Medicaid Program; State Option To Establish Non-Emergency Medical Transportation Program, 48604-48608 [E7-16172]
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Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Proposed Rules
second paragraph of the column, the
language ‘‘Responsiveness Test:
Charitable Trusts. Before enactment of
the PPA,’’ is corrected to read
‘‘Responsiveness Test: Charitable
Trusts. Before enactment of the PPA,’’.
2. On page 42336, column 2, in the
preamble, under the paragraph heading
‘‘Qualification Requirements for Type III
Supporting Organizations Prior to
Enactment of the Pension Protection
Act’’, seventh line of the second
paragraph of the column, the language
‘‘trust under state law, (2) each
publicly’’ is corrected to read ‘‘trust
under State law, (2) each publicly’’.
3. On page 42336, column 3, in the
preamble, under the paragraph heading
‘‘PPA Amendments to Qualification
Requirements for Type III Supporting
Organizations’’, second line of the
second paragraph, the language
‘‘enacted Code sections 509(d) and’’ is
corrected to read ‘‘enacted Code
sections 509(f) and’’.
4. On page 42336, column 3, in the
preamble, under the paragraph heading
‘‘PPA Amendments to Qualification
Requirements for Type III Supporting
Organizations’’, third line from the
bottom of the column, the language
‘‘Protection of 2006,’’ as Passed by the’’
is corrected to read ‘‘Protection Act of
2006,’’ as Passed by the’’.
LaNita Van Dyke,
Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief
Counsel (Procedure and Administration).
[FR Doc. E7–16715 Filed 8–23–07; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 440
[CMS–2234–P]
RIN 0938–A045
Medicaid Program; State Option To
Establish Non-Emergency Medical
Transportation Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
implement section 6083 of the Deficit
Reduction Act of 2005 which provides
States with additional State plan
flexibility to establish a non-emergency,
medical transportation brokerage
program, and to receive the Federal
medical assistance percentage rate. This
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SUMMARY:
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authority supplements the current
authority that States have to provide
non-emergency medical transportation
to Medicaid beneficiaries who need
access to medical care, but have no
other means of transportation.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on September 24, 2007.
ADDRESSES: In commenting, please refer
to file code CMS–2234–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (no duplicates, please):
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.cms.hhs.gov/eRulemaking. Click
on the link ‘‘Submit electronic
comments on CMS regulations with an
open comment period.’’ (Attachments
should be in Microsoft Word,
WordPerfect, or Excel; however, we
prefer Microsoft Word.)
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–2244–
P, P.O. Box 8017, Baltimore, MD 21244–
8017.
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 (one
original and two copies) to the following
address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–2234–
P, 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 (one original
and two copies) before the close of the
comment period to one of the following
addresses. If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
7195 in advance to schedule your
arrival with one of our staff members.
Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500
Security Boulevard, Baltimore, MD
21244–1850.
(Because access to the interior of the
HHH 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
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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.)
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
Submission of comments on
paperwork requirements. You may
submit comments on this document’s
paperwork requirements by mailing
your comments to the addresses
provided at the end of the ‘‘Collection
of Information Requirements’’ section in
this document.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Donna Schmidt, (410) 786–5532.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this rule to assist us in fully
considering issues and developing
policies. You can assist us by
referencing the file code CMS–2234–P
and the specific ‘‘issue identifier’’ that
precedes the section on which you
choose to comment.
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.cms.hhs.gov/
eRulemaking. Click on the link
‘‘Electronic Comments on CMS
Regulations’’ 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
For more than a decade, States have
been asking for the tools to modernize
their Medicaid programs. With the
enactment of section 6083 of the Deficit
Reduction Act of 2005 (DRA), Pub. L.
109–171, on February 8, 2006, States
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now have new options to create
programs that are more aligned with
today’s Medicaid populations and the
health care environment. Cost sharing,
benefit flexibility through benchmark
plans, the health opportunity accounts
(HOA), and the flexibility to design costeffective transportation programs
provide opportunities to modernize
Medicaid, make the cost of the program
and health care more affordable, and
expand coverage for the uninsured.
B. Statutory Authority
Section 6083 of the DRA amended
section 1902(a) of the Social Security
Act (the Act) by adding a new section
1902(a)(70), which allows States to
amend their Medicaid State plans to
establish a non-emergency medical
transportation brokerage program
without regard to statutory requirements
for comparability, state-wideness, and
freedom of choice. This proposed
regulation would provide States with
the flexibility granted by the statute.
II. Provisions of the Proposed
Regulations
[If you choose to comment on issues in
this section, please include the caption
‘‘Provisions of the Proposed
Regulations’’ at the beginning of your
comments.]
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A. Overview
The Department of Health and Human
Services (DHHS) began issuing guidance
about the new flexibilities available to
States within months of the enactment
of the DRA. On March 31, 2006, DHHS
issued a State Medicaid Director letter
providing guidance on the
implementation of section 6083 of the
DRA. The proposed regulation would
formalize the guidance issued on nonemergency medical transportation
programs. The proposed regulation
would add a new paragraph (4) to 42
CFR 440.170(a).
B. Requirements of the Provision for
State Plans
Under § 431.53, States are required in
their Title XIX State plans to ensure
necessary transportation of Medicaid
beneficiaries to and from providers.
Expenditures for transportation may be
claimed as administrative costs, or a
State may elect to include transportation
as medical assistance under its State
Medicaid plan.
Before enactment of the DRA, if a
State wanted to provide transportation
as medical assistance under the State
plan, it could not restrict beneficiary
choice by selectively contracting with a
broker, nor could it provide services
differently in different areas of the State
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without receiving, under section 1915(b)
of the Act, a waiver of freedom of
choice, comparability, and statewideness otherwise required at section
1902(a) of the Act. These waivers
allowed States to selectively contract
with brokers and to operate their
programs differently in different areas of
the State.
