[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Pages 5444-5447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01835]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-6059-N4]
Medicare, Medicaid, and Children's Health Insurance Programs:
Announcement of the Extended Temporary Moratoria on Enrollment of
Ground 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 Medicare Part B ground ambulance suppliers and
Medicare home health agencies, subunits, and branch locations in
specific locations within designated metropolitan areas in Florida,
Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and
combat fraud, waste, and abuse. These moratoria also apply to the
enrollment of home health agencies and ground ambulance suppliers in
Medicaid and the Children's Health Insurance Program.
DATES: Effective Date: January 29, 2016.
FOR FURTHER INFORMATION CONTACT: Belinda Gravel, (410) 786-8934. 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 Children's Health Insurance
Program
[[Page 5445]]
(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) that first established temporary moratoria in
certain geographic locations, or the February 4, 2014 (79 FR 6475)
document that extended and expanded such moratoria (hereinafter
referred to as the February 4, 2014 moratoria document).
Based on this authority and our regulations at Sec. 424.570, we
initially imposed moratoria to prevent enrollment of new home health
agencies, subunits, and branch locations \1\ (hereafter referred to as
HHAs) in Miami-Dade County, Florida and Cook County, Illinois, as well
as surrounding counties, and Medicare Part B ground ambulance suppliers
in Harris County, Texas and surrounding counties, in a notice issued on
July 31, 2013 (78 FR 46339). We exercised this authority again in a
document published on February 4, 2014 (79 FR 6475) when we extended
the existing moratoria for an additional 6 months and expanded it to
include enrollment of HHAs in Broward County, Florida; Dallas County,
Texas; Harris County, Texas; and Wayne County, Michigan and surrounding
counties, and enrollment of ground ambulance suppliers in Philadelphia,
Pennsylvania and surrounding counties. Then, we further extended these
moratoria in documents issued on August 1, 2014 (79 FR 44702), February
2, 2015 (80 FR 5551), and July 28, 2015 (80 FR 44967).
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\1\ As noted in the preamble to the final rule with comment
period implementing the moratorium authority (February 2, 2011, CMS-
6028-FC (76 FR 5870), home health agency subunits and branch
locations are subject to the moratoria to the same extent as any
other newly enrolling home health agency.
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B. Determination of the Need for Moratoria
In imposing 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 Office of Inspector General (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
these moratoria, CMS reviewed Medicare data for these areas and found
no concerns with beneficiary access to HHAs or ground ambulance
suppliers. CMS also consulted with the appropriate State Medicaid
Agencies and with the appropriate State Departments of Emergency
Medical Services to determine if the moratoria would create access to
care concerns 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 would not create access to care issues
for Medicaid or CHIP beneficiaries.
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. 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 is 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 the Florida counties of Broward, Miami-Dade, and Monroe;
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, Kaufman, 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; 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 of the notice in the Federal Register on July 31, 2013
(78 FR 46339) and the moratoria document on February 4, 2014 (79 FR
6475), and were subsequently extended by documents published in the
Federal Register on August 1, 2014 (79 FR 44702), February 2, 2015 (80
FR 5551), and July 28, 2015 (80 FR 44967).
As provided in Sec. 424.570(b), CMS may deem it necessary to
extend previously-imposed moratoria in 6-month increments. Under this
authority, 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. Sec. 455.470 and
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 the HHS OIG regarding the extension of the
moratoria on new HHAs and ground ambulance suppliers in all of the
moratoria counties, and the HHS OIG agrees 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
[[Page 5446]]
provider/supplier numbers. (For more information regarding the
monitored indicators, see 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 make sure 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 the enrollment
moratoria in the following counties for HHAs and ground ambulance
suppliers:
Table 1--HHA Moratoria
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State City/metropolitan area Counties
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FL................ Fort Lauderdale.......... Broward.
FL................ Miami.................... Monroe
Miami-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--Ground Ambulance Moratoria
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State City/metropolitan 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. Clarification of Right to Judicial Review
Section 1866(j)(7)(B) of the Act states that there shall be no
judicial review under section 1869, section 1878, or otherwise, of a
temporary moratorium imposed on the enrollment of new providers of
services and suppliers if the Secretary determines that the moratorium
is necessary to prevent or combat fraud, waste, or abuse. Accordingly,
our regulations at 42 CFR 498.5(l)(4) state that for appeals of denials
based on a temporary moratorium, the scope of review will be limited to
whether the temporary moratorium applies to the provider or supplier
appealing the denial. The agency's basis for imposing a temporary
moratorium is not subject to review. Our regulations do not limit the
right to seek judicial review of a final agency decision that the
temporary moratorium applies to a particular provider or supplier. In
the preamble to the February 2, 2011 (76 FR 5918) final rule with
comment period establishing this regulation, we explained that ``a
provider or supplier may administratively appeal an adverse
determination based on the imposition of a temporary moratorium up to
and including the Department Appeal Board (DAB) level of review.'' We
are clarifying that providers and suppliers that have received
unfavorable decisions in accordance with the limited scope of review
described in Sec. 498.5(l)(4) may seek judicial review of those
decisions after they exhaust their administrative appeals. We
reiterate, however, that section 1866(j)(7)(B) of the Act precludes
judicial review of the agency's basis for imposing a temporary
moratorium.
V. Collection of Information Requirements
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
VI. 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 one year). This document will prevent the enrollment of new home
health providers and ground ambulance suppliers in Medicare and new
home health providers and ground ambulance suppliers in Medicaid and
CHIP. Though savings may accrue by denying enrollments, the monetary
amount cannot be quantified. After the imposition of the initial
moratoria on July 31, 2013, 848 HHAs and 14 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
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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
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 purposes 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
one year of $100 million in 1995 dollars, updated annually for
inflation. In 2015, that threshold is approximately $144 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. Because 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.
Dated: December 7, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-01835 Filed 1-29-16; 4:15 pm]
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