Medicare Program; Updates to Lists Related to Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Conditions of Payment, 2051-2058 [2022-00572]
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Federal Register / Vol. 87, No. 9 / Thursday, January 13, 2022 / Rules and Regulations
particular, the Act addresses actions
that may result in the expenditure by a
State, local, or tribal government, in the
aggregate, or by the private sector of
$100,000,000 (adjusted for inflation) or
more in any one year. Though this rule
will not result in such an expenditure,
we do discuss the effects of this rule
elsewhere in this preamble.
F. Environment
We have analyzed this rule under
Department of Homeland Security
Directive 023–01, Rev. 1, associated
implementing instructions, and
Environmental Planning COMDTINST
5090.1 (series), which guide the Coast
Guard in complying with the National
Environmental Policy Act of 1969 (42
U.S.C. 4321–4370f), and have
determined that this action is one of a
category of actions that do not
individually or cumulatively have a
significant effect on the human
environment. This rule involves safety
zones to protect waterway users that
would prohibit entry within 250 yards
of dredging operations, within Marcus
Hook Anchorage and will close only one
side of the main navigation channel. It
is categorically excluded from further
review under paragraph L[60a] of
Appendix A, Table 1 of DHS Instruction
Manual 023–01–001–01, Rev. 1. A
Record of Environmental Consideration
supporting this determination is
available in the docket. For instructions
on locating the docket, see the
ADDRESSES section of this preamble.
G. Protest Activities
The Coast Guard respects the First
Amendment rights of protesters.
Protesters are asked to call or email the
person listed in the FOR FURTHER
INFORMATION CONTACT section to
coordinate protest activities so that your
message can be received without
jeopardizing the safety or security of
people, places or vessels.
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List of Subjects in 33 CFR Part 165
Harbors, Marine safety, Navigation
(water), Reporting and recordkeeping
requirements, Security measures,
Waterways.
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
1. The authority citation for part 165
continues to read as follows:
■
Authority: 46 U.S.C. 70034, 70051; 33 CFR
1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 00170.1, Revision No. 01.2.
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2. Add § 165.T05–0022, to read as
follows:
■
§ 165.T05–0022 Safety Zones, Delaware
River Dredging; Marcus Hook, PA.
(a) Location. The following areas are
safety zones:
(1) Safety zone one includes all waters
within 250 yards of the dredge
displaying lights and shapes for vessels
restricted in ability to maneuver as
described in 33 CFR 83.27, as well as all
related dredge equipment, while the
dredge is operating in Marcus Hook
Range. For enforcement purposes
Marcus Hook Range includes all
navigable waters of the Delaware River
shoreline to shoreline, bound by a line
drawn perpendicular to the center line
of the channel at the farthest upriver
point of the range to a line drawn
perpendicular to the center line of the
channel at the farthest downriver point
of the range.
(2) Safety zone two includes all the
waters of Anchorage 7 off Marcus Hook
Range, as described in 33 CFR
110.157(a)(8) and depicted on U. S.
Nautical Chart 12312.
(b) Definitions. As used in this
section, designated representative
means any Coast Guard commissioned,
warrant, or petty officer who has been
authorized by the Captain of the Port to
assist with enforcement of the safety
zone described in paragraph (a) of this
section.
(c) Regulations. (1) Entry into or
transiting within the safety zone one is
prohibited unless vessels obtain
permission from the Captain of the Port
via VHF–FM channel 16 or 215–271–
4807, or make satisfactory passing
arrangements via VHF–FM channel 13
or 16 with the operating dredge per this
section and the rules of the Road (33
CFR subchapter E). Vessels requesting to
transit shall contact the operating
dredge via VHF–FM channel 13 or 16 at
least 1 hour prior to arrival.
(2) Vessels desiring to anchor in safety
zone two, Anchorage 7 off Marcus Hook
Range, must obtain permission from the
COTP at least 24 hours in advance by
calling (215) 271–4807. The COTP will
permit, at minimum, one vessel at a
time to anchor on a ‘‘first-come, firstserved’’ basis. Vessels will only be
allowed to anchor for a 12 hour period.
Vessels that require an examination by
the Public Health Service, Customs, or
Immigration authorities will be directed
to an anchorage for the required
inspection by the COTP.
(3) Vessels desiring to anchor in safety
zone two, Anchorage 7 off Marcus Hook
Range, must be at least 650 feet in
length overall.
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2051
(4) This section applies to all vessels
except those engaged in the following
operations: Enforcement of laws, service
of aids to navigation, and emergency
response.
(d) Enforcement. The U.S. Coast
Guard may be assisted by federal, state
and local agencies in the patrol and
enforcement of the zone.
(e) Enforcement period. This rule will
be enforced from January 6, 2022,
through January 31, 2022, unless
cancelled earlier by the Captain of the
Port.
Dated: January 6, 2022.
Jonathan D. Theel,
Captain, U. S. Coast Guard, Captain of the
Port, Delaware Bay.
[FR Doc. 2022–00560 Filed 1–12–22; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 410 and 414
[CMS–6081–N]
Medicare Program; Updates to Lists
Related to Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS) Conditions of Payment
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Updates to and selection of
certain codes.
AGENCY:
This document announces the
updated Healthcare Common Procedure
Coding System (HCPCS) codes on the
Master List of DMEPOS Items
Potentially Subject to Face-to-Face
Encounter and Written Order Prior to
Delivery and/or Prior Authorization
Requirements. It also announces the
initial selection of HCPCS codes on the
Required Face-to-Face Encounter and
Written Order Prior to Delivery List and
the updates the HCPCS codes on the
Required Prior Authorization List.
DATES: The implementation is effective
on April 13, 2022. Prior authorization
will be implemented in 3 incremental
phases, with the final phase being
national implementation. Phase 1
includes 1 state per jurisdiction and is
effective April 13, 2022, Phase 2
includes 4 States per jurisdiction and is
effective July 12, 2022, and Phase 3 is
nationwide and is effective October 10,
2022.
FOR FURTHER INFORMATION CONTACT:
Susan Billet, (410) 786–1062.
SUMMARY:
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Emily Calvert, (410) 786–4277.
Stephanie Collins, (410) 786–3100.
Jennifer Phillips, (410) 786–1023.
Olufemi Shodeke, (410) 786–1649.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1832, 1834, and 1861 of the
Social Security Act (the Act) establishes
benefits and the provisions of payment
for Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS) items under Part B of the
Medicare program.
Section 1834(a)(1)(E)(iv) of the Act
provides conditions of coverage specific
to Power Mobility Devices (PMDs).
Specifically, it provides that payment
may not be made for a covered item
consisting of a motorized or power
wheelchair unless a physician (as
defined in section 1861(r)(1) of the Act),
physician assistant (PA), nurse
practitioner (NP), or clinical nurse
specialist (CNS) (as such non-physician
practitioners are defined in section
1861(aa)(5) of the Act) has conducted a
face-to-face examination of the
individual and written a prescription for
the item.
Section 1834(a)(11)(B) of the Act
requires a physician, PA, NP, or CNS to
have a face-to-face encounter with the
beneficiary within the 6-month period
prior to the written order for certain
DMEPOS items (or other reasonable
timeframe as determined by the
Secretary of the Department of Health
and Human Services (the Secretary)).
Section 1834(a)(15)(A) of the Act
authorizes the Secretary to develop and
periodically update a list of DMEPOS
items that the Secretary determines, on
the basis of prior payment experience,
are frequently subject to unnecessary
utilization and to develop a prior
authorization process for these items.
In 2006, we issued Final Rule
‘‘Medicare Program; Conditions for
Payment of Power Mobility Devices,
including Power Wheelchairs and
Power-Operated Vehicles’’ (71 FR
17021) to implement the requirements
for a face-to-face examination and
written order prior to delivery for PMDs,
in accordance with legislation found in
section 302(a)(2) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108–
173), as codified in amended section
1834(a)(1)(E)(iv) of the Act. This
regulation applied to all power mobility
devices—including power wheelchairs
and power operated vehicles
(hereinafter referred to as PMDs). The
requirements for PMDs mandated a 7element order/prescription for payment.
In the November 16, 2012 Federal
Register, we published final rule titled
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‘‘Medicare Program; Revisions to
Payment Policies Under the Physician
Fee Schedule, DME Face-to-Face
Encounters, Elimination of the
Requirement for Termination of NonRandom Prepayment Complex Medical
Review and Other Revisions to Part B
for CY 2013’’ (77 FR 68892) requiring
face-to-face encounter and written order
prior to delivery for specified DMEPOS
items, in accordance with the
authorizing legislation found section
6407 of the Patient Protection and
Affordable Care Act of 2010 (Pub. L.
111–148) and amended section
1834(a)(11)(B) of the Act. The
regulation, as codified in 42 CFR 410.38,
specified the inclusion criteria for
creating a list of DMEPOS items to be
subject to face-to-face encounter and
written order prior to delivery
requirements. It also mandated a 5element order/prescription for payment
of specified DMEPOS items.
In the December 30, 2015 Federal
Register, we published final rule titled
‘‘Medicare Program; Prior Authorization
Process for Certain Durable Medical
Equipment, Prosthetics, and Supplies’’
(80 FR 81674), in accordance with
section 1834(a)(15) of the Act, we
established the Master List of Items
Frequently Subject to Unnecessary
Utilization. The 2015 Master List
included certain DMEPOS items that the
Secretary determined, on the basis of
prior payment experience, are
frequently subject to unnecessary
utilization, and created a prior
authorization process for these items.
On November 8, 2019, we published
a final rule titled, ‘‘Medicare Program;
End-Stage Renal Disease Prospective
Payment System, Payment for Renal
Dialysis Services Furnished to
Individuals with Acute Kidney Injury,
End-Stage Renal Disease Quality
Incentive Program, Durable Medical
Equipment, Prosthetics, Orthotics and
Supplies (DMEPOS) Fee Schedule
Amounts, DMEPOS Competitive
Bidding Program (CBP) Amendments,
Standard Elements for a DMEPOS
Order, and Master List of DMEPOS
Items Potentially Subject to a Face-toFace Encounter and Written Order Prior
to Delivery and/or Prior Authorization
Requirements’’ (84 FR 60648). The rule
became effective January 1, 2020,
harmonizing the lists of DMEPOS items
created by former rules and establishing
one ‘‘Master List of DMEPOS Items
Potentially Subject to Face-To-Face
Encounter and Written Orders Prior to
Delivery and/or Prior Authorization
Requirements’’ (the ‘‘Master List’’).
Items are selected from the Master List
for inclusion on the Face-To-Face
Encounter and Written Orders Prior to
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Delivery List and/or Prior Authorization
List through the Federal Register.
II. Provisions of the Document
This document serves to publish three
separate lists. First, it provides an
update to the Master List of items from
which we can select to include on the
Required Face to Face Encounter and
Written Order Prior to Delivery List,
and/or Required Prior Authorization
List. This document also serves to
announce the initial selection of items
to be included on the Required Face-toFace Encounter and Written Order Prior
to Delivery List. Lastly, it updates the
items included on the Required Prior
Authorization List.
