UPDATED: October 14, 2020

NOTE:  Please remember that we are all operating in uncharted territory and there are very few clear answers. This is a very fluid situation and recommendations may change based upon events or guidance from the federal and state governments. Please check back often for updates.

IF YOU ARE NOT INSURED THROUGH PRMS:  Please do not rely on this information as more than one company’s risk management thoughts.  Nothing presented here is legal advice.  You should check with your own risk managers.

Quick Links:

 

I’ve heard that the DEA waiver of the one in-person visit requirement before prescribing controlled substances has expired.  Is that true?

No.  The DEA did recently issue a Final Rule to finalize a regulation under the Ryan Haight Act.  The formal name for this law is the Ryan Haight Online Pharmacy Consumer Protection Act, and as the name indicates, the law’s primary focus is online pharmacies.  The in-person requirement is the DEA’s way to protect the public from prescriptions based solely on an online questionnaire.  The new Final Rule related to the Ryan Haight Act relates to online pharmacies and actually consists of minuscule changes to the Interim Rule covering the issue.  For more information on this new Final Rule:

  • From the DEA.
  • From an attorney blogger who focuses on DEA actions (not limited to telemedicine).

This Final Rule did, in the comments, cover the in-person requirement, but in the context of that requirement’s purpose - to protect the public from online pharmacies filling prescriptions based solely on an online form.

Interestingly, the comments note the DEA’s obligation to have issued a regulation for the telemedicine registration that was due October 2019.  The DEA indicated more on that would be forthcoming in the future.

The DEA’s temporary waiver of the in-person visit requirement due to the pandemic will expire when HHS declares the public health emergency  (PHE) expires.  The PHE is currently set to expire October 23rd, has already been been extended to January.  See next FAQ below.

While everyone doing telemedicine is hoping that the DEA will decide to not put this in-person visit requirement back into effect after the PHE expires, we do wonder if the DEA by mentioning this requirement in the Final Rule is signaling that it will go back into effect post-PHE.

(Added 10/5/20)

Have you heard anything about the Public Health Emergency (PHE) being renewed?

Yes!  It has already been renewed.  On October 2nd, the Secretary of HHS’ Declaration of Public Health Emergency, set to expire on October 23rd, has been renewed, effective October 23rd.  So the PHE has been extended 90 days from October 23rd, so mid-January.

(Added 10/5/20)

If I am treating patients in the state where I am licensed but am not currently in that state myself, do I need a license and/or DEA registration for the state in which I am currently located?

Presuming you are not just there for vacation, you should keep the following in mind:

  • Before the Public Health Emergency (PHE), to prescribe controlled substances, you needed a DEA registration in the state where you are located as well as in the patient’s state, if different. See slide 36 of this DEA presentation.
    • Note that pre-PHE, the DEA often denied the registration in the patient’s state if the physician did not have a mailing address in the patient’s state.
    • During the PHE, the DEA has temporarily waived the requirement of having a registration in the patient’s state.
    • While we can hope this remains waived post-PHE, the DEA may go back to requiring the registration in the patient’s state.

If you have relocated to a new state:

  • If you will treat patients in your new state, you need to ensure licensure requirements in your new state are met.
    • And you will need a DEA registration in that state to prescribe controlled substances. Depending on where your patients are located, and on whether the DEA again requires registration in the patient’s state post-PHE, you may be able to transfer your existing DEA registration to your new state.
  • If you will not be treating patients in your new state:
    • Ensure you are meeting licensure requirements in your patients’ states
    • And check with your state’s licensing board to confirm no license in your state is needed since you are not treating patients in your state.
    • Note that if you need a DEA registration in your state, the DEA website currently says state licensure is required for a DEA registration.

(Added 9/2/2020)

Has HHS extended the Public Health Emergency (PHE)?

Yes! HHS has extended the Public Health Emergency (PHE) declaration for another 90 days starting 10/23/20, and we wanted to let you all know about this continued extension.  This means that the following regulatory waivers, in effect only during the PHE, will remain in effect until mid-January (when the PHE could be extended again).

(Added 7/24/20)

SEEING NEW PATIENTS REMOTELY:

For those new patients that I am comfortable assessing for the first time remotely, I understand that I am able to do so.  Is that correct?

While this may technically be allowed during HHS’ declaration of a Public Health Emergency (PHE), it is important to think ahead about your continued ability to treat after the PHE expires.  

Pre-pandemic, whether an in-person visit was required varied by state, with most states not requiring it for the establishment of a treatment relationship.  However, in terms of prescribing, particularly controlled substances, there were limitations in many states, as well as from the federal government.

The PHE is currently set to expire in late July.  It can be extended at that point, or it can be discontinued earlier.  

