2025-01099. Special Registrations for Telemedicine and Limited State Telemedicine Registrations

Table 1—Patients Loaded Hourly Wage

Occupation	Hourly wage ($)	Load for benefits ($)	Loaded hourly wage ($)
All Occupations	23.11	10.47	33.58

Therefore, the patient's cost of time to travel and wait for a practitioner's visit—and thus the time cost savings achieved by telemedicine patients who could forego such a trip—equals $25.19 (0.75 × $33.58), as can be seen in Table 2 below.

Table 2—Patient Cost of Time

[per Practitioner's Appointment]

Cost savings	Hourly opportunity cost ($)	Travel and wait time (hours)	Cost per appointment ($)
Time cost savings	33.58	0.75	25.19

B. Patient's Cost of Travel per Practitioner Visit

To determine the cost of travel to and from a practitioner's appointment, DEA used data from the Southwest Rural Health Research Center in the Texas A&M School of Public Health, and mileage reimbursement rates from the U.S. Internal Revenue Service (IRS). According to a 2017 survey by the Southwest Rural Health Research Center, the average national round-trip travel distance for a doctor's visit was 9.9 miles, or 19.8 miles round-trip.^[117] The IRS travel reimbursement rate for businesses is 67 cents per mile.^[118] Therefore, the patient's cost of travel to and from a practitioner's appointment—and thus the travel cost savings achieved by telemedicine patients who could forego such a trip—equals $13.27 (19.8 miles x $0.67 per mile), as can be seen in Table 3 below.

Table 3—Patient Travel Cost Savings per Trip

Cost savings	Travel cost per mile ($)	Travel distance (miles)	Per appointment cost ($)
Travel cost savings	0.67	19.8	13.27

( print page 6568)

C. Total Number of Telemedicine Visits

The proposed rule's patient cost savings result from eliminating the need for an initial in-person medical evaluation or visit. Subsequent telemedicine visits are allowed after that initial in-person medical evaluation or visit, even without the COVID-19 PHE telemedicine flexibilities. So, to calculate the total patient cost savings under the proposed rule, DEA needed to estimate the total number of first-time telemedicine visits resulting in prescriptions for controlled substances.^[119] Given the absence of direct information on this point, however, it was necessary for DEA to perform a multi-step analysis or derivation using different available data sources at each step to derive an estimate. First, DEA established the total annual practitioner visits using available data. Second, the total was further refined to those practitioner visits conducted via telemedicine. Third, the total was reduced to those that constituted first-time telemedicine visits. Fourth, DEA determined the proportion of the first-time telemedicine visits that would result in prescriptions. Fifth, it refined the total number of first-time telemedicine visits resulting in prescriptions of controlled substances. And lastly, DEA considered the impact of proposed requirements and determined the total number of first-time telemedicine visits resulting in prescriptions of controlled substances under the proposed rule. DEA performed this multi-step analysis to derive the low, moderate (primary), and high estimates of the number of first-time telemedicine visits resulting in prescriptions for controlled substances, which resulted in low, moderate (primary), and high values for the total patient cost savings.

i. Total Number of Telemedicine Visits Under the Current Telemedicine Rate

Step 1: Total Annual Practitioner Visits. As described above, DEA initially established the total annual practitioner visits using available data. According to the Centers' for Disease Control and Prevention (CDC) 2019 National Ambulatory Medical Care (NAMC) sample survey, it was estimated that there were a total of 1,036,484,000 practitioner visits that year, although not all of these visits resulted in prescriptions, as can be seen in Table 4.^[120] An analysis of this survey revealed that a total of 3,476,239,000 prescriptions were issued during medical visits that year, as can be seen in Table 4.^[121] This means that for every one practitioner visit, there were approximately 3.35 prescriptions, calculated as a coefficient of roughly 0.2982, which can be seen in Table 5.

Table 4—Estimate of Number of Prescriptions Using Visit Data

Number of prescriptions	Number of visits (thousands)	Total number of prescriptions (thousands)
0	291,394
1	192,488	192,488
2	129,561	259,122
3	84,898	254,694
4	60,766	243,064
5	52,613	263,065
6	34,041	204,246
And 7	28,900	202,300
8	29,043	232,344
9	23,393	210,537
10	15,320	153,200
11	17,034	187,374
12	14,744	176,928
13	13,419	174,447
14	10,635	148,890
15+	38,236	* 573,540
Total	** 1,036,485	3,476,239
* Used 15 as an approximation for 15+.
** The published total shows 1,036,484, so there is a rounding error of 1.

Table 5—Estimate of Visit per Prescription Coefficient

NAMC visits	1,036,484,000
NAMC prescriptions	3,476,239,000
Prescriptions per visits ratio	3.35
Visit per prescription coefficient	0.2982

To estimate the total number of practitioner's visits, DEA did not use the NAMC survey because the survey results have been volatile year-to-year, and it only includes “nonfederal office-based patient care physicians, excluding anesthesiologists, radiologists, and pathologists.” ^[122] Instead, DEA used the derived coefficient in conjunction with IQVIA's more comprehensive 2019 prescription data to derive a more representative figure.^[123] In 2019, IQVIA reported 4,386,834,000 prescriptions.^[124] By multiplying this number by the coefficient 0.2982, DEA estimated that there were approximately 1,308,153,900 practitioner visits, as can be seen in Table 6.

( print page 6569)

Table 6—Estimate of Number of Practitioner Visits

Coefficient	0.2982
IQVIA prescriptions	4,386,834,000
Visits—IQVIA prescriptions	1,308,153,900

Step 2: Rate of Telemedicine. DEA then further refined the total number of practitioner visits to those conducted through telemedicine. According to the Fair Health Monthly Telehealth Regional Tracker, as of July 2024, 4.7 percent of medical claims were conducted through telehealth.^[125] As can be seen in Table 7, DEA then used this percentage to refine the total 1,308,153,900 practitioner visits to those likely to be conducted through telemedicine once a final rule is promulgated. Applying 4.7 percent, or the current telemedicine rate, to the 1,308,153,900 total practitioner's visits gives a total of 68,024,003 practitioner visits conducted via telemedicine, as can be seen in Table 7.

Table 7—Number of Telemedicine Visits

Total practitioner visits	1,308,153,900
Telemedicine rate	0.047
Telemedicine visits	68,024,003

Step 3: First-Time Visits. DEA needed to further refine the total number of telemedicine practitioner visits to those that constituted first-time telemedicine visits. DEA's focus on first-time telemedicine practitioner visits, rather than all telemedicine visits, was to prevent an overestimation of the total patient cost savings. Under the status quo, after one bona fide in-person medical evaluation, patients are typically permitted to be seen via telehealth thereafter when receiving prescriptions for controlled substances. A potential overestimate of total patient cost savings arises from the fact that patient cost savings under the proposed rule primarily hinge on the bypassing of a first-time, in-person medical evaluation, but not subsequent telemedicine visits.

A 2022 study analyzing trends between 2017-2020 in interstate telehealth use by Medicare beneficiaries, a subset of the population impacted by the proposed rule, shows that the vast majority of practitioner visits are for returning patients, and approximately 10 percent of those practitioner visits are new visits.^[126] This is in line with the CDC's 2019 NAMC nonfederal survey where 16.8 percent of office visits were for new patients. The CDC's 2019 NAMC survey, however, was not limited to telehealth visits, so DEA decided that the 10 percent estimate from the 2022 interstate telehealth study was more applicable to this analysis.^[127] Taking 10 percent of 68,024,003 practitioner visits conducted via telemedicine would provide a total of approximately 6,802,400 first-time, telemedicine practitioner visits, as can be seen in Table 8.

Table 8—Number of First-Time Telemedicine Visits

Telemedicine visits	68,024,003
First-time telemedicine visit rate	0.1
First-time telemedicine visits	6,802,400

Step 4: Visits Resulting in Prescriptions. DEA needed to determine the fraction of first-time telemedicine visits that would result in prescriptions. Looking again at CDC's 2019 NAMC survey (Table 4 above), DEA determined, as reflected in Table 4, that 291,394,000 visits did not include any prescribing, which means 745,090,000 of the 1,036,484,000 visits, or approximately 72 percent of the visits, did in fact result in the issuance of prescriptions. Because only 72 percent of visits resulted in a prescription, DEA applied the 72 percent to the calculated 6,802,400 first-time, telemedicine visits resulting in approximately a total of 4,889,996 first-time telemedicine visits resulting in the issuance of prescriptions, as can be seen in Table 9.

( print page 6570)

Table 9—Estimate of Number of First-Time Telemedicine Visits With Prescriptions

First-time telemedicine visits		6,802,400
NAMC survey visits—total	1,036,484,000
NAMC survey visits—0 prescriptions	291,394,000
NAMC survey rate—0 prescriptions	0.28
NAMC survey rate—with prescriptions	0.72	* 0.72
First-time telemedicine visits with prescriptions		4,889,996
* Rounded.

Step 5: Prescriptions for Controlled Substances. DEA then refined the total number of first-time telemedicine visits resulting in prescriptions for controlled substances. According to the Federal Trade Commission (FTC), Surescripts has 95% market share in e-prescribing services as of 2023.^[128] DEA was able to use 2021 data from the Surescripts National Progress Report to determine that approximately 16 percent of all prescriptions (paper and electronic) are for controlled substances.^[129] Applying this 16 percent to the total number of 4,889,996 telemedicine visits resulting in the issuance of prescriptions, provides a value of approximately 782,399 first-time telemedicine visits resulting in prescriptions for controlled substances, as can be seen in Table 10.

Table 10—Current Estimate of Number of First-Time Telemedicine Visits Resulting in Prescriptions of Controlled Substances

First-time telemedicine visits with prescriptions	4,889,995.73
Controlled substance (CS) rate	0.16
First-time telemedicine visits with CS prescriptions	782,399

Step 6: Effect of the Proposed Rule. Lastly, DEA determined the total number of first-time telemedicine visits resulting in prescriptions of controlled substances under the proposed rule. Under the proposed rule, patients would not have an in-person follow-up visit after the first-time telemedicine visit; they would never have to see the prescribing practitioner in person. Based on a study by Epic Research of primary care visits between March 1, 2020, and October 15, 2022, 61 percent of telehealth visits did not require an in-person follow-up.^[130] A similar study by Epic Research on specialty visits provided that 85 percent of mental health and psychiatry telehealth visits did not have an in-person follow-up visit.^[131] Because this proposed rule is not limited to mental health, DEA applied the broader and lower 61 percent to the 782,399 first-time telemedicine visits resulting in prescriptions of controlled substances. The multi-step analysis ultimately derived a current estimate of 477,264 first-time telemedicine visits resulting in prescriptions of controlled substances under the proposed rule, as can be seen in Table 11.

Table 11—Current Estimate of Number of First-Time Telemedicine Visits Resulting in Prescriptions of Controlled Substances Under the Proposed Rule

NAMC visits	1,036,484,000
NAMC prescriptions	3,476,239,000
Prescriptions per visits ratio	3.35
Visit per prescription coefficient	0.2982	0.2982
IQVIA prescriptions		4,386,834,000
Visits—IQVIA prescriptions		1,308,153,900	1,308,153,900
Telemedicine rate			0.047
Telemedicine visits			68,024,003	68,024,003
First time telemedicine visit rate				0.1
First-time telemedicine visits				6,802,400
NAMC survey visits—total	1,036,484,000
NAMC survey visits—0 prescriptions	291,394,000
NAMC survey rate—0 prescriptions	0.28
NAMC survey rate—with prescriptions	0.72			0.72
First-time telemedicine visits with prescriptions				4,889,996	4,889,996
Controlled substance (CS) rate					0.16
First-time telemedicine visits with CS prescriptions					782,399
First-time telemedicine visits that do not have an in-person follow up visit.					0.61
( print page 6571)
First-time telemedicine visits under the proposed rule with CS prescriptions					477,264

ii. Forecasted Total Number of Telemedicine Visits

To project the future level of telemedicine visits, a forecast is required, utilizing the usage rate of telemedicine.^[132] A forecast has two critical elements:

1. Baseline (or starting) value, and the

2. Growth rate from that baseline value.

A typical forecast relies on the existing value and the historic data to extrapolate an expected growth rate. However, this process becomes more complex with volatile historical data, as fluctuations make it challenging to determine a stable baseline and reliable growth trend.^[133] In the case of telemedicine, the past five years have seen significant volatility in usage rates, resulting in baseline level and growth rates that have been significantly distorted, with the rate both increasing and decreasing depending on the time interval, as can be seen in Table 12. Specifically, the rate of telemedicine usage surged from 0.2 percent in 2019 to 13 percent in the April 2020 peak according to Fair Health's analysis of medical claims and to 31.2 percent in the second quarter of 2020 based on an analysis of doctor visits by Epic Research.^[134] However, this trend reversed in subsequent years, with rates gradually declining. By the third quarter of 2023, the telemedicine usage rate had dropped to 5.8%, and as of July 2024, it stood at 4.7 percent, based on data from Epic Research.^[135]

Table 12—Historical Telemedicine Rate

Year	Month	Fair health (claims) (%)	YOY change (%)	Quarter	Epic research (doctor visits) (%)	YOY change (%)
2019	April	0.15		2Q	0.2
2020	April	13.0	8566.7	2Q	31.2	15500.0
2021				2Q	9.1	−70.8
2022				2Q	7.1	−22.0
2023	May	5.4		2Q	6.0	−15.5
2024	May	4.8	−11.1
2024	July	4.7

Uncertainty and Factors that May Affect Future Telemedicine Usage. The future of telemedicine is difficult to predict. Patients may start to embrace telemedicine again, or they may continue to return to in-person visits as pandemic habits recede, especially given the lack of in-person exams and vital sign measurements in telehealth.^[136] This uncertainty is reflected in corporate behavior. In March 2023, Walmart announced plans to further expand its telehealth services by opening 28 additional health centers.^[137] However, less than a year later, in May 2024, the company reversed course, announcing the closure of all 51 of their health centers and its telehealth service as it no longer believed it a sustainable business model.

