Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 2051 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01, Rev. 1, associated 

implementing instructions, and 

Environmental Planning COMDTINST 

5090.1 (series), which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 (42 

U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves safety 

zones to protect waterway users that 

would prohibit entry within 250 yards 

of dredging operations, within Marcus 

Hook Anchorage and will close only one 

side of the main navigation channel. It 

is categorically excluded from further 

review under paragraph L[60a] of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 1. A 

Record of Environmental Consideration 

supporting this determination is 

available in the docket. For instructions 

on locating the docket, see the 

ADDRESSES section of this preamble. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 00170.1, Revision No. 01.2. 

■ 2. Add § 165.T05–0022, to read as 

follows: 

§ 165.T05–0022 Safety Zones, Delaware 

River Dredging; Marcus Hook, PA. 

(a) Location. The following areas are 

safety zones: 

(1) Safety zone one includes all waters 

within 250 yards of the dredge 

displaying lights and shapes for vessels 

restricted in ability to maneuver as 

described in 33 CFR 83.27, as well as all 

related dredge equipment, while the 

dredge is operating in Marcus Hook 

Range. For enforcement purposes 

Marcus Hook Range includes all 

navigable waters of the Delaware River 

shoreline to shoreline, bound by a line 

drawn perpendicular to the center line 

of the channel at the farthest upriver 

point of the range to a line drawn 

perpendicular to the center line of the 

channel at the farthest downriver point 

of the range. 

(2) Safety zone two includes all the 

waters of Anchorage 7 off Marcus Hook 

Range, as described in 33 CFR 

110.157(a)(8) and depicted on U. S. 

Nautical Chart 12312. 

(b) Definitions. As used in this 

section, designated representative 

means any Coast Guard commissioned, 

warrant, or petty officer who has been 

authorized by the Captain of the Port to 

assist with enforcement of the safety 

zone described in paragraph (a) of this 

section. 

(c) Regulations. (1) Entry into or 

transiting within the safety zone one is 

prohibited unless vessels obtain 

permission from the Captain of the Port 

via VHF–FM channel 16 or 215–271– 

4807, or make satisfactory passing 

arrangements via VHF–FM channel 13 

or 16 with the operating dredge per this 

section and the rules of the Road (33 

CFR subchapter E). Vessels requesting to 

transit shall contact the operating 

dredge via VHF–FM channel 13 or 16 at 

least 1 hour prior to arrival. 

(2) Vessels desiring to anchor in safety 

zone two, Anchorage 7 off Marcus Hook 

Range, must obtain permission from the 

COTP at least 24 hours in advance by 

calling (215) 271–4807. The COTP will 

permit, at minimum, one vessel at a 

time to anchor on a ‘‘first-come, firstserved’’ basis. Vessels will only be 

allowed to anchor for a 12 hour period. 

Vessels that require an examination by 

the Public Health Service, Customs, or 

Immigration authorities will be directed 

to an anchorage for the required 

inspection by the COTP. 

(3) Vessels desiring to anchor in safety 

zone two, Anchorage 7 off Marcus Hook 

Range, must be at least 650 feet in 

length overall. 

(4) This section applies to all vessels 

except those engaged in the following 

operations: Enforcement of laws, service 

of aids to navigation, and emergency 

response. 

(d) Enforcement. The U.S. Coast 

Guard may be assisted by federal, state 

and local agencies in the patrol and 

enforcement of the zone. 

(e) Enforcement period. This rule will 

be enforced from January 6, 2022, 

through January 31, 2022, unless 

cancelled earlier by the Captain of the 

Port. 

Dated: January 6, 2022. 

Jonathan D. Theel, 

Captain, U. S. Coast Guard, Captain of the 

Port, Delaware Bay. 

[FR Doc. 2022–00560 Filed 1–12–22; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 410 and 414 

[CMS–6081–N] 

Medicare Program; Updates to Lists 

Related to Durable Medical Equipment, 

Prosthetics, Orthotics, and Supplies 

(DMEPOS) Conditions of Payment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Updates to and selection of 

certain codes. 

SUMMARY: This document announces the 

updated Healthcare Common Procedure 

Coding System (HCPCS) codes on the 

Master List of DMEPOS Items 

Potentially Subject to Face-to-Face 

Encounter and Written Order Prior to 

Delivery and/or Prior Authorization 

Requirements. It also announces the 

initial selection of HCPCS codes on the 

Required Face-to-Face Encounter and 

Written Order Prior to Delivery List and 

the updates the HCPCS codes on the 

Required Prior Authorization List. 

DATES: The implementation is effective 

on April 13, 2022. Prior authorization 

will be implemented in 3 incremental 

phases, with the final phase being 

national implementation. Phase 1 

includes 1 state per jurisdiction and is 

effective April 13, 2022, Phase 2 

includes 4 States per jurisdiction and is 

effective July 12, 2022, and Phase 3 is 

nationwide and is effective October 10, 

2022. 