A. Master List of DMEPOS Items
Frequently Subject to Unnecessary
Utilization
The Master List includes items that
appear on the DMEPOS Fee Schedule
and meet the following criteria, as
established in 84 FR 60648:
• Have an average purchase fee of
$500 or greater that is adjusted annually
for inflation, or an average monthly
rental fee schedule of $50 or greater that
is adjusted annually for inflation, or
items identified as accounting for at
least 1.5 percent of Medicare
expenditures for all DMEPOS items over
a recent 12-month period, that are
also—
++ Identified in a Government
Accountability Office (GAO) or
Department of Health and Human
Services Office of Inspector General
(OIG) report that is national in scope
and published in 2015 or later as having
a high rate of fraud or unnecessary
utilization; or
++ Listed in the 2018 or subsequent
year Comprehensive Error Rate Testing
(CERT) program’s Medicare Fee-forService (FFS) Supplemental Improper
Payment Data Report as having a high
improper payment rate.
• Any items with at least 1,000 claims
and $1 million in payments during a
recent 12-month period that are
determined to have aberrant billing
patterns and lack explanatory
contributing factors (for example, new
technology or coverage policies that
may require time for providers and
suppliers to be educated on billing
policies). Items with aberrant billing
patterns would be identified as those
items with payments during a 12-month
timeframe that exceed payments made
during the preceding 12-months by the
greater of—
++ Double the percent change of all
DMEPOS claim payments for items that
meet the previous claim and payment
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criteria, from the preceding 12-month
period; or
++ Exceeding a 30 percent increase in
payments for the items from the
preceding 12-month period.
• Any items statutorily requiring a
face-to-face encounter, a written order
prior to delivery, or prior authorization.
In the November 2019 final rule noted
previously, we described the
maintenance process of the Master List
as follows:
• The Master List will be updated
annually, and more frequently as
needed (for example, to address
emerging billing trends), and to reflect
the thresholds specified in the
regulations.
• Items on the DMEPOS Fee Schedule
that meet the payment threshold criteria
set forth in § 414.234(b)(1) are added to
the list when the item is also listed in
a CERT, OIG, or GAO report published
after 2020, and items not meeting the
cost (approximately $500 purchase or
$50 rental) thresholds may still be
added based on findings of aberrant
billing patterns.
• Items are removed from the Master
List 10 years after the date the item was
added, unless the item was identified in
an OIG report, GAO report, or having
been identified in the CERT Medicare
Fee for Service Supplemental Improper
Payment Data report as having a high
improper payment rate, within the 5year period preceding the anticipated
date of expiration.
• Items are removed from the list
sooner than 10 years if the purchase
amount drops below the payment
threshold.
• Items already on the Master List
that are identified on a subsequent OIG,
GAO, or CERT report will remain on the
list for 10 years from the publication
date of the new report.
• Items are updated on the Master
List when the Healthcare Common
Procedure Coding System (HCPCS)
codes representing an item have been
discontinued and cross-walked to an
equivalent item.
• We will notify the public of any
additions and deletions from the Master
List by posting a notification in the
Federal Register and on the CMS Prior
Authorization website at https://
www.cms.gov/research-statistics-datasystems/medicare-fee-servicecompliance-programs/priorauthorization-and-pre-claim-reviewinitiatives.
This document provides the annual
update to the Master List of DMEPOS
Items Potentially Subjected to a Face-toFace Encounter and Written Order Prior
to Delivery and/or Prior Authorization
Requirements stated in the November
2019 final rule (84 FR 60648). As noted
previously, we adjust the ‘‘payment
threshold’’ each year for inflation.
Certain DMEPOS fee schedule amounts
are updated for 2021 1 by the percentage
increase in the consumer price index for
all urban consumers (United States city
average) CPI–U for the 12-month period
ending June 30, 2020, adjusted by the
change in the economy-wide
productivity equal to the 10-year
2053
moving average of changes in annual
economy-wide private non-farm
business multi-factor productivity
(MFP). The productivity adjustment is
0.4 percent and the CPI–U percentage
increase is 0.6 percent. Thus, the 0.6
percentage increase in the CPI–U is
reduced by the 0.4 percentage increase
in the MFP resulting in a net increase
of 0.2 percent for the update factor for
CY 2021.
For CY 2021, the 0.2 percent update
factor was applied to the CY 2020
average price threshold of $500,
resulting in a CY 2021 adjusted payment
threshold of $501 ($500 × 1.002). This
results in a CY 2021 adjusted purchase
price threshold of $501. An update
factor of 0.2 percent was applied to the
CY 2020 average monthly rental fee of
$50, resulting in an adjusted payment
threshold of $50.10 ($50 × 1.002).
Rounding this figure to the nearest
whole dollar amount results in a CY
2021 adjusted monthly rental fee
threshold of $50.
A total of 31 HCPCS codes (see Table
1) meeting the criteria outlined
previously are added to the Master List.
Of these 31 HCPCS codes, 18 are added
because these items meet the updated
payment threshold and are listed in an
OIG or GAO report of a national scope
or a CERT DME and DMEPOS Service
Specific Report(s) or both, and 13 are
added for being identified as accounting
for at least 1.5 percent of Medicare
expenditures for all DMEPOS items over
a recent 12-month period.
TABLE 1—ADDITIONS TO THE MASTER LIST
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HCPCS
A4352
A5121
A6203
A6219
A6242
A7030
A7031
E0467
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E0565
E0650
E0651
E0652
E0656
E0657
E0670
E0675
E0740
E0744
E0745
E0764
..............
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E0766
E1226
E2202
E2203
E2613
..............
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Description
Intermittent Urinary Catheter; Coude (Curved) Tip, With Or Without Coating (Teflon, Silicone, Silicone Elastomeric, Or Hydrophilic, Etc.), Each.
Skin Barrier; Solid, 6 x 6 Or Equivalent, Each.
Composite Dressing, Sterile, Pad Size 16 Sq. In. Or Less, With Any Size Adhesive Border, Each Dressing.
Gauze, Non-Impregnated, Sterile, Pad Size 16 Sq. In. Or Less, With Any Size Adhesive Border, Each Dressing.
Hydrogel Dressing, Wound Cover, Sterile, Pad Size 16 Sq. In. Or Less, Without Adhesive Border, Each Dressing.
Full Face Mask Used With Positive Airway Pressure Device, Each.
Face Mask Interface, Replacement For Full Face Mask, Each.
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.
Compressor, Air Power Source For Equipment Which Is Not Self-Contained Or Cylinder Driven.
Pneumatic Compressor, Non-Segmental Home Model.
Pneumatic Compressor, Segmental Home Model Without Calibrated Gradient Pressure.
Pneumatic Compressor, Segmental Home Model With Calibrated Gradient Pressure.
Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Trunk.
Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Chest.
Segmental Pneumatic Appliance For Use With Pneumatic Compressor, Integrated, 2 Full Legs And Trunk.
Pneumatic Compression Device, High Pressure, Rapid Inflation/Deflation Cycle, For Arterial Insufficiency (Unilateral Or Bilateral System).
Non-Implanted Pelvic Floor Electrical Stimulator, Complete System.
Neuromuscular Stimulator For Scoliosis.
Neuromuscular Stimulator, Electronic Shock Unit.
Functional Neuromuscular Stimulation, Transcutaneous Stimulation Of Sequential Muscle Groups Of Ambulation With Computer Control, Used For
Walking By Spinal Cord Injured, Entire System, After Completion Of Training Program.
Electrical Stimulation Device Used For Cancer Treatment, Includes All Accessories, Any Type.
Wheelchair Accessory, Manual Fully Reclining Back, (Recline Greater Than 80 Degrees), Each.
Manual Wheelchair Accessory, Nonstandard Seat Frame Width, 24–27 Inches.
Manual Wheelchair Accessory, Nonstandard Seat Frame Depth, 20 To Less Than 22 Inches.
Positioning Wheelchair Back Cushion, Posterior, Width Less Than 22 Inches, Any Height, Including Any Type Mounting Hardware.
1 CY 2021 Update for Durable Medical
Equipment, Prosthetics, Orthotics and Supplies
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(DMEPOS) Fee Schedule (December 4, 2020):
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https://www.cms.gov/Regulations-and-Guidance/
Guidance/Transmittals/Transmittals/r10504cp.
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TABLE 1—ADDITIONS TO THE MASTER LIST—Continued
HCPCS
L0830
L1005
L1906
L2580
L2624
L7368
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Description
Halo Procedure, Cervical Halo Incorporated Into Milwaukee Type Orthosis.
Tension Based Scoliosis Orthosis And Accessory Pads, Includes Fitting And Adjustment.
Ankle Foot Orthosis, Multiligamentous Ankle Support, Prefabricated, Off-The-Shelf.
Addition To Lower Extremity, Pelvic Control, Pelvic Sling.
Addition To Lower Extremity, Pelvic Control, Hip Joint, Adjustable Flexion, Extension, Abduction Control, Each.
Lithium Ion Battery Charger, Replacement Only.
The following five HCPCS codes (see
Table 2) are removed from the Master
List because they no longer have a
DMEPOS Fee Schedule price of $501 or
greater, or an average monthly rental fee
schedule of $50 or greater, and are
identified as accounting for at least 1.5
percent of Medicare expenditures for all
DMEPOS items over a recent 12-month
period or both.
TABLE 2—DELETIONS FROM THE MASTER LIST
HCPCS
A4253
A4351
E2369
E2377
L3761
..............
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Description
Blood Glucose Test or Reagent Strips for Home Blood Glucose Monitor, Per 50 Strips.
Intermittent Urinary Catheter; Straight Tip, With or Without Coating (Teflon, Silicone, Silicone Elastomer, Or Hydrophilic, Etc.), Each.
Power Wheelchair Component, Drive Wheel Gear Box, Replacement Only.
Power Wheelchair Accessory, Expandable Controller, Including All Related Electronics and Mounting Hardware, Upgrade Provided At Initial Issue.
Elbow Orthosis (Eo), With Adjustable Position Locking Joint(S), Prefabricated, Off-The-Shelf.
The full updated list is available in
the download section of the following
CMS website: https://www.cms.gov/
Research-Statistics-Data-and-Systems/
Monitoring-Programs/Medicare-FFSCompliance-Programs/DMEPOS/PriorAuthorization-Process-for-CertainDurable-Medical-Equipment-ProstheticOrthotics-Supplies-Items.
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B. Items Subject to Face-to-Face
Encounter and Written Order Prior to
Delivery Requirements
In the November 2019 final rule, we
stated that since the face-to-face
encounter and written orders are
statutorily required for PMDs, they
would be included on the Master List
and the Required Face-to-Face
Encounter and Written Order Prior to
Delivery List in accordance with our
statutory obligation, and would remain
there.
The Required Face-to-Face Encounter
and Written Order Prior to Delivery List,
as specified in § 410.38(c)(8), is
comprised of PMDs and those items
selected from the Master List (as
described in § 414.234(b)) to require a
face-to-face encounter and a written
order prior to delivery as a condition of
payment.
The rule established a process of
placing items on the Required Face-toFace Encounter and Written Order Prior
to Delivery List, including that they be
communicated to the public and
effective no less than 60 days after a
Federal Register document publication
and CMS website posting.
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We note that following the
publication of the November 2019 final
rule (84 FR 60648), the serious public
health threats posed by the spread of the
2019 Novel Coronavirus (COVID–19)
became known, and subsequently the
addition of new items on the Required
Face-to-Face Encounter and Written
Order Prior to Delivery List was placed
on hold.