Even if the rule proposed in this NPRM were finalized, it remains unclear how state-level regulations will evolve and impact the telemedicine market. While 43 states and the District of Columbia (DC) may require commercial insurers to cover telehealth services (coverage parity), only a handful of states mandate equal reimbursement rates for telehealth and in-person care (payment parity).^[138] Further, some states have rolled back telemedicine flexibilities introduced during the pandemic and reverted to pre-pandemic restrictions. As of December 2023, 30 states have banned or heavily restricted telehealth appointments with out-of-state doctors.^[139]

Technology could also play a critical role in shaping the telemedicine market. ( print page 6572) For example, technological advances could reduce the cost of remote patient monitoring devices, further driving the demand of telemedicine.^[140] On the other hand, some communities may still not be able to utilize telemedicine in their homes, because they continue to lack the broadband internet to support the technology either because such broadband service is unavailable or unaffordable.^[141] Ultimately, the telemedicine market has been shaped by a shifting landscape of factors, making it difficult to pinpoint any one baseline value or rate of growth with any certainty.

Low, Moderate (Primary), and High Estimates. Given these uncertainties, DEA analyzed a range of possible baseline values and growth rates for telemedicine usage ( i.e., rates of telemedicine) to demonstrate a range of possible outcomes. This approach allows for the derivation of a low, moderate, and high estimate of the total number of telemedicine visits over the next 10 years.

• For the low estimate, DEA selected a baseline telemedicine usage rate of 0.2 percent, reflecting the lower levels of use observed in 2019, prior to the COVID-19 pandemic. A growth rate of 2 percent was chosen, corresponding to the projected growth rate of primary care between 2022 and 2026.^[142]

• For the moderate (primary) estimate, DEA used a baseline telemedicine usage rate of 4.7 percent, mirroring the current rate of telemedicine. A growth rate of 4.95% was derived by taking the average of two different projections: a robust growth rate of 19 percent and a negative rate of -9.1 percent.^[143]

• For the high estimate, DEA selected a baseline telemedicine usage rate of 13 percent, reflecting the usage observed at the April 2020 peak by Fair Health's more comprehensive claims data during the pandemic. A growth rate of 19 percent was chosen based on estimates from one source,Fortune Business Insights, which projected that growth rate per year between 2024 and 2032.^[144]

The scenarios provided are informed projections, based on factors that could influence telemedicine usage and growth. While these projections draw on available data and insights from healthcare, they are ultimately speculative. The scenarios are summarized in Table 13 below.

Table 13—Summary of the Three Scenarios

Scenario	Telemedicine Rate (%)	Growth (%)	Demand
Low	0.20	2	Telemedicine usage returns to pre-pandemic level with low growth, corresponding to demand for healthcare services.
Moderate (Primary)	4.70	4.95	Telemedicine usage remains at current level with moderate growth.
High	* 13	19	Telemedicine usage surges to the pandemic peak level and grows at high growth rate.

As seen in Table 11, “telemedicine rate” of “0.047” (4.7 percent) is a key factor in estimating “first-time telemedicine visits under the proposed rule with [controlled substance] prescriptions” of 477,264. Varying the “telemedicine rate” to 0.2 percent and 13 percent would result in “first-time telemedicine visits under the proposed rule with [controlled substance] prescriptions” to 20,309 (477,264 × (0.2/4.7)) and 1,320,092 (477,264 × (13/4.7)), respectively. DEA estimates the number of first-time telemedicine visits under the proposed rule with controlled substance prescriptions would reach these levels in the first year of implementation of this proposed rule. Table 14 below summarizes the first-year numbers and growth rates of first-time telemedicine visits under the proposed rule with controlled substance prescriptions for the low, moderate (primary), and high estimates.

Table 14—“Year 1” Visits and Growth Rates

	Low	Moderate (primary)	High
(Year 1) First-time telemedicine visits under the proposed rule with CS prescriptions	20,309	477,264	1,320,092
Annual Growth Rate	2.00%	4.95%	19.00%

( print page 6573)

Applying the growth rates to the `Year 1' patient visit figures, DEA generated a 10-year forecast as shown in Table 15 below.

Table 15—Number of Visits Forecast

Year	Low		Moderate (primary)		High
	Growth rate (%)	Patient visits	Growth rate (%)	Patient visits	Growth rate (%)	Patient visits
1		20,309		477,264		1,320,092
2	2	20,715	4.95	500,889	19	1,570,909
3	2	21,129	4.95	525,683	19	1,869,382
4	2	21,552	4.95	551,704	19	2,224,565
5	2	21,983	4.95	579,013	19	2,647,232
6	2	22,423	4.95	607,674	19	3,150,206
7	2	22,871	4.95	637,754	19	3,748,745
8	2	23,328	4.95	669,323	19	4,461,007
9	2	23,795	4.95	702,454	19	5,308,598
10	2	24,271	4.95	737,225	19	6,317,232

D. Total Patient Cost Savings

Each telemedicine visit saves patients time and travel costs of $25.19 and $13.27, respectively, for a total savings of $38.46. Applying the cost savings of $38.46 to the estimated number of first-time telemedicine visits under the proposed rule with controlled substance prescriptions results in a 10-year forecast of patient cost savings for low, moderate (primary), and high scenarios as shown in Table 16 below.

Table 16—Patient Annual Total Cost Savings

Year	Low ($)	Moderate (primary) ($)	High ($)
1	781,084	18,355,573	50,770,738
2	796,699	19,264,191	60,417,160
3	812,621	20,217,768	71,896,432
4	828,890	21,218,536	85,556,770
5	845,466	22,268,840	101,812,543
6	862,389	23,371,142	121,156,923
7	879,619	24,528,019	144,176,733
8	897,195	25,742,163	171,570,329
9	915,156	27,016,381	204,168,679
10	933,463	28,353,674	242,960,743
Present Value *	7,657,624	205,278,372	1,096,535,599
Annualized Cost *	852,497	22,852,928	122,073,501
* Present value and annualized values are based on a two percent (2%) discount rate.

E. Patient Benefit: Increased Access to Care

DEA believes this proposed rule may improve patient access to care. However, DEA maintains that telemedicine is not as effective as in-person visits. According to a NCHS Data Brief from February 2024, only 4.0 percent of primary care physicians, 6.3 percent of surgical specialty physicians, and 6.0 percent of medical special physicians believe telemedicine is as effective as in-person visits.^[145]

Telemedicine has emerged as a vital solution for enhancing healthcare accessibility, especially in the face of healthcare shortages. Notably, it extends its benefits to patients in remote and other underserved areas, including by providing access to specialized care. As of July 2024, telehealth utilization is 4.7 percent of medical claims (Table 12), a significant leap from the 0.17 percent recorded in January 2019, before the COVID-19 pandemic, demonstrating its growing importance.^[146] Most notably, mental health claims using telehealth had risen from 39.6 percent to 68.2 percent during this period, demonstrating that the utilization of telemedicine for mental healthcare experienced a significant surge during the pandemic.^[147]

The importance of telemedicine becomes even more apparent when considering the acute shortage of mental health professionals. Over 75 percent of all U.S. counties are classified as having mental health shortage areas, with 50 percent lacking any mental health professionals. Long-distance travel for treatment remains a major accessibility barrier for individuals in rural areas with limited transportation options.^[148] As of June 2023, there were 6,546 designated “Mental Health—Health Professional Shortage Areas” covering a total population of 163,355,252 ( print page 6574) people.^[149] However, it is crucial to note that the healthcare shortage issue extends beyond mental health professionals. A September 2022 report revealed that 97.6 million Americans live in areas with a primary health professional shortage, highlighting a broad need for enhanced access to a range of specialties.^[150]

The utilization of telehealth is more prevalent among urban Americans and Americans between the ages of 31 to 50 with respect to non-hospital-based provider-to-patient telehealth claims, which is the largest category of telehealth.^[151] However, when examining discharge-related provider-to-patient telehealth claims, rural Americans and those over age 50 are the most prevalent.^[152] DEA is not certain as to why these disparities exist, but they could suggest that limited access to routine and preventative care in rural areas and for older patients result in higher rates of hospitalizations, leading to more discharge-related provider-to-patient telehealth claims. With greater access, rural Americans and older patients may increase their non-hospital-based provider-to-patient telemedicine. With the potential for a broader range of telemedicine practices enabled by the proposed Special Registration framework, qualified practitioners and MLPs could effectively reach a larger patient population, ultimately resulting in improved healthcare outcomes and reduced costs for patients across the nation.

As discussed further below, healthcare systems may, instead of lowering costs, be able to provide increased care at a similar cost based on an evaluation of health care systems.¹⁵³ While practitioners may be able to reduce travel to and from the office, this time saving is likely much less than patients' since practitioners may still go to the office and may see many patients. However, this travel time savings may allow practitioners to become more available to patients, increasing access to care. While DEA is unable to quantify all the benefits to increased patient access to care, DEA believes it is not negligible.

III. Practitioner and MLP Costs, Cost Savings, and Transfers

The proposed rule would impact qualified practitioners (limited to physicians, mid-level practitioners, and covered online telemedicine platforms) by imposing registration costs, imposing recordkeeping costs, creating transfer payments, allowing for travel cost savings, and allowing for greater demand for their services. Costs of the proposed rule are specific to the cost of applying for the conventional registration (for covered online telemedicine platforms), Special Registration for Telemedicine, State Telemedicine Registration, and for PDMP checks due to the increased risk of diversion from more practitioners having the authority to prescribe Schedule II-V controlled substances. DEA estimates that there will be no additional infrastructure cost for patients or providers with the Special Registration for Telemedicine, as DEA has concluded that most patients and providers will already possess or have ready access to a telecommunications system meeting the requirements of the proposed rule. An analysis of all costs is detailed below.

A. Number of Conventional Registrations, Special Registrations, and State Telemedicine Registrations

When it comes to analyzing the costs, cost savings, benefits, and transfers of practitioners, DEA has to consider that qualified practitioners will need to apply for two new types of registrations, with covered online telemedicine platforms needing to first ensure that they have a conventional registration with DEA pursuant to 21 U.S.C. 823(g) in their capacity as a platform practitioner. As discussed above, practitioners will have to apply for a Special Registration (either the Telemedicine Prescribing Registration, the Advanced Telemedicine Prescribing Registration, or the Telemedicine Platform Registration), as well as State Telemedicine Registrations (either State Telemedicine Registration for Clinician Special Registrants or State Telemedicine Registration for Platform Special Registrants), an ancillary type of registration required for each state in which patients are located that will be treated by the practitioner.

The number of conventional registrations under 21 U.S.C. 823(g) will be equal to the number of Telemedicine Platform Registrations, because one conventional registration is required to obtain a Telemedicine Platform Registration; currently, no online telemedicine platforms have a conventional registration. As a starting point to determine the number of conventional registrations, Special Registrations and State Telemedicine Registrations to be expected under the proposed rule, DEA first looked at current registrations held by practitioners. For the number of covered online telemedicine platforms, DEA used the number of telemedicine companies as a proxy.

As of October 19, 2024, there were 2,153,900 DEA registrants.^[154] Among them, 1,122,940 were physicians who fall under this proposed rule (medical doctors and doctors of osteopathy), 403,748 were nurse practitioners (“NPs”), and 168,201 were physician assistants (“PAs”), as shown in Table 17 below.^[155] These numbers exceed the actual employment figures in these fields. Specifically, there are 770,850 physicians, 280,140 nurse practitioners, and 145,740 physician assistants according to BLS.^[156] This variation can be attributed to the fact that some registrants maintain registrations in multiple states or locations.^[157] The number of employed can serve as a proxy for primary registrations, i.e. the 823(g) registration predominantly used by a practitioner, while the difference between these two sets of numbers (number of registrants and employment numbers) provides an estimate of non-primary registrations.

( print page 6575)

Table 17—Registrations by Occupation

Occupation	Number of employed	Number of registrants	Registrations per employed	Primary registrations	Non-primary registrations
Physicians	770,850	1,122,940	1.46	770,850	352,090
Nurse Practitioner	280,140	403,748	1.44	280,140	123,608
Physician Assistant	145,740	168,201	1.15	145,740	22,461
Total	1,196,730	1,694,889	1.42	1,196,730	498,159
* Non-Primary Registrations figures are the differences between the Number of Registrants and Number of Employed.