Once the PHE is no longer in effect, the rules will change and there could be issues related to your treatment without an in-person visit, including but not limited to: 

  • Licensure: If you are not licensed in the patient’s state, remember that state licensure waivers are temporary, and many have expiration dates (which could be prior to the PHE expiration date).  
  • Prescribing: The federal government has been clear that the relaxation of controlled substances prescribing laws is only temporary.  So keep the following in mind for after the PHE:
  • The in-person visit prior to prescribing controlled substances requirement will likely be back in effect.  It is possible that the federal government may require that one in-person visit for those patients previously prescribed controlled substances without an in-person visit.  Note that this could also be true under state law.
  • The requirement of having a federal DEA registration in the patient’s state (as well as the prescriber’s state, if different) will likely be back in effect.  

(Added 5/8/20)

COVID-19:

What should I know about taking care of patients in this pandemic?

The Center for the Study of Traumatic Stress has put out a guide for psychiatrists discussing how you can help your patients deal with their responses to the COVID-19 pandemic. (Added 3/27/20)

BUPRENORPHINE PATIENTS:

I have many questions about treating buprenorphine patients, such as whether new and established patients can be tested by phone.  Where can I find answers?

SAMHSA has prepared FAQs.

(Added 4/8/20)

How do I address the necessary drug testing for my buprenorphine patients?

The American Society of Addiction Medicine (ASAM) has useful information on its website, www.asam.org.  There are also specific recommendations for adjusting drug testing protocols here.  (Added 3/26/20)

REMS:

I have patients on medications with a REMS.  The required lab monitoring cannot be done by home-bound patients.  Has the government relaxed any of these rules?

Yes – see this resource.  (Added 3/25/20) 

SEEING PATIENTS

What is going to happen when the pandemic ends – what will change?

That is currently the great unknown.  However, we do know the issues and what to watch for.  Please see our resource “PREPARING FOR WHAT’S NEXT – TO DO LIST”     

(Added 5/21/20)

I’m considering re-opening my practice.  Do you have any guidelines related to re-opening?

Here are various resources that you may find useful:

What recommendations do you have while my office remains open and I’m seeing patients in person?

The most important thing is to protect yourself, your patients, and staff.  Here are some actions you may want to consider implementing:                 

  • Contact all patients prior to their appointments and ask that they not come to the office under the following circumstances:
    • If they are symptomatic – fever, cough, runny nose, difficulty breathing
    • If they (or their family members) have recently traveled to certain countries – China, Iran, South Korea, Italy, Japan, Hong Kong
    • If they believe they may have been exposed to coronavirus
  • Make certain that this is also told to new patients scheduling their first appointments. Patients should be told that those with  apparent symptoms will not be allowed in the office.
  • Post a sign (with the information described above) on the door to your office and perhaps inside as well.
  • If available, have disinfecting wipes and hand sanitizer available.
  • Wiping down of surfaces should be done frequently.
  • Enable everyone in the office, patients, staff, and you, to practice social distancing.
I’m in an area where the expectation is that I will not have patients see me in my office, so my office is basically closed.  However, there are a few patients that I need to continue to see in person and they want to come to the office to be seen.  Is there anything else I need to do?

You should have a documented office policy for seeing patients in the office during the COVID-19 pandemic, which may include screening before entering, masks utilized, social distancing, etc.  Additionally, in each patient’s chart, note the specific reason for this patient being seen in the office, and that the patient understood the risks of being seen, and agreed to be seen in the office.  (Added 4/3/20)

In the event I need to see patients in my office, such as for TMS treatment, do I need patients to sign an informed consent document to be seen in the office?

While this is not typically required, you may choose to do this.  If so, you may want to document that the following was discussed with the patient:

  • The general risk of COVID-19 transmission associated with an outpatient medical office
  • The specific risks of COVID-19 transmission associated with TMS (or other) treatment in the office
  • The steps the office is taking to minimize the risk, including PPE and other safety measures

And either:

  • The patient had no questions and agreed to proceed with treatment OR
  • All of the patient’s questions were answered and the patient agreed to proceed with treatment

(Added 4/22/20)

Can I refuse to see patients who are symptomatic when they show up in my office?

You can refuse to see patients who are ill – tell them you are taking this seriously and so should they.

I've seen some good signs in other offices.  Where can I find signs to print?

The CDC has many signs available for download that you may find relevant. 

(Added 4/23/20)

I’m not sure that my landlord understands what COVID precautions are required for the building.  Do you have any relevant resources?

Yes - this article may be useful.  Be sure to document and retain your communications and attempts to ensure that the appropriate precautions have been taken. 

(Added 6/9/2020)

 

Can I treat my patients by phone?