The DRA gives the States greater
flexibility in providing non-emergency
medical transportation. States are no
longer required to obtain a section
1915(b) waiver in order to provide nonemergency transportation as an optional
medical service through a competitively
contracted broker. A State plan
amendment for such a brokerage
program eliminates the administrative
burden of the 1915(b) biannual waiver
renewal. Under new section 1902(a)(70)
of the Act, a State may now use a nonemergency medical transportation
brokerage program when providing
transportation as medical assistance
under the State plan, notwithstanding
the provisions of sections 1902(a)(1),
1902(a)(10)(B), and 1902(a)(23) of the
Act, concerning state-wideness,
comparability, and freedom of choice,
respectively.
Current regulations provide that when
a State includes transportation in its
State plan as medical assistance, it is
required to use a direct vendor payment
system that is consistent with applicable
regulations at § 440.170(a), and it must
also comply with all other requirements
related to medical services, including
freedom of choice, comparability, and
state-wideness. To implement the
provisions of section 1902(a)(70) of the
Act, we propose revising § 440.170(a) to
add a new paragraph (4), Nonemergency medical transportation
brokerage program, to reflect the
increased flexibility allowed by the
DRA.
We propose allowing, at the option of
the State, the establishment of a nonemergency medical transportation
brokerage program. We believe that this
may prove to be a more cost-effective
way of providing transportation for
individuals eligible for medical
assistance under the State plan, who
need access to medical care or services
and have no other means of
transportation.
As provided by the statute, we
propose specifying in § 440.170(a)(4)
that the broker could provide for
transport services that include
wheelchair vans, taxis, stretcher cars,
bus passes and tickets, secured
transportation. We are interpreting
‘‘secured transportation’’ in this context
to mean a form of transportation
containing an occupant protection
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system that addresses the safety needs
of disabled or special needs individuals.
The Deficit Reduction Act also
provides that other forms of
transportation may be included as
determined by the Secretary to be
appropriate. At this time, we are not
proposing to determine any additional
transportation services to be generally
appropriate. We are proposing,
however, to allow States to identify
additional transportation alternatives
that are otherwise covered under the
State plan (and not specific to services
available through transportation
brokers). CMS will review these
alternatives in the State plan
amendment approval process for
transportation services generally. In that
process, we will consider individual
circumstances in the State and
applicable utilization controls. For
example, air transportation may be
appropriate in States with significant
rural populations and low population
density, but not in other States. Even in
those States, air transportation may only
be appropriate with appropriate
utilization controls. Thus, we are
proposing to make this determination in
the context of our review of State plan
amendments based on the information
furnished by the State.
At § 440.170(a)(4), we propose that
the competitive bidding process be
consistent with applicable Department
regulations at 45 CFR 92.36, based on
the State’s evaluation of the broker’s
experience, performance, references,
resources, qualifications and cost, and
that the contract with the broker include
oversight procedures to monitor
beneficiary access and complaints, and
ensure that transport personnel are
licensed, qualified, competent, and
courteous. We are proposing that State
and local bodies that wish to serve as
brokers compete on the same terms as
non-governmental entities.
We propose in paragraph (a)(4)(iv) to
include prohibitions on broker selfreferrals and conflict of interest, based
on the prohibitions on physician
referrals under section 1877 of the Act
(42 U.S.C. 1395(nn)). Section 1877 of
the Act generally prohibits a physician
from making referrals for certain
designated health services payable by
Medicare to an entity, with which he or
she (or an immediate family member)
has a financial relationship (ownership
or compensation) unless an exception
applies. In addition, to prevent other
types of fraud and abuse, the antikickback provisions in section
1128B(b)of the Act (42 U.S.C. 1320a–
7b(b)) and the provisions in the civil
False Claims Act (31 U.S.C. 3729) also
apply to this transportation program as
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they apply to the Medicaid program
generally.
We believe that the Congress intended
that section 1877 of the Act and the
applicable regulations be used as a
model for establishing broker
prohibitions on referrals, conflicts of
interest, and impermissible kickbacks,
in order to prevent fraud and abuse.
A financial relationship, as defined in
our regulations implementing section
1877 of the Act at § 411.354(a), includes
any direct or indirect ownership or
investment interest in the entity that
furnishes designated health services and
any compensation arrangement between
such an entity and the physician or an
immediate family member of the
physician.
Section 1877 of the Act includes
certain ownership and investment
exceptions, compensation exceptions,
and some exceptions that apply to
ownership, investment, and
compensation relationships. In addition,
section 1877(b)(4) of the Act allows the
Secretary to create an exception in the
case of any other financial relationship
that does not pose a risk of program or
patient abuse.
For purposes of new § 440.170(a), we
propose that the term ‘‘transportation
broker’’ include contractors, owners,
investors, Boards of Directors, corporate
officers, and employees.
We propose to use the definition of
‘‘financial relationship’’ as set forth in
regulations at § 411.354(a) by means of
cross-reference, with the term
‘‘transportation broker’’ substituted for
‘‘physician’’ and ‘‘non-emergency
transportation’’ substituted for ‘‘DHS.’’
We propose to use the definition of
‘‘immediate family member’’ or member
of a ‘‘physician’s immediate family’’ as
set forth in the physician self-referral
provisions in § 411.351, with the term
‘‘transportation broker’’ substituted for
‘‘physician.’’
Based on the prohibitions in section
1877 of the Act, we propose that the
broker be an independent entity, in that
the broker may not itself provide
transportation under the contract with
the State and that the broker may not
refer or subcontract to a transportation
service provider with which it has
certain financial relationships, unless
certain exceptions apply. Federal funds
may not be used for any prohibited
referrals.
Similar to some of the ownership
exceptions in section 1877 of the Act,
we propose including exceptions for a
non-governmental broker that provides
transportation in a rural area when there
is no other qualified provider available;
when the necessary transportation
provided by the non-governmental
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broker is so specialized that no other
qualified provider is available; or when
the availability of qualified providers
other than the non-governmental broker
is insufficient to meet the existing need.
