Telehealth After COVID: Federal and State Considerations
- December 01, 2021
- Kyle Faget , Foley & Lardner LLP
This article explores how states and the federal government pivoted to make telehealth more accessible during the COVID-19 public health emergency, and how loss of the flexibilities afforded during the pandemic may impact the ability to deliver care via telehealth post-pandemic. Issues explored include state licensure requirements, waivers thereto, the interstate medical licensure compact and similar compacts available for other provider types, and exceptions to licensure that may enable providers to continue delivering care in certain situations post-pandemic across state lines. Additionally, this article explores relaxed telehealth practice requirements applicable to Medicare, how DEA registration requirements do not fit telehealth care delivery models, waiver of the in-person physical examination required in advance of prescribing controlled substances and how failure to continue this practice will stifle certain critical telemedicine offerings.
Telehealth use skyrocketed during the public health emergency (PHE) that was catalyzed by the COVID-19 pandemic. Many providers had to quickly adapt to using a platform that had previously been overlooked by many as underdeveloped and too complicated. Patients and providers alike questioned whether health care delivered virtually could be “good health care.” Moreover, use of telehealth technology and familiarizing oneself with the applicable legal and regulatory practice standards were shunned as too complicated, especially when a number of states did not require insurers to compensate clinicians for virtual visits or to compensate them at the in-office rate. For many, the barrier to entry was too high until COVID-19 compelled everyone to make telehealth the norm rather than the exception.
States and federal agencies responded to the need for virtual care by implementing waivers that allowed for seamless telehealth practice. Many clinicians had never practiced telehealth without reliance on waivers, and those who are well-versed in telehealth are understandably concerned about what telehealth practice will look like when the waivers expire: Will clinicians be expected to revert to brick-and-mortar practice? Will clinicians have to educate themselves about compliant telehealth practice and institute such practices overnight? Will there be legislative efforts to make the waivers permanent? While the answers may not be immediately clear, there are some specific issues at the state and federal levels that deserve careful attention.
The following section will address state considerations, such as licensure requirements, exceptions to those requirements, licensure compacts, and licensure waivers.
General Licensure Requirement
All clinicians are required to comply with the licensure requirements of the state(s) in which they practice medicine, which is determined by the location of the patient at the time of the telehealth visit. For example, a Massachusetts-licensed clinician is practicing medicine in the state of Vermont if she has a telehealth visit with a patient who is physically located in Vermont. In this case, the clinician would need a license to practice in Vermont.
Most states require physicians to be fully licensed in the state where a patient is located at the time of the telehealth visit, but not all of them explicitly address the telehealth services in relevant licensing statutes. Where states do not specifically address telehealth in their licensing statutes, the default assumption is that a full license is needed to provide telehealth services to patients located in those states. Some states, such as Florida, Maine, and Minnesota allow physicians to obtain special purpose licenses or registrations to practice telemedicine in their state.
Exceptions to general licensure requirements include the bordering state exception, peer-to-peer consultation, and the follow-up care exception, all discussed in the following section.
The bordering state exception allows physicians from bordering states to practice across state lines. One such example is Virginia, which provides license reciprocity for physicians providing telemedicine services to patients in Virginia if the physician is licensed in a bordering state, which includes Maryland, Washington D.C., North Carolina, Tennessee, Kentucky, and West Virginia.
The peer-to-peer consultation exception provides that out-of-state physicians who are consulting with a physician in a given state need not be licensed in that state. In these circumstances, the out-of-state physician typically must be licensed in the state where the physician is physically located, and the in-state physician must be licensed in the state where she and the patient are located. The in-state physician is responsible for maintaining the physician-patient relationship, while the out-of-state physician’s services are only for secondary consultation purposes.
Some states with peer-to-peer consultation exceptions do allow the out-of-state physician to have direct contact with the patient, with limitations. For example, an out-of-state physician is exempt from Minnesota licensure requirements if 1) she is licensed in another state, 2) provides interstate telemedicine services in consultation with the Minnesota-based and licensed physician, and 3) the Minnesota-based and licensed physician retains ultimate authority over the diagnosis and care of the patient.The scope of the peer-to-peer consultation exception varies between states. In Connecticut, a physician who provides only “irregular” consultations is exempt from state licensure requirements, though “irregular” is not defined. In Iowa, state law specifically requires that a physician “practices in Iowa for a period not greater than 10 consecutive days and not more than 20 total days in any calendar year” to fall under the purview of the exception.