The answer depends on your patients’ clinical needs.  You must continue to meet their clinical needs, even during this public health emergency.

Based on your practice, and your patients, the telephone may be an appropriate solution.  If your patients are stable, you may feel comfortable meeting their clinical needs with a telephone call, even postponing that telephone appointment for a short while.  Conversely, if you have high risk patients on high risk medication with possible significant side effect possible, you will need to figure out a way to provide appropriate clinical care, such as via telepsychiatry.

Either way, your current patients all need a way to contact you, as always.

Can I prescribe controlled substances for new patients based only on a telephone evaluation?

It depends on what type of controlled substance you are prescribing for the new patient.  For federal requirements, refer to the DEA’s decision tree.  Also  remember that states can have their own requirements for and restrictions on prescribing controlled substances.  

(Added 4/8/20)

 STANDARD OF CARE

I know the standard of care when I treat patients in-person.  Is it the same when treating patients remotely?

Yes.  We know that there is a lack of uniformity in terms of telemedicine laws across the nation.  However, there are two things that are true, wherever you practice telemedicine:

  • The standard of care is the same whether treatment is rendered in person or via telemedicine
  • Services are deemed rendered where the patient is located, not where the physician is

So, for example, just as you need to be able to hospitalize an imminently suicidal patient in your office, you need to be able to contact emergency services in the patient’s locale to get the remote patient hospitalized.  So it is important to know your patient’s location.

During the pandemic, how can the standard of care be the same as pre-pandemic?  Isn’t there a “disaster standard of care”?

There is no disaster standard of care, nor is there the need for one.  The standard of care is flexible for all situations - it always compares your care to that of a similar psychiatrist in similar circumstances.

That said, in these challenging times, it’s important to not lose track of the basics.  Regardless of the treatment modality, you always need to deliver good clinical care.  If you are treating a patient at risk for suicide, you still need to assess (and document!) and implement an appropriate treatment plan.  If prescribing controlled substances, it may be helpful to check the applicable Prescription Monitoring Program, if possible.  And, as always, do not apologize for any adverse outcome until you speak with your risk manager.  Given today’s circumstances, there may be outcomes that are less than optimal and likely would not have occurred pre-pandemic.  But that doesn’t mean there was an error - so you should not treat it as such.  And remember, even if there was an error, that in and of itself, is not malpractice.  Again, your risk managers should be contacted for guidance.

(Added 5/8/20)

I’ve been told by the telepschiatry company I work for not to worry about the Ryan Haight Act, specifically the requirement for one in-person visit prior to prescribing controlled substances.  I realize this requirement has been temporarily lifted during the pandemic, but my guidance from the company was pre-COVID.  When the provision is back in effect, I doubt the company’s position will change.  The company basically says that since no one else follows the in-person visit requirement, we do not have to either, because the standard of care is determined by what everyone else is doing.  Now I’m questioning whether this is accurate.

You should keep at least these two points in mind:

  1. The standard of care is relevant in medical malpractice litigation, which is citizen versus citizen (such as patient versus physician).  But the factor with the most weight in determining the standard of care in a lawsuit is compliance with federal and state laws, such as the Ryan Haight Act.
  2. You also have another professional liability exposure which may be more relevant.  That additional exposure is an administrative investigation by a regulatory agency.  This is government versus citizensuch as the DEA investigating a physician for violating the Ryan Haight Act.  In such an action, there is no standard of care issue.  Rather, the only issue is whether the physician complied with the law.  It is irrelevant that other physiciansalso did not comply with the law.

Given how complicated this issue is, you may want to review this resource that details the requirement for the in-person visit and the very limited exceptions. 

(Added 6/22/20)

INFORMED CONSENT

Are informed consent requirements for telemedicine the same as for an in-person encounter?

In addition to the informed consent needed for treatment (the same as if the patient was seen in your office), most states and professional organizations that have addressed telemedicine require informed consent.  Some of those states will elaborate on what is needed for consent to telemedicine, but most do not.

If you do not have state guidance on informed consent requirements, you can follow the recommendations for informed consent in the guidelines from the Federation of State Medical Boards:

  • Identification of the patient, the physician and the physician’s credentials;
  • The patient agrees that the physician determines whether or not the condition being diagnosed and/or treated is appropriate for a telemedicine encounter; and
  • Details on security measures taken with the use of telemedicine technologies, such as encrypting data, password protected screen savers and data files, or utilizing other reliable authentication techniques, as well as potential risks to privacy notwithstanding such measures

 

PRMS INSURANCE POLICY

Is telepsychiatry covered by my professional liability insurance policy through PRMS?

Yes!

