Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16413 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6062–N] 

Medicare Program; Updates to the List 

of Durable Medical Equipment (DME) 

Specified Covered Items That Require 

a Face-to-Face Encounter and a 

Written Order Prior to Delivery 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice updates the 

Healthcare Common Procedure Coding 

System (HCPCS) codes on the Durable 

Medical Equipment (DME) List of 

Specified Covered Items that require a 

face-to-face encounter and a written 

order prior to delivery. 

DATES: March 27, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Charlene Harven (410) 786–8228. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 1832, 1834, and 1861 of 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)(11)(B)(i) of the Act, as 

redesignated by the Affordable Care Act, 

authorizes us to require, for Specified 

Covered Items, that payment may only 

be made under section 1834(a) of the 

Act if a physician has communicated to 

the supplier a written order for the item 

before delivery of the item. Section 

1834(b)(3) of the Act states that section 

1834(a)(11) of the Act applies to 

prosthetic devices, orthotics, and 

prosthetics in the same manner as it 

applies to items of DME. Section 

1834(a)(11)(B)(ii) of the Act requires a 

physician to document that a physician, 

physician assistant (PA), nurse 

practitioner (NP) or clinical nurse 

specialist (CNS) has had a face-to-face 

encounter examination with a 

beneficiary in the 6 months prior to the 

written order for certain items of 

durable medical equipment (DME) or 

during a different reasonable timeframe 

determined by the Secretary. 

In the Calendar Year (CY) 2013 

Physician Fee Schedule (PFS) final rule 

with comment period, which appeared 

in the November 16, 2012 Federal 

Register (77 FR 69147), we 

implemented section 1834(a)(11)(B) of 

the Act by making revisions to 42 CFR 

410.38(g). Among other things, we 

established a list of Specified Covered 

Items that require a written order prior 

to delivery and a face-to-face encounter 

during the 6 months prior to the written 

order. (See 42 CFR 410.38(g)(2).) The list 

of Specified Covered Items contains 

items that meet at least one of the 

following three criteria: 

• Any item described by a Healthcare 

Common Procedure Coding System 

(HCPCS) code for the following types of 

durable medical equipment: 

++ Transcutaneous electrical nerve 

stimulation (TENS) unit. 

++ Rollabout chair. 

++ Oxygen and respiratory 

equipment. 

++ Hospital beds and accessories. 

++ Traction-cervical. 

• Any item of durable medical 

equipment that appears on the DMEPOS 

Fee Schedule with a price ceiling at or 

greater than $1,000. 

• Any other item of durable medical 

equipment that CMS adds to the list of 

Specified Covered Items through the 

notice and comment rulemaking process 

in order to reduce the risk of fraud, 

waste, and abuse. 

II. Provisions of the Notice 

In the CY 2013 Physician Fee 

Schedule final rule with comment 

period (77 FR 69154), we stated that we 

would publish annually an updated List 

of Specified Covered Items. (See also 42 

CFR 410.38(g)(2).) We specified that we 

would—(1) Add to the list any item of 

DME (described by an HCPCS code) that 

in the future appears on the DMEPOS 

Fee Schedule with a price ceiling at or 

greater than $1,000; and (2) remove from 

the list any item of DME with a HCPCS 

code that is no longer covered by 

Medicare or that has been discontinued. 

The purpose of this notice is to 

provide the annual update to the DME 

List of Specified Covered Items as stated 

in the CY 2013 Physician Fee Schedule 

final rule (77 FR 69154) and as specified 

in our regulations at § 410.38(g). 

This year’s update does not reflect 

any additions because there are no new 

items that appear on the DMEPOS Fee 

Schedule with a price ceiling at or 

greater than $1,000. There are also no 

new HCPCS codes for any of the five 

types of durable medical equipment 

listed previously. However, the 

following two HCPCS codes were 

removed from the list because they are 

for items that are no longer payable by 

Medicare: 

HCPCS code Short descriptor 

E0457 ................................ Chest shell. 

E0459 ................................ Chest wrap. 

The full updated list is available in 

the download section of the following 

CMS Web site: http://www.cms.gov/

Research-Statistics-Data-and-Systems/

Monitoring-Programs/Medicare-FFSCompliance-Programs/Medical-Review/

FacetoFaceEncounterRequirementfor

CertainDurableMedicalEquipment.html. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

IV. Impact Statement 

We have examined the impact of this 

notice 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 Social 

Security 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) and the Congressional 

Review Act (5 U.S.C. 804(2)). 

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). 

The CY 2013 expenditures for the two 

HCPCS codes being removed via this 

notice was approximately $9,000. 

Therefore, this notice 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 

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16414 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 

determined, and the Secretary certifies, 

that this notice 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 a regulatory 

impact analysis 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 

notice 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. 

In 2014, that threshold is approximately 

$141 million. This notice 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 notice does not impose any 

costs on State or local governments, the 

requirements of Executive Order 13132 

are not applicable. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget. 

Dated: March 10, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2015–07108 Filed 3–26–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Modification of National Customs 

Automation Program (NCAP) Test 

Concerning Automated Commercial 

Environment (ACE) Cargo Release for 

Type 03 Entries and for Truck Carriers 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: General notice. 

SUMMARY: This document announces 

U.S. Customs and Border Protection’s 

(CBP’s) plan to modify the National 

Customs Automation Program (NCAP) 

test concerning Automated Commercial 

Environment (ACE) cargo release to 

allow importers and customs brokers to 

file type 03 entries for all modes of 

transportation and to file, for cargo 

transported in the truck mode, entries 

for split shipments or partial shipments 

and entry on cargo which has been 

moved in-bond from the first U.S. port 

of unlading. 

DATES: The ACE Cargo Release Test 

modifications became effective on 

March 1, 2015. The ACE Cargo Release 

Test will continue until CBP publishes 

in the Federal Register an 

announcement of its conclusion. 

ADDRESSES: Comments or questions 

concerning this notice and indication of 

interest in participation in ACE Cargo 

Release Test should be submitted, via 

email, to Steven Zaccaro at 

steven.j.zaccaro@cbp.dhs.gov. In the 

subject line of your email, please use, 

‘‘Comment on ACE Cargo Release 03 

Entries and Truck Mode.’’ The body of 

the email should identify the ports 

where filings are likely to occur. 

FOR FURTHER INFORMATION CONTACT: For 

policy questions related to ACE, contact 

Josephine Baiamonte, Acting Director, 

Business Transformation, ACE Business 

Office, Office of International Trade, at 

josephine.baiamonte@dhs.gov. For 

policy questions related to ISF, contact 

Craig Clark, Program Manager, Cargo 

and Conveyance Security, Office of 

Field Operations, at craig.clark@

cbp.dhs.gov. For technical questions, 

contact Steven Zaccaro, Client 

Representative Branch, ACE Business 

Office, Office of International Trade, at 

steven.j.zaccaro@cbp.dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

I. The National Customs Automation 

Program 

This test notice, and the Customs 

related electronic functions it describes, 

are part of the National Customs 

Automation Program (NCAP). NCAP 

was established in Subtitle B of Title 

VI—Customs Modernization, in the 

North American Free Trade Agreement 

Implementation Act (Pub. L. 103–182, 

107 Stat. 2057, 2170, December 8, 1993) 

(Customs Modernization Act). See 19 

U.S.C. 1411. Through NCAP, the initial 

focus of customs modernization was on 

trade compliance and the development 

of the Automated Commercial 

Environment (ACE), the planned 

successor to the legacy Customs 

Automated Commercial System (ACS). 

ACE is an automated and electronic 

system for commercial trade processing. 

ACE will streamline business processes, 

facilitate growth in trade, ensure cargo 

security, and foster participation in 

global commerce, while ensuring 

compliance with U.S. laws and 

regulations and reducing costs for CBP 

and all its communities of interest. The 

ability to meet these objectives depends 

upon successfully modernizing CBP’s 

business functions and the information 

technology that supports those 

functions. CBP’s modernization efforts 

are accomplished through phased 

releases of ACE component 

functionality, designed to introduce a 

new capability or to replace a specific 

legacy ACS function. Each release will 

begin with a test, and will end with 

mandatory compliance with the new 

ACE feature, thus retiring the legacy 

ACS function. Each release builds on 

previous releases, and sets the 

foundation for subsequent releases. 

The ACE Cargo Release test was 

previously known as the Simplified 

Entry Test, because the test simplified 

the entry process by reducing the 

number of data elements required to 

obtain release for cargo transported by 

air. The original test notice required 

participants to be a member of the 

Customs-Trade Partnership Against 

Terrorism (C–TPAT) program. Through 

phased releases of ACE component 

functionality, this test has been 

expanded to allow all eligible 

participants to join the test for an 

indefinite period regardless of the 

C–TPAT status of an importer self-filer 

or a customs broker. CBP also expanded 

the ACE Cargo release test to allow ACEparticipating brokers and importers to 

file for release of cargo transported by 

air, ocean, or rail. See 79 FR 6210 

(February 3, 2014). For these three 

modes of transportation, CBP limited 

the ACE Cargo Release test to formal 

consumption entries, which ACS 

termed Type 01 entries; and to informal 

entries, which ACS termed Type 11 

entries. See 79 FR 6210. 

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