10760 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Proposed Rules 

nutrition would continue for as long as 

medical necessity and Part B coverage 

continues and the bid limits would be 

based on the average monthly costs per 

beneficiary for the bundle of items and 

services. We are soliciting comments on 

the following list of questions regarding 

proposals we may make to change the 

payment rules and other rules for DME 

and enteral nutrition under the 

DMEPOS competitive bidding program. 

• Are lump sum purchases and 

capped rental payment rules for DME 

and enteral nutrition equipment that 

were implemented to prevent prolonged 

rental payments still needed now that 

monthly payment amounts can be 

established under competitive bidding 

programs for furnishing everything the 

beneficiary needs each month related to 

the covered DME item or enteral 

nutrition? 

• Are there reasons why beneficiaries 

need to own expensive DME or enteral 

nutrition equipment rather than use 

such equipment as needed on a 

continuous monthly basis? 

• Would there be any negative 

impacts associated with continuous 

bundled monthly payments for enteral 

nutrients, supplies, and equipment or 

for certain DME? If so, please explain. 

• Certain DME items such as speech 

generating devices and specialized 

wheelchairs may be adjusted or 

personalized to address individual 

patient needs. Would payment on a 

bundled, continuous rental basis 

adversely impact access to these items 

and services? If so, please provide a 

detailed explanation regarding how this 

method of payment would create a 

negative impact on access to these items 

and services or other items and services 

currently subject to competitive 

bidding. 

• If payment on a capped rental, rentto-own basis or lump sum purchase 

basis is maintained for certain items 

under the competitive bidding program, 

should a requirement be added to the 

regulations specifying that the supplier 

that transfers title to the equipment to 

the beneficiary is responsible for all 

maintenance and servicing of the 

beneficiary-owned equipment for the 

remainder of the equipment’s 

reasonable useful lifetime with no 

additional payment for these services? 

The cost of such a mandatory supplier 

warranty would be factored into the 

bids submitted by the suppliers and the 

payment amounts established based on 

the bids for the items. If such a 

requirement was established, should the 

term maintenance and servicing be 

defined to include all necessary 

maintenance, servicing and repairs that 

are currently paid for separately under 

the Medicare program in addition to any 

additional adjustments or 

personalization of the equipment that 

may be needed once title transfers to the 

patient? We believe these requirements 

may be necessary to safeguard the 

beneficiary and access to necessary 

services related to beneficiary-owned 

DME. 

• Would payment on a bundled, 

continuous rental basis for certain items 

adversely impact the beneficiary’s 

ability to direct their own care, follow 

a plan of care outlined by a physician, 

nurse practitioner or other medical 

provider (for example, occupational, 

physical or speech therapist), or provide 

for appropriate care transitions? If so, 

please explain. 

• What are the advantages or 

disadvantages for beneficiaries and 

suppliers of bundled bidding and 

payments for enteral nutrients, supplies, 

and equipment or DME? 

• Should competitive bidding 

programs utilizing bundled payments be 

established throughout the entire United 

States so that all beneficiaries are 

included under programs where 

suppliers have an obligation to furnish 

covered items and all related items and 

services? 

• Is a continuous bundled monthly 

payment used by commercial payers or 

State Medicaid programs for enteral 

nutrients, supplies, and DME and do 

these approaches inform this potential 

new payment arrangement for Medicare. 

Dated: January 31, 2014. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: February 4, 2014. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2014–04031 Filed 2–24–14; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

6 CFR Chapter I 

8 CFR Chapter I 

19 CFR Chapter I 

33 CFR Chapter I 

44 CFR Chapter I 

46 CFR Chapters I and III 

49 CFR Chapter XII 

[Docket No. DHS–2014–0006] 

Retrospective Review of Existing 

Regulations; Request for Public Input 

AGENCY: Office of the General Counsel, 

DHS. 

ACTION: Notice and request for 

comments. 

SUMMARY: The Department of Homeland 

Security (Department or DHS) is seeking 

comments from the public on specific 

existing significant DHS rules that the 

Department should consider as 

candidates for modification, 

streamlining, expansion, or repeal. 

These efforts will help DHS ensure that 

its regulations contain necessary, 

properly tailored, and up-to-date 

requirements that effectively achieve 

regulatory objectives without imposing 

unwarranted costs. 

DHS is seeking this input pursuant to 

the process identified in DHS’s Final 

Plan for the Retrospective Review of 

Existing Regulations. According to the 

Final Plan, DHS will initiate its 

retrospective review process, on a threeyear cycle, by seeking input from the 

public. The most helpful input will 

identify specific regulations and include 

actionable data supporting the 

nomination of specific regulations for 

retrospective review. 

DATES: Written comments are requested 

on or before March 28, 2014. Late-filed 

comments will be considered to the 

extent practicable. 

ADDRESSES: You may submit comments, 

identified by docket number DHS– 

2014–0006, through the 

Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

FOR FURTHER INFORMATION CONTACT: 

Charlotte Skey, Senior Regulatory 

Economist, Office of the General 

Counsel, U.S. Department of Homeland 

Security. Email: Regulatory.Review@

dhs.gov. 

