Category: Telemedicine

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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

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

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

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

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

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

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Florida’s New Medical Marijuana Law and Telemedicine Exams

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

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

The statutory language is as follows:

(4) PHYSICIAN CERTIFICATION.—

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

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

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

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

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

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

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

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

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

What Will the Board’s Proposed Rule Do?

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

Why is the Hearing and Proposed Rule Important?

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

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

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

What’s Next?

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

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

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

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

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

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

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

Highlights of the new law include the following:

Definition of Telemedicine

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

Doctor-Patient Relationship

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

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

Standard of Care

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

Remote Prescribing

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

Commercial Insurance Coverage

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

Display Payment Practices

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

Follow-up Care

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

Medical Records

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

Mental Health

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

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

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

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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

Ohio

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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New Resources for Telehealth Chronic Care Management (CCM) Rules

Medicare’s 60-Day Proposed Refund Rule Imposes Significant Liability on Providers

More good news for hospitals, health care providers, and entrepreneurs interested in telehealth and Chronic Care Management (CCM).  CMS just recently introduced a new educational initiative called Connected Care: the Chronic Care Management Resource.  The initiative is designed to raise awareness of the benefits of CCM services for Medicare beneficiaries with multiple chronic conditions and to provide health care professionals with support to implement CCM programs.

CCM is a powerful, patient-oriented service covered by Medicare since 2015, and perfectly suited for tech-savvy providers and telehealth practices, as CCM may be provided via remote care services. CCM is another way health care providers and software companies can harness telemedicine technology to leverage staffing, improve patient care, increase doctor-patient contact, decrease inpatient length of stay, and ultimately reduce overall patient costs.  The CCM and Complex CCM billing codes pay providers on a monthly capitated (per patient per month) basis.

  • CPT 99490 allows eligible practitioners and suppliers to bill for at least 20 minutes of non-face-to-face clinical staff time directed by a physician or other qualified health professionals each month to coordinate care for beneficiaries who have two or more serious chronic conditions that are expected to last at least 12 months.
  • CPT 99487 is for complex CCM that requires substantial revision of a care plan, moderate or high complexity medical decision making, and 60 minutes of clinical staff time.
  • CPT 99489 is a complex CCM add-on code for each additional 30 minutes of clinical staff time.
  • HCPCS G0506 is an add-on code to the CCM initiating visit for providing a comprehensive assessment and care planning to patients.

CMS recognizes CCM as one of the critical components of primary care that contributes to better health and care for individuals, and holds promise for reducing overall health care costs.  Indeed, CCM can be used in many settings, including primary care, gerontology, and even in the hospital setting.  Hospitals offering outpatient CCM services may bill Medicare under the Outpatient Prospective Payment System (“OPPS”) for the facility portion of the service. In addition, Medicare will pay for the physician/practitioner time directing the CCM services under the Physician Fee Schedule.

Connected Care is a nationwide effort within fee-for-service Medicare that includes a focus on racial and ethnic minorities, as well as rural populations, who tend to have higher rates of chronic disease.  The initiative was developed by the CMS Office of Minority Health and the Federal Office of Rural Health Policy at the Health Resources and Service Administration.

Here are some of the resources available to help educate patients and health care providers on CCM services:

Hospitals, health care providers, and other companies using telehealth and non-face-to-face technologies to develop patient population health and care coordination services should take a serious look at CCM billing, and keep abreast of developments that can drive recurring revenue and improve the patient care experience.

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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