[Federal Register Volume 88, Number 10 (Tuesday, January 17, 2023)]
[Rules and Regulations]
[Pages 2546-2550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 410 and 414

[CMS-6088-N]
RIN 0938-ZB76


Medicare Program; Updates to Face-to-Face Encounter and Written 
Order Prior to Delivery List

AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of 
Health and Human Services (HHS).

ACTION: Update to certain codes.

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SUMMARY: This document announces updates to the Healthcare Common 
Procedure Coding System (HCPCS) codes on the Required Face-to-Face 
Encounter and Written Order Prior to Delivery List.

DATES: The implementation is effective on April 17, 2023.

FOR FURTHER INFORMATION CONTACT: 
    Cristine Egan (410) 786-8088.
    Olufemi Shodeke (410) 786-1649.
    Jennifer Phillips (410) 786-1023.
    Misty Whitaker (410) 786-4975.

SUPPLEMENTARY INFORMATION: 

I. Background

    On November 8, 2019, the Centers for Medicare & Medicaid Services 
published a final rule titled, ``Medicare Program; End-Stage Renal 
Disease Prospective Payment System, Payment for Renal Dialysis Services 
Furnished to Individuals with Acute Kidney Injury, End-Stage Renal 
Disease Quality Incentive Program, Durable Medical Equipment, 
Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Amounts, 
DMEPOS Competitive Bidding Program (CBP) Amendments, Standard Elements 
for a DMEPOS Order, and Master List of DMEPOS Items Potentially Subject 
to a Face-to-Face Encounter and Written Order Prior to Delivery and/or 
Prior Authorization Requirements'' (84 FR 60648). The rule became 
effective January 1, 2020, harmonizing the lists of DMEPOS items 
created by former rules and establishing one ``Master List of DMEPOS 
Items Potentially Subject to Face-to-Face Encounter and Written Orders 
Prior to Delivery and/or Prior Authorization Requirements'' (the 
``Master List''). The rule provided that items would be selected from 
the Master List for inclusion on the Face-to-Face Encounter and Written 
Orders Prior to Delivery List and/or Prior Authorization List through 
the Federal Register. It also clarified that certain items (that is, 
power mobility devices (PMDs)) require a face-to-face encounter per 
statute and would remain on the list indefinitely.
    On January 13, 2022, in accordance with the November 2019 final 
rule (84 FR 60648), we selected codes from the Master List and 
published the first iteration of the Required Face-to-Face Encounter 
and Written Order Prior to Delivery List (hereinafter referred to as 
``F2F/WOPD List''). (For more detailed information see 87 FR 2051). The 
F2F/WOPD List became effective on April 13, 2022. It included 46 K-
codes representative of PMDs as well as 7 Healthcare Common Procedure 
Coding System (HCPCS) that describe other items.

II. Provisions of the Document

    This document announces that CMS has selected an additional set of 
items to be added to the F2F/WOPD List.

A. Reiteration of the Face-to-Face Encounter and Written Order Prior to 
Delivery List Process and DMEPOS Items Currently on The List

    The F2F/WOPD List, as described at Sec.  410.38(c)(8), is comprised 
of PMDs, per statute, and those items selected from the Master List 
(which is described in Sec. Sec.  410.38(c)(7) and 414.234(b)). Items 
on this list require a face-to-face encounter and a written order prior 
to delivery as a condition of payment.
    In the November 2019 final rule, we stated that since the face-to-
face encounter and written orders are statutorily required for PMDs, 
per section 1834(a)(1)(E)(iv) of the Act, they are included on the 
Master List and the F2F/WOPD List in accordance with our statutory 
obligation, and will remain there. These codes, as listed in Table 1, 
will remain on the F2F/WOPD List.

