PTSD
    • ALS
    • Crohn’s Disease
    • Parkinson’s Disease
    • Multiple Sclerosis
    • A condition of the “same kind or class” (though the precise meaning of this phrase is not further defined)
    • Patients also qualify if they have chronic pain related to a qualifying condition or are terminally ill
  • Physician Certification. To recommend medical marijuana, a physician must diagnose a patient with a qualifying condition and conclude the medical use of marijuana would likely outweigh the potential health risks to the patient. The physician must be physically present in the same room as the patient when conducting this examination.  Click here for our prior discussion of Florida medical marijuana and telemedicine examinations.
  • Re-Certification and Exams. Once the initial certification is issued, the physician must re-evaluate the existing qualified patient at least once every 30 weeks (210 days) before issuing a new certification.
  • No Waiting Period. The 90-day waiting period previously required under the 2014 Compassionate Use law no longer applies.  A qualifying patient may receive a medical marijuana certification during his or her first visit with a physician.
  • Informed Consent. A certifying physician must obtain the patient’s informed written consent for medical use of marijuana each time the physician issues a certification for the patient.
  • 70-Day Supply. Patients can obtain a marijuana certification for a 70-day supply, with two refills (i.e., a maximum supply of 210 days).  The law requires the Florida Department of Health to issue regulations that quantify a daily dose amount when calculating that 70-day supply.  Once the patient has exhausted his or her supply, the patient must obtain a new physician certification.
  • Medical Marijuana Use Registry. The Department of Health will create an online medical marijuana use registry for physicians and patients.  Physicians are responsible for checking the registry to ensure their patient is listed in the registry and must document in the registry that the patient has been certified for medical marijuana use.
  • Patient Registration; Identification Cards. Before obtaining medical marijuana, patients must: 1) provide proof of Florida residency, 2) be registered with the Department of Health in the medical marijuana use registry, and 3) possess a medical marijuana use registry identification card.  No later than October 3, 2017, the Department of Health will issue medical marijuana use registry identification cards for qualified patients.  These cards must be renewed annually.
  • No Smoking. The law prohibits the administration of marijuana in a form for smoking, seeds, or flower (except for flower in a sealed, tamper-proof receptacle for vaping), but allows for edibles and vaping.
  • Pregnant Women and Minors. A physician may only issue low-THC cannabis to a patient who is pregnant.  If a patient is younger than 18 years of age, a second physician must concur with the certification for medical marijuana to be dispensed to the patient.
  • Tax Exempt. Like other medications in Florida, purchases of medical marijuana and marijuana delivery devices will be exempt from state sales-tax.
  • Physician Course and Examination. Before being qualified to certify patients for medical marijuana, a physician must complete a two-hour course and exam administered by the Florida Medical Association or the Florida Osteopathic Medical Association.  Physicians who have already taken a medical marijuana course under the former Compassionate Use law must still take this new course and examination within 90 days of the course becoming available.
  • No Financial Interest. Physicians who certify patients for medical marijuana cannot be employed by, or have any direct or indirect economic interest in, a medical marijuana treatment center or marijuana testing lab.
  • Emergency Rules. The Florida Department of Health will adopt emergency rules necessary to implement the new law.  According to Amendment 2, the Department of Health has until July to issue rules.

It is important to note federal law still criminalizes the possession, use, and sale of marijuana.  The new Florida law does not immunize violations of such federal law or any non-medical use, possession or production of marijuana.  We will continue to monitor changes to Florida regulations on this issue.

For more information on other developments in health care laws affecting physicians, hospitals, and other providers, including the team, publications, and other materials, visit Foley’s Health Care practice.

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Florida’s New Medical Marijuana Law and Telemedicine Exams

Following a special session, the Florida Legislature on June 9, 2017 passed two important bills regarding medical marijuana in the Sunshine State: SB 8A and SB 6A. Together, these bills implement Article X, section 29 of the Florida Constitution, which was added after voters approved Amendment 2, expanding the medical use of marijuana for qualifying patients.  Florida Governor Rick Scott is expected to sign both bills into law.  The new laws would become effective immediately upon signature.

Among the more than 80 pages of legislation, there is one small sentence with big implications for telemedicine and virtual care providers.  Under the new law, the physician issuing a medical marijuana certification must be physically present in the same room as the patient when conducting the certification examination – meaning physicians may not issue a certification for medical marijuana via a telemedicine exam.  For the foreseeable future, Florida residents seeking medical marijuana prescriptions will be limited to in-person examinations.

