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[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Rules and Regulations]
[Pages 44702-44704]
From the Federal Register Online via the Government Printing 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 press@cms.hhs.gov.

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
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

                   Table 2--Part B Ambulance Moratoria
------------------------------------------------------------------------
     State               City/metro area                 Counties
------------------------------------------------------------------------
PA/NJ..........  Philadelphia...................  Bucks.
                                                  Burlington (NJ).
                                                  Camden (NJ).
                                                  Delaware.
                                                  Gloucester (NJ).
                                                  Montgomery.
                                                  Philadelphia.
TX.............  Houston........................  Brazoria.
                                                  Chambers.
                                                  Fort Bend.
                                                  Galveston.
                                                  Harris.
                                                  Liberty.
                                                  Montgomery.
                                                  Waller.
------------------------------------------------------------------------

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]
BILLING CODE 4120-01-P
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