Category: Digital Health

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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

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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

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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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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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Prescribing Controlled Substances Without an In-Person Exam: The Practice of Telemedicine Under the Ryan Haight Act

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Editor’s Note: This article is the second in a series addressing telemedicine prescribing and controlled substances, designed to give some much needed practical guidance and orientation to established healthcare providers, hospitals, and entrepreneurs alike. The first article addressed federal rules for prescribing controlled substances under the Ryan Haight Act.  Subsequent articles will discuss the prescribing controlled substances via telemedicine under state laws.

As providers are becoming more comfortable with delivering care via telemedicine technologies, many of them are looking to explore services other than low acuity triage consults.  One area of patient service opportunity – and particular confusion – is prescribing controlled substances via telemedicine.

As discussed in greater detail in the first article in this series, the Ryan Haight Online Pharmacy Consumer Protection Act was designed to combat the rogue internet pharmacies that proliferated in the late 1990s, selling controlled substances online.  Although the Act was intended to target “rogue” internet pharmacies, legitimate healthcare providers who prescribe controlled substances via telemedicine must carefully review the regulations to ensure compliance.  Among other things, the Act requires a practitioner to have conducted at least one in-person medical evaluation of the patient prior to issuing a prescription for a controlled substance.

However, the Ryan Haight Act contains an important exception to the in-person exam requirement for practitioners engaged in the “practice of telemedicine.”  Indeed, there are seven separate “practice of telemedicine” exceptions under the Act.  They are technical, and providers should not assume their approach to telemedicine or telehealth does, in fact, meet an exception under the Ryan Haight Act.  Providers must devote the resources to really understanding these laws and how to apply them to their business or services.

Practice of Telemedicine Under the Ryan Haight Act

The Act contains the following “practice of telemedicine” exceptions:

(1) Treatment in a hospital or clinic. The practice of telemedicine is being conducted while the patient is being treated by, and physically located in, a hospital or clinic registered under section 303(f) of the Act (21 U.S.C. 823(f)) by a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable State law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the patient is located, unless the practitioner:

(i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d); or

(ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);

(2) Treatment in the physical presence of a practitioner. The practice of telemedicine is being conducted while the patient is being treated by, and in the physical presence of, a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable State law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the patient is located, unless the practitioner:

(i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d)); or

(ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);

(3) Indian Health Service or tribal organization. The practice of telemedicine is being conducted by a practitioner who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act; who is acting within the scope of the employment, contract, or compact; and who is designated as an Internet Eligible Controlled Substances Provider by the Secretary of Health and Human Services under section 311(g)(2) of the Act (21 U.S.C. 831(g)(2));

(4) Public health emergency declared by the Secretary of Health and Human Services. The practice of telemedicine is being conducted during a public health emergency declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act (42 U.S.C. 247d), and involves patients located in such areas, and such controlled substances, as the Secretary of Health and Human Services, with the concurrence of the Administrator, designates, provided that such designation shall not be subject to the procedures prescribed by the Administrative Procedure Act (5 U.S.C. 551–559 and 701–706);

(5) Special registration. The practice of telemedicine is being conducted by a practitioner who has obtained from the Administrator a special registration under section 311(h) of the Act (21 U.S.C. 831(h));

(6) Department of Veterans Affairs medical emergency. The practice of telemedicine is being conducted:

(i) In a medical emergency situation:

(A) That prevents the patient from being in the physical presence of a practitioner registered under section 303(f) of the Act (21 U.S.C. 823(f)) who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor;

(B) That prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f) of the Act (21 U.S.C. 823(f));

(C) During which the primary care practitioner of the patient or a practitioner otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and

(D) That requires immediate intervention by a health care practitioner using controlled substances to prevent what the practitioner reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and

(ii) By a practitioner that:

(A) Is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;

(B) Is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f); and

(C) Issues a controlled substance prescription in this emergency context that is limited to a maximum of a five-day supply which may not be extended or refilled; or

(7) Other circumstances specified by regulation. The practice of telemedicine is being conducted under any other circumstances that the Administrator and the Secretary of Health and Human Services have jointly, by regulation, determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.