          Table 1--Statutorily Required Power Mobility Devices
                         [Currently on the list]
------------------------------------------------------------------------
           HCPCS                             Description
------------------------------------------------------------------------
K0800......................  Power Operated Vehicle, Group 1 Standard,
                              Patient Weight Capacity Up To And
                              Including 300 Pounds.
K0801......................  Power Operated Vehicle, Group 1 Heavy Duty,
                              Patient Weight Capacity, 301 To 450
                              Pounds.
K0802......................  Power Operated Vehicle, Group 1 Very Heavy
                              Duty, Patient Weight Capacity 451 To 600
                              Pounds.
K0806......................  Power Operated Vehicle, Group 2 Standard,
                              Patient Weight Capacity Up To And
                              Including 300 Pounds.
K0807......................  Power Operated Vehicle, Group 2 Heavy Duty,
                              Patient Weight Capacity 301 To 450 Pounds.
K0808......................  Power Operated Vehicle, Group 2 Very Heavy
                              Duty, Patient Weight Capacity 451 To 600
                              Pounds.
K0813......................  Power Wheelchair, Group 1 Standard,
                              Portable, Sling/Solid Seat And Back,
                              Patient Weight Capacity Up To And
                              Including 300 Pounds.
K0814......................  Power Wheelchair, Group 1 Standard,
                              Portable, Captains Chair, Patient Weight
                              Capacity Up To And Including 300 Pounds.
K0815......................  Power Wheelchair, Group 1 Standard, Sling/
                              Solid Seat And Back, Patient Weight
                              Capacity Up To And Including 300 Pounds.
K0816......................  Power Wheelchair, Group 1 Standard,
                              Captains Chair, Patient Weight Capacity Up
                              To And Including 300 Pounds.
K0820......................  Power Wheelchair, Group 2 Standard,
                              Portable, Sling/Solid Seat/Back, Patient
                              Weight Capacity Up To And Including 300
                              Pounds.

[[Page 2547]]

