18472 Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Proposed Rules 

opportunity for public comment. We 

conclude our review of the proposed 

amendment after the close of the public 

comment period and determine whether 

the amendment should be approved, 

approved in part, or not approved. At 

that time, we will also make the 

determinations and certifications 

required by the various laws and 

executive orders governing the 

rulemaking process and include them in 

the final rule. 

List of Subjects in 30 CFR Part 938 

Intergovernmental relations, Surface 

mining, Underground mining. 

Dated: February 18, 2011. 

Thomas D. Shope, 

Regional Director, Appalachian Region. 

[FR Doc. 2011–7907 Filed 4–1–11; 8:45 am] 

BILLING CODE 4310–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 424 

[CMS–6036–P2] 

RIN 0938–AQ57 

Medicare Program; Revisions to the 

Durable Medical Equipment, 

Prosthetics, Orthotics, and Supplies 

(DMEPOS) Suppliers Safeguards 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

remove the definition of and modify 

requirements regarding ‘‘direct 

solicitation;’’ allow DMEPOS suppliers, 

including DMEPOS competitive bidding 

program contract suppliers, to contract 

with licensed agents to provide 

DMEPOS supplies unless prohibited by 

State law; remove the requirement for 

compliance with local zoning laws; and 

modify certain State licensing 

requirement exceptions. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on June 3, 2011. 

ADDRESSES: In commenting, please refer 

to file code CMS–6036–P2. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–6036–P2, P.O. Box 8013, 

Baltimore, MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–6036–P2, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Katie Mucklow Lehman, (410) 786– 

0537. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 

8:30 a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

A. General Overview 

Medicare services are furnished by 

two types of entities, providers, and 

suppliers. At § 400.202, the term 

‘‘provider’’ is defined as a hospital, a 

critical access hospital (CAH), a skilled 

nursing facility (SNF), a comprehensive 

outpatient rehabilitation facility (CORF), 

a home health agency (HHA), or a 

hospice that has in effect an agreement 

to participate in Medicare, or a clinic, a 

rehabilitation agency, or a public health 

agency that has in effect a similar 

agreement but only to furnish outpatient 

physical therapy or speech pathology 

services, or a community mental health 

center that has in effect a similar 

agreement but only to furnish partial 

hospitalization services. The term 

‘‘provider’’ is also defined in sections 

1861(u) and 1866(e) of the Social 

Security Act (the Act). 

For purposes of the durable medical 

equipment, prosthetics, orthotics, and 

supplies (DMEPOS) supplier standards, 

the term ‘‘supplier’’ is defined in 

§ 424.57(a) as an entity or individual, 

including a physician or Part A 

provider, that sells or rents Part B 

covered DMEPOS items to Medicare 

beneficiaries that meet the DMEPOS 

supplier standards. A supplier that 

furnishes DMEPOS is one category of 

supplier. Other supplier categories may 

include, for example, physicians, nurse 

practitioners, and physical therapists. If 

a supplier, such as a physician or 

physical therapist, also furnishes 

DMEPOS to a patient, then the supplier 

is also considered to be a DMEPOS 

supplier. The term ‘‘DMEPOS’’ 

encompasses the types of items 

included in the definition of medical 

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Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Proposed Rules 18473 

equipment and supplies in section 

1834(j)(5) of the Act. 

The term DMEPOS is defined at 

section 1861(n) of the Act. This 

definition, in part, excludes from 

coverage as DMEPOS, items furnished 

in skilled nursing facilities and 

hospitals. Also, the term DMEPOS is 

included in the definition of ‘‘medical 

and other health services’’ found at 

section 1861(s)(6) of the Act. 

Furthermore, the term is defined in 

§ 414.202 as equipment furnished by a 

supplier or a HHA that— 

• Can withstand repeated use; 

• Is primarily and customarily used 

to serve a medical purpose; 

• Generally is not useful to an 

individual in the absence of an illness 

or injury; and 

• Is for use in the home. 

