Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment, 25947-25949 [2018-11953]
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Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations
amozie on DSK3GDR082PROD with RULES
not likely to have an economically
significant impact.
Specifically, the RIA for the 2017 Rule
stated that, ‘‘[. . .] manufacturers are
required to ensure they do not
overcharge covered entities, and a civil
monetary penalty could result from
overcharging if it met the standards in
this final rule. HHS envisions using
these penalties in rare situations. Since
the Program’s inception, issues related
to overcharges have been resolved
between a manufacturer and a covered
entity and any issues have generally
been due to technical errors in the
calculation. For the penalties to be used
as defined in the statute and in this
[2017] rule, the manufacturer
overcharge would have to be the result
of a knowing and intentional act. Based
on anecdotal information received from
covered entities, HHS anticipates that
this would occur very rarely if at all.’’
Since the civil penalties envisioned in
the 2017 Rule were expected to be rare,
delay of these civil penalties is unlikely
to have an economically significant
impact.
Additionally, the 2017 Rule codified
the practice of manufacturers charging
$0.01 for drugs with a ceiling price
below $0.01, which the 2017 Rule RIA
described as ‘‘[. . .] a long-standing
HRSA policy, and HRSA believes the
majority of manufacturers currently
follow the practice of charging $0.01.’’
Delay of this rule will delay the
codification of this practice, but since it
is already a longstanding policy and
widespread practice, the impact of delay
is not likely to be economically
significant.
Executive Order 13771, titled
‘‘Reducing Regulation and Controlling
Regulatory Costs,’’ was issued on
January 30, 2017. This rule is not
subject to the requirements of E.O.
13771 because this rule results in no
more than de minimis costs.
The Regulatory Flexibility Act (RFA)
The Regulatory Flexibility Act (5
U.S.C. 601 et seq.) (RFA) and the Small
Business Regulatory Enforcement and
Fairness Act of 1996, which amended
the RFA, require HHS to analyze
options for regulatory relief of small
businesses. If a rule has a significant
economic effect on a substantial number
of small entities, the Secretary must
specifically consider the economic
effect of the rule on small entities and
analyze regulatory options that could
lessen the impact of the rule. HHS will
use an RFA threshold of at least a 3
percent impact on at least 5 percent of
small entities.
For purposes of the RFA, HHS
considers all health care providers to be
VerDate Sep<11>2014
16:50 Jun 04, 2018
Jkt 244001
small entities either by meeting the
Small Business Administration (SBA)
size standard for a small business, or by
being a nonprofit organization that is
not dominant in its market. The current
SBA size standard for health care
providers ranges from annual receipts of
$7 million to $35.5 million. As of
January 1, 2018, over 12,800 covered
entities participate in the 340B Program,
which represent safety-net health care
providers across the country.
In addition, the rule would affect drug
manufacturers (North American
Industry Classification System code
325412: Pharmaceutical Preparation
Manufacturing). The small business size
standard for drug manufacturers is 750
employees. Approximately 600 drug
manufacturers participate in the 340B
Program. While it is possible to estimate
the impact of the rule on the industry
as a whole, the data necessary to project
changes for specific or groups of
manufacturers is not available, as HRSA
does not collect the information
necessary to assess the size of an
individual manufacturer that
participates in the 340B Program. HHS
has determined, and the Secretary
certifies that this final rule will not have
a significant impact on the operations of
a substantial number of small
manufacturers; therefore, we are not
preparing an analysis of impact for this
RFA. HHS estimates that the economic
impact on small entities and small
manufacturers will be minimal.
Unfunded Mandates Reform Act
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate that may
result in the expenditure by State, local,
and Tribal governments, in the
aggregate, or by the private sector, of
$100 million or more (adjusted annually
for inflation) in any one year.’’ In 2017,
that threshold is approximately $148
million. HHS does not expect this rule
to exceed the threshold.
