[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]


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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.

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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:

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         HCPCS code                         Description
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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