Examples of DMEPOS supplies 

include items such as blood glucose 

monitors, hospital beds, nebulizers, 

oxygen delivery systems, and 

wheelchairs.Prosthetic devices are 

included in the definition of ‘‘medical 

and other health services’’ under section 

1861(s)(8) of the Act. Prosthetic devices 

are defined in this section of the Act as 

‘‘devices (other than dental) which 

replace all or part of an internal body 

organ (including colostomy bags and 

supplies directly related to colostomy 

care), including replacement of such 

devices, and including one pair of 

conventional eyeglasses or contact 

lenses furnished subsequent to each 

cataract surgery with insertion of an 

intraocular lens.’’ Other examples of 

prosthetic devices include cardiac 

pacemakers, cochlear implants, 

electrical continence aids, electrical 

nerve stimulators, and tracheostomy 

speaking valves. 

Section 1861(s)(9) of the Act provides 

for the coverage of ‘‘leg, arm, back, and 

neck braces, and artificial legs, arms, 

and eyes, including replacement if 

required because of a change in the 

patient’s physical condition.’’ As 

indicated by section 1834(h)(4)(C) of the 

Act, these items are often referred to as 

‘‘orthotics and prosthetics.’’ Under 

section 1834(h)(4)(B) of the Act, 

prosthetic devices do not include 

parenteral and enteral nutrition 

nutrients and implantable items payable 

under section 1833(t) of the Act. 

Section 1861(s)(5) of the Act includes 

‘‘surgical dressings, and splints, casts, 

and other devices used for reduction of 

fractures and dislocations’’ as one of the 

‘‘medical and other health services’’ that 

is covered by Medicare. Other items that 

may be furnished by suppliers would 

include the following (among others): 

• Prescription drugs used in 

immunosuppressive therapy furnished 

to an individual who receives an organ 

transplant for which payment is made 

under this title, and that are furnished 

within a certain time period after the 

date of the transplant procedure as 

noted at section 1861(s)(2)(J) of the Act. 

• Extra-depth shoes with inserts or 

custom molded shoes with inserts for an 

individual with diabetes as listed at 

section 1861(s)(12) of the Act. 

• Home dialysis supplies and 

equipment, self-care home dialysis 

support services, and institutional 

dialysis services and supplies included 

at section 1861(s)(2)(F) of the Act. 

• Oral drugs prescribed for use as an 

anticancer therapeutic agent as specified 

in section 1861(s)(2)(Q) of the Act. 

• Self-administered erythropoietin as 

described in section 1861(s)(2)(O) of the 

Act. 

B. Statutory Authority 

Various sections of the Act and the 

regulations require providers and 

suppliers to furnish information 

concerning the amounts due and the 

identification of individuals or entities 

that furnish medical services to 

beneficiaries before payment can be 

made. The following is an overview of 

the sections that grant this authority. 

• Sections 1102 and 1871 of the Act 

provide general authority for the 

Secretary of Health and Human Services 

(the Secretary) to prescribe regulations 

for the efficient administration of the 

Medicare program. Under this authority, 

this proposed rule will require the 

collection of information from providers 

and suppliers for the purpose of 

enrolling in the Medicare program and 

granting privileges to bill the program 

for health care services furnished to 

Medicare beneficiaries. 

• Section 1834(j)(1)(A) of the Act 

states that no payment may be made for 

items furnished by a supplier of medical 

equipment and supplies unless such 

supplier obtains (and renews at such 

intervals as the Secretary may require) 

a supplier number. In order to obtain a 

supplier billing number, a supplier must 

comply with certain supplier standards 

as identified by the Secretary. 

We are authorized to collect 

information on the Medicare enrollment 

application (that is, the CMS–855, 

(Office of Management and Budget 

(OMB) approval number 0938–0685)) to 

ensure that correct payments are made 

to providers and suppliers under the 

Medicare program as established by 

Title XVIII of the Act. 

In the August 27, 2010 we published 

a final rule (75 FR 52629) regarding 

DMEPOS supplier standards which 

became effective on September 27, 2010. 