DEA believes covered online telemedicine platforms are best represented by telemedicine companies. IBISWorld estimates that as of 2023 there were 1,306 such companies in the United States.^[158]

Current Telemedicine Rate Estimate of Number of Registrations. According to the Fair Health Monthly Telehealth Regional Tracker, as of July 2024, 4.7 percent of medical claims were conducted through telehealth.^[159] There may be some variation in how Physicians, Nurse Practitioners, and Physician Assistants prescribe.^[160] Telemedicine prescribing also may not be at the exact same rate as in-person.^[161] However, given the uncertainty in the exact difference and for simplicity, DEA has assumed that each practitioner type prescribes at the same rate and uses telemedicine to prescribe at the same rate as in-person. DEA applied the `telemedicine rates' in Table 13 to the total number of employed physicians, nurse practitioners, and physician assistants to estimate the number of individual practitioner Special Registrations there will be under the proposed rule. Applying the `telemedicine rates' of 0.2 percent, 4.7 percent, and 13 percent to the total number of physicians, nurse practitioners, and physician assistants of 1,196,730, the estimated number of individual telemedicine prescribing registrations are 2,393, 56,246, and 155,575 for low, moderate (primary), and high estimates, respectively.^[162] Using the 2023 IBISWorld estimate of telemedicine companies of 1,306 provides an estimate of 1,306 Telemedicine Platform Registrations .^[163] The number of conventional registrations would then also be 1,306, in line with Telemedicine Platform Registrations. Applying the relationship between the low (0.2 percent), moderate (primary) (4.7 percent), and high (13 percent) “telemedicine rates” to the moderate (primary) estimate of 1,306 Telemedicine Platform Registrations from IBISWorld, results in a low estimate of 56 (1,306 × (0.2/4.7)) and a high estimate of 3,612 (1,306 × (13/4.7)).

Assuming the rate of registrants obtaining DEA registrations are in line with the rate of those that will obtain clinician State Telemedicine Registrations, DEA used 0.2 percent, 4.7 percent, and 13 percent of the total number of registrations to provide the low, moderate (primary), and high estimates of how many clinician State Telemedicine Registrations there will be under the proposed rule. Multiplying the total number of registrations of 1,694,889 (from Table 17) by 0.2 percent, 4.7 percent, and 13 percent, results in 3,390, 79,660, and 220,336 clinician State Telemedicine Registrations for low, moderate (primary), and high estimates, respectively. Assuming a similar relationship holds for platforms, the number of platform State Telemedicine Registrations are estimated to be 42 percent (from Table 17, 1.42 registrations per employed minus 1) higher than the level of Telemedicine Platform Registrations. However, platforms are expected to be registered in more states than clinician practitioners. Based on a DEA analysis of the distributions of other national registrant types, a rate of 10 times the clinician practitioner rate was chosen.^[164] The number of platform State Telemedicine Registrations is then estimated to be 420% (42% × 10) higher than the level of Telemedicine Platform Registrations, or 291 (56 × 5.20), 6,791 (1,306 × 5.20), and 18,782 (3,612 × 5.20) for low, moderate (primary), and high estimates respectively. DEA estimates the number of special registrations would reach these levels in the first year of implementation of this proposed rule. Table 18 below summarizes the first-year numbers and growth rates of special registrations for the low, moderate (primary), and high estimates.

Table 18—“Year 1” Special Registrations and Growth Rates

	Low	Moderate (primary)	High
“Telemedicine rate”	0.20%	4.70%	13.00%
Year 1 Patient Visits	20,309	477,264	1,320,092
Year 1 Telemedicine Prescribing-Individual	2,393	56,246	155,575
Year 1 State Telemedicine-Individual	3,390	79,660	220,336
Year 1 Conventional-Platform	56	1,306	3,612
( print page 6576)
Year 1 Telemedicine Platform	56	1,306	3,612
Year 1 State Telemedicine-Platform	291	6,791	18,782
Year 1 Total Registrations	6,186	145,309	401,917
Annual Growth Rate	2.00%	4.95%	19.00%

Applying the growth rates to the `Year 1' registration figures, DEA generated 10-year forecasts for the low, moderate (primary), and high estimates as shown in Tables 19, 20, and 21 below.

Table 19—Registrations Forecast (Low, 0.2 percent “telemedicine rate”)

Year	Growth rate (%)	Telemedicine prescribing- individual	State telemedicine- individual	Conventional- platform	Telemedicine platform	State telemedicine- platform
1		2,393	3,390	56	56	291
2	2	2,441	3,458	57	57	297
3	2	2,490	3,527	58	58	303
4	2	2,540	3,598	59	59	309
5	2	2,591	3,670	60	60	315
6	2	2,643	3,743	61	61	321
7	2	2,696	3,818	62	62	327
8	2	2,750	3,894	63	63	334
9	2	2,805	3,972	64	64	341
10	2	2,861	4,051	65	65	348

Table 20—Registrations Forecast (Moderate (Primary), 4.7 Percent “Telemedicine Rate”)

Year	Growth rate (%)	Telemedicine prescribing- individual	State telemedicine- individual	Conventional- platform	Telemedicine platform	State telemedicine- platform
1		56,246	79,660	1,306	1,306	6,791
2	4.95	59,030	83,603	1,371	1,371	7,127
3	4.95	61,952	87,741	1,439	1,439	7,480
4	4.95	65,019	92,084	1,510	1,510	7,850
5	4.95	68,237	96,642	1,585	1,585	8,239
6	4.95	71,615	101,426	1,663	1,663	8,647
7	4.95	75,160	106,447	1,745	1,745	9,075
8	4.95	78,880	111,716	1,831	1,831	9,524
9	4.95	82,785	117,246	1,922	1,922	9,995
10	4.95	86,883	123,050	2,017	2,017	10,490

( print page 6577)

Table 21—Registrations Forecast (High, 13.0 Percent “Telemedicine Rate”)

Year	Growth rate (%)	Telemedicine prescribing- individual	State telemedicine- individual	Conventional- platform	Telemedicine platform	State telemedicine- platform
1		155,575	220,336	3,612	3,612	18,782
2	19	185,134	262,200	4,298	4,298	22,351
3	19	220,309	312,018	5,115	5,115	26,598
4	19	262,168	371,301	6,087	6,087	31,652
5	19	311,980	441,848	7,244	7,244	37,666
6	19	371,256	525,799	8,620	8,620	44,823
7	19	441,795	625,701	10,258	10,258	53,339
8	19	525,736	744,584	12,207	12,207	63,473
9	19	625,626	886,055	14,526	14,526	75,533
10	19	744,495	1,054,405	17,286	17,286	89,884

DEA also expects that State Telemedicine Registrations could potentially be much greater than this estimate given the fact that State Telemedicine Registrations will not require a physical location. However, based on an analysis done on Medicare beneficiaries using 2020 data, only 5 percent of telemedicine takes place across state lines and most of this out-of-state care was for established patient care.^[165] To the extent established patient care was a practitioner-patient relationship established following an in-person medical evaluation it would also not be considered telemedicine per the proposed rule. Further, out of state telehealth represented only 0.8 percent of all visits.^[166] It is unclear how willing practitioners will be to register in multiple states to handle a very limited number of their patients who need telemedicine across state lines, and which represents such a small share of their total patient load. However, DEA believes these numbers could grow substantially based on having permanent telemedicine flexibilities in place around which practitioners can restructure their practices without comparable worry of future removal or expiration. This would be in line with an increasing number of practitioners working for platforms that serve a much broader geographical region compared to a typical physician office.

B. Practitioner and MLP Cost to Apply for Special Registration

In order to estimate the time cost for applying for the conventional registration, Special Registration ( Telemedicine Prescribing Registration and the Advanced Telemedicine Prescribing Registration, or the Telemedicine Platform Registration) and the State Telemedicine Registration ( State Telemedicine for Individual Special Registrants or State Telemedicine for Platform Special Registrants), DEA used an estimate of the amount of time and the value of that time for a practitioner to apply for the registration. To calculate the labor cost of applying for either the conventional registration, Special Registration or the State Telemedicine Registration, DEA estimates that on average it will take ten minutes (0.17 hours) to complete the registration application.^[167] Should the application for a Special Registration or the State Telemedicine Registration be completed at the same time, the extra cost would be minimal. However, erring on the side of caution, DEA has assumed applications will be done separately and therefore has not made such a reduction.

Typically, practitioners delegate the task of completing DEA registration applications to their medical office administration or secretarial staff, or they may opt to use a credentialing company. For this reason, DEA has used the BLS median hourly wages for Medical Secretaries and Administrative Assistants, occupational code 43-6013, of $19.54.^[168] Additionally, BLS reports that average wages and salaries for civilians are 69 percent of total compensation. The 68.8 percent of total compensation equates to 45.3 percent (100 percent/68.8 percent—1) load on wages and salaries.^[169] The load of 45.3 percent, or $8.85 (0.453 × $19.54), is added to the hourly rate to estimate the loaded hourly rates. As can be seen in Table 22, the loaded hourly wage for completing DEA registration applications is $28.39 ($19.54 + $8.85).

To calculate the labor cost of applying for either the Special Registration or the State Telemedicine Registration, DEA estimates that on average it will take ten minutes (0.17 hours) for an applicant to apply for any of them.^[170] The estimated labor cost to complete the application is $4.83 ($28.39 × 0.17). These registrations are for three years, so the annualized labor cost of registration is $1.61 ($4.83/3). This calculation is shown in Table 22 below.

Table 22—Per Application Cost

Occupation	Hourly wage ($)	Load for benefits ($)	Loaded hourly wage ($)	Application time (hours)	Cost per application ($)	Annualized cost per application ($)
Medical Secretaries and Administrative Assistants	19.54	8.85	28.39	0.17	4.83	1.61

( print page 6578)

C. Practitioner and MLP Cost to Report to DEA

The proposed rule requires special registrants to report to DEA, on an annual basis, the total number of new patients in each state treated under their Special Registration for Telemedicine, the total number of prescriptions for Schedule II controlled substances issued by the special registrant, and the total number of prescriptions for qualified Schedule III-V controlled substances issued by the special registrant for the preceding year. The special registrant would be required to electronically report this data through the DEA Office of Diversion Control's secure network application.

DEA believes the creation of this report by the registrant's electronic prescription controlled substance (EPCS) system will be a minimal one-time expense. EPCS systems already are required by CFR 1311.120(b)(27)(i) to track controlled substance transactions. The new piece of data that will be needed for this to be fully automated is tracking which patients fall under the proposed rule's telemedicine requirements. DEA believes this can be added to these existing systems during routine operation and maintenance and tracked with minimal cost and effort.

DEA believes the annual running of this report and submitting electronically to DEA can be done in six minutes (0.10 hours). Using the previously calculated loaded hourly wage for Medical Secretaries and Administrative Assistants of $28.39, the cost per report is $2.84 ($28.39 × 0.1), as can be seen in Table 23 below.

Table 23—Per Report Cost

Occupation	Hourly wage ($)	Load for benefits ($)	Loaded hourly wage ($)	Reporting time (hours)	Cost per report ($)
Medical Secretaries and Administrative Assistants	19.54	8.85	28.39	0.10	2.84

D. Practitioner and MLP Cost to Check PDMP per Visit

The proposed rule immediately requires practitioners to complete a PDMP check of (1) the state/territory where the patient is located; (2) the state/territory where the practitioner is located; and (3) any state/territory with PDMP reciprocity agreements with either the state/territory where the patient is located or the state/territory where the practitioner is located. With a delayed effective date of three years, it requires a PDMP review of all 50 states and any U.S. districts and territories that maintain a PDMP prior to issuing a telemedicine prescription under the Special Registration. While a single comprehensive system that can check all 50 states and any U.S. districts and territories that maintain a PDMP is not currently available, once that system is in place, DEA believes it will perform similarly to existing PDMP checks. Based on a 2018 study, it takes a practitioner 27 seconds to log in and 37 seconds to retrieve a report once logged in.^[171] The total time it takes to retrieve a PDMP report is roughly a minute (27 + 37 = 64 seconds) or 0.017 of an hour (1/60).

From BLS data, DEA used the weighted average of the mean hourly wages for Physicians (occupation code 29-1210) and Surgeons (occupation code 29-1240) to represent the wages for all practitioners. For Physicians, the mean hourly wage and employment are $126.85 and 716,950, and for Surgeons, the mean hourly wage and employment are $167.74 and 53,900; the weighted average of the median hourly wages is $129.71.^[172] DEA also used the average of the median hourly wages for Physician Assistants (occupation code 29-1071) of $62.51 and Nurse Practitioners (occupation code 29-1171) of $60.70 to represent the hourly wages of MLPs. As calculated earlier, a load of 45.3 for benefits is added to these wages to calculate loaded wages. The loaded wages for physicians, PAs, and NPs are $188.47 ($129.71 × 1.453), $90.83 ($62.51 × 1.453), and $88.20 ($60.70 × 1.453), respectively. The estimated labor cost to complete the review for physicians is $3.20 ($188.47 × 0.017), for physician assistants is $1.54 ($90.83 × 0.017), and for nurse practitioners is $1.50 ($88.20 × 0.017).