The follow-up care exception allows an out-of-state physician to provide follow-up care without needing to obtain licensure in the state where the patient is located. In Kansas, for example, an out-of-state physician may provide verbal, written, or electronic communications that are incidental to services that she lawfully provided and conveyed to any patient located in Kansas.Additionally, the Kansas licensure requirement does not apply to any health care provider who in good faith renders emergency care or assistance at the scene of an emergency or accident. Oregon is another example of a state that has a licensure exception for a licensed physician located outside the state, but who has an established physician-patient relationship with someone who is in Oregon temporarily and requires that physician’s direct medical treatment.
Licensure exceptions aside, a clinician hoping to practice telehealth with regularity across state lines is best served by obtaining a full, unrestricted license to practice within the state or a special telehealth license or registration where possible. The licensure process can be time intensive, taking anywhere from 6 months to over one year. One expedited pathway to licensure for qualified clinicians who seek to practice in multiple states is the Interstate Medical Licensure Compact (IMLC) and the Nurse Licensure Compact (NLC). Generally, a licensure compact is an agreement between states to work together to streamline the licensing process by leveraging the existing information previously submitted by a licensed clinician in their state of principal licensure.
To be eligible for licensure via the IMLC, a physician must: 1) hold a full, unrestricted medical license in a member state and either live, work, or conduct at least 25% of her practice of medicine in that state; 2) have graduated from an accredited medical school or an eligible international medical school; 3) successfully completed ACGME or AOA accredited graduate medical education; 4) passed each component of the USMLE, COMLEX-USA, or equivalent in no more than three attempts; 5) hold a current specialty certification or time-unlimited certification by an ABMS or AOABOS board; 6) have no history of disciplinary action toward her medical license; 7) have no criminal history; 8) have no history of controlled substance actions toward her medical license; and 9) not currently be under investigation. The IMLC currently includes 30 states, the District of Columbia, and the Territory of Guam.The NLC currently includes 38 states. As additional states enact the IMLC, the more coordinated the process of interstate medical licensure and practice will become. Physicians who are not eligible for the expedited process can still seek additional licenses in member states using the traditional state-by-state process. What becomes clear to any clinician hoping to practice across the country is there is no expeditious route for obtaining the required licensure everywhere.
COVID-19 exacerbated the severe shortage of health care providers in states overwhelmed by the pandemic, and it inspired many states to pass emergency executive orders that implemented licensure waivers, thereby allowing clinicians to practice across state lines. For example, an Executive Order allowed licensed physicians in current good standing in any state to practice medicine in New York without civil or criminal penalty related to lack of licensure or registration(this Executive Order expired on June 25, 2021).
In an advisory notice, New York’s Office of the Professions noted its understanding of the concern regarding the short notice of the expiration of the COVID-19 Disaster Emergency, and stated it will take that into consideration in any potential inquiries involving activity that had previously been authorized by Executive Order 202 and its successor Executive Orders at this time.Nonetheless, there exists an expectation that licensed professionals exercise due diligence and good faith efforts to return to compliance with all statutory and regulatory requirements without delay.
In Florida, for purposes of preparing for, responding to, and mitigating any effect of COVID-19, health care professionals, advanced life support professionals, and basic life support professionals holding a valid, unrestricted, and unencumbered license in any state, territory, and/ or district were enabled to render such services in Florida provided that the health care professional did not represent or hold herself out as a health care practitioner licensed to practice in Florida.Moreover, physicians (both medical and osteopathic), physician assistants, and advanced practice registered nurses not licensed in the state of Florida were enabled via Emergency Order to provide health care services to a patient using telehealth. Florida’s emergency waivers ended on June 26, 2021. The Florida Department of Health issued a guidance update noting that out-of-state health care practitioners are no longer authorized to render services for patients in Florida unless they become licensed to practice in Florida.
Although several states still have licensure waivers in place,many have either actively ended their emergency declarations or simply allowed their emergency declarations to expire, which is creating one of the largest hurdles clinicians face when contemplating practicing via telehealth across state lines: licensure. Observers have questioned whether the pandemic will cause states to rethink their approach to licensure. So far, there is no evidence to support the commencement of a national licensure system, and there is little evidence to suggest states will move toward a more flexible licensure system. Nonetheless, the pandemic may be a catalyst for more states to join licensure compacts. For example, Delaware’s Telehealth Access Preservation and Modernization Act of 2021 will bring Delaware into the IMLC effective July 1, 2022, making it easier for out-of-state physicians to become licensed to provide telemedicine services in Delaware. Time will tell if more states follow suit.