 
K0821......................  Power Wheelchair, Group 2 Standard,
                              Portable, Captains Chair, Patient Weight
                              Capacity Up To And Including 300 Pounds.
K0822......................  Power Wheelchair, Group 2 Standard, Sling/
                              Solid Seat/Back, Patient Weight Capacity
                              Up To And Including 300 Pounds.
K0823......................  Power Wheelchair, Group 2 Standard,
                              Captains Chair, Patient Weight Capacity Up
                              To And Including 300 Pounds.
K0824......................  Power Wheelchair, Group 2 Heavy Duty, Sling/
                              Solid Seat/Back, Patient Weight Capacity
                              301 To 450 Pounds.
K0825......................  Power Wheelchair, Group 2 Heavy Duty,
                              Captains Chair, Patient Weight Capacity
                              301 To 450 Pounds.
K0826......................  Power Wheelchair, Group 2 Very Heavy Duty,
                              Sling/Solid Seat/Back, Patient Weight
                              Capacity 451 To 600 Pounds.
K0827......................  Power Wheelchair, Group 2 Very Heavy Duty,
                              Captains Chair, Patient Weight Capacity
                              451 To 600 Pounds.
K0828......................  Power Wheelchair, Group 2 Extra Heavy Duty,
                              Sling/Solid Seat/Back, Patient Weight
                              Capacity 601 Pounds Or More.
K0829......................  Power Wheelchair, Group 2 Extra Heavy Duty,
                              Captains Chair, Patient Weight Capacity
                              601 Pounds Or More.
K0835......................  Power Wheelchair, Group 2 Standard, Single
                              Power Option, Sling/Solid Seat/Back,
                              Patient Weight Capacity Up To And
                              Including 300 Pounds.
K0836......................  Power Wheelchair, Group 2 Standard, Single
                              Power Option, Captains Chair, Patient
                              Weight Capacity Up To And Including 300
                              Pounds.
K0837......................  Power Wheelchair, Group 2 Heavy Duty,
                              Single Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity 301 To 450
                              Pounds.
K0838......................  Power Wheelchair, Group 2 Heavy Duty,
                              Single Power Option, Captains Chair,
                              Patient Weight Capacity 301 To 450 Pounds.
K0839......................  Power Wheelchair, Group 2 Very Heavy Duty,
                              Single Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity 451 To 600
                              Pounds.
K0840......................  Power Wheelchair, Group 2 Extra Heavy Duty,
                              Single Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity 601 Pounds
                              Or More.
K0841......................  Power Wheelchair, Group 2 Standard,
                              Multiple Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity Up To And
                              Including 300 Pounds.
K0842......................  Power Wheelchair, Group 2 Standard,
                              Multiple Power Option, Captains Chair,
                              Patient Weight Capacity Up To And
                              Including 300 Pounds.
K0843......................  Power Wheelchair, Group 2 Heavy Duty,
                              Multiple Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity 301 To 450
                              Pounds.
K0848......................  Power Wheelchair, Group 3 Standard, Sling/
                              Solid Seat/Back, Patient Weight Capacity
                              Up To And Including 300 Pounds.
K0849......................  Power Wheelchair, Group 3 Standard,
                              Captains Chair, Patient Weight Capacity Up
                              To And Including 300 Pounds.
K0850......................  Power Wheelchair, Group 3 Heavy Duty, Sling/
                              Solid Seat/Back, Patient Weight Capacity
                              301 To 450 Pounds.
K0851......................  Power Wheelchair, Group 3 Heavy Duty,
                              Captains Chair, Patient Weight Capacity
                              301 To 450 Pounds.
K0852......................  Power Wheelchair, Group 3 Very Heavy Duty,
                              Sling/Solid Seat/Back, Patient Weight
                              Capacity 451 To 600 Pounds.
K0853......................  Power Wheelchair, Group 3 Very Heavy Duty,
                              Captains Chair, Patient Weight Capacity,
                              451 To 600 Pounds.
K0854......................  Power Wheelchair, Group 3 Extra Heavy Duty,
                              Sling/Solid Seat/Back, Patient Weight
                              Capacity 601 Pounds Or More.
K0855......................  Power Wheelchair, Group 3 Extra Heavy Duty,
                              Captains Chair, Patient Weight Capacity
                              601 Pounds Or More.
K0856......................  Power Wheelchair, Group 3 Standard, Single
                              Power Option, Sling/Solid Seat/Back,
                              Patient Weight Capacity Up To And
                              Including 300 Pounds.
K0857......................  Power Wheelchair, Group 3 Standard, Single
                              Power Option, Captains Chair, Patient
                              Weight Capacity Up To And Including 300
                              Pounds.
K0858......................  Power Wheelchair, Group 3 Heavy Duty,
                              Single Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity 301 To 450
                              Pounds.
K0859......................  Power Wheelchair, Group 3 Heavy Duty,
                              Single Power Option, Captains Chair,
                              Patient Weight Capacity 301 To 450 Pounds.
K0860......................  Power Wheelchair, Group 3 Very Heavy Duty,
                              Single Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity 451 To 600
                              Pounds.
K0861......................  Power Wheelchair, Group 3 Standard,
                              Multiple Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity Up To And
                              Including 300 Pounds.
K0862......................  Power Wheelchair, Group 3 Heavy Duty,
                              Multiple Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity 301 To 450
                              Pounds.
K0863......................  Power Wheelchair, Group 3 Very Heavy Duty,
                              Multiple Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity 451 To 600
                              Pounds.
K0864......................  Power Wheelchair, Group 3 Extra Heavy Duty,
                              Multiple Power Option, Sling/Solid Seat/
                              Back, Patient Weight Capacity 601 Pounds
                              Or More.
------------------------------------------------------------------------

    Section 1834(a)(11)(B) of the Act authorizes the Secretary to 
select other DMEPOS HCPCS codes that will require a face-to-face 
encounter and written order prior to delivery as a condition of 
payment. The November 2019 final rule established a process of placing 
other DMEPOS items, in addition to PMDs, on the F2F/WOPD List. We 
included in the 2022 Federal Register seven additional DMEPOS HCPCS 
codes not required by statute. These items were selected from the 
Master List to be placed on the F2F/WOPD List and are listed in Table 
2. The items listed in both Table 1 and Table 2 will remain on the F2F/
WOPD list.