I recall seeing on the renewal application a question about whether I utilized telepsychiatry.  At that time I was not, and really never intended to, but believe I need to start using it now due to coronavirus.  Do I need to let PRMS know that I’m now doing it?

We expect that most policyholders will be doing some form of telemedicine during this public health emergency.  If your use of telemedicine is limited to the duration of the emergency, there is no need to notify us.  If your use of telemedicine is limited to the duration of the emergency, there is no need to notify us.  If after the emergent need to use telemedicine passes, you decide to continue using this treatment modality, then you would need to contact your Underwriter.

TELEPSYCH PLATFORM

I’ve heard that the government no longer requires me to get a Business Associate Agreement with the service I use for telemedicine.  Is that true?

The Office for Civil Rights, the agency within HHS responsible for enforcing the HIPAA Privacy and Security Rules, has temporarily ceased enforcing this requirement:  “OCR will exercise its enforcement discretion and will not impose penalties for noncompliance with the regulatory requirements under the HIPAA Rules against covered health care providers in connection with the good faith provision of telehealth during the COVID-19 nationwide public health emergency.”  For more information, click here(Added 3/17/20)

HHS’ declaration of a public heath emergency (PHE) has been renewed, effective April 26, 2020.  PHE declarations last 90 days, unless cancelled earlier. (Added 4/28/20)

How do I know which service to use?

The first suggestion is to consider the use of a true telemedicine platform (versus social media video-conferencing).  These vendors know about the HIPAA requirements. As noted above, OCR is temporarily waiving enforcement against covered entities not using HIPAA-compliant telemedicine platforms.  (Added 3/19/20)

Then consider the cost options.  While we cannot endorse or recommend specific platforms, we do know that there are several reasonably priced telemedicine platforms, and some even have a free plan for solo practitioners (that does include a BAA).  Two that we are aware of – but are not endorsing or recommending – are:

  • VSee: may have temporarily discontinued the free service (modified 4/6/20)
  • Doxy.me 

There are likely others out there.  When considering a free service, knowing that free is not a sustainable business model, you may want to ask the vendor what the catch is.  For example, are they selling aggregated data?

TELEPSYCH ETIQUETTE

I’ll be doing telepsychiatry for the first time.  I’m wondering about camera angles, what to wear, etc.  Are you aware of any guidelines?

Most psychiatrists have not had any training on telepsychiatry.  We have have developed tips for before, during, and after the telepsych encounter.  (Added 4/24/20)

Do you have any instructions I can give my patients to help them with telepsych visits?

Yes - this resource may be useful.

(Added 4/30/20)

LICENSURE

Has PRMS heard anything about waiver of state licensure requirements?

There does seem to be some movement. We are tracking the various actions in the states that are taking place – the governor allows the state licensing boards to waive licensure for out of state physicians, the boards choose to do so and can limit the waiver to very narrow circumstances.  Click here for what we have found so far in terms of enacted waivers. 

While this is encouraging, keep the following in mind:

  • It may be that states have only cleared the way for the state licensing board to waive licensure requirements in the event they choose to do so.
  • It is possible that these waivers may not apply to all medical specialties or to those who are not treating patients with Coronavirus.
Many of my colleagues are positive that they can see Medicare patients in states where they are not licensed.  They report that licensure requirements have been officially waived by Medicare / CMS / HHS.  Is this right?

There continues to be much confusion around this.  There is a waiver of state licensure requirements when treating Medicare patients, but that is only a waiver of a Medicare requirement for PAYMENT - it is NOT a waiver of state licensure requirements from the patient’s state licensing board.

For more information:

  • From CMS:  CMS has “temporarily waive(d) Medicare and Medicaid’s requirements that physicians and non-physician practitioners be licensed in the state where they are providing services.  State requirements will still apply...This waiver does not have the effect of waiving State or local licensure requirements or any requirement specified by the State or local government as a condition for waiving its licensure requirements.”
  • From the American Telemedicine Association: “This waives Medicare and Medicaid requirements that a provider be licensed in the state where the patient is, but does not preempt states’ licensing requirements.”
  • From JDSupra article: “These waivers alone do not waive the requirement for physicians and other healthcare providers to maintain licensure in states where they are practicing a licensed profession, including via telehealth. State law continues to govern whether a provider is authorized to provide professional services in that state without holding active license from that state’s medical board.”

(Added 4/8/20)

I am intending to only treat patients via telepsychiatry who live in a state where I am licensed.  I am good to go, right?

Certainly you’ve eliminated what could be a significant barrier to telemedicine.  Just be sure that you are complying with the laws (related to telemedicine, prescribing, etc.) of both states.  As an example, this may be the first time in a long time that you are utilizing your license in the patient’s state.  You may learn that the patient’s state has requirements related to prescribing, such as a requirement that you check the Prescription Monitoring Program in the patient’s state prior to prescribing.

