Category: Telemedicine

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Alaska’s Telemedicine Business Registry: What You Need to Know

telemedicine business registry

Alaska’s Department of Commerce, Community, and Economic Development has finalized new regulations to create a special Telemedicine Business Registry for health care providers delivering telemedicine services in the Frontier State. The regulations in Title 12, Chapter 02 of the Alaska Administrative Code were effective on April 28, 2017 and implement provisions of Alaska SB 74 that was signed into law last summer.

Under the regulations, companies must be registered with the telemedicine business registry before providing telemedicine services to patients located in Alaska. To register, a business performing telemedicine services must submit an application and registration fee. A telemedicine company operating under multiple names to perform telemedicine services must file a separate registration for each name.

If the name, address, or contact information of a business on the telemedicine business registry changes, the business performing telemedicine services must submit a Business Registry Change Form within 30 days of the change.

A business that fails to comply with the regulations section in a timely manner may not perform telemedicine services in Alaska and must submit a new application to the telemedicine business registry before resuming telemedicine services.

Telemedicine companies and health care providers offering services in Alaska should be mindful of these developments. We will continue to monitor Alaska for any changes that affect or improve telemedicine opportunities in the state.

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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New Jersey’s Telemedicine Law: What Providers Need to Know

new jersey telemedicine

New Jersey has a new telemedicine law, recently signed by Governor Chris Christie. The law cements the validity of telehealth services in the Garden State, establishes telemedicine practice standards, and imposes telehealth coverage requirements for New Jersey Medicaid, Medicaid managed care, commercial health plans, and other State-funded health insurance. After a year of debate in the New Jersey Legislature, the bill (SB 291 now P.L.2017, c.117) unanimously passed both the House and Senate before going to the Governor’s Office. The law is effective July 21, 2017.

The new law is quite lengthy, but we have summarized and explained the essential provisions below:

Key Definitions

  • Telemedicine is broadly defined as the delivery of a health care service using electronic communications, information technology, or other electronic or technological means to bridge the gap between a health care provider who is located at a distant site and a patient who is located at an originating site. The term does not include “the use, in isolation, of audio-only telephone conversation, electronic mail, instant messaging, phone text, or facsimile transmission.

  • Telehealth is defined as the use of information and communications technologies, including telephones, remote patient monitoring devices, or other electronic means, to support clinical health care, provider consultation, patient and professional health-related education, public health, health administration, and other services.
  • Asynchronous Store-and-Forward is defined as the acquisition and transmission of images, diagnostics, data, and medical information either to, or from, an originating site or to, or from, the health care provider at a distant site, which allows for the patient to be evaluated without being physically present.
  • Health Care Provider is broadly defined as an individual who provides a health care service to a patient, which includes, but is not limited to, a licensed physician, nurse, nurse practitioner, psychologist, psychiatrist, psychoanalyst, clinical social worker, physician assistant, professional counselor, respiratory therapist, speech pathologist, audiologist, optometrist, or any other health care professional acting within the scope of a valid license or certification issued pursuant to Title 45 of the New Jersey Statutes.

Telemedicine Communication Modalities

  • The law also states that telemedicine services must be provided “using interactive, real-time, two-way communication technologies” (a requirement that interestingly does not appear to extend to “telehealth services” under the statute itself). Synchronous audio-video is not mandated except for Schedule II prescribing.
  • Interactive Audio with Store-and-Forward. A provider engaging in telemedicine or telehealth may use asynchronous store-and-forward technology to allow for the electronic transmission of images, diagnostics, data, and medical information; except that the provider may use interactive, real-time, two-way audio in combination with asynchronous store-and-forward technology, without video capabilities, if, after accessing and reviewing the patient’s medical records, the provider determines that the provider is able to meet the same standard of care as if the health care services were being provided in person.
  • Audio-Only or Text-Based Communications. The law excludes from the definition of telemedicine consultations provided by “the use, in isolation, of audio-only telephone conversation, electronic mail, instant messaging, phone text, or facsimile transmission.”