For purposes of this regulation we
propose that a qualified provider would
be any Medicaid participating provider
or other provider determined by the
State to be qualified. A ‘‘rural area,’’ as
defined in § 412.62(f)(iii), is any area
that is outside an urban area. These
exceptions address specific
circumstances in which there is a lack
of transportation resources and there is
documentation to support these
exceptions.
Governmental Brokerages
We did not wish to prevent a
government entity that is awarded a
brokerage contract through the
competitive bidding process from
referring an individual in need of
transportation service to a government
transportation provider that is generally
available in the community. Therefore,
we have included an exception to allow
such a governmental broker to provide
an individual transportation service or
to arrange for the individual
transportation service by referring to or
subcontracting with another
government-owned or -controlled
transportation provider, when certain
conditions have been met that will
assure an arms-length transaction.
The broker would first be required to
be a distinct governmental unit, and the
contract could not include payment of
costs other than those unique to the
distinct brokerage function. This means
the contract could not provide for
payment of costs normally shared with
or paid by other governmental units
(such as a regional transportation
authority). This requirement would
ensure that the distinct broker unit did
not have direct financial conflicts of
interest resulting from commingling
funding with State or local general
revenue funds. Second, the broker
would have to document, after
considering the specific transportation
needs of the individual, that the
government provider was the most
appropriate, effective, and lowest cost
alternative for each individual
transportation service. And third, the
broker would have to document that for
each individual transportation service,
the Medicaid program was paying no
more than the rate charged to the
general public. Because there could still
be conflicts of interest resulting from
management oversight from a parent or
related governmental unit, we
considered proposing to limit the
exception to circumstances where the
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distinct unit governmental broker was
independent of external review and
oversight by the parent entity. However,
we currently believe that the proposed
conditions would be sufficient to
protect against inappropriate intergovernmental referrals.
We are soliciting comments,
suggestions, and examples regarding the
following exceptions mentioned above:
the service area is rural and there is no
other Medicaid participating or
qualified provider available except the
non-governmental broker; the
transportation provided by the nongovernmental broker is so specialized
that no other qualified provider is
available (including comments on how
‘‘specialized’’ should be defined);
available qualified providers other than
the non-governmental broker are
insufficient to meet the need; the broker
is a distinct government unit and is paid
only for costs that are unique to the
distinct brokerage function and the
broker documents that services
provided by any other governmental
entity are the most appropriate, least
costly alternative, and the Medicaid
program is paying no more than the rate
charged to the public.
Additionally, we are proposing to
include a prohibition on a broker
accepting any form of remuneration or
payment from a transportation provider
in exchange for influencing a referral or
subcontract for transportation services.
We also propose that in referring or
subcontracting with transportation
providers, the broker be prohibited from
withholding necessary transportation
from a recipient or providing
transportation that is not the most
appropriate and cost-effective means of
transportation.
Under section 1905(a)(28) of the Act,
the Secretary is given the authority to
specify any other medical care which
can be covered by the State. We would
therefore use authority to make Federal
financial participation available at the
medical assistance rate for the cost of
the brokerage contract, providing that
such a contract complied with the
requirements set forth in this regulation.
In accordance with Federal
requirements in sections 1902(a)(2) and
1903(w) of the Act and applicable
Federal regulations described at
§ 433.50 through § 433.74, under the
brokerage contract with the State
Medicaid agency, the non-Federal share
of the Medicaid payments made for
operating a transportation brokerage
program could only be derived from
permissible sources and must comply
with the applicable statute and
regulations cited above. Also, the return
of any Medicaid payments (directly or
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indirectly) to a State or local
government entity under the nonemergency transportation brokerage
program is prohibited.
We propose that the State, in
contracting with the broker, would be
required to specify that violation of
these provisions would be deemed to be
a breach of contract and that the State
could move to terminate the contract
with the broker.
III. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 60day notice in the Federal Register and
solicit public comment before a
collection of information requirement is
submitted to the Office of Management
and Budget (OMB) for review and
approval. In order to fairly evaluate
whether an information collection
should be approved by OMB, section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we
solicit comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
We are soliciting public comment on
each of these issues for the following
sections of this document that contain
information collection requirements:
Section 6083 of the DRA (Nonemergency Medical Transportation
Brokerage Program) provides States with
the option to submit a State Plan
amendment (SPA) to establish a nonemergency medical transportation
brokerage program. To effectuate this
option, States must submit an
amendment to their existing State Plan.
CMS has provided States with a letter
providing guidance on this provision
and the implementation of the DRA, and
an associated SPA template for use by
States to modify their Medicaid State
plan if they choose to implement this
option.
The template is a total of five pages
and we estimate that it will take no
more than 12 minutes for a State to
actually complete and submit the
template to CMS. The potential number
of respondents is 56 (50 States, DC, and
five territories); however, we do not
expect the territories and/or all 50 states
to respond. We estimate that only five
States will submit annually. Once
approved, the State will not need to
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resubmit unless it is materially changing
the brokerage program.
At this rate, it will cost no more than
$50 (or $50 × 1⁄5 hrs × 5 states); the
national total for the first year could be
potentially $560 (56 × $10).
We have submitted a copy of this
proposed rule to OMB for its review of
the information collection requirements
described above. These requirements are
not effective until they have been
approved by OMB.
If you comment on these information
collection and recordkeeping
requirements, please mail copies
directly to the following:
Centers for Medicare & Medicaid
Services, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development, Attn: Melissa
Musotto, [CMS–2234–P], Room C4–26–
05, 7500 Security Boulevard, Baltimore,
MD 21244–1850; and
Office of Information and Regulatory
Affairs, Office of Management and
Budget, Room 10235, New Executive
Office Building, Washington, DC 20503,
Attn: Katherine Astrich, CMS Desk
Officer, CMS–2244–P,
katherine_astrich@omb.eop.gov. Fax
(202) 395–6974.