I have patients that see me in my office, but live in a different state where I am not licensed.  Given that I’m only doing telepsychiatry during this public health emergency, and it’s for continuity of care, I do not need a license in the patient’s state, right?

As noted above, we are hopeful that licensing boards will relax their licensure requirements during this exceptional time, and there is movement on this issue.  In addition to our list above, you can check the licensing board websites in the event waiver information is posted there.  (Added 3/19/20)

Presuming no waiver of licensure is available, there are some situations where you may decide to do the remote visit without the waiver.  For example, if you are in a border jurisdiction (such as Maryland, Virginia, and the District of Columbia), you may feel comfortable doing a few remote sessions without checking with the out of state board.  If you choose this option, you should not rely on it for any longer than the emergency lasts.

If I am treating patients in the state where I am licensed but am not currently in that state myself, do I need a license and/or DEA registration for the state in which I am currently located?

Presuming you are not just there for vacation, you should keep the following in mind:

  • Before the Public Health Emergency (PHE), to prescribe controlled substances, you needed a DEA registration in the state where you are located as well as in the patient’s state, if different. See slide 36 of this DEA presentation.
    • Note that pre-PHE, the DEA often denied the registration in the patient’s state if the physician did not have a mailing address in the patient’s state.
    • During the PHE, the DEA has temporarily waived the requirement of having a registration in the patient’s state.
    • While we can hope this remains waived post-PHE, the DEA may go back to requiring the registration in the patient’s state.

If you have relocated to a new state:

  • If you will treat patients in your new state, you need to ensure licensure requirements in your new state are met.
    • And you will need a DEA registration in that state to prescribe controlled substances. Depending on where your patients are located, and on whether the DEA again requires registration in the patient’s state post-PHE, you may be able to transfer your existing DEA registration to your new state.
  • If you will not be treating patients in your new state:
    • Ensure you are meeting licensure requirements in your patients’ states
    • And check with your state’s licensing board to confirm no license in your state is needed since you are not treating patients in your state.
    • Note that if you need a DEA registration in your state, the DEA website currently says state licensure is required for a DEA registration.

(Added 9/1/2020)

STATE SPECIFIC REQUIREMENTS

I’ve never done telemedicine before, but I’m sure there are laws and regulations about it in the states.  If my patient is in a different state, do I just need to follow the requirements of just my state, or just the patient’s state, or both?

When remotely treating a patient in a different state, you will need to follow the requirements of both your and your patient’s state.

You can review the licensing board websites for both states, and search for telemedicine to find applicable statutes, regulations, and board policies.

If you cannot find any such telemedicine requirements for a state, you can follow the guidelines of the Federation of State Medical Boards.  This association of all state medical and osteopathic licensing boards has developed telemedicine guidelines, which some states have adopted as drafted, and other states have adopted modified versions of the guidelines. 

REIMBURSEMENT:

I’ve been contacted by a health plan and told I must provide written quality of care protocols and confidentiality protocols for telemedicine visits.  Do you have any resources?

In normal times, the health plan would typically be sending those telemedicine guidelines to you!  You should be able to easily create the requested protocols by using the model guidelines for telemedicine from the Federation of State Medical Boards (FSMB).  You can supplement these guidelines with any state-specific telemedicine standards that your state may have.  To find state requirements, you can search the internet for the name of your state licensing board and “telemedicine.”  You can also go directly to the board’s website and search “telemedicine.”  The FSMB has a directory of state licensing boards.

Many of my colleagues are positive that they can see Medicare patients in states where they are not licensed.  They report that licensure requirements have been officially waived by Medicare / CMS / HHS.  Is this right?

There continues to be much confusion around this.  There is a waiver of state licensure requirements when treating Medicare patients, but that is only a waiver of a Medicare requirement for PAYMENT - it is NOT a waiver of state licensure requirements from the patient’s state licensing board.

For more information:

 - From CMS:  CMS has “temporarily waive(d) Medicare and Medicaid’s requirements that physicians and non-physician practitioners be licensed in the state where they are providing services.  State requirements will still apply...This waiver does not have the effect of waiving State or local licensure requirements or any requirement specified by the State or local government as a condition for waiving its licensure requirements.”

 - From the American Telemedicine Association: “This waives Medicare and Medicaid requirements that a provider be licensed in the state where the patient is, but does not preempt states’ licensing requirements.”

- From JDSupra article:  “These waivers alone do not waive the requirement for physicians and other healthcare providers to maintain licensure in states where they are practicing a licensed profession, including via telehealth.  State law continues to govern whether a provider is authorized to provide professional services in that state without holding active license from that state’s medical board.”