Table 24—PDMP Check Time Cost

Occupation	Hourly wage ($)	Load for benefits ($)	Loaded hourly wage ($)	PDMP check time (hours)	Cost per PDMP check ($)
Physicians	129.71	58.76	188.47	0.017	3.20
Physician Assistants	62.51	28.32	90.83	0.017	1.54
Nurse Practitioners	60.70	27.50	88.20	0.017	1.50

For simplicity, DEA calculated a single cost of a PDMP check based on the weighted average of the three occupations. Using the `Number of Registrants' from Table 17 to calculate weights, the weighted average of the PDMP check is $2.63.^[173]

Recordkeeping and Infrastructure Costs. This proposed rule requires practitioners to maintain records relating to the Special Registration for Telemedicine. DEA believes that the recordkeeping requirements related to the Special Registration for Telemedicine will not impose major ( print page 6579) additional costs on registrants. Practitioners who prescribe using a Special Registration would face additional recordkeeping requirements; but, given that the photographic record, Special Registration telemedicine encounter record, credential verification and conduct-related recordkeeping, and centralized recordkeeping required by proposed 21 CFR 1304.04(i)-(l) is not extensive, DEA does not anticipate it imposes a major burden on registrants. DEA also examined the cost of technology for telemedicine, both capital investment and operational expenses, in order to operate under the proposed Special Registration for Telemedicine framework. DEA believes that these initial investments have already been made by the practitioners most likely to apply for the Special Registration for Telemedicine and that there will be no additional technology or infrastructure cost to these practitioners to use the Special Registration for Telemedicine.

E. Practitioner and MLP Total Costs; Cost Savings

Total Cost. As mentioned previously, the three types of costs to practitioners are: (1) registration time costs, (2) reporting time costs, and (3) PDMP check costs. In summary, these costs are listed in Table 25 below.

Table 25—Unit Cost Summary

	Unit costs
Registration application labor cost, annualized (applies to all registrations)	1.61
Reporting cost (applies to the number of primary special registration)	2.84
PDMP check cost (applies to all visit)	2.63

Unlike patient travel time and cost savings, since the PDMP check is required for all visits and not just first-time visits, there will not be a first-time visit adjustment. While PDMP checks will be required for all special registration prescriptions under this proposed rule, many practitioners already conduct PDMP checks. Due to a combination of the following factors, this would lower the additional burden imposed by this proposed rule:

(1) 45 out of 50 states require PDMP checks in some form,^[174]

(2) Some states, such as California and New York, require PDMP checks for Schedule II-IV drugs (excluding Schedule V),^[175]

(3) Other states have requirements that focus on the initial visit and do not always require checks for all follow-up visits.^[176]

(4) Compliance with existing state laws is not 100 percent and the proposed rule may have an impact, but there will also be instances of non-compliance.^[177]

However, to be conservative, DEA applied the full cost of $2.63 to all telemedicine visits leading to a special registration prescription by backing out the 0.1 factor applied for first-time visits in Table 8, in other words by multiplying the number of first-time telemedicine visits (Table 11) under the proposed rule with controlled substance prescriptions by 10. The proposed rule intends for there to be a nationwide PDMP that would allow for one PDMP check per visit. However, until such a system is put in place, for the first three years practitioners will only be required under the proposed rule to check the state location of the patient, the state location of the practitioner, and all states with reciprocity agreements with either of those two states. This could increase the number of checks per visit to two for some practitioners.

However, patients and practitioners may be in the same state. Also, based on a September 2023 analysis done by DEA of state PDMP participation, the average state, including the District of Columbia, only shares PDMP data with 30 other states.^[178] Both factors could substantially reduce the number of PDMP checks from two to something much closer to one. For simplicity, DEA will assume there will be only one PDMP check required, in line with its long-term expectation.

Applying the annualized registration application labor cost of $1.61 to the number of registrations in Table 19, 20, and 21, the reporting cost of $2.84 to the number of primary (non-state) special registrations in Table 19, 20, and 21, and the PDMP check cost of $2.63 to all telemedicine visits that result in a controlled substances prescription (10 times the number of first-time visits from Table 15), the 10-year cost forecast is shown in Tables 26, 27, and 28 below for the low, moderate (primary), and high estimates.

Table 26—Total Practitioner and MLP Cost (Low)

Year	Registration application labor cost ($)	Reporting cost ($)	PDMP check cost ($)
1	9,959	6,955	534,127
2	10,159	7,094	544,805
3	10,362	7,236	555,693
4	10,570	7,381	566,818
5	10,781	7,529	578,153
6	10,995	7,679	589,725
7	11,214	7,833	601,507
8	11,437	7,989	613,526
9	11,666	8,148	625,809
10	11,898	8,310	638,327
Present Value *	97,631	68,185	5,236,494
( print page 6580)
Annualized Cost *	10,869	7,591	582,961
* Present value and annualized values are based on a two percent (2%) discount rate.

Table 27—Total Practitioner and MLP Cost (Moderate—Primary)

Year	Registration application labor cost ($)	Reporting cost ($)	PDMP check cost ($)
1	233,947	163,448	12,552,043
2	245,528	171,539	13,173,381
3	257,682	180,030	13,825,463
4	270,437	188,942	14,509,815
5	283,824	198,294	15,228,042
6	297,873	208,110	15,981,826
7	312,617	218,410	16,772,930
8	328,089	229,219	17,603,195
9	344,331	240,568	18,474,540
10	361,376	252,476	19,389,018
Present Value *	2,616,334	1,827,907	140,374,966
Annualized Cost *	291,267	203,495	15,627,458
* Present value and annualized values are based on a two percent (2%) discount rate.

Table 28—Total Practitioner and MLP Cost (High)

Year	Registration application labor cost ($)	Reporting cost ($)	PDMP check cost ($)
1	647,086	452,091	34,718,420
2	770,032	537,987	41,314,907
3	916,340	640,204	49,164,747
4	1,090,445	761,844	58,506,060
5	1,297,631	906,596	69,622,202
6	1,544,180	1,078,848	82,850,418
7	1,837,575	1,283,831	98,591,994
8	2,186,713	1,527,758	117,324,484
9	2,602,188	1,818,032	139,616,127
10	3,096,603	2,163,458	166,143,202
Present Value *	13,975,657	9,764,161	749,841,038
Annualized Cost *	1,555,861	1,087,010	83,477,199
* Present value and annualized values are based on a two percent (2%) discount rate.

Cost Savings. The following sections summarize the expected cost savings related to the Special Registration for Telemedicine and State Telemedicine Registration that are realized by practitioners. As discussed in the healthcare system section, there may not be a cost savings on the healthcare system side based on an evaluation of health care systems.^[179] While practitioners may be able to reduce travel to and from the office, this time savings is likely much less than patients since practitioners may still go to the office and may see many patients, each of whom would be saving travel time. Practitioners may also become more available to patients which may offset any travel time and cost savings. In line with this, DEA believes the net cost savings for practitioners will be $0.

F. Practitioner and MLP Transfers

The following sections summarize the changes in transfers related to the expected new conventional registrations, the Special Registration for Telemedicine ( Telemedicine Prescribing Registration, the Advanced Telemedicine Prescribing Registration and Telemedicine Platform Registration) and the State Telemedicine Registration ( State Telemedicine for Individual Special Registrants and State Telemedicine for Platform Special Registrants) realized by practitioners. As discussed earlier, registrations fees paid to DEA are considered to be “transfers.”

DEA proposes to set Special Registration fees to recover the cost of administering the registrations and operating the diversion control aspect of the proposed new business activities. Due to a myriad of unknowns, DEA is unable to calculate a cost that would need to be recovered. Therefore, DEA proposed to set the State Telemedicine ( print page 6581) for Individual Special Registration fee at $50 per three years and other Special Registration fees at the same rate as the “dispensing or instructing” business activity (currently $888 per three years) as discussed further below. 21 CFR 1301.13(e)(1)(iv). Other than the State Telemedicine for Individual Special Registration, the Special Registration provides authority to dispense controlled substances similar to the various registrants in the “dispensing or instructing” business activity. DEA's cost of administering the registrations and operating the diversion control aspect of the Special Registrations are expected to be similar to that of registrations in the “dispensing or instructing” business activity.

Conventional Registration Transfers. In order to prescribe controlled substances using a Special Registration for Telemedicine, practitioners generally must have three registrations. First, a practitioner must be registered under 21 U.S.C. 823(g), i.e. a conventional registration, unless exempt from requirement of registration pursuant to 21 CFR 1301.23(a). The fee for such 823(g) registrations, “dispensing or instructing” business activity, is currently $888 for a three-year cycle ($296/year) pursuant to 21 CFR 1301.13(e)(1)(iv), unless exempt from fees pursuant to 21 CFR 1301.21(a). Unless subject to an exemption, all clinician practitioners that prescribe or dispense controlled substances must have this registration; therefore, the proposed rule does not impact this registration category or fee for clinician practitioners.

Covered online telemedicine platforms must also be registered as practitioners. DEA applied the annualized registration fee calculated previously of $296 to the number of conventional registrations from Tables 19, 20, and 21 to estimate the conventional registration transfers for low, moderate (primary), and high estimates.

Special Registration Transfers. The proposed rule adds two new DEA registrations (and fees) that practitioners must obtain: a Special Registration for Telemedicine (either the Telemedicine Prescribing Registration, the Advanced Telemedicine Prescribing Registration and Telemedicine Platform Registration), and State Telemedicine Registrations ( State Telemedicine for Individual Special Registrants and State Telemedicine for Platform Special Registrants ).^[180]

As discussed earlier, DEA proposes to set the fee for the individual Special Registration for Telemedicine ( Telemedicine Prescribing Registration and Advanced Telemedicine Prescribing Registration) at the same fee as the “dispensing or instructing” business activity, currently $888 per three years pursuant to 21 CFR 1301.13(e)(1)(iv). For now, DEA proposes to set the registration fee for Platform Special Registrants at the same fee as the Individual Special Registrants and registrants under the conventional registration of institutions, such as hospitals and clinics. As DEA gathers more data (such as pharmacy and practitioner reports included in this proposed rule) on the burden DEA incurs from Platform Special Registrants, this fee will be reevaluated. DEA applied the annualized registration fee of $296 to the number of Special Registrations, labeled “Telemedicine Prescribing-Individual” (which includes “Telemedicine Prescribing” and “Advanced Telemedicine Prescribing” registrations) and “Telemedicine Platform” in Tables 19, 20, and 21, to estimate the primary special registration transfers for low, moderate (primary), and high estimates.

State Telemedicine Registration Transfers. It is also statutorily required that a practitioner “is registered under section 823(g) of this title in the State in which the patient will be located when receiving the telemedicine treatment. . . .” 21 U.S.C. 831(h)(B). Therefore, the proposed rule would create the State Telemedicine Registration ( State Telemedicine for Individual Special Registrants and State Telemedicine for Platform Special Registrants) to satisfy this requirement.

Registration fees generally cover two primary costs: (1) costs associated with processing and administering registrations, and (2) costs associated with general oversight and enforcement of controlled substance laws and regulations. The State Telemedicine for Individual Special Registration is an ancillary registration to the Special Registration and DEA proposes to set the fee at a level to recover DEA's cost of processing and administering the registration only. Based on an internal DEA 2021 study, as can be seen in Table 29 below, the total annual registration cost to DEA was $28,930,063.^[181] This equates to a registration cost per registration of $45.^[182]

Table 29—Historical Registration Cost of Conventional DEA Registration

Annual cost categories	Annual cost ($)	Registrations per year	Cost per registration ($)
Labor cost of processing registrations	17,107,968	645,734	26.49
Labor cost of pre-registration investigations	2,955,422	645,734	4.58
Cost to maintain the registration IT system	8,866,672	645,734	13.73
Total	28,930,062		45

Adjusting the $45 cost for inflation, from 2020 to current (end of 2023) dollars, the current estimated cost to process and administer a registration is $50.^[183] Since the registration is a three-year registration, the annualized registration fee is $17 ($50/3).

The cost to DEA of administering the platform State Telemedicine Registration ( State Telemedicine for Platform Special Registrants) is not ( print page 6582) limited to the marginal registration cost. An individual doctor's time is finite, whether they are serving patients in one state or multiple states. However, for a platform there can be a much greater number of patients, number of doctors, and risk of diversion given the broader scope of practice as compared to an individual practitioner. Each additional state creates access to a new pool of patients and a diversion risk that cannot be fully covered from the fees from the Telemedicine Platform Registration and other State Telemedicine for Platform Special Registrations. DEA is proposing a $888 platform State Telemedicine Registration ( State Telemedicine for Platform Special Registrants) fee with an annual rate over three years of $296 (888/3). Three-year registration fees and annualized fees are summarized in Table 30 below.

Table 30—Registration Fees and Annualized Registration Fees

	Registration fee/transfer ($)	Annualized registration fee/transfer ($)
Telemedicine Prescribing-Individual	888	296
State Telemedicine-Individual	50	17
Conventional-Platform	888	296
Telemedicine Platform	888	296
State Telemedicine-Platform	888	296

As with the Telemedicine Platform Registration fee, as DEA gathers more data (such as from pharmacy and practitioner reporting included in this proposed rule) on the burden from these registrants this fee may be adjusted in the future. DEA applied the annualized registration fee of $17 to the number of individual state registrations and the annualized registration fee of $296 to the number of platform state registrations from Tables 19, 20, and 21 to estimate the state registration transfers for low, moderate (primary), and high estimates.