IV. Regulatory Impact Statement
[If you choose to comment on issues in
this section, please include the caption
‘‘Regulatory Impact Statement’’ at the
beginning of your comments.]
We have examined the impact of this
rule as required by Executive Order
12866 (September 1993, Regulatory
Planning and Review), the Regulatory
Flexibility Act (RFA) (September 19,
1980, Pub. L. 96–354), section 1102(b) of
the Social Security Act, the Unfunded
Mandates Reform Act of 1995 (Pub. L.
104–4), and Executive Order 13132.
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). We estimate that this
regulation will have estimated budget
savings of $60 million between FY 2006
and FY 2010 due to the implementation
of section 6083 of the Deficit Reduction
Act of 2005. This rule would not reach
the economic threshold and thus is not
considered a major rule.
The RFA requires agencies to analyze
options for regulatory relief of small
businesses. For purposes of the RFA,
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small entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of $6.5 million to $30.5 million in any
1 year. Individuals and States are not
included in the definition of a small
entity. We are not preparing an analysis
for the RFA because we have
determined, and the Secretary certifies,
that this rule would not have a
significant economic impact on a
substantial number of small entities.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 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 we have determined,
and the Secretary certifies, that this rule
would not have a significant impact on
the operations of a substantial number
of small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
That threshold level is currently
approximately $120 million. This rule
would have no consequential effect on
State, local, or tribal governments or on
the private sector.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule and subsequent final rule
that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
Since this regulation would not impose
any costs on State or local governments,
the requirements of E.O. 13132 are not
applicable.
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 440
Grant programs—health, Medicaid.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services would amend 42 CFR
chapter IV as set forth below:
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PART 440—SERVICES: GENERAL
PROVISIONS
1. The authority citation for part 440
continues to read as follows:
Authority: Sec. 1102 of the Social Security
Act (42 U.S.C. 1302), as amended.
2. A new authority citation is added
in numerical order to § 440.1 to read as
follows:
§ 440.1
Basis and purpose.
*
*
*
*
*
1902(a)(70), State option to establish a
non-emergency medical transportation
program.
*
*
*
*
*
3. Section 440.170 is amended by
revising paragraph (a)(2) and adding
new paragraph (a)(4) to read as follows:
rfrederick on PROD1PC67 with PROPOSALS
§ 440.170 Any other medical care or
remedial care recognized under State law
and specified by the Secretary.
(a) * * *
(2) Except as provided in paragraph
(a)(4), transportation, as defined in this
section, is furnished only by a provider
to whom a direct vendor payment can
appropriately be made by the agency.
(3) * * *
(4) Non-emergency medical
transportation brokerage program. At
the option of the State, and
notwithstanding § 431.50 (statewide
operation) and § 431.51 (freedom of
choice of providers) of this chapter and
§ 440.240 (comparability of services for
groups), a State plan may provide for
the establishment of a non-emergency
medical transportation brokerage
program in order to more costeffectively provide non-emergency
medical transportation services for
individuals eligible for medical
assistance under the State plan who
need access to medical care or services,
and have no other means of
transportation. These transportation
services include wheelchair vans, taxis,
stretcher cars, bus passes and tickets,
secured transportation containing an
occupant protection system that
addresses safety needs of disabled or
special needs individuals, and other
forms of transportation otherwise
covered under the state plan.
(i) Non-emergency medical
transportation services may be provided
under contract with an individual or
entity that meets the following
requirements:
(A) Is selected through a competitive
bidding process that is consistent with
45 CFR part 92.36 and is based on the
State’s evaluation of the broker’s
experience, performance, references,
resources, qualifications, and costs.
VerDate Aug<31>2005
13:20 Aug 23, 2007
Jkt 211001
(B) Has oversight procedures to
monitor beneficiary access and
complaints and ensure that transport
personnel are licensed, qualified,
competent, and courteous.
(C) Is subject to regular auditing and
oversight by the State in order to ensure
the quality of the transportation services
provided and the adequacy of
beneficiary access to medical care and
services.
(D) Is subject to a written contract that
imposes the requirements related to
prohibitions on referrals and conflicts of
interest described at § 440.170(a)(4)(ii),
and provides for the broker to be liable
for the full cost of services resulting
from a prohibited referral or
subcontract.
(ii) Federal financial participation is
available at the medical assistance rate
for the cost of a written brokerage
contract that:
(A) Except as provided in paragraph
(a)(4)(ii)(B) of this section, prohibits the
broker (including contractors, owners,
investors, Boards of Directors, corporate
officers, and employees) from providing
non-emergency medical transportation
services or making a referral or
subcontracting to a transportation
service provider if:
(1) The broker has a financial
relationship with the transportation
provider as defined at § 411.354(a) of
this chapter with ‘‘transportation
broker’’ substituted for ‘‘physician’’ and
‘‘non-emergency transportation’’
substituted for ‘‘DHS’’; or
(2) The broker has an immediate
family member, as defined at § 411.351
of this chapter, that has a direct or
indirect financial relationship with the
transportation provider, with the term
‘‘transportation broker’’ substituted for
‘‘physician.’’
(B) Exceptions: The prohibitions
described at clause (A) of this paragraph
do not apply if there is documentation
to support the following:
(1) Transportation is provided in a
rural area, as defined at § 412.62(f), and
there is no other available Medicaid
participating provider or other provider
determined by the State to be qualified
except the non-governmental broker.
(2) Transportation is so specialized
that there is no other available Medicaid
participating provider or other provider
determined by the State to be qualified
except the non-governmental broker.
(3) Except for the non-governmental
broker, the availability of other
Medicaid participating providers or
other providers determined by the State
to be qualified is insufficient to meet the
need for transportation.
