[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Rules and Regulations]
[Pages 44702-44704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18174]
[[Page 44702]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 424
[CMS-6059-N]
Medicare, Medicaid, and Children's Health Insurance Programs:
Announcement of the Extended Temporary Moratoria on Enrollment of
Ambulance Suppliers and Home Health Agencies in Designated Geographic
Locations
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Extension of temporary moratoria.
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SUMMARY: This document announces the extension of temporary moratoria
on the enrollment of new ambulance suppliers and home health agencies
(HHAs) in specific locations within designated metropolitan areas in
Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to
prevent and combat fraud, waste, and abuse.
DATES: Effective Date: July 29, 2014.
FOR FURTHER INFORMATION CONTACT: August Nemec, (410) 786-0612.
News media representatives must contact CMS' Public Affairs Office
at (202) 690-6145 or email them at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. CMS' Imposition of Temporary Enrollment Moratoria
Section 6401(a) of the Affordable Care Act added a new section
1866(j)(7) to the Social Security Act (the Act) to provide the
Secretary with authority to impose a temporary moratorium on the
enrollment of new Medicare, Medicaid or CHIP providers and suppliers,
including categories of providers and suppliers, if the Secretary
determines a moratorium is necessary to prevent or combat fraud, waste,
or abuse under these programs. For a more detailed explanation of these
authorities, please see the July 31, 2013 notice (78 FR 46339) or
February 4, 2014 extension and establishment of a temporary moratoria
document (hereinafter referred to as the February 4, 2014 moratoria
document) (79 FR 6475).
Based on this authority and our regulations at Sec. 424.570, we
have implemented two phases of the moratoria to date. In the notice
issued on July 31, 2013 (78 FR 46339), we imposed moratoria on the
enrollment of home health agencies in Miami-Dade County, Florida and
Cook County, Illinois and surrounding counties and on the enrollment of
ground ambulance suppliers in the Harris County, Texas area and
surrounding counties. Then, in the document published on February 4,
2014 (79 FR 6475), we imposed moratoria on the enrollment of home
health agencies in Broward County, Florida, Dallas County, Texas and
Wayne County, Michigan and surrounding counties and on the enrollment
of ground ambulance suppliers in Philadelphia, PA and surrounding
counties.
B. Determination of the Need for Extending a Moratorium
In extending these enrollment moratoria, CMS considered both
qualitative and quantitative factors suggesting a high risk of fraud,
waste, or abuse. CMS relied on law enforcement's longstanding
experience with ongoing and emerging fraud trends and activities
through civil, criminal, and administrative investigations and
prosecutions. CMS' determination of a high risk of fraud, waste, or
abuse in these provider and supplier types within these geographic
locations was then confirmed by CMS' data analysis, which relied on
factors the agency identified as strong indicators of risk. (For a more
detailed explanation of this determination process and of these
authorities, see the July 31, 2013 notice (78 FR 46339) or February 4,
2014 moratoria document (79 FR 6475)).
1. Consultation With Law Enforcement
In consultation with the HHS-OIG and the Department of Justice
(DOJ), CMS identified two provider and supplier types in nine
geographic locations that warrant a temporary enrollment moratorium.
For a more detailed discussion of this consultation process, see the
July 31, 2013 notice (78 FR 46339) or February 4, 2014 moratoria
document (79 FR 6475).
2. Beneficiary Access to Care
Beneficiary access to care in Medicare, Medicaid, and CHIP is of
critical importance to CMS and its state partners, and CMS carefully
evaluated access for the target moratorium locations. Prior to imposing
and extending these moratoria, CMS consulted with the appropriate State
Medicaid Agencies and with the appropriate State Department of
Emergency Medical Services to determine if the moratoria would create
an access to care issue for Medicaid and CHIP beneficiaries in the
targeted locations and surrounding counties. All of CMS' state partners
were supportive of CMS analysis and proposals, and together with CMS,
determined that these moratoria will not create access to care issues
for Medicaid or CHIP beneficiaries. CMS also reviewed Medicare data for
these areas and found there are no current problems with access to HHAs
or ground ambulance suppliers.
3. Lifting a Temporary Moratorium
In accordance with Sec. 424.570(b), a temporary enrollment
moratorium imposed by CMS will remain in effect for 6 months. (For a
more detailed explanation of how CMS can lift a temporary moratorium,
see the July 31, 2013 notice (78 FR 46339) or February 4, 2014
moratoria document (79 FR 6475).) If CMS deems it necessary, the
moratorium may be extended in 6-month increments. CMS will evaluate
whether to extend or lift the moratorium before any subsequent
moratorium periods. If one or more of the moratoria announced in this
document are extended or lifted, CMS will publish a document to that
effect in the Federal Register.
Once a moratorium is lifted, the provider or supplier types that
were unable to enroll because of the moratorium will be designated to
CMS' high screening level under Sec. 424.518(c)(3)(iii) and Sec.
455.450(e)(2) for 6 months from the date the moratorium was lifted.
II. Extension of Home Health and Ambulance Moratoria--Geographic
Locations
As noted earlier, we previously imposed moratoria on the enrollment
of new HHAs in Broward county, Miami-Dade and Monroe and their
surrounding counties in Florida, the Illinois counties of Cook, DuPage,
Kane, Lake, McHenry, and Will, the Michigan counties of Macomb, Monroe,
Oakland Washtenaw, and Wayne and the Texas counties of Brazoria,
Chambers, Collin, Fort Bend, Galveston, Dallas, Harris, Liberty,
Denton, Ellis, Kauffman, Montgomery, Rockwall, Tarrant, and Waller.