Executive Order 13132—Federalism
HHS has reviewed this final rule in
accordance with Executive Order 13132
regarding federalism, and has
determined that it does not have
‘‘federalism implications.’’ This final
rule would not ‘‘have substantial direct
effects on the States, or on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’
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25947
Paperwork Reduction Act
The Paperwork Reduction Act of 1995
(44 U.S.C. 3507(d)) requires that OMB
approve all collections of information
by a federal agency from the public
before they can be implemented. This
final rule is projected to have no impact
on current reporting and recordkeeping
burden for manufacturers under the
340B Program. This final rule would
result in no new reporting burdens.
Dated: May 30, 2018.
George Sigounas
Administrator, Health Resources and Services
Administration.
Approved: May 31, 2018.
Alex M. Azar II
Secretary, Department of Health and Human
Services.
[FR Doc. 2018–12103 Filed 6–1–18; 11:15 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 414
[CMS–6080–N]
Medicare Program; Update to the
Required Prior Authorization List of
Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS) Items That Require Prior
Authorization as a Condition of
Payment
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Update to list.
AGENCY:
This document announces the
addition of 31 Healthcare Common
Procedure Coding System (HCPCS)
codes to the Required Prior
Authorization List of Durable Medical
Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Items that require
prior authorization as a condition of
payment. Prior authorization for these
codes will be implemented nationwide.
DATES: Implementation is effective on
September 1, 2018.
FOR FURTHER INFORMATION CONTACT:
Emily Calvert, (410) 786–4277.
Andre Damonze, (410) 786–1795.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Sections 1832, 1834, and 1861 of the
Social Security Act (the Act) establish
that the provision of durable medical
equipment, prosthetic, orthotics, and
supplies (DMEPOS) is a covered benefit
under Part B of the Medicare program.
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Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations
Section 1834(a)(15) 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 the December 30, 2015 final rule
(80 FR 81674) titled ‘‘Medicare Program;
Prior Authorization Process for Certain
Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies,’’
we implemented section 1834(a)(15) of
the Act by establishing an initial Master
List (called the Master List of Items
Frequently Subject to Unnecessary
Utilization) of certain DMEPOS that the
Secretary determined, on the basis of
prior payment experience, are
frequently subject to unnecessary
utilization and by establishing a prior
authorization process for these items. In
the same final rule, we also stated that
we would inform the public of those
DMEPOS items on the Required Prior
Authorization List in the Federal
Register with 60-day notice before
implementation. The Required Prior
Authorization List specified in
§ 414.234(c)(1) is selected from the
Master List of Items Frequently Subject
to Unnecessary Utilization (as described
in § 414.234(b)(1)), and items on the
Required Prior Authorization List
require prior authorization as a
condition of payment.
In addition to the prior authorization
process for certain DMEPOS items that
we established under section
1834(a)(15) of the Act, on September 1,
2012, we implemented the Medicare
Prior Authorization for Power Mobility
Devices (PMDs) Demonstration that
would operate for a period of 3 years
(September 1, 2012 through August 31,
2015). This demonstration was
established under section 402(a)(1)(J) of
the Social Security Amendments of
1967 (42 U.S.C. 1395b–1(a)(1)(J)), which
authorizes the Secretary to conduct
demonstrations designed to develop or
demonstrate improved methods for the
investigation and prosecution of fraud
in the provision of care or services
provided under the Medicare program.
The demonstration was initially
implemented in California, Florida,
Illinois, Michigan, New York, North
Carolina, and Texas. These states were
selected for the demonstration based
upon their history of having high levels
of improper payments and incidents of
fraud related to PMDs. On October 1,
HCPCS code
..............................
..............................
..............................
..............................
..............................
..............................
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..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
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..............................
..............................
..............................
..............................
..............................
K0842
K0843
K0848
K0849
K0850
K0851
K0852
K0853
K0854
K0855
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K0813
K0814
K0815
K0816
K0820
K0821
K0822
K0823
K0824
K0825
K0826
K0827
K0828
K0829
K0835
K0836
K0837
K0838
K0839
K0840
K0841
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
II. Provisions of the Document
The purpose of this document is to
inform the public that we are updating
the Required Prior Authorization List of
DMEPOS items that require prior
authorization as a condition of payment
to include all of the power mobility
devices that are part of the PMD
demonstration, which are also included
on the Master List of Items Frequently
Subject to Unnecessary Utilization. To
assist stakeholders in preparing for
implementation of the prior
authorization program, CMS is
providing 90 days’ notice.