The statutory language is as follows:

(4) PHYSICIAN CERTIFICATION.—

(a) A qualified physician may issue a physician certification only if the qualified physician:

1. Conducted a physical examination while physically present in the same room as the patient and a full assessment of the medical history of the patient.

Since last year, the Florida Board of Medicine has been considering prohibiting physicians from ordering medical marijuana via telemedicine.  In December 2016, the Board issued a proposed amendment to its telemedicine regulations to clarify that physicians may not order medical cannabis or low-THC cannabis via telemedicine.  The Board subsequently held public hearings on the issue, with a third hearing scheduled for August 4, 2017.  It is unclear how the Board will proceed on its proposed regulation, as the new statute also charges the Department of Health, the Board of Medicine, and the Board of Osteopathic Medicine to adopt rules underneath the law.

Some states, like California, do not prohibit telemedicine-based examinations for medical marijuana, while others, like Colorado, require an in-person examination prior to recommending medical marijuana.  Even in states that allow telemedicine-based examinations for medical marijuana, providers should keep in mind that the examination for the condition for which medical marijuana is being recommended must be an appropriate prior examination and meet the standard of care.

It is also important to note federal law still criminalizes the possession, use, and sale of marijuana.  The new Florida law does not immunize violations of such federal law or any non-medical use, possession, or production of marijuana.  We will continue to monitor changes to Florida regulations on this issue.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Virtual Care practice.

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Florida Board of Medicine to Hold Another Hearing on Telemedicine and Medical Marijuana Rules

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On August 4, 2017, the Florida Board of Medicine will hold a third public hearing to discuss its proposed amendment to Florida’s telemedicine practice rules regarding medical marijuana. The Board held two prior public hearings, after which it delayed implementation of the rule for further consideration.

Notice of the upcoming public hearing comes only days after state lawmakers failed to pass a medical marijuana bill.  Absent a special session of the Florida Legislature, the Department of Health’s Office of Compassionate Use is now tasked with creating rules to implement Amendment 2.  Amendment 2, passed by voters last Fall, changed the Florida Constitution to allow the medical use of marijuana for individuals with debilitating medical conditions as determined by a licensed Florida physician.  The Department of Health released proposed rules on January 17, 2017, but those rules were criticized by advocates as not aligning with the changes to the Florida Constitution made by Amendment 2.  The Department of Health has until July to issue final regulations.  The Board of Medicine’s proposed rule is distinct from, and does not substitute, the Department’s proposed rule.

What Will the Board’s Proposed Rule Do?

The Board’s proposed rule would prohibit physicians from ordering medical marijuana via telemedicine. The amendment would add a new Section (5) to the Standards for Telemedicine Practice under 64B8-9.0141, F.A.C. If the proposed amendment is finalized, the regulation would state as follows: “(5) Medical cannabis or low-THC cannabis, as defined by s. 381.986, F.S., may not be ordered by means of telemedicine.”

Why is the Hearing and Proposed Rule Important?

Interested physicians, providers, and entrepreneurs may want to attend the public hearing, both to learn more about the Board’s position on medical marijuana and telemedicine, understand the implications if the proposed rule were to be enacted, and to contribute their perspectives to inform the Board’s discussion. Some points of potentially-useful clarification participants might discuss at the hearing include, for example:

  • Whether or not it is appropriate to limit the use of telemedicine based on the physician’s choice of recommended treatment (e.g., medical marijuana vs pharmaceutical prescriptions), rather than based on the applicable standard of care and the patient’s clinical condition(s).
  • Whether or not a physician may conduct a telemedicine-based exam to qualify a patient for Florida’s compassionate use registry (and start the 90 day clock), assuming the physician subsequently conducts an in-person exam prior to ordering medical marijuana.
  • Whether or not a physician may use telemedicine-based exams for follow-up exams or interim consults with patients receiving medical marijuana, in conjunction with in-person exams.
  • Whether or not the Board’s proposed regulation conflicts or complies with the language in the Florida Constitution created by Amendment 2.
  • Whether or not the Board’s proposed regulation conflicts or complies with the forthcoming regulations to be issued by the Department of Health in July (which should be available ahead of the Board’s August hearing).

Some states, like California, do not prohibit telemedicine-based examinations for medical marijuana, while others, like Colorado, require an in-person examination prior to recommending medical marijuana. Even in states that allow telemedicine-based examinations for medical marijuana, providers should keep in mind that the examination for the condition for which medical marijuana is being recommended must be an appropriate medical examination and meet the standard of care

What’s Next?