(4) The broker is a distinct
government entity and the individual
PO 00000
Frm 00018
Fmt 4702
Sfmt 4702
service is provided by the broker, or is
referred to or subcontracted with
another government-owned or operated
transportation provider generally
available in the community, if the
following conditions are met:
(i) The contract with the broker
provides for payment that does not
exceed actual costs calculated as a
distinct unit, excluding personnel or
other costs shared with or allocated
from parent or related entities;
(ii) The broker documents that, with
respect to the individual’s specific
transportation needs, the government
provider is the most appropriate and
lowest cost alternative; and
(iii) The broker documents that the
Medicaid program is paying no more
than the rate charged to the general
public.
(C) Transportation providers may not
offer or make any payment or other form
of remuneration, including any
kickback, rebate, cash, gifts, or service
in kind to the broker in order to
influence referrals or subcontracting for
non-emergency medical transportation
provided to a Medicaid recipient.
(D) In referring or subcontracting for
non-emergency medical transportation
with transportation providers, a broker
may not withhold necessary nonemergency medical transportation from
a Medicaid recipient or provide nonemergency medical transportation that
is not the most appropriate and a costeffective means of transportation for that
recipient for the purpose of financial
gain, or for any other purpose.
(E) The non-Federal share of all
Medicaid payments under the
transportation brokerage program must
be in compliance with applicable
Federal requirements in sections
1902(a)(2) and 1903(w) of the Act, and
applicable Federal regulations set forth
at § 433.50 through § 433.74 of this
chapter.
*
*
*
*
*
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program)
Dated: August 30, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: May 10, 2007.
Michael O. Leavitt,
Secretary.
Editorial Note: This document was
received at the Office of the Federal Register
on August 13, 2007.
[FR Doc. E7–16172 Filed 8–23–07; 8:45 am]
BILLING CODE 4120–01–P
E:\FR\FM\24AUP1.SGM
24AUP1
Agencies
[Federal Register Volume 72, Number 164 (Friday, August 24, 2007)]
[Proposed Rules]
[Pages 48604-48608]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16172]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 440
[CMS-2234-P]
RIN 0938-A045
Medicaid Program; State Option To Establish Non-Emergency Medical
Transportation Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would implement section 6083 of the Deficit
Reduction Act of 2005 which provides States with additional State plan
flexibility to establish a non-emergency, medical transportation
brokerage program, and to receive the Federal medical assistance
percentage rate. This authority supplements the current authority that
States have to provide non-emergency medical transportation to Medicaid
beneficiaries who need access to medical care, but have no other means
of transportation.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 24,
2007.
ADDRESSES: In commenting, please refer to file code CMS-2234-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to https://www.cms.hhs.gov/eRulemaking. Click
on the link ``Submit electronic comments on CMS regulations with an
open comment period.'' (Attachments should be in Microsoft Word,
WordPerfect, or Excel; however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-2244-P, P.O. Box 8017, Baltimore, MD
21244-8017.
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 (one
original and two copies) to the following address ONLY:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-2234-P, 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 (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-7195 in advance to schedule your arrival
with one of our staff members.
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD
21244-1850.
(Because access to the interior of the HHH 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.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
Submission of comments on paperwork requirements. You may submit
comments on this document's paperwork requirements by mailing your
comments to the addresses provided at the end of the ``Collection of
Information Requirements'' section in this document.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Donna Schmidt, (410) 786-5532.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on all
issues set forth in this rule to assist us in fully considering issues
and developing policies. You can assist us by referencing the file code
CMS-2234-P and the specific ``issue identifier'' that precedes the
section on which you choose to comment.
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.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on
CMS Regulations'' 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
For more than a decade, States have been asking for the tools to
modernize their Medicaid programs. With the enactment of section 6083
of the Deficit Reduction Act of 2005 (DRA), Pub. L. 109-171, on
February 8, 2006, States
[[Page 48605]]
now have new options to create programs that are more aligned with
today's Medicaid populations and the health care environment. Cost
sharing, benefit flexibility through benchmark plans, the health
opportunity accounts (HOA), and the flexibility to design cost-
effective transportation programs provide opportunities to modernize
Medicaid, make the cost of the program and health care more affordable,
and expand coverage for the uninsured.
B. Statutory Authority
Section 6083 of the DRA amended section 1902(a) of the Social
Security Act (the Act) by adding a new section 1902(a)(70), which
allows States to amend their Medicaid State plans to establish a non-
emergency medical transportation brokerage program without regard to
statutory requirements for comparability, state-wideness, and freedom
of choice. This proposed regulation would provide States with the
flexibility granted by the statute.
II. Provisions of the Proposed Regulations
[If you choose to comment on issues in this section, please include the
caption ``Provisions of the Proposed Regulations'' at the beginning of
your comments.]
A. Overview
The Department of Health and Human Services (DHHS) began issuing
guidance about the new flexibilities available to States within months
of the enactment of the DRA. On March 31, 2006, DHHS issued a State
Medicaid Director letter providing guidance on the implementation of
section 6083 of the DRA. The proposed regulation would formalize the
guidance issued on non-emergency medical transportation programs. The
proposed regulation would add a new paragraph (4) to 42 CFR 440.170(a).
B. Requirements of the Provision for State Plans
Under Sec. 431.53, States are required in their Title XIX State
plans to ensure necessary transportation of Medicaid beneficiaries to
and from providers. Expenditures for transportation may be claimed as
administrative costs, or a State may elect to include transportation as
medical assistance under its State Medicaid plan.
Before enactment of the DRA, if a State wanted to provide
transportation as medical assistance under the State plan, it could not
restrict beneficiary choice by selectively contracting with a broker,
nor could it provide services differently in different areas of the
State without receiving, under section 1915(b) of the Act, a waiver of
freedom of choice, comparability, and state-wideness otherwise required
at section 1902(a) of the Act. These waivers allowed States to
selectively contract with brokers and to operate their programs
differently in different areas of the State.