The following 31 DMEPOS items are
being added to the Required Prior
Authorization List:
Description
Power wheelchair, group 1 standard, portable, sling/solid seat and back, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 1 standard, portable, captains chair, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 1 standard, sling/solid seat and back, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 1 standard, captains chair, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 2 standard, portable, sling/solid seat/back, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 2 standard, portable, captains chair, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 2 standard, sling/solid seat/back, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 2 standard, captains chair, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 2 heavy duty, sling/solid seat/back, patient weight capacity 301 to 450 pounds.
Power wheelchair, group 2 heavy duty, captains chair, patient weight capacity 301 to 450 pounds.
Power wheelchair, group 2 very heavy duty, sling/solid seat/back, patient weight capacity 451 to 600 pounds.
Power wheelchair, group 2 very heavy duty, captains chair, patient weight capacity 451 to 600 pounds.
Power wheelchair, group 2 extra heavy duty, sling/solid seat/back, patient weight capacity 601 pounds or more.
Power wheelchair, group 2 extra heavy duty, captains chair, patient weight 601 pounds or more.
Power wheelchair, group 2 standard, single power option, sling/solid seat/back, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 2 standard, single power option, captains chair, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 2 heavy duty, single power option, sling/solid seat/back, patient weight capacity 301 to 450 pounds.
Power wheelchair, group 2 heavy duty, single power option, captains chair, patient weight capacity 301 to 450 pounds.
Power wheelchair, group 2 very heavy duty, single power option, sling/solid seat/back, patient weight capacity 451 to 600 pounds.
Power wheelchair, group 2 extra heavy duty, single power option, sling/solid seat/back, patient weight capacity 601 pounds or more.
Power wheelchair, group 2 standard, multiple power option, sling/solid seat/back, patient weight capacity up to and including 300
pounds.
Power wheelchair, group 2 standard, multiple power option, captains chair, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 2 heavy duty, multiple power option, sling/solid seat/back, patient weight capacity 301 to 450 pounds.
Power wheelchair, group 3 standard, sling/solid seat/back, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 3 standard, captains chair, patient weight capacity up to and including 300 pounds.
Power wheelchair, group 3 heavy duty, sling/solid seat/back, patient weight capacity 301 to 450 pounds.
Power wheelchair, group 3 heavy duty, captains chair, patient weight capacity 301 to 450 pounds.
Power wheelchair, group 3 very heavy duty, sling/solid seat/back, patient weight capacity 451 to 600 pounds.
Power wheelchair, group 3 very heavy duty, captains chair, patient weight capacity 451 to 600 pounds.
Power wheelchair, group 3 extra heavy duty, sling/solid seat/back, patient weight capacity 601 pounds or more.
Power wheelchair, group 3 extra heavy duty, captains chair, patient weight capacity 601 pounds or more.
These codes will be subject to the
requirements of the prior authorization
program for certain DMEPOS items as
outlined in § 414.234. We believe
continued prior authorization of these
codes will help further our program
VerDate Sep<11>2014
2014, we expanded the demonstration
to 12 additional states (Pennsylvania,
Ohio, Louisiana, Missouri, Washington,
New Jersey, Maryland, Indiana,
Kentucky, Georgia, Tennessee, and
Arizona) that have high expenditures
and improper payments for PMDs based
on 2012 billing data. On July 15, 2015,
we announced we were extending the
demonstration for 3 years, through
August 31, 2018.
16:50 Jun 04, 2018
Jkt 244001
integrity goals of reducing fraud, waste,
and abuse, while protecting access to
care. We will implement a prior
authorization program for these codes
nationwide, for dates of service
beginning September 1, 2018. This
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Sfmt 4700
approach will allow continuity for those
suppliers in the 19 states familiar with
prior authorization of PMDs under the
demonstration, and allows sufficient
time for education and outreach to
suppliers in the remaining states.
