[Federal Register Volume 89, Number 93 (Monday, May 13, 2024)]
[Rules and Regulations]
[Pages 41324-41331]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-10356]



[[Page 41324]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 410 and 414

[CMS-6095-N]


Medicare Program; Updates to the Master List of Items Potentially 
Subject to Face-to-Face Encounter and Written Order Prior To Delivery 
and/or Prior Authorization Requirements; Updates to the Required Face-
to-Face and Written Order Prior To Delivery List; and Updates to the 
Required Prior Authorization List

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

ACTION: Updates to the Master List of Items Potentially Subject to 
Face-To-Face Encounter and Written Order Prior to Delivery and/or Prior 
Authorization Requirements (the ``Master List'') and updates to the 
Required Face-to-Face and Written Order Prior to Delivery List and the 
Required Prior Authorization List.

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

DATES: Implementation of updates to the Master List and the Required 
Face-to-Face and Written Order Prior to Delivery List are effective on 
August 12, 2024. Required prior authorization of newly added lumbar-
sacral orthoses and lower limb orthoses is effective nationwide on 
August 12, 2024. Prior authorization of newly added osteogenesis 
stimulators will be implemented in two phases, with phase 1 including 
one State per Durable Medical Equipment Medicare Administrative 
Contractor (DME MAC) jurisdiction on August 12, 2024. The States 
included in phase 1 are California, Florida, Ohio, and Pennsylvania. 
Phase 2 will include all remaining U.S. States and territories not 
included in phase 1, effective on November 12, 2024.

FOR FURTHER INFORMATION CONTACT: 
    For information related to the Master List or Required Prior 
Authorization List, contact Susan Billet, (410) 786-1062; Emily 
Calvert, (410) 786-4277; Justin Carlisle, (410) 786-4265; Stephanie 
Collins, (410) 786-0959; or Jessica Martindale, (410) 786-1558.
    For information related to the Required Face-to-Face Encounter and 
Written Order Prior to Delivery List, contact Jennifer Phillips, (410) 
786-1023; Misty Whitaker, (410) 786-4975; Olufemi Shodeke, (410) 786-
1649; or Cristine Egan, (410) 786-8088.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 8, 2019, the Centers for Medicare & Medicaid Services 
(CMS) 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'' (the November 2019 final rule) (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 Master List serves as a library of items, that have been 
identified as potential vulnerabilities to the Trust Fund based on 
criteria outlined in 42 CFR 414.234(b), from which items may be 
selected to be placed on either the Required Face-to-Face Encounter and 
Written Orders Prior to Delivery List (the ``F2F/WOPD List'') and/or 
Required Prior Authorization List under the authority provided under 
sections 1834(a)(1)(E)(iv), 1834(a)(11)(B), and 1834(a)(15) of the Act. 
Only those items that are selected and announced via Federal Register 
notice are subject to such regulatory conditions of payment. The 
November 2019 final rule provided that the Federal Register notice 
would be for a period of no less than 60 days. It also clarified that 
certain items (that is, power mobility devices) require a face-to-face 
encounter per statute and would remain on both the Master List and the 
F2F/WOPD List, indefinitely.
    The November 2019 final rule information related to face-to-face 
encounters, written orders prior to delivery, and 5-element order/
prescription for specified DMEPOS items was codified in 42 CFR 410.38. 
The information in the November 2019 final rule related to the creation 
and maintenance of the Master List is codified at 42 CFR 414.234. The 
November 2019 final rule also includes information related to the prior 
authorization process, as initially outlined in the December 30, 2015 
final rule titled ``Medicare Program; Prior Authorization Process for 
Certain Durable Medical Equipment, Prosthetics, and Supplies'' (80 FR 
81674).
    The Master List was last updated in 2022 and currently includes 439 
items.
    In 2022 and 2023, CMS published the first and second iterations of 
the Required Face-to-Face Encounter and Written Orders Prior to 
Delivery List, respectively. There are currently 63 items on the list, 
including 46 power mobility devices that were included per statute.
    The Required Prior Authorization List was last updated in 2022 and 
currently includes 62 items. All the lists discussed in this notice are 
available on the cms.gov website.

II. Provisions of the Document

    This document serves to update three separate lists. First, it 
provides an update to the Master List. Next, this document updates the 
items included on the Required Face-to-Face and Written Order Prior to 
Delivery List. Finally, this document updates items included on the 
Required Prior Authorization List.

A. Master List

    The Master List includes items that appear on the DMEPOS Fee 
Schedule and meet one of the following criteria, as stated in 42 CFR 
414.234(b)(1):
     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) Medicare Fee-for-Service Supplemental Improper Payment 
Data report as having a high improper payment rate.

[[Page 41325]]

     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 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 regulation at Sec.  414.234 (b)(2) and the November 2019 
final rule noted previously, the maintenance process of the Master List 
is described 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 Sec.  414.234(b)(1) are added to the 
list when the item is also listed in the CERT Medicare Fee-for-Service 
Supplemental Improper Payment Data report published after 2020, or in 
an OIG or GAO report published after 2020, and items not meeting the 
cost thresholds (originally set at $500 for purchases and $50 for 
rentals and adjusted for inflation) 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 on the Master List are updated when the 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 http://go.cms.gov/DMEPOSPA.
    This document provides the annual update to the Master List of 
DMEPOS Items Potentially Subjected to a Face-to-Face 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. Specifically, in accordance with 42 CFR 414.234(b)(1)(i) the 
$500 average purchase fee threshold and the $50 average monthly rental 
fee threshold is adjusted using the consumer price index for all urban 
consumers (CPI-U), reduced by the 10-year moving average of changes in 
annual economy-wide private nonfarm business multifactor productivity 
(MFP) as projected by the Secretary for the 10-year period ending with 
the applicable FY, year, cost reporting period, or other annual period.
    The DMEPOS fee schedule amounts are also updated every year to 
account for inflation. For CY2021,\1\ 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 was 0.6 
percent. 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 (referred to as the productivity 
adjustment) was 0.4 percent. Beginning with the November 18, 2021 
release of productivity data, the Bureau of Labor Statistics replaced 
the term multifactor productivity with total factor productivity 
stating that this was a change in terminology only and will not affect 
the data or methodology. Thus, for CY 2021, we applied an update factor 
of 0.2 percent (reduce the 0.6 percentage increase in the CPI-U by the 
productivity adjustment of 0.4 percentage point). Applying the 0.2 
percent update factor to the CY 2020 average price threshold of $500 
results in a CY 2021 adjusted payment threshold of $501 ($500 x 1.002) 
and an updated rental payment threshold of $50.10 ($50 x 1.002), which 
we round to $50.
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    \1\ https://www.cms.gov/medicaremedicare-fee-service-paymentdmeposfeescheddmepos-fee-schedule/dme21.
---------------------------------------------------------------------------

    The DME Fee Schedule was updated for CY 2022 \2\ and CY 2023,\3\ 
however due to the Covid-19 Public Health Emergency (PHE), the Master 
List was not updated.
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    \2\ https://www.cms.gov/medicaremedicare-fee-service-paymentdmeposfeescheddmepos-fee-schedule/dme22.
    \3\ https://www.cms.gov/medicaremedicare-fee-service-paymentdmeposfeescheddmepos-fee-schedule/dme23.
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    For CY 2022, the CPI-U increase was 5.4 percent and the 
productivity adjustment was 0.3 percentage points. Thus, for CY 2022, 
we applied an update factor of 5.1 percent (5.4 percent reduced by 0.3 
percentage points).
    For CY 2022, the adjusted purchase price threshold was $527 and the 
adjusted monthly rental fee threshold was $53. We calculated this by 
applying the 5.1 percent update factor to the CY 2021 average price 
threshold of $501, resulting in a CY 2022 adjusted payment threshold of 
$526.55 ($501 x 1.051), and to the CY 2021 average monthly rental fee 
of $50, resulting in an adjusted payment threshold of $52.55 ($50 x 
1.051). Rounded to the nearest whole dollars results in thresholds of 
$527 and $53.
    For CY 2023, the CPI-U increase was 9.1 percent and the 
productivity adjustment was 0.4 percentage points. Thus, for CY 2023, 
we applied an update factor of 8.7 percent (9.1 percent reduced by 0.4 
percentage points).
    For CY 2023 the adjusted purchase price threshold was $573 and the 
adjusted monthly rental fee threshold of $58. We calculated this by 
applying the 8.7 percent update factor to the CY 2022 average price 
threshold of $527, resulting in a CY 2023 adjusted payment threshold of 
$572.85 ($527 x 1.087), and to the CY 2022 average monthly rental fee 
of $53, resulting in an adjusted payment threshold of $57.61 ($53 x 
1.087). Rounded to the nearest whole dollar, these figures are $573 and 
$58.
    For CY 2024, the CPI-U increase was 3.0 percent and the 
productivity adjustment was 0.4 percentage points. Thus, for CY 2024, 
we applied an update factor of 2.6 percent (3.0 percent reduced by 0.4 
percentage points).
    For CY 2024, the adjusted purchase price threshold is $588 and the 
adjusted monthly rental fee threshold is $60. We calculated this by 
applying the 2.6 percent update factor to the CY 2023 average price 
threshold of $573, resulting in a CY 2024 adjusted payment threshold of 
$587.89 ($573 x 1.026), and to the CY 2023 average monthly rental fee 
of $58, resulting in an adjusted payment threshold of $59.51 ($58 x

[[Page 41326]]

1.026). Rounding to the nearest whole dollar, these figures are $588 
and $60.
    We are adding a total of 76 HCPCS codes (see Table 1) meeting the 
criteria outlined previously to the Master List. Of these 76 HCPCS 
codes, 56 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 Medicare Fee-for-Service Supplemental Improper Payment Data 
report, or both; and 20 are being added for aberrant billing patterns. 
The codes added due to aberrant billing patterns represent items for 
which data show suppliers submitted at least 1,000 claims and received 
at least $1 million in payments during the two 12-month periods from 
July 2021 to June 2022 and July 2022 to June 2023. There was more than 
a 30 percent increase in payments for each item from the preceding 12-
month period. CMS did not identify explanatory contributing factors for 
the aberrant billing.

                  Table 1--Additions to the Master List
------------------------------------------------------------------------
          HCPCS                             Description
------------------------------------------------------------------------
A4342....................  Accessories for patient inserted indwelling
                            intraurethral drainage device with valve,
                            replacement only, each.
A4353....................  Intermittent urinary catheter, with insertion
                            supplies.
A4393....................  Ostomy pouch, urinary, with extended wear
                            barrier attached, with built-in convexity (1
                            piece), each.
A4408....................  Ostomy skin barrier, with flange (solid,
                            flexible or accordion), extended wear, with
                            built-in convexity, larger than 4 x 4
                            inches, each.
A4410....................  Ostomy skin barrier, with flange (solid,
                            flexible or accordion), extended wear,
                            without built-in convexity, larger than 4 x
                            4 inches, each.
A5056....................  Ostomy pouch, drainable, with extended wear
                            barrier attached, with filter, (1 piece),
                            each.
A5057....................  Ostomy pouch, drainable, with extended wear
                            barrier attached, with built in convexity,
                            with filter, (1 piece), each.
A6021....................  Collagen dressing, sterile, size 16 sq. in.
                            or less.
A6023....................  Collagen dressing, sterile, size more than 48
                            sq. in.
A6238....................  Hydrocolloid dressing, wound cover, sterile,
                            pad size more than 16 sq. in. but less than
                            or equal to 48 sq. in.
A6251....................  Specialty absorptive dressing, wound cover,
                            sterile, pad size 16 sq. in. or less,
                            without adhesive border, each dressing.
A6266....................  Gauze, impregnated, other than water, normal
                            saline, or zinc paste, sterile, any width,
                            per linear yard.
E0482....................  Cough stimulating device, alternating
                            positive and negative airway pressure.
E0490....................  Power source and control electronics unit for
                            oral device/appliance for neuromuscular
                            electical stimulation of the tongue muscle,
                            controlled by hardware remote.
E0500....................  Intermittent Positive Pressure Breathing
                            machine, all types, with built-in
                            nebulizations; manual ot automatic valves;
                            internal or ecternal power source.
E0562....................  Humidifier, heated, used with positive airway
                            pressure device.
E0618....................  Apnea monitor, without recording feature.
E0677....................  Non-pneumatic sequential compression garment,
                            trunk.
E0680....................  Non-pneumatic compression controller with
                            sequential calibrated gradient pressure.
E0681....................  Non-pneumatic compression controller without
                            calibrated gradient pressure.
E0693....................  Ultraviolet light therapy system panel,
                            includes bulbs/lamps, timer and eye
                            protection, 6 foot panel.
E0749....................  Osteogenesis stimulator, electrical,
                            surgically implanted.
E0782....................  Infusion pump, implantable, non-programmable
                            (includes all components, e.g., pump,
                            catheter, connectors, etc.).
E0783....................  Infusion pump system, implantable,
                            programmable (includes all components, e.g.,
                            pump, catheter, connectors, etc.).
E0785....................  Implantable intraspinal (epidural/
                            intrathecal) catheter used with implantable
                            infusion pump, replacement.
E0786....................  Implantable programmable infusion pump,
                            replacement (excludes implantable
                            intraspinal catheter).
E0984....................  Manual wheelchair accessory, power add-on to
                            convert manual wheelchair to motorized
                            wheelchair, tiller control.
E1050....................  Fully-reclining wheelchair, fixed full length
                            arms, swing away detachable elevating leg
                            rests.
E1060....................  Fully-reclining wheelchair, detachable arms,
                            desk or full length, swing away detachable
                            elevating legrests.
E1070....................  Fully-reclining wheelchair, detachable arms
                            (desk or full length) swing away detachable
                            footrest.
E1083....................  Hemi-wheelchair, fixed full length arms,
                            swing away detachable elevating leg rest.
E1084....................  Hemi-wheelchair, detachable arms desk or full
                            length arms, swing away detachable elevating
                            leg rests.
E1087....................  High strength lightweight wheelchair, fixed
                            full length arms, swing away detachable
                            elevating leg rests.
E1088....................  High strength lightweight wheelchair,
                            detachable arms desk or full length, swing
                            away detachable elevating leg rests.
E1092....................  Wide heavy duty wheelchair, detachable arms
                            (desk or full length), swing away detachable
                            elevating leg rests.
E1093....................  Wide heavy duty wheelchair, detachable arms
                            desk or full length arms, swing away
                            detachable footrests.
E1100....................  Semi-reclining wheelchair, fixed full length
                            arms, swing away detachable elevating leg
                            rests.
E1110....................  Semi-reclining wheelchair, detachable arms
                            (desk or full length) elevating leg rest.
E1150....................  Wheelchair, detachable arms, desk or full
                            length swing away detachable elevating
                            legrests.
E1160....................  Wheelchair, fixed full length arms, swing
                            away detachable elevating legrests.
E1170....................  Amputee wheelchair, fixed full length arms,
                            swing away detachable elevating legrests.
E1171....................  Amputee wheelchair, fixed full length arms,
                            without footrests or legrest.
E1172....................  Amputee wheelchair, detachable arms (desk or
                            full length) without footrests or legrest.
E1180....................  Amputee wheelchair, detachable arms (desk or
                            full length) swing away detachable
                            footrests.
E1190....................  Amputee wheelchair, detachable arms (desk or
                            full length) swing away detachable elevating
                            legrests.
E1195....................  Heavy duty wheelchair, fixed full length
                            arms, swing away detachable elevating
                            legrests.
E1200....................  Amputee wheelchair, fixed full length arms,
                            swing away detachable footrest.
E1221....................  Wheelchair with fixed arm, footrests.
E1222....................  Wheelchair with fixed arm, elevating
                            legrests.
E1223....................  Wheelchair with detachable arms, footrests.
E1224....................  Wheelchair with detachable arms, elevating
                            legrests.
E1240....................  Lightweight wheelchair, detachable arms,
                            (desk or full length) swing away detachable,
                            elevating legrest.
E1270....................  Lightweight wheelchair, fixed full length
                            arms, swing away detachable elevating
                            legrests.
E1280....................  Heavy duty wheelchair, detachable arms (desk
                            or full length) elevating legrests.
E1295....................  Heavy duty wheelchair, fixed full length
                            arms, elevating legrest.
E1296....................  Special wheelchair seat height from floor.
E2341....................  Power wheelchair accessory, nonstandard seat
                            frame width, 24-27 inches.

[[Page 41327]]

 
E2342....................  Power wheelchair accessory, nonstandard seat
                            frame depth, 20 or 21 inches.
E2343....................  Power wheelchair accessory, nonstandard seat
                            frame depth, 22-25 inches.
E2510....................  Speech generating device, synthesized speech,
                            permitting multiple methods of message
                            formulation and multiple methods of device
                            access.
E2606....................  Positioning wheelchair seat cushion, width 22
                            inches or greater, any depth.
E2631....................  Wheelchair accessory, addition to mobile arm
                            support, elevating proximal arm.
K0010....................  Standard--weight frame motorized/power
                            wheelchair.
K0011....................  Standard--weight frame motorized/power
                            wheelchair with programmable control
                            parameters for speed adjustment, tremor
                            dampening, acceleration control and braking.
K0012....................  Lightweight portable motorized/power
                            wheelchair.
L0457....................  TLSO, flexible, provides trunk support,
                            thoracic region, rigid posterior panel and
                            soft anterior apron, extends from the
                            sacrococcygeal junction and terminates just
                            inferior to the scapular spine, restricts
                            gross trunk motion in the sagittal plane,
                            produces intracavitary pressure to reduce
                            load on the intervertebral disks, includes
                            straps and closures, prefabricated, off-the-
                            shelf.
L1681....................  Hip orthosis, bilateral hip joints and thigh
                            cuffs, adjustable flexion, extension,
                            abduction control of hip joint,
                            postoperative hip abduction type,
                            prefabricated item that has been trimmed,
                            bent, molded, assembled, or otherwise
                            customized to fit a specific patient by an
                            individual with expertise.
L2006....................  Knee ankle foot device, any material, single
                            or double upright, swing and stance phase
                            microprocessor control with adjustability,
                            includes all components (e.g., sensors,
                            batteries, charger), any type activation,
                            with or without ankle joint(s), custom
                            fabricated.
L2280....................  Addition to lower extremity, molded inner
                            boot.
L3761....................  Elbow orthosis (EO), with adjustable position
                            locking joint(s), prefabricated, off-the-
                            shelf.
L4000....................  Replace girdle for spinal orthosis (cervical-
                            thoracic-lumbar-sacral orthosis or shoulder
                            orthosis.
L5615....................  Addition, endoskeletal knee-shin system, 4
                            bar linkage or multiaxial, fluid swing and
                            stance phase control.
L5926....................  Addition to lower extremity prosthesis,
                            endoskeletal, knee disarticulation, above
                            knee, hip disarticulation, positional
                            rotation unit, any type.
L5991....................  Addition to lower extremity prostheses,
                            osseointegrated external prosthetic
                            connector.
L6026....................  Transcarpal/metacarpal or partial hand
                            disarticulation prosthesis, external power,
                            self-suspended, inner socket with removable
                            forearm section, electrodes and cables, two
                            batteries, charger, myoelectric control of
                            terminal device, excludes terminal devices.
L7366....................  Battery charger, twelve volt, each.
------------------------------------------------------------------------

    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 has 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. Additionally, items are removed from the list sooner 
than 10-year timeframe if the purchase or monthly rental amount drops 
below the payment threshold. There are three (See Table 2) HCPCS codes 
being removed from the Master List for the CY 2024 update, as they no 
longer meet the criteria for inclusion.

                 Table 2--Deletions From the Master List
------------------------------------------------------------------------
          HCPCS                             Description
------------------------------------------------------------------------
A7025....................  High frequency chest wall oscillation system
                            vest, replacement for use with patient owned
                            equipment.
E0565....................  Compressor air power source.
L1833....................  Knee orthosis (KO), adjustable knee joints
                            (unicentric or polycentric), positional
                            orthosis, rigid support, prefabricated, off-
                            the shelf.
------------------------------------------------------------------------

    The full updated Master List is available in the Downloads & Links 
section of the following CMS website: http://go.cms.gov/DMEPOSPA

B. Items Subject to Face-to-Face Encounter and Written Order Prior to 
Delivery Requirements

    As previously stated, 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.
    When selecting these items, we balance our program integrity goals 
with the needs of beneficiaries to 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 for use of telehealth, as defined in 42 CFR 410.78 and 
414.65, when appropriate to meet our coverage requirements for 
beneficiaries.
    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, and necessary 
documentation for items on the F2F/WOPD List.
    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

[[Page 41328]]

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.
    Prior to publication of this Federal Register notice, 63 items have 
been included on the F2F/WOPD List. We have not been notified of any 
issues related to beneficiary access, and billing trends have been 
consistent with anticipated volumes.
    Based on our regulatory authority at 42 CFR 410.38, this Federal 
Register notice is adding the following 13 additional HCPCS codes to 
the F2F/WOPD List (See Table 3).
    We have selected codes for three hospital beds, two osteogenesis 
stimulators, six lumbar sacral orthoses, and two knee orthoses. We note 
that such items were selected based on our analysis of the CERT 
improper payment information, practitioner encounter information, 
jurisdictionally identified billing vulnerabilities, policy analysis, 
and in coordination with the prior authorization program.
    We continue to believe additional practitioner oversight of 
beneficiaries in need of items included on the F2F/WOPD List will help 
further our program integrity goals of reducing fraud, waste, and 
abuse. It helps ensure beneficiary receipt of items specific to their 
medical needs, as the written order/prescription must be communicated 
to the supplier prior to delivery. For such items, we continue to 
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.

  Table 3--Additions to the F2F/WOPD List--New Non-Statutorily Required
                                  Items
------------------------------------------------------------------------
          HCPCS                             Description
------------------------------------------------------------------------
E0290....................  Hospital bed, fixed height, without side
                            rails, with mattress.
E0301....................  Hospital bed, heavy duty, extra wide, with
                            weight capacity greater than 350 pounds, but
                            less than or equal to 600 pounds, with any
                            type side rails, without mattress.
E0304....................  Hospital bed, extra heavy duty, extra wide,
                            with weight capacity greater than 600
                            pounds, with any type side rails, with
                            mattress.
E0760....................  Osteogenesis stimulator, low intensity
                            ultrasound, non-invasive.
E0747....................  Osteogenesis stimulator, electrical, non-
                            invasive, other than spinal applications.
L0635....................  Lumbar-sacral orthosis (LSO), sagittal-
                            coronal control, lumbar flexion, rigid
                            posterior frame/panel(s), lateral
                            articulating design to flex the lumbar
                            spine, 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,
                            anterior panel, pendulous abdomen design,
                            prefabricated, includes fitting and
                            adjustment.
L0636....................  Lumbar-sacral orthosis (LSO), sagittal-
                            coronal control, lumbar flexion, rigid
                            posterior frame/panels, lateral articulating
                            design to flex the lumbar spine, 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, anterior panel, pendulous
                            abdomen design, custom fabricated.
L0638....................  Lumbar-sacral orthosis (LSO), 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, custom fabricated.
L0639....................  Lumbar-sacral orthosis (LSO), sagittal-
                            coronal control, rigid shell(s)/panel(s),
                            posterior extends from sacrococcygeal
                            junction to T-9 vertebra, anterior extends
                            from symphysis pubis to xyphoid, produces
                            intracavitary pressure to reduce load on the
                            intervertebral discs, overall strength is
                            provided by overlapping rigid material and
                            stabilizing closures, includes straps,
                            closures, may include soft interface,
                            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.
L0640....................  Lumbar-sacral orthosis (LSO), sagittal-
                            coronal control, rigid shell(s)/panel(s),
                            posterior extends from sacrococcygeal
                            junction to T-9 vertebra, anterior extends
                            from symphysis pubis to xiphoid, produces
                            intracavitary pressure to reduce load on the
                            intervertebral discs, overall strength is
                            provided by overlapping rigid material and
                            stabilizing closures, includes straps,
                            closures, may include soft interface,
                            pendulous abdomen design, custom fabricated.
L0651....................  Lumbar-sacral orthosis (LSO), sagittal-
                            coronal control, rigid shell(s)/panel(s),
                            posterior extends from sacrococcygeal
                            junction to T-9 vertebra, anterior extends
                            from symphysis pubis to xyphoid, produces
                            intracavitary pressure to reduce load on the
                            intervertebral discs, overall strength is
                            provided by overlapping rigid material and
                            stabilizing closures, includes straps,
                            closures, may include soft interface,
                            pendulous abdomen design, prefabricated, off-
                            the-shelf.
L1845....................  Knee orthosis (KO), double 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.
L1852....................  Knee orthosis (KO), double 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.
------------------------------------------------------------------------

    Per the regulatory guidelines established at Sec.  414.234(b), and 
as previously discussed, items may be removed from the Master List. If 
items are removed from the Master List, they are no longer eligible for 
inclusion on the F2F/WOPD List. As such, as of the effective date of 
this Federal Register notice, HCPCS L1833 is removed from the Master 
List and is likewise removed from the Required F2F/WOPD List.

                Table 4--Deletions From the F2F/WOPD List
------------------------------------------------------------------------
          HCPCS                             Description
------------------------------------------------------------------------
L1833....................  Knee orthosis (KO), adjustable knee joints
                            (unicentric or polycentric), positional
                            orthosis, rigid support, prefabricated, off-
                            the shelf.
------------------------------------------------------------------------


[[Page 41329]]

    The F2F/WOPD List is available on the following CMS website: F2F/
WOPD List.