Further, we previously imposed moratoria on the enrollment of new
ground ambulance suppliers in the Texas Counties of Brazoria, Chambers,
Fort Bend, Galveston, Harris, Liberty, Montgomery, and Waller and the
Pennsylvania counties of Bucks, Delaware, Montgomery; and Philadelphia
and the New Jersey counties of Burlington, Camden, and Gloucester.
These moratoria became effective upon publication in the Federal
Register of a notice on July 31, 2013 (78 FR 46340)
[[Page 44703]]
and a moratoria document on February 4, 2014 (79 FR 6475).
In accordance with Sec. 424.570(b), CMS may deem it necessary to
extend previously-imposed moratoria in 6-month increments. Under its
authority at Sec. 424.570(b), CMS is extending the temporary moratoria
on the Medicare enrollment of HHAs and ground ambulance suppliers in
the geographic locations discussed herein. Under regulations at Sec.
455.470 and Sec. 457.990, these moratoria also apply to the enrollment
of HHAs and ground ambulance suppliers in Medicaid and CHIP. Under
Sec. 424.570(b), CMS is required to publish a document in the Federal
Register announcing any extension of a moratorium, and this extension
of moratoria document fulfills that requirement.
CMS consulted with both the HHS-OIG and DOJ regarding the extension
of the moratoria on new HHAs and ground ambulance suppliers in all of
the moratoria counties, and both HHS-OIG and DOJ agree that a
significant potential for fraud, waste, and abuse continues to exist in
these geographic areas. The circumstances warranting the imposition of
the moratoria have not yet abated, and CMS has determined that the
moratoria are still needed as we monitor the indicators and continue
with administrative actions such as payment suspensions and revocations
of provider/supplier numbers. (For more information regarding the
monitored indicators, see section I.B. of the February 4, 2014
moratoria document (79 FR 6475).)
Based upon CMS' consultation with the relevant State Medicaid
Agencies, CMS has concluded that extending these moratoria will not
create an access to care issue for Medicaid or CHIP beneficiaries in
the affected counties at this time. CMS also reviewed Medicare data for
these areas and found there are no current problems with access to HHAs
or ground ambulance suppliers. Nevertheless, the agency will continue
to monitor these locations to ensure that no access to care issues
arise in the future.
Based upon our consultation with law enforcement and consideration
of the factors and activities described previously, CMS has determined
that the temporary enrollment moratoria should be extended for an
additional 6 months.
III. Summary of the Moratoria Locations
CMS is executing its authority under sections 1866(j)(7),
1902(kk)(4), and 2107(e)(1)(D) of the Act to extend these moratoria in
the following counties for these providers and suppliers:
Table 1--HHA Moratoria
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State City/metro area Counties
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FL............. Fort Lauderdale................ Broward.
FL............. Miami.......................... Monroe.
Dade.
IL............. Chicago........................ Cook.
DuPage.
Kane.
Lake.
McHenry.
Will.
MI............. Detroit........................ Macomb.
Monroe.
Oakland.
Washtenaw.
Wayne.
TX............. Dallas......................... Collin.
Dallas.
Denton.
Ellis.
Kaufman.
Rockwall.
Tarrant.
TX............. Houston........................ Brazoria.
Chambers.
Fort Bend.
Galveston.
Harris.
Liberty.
Montgomery.
Waller.
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Table 2--Part B Ambulance Moratoria
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State City/metro area Counties
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PA/NJ.......... Philadelphia................... Bucks.
Burlington (NJ).
Camden (NJ).
Delaware.
Gloucester (NJ).
Montgomery.
Philadelphia.
TX............. Houston........................ Brazoria.
Chambers.
Fort Bend.
Galveston.
Harris.
Liberty.
Montgomery.
Waller.
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IV. 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. 35).
V. Regulatory Impact Statement
CMS has examined the impact of this document as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), 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
(March 22, 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 Orders 12866 and 13563 direct 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 regulatory
actions with economically significant effects ($100 million or more in
any 1 year). This document will prevent the enrollment of new home
health providers and ambulance suppliers in Medicare, and new home
health providers and ambulance suppliers in Medicaid and CHIP. Though
savings may accrue by denying enrollments, the monetary amount cannot
be quantified. After the imposition of the moratoria on July 30, 2013,
231 HHAs and 7 ambulance companies in all geographic areas affected by
the moratoria had their applications denied. We have found the number
of applications that are denied after 60 days declines dramatically, as
most providers and suppliers will not submit applications during the
moratoria period. Therefore, this document does not reach the economic
threshold and thus is not considered a major action.
The RFA requires agencies to analyze options for regulatory relief
of small entities. 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
$7.0 million to $35.5 million in any one year. Individuals and states
are not included in the definition of a small entity. CMS is not
preparing an analysis for the RFA because it has determined, and the
Secretary certifies, that this document will not have a significant
[[Page 44704]]
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 an action 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 604 of the RFA.
For purposes of section 1102(b) of the Act, CMS defines a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area for Medicare payment regulations and has fewer than
100 beds. CMS is not preparing an analysis for section 1102(b) of the
Act because it has determined, and the Secretary certifies, that this
document will 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 regulatory action whose mandates require spending in any 1
year of $100 million in 1995 dollars, updated annually for inflation.
In 2014, that threshold is approximately $141 million. This document
will 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 regulatory action (and
subsequent final action) that imposes substantial direct requirement
costs on state and local governments, preempts state law, or otherwise
has Federalism implications. Since this document does not impose any
costs on state or local governments, the requirements of Executive
Order 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, the
Office of Management and Budget reviewed this document.
Authority: Sections 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh) and 44 U.S.C. Chapter 35; Sec. 1103 of the
Social Security Act (42 U.S.C. 1302).
Dated: July 2, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-18174 Filed 7-29-14; 4:15 pm]
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