FOR FURTHER INFORMATION CONTACT:

Susan Billet, (410) 786–1062. 


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Emily Calvert, (410) 786–4277. 

Stephanie Collins, (410) 786–3100. 

Jennifer Phillips, (410) 786–1023. 

Olufemi Shodeke, (410) 786–1649. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 1832, 1834, and 1861 of the 

Social Security Act (the Act) establishes 

benefits and the provisions of payment 

for Durable Medical Equipment, 

Prosthetics, Orthotics, and Supplies 

(DMEPOS) items under Part B of the 

Medicare program. 

Section 1834(a)(1)(E)(iv) of the Act 

provides conditions of coverage specific 

to Power Mobility Devices (PMDs). 

Specifically, it provides that payment 

may not be made for a covered item 

consisting of a motorized or power 

wheelchair unless a physician (as 

defined in section 1861(r)(1) of the Act), 

physician assistant (PA), nurse 

practitioner (NP), or clinical nurse 

specialist (CNS) (as such non-physician 

practitioners are defined in section 

1861(aa)(5) of the Act) has conducted a 

face-to-face examination of the 

individual and written a prescription for 

the item. 

Section 1834(a)(11)(B) of the Act 

requires a physician, PA, NP, or CNS to 

have a face-to-face encounter with the 

beneficiary within the 6-month period 

prior to the written order for certain 

DMEPOS items (or other reasonable 

timeframe as determined by the 

Secretary of the Department of Health 

and Human Services (the Secretary)). 

Section 1834(a)(15)(A) of the Act 

authorizes the Secretary to develop and 

periodically update a list of DMEPOS 

items that the Secretary determines, on 

the basis of prior payment experience, 

are frequently subject to unnecessary 

utilization and to develop a prior 

authorization process for these items. 

In 2006, we issued Final Rule 

‘‘Medicare Program; Conditions for 

Payment of Power Mobility Devices, 

including Power Wheelchairs and 

Power-Operated Vehicles’’ (71 FR 

17021) to implement the requirements 

for a face-to-face examination and 

written order prior to delivery for PMDs, 

in accordance with legislation found in 

section 302(a)(2) of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (Pub. L. 108– 

173), as codified in amended section 

1834(a)(1)(E)(iv) of the Act. This 

regulation applied to all power mobility 

devices—including power wheelchairs 

and power operated vehicles 

(hereinafter referred to as PMDs). The 

requirements for PMDs mandated a 7- 

element order/prescription for payment. 

In the November 16, 2012 Federal 

Register, we published final rule titled 

‘‘Medicare Program; Revisions to 

Payment Policies Under the Physician 

Fee Schedule, DME Face-to-Face 

Encounters, Elimination of the 

Requirement for Termination of NonRandom Prepayment Complex Medical 

Review and Other Revisions to Part B 

for CY 2013’’ (77 FR 68892) requiring 

face-to-face encounter and written order 

prior to delivery for specified DMEPOS 

items, in accordance with the 

authorizing legislation found section 

6407 of the Patient Protection and 

Affordable Care Act of 2010 (Pub. L. 

111–148) and amended section 

1834(a)(11)(B) of the Act. The 

regulation, as codified in 42 CFR 410.38, 

specified the inclusion criteria for 

creating a list of DMEPOS items to be 

subject to face-to-face encounter and 

written order prior to delivery 

requirements. It also mandated a 5- 

element order/prescription for payment 

of specified DMEPOS items. 

In the December 30, 2015 Federal 

Register, we published final rule titled 

‘‘Medicare Program; Prior Authorization 

Process for Certain Durable Medical 

Equipment, Prosthetics, and Supplies’’ 

(80 FR 81674), in accordance with 

section 1834(a)(15) of the Act, we 

established the Master List of Items 

Frequently Subject to Unnecessary 

Utilization. The 2015 Master List 

included certain DMEPOS items that the 

Secretary determined, on the basis of 

prior payment experience, are 

frequently subject to unnecessary 

utilization, and created a prior 

authorization process for these items. 

On November 8, 2019, we 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-toFace 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’’). 

Items are 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. 

II. Provisions of the Document 

This document serves to publish three 

separate lists. First, it provides an 

update to the Master List of items from 

which we can select to include on the 

Required Face to Face Encounter and 

Written Order Prior to Delivery List, 

and/or Required Prior Authorization 

List. This document also serves to 

announce the initial selection of items 

to be included on the Required Face-toFace Encounter and Written Order Prior 

to Delivery List. Lastly, it updates the 

items included on the Required Prior 

Authorization List. 

