[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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
------------------------------------------------------------------------
       State          City/metropolitan area            Counties
------------------------------------------------------------------------
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.
------------------------------------------------------------------------


                   Table 2--Ground Ambulance Moratoria
------------------------------------------------------------------------
       State          City/metropolitan 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. 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

[[Page 5447]]

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]
 BILLING CODE 4120-01-P