II. Provisions of the Proposed 

Regulations 

This proposed rule would apply to all 

DMEPOS suppliers and would revise 

several of the DMEPOS supplier 

standards set forth at § 424.57(c). 

With the passage of the Affordable 

Care Act and efforts to focus on waste, 

fraud, and abuse of our Medicare 

system, one of our goals has been to 

reduce expenditures and provide better 

quality and access to care. This rule is 

in furtherance of this goal but also 

addresses the realities that certain 

suppliers confront as they attempt to 

provide quality care and maintain 

access for beneficiaries. 

To ensure that DMEPOS suppliers 

understand how CMS interprets the 

DMEPOS supplier standards, we are 

revising certain supplier standards 

specified in § 424.57(c). Further, we are 

clarifying our interpretation of these 

provisions so as to ensure that our 

approach protects against fraud, waste, 

and abuse but also preserves access to 

services for our beneficiaries. 

A. Direct Solicitation 

The August 27, 2010 final rule 

implemented an expansion of a 

provision regarding the ‘‘direct 

solicitation’’ of Medicare beneficiaries 

by DMEPOS suppliers in 

§ 424.57(c)(11). The final rule enlarged 

the scope of the provision beyond 

prohibiting unsolicited telephone 

contacts to include in-person contacts, 

e-mail, and instant messaging. We 

continue to be concerned about the 

potential for abuse caused by ‘‘direct 

solicitation’’ by DMEPOS suppliers and 

will continue to evaluate DMEPOS 

supplier marketing practice to ensure 

our beneficiaries are protected from 

abusive practices. Based upon our 

continuing need to evaluate these 

practices, we believe further 

investigation is necessary to determine 

how the agency plans to address this 

concern. In the interim, we intend to 

instruct Medicare contractors to 

continue applying the restrictions on 

telephone solicitation that were in effect 

before publication of the August 27, 

2010 final rule, instead of implementing 

the final rule’s requirements regarding 

‘‘direct solicitation.’’ 

The original intent of the August 27, 

2010 final rule was to limit the 

circumstances in which DMEPOS 

suppliers could directly contact 

beneficiaries. The purpose was to 

inhibit the direct, coercive, and targeted 

solicitation of our nation’s senior 

citizens. We are concerned that these 

solicitations and subsequent purchases 

can be fraudulent or abusive in nature, 

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18474 Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Proposed Rules 

which may result in monetary increases 

in health care costs and further drains 

on the Medicare Trust Fund. 

Since publication of the August 27, 

2010 final rule, we discovered that 

implementation of the expanded 

portions of this provision as written is 

unfeasible. The definition of ‘‘direct 

solicitation’’ has been criticized as 

overly broad as it covers some types of 

marketing activity outside the bounds of 

what we intended to prohibit under our 

regulations. Thus, we are proposing to 

revise § 424.57(a) to remove the 

definition of ‘‘direct solicitation’’ and 

revise our regulations at § 424.57(c)(11). 

The supplier standard at 

§ 424.57(c)(11) currently states that 

suppliers must do the following: 

Agree not to make a direct solicitation (as 

defined in § 424.57(a)) of a Medicare 

beneficiary unless one or more of the 

following applies: 

(i) The individual has given written 

permission to the supplier or the ordering 

physician or nonphysician practitioner to 

contact them concerning the furnishing of a 

Medicare-covered item that is to be rented or 

purchased. 

(ii) The supplier has furnished a Medicarecovered item to the individual and the 

supplier is contacting the individual to 

coordinate the delivery of the item. 

(iii) If the contact concerns the furnishing 

of a Medicare-covered item other than a 

covered item already furnished to the 

individual, the supplier has furnished at least 

one covered item to the individual during the 

15-month period preceding the date on 

which the supplier makes such contact. 