[[Page 2548]]



             Table 2--Non-Statutorily Required DMEPOS Items
                         [Currently on the list]
------------------------------------------------------------------------
           HCPCS                             Description
------------------------------------------------------------------------
E0748......................  Osteogenesis Stimulator, Electrical, Non-
                              Invasive, Spinal Applications.
L0648......................  Lumbar-Sacral Orthosis, Sagittal Control,
                              With Rigid Anterior And Posterior Panels,
                              Posterior Extends From Sacrococcygeal
                              Junction To T-9 Vertebra, Produces
                              Intracavitary Pressure To Reduce Load On
                              The Intervertebral Discs, Includes Straps,
                              Closures, May Include Padding, Shoulder
                              Straps, Pendulous Abdomen Design,
                              Prefabricated, Off-The-Shelf.
L0650......................  Lumbar-Sacral Orthosis, Sagittal-Coronal
                              Control, With Rigid Anterior And Posterior
                              Frame/Panel(S), Posterior Extends From
                              Sacrococcygeal Junction To T-9 Vertebra,
                              Lateral Strength Provided By Rigid Lateral
                              Frame/Panel(S), Produces Intracavitary
                              Pressure To Reduce Load On Intervertebral
                              Discs, Includes Straps, Closures, May
                              Include Padding, Shoulder Straps,
                              Pendulous Abdomen Design, Prefabricated,
                              Off-The-Shelf.
L1832......................  Knee Orthosis, Adjustable Knee Joints
                              (Unicentric Or Polycentric), Positional
                              Orthosis, Rigid Support, Prefabricated
                              Item That Has Been Trimmed, Bent, Molded,
                              Assembled, Or Otherwise Customized To Fit
                              A Specific Patient By An Individual With
                              Expertise.
L1833......................  Knee Orthosis, Adjustable Knee Joints
                              (Unicentric Or Polycentric), Positional
                              Orthosis, Rigid Support, Prefabricated,
                              Off-The Shelf.
L1851......................  Knee Orthosis (KO), Single Upright, Thigh
                              And Calf, With Adjustable Flexion And
                              Extension Joint (Unicentric Or
                              Polycentric), Medial-Lateral And Rotation
                              Control, With Or Without Varus/Valgus
                              Adjustment, Prefabricated, Off-The-Shelf.
L3960......................  Shoulder Elbow Wrist Hand Orthosis,
                              Abduction Positioning, Airplane Design,
                              Prefabricated, Includes Fitting And
                              Adjustment.
------------------------------------------------------------------------

B. New DMEPOS Items Being Placed on the Face-to-Face Encounter and 
Written Order Prior to Delivery List

    PMDs are included on the F2F/WOPD List per statutory obligation. 
For the other DMEPOS items, we consider factors such as operational 
limitations, item utilization, cost-benefit analysis (for example, 
comparing the cost of review versus the anticipated amount of improper 
payment identified), emerging trends (for example, billing patterns, 
medical review findings), vulnerabilities identified in official agency 
reports, or other analysis such as acute needs and pandemic impacts.
    When selecting items, we balance our program integrity goals with 
the needs of Medicare enrollees, particularly those in need of medical 
devices to assist with functional activities and ambulation within 
their home. In consideration of access issues, we note that the face-
to-face regulation at 42 CFR 410.38(d)(2)(ii) allows for use of 
telehealth, provided that the requirements in 42 CFR 410.78 and 414.65 
are met.
    The first iteration of the F2F/WOPD list was released earlier in 
the COVID-19 Public Health Emergency (PHE). The unprecedented PHE, 
coupled with the list's newness, led the Agency to initially proceed 
with the selection of seven items. Feedback received to date has been 
positive. We have not been notified of any issues related to Medicare 
beneficiaries' access, and billing trends have been consistent with 
anticipated volumes.
    Lower limb orthoses (LLO) and lumbar-sacral orthoses (LSO) have 
been identified by CMS' Comprehensive Error Rate Testing (CERT) program 
as two of the top 20 DMEPOS service types with improper payments over 
the past several years, and have been associated with recent fraud 
schemes. In 2021, LLOs had an improper payment rate of 50.6 percent and 
LSOs had an improper payment rate of 44.2 percent. The CERT improper 
payment rate is a measurement of payments that that do not meet 
Medicare requirements. Insufficient documentation and medical necessity 
are the top two LLO and LSO errors noted in the 2021 CERT report.\1\
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    \1\ 2021 Medicare Fee-for-Service Supplemental Improper Payment 
Data https://www.cms.gov/files/document/2021-medicare-fee-service-supplemental-improper-payment-data.pdf-0.
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    In an effort to ensure practitioner involvement, via in-person 
face-to-face encounters or telehealth encounters meeting Medicare's 
regulatory requirements, we are adding the following 10 additional 
HCPCS codes for inclusion on the Required F2F/WOPD List. We are 
releasing these codes in this Federal Register publication with 90 
days' notice prior to implementation. At this time, we are not removing 
any items from the F2F/WOPD List.