We also note that in an interim final
rule with comment period titled
‘‘Medicare and Medicaid Programs;
Policy and Regulatory Revisions in
Response to the COVID–19 Public
Health Emergency’’ and published on
April 6, 2020 (84 FR 19230), we stated
that ‘‘to the extent an NCD or LCD
(including articles) would otherwise
require a face-to-face or in-person
encounter for evaluations, assessments,
certifications or other implied face-toface services, those requirements would
not apply during the PHE for the
COVID–19 pandemic.’’ This language
does not apply to the face-to-face
encounter and written order prior to
delivery requirements stemming from
42 CFR 410.38 and section 1834 of the
Act; therefore, the ongoing direction
provided in the April 2020 rule is not
affected by this document. The list of
DMEPOS items selected and
promulgated in this document will
require a face-to-face encounter
(conducted either via telehealth or inperson), per 42 CFR 410.38, effective
after 90 days’ notice.
At this time, we believe it appropriate
to add a limited list of items that pose
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a risk to the Medicare Trust Funds, to
be subject to additional practitioner
oversight via the face-to-face encounter
and written order prior to delivery
requirements.
To assist stakeholders in preparing for
implementation of the Required Face-toFace Encounter and Written Order Prior
to Delivery List, we are publishing the
proposed code additions and providing
90 days’ notice.
Per statutory requirements, Table 3
lists DMEPOS HCPCS codes for PMDs.
Section 1834(a)(1)(E)(iv) of the Act
explicitly requires a face-to-face and
written order for PMDs; therefore, PMDs
require a face-to-face encounter per
statute. To reflect this, PMDs will both
be placed and will remain on the
Required Face-to-Face Encounter and
Written Order Prior to Delivery List
indefinitely.
Section 1834(a)(11)(B) of the Act
authorizes the Secretary to select other
DMEPOS HCPCS codes that will require
a face-to-face encounter and written
order prior to delivery as a condition of
payment. In addition to PMDs, this
Federal Register document announces
the addition of seven other DMEPOS
HCPCS codes, not required by statute,
that are selected from the Master List to
be placed on the Required Face-to-Face
Encounter and Written Order Prior to
Delivery List as listed in Table 4, based
on our regulatory authority at 42 CFR
410.38.
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TABLE 3—STATUTORILY REQUIRED POWER MOBILITY DEVICES
HCPCS
K0800
K0801
K0802
K0806
K0807
K0808
K0813
K0814
K0815
K0816
K0820
K0821
K0822
K0823
K0824
K0825
K0826
K0827
K0828
K0829
K0835
K0836
K0837
K0838
K0839
K0840
K0841
K0842
K0843
K0848
K0849
K0850
K0851
K0852
K0853
K0854
K0855
K0856
K0857
K0858
K0859
K0860
K0861
K0862
K0863
K0864
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
Description
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Power
Operated Vehicle, Group 1 Standard, Patient Weight Capacity Up To And Including 300 Pounds.
Operated Vehicle, Group 1 Heavy Duty, Patient Weight Capacity, 301 To 450 Pounds.
Operated Vehicle, Group 1 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.
Operated Vehicle, Group 2 Standard, Patient Weight Capacity Up To And Including 300 Pounds.
Operated Vehicle, Group 2 Heavy Duty, Patient Weight Capacity 301 To 450 Pounds.
Operated Vehicle, Group 2 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.
Wheelchair, Group 1 Standard, Portable, Sling/Solid Seat And Back, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 1 Standard, Portable, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 1 Standard, Sling/Solid Seat And Back, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 1 Standard, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 2 Standard, Portable, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 2 Standard, Portable, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 2 Standard, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 2 Standard, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 2 Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.
Wheelchair, Group 2 Heavy Duty, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.
Wheelchair, Group 2 Very Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.
Wheelchair, Group 2 Very Heavy Duty, Captains Chair, Patient Weight Capacity 451 To 600 Pounds.
Wheelchair, Group 2 Extra Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More.
Wheelchair, Group 2 Extra Heavy Duty, Captains Chair, Patient Weight Capacity 601 Pounds Or More.
Wheelchair, Group 2 Standard, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 2 Standard, Single Power Option, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 2 Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.
Wheelchair, Group 2 Heavy Duty, Single Power Option, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.
Wheelchair, Group 2 Very Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.
Wheelchair, Group 2 Extra Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More.
Wheelchair, Group 2 Standard, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 2 Standard, Multiple Power Option, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 2 Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.
Wheelchair, Group 3 Standard, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 3 Standard, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 3 Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.
Wheelchair, Group 3 Heavy Duty, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.
Wheelchair, Group 3 Very Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.
Wheelchair, Group 3 Very Heavy Duty, Captains Chair, Patient Weight Capacity, 451 To 600 Pounds.
Wheelchair, Group 3 Extra Heavy Duty, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More.
Wheelchair, Group 3 Extra Heavy Duty, Captains Chair, Patient Weight Capacity 601 Pounds Or More.
Wheelchair, Group 3 Standard, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 3 Standard, Single Power Option, Captains Chair, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 3 Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.
Wheelchair, Group 3 Heavy Duty, Single Power Option, Captains Chair, Patient Weight Capacity 301 To 450 Pounds.
Wheelchair, Group 3 Very Heavy Duty, Single Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.
Wheelchair, Group 3 Standard, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity Up To And Including 300 Pounds.
Wheelchair, Group 3 Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 301 To 450 Pounds.
Wheelchair, Group 3 Very Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 451 To 600 Pounds.
Wheelchair, Group 3 Extra Heavy Duty, Multiple Power Option, Sling/Solid Seat/Back, Patient Weight Capacity 601 Pounds Or More.
TABLE 4—NON-STATUTORILY REQUIRED DMEPOS ITEMS
HCPCS
Description
E0748 ..............
L0648 ..............
Osteogenesis Stimulator, Electrical, Non-Invasive, Spinal Applications.
Lumbar-Sacral Orthosis, Sagittal Control, With Rigid Anterior And Posterior Panels, Posterior Extends From Sacrococcygeal Junction To T–9
Vertebra, Produces Intracavitary Pressure To Reduce Load On The Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-The-Shelf.
Lumbar-Sacral Orthosis, Sagittal-Coronal Control, With Rigid Anterior And Posterior Frame/Panel(S), Posterior Extends From Sacrococcygeal Junction To T–9 Vertebra, Lateral Strength Provided By Rigid Lateral Frame/Panel(S), Produces Intracavitary Pressure To Reduce Load On
Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-TheShelf.
Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated Item That Has Been Trimmed,
Bent, Molded, Assembled, Or Otherwise Customized To Fit A Specific Patient By An Individual With Expertise.
Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated, Off-The Shelf.
Knee Orthosis (KO), Single Upright, Thigh And Calf, With Adjustable Flexion And Extension Joint (Unicentric Or Polycentric), Medial-Lateral And
Rotation Control, With Or Without Varus/Valgus Adjustment, Prefabricated, Off-The-Shelf.
Shoulder Elbow Wrist Hand Orthosis, Abduction Positioning, Airplane Design, Prefabricated, Includes Fitting And Adjustment.
L0650 ..............
L1832 ..............
L1833 ..............
L1851 ..............
jspears on DSK121TN23PROD with RULES1
L3960 ..............
As previously stated, PMDs are
included on the Required Face-to-Face
Encounter and Written Order Prior to
Delivery List per statutory obligation.
For the other DMEPOS items, we
considered factors such as operational
limitations, item utilization, acute
needs, pandemic impacts, cost-benefit
analysis (for example, comparing the
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cost of review versus the anticipated
amount of improper payment
identified), emerging trends (for
example, billing patterns, medical
review findings), vulnerabilities
identified in official agency reports, or
other analysis.
In selecting these items, we must
balance our program integrity goals with
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the needs of patients, particularly those
in need of medical devices to assist with
functional activities and ambulation
within their home. In other words, we
must ensure the appropriate application
and oversight of the face-to-face
encounter requirements. In
consideration of access issues, we note
that the regulation 42 CFR 410.38 allows
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for use of telehealth, as defined in 42
CFR 410.78 and 414.65, when
appropriate to meet our coverage
requirements for beneficiaries.
We also believe transparency and
education will aid in compliance with
these payment requirements and
continued access. As such, we will
make information widely available to
the public at appropriate literacy levels
regarding face-to-face encounter
requirements, prior authorization, and
necessary documentation for items on
Required Face-to-Face Encounter and
Written Order Prior to Delivery and
Prior Authorization Lists.
We believe additional practitioner
oversight of beneficiaries in need of
items represented by these HCPCS
codes will help further our program
integrity goals of reducing fraud, waste,
and abuse. It will also help ensure
beneficiary receipt of items specific to
their medical needs. For items on the
Required Face-to-Face Encounter and
Written Order Prior to Delivery List
(Tables 3 and 4), the written order/
prescription must be communicated to
the supplier prior to delivery. For such
items, we require the treating
practitioner to have a face-to-face
encounter with the beneficiary within
the 6 months preceding the date of the
written order/prescription. If the face-toface encounter is a telehealth encounter,
the requirements of 42 CFR 410.78 and
414.65 must be met for DMEPOS
coverage purposes.
Consistent with § 410.38(d), the faceto-face encounter must be documented
in the pertinent portion of the medical
record (for example, history, physical
examination, diagnostic tests, summary
of findings, progress notes, treatment
plans or other sources of information
that may be appropriate). The
supporting documentation must include
subjective and objective beneficiary
specific information used for
diagnosing, treating, or managing a
clinical condition for which the
DMEPOS item(s) is ordered. Upon
request by CMS or its review
contractors, a supplier must submit
additional documentation to support
and substantiate the medical necessity
for the DMEPOS item or both.
The Required Face-to-Face Encounter
and Written Order Prior to Delivery List
is available on the following CMS
website: https://www.cms.gov/ResearchStatistics-Data-and-Systems/MonitoringPrograms/Medicare-FFS-CompliancePrograms/Medical-Review/FacetoFace
EncounterRequirementforCertain
DurableMedicalEquipment.
C. Items Subject to Prior Authorization
Requirements
The November 8, 2019 final rule (84
FR 60648) maintained the process
established in the December 30, 2015
final rule (80 FR 81674) that when items
are placed on the Required Prior
Authorization List, we would inform the
public of those DMEPOS items on the
Required Prior Authorization List in the
Federal Register with no less than 60
days’ notice before implementation, and
post notification on the CMS website.
The Required Prior Authorization List
specified in § 414.234(c)(1) is selected
from the Master List (as described in
§ 414.234(b)), and those selected items
require prior authorization as a
condition of payment. Additionally,
§ 414.234 (c)(1)(ii) states that CMS may
elect to limit the prior authorization
requirement to a particular region of the
country if claims data analysis shows
that unnecessary utilization of the
selected item(s) is concentrated in a
particular region.
The purpose of this document is to
inform the public that we are updating
the Required Prior Authorization List to
include six additional Power Mobility
Devices (PMDs) and five additional
Orthoses HCPCS codes. To assist
stakeholders in preparing for
implementation of the prior
authorization program, we are providing
90 days’ notice.
The following six HCPCS codes for
PMDs and five HCPCS codes for
Orthoses are added to the Required
Prior Authorization List:
TABLE 5—ADDITIONS TO THE REQUIRED PRIOR AUTHORIZATION LIST
HCPCS
K0800
K0801
K0802
K0806
K0807
K0808
L0648
..............