State laws and regulations are not the only place where physicians have enjoyed relaxed licensure and registration requirements. This section discusses temporary Medicare flexibilities and Drug Enforcement Administration (DEA) registration requirements and applicable waivers.
Relaxed Telehealth Practice Requirements Applicable to Medicare
Then-Secretary of the U.S. Department of Health and Human Services (HHS), Alex Azar, declared the existence of a PHE on January 27, 2020. On March 13, 2020, the President of the United States issued a proclamation that the COVID-19 outbreak in the U.S. constituted a national emergency. When the President of the United States declares a major disaster under the Stafford Act or an emergency under the National Emergencies Act, and the HHS Secretary declares a PHE under section 319 of the Public Health Service Act, the Secretary is authorized to take certain actions in addition to his or her regular authorities under section 1135 of the Social Security Act (SSA). Under section 1135 of the SSA, the Secretary may waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP), and Health Insurance Portability and Accountability Act (HIPAA) requirements as necessary to ensure, to the maximum extent feasible, that sufficient health care items and services are available—for the duration of the emergency and in the areas impacted by the emergency—to meet the needs of individuals enrolled in SSA programs. In addition to the 1135 waivers, Congress passed and the President signed several bills that provide varying degrees of regulatory and financial relief for health care providers during the COVID-19 PHE.These bills have triggered a cascade of actions from the Centers for Medicare & Medicaid Services (CMS) designed to increase flexibilities for providers and increase access to and use of telehealth services.
Pre-pandemic, Medicare coverage for telehealth services was only available to patients in certain geographic locations, i.e., a rural Health Professional Shortage Area (HPSA) in a rural census tract or a county outside of a Metropolitan Statistical Area (MSA). During the PHE, Medicare geographic telehealth coverage limitations do not apply. Before COVID-19, Medicare coverage for telehealth services was only available when patients received telehealth services at certain qualifying originating sites or at the place where a patient is located at the time telehealth services are delivered. For example, Medicare coverage for telehealth services was only available if a patient was physically present at a physician’s office, hospital, critical access hospital, or community mental health center, etc. when receiving telehealth services. These originating site restrictions have been temporarily lifted during the PHE, allowing patients to receive telehealth services in their homes and have those services be covered by Medicare. Another temporary flexibility enjoyed by providers reimbursed by Medicare is the expansion of provider types that may provide Medicare-covered telehealth services. Prior to COVID-19, only certain providers could engage in Medicare-covered telehealth services, i.e., physicians, nurse practitioners, physician assistants, nurse-midwives, clinical nurse specialists, certified registered nurse anesthetists, clinical psychologists, clinical social workers, registered dietitians, and nutrition professionals. CMS expanded the types of distant site health care providers who may provide telehealth services to include all providers who are eligible to bill Medicare for their professional services, e.g., physical therapists, occupational therapists, and speech language pathologists. Medicare reimbursement of telehealth services has historically been conditioned upon the use of real-time audio-visual communication. However, during the PHE, CMS has temporarily made coverage available for a limited number of services via audio-only communication.
In addition to the practice standard flexibilities made available to health care providers and Medicare beneficiaries during the PHE, CMS made payment for telehealth services the same as payment for in-person services. CMS also temporarily expanded the number of telehealth services eligible for reimbursement by adding 160 reimbursable services on a temporary basis, e.g., emergency department visits, physical and occupational therapy.Some of these services were made reimbursable on a permanent basis, and the calendar year (CY) 2021 physician fee schedule was updated to include a number of additional telehealth codes. For CY 2022, CMS received several requests to permanently add numerous services to the list of covered Medicare telehealth services, but none of them met CMS’s criteria for permanent addition to the Medicare telehealth services list. It is expected therefore that Medicare reimbursement for numerous codes will expire upon the conclusion of the PHE.