Anyone may attend the Florida Board of Medicine public hearing and request to be heard, ask a question, or make a statement.  The hearing will occur on August 4, 2017, at 8:00 am, at:

The Hyatt Regency Miami
400 SE 2nd Avenue
Miami, Florida 33131

We will continue to monitor changes to Florida regulations on this issue.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Virtual Care practice.

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“Lone Star” Joins the Rest of Nation as Texas Passes New Telemedicine Law

Texas

On May 12, 2017, the Texas State Legislature passed SB 1107, a law expanding the use of telemedicine in the Lone Star State. The bill is now on its way to Governor Abbot’s desk where he is expected to sign it into law.  Specifically, SB 1107 changes prior Texas law and now allows physicians in Texas to use telemedicine to establish a valid physician-patient relationship without the need for an in-person exam.

The change is the product of months of negotiations between various medical boards, regulatory agencies, and industry groups and may finally bring an end to the longtime telemedicine standoff in the Lone Star State.

Highlights of the new law include the following:

Definition of Telemedicine

“Telemedicine medical services” is defined as health care services delivered by a Texas-licensed physician, or a health professional acting under the delegation and supervision of a Texas-licensed physician, and  acting within the scope of the physician’s or health professional’s license, to a patient at a different physical location than the physician or health professional using telecommunications or information technology.  The law also defines “telehealth service” as a health service, other than a telemedicine medical service, delivered by a health professional licensed, certified, or otherwise entitled to practice in Texas and acting within the scope of the health professional’s license, certification, or entitlement, to a patient at a different physical location than the health professional using telecommunications or information technology.

Doctor-Patient Relationship

A physician may establish a valid doctor-patient relationship solely via telemedicine without the need for an in-person exam.  Under the new law, a physician may provide services to, and establish a physician-patient relationship with, a Texas patient through the following telemedicine modalities:

  • Synchronous audiovisual interaction between the practitioner and the patient in another location;
  • Asynchronous store and forward technology, including asynchronous store and forward technology in conjunction with synchronous audio interaction between the practitioner and the patient in another location, as long as the practitioner uses clinical information from: a) clinically relevant photographic or video images, including diagnostic images; or b) the patient’s relevant medical records, such as the relevant medical history, laboratory and pathology results, and prescriptive histories; or
  • Another form of audiovisual telecommunication technology that allows the practitioner to comply with the standard of care described in the law.

Standard of Care

The standard of care for a physician delivering care via telemedicine is the same standard of care as when delivering in-person services.  The rule prohibits any other agency with regulatory authority over a health professional from adopting rules imposing a higher (i.e., more restrictive) standard of care for telemedicine services.

Remote Prescribing

Note, rules on prescribing via telemedicine remain to be addressed in full.  This is because the law requires the Texas Medical Board, Board of Nursing, Physician Assistant Board, and Board of Pharmacy, to jointly adopt rules and publish FAQ responses relating to defining valid prescriptions for telemedicine exams.  Any such rule, however, must allow for telemedicine-based doctor-patient relationships.  The law expressly prohibits the use of telemedicine to prescribe an abortifacient or any other drug or device that terminates a pregnancy.

Commercial Insurance Coverage

Texas is among the majority of states to have enacted a telehealth commercial insurance coverage law.  Texas’ coverage law prohibits a health plan from excluding a telemedicine service from coverage solely because the service is not provided through a face-to-face consultation.  The new statute narrows the Texas coverage parity law by excluding coverage for a telemedicine or a telehealth service provided by only synchronous or asynchronous audio interaction or facsimile.

Display Payment Practices

Every health plan must adopt and display its policies and payment practices for telemedicine services in a conspicuous manner on its website.  This is designed to promote clarity in telehealth insurance coverage.

Follow-up Care

A physician providing telemedicine services to a patient must provide the patient with guidance on appropriate follow-up care.

Medical Records

Within 72 hours of the telemedicine encounter, if the patient consents and has a primary care physician, the telemedicine practitioner must provide the patient’s primary care physician with a medical record or other report containing an explanation of the treatment and the evaluation, analysis or diagnosis of the patient’s condition.

Mental Health

The statute clarifies that the provisions of the new law do not apply to mental health services.

Passage of this new legislation is welcome news for telemedicine companies and health care providers looking to offer telemedicine services in Texas.  We will continue to monitor Texas for any rule changes that affect or improve telemedicine opportunities in the state.

For more information on telemedicine, telehealth, virtual care, and other health innovations, including the team, publications, and other materials, visit Foley’s Telemedicine and Virtual Care practice.

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