           Table 3--New Non-Statutorily Required DMEPOS Items
------------------------------------------------------------------------
           HCPCS                             Description
------------------------------------------------------------------------
L0631......................  Lumbar-Sacral Orthosis, Sagittal Control,
                              With Rigid Anterior And Posterior Panels,
                              Posterior Extends From Sacrococcygeal
                              Junction To T-9 Vertebra, Produces
                              Intracavitary Pressure To Reduce Load On
                              The Intervertebral Discs, Includes Straps,
                              Closures, May Include Padding, Shoulder
                              Straps, Pendulous Abdomen Design,
                              Prefabricated Item That Has Been Trimmed,
                              Bent, Molded, Assembled, Or Otherwise
                              Customized To Fit A Specific Patient By An
                              Individual With Expertise.
L0637......................  Lumbar-Sacral Orthosis, Sagittal-Coronal
                              Control, With Rigid Anterior And Posterior
                              Frame/Panels, Posterior Extends From
                              Sacrococcygeal Junction To T-9 Vertebra,
                              Lateral Strength Provided By Rigid Lateral
                              Frame/Panels, Produces Intracavitary
                              Pressure To Reduce Load On Intervertebral
                              Discs, Includes Straps, Closures, May
                              Include Padding, Shoulder Straps,
                              Pendulous Abdomen Design, Prefabricated
                              Item That Has Been Trimmed, Bent, Molded,
                              Assembled, Or Otherwise Customized To Fit
                              A Specific Patient By An Individual With
                              Expertise.
L1843......................  Knee Orthosis, Single Upright, Thigh And
                              Calf, With Adjustable Flexion And
                              Extension Joint (Unicentric Or
                              Polycentric), Medial-Lateral And Rotation
                              Control, With Or Without Varus/Valgus
                              Adjustment, Prefabricated Item That Has
                              Been Trimmed, Bent, Molded, Assembled, Or
                              Otherwise Customized To Fit A Specific
                              Patient By An Individual With Expertise.

[[Page 2549]]

 
L1932......................  Ankle Foot Orthosis, Rigid Anterior Tibial
                              Section, Total Carbon Fiber Or Equal
                              Material, Prefabricated, Includes Fitting
                              And Adjustment.
L1940......................  Ankle Foot Orthosis, Plastic Or Other
                              Material, Custom-Fabricated.
L1951......................  Ankle Foot Orthosis, Spiral, (Institute Of
                              Rehabilitative Medicine Type), Plastic Or
                              Other Material, Prefabricated, Includes
                              Fitting And Adjustment.
L1960......................  Ankle Foot Orthosis, Posterior Solid Ankle,
                              Plastic, Custom-Fabricated.
L1970......................  Ankle Foot Orthosis, Plastic With Ankle
                              Joint, Custom-Fabricated.
L2005......................  Knee Ankle Foot Orthosis, Any Material,
                              Single Or Double Upright, Stance Control,
                              Automatic Lock And Swing Phase Release,
                              Any Type Activation, Includes Ankle Joint,
                              Any Type, Custom Fabricated.
L2036......................  Knee Ankle Foot Orthosis, Full Plastic,
                              Double Upright, With Or Without Free
                              Motion Knee, With Or Without Free Motion
                              Ankle, Custom Fabricated.
------------------------------------------------------------------------