DEA Registration Requirements
The federal Controlled Substances Act (CSA) provides that every practitioner who prescribes any controlled substance must register with the federal DEA.DEA practitioner registration is based on a state license to practice medicine and prescribe controlled substances. The DEA relies on state licensing boards to determine whether a practitioner is qualified to dispense, prescribe, or administer controlled substances and to determine which schedules the practitioner may dispense, prescribe, or administer. State authority regarding dispensing, prescribing, or administering controlled substances is limited to the issuing state; a DEA registration based on a state license cannot authorize controlled substance dispensing outside the state. Therefore, when an individual practitioner practices in more than one state, the practitioner must obtain a separate DEA registration for each state by filing a separate application for each state.
To obtain a DEA registration, a practitioner must apply using DEA Form 224.A separate registration is required for “each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person.” However, the practitioner is not required to register with DEA for multiple locations within a single state where the practitioner is already registered if the practitioner only prescribes controlled substances at that secondary location (i.e., does not maintain supplies of controlled substances, administer, or directly dispense at that location). The DEA has noted that an individual practitioner may use their home address as the principal place of business or professional practice, but may not use a Post Office box or Private Mailbox (PMB) address as the practitioner’s registered address.
The DEA has made clear that a practitioner’s registered address must be the physical location of one’s principal place of business or professional practice where controlled substances are manufactured, distributed, imported, exported, or dispensed.This requirement has historically been difficult for telehealth clinicians to satisfy. While it is not uncommon for a clinician to be licensed or registered to practice in a state other than where she is physically located, many of them do not have a corresponding brick-and-mortar presence in those other states. DEA registration laws and regulations do not expressly address the registration process for a telemedicine clinician who has no physical brick-and-mortar location in a state.
Waiver of the Registration Requirement
In response to the PHE, and to ensure adequate medical care for the duration of this PHE, the DEA has granted an exception for practitioners to those provisions of DEA regulations that normally require practitioners to register in each state where they dispense controlled substances.The DEA specifically provided,
“Under the exception being announced today, DEA-registered practitioners are not required to obtain additional registration(s) with DEA in the additional state(s) where the dispensing (including prescribing and administering) occurs, for the duration of the public health emergency declared on January 31, 2020, if authorized to dispense controlled substances by both the state in which a practitioner is registered with DEA and the state in which the dispensing occurs.”
Thus, practitioners need only be registered with the DEA in one state and have permission under state law to practice using controlled substances in the state where the dispensing occurs. Moreover, practitioners are not required to apply for this exception from the DEA individually; the DEA has instead granted this exception to all DEA-registered practitioners who satisfy the conditions in the letter. Note, however, that although the DEA waived its registration requirement, practitioners must still adhere to state-controlled substance prescribing registration requirements, if applicable.
The DEA’s registration exception has resulted in an influx of practitioners providing care and prescribing controlled substances across state lines without having a physical brick-and-mortar location in each state. Entire practices have been established in reliance on the registration exception, which will expire when the PHE ends. Unless a legislative fix is enacted to address the physical location requirement before the PHE expires, practitioners will need a plan for coming into compliance with pre-pandemic registration requirements.
Waiver of the In-Person Physical Examination Requirement
In advance of COVID-19, the Controlled Substances Act (CSA) required that a prescription for a controlled substance issued by means of the Internet must, absent a waiver, be predicated on an in-person medical evaluation.Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) amended the federal CSA by adding a series of new regulatory requirements and criminal provisions designed to combat the proliferation of so-called “rogue Internet sites” that unlawfully dispensed controlled substances by means of the Internet via form-only online prescribing for controlled substances. With respect to telemedicine practices and remote prescribing, no controlled substance may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. The term “valid prescription” means a prescription 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. The term “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals. Once the prescribing practitioner has conducted an in-person medical evaluation, the regulation does not set an expiration period or a requirement for subsequent annual examinations.The Ryan Haight
The in-person examination requirement under the Ryan Haight Act and its implementing regulations has presented a barrier to legitimate telemedicine practitioners who prescribe controlled substances as part of their clinical practice. Although there are some exceptions to the in-person exam requirement, none readily apply to a direct-to-patient service where the patient is at the patient’s home, for example.Although the DEA is currently in the process of drafting regulations that will create a special registration process allowing physicians and nurse practitioners to prescribe controlled substances via telemedicine without an in-person exam, the regulations were required to be promulgated by October 24, 2019; there is currently no indication as to when the DEA might roll out these regulations.