The DRA gives the States greater flexibility in providing non-
emergency medical transportation. States are no longer required to
obtain a section 1915(b) waiver in order to provide non-emergency
transportation as an optional medical service through a competitively
contracted broker. A State plan amendment for such a brokerage program
eliminates the administrative burden of the 1915(b) biannual waiver
renewal. Under new section 1902(a)(70) of the Act, a State may now use
a non-emergency medical transportation brokerage program when providing
transportation as medical assistance under the State plan,
notwithstanding the provisions of sections 1902(a)(1), 1902(a)(10)(B),
and 1902(a)(23) of the Act, concerning state-wideness, comparability,
and freedom of choice, respectively.
Current regulations provide that when a State includes
transportation in its State plan as medical assistance, it is required
to use a direct vendor payment system that is consistent with
applicable regulations at Sec. 440.170(a), and it must also comply
with all other requirements related to medical services, including
freedom of choice, comparability, and state-wideness. To implement the
provisions of section 1902(a)(70) of the Act, we propose revising Sec.
440.170(a) to add a new paragraph (4), Non-emergency medical
transportation brokerage program, to reflect the increased flexibility
allowed by the DRA.
We propose allowing, at the option of the State, the establishment
of a non-emergency medical transportation brokerage program. We believe
that this may prove to be a more cost-effective way of providing
transportation for individuals eligible for medical assistance under
the State plan, who need access to medical care or services and have no
other means of transportation.
As provided by the statute, we propose specifying in Sec.
440.170(a)(4) that the broker could provide for transport services that
include wheelchair vans, taxis, stretcher cars, bus passes and tickets,
secured transportation. We are interpreting ``secured transportation''
in this context to mean a form of transportation containing an occupant
protection system that addresses the safety needs of disabled or
special needs individuals.
The Deficit Reduction Act also provides that other forms of
transportation may be included as determined by the Secretary to be
appropriate. At this time, we are not proposing to determine any
additional transportation services to be generally appropriate. We are
proposing, however, to allow States to identify additional
transportation alternatives that are otherwise covered under the State
plan (and not specific to services available through transportation
brokers). CMS will review these alternatives in the State plan
amendment approval process for transportation services generally. In
that process, we will consider individual circumstances in the State
and applicable utilization controls. For example, air transportation
may be appropriate in States with significant rural populations and low
population density, but not in other States. Even in those States, air
transportation may only be appropriate with appropriate utilization
controls. Thus, we are proposing to make this determination in the
context of our review of State plan amendments based on the information
furnished by the State.
At Sec. 440.170(a)(4), we propose that the competitive bidding
process be consistent with applicable Department regulations at 45 CFR
92.36, based on the State's evaluation of the broker's experience,
performance, references, resources, qualifications and cost, and that
the contract with the broker include oversight procedures to monitor
beneficiary access and complaints, and ensure that transport personnel
are licensed, qualified, competent, and courteous. We are proposing
that State and local bodies that wish to serve as brokers compete on
the same terms as non-governmental entities.
We propose in paragraph (a)(4)(iv) to include prohibitions on
broker self-referrals and conflict of interest, based on the
prohibitions on physician referrals under section 1877 of the Act (42
U.S.C. 1395(nn)). Section 1877 of the Act generally prohibits a
physician from making referrals for certain designated health services
payable by Medicare to an entity, with which he or she (or an immediate
family member) has a financial relationship (ownership or compensation)
unless an exception applies. In addition, to prevent other types of
fraud and abuse, the anti-kickback provisions in section 1128B(b)of the
Act (42 U.S.C. 1320a-7b(b)) and the provisions in the civil False
Claims Act (31 U.S.C. 3729) also apply to this transportation program
as
[[Page 48606]]
they apply to the Medicaid program generally.
We believe that the Congress intended that section 1877 of the Act
and the applicable regulations be used as a model for establishing
broker prohibitions on referrals, conflicts of interest, and
impermissible kickbacks, in order to prevent fraud and abuse.
A financial relationship, as defined in our regulations
implementing section 1877 of the Act at Sec. 411.354(a), includes any
direct or indirect ownership or investment interest in the entity that
furnishes designated health services and any compensation arrangement
between such an entity and the physician or an immediate family member
of the physician.
Section 1877 of the Act includes certain ownership and investment
exceptions, compensation exceptions, and some exceptions that apply to
ownership, investment, and compensation relationships. In addition,
section 1877(b)(4) of the Act allows the Secretary to create an
exception in the case of any other financial relationship that does not
pose a risk of program or patient abuse.
For purposes of new Sec. 440.170(a), we propose that the term
``transportation broker'' include contractors, owners, investors,
Boards of Directors, corporate officers, and employees.
We propose to use the definition of ``financial relationship'' as
set forth in regulations at Sec. 411.354(a) by means of cross-
reference, with the term ``transportation broker'' substituted for
``physician'' and ``non-emergency transportation'' substituted for
``DHS.'' We propose to use the definition of ``immediate family
member'' or member of a ``physician's immediate family'' as set forth
in the physician self-referral provisions in Sec. 411.351, with the
term ``transportation broker'' substituted for ``physician.''
Based on the prohibitions in section 1877 of the Act, we propose
that the broker be an independent entity, in that the broker may not
itself provide transportation under the contract with the State and
that the broker may not refer or subcontract to a transportation
service provider with which it has certain financial relationships,
unless certain exceptions apply. Federal funds may not be used for any
prohibited referrals.
Similar to some of the ownership exceptions in section 1877 of the
Act, we propose including exceptions for a non-governmental broker that
provides transportation in a rural area when there is no other
qualified provider available; when the necessary transportation
provided by the non-governmental broker is so specialized that no other
qualified provider is available; or when the availability of qualified
providers other than the non-governmental broker is insufficient to
meet the existing need.
