Rule2026-00487
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 13, 2026
Effective
April 13, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
Full Text
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<title>Federal Register, Volume 91 Issue 8 (Tuesday, January 13, 2026)</title>
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[Federal Register Volume 91, Number 8 (Tuesday, January 13, 2026)]
[Rules and Regulations]
[Pages 1250-1255]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-00487]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 410 and 414
[CMS-6097-N]
RIN 0938-ZB98
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 and Written Order Prior to Delivery List; and
Updates to 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, the Required Face-
to-Face and Written Order Prior to Delivery List, and the Required
Prior Authorization List are effective on April 13, 2026.
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; Olufemi Shodeke, (410) 786-1649; or Cristine Egan, (410) 786-
8088.
For information related to the Master List or Required Prior
Authorization List, contact Emily Calvert, (410) 786-4277; Justin
Carlisle, (410) 786-4265; Stephanie Collins, (410) 786-0959; (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 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 5-element
order/prescription for specified DMEPOS items were 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 on May 13, 2024 (89 FR 41324) and
currently includes 512 items. The Master list is available on the CMS
website at: <a href="http://go.cms.gov/DMEPOSPA">http://go.cms.gov/DMEPOSPA</a>.
In 2024, CMS published the most recent iteration of the Required
Face-to-Face Encounter and Written Order Prior to Delivery List. There
are currently 75 items on the list, including 46 PMDs that were
included per statute. This list is also available on the CMS website
<a href="http://go.cms/gov/DMEPOSF2F">http://go.cms/gov/DMEPOSF2F</a>.
The Required Prior Authorization List was last updated in 2024 and
currently includes 67 items. All the lists discussed in this notice are
available on the CMS website at: <a href="http://go.cms.gov/DMEPOSPA">http://go.cms.gov/DMEPOSPA</a>.
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):
<bullet> 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.
<bullet> 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
[[Page 1251]]
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.
<bullet> 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:
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> Items are removed from the list sooner than 10 years if
the purchase amount drops below the payment threshold.
<bullet> 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.
<bullet> Items on the Master List are updated when the HCPCS codes
representing an item have been discontinued and cross walked to an
equivalent item.
<bullet> 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: <a href="http://go.cms.gov/DMEPOSPA">http://go.cms.gov/DMEPOSPA</a>.
This document provides the annual update to 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
(MFP) 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 the statutory sections 1834(a)(14), 1834(h)(4)
and 1842(s)(1)(B) of the Act, certain DMEPOS fee schedule amounts are
updated for calendar year (CY) 2025,\1\ by the percentage increase in
the CPI-U for the 12-month period ending June 30, 2024, 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 (MFP) (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. We note that previously the productivity measure
referenced in section 1886(b)(3)(B)(xi)(II) of the Act, was referred to
by BLS as private nonfarm business multifactor productivity. Beginning
with the November 18, 2021, release of productivity data, BLS replaced
the term multifactor productivity (MFP) with total factor productivity
(TFP). BLS noted that this is a change in terminology only and will not
affect the data or methodology. As a result of this change, the
productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the
Act is now published by BLS as private nonfarm business total factor
productivity. However, as mentioned previously, the data and methods
are unchanged. Please see <a href="http://www.bls.gov">www.bls.gov</a> for the BLS historically
published TFP data. For CY 2025, the productivity adjustment is 0.6
percent and the CPI-U percentage increase is 3.0 percent. Thus, the 3.0
percentage increase in the CPI-U is reduced by the 0.6 percentage
increase in the TFP resulting in a net increase of 2.4 percent for the
update factor for CY 2025.
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\1\ <a href="https://www.cms.gov/medicaremedicare-fee-service-paymentdmeposfeescheddmepos-fee-schedule/dme25">https://www.cms.gov/medicaremedicare-fee-service-paymentdmeposfeescheddmepos-fee-schedule/dme25</a>.
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For CY 2025, the adjusted purchase price threshold is $602, and the
adjusted monthly rental fee threshold is $61. We calculated this by
applying the 2.4 percent update factor to the CY 2024 average price
threshold of $588, resulting in a CY 2025 adjusted payment threshold of
$602.11 ($588 x 1.024), and to the CY 2024 average monthly rental fee
of $60, resulting in an adjusted payment threshold of $61.44 ($60 x
1.024). Rounding to the nearest whole dollar, these figures are $602
and $61.
We are also adding a total of 18 HCPCS codes (see Table 1) meeting
the criteria outlined previously to the Master List. Of these 18 HCPCS
codes, 8 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 10 are being added for aberrant billing patterns.
The codes added due to aberrant billing patterns represents items for
which data show suppliers submitted at least 1,000 claims and received
at least $1 million in payments during the 12-month periods from July
2023 to June 2024. 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.
[[Page 1252]]
Table 1--Additions to the Master List
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
A4238.......................... Supply allowance for adjunctive, non-
implanted continuous glucose monitor
(cgm), includes all supplies and
accessories, 1 month supply = 1 unit
of service.