The DEA articulated another exception to the registration requirementsby temporarily waiving the in-person exam requirement during the PHE. The waiver requires that “telemedicine communication be conducted using an audio-visual, real-time, two-way interactive communication system” (i.e., the prescriber must always use audio-video prior to prescribing a controlled substance to meet federal law and regulations).
Exception to the In-Person Physical Examination Requirement
The DEA exception has enabled practitioners to utilize telehealth for prescribing across state lines without a registration and without an in-person physical examination. This practice has been in place since March 25, 2020, but it will no longer be available when the PHE abates. Since the COVID-19 pandemic began, a number of national telehealth companies have come to rely on these waivers for legitimate telemedicine practice, and there is no reason to believe that an in-person physical examination would not be required when the PHE ends, as is required by statute. It is possible that the DEA will roll out special registration for telemedicine prescribing in advance of the PHE’s conclusion, but the rollout will likely need to occur well in advance of the PHE’s expiration so that practitioners have time to navigate the registration process. Alternatively, legislation that addresses the statutorily-based in-person physical examination requirement could be passed before the PHE concludes.
Short of legal fixes, practices will need to come into compliance with the applicable laws and regulations or transfer care to another practitioner who can offer care compliantly. Either route will be disruptive for patients and stressful for practitioners. One hopes that policy makers will consider continuity of care when deciding how to transition from being in a state of public health emergency to operating under less exigent circumstances.
Telehealth is a silver lining flowing from the COVID-19 pandemic, but what has really enabled telehealth to flourish is the existence of temporary waivers. The telehealth-directed waivers removed barriers that had either deterred or prohibited robust telehealth practice. Rolling back the waivers could have the unintended effect of stifling telehealth once again. Stifling this mechanism of delivering care does not make sense given how successful telehealth has been for treating certain conditions. States understandably want to have insight into and control over who is delivering care in their states. That said, licensure compacts provide an efficient mechanism for licensure without sacrificing diligence. Unless licensure boards are simply trying to cap the number of licensed providers available in a given state, the licensure compacts present a viable option for streamlined licensure.
On the federal level, the pre-COVID DEA system of registration and practice did not lend itself to telehealth practice. The DEA’s wavier of registration requirements allowed practitioners to practice across state lines without needing to secure multiple DEA registrations. If the physical location requirement was removed from the registration process, practitioners could enjoy the geographic freedom they have enjoyed throughout the current PHE. Additionally, if the in-office physical examination requirement was removed, practitioners could continue providing care to the thousands of patients who have been prescribed, and will continue to be prescribed, controlled substances. The legislative fix needs to ferret out the real culprit, which is form-only online prescribing (medical records-based prescribing) as opposed to legitimate telehealth services; however, these federal issues require legislative action. Coalitions therefore need to start pressuring legislatures now instead of waiting until this current PHE comes to an end.
Kyle Faget is a partner and business lawyer with Foley & Lardner LLP. She is the Co-Chair of firm’s Health Care Practice Group, Co-Chair, Health Care & Life Sciences Sector – Medical Devices, and a core member of the firm’s life sciences and telemedicine industry teams. Kyle advises investors, academic medical centers, physician practices, and consultants on a range of business, legal and regulatory issues affecting the telemedicine industry. Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code. She regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products, including licensing agreements, collaboration agreements, clinical trial agreements, and an array services agreements. Prior to joining the firm, Kyle held in-house positions at pre-commercial and commercial stage companies. Contact her via email at [email protected].
1 Fla. Stat. § 456.47(4); Me. Rev. Stat. tit. 32, § 3300-D(3); Minn. Stat. § 17.032 Subd. 1(a).
2 Virginia Code § 54.1-2901(A)(7).
3 Minn. Stat. § 147.032, Subd. 2(3).
4 Conn. Gen. Stat. § 20-9(d); Iowa Admin. Code § 653-9.1.
5 See Kan. Admin. Regs. 100-26-1; see also Kan. Admin. Regs. 100-26-3.
6 Kan. Stat. § 65-2803(b); see also id. § 65-2872(a) (“The practice of the healing arts shall not be construed to include the following persons: (a) Persons rendering gratuitous services in the case of an emergency.”).
7 See Or. Rev. Stat. § 677.137(4); Or. Admin. R. 847-025-0020(3) (licensure exception for a physician “Located outside the state and has an established physician-patient relationship with a person who is in Oregon temporarily and who requires the direct medical treatment by that physician.”).
