[Federal Register Volume 91, Number 145 (Thursday, July 30, 2026)]
[Rules and Regulations]
[Pages 47972-47978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-15446]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 410 and 414
[CMS-6109-N]
RIN 0938-ZC04
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 Encounter 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''); Updates to the
Required Face-to-Face Encounter and Written Order Prior to Delivery
List; and Updates to the Required Prior Authorization List.
-----------------------------------------------------------------------
SUMMARY: This document announces updates to the 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
Encounter and Written Order Prior to Delivery List and the Required
Prior Authorization List.
DATES: Implementation of updates to the Master List, the Required Face-
to-Face Encounter and Written Order Prior to Delivery List, and the
Required Prior Authorization List, excluding upper limb orthoses, are
effective October 28, 2026.
Prior authorization requirements for the upper limb orthoses will
be implemented in three phases. Phase one includes New York, Michigan,
Florida, and California and is effective October 28, 2026. Phase two
includes the States in phase one and Pennsylvania, Massachusetts, Ohio,
Illinois, Texas, Georgia, Arizona, and Oregon and is effective January
26, 2027. Phase three includes all States and territories not included
in phases one and two and is effective April 26, 2027.
FOR FURTHER INFORMATION CONTACT: 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; or Olufemi Shodeke, (410) 786-1649.
For information related to the Master List or Required Prior
Authorization List, contact Justin Carlisle, (410) 786-4265; Karen
Leban, (410) 786-2476; or Jessica Martindale, (410) 786-1558.
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
Social Security Act (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
(PMDs)) require a face-to-face encounter per statute and would remain
on both the Master List and the F2F/WOPD List.
The requirements in the November 2019 final rule related to face-
to-face encounters, written orders prior to delivery, and standard
written orders for specified DMEPOS items were codified in 42 CFR
410.38. The information in
[[Page 47973]]
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, Orthotics, and Supplies'' (80
FR 81674).
The Master List was last updated via the document published in the
January 13, 2026 Federal Register (91 FR 1250 through 1252) and
currently includes 530 items. The Master List is available on the CMS
website at: http://go.cms.gov/DMEPOSPA.
The January 2026 Federal Register document (91 FR 1252 and 1253)
also included the most recent iteration of the Required Face-to-Face
Encounter and Written Order Prior to Delivery List. There are currently
83 items on the list, including 46 PMDs that were included per statute.
This list is also available on the CMS website at: http://go.cms.gov/DMEPOSF2F.
The Required Prior Authorization List was last updated via the
January 2026 Federal Register document (91 FR 1253 and 1254) and
currently includes 74 items. All the lists discussed in this notice are
available on the CMS website at: http://go.cms.gov/DMEPOSPA.
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 Encounter and Written Order
Prior to Delivery List. Finally, this document updates items 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.
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 percentage 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) and in the November 2019
final rule, 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 website at: http://go.cms.gov/DMEPOSPA.
This document updates the Master List of DMEPOS Items Potentially
Subject 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 as projected by the Secretary for the
10-year period ending with the applicable fiscal year, year, cost
reporting period, or other annual period.
In accordance with sections 1834(a)(14), 1834(h)(4) and
1842(s)(1)(B) of the Act, we updated certain DMEPOS fee schedule
amounts for calendar year (CY) 2026,\1\ by the percentage increase in
the CPI-U for the 12-month period ending June 30, 2025, adjusted by the
change in the economy-wide productivity measure referenced in section
1886(b)(3)(B)(xi)(II) of the Act as equal to the 10-year moving average
of changes in annual economy-wide, private nonfarm business multi-
factor productivity (as projected by the Secretary for the 10-year
period ending with the applicable fiscal year, year, cost reporting
period, or other annual period) (the ``productivity adjustment''). The
U.S. Department of Labor's Bureau of Labor Statistics (BLS) publishes
the official measures of productivity for the U.S. economy. The
productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the
Act is
[[Page 47974]]
published by BLS as private nonfarm business total factor productivity
(TFP), previously referred to as multifactor productivity.\2\ Please
see https://www.bls.gov/productivity/ for the BLS historical published
TFP data. For CY 2026, the productivity adjustment is estimated to be
0.7 percent and the CPI-U percentage increase is 2.7 percent. Thus, the
2.7 percentage increase in the CPI-U is reduced by a 0.7 percentage
point productivity adjustment resulting in a net increase of 2.0
percent for the update factor for CY 2026.
---------------------------------------------------------------------------
\1\ 2026 DMEPOS Fee Schedule; available at https://www.cms.gov/medicare/payment/fee-schedules/dmepos/dmepos-fee-schedule/dme26.