A. Master List of DMEPOS Items 

Frequently Subject to Unnecessary 

Utilization 

The Master List includes items that 

appear on the DMEPOS Fee Schedule 

and meet the following criteria, as 

established in 84 FR 60648: 

• Have an average purchase fee of 

$500 or greater that is adjusted annually 

for inflation, or an average monthly 

rental fee schedule of $50 or greater that 

is adjusted annually for inflation, or 

items identified as accounting for at 

least 1.5 percent of Medicare 

expenditures for all DMEPOS items over 

a recent 12-month period, that are 

also— 

++ Identified in a Government 

Accountability Office (GAO) or 

Department of Health and Human 

Services Office of Inspector General 

(OIG) report that is national in scope 

and published in 2015 or later as having 

a high rate of fraud or unnecessary 

utilization; or 

++ Listed in the 2018 or subsequent 

year Comprehensive Error Rate Testing 

(CERT) program’s Medicare Fee-forService (FFS) Supplemental Improper 

Payment Data Report as having a high 

improper payment rate. 

• Any items with at least 1,000 claims 

and $1 million in payments during a 

recent 12-month period that are 

determined to have aberrant billing 

patterns and lack explanatory 

contributing factors (for example, new 

technology or coverage policies that 

may require time for providers and 

suppliers to be educated on billing 

policies). Items with aberrant billing 

patterns would be identified as those 

items with payments during a 12-month 

timeframe that exceed payments made 

during the preceding 12-months by the 

greater of— 

++ Double the percent change of all 

DMEPOS claim payments for items that 

meet the previous claim and payment 


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1CY 2021 Update for Durable Medical 

Equipment, Prosthetics, Orthotics and Supplies 

(DMEPOS) Fee Schedule (December 4, 2020): https://www.cms.gov/Regulations-and-Guidance/ 

Guidance/Transmittals/Transmittals/r10504cp. 

criteria, from the preceding 12-month 

period; or 

++ Exceeding a 30 percent increase in 

payments for the items from the 

preceding 12-month period. 

• Any items statutorily requiring a 

face-to-face encounter, a written order 

prior to delivery, or prior authorization. 

In the November 2019 final rule noted 

previously, we described the 

maintenance process of the Master List 

as follows: 

• The Master List will be updated 

annually, and more frequently as 

needed (for example, to address 

emerging billing trends), and to reflect 

the thresholds specified in the 

regulations. 

• Items on the DMEPOS Fee Schedule 

that meet the payment threshold criteria 

set forth in § 414.234(b)(1) are added to 

the list when the item is also listed in 

a CERT, OIG, or GAO report published 

after 2020, and items not meeting the 

cost (approximately $500 purchase or 

$50 rental) thresholds may still be 

added based on findings of aberrant 

billing patterns. 

• Items are removed from the Master 

List 10 years after the date the item was 

added, unless the item was identified in 

an OIG report, GAO report, or having 

been identified in the CERT Medicare 

Fee for Service Supplemental Improper 

Payment Data report as having a high 

improper payment rate, within the 5- 

year period preceding the anticipated 

date of expiration. 

• Items are removed from the list 

sooner than 10 years if the purchase 

amount drops below the payment 

threshold. 

• Items already on the Master List 

that are identified on a subsequent OIG, 

GAO, or CERT report will remain on the 

list for 10 years from the publication 

date of the new report. 

• Items are updated on the Master 

List when the Healthcare Common 

Procedure Coding System (HCPCS) 

codes representing an item have been 

discontinued and cross-walked to an 

equivalent item. 

• We will notify the public of any 

additions and deletions from the Master 

List by posting a notification in the 

Federal Register and on the CMS Prior 

Authorization website at https://

www.cms.gov/research-statistics-datasystems/medicare-fee-servicecompliance-programs/priorauthorization-and-pre-claim-reviewinitiatives. 

This document provides the annual 

update to the Master List of DMEPOS 

Items Potentially Subjected to a Face-toFace Encounter and Written Order Prior 

to Delivery and/or Prior Authorization 

Requirements stated in the November 

2019 final rule (84 FR 60648). As noted 

previously, we adjust the ‘‘payment 

threshold’’ each year for inflation. 

Certain DMEPOS fee schedule amounts 

are updated for 2021 1 by the percentage 

increase in the consumer price index for 

all urban consumers (United States city 

average) CPI–U for the 12-month period 

ending June 30, 2020, adjusted by the 

change in the economy-wide 

productivity equal to the 10-year 

moving average of changes in annual 

economy-wide private non-farm 

business multi-factor productivity 

(MFP). The productivity adjustment is 

0.4 percent and the CPI–U percentage 

increase is 0.6 percent. Thus, the 0.6 

percentage increase in the CPI–U is 

reduced by the 0.4 percentage increase 

in the MFP resulting in a net increase 

of 0.2 percent for the update factor for 

CY 2021. 