(Added 4/8/20)

Is it true that CMS is now paying for more telephone sessions?

Yes!  For more information, click here.  (Added 5/11/20)

 

 

I’ve heard that the DEA waiver of the one in-person visit requirement before prescribing controlled substances has expired.  Is that true?

No.  The DEA did recently issue a Final Rule to finalize a regulation under the Ryan Haight Act.  The formal name for this law is the Ryan Haight Online Pharmacy Consumer Protection Act, and as the name indicates, the law’s primary focus is online pharmacies.  The in-person requirement is the DEA’s way to protect the public from prescriptions based solely on an online questionnaire.  The new Final Rule related to the Ryan Haight Act relates to online pharmacies and actually consists of minuscule changes to the Interim Rule covering the issue.  For more information on this new Final Rule:

  • From the DEA.
  • From an attorney blogger who focuses on DEA actions (not limited to telemedicine).

This Final Rule did, in the comments, cover the in-person requirement, but in the context of that requirement’s purpose - to protect the public from online pharmacies filling prescriptions based solely on an online form.

Interestingly, the comments note the DEA’s obligation to have issued a regulation for the telemedicine registration that was due October 2019.  The DEA indicated more on that would be forthcoming in the future.

The DEA’s temporary waiver of the in-person visit requirement due to the pandemic will expire when HHS declares the public health emergency  (PHE) expires.  The PHE is currently set to expire October 23rd, has already been extended to January. See next FAQ below. 

While everyone doing telemedicine is hoping that the DEA will decide to not put this in-person visit requirement back into effect after the PHE expires, we do wonder if the DEA by mentioning this requirement in the Final Rule is signaling that it will go back into effect post-PHE.

(Added 10/5/20)

Have you heard anything about the Public Health Emergency (PHE) being renewed?

Yes!  It has already been renewed.  On October 2nd, the Secretary of HHS’ Declaration of Public Health Emergency, set to expire on October 23rd, has been renewed, effective October 23rd.  So the PHE has been extended 90 days from October 23rd, so mid-January.

(Added 10/5/20)

If I am treating patients in the state where I am licensed but am not currently in that state myself, do I need a license and/or DEA registration for the state in which I am currently located?

Presuming you are not just there for vacation, you should keep the following in mind:

  • Before the Public Health Emergency (PHE), to prescribe controlled substances, you needed a DEA registration in the state where you are located as well as in the patient’s state, if different. See slide 36 of this DEA presentation.
    • Note that pre-PHE, the DEA often denied the registration in the patient’s state if the physician did not have a mailing address in the patient’s state.
    • During the PHE, the DEA has temporarily waived the requirement of having a registration in the patient’s state.
    • While we can hope this remains waived post-PHE, the DEA may go back to requiring the registration in the patient’s state.

If you have relocated to a new state:

  • If you will treat patients in your new state, you need to ensure licensure requirements in your new state are met.
    • And you will need a DEA registration in that state to prescribe controlled substances. Depending on where your patients are located, and on whether the DEA again requires registration in the patient’s state post-PHE, you may be able to transfer your existing DEA registration to your new state.
  • If you will not be treating patients in your new state:
    • Ensure you are meeting licensure requirements in your patients’ states
    • And check with your state’s licensing board to confirm no license in your state is needed since you are not treating patients in your state.
    • Note that if you need a DEA registration in your state, the DEA website currently says state licensure is required for a DEA registration.

(Added 9/1/2020)

I’ve been told by the telepschiatry company I work for not to worry about the Ryan Haight Act, specifically the requirement for one in-person visit prior to prescribing controlled substances.  I realize this requirement has been temporarily lifted during the pandemic, but my guidance from the company was pre-COVID.  When the provision is back in effect, I doubt the company’s position will change.  The company basically says that since no one else follows the in-person visit requirement, we do not have to either, because the standard of care is determined by what everyone else is doing.  Now I’m questioning whether this is accurate.

You should keep at least these two points in mind:

  1. The standard of care is relevant in medical malpractice litigation, which is citizen versus citizen (such as patient versus physician).  But the factor with the most weight in determining the standard of care in a lawsuit is compliance with federal and state laws, such as the Ryan Haight Act.
  2. You also have another professional liability exposure which may be more relevant.  That additional exposure is an administrative investigation by a regulatory agency.  This is government versus citizensuch as the DEA investigating a physician for violating the Ryan Haight Act.  In such an action, there is no standard of care issue.  Rather, the only issue is whether the physician complied with the law.  It is irrelevant that other physiciansalso did not comply with the law.

Given how complicated this issue is, you may want to review this resource that details the requirement for the in-person visit and the very limited exceptions. 