A6214.......................... Foam dressing, wound cover, sterile,
pad size more than 48 square inch.,
with any size adhesive border, each
dressing.
A6233.......................... Gauze, impregnated, hydrogel, for
direct wound contact, sterile, pad
size more than 48 square inch, each
dressing.
A6583.......................... Gradient compression wrap with
adjustable straps, below knee, 30-50
mmhg, each.
A6593.......................... Accessory for gradient compression
garment or wrap with adjustable
straps, not-otherwise specified.
A7025.......................... High frequency chest wall oscillation
system vest, replacement for use with
patient owned equipment.
E0468.......................... Home ventilator, dual-function
respiratory device, also performs
additional function of cough
stimulation, includes all accessories,
components and supplies for all
functions.
E0469.......................... Lung expansion airway clearance,
continuous high frequency oscillation,
and nebulization device.
E0691.......................... Ultraviolet light therapy system,
includes bulbs/lamps, timer and eye
protection; treatment area 2 square
feet or less.
E0743.......................... External lower extremity nerve
stimulator for restless legs syndrome,
each.
E0762.......................... Transcutaneous electrical joint
stimulation device system, includes
all accessories.
E1399.......................... Durable medical equipment,
miscellaneous.
E2103.......................... Non-adjunctive, non-implanted
continuous glucose monitor or
receiver.
E2377.......................... Power wheelchair accessory, expandable
controller, including all related
electronics and mounting hardware,
upgrade provided at initial issue.
L1499.......................... Spinal orthosis, not otherwise
specified.
L2999.......................... Lower extremity orthoses, not otherwise
specified.
L5783.......................... Addition to lower extremity, user
adjustable, mechanical, residual limb
volume management system.
L5841.......................... Addition, endoskeletal knee-shin
system, polycentric, pneumatic swing,
and stance phase control.
------------------------------------------------------------------------
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 no HCPCS codes being removed
from the Master List for the CY 2025 update.
The full updated Master List is available in the Downloads & Links
section of the following CMS website at: <a href="http://go.cms.gov/DMEPOSPA">http://go.cms.gov/DMEPOSPA</a>.
B. Items Subject to Face-to-Face Encounter and Written Order Prior to
Delivery Requirements
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.
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, 75 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 eight additional HCPCS codes to
the F2F/WOPD List (See Table 2). We have selected eight codes related
to oxygen and its delivery systems. We note that such items were
selected based on practitioner encounter information, jurisdictionally
identified billing vulnerabilities, policy analysis, and our analysis
of the CERT improper payment information. Oxygen Supplies/Equipment
have been identified by CMS' Comprehensive Rate Testing (CERT) program
as one of the top 20 DMEPOS service types with improper payments over
the past several years. In 2024, oxygen supplies/equipment had an
improper payment rate of 11.3% with a projected improper payment of
approximately $81 million.
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.
[[Page 1253]]
Table 2--Additions to the F2F/WOPD List--New Non-Statutorily Required
Items
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
E0424.......................... Stationary compressed gaseous oxygen
system, rental; includes container,
contents, regulator, flowmeter,
humidifier, nebulizer, cannula or
mask, and tubing.
E0431.......................... Portable gaseous oxygen system, rental;
includes portable container,
regulator, flowmeter, humidifier,
cannula or mask, and tubing.
E0433.......................... Portable liquid oxygen system, rental;
home liquefier used to fill portable
liquid oxygen containers, includes
portable containers, regulator,
flowmeter, humidifier, cannula or mask
and tubing, with or without supply
reservoir and contents gauge.
E0434.......................... Portable liquid oxygen system, rental;
includes portable container, supply
reservoir, humidifier, flowmeter,
refill adaptor, contents gauge,
cannula or mask, and tubing.
E0439.......................... Stationary liquid oxygen system,
rental; includes container, contents,
regulator, flowmeter, humidifier,
nebulizer, cannula or mask, & tubing.
E1390.......................... Oxygen concentrator, single delivery
port, capable of delivering 85 percent
or greater oxygen concentration at the
prescribed flow rate.
E1391.......................... Oxygen concentrator, dual delivery
port, capable of delivering 85 percent
or greater oxygen concentration at the
prescribed flow rate, each.
E1392.......................... Portable oxygen concentrator, rental.
------------------------------------------------------------------------
The F2F/WOPD List is available on the following CMS website at:
<a href="http://go.cms/gov/DMEPOSF2F">http://go.cms/gov/DMEPOSF2F</a>.
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 seven HCPCS codes (See Table 3). To assist stakeholders
in preparing for implementation of the prior authorization program, we
are providing 90 days' notice.
The following five HCPCS codes for orthoses and two HCPCS codes for
pneumatic compression devices are added to the Required Prior
Authorization List:
Table 3--Additions to the Required Prior Authorization List
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
L0651.......................... Lumbar-sacral orthosis, 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.