SUPPLEMENTARY INFORMATION: 

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Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Proposed Rules 10761 

1Twice a year, DHS posts a progress report on the 

DHS Web site; the report provides the status of DHS 

regulations currently under retrospective review. 

The most recent progress report was published in 

July 2013 and is available on the DHS Web site at 

http://www.dhs.gov/latest-progress. 

I. Public Participation 

Interested persons are invited to 

comment on this notice by submitting 

written data, views, or arguments using 

the method identified in the ADDRESSES

section. 

Instructions: All submissions must 

include the agency name and docket 

number for this notice. All comments 

received will be posted without change 

to http://www.regulations.gov. 

Docket: For access to the docket to 

read background documents or 

comments, go to http://

www.regulations.gov. 

II. Background 

On January 18, 2011, the President 

issued Executive Order 13563, 

‘‘Improving Regulation and Regulatory 

Review,’’ to ensure that Federal 

regulations seek more affordable, less 

intrusive means to achieve policy goals 

and that agencies give careful 

consideration to the benefits and costs 

of those regulations. 76 FR 3821. The 

Executive Order required each 

Executive Branch agency to develop a 

preliminary plan to periodically review 

its existing regulations to determine 

whether any regulations should be 

modified, streamlined, expanded, or 

repealed so as to make the agency’s 

regulatory program more effective or 

less burdensome in achieving its 

regulatory objectives. 

DHS’s approach to conducting 

retrospective review focuses on public 

openness and transparency and on the 

critical role of public input in 

conducting retrospective review. To that 

end, DHS published a notice and 

request for comments in the Federal 

Register on March 14, 2011. 76 FR 

13526. In that notice, DHS solicited 

public input on how DHS should 

structure its retrospective review and 

which DHS rules would benefit from 

retrospective review. On June 6, 2011, 

DHS published a notice of availability; 

request for comments announcing the 

availability and seeking comment on its 

Preliminary Plan for the Retrospective 

Review of Existing Regulations. 76 FR 

32331. DHS considered this public 

input as it developed a Final Plan. 

On August 22, 2011, DHS issued its 

Final Plan for the Retrospective Review 

of Existing Regulations (Final Plan or 

DHS Final Plan). The DHS Final Plan is 

available online at http://www.dhs.gov/ 

xlibrary/assets/dhs-ogc-finalretrospective-review-plan-8-22-11- 

final.pdf. The Final Plan established a 

process for identifying regulations that 

may be obsolete, unnecessary, 

unjustified, excessively burdensome, or 

counterproductive. Under the Final 

Plan, DHS (and/or a DHS component) 

will publish a notice in the Federal 

Register every three years seeking 

public input regarding the regulations 

that should be subject to retrospective 

review. The previous Federal Register 

notice from DHS seeking such public 

input was published in 2011. 76 FR 

13526. The notice published today in 

the Federal Register requesting 

nominations for additional regulations 

that should be subject to retrospective 

review fulfills the DHS commitment to 

seek public input via the Federal 

Register on a three-year cycle. 

It is important to note that DHS 

continually evaluates its regulatory 

program for rules that are candidates for 

retrospective review. DHS does so 

through legally mandated retrospective 

review requirements (e.g., Unified 

Agenda reviews and reviews under 

section 610 of the Regulatory Flexibility 

Act) and through other informal and 

long-established mechanisms (e.g., use 

of Advisory Councils, feedback from 

DHS field personnel, input from 

internal working groups, and outreach 

to regulated entities). This Federal 

Register notice supplements these 

existing extensive DHS retrospective 

review efforts.1

II. DHS’s Regulatory Responsibility 

DHS’s mission is to ensure a 

homeland that is safe, secure, and 

resilient against terrorism and other 

hazards. The Department carries out its 

mission through the Office of the 

Secretary and 28 components, including 

the following seven operational 

components: U.S. Citizenship and 

Immigration Services, U.S. Coast Guard, 

U.S. Customs and Border Protection, 

Federal Emergency Management 

Agency, U.S. Immigration and Customs 

Enforcement, U.S. Secret Service, and 

Transportation Security Administration. 

Our mission gives us five main areas 

of responsibility: (1) Prevent terrorism 

and enhance security; (2) secure and 

manage our borders; (3) enforce and 

administer our immigration laws; (4) 

safeguard and secure cyberspace; and 

(5) ensure resilience to disasters. To 

further these areas, DHS has 

responsibility for a broad range of 

regulations. For example, to secure and 

manage our borders, DHS regulates 

people and goods entering and exiting 

the United States. DHS, to combat 

terrorism, regulates aviation security, 

high-risk chemical facilities, and 

infrastructure protection. DHS also 

issues regulations to administer 

immigration and citizenship benefits as 

well as regulations covering maritime 

safety and environmental protection. 