We propose to revise this supplier 

standard to remove the prohibition 

against suppliers’ ‘‘direct solicitation’’ of 

patients, which included, but was not 

limited to, a prohibition on telephone, 

computer e-mail or instant messaging, 

or in-person contacts and to revert to 

restrictions on suppliers effective before 

publication of the August 27, 2010 final 

rule. Thus, we are proposing to remove 

the definition of ‘‘direct solicitation’’ and 

to revise the supplier standard at 

§ 424.57(c)(11) to read as follows: 

Must agree not to contact a 

beneficiary by telephone when 

supplying a Medicare-covered item 

unless one of the following applies: 

(i) The individual has given written 

permission to the supplier to contact them by 

telephone concerning the furnishing of a 

Medicare-covered item that is to be rented or 

purchased. 

(ii) The supplier has furnished a Medicarecovered item to the individual and the 

supplier is contacting the individual to 

coordinate the delivery of the item. 

(iii) If the contact concerns the furnishing 

of a Medicare-covered item other than a 

covered item already furnished to the 

individual, the supplier has furnished at least 

one covered item to the individual during the 

15-month period preceding the date on 

which the supplier makes such contact. 

Although we are proposing to modify 

the supplier standard on direct 

solicitation at § 424.57(c)(11), we will 

continue to actively monitor the issue of 

potentially unwanted and unsolicited 

communications between DMEPOS 

suppliers and beneficiaries. In the event 

we believe that we need to take action 

to limit these types of communications, 

we will engage in further rulemaking to 

address this concern. 

B. Contractual Arrangement Issues 

In the August 27, 2010 final rule, we 

sought to ensure oversight of DMEPOS 

suppliers by adding an additional layer 

of oversight in the form of State law. 

The absence of express State law in 

certain areas of DMEPOS suppliers 

oversight has led to confusion among 

suppliers as to who they may contract 

with under our programs. We are 

seeking to clarify that contracting with 

an individual or entity for licensed 

services is permissible in the absence of 

an express prohibition. In addition, the 

existing supplier standards permits 

competitive bidding program contract 

suppliers to contract for licensed 

services if such contracting is permitted 

by the State where the licensed services 

are performed. As with other suppliers, 

we believe contract suppliers may 

contract for licensed services in the 

absence of an express State prohibition. 

By making the proposed clarification 

(that is, it is permissible for suppliers to 

contract for licensed services in the 

absence of an express State prohibition), 

we believe the requirements for contract 

suppliers are also clarified and that the 

reference to competitive bidding 

program contract suppliers in the 

existing regulation is unnecessary and 

redundant. Therefore, we are proposing 

to revise § 424.57(c)(1)(ii) by -(1) 

removing the reference to contract 

suppliers; and (2) specifying that a 

DMEPOS supplier may contract with an 

individual or other entity to provide the 

licensed services unless expressly 

prohibited by State law. 

Suppliers are reminded that they 

must always comply with any 

applicable Federal and State laws, 

including, without limitation, those 

related to fraud and abuse. 

C. Local Zoning Requirements 

In the August 27, 2010 final rule, we 

finalized regulations at 

§ 424.57(c)(1)(iii), that required 

DMEPOS suppliers to comply with all 

local zoning requirements. The 

requirement that suppliers comply with 

local zoning requirements was 

originally intended to add an additional 

level of protection to the Medicare 

program by helping to prevent waste, 

fraud, and abuse. Under this new zoning 

compliance requirement, we could 

ensure DMEPOS suppliers were actually 

providing goods and services to 

Medicare beneficiaries in a physical 

location rather than out of a residence, 

a practice often prohibited by municipal 

code zoning requirements. 

However, because State and 

municipal laws vary considerably and 

are often subject to frequent changes, we 

believe that the task of ensuring 

suppliers comply with local zoning laws 

is best left to the States. Our contractors 

do not have access to the information 

needed to verify each and every 

compliance requirement, nor are they 

aware of municipal code provisions, 

including zoning exceptions, needed to 

complete compliance verification. 

