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
| Published date | 11 February 2020 |
| Citation | 85 FR 7666 |
| Record Number | 2020-02644 |
| Section | Rules and Regulations |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 85 Issue 28 (Tuesday, February 11, 2020)
[Federal Register Volume 85, Number 28 (Tuesday, February 11, 2020)]
[Rules and Regulations]
[Pages 7666-7668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02644]
[[Page 7666]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 414
[CMS-6080-N3]
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 and phases.
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SUMMARY: This document announces the continuation of prior
authorization for 45 Healthcare Common Procedure Coding System (HCPCS)
codes on the Required Prior Authorization List of DMEPOS Items that
require prior authorization as a condition of payment, as well as the
addition of six HCPCS codes to this list. Prior authorization for the
additional codes will be implemented in two phases.
DATES: Phase one of implementation is effective on May 11, 2020. Phase
two of implementation is effective on October 8, 2020.
FOR FURTHER INFORMATION CONTACT: Tara Bramhall, (410) 786-8256. Erica
Ross, (410) 786-7480.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 1832, 1834, and 1861 of the Social Security Act (the Act)
establishes that the provision of durable medical equipment,
prosthetics, orthotics, and supplies (DMEPOS) are covered benefits
under Part B of the Medicare program.
Section 1834(a)(15) of the Act authorizes the Secretary to develop
and periodically update a list of DMEPOS items and supplies 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.
On November 8, 2019, CMS published a final rule (84 FR 60648)
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.'' Through this rule we harmonized the lists of DMEPOS
items created by former rules and established 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''). This rule was effective January 1, 2020.
II. Provisions of the Document
In the November 8, 2019, final rule (84 FR 60648), we stated that
the items currently subject to prior authorization would be
grandfathered into the prior authorization program until the
implementation of the first Required Prior Authorization List published
subsequent to this rule, to avoid the administrative and stakeholder
burdens associated with the termination of the current prior
authorization program and the implementation of a revised program
created under this rule. This rule also maintained the process
established in the December 30, 2015, final Rule 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 (84 FR 60753).
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, we stated 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 all 45
Power Mobility Device (PMD) and Pressure Reducing Support Services
(PRSS) HCPCS codes currently on the Required Prior Authorization List
will continue to be subject to the requirements of prior authorization
(see 81 FR 93636, 83 FR 25947, and 84 FR 16616). In addition, we are
updating the Required Prior Authorization List to include six Lower
Limb Prosthetic (LLP) 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 LLPs are added to the Required
Prior Authorization List:
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HCPCS Description
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L5856....................... Addition to lower extremity prosthesis,
endoskeletal knee-shin system,
microprocessor control feature, swing and
stance phase, includes electronic
sensor(s), any type.
L5857....................... Addition to lower extremity prosthesis,
endoskeletal knee-shin system,
microprocessor control feature, swing
phase only, includes electronic
sensor(s), any type.
L5858....................... Addition to lower extremity prosthesis,
endoskeletal knee-shin system,
microprocessor control feature, stance
phase only, includes electronic
sensor(s), any type.
L5973....................... Endoskeletal ankle foot system,
microprocessor controlled feature,
dorsiflexion and/or plantar flexion
control, includes power source.
L5980....................... All lower extremity prostheses, flex foot
system.
L5987....................... All lower extremity prosthesis, shank foot
system with vertical loading pylon.
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We believe prior authorization of these six additional HCPCS codes
for LLPs will help further our program integrity goals of reducing
fraud, waste, and abuse, while also protecting access to care. LLPs
have been identified by
[[Page 7667]]
CMS' Comprehensive Error Rate Testing (CERT) program as one of the top
20 DMEPOS service types with improper payments over the past several
years.\1\ The 2018 Medicare Fee-for-Service Supplemental Data reported
over $46 million in projected improper payments for LLPs.\2\
Additionally, the Office of Inspector General (OIG) has previously
reported that Medicare has inappropriately paid for LLPs that did not
meet certain Medicare requirements.\3\
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\1\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/CERT/CERT-Reports.html?DLSort=0&DLEntries=10&DLPage=1&DLSortDir=descending.
\2\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/CERT/Downloads/2018MedicareFFSSuplementalImproperPaymentData.pdf.
\3\ https://oig.hhs.gov/oei/reports/oei-02-10-00170.pdf.
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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 LLPs in two 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 nationwide implementation
occurs in phase two. In phase one of implementation, which begins on
the date specified in the DATES section, we will limit the prior
authorization requirement to one state in each of the four DME Medicare
Administrative Contractors (MAC) geographic jurisdictions as follows:
California, Michigan, Pennsylvania, and Texas. In phase two, which
begins on the date specified in the DATES section of this document, we
will expand the program to the remaining states in all four DME MAC
jurisdictions. The prior authorization program for the 45 codes
currently subject to the DMEPOS prior authorization requirement will
remain in place uninterrupted in all states.
Prior to furnishing the item 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 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 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 81692), 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/Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items.html.
III. Collection of Information Requirements
This document announces the continuation of prior authorization for
45 HCPCS codes, and the addition of six HCPCS codes for LLPs 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 March 31, 2022.
IV. Regulatory Impact Statement
We have examined the impact of this action 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), the Congressional
Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing
Regulation and Controlling Regulatory Costs (January 30, 2017).
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
economically significant effects ($100 million or more in any 1 year).
This document does not reach the economic threshold and, thus, is not
considered a major rule.
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 $7.5 million to $38.5 million in any one year. Individuals
and states are not included in the definition of a small entity. We are
not preparing an analysis for the RFA because we have determined, and
the Secretary certifies, that this 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 action 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 one year of
$100 million in 1995 dollars, updated annually for inflation. In 2019,
that threshold is approximately $154 million. This action 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
[[Page 7668]]
rule) that imposes substantial direct requirement costs on state and
local governments, preempts state law, or otherwise has federalism
implications. Since this action does not impose any costs on state or
local governments, the requirements of Executive Order 13132 are not
applicable.
Executive Order 13771, titled Reducing Regulation and Controlling
Regulatory Costs, was issued on January 30, 2017 and requires that the
costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' OMB's interim
guidance, issued on April 5, 2017, https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/M-17-21-OMB.pdf, explains that
for Fiscal Year 2017 the above requirements only apply to each new
``significant regulatory action that imposes costs.'' It has been
determined that this document is not a ``significant regulatory
action'' and thus does not trigger the aforementioned requirements of
Executive Order 13771.
In accordance with the provisions of Executive Order 12866, this
document was reviewed by the Office of Management and Budget.
Dated: November 5, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Editorial note: This document was received for publication by
the Office of the Federal Register on February 5, 2020.
[FR Doc. 2020-02644 Filed 2-7-20; 11:15 am]
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