For CY 2021, the 0.2 percent update 

factor was applied to the CY 2020 

average price threshold of $500, 

resulting in a CY 2021 adjusted payment 

threshold of $501 ($500 × 1.002). This 

results in a CY 2021 adjusted purchase 

price threshold of $501. An update 

factor of 0.2 percent was applied to the 

CY 2020 average monthly rental fee of 

$50, resulting in an adjusted payment 

threshold of $50.10 ($50 × 1.002). 

Rounding this figure to the nearest 

whole dollar amount results in a CY 

2021 adjusted monthly rental fee 

threshold of $50. 

A total of 31 HCPCS codes (see Table 

1) meeting the criteria outlined 

previously are added to the Master List. 

Of these 31 HCPCS codes, 18 are added 

because these items meet the updated 

payment threshold and are listed in an 

OIG or GAO report of a national scope 

or a CERT DME and DMEPOS Service 

Specific Report(s) or both, and 13 are 

added for being identified as accounting 

for at least 1.5 percent of Medicare 

expenditures for all DMEPOS items over 

a recent 12-month period. 

TABLE 1—ADDITIONS TO THE MASTER LIST

HCPCS Description 

A4352 .............. Intermittent Urinary Catheter; Coude (Curved) Tip, With Or Without Coating (Teflon, Silicone, Silicone Elastomeric, Or Hydrophilic, Etc.), Each. 

A5121 .............. Skin Barrier; Solid, 6 x 6 Or Equivalent, Each. 

A6203 .............. Composite Dressing, Sterile, Pad Size 16 Sq. In. Or Less, With Any Size Adhesive Border, Each Dressing. 

A6219 .............. Gauze, Non-Impregnated, Sterile, Pad Size 16 Sq. In. Or Less, With Any Size Adhesive Border, Each Dressing. 

A6242 .............. Hydrogel Dressing, Wound Cover, Sterile, Pad Size 16 Sq. In. Or Less, Without Adhesive Border, Each Dressing. 

A7030 .............. Full Face Mask Used With Positive Airway Pressure Device, Each. 

A7031 .............. Face Mask Interface, Replacement For Full Face Mask, Each. 

E0467 .............. Home Ventilator, Multi-Function Respiratory Device, Also Performs Any Or All Of The Additional Functions Of Oxygen Concentration, Drug 

Nebulization, Aspiration, And Cough Stimulation, Includes All Accessories, Components And Supplies For All Functions. 

E0565 .............. Compressor, Air Power Source For Equipment Which Is Not Self-Contained Or Cylinder Driven. 

E0650 .............. Pneumatic Compressor, Non-Segmental Home Model. 

E0651 .............. Pneumatic Compressor, Segmental Home Model Without Calibrated Gradient Pressure. 

E0652 .............. Pneumatic Compressor, Segmental Home Model With Calibrated Gradient Pressure. 

E0656 .............. Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Trunk. 

E0657 .............. Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Chest. 

E0670 .............. Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Integrated, 2 Full Legs And Trunk. 

E0675 .............. Pneumatic Compression Device, High Pressure, Rapid Inflation/Deflation Cycle, For Arterial Insufficiency (Unilateral Or Bilateral System). 

E0740 .............. Non-Implanted Pelvic Floor Electrical Stimulator, Complete System. 

E0744 .............. Neuromuscular Stimulator For Scoliosis. 

E0745 .............. Neuromuscular Stimulator, Electronic Shock Unit. 

E0764 .............. Functional Neuromuscular Stimulation, Transcutaneous Stimulation Of Sequential Muscle Groups Of Ambulation With Computer Control, Used For 

Walking By Spinal Cord Injured, Entire System, After Completion Of Training Program. 

E0766 .............. Electrical Stimulation Device Used For Cancer Treatment, Includes All Accessories, Any Type. 

E1226 .............. Wheelchair Accessory, Manual Fully Reclining Back, (Recline Greater Than 80 Degrees), Each. 

E2202 .............. Manual Wheelchair Accessory, Nonstandard Seat Frame Width, 24–27 Inches. 

E2203 .............. Manual Wheelchair Accessory, Nonstandard Seat Frame Depth, 20 To Less Than 22 Inches. 

E2613 .............. Positioning Wheelchair Back Cushion, Posterior, Width Less Than 22 Inches, Any Height, Including Any Type Mounting Hardware. 


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TABLE 1—ADDITIONS TO THE MASTER LIST—Continued 

HCPCS Description 

L0830 .............. Halo Procedure, Cervical Halo Incorporated Into Milwaukee Type Orthosis. 

L1005 .............. Tension Based Scoliosis Orthosis And Accessory Pads, Includes Fitting And Adjustment. 

L1906 .............. Ankle Foot Orthosis, Multiligamentous Ankle Support, Prefabricated, Off-The-Shelf. 

L2580 .............. Addition To Lower Extremity, Pelvic Control, Pelvic Sling. 