Therefore, we are proposing to 

remove the language in 

§ 424.57(c)(1)(iii) which requires 

DMEPOS suppliers to comply with local 

zoning requirements as part of the 

supplier standards. We note that 

DMEPOS suppliers would still be 

required to comply with all applicable 

Federal and State laws to comply with 

the supplier standards. Furthermore, 

suppliers are still required to comply 

with all applicable local zoning 

requirements. However, we believe that 

allowing local municipalities to enforce 

their zoning requirements is most 

appropriate since the local 

municipalities are most familiar with 

their respective requirements and have 

jurisdiction over these matters. 

D. State Licensing Requirement 

Exceptions 

DMEPOS supplier standards require 

that DMEPOS suppliers maintain a 

physical facility on an appropriate site 

as specified in § 424.57(c)(7)(i). 

Currently, § 424.57(c)(7)(i)(A) states that 

DMEPOS suppliers must meet certain 

square footage requirements. This 

provision has an exception for Statelicensed orthotic and prosthetic 

professionals providing custom 

fabricated orthotics or prosthetics in 

private practice. We are proposing that 

if a State does not offer licensure for 

orthotic and prosthetic personnel 

providing custom fabricated orthotics or 

prosthetics in private practice, then 

those non-State licensed suppliers in 

private practice would also meet the 

exception. However, if the suppliers’ 

State does offer licensure for this 

practice area, the exception would 

apply only to those holding the 

applicable State license. 

Therefore, we propose to modify 

§ 424.57(c)(7)(i)(A) to add a provision 

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Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Proposed Rules 18475 

that allows prosthetic and orthotic 

professionals to qualify for the 

minimum square footage exception if 

the State does not offer licensure. We 

are proposing this modification because 

we believe that due to the variations in 

State licensing procedures, comparable 

practitioners should not be excluded 

under this rule. However, if a State does 

offer licensure for such professionals, 

the orthotics and prosthetics 

professionals would be required to 

obtain licensure in order to qualify for 

the exception to the minimum square 

footage requirement set forth in 

§ 424.57(c)(7)(i)(A). 

In addition, our current regulations at 

§ 424.57(c)(30)(i) state that suppliers 

must be open to the public a minimum 

of 30 hour per week. Paragraph 

(c)(30)(ii)(B) of this section specifies an 

exception to the minimum hours of 

operations requirement for licensed 

non-physician practitioners whose 

services are defined in section 1861 (p) 

and (g) of the Act. We note that section 

1861(p) and (g) of the Act define certain 

outpatient physical therapy services and 

certain outpatient occupational therapy 

services, respectively. Therefore, to 

clarify which non-physician 

practitioners qualify for the minimum 

hours of operations exception, we are 

proposing to revise § 424.57(c)(30)(ii)(B) 

by removing the phrase ‘‘licensed nonphysician practitioners’’ and more 

specifically referring to the applicable 

sections of the Act. This also should 

remove any associated confusion that 

the public has regarding the impact of 

licensure in meeting this exception. 

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. chapter 35). 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

V. Regulatory Impact Statement 

We have examined the impacts of this 

rule as required by Executive Order 

12866 on Regulatory Planning and 

review (September 30, 1993), 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 (Pub. L. 

104–4), Executive Order 13132 on 

Federalism (August 4, 1999), and the 

Congressional Review Act (5 U.S.C. 

804(2)). 

Executive Order 12866 directs 

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). This proposed rule does 

not reach the economic threshold and 

thus is not considered a major rule. 

The RFA requires agencies to analyze 

options for regulatory relief for small 

entities, if a rule has a significant impact 

on a substantial number of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and 

government agencies. Most hospitals 

and most other providers and suppliers 

are small entities, either by nonprofit 

status or by having revenues of $7.0 to 

$34.5 million in any 1 year. (For details, 

see the Small Business Administration’s 

Web site at http://ecfr.gpoaccess.gov/

cgi/t/text/text-idx?c=ecfr&sid=2465b064

ba6965cc1fbd2eae60854b11&rgn=div8&

view=text&node=13:1.0.1.1.16.1.266.9&

idno=13 (refer to the 620000 series. 

