Medicare Program; Revisions to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers Safeguards, 18472-18476 [2011-7885]
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Federal Register / Vol. 76, No. 64 / Monday, April 4, 2011 / Proposed Rules
opportunity for public comment. We
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Dated: February 18, 2011.
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[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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
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
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SUMMARY:
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to https://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
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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: https://
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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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
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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.
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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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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.
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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
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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
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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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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.
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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
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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 https://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.
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18475
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
E:\FR\FM\04APP1.SGM
04APP1
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
mstockstill on DSKH9S0YB1PROD with PROPOSALS
§ 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
VerDate Mar<15>2010
18:37 Apr 01, 2011
Jkt 223001
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)
PO 00000
Frm 00058
Fmt 4702
Sfmt 4702
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
Federal Communications
Commission.
ACTION: Proposed rule.
AGENCY:
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: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Federal Communications
Commission’s Web Site: https://
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
SUMMARY:
E:\FR\FM\04APP1.SGM
04APP1
Agencies
[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Proposed Rules]
[Pages 18472-18476]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7885]
=======================================================================
-----------------------------------------------------------------------
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 https://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: https://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 Sec. 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 Sec. 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
[[Page 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 Sec. 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 Sec.
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 Sec. 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 Sec. 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,
[[Page 18474]]
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 Sec. 424.57(a) to remove
the definition of ``direct solicitation'' and revise our regulations at
Sec. 424.57(c)(11).
The supplier standard at Sec. 424.57(c)(11) currently states that
suppliers must do the following:
Agree not to make a direct solicitation (as defined in Sec.
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 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.
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 Sec. 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 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.
Although we are proposing to modify the supplier standard on direct
solicitation at Sec. 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 Sec. 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
Sec. 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 Sec.
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 Sec.
424.57(c)(7)(i). Currently, Sec. 424.57(c)(7)(i)(A) states that DMEPOS
suppliers must meet certain square footage requirements. This provision
has an exception for State-licensed 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 Sec. 424.57(c)(7)(i)(A) to add a
provision
[[Page 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 Sec. 424.57(c)(7)(i)(A).
In addition, our current regulations at Sec. 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 Sec.
424.57(c)(30)(ii)(B) by removing the phrase ``licensed non-physician
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 https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=2465b064ba6965cc1fbd2eae60854b11&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 Sec. 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
[[Page 18476]]
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
Sec. 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 non-
physician practitioners'' and adding the phrase ``A physical or
occupational therapist'' in its place.
The additions and revisions read as follows:
Sec. 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