82_FR_2368 82 FR 2363 - Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations

82 FR 2363 - Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 82, Issue 5 (January 9, 2017)

Page Range2363-2366
FR Document2016-32007

This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states.

Federal Register, Volume 82 Issue 5 (Monday, January 9, 2017)
[Federal Register Volume 82, Number 5 (Monday, January 9, 2017)]
[Notices]
[Pages 2363-2366]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-32007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-6059-N6]


Medicare, Medicaid, and Children's Health Insurance Programs: 
Announcement of the Extension of Temporary Moratoria on Enrollment of 
Part B Non-Emergency 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 statewide temporary 
moratoria on the enrollment of new Medicare Part B non-emergency ground 
ambulance providers and suppliers and Medicare home health agencies, 
subunits, and branch locations in Florida, Illinois, Michigan, Texas, 
Pennsylvania, and New Jersey, as applicable, to prevent and combat 
fraud, waste, and abuse. This extension also applies to the enrollment 
of new non-emergency ground ambulance suppliers and home health 
agencies, subunits, and branch locations in Medicaid and the Children's 
Health Insurance Program in those states.

DATES: Effective January 29, 2017.

FOR FURTHER INFORMATION CONTACT: Steve Manning, (410) 786-1691.
    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' Implementation of Temporary Enrollment Moratoria

    Under the Patient Protection and Affordable Care Act (Pub. L. 111-
148), as amended by the Health Care and Education Reconciliation Act of 
2010 (Pub. L. 111-152) (collectively known as the Affordable Care Act), 
the Congress provided the Secretary with new tools and resources to 
combat fraud, waste, and abuse in Medicare, Medicaid, and the 
Children's Health Insurance Program (CHIP). 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. Section 6401(b) of the Affordable Care Act added specific 
moratorium language applicable to Medicaid at section 1902(kk)(4) of 
the Act, requiring States to comply with any moratorium imposed by the 
Secretary unless the State determines that the imposition of such 
moratorium would adversely impact Medicaid beneficiaries' access to 
care. Section 6401(c) of the Affordable Care Act amended section 
2107(e)(1) of the Act to provide that all of the Medicaid provisions in 
sections 1902(a)(77) and 1902(kk) are also applicable to CHIP.
    In the February 2, 2011 Federal Register (76 FR 5862), CMS 
published a final rule with comment period titled, ``Medicare, 
Medicaid, and Children's Health Insurance Programs; Additional 
Screening Requirements, Application Fees, Temporary Enrollment 
Moratoria, Payment Suspensions and Compliance Plans for Providers and 
Suppliers,'' which implemented section 1866(j)(7) of the Act by 
establishing new regulations at 42 CFR 424.570. Under Sec.  
424.570(a)(2)(i) and (iv), CMS, or CMS in consultation with the 
Department of Health and Human Services' Office of Inspector General 
(HHS-OIG) or the Department of Justice (DOJ), or both, may impose a 
temporary moratorium on newly enrolling Medicare providers and 
suppliers if CMS determines that there is a significant potential for 
fraud, waste, or abuse with respect to a particular provider or 
supplier type, or particular geographic locations, or both. At Sec.  
424.570(a)(1)(ii), CMS stated that it would announce any temporary 
moratorium in a Federal Register document that includes the rationale 
for the imposition of such moratorium. This document fulfills that 
requirement.
    In accordance with section 1866(j)(7)(B) of the Act, there is no 
judicial review under sections 1869 and 1878 of the Act, or otherwise, 
of the decision to impose a temporary enrollment moratorium. A provider 
or supplier may use the existing appeal procedures at 42 CFR part 498 
to administratively appeal a denial of billing privileges based on the 
imposition of a temporary moratorium; however the scope of any such 
appeal is limited solely to assessing whether the temporary moratorium 
applies to the provider or supplier appealing the denial. Under Sec.  
424.570(c), CMS denies the enrollment application of a provider or 
supplier if the provider or supplier is subject to a moratorium. If the 
provider or supplier was required to pay an application fee, the 
application fee will be refunded if the application was denied as a 
result of the imposition of a temporary moratorium (see Sec.  
424.514(d)(2)(v)(C)).
    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).\2\ We 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 them 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), July 28, 2015 (80 FR 44967), and February 2, 2016 
(81 FR 5444). On August 3, 2016 (81 FR 51120), we extended the current 
moratoria for an additional 6 months and expanded them to statewide for 
the