\2\ https://www.bls.gov/productivity/notices/2021/mfp-to-tfp-term-change.htm.
---------------------------------------------------------------------------
For CY 2026, the adjusted purchase price threshold is $614, and the
adjusted monthly rental fee threshold is $62. We calculated this by
applying the 2.0 percent update factor to the CY 2025 average price
threshold of $602, resulting in a CY 2026 adjusted payment threshold of
$614.02 ($602 x 1.02), and to the CY 2025 average monthly rental fee of
$61, resulting in an adjusted payment threshold of $62.22 ($61 x 1.02).
Rounding to the nearest whole dollar, these figures are $614 and $62.
We are adding a total of 20 HCPCS codes (see Table 1) meeting the
criteria outlined previously to the Master List. Of these 20 HCPCS
codes, A4239, A6022, A6197, K0831, L0456, L0486, L1833, and L3916 are
being added for aberrant billing patterns. These codes represent items
for which data shows suppliers submitted at least 1,000 claims and
received at least $1 million in payments during the 12 months from July
2024 to June 2025. 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. The
remaining 12 codes 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.
Table 1--Additions to the Master List
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
A4239.......................... Supply allowance for non-adjunctive,
non-implanted continuous glucose
monitor (CGM) including all supplies
and accessories (1 month supply = 1
unit of service).
A4594.......................... Neuromodulation stimulator system,
adjunct to rehabilitation therapy
regime, mouthpiece each.
A6022.......................... Collagen dressing, sterile, size more
than 16 square (sq) inches (in) but
less than or equal to 48 sq in each.
A6197.......................... Alginate or other fiber gelling
dressing, wound cover, sterile, pad
size more than 16 square (sq) inches
(in) but less than or equal to 48
sq.in., each dressing.
E0658.......................... Segmental pneumatic appliance for use
with pneumatic compressor, integrated,
2 full arms and chest.
E0659.......................... Segmental pneumatic appliance for use
with pneumatic compressor, integrated,
head, neck, and chest.
E0683.......................... Non-pneumatic, non-sequential,
peristaltic wave compression pump.
E0734.......................... External upper limb tremor stimulator
of the peripheral nerves of the wrist.
E0738.......................... Upper extremity rehabilitation system
providing active assistance to
facilitate muscle re-education,
including a microprocessor, all
components, and accessories.
E0739.......................... Rehabilitation system with interactive
interface providing active assistance
in rehabilitation therapy, includes
all components and accessories,
motors, microprocessors, sensors.
E2001.......................... Suction pump, home model, portable or
stationary, electric, any type, for
use with an external urine and/or
fecal management system.
E2298.......................... Complex rehabilitative power wheelchair
accessory, power seat elevation
system, any type.
K0831.......................... Power wheelchair, group 2 standard,
seat elevator, captain's chair,
patient weight capacity up to and
including 300 pounds.
L0456.......................... Thoracic-lumbar-sacral orthosis,
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
item that has been trimmed, bent,
molded, assembled, or otherwise
customized to fit a specific patient
by an individual with expertise.
L0486.......................... Thoracic-lumbar-sacral orthosis,
triplanar control, two piece rigid
plastic shell with interface liner,
multiple straps and closures,
posterior extends from sacrococcygeal
junction and terminates just inferior
to scapular spine, anterior extends
from symphysis pubis to sternal notch,
lateral strength is enhanced by
overlapping plastic, restricts gross
trunk motion in the sagittal, coronal,
and transverse planes, includes a
carved plaster or CAD-CAM model,
custom fabricated.
L1833.......................... Knee orthosis, adjustable knee joints
(unicentric or polycentric),
positional orthosis, rigid support,
prefabricated, off-the-shelf.
L1933.......................... Ankle foot orthosis, rigid anterior
tibial section, total carbon fiber or
equal material, prefabricated, off-the-
shelf.
L1952.......................... Ankle foot orthosis, spiral, (Institute
of rehabilitative medicine type),
plastic or other material,
prefabricated, off-the-shelf.
L3916.......................... Wrist hand orthosis, includes one or
more nontorsion joint(s), elastic
bands, turnbuckles, may include soft
interface, straps, prefabricated, off-
the-shelf.
L5827.......................... Endoskeletal knee-shin system, single
axis, electromechanical swing and
stance phase control, with or without
shock absorption and stance extension
damping.
------------------------------------------------------------------------
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 a 10-year timeframe if the purchase or monthly rental amount drops
below the payment threshold. There are no HCPCS codes being removed
from the Master List for the CY 2026 update.