L2624 .............. Addition To Lower Extremity, Pelvic Control, Hip Joint, Adjustable Flexion, Extension, Abduction Control, Each. 

L7368 .............. Lithium Ion Battery Charger, Replacement Only. 

The following five HCPCS codes (see 

Table 2) are removed from the Master 

List because they no longer have a 

DMEPOS Fee Schedule price of $501 or 

greater, or an average monthly rental fee 

schedule of $50 or greater, and are 

identified as accounting for at least 1.5 

percent of Medicare expenditures for all 

DMEPOS items over a recent 12-month 

period or both. 

TABLE 2—DELETIONS FROM THE MASTER LIST

HCPCS Description 

A4253 .............. Blood Glucose Test or Reagent Strips for Home Blood Glucose Monitor, Per 50 Strips. 

A4351 .............. Intermittent Urinary Catheter; Straight Tip, With or Without Coating (Teflon, Silicone, Silicone Elastomer, Or Hydrophilic, Etc.), Each. 

E2369 .............. Power Wheelchair Component, Drive Wheel Gear Box, Replacement Only. 

E2377 .............. Power Wheelchair Accessory, Expandable Controller, Including All Related Electronics and Mounting Hardware, Upgrade Provided At Initial Issue. 

L3761 .............. Elbow Orthosis (Eo), With Adjustable Position Locking Joint(S), Prefabricated, Off-The-Shelf. 

The full updated list is available in 

the download section of the following 

CMS website: https://www.cms.gov/ 

Research-Statistics-Data-and-Systems/ 

Monitoring-Programs/Medicare-FFSCompliance-Programs/DMEPOS/PriorAuthorization-Process-for-CertainDurable-Medical-Equipment-ProstheticOrthotics-Supplies-Items. 

B. Items Subject to Face-to-Face 

Encounter and Written Order Prior to 

Delivery Requirements 

In the November 2019 final rule, we 

stated that since the face-to-face 

encounter and written orders are 

statutorily required for PMDs, they 

would be included on the Master List 

and the Required Face-to-Face 

Encounter and Written Order Prior to 

Delivery List in accordance with our 

statutory obligation, and would remain 

there. 

The Required Face-to-Face Encounter 

and Written Order Prior to Delivery List, 

as specified in § 410.38(c)(8), is 

comprised of PMDs and those items 

selected from the Master List (as 

described in § 414.234(b)) to require a 

face-to-face encounter and a written 

order prior to delivery as a condition of 

payment. 

The rule established a process of 

placing items on the Required Face-toFace Encounter and Written Order Prior 

to Delivery List, including that they be 

communicated to the public and 

effective no less than 60 days after a 

Federal Register document publication 

and CMS website posting. 

We note that following the 

publication of the November 2019 final 

rule (84 FR 60648), the serious public 

health threats posed by the spread of the 

2019 Novel Coronavirus (COVID–19) 

became known, and subsequently the 

addition of new items on the Required 

Face-to-Face Encounter and Written 

Order Prior to Delivery List was placed 

on hold. 

We also note that in an interim final 

rule with comment period titled 

‘‘Medicare and Medicaid Programs; 

Policy and Regulatory Revisions in 

Response to the COVID–19 Public 

Health Emergency’’ and published on 

April 6, 2020 (84 FR 19230), we stated 

that ‘‘to the extent an NCD or LCD 

(including articles) would otherwise 

require a face-to-face or in-person 

encounter for evaluations, assessments, 

certifications or other implied face-toface services, those requirements would 

not apply during the PHE for the 

COVID–19 pandemic.’’ This language 

does not apply to the face-to-face 

encounter and written order prior to 

delivery requirements stemming from 

42 CFR 410.38 and section 1834 of the 

Act; therefore, the ongoing direction 

provided in the April 2020 rule is not 

affected by this document. The list of 

DMEPOS items selected and 

promulgated in this document will 

require a face-to-face encounter 

(conducted either via telehealth or inperson), per 42 CFR 410.38, effective 

after 90 days’ notice. 

At this time, we believe it appropriate 

to add a limited list of items that pose 

a risk to the Medicare Trust Funds, to 

be subject to additional practitioner 

oversight via the face-to-face encounter 

and written order prior to delivery 

requirements. 

To assist stakeholders in preparing for 

implementation of the Required Face-toFace Encounter and Written Order Prior 

to Delivery List, we are publishing the 

proposed code additions and providing 

90 days’ notice. 

Per statutory requirements, Table 3 

lists DMEPOS HCPCS codes for PMDs. 

Section 1834(a)(1)(E)(iv) of the Act 

explicitly requires a face-to-face and 

written order for PMDs; therefore, PMDs 

require a face-to-face encounter per 

statute. To reflect this, PMDs will both 

be placed and will remain on the 

Required Face-to-Face Encounter and 

Written Order Prior to Delivery List 

indefinitely. 