..............
..............
..............
..............
..............
..............
L0650 ..............
L1832 ..............
jspears on DSK121TN23PROD with RULES1
L1833 ..............
L1851 ..............
Description
Power operated vehicle, group 1 standard, patient weight capacity up to and including 300 pounds.
Power Operated Vehicle, Group 1 Heavy Duty, Patient Weight Capacity, 301 To 450 Pounds.
Power Operated Vehicle, Group 1 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.
Power Operated Vehicle, Group 2 Standard, Patient Weight Capacity Up To And Including 300 Pounds.
Power Operated Vehicle, Group 2 Heavy Duty, Patient Weight Capacity 301 To 450 Pounds.
Power Operated Vehicle, Group 2 Very Heavy Duty, Patient Weight Capacity 451 To 600 Pounds.
Lumbar-Sacral Orthosis, Sagittal Control, With Rigid Anterior And Posterior Panels, Posterior Extends From Sacrococcygeal Junction To T–9
Vertebra, Produces Intracavitary Pressure To Reduce Load On The Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-The-Shelf.
Lumbar-Sacral Orthosis, Sagittal-Coronal Control, With Rigid Anterior And Posterior Frame/Panel(S), Posterior Extends From Sacrococcygeal Junction To T–9 Vertebra, Lateral Strength Provided By Rigid Lateral Frame/Panel(S), Produces Intracavitary Pressure To Reduce Load On
Intervertebral Discs, Includes Straps, Closures, May Include Padding, Shoulder Straps, Pendulous Abdomen Design, Prefabricated, Off-TheShelf.
Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated Item That Has Been Trimmed,
Bent, Molded, Assembled, Or Otherwise Customized To Fit A Specific Patient By An Individual With Expertise.
Knee Orthosis, Adjustable Knee Joints (Unicentric Or Polycentric), Positional Orthosis, Rigid Support, Prefabricated, Off-The Shelf.
Knee Orthosis (Ko), Single Upright, Thigh And Calf, With Adjustable Flexion And Extension Joint (Unicentric Or Polycentric), Medial-Lateral And
Rotation Control, With Or Without Varus/Valgus Adjustment, Prefabricated, Off-The-Shelf.
We believe prior authorization of
these six additional HCPCS codes for
PMDs and five HCPCS codes for
Orthoses will help further our program
integrity goals of reducing fraud, waste,
and abuse, while also protecting access
to care. For PMDs, the OIG has
previously reported that Medicare has
inappropriately paid for items that did
not meet certain Medicare
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requirements.2 Lower limb orthoses
(LLO) and lumbar-sacral orthoses (LSO)
have been identified by CMS’
Comprehensive Error Rate Testing
(CERT) program as two of the top 20
DMEPOS service types with improper
2 OIG Report A–09–12–02068—Medicare Paid
Suppliers For Power Mobility Device Claims That
Did Not Meet Federal Requirements For Physicians’
Face-To-Face Examinations Of Beneficiaries
(January 2015): https://oig.hhs.gov/oas/reports/
region9/91202068.pdf.
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payments over the past several years.
Since 2016, LLOs have had an improper
payment rate above 60 percent, with
projected improper payments ranging
between $235 and $501 million.
Similarly, LSOs have had an improper
payment rate above 32 percent, with
projected improper payments ranging
between $116 and $177 million, since
2016. Additionally, in 2019, the
Department of Justice (DOJ) announced
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federal indictments and law
enforcement actions stemming from
fraudulent claims submitted for
medically unnecessary back, shoulder,
wrist, and knee braces. Administrative
actions were taken against 130 DMEPOS
companies that were enticing Medicare
beneficiaries with offers of low or nocost orthotic braces. The investigation
found that some DME companies and
licensed medical professionals allegedly
participated in health care fraud
schemes involving more than $1.2
billion in loss.3
These codes will be subject to the
requirements of the prior authorization
program for certain DMEPOS items as
outlined in § 414.234. We will
implement a prior authorization
program for the six newly added codes
for PMDs nationwide and five newly
added codes for Orthoses in 3 phases.
This phased-in approach will allow us
to identify and resolve any unforeseen
issues by using a smaller claim volume
in phase one before implementing
phases 2 and 3. State selection for the
three phases was completed based on
utilization data for the items selected.
• For phase 1, which begins on the
date specified in the DATES section, we
selected the State in each DME MAC
jurisdiction with the highest utilization:
New York, Illinois, Florida, and
California.
• For phase 2, which begins on the
date specified in the DATES section of
this document, we selected the next
three States with the highest utilization
in each DME MAC jurisdiction:
Maryland, Pennsylvania, New Jersey,
Michigan, Ohio, Kentucky, Texas, North
Carolina, Georgia, Missouri, Arizona,
and Washington.
• For phase 3, which begins on the
date specified in the DATES section of
this document, prior authorization
expands to all remaining States and
territories not captured in phases 1 and
2.
The prior authorization program for
the 51 codes currently subject to the
DMEPOS prior authorization
requirement will continue
uninterrupted.
Prior to providing an item on the
Required Prior Authorization List to the
beneficiary and submitting the claim for
processing, a requester must submit a
prior authorization request. The request
3 Federal Indictments & Law Enforcement Actions
in One of the Largest Health Care Fraud Schemes
Involving Telemedicine and Durable Medical
Equipment Marketing Executives Results in Charges
Against 24 Individuals Responsible for Over $1.2
Billion in Losses (April 9, 2019): https://
www.justice.gov/opa/pr/federal-indictments-andlaw-enforcement-actions-one-largest-health-carefraud-schemes.
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must include evidence that the item
complies with all applicable Medicare
coverage, coding, and payment rules.
Consistent with § 414.234(d), such
evidence must include the written
order/prescription, relevant information
from the beneficiary’s medical record,
and relevant supplier-produced
documentation. After receipt of all
applicable required Medicare
documentation, CMS or one of its
review contractors will conduct a
medical review and communicate a
decision that provisionally affirms or
non-affirms the request.
We will issue specific prior
authorization guidance for these
additional items in subregulatory
communications, including final
timelines customized for the DMEPOS
item subject to prior authorization, for
communicating a provisionally affirmed
or non-affirmed decision to the
requester. In the December 30, 2015
final rule (80 FR 81674) we stated that
this approach to final timelines provides
flexibility to develop a process that
involves fewer days, as may be
appropriate, and allows us to safeguard
beneficiary access to care. If at any time
we become aware that the prior
authorization process is creating barriers
to care, we can suspend the program.
For example, we will review questions
and complaints from consumers and
providers that come through regular
sources such as 1–800–Medicare.
The updated Required Prior
Authorization List is available in the
download section of the following CMS
website: https://www.cms.gov/ResearchStatistics-Data-and-Systems/MonitoringPrograms/Medicare-FFS-CompliancePrograms/DMEPOS/Downloads/
DMEPOS_PA_Required-PriorAuthorization-List.pdf.
III. Collection of Information
Requirements
This document provides updates to
the Master List and announces the
selection of HCPCS codes to be placed
on the Required Face-to-Face Encounter
and Written Order Prior to Delivery List
and Required Prior Authorization List.
Additionally, this document
announces the continuation of prior
authorization for 51 HCPCS codes, and
the addition of six HCPCS codes for
PMDs and five HCPCS codes for
Orthoses on the Required Prior
Authorization List. There is an
information collection burden
associated with this program that is
currently approved under OMB control
number 0938–1293, which expires
March 31, 2022. This package accounts
for burdens associated with the addition
of items to the Required Prior
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2057
Authorization Lists and assumes a
burden for 2021 of approximately $10
million for providers to comply with the
required information collection. We will
reassess this burden soon and will seek
comment on our assessment in a
Federal Register notice as required
under the Paperwork Reduction Act of
1995.
IV. Regulatory Impact Statement
We have examined the impact of this
regulatory document as required by
Executive Order 12866 on Regulatory
Planning and Review (September 30,
1993), Executive Order 13563 on
Improving Regulation and Regulatory
Review (January 18, 2011), the
Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96–354),
section 1102(b) of the Act, section 202
of the Unfunded Mandates Reform Act
of 1995 (March 22, 1995; Pub. L. 104–
4), Executive Order 13132 on
Federalism (August 4, 1999), and the
Congressional Review Act (5 U.S.C.
804(2)).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). A Regulatory Impact Analysis
(RIA) must be prepared for major rules
with significant regulatory action/s and/
or with economically significant effects
($100 million or more in any 1 year).
This regulatory document is not
significant and does not reach the
economic threshold and thus is not
considered a major regulatory
document. Per our analysis, the
additional items being added to the
prior authorization program (excluding
PMDs) 4 have an estimated net savings
of $14.8 million. Gross savings is based
upon a 10 percent reduction in the total
amount paid for claims in Calendar Year
2019. We deducted from the gross
savings the anticipated cost for
performing the prior authorization
reviews in order to estimate the net
savings. Our gross savings estimate of 10
percent is based on previous results
from other prior authorization programs,
4 The additional PMD codes that will be added
were not included in the data analysis because PMD
codes are already part of a successful prior
authorization program. Since some PMDs are
already subject to prior authorization, other PMDs
may demonstrate billing shifts across the policy
groups, and as such, savings are more difficult to
accurately forecast and may be less identifiable.
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including prior authorization of other
DMEPOS items.
The RFA requires agencies to analyze
options for regulatory relief of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of less than $8.0 million to $41.5
million in any 1 year. Individuals and
States are not included in the definition
of a small entity. We are not preparing
an analysis for the RFA because we have
determined, and the Secretary certifies,
that this regulatory document will not
have a significant economic impact on
a substantial number of small entities.
In addition, section 1102(b) of the Act
requires us to prepare an RIA if a rule
may have a significant impact on the
operations of a substantial number of
small rural hospitals. This analysis must
conform to the provisions of section 604
of the RFA. For purposes of section
1102(b) of the Act, we define a small
rural hospital as a hospital that is
located outside of a Metropolitan
Statistical Area for Medicare payment
regulations and has fewer than 100
beds. We are not preparing an analysis
for section 1102(b) of the Act because
we have determined, and the Secretary
certifies, that this regulatory document
will not have a significant impact on the
operations of a substantial number of
small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2021, that threshold is approximately
$158 million. This regulatory document
will have no consequential effect on
State, local, or tribal governments or on
the private sector.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final rule
or other regulatory document) that
imposes substantial direct requirement
costs on State and local governments,
preempts State law, or otherwise has
Federalism implications. Since this
regulatory document does not impose
any costs on State or local governments,
the requirements of Executive Order
13132 are not applicable.
In accordance with the provisions of
Executive Order 12866, this document
was reviewed by the Office of
Management and Budget.
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The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Lynette Wilson, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
I. Background
Centers for Medicare & Medicaid
Services
In the final rule with comment period
that appeared in the November 16, 2021,
Federal Register (86 FR 63458) titled
‘‘Medicare Program: Hospital Outpatient
Prospective Payment and Ambulatory
Surgical Center Payment Systems and
Quality Reporting Programs; Price
Transparency of Hospital Standard
Charges; Radiation Oncology Model’’
(hereinafter referred to as the CY 2022
OPPS/ASC final rule with comment
period), there were a number of
technical and typographical errors that
are identified and corrected in this
correcting document. The provisions in
this correction document are effective as
if they had been included in the
document that appeared in the
November 16, 2021 Federal Register.