I need a summary of federal requirements  for prescribing controlled substances - what types of visits are allowed, how to get prescriptions to pharmacies, etc.  Where can I find this information?  

The DEA has a great resource.  Also keep in mind that states can have their own requirements and restrictions.

(Added 4/8/20)

Am I able to prescribe controlled substances on the basis of a telepsychiatry encounter?

This requires careful analysis, as there could be restrictions on prescribing controlled substances under both federal and state law.

Federal law:  If you have not seen the patient at least once in person, the Ryan Haight Act amendment to the Controlled Substances Act precludes you from prescribing controlled substances without that one prior in-person visit.  There are a few, very limited exceptions to this prohibition, including:

  • A public health emergency (see next question below)
  • A federal telemedicine registration, which does not exist yet, despite the fact that the DEA was required roll this out in October 2019
  • Other exceptions

For more details, see the Foley & Larder article and the Telepsychiatry Checklist under “Telepsychiatry Resources” below.

State law:  States can also have legal requirements related to prescribing controlled substances that would have to be followed.  This is true even if there are no federal prohibitions, such as prescribing for a patient you have seen in person before. Also, state law prescribing requirements may not be limited to controlled substances.

I want to treat new patients via telepsychiatry, and it is likely that I will be prescribing controlled substances.  I’ve done the research and have found the exception to the one in-person visit requirement for public health emergencies, which we currently have.  Any problems prescribing controlled substances to new patients via telepsychiatry based on this exception?

HHS Secretary Azar declared a public health emergency on January 27, 2020.  This declaration lasts for the duration of the emergency or 90 days, but it may be extended.  For the duration of the emergency, you should document the public health emergency as the basis for prescribing controlled substances without the in-person visit.  We do not know whether there will be a requirement for an in-person evaluation post-emergency, but in determining which patients you accept, you may want to consider this possibility.

A few more points to consider:

  • The fact that there is a public health emergency does not change the standard of care. You must ensure that your online examination is sufficient to support the prescribing of the chosen medication.
  • You must still meet state law requirements. If a particular state requires an in-person examination prior to prescribing controlled substances, you must still conduct such an examination unless the state has a similar public health emergency exception.
  • There is a possibility that this situation will encourage drug seekers so you will want to be cautious with your patient selection.
  • Be sure check the Prescription Monitoring Program prior to prescribing.

The DEA has issued a statement confirming this public health emergency declaration exception. (Added 3/19/20)

HHS’ declaration of a public heath emergency (PHE), which is the exception to the one in-person visit requirement prior to prescribing controlled substances, has been renewed, effective April 26, 2020.  PHE declarations last 90 days, unless cancelled earlier. (Added 4/24/20)

The DEA has also issued a waiver of the requirement to have a DEA registration in the patient’s state to prescribed controlled substances. (Added 9/2/20)

What have you heard about criminals posing as OCR investigators seeking patient information?

OCR posted on its Privacy and Security listserves an alert about reports of someone posing as an OCR investigator contacting providers by telephone seeking patient information.  For more information, click here

(Added 4/6/20)

Are there any HIPAA or 42 CFR Part 2 related concerns?

If you are doing telepsychiatry, you need to protect the confidentiality and security of your patients’ information.  You’ll need a HIPAA-compliant platform, and Business Associate Agreement from the vendor, as addressed above under “Telemedicine Platform.”

For more information on coronavirus-related disclosures, you may want to review an article by the law firm of Foley & Lardner

For more information from OCR:

(Added 3/26/20)

I’ve seen many news reports showing hospitalized patients.  Didn’t hospitals get in trouble in the past for violating HIPAA by allowing cameras in the hospital?

Yes, several hospitals entered resolution agreements with OCR in the past based on allowing reality TV shows to be taped in the ER without having patients’ authorizations.  And OCR has just put out a guidance document saying media cannot film in hospitals without patient authorization - and specifically said blurring patients’ faces does not comply with HIPAA.

(Added 5/8/20)

We have a substance use disorder treatment program.  What has SAMHSA said related to COVID-19?

SAMHSA has put out at least these three resources:

(Updated 4/8/20)

I’ve heard that phishing attempts have actually increased since the coronavirus outbreak.  What should we be looking for to stop these attempts?

Unfortunately criminals have already seen the coronavirus as an opportunity to breach systems’ security to access patient information.  To manage the risks associated with an increase in phishing activity, keep these points in mind:

  • Be wary of emails with coronavirus in the subject line, unless it is from a known sender
  • Consider ignoring coronavirus emails from unknown senders and seeking information directly from the CDC website or WHO website.
  • Be aware that there is a large amount of “internet click bait” on websites offering information or fake articles about the coronavirus.

