83 FR 13677 - Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items; Update to the Master List of Items Frequently Subject to Unnecessary Utilization
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 83, Issue 62 (March 30, 2018)
Centers for Medicare & Medicaid Services
Federal Register Volume 83, Issue 62 (March 30, 2018)
| Page Range | 13677-13679 | |
| FR Document | 2018-06552 |
[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)] [Rules and Regulations] [Pages 13677-13679] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06552] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 414 [CMS-6078-N] Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items; Update to the Master List of Items Frequently Subject to Unnecessary Utilization AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Master list deletions. ----------------------------------------------------------------------- SUMMARY: This document announces the deletion of four Healthcare Common Procedure Coding System (HCPCS) codes from the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment. DATES: This action is applicable on April 30, 2018. FOR FURTHER INFORMATION CONTACT: Emily Calvert, (410) 786-4277. Andre Damonze, (410) 786-1795. SUPPLEMENTARY INFORMATION: I. Background 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 Social Security Act (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 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 DME and/or DMEPOS Service Specific Report(s). The rule described the maintenance process of the Master List as follows: The Master List is self-updating annually. That is, items on the DMEPOS Fee Schedule that meet the ``payment threshold'' are added to the list when [[Page 13678]] the item is listed in a future OIG or GAO report of a national scope or listed in a future CERT DME and/or DMEPOS Service Specific Report(s). Items remain on the Master List for 10 years from the date the item was added to the Master List. Items are updated on the Master List when the Healthcare Common Procedure Coding System (HCPCS) codes representing an item have been discontinued and cross-walked to an equivalent item. Items are removed from the list sooner than 10 years if the purchase amount drops below the ``payment threshold''. Items that age off the Master List because they have been on the list for 10 years can remain on or be added back to the Master List if a subsequent GAO/OIG, or CERT DME and/or DMEPOS Service Specific Report(s) identifies the item to be frequently subject to unnecessary utilization. Items already on the Master List that are identified by a GAO/OIG, or CERT DME and/or DMEPOS Service Specific Report(s) will remain on the list for 10 years from the publication date of the new report(s). 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 website. II. Provisions of the Document In the December 30, 2015 final rule (80 FR 81674), we stated that we would 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 website. This document is to provide the annual update to the Master List of Items Frequently Subject to Unnecessary Utilization. As noted previously, we adjust the ``payment threshold'' each year for inflation. More specifically, we stated in the preamble to the December 2015 final rule (80 FR 81679) that we will apply the same percentage adjustment to the ``payment threshold'' as we do to the DMEPOS fee schedule. In accordance with section 1834(a)(14) of the Act, certain DMEPOS fee schedule amounts are updated annually by the percentage increase in the consumer price index for all urban consumers (United States city average) or CPI-U for the 12-month period ending June 30 of the previous year, adjusted by the change in the economy- wide productivity equal to the 10-year moving average of changes in annual economy-wide private non-farm business multifactor productivity (MFP). We use this same methodology to adjust the Master List Payment Threshold for inflation. For calendar year (CY) 2017, the MFP adjustment is 0.3 percent and the CPI-U percentage increase is 1 percent. Thus, the 1 percentage increase in the CPI-U is reduced by the 0.3 percentage increase in the MFP resulting in a net increase of 0.7 percent to be used as the update factor. We applied the 0.7 percent update factor to the average purchase fee of $1,000, resulting in a CY 2017 adjusted ``payment threshold'' of $1,007 ($1,000 x 1.007). We also applied the 0.7 percent update factor to the average monthly rental fee of $100, resulting in an adjusted ``payment threshold'' of $100.70 ($100 x 1.007). Rounding this figure to the nearest whole dollar amount resulted in a CY 2017 adjusted monthly rental fee threshold amount of $101. For CY 2018, the MFP adjustment is 0.5 percent and the CPI-U percentage increase is 1.6 percent. Thus, the 1.6 percentage increase in the CPI-U is reduced by the 0.5 percentage increase in the MFP resulting in a net increase of 1.1 percent to be used as the update factor. We applied the 1.1 percent update factor to the CY 2017 average purchase fee of $1,007, resulting in a CY 2018 adjusted ``payment threshold'' of $1,018.07 ($1,007 x 1.011). Rounding this figure to the nearest whole dollar amount resulted in a CY 2018 adjusted ``payment threshold'' amount of $1,018. We also applied the update factor of 1.1 percent to the CY 2017 average monthly rental fee of $101, resulting in an adjusted ``payment threshold'' of $102.11 ($101 x 1.011). Rounding this figure to the nearest