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Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Rules and Regulations
HCPCS codes K0856 and K0861, which
we placed on the Required Prior
Authorization List in a December 21,
2016 notice (81 FR 93636), will
continue to be subject to the
requirements of prior authorization as
well.
Although the PMD demonstration’s
prior authorization process is similar to
the process used for those items on the
Required Prior Authorization List, some
differences do exist. In particular, items
on the Required Prior Authorization List
require prior authorization as a
condition of payment. As such, lack of
a provisionally affirmed prior
authorization request will result in a
claim denial. Under the PMD
demonstration, requesting prior
authorization is optional, and claims
submitted for payment without an
associated prior authorization decision
are subject to prepayment review and
assessed a 25-percent reduction in
Medicare payment if found payable.
Additionally, under the PMD
demonstration, physicians/treating
practitioners may submit prior
authorization requests and are eligible
to bill HCPCS code G9156 for an
incentive payment. This process is not
available for items on the Required Prior
Authorization List.
Prior to furnishing the item to the
beneficiary and prior to submitting the
claim for processing, a requester must
submit a prior authorization request that
includes evidence that the item
complies with all applicable Medicare
coverage, coding, and payment rules.
Consistent with § 414.234(d), such
evidence must include the order,
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 in subregulatory
communications, including final
timelines, which are customized for the
DMEPOS items subject to prior
authorization, for communicating a
provisionally affirmed or non-affirmed
decision to the requester. In the
December 30, 2015 final rule, to allow
us to safeguard beneficiary access to
care, we stated that this approach to
final timelines provides the flexibility to
develop a process that involves fewer
days, as may be appropriate. If at any
time we become aware that the prior
authorization process is creating barriers
to care, we can suspend the program.
VerDate Sep<11>2014
16:50 Jun 04, 2018
Jkt 244001
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/PriorAuthorization-Process-for-CertainDurable-Medical-Equipment-ProstheticOrthotics-Supplies-Items.html. We will
post additional educational resources to
the website.
III. Collection of Information
Requirements
This notice announces the addition of
DMEPOS items on the Required Prior
Authorization List and does not impose
any new information collection burden
under the Paperwork Reduction Act of
1995. However, there is an information
collection burden associated with this
program that is currently approved
under OMB control number 0938–1293
which expires February 28, 2019.
Dated: May 14, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2018–11953 Filed 6–1–18; 4:15 pm]
BILLING CODE 4120–01–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 73
[MB Docket No. 13–249; FCC 18–64]
Revitalization of the AM Radio Service
Federal Communications
Commission.
ACTION: Denial of petition for
reconsideration; dismissal of petition for
emergency partial stay and processing
freeze pending review of petition for
reconsideration and motion for
extension of time.
AGENCY:
This document denies the
Petition for Reconsideration of the
Second Report and Order in this
proceeding, filed by Prometheus Radio
Project (Prometheus) on April 10, 2017.
This document dismisses as moot the
Petition for Emergency Partial Stay and
Processing Freeze Pending Review of
Petition for Reconsideration filed by
Prometheus April 3, 2017, and the
Motion for Extension of Time filed by
Prometheus May 11, 2017.
DATES: June 5, 2018.
ADDRESSES: Federal Communications
Commission, 445 12th Street SW,
Washington, DC 20554.
FOR FURTHER INFORMATION CONTACT:
Albert Shuldiner, Chief, Media Bureau,
SUMMARY:
PO 00000
Frm 00069
Fmt 4700
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25949
Audio Division, (202) 418–2700 or
Albert.Shuldiner@fcc.gov; Thomas
Nessinger, Senior Counsel, Media
Bureau, Audio Division, (202) 418–2700
or Thomas.Nessinger@fcc.gov.
SUPPLEMENTARY INFORMATION: This is a
summary of the Commission’s Order on
Reconsideration, MB Docket No. 13–
249, FCC 18–64, adopted on May 21,
2018, and released on May 22, 2018.
The full text of this document is
available for public inspection and
copying during regular business hours
in the FCC Reference Center, Federal
Communications Commission, 445 12th
Street SW, Washington, DC 20554. This
document will also be available via
ECFS at https://www.fcc.gov/ecfs/.
