81 FR 93636 - Medicare Program; Implementation of Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items and Publication of the Initial Required Prior Authorization List of DMEPOS Items That Require Prior Authorization as a Condition of Payment
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 245 (December 21, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 245 (December 21, 2016)
| Page Range | 93636-93637 | |
| FR Document | 2016-30273 |
[Federal Register Volume 81, Number 245 (Wednesday, December 21, 2016)] [Rules and Regulations] [Pages 93636-93637] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30273] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 414 [CMS-6072-N] Medicare Program; Implementation of Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items and Publication of the Initial Required Prior Authorization List of DMEPOS Items That Require Prior Authorization as a Condition of Payment AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Implementation of list and phases. ----------------------------------------------------------------------- SUMMARY: This document announces the implementation of the prior authorization program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items in two phases and the issuance of the initial Required Prior Authorization List of DMEPOS items that require prior authorization as a condition of payment. DATES: Phase one of implementation is effective on March 20, 2017. Phase two of implementation is effective on July 17, 2017. FOR FURTHER INFORMATION CONTACT: Jennifer Phillips, (410) 786-1023. Linda O'Hara (410) 786-8347. Scott Lawrence (410) 786-4313. 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. 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, [[Page 93637]] 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. The Master List is self-updating annually, and items remain on the Master List for 10 years from the date the item was added to the Master List. Items are removed from the list sooner than 10 years if the purchase amount drops below the payment threshold described later in this section. We will notify the public annually of any additions and deletions from the Master List by posting the notification in the Federal Register and on the CMS Prior Authorization Web site. The Master List includes items that meet the following criteria: ++ Appear on the DMEPOS Fee Schedule list. ++ Have an average purchase fee of $1,000 or greater (adjusted annually for inflation) or an average monthly rental fee schedule of $100 or greater (adjusted annually for inflation). (These dollar amounts are referred to as the payment threshold). ++ Meet either of the following criteria: --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 2007 or later as having a high rate of fraud or unnecessary utilization. --Listed in the 2011 or later Comprehensive Error Rate Testing (CERT) program's Annual Medicare Fee-For-Service (FFS) Improper Payment Rate Report and/or the Supplementary Appendices for the Medicare Fee- for-Service Improper Payments Report. II. Provisions of the Document In the December 30, 2015 final rule (80 FR 81689), we 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. 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 we are implementing the prior authorization program for certain DMEPOS items and to provide the initial Required Prior Authorization List of DMEPOS items that require prior authorization as a condition of payment. To assist stakeholders in preparing for implementation of the prior authorization program, CMS is providing 90 days' notice. The following two DMEPOS items, represented by HCPCS (Healthcare Common Procedure Coding System) codes K0856 and K0861 are added to the Required Prior Authorization List:K0856 HCPCS: Power wheelchair, group 3 standard, single power option, sling/solid seat/back, patient weight capacity up to and including 300 pounds. K0861 HCPCS: Power wheelchair, group 3 standard, multiple power option, sling/solid seat/back, patient weight capacity up to and including 300 pounds. Power wheelchairs, represented by HCPCS codes K0856 and K0861, will be subject to the requirements of the prior authorization program for certain DMEPOS items as outlined in Sec. 414.234. (We note that these Group 3 power wheelchairs are not part of the separate Prior Authorization of Power Mobility Devices (PMDs) Demonstration.) We will implement a national prior authorization program for K0856 and K0861 in two phases, as specified in the DATES section of this document. We are implementing the program in this manner to test the new prior authorization program because new complex claims processing systems changes are required for implementation. This phased-in approach will allow us to identify and resolve any unforeseen issues by using a smaller claim volume in phase one before national implementation occurs in phase two. In phase one of implementation, which begins as specified in the DATES section of this document, we will limit the prior authorization requirement to one state in each of the four DME Medicare Administrative Contractors (MAC) geographic jurisdictions, as follows: Illinois, Missouri, New York, and West Virginia. Initially limiting the program to one state in each of the DME MAC geographic jurisdictions allows us to test the national claims processing system and the local DME MAC processes. In phase two, which begins as specified in the DATES section of this document, we will expand the program to the remaining states. 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 item subject to prior authorization, for communicating a provisionally affirmed or non-affirmed decision to the requester. In the December 30, 2015 final rule, 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. III. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Dated: December 1, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2016-30273 Filed 12-19-16; 4:15 pm] BILLING CODE 4120-01-P
![93636 Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Rules and Regulations
J. Executive Order 12898: Federal EPA proposes to take on the exemption apply the two standards enunciated in
Actions To Address Environmental petitions. TSCA section 6(e)(3)(B).
Justice in Minority Populations and [FR Doc. 2016–30055 Filed 12–20–16; 8:45 am]
Low-Income Populations §§ 750.14 and 750.15 [Removed]
BILLING CODE 6560–50–P
This action does not establish an ■ 5. Remove §§ 750.14 and 750.15.
environmental health or safety standard, § 750.16 [Redesignated as § 750.14]
and is therefore not is not subject to DEPARTMENT OF HEALTH AND
environmental justice considerations ■ 6. Redesignate § 750.16 as § 750.14. HUMAN SERVICES
under Executive Order 12898 (59 FR §§ 750.17 through 750.20 [Removed]
7629, February 16, 1994), because it Centers for Medicare & Medicaid
does not establish an environmental ■ 7. Remove §§ 750.17 through 750.20. Services
health or safety standard. This
§§ 750.21 [Redesignated as § 750.15] 42 CFR Part 414
regulatory action is a procedural change
and does not have any impact on human ■ 8. Redesignate § 750.21 as § 750.15, [CMS–6072–N]
health or the environment. and revise it to read as follows:
Medicare Program; Implementation of
K. Congressional Review Act (CRA) § 750.15 Final rule.
Prior Authorization Process for Certain
This rule is exempt from the CRA (5 (a) [Reserved] Durable Medical Equipment,
U.S.C. 801 et seq.) because it is a rule (b) EPA will grant or deny petitions Prosthetics, Orthotics, and Supplies
of agency organization, procedure or under TSCA section 6(e)(3)(B) (DMEPOS) Items and Publication of the
practice that does not substantially submitted pursuant to § 750.11. Initial Required Prior Authorization List
affect the rights or obligations of non- (c) In determining whether to grant an of DMEPOS Items That Require Prior
agency parties. exemption to the PCB ban, the Agency Authorization as a Condition of
List of Subjects in 40 CFR Part 750 shall apply the two standards Payment
enunciated in TSCA section 6(e)(3)(B).
Administrative practice and AGENCY: Centers for Medicare &
■ 9. Revise § 750.30 to read as follows: Medicaid Services (CMS), HHS.
procedure, Chemicals, Environmental
protection, Hazardous substances. § 750.30 Applicability ACTION: Implementation of list and
Dated: December 8, 2016. Sections 750.30 through 750.35 apply phases.
Gina McCarthy, to all rulemakings under authority of SUMMARY: This document announces the
Administrator. section 6(e)(3)(B) of the Toxic implementation of the prior
Therefore, 40 CFR chapter I is Substances Control Act (TSCA), 15 authorization program for certain
amended as follows: U.S.C. 2605(e)(3)(B) with respect to durable medical equipment, prosthetics,
petitions for PCB processing and orthotics, and supplies (DMEPOS) items
PART 750—PROCEDURES FOR distribution in commerce exemptions in two phases and the issuance of the
RULEMAKING UNDER SECTION 6 OF filed pursuant to § 750.31(a). initial Required Prior Authorization List
THE TOXIC SUBSTANCES CONTROL ■ 10. Revise § 750.33 to read as follows: of DMEPOS items that require prior
ACT [AMENDED] authorization as a condition of payment.
§ 750.33 Notice of proposed rulemaking.
■ 1. The authority citation for part 750 DATES: Phase one of implementation is
Rulemaking for PCB exemptions filed effective on March 20, 2017. Phase two
continues to read as follows: pursuant to § 750.31(a) shall begin with of implementation is effective on July
Authority: 15 U.S.C. 2605. the publication of a notice of proposed 17, 2017.
rulemaking in the Federal Register. The
Subpart A—[Removed and Reserved] FOR FURTHER INFORMATION CONTACT:
notice shall state in summary form the Jennifer Phillips, (410) 786–1023.
required information described in Linda O’Hara (410) 786–8347.
■ 2. Subpart A, consisting of §§ 750.1
§ 750.31(c). Scott Lawrence (410) 786–4313.
through 750.9 and an appendix, is
removed and reserved. §§ 750.34 and 750.35 [Removed] SUPPLEMENTARY INFORMATION:
■ 3. Revise § 750.10 to read as follows:
■ 11. Remove §§ 750.34 and 750.35. I. Background
§ 750.10 Applicability Sections 1832, 1834, and 1861 of the
§ 750.36 [Redesignated as § 750.34]
Sections 750.10–750.15 apply to all Social Security Act (the Act) establish
rulemakings under authority of section ■ 12. Redesignate § 750.36 as § 750.34. that the provision of durable medical
6(e)(3)(B) of the Toxic Substances §§ 750.37 through 750.40 [Removed] equipment, prosthetic, orthotics, and
Control Act (TSCA), 15 U.S.C. supplies (DMEPOS) is a covered benefit
2605(e)(3)(B) with respect to petitions ■ 13. Remove §§ 750.37 through 750.40. under Part B of the Medicare program.
filed pursuant to § 750.11(a). § 750.41 [Redesignated as § 750.35]
Section 1834(a)(15) of the Act
■ 4. Revise § 750.13 to read as follows: authorizes the Secretary to develop and
■ 14. Redesignate § 750.41 as § 750.35, periodically update a list of DMEPOS
§ 750.13 Notice of proposed rulemaking. and revise it to read as follows: items that the Secretary determines, on
asabaliauskas on DSK3SPTVN1PROD with RULES
Rulemaking for PCB exemptions filed the basis of prior payment experience,
§ 750.35 Final rule.
pursuant to § 750.11(a) shall begin with are frequently subject to unnecessary
the publication of a notice of proposed (a) [Reserved] utilization and to develop a prior
rulemaking in the Federal Register. The (b) EPA will grant or deny petitions authorization process for these items.
notice shall state in summary form the under TSCA section 6(e)(3)(B) In the December 30, 2015 final rule
required information described in submitted pursuant to § 750.31. (80 FR 81674), titled ‘‘Medicare
§ 750.11(c). Due to time constraints, the (c) In determining whether to grant an Program; Prior Authorization Process for
notice need not indicate what action exemption to the PCB ban, EPA will Certain Durable Medical Equipment,
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![Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Rules and Regulations 93637
Prosthetics, Orthotics, and Supplies’’, stated that CMS may elect to limit the processes. In phase two, which begins
we implemented section 1834(a)(15) of prior authorization requirement to a as specified in the DATES section of this
the Act by establishing an initial Master particular region of the country if claims document, we will expand the program
List (called the Master List of Items data analysis shows that unnecessary to the remaining states.
Frequently Subject to Unnecessary utilization of the selected item(s) is
Prior to furnishing the item to the
Utilization) of certain DMEPOS that the concentrated in a particular region. The
beneficiary and prior to submitting the
Secretary determined, on the basis of purpose of this document is to inform
prior payment experience, are the public that we are implementing the claim for processing, a requester must
frequently subject to unnecessary prior authorization program for certain submit a prior authorization request that
utilization and by establishing a prior DMEPOS items and to provide the includes evidence that the item
authorization process for these items. initial Required Prior Authorization List complies with all applicable Medicare
The Master List is self-updating of DMEPOS items that require prior coverage, coding, and payment rules.
annually, and items remain on the authorization as a condition of payment. Consistent with § 414.234(d), such
Master List for 10 years from the date To assist stakeholders in preparing for evidence must include the order,
the item was added to the Master List. implementation of the prior relevant information from the
Items are removed from the list sooner authorization program, CMS is beneficiary’s medical record, and
than 10 years if the purchase amount providing 90 days’ notice. relevant supplier-produced
drops below the payment threshold The following two DMEPOS items, documentation. After receipt of all
described later in this section. We will represented by HCPCS (Healthcare applicable required Medicare
notify the public annually of any Common Procedure Coding System) documentation, CMS or one of its
additions and deletions from the Master codes K0856 and K0861 are added to review contractors will conduct a
List by posting the notification in the the Required Prior Authorization List: medical review and communicate a
Federal Register and on the CMS Prior • K0856 HCPCS: Power wheelchair,
decision that provisionally affirms or
Authorization Web site. The Master List group 3 standard, single power option,
non-affirms the request.