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. In addition to PMDs, this 

Federal Register document announces 

the addition of seven other DMEPOS 

HCPCS codes, not required by statute, 

that are selected from the Master List to 

be placed on the Required Face-to-Face 

Encounter and Written Order Prior to 

Delivery List as listed in Table 4, based 

on our regulatory authority at 42 CFR 

410.38. 


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TABLE 3—STATUTORILY REQUIRED POWER MOBILITY DEVICES

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. 

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. 

TABLE 4—NON-STATUTORILY REQUIRED DMEPOS ITEMS

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-TheShelf. 

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. 

As previously stated, PMDs are 

included on the Required Face-to-Face 

Encounter and Written Order Prior to 

Delivery List per statutory obligation. 

For the other DMEPOS items, we 

considered factors such as operational 

limitations, item utilization, acute 

needs, pandemic impacts, 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. 

In selecting these items, we must 

balance our program integrity goals with 

the needs of patients, particularly those 

in need of medical devices to assist with 

functional activities and ambulation 

within their home. In other words, we 

must ensure the appropriate application 

and oversight of the face-to-face 

encounter requirements. In 

consideration of access issues, we note 

that the regulation 42 CFR 410.38 allows 


jspears on DSK121TN23PROD with RULES1
2056 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 

2OIG Report A–09–12–02068—Medicare Paid 

Suppliers For Power Mobility Device Claims That 

Did Not Meet Federal Requirements For Physicians’ 

Face-To-Face Examinations Of Beneficiaries 

(January 2015): https://oig.hhs.gov/oas/reports/ 

region9/91202068.pdf. 

for use of telehealth, as defined in 42 

CFR 410.78 and 414.65, when 

appropriate to meet our coverage 

requirements for beneficiaries. 

We also 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, prior authorization, and 

necessary documentation for items on 

Required Face-to-Face Encounter and 

Written Order Prior to Delivery and 

Prior Authorization Lists. 

We believe additional practitioner 

oversight of beneficiaries in need of 

items represented by these HCPCS 

codes will help further our program 

integrity goals of reducing fraud, waste, 

and abuse. It will also help ensure 

beneficiary receipt of items specific to 

their medical needs. For items on the 

Required Face-to-Face Encounter and 

Written Order Prior to Delivery List 

(Tables 3 and 4), 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 beneficiary within 

the 6 months preceding the date of the 

written order/prescription. If the face-toface encounter is a telehealth encounter, 

the requirements of 42 CFR 410.78 and 

414.65 must be met for DMEPOS 

coverage purposes. 

Consistent with § 410.38(d), the faceto-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 or both. 

The Required Face-to-Face Encounter 

and Written Order Prior to Delivery List 

is available on the following CMS 

website: https://www.cms.gov/ResearchStatistics-Data-and-Systems/MonitoringPrograms/Medicare-FFS-CompliancePrograms/Medical-Review/FacetoFace

EncounterRequirementforCertain

DurableMedicalEquipment. 

C. Items Subject to Prior Authorization 

Requirements 

The November 8, 2019 final rule (84 

FR 60648) maintained the process 

established in the December 30, 2015 

final rule (80 FR 81674) that when items 

are placed on the Required Prior 

Authorization List, we would inform the 

public of those DMEPOS items on the 

Required Prior Authorization List in the 

Federal Register with no less than 60 

days’ notice before implementation, and 

post notification on the CMS website. 

The Required Prior Authorization List 

specified in § 414.234(c)(1) is selected 

from the Master List (as described in 

§ 414.234(b)), and those selected items 

require prior authorization as a 

condition of payment. Additionally, 

§ 414.234 (c)(1)(ii) states that CMS may 

elect to limit the prior authorization 

requirement to a particular region of the 

country if claims data analysis shows 

that unnecessary utilization of the 

selected item(s) is concentrated in a 

particular region. 

The purpose of this document is to 

inform the public that we are updating 

the Required Prior Authorization List to 

include six additional Power Mobility 

Devices (PMDs) and five additional 

Orthoses HCPCS codes. To assist 

stakeholders in preparing for 

implementation of the prior 

authorization program, we are providing 

90 days’ notice. 

The following six HCPCS codes for 

PMDs and five HCPCS codes for 

Orthoses are added to the Required 

Prior Authorization List: 

TABLE 5—ADDITIONS TO THE REQUIRED PRIOR AUTHORIZATION 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. 

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-TheShelf. 

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. 

We believe prior authorization of 

these six additional HCPCS codes for 

PMDs and five HCPCS codes for 

Orthoses will help further our program 

integrity goals of reducing fraud, waste, 

and abuse, while also protecting access 

to care. For PMDs, the OIG has 

previously reported that Medicare has 

inappropriately paid for items that did 

not meet certain Medicare 

requirements.2 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. 