[[Page 2364]]

enrollment of new HHAs in Florida, Illinois, Michigan, and Texas, and 
Part B non-emergency ambulance suppliers in New Jersey, Pennsylvania, 
and Texas. Our August 3, 2016 publication also announced the lifting of 
temporary moratoria for all Part B emergency ambulance suppliers.\3\
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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.
    \2\ CMS has identified an error in the provider and beneficiary 
saturation data described in our July 31, 2013 Federal Register 
notice (78 FR 46339). We have subsequently revised the methodology 
by which we determine provider and beneficiary saturation. Following 
these revisions to the methodology, we simulated application of our 
current 2016 methodology to the 2013 data, and determined that the 
2013 decision to impose the moratorium would not have been impacted 
had the revised methodology been applied. Provider saturation 
remains one of the criteria used to determine whether to implement a 
moratorium. CMS has made market saturation data publicly available 
at https://data.cms.gov/market-saturation.
    \3\ CMS also concurrently announced a demonstration under the 
authority provided in section 402(a)(l)(J) of the Social Security 
Amendments of 1967 (42 U.S.C. 1395b-l(a)(l)(J)) that allows for 
access to care-based exceptions to the moratoria in certain limited 
circumstances after a heightened review of that provider has been 
conducted. This exception process also applies to Medicaid and CHIP 
providers in each state. This announcement may be found in the 
Federal Register document issued on August 3, 2016 (81 FR 51116).
---------------------------------------------------------------------------