Furthermore, based on review of DEA's registration data, approximately 8.2 percent of physicians, nurse practitioners, and physician assistants are exempt from paying registration fees. Therefore, a factor of 91.8 percent (100 − 8.2) was applied to the number of individual primary and state registrations to estimate the number of fee-paying registrations. The annualized fees and fee-paying percentages for the various registrations are summarized in Table 31 below.

Table 31—Annualized Registration Fees and Fee-Paying Percentages

	Annualized registration fee/transfer ($)	Fee paying
Telemedicine Prescribing-Individual	296	91.8%
State Telemedicine-Individual	17	91.8%
Conventional-Platform	296	100%
Telemedicine Platform	296	100%
State Telemedicine-Platform	296	100%

Summary of Practitioner Transfers. Applying the annualized registration fees and fee-paying percentages (Table 31) to the number of registrations from Table 19, 20, and 21, results in registration fee transfers as shown in Tables 32, 33, and 34 for low, moderate (primary), and high estimates respectively.

Table 32—Total Transfer Payments by Registration

[Low]

Year	Telemedicine prescribing- individual ($)	State telemedicine- individual ($)	Conventional- platform ($)	Telemedicine platform ($)	State telemedicine- platform ($)
1	650,245	51,867	16,576	16,576	86,136
2	663,288	52,907	16,872	16,872	87,912
3	676,603	53,963	17,168	17,168	89,688
4	690,189	55,049	17,464	17,464	91,464
5	704,047	56,151	17,760	17,760	93,240
6	718,177	57,268	18,056	18,056	95,016
7	732,579	58,415	18,352	18,352	96,792
8	747,252	59,578	18,648	18,648	98,864
9	762,197	60,772	18,944	18,944	100,936
10	777,414	61,980	19,240	19,240	103,008
Present Value *	6,376,680	508,519	160,426	160,426	844,385
( print page 6583)
Annualized Cost *	709,894	56,612	17,860	17,860	94,002
* Present value and annualized values are based on a two percent (2%) discount rate.

Table 33—Total Transfer Payments by Registration

[Moderate—Primary]

Year	Telemedicine prescribing- individual ($)	State Telemedicine- Individual ($)	Conventional- platform ($)	Telemedicine platform ($)	State telemedicine- platform ($)
1	15,283,613	1,218,798	386,576	386,576	2,010,136
2	16,040,104	1,279,126	405,816	405,816	2,109,592
3	16,834,093	1,342,437	425,944	425,944	2,214,080
4	17,667,483	1,408,885	446,960	446,960	2,323,600
5	18,541,904	1,478,623	469,160	469,160	2,438,744
6	19,459,801	1,551,818	492,248	492,248	2,559,512
7	20,423,076	1,628,639	516,520	516,520	2,686,200
8	21,433,905	1,709,255	541,976	541,976	2,819,104
9	22,495,002	1,793,864	568,912	568,912	2,958,520
10	23,608,544	1,882,665	597,032	597,032	3,105,040
Present Value *	170,923,255	13,630,288	4,323,434	4,323,434	22,480,387
Annualized Cost *	19,028,293	1,517,413	481,313	481,313	2,502,663
* Present value and annualized values are based on a two percent (2%) discount rate.

Table 34—Total Transfer Payments by Registration

[High]

Year	Telemedicine prescribing- individual ($)	State telemedicine- individual ($)	Conventional- platform ($)	Telemedicine platform ($)	State telemedicine- platform ($)
1	42,274,084	3,371,141	1,069,152	1,069,152	5,559,472
2	50,306,092	4,011,660	1,272,208	1,272,208	6,615,896
3	59,864,124	4,773,875	1,514,040	1,514,040	7,873,008
4	71,238,386	5,680,905	1,801,752	1,801,752	9,368,992
5	84,773,701	6,760,274	2,144,224	2,144,224	11,149,136
6	100,880,650	8,044,725	2,551,520	2,551,520	13,267,608
7	120,048,072	9,573,225	3,036,368	3,036,368	15,788,344
8	142,857,192	11,392,135	3,613,272	3,613,272	18,788,008
9	170,000,102	13,556,642	4,299,696	4,299,696	22,357,768
10	202,300,137	16,132,397	5,116,656	5,116,656	26,605,664
Present Value *	913,025,030	72,809,126	23,092,483	23,092,483	120,077,218
Annualized Cost *	101,643,906	8,105,587	2,570,806	2,570,806	13,367,780
* Present value and annualized values are based on a two percent (2%) discount rate.

G. Summary of Practitioner Costs, Cost Savings, Benefits, and Transfers

The costs to practitioners and MLPs and registration fees (transfers) are summarized in Table 35 below. ( print page 6584)

Table 35—Summary of Practitioner and MLP Costs and Transfers

Year	Low		Moderate (primary)		High
	Cost to practitioners and MLPS ($ million)	Transfers ($ million)	Cost to practitioners and MLPs ($ million)	Transfers ($ million)	Cost to practitioners and MLPs ($ million)	Transfers ($ million)
1	0.55	0.82	13	19	36	53
2	0.56	0.84	14	20	43	63
3	0.57	0.85	14	21	51	76
4	0.58	0.87	15	22	60	90
5	0.60	0.89	16	23	72	107
6	0.61	0.91	16	25	85	127
7	0.62	0.92	17	26	102	151
8	0.63	0.94	18	27	121	180
9	0.65	0.96	19	28	144	215
10	0.66	0.98	20	30	171	255
Present Value *	5.40	8.05	145	216	774	1,152
Annualized Cost **	0.60	0.90	16	24	86	128
* Present value and annualized values are based on a two percent (2%) discount rate.
** Figures are rounded as shown.

IV. Pharmacy Costs

Under the proposed rule, pharmacies would be required to submit monthly reports in accordance with proposed § 1304.60. DEA assumes similar reports are already being submitted to state PDMPs electronically and pharmacies would be able to submit reports as required by § 1304.60 with minimal additional costs.

V. Healthcare System Costs and Cost Savings

Based on the available research, DEA anticipates that there will be no significant net economic impact on healthcare systems due to the proposed rule. According to one peer-reviewed medical journal article from 2020, telehealth is expected to reduce costs in health systems between 32 percent to 53 percent of the time. However, evidence suggests that it does not routinely reduce the cost of care delivery for the health system as a whole.^[184] A more recent 2023 study, focused on payment analysis for telehealth and in-person care, comes to a similar conclusion, noting the lack of cost differential and concluding that the primary benefit of telehealth is increased access and convenience, not cost savings.^[185]

VI. State Costs

The proposed rule immediately requires practitioners to complete a PDMP check of: (1) the state/territory where the patient is located; (2) the state/territory where the practitioner is located; and (3) any state/territory with PDMP reciprocity agreements with either the state/territory where the patient is located or the state/territory where the practitioner is located. However, three years after the proposed rule's effective date, in order for Schedule II prescribing to continue across state lines, DEA is requiring that practitioners conduct PDMP checks for patients in all 50 states and any U.S. districts and territories that maintain a PDMP. Based on a September 2023 analysis conducted by DEA of State PDMP participation, the average state, including the District of Columbia, only shares PDMP data with 30 other states, as can be seen in Table 36.^[186] Based on that study, California was the only state that does not share data with any other state or a U.S. district and territory. However, California now does share PDMP data with Oregon. Guam and Northern Mariana Islands both share with Nebraska and each other. Puerto Rico shares with 30 states plus the District of Columbia.

Table 36—PDMP Sharing Among 50 States and the District of Columbia

	Number of states sharing with
Minimum	1
Minimum*	10
Average	30
Median	32
Maximum	45
* Excluding California.

This is a significant improvement since practitioners first gained access to PDMPs in 1990 and electronic sharing of PDMP data was started in 2010.^[187] Further, most states use the same PDMP interconnectivity hub, with the two primary ones being PMP InterConnect and RxCheck.^[188] However, even with these improvements and similarities, “there are some variances when it comes to data sharing and integration ( i.e., assigned user roles, patient matching methods, percentage of provider population integrated, retention of PDMP data or reports) that pose challenges” according to a report by the Prescription Drug Monitoring Program Training and Technical Assistance Center.^[189]

( print page 6585)

DEA does not have a basis to determine what the cost and coordination hurdles are in trying to implement 50-state sharing of PDMP data or how much more PDMP data sharing would have happened without this rule. Based on a 2016 study, there is evidence that states who have implemented PDMPs had a decline in the rate of opioid-related deaths in the year after their inauguration and that those declines were strongest in states whose PDMPs had the most comprehensive and efficient features, such as more frequently updated data.^[190] DEA believes increased state sharing will produce similar results and that any costs associated with implementation will be surpassed by the benefit of lower opioid-related deaths.

From 2012 to 2016, SAMHSA funded projects across nine states to, among other things, increase PDMP access across states.^[191] Based on a report from the CDC, these projects were successful in increasing interstate PDMP data sharing, and this sharing brought about a decrease in prescription opioid abuse. Accordingly, there is reason for optimism that states can implement sharing and that outside groups can have a positive impact as well. This proposed rule would not create any mandate for states. Any costs incurred in PDMP data sharing among states are incurred outside of this rule. Therefore, any cost to states as a result of this rule would be minimal.

VII. Diversion

Requiring an in-person medical evaluation serves as a safeguard against diversion, consistent with the Ryan Haight Act. Certain signs of diversion or misuse of controlled substances may go undetected without an in-person assessment, as some indicators are either essential to observe personally or are more reliably detected when face-to-face. Without this safeguard, new diversion paradigms have emerged in telemedicine.^[192] Therefore, in the absence of an in-person medical evaluation requirement, DEA believes that other anti-diversion safeguards—such as those proposed in this NPRM—are necessary, beyond the measures that have been in place since March 2020, to address the ongoing risks of diversion.

Admittedly, there is little quantified data on diversion since the onset of the COVID-19 pandemic. However, the intentionally concealed and frequently underreported nature of drug diversion makes these illicit activities inherently difficult to track.^[193] By design, illegal activities like diversion are meant to evade detection, which complicates the collection of comprehensive and reliable quantitative data. Furthermore, diversion of controlled substances can take on many forms, from theft and fraud to improper prescribing making it difficult to quantify in a standardized method. Arguably, data shedding more light on diversion rates could be pulled from state PDMPs; however, as discussed above, the fragmented nature of PDMPs across the states fails to provide a comprehensive set of standardized data.

Given the dearth of comprehensive standardized data on diversion, DEA has had to rely on qualitative information and insights, such as anecdotal information, expert testimony from industry, and the specialized experience and knowledge of DEA's diversion investigators to identify emerging trends and inform enforcement strategies. Under the proposed NPRM, DEA would be implementing a system requiring pharmacies to inform DEA monthly about practitioner special registration prescriptions in accordance with proposed § 1304.60, which will allow DEA to collect more uniform and comprehensive data in order to carry out more quantitative analyses to evaluate the diversion of controlled substances via telemedicine.

VIII. Summary of Economic Impact

DEA estimates a cost savings to patients of $38.46 per first-time telemedicine visit that results in a controlled substance prescription. DEA estimates an annualized cost to practitioners, MLPs, and platforms of $1.61 for the labor cost of a registration application. DEA estimates a cost to practitioners and MLPs of $2.84 for annual reporting. DEA estimates a cost to practitioners and MLPs of $2.63 for PDMP checks. These unit costs were applied to the 10-year forecast of visits and registrations to develop a 10-year forecast of the cost savings, costs, and transfers. Furthermore, the annualized registration fees (transfers) were applied to the 10-year forecast of registrations to develop a 10-year forecast of transfers. The resulting cost savings, costs, and transfers for low, moderate (primary), and high estimates are shown in Table 37 below.

Table 37—Summary of Economic Impact ($ millions)

Year	1	2	3	4	5	6	7	8	9	10
Low Estimate
Patient cost savings	0.78	0.80	0.81	0.83	0.85	0.86	0.88	0.90	0.92	0.93
Costs	0.55	0.56	0.57	0.58	0.60	0.61	0.62	0.63	0.65	0.66
Net Cost Savings	0.23	0.23	0.24	0.24	0.25	0.25	0.26	0.26	0.27	0.27
( print page 6586)
Transfers	0.82	0.84	0.85	0.87	0.89	0.91	0.92	0.94	0.96	0.98
Moderate (Primary) Estimate
Patient cost savings	18	19	20	21	22	23	25	26	27	28
Costs	13	14	14	15	16	16	17	18	19	20
Net Cost Savings	5	6	6	6	7	7	7	8	8	8
Transfers	19	20	21	22	23	25	26	27	28	30
High Estimate
Patient cost savings	51	60	72	86	102	121	144	172	204	243
Costs	36	43	51	60	72	85	102	121	144	171
Net Cost Savings	15	18	21	25	30	36	42	51	60	72
Transfers	53	63	76	90	107	127	151	180	215	255
* Figures are rounded as shown, Net Cost Savings may not add exactly in the table.