Since 2016, LLOs have had an improper 

payment rate above 60 percent, with 

projected improper payments ranging 

between $235 and $501 million. 

Similarly, LSOs have had an improper 

payment rate above 32 percent, with 

projected improper payments ranging 

between $116 and $177 million, since 

2016. Additionally, in 2019, the 

Department of Justice (DOJ) announced 


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3Federal Indictments & Law Enforcement Actions 

in One of the Largest Health Care Fraud Schemes 

Involving Telemedicine and Durable Medical 

Equipment Marketing Executives Results in Charges 

Against 24 Individuals Responsible for Over $1.2 

Billion in Losses (April 9, 2019): https://

www.justice.gov/opa/pr/federal-indictments-andlaw-enforcement-actions-one-largest-health-carefraud-schemes. 

4The additional PMD codes that will be added 

were not included in the data analysis because PMD 

codes are already part of a successful prior 

authorization program. Since some PMDs are 

already subject to prior authorization, other PMDs 

may demonstrate billing shifts across the policy 

groups, and as such, savings are more difficult to 

accurately forecast and may be less identifiable. 

federal indictments and law 

enforcement actions stemming from 

fraudulent claims submitted for 

medically unnecessary back, shoulder, 

wrist, and knee braces. Administrative 

actions were taken against 130 DMEPOS 

companies that were enticing Medicare 

beneficiaries with offers of low or nocost orthotic braces. The investigation 

found that some DME companies and 

licensed medical professionals allegedly 

participated in health care fraud 

schemes involving more than $1.2 

billion in loss.3

These codes will be subject to the 

requirements of the prior authorization 

program for certain DMEPOS items as 

outlined in § 414.234. We will 

implement a prior authorization 

program for the six newly added codes 

for PMDs nationwide and five newly 

added codes for Orthoses in 3 phases. 

This phased-in approach will allow us 

to identify and resolve any unforeseen 

issues by using a smaller claim volume 

in phase one before implementing 

phases 2 and 3. State selection for the 

three phases was completed based on 

utilization data for the items selected. 

• For phase 1, which begins on the 

date specified in the DATES section, we 

selected the State in each DME MAC 

jurisdiction with the highest utilization: 

New York, Illinois, Florida, and 

California. 

• For phase 2, which begins on the 

date specified in the DATES section of 

this document, we selected the next 

three States with the highest utilization 

in each DME MAC jurisdiction: 

Maryland, Pennsylvania, New Jersey, 

Michigan, Ohio, Kentucky, Texas, North 

Carolina, Georgia, Missouri, Arizona, 

and Washington. 

• For phase 3, which begins on the 

date specified in the DATES section of 

this document, prior authorization 

expands to all remaining States and 

territories not captured in phases 1 and 

2. 

The prior authorization program for 

the 51 codes currently subject to the 

DMEPOS prior authorization 

requirement will continue 

uninterrupted. 

Prior to providing an item on the 

Required Prior Authorization List to the 

beneficiary and submitting the claim for 

processing, a requester must submit a 

prior authorization request. The request 

must include evidence that the item 

complies with all applicable Medicare 

coverage, coding, and payment rules. 

Consistent with § 414.234(d), such 

evidence must include the written 

order/prescription, relevant information 

from the beneficiary’s medical record, 

and relevant supplier-produced 

documentation. After receipt of all 

applicable required Medicare 

documentation, CMS or one of its 

review contractors will conduct a 

medical review and communicate a 

decision that provisionally affirms or 

non-affirms the request. 

We will issue specific prior 

authorization guidance for these 

additional items in subregulatory 

communications, including final 

timelines customized for the DMEPOS 

item subject to prior authorization, for 

communicating a provisionally affirmed 

or non-affirmed decision to the 

requester. In the December 30, 2015 

final rule (80 FR 81674) we stated that 

this approach to final timelines provides 

flexibility to develop a process that 

involves fewer days, as may be 

appropriate, and allows us to safeguard 

beneficiary access to care. If at any time 

we become aware that the prior 

authorization process is creating barriers 

to care, we can suspend the program. 

For example, we will review questions 

and complaints from consumers and 

providers that come through regular 

sources such as 1–800–Medicare. 

The updated Required Prior 

Authorization List is available in the 

download section of the following CMS 

website: https://www.cms.gov/ResearchStatistics-Data-and-Systems/MonitoringPrograms/Medicare-FFS-CompliancePrograms/DMEPOS/Downloads/ 

DMEPOS_PA_Required-PriorAuthorization-List.pdf. 

III. Collection of Information 

Requirements 

This document provides updates to 

the Master List and announces the 

selection of HCPCS codes to be placed 

on the Required Face-to-Face Encounter 

and Written Order Prior to Delivery List 

and Required Prior Authorization List. 