whole dollar amount resulted in a CY 2018 adjusted monthly rental fee threshold of $102. This update does not reflect any additions because there are no new items that meet the updated ``payment threshold'' that are listed in an OIG or GAO report of a national scope or a CERT DME and/or DMEPOS Service Specific Report(s). The following four HCPCS codes are removed from the Master List of Items Frequently Subject to Unnecessary Utilization because they no longer have a DMEPOS Fee Schedule price of $1,018 or greater or an average monthly rental fee schedule of $102 or greater: ---------------------------------------------------------------------------------------------------------------- HCPCS Description ---------------------------------------------------------------------------------------------------------------- E0260............................................................ Hospital bed semi-electric (head and foot adjustment) with any type side rails with mattress. E0601............................................................ Continuous Airway Pressure (CPAP) Device. E1390............................................................ Oxygen Concentrator. K0004............................................................ High strength, lightweight wheelchair. ---------------------------------------------------------------------------------------------------------------- The full updated list is also 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 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.). 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 [[Page 13679]] 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 1 year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this 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 1 year of $100 million in 1995 dollars, updated annually for inflation. Currently, that threshold is approximately $148 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 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: February 28, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2018-06552 Filed 3-29-18; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Rules and Regulations 13677
in the preemption provisions of FFDCA This action does not involve any and pests, Reporting and recordkeeping
section 408(n)(4). As such, the Agency technical standards that would require requirements.
has determined that this action will not Agency consideration of voluntary Dated: March 12, 2018.
have a substantial direct effect on States consensus standards pursuant to section
Michael L. Goodis,
or tribal governments, on the 12(d) of the National Technology
relationship between the national Transfer and Advancement Act Director, Registration Division, Office of
government and the States or tribal (NTTAA) (15 U.S.C. 272 note). Pesticide Programs.
governments, or on the distribution of Therefore, 40 CFR chapter I is
power and responsibilities among the VIII. Congressional Review Act
amended as follows:
various levels of government or between Pursuant to the Congressional Review
the Federal Government and Indian Act (5 U.S.C. 801 et seq.), EPA will PART 180—[AMENDED]
tribes. Thus, the Agency has determined submit a report containing this rule and
that Executive Order 13132, entitled other required information to the U.S. ■ 1. The authority citation for part 180
‘‘Federalism’’ (64 FR 43255, August 10, Senate, the U.S. House of continues to read as follows:
1999) and Executive Order 13175, Representatives, and the Comptroller
Authority: 21 U.S.C. 321(q), 346a and 371.
entitled ‘‘Consultation and Coordination General of the United States prior to
with Indian Tribal Governments’’ (65 FR publication of the rule in the Federal ■ 2. In § 180.910, add alphabetically the
67249, November 9, 2000) do not apply Register. This action is not a ‘‘major inert ingredients to the table to read as
to this action. In addition, this action rule’’ as defined by 5 U.S.C. 804(2). follows:
does not impose any enforceable duty or
contain any unfunded mandate as List of Subjects in 40 CFR Part 180 § 180.910 Inert ingredients used pre- and
described under Title II of the Unfunded Environmental protection, post-harvest; exemptions from the
Mandates Reform Act (UMRA) (2 U.S.C. Administrative practice and procedure, requirement of a tolerance.
1501 et seq.). Agricultural commodities, Pesticides * * * * *
Inert ingredients Limits Uses
* * * * * * *
N,N-Dimethyl 9-decenamide (CAS Reg. No. 1356964– Not to exceed 20% by weight of pesticide formulation .. Surfactant, solvent
77–6).
N,N-Dimethyldodecanamide (CAS Reg. No. 3007–53–2) Not to exceed 20% by weight of pesticide formulation .. Surfactant, solvent
* * * * * * *
N,N-Dimethyltetradecanamide (CAS Reg. No. 3015–65– Not to exceed 20% by weight of pesticide formulation .. Surfactant, solvent
4).
* * * * * * *
[FR Doc. 2018–06108 Filed 3–29–18; 8:45 am] subject to Prior Authorization as a • Appear on the DMEPOS Fee
BILLING CODE 6560–50–P condition of payment. Schedule list.
• Have an average purchase fee of
DATES: This action is applicable on
$1,000 or greater (adjusted annually for
April 30, 2018.
DEPARTMENT OF HEALTH AND inflation) or an average monthly rental
FOR FURTHER INFORMATION CONTACT: fee schedule of $100 or greater (adjusted
HUMAN SERVICES
Emily Calvert, (410) 786–4277. annually for inflation). (These dollar
Centers for Medicare & Medicaid Andre Damonze, (410) 786–1795. amounts are referred to as the ‘‘payment
Services threshold’’.)