Finally, DHS promulgates a wide range 

of regulations concerning disaster 

preparedness, response, and recovery. 

III. Request for Input 

A. Importance of Public Feedback 

A central tenet of the DHS Final Plan 

is the critical and essential role of 

public input in driving and focusing 

DHS retrospective review. Because the 

impacts and effects of a rule tend to be 

widely dispersed in society, members of 

the public—especially the regulated 

entities of our rulemakings—are likely 

to have useful information, data, and 

perspectives on the benefits and 

burdens of our existing regulations. 

Given this importance of public input, 

the primary factor for rule section in 

DHS retrospective review is public 

feedback. 

B. Maximizing the Value of Public 

Feedback 

This notice contains a list of 

questions, the answers to which will 

assist DHS in identifying those 

regulations that may benefit from DHS 

retrospective review. DHS encourages 

public comment on these questions and 

seeks any other data commenters 

believe are relevant to DHS’s 

retrospective review efforts. The DHS 

Final Plan provides instruction on the 

type of feedback that is most useful to 

the Department: 

DHS will afford significantly greater weight 

to feedback that identifies specific 

regulations, includes actionable data, or 

provides viable alternatives that meet 

statutory obligations and regulatory 

objectives. Feedback that simply states that a 

stakeholder feels strongly that DHS should 

change a regulation, but does not contain 

specific information on how the proposed 

change would impact the costs and benefits 

of the regulation, is much less useful to DHS. 

DHS is looking for new information and new 

economic data to support any proposed 

changes. (emphasis added) 

We highlight a few of those points 

here, noting that comments that will be 

most useful to DHS are those that are 

guided by the principles below. 

Commenters should consider these 

principles as they answer and respond 

to the questions in this notice. 

• Commenters should identify, with 

specificity, the regulation at issue, 

providing the Code of Federal 

Regulation (CFR) cite where available. 

• Commenters should provide, in as 

much detail as possible, an explanation 

why a regulation should be modified, 

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10762 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Proposed Rules 

streamlined, expanded, or repealed, as 

well as specific suggestions of ways the 

Department can better achieve its 

regulatory objectives. 

• Commenters should provide 

specific data that document the costs, 

burdens, and benefits of existing 

requirements. Commenters might also 

address how DHS can best obtain and 

consider accurate, objective information 

and data about the costs, burdens, and 

benefits of existing regulations and 

whether there are existing sources of 

data that DHS can use to evaluate the 

post-promulgation effects of its 

regulations over time. 

• Particularly where comments relate 

to a rule’s costs or benefits, comments 

will be most useful if there are data and 

experience under the rule available to 

ascertain the rule’s actual impact. For 

that reason, we encourage the public to 

emphasize those rules that have been in 

effect for a sufficient amount of time to 

warrant a fair evaluation. 

• Comments that rehash debates over 

recently issued rules will be less useful. 

C. List of Questions for Commenters 

The below nonexhaustive list of 

questions is meant to assist members of 

the public in the formulation of 

comments and is not intended to restrict 

the issues that commenters may 

address: 

(1) Are there regulations that simply 

make no sense or have become 

unnecessary, ineffective, or ill advised 

and, if so, what are they? Are there 

regulations that can simply be repealed 

without impairing the Department’s 

regulatory programs and, if so, what are 

they? 

(2) Are there regulations that have 

become outdated and, if so, how can 

they be modernized to better 

accomplish their regulatory objectives? 

(3) Are there regulations that are still 

necessary, but have not operated as well 

as expected such that a modified, 

stronger, or slightly different approach 

is justified? 

(4) Does the Department currently 

collect information that it does not need 

or effectively use to achieve regulatory 

objectives? 

(5) Are there regulations that are 

unnecessarily complicated or could be 

streamlined to achieve regulatory 

objectives in more efficient ways? If so, 

how can they be streamlined and/or 

made less complicated? 

(6) Are there regulations that have 

been overtaken by technological 

developments? Can new technologies be 

leveraged to modify, streamline, or do 

away with existing regulatory 

requirements? 

(7) Are there any Departmental 

regulations that are not tailored to 

impose the least burden on society, 

consistent with achieving the regulatory 

objectives? 

(8) How can the Department best 

obtain and consider accurate, objective 

information and data about the costs, 

burdens, and benefits of existing 

regulations? Are there existing sources 

of data the Department can use to 

evaluate the post-promulgation effects 

of regulations over time? 

(9) Are there regulations that are 

working well that can be expanded or 

used as a model to fill gaps in other 

DHS regulatory programs? 

(10) Are there any regulations that 

create difficulty because of duplication, 

overlap, or inconsistency of 

requirements? 

The Department notes that this notice 

is issued solely for information and 

program planning purposes. Responses 

to this notice do not bind DHS to any 

further actions related to the response. 

Christina E. McDonald, 

Associate General Counsel for Regulatory 

Affairs. 

[FR Doc. 2014–04116 Filed 2–25–14; 8:45 am] 

BILLING CODE 9110–9B–P 

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