Additionally, this document 

announces the continuation of prior 

authorization for 51 HCPCS codes, and 

the addition of six HCPCS codes for 

PMDs and five HCPCS codes for 

Orthoses on the Required Prior 

Authorization List. There is an 

information collection burden 

associated with this program that is 

currently approved under OMB control 

number 0938–1293, which expires 

March 31, 2022. This package accounts 

for burdens associated with the addition 

of items to the Required Prior 

Authorization Lists and assumes a 

burden for 2021 of approximately $10 

million for providers to comply with the 

required information collection. We will 

reassess this burden soon and will seek 

comment on our assessment in a 

Federal Register notice as required 

under the Paperwork Reduction Act of 

1995. 

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. Per our analysis, the 

additional items being added to the 

prior authorization program (excluding 

PMDs) 4 have an estimated net savings 

of $14.8 million. Gross savings is based 

upon a 10 percent reduction in the total 

amount paid for claims in Calendar Year 

2019. We deducted from the gross 

savings the anticipated cost for 

performing the prior authorization 

reviews in order to estimate the net 

savings. Our gross savings estimate of 10 

percent is based on previous results 

from other prior authorization programs, 


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2058 Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations 

including prior authorization of other 

DMEPOS items. 

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 

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 2021, that threshold is approximately 

$158 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 10, 2022. 

Lynette Wilson, 

Federal Register Liaison, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2022–00572 Filed 1–12–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 412, 416, 419, and 512 

Office of the Secretary 

45 CFR Part 180 

[CMS–1753–CN] 

RIN 0938–AU43 

Medicare Program: Hospital Outpatient 

Prospective Payment and Ambulatory 

Surgical Center Payment Systems and 

Quality Reporting Programs; Price 

Transparency of Hospital Standard 

Charges; Radiation Oncology Model; 

Correction 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Final rule with comment period; 

correction. 

SUMMARY: This document corrects 

technical errors in the final rule with 

comment period that appeared in the 

Federal Register on November 16, 2021, 

titled ‘‘Medicare Program: Hospital 

Outpatient Prospective Payment and 

Ambulatory Surgical Center Payment 

Systems and Quality Reporting 

Programs; Price Transparency of 

Hospital Standard Charges; Radiation 

Oncology Model.’’ 

DATES: 

Effective date: Effective January 13, 

2022. 

Applicability date: The corrections in 

this correcting document are applicable 

beginning January 1, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Marjorie Baldo via email 

Marjorie.Baldo@cms.hhs.gov or at (410) 

786–4617. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the final rule with comment period 

that appeared in the November 16, 2021, 

Federal Register (86 FR 63458) titled 

‘‘Medicare Program: Hospital Outpatient 

Prospective Payment and Ambulatory 

Surgical Center Payment Systems and 

Quality Reporting Programs; Price 

Transparency of Hospital Standard 

Charges; Radiation Oncology Model’’ 

(hereinafter referred to as the CY 2022 

OPPS/ASC final rule with comment 

period), there were a number of 

technical and typographical errors that 

are identified and corrected in this 

correcting document. The provisions in 

this correction document are effective as 

if they had been included in the 

document that appeared in the 

November 16, 2021 Federal Register. 

Accordingly, the corrections are 

effective January 1, 2022. 

II. Summary of Errors 

A. Summary of Errors in the Preamble 

1. Hospital Outpatient Prospective 

Payment System (OPPS) Corrections 

On page 63463, use of incorrect wage 

index assignments for community 

mental health centers (CMHCs) resulted 

in an inaccurate payment impact 

estimate. We stated that ‘‘we estimate a 

1.1 percent increase in CY 2022 

payments to CMHCs relative to their CY 

2021 payments.’’ We are correcting our 

estimate of the increase in payments for 

CMHCs from ‘‘1.1 percent’’ to ‘‘1.6 

percent’’. 

On page 63490, we noted that one 

commenter, a hospital association, 

supported CMS’s proposal to continue 

to unpackage Omidria in the ASC 

setting. However, there were several 

commenters, including several hospital 

associations, that expressed broad 

support for CMS’s proposal to 

unpackage and pay separately for nonopioid pain management drugs that 

function as surgical supplies, including 

the drug Omidria. We are correcting the 

text to acknowledge the additional 

commenters. 

On page 63497, the table number for 

the table included on this page was 

inadvertently omitted from the table’s 

title. Therefore, we are adding the 

number ‘‘4’’ to the table’s title. 

On page 63543 and 63544, we listed 

the incorrect APC assignment for CPT 

codes 66989 and 66991. We are 

correcting the APC assignment for these 

codes from APC 1526 to APC 1563. 

On page 63548, second column, under 

section ‘‘6. Calculus Aspiration With 

Lithotripsy Procedure (APC 5376)’’ of 

the APC-Specific section, we are 

correcting the long descriptor for 


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