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, 44967-44970 [2015-18327]
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44967
Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices
resilience. Even when these domains
have been included, there is no
evaluation of whether these efforts have
resulted in improved resilience
outcomes among seniors (e.g., greater
self-sufficiency). This study will
quantify the contribution that AFIs and
SVs have made to improving resilience
outcomes for older adults and provide
guidance to local health departments
(LHDs) for improving their engagement
with AFIs/SVs.
The Office of Public Health
Preparedness and Response proposes to
conduct a new information collection,
Examining How Local Health
Departments Can Leverage Age-Friendly
Cities Initiatives to Build Resilience in
Elderly Populations. Information
collection activities will target four
groups. Respondents will include AFI
Staff, Village Directors, LHD
Representatives, and adults aged 65+
within the AFI and SV communities.
The study will outline where current
AFIs and CR efforts align; conduct
interviews in AFIs and SVs across the
U.S. to understand relationships with
LHDs; clarify the process through which
policymakers can incorporate CR into
AFIs; survey test sites in a quasiexperimental design of AFIs currently
underway; and develop a toolkit to help
LHDs identify the need for AFIs,
evaluate and monitor AFIs ability to
improve resilience, develop effective
and efficient partnerships with AFIs to
expand AFI–LHD efforts across the U.S
to build community resilience.
OMB approval is requested for two
years. Participation in the survey is
voluntary. There are no costs to
respondents other than their time. The
total estimated annual burden hours are
302. A summary of annualized burden
hours is below.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Age Friendly Initiative Staff .............................
Interview Guide for Age Friendly Initiative
Staff.
Interview Guide for Senior Village Director ...
Interview Guide for Local Health Department
Representative.
Senior Village Survey .....................................
Senior Village Survey .....................................
Senior Village Director ....................................
Local Health Department Representative .......
Older Adult—Screened Out ............................
Older Adult—Participant .................................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–18424 Filed 7–27–15; 8:45am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Background
Centers for Medicare & Medicaid
Services
[CMS–6059–N3]
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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Extension of temporary
moratoria.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
AGENCY:
This document announces the
extension of temporary moratoria on the
enrollment of new ambulance suppliers
and home health agencies, subunits, and
branch locations in specific locations
within designated metropolitan areas in
Florida, Illinois, Michigan, Texas,
Pennsylvania, and New Jersey to
SUMMARY:
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prevent and combat fraud, waste, and
abuse.
DATES: Effective Date: July 29, 2015.
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 press@
cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
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 or notice) (79 FR
6475).
Based on this authority and our
regulations at § 424.570, we initially
PO 00000
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Number of
responses per
respondent
Average
burden per
response
(in hrs)
16
1
30/60
15
8
1
1
30/60
30/60
716
775
1
1
2/60
20/60
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 part B
ambulance suppliers in Harris County,
Texas and surrounding counties, in a
notice issued on July 31, 2013 (78 FR
46339). We then exercised this authority
again in a notice 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 the previously
mentioned moratoria in moratoria
documents issued on August 1, 2014 (79
FR 44702) and February 2, 2015 (80 FR
5551).
1 As noted in the preamble to the final rule
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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Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices
3. Lifting a Temporary Moratorium
B. Determination of the Need for
Moratorium
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).
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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.
In accordance with § 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
§ 424.518(c)(3)(iii) and § 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 in the
Federal Register of a notice on July 31,
2013 (78 FR 46339) and a 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) and February 2, 2015 (80 FR
5551).
As provided in § 424.570(b), CMS
may deem it necessary to extend
previously-imposed moratoria in 6month 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 § 455.470
and § 457.990, these moratoria also
apply to the enrollment of HHAs and
ground ambulance suppliers in
Medicaid and CHIP. Under § 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 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
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 these
moratoria in the following counties for
these providers and suppliers:
TABLE 1—HHA MORATORIA
State
City/metro area
FL .................
Fort Lauderdale ...........
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Counties
Broward.
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Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices
44969
TABLE 1—HHA MORATORIA—Continued
State
City/metro area
FL .................
IL ..................
MI .................
TX ................
TX ................
Miami ...........................
Chicago .......................
Detroit ..........................
Dallas ..........................
Houston .......................
Counties
Monroe, Miami-Dade.
Cook, DuPage, Kane, Lake, McHenry, Will.
Macomb, Monroe, Oakland, Washtenaw, Wayne.
Collin, Dallas, Denton, Ellis, Kaufman, Rockwall, Tarrant.
Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, Waller.
TABLE 2—PART B AMBULANCE MORATORIA
State
City/metro area
PA/NJ ...........
TX ................
Philadelphia .................
Houston .......................
Counties
Bucks, Burlington (NJ), Camden (NJ), Delaware, Gloucester (NJ), Montgomery, Philadelphia.
Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, Waller.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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
§ 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,
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19:17 Jul 27, 2015
Jkt 235001
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 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 31,
2013, 848 HHAs and 14 ambulance
companies in all geographic areas
affected by the moratoria had their
applications denied. We have found the
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Fmt 4703
Sfmt 4703
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
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
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Federal Register / Vol. 80, No. 144 / Tuesday, July 28, 2015 / Notices
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: July 1, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2015–18327 Filed 7–24–15; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Disaster Information Collection
Plans.
OMB No.: NEW.
Description: This request is for
approval of a plan for conducting more
than one information collection that is
very similar, voluntary, low-burden and
uncontroversial. The Information
collections under this generic clearance
will be activated during a disaster.
These forms will be used after a disaster
to develop a technical assistance plan
for affected ACF programs.
Presidential Policy Directive-8 (PPD–
8), which was signed into law in 2011,
provides federal guidance and planning
procedures under established phases—
protection, preparedness, response,
recovery, and mitigation. The data
collection addresses response, and
recovery for ACF programs with a
statutory preparedness planning
requirement and other programs
without that requirement.
ACF/Office of Human Services
Emergency Preparedness and Response
(OHSEPR) has a requirement under
PPD–8, the National Response
Framework, and the National Disaster
Recovery Framework to report impacts
of disasters to ACF-supported human
services programs to the HHS
Secretary’s Operation Center (SOC).
ACF/OHSEPR works in conjunction
with the Assistant Secretary for
Preparedness and Response (ASPR), and
the Federal Emergency Management
Agency (FEMA) to ensure that impacted
ACF programs are returned to their
normal or close to normal operations.
The primary purpose of the
information collection pertains to ACF’s
initiative to provide real time updates
during the response and recovery
phases of a disaster; the information
will be used to respond to inquiries
about human services response and
recovery efforts, specifically for
individuals, children, and families that
need support from ACF programs.
Further, the information collection will
be used to support ACF/OHSEPR’s goal
to quickly identify critical gaps,
resources, needs, and services to
support State, local and non-profit
capacity for disaster case management
and to augment and build capacity
where none exists.
Respondents: Varies, depending on
programmatic impact (could be state
administrators, or grantees).
Annual Burden Estimates
The estimate is based on a single
disaster per year. The estimate is for one
state administrator to go through all the
applicable questions with the Regional
and Central Office staff, if applicable.
Number of
respondents
Number of
responses per
respondent
Burden
hours per
response
Total burden
hours
Program Specific Disaster Information Collection ...................
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Instrument
50
15
0.5
25
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
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19:17 Jul 27, 2015
Jkt 235001
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Administration for Native Americans;
Notice of Meeting
Administration for Children
and Families, HHS.
AGENCY:
ACTION:
Notice of Tribal Consultation.
The Department of Health and
Human Services (HHS), Administration
for Children and Families (ACF), will
host a Tribal Consultation to consult on
ACF programs and tribal priorities.
SUMMARY:
Robert Sargis,
Reports Clearance Officer.
DATES:
[FR Doc. 2015–18440 Filed 7–27–15; 8:45 am]
ADDRESSES:
BILLING CODE 4184–01–P
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September 14, 2015.
901 D Street SW.,
Washington, DC.
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]]>Agencies
[Federal Register Volume 80, Number 144 (Tuesday, July 28, 2015)]
[Notices]
[Pages 44967-44970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18327]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-6059-N3]
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.
-----------------------------------------------------------------------
SUMMARY: This document announces the extension of temporary moratoria
on the enrollment of new ambulance suppliers and 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.
DATES: Effective Date: July 29, 2015.
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 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 or notice) (79 FR 6475).
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 part B ambulance suppliers in Harris
County, Texas and surrounding counties, in a notice issued on July 31,
2013 (78 FR 46339). We then exercised this authority again in a notice
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 the
previously mentioned moratoria in moratoria documents issued on August
1, 2014 (79 FR 44702) and February 2, 2015 (80 FR 5551).
---------------------------------------------------------------------------
\1\ As noted in the preamble to the final rule 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.
---------------------------------------------------------------------------
[[Page 44968]]
B. Determination of the Need for Moratorium
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 in the Federal Register of a notice on July 31, 2013
(78 FR 46339) and a 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) and February 2, 2015
(80 FR 5551).
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. 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 the HHS-OIG regarding the extension of the
moratoria on new HHAs and ground ambulance suppliers in all of the
moratoria counties, and 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 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 these moratoria in
the following counties for these providers and suppliers:
Table 1--HHA Moratoria
------------------------------------------------------------------------
State City/metro area Counties
------------------------------------------------------------------------
FL................ Fort Lauderdale.............. Broward.
[[Page 44969]]
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--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. 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 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 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 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 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
[[Page 44970]]
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: July 1, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-18327 Filed 7-24-15; 4:15 pm]
BILLING CODE 4120-01-P