includes items that meet the following sling/solid seat/back, patient weight
criteria: capacity up to and including 300 We will issue specific prior
++ Appear on the DMEPOS Fee pounds. authorization guidance in subregulatory
Schedule list. • K0861 HCPCS: Power wheelchair, communications, including final
++ Have an average purchase fee of group 3 standard, multiple power timelines, which are customized for the
$1,000 or greater (adjusted annually for option, sling/solid seat/back, patient DMEPOS item subject to prior
inflation) or an average monthly rental weight capacity up to and including 300 authorization, for communicating a
fee schedule of $100 or greater (adjusted pounds. provisionally affirmed or non-affirmed
annually for inflation). (These dollar Power wheelchairs, represented by decision to the requester. In the
amounts are referred to as the payment HCPCS codes K0856 and K0861, will be December 30, 2015 final rule, we stated
threshold). subject to the requirements of the prior
that this approach to final timelines
++ Meet either of the following authorization program for certain
provides flexibility to develop a process
criteria: DMEPOS items as outlined in § 414.234.
(We note that these Group 3 power that involves fewer days, as may be
—Identified in a Government
wheelchairs are not part of the separate appropriate, and allows us to safeguard
Accountability Office (GAO) or
Prior Authorization of Power Mobility beneficiary access to care. If at any time
Department of Health and Human
Services Office of Inspector General Devices (PMDs) Demonstration.) we become aware that the prior
(OIG) report that is national in scope We will implement a national prior authorization process is creating barriers
and published in 2007 or later as having authorization program for K0856 and to care, we can suspend the program.
a high rate of fraud or unnecessary K0861 in two phases, as specified in the III. Collection of Information
utilization. DATES section of this document. We are
Requirements
—Listed in the 2011 or later implementing the program in this
Comprehensive Error Rate Testing manner to test the new prior This document does not impose
(CERT) program’s Annual Medicare Fee- authorization program because new information collection requirements,
For-Service (FFS) Improper Payment complex claims processing systems that is, reporting, recordkeeping or
Rate Report and/or the Supplementary changes are required for third-party disclosure requirements.
Appendices for the Medicare Fee-for- implementation. This phased-in Consequently, there is no need for
Service Improper Payments Report. approach will allow us to identify and review by the Office of Management and
resolve any unforeseen issues by using Budget under the authority of the
II. Provisions of the Document a smaller claim volume in phase one
Paperwork Reduction Act of 1995 (44
In the December 30, 2015 final rule before national implementation occurs
(80 FR 81689), we stated that we would U.S.C. 3501 et seq.).
in phase two.
inform the public of those DMEPOS In phase one of implementation, Dated: December 1, 2016.
items on the Required Prior which begins as specified in the DATES Andrew M. Slavitt,
Authorization List in the Federal section of this document, we will limit Acting Administrator, Centers for Medicare
Register with 60-day notice before the prior authorization requirement to & Medicaid Services.
implementation. The Required Prior one state in each of the four DME [FR Doc. 2016–30273 Filed 12–19–16; 4:15 pm]
asabaliauskas on DSK3SPTVN1PROD with RULES
Authorization List specified in Medicare Administrative Contractors
BILLING CODE 4120–01–P
§ 414.234(c)(1) is selected from the (MAC) geographic jurisdictions, as
Master List of Items Frequently Subject follows: Illinois, Missouri, New York,
to Unnecessary Utilization (as described and West Virginia. Initially limiting the
in § 414.234(b)(1)), and items on the program to one state in each of the DME
Required Prior Authorization List MAC geographic jurisdictions allows us
require prior authorization as a to test the national claims processing
condition of payment. Additionally, we system and the local DME MAC
VerDate Sep<11>2014 17:05 Dec 20, 2016 Jkt 241001 PO 00000 Frm 00067 Fmt 4700 Sfmt 9990 E:\FR\FM\21DER1.SGM 21DER1](https://thefederalregister.org/doc/81_FR_93881/page/2.svg)
Document Created: 2018-02-14 09:11:43
Document Modified: 2018-02-14 09:11:43
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Implementation of list and phases. | |
| Dates | Phase one of implementation is effective on March 20, 2017. Phase two of implementation is effective on July 17, 2017. | |
| Contact | Jennifer Phillips, (410) 786-1023. Linda O'Hara (410) 786-8347. Scott Lawrence (410) 786-4313. | |
| FR Citation | 81 FR 93636 |
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