The full updated Master List is available on the CMS website at:
http://go.cms.gov/DMEPOSPA.
B. Items Subject to Face-to-Face Encounter and Written Order Prior to
Delivery Requirements
The F2F/WOPD List includes PMDs that are required by 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
[[Page 47975]]
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.
Consistent with Sec. 410.38(d), the face-to-face encounter must be
documented in the pertinent portion of the medical record (for example,
history, physical examination, diagnostic tests, summary of findings,
progress notes, treatment plans or other sources of information that
may be appropriate). The supporting documentation must include
subjective and objective beneficiary-specific information used for
diagnosing, treating, or managing a clinical condition for which the
DMEPOS item(s) is ordered. Upon request by CMS or its review
contractors, a supplier must submit additional documentation to support
and substantiate the medical necessity for the DMEPOS item.
Prior to publication of this Federal Register notice, 83 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 22 additional HCPCS codes to
the F2F/WOPD List (See Table 2).
We have selected three codes for lumbar-sacral orthoses, four codes
for lower limb orthoses, two codes for upper limb orthoses, eight
wheelchair codes, three codes for home ventilators, one code related to
oxygen and its delivery system, and one code for an air-fluidized bed.
Lumbar-sacral orthoses, lower limb orthoses, upper limb orthoses,
ventilators, oxygen supplies/equipment and hospital bed/accessories
were identified by CMS' Comprehensive Error Rate Testing (CERT) program
as being within the top 20 DMEPOS service types with improper payments
in 2025. Several of these codes were also identified by HHS program
integrity experts, including our contractors performing medical review
as being vulnerable to fraud.
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.
The proposed items were selected based on the clinical
appropriateness of requiring a practitioner encounter within the
preceding 6 months, jurisdictionally identified billing
vulnerabilities, and data analysis, including our analysis of the CERT
improper payment information.
Table 2--Additions to the F2F/WOPD List--New Non-Statutorily Required
Items
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
E0194.......................... Air fluidized bed.
E0466.......................... Home ventilator, any type, used with
non-invasive interface, (for example,
mask, chest shell).
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.
E0468.......................... Home ventilator, dual-function
respiratory device, also performs
additional function of cough
stimulation, includes all accessories,
components and supplies for all
functions.
E1161.......................... Manual adult size wheelchair, includes
tilt in space.
K0002.......................... Standard hemi (low seat) wheelchair.
K0003.......................... Lightweight wheelchair.
K0004.......................... High strength, lightweight wheelchair.
K0005.......................... Ultralightweight wheelchair.
K0006.......................... Heavy duty wheelchair.
K0007.......................... Extra heavy-duty wheelchair.
K0738.......................... Portable gaseous oxygen system, rental;
home compressor used to fill portable
oxygen cylinders; includes portable
containers, regulator, flowmeter,
humidifier, cannula or mask, and
tubing.
K0831.......................... Power wheelchair, group 2 standard,
seat elevator, captain's chair,
patient weight capacity up to and
including 300 pounds.
L0486.......................... Thoracic-lumbar-sacral orthosis,
triplanar control, two piece rigid
plastic shell with interface liner,
multiple straps and closures,
posterior extends from sacrococcygeal
junction and terminates just inferior
to scapular spine, anterior extends
from symphysis pubis to sternal notch,
lateral strength is enhanced by
overlapping plastic, restricts gross
trunk motion in the sagittal, coronal,
and transverse planes, includes a
carved plaster or CAD-CAM model,
custom fabricated.
L0456.......................... Thoracic-lumbar-sacral orthosis,
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
item that has been trimmed, bent,
molded, assembled, or otherwise
customized to fit a specific patient
by an individual with expertise.
L0457.......................... Thoracic-lumbar-sacral orthosis,
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.
L1833.......................... Knee orthosis, adjustable knee joints
(unicentric or polycentric),
positional orthosis, rigid support,
prefabricated, off-the-shelf.
L1906.......................... Ankle foot orthosis, multi-ligamentous
ankle support, prefabricated, off-the-
shelf.
L1933.......................... Ankle foot orthoses, rigid anterior
tibial section, total carbon fiber or
equal material, prefabricated, off-the-
shelf.
L1952.......................... Ankle foot orthosis, spiral, (Institute
of rehabilitative medicine type),
plastic or other material,
prefabricated, off-the-shelf.
L3761.......................... Elbow orthosis, with adjustable
position locking joint(s),
prefabricated, off-the-shelf.