There are four categories of provider 

revenues listed, $7.0, $10.0, $13.5, and 

$34.5 million or less). Individuals and 

States are not included in the definition 

of a small entity. 

We are not preparing an analysis for 

the RFA because the Secretary has 

determined that this rule will not have 

a significant economic impact on a 

substantial number of small entities. We 

have determined that the RFA is 

reasonable given that the provisions 

contained in this proposed rule are 

primarily procedural and do not require 

DMEPOS suppliers to incur additional 

operating costs. We also believe that the 

regulatory impact of this proposed rule 

is negligible and not calculable. This 

proposed rule would revise and clarify 

our current policy in the DMEPOS 

supplier standards covered in § 424.57. 

Therefore, we anticipate a minimal 

economic impact, if any, on small 

entities. 

As of March 2008, there were 113,154 

individual DMEPOS suppliers. 

However, due to the affiliation of some 

DMEPOS suppliers with chains, there 

were only approximately 65,984 unique 

billing numbers. We believe that 

approximately 20 percent of the 

DMEPOS suppliers are located in rural 

areas. 

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 603 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 and has 

fewer than 100 beds. We are not 

preparing an analysis for section 1102(b) 

of the Act because the Secretary has 

determined that this proposed rule will 

not have a significant impact on the 

operations of a substantial number of 

small rural hospitals. Any language 

herein impacting rural institutions will 

only serve to place fewer restrictions on 

these entities, creating a small burden, 

if any. We understand that a large 

number of DMEPOS suppliers fall into 

this category, however these provisions 

are very narrow in scope and we expect 

that legitimate DMEPOS suppliers are 

already meeting these provisions. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

also requires that agencies assess 

anticipated costs and benefits before 

issuing any rule that may result in 

expenditure in any 1 year by State, 

local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million. In 2011, that threshold 

was approximately $136 million. This 

rule does not mandate expenditures by 

State, local, or tribal governments, in the 

aggregate, or by the private sector of 

$135 million and therefore no analysis 

is required. 

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 regulation does not impose 

any costs on State or local governments, 

the requirements of E.O. 13132 are not 

applicable. 

We have considered alternatives to all 

of the provisions. 

For instance, to reduce the burden 

associated with the provision limiting 

‘‘direct solicitation,’’ but also to establish 

some standards of conduct and 

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18476 Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Proposed Rules 

beneficiary protection, we are relaxing 

the current rule barring ‘‘direct 

solicitation’’ and are reverting to the 

requirements in place prior to the 

August 27, 2010 final rule. We did 

consider the alternative of not 

proceeding with the proposed 

provisions; however, we believe that the 

proposed rule is necessary to ensure 

consistency and clarity with regard to 

supplier standards. In addition, we are 

relaxing our standards to enable certain 

nonphysician practitioners to more 

easily provide access to care for our 

beneficiaries by reducing the burden 

associated with the provisions limiting 

licensed professionals, zoning 

requirements, and addressing certain 

contractual arrangement issues. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects in 42 CFR Part 424 

Emergency medical services, Health 

facilities, Health professionals, 

Medicare, Reporting and recordkeeping 

requirements. 

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services proposed to amend 

42 CFR part 424 as set forth below: 

PART 424—CONDITIONS FOR 

MEDICARE PAYMENT 

1. The authority citation for part 424 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395hh). 

Subpart D—To Whom Payment Is 

Ordinarily Made 

§ 424.57 Amended 

2. Section 424.57 is amended by— 

A. Removing the definition of ‘‘Direct 

solicitation’’ in paragraph (a). 

B. Revising paragraph (c)(1)(ii). 

C. Removing paragraph (c)(1)(iii). 

D. Revising paragraphs (c)(7)(i)(A) and 

(c)(11). 

E. In paragraph (c)(30)(ii)(B), 

removing the phrase ‘‘Licensed nonphysician practitioners’’ and adding the 

phrase ‘‘A physical or occupational 

therapist’’ in its place. 

The additions and revisions read as 

follows: 

§ 424.57 Special payment rules for items 

furnished by DMEPOS suppliers and 

issuance of DMEPOS supplier billing 

privileges. 