C. Items Subject to Prior Authorization Requirements

    The Required Prior Authorization List specified in Sec.  
414.234(c)(1) is selected from the Master List (as described in Sec.  
414.234(b)), and those selected items require prior authorization as a 
condition of payment. As stated in Sec.  414.234(c), we 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. Additionally, 
Sec.  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.
    We are updating the Required Prior Authorization List to include 
the addition of nine HCPCS codes and removal of one HCPCS code. HCPCS 
code L1833 is being removed from the Required Prior Authorization List 
as the item no longer meets the criteria to be maintained on the Master 
List and is no longer eligible for inclusion. The remaining 61 HCPCS 
codes currently on the Required Prior Authorization List remain on the 
List without interruption. To assist stakeholders in preparing for 
implementation of the prior authorization program, we are providing 90 
days' notice.

      Table 5--Deletions From The Required Prior Authorization List
------------------------------------------------------------------------
          HCPCS                             Description
------------------------------------------------------------------------
L1833....................  Knee orthosis (KO), adjustable knee joints
                            (unicentric or polycentric), positional
                            orthosis, rigid support, prefabricated, off-
                            the shelf.
------------------------------------------------------------------------

    The following three HCPCS codes for osteogenesis stimulators, three 
HCPCS codes for lumbar-sacral orthoses (LSO), and three HCPCS codes for 
lower limb orthoses (LLO) are added to the Required Prior Authorization 
List:

       Table 6--Additions to the Required Prior Authorization List
------------------------------------------------------------------------
          HCPCS                             Description
------------------------------------------------------------------------
E0747....................  Osteogenesis stimulator, electrical, non-
                            invasive, other than spinal applications.
E0748....................  Osteogenesis stimulator, electrical, non-
                            invasive, spinal applications.
E0760....................  Osteogenesis stimulator, low intensity
                            ultrasound, non-invasive.
L0631....................  Lumbar-sacral orthosis (LSO), 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 (LSO), 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.
L0639....................  Lumbar-sacral orthosis (LSO), sagittal-
                            coronal control, rigid shell(s)/panel(s),
                            posterior extends from sacrococcygeal
                            junction to T-9 vertebra, anterior extends
                            from symphysis pubis to xyphoid, produces
                            intracavitary pressure to reduce load on the
                            intervertebral discs, overall strength is
                            provided by overlapping rigid material and
                            stabilizing closures, includes straps,
                            closures, may include soft interface,
                            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 (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 item that has been trimmed,
                            bent, molded, assembled, or otherwise
                            customized to fit a specific patient by an
                            individual with expertise.
L1845....................  Knee orthosis (KO), double 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.
L1951....................  Ankle foot orthosis (AFO), spiral, (institute
                            of rehabilitative medicine type), plastic or
                            other material, prefabricated, includes
                            fitting and adjustment.
------------------------------------------------------------------------

    We believe prior authorization of these nine additional HCPCS codes 
will help further our program integrity goals of reducing fraud, waste, 
and abuse, while also protecting access to care.
    In recent years, osteogenesis stimulators have been a concern due 
to continually high improper payment rates, having been identified in 
CMS' CERT Medicare Fee-for-Service Supplemental Improper Payment Data 
reports (2017-2020) as having improper payment rates ranging from 8.5 
to 40.9 percent.
    LSOs and LLOs have been identified by the CERT program as two of 
the top 20 DMEPOS service types with improper payments over the past 
several years. Since 2020, LLOs have had an improper payment rate 
ranging from 44 to 66 percent, with projected improper payments ranging 
between $76 and $187 million. Similarly, LSOs have had an improper 
payment ranging from 35 to 58 percent, with projected improper payments 
ranging between $78 and $178 million since 2020. In 2019, the 
Department of Justice (DOJ) announced 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 no-cost 
orthotic braces. The investigation found that some DMEPOS companies and 
licensed medical professionals allegedly participated in health care 
fraud schemes involving more than $1.2

[[Page 41330]]

billion in loss.\4\ In 2022, CMS added several LSOs and LLOs to the 
Required Prior Authorization list (87 FR 2051); however, additional 
program integrity action in this space is warranted.\5\
---------------------------------------------------------------------------

    \4\ https://www.justice.gov/opa/pr/federal-indictments-and-law-enforcement-actions-one-largest-health-care-fraud-schemes.
    \5\ Due to the need for certain patients to receive an orthoses 
item that may otherwise be subject to PA when the 2-day expedited 
review would delay care and risk the health or life of the 
beneficiary, we suspended prior authorization requirements for 
certain codes in these limited circumstances, effective April 13, 
2022. This suspension remains in effect. https://www.federalregister.gov/documents/2022/08/10/2022-17187/medicare-program-suspension-of-required-prior-authorization-for-certain-durable-medical-equipment.
---------------------------------------------------------------------------

    These codes will be subject to the requirements of the prior 
authorization program for certain DMEPOS items as outlined in Sec.  
414.234. We will implement a prior authorization program for the three 
newly added LSO and the three newly added LLO codes nationwide, 
beginning on the date specified in the in the DATES section. We will 
implement prior authorization for the three newly added osteogenesis 
stimulator codes in two phases beginning on the dates specified in the 
in the DATES section. This phased-in approach will allow us to identify 
and resolve any unforeseen issues by using a smaller claim volume in 
phase 1 before implementing phase 2. We selected States for the two 
phases based on utilization data.
    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 of the newly added osteogenesis stimulators: 
California, Florida, Ohio, and Pennsylvania.
    For phase 2, which begins on the date specified in the DATES 
section, prior authorization expands to all remaining States and 
territories not captured in phase 1.
    The prior authorization program for the remaining 61 HCPCS 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 Sec.  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 sub regulatory communications, final timelines 
customized for the DMEPOS item subject to prior authorization and 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 
Downloads & Links section of the following CMS website: http://go.cms.gov/DMEPOSPA.

III. Collection of Information Requirements

    This document provides updates to the Master List, the F2F/WOPD 
List, and the Required Prior Authorization List.
    A total of 76 HCPCS codes (see Table 1) meeting the criteria 
outlined previously are added to the Master List. Of these 76 HCPCS 
codes, 56 are added because these items meet the updated payment 
threshold and are listed in an OIG or GAO report of a national scope, a 
CERT Medicare Fee-for-Service Supplemental Improper Payment Data 
report, or both; and 20 are being added for aberrant billing patterns. 
There are three HCPCS codes (see Table 2) being removed from the Master 
List for the CY 2024 update, as these no longer meet the criteria for 
inclusion, as outlined previously.
    Thirteen HCPCS are being added to the F2F/WOPD List. Of these 13 
codes, three are hospital beds, two are osteogenesis stimulators, six 
are lumbar sacral orthoses, and two are knee orthoses. This notice 
removes one knee orthosis code from the F2F/WOPD List.
    The 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.).
    This notice removes one HCPCS code from the Required Prior 
Authorization List, as it no longer meets the requirements for 
inclusion (see Table 5). A total of nine HCPCS codes (see Table 6) are 
selected for addition to the Required Prior Authorization List. Of 
these nine HCPCS codes, three are osteogenesis stimulators, three are 
LSOs, and three are LLOs. The remaining 61 HCPCS codes currently 
subject to the DMEPOS prior authorization requirement will continue 
uninterrupted.
    There is an information collection burden associated with this 
program that is currently approved under OMB control number 0938-1293, 
which expires August 31, 2025. This package accounts for burdens 
associated with the addition of items to the Required Prior 
Authorization Lists and assumes a burden for 2024 of approximately $8.4 
million for providers to comply with the required information 
collection. The burden associated with the additions to the Required 
Prior Authorization List has been assessed in the PRA package 
referenced previously and is included in this 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), Executive Order 14094 entitled ``Modernizing 
Regulatory Review'' (April 6, 2023), 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 significant effects ($200 
million or more in any 1 year). This regulatory

[[Page 41331]]

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 have an estimated net savings of $32.1 million. Gross savings 
is based upon a 20 percent reduction in the total amount paid for 
claims in CY 2022. We deducted from the gross savings the anticipated 
cost for performing the prior authorization reviews to estimate the net 
savings. Our gross savings estimate of 20 percent is based on previous 
results from other prior authorization programs, 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 $9.0 million to $47.0 million in any one 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 2024, that 
threshold is approximately $183 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 Chyana Woodyard who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

Chyana Woodyard,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2024-10356 Filed 5-10-24; 8:45 am]
BILLING CODE 4120-01-P