For purposes of this regulation we propose that a qualified
provider would be any Medicaid participating provider or other provider
determined by the State to be qualified. A ``rural area,'' as defined
in Sec. 412.62(f)(iii), is any area that is outside an urban area.
These exceptions address specific circumstances in which there is a
lack of transportation resources and there is documentation to support
these exceptions.
Governmental Brokerages
We did not wish to prevent a government entity that is awarded a
brokerage contract through the competitive bidding process from
referring an individual in need of transportation service to a
government transportation provider that is generally available in the
community. Therefore, we have included an exception to allow such a
governmental broker to provide an individual transportation service or
to arrange for the individual transportation service by referring to or
subcontracting with another government-owned or -controlled
transportation provider, when certain conditions have been met that
will assure an arms-length transaction.
The broker would first be required to be a distinct governmental
unit, and the contract could not include payment of costs other than
those unique to the distinct brokerage function. This means the
contract could not provide for payment of costs normally shared with or
paid by other governmental units (such as a regional transportation
authority). This requirement would ensure that the distinct broker unit
did not have direct financial conflicts of interest resulting from
commingling funding with State or local general revenue funds. Second,
the broker would have to document, after considering the specific
transportation needs of the individual, that the government provider
was the most appropriate, effective, and lowest cost alternative for
each individual transportation service. And third, the broker would
have to document that for each individual transportation service, the
Medicaid program was paying no more than the rate charged to the
general public. Because there could still be conflicts of interest
resulting from management oversight from a parent or related
governmental unit, we considered proposing to limit the exception to
circumstances where the distinct unit governmental broker was
independent of external review and oversight by the parent entity.
However, we currently believe that the proposed conditions would be
sufficient to protect against inappropriate inter-governmental
referrals.
We are soliciting comments, suggestions, and examples regarding the
following exceptions mentioned above: the service area is rural and
there is no other Medicaid participating or qualified provider
available except the non-governmental broker; the transportation
provided by the non-governmental broker is so specialized that no other
qualified provider is available (including comments on how
``specialized'' should be defined); available qualified providers other
than the non-governmental broker are insufficient to meet the need; the
broker is a distinct government unit and is paid only for costs that
are unique to the distinct brokerage function and the broker documents
that services provided by any other governmental entity are the most
appropriate, least costly alternative, and the Medicaid program is
paying no more than the rate charged to the public.
Additionally, we are proposing to include a prohibition on a broker
accepting any form of remuneration or payment from a transportation
provider in exchange for influencing a referral or subcontract for
transportation services. We also propose that in referring or
subcontracting with transportation providers, the broker be prohibited
from withholding necessary transportation from a recipient or providing
transportation that is not the most appropriate and cost-effective
means of transportation.
Under section 1905(a)(28) of the Act, the Secretary is given the
authority to specify any other medical care which can be covered by the
State. We would therefore use authority to make Federal financial
participation available at the medical assistance rate for the cost of
the brokerage contract, providing that such a contract complied with
the requirements set forth in this regulation.
In accordance with Federal requirements in sections 1902(a)(2) and
1903(w) of the Act and applicable Federal regulations described at
Sec. 433.50 through Sec. 433.74, under the brokerage contract with
the State Medicaid agency, the non-Federal share of the Medicaid
payments made for operating a transportation brokerage program could
only be derived from permissible sources and must comply with the
applicable statute and regulations cited above. Also, the return of any
Medicaid payments (directly or
[[Page 48607]]
indirectly) to a State or local government entity under the non-
emergency transportation brokerage program is prohibited.
We propose that the State, in contracting with the broker, would be
required to specify that violation of these provisions would be deemed
to be a breach of contract and that the State could move to terminate
the contract with the broker.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements:
Section 6083 of the DRA (Non-emergency Medical Transportation
Brokerage Program) provides States with the option to submit a State
Plan amendment (SPA) to establish a non-emergency medical
transportation brokerage program. To effectuate this option, States
must submit an amendment to their existing State Plan. CMS has provided
States with a letter providing guidance on this provision and the
implementation of the DRA, and an associated SPA template for use by
States to modify their Medicaid State plan if they choose to implement
this option.
The template is a total of five pages and we estimate that it will
take no more than 12 minutes for a State to actually complete and
submit the template to CMS. The potential number of respondents is 56
(50 States, DC, and five territories); however, we do not expect the
territories and/or all 50 states to respond. We estimate that only five
States will submit annually. Once approved, the State will not need to
resubmit unless it is materially changing the brokerage program.
At this rate, it will cost no more than $50 (or $50 x \1/5\ hrs x 5
states); the national total for the first year could be potentially
$560 (56 x $10).
We have submitted a copy of this proposed rule to OMB for its
review of the information collection requirements described above.
These requirements are not effective until they have been approved by
OMB.
If you comment on these information collection and recordkeeping
requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, Division of Regulations Development,
Attn: Melissa Musotto, [CMS-2234-P], Room C4-26-05, 7500 Security
Boulevard, Baltimore, MD 21244-1850; and
Office of Information and Regulatory Affairs, Office of Management
and Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn: Katherine Astrich, CMS Desk Officer, CMS-2244-P,
katherine_astrich@omb.eop.gov. Fax (202) 395-6974.
IV. Regulatory Impact Statement
[If you choose to comment on issues in this section, please include the
caption ``Regulatory Impact Statement'' at the beginning of your
comments.]
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
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). We estimate
that this regulation will have estimated budget savings of $60 million
between FY 2006 and FY 2010 due to the implementation of section 6083
of the Deficit Reduction Act of 2005. This rule would not reach the
economic threshold and thus is not considered a major rule.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
$6.5 million to $30.5 million in any 1 year. Individuals and States are
not included in the definition of a small entity. We are not preparing
an analysis for the RFA because we have determined, and the Secretary
certifies, that this rule would not have a significant economic impact
on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 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 we have determined, and
the Secretary certifies, that this rule would not have a significant
impact on the operations of a substantial number of small rural
hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. That threshold
level is currently approximately $120 million. This rule would have no
consequential effect on State, local, or tribal governments or on the
private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule and subsequent
final rule that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this regulation would not impose any costs on State
or local governments, the requirements of E.O. 13132 are not
applicable.