8 Interstate Medical Licensure Compact, Introduction, https://www.imlcc.org/a-faster-pathway-to-physician-licensure/.
10 Executive Order No. 202.5 (Mar. 18, 2020); Executive Order 202.10 (Mar. 23, 2020).
14 State of Florida, Department of Health, Emergency Order, DOH No. 20-002 (Mar. 16, 2020).
15 See id.
17 See e.g., Nevada, Declaration of Emergency Directive 050 (Sept. 2, 201); Iowa, Emergency Proclamation (Aug. 19, 2021).
18 Delaware, H.B. 160 (effective July 1, 2021), https://legis.delaware.gov/json/BillDetail/GenerateHtmlDocument?legislationId=58579&legislationTypeId=1&docTypeId=2&legislationName=HB160.
19 See Public Law No: 116-136, Coronavirus Aid, Relief, and Economic Security Act’’ or the ‘‘CARES Act’’ (Mar. 27, 2020); Public Law 116–123, Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Mar. 6, 2020) CMS, Interim Final Rule, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-5531) (Spring 2020).
20 For example, telephone E/M codes 99441–99443.
21 See CMS, List of Telehealth Services, https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.
22 e.g., group psychotherapy (CPT code 90853), psychological and neuropsychological testing (CPT code 96121), domiciliary, rest home, or custodial care services, established patients (CPT codes 99334-99335), home visits, established patient (CPT codes 99347-99348), cognitive Assessment and care planning services (CPT code 99483), visit complexity inherent to certain office/outpatient E & M (HCPCS code G2211), prolonged services (HCPCS code G2212). See CMS, Physician Fee Schedule, https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched.
23 See supra note 21.
24 See 21 U.S.C. § 822(a)(2) (“Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney general a registration issued in accordance with the rules and regulations promulgated by him”); see also 21 U.S.C. § 802(10) (“The term ‘dispense’ means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term ‘dispenser’ means a practitioner who so delivers a controlled substance to an ultimate user or research subject.”).
25 DEA, Registration Q&A, https://www.deadiversion.usdoj.gov/faq/registration_faq.htm; 21 U.S.C. 823(f)).
26 DEA, Registration Q&A, https://www.deadiversion.usdoj.gov/faq/registration_faq.htm; see Registration Requirements for Individual Practitioners Operating in a “Locum Tenens” Capacity, 75 FR 55499, 55501 (Oct. 28, 2009).
27 75 Fed. Reg. 55499, 55501 (Oct. 28, 2009).
28 See DEA Form 224, New Application for Registration, https://www.deadiversion.usdoj.gov/drugreg/reg_apps/224/224_instruct.htm.
29 See 21 C.F.R. § 1301.12(a); DEA, Registration Q&A, https://www.deadiversion.usdoj.gov/faq/registration_faq.htm; see also 21 C.F.R. § 802 (defining “dispense” to include “the prescribing and administering of a controlled substance”).
30 71 Fed. Reg. 69,480, 69,479 (Dec. 1, 2006).
31 DEA, Registration Q&A, https://www.deadiversion.usdoj.gov/faq/registration_faq.htm.
33 Id.; 21 CFR 1301.12(a).
34 DEA, Letter to Registrants (effective March 25, 2020), https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf
36 Notwithstanding the DEA federal rules, physicians still must comply with state laws on controlled substance prescribing. If a state law is more restrictive than the federal rules, the more restrictive provisions apply.
37 See 21 U.S.C. 829(e)(1).
38 The Act was enacted on October 15, 2008, and was effective April 13, 2009. The DEA issued regulations effective that same date. See 21 C.F.R. Part 1300, 1301, 1304, et al.; see also 74 Fed. Reg. 15596 (April 6, 2009).
39 21 C.F.R. § 1306.09(a).
40 21 C.F.R. § 1300.04(l)(1); 21 U.S.C. § 829(e)(2)(A).
41 21 C.F.R. § 1300.04(f); 21 U.S.C. § 829(e)(2)(B).
42 See 21 C.F.R. § 1300.04(i).
43 The Ryan Haight Online Pharmacy Consumer Protection Act of 2008, 21 U.S.C. § 829.
45 See DEA temporary telemedicine policy at https://www.deadiversion.usdoj.gov/coronavirus.html.