How Useful Are the Ryan Haight Act Exceptions for Telemedicine?

Some of the exceptions are very narrow and do not account for current clinical telemedicine practices.  However, others are well-suited to institutional telemedicine arrangements.  And others are of use to only a limited subset of practitioners or particular environments (e.g., public health emergency, Indian tribal organization).  One exception requires a patient-site telepresenter who is also registered with the Drug Enforcement Agency (DEA) (and presumably independently able to prescribe controlled substances for the patient).

Overall, the exceptions have limited utility in contemporary telemedicine arrangements, most notably telemedicine services directly to the patient’s home.  For that reason, the exceptions do not easily align with direct-to-patient service models frequently sought by patients in areas such as telepsychiatry (e.g., where the patient is at his or her home at the time of the telemedicine consult).  The main exception designed to accommodate this type of telemedicine practice – the special registration – has not yet been implemented by the DEA.

The DEA seems to recognize the exceptions have not kept pace with the rapid developments in telemedicine-based practices.  To be fair, Congress gave the DEA a very brief window to draft regulations in order to implement the Act within the short time period between the passage of the Act and its effective date (only six months).  The DEA’s interim final rule was effective a mere nine days after it was published, leaving no time for public comment.  Fortunately, DEA has announced plans to activate the special telemedicine registration provision (exception #5).  This would allow practitioners to use telemedicine to prescribe controlled substances without the per se in-person exam.  The new rule is anticipated to be published this year.

If I Meet an Exception, Can I Prescribe Controlled Substances Without Any In-Person Exam?

No, not necessarily.  Whether the exam is conducted in-person or via the practice of telemedicine, a prescription for a controlled substance must always be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice.  Moreover, practitioners must comply with both federal and state laws, as DEA considers a physician who engages in the unauthorized practice of medicine under state law to be someone who is not acting in the usual course of his or her professional practice.  For example, according to DEA, a controlled substance prescription issued by a physician who lacks the license or other authority necessary to practice medicine within the state is not a valid prescription under federal law.

Some states prohibit the prescribing of controlled substances via telemedicine, but others do allow it.  The remaining states are silent, or allow/disallow its use in certain specialties (e.g., cannot be used in connection with treatment of chronic nonmalignant pain).  The federal and state laws must be read in harmony with each other (not unlike how HIPAA interacts with more restrictive state medical privacy laws).  Understanding how these layers intersect will enable providers to see the pathways and approaches available to compliant prescribing of controlled substances via telemedicine.  This is particularly useful for those telemedicine providers in specialties that involve chronic disease management with pharmacotherapy, for example, adolescent and adult psychiatry, substance abuse/recovery, endocrinology, hormone replacement therapy, and medical weight loss.

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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Telemedicine Prescribing and Controlled Substances Laws

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Editor’s Note: This article is the first of a series addressing telemedicine prescribing and controlled substances, designed to give some much needed practical guidance and orientation to established health care providers, hospitals, and entrepreneurs alike.

As providers become more comfortable with delivering care via telemedicine, telehealth, and digital health technologies, some are exploring services beyond low acuity consults.  One area of opportunity – and notable confusion – is prescribing controlled substances via telemedicine.  This particularly affects specialties that couple chronic disease management with pharmacotherapy.  For example, adolescent and adult telepsychiatry, substance abuse/recovery, endocrinology, hormone replacement therapy, and medical weight loss.

Providers are increasingly inquiring about telemedicine prescribing laws and rules, as well as strategies and approaches for business models and service lines that not only satisfy patient needs, but comply with the layers of intersecting state and federal laws on telemedicine, medical practice, fraud and abuse, and controlled substances.  Indeed, telemedicine prescribing of controlled substances was one of the “Telehealth Top 10” for 2015, and has only continued to generate interest since that time.

What is the Federal Ryan Haight Act?