Accordingly, the corrections are
effective January 1, 2022.
42 CFR Parts 412, 416, 419, and 512
II. Summary of Errors
Dated: January 10, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2022–00572 Filed 1–12–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A. Summary of Errors in the Preamble
Office of the Secretary
1. Hospital Outpatient Prospective
Payment System (OPPS) Corrections
45 CFR Part 180
[CMS–1753–CN]
RIN 0938–AU43
Medicare Program: Hospital Outpatient
Prospective Payment and Ambulatory
Surgical Center Payment Systems and
Quality Reporting Programs; Price
Transparency of Hospital Standard
Charges; Radiation Oncology Model;
Correction
Centers for Medicare &
Medicaid Services (CMS), Department
of Health and Human Services (HHS).
ACTION: Final rule with comment period;
correction.
AGENCY:
This document corrects
technical errors in the final rule with
comment period that appeared in the
Federal Register on November 16, 2021,
titled ‘‘Medicare Program: Hospital
Outpatient Prospective Payment and
Ambulatory Surgical Center Payment
Systems and Quality Reporting
Programs; Price Transparency of
Hospital Standard Charges; Radiation
Oncology Model.’’
DATES:
Effective date: Effective January 13,
2022.
Applicability date: The corrections in
this correcting document are applicable
beginning January 1, 2022.
FOR FURTHER INFORMATION CONTACT:
Marjorie Baldo via email
Marjorie.Baldo@cms.hhs.gov or at (410)
786–4617.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
On page 63463, use of incorrect wage
index assignments for community
mental health centers (CMHCs) resulted
in an inaccurate payment impact
estimate. We stated that ‘‘we estimate a
1.1 percent increase in CY 2022
payments to CMHCs relative to their CY
2021 payments.’’ We are correcting our
estimate of the increase in payments for
CMHCs from ‘‘1.1 percent’’ to ‘‘1.6
percent’’.
On page 63490, we noted that one
commenter, a hospital association,
supported CMS’s proposal to continue
to unpackage Omidria in the ASC
setting. However, there were several
commenters, including several hospital
associations, that expressed broad
support for CMS’s proposal to
unpackage and pay separately for nonopioid pain management drugs that
function as surgical supplies, including
the drug Omidria. We are correcting the
text to acknowledge the additional
commenters.
On page 63497, the table number for
the table included on this page was
inadvertently omitted from the table’s
title. Therefore, we are adding the
number ‘‘4’’ to the table’s title.
On page 63543 and 63544, we listed
the incorrect APC assignment for CPT
codes 66989 and 66991. We are
correcting the APC assignment for these
codes from APC 1526 to APC 1563.
On page 63548, second column, under
section ‘‘6. Calculus Aspiration With
Lithotripsy Procedure (APC 5376)’’ of
the APC-Specific section, we are
correcting the long descriptor for
E:\FR\FM\13JAR1.SGM
13JAR1
]]>Agencies
[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Rules and Regulations]
[Pages 2051-2058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00572]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 410 and 414
[CMS-6081-N]
Medicare Program; Updates to Lists Related to Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Conditions of
Payment
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Updates to and selection of certain codes.
-----------------------------------------------------------------------
SUMMARY: This document announces the updated Healthcare Common
Procedure Coding System (HCPCS) codes on the Master List of DMEPOS
Items Potentially Subject to Face-to-Face Encounter and Written Order
Prior to Delivery and/or Prior Authorization Requirements. It also
announces the initial selection of HCPCS codes on the Required Face-to-
Face Encounter and Written Order Prior to Delivery List and the updates
the HCPCS codes on the Required Prior Authorization List.
DATES: The implementation is effective on April 13, 2022. Prior
authorization will be implemented in 3 incremental phases, with the
final phase being national implementation. Phase 1 includes 1 state per
jurisdiction and is effective April 13, 2022, Phase 2 includes 4 States
per jurisdiction and is effective July 12, 2022, and Phase 3 is
nationwide and is effective October 10, 2022.
FOR FURTHER INFORMATION CONTACT:
Susan Billet, (410) 786-1062.
[[Page 2052]]
Emily Calvert, (410) 786-4277.
Stephanie Collins, (410) 786-3100.
Jennifer Phillips, (410) 786-1023.
Olufemi Shodeke, (410) 786-1649.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1832, 1834, and 1861 of the Social Security Act (the Act)
establishes benefits and the provisions of payment for Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) items under
Part B of the Medicare program.
Section 1834(a)(1)(E)(iv) of the Act provides conditions of
coverage specific to Power Mobility Devices (PMDs). Specifically, it
provides that payment may not be made for a covered item consisting of
a motorized or power wheelchair unless a physician (as defined in
section 1861(r)(1) of the Act), physician assistant (PA), nurse
practitioner (NP), or clinical nurse specialist (CNS) (as such non-
physician practitioners are defined in section 1861(aa)(5) of the Act)
has conducted a face-to-face examination of the individual and written
a prescription for the item.
Section 1834(a)(11)(B) of the Act requires a physician, PA, NP, or
CNS to have a face-to-face encounter with the beneficiary within the 6-
month period prior to the written order for certain DMEPOS items (or
other reasonable timeframe as determined by the Secretary of the
Department of Health and Human Services (the Secretary)).
Section 1834(a)(15)(A) of the Act authorizes the Secretary to
develop and periodically update a list of DMEPOS items that the
Secretary determines, on the basis of prior payment experience, are
frequently subject to unnecessary utilization and to develop a prior
authorization process for these items.
In 2006, we issued Final Rule ``Medicare Program; Conditions for
Payment of Power Mobility Devices, including Power Wheelchairs and
Power-Operated Vehicles'' (71 FR 17021) to implement the requirements
for a face-to-face examination and written order prior to delivery for
PMDs, in accordance with legislation found in section 302(a)(2) of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(Pub. L. 108-173), as codified in amended section 1834(a)(1)(E)(iv) of
the Act. This regulation applied to all power mobility devices--
including power wheelchairs and power operated vehicles (hereinafter
referred to as PMDs). The requirements for PMDs mandated a 7-element
order/prescription for payment.
In the November 16, 2012 Federal Register, we published final rule
titled ``Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the
Requirement for Termination of Non-Random Prepayment Complex Medical
Review and Other Revisions to Part B for CY 2013'' (77 FR 68892)
requiring face-to-face encounter and written order prior to delivery
for specified DMEPOS items, in accordance with the authorizing
legislation found section 6407 of the Patient Protection and Affordable
Care Act of 2010 (Pub. L. 111-148) and amended section 1834(a)(11)(B)
of the Act. The regulation, as codified in 42 CFR 410.38, specified the
inclusion criteria for creating a list of DMEPOS items to be subject to
face-to-face encounter and written order prior to delivery
requirements. It also mandated a 5-element order/prescription for
payment of specified DMEPOS items.
In the December 30, 2015 Federal Register, we published final rule
titled ``Medicare Program; Prior Authorization Process for Certain
Durable Medical Equipment, Prosthetics, and Supplies'' (80 FR 81674),
in accordance with section 1834(a)(15) of the Act, we established the
Master List of Items Frequently Subject to Unnecessary Utilization. The
2015 Master List included certain DMEPOS items that the Secretary
determined, on the basis of prior payment experience, are frequently
subject to unnecessary utilization, and created a prior authorization
process for these items.
On November 8, 2019, we published a final rule titled, ``Medicare
Program; End-Stage Renal Disease Prospective Payment System, Payment
for Renal Dialysis Services Furnished to Individuals with Acute Kidney
Injury, End-Stage Renal Disease Quality Incentive Program, Durable
Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee
Schedule Amounts, DMEPOS Competitive Bidding Program (CBP) Amendments,
Standard Elements for a DMEPOS Order, and Master List of DMEPOS Items
Potentially Subject to a Face-to-Face Encounter and Written Order Prior
to Delivery and/or Prior Authorization Requirements'' (84 FR 60648).
The rule became effective January 1, 2020, harmonizing the lists of
DMEPOS items created by former rules and establishing one ``Master List
of DMEPOS Items Potentially Subject to Face-To-Face Encounter and
Written Orders Prior to Delivery and/or Prior Authorization
Requirements'' (the ``Master List''). Items are selected from the
Master List for inclusion on the Face-To-Face Encounter and Written
Orders Prior to Delivery List and/or Prior Authorization List through
the Federal Register.
II. Provisions of the Document
This document serves to publish three separate lists. First, it
provides an update to the Master List of items from which we can select
to include on the Required Face to Face Encounter and Written Order
Prior to Delivery List, and/or Required Prior Authorization List. This
document also serves to announce the initial selection of items to be
included on the Required Face-to-Face Encounter and Written Order Prior
to Delivery List. Lastly, it updates the items included on the Required
Prior Authorization List.
A. Master List of DMEPOS Items Frequently Subject to Unnecessary
Utilization
The Master List includes items that appear on the DMEPOS Fee
Schedule and meet the following criteria, as established in 84 FR
60648:
Have an average purchase fee of $500 or greater that is
adjusted annually for inflation, or an average monthly rental fee
schedule of $50 or greater that is adjusted annually for inflation, or
items identified as accounting for at least 1.5 percent of Medicare
expenditures for all DMEPOS items over a recent 12-month period, that
are also--
++ Identified in a Government Accountability Office (GAO) or
Department of Health and Human Services Office of Inspector General
(OIG) report that is national in scope and published in 2015 or later
as having a high rate of fraud or unnecessary utilization; or
++ Listed in the 2018 or subsequent year Comprehensive Error Rate
Testing (CERT) program's Medicare Fee-for-Service (FFS) Supplemental
Improper Payment Data Report as having a high improper payment rate.
Any items with at least 1,000 claims and $1 million in
payments during a recent 12-month period that are determined to have
aberrant billing patterns and lack explanatory contributing factors
(for example, new technology or coverage policies that may require time
for providers and suppliers to be educated on billing policies). Items
with aberrant billing patterns would be identified as those items with
payments during a 12-month timeframe that exceed payments made during
the preceding 12-months by the greater of--
++ Double the percent change of all DMEPOS claim payments for items
that meet the previous claim and payment
[[Page 2053]]
criteria, from the preceding 12-month period; or
++ Exceeding a 30 percent increase in payments for the items from
the preceding 12-month period.
Any items statutorily requiring a face-to-face encounter,
a written order prior to delivery, or prior authorization.
In the November 2019 final rule noted previously, we described the
maintenance process of the Master List as follows:
The Master List will be updated annually, and more
frequently as needed (for example, to address emerging billing trends),
and to reflect the thresholds specified in the regulations.
Items on the DMEPOS Fee Schedule that meet the payment
threshold criteria set forth in Sec. 414.234(b)(1) are added to the
list when the item is also listed in a CERT, OIG, or GAO report
published after 2020, and items not meeting the cost (approximately
$500 purchase or $50 rental) thresholds may still be added based on
findings of aberrant billing patterns.
Items are removed from the Master List 10 years after the
date the item was added, unless the item was identified in an OIG
report, GAO report, or having been identified in the CERT Medicare Fee
for Service Supplemental Improper Payment Data report as having a high
improper payment rate, within the 5-year period preceding the
anticipated date of expiration.