Documents will be available
electronically in ASCII, Microsoft Word,
and/or Adobe Acrobat. Copies of the
materials can be obtained from the
FCC’s Reference Information Center at
(202) 418–0270. Alternative formats are
available for people with disabilities
(Braille, large print, electronic files,
audio format), by sending an email to
fcc504@fcc.gov or calling the
Commission’s Consumer and
Governmental Affairs Bureau at (202)
418–0530 (voice), (202) 418–0432
(TTY). This document is not subject to
the Congressional Review Act. The
Commission is, therefore, not required
to submit a copy of this Order on
Reconsideration to the General
Accounting Office pursuant to the
Congressional Review Act, see 5 U.S.C.
801(a)(1)(A), because the Petition for
Reconsideration was denied and the
Petition for Emergency Stay and Motion
for Extension of Time were dismissed as
moot.
The Commission rejected
Prometheus’s contentions that the
Commission’s decision not to adopt a
proposed distance limit for siting crossservice FM translator stations
(translators re-broadcasting AM station
signals) was not a logical outgrowth of
the proposed rule and was arbitrary and
capricious. It found that the decision
not to adopt the proposed 40-mile limit
was reasonably foreseeable, especially
given that commenters had proposed
omitting the 40-mile limit and that
Prometheus had access to those
comments. The Commission further
found that its actions were not arbitrary
and capricious, finding that
Prometheus’s contentions do not raise
legitimate concerns and are at best
speculative. Prometheus did not provide
evidence that omission of a distance
limit encourages translators to ‘‘box in’’
incumbent low-power FM (LPFM)
stations, restricting their ability to
change sites. Additionally, the
E:\FR\FM\05JNR1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Rules and Regulations]
[Pages 25947-25949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11953]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 414
[CMS-6080-N]
Medicare Program; Update to the Required Prior Authorization List
of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
(DMEPOS) Items That Require Prior Authorization as a Condition of
Payment
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Update to list.
-----------------------------------------------------------------------
SUMMARY: This document announces the addition of 31 Healthcare Common
Procedure Coding System (HCPCS) codes to the Required Prior
Authorization List of Durable Medical Equipment, Prosthetics,
Orthotics, and Supplies (DMEPOS) Items that require prior authorization
as a condition of payment. Prior authorization for these codes will be
implemented nationwide.
DATES: Implementation is effective on September 1, 2018.
FOR FURTHER INFORMATION CONTACT:
Emily Calvert, (410) 786-4277.
Andre Damonze, (410) 786-1795.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1832, 1834, and 1861 of the Social Security Act (the Act)
establish that the provision of durable medical equipment, prosthetic,
orthotics, and supplies (DMEPOS) is a covered benefit under Part B of
the Medicare program.
[[Page 25948]]
Section 1834(a)(15) 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 the December 30, 2015 final rule (80 FR 81674) titled ``Medicare
Program; Prior Authorization Process for Certain Durable Medical
Equipment, Prosthetics, Orthotics, and Supplies,'' we implemented
section 1834(a)(15) of the Act by establishing an initial Master List
(called the Master List of Items Frequently Subject to Unnecessary
Utilization) of certain DMEPOS that the Secretary determined, on the
basis of prior payment experience, are frequently subject to
unnecessary utilization and by establishing a prior authorization
process for these items. In the same final rule, we also stated that we
would inform the public of those DMEPOS items on the Required Prior
Authorization List in the Federal Register with 60-day notice before
implementation. The Required Prior Authorization List specified in
Sec. 414.234(c)(1) is selected from the Master List of Items
Frequently Subject to Unnecessary Utilization (as described in Sec.
414.234(b)(1)), and items on the Required Prior Authorization List
require prior authorization as a condition of payment.
