2025-01049. Expansion of Buprenorphine Treatment via Telemedicine Encounter

Table 1—Number of Affected Entities and Small Entities

NAICS code	Number of firms	SBA size standard ($)	Number of small firms *
621111—Offices of Physicians, Excepting Mental Health Specialists	161,286	14,000,000	157,060
621112—Offices of Physicians, Mental Health Specialists	10,561	12,000,000	10,392
621420—Outpatient Mental Health and Substance Abuse Centers	6,523	16,500,000	5,849
622110—General Medical and Surgical Hospitals	2,560	41,500,000	1,047
622210—Psychiatric and Substance Abuse Hospitals	396	41,500,000	204
Total	181,326		174,552
Percent of Total			96.3%
* Not all decimal places shown.

From above, E.O. 12866 section, DEA and HHS estimate that audio-only telemedicine services will be provided by 37,425 providers to 67,552 patients, annually. Therefore, this final rule is estimated to affect 37,425 individual practitioners employed by some of the 174,552 small businesses in industries potentially affected by this final rule. Since some small entities will employ more than one practitioner, the number of affected small entities is expected to be less than 37,425 and is expected to be concentrated in the 621111, 621112, and 621420 industries, with a combined total of 173,301 small entities. Therefore, the number of small entities affected by this final rule is estimated to be approximately 21.6%, which is a substantial number of the representative industries.

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

• In order to continue, the affected firms must generate enough revenue to pay the wages of practitioners, and other operating expenses.
• Therefore, revenue for firms must be greater than the wages paid to practitioners.
• Therefore, if the cost of the final rule is not economically significant when compared to individual wages for practitioners, the cost of the final rule is not economically significant when ( print page 6521) compared to the annual revenue of the firms.

From 2021 data provided by CMS, DEA and HHS estimate that 67,552 patients received telemedicine services prior to receiving a prescription for buprenorphine. These services were provided by 37,425 separate providers, for approximately 1.8 ^[77] patients per provider.

DEA and HHS estimate a non-loaded median hourly wage of $119.54 ^[78] and $62.11 ^[79] for potentially affected physicians and MLPs, respectively. Applying the hourly wage rates to the estimated time to apply, DEA and HHS estimate the labor cost per PDMP review is $1.99 ($119.54 × 1/60) and $1.04 ($62.11 × 1/60) per physician and MLP, respectively. The non-loaded wage rates are calculated to represent the cost to the individual, whereas previously the loaded wage rates were calculated to represent the total cost of employment to the entity and to the economy. These rates are multiplied by 1.8 patients, for total labor costs of $3.59 and $1.88, respectively.

The loaded unit cost of conducting a PDMP review is compared to the non-loaded annual wage rate for practitioners. Based on the Bureau of Labor Statistics' (“BLS”) Occupational and Employment and Wages data, DEA and HHS estimate an average annual wage of $248,640 for physicians and $118,553 for MLPs. Unit costs of $3.59 and $1.88 represent 0.001 0.002 percent of those wages. Table 2 presents the details of the calculation.

Table 2—Costs and Fees as Percent of Wages

	Mean hourly wage ($)	Time to review (hours)	Cost per patient ($)	Cost per 1.8 patients ($)	Mean annual wage ($)	Additional costs as percent of wage (%)
Physicians	119.54	0.0167	1.99	3.59	248,640	0.001
MLP	62.11	0.0167	1.04	1.88	118,553	0.002