[[Page 47976]]
L3916.......................... Wrist hand orthosis, includes one or
more nontorsion joint(s), elastic
bands, turnbuckles, may include soft
interface, straps, prefabricated, off-
the-shelf.
------------------------------------------------------------------------
The F2F/WOPD List is available on the CMS website at: http://go.cms.gov/DMEPOSF2F.
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 eight HCPCS codes (See Table 3). To assist stakeholders
in preparing for implementation of the prior authorization program, we
are providing at least 90 days' notice as further described as follows.
The following HCPCS codes for a pressure-reducing support surface,
manual wheelchair base, knee orthosis, thoracic-lumbar-sacral orthoses,
and upper-limb orthoses are being added to the Required Prior
Authorization List:
Table 3--Additions to the Required Prior Authorization List
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
E0194.......................... Air fluidized bed.
K0005.......................... Ultralightweight wheelchair.
L1833.......................... Knee orthosis, adjustable knee joints
(unicentric or polycentric),
positional orthosis, rigid support,
prefabricated, off-the-shelf.
L0456.......................... Thoracic-lumbar-sacral orthosis,
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
item that has been trimmed, bent,
molded, assembled, or otherwise
customized to fit a specific patient
by an individual with expertise.
L0457.......................... Thoracic-lumbar-sacral orthosis,
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.
L0486.......................... Thoracic-lumbar-sacral orthosis,
triplanar control, two piece rigid
plastic shell with interface liner,
multiple straps and closures,
posterior extends from sacrococcygeal
junction and terminates just inferior
to scapular spine, anterior extends
from symphysis pubis to sternal notch,
lateral strength is enhanced by
overlapping plastic, restricts gross
trunk motion in the sagittal, coronal,
and transverse planes, includes a
carved plaster or CAD-CAM model,
custom fabricated.
L3761.......................... Elbow orthosis, with adjustable
position locking joint(s),
prefabricated, off-the-shelf.
L3916.......................... Wrist hand orthosis, includes one or
more nontorsion joint(s), elastic
bands, turnbuckles, may include soft
interface, straps, prefabricated, off-
the-shelf.
------------------------------------------------------------------------
We believe prior authorization of these eight additional HCPCS
codes will help further our program integrity goals of reducing fraud,
waste, and abuse, while also protecting access to care. In addition,
recent enforcement actions by the U.S. Department of Justice have
continued to demonstrate broader program integrity risks, including
fraudulent billing schemes involving medically unnecessary equipment,
the submission of claims lacking documentation of medical necessity,
and the use of telemarketing arrangements targeting Medicare
beneficiaries.\3\ Additionally, the CMS Fraud Defense Operations Center
has reported over $1.5 billion in payments suspended for DMEPOS items
associated with suspected fraudulent billing.\4\
---------------------------------------------------------------------------
\3\ DOJ July 2025 Press Release; available at www.justice.gov/opa/pr/durable-medical-equipment-owner-sentenced-12-years-61-million-medicare-fraud-scheme.
\4\ Fraud Defense Operations Center Fast Facts; available at
https://www.cms.gov/files/document/fdoc-fact-sheet-updated.pdf.
---------------------------------------------------------------------------
Orthoses have been identified by the CERT program as one of the top
DMEPOS service types with improper payments over the past several
years. From 2023 to 2025, improper payment rates remained consistently
elevated, ranging from approximately 40 percent to 48 percent for upper
limb orthoses and 35 percent to 47 percent for lower limb orthoses. The
improper payment rate for manual wheelchairs ranged from 22.1 percent
to 42 percent over that same time period.5 6 7 Additionally,
claims for certain pressure-reducing support surfaces have been denied
through medical reviews for not meeting Medicare requirements for
payment.
---------------------------------------------------------------------------
\5\ 2023 CMS Medicare Fee for Service (FFS) Supplemental and
Improper Payment Data (CERT); available at https://www.cms.gov/files/document/2023medicarefee-servicesupplementalimproperpaymentdatapdf.pdf.
\6\ 2024 CMS Medicare FFS Supplemental and Improper Payment Data
(CERT); available at https://www.cms.gov/files/document/2024-medicare-fee-service-supplemental-improper-payment-data.pdf.
\7\ 2025 CMS Medicare FFS Supplemental and Improper Payment Data
(CERT); available at https://www.cms.gov/files/document/nov-2025-medicare-ffs-supplemental-improper-payment-data-2025922.pdf.