DEA calculated the present value and annualized figures for the cost savings, costs and transfers shown in Table 37. The resulting present value and annualized figures are shown in Table 38 below.

Table 38—Net Present Value and Annualized Cost Savings/Costs ($ millions)

	Low	Moderate (Primary)	High
			h	PV*	A*	PV*
Patient—Cost Savings	7.7	0.85	205	23	1,097	122
Practitioner cost	5.4	0.60	145	16	774	86
NPV (Cost Savings)	2.3	0.25	60	7	323	36
Registration fee (Transfers)	8.1	0.90	216	24	1,152	128
* Present value (PV) and annualized (A) values are based on a two percent (2%) discount rate.

While DEA believes that the benefits of increased availability for treatment outweigh the dangers of a potential increase in diversion—so long as prescribers using the Special Registration for Telemedicine adhere to the safeguards inherent in the requirements of the proposed rule—the data system DEA is implementing will allow DEA to monitor the actual impact of the rule and be able to proactively make any necessary changes, either on the enforcement side or the regulatory side.

Regulatory Flexibility Act

The Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) (“RFA”), has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities.

In accordance with the RFA, DEA evaluated the impact of this proposed rule on small entities. The proposed rule allows for DEA-registered physicians and MLPs, or practitioners, to apply for three types of Special Registrations: the (1) Telemedicine Prescribing Registration authorizing qualified practitioners to prescribe Schedule III-V controlled substances via telemedicine; (2) the Advanced Telemedicine Prescribing Registration, authorizing qualified specialized practitioners ( e.g., psychiatrists, hospice care physicians) to prescribe Schedule II-V controlled substances via telemedicine, and (3) a Telemedicine Platform Registration, authorizing covered online telemedicine platforms, in their capacity as platform practitioners, to dispense Schedule II-V controlled substances.

The proposed rule immediately requires practitioners to complete a PDMP check of (1) the state/territory where the patient is located; (2) the state/territory where the practitioner is located; and (3) any state/territory with PDMP reciprocity agreements with either the state/territory where the patient is located or the state/territory where the practitioner is located. With a delayed effective date of three years, it requires a PDMP review of all 50 states and any U.S. districts and territories that maintain a PDMP prior to issuing a telemedicine prescription under the Special Registration.

A significant number of physicians and MLPs work in offices and institutions that meet the RFA's definition of small entities. To estimate the number of affected entities, DEA first determined the North American Industry Classification System (“NAICS”) codes that most closely represent businesses that employ the potential applicants for the Special Registrations for Telemedicine. Then, DEA researched economic data for those codes. The source of the economic data is the Small Business Administration (“SBA”), Office of Advocacy, and is based on data provided by the U.S. Census Bureau, Statistics of U.S. Businesses (“SUSB”).^[194] The following business NAICS codes are estimated to represent businesses that employ the affected persons (potential applicants):

• 621111—Offices of Physicians, Except Mental Health Specialists
• 621112—Offices of Physicians, Mental Health Specialists
• 621420—Outpatient Mental Health and Substance Abuse Centers
• 622210—Psychiatric and Substance Abuse Hospitals

SUSB data contains the number of firms by size ranges for each of the NAICS codes. For the purposes of this analysis, the term “firm” as defined in the SUSB is used interchangeably with “entity” as defined in the RFA.

To estimate the number of affected entities that are small entities, DEA compared the SUSB data for the number ( print page 6587) of firms in various firm size ranges with SBA size standards for each of the representative NAICS codes. The SBA size standard is the firm size based on the number of employees or annual receipts depending on industry. The SBA size standards for NAICS codes 621111, 621112, 621420, and 622210 are annual receipts of $16.0 million, $13.5 million, $19.0 million, and $47.0 million, respectively.^[195]

The firms in each size range below the SBA size standard are small firms. The number of firms below the SBA size standard was added to determine the total number of small firms in each NAICS code. DEA estimates that a total of 175,503 entities are affected by this proposed rule, of which 172,436 (98.25 percent) are small entities. The analysis is summarized in Table 39 below.^[196]

Table 39—Number of Affected Entities and Small Entities

NAICS Code	Number of firms	SBA size standard ($)	Number of small firms
621111—Offices of Physicians, Except Mental Health Specialists	161,286	16,000,000	157,563
621112—Offices of Physicians, Mental Health Specialists	10,561	13,500,000	10,400
621420—Outpatient Mental Health and Substance Abuse Centers	6,523	19,000,000	5,849
622210—Psychiatric and Substance Abuse Hospitals	396	47,000,000	200
Total	178,766		174,012
Percent of Total			97.3 percent

The cost of the proposed rule impacts the affected entities and small entities on a “per person” basis. Rather than estimating the number of physicians and MLPs per firm, then the cost per firm, then whether the cost is significant, DEA employed a more direct approach based on the following logic:

• In order to continue as a financially stable entity, the affected firms must generate enough revenue to pay the wages of physicians and MLPs, and other operating expenses.
• Therefore, revenue for firms must be greater than the wages paid to practitioners.
• Therefore, if the cost of the proposed rule is not economically significant when compared to individual wages for practitioners, the cost of the proposed rule is not economically significant when compared to the annual revenue of the firms.

In this analysis DEA has assumed a practitioner falls under the platform registration even though that registration is designed for telemedicine companies who are serving as intermediaries between patients and clinician practitioners, which is expected to exclude physician offices that have only one physician. If the cost is not burdensome for a single physician office, then it would not, presumably, be a burden for larger offices as well.

As covered above, DEA estimates the cost to apply at $4.83 per application and that each registrant would apply for 2.5 individual Special Registrations (1 initial and 1.5 state) and 3.5 platform registrations (1 conventional, 1 initial telemedicine, and 1.5 state) for a total of 6 (2.5 + 3.5), at an annual rate of 2 Special Registrations per year ( 6/3 ), giving a total cost of $9.66 ($4.83 × 2). This would also mean there would be fees of $888 for the platform conventional registration, $1,776 (888 × 2) for both the individual and platform initial Special Registration and $150 ($50 × 3) for 3 special state registrations, for a total of $2,814 ($888 + $1,776 + $150), or $938 per year ($2,814/3).

DEA estimates the cost for reporting to DEA would be $2.84 per report. With one report per year, that would be an annual cost of $2.84. DEA estimates the cost per PDMP check for physicians, physician assistants, and nurse practitioners is $3.20, $1.54, and $1.50, respectively. DEA estimates the number of new PDMP checks per year by taking the total number of new PDMP checks and dividing by the number of Special Registrations. For the high estimate, the number of new PDMP checks per year is 83 (63,172,320/761,781). Being conservative, DEA used the year 10 figures. The total annual cost of the new PDMP checks per year is $266 (84 × $3.20), $128 (83 × $1.54), and $125 (83 × 1.50), respectively for physicians, physician assistants, and nurse practitioners.

The average annual total economic impact for each registrant who prescribes under this proposed rule is then the combination of the PDMP check cost, registration time cost, reporting cost, and annualized registration fee. For physicians, physician assistants, and nurse practitioners, this is $1,210 ($266 + $3.22 + $2.84 + $938), $1,072 ($128 + $3.22 + $2.84 + $938), and $1,069 ($125 + $3.22 + $2.84 + $938), respectively.

The average annual total economic impacts are compared to the loaded annual mean wages for physicians and MLPs (physician assistants and nurse practitioners). Based on the Bureau of Labor Statistics' (BLS) Occupational Employment and Wages data, DEA estimates an annual mean wage of $263,840 for physicians (occupation code 29-1210),^[197] $130,490 for physician assistants (occupation code 29-1071),^[198] and $128,490 for nurse practitioners (occupation code 29-1171).^[199] Based on the previously calculated load of 45.3 percent, the loaded annual mean wages are then $383,360 ($263,840 × 1.453), $189,602 ($130,490 × 1.453), and $186,696 ($128,490 × 1.453), respectively.

The total annual fees and costs are then 0.32 percent ($1,210/$383,360), ( print page 6588) 0.57 percent ($1,072/$189,602), and 0.57 percent ($1,069/$186,696) of loaded annual wages for physicians, physician assistants, and nurse practitioners, respectively. Table 40 presents the details of the calculation.

Table 40—Costs and Fees as Percent of Wages

	Registration cost ($)	Reporting cost ($)	PDMP check cost ($)	Annualized registration fee cost ($)	Total cost and fees ($)	Loaded annual mean wage ($)	Costs and fees as percent of wage (percent)
Physicians	3.22	2.84	266	938	1,210	383,360	0.32
Physician Assistants	3.22	2.84	128	938	1,072	189,602	0.57
Nurse Practitioners	3.22	2.84	125	938	1,069	186,696	0.57

The economic impact of applying for the Special Registration for Telemedicine represents a small fraction (0.32 percent, 0.57 percent, and 0.57 percent) of annual wages. DEA estimates the proposed rule will not have a significant economic impact on individual physicians and MLPs. The small entities that employ the potentially affected physicians and MLPs are expected to generate enough revenue to pay their wages. Therefore, DEA concludes the proposed rule will not have a significant economic impact on a substantial number of small entities.

Executive Order 13175, Consultation and Coordination With Indian Tribal Governments

DEA has determined that this proposed rule may have Tribal implications, as defined by Executive Order 13175. The determination that this proposed rule will have Tribal implications is, in part, based off the several public comments made by Tribal organizations on the 2023 General Telemedicine NPRM and the Buprenorphine NPRM, stating that the requirements in those two proposed rules would have a substantial impact on Tribal communities. The most prominent concerns of the Tribal organizations involved the extreme remoteness and practitioner shortages faced by some Tribal communities. Specifically, as a result of these obstacles to care, the Tribal communities noted the challenges posed by, as proposed in the 2023 NPRMs, necessitating an in-person medical examination to obtain prescriptions for certain substances, as well as the 30-day telemedicine prescription supply limit. On June 13 and 27, 2024, OTJ and DEA hosted two Tribal consultations to have broad discussions regarding the practice of telemedicine with Tribal communities. Many of the Tribal organizations that participated in the two Tribal consultations reiterated their concerns about any telemedicine rule that would require an in-person medical examination to obtain prescriptions for certain substances and a 30-day telemedicine prescription supply limit.

After carefully considering the information and insights shared in the public comments to the two 2023 NPRMs, during the Telemedicine Listening Sessions, and during the June 2024 Tribal Consultations, DEA reevaluated its approach and determined that the best course of action was to proceed with the promulgation of a Special Registration rule. Notably, this proposed Special Registration rule no longer contains an in-person medical examination requirement for certain substances and no longer contains a 30-day telemedicine prescription supply limit requirement; DEA believes these changes have largely addressed the prominent concerns raised by Tribes. DEA encourages Tribal members and entities to submit public comments on this Special Registration NPRM. Furthermore, it intends to continue Tribal consultations on Telemedicine, including the proposed requirements of the Special Registration NPRM, to ensure meaningful collaboration with Tribal governments impacted by DEA's telemedicine policies.

Paperwork Reduction Act of 1995

This proposed rule would impose new collections and modify existing collections of information under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501-3521. DEA has identified the following collection(s) of information related to this proposed rule. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. Copies of existing information collections approved by OMB may be obtained at http://www.reginfo.gov/​public/​do/​PRAMain.

A. Collections of Information Associated With the Proposed Rule

1. Title: Application for Registration, Registration Renewal, Special Registration for Telemedicine, and Changes and Modifications to Special Registration for Telemedicine, Forms DEA-224/224A/224S/224S-M

OMB Control Number: 1117-0014

Form Number: DEA-224/DEA-224A/DEA-224S/224S-M

DEA is proposing to amend its regulations by creating two new forms for all Special Registration applicants to use when applying for or modifying a Special Registration for Telemedicine and a State Telemedicine Registration. DEA Form 224S ( Application for Special Registration for Telemedicine Under the Controlled Substances Act) will allow Special Registration applicants to use one form to apply for the Telemedicine Prescribing Registration (CS III-V), the Advanced Telemedicine Prescribing Registration (CS II-V), the Telemedicine Platform Registration (CS II-V), and the State Telemedicine Registration for each state in which a patient will be located. Special Registration applicants will be required to provide one Special Registered Location. Platform practitioners will be required to disclose all employment, contractual relationships, or professional affiliations with any clinician special registrant and Online Pharmacy and their respective registration numbers. Clinician practitioners will be required to disclose all employment, contractual relationships, and professional affiliations, including with any covered online telemedicine platforms and the respective covered online telemedicine platform' s Telemedicine Platform Special Registration number; their practice specialties; and attest to their ability and intention to check relevant state PDMPs prior to issuing a special registration prescription. All Special Registration applicants will also be required to attest to having devised, and committing to maintain, anti-diversion ( print page 6589) policies and procedures and to the facts and circumstances that form the basis for their legitimate need for a Special Registration for Telemedicine. Additionally, those practitioners that are exempt from obtaining State Telemedicine Registrations will be required to identify all states in which patients will be located when being treated via telemedicine.