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 440
Grant programs--health, Medicaid.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services would amend 42 CFR chapter IV as set forth below:
[[Page 48608]]
PART 440--SERVICES: GENERAL PROVISIONS
1. The authority citation for part 440 continues to read as
follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302), as amended.
2. A new authority citation is added in numerical order to Sec.
440.1 to read as follows:
Sec. 440.1 Basis and purpose.
* * * * *
1902(a)(70), State option to establish a non-emergency medical
transportation program.
* * * * *
3. Section 440.170 is amended by revising paragraph (a)(2) and
adding new paragraph (a)(4) to read as follows:
Sec. 440.170 Any other medical care or remedial care recognized under
State law and specified by the Secretary.
(a) * * *
(2) Except as provided in paragraph (a)(4), transportation, as
defined in this section, is furnished only by a provider to whom a
direct vendor payment can appropriately be made by the agency.
(3) * * *
(4) Non-emergency medical transportation brokerage program. At the
option of the State, and notwithstanding Sec. 431.50 (statewide
operation) and Sec. 431.51 (freedom of choice of providers) of this
chapter and Sec. 440.240 (comparability of services for groups), a
State plan may provide for the establishment of a non-emergency medical
transportation brokerage program in order to more cost-effectively
provide non-emergency medical transportation services for individuals
eligible for medical assistance under the State plan who need access to
medical care or services, and have no other means of transportation.
These transportation services include wheelchair vans, taxis, stretcher
cars, bus passes and tickets, secured transportation containing an
occupant protection system that addresses safety needs of disabled or
special needs individuals, and other forms of transportation otherwise
covered under the state plan.
(i) Non-emergency medical transportation services may be provided
under contract with an individual or entity that meets the following
requirements:
(A) Is selected through a competitive bidding process that is
consistent with 45 CFR part 92.36 and is based on the State's
evaluation of the broker's experience, performance, references,
resources, qualifications, and costs.
(B) Has oversight procedures to monitor beneficiary access and
complaints and ensure that transport personnel are licensed, qualified,
competent, and courteous.
(C) Is subject to regular auditing and oversight by the State in
order to ensure the quality of the transportation services provided and
the adequacy of beneficiary access to medical care and services.
(D) Is subject to a written contract that imposes the requirements
related to prohibitions on referrals and conflicts of interest
described at Sec. 440.170(a)(4)(ii), and provides for the broker to be
liable for the full cost of services resulting from a prohibited
referral or subcontract.
(ii) Federal financial participation is available at the medical
assistance rate for the cost of a written brokerage contract that:
(A) Except as provided in paragraph (a)(4)(ii)(B) of this section,
prohibits the broker (including contractors, owners, investors, Boards
of Directors, corporate officers, and employees) from providing non-
emergency medical transportation services or making a referral or
subcontracting to a transportation service provider if:
(1) The broker has a financial relationship with the transportation
provider as defined at Sec. 411.354(a) of this chapter with
``transportation broker'' substituted for ``physician'' and ``non-
emergency transportation'' substituted for ``DHS''; or
(2) The broker has an immediate family member, as defined at Sec.
411.351 of this chapter, that has a direct or indirect financial
relationship with the transportation provider, with the term
``transportation broker'' substituted for ``physician.''
(B) Exceptions: The prohibitions described at clause (A) of this
paragraph do not apply if there is documentation to support the
following:
(1) Transportation is provided in a rural area, as defined at Sec.
412.62(f), and there is no other available Medicaid participating
provider or other provider determined by the State to be qualified
except the non-governmental broker.
(2) Transportation is so specialized that there is no other
available Medicaid participating provider or other provider determined
by the State to be qualified except the non-governmental broker.
(3) Except for the non-governmental broker, the availability of
other Medicaid participating providers or other providers determined by
the State to be qualified is insufficient to meet the need for
transportation.
(4) The broker is a distinct government entity and the individual
service is provided by the broker, or is referred to or subcontracted
with another government-owned or operated transportation provider
generally available in the community, if the following conditions are
met:
(i) The contract with the broker provides for payment that does not
exceed actual costs calculated as a distinct unit, excluding personnel
or other costs shared with or allocated from parent or related
entities;
(ii) The broker documents that, with respect to the individual's
specific transportation needs, the government provider is the most
appropriate and lowest cost alternative; and
(iii) The broker documents that the Medicaid program is paying no
more than the rate charged to the general public.
(C) Transportation providers may not offer or make any payment or
other form of remuneration, including any kickback, rebate, cash,
gifts, or service in kind to the broker in order to influence referrals
or subcontracting for non-emergency medical transportation provided to
a Medicaid recipient.
(D) In referring or subcontracting for non-emergency medical
transportation with transportation providers, a broker may not withhold
necessary non-emergency medical transportation from a Medicaid
recipient or provide non-emergency medical transportation that is not
the most appropriate and a cost-effective means of transportation for
that recipient for the purpose of financial gain, or for any other
purpose.
(E) The non-Federal share of all Medicaid payments under the
transportation brokerage program must be in compliance with applicable
Federal requirements in sections 1902(a)(2) and 1903(w) of the Act, and
applicable Federal regulations set forth at Sec. 433.50 through Sec.
433.74 of this chapter.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
Dated: August 30, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: May 10, 2007.
Michael O. Leavitt,
Secretary.
Editorial Note: This document was received at the Office of the
Federal Register on August 13, 2007.
[FR Doc. E7-16172 Filed 8-23-07; 8:45 am]
BILLING CODE 4120-01-P