Items are removed from the list sooner than 10 years if
the purchase amount drops below the payment threshold.
Items already on the Master List that are identified on a
subsequent OIG, GAO, or CERT report will remain on the list for 10
years from the publication date of the new report.
Items are updated on the Master List when the Healthcare
Common Procedure Coding System (HCPCS) codes representing an item have
been discontinued and cross-walked to an equivalent item.
We will notify the public of any additions and deletions
from the Master List by posting a notification in the Federal Register
and on the CMS Prior Authorization website at https://www.cms.gov/research-statistics-data-systems/medicare-fee-service-compliance-programs/prior-authorization-and-pre-claim-review-initiatives.
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. Certain DMEPOS fee schedule amounts are updated for 2021 \1\
by the percentage increase in the consumer price index for all urban
consumers (United States city average) CPI-U for the 12-month period
ending June 30, 2020, adjusted by the change in the economy-wide
productivity equal to the 10-year moving average of changes in annual
economy-wide private non-farm business multi-factor productivity (MFP).
The productivity adjustment is 0.4 percent and the CPI-U percentage
increase is 0.6 percent. Thus, the 0.6 percentage increase in the CPI-U
is reduced by the 0.4 percentage increase in the MFP resulting in a net
increase of 0.2 percent for the update factor for CY 2021.
---------------------------------------------------------------------------
\1\ CY 2021 Update for Durable Medical Equipment, Prosthetics,
Orthotics and Supplies (DMEPOS) Fee Schedule (December 4, 2020):
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Transmittals/r10504cp.
---------------------------------------------------------------------------
For CY 2021, the 0.2 percent update factor was applied to the CY
2020 average price threshold of $500, resulting in a CY 2021 adjusted
payment threshold of $501 ($500 x 1.002). This results in a CY 2021
adjusted purchase price threshold of $501. An update factor of 0.2
percent was applied to the CY 2020 average monthly rental fee of $50,
resulting in an adjusted payment threshold of $50.10 ($50 x 1.002).
Rounding this figure to the nearest whole dollar amount results in a CY
2021 adjusted monthly rental fee threshold of $50.
A total of 31 HCPCS codes (see Table 1) meeting the criteria
outlined previously are added to the Master List. Of these 31 HCPCS
codes, 18 are added because these items meet the updated payment
threshold and are listed in an OIG or GAO report of a national scope or
a CERT DME and DMEPOS Service Specific Report(s) or both, and 13 are
added for being identified as accounting for at least 1.5 percent of
Medicare expenditures for all DMEPOS items over a recent 12-month
period.
Table 1--Additions to the Master List
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
A4352.................. Intermittent Urinary Catheter; Coude (Curved)
Tip, With Or Without Coating (Teflon,
Silicone, Silicone Elastomeric, Or
Hydrophilic, Etc.), Each.
A5121.................. Skin Barrier; Solid, 6 x 6 Or Equivalent, Each.
A6203.................. Composite Dressing, Sterile, Pad Size 16 Sq.
In. Or Less, With Any Size Adhesive Border,
Each Dressing.
A6219.................. Gauze, Non-Impregnated, Sterile, Pad Size 16
Sq. In. Or Less, With Any Size Adhesive
Border, Each Dressing.
A6242.................. Hydrogel Dressing, Wound Cover, Sterile, Pad
Size 16 Sq. In. Or Less, Without Adhesive
Border, Each Dressing.
A7030.................. Full Face Mask Used With Positive Airway
Pressure Device, Each.
A7031.................. Face Mask Interface, Replacement For Full Face
Mask, Each.
E0467.................. Home Ventilator, Multi-Function Respiratory
Device, Also Performs Any Or All Of The
Additional Functions Of Oxygen Concentration,
Drug Nebulization, Aspiration, And Cough
Stimulation, Includes All Accessories,
Components And Supplies For All Functions.
E0565.................. Compressor, Air Power Source For Equipment
Which Is Not Self-Contained Or Cylinder
Driven.
E0650.................. Pneumatic Compressor, Non-Segmental Home Model.
E0651.................. Pneumatic Compressor, Segmental Home Model
Without Calibrated Gradient Pressure.
E0652.................. Pneumatic Compressor, Segmental Home Model With
Calibrated Gradient Pressure.
E0656.................. Segmental Pneumatic Appliance For Use With
Pneumatic Compressor, Trunk.
E0657.................. Segmental Pneumatic Appliance For Use With
Pneumatic Compressor, Chest.
E0670.................. Segmental Pneumatic Appliance For Use With
Pneumatic Compressor, Integrated, 2 Full Legs
And Trunk.
E0675.................. Pneumatic Compression Device, High Pressure,
Rapid Inflation/Deflation Cycle, For Arterial
Insufficiency (Unilateral Or Bilateral
System).
E0740.................. Non-Implanted Pelvic Floor Electrical
Stimulator, Complete System.
E0744.................. Neuromuscular Stimulator For Scoliosis.
E0745.................. Neuromuscular Stimulator, Electronic Shock
Unit.
E0764.................. Functional Neuromuscular Stimulation,
Transcutaneous Stimulation Of Sequential
Muscle Groups Of Ambulation With Computer
Control, Used For Walking By Spinal Cord
Injured, Entire System, After Completion Of
Training Program.
E0766.................. Electrical Stimulation Device Used For Cancer
Treatment, Includes All Accessories, Any Type.
E1226.................. Wheelchair Accessory, Manual Fully Reclining
Back, (Recline Greater Than 80 Degrees), Each.
E2202.................. Manual Wheelchair Accessory, Nonstandard Seat
Frame Width, 24-27 Inches.
E2203.................. Manual Wheelchair Accessory, Nonstandard Seat
Frame Depth, 20 To Less Than 22 Inches.
E2613.................. Positioning Wheelchair Back Cushion, Posterior,
Width Less Than 22 Inches, Any Height,
Including Any Type Mounting Hardware.
[[Page 2054]]
L0830.................. Halo Procedure, Cervical Halo Incorporated Into
Milwaukee Type Orthosis.
L1005.................. Tension Based Scoliosis Orthosis And Accessory
Pads, Includes Fitting And Adjustment.
L1906.................. Ankle Foot Orthosis, Multiligamentous Ankle
Support, Prefabricated, Off-The-Shelf.
L2580.................. Addition To Lower Extremity, Pelvic Control,
Pelvic Sling.
L2624.................. Addition To Lower Extremity, Pelvic Control,
Hip Joint, Adjustable Flexion, Extension,
Abduction Control, Each.
L7368.................. Lithium Ion Battery Charger, Replacement Only.
------------------------------------------------------------------------
The following five HCPCS codes (see Table 2) are removed from the
Master List because they no longer have a DMEPOS Fee Schedule price of
$501 or greater, or an average monthly rental fee schedule of $50 or
greater, and are identified as accounting for at least 1.5 percent of
Medicare expenditures for all DMEPOS items over a recent 12-month
period or both.
Table 2--Deletions From the Master List
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
A4253.................. Blood Glucose Test or Reagent Strips for Home
Blood Glucose Monitor, Per 50 Strips.
A4351.................. Intermittent Urinary Catheter; Straight Tip,
With or Without Coating (Teflon, Silicone,
Silicone Elastomer, Or Hydrophilic, Etc.),
Each.
E2369.................. Power Wheelchair Component, Drive Wheel Gear
Box, Replacement Only.
E2377.................. Power Wheelchair Accessory, Expandable
Controller, Including All Related Electronics
and Mounting Hardware, Upgrade Provided At
Initial Issue.
L3761.................. Elbow Orthosis (Eo), With Adjustable Position
Locking Joint(S), Prefabricated, Off-The-
Shelf.
------------------------------------------------------------------------
The full updated list is available in the download section of the
following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/DMEPOS/Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items.
B. Items Subject to Face-to-Face Encounter and Written Order Prior to
Delivery Requirements
In the November 2019 final rule, we stated that since the face-to-
face encounter and written orders are statutorily required for PMDs,
they would be included on the Master List and the Required Face-to-Face
Encounter and Written Order Prior to Delivery List in accordance with
our statutory obligation, and would remain there.
The Required Face-to-Face Encounter and Written Order Prior to
Delivery List, as specified in Sec. 410.38(c)(8), is comprised of PMDs
and those items selected from the Master List (as described in Sec.
414.234(b)) to require a face-to-face encounter and a written order
prior to delivery as a condition of payment.
The rule established a process of placing items on the Required
Face-to-Face Encounter and Written Order Prior to Delivery List,
including that they be communicated to the public and effective no less
than 60 days after a Federal Register document publication and CMS
website posting.
We note that following the publication of the November 2019 final
rule (84 FR 60648), the serious public health threats posed by the
spread of the 2019 Novel Coronavirus (COVID-19) became known, and
subsequently the addition of new items on the Required Face-to-Face
Encounter and Written Order Prior to Delivery List was placed on hold.
We also note that in an interim final rule with comment period
titled ``Medicare and Medicaid Programs; Policy and Regulatory
Revisions in Response to the COVID-19 Public Health Emergency'' and
published on April 6, 2020 (84 FR 19230), we stated that ``to the
extent an NCD or LCD (including articles) would otherwise require a
face-to-face or in-person encounter for evaluations, assessments,
certifications or other implied face-to-face services, those
requirements would not apply during the PHE for the COVID-19
pandemic.'' This language does not apply to the face-to-face encounter
and written order prior to delivery requirements stemming from 42 CFR
410.38 and section 1834 of the Act; therefore, the ongoing direction
provided in the April 2020 rule is not affected by this document. The
list of DMEPOS items selected and promulgated in this document will
require a face-to-face encounter (conducted either via telehealth or
in-person), per 42 CFR 410.38, effective after 90 days' notice.
At this time, we believe it appropriate to add a limited list of
items that pose a risk to the Medicare Trust Funds, to be subject to
additional practitioner oversight via the face-to-face encounter and
written order prior to delivery requirements.
To assist stakeholders in preparing for implementation of the
Required Face-to-Face Encounter and Written Order Prior to Delivery
List, we are publishing the proposed code additions and providing 90
days' notice.
Per statutory requirements, Table 3 lists DMEPOS HCPCS codes for
PMDs. Section 1834(a)(1)(E)(iv) of the Act explicitly requires a face-
to-face and written order for PMDs; therefore, PMDs require a face-to-
face encounter per statute. To reflect this, PMDs will both be placed
and will remain on the Required Face-to-Face Encounter and Written
Order Prior to Delivery List indefinitely.
Section 1834(a)(11)(B) of the Act authorizes the Secretary to
select other DMEPOS HCPCS codes that will require a face-to-face
encounter and written order prior to delivery as a condition of
payment. In addition to PMDs, this Federal Register document announces
the addition of seven other DMEPOS HCPCS codes, not required by
statute, that are selected from the Master List to be placed on the
Required Face-to-Face Encounter and Written Order Prior to Delivery
List as listed in Table 4, based on our regulatory authority at 42 CFR
410.38.
[[Page 2055]]
Table 3--Statutorily Required Power Mobility Devices
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
K0800.................. Power Operated Vehicle, Group 1 Standard,
Patient Weight Capacity Up To And Including
300 Pounds.
K0801.................. Power Operated Vehicle, Group 1 Heavy Duty,
Patient Weight Capacity, 301 To 450 Pounds.