DEA Form 224S-M ( Application for Changes and Modifications to Special Registration) provides special registrants with a means to comply with the proposed requirement of notifying DEA, within 14 business days, of any changes to the information provided in the Special Registration application (Form 224S); such changes include if a clinician special registrant becomes employed by, contracts with, or otherwise becomes professionally affiliated with a new DTC online telemedicine platform not previously disclosed on the original Form 224S or if any clinician special registrant or platform special registrant needs to make modifications to their Special Registration. The information submitted on these two forms will enhance transparency, patient safety, and anti-diversion efforts.

The below estimates are based on the “moderate (primary)” estimates made in the E.O. 12866 section above. DEA estimates the following number of respondents and burden associated with this collection of information:

• Number of respondents: 670,916
• Frequency of response: 1 per year
• Number of responses: 718,917
• Burden per response: 0.20 hours (calculated)
• Total annual hour burden: 144,200 hours

2. Title: Special Registration Recordkeeping and Prescribing Requirements

OMB Control Number: 1117-New

Form Number: N/A

Clinician special registrants will remain subject to existing recordkeeping and prescribing requirements. However, under this rule, DEA is proposing additional requirements under the Special Registration framework.

Clinician special registrants would be required to maintain all records arising from telemedicine encounters under the Special Registration framework at the special registered location for a minimum of two (2) years. The clinician special registrant will be required to maintain a record of the date and time of the telemedicine encounter, the address of the patient during the telemedicine encounter, and the home address of the patient. This proposed requirement enhances public safety by making detection of diversion patterns and illegitimate prescribing practices easier to spot during DEA investigations. It will also alleviate the practical burden for special registrants by centralizing recordkeeping at the special registered location rather than requiring special registrants to maintain records in every state where telemedicine patients are located. Additionally, this proposed rule will require, in addition to the requirements of a prescription found in 21 CFR 1306.05(a), two additional elements for special registration prescriptions to include: (1) the Special Registration numbers of the clinician practitioner and, if a platform practitioner facilitated the prescription, the platform practitioner; and (2) State Telemedicine Registration number of the clinician practitioner and, if a platform practitioner facilitated the prescription, the platform practitioner. If a clinician special registrant is exempt from obtaining a State Telemedicine Registration, the clinician special registrant will be required to instead provide a notation on the prescription identifying the state in which the patient is located. This information will provide the pharmacist with the necessary information to determine whether the clinician practitioner has the authority to prescribe, and the platform practitioner has the authority to dispense, Schedule II controlled substances, and provide the pharmacist with the information necessary to verify that special registration prescriptions are prescribed and dispensed by special registrants authorized within the appropriate state.

This proposed rule requires that clinician special registrants, or a delegated employee or contractor under the direct supervision of the clinician special registrant, verify the identity of patients seeking treatment via telemedicine by requiring that the patient present a state or federal government-issued photo identification card or acceptable alternative forms of identification through the camera of the audio-video telecommunications system. The clinician special registrant will be required to photograph the patient presenting their photo identification card or other acceptable documents during an initial telemedicine encounter or accept a copy of such identification card or document and will be required to maintain this photographic record for a minimum of two (2) years. The photographic records, or copies of such, will be securely stored in the patient's medical record or chart to ensure patient privacy. This requirement ensures that patients' identities are verified, and the photographic record establishes a clear link between the patient's identity and the special registration prescription.

Platform special registrants will be required to maintain certain clinician special registrant records insomuch as that platform special registrant has a covered platform relationship with the clinician special registrant. Such records include documents related to verification of the clinical special registrant's credentials; employment contracts and any other contract between the platform special registrant and clinician special registrant; and any disciplinary actions or sanctions, or documentation of complaints, disputes, or incidents involving the practice of telemedicine. The platform special registrant will be required to maintain and update the credential verification and conduct-related records for a minimum of two (2) years. This requirement will help to address any potential issues of diversion, misconduct, or inadequate screening procedures and provides additional regulatory oversight over remote prescribing.

This proposed rule will require, in addition to the requirements of a prescription found in 21 CFR 1306.05(a), two additional elements for special registration prescriptions to include: (1) the Special Registration numbers of the clinician practitioner and, if a platform practitioner facilitated the prescription, the platform practitioner; and (2) State Telemedicine Registration number of the clinician practitioner and, if a platform practitioner facilitated the prescription, the platform practitioner. If a clinician special registrant is exempt from obtaining a State Telemedicine Registration, the clinician special registrant will be required to instead provide a notation on the prescription identifying the state in which the patient is located. This information will provide the pharmacist with the necessary information to determine whether the clinician practitioner has the authority to prescribe, and the platform practitioner has the authority to dispense, Schedule II controlled substances, and provide the pharmacist with the information necessary to verify that special registration prescriptions are prescribed and dispensed by special registrants authorized within the appropriate state.

The below estimates are based on the “moderate (primary)” estimates made in the E.O. 12866 section above. DEA estimates the following number of ( print page 6590) respondents and burden associated with this collection of information:

• Number of respondents: 57,552
• Frequency of response: 174.26562 (as needed, calculated)
• Number of responses: 10,029,335
• Burden per response: 0.0008602 (calculated)
• Total annual hour burden: 8,627 hours

3. Title: Special Registration Reporting Requirements

OMB Control Number: 1117-New

Form Number: N/A

This proposed rule will require both individual special registrants and platform special registrants to electronically report to DEA under 21 CFR 1304.61, on an annual basis, the total number of new patients in each state where at least one special registration prescription for a Schedule II controlled substance and certain Schedule III-V controlled substances, including Ketamine, Tramadol, and any depressant constituting a benzodiazepine, has been issued; the total number of special registration prescriptions for Schedule II controlled substances issued by the special registrant in aggregate and across all states; and the total number of special registration prescriptions for certain Schedule III-V controlled substances, including Ketamine, Tramadol, and any depressants constituting a benzodiazepines, which were issued by the special registrant, in aggregate and across all states. Amid the ongoing opioid epidemic, this vital information will provide DEA with accurate and up to date data on the prescribing of controlled substances via telemedicine.

This proposed rule will also require pharmacies to electronically report, within the first seven (7) days of the start of every month, aggregate data for the special registration prescriptions filled during the preceding month for each Schedule II controlled substance and certain Schedule III-V controlled substances, including Ketamine, Tramadol, and any depressant constituting a benzodiazepine. For each of these controlled substances, the pharmacy will be required to report the number of prescriptions filled, the volume of the controlled substance dispensed, and the number of patients prescribed the controlled substance. These requirements provide valuable oversight of telemedicine prescriptions under the Special Registration, enable the detection of irregularities or suspicious prescribing and dispensing practices, and will help DEA understand any shifts in demand for medications via telemedicine.

The below estimates are based on the “moderate (primary)” estimates made in the E.O. 12866 section above. DEA estimates the following number of respondents and burden associated with this collection of information:

• Number of respondents: 69,134
• Frequency of response: 6.950774 (calculated)
• Number of responses: 871,488
• Burden per response: 0.006863 hours (calculated)
• Total annual hour burden: 5,981 hours

B. Request for Comments Regarding the Proposed Collections of Information

Written comments and suggestions from the public and affected entities concerning the proposed collections of information are encouraged. Under the PRA, DEA is required to provide a notice regarding the proposed collections of information in the Federal Register with the notice of proposed rulemaking and solicit public comment. Pursuant to section 3506(c)(2) of the PRA (44 U.S.C. 3506(c)(2)), DEA solicits comment on the following issues:

• Whether the proposed collection of information is necessary for the proper performance of the functions of DEA, including whether the information will have practical utility.
• The accuracy of DEA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Recommendations to enhance the quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.

All comments concerning collections of information under the Paperwork Reduction Act must be submitted to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please state that your comments refer to RIN 1117-AB40/Docket No. DEA-407. All comments must be submitted to OMB on or before March 18, 2025. [“The final rule will respond to any OMB or public comments on the information collection requirements contained in this proposed rule.”]

If you need a copy of the proposed information collection instrument(s) with instructions or additional information, please contact the Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: [phone].

Unfunded Mandates Reform Act of 1995

The estimated annual impact of this proposed rule is minimal. Thus, DEA has determined in accordance with the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.) that this action would not result in any federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year. Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of UMRA.

List of Subjects

21 CFR Part 1300

• Chemicals
• Drug traffic control

21 CFR Part 1301

• Administrative practice and procedure
• Drug traffic control
• Exports
• Imports
• Prescription

• , drugs
• Security measures

21 CFR Part 1304

• Drug traffic control
• Reporting and recordkeeping requirements

21 CFR Part 1306

• Administrative practice and procedure
• Drug traffic control
• Prescription drugs
• Reporting and recordkeeping requirements

For the reasons set out above, the Drug Enforcement Administration proposes to amend 21 CFR parts 1300, 1301, 1304, and 1306 as follows:

PART 1300—DEFINITIONS

1. Revise the authority citation for part 1300 to read as follows:

Authority: 21 U.S.C. 802, 821, 822, 829, 831(h), 871(b), 951, 958(f).

2. In § 1300.01(b) the add the term “ Clinician practitioner” and revise the term “ Institutional practitioner” shall be revised, as follows:

§ 1300.01

Definitions related to controlled substances

* * * * *

Clinician practitioner is an individual practitioner who provides direct patient care or assesses, diagnoses, or treats medical conditions.

* * * * *

Institutional practitioner means a hospital or other person (other than an individual) licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which it ( print page 6591) practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy or covered online telemedicine platform.

* * * * *

3. Revise and republish § 1300.04 to read as follows:

§ 1300.04

Definitions relating to the dispensing of controlled substances by means of the internet.

Any term not defined in this part or elsewhere in this chapter shall have the definition set forth in sections 102 and 309 of the Act (21 U.S.C. 802, 829).

Advanced Telemedicine Prescribing Registration means a type of Special Registration for Telemedicine in which the registered practitioner is authorized to prescribe Schedules II through V controlled substances through the practice of telemedicine under 21 U.S.C. 802(54)(E).

Audio-video telecommunications system means the multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and practitioner, mid-level practitioner, or pharmacist.

Clinician special registrant means a special registrant issued either the Telemedicine Prescribing Registration or the Advanced Telemedicine Prescribing Registration under 1301.11(c)(2) and (3) of this chapter, respectively.

Covered online telemedicine platform means an entity that facilitates connections between patients and clinician practitioners, via an audio-video telecommunications system, for the diagnosis and treatment of patients that may result in the prescription of controlled substances, but is not a hospital, clinic, local in-person medical practice, or insurance provider, and meets one or more of the following criteria:

(1) The entity explicitly promotes or advertises the prescribing of controlled substances through the platform;

(2) The entity has financial interests, whether direct incentives or otherwise, tied to the volume or types of controlled substance prescriptions issued through the platform, including but not limited to, ownership interest in pharmacies used to fill patients' prescriptions, or rebates from those pharmacies;

(3) The entity exerts control or influence on clinical decision-making processes or prescribing related to controlled substances, including, but not limited to: prescribing guidelines or protocols for clinician practitioners employed or contracted by the platform; consideration of clinician practitioner prescribing rates in the entity's hiring, retention, or compensation decisions; imposing explicit or de facto prescribing quotas; directing patients to preferred pharmacies; and/or

(4) The entity has control or custody of the prescriptions or medical records of patients who are prescribed controlled substances through the platform.

Covered platform relationship means the formal association between a covered online telemedicine platform and a clinician practitioner it directly employs, contracts with, or is otherwise professionally affiliated with to introduce or facilitate connections between patients seeking remote medical consultations and the individual practitioner, via an audio-video telecommunications system, for the diagnosis of patients and the treatment of those patients via prescription of controlled substances.

Covering practitioner means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who:

(1) Has conducted at least one in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and

(2) Is temporarily unavailable to conduct the evaluation of the patient.

Deliver, distribute, or dispense by means of the internet refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the internet.

Filling new prescriptions for controlled substances in Schedule III, IV, or V means filling a prescription for an individual for a controlled substance in Schedule III, IV, or V, if:

(1) The pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other than by means of the internet and pursuant to the valid prescription of a practitioner that meets the applicable requirements of subsections (b) and (c) of section 309 of the Act (21 U.S.C. 829) and §§ 1306.21 and 1306.22 of this chapter (for purposes of this definition, such a prescription shall be referred to as the “original prescription”);

(2) The pharmacy contacts the practitioner who issued the original prescription at the request of that individual to determine whether the practitioner will authorize the issuance of a new prescription for that individual for the controlled substance described in paragraph (d)(1) of this section ( i.e., the same controlled substance as described in paragraph (d)(1)); and

(3) The practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription.

Homepage means the opening or main page or screen of the website of an online pharmacy that is viewable on the internet.

Hospice care means a set of special services that are provided to individuals who are terminally ill. The focus is on comfort, not on curing an illness. Hospice programs can be delivered in a person's home or in a hospice center.

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. Nothing in this paragraph shall be construed to imply that one in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.

Internet means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio.

Local in-person medical practice means a medical practice where all its offices are within 100 miles of each other, and where less than 50 percent of the total prescriptions for controlled substances collectively issued by the practice's physicians and mid-level practitioners are issued via telemedicine, in any given calendar month, but is not a hospital, clinic, or insurance provider.