For more information and guidance on defending against coronavirus-related cyber scams: www.us-cert.gov/ncas/current-activity/2020/03/06/defending-against-covid-19-cyber-scams  (Updated 3/19/20)

The AMA has issued guidance “Working from home during the COVID-19 pandemic - what physicians need to know”. (Added 4/16/20)

The FBI on 4/21 issued a Flash Alert, COVID-19 Email Phishing Against US Healthcare Providers.  This alert provides specific details about phishing emails, including sender names, subjects, and attached file names.  (Added 4/23/20)

In light of the pandemic, I now realize that some advanced planning for disasters would have been helpful.  Do you have any planning resources?

Related to contingency planning, we have two articles – Disaster Planning and Failing to Plan.  We also have a tool to help you get started.

In the event your practice suddenly needs to be closed, we have an article on closing on short notice and the APA has a resource document from 2007.

(Added 5/7/20)

There are so many ethic issues raised during this pandemic.  Have you seen any guidance for psychiatrists?

Yes, the APA has issued several new COVID-related ethics opinions  

(Added 5/21/20)

What else do you have to help me with telepsychiatry?

We have several resources that should be useful to you:

What are other organizations offering?

From the AMA:

From the APA:

(Added 3/26/20)

I’m not sure how to go forward with my solo practice in light of coronavirus.  I am not set up for telemedicine but I do not feel comfortable seeing patients in my office.  Do I have to figure out a way to do all appointments remotely or can I basically put my practice on hold?

The answer depends on your patients’ clinical needs.  You must continue to meet their clinical needs until you formally terminate the treatment relationship.  Ethically, it does not seem reasonable or appropriate to terminate based solely on access issues raised by coronavirus.

If you have a small practice, and all patients are stable, it may be sufficient to monitor your patients through telephone contact. Depending upon the patient, you may decide that even this is not immediately necessary.  Conversely, if you have high risk patients on high risk medication with significant side effect possible, you will need to figure out a way to provide appropriate clinical care, such as via telepsychiatry.

Either way, your current patients all need a way to contact you, as always.

I can make arrangements to treat my patients remotely, but insurance companies rarely reimburse for telephone calls and not all reimburse for telepsychiatry visits.  Am I expected to treat for free?

The standard of care is the same, whether treating patients in person or remotely.  That standard is to provide good clinical care.  Unfortunately, in this public health emergency, your services may not be reimbursed at the same rate, or possibly not at all.  Now more than ever, physicians need to understand that the standard of care is not based upon whether they will be compensated for their services. 

At what point is it unethical to keep my office open and see patients in person?

While we are not the ethics experts, here are our risk management thoughts: 

  • Location is one important factor to consider.  While we are all asked to practice social distancing, in those states where the governor has asked citizens to stay home, you should begin treating patients remotely.  If you are in an area where the coronavirus does not appear at this time to be as prevalent, you may have some time to continue to see patients in person, but unfortunately, we believe you should start planning to treat patients remotely.
  • Keep in mind that asymptomatic patients could transmit coronavirus patients.
  • It is also important to keep your own health in mind, and the more interaction with people you have, the greater the risk for you.
NEW YORK ONLY:  I’m licensed in New York and just received an alert that I need to do an attestation for New York’s Office of Mental Health (OMH) to see via telemedicine.  I do not know anything about this – does it apply to me?

It may not apply to you – it only applies to “programs” licensed by OMH.  Private psychiatrists not operating under an OMH license do not need to do the attestation.

Can I be reimbursed by third-party payers for telemedicine? 

Some payers will reimburse for telemedicine; others will not.  If reimbursement is possible, be sure to check any requirements, such as minimum equipement requirements, imposed by the payer.  If you are an APA member, you may contact them with reimbursement questions.

Note: The federal government has relaxed several requirements related to the provision of telemedicine services to federal health program beneficiaries, such as Medicare and Medicaid patients. But these federal waivers relate to government payment only – state law still controls whether a license is required to treat patients in that state. (Added 3/20/20)

For more information on Medicare and telehealth, CMS has issued FAQs. (Added 3/26/20)

Have you heard anything about reimbursement for remote treatment from any health plan?

Here is what Optum put out on 3/19/20.  You may also want to contact your District Branch for additional information.  (Added 3/25/20)

Are there guidelines specific to a medical office that does not treat coronavirus?

In terms of guidelines, the ones we are currently aware of address medical offices that are seeing and treating patients with suspected coronavirus.  The CDC has compiled various resources, including:

  • Information for healthcare professionals
  • Information for keeping workplaces safe 
Is there a good source of resources about coronavirus in general?

In addition to CDC, the ACCME has compiled various education resources that can be accessed here