    The current complete F2F/WOPD List is available on the following 
CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment.
    We believe transparency and education will aid in compliance with 
these payment requirements and continued access. As such, we will make 
information widely available to the public at appropriate literacy 
levels regarding face-to-face encounter requirements, written order 
prior to delivery requirements, and necessary documentation for items 
on F2F/WOPD List.
    We continue to believe greater practitioner involvement in the care 
of Medicare enrollees in need of items included on the F2F/WOPD List 
will help further our program integrity goals of reducing fraud, waste, 
and abuse. It will also help ensure Medicare enrollee receipt of items 
specific to their medical needs. For items on the F2F/WOPD List, the 
written order/prescription must be communicated to the supplier prior 
to delivery. For such items, we require the treating practitioner to 
have a face-to-face encounter with the Medicare enrollee within the 6 
months preceding the date of the written order/prescription. If the 
face-to-face encounter is a telehealth encounter, the requirements of 
42 CFR 410.78 and 414.65 must be met for DMEPOS coverage purposes.
    Consistent with Sec.  410.38(d), the face-to-face encounter must be 
documented in the pertinent portion of the medical record (for example, 
history, physical examination, diagnostic tests, summary of findings, 
progress notes, treatment plans or other sources of information that 
may be appropriate). The supporting documentation must include 
subjective and objective beneficiary specific information used for 
diagnosing, treating, or managing a clinical condition for which the 
DMEPOS item(s) is ordered. Upon request by CMS or its review 
contractors, a supplier must submit additional documentation to support 
and substantiate the medical necessity for the DMEPOS item.
    Section 410.38(c)(8) of the Act states new additions to the F2F/
WOPD list will be communicated to the public and effective no less than 
60 days after a Federal Register document publication and a CMS website 
posting. To assist stakeholders in preparing for implementation of the 
new items, these changes will become effective 90 days after 
publication of this rule. Stakeholders may refer to the CMS website 
posting for more information on the implementation date.

III. Collection of Information Requirements

    This document announces the selection of additional HCPCS codes to 
be placed on the F2F/WOPD List. These updates to the F2F/WOPD List do 
not constitute information collections requirements, that is, 
reporting, recordkeeping or third-party disclosure requirements. 
Consequently, there is no need for review by the Office of Management 
and Budget under the authority of the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

IV. Regulatory Impact Statement

    We have examined the impact of this regulatory document as required 
by Executive Order 12866 on Regulatory Planning and Review (September 
30, 1993), Executive Order 13563 on Improving Regulation and Regulatory 
Review (January 18, 2011), the Regulatory Flexibility Act (RFA) 
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
Regulatory Impact Analysis (RIA) must be prepared for major rules with 
significant regulatory action/s and/or with economically significant 
effects ($100 million or more in any 1 year). This regulatory document 
is not significant and does not reach the economic threshold and thus 
is not considered a major regulatory document.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
less than $8.0 million to $41.5 million in any 1 year. Individuals and 
States are not included in the definition of a small entity. We are not 
preparing an analysis for the RFA because we have determined, and the 
Secretary certifies, that this regulatory document will not have a 
significant economic impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. We are not preparing 
an analysis for section 1102(b) of the Act because we have determined, 
and the Secretary

[[Page 2550]]

certifies, that this regulatory document will not have a significant 
impact on the operations of a substantial number of small rural 
hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2022, that 
threshold is approximately $165 million. This regulatory document will 
have no consequential effect on State, local, or tribal governments or 
on the private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule or other regulatory document) that imposes substantial 
direct requirement costs on State and local governments, preempts State 
law, or otherwise has Federalism implications. Since this regulatory 
document does not impose any costs on State or local governments, the 
requirements of Executive Order 13132 are not applicable.
    In accordance with the provisions of Executive Order 12866, this 
document was reviewed by the Office of Management and Budget.
    The Administrator of the Centers for Medicare & Medicaid Services 
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: January 11, 2023.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2023-00718 Filed 1-13-23; 8:45 am]
BILLING CODE 4120-01-P