Online pharmacy means a person, entity, or internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the internet. The term includes, but is not limited to, a pharmacy that has obtained a modification of its registration pursuant to §§ 1301.13 and 1301.19 of this chapter that currently authorizes it to dispense controlled substances by means of the internet, regardless of whether the pharmacy is currently dispensing controlled substances by ( print page 6592) means of the internet. The term does not include:

(1) Manufacturers or distributors registered under subsection (a), (b), (d), or (e) of section 303 of the Act (21 U.S.C. 823(a), (b), (d), or (e)) (§ 1301.13 of this chapter) who do not dispense controlled substances to an unregistered individual or entity;

(2) Nonpharmacy practitioners who are registered under section 303(f) of the Act (21 U.S.C. 823(f)) (§ 1301.13 of this chapter) and whose activities are authorized by that registration;

(3) Any hospital or other medical facility that is operated by an agency of the United States (including the Armed Forces), provided such hospital or other facility is registered under section 303(f) of the Act (21 U.S.C. 823(f)) (§ 1301.13 of this chapter);

(4) A health care facility owned or operated by an Indian tribe or tribal organization, only to the extent such facility is carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act;

(5) Any agent or employee of any hospital or facility referred to in paragraph (h)(3) or (h)(4) of this section, provided such agent or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of health care facilities specified in paragraph (h)(4) of this section, only to the extent such individuals are furnishing services pursuant to the contracts or compacts described in such paragraph;

(6) Mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance;

(7) A person, entity, or internet site that is not in the United States and does not facilitate the delivery, distribution, or dispensing of a controlled substance by means of the internet to any person in the United States;

(8) A pharmacy registered under section 303(f) of the Act (21 U.S.C. 823(f)) (§ 1301.13 of this chapter) whose dispensing of controlled substances via the internet consists solely of:

(i) Refilling prescriptions for controlled substances in Schedule III, IV, or V, as defined in paragraph (k) of this section; or

(ii) Filling new prescriptions for controlled substances in Schedule III, IV, or V, as defined in paragraph (d) of this section;

(9)(i) Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the internet consists solely of filling prescriptions that were electronically prescribed in a manner authorized by this chapter and otherwise in compliance with the Act.

(ii) A registered pharmacy will be deemed to meet this exception if, in view of all of its activities other than those referred to in paragraph (h)(9)(i) of this section, it would fall outside the definition of an online pharmacy;

(10)(i) Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the internet consists solely of the transmission of prescription information between a pharmacy and an automated dispensing system located in a long term care facility when the registration of the automated dispensing system is held by that pharmacy as described in §§ 1301.17 and 1301.27 and the pharmacy is otherwise complying with this chapter.

(ii) A registered pharmacy will be deemed to meet this exception if, in view of all of its activities other than those referred to in paragraph (h)(10)(i) of this section, it would fall outside the definition of an online pharmacy; or

(11) A covered online telemedicine platform as defined in this section.

Palliative care means patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering. Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and to facilitate patient autonomy, access to information, and choice.

Platform practitioner means a covered online telemedicine platform that dispenses controlled substances by virtue of its central involvement as an intermediary in the remote prescribing of controlled substances by an individual practitioner. Platform practitioners are subject to the requirements imposed upon non-pharmacist practitioners under the Controlled Substances Act, 21 U.S.C. 801-904, and its regulations.

Platform special registrant means a special registrant issued the Telemedicine Platform Registration under 1301.11(c)(4) of this chapter.

Practice of telemedicine means the practice of medicine in accordance with applicable federal and state laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system defined in 42 CFR 410.78(a)(3), which practice falls within a category listed in paragraphs (1) through (7) of this definition:

(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)); ( print page 6593)

(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.

Refilling prescriptions for controlled substances in Schedule III, IV, or V: (1) Means the dispensing of a controlled substance in Schedule III, IV, or V in accordance with refill instructions issued by a practitioner as part of a valid prescription that meets the requirements of subsections (b) and (c) of section 309 of the Act (21 U.S.C. 829) and §§ 1306.21 and 1306.22 of this chapter, as appropriate; and

(2) Does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed.

Special registered location means the physical address of record for a Special Registration for Telemedicine. The special registered location shall be the same address as one of the special registrant's 1301.13(e)(1)(iv) registered locations, unless exempted by § 1301.13(k)(1) of this chapter, in which case the special registered location shall be the physical address provided on the special registrant's Form 224S.

Special registrant means a practitioner who has been issued a Special Registration for Telemedicine (either a Telemedicine Prescribing Registration, an Advanced Telemedicine Prescribing Registration, or a Telemedicine Platform Registration).

Special Registration for Telemedicine means a registration issued by the Administrator pursuant to section 311(h) of the Act (21 U.S.C. 831(h)) to a practitioner who seeks to engage in the practice of telemedicine pursuant to section 102(54)(E) of the Act (21 U.S.C. 802(54)(E)) and 1300.04 of this chapter, which may be used to prescribe controlled substances by means of the internet (within the meaning of section 102(51) of the Act (21 U.S.C. 802(51)) without having first conducted an in-person medical evaluation with patients to whom such prescriptions are being issued. The three types of Special Registration for Telemedicine are the Telemedicine Prescribing Registration, the Advanced Telemedicine Prescribing Registration, and the Telemedicine Platform Registration.

Special registration prescription means a prescription, defined under § 1300.01 of this chapter, for controlled substances issued under a practitioner's Special Registration for Telemedicine for a legitimate medical purpose in the usual course of professional practice through the utilization of an audio-video telecommunications system defined in this section. A special registration prescription is facilitated if:

(1) The prescription is issued to a patient who was introduced to the prescribing practitioner through a covered platform relationship; or

(2) A covered online telemedicine platform facilitated the telemedicine encounter that resulted in the prescription, including by providing audio-visual communication services.

State Telemedicine Registration means a limited type of 21 U.S.C. 823(g) registration authorizing an individual special registrant to prescribe special registration prescriptions to patients located within the state or a platform special registrant to dispense Schedule II-V controlled substances to patients located within the state, as required by section 311(h)(1)(B) of the Act (21 U.S.C. 831(h)(1)(B)).

Telemedicine Platform Registration means a type of Special Registration for Telemedicine in which the registered covered online telemedicine platform is authorized to dispense Schedules II through V controlled substances through the practice of telemedicine under 21 U.S.C. 802(54)(E).

Telemedicine Prescribing Registration means a type of Special Registration for Telemedicine in which the registered practitioner is authorized to prescribe Schedules III through V controlled substances through the practice of telemedicine under 21 U.S.C. 802(54)(E).

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.

(3) The definition of valid prescription shall not be construed to imply that one in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.

PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

4. The authority citation for part 1301 continues to read as follows:

( print page 6594) Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.

5. In § 1301.11, revise the section heading and add paragraphs (c) and (d) to read as follows:

§ 1301.11

Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy; Eligibility Requirements for Special Registration for Telemedicine; State Telemedicine Registrations.

* * * * *

(c) Eligibility for Special Registration for Telemedicine. Clinician practitioners and covered online telemedicine platforms are eligible for the Special Registration for Telemedicine under § 1300.04 of this chapter. Clinician practitioners are eligible for either the Telemedicine Prescribing Registration or Advanced Telemedicine Prescribing Registration, and platform practitioners are eligible for the Telemedicine Platform Registration pursuant to 21 U.S.C. 802(54)(E) and 21 U.S.C. 831(h) subject to the following:

(1) In general. (i) A clinician practitioner applicant or a covered online telemedicine platform applicant shall be required to hold one or more registrations under § 1301.13(e)(1)(iv) of this chapter in a state in which they are licensed, registered, or otherwise permitted to prescribe or dispense controlled substances through telemedicine. Clinician practitioners exempted from obtaining a State Telemedicine Registration for every state in which patients to whom they will issue special registration prescriptions are located under § 1301.11(d) of this chapter are exempted from this requirement.

(ii) Notwithstanding § 1301.23(a) of this chapter, all clinician practitioners must apply for and obtain a Telemedicine Prescribing Registration or Advanced Telemedicine Prescribing Registration before issuing special registration prescriptions.

(2) Telemedicine Prescribing Registration (Schedules III-V). If the condition required in paragraph (c)(1) of this section is satisfied, a Practitioner or Mid-Level Practitioner, as defined under § 1300.01(b) of this chapter, may have a legitimate need under 21 U.S.C. 831(h) for the Telemedicine Prescribing Registration and may apply for the registration to prescribe Schedules III-V controlled substances when they anticipate that they will be treating patients for whom requiring in-person medical evaluations could impose significant burdens on the patients to maintain a bona fide practitioner-patient relationships.

(3) Advanced Telemedicine Prescribing Registration (Schedules II-V). If the condition required in paragraph (c)(1) of this section is satisfied, a Practitioner or Mid-Level Practitioner may have a legitimate need under 21 U.S.C. 831(h) for the Advanced Telemedicine Prescribing Registration, and may apply for the registration to prescribe Schedules II-V controlled substances, when they anticipate that they will be treating patients for whom requiring in-person medical evaluations could impose significant burdens on the patient to maintain bona fide practitioner-patient relationships, and the practitioner or Mid-Level Practitioner is one or more of the following:

(i) The practitioner is a psychiatrist or is board certified in the treatment of psychiatric or psychological disorders;

(ii) The practitioner is a hospice care physician or is board certified in hospice care;

(iii) The practitioner is a palliative care physician or is board certified in palliative care;

(iv) The practitioner renders treatment at one or more long term care facilities;

(v) The practitioner is a pediatrician or is board certified in pediatric care; and/or

(vi) The practitioner is a neurologist or is board certified in the treatment of neurological disorders unrelated to the treatment and management of pain.

(4) Telemedicine Platform Registration (Schedules II-V). A covered online telemedicine platform, as defined under § 1300.04 of this chapter, may have a legitimate need under 21 U.S.C. 831(h) for the Telemedicine Platform Registration, and shall apply for the registration to dispense Schedules II-V controlled substances, when the covered online telemedicine platform:

(i) Anticipates being compensated for introducing or facilitating connections between patients seeking remote medical consultations and practitioners, via an audio-video telecommunications system, for the diagnosis of patients and the treatment of those patients via prescription of controlled substances;

(ii) Is compliant with federal and state regulations;

(iii) Provides oversight over clinician practitioners' prescribing practices; and

(iv) Takes measures to prioritize patient safety and prevent diversion, abuse, or misuse of controlled substances.

(d) State Telemedicine Registrations. Practitioners issued any of the three types of Special Registration for Telemedicine shall obtain a State Telemedicine Registration defined under § 1300.04 of this chapter, for every state in which patients to whom special registration prescriptions will be issued are located. As a limited type of 21 U.S.C. 823(g) registration, the Administrator shall issue the State Telemedicine Registration when it is consistent with the public interest pursuant 21 U.S.C. 823(g)(1). The following clinician practitioners are exempted from obtaining a State Telemedicine Registration for every state:

(1) Officials of the U.S. Army, Navy, Marine Corps, Air Force, Space Force, Coast Guard, Public Health Service, or Bureau of Prisons who are authorized to prescribe via telemedicine in the course of their official duties;

(2) Veterans Health Administration (VHA) covered health care professionals under 38 U.S.C. 1730C(b), acting within the scope of their employment who are utilizing the registration of a hospital or clinic operated by the VHA registered under 21 U.S.C. 823(g) after having obtained the approval of the Secretary of the Veterans Affairs (VA) to utilize the 823(g) registration of a VHA-operated hospital or clinic; and

(3) Health care professionals acting within the scope of their contract with VHA and who have access to, and chart patient records within, the VHA's electronic health records, are subject to all policies of the VHA, and are utilizing the registration of a hospital or clinic operated by the VHA registered under 21 U.S.C. 823(g) after having obtained the approval of the Secretary of the Veterans Affairs (VA) to utilize the 823(g) registration of a VA-operated hospital or clinic; and

(4) Any practitioner otherwise exempted from registration under 21 U.S.C. 822(d).

6. In § 1301.13, add paragraphs (e)(1)(xi), (xii), (xiii), (xiv), and (xv), (k), (l) to read as follows:

§ 1301.13

Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.

* * * * *

(e) * * *

(1) ( print page 6595)

Business activity	Controlled substances	DEA application forms	Application fees ($)	Registration period (years)	Coincident activities allowed
*         *         *         *         *         *         *
(xi) Telemedicine Prescribing (Special Registration)	Schedules III-V	New—224S Renewal—224S Modification—224S(M)	888	3
(xii) Advanced Telemedicine Prescribing (Special Registration)	Schedules II-V	New—224S Renewal—224S Modification—224S(M)	888	3
(xiii) Telemedicine Platform (Special Registration)	Schedules II-V	New—224S Renewal—224S Modification—224S(M)	888	3
(xiv) State Telemedicine for Individual Special Registrants (Ancillary Registration to a Special Registration)	(Determined by the Special Registration held)	New—224S Renewal—224S Modification—224S(M)	50	3
(xv) State Telemedicine for Platform Special Registrants (Ancillary Registration to a Special Registration)	(Determined by the Special Registration held)	New—224S Renewal—224S Modification—224S(M)	888	3