L1844.......................... Knee orthosis, single upright, thigh
and calf, with adjustable flexion and
extension joint (unicentric or
polycentric), medial-lateral and
rotation control, with or without
varus/valgus adjustment, custom
fabricated.
L1846.......................... Knee orthosis, 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, custom
fabricated.
L1852.......................... Knee orthosis, 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.
L1932.......................... Ankle foot orthosis, rigid anterior
tibial section, total carbon fiber or
equal material, prefabricated,
includes fitting and adjustment.
E0651.......................... Pneumatic compressor, segmental home
model without calibrated gradient
pressure.
E0652.......................... Pneumatic compressor, segmental home
model with calibrated gradient
pressure.
------------------------------------------------------------------------
We believe prior authorization of these seven additional HCPCS
codes will help further our program integrity goals of crushing fraud,
waste, and abuse, while also protecting access to care.
Orthoses have been identified by the CERT program as one of the top
20 DMEPOS service types with improper payments over the past several
years. Orthoses have had an improper payment rate ranging from 35.2-
57.5 percent, with projected improper payments ranging between $91 to
$178 million. 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
billion in loss.\2\ Similarly, in 2022, the DOJ convicted the owners
and operators of four orthotic brace suppliers in Texas and Arkansas
for a $6.5 million illegal kickback scheme, including violations of the
federal Anti-Kickback Statute.\3\ Also, the OIG released a report May
2024 stating that Medicare remains vulnerable to fraud, waste and abuse
related to off-the-shelf orthotic braces
[[Page 1254]]
and recommended that CMS strengthen its oversight of Medicare billing
for these braces by determining whether to conduct additional
prepayment or postpayment reviews.\4\ In response to the OIG's findings
and recommendation, in 2022 and 2024, CMS added several lumbar-sacral
orthoses and lower limb orthoses to the Required Prior Authorization
list (87 FR 2051); however, additional program integrity action in this
space is warranted.
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\2\ <a href="https://www.justice.gov/opa/pr/federal-indictments-and-law-enforcement-actions-one-largest-health-care-fraud-schemes">https://www.justice.gov/opa/pr/federal-indictments-and-law-enforcement-actions-one-largest-health-care-fraud-schemes</a>.
\3\ <a href="https://www.justice.gov/archives/opa/pr/orthotic-brace-suppliers-convicted-65-million-health-care-fraud-scheme">https://www.justice.gov/archives/opa/pr/orthotic-brace-suppliers-convicted-65-million-health-care-fraud-scheme</a>.
\4\ <a href="https://oig.hhs.gov/reports/recommendations/tracker/?view-mode=report-grouped&search=A-09-21-03019&hhs-agency=all#results">https://oig.hhs.gov/reports/recommendations/tracker/?view-mode=report-grouped&search=A-09-21-03019&hhs-agency=all#results</a>.
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In recent years, pneumatic compression devices 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 (2021 to 2024) as having improper payment rates ranging
from 61.5 to 78.9 percent with projected improper payments ranging from
$29,605,954 to $41,580,669. In particular, there has been a significant
increase in improper payments due to medical necessity. In 2020, the
error rate due to medical necessity was zero percent; however, in 2024,
it was 37.1 percent, demonstrating that additional program integrity
action is warranted.
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 five
newly added orthoses and the two pneumatic compression devices
nationwide, beginning on the date specified in the DATES section.
The prior authorization program for the remaining 67 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 at: <a href="http://go.cms.gov/DMEPOSPA">http://go.cms.gov/DMEPOSPA</a>.
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 18 HCPCS codes (see Table 1) meeting the criteria
outlined previously are added to the Master List. Of these 18 HCPCS
codes, 8 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 10 are being added for aberrant billing patterns.
There are no HCPCS codes being removed from the Master List for the CY
2025 update.
Eight HCPCS codes (see Table 2) are being added to the F2F/WOPD
List. The selected HCPCS codes are all related to oxygen and its
delivery systems. 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 seven HCPCS codes (see Table 3) are selected for
addition to the Required Prior Authorization List. Of these seven HCPCS
codes, five are orthoses items, and two are pneumatic compression
device items. The remaining 67 HCPCS codes currently subject to the
DMEPOS prior authorization requirement, will continue uninterrupted.
There is an 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 $8.4
million for providers to comply with the prior authorization
requirement.\5\ 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.
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\5\ The annual burden of $8.4 million is associated with the PRA
package approved in 2022. This PRA package is in the renewal process
and has an updated annual burden of $4.8 million.
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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; 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
[[Page 1255]]
rights and obligations of recipients thereof; or (4) raise novel 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 $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 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 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
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 2025, that
threshold is approximately $187 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 Evell J. Barco Holland who is the Federal Register Liaison,
to electronically sign this document for purposes of publication in the
Federal Register.
Evell J. Barco Holland,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2026-00487 Filed 1-12-26; 8:45 am]
BILLING CODE 4120-01-P
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</html>Indexed from Federal Register on January 13, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.