---------------------------------------------------------------------------
Upon implementation, 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 newly added pressure-reducing support
surface, manual wheelchair, knee
[[Page 47977]]
orthosis, and thoracic-lumbar-sacral orthoses codes beginning on the
date specified in the DATES section. We will implement a prior
authorization program for the two newly added upper limb orthoses codes
(L3761 and L3916) in three phases beginning on the dates specified in
the DATES section. This phased-in approach will allow us to identify
and resolve any unforeseen issues by using smaller claim volumes in
phase one and phase two before nationwide implementation occurs in
phase three.
In phase one of the implementation, which begins on the date
specified in the DATES section, we will limit the prior authorization
requirement of the upper limb orthoses to four states (one in each DME
MAC jurisdiction) as follows: New York, Michigan, Florida, and
California.
In phase two, which begins on the date specified in the DATES
section, the prior authorization requirement of the upper limb orthoses
items will expand to Pennsylvania, Massachusetts, Ohio, Illinois,
Texas, Georgia, Arizona, and Oregon.
In phase three, which begins on the date specified in the DATES
section, the prior authorization requirement of the upper limb orthoses
items will expand nationally to all remaining states and territories
not included in the first two phases.
The prior authorization program for the remaining 74 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 on the
CMS website at: http://go.cms.gov/DMEPOSPA.
III. Collection of Information Requirements
This document provides updates to the Master List, the Required
Face-to-Face and Written Order Prior to Delivery List, and the Required
Prior Authorization List.
A total of 20 HCPCS codes (see Table 1) meeting the criteria
outlined previously are added to the Master List. Of these 20 HCPCS
codes, 12 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 8 are being added for aberrant billing patterns.
There are no HCPCS codes being removed from the Master List for the CY
2026 update.
Twenty-two HCPCS codes (see Table 2) are being added to the F2F/
WOPD List. These codes include three for lumbar-sacral orthoses, four
for lower limb orthoses, two for upper limb orthoses, eight for
wheelchairs, three for home ventilators, one related to oxygen
delivery, and one for air-fluidized beds. The 83 codes currently
subject to the F2F/WOPD requirements will continue to remain on the
Required F2F/WOPD List. Therefore, a total of 105 codes will be subject
to face-to-face encounter and written order prior to delivery as a
condition of payment. 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.).
A total of eight HCPCS codes (see Table 3) are selected for
addition to the Required Prior Authorization List. Of these eight HCPCS
codes, one is a pressure reducing support surface, one is a manual
wheelchair, and six are orthoses. The remaining 74 HCPCS codes
currently subject to the DMEPOS prior authorization requirement will
continue uninterrupted.
The information collection burden associated with the DMEPOS prior
authorization program is currently approved by OMB under control number
0938-1293 (CMS-10524). The control number accounts for the burden
associated with the addition of items to the Required Prior
Authorization Lists and assumes an annual burden of approximately $4.8
million for providers to comply with the prior authorization
requirement. 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 impacts of this regulatory notice as required
by Executive Order 12866, ``Regulatory Planning and Review''; Executive
Order 13132, ``Federalism``; Executive Order 13563, ``Improving
Regulation and Regulatory Review''; Executive Order 14192, ``Unleashing
Prosperity Through Deregulation''; the Regulatory Flexibility Act (RFA)
(Pub. L. 96-354); section 1102(b) of the Social Security Act; section
202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4); 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 those regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety, and other advantages; as well as the
distributive impacts). Section 3(f) of Executive Order 12866 defines a
``significant regulatory action'' as any regulatory action that is
likely to result in a regulatory notice that may: (1) have an annual
effect on the economy of $100 million or more or adversely affect in a
material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or tribal governments or communities; (2) create a serious
inconsistency or otherwise interfere with an action taken or planned by
another agency; (3) materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise novel
[[Page 47978]]
legal or policy issues arising out of legal mandates, or the
President's priorities.
A regulatory impact analysis (RIA) must be prepared for a
regulatory action that is significant under section 3(f)(1) of E.O.
12866. This regulatory notice is not significant and does not reach the
economic threshold and thus is not considered a major regulatory
notice.
Per our analysis, the additional items being added to the prior
authorization program have an estimated net savings of $15.8 million
after deducting implementation costs from gross savings. Gross savings
were estimated by reducing the estimated total amount paid for these
items in CY 2025 by a reduction in the items' improper payment rates.
The Regulatory Flexibility Act (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 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
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
notice 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 notice 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 2026, that
threshold is approximately $193 million. This regulatory notice 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
notice 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
notice was reviewed by the Office of Management and Budget.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Dr. Mehmet Oz, 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. 2026-15446 Filed 7-29-26; 8:45 am]
BILLING CODE 4120-01-P