Telemedicine Practice Standards

  • Provider-Patient Relationship. A valid provider-patient relationship may be established via telemedicine or telehealth without an in-person exam. Moreover, New Jersey licensing boards are prohibited from passing regulations that would require an in-person exam as a prerequisite to delivering telemedicine or telehealth services. A valid provider-patient relationship must include, at a minimum, the following:
    • Properly identifying the patient using, at a minimum, the patient’s name, date of birth, phone number, and address. The provider may additionally use the patient’s assigned identification number, social security number, photo, health insurance policy number, or other appropriate patient identifier associated directly with the patient.
    • Disclosing and validating the provider’s identity and credentials, such as the provider’s license, title, and, if applicable, specialty and board certifications.
    • For an initial consult with a new patient, the provider must review the patient’s medical history and any available medical records before initiating the telemedicine consult. (For telehealth consults conducted in connection with a pre-existing provider-patient relationship, the provider may review the information with the patient contemporaneously during the consult.)
    • The provider must determine whether or not he/she will be able to meet the standard of care. This determination must be done prior to each unique patient consult.
  • A health care provider delivering services via telemedicine or telehealth must adhere to the following practice standards.
    • The provider’s identity, professional credentials, and contact must be made available to the patient during and after the provision of services. The contact information must enable the patient to contact the provider (or a substitute provider authorized to act on behalf of the provider who provided services) for at least 72 hours following the provision of services.
    • The provider must review the patient’s medical history and any available medical records.
    • After the consult, the patient’s medical information must be made available to the patient upon his/her request. If the patient consents/requests, the information must be forwarded directly to the patient’s primary care provider or health care provider(s) of record.
    • If a patient has no health care provider of record, the telemedicine or telehealth provider is allowed to advise the patient to contact a primary care provider, and, upon request by the patient, may assist the patient with locating a primary care provider or other in-person medical assistance that, to the extent possible, is located within reasonable proximity to the patient.
    • The telemedicine or telehealth provider must refer the patient to appropriate follow up care where necessary, including making appropriate referrals for emergency or complimentary care, if needed.
  • Standard of Care. Diagnosis, treatment, and consultation recommendations, including discussions regarding the risk and benefits of the patient’s treatment options, made via telemedicine or telehealth, including the issuance of a prescription based on a telemedicine or telehealth consult, are held to the same standard of care or practice standards as are applicable to in-person settings. If telemedicine or telehealth services are not consistent with this standard of care, the provider must direct the patient to seek in-person care.
  • Telemedicine Prescribing. A provider may prescribe medications via telemedicine only after establishing a valid provider-patient relationship.
    • Unless the provider has established a valid provider-patient relationship, a provider shall not issue a prescription to a patient based solely on the responses provided in an online questionnaire.
    • With regard to prescribing controlled substances via telemedicine, the law does not prohibit the activity except for Schedule II drugs. A provider may prescribe Schedule II controlled substances via telemedicine only after conducting an initial in-person examination of the patient. Moreover, subsequent in-person exams are required every three months for the duration of time that the patient is being prescribed the Schedule II controlled dangerous substance. Note: despite the New Jersey law, providers must still comply with the prescribing requirements under the federal Ryan Haight Act.
    • The New Jersey in-person exam requirement does not apply to prescriptions for Schedule II controlled stimulant drugs for use by a patient under the age of 18 if: 1) the provider uses interactive, real-time, two-way audio and video technologies; and 2) has obtained written consent from the minor patient’s parent or guardian to waive the in-person exam.
  • Patient Consent. The law does not require patient informed consent to telehealth services (although New Jersey Medicaid requires it for certain specialties). However, to the extent the provider must obtain patient consent for certain activities (e.g., recommending a primary care referral, clinical procedures), the patient’s consent may be oral, written, or digital in nature, provided that the chosen method of consent is deemed appropriate under the standard of care.
  • Originating site. There are no geographic or facility restrictions on originating sites, which are simply defined as “a site at which a patient is located at the time that health care services are provided to the patient by means of telemedicine or telehealth.”
  • Patient-Site Telepresenter. There is no requirement to use a patient-site telepresenter, unless otherwise needed by medical standard of care expectations.
  • Medical Records; HIPAA. Providers must maintain a complete record of the patient’s care and comply with all applicable State and federal statutes and regulations for recordkeeping, confidentiality, and disclosure of the patient’s medical record.

Other unique and notable highlights of the New Jersey law include:

  • Business Registration for Telemedicine or Telehealth Organizations. The law requires each telemedicine or telehealth organization operating in New Jersey to annually register with the Department of Health and submit annual reports on activity and encounter data. The content of the reports will be specified further in forthcoming regulations, but we know the reports will include, at least, for each consult: the patient’s race and ethnicity; the diagnostic codes; the evaluation management codes; and the source of payment for the consult. The Department of Health will compile the information into a statewide database. A “Telemedicine or telehealth organization” is a corporation, sole proprietorship, partnership, or limited liability company that is organized for the primary purpose of administering services in the furtherance of telemedicine or telehealth.
  • Telemedicine and Telehealth Review Commission. The law creates a seven-member New Jersey Telemedicine and Telehealth Review Commission. The Commission will review the information reported by telemedicine and telehealth organizations and make recommendations for policy and law changes to promote and improve the quality, efficiency, and effectiveness of telemedicine and telehealth services in New Jersey.
  • Exceptions to Provider-Patient Relationship. Telemedicine or telehealth may be practiced without a proper provider-patient relationship in the following circumstances:
    • During informal consultations performed by a provider outside the context of a contractual relationship, or on an irregular or infrequent basis, without the expectation or exchange of direct or indirect compensation.
    • During episodic consultations by a medical specialist located in another jurisdiction who provides consultation services, upon request, to a properly licensed or certified health care provider in New Jersey.
    • When a provider furnishes medical assistance in response to an emergency or disaster, provided that there is no charge for the medical assistance.
    • When a substitute provider, who is acting on behalf of an absent provider in the same specialty, provides health care services on an on-call or cross-coverage basis, provided that the absent provider has designated the substitute provider as an on-call provider or cross-coverage service provider.
  • Mental health screeners, screening services, and screening psychiatrists subject to the provisions of P.L.1987, c.116 (C.30:4-27.1 et seq.) are not required to obtain a separate authorization in order to engage in telemedicine or telehealth for mental health screening purposes, and are not required to request and obtain a waiver from existing regulations prior to engaging in telemedicine or telehealth.

New Jersey Telemedicine and Telehealth Insurance Coverage

The law establishes fairly broad coverage of telemedicine and telehealth services, both under New Jersey Medicaid and commercial health insurance plans. However, the law does not explicitly impose a payment parity requirement (i.e., mandating that reimbursement for telemedicine and telehealth services be equal to reimbursement rates for identical in-person services). Instead the law sets the in-person reimbursement rate as the maximum ceiling for telemedicine and telehealth reimbursement rates.

  • With regard to Medicaid and Medicaid managed care, the law states that the State Medicaid Program and NJ FamilyCare Program “shall provide coverage and payment for health care services delivered to a benefits recipient through telemedicine or telehealth, on the same basis as, and at a provider reimbursement rate that does not exceed the provider reimbursement rate that is applicable, when the services are delivered through in-person contact and consultation in New Jersey.”
    • Reimbursement payments may be provided either to the individual practitioner who delivered the reimbursable services, or to the agency, facility, or organization that employs the individual practitioner who delivered the reimbursable services, as appropriate.
    • The programs may limit coverage to services that are delivered by participating health care providers, but may not charge any deductible, copayment, or coinsurance for a health care service, delivered through telemedicine or telehealth, in an amount that exceeds the deductible, copayment, or coinsurance amount that is applicable to an in-person consultation.
  • With regard to commercial health insurance plans, the law states that “a carrier that offers a health benefits plan in [New Jersey] shall provide coverage and payment for health care services delivered to a covered person through telemedicine or telehealth, on the same basis as, and at a provider reimbursement rate that does not exceed the provider reimbursement rate that is applicable, when the services are delivered through in-person contact and consultation in New Jersey.”
    • Reimbursement payments may be provided either to the individual practitioner who delivered the reimbursable services, or to the agency, facility, or organization that employs the individual practitioner who delivered the reimbursable services, as appropriate.
    • A carrier may limit coverage to services that are delivered by health care providers in the health benefits plan’s network, but may not charge any deductible, copayment, or coinsurance for a health care service, delivered through telemedicine or telehealth, in an amount that exceeds the deductible, copayment, or coinsurance amount that is applicable to an in-person consultation.
  • The law establishes similar telemedicine and telehealth coverage requirements for contracts purchased through the New Jersey State Health Benefits Commission and the New Jersey School Employees’ Health Benefits Commission.

Passage of this new legislation is welcome news for telemedicine companies and health care providers looking to offer telemedicine services in New Jersey. We will continue to monitor New Jersey 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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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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