(c) * * * 

(1) * * * 

(ii) State licensure and regulatory 

requirements. If a State requires 

licensure to furnish certain items or 

services, a DMEPOS supplier— 

(A) Must be licensed to provide the 

item or service; and 

(B) May contract with an individual 

or other entity to provide the licensed 

services unless expressly prohibited by 

State law. 

* * * * * 

(7) * * * 

(i) * * * 

(A)(1) Except for orthotic and 

prosthetic personnel described in 

paragraph (c)(7)(i)(A)(2) of this section, 

maintains a practice location that is at 

least 200 square feet beginning— 

(i) September 27, 2010 for a 

prospective DMEPOS supplier; 

(ii) The first day after termination of 

an expiring lease for an existing 

DMEPOS supplier with a lease that 

expires on or after September 27, 2010 

and before September 27, 2013; or 

(iii) September 27, 2013, for an 

existing DMEPOS supplier with a lease 

that expires on or after September 27, 

2013. 

(2) Orthotic and prosthetic personnel 

providing custom fabricated orthotics or 

prosthetics in private practice do not 

have to meet the practice location 

requirements in paragraph(c)(7)(i)(A)(1) 

of this section if the orthotic and 

prosthetic personnel are— 

(i) State-licensed; or 

(ii) Practicing in a State that does not 

offer State licensure for orthotic and 

prosthetic personnel. 

* * * * * 

(11) Must agree not to contact a 

beneficiary by telephone when 

supplying a Medicare-covered item 

unless one of the following applies: 

(i) The individual has given written 

permission to the supplier to contact 

them by telephone concerning the 

furnishing of a Medicare-covered item 

that is to be rented or purchased. 

(ii) The supplier has furnished a 

Medicare-covered item to the individual 

and the supplier is contacting the 

individual to coordinate the delivery of 

the item. 

(iii) If the contact concerns the 

furnishing of a Medicare-covered item 

other than a covered item already 

furnished to the individual, the supplier 

has furnished at least one covered item 

to the individual during the 15-month 

period preceding the date on which the 

supplier makes such contact. 

* * * * * 

Authority: (Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: February 9, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: February 25, 2011. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2011–7885 Filed 4–1–11; 8:45 am] 

BILLING CODE 4120–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 1 

[WT Docket No. 11–40; FCC 11–29] 

Improving Communications Services 

for Native Nations by Promoting 

Greater Utilization of Spectrum Over 

Tribal Lands 

AGENCY: Federal Communications 

Commission. 

ACTION: Proposed rule. 

SUMMARY: This document seeks 

comment on a range of specific 

proposals and issues with the objective 

of promoting greater use of spectrum 

over unserved and underserved Tribal 

lands. 

DATES: Comments are due on or before 

May 19, 2011; reply comments are due 

on or before June 20, 2011. 

ADDRESSES: You may submit comments, 

identified by WT Docket No. 11–40, by 

any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Federal Communications 

Commission’s Web Site: http:// 

fjallfoss.fcc.gov/ecfs2/. Follow the 

instructions for submitting comments. 

• Paper Filers: Parties who choose to 

file by paper must file an original and 

four copies of each filing. Filings can be 

sent by hand or messenger delivery, by 

commercial overnight courier, or by 

first-class or overnight U.S. Postal 

Service mail. All filings must be 

addressed to the Commission’s 

Secretary, Office of the Secretary, 

Federal Communications Commission. 

• All hand-delivered or messengerdelivered paper filings for the 

Commission’s Secretary must be 

delivered to FCC Headquarters at 445 

12th St., SW., Room TW–A325, 

Washington, DC 20554. All hand 

deliveries must be held together with 

rubber bands or fasteners. Any 

envelopes must be disposed of before 

entering the building. 

• Commercial overnight mail (other 

than U.S. Postal Service Express Mail 

and Priority Mail) must be sent to 9300 

mstockstill on DSKH9S0YB1PROD with PROPOSALS