The Ryan Haight Online Pharmacy Consumer Protection Act was designed to combat the rogue internet pharmacies that proliferated in the late 1990s, selling controlled substances online.  The Act took effect April 13, 2009 and the Drug Enforcement Agency (DEA) issued regulations effective that same date.  The Act essentially imposed a federal prohibition on form-only online prescribing for controlled substances.  Although the Act was intended to target “rogue” internet pharmacies, legitimate healthcare providers who prescribe controlled substances via telemedicine must carefully review the regulations to ensure compliance.

What Does the Ryan Haight Act Mean for Healthcare Professionals?

Under the Ryan Haight Act, no controlled substance may be delivered, distributed, or dispensed by means of the internet (which, for all practical purposes, includes telemedicine technologies) without a valid prescription.  A valid prescription is one that is issued for a legitimate medical purpose in the usual course of professional practice by: 1) a practitioner who has conducted at least one in-person medical evaluation of the patient; or 2) a covering practitioner.  An “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the prescribing practitioner, without regard to whether portions of the evaluation are conducted by other health professionals.

While the DEA has historically viewed the lack of an in-person medical evaluation as a red flag of potential drug diversion, the Ryan Haight Act makes it unambiguous that it is a per se violation of the federal Controlled Substances Act for a practitioner to issue a prescription for a controlled substance by means of the Internet without having conducted at least one in-person medical evaluation, except in certain specified circumstances.  Once the prescribing practitioner has conducted an in-person medical evaluation, the Ryan Haight Act does not set an expiration period or a mandatory requirement of subsequent annual re-examinations (although specific controlled substances, such as suboxone, may have their own rules).  Of course, this does not mean that conducting one in-person medical evaluation is sufficient in every clinical situation.  Even where the practitioner has conducted an in-person exam, a prescription for a controlled substance must still be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice.

Can a Health Care Provider Prescribe Controlled Substances via Telemedicine?

The Ryan Haight Act does not prohibit the use of telemedicine to prescribe controlled substances, and a provider may do so if federal and state requirements are met.  However, the challenge for many providers is understanding these laws and applying them to the processes of their specific service line or business.  There are solutions and approaches that can work for primary care practices, hospitals, telepsychiatry groups, and the like.  Moreover, the Ryan Haight Act has seven exceptions to the in-person medical evaluation requirement for when a prescriber is engaged in the practice of telemedicine.  For DEA purposes, keep in mind that “practice of telemedicine” is a defined term of art, and the exceptions are technical and specific.  Providers should not assume their approach to telemedicine or virtual care does, in fact, meet a “practice of telemedicine” exception under the Ryan Haight Act.  The next articles will discuss the practice of telemedicine exceptions under the Ryan Haight Act, as well as state laws.

What’s Next for the Ryan Haight Act?

In 2015, the American Telemedicine Association sent a letter to the DEA, advocating for provider-friendly changes to federal controlled substance prescribing rules.  Disclosure: attorneys in Foley’s telemedicine practice were contributing authors to the letter.  The letter urged DEA to open a special registration process allowing psychiatrists and physicians to prescribe controlled substances via telemedicine without the need for an in-person exam.  The ATA letter noted that “the interpretation of the [Ryan Haight] Act’s general prohibition of prescribing controlled substances by means of the internet has become overly restrictive.”

In 2016, DEA announced plans to issue a new rule to activate the special registration process allowing physicians to use telemedicine to prescribe controlled substances without an in-person exam.  The most recent notice of rulemaking stated the proposed rule was expected to be published in January 2017.  As of this article, the proposed rule has not yet been released, but is anticipated to be published this year.

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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Ohio Telemedicine Prescribing and Controlled Substances Laws

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The Ohio Medical Board just last week adopted new rules for telemedicine prescribing of drugs and controlled substances, allowing providers to prescribe drugs via telemedicine without conducting an in-person examination.  Effective March 23, 2017, the new rule 4731-11-09 and rule 7331-11-01 set forth the requirements a physician must follow when prescribing via telemedicine in Ohio.