K0802.................. Power Operated Vehicle, Group 1 Very Heavy
Duty, Patient Weight Capacity 451 To 600
Pounds.
K0806.................. Power Operated Vehicle, Group 2 Standard,
Patient Weight Capacity Up To And Including
300 Pounds.
K0807.................. Power Operated Vehicle, Group 2 Heavy Duty,
Patient Weight Capacity 301 To 450 Pounds.
K0808.................. Power Operated Vehicle, Group 2 Very Heavy
Duty, Patient Weight Capacity 451 To 600
Pounds.
K0813.................. Power Wheelchair, Group 1 Standard, Portable,
Sling/Solid Seat And Back, Patient Weight
Capacity Up To And Including 300 Pounds.
K0814.................. Power Wheelchair, Group 1 Standard, Portable,
Captains Chair, Patient Weight Capacity Up To
And Including 300 Pounds.
K0815.................. Power Wheelchair, Group 1 Standard, Sling/Solid
Seat And Back, Patient Weight Capacity Up To
And Including 300 Pounds.
K0816.................. Power Wheelchair, Group 1 Standard, Captains
Chair, Patient Weight Capacity Up To And
Including 300 Pounds.
K0820.................. Power Wheelchair, Group 2 Standard, Portable,
Sling/Solid Seat/Back, Patient Weight Capacity
Up To And Including 300 Pounds.
K0821.................. Power Wheelchair, Group 2 Standard, Portable,
Captains Chair, Patient Weight Capacity Up To
And Including 300 Pounds.
K0822.................. Power Wheelchair, Group 2 Standard, Sling/Solid
Seat/Back, Patient Weight Capacity Up To And
Including 300 Pounds.
K0823.................. Power Wheelchair, Group 2 Standard, Captains
Chair, Patient Weight Capacity Up To And
Including 300 Pounds.
K0824.................. Power Wheelchair, Group 2 Heavy Duty, Sling/
Solid Seat/Back, Patient Weight Capacity 301
To 450 Pounds.
K0825.................. Power Wheelchair, Group 2 Heavy Duty, Captains
Chair, Patient Weight Capacity 301 To 450
Pounds.
K0826.................. Power Wheelchair, Group 2 Very Heavy Duty,
Sling/Solid Seat/Back, Patient Weight Capacity
451 To 600 Pounds.
K0827.................. Power Wheelchair, Group 2 Very Heavy Duty,
Captains Chair, Patient Weight Capacity 451 To
600 Pounds.
K0828.................. Power Wheelchair, Group 2 Extra Heavy Duty,
Sling/Solid Seat/Back, Patient Weight Capacity
601 Pounds Or More.
K0829.................. Power Wheelchair, Group 2 Extra Heavy Duty,
Captains Chair, Patient Weight Capacity 601
Pounds Or More.
K0835.................. Power Wheelchair, Group 2 Standard, Single
Power Option, Sling/Solid Seat/Back, Patient
Weight Capacity Up To And Including 300
Pounds.
K0836.................. Power Wheelchair, Group 2 Standard, Single
Power Option, Captains Chair, Patient Weight
Capacity Up To And Including 300 Pounds.
K0837.................. Power Wheelchair, Group 2 Heavy Duty, Single
Power Option, Sling/Solid Seat/Back, Patient
Weight Capacity 301 To 450 Pounds.
K0838.................. Power Wheelchair, Group 2 Heavy Duty, Single
Power Option, Captains Chair, Patient Weight
Capacity 301 To 450 Pounds.
K0839.................. Power Wheelchair, Group 2 Very Heavy Duty,
Single Power Option, Sling/Solid Seat/Back,
Patient Weight Capacity 451 To 600 Pounds.
K0840.................. Power Wheelchair, Group 2 Extra Heavy Duty,
Single Power Option, Sling/Solid Seat/Back,
Patient Weight Capacity 601 Pounds Or More.
K0841.................. Power Wheelchair, Group 2 Standard, Multiple
Power Option, Sling/Solid Seat/Back, Patient
Weight Capacity Up To And Including 300
Pounds.
K0842.................. Power Wheelchair, Group 2 Standard, Multiple
Power Option, Captains Chair, Patient Weight
Capacity Up To And Including 300 Pounds.
K0843.................. Power Wheelchair, Group 2 Heavy Duty, Multiple
Power Option, Sling/Solid Seat/Back, Patient
Weight Capacity 301 To 450 Pounds.
K0848.................. Power Wheelchair, Group 3 Standard, Sling/Solid
Seat/Back, Patient Weight Capacity Up To And
Including 300 Pounds.
K0849.................. Power Wheelchair, Group 3 Standard, Captains
Chair, Patient Weight Capacity Up To And
Including 300 Pounds.
K0850.................. Power Wheelchair, Group 3 Heavy Duty, Sling/
Solid Seat/Back, Patient Weight Capacity 301
To 450 Pounds.
K0851.................. Power Wheelchair, Group 3 Heavy Duty, Captains
Chair, Patient Weight Capacity 301 To 450
Pounds.
K0852.................. Power Wheelchair, Group 3 Very Heavy Duty,
Sling/Solid Seat/Back, Patient Weight Capacity
451 To 600 Pounds.
K0853.................. Power Wheelchair, Group 3 Very Heavy Duty,
Captains Chair, Patient Weight Capacity, 451
To 600 Pounds.
K0854.................. Power Wheelchair, Group 3 Extra Heavy Duty,
Sling/Solid Seat/Back, Patient Weight Capacity
601 Pounds Or More.
K0855.................. Power Wheelchair, Group 3 Extra Heavy Duty,
Captains Chair, Patient Weight Capacity 601
Pounds Or More.
K0856.................. Power Wheelchair, Group 3 Standard, Single
Power Option, Sling/Solid Seat/Back, Patient
Weight Capacity Up To And Including 300
Pounds.
K0857.................. Power Wheelchair, Group 3 Standard, Single
Power Option, Captains Chair, Patient Weight
Capacity Up To And Including 300 Pounds.
K0858.................. Power Wheelchair, Group 3 Heavy Duty, Single
Power Option, Sling/Solid Seat/Back, Patient
Weight Capacity 301 To 450 Pounds.
K0859.................. Power Wheelchair, Group 3 Heavy Duty, Single
Power Option, Captains Chair, Patient Weight
Capacity 301 To 450 Pounds.
K0860.................. Power Wheelchair, Group 3 Very Heavy Duty,
Single Power Option, Sling/Solid Seat/Back,
Patient Weight Capacity 451 To 600 Pounds.
K0861.................. Power Wheelchair, Group 3 Standard, Multiple
Power Option, Sling/Solid Seat/Back, Patient
Weight Capacity Up To And Including 300
Pounds.
K0862.................. Power Wheelchair, Group 3 Heavy Duty, Multiple
Power Option, Sling/Solid Seat/Back, Patient
Weight Capacity 301 To 450 Pounds.
K0863.................. Power Wheelchair, Group 3 Very Heavy Duty,
Multiple Power Option, Sling/Solid Seat/Back,
Patient Weight Capacity 451 To 600 Pounds.
K0864.................. Power Wheelchair, Group 3 Extra Heavy Duty,
Multiple Power Option, Sling/Solid Seat/Back,
Patient Weight Capacity 601 Pounds Or More.
------------------------------------------------------------------------
Table 4--Non-Statutorily Required DMEPOS Items
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
E0748.................. Osteogenesis Stimulator, Electrical, Non-
Invasive, Spinal Applications.
L0648.................. Lumbar-Sacral Orthosis, Sagittal Control, With
Rigid Anterior And Posterior Panels, Posterior
Extends From Sacrococcygeal Junction To T-9
Vertebra, Produces Intracavitary Pressure To
Reduce Load On The Intervertebral Discs,
Includes Straps, Closures, May Include
Padding, Shoulder Straps, Pendulous Abdomen
Design, Prefabricated, Off-The-Shelf.
L0650.................. Lumbar-Sacral Orthosis, Sagittal-Coronal
Control, With Rigid Anterior And Posterior
Frame/Panel(S), Posterior Extends From
Sacrococcygeal Junction To T-9 Vertebra,
Lateral Strength Provided By Rigid Lateral
Frame/Panel(S), Produces Intracavitary
Pressure To Reduce Load On Intervertebral
Discs, Includes Straps, Closures, May Include
Padding, Shoulder Straps, Pendulous Abdomen
Design, Prefabricated, Off-The-Shelf.
L1832.................. Knee Orthosis, Adjustable Knee Joints
(Unicentric Or Polycentric), Positional
Orthosis, Rigid Support, Prefabricated Item
That Has Been Trimmed, Bent, Molded,
Assembled, Or Otherwise Customized To Fit A
Specific Patient By An Individual With
Expertise.
L1833.................. Knee Orthosis, Adjustable Knee Joints
(Unicentric Or Polycentric), Positional
Orthosis, Rigid Support, Prefabricated, Off-
The Shelf.
L1851.................. Knee Orthosis (KO), Single Upright, Thigh And
Calf, With Adjustable Flexion And Extension
Joint (Unicentric Or Polycentric), Medial-
Lateral And Rotation Control, With Or Without
Varus/Valgus Adjustment, Prefabricated, Off-
The-Shelf.
L3960.................. Shoulder Elbow Wrist Hand Orthosis, Abduction
Positioning, Airplane Design, Prefabricated,
Includes Fitting And Adjustment.
------------------------------------------------------------------------
As previously stated, PMDs are included on the Required Face-to-
Face Encounter and Written Order Prior to Delivery List per statutory
obligation. For the other DMEPOS items, we considered factors such as
operational limitations, item utilization, acute needs, pandemic
impacts, cost-benefit analysis (for example, comparing the cost of
review versus the anticipated amount of improper payment identified),
emerging trends (for example, billing patterns, medical review
findings), vulnerabilities identified in official agency reports, or
other analysis.
In selecting these items, we must balance our program integrity
goals with the needs of patients, particularly those in need of medical
devices to assist with functional activities and ambulation within
their home. In other words, we must ensure the appropriate application
and oversight of the face-to-face encounter requirements. In
consideration of access issues, we note that the regulation 42 CFR
410.38 allows
[[Page 2056]]
for use of telehealth, as defined in 42 CFR 410.78 and 414.65, when
appropriate to meet our coverage requirements for beneficiaries.
We also believe transparency and education will aid in compliance
with these payment requirements and continued access. As such, we will
make information widely available to the public at appropriate literacy
levels regarding face-to-face encounter requirements, prior
authorization, and necessary documentation for items on Required Face-
to-Face Encounter and Written Order Prior to Delivery and Prior
Authorization Lists.
We believe additional practitioner oversight of beneficiaries in
need of items represented by these HCPCS codes will help further our
program integrity goals of reducing fraud, waste, and abuse. It will
also help ensure beneficiary receipt of items specific to their medical
needs. For items on the Required Face-to-Face Encounter and Written
Order Prior to Delivery List (Tables 3 and 4), the written order/
prescription must be communicated to the supplier prior to delivery.
For such items, we require the treating practitioner to have a face-to-
face encounter with the beneficiary within the 6 months preceding the
date of the written order/prescription. If the face-to-face encounter
is a telehealth encounter, the requirements of 42 CFR 410.78 and 414.65
must be met for DMEPOS coverage purposes.