In addition to the prior authorization process for certain DMEPOS
items that we established under section 1834(a)(15) of the Act, on
September 1, 2012, we implemented the Medicare Prior Authorization for
Power Mobility Devices (PMDs) Demonstration that would operate for a
period of 3 years (September 1, 2012 through August 31, 2015). This
demonstration was established under section 402(a)(1)(J) of the Social
Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J)), which
authorizes the Secretary to conduct demonstrations designed to develop
or demonstrate improved methods for the investigation and prosecution
of fraud in the provision of care or services provided under the
Medicare program. The demonstration was initially implemented in
California, Florida, Illinois, Michigan, New York, North Carolina, and
Texas. These states were selected for the demonstration based upon
their history of having high levels of improper payments and incidents
of fraud related to PMDs. On October 1, 2014, we expanded the
demonstration to 12 additional states (Pennsylvania, Ohio, Louisiana,
Missouri, Washington, New Jersey, Maryland, Indiana, Kentucky, Georgia,
Tennessee, and Arizona) that have high expenditures and improper
payments for PMDs based on 2012 billing data. On July 15, 2015, we
announced we were extending the demonstration for 3 years, through
August 31, 2018.
II. Provisions of the Document
The purpose of this document is to inform the public that we are
updating the Required Prior Authorization List of DMEPOS items that
require prior authorization as a condition of payment to include all of
the power mobility devices that are part of the PMD demonstration,
which are also included on the Master List of Items Frequently Subject
to Unnecessary Utilization. To assist stakeholders in preparing for
implementation of the prior authorization program, CMS is providing 90
days' notice.
The following 31 DMEPOS items are being added to the Required Prior
Authorization List:
------------------------------------------------------------------------
HCPCS code Description
-----------------------------------------------------------------------
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 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.
------------------------------------------------------------------------
These codes will be subject to the requirements of the prior
authorization program for certain DMEPOS items as outlined in Sec.
414.234. We believe continued prior authorization of these codes will
help further our program integrity goals of reducing fraud, waste, and
abuse, while protecting access to care. We will implement a prior
authorization program for these codes nationwide, for dates of service
beginning September 1, 2018. This approach will allow continuity for
those suppliers in the 19 states familiar with prior authorization of
PMDs under the demonstration, and allows sufficient time for education
and outreach to suppliers in the remaining states.
[[Page 25949]]
HCPCS codes K0856 and K0861, which we placed on the Required Prior
Authorization List in a December 21, 2016 notice (81 FR 93636), will
continue to be subject to the requirements of prior authorization as
well.
Although the PMD demonstration's prior authorization process is
similar to the process used for those items on the Required Prior
Authorization List, some differences do exist. In particular, items on
the Required Prior Authorization List require prior authorization as a
condition of payment. As such, lack of a provisionally affirmed prior
authorization request will result in a claim denial. Under the PMD
demonstration, requesting prior authorization is optional, and claims
submitted for payment without an associated prior authorization
decision are subject to prepayment review and assessed a 25-percent
reduction in Medicare payment if found payable. Additionally, under the
PMD demonstration, physicians/treating practitioners may submit prior
authorization requests and are eligible to bill HCPCS code G9156 for an
incentive payment. This process is not available for items on the
Required Prior Authorization List.
Prior to furnishing the item to the beneficiary and prior to
submitting the claim for processing, a requester must submit a prior
authorization request that includes 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 order,
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 in
subregulatory communications, including final timelines, which are
customized for the DMEPOS items subject to prior authorization, for
communicating a provisionally affirmed or non-affirmed decision to the
requester. In the December 30, 2015 final rule, to allow us to
safeguard beneficiary access to care, we stated that this approach to
final timelines provides the flexibility to develop a process that
involves fewer days, as may be appropriate. If at any time we become
aware that the prior authorization process is creating barriers to
care, we can suspend the program.
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/Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items.html. We
will post additional educational resources to the website.
III. Collection of Information Requirements
This notice announces the addition of DMEPOS items on the Required
Prior Authorization List and does not impose any new information
collection burden under the Paperwork Reduction Act of 1995. However,
there is an information collection burden associated with this program
that is currently approved under OMB control number 0938-1293 which
expires February 28, 2019.
Dated: May 14, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-11953 Filed 6-1-18; 4:15 pm]
BILLING CODE 4120-01-P