SUPPLEMENTARY INFORMATION:
• Meet either of the following criteria:
42 CFR Part 414 I. Background ++ Identified in a Government
Accountability Office (GAO) or
[CMS–6078–N] In the December 30, 2015 final rule Department of Health and Human
(80 FR 81674) titled ‘‘Medicare Program; Services Office of Inspector General
Medicare Program; Prior Authorization Prior Authorization Process for Certain (OIG) report that is national in scope
Process for Certain Durable Medical Durable Medical Equipment, and published in 2007 or later as having
Equipment, Prosthetics, Orthotics, and Prosthetics, Orthotics, and Supplies,’’ a high rate of fraud or unnecessary
Supplies (DMEPOS) Items; Update to we implemented section 1834(a)(15) of utilization.
the Master List of Items Frequently the Social Security Act (the Act) by ++ Listed in the 2011 or later
Subject to Unnecessary Utilization establishing an initial Master List Comprehensive Error Rate Testing
AGENCY: Centers for Medicare & (called the Master List of Items (CERT) program’s Annual Medicare Fee-
Medicaid Services (CMS), HHS. Frequently Subject to Unnecessary For-Service (FFS) Improper Payment
ACTION: Master list deletions. Utilization) of certain DMEPOS that the Rate Report DME and/or DMEPOS
Secretary determined, on the basis of Service Specific Report(s).
amozie on DSK30RV082PROD with RULES
SUMMARY: This document announces the prior payment experience, are The rule described the maintenance
deletion of four Healthcare Common frequently subject to unnecessary process of the Master List as follows:
Procedure Coding System (HCPCS) utilization and by establishing a prior • The Master List is self-updating
codes from the Master List of Items authorization process for these items. annually. That is, items on the DMEPOS
Frequently Subject to Unnecessary The Master List includes items that Fee Schedule that meet the ‘‘payment
Utilization that could be potentially meet the following criteria: threshold’’ are added to the list when
VerDate Sep<11>2014 18:02 Mar 29, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 E:\FR\FM\30MRR1.SGM 30MRR1](https://thefederalregister.org/doc/83_FR_13739/page/1.svg)
![Federal Register / Vol. 83, No. 62 / Friday, March 30, 2018 / Rules and Regulations 13679
effects, distributive impacts, and Executive Order 13771, titled 418–3634. Direct press inquiries to
equity). A regulatory impact analysis Reducing Regulation and Controlling Janice Wise at (202) 418–8165.
(RIA) must be prepared for major rules Regulatory Costs, was issued on January SUPPLEMENTARY INFORMATION: This is a
with economically significant effects 30, 2017 and requires that the costs summary of the Commission’s Report
($100 million or more in any 1 year). associated with significant new and Order (Order), FCC 18–16, adopted
This document does not reach the regulations ‘‘shall, to the extent and released on February 20, 2018. The
economic threshold and thus is not permitted by law, be offset by the full text of this document is available
considered a major rule. elimination of existing costs associated electronically via the FCC’s Electronic
The RFA requires agencies to analyze with at least two prior regulations.’’ Document Management System
options for regulatory relief of small OMB’s interim guidance, issued on (EDOCS) website at http://
entities. For purposes of the RFA, small April 5, 2017, https:// fjallfoss.fcc.gov/edocs_public/ or via the
entities include small businesses, www.whitehouse.gov/sites/ FCC’s Electronic Comment Filing
nonprofit organizations, and small whitehouse.gov/files/omb/memoranda/ System (ECFS) website at http://
governmental jurisdictions. Most 2017/M-17-21-OMB.pdf, explains that fjallfoss.fcc.gov/ecfs2/. (Documents will
hospitals and most other providers and for Fiscal Year 2017 the above be available electronically in ASCII,
suppliers are small entities, either by requirements only apply to each new Microsoft Word, and/or Adobe Acrobat.)