Prescribing Drugs via Telemedicine

An Ohio physician may prescribe non-controlled substances via telemedicine, without an in-person exam, if the physician satisfies the following nine requirements:

  • Establishes the patient’s identity and physical location;
  • Obtains the patient’s informed consent for treatment through remote examination;
  • Requests the patient’s consent and, if granted, forwards the medical record to the patient’s primary care provider or other health care provider, if applicable, or refers the patient to an appropriate health care provider or health care facility;
  • Completes a medical evaluation through interaction with the patient that meets the minimal standards of care appropriate to the condition for which the patient presents;
  • Establishes a diagnosis and treatment plan, including documentation of necessity for the utilization of a prescription drug, including contraindications to the recommended treatment;
  • Documents in the medical record the care provided, patient’s consent, medical information, and any referrals made to other providers;
  • Provides appropriate follow-up care or recommends follow-up care;
  • Makes the medical record of the visit available to the patient; and
  • Uses appropriate technology sufficient for the physician to conduct the above as if the medical evaluation occurred during an in-person visit.

Prescribing Controlled Substances via Telemedicine

An Ohio physician may prescribe controlled substances via telemedicine, without an in-person exam, if the physician satisfies the nine steps outlined above and when one of the following six situations exists:

  • The patient is an “active patient” of a health care provider who is a colleague of the physician and the controlled substances are provided through an on call or cross coverage arrangement between the health care providers. “Active patient” is a defined term under the new rules and means that “within the previous twenty-four months the physician or other health care provider acting within the scope of their professional license conducted at least one in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine as that term is defined in 21 C.F.R. 1300.04, in effect as of the effective date of this rule.”
  • The patient is located in a DEA-registered hospital or clinic;
  • The patient is being treated by, and in the physical presence of, an Ohio-licensed physician or health care practitioner registered with the DEA;
  • The telemedicine consult is conducted by a practitioner who has obtained a DEA special registration for telemedicine;
  • A hospice program physician prescribes the controlled substance to a hospice program patient in accordance with the board of pharmacy rules; or
  • The physician is the medical director of, or attending physician at, an “institutional facility” (defined in rule 4729-17-01) and 1) the controlled substance is being provided to a person who has been admitted as an inpatient to or is a resident of an institutional facility, and 2) the prescription is transmitted to the pharmacy by a means that is compliant with Ohio board of pharmacy rules.

The above six situations largely mirror exceptions under the federal Ryan Haight Act.  Telemedicine advocates have noted the Ryan Haight Act’s rules on prescribing controlled substances have hindered contemporary, legitimate telemedicine practices.  Members of the American Telemedicine Association have advocated for provider-friendly changes, and the DEA is expected to issue new rules this year, opening a special telemedicine registration for prescribers.

The Buckeye State now joins others (e.g., Delaware, Florida, New Hampshire, and West Virginia) that have carved out express exceptions to allow for 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 and hospitalists/emergency medicine.

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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Key Takeaways From FHA’s Health Law Summit

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Foley recently co-hosted the Florida Hospital Association’s (FHA) 2017 Health Law Summit, which brought together more than 40 in-house attorneys and compliance officers from FHA member hospitals to discuss the current state and future direction of the health care industry.

Amid so much economic and political uncertainty, we are diligent about keeping our fingers on the pulse of the macro trends impacting providers operating in the U.S. health system. While we know you’ve been paying close attention to these developments as well, following is a brief recap that encapsulates the key takeaways from event speakers and other health care practitioners in attendance.

Telehealth and Destination Medicine

Florida has rapidly become a hotspot for the burgeoning area of destination medicine, and hospitals must account for the movement, lest they lose valuable revenue and patients to specialty competitors. While current laws and regulations are complex, there are avenues to create compliant offerings, including telehealth and online second opinion programs.

Health Care Privacy and Cybersecurity

Managing relationships with vendors, especially those who handle protected health information, is key. Best practices include conducting due diligence and negotiating appropriate contractual protection.

Labor and Employment Law

Laws affecting the workplace are in a state of flux, but changes are on the horizon under the new administration, which is generally viewed as being pro-employer. Hospital executives are eager to see how the DOL will be steered on issues such as overtime, worker safety and collective bargaining, to name a few.

False Claims Act Investigations and Enforcement

Civil Investigative Demands (CID) served by the government must be treated differently than other kinds of subpoenas or demands, and misperceived responses can have an adverse impact. In-house counsel who receive CIDs must have an escalation plan that addresses potential high-risk or high-likelihood scenarios, including investigations, litigation, settlements, liability, damages, insurance and disclosures.

Update on Stark Law and Anti-Kickback Statute

Government enforcement of such violations is expanding at a rapid rate, particularly in Florida. There were several notable public settlements in the state last year, as well as changes made to 11th Circuit case law, so it’s important for in-house counsel to stay abreast of these developments.

Boards and Hospital Governance and Compliance

The Department of Justice is increasingly holding individual leaders responsible for the stewardship of their hospitals. Educating hospital boards is vital to effective compliance, especially related to financial arrangements and quality of care.

 

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The Joint Commission Bans Text Messaging for Patient Care Orders

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The Joint Commission, which accredits hospitals and other health care organizations, recently announced it will not permit hospitals and other health care organizations to use secure text messaging platforms to transmit orders. The announcement is the most recent in a back-and-forth series of guidance statements regarding the use of secure messaging in hospitals and other health care organizations.

In a 2011 FAQ, the Joint Commission stated it was not acceptable for physicians or licensed independent practitioners to text orders for patient care, treatment, or services to hospitals or other health care settings.  The Joint Commission reversed its position in May 2016, stating providers could “text orders as long as a secure text messaging platform is used and the required components of an order are included.”  The Joint Commission credited the evolution of health care communications technology as part of the reason for its decision to reexamine and allow provider text messaging.  Then, in July 2016, the Joint Commission “hit unsubscribe” on its guidance and delayed the use of text messaging until it had time to further consider the clinical and operational implications.

During that period, the Joint Commission worked with the Centers for Medicare & Medicaid Services (“CMS”) to develop guidelines for text-message-based orders to ensure consistency with the Medicare’s Conditions of Participation. As a result of this collaboration, The Joint Commission and CMS developed a set of recommendations contained in its new clarification on the use of messaging for patient care orders.  The guidance is summarized as follows:

  1. All health care organizations should have policies prohibiting the use of unsecured text messaging – that is, short message service (“SMS”) text messaging from a personal mobile device – for communicating protected health information.
  2. Computerized provider order entry (“CPOE”) should be the preferred method for submitting orders, as it allows providers to directly enter orders into the electronic health record.
  3. In the event that a CPOE or written order cannot be submitted, a verbal order is acceptable.
  4. The use of secure text orders is not permitted at this time.

The Joint Commission mentioned a few interesting factors that influenced this decision. In particular, the focus was on the technical capabilities of the modality of the communication.  It noted that secure text messaging of an order is an asynchronous interaction, whereas a verbal order allows for a real-time, synchronous clarification and confirmation of the order with the ordering practitioner.  Similarly, if a clinical decision support recommendation or other alert is triggered during the order entry process, the individual entering the order may need to contact the ordering practitioner for additional information.  When this type of alert is triggered during the entry of a verbal order, the entering practitioner can immediately discuss the issue with the ordering practitioner.  However, if this occurs with a text order, the delay in communication between the entering practitioner and the ordering practitioner may cause a delay in treatment.

Many of the Joint Commission’s data privacy and security concerns had been addressed through recent technological developments in the health care application space. Despite these advancements, the Joint Commission remains concerned about transmitting text orders even through a secure text messaging system due to the unknown impact of secure text orders on patient safety.  The Joint Commission will continue to monitor advancements in the field, and will determine whether future guidance on the use of secure text messaging is warranted.

Secure text messaging may be a convenient mode of communication for practitioners, but this recent guidance indicates that the Joint Commission and CMS do not approve of this use at hospitals or other health care organizations. Health care organizations should update their policies and procedures to ensure that text messaging in any form (secured or unsecured) is not permitted within the organization.

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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