Consistent with Sec. 410.38(d), the face-to-face encounter must be
documented in the pertinent portion of the medical record (for example,
history, physical examination, diagnostic tests, summary of findings,
progress notes, treatment plans or other sources of information that
may be appropriate). The supporting documentation must include
subjective and objective beneficiary specific information used for
diagnosing, treating, or managing a clinical condition for which the
DMEPOS item(s) is ordered. Upon request by CMS or its review
contractors, a supplier must submit additional documentation to support
and substantiate the medical necessity for the DMEPOS item or both.
The Required Face-to-Face Encounter and Written Order Prior to
Delivery List is available on the following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/FacetoFaceEncounterRequirementforCertainDurableMedicalEquipment.
C. Items Subject to Prior Authorization Requirements
The November 8, 2019 final rule (84 FR 60648) maintained the
process established in the December 30, 2015 final rule (80 FR 81674)
that when items are placed on the Required Prior Authorization List, we
would inform the public of those DMEPOS items on the Required Prior
Authorization List in the Federal Register with no less than 60 days'
notice before implementation, and post notification on the CMS website.
The Required Prior Authorization List specified in 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. 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.
The purpose of this document is to inform the public that we are
updating the Required Prior Authorization List to include six
additional Power Mobility Devices (PMDs) and five additional Orthoses
HCPCS codes. To assist stakeholders in preparing for implementation of
the prior authorization program, we are providing 90 days' notice.
The following six HCPCS codes for PMDs and five HCPCS codes for
Orthoses are added to the Required Prior Authorization List:
Table 5--Additions to the Required Prior Authorization List
------------------------------------------------------------------------
HCPCS Description
------------------------------------------------------------------------
K0800.................. Power operated vehicle, group 1 standard,
patient weight capacity up to and including
300 pounds.
K0801.................. Power Operated Vehicle, Group 1 Heavy Duty,
Patient Weight Capacity, 301 To 450 Pounds.
K0802.................. Power Operated Vehicle, Group 1 Very Heavy
Duty, Patient Weight Capacity 451 To 600
Pounds.
K0806.................. Power Operated Vehicle, Group 2 Standard,
Patient Weight Capacity Up To And Including
300 Pounds.
K0807.................. Power Operated Vehicle, Group 2 Heavy Duty,
Patient Weight Capacity 301 To 450 Pounds.
K0808.................. Power Operated Vehicle, Group 2 Very Heavy
Duty, Patient Weight Capacity 451 To 600
Pounds.
L0648.................. Lumbar-Sacral Orthosis, Sagittal Control, With
Rigid Anterior And Posterior Panels, Posterior
Extends From Sacrococcygeal Junction To T-9
Vertebra, Produces Intracavitary Pressure To
Reduce Load On The Intervertebral Discs,
Includes Straps, Closures, May Include
Padding, Shoulder Straps, Pendulous Abdomen
Design, Prefabricated, Off-The-Shelf.
L0650.................. Lumbar-Sacral Orthosis, Sagittal-Coronal
Control, With Rigid Anterior And Posterior
Frame/Panel(S), Posterior Extends From
Sacrococcygeal Junction To T-9 Vertebra,
Lateral Strength Provided By Rigid Lateral
Frame/Panel(S), Produces Intracavitary
Pressure To Reduce Load On Intervertebral
Discs, Includes Straps, Closures, May Include
Padding, Shoulder Straps, Pendulous Abdomen
Design, Prefabricated, Off-The-Shelf.
L1832.................. Knee Orthosis, Adjustable Knee Joints
(Unicentric Or Polycentric), Positional
Orthosis, Rigid Support, Prefabricated Item
That Has Been Trimmed, Bent, Molded,
Assembled, Or Otherwise Customized To Fit A
Specific Patient By An Individual With
Expertise.
L1833.................. Knee Orthosis, Adjustable Knee Joints
(Unicentric Or Polycentric), Positional
Orthosis, Rigid Support, Prefabricated, Off-
The Shelf.
L1851.................. Knee Orthosis (Ko), Single Upright, Thigh And
Calf, With Adjustable Flexion And Extension
Joint (Unicentric Or Polycentric), Medial-
Lateral And Rotation Control, With Or Without
Varus/Valgus Adjustment, Prefabricated, Off-
The-Shelf.
------------------------------------------------------------------------
We believe prior authorization of these six additional HCPCS codes
for PMDs and five HCPCS codes for Orthoses will help further our
program integrity goals of reducing fraud, waste, and abuse, while also
protecting access to care. For PMDs, the OIG has previously reported
that Medicare has inappropriately paid for items that did not meet
certain Medicare requirements.\2\ Lower limb orthoses (LLO) and lumbar-
sacral orthoses (LSO) have been identified by CMS' Comprehensive Error
Rate Testing (CERT) program as two of the top 20 DMEPOS service types
with improper payments over the past several years. Since 2016, LLOs
have had an improper payment rate above 60 percent, with projected
improper payments ranging between $235 and $501 million. Similarly,
LSOs have had an improper payment rate above 32 percent, with projected
improper payments ranging between $116 and $177 million, since 2016.
Additionally, in 2019, the Department of Justice (DOJ) announced
[[Page 2057]]
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
DME companies and licensed medical professionals allegedly participated
in health care fraud schemes involving more than $1.2 billion in
loss.\3\
---------------------------------------------------------------------------
\2\ OIG Report A-09-12-02068--Medicare Paid Suppliers For Power
Mobility Device Claims That Did Not Meet Federal Requirements For
Physicians' Face-To-Face Examinations Of Beneficiaries (January
2015): https://oig.hhs.gov/oas/reports/region9/91202068.pdf.
\3\ Federal Indictments & Law Enforcement Actions in One of the
Largest Health Care Fraud Schemes Involving Telemedicine and Durable
Medical Equipment Marketing Executives Results in Charges Against 24
Individuals Responsible for Over $1.2 Billion in Losses (April 9,
2019): https://www.justice.gov/opa/pr/federal-indictments-and-law-enforcement-actions-one-largest-health-care-fraud-schemes.
---------------------------------------------------------------------------
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 six
newly added codes for PMDs nationwide and five newly added codes for
Orthoses in 3 phases. This phased-in approach will allow us to identify
and resolve any unforeseen issues by using a smaller claim volume in
phase one before implementing phases 2 and 3. State selection for the
three phases was completed based on utilization data for the items
selected.
For phase 1, which begins on the date specified in the
DATES section, we selected the State in each DME MAC jurisdiction with
the highest utilization: New York, Illinois, Florida, and California.
For phase 2, which begins on the date specified in the
DATES section of this document, we selected the next three States with
the highest utilization in each DME MAC jurisdiction: Maryland,
Pennsylvania, New Jersey, Michigan, Ohio, Kentucky, Texas, North
Carolina, Georgia, Missouri, Arizona, and Washington.
For phase 3, which begins on the date specified in the
DATES section of this document, prior authorization expands to all
remaining States and territories not captured in phases 1 and 2.
The prior authorization program for the 51 codes currently subject
to the DMEPOS prior authorization requirement will continue
uninterrupted.
Prior to providing an item on the Required Prior Authorization List
to the beneficiary and submitting the claim for processing, a requester
must submit a prior authorization request. The request must include
evidence that the item complies with all applicable Medicare coverage,
coding, and payment rules. Consistent with 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 subregulatory communications, including final
timelines customized for the DMEPOS item subject to prior
authorization, for communicating a provisionally affirmed or non-
affirmed decision to the requester. In the December 30, 2015 final rule
(80 FR 81674) we stated that this approach to final timelines provides
flexibility to develop a process that involves fewer days, as may be
appropriate, and allows us to safeguard beneficiary access to care. If
at any time we become aware that the prior authorization process is
creating barriers to care, we can suspend the program. For example, we
will review questions and complaints from consumers and providers that
come through regular sources such as 1-800-Medicare.
The updated Required Prior Authorization List is available in the
download section of the following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/DMEPOS/Downloads/DMEPOS_PA_Required-Prior-Authorization-List.pdf.
III. Collection of Information Requirements
This document provides updates to the Master List and announces the
selection of HCPCS codes to be placed on the Required Face-to-Face
Encounter and Written Order Prior to Delivery List and Required Prior
Authorization List.
Additionally, this document announces the continuation of prior
authorization for 51 HCPCS codes, and the addition of six HCPCS codes
for PMDs and five HCPCS codes for Orthoses on the Required Prior
Authorization List. There is an information collection burden
associated with this program that is currently approved under OMB
control number 0938-1293, which expires March 31, 2022. This package
accounts for burdens associated with the addition of items to the
Required Prior Authorization Lists and assumes a burden for 2021 of
approximately $10 million for providers to comply with the required
information collection. We will reassess this burden soon and will seek
comment on our assessment in a Federal Register notice as required
under the Paperwork Reduction Act of 1995.
IV. Regulatory Impact Statement
We have examined the impact of this regulatory document as required
by Executive Order 12866 on Regulatory Planning and Review (September
30, 1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
Regulatory Impact Analysis (RIA) must be prepared for major rules with
significant regulatory action/s and/or with economically significant
effects ($100 million or more in any 1 year). This regulatory document
is not significant and does not reach the economic threshold and thus
is not considered a major regulatory document. Per our analysis, the
additional items being added to the prior authorization program
(excluding PMDs) \4\ have an estimated net savings of $14.8 million.
Gross savings is based upon a 10 percent reduction in the total amount
paid for claims in Calendar Year 2019. We deducted from the gross
savings the anticipated cost for performing the prior authorization
reviews in order to estimate the net savings. Our gross savings
estimate of 10 percent is based on previous results from other prior
authorization programs,
[[Page 2058]]
including prior authorization of other DMEPOS items.
---------------------------------------------------------------------------
\4\ The additional PMD codes that will be added were not
included in the data analysis because PMD codes are already part of
a successful prior authorization program. Since some PMDs are
already subject to prior authorization, other PMDs may demonstrate
billing shifts across the policy groups, and as such, savings are
more difficult to accurately forecast and may be less identifiable.
---------------------------------------------------------------------------
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
less than $8.0 million to $41.5 million in any 1 year. Individuals and
States are not included in the definition of a small entity. We are not
preparing an analysis for the RFA because we have determined, and the
Secretary certifies, that this regulatory document will not have a
significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare an
RIA if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. This analysis must conform
to the provisions of section 604 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area for Medicare
payment regulations and has fewer than 100 beds. We are not preparing
an analysis for section 1102(b) of the Act because we have determined,
and the Secretary certifies, that this regulatory document will not
have a significant impact on the operations of a substantial number of
small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2021, that
threshold is approximately $158 million. This regulatory document will
have no consequential effect on State, local, or tribal governments or
on the private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule or other regulatory document) that imposes substantial
direct requirement costs on State and local governments, preempts State
law, or otherwise has Federalism implications. Since this regulatory
document does not impose any costs on State or local governments, the
requirements of Executive Order 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, this
document was reviewed by the Office of Management and Budget.
The Administrator of the Centers for Medicare & Medicaid Services
(CMS), Chiquita Brooks-LaSure, having reviewed and approved this
document, authorizes Lynette Wilson, who is the Federal Register
Liaison, to electronically sign this document for purposes of
publication in the Federal Register.
Dated: January 10, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2022-00572 Filed 1-12-22; 8:45 am]
BILLING CODE P