nonprofit status or by having revenues ‘‘significant regulatory action that This document is also available for
of less than $7.5 million to $38.5 imposes costs.’’ It has been determined public inspection and copying during
million in any 1 year. Individuals and that this document is not a ‘‘significant regular business hours in the FCC
states are not included in the definition regulatory action’’ and thus does not Reference Information Center, which is
of a small entity. We are not preparing trigger the aforementioned requirements located in Room CY–A257 at FCC
an analysis for the RFA because we have of Executive Order 13771. Headquarters, 445 12th Street SW,
determined, and the Secretary certifies, In accordance with the provisions of Washington, DC 20554. The Reference
that this document will not have a Executive Order 12866, this document Information Center is open to the public
significant economic impact on a was reviewed by the Office of Monday through Thursday from 8:00
substantial number of small entities. Management and Budget. a.m. to 4:30 p.m. and Friday from 8:00
In addition, section 1102(b) of the Act
Dated: February 28, 2018. a.m. to 11:30 a.m. The complete text
requires us to prepare an RIA if a rule
Seema Verma, may be purchased from the
may have a significant impact on the
Administrator, Centers for Medicare & Commission’s copy contractor, 445 12th
operations of a substantial number of
Medicaid Services. Street SW, Room CY–B402, Washington,
small rural hospitals. This analysis must
DC 20554. Alternative formats are
conform to the provisions of section 604 [FR Doc. 2018–06552 Filed 3–29–18; 8:45 am]
of the RFA. For purposes of section BILLING CODE 4120–01–P
available for people with disabilities
1102(b) of the Act, we define a small (Braille, large print, electronic files,
rural hospital as a hospital that is audio format), by sending an email to
located outside of a Metropolitan fcc504@fcc.gov or calling the
FEDERAL COMMUNICATIONS
Statistical Area for Medicare payment Commission’s Consumer and
COMMISSION
regulations and has fewer than 100 Governmental Affairs Bureau at (202)
beds. We are not preparing an analysis 47 CFR Parts 74, 76, and 78 418–0530 (voice), (202) 418–0432
for section 1102(b) of the Act because (TTY).
[MB Docket No. 17–231; FCC 18–16]
we have determined, and the Secretary Synopsis
certifies, that this action will not have Maintenance of Copies of FCC Rules I. Report and Order
a significant impact on the operations of
a substantial number of small rural AGENCY: Federal Communications 1. In this Order, we eliminate rules
hospitals. Commission. that require certain broadcast and cable
Section 202 of the Unfunded ACTION: Final rule. entities to maintain paper copies of the
Mandates Reform Act of 1995 also Commission’s regulations. As part of
requires that agencies assess anticipated SUMMARY: In this document, the Federal our initiative to modernize our media
costs and benefits before issuing any Communications Commission (FCC or regulations, we issued a Notice of
rule whose mandates require spending Commission) eliminates rules that Proposed Rulemaking (NPRM)
in any 1 year of $100 million in 1995 require certain broadcast and cable proposing to eliminate requirements
dollars, updated annually for inflation. entities to maintain paper copies of the that regulatees maintain copies of
Currently, that threshold is Commission’s regulations. As set forth certain portions of the Code of Federal
approximately $148 million. This action below, we conclude that eliminating Regulations (CFR). We received
will have no consequential effect on these requirements, which apply to low unanimous support for this proposal. As
state, local, or tribal governments or on power TV, TV and FM translators, TV set forth below, we conclude that
the private sector. and FM booster stations, cable eliminating these requirements, which
Executive Order 13132 establishes television relay station (CARS) apply to low power TV, TV and FM
certain requirements that an agency licensees, and certain cable operators, translators, TV and FM booster stations,
must meet when it promulgates a will advance the Commission’s goal of cable television relay station (CARS)
proposed rule (and subsequent final reducing outdated regulations and licensees, and certain cable operators,
rule) that imposes substantial direct unnecessary regulatory burdens that can will advance the Commission’s goal of
requirement costs on state and local impede competition and innovation in reducing outdated regulations and
amozie on DSK30RV082PROD with RULES
governments, preempts state law, or media markets. unnecessary regulatory burdens that can
otherwise has Federalism implications. DATES: Effective March 30, 2018. impede competition and innovation in
Since this action does not impose any FOR FURTHER INFORMATION CONTACT: For media markets.
costs on state or local governments, the additional information, contact Jonathan 2. We adopt the proposal to eliminate
requirements of Executive Order 13132 Mark, Jonathan.Mark@fcc.gov, of the the requirement, set forth in § 74.769 of
are not applicable. Media Bureau, Policy Division, (202) our rules, that licensees or permittees of
VerDate Sep<11>2014 18:02 Mar 29, 2018 Jkt 244001 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\FR\FM\30MRR1.SGM 30MRR1](https://thefederalregister.org/doc/83_FR_13739/page/3.svg)
Document Created: 2018-11-01 08:58:43
Document Modified: 2018-11-01 08:58:43
| 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 | Master list deletions. | |
| Dates | This action is applicable on April 30, 2018. | |
| Contact | Emily Calvert, (410) 786-4277. | |
| FR Citation | 83 FR 13677 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR