[Federal Register Volume 76, Number 64 (Monday, April 4, 2011)]
[Proposed Rules]
[Pages 18472-18476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7885]
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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.
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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 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 http://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