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)).
    Because fraud schemes are highly migratory and transitory in 
nature, many of CMS' program integrity authorities and anti-fraud 
activities are designed to allow the agency to adapt to emerging fraud 
in different locations. The laws and regulations governing CMS' 
moratoria authority give us flexibility to use any and all relevant 
criteria for future moratoria, and CMS may rely on additional or 
different criteria as the basis for future moratoria.
1. Application to Medicaid and the Children's Health Insurance Program 
(CHIP)
    The February 2, 2011, final rule also implemented section 
1902(kk)(4) of the Act, establishing new Medicaid regulations at Sec.  
455.470. Under Sec.  455.470(a)(1) through (3), the Secretary may 
impose a temporary moratorium, in accordance with Sec.  424.570, on the 
enrollment of new providers or provider types after consulting with any 
affected State Medicaid agencies. The State Medicaid agency must impose 
a temporary moratorium on the enrollment of new providers or provider 
types identified by the Secretary as posing an increased risk to the 
Medicaid program unless the State determines that the imposition of 
such moratorium would adversely affect Medicaid beneficiaries' access 
to medical assistance and so notifies the Secretary. The final rule 
also implemented section 2107(e)(1)(D) of the Act by providing, at 
Sec.  457.990 of the regulations, that all of the provisions that apply 
to Medicaid under sections 1902(a)(77) and 1902(kk) of the Act, as well 
as the implementing regulations, also apply to CHIP.
    Section 1866(j)(7) of the Act authorizes imposition of a temporary 
enrollment moratorium for Medicare, Medicaid, and/or CHIP, ``if the 
Secretary determines such moratorium is necessary to prevent or combat 
fraud, waste, or abuse under either such program.'' While there may be 
exceptions, CMS believes that generally, a category of providers or 
suppliers that poses a risk to the Medicare program also poses a 
similar risk to Medicaid and CHIP. Many of the new anti-fraud 
provisions in the Affordable Care Act reflect this concept of 
``reciprocal risk'' in which a provider that poses a risk to one 
program poses a risk to the other programs. For example, section 6501 
of the Affordable Care Act titled, ``Termination of Provider 
Participation under Medicaid if Terminated Under Medicare or Other 
State Plan,'' which amends section 1902(a)(39) of the Act, requires 
State Medicaid agencies to terminate the participation of an individual 
or entity if such individual or entity is terminated under Medicare or 
any other State Medicaid plan. Additional provisions in title VI, 
Subtitles E and F of the Affordable Care Act also support the 
determination that categories of providers and suppliers pose the same 
risk to Medicaid as to Medicare. Section 6401(a) of the Affordable Care 
Act required us to establish levels of screening for categories of 
providers and suppliers based on the risk of fraud, waste, and abuse 
determined by the Secretary. Section 6401(b) of the Affordable Care Act 
required State Medicaid agencies to screen providers and suppliers 
based on the same levels established for the Medicare program. This 
reciprocal concept is also reflected in the Medicare moratoria 
regulations at Sec.  424.570(a)(2)(ii) and (iii), which permit CMS to 
impose a Medicare moratorium based solely on a State imposing a 
Medicaid moratorium. Accordingly, CMS has determined that there is a 
reasonable basis for concluding that a category of providers or 
suppliers that poses a risk to Medicare also poses a similar risk to 
Medicaid and CHIP, and that a moratorium in all of these programs is 
necessary to effectively combat this risk.
2. Consultation With Law Enforcement
    In consultation with the HHS Office of Inspector General (OIG) and 
the Department of Justice (DOJ), CMS previously 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).
3. Data Analysis
    In addition to consulting with law enforcement, CMS also analyzed 
its own data to identify specific provider and supplier types within 
geographic locations with significant potential for fraud, waste or 
abuse, therefore warranting the imposition of enrollment moratoria.
4. 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 with every 
imposition and extension of the moratoria. Prior to imposing and 
extending 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. All of 
CMS' State partners were supportive of CMS' analysis and proposals, and 
together with CMS, determined that continuation of these moratoria 
would not create access to care issues for Medicaid or CHIP 
beneficiaries.
5. When a Temporary Moratorium Does Not Apply
    Under Sec.  424.570(a)(1)(iii), a temporary moratorium does not 
apply to any of the following: (1) Changes in practice location (2) 
changes in provider or supplier information, such as phone number or 
address; or (3) changes in ownership (except changes in ownership of 
HHAs that require initial enrollment under Sec.  424.550). Also, in

[[Page 2365]]

accordance with Sec.  424.570(a)(1)(iv), a temporary moratorium does 
not apply to any enrollment application that a Medicare contractor has 
already approved, but has not yet entered into the Provider Enrollment, 
Chain, and Ownership System (PECOS) at the time the moratorium is 
imposed.
6. 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 the end of the initial 6-month period and, if applicable, any 
subsequent moratorium periods. If one or more of the moratoria 
announced in this document are extended, CMS will publish a document 
regarding such extensions in the Federal Register.
    As provided in Sec.  424.570(d), CMS may lift a moratorium at any 
time if the President declares an area a disaster under the Robert T. 
Stafford Disaster Relief and Emergency Assistance Act, if circumstances 
warranting the imposition of a moratorium have abated, if the Secretary 
has declared a public health emergency, or if, in the judgment of the 
Secretary, the moratorium is no longer needed.
    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. Sec.  424.518(c)(3)(iii) and 
455.450(e)(2) for 6 months from the date the moratorium was lifted.

II. Extension of Home Health and Ambulance Moratoria--Geographic 
Locations

    CMS currently has in place moratoria on newly enrolling HHAs in 
Florida, Illinois, Michigan, and Texas and Part B non-emergency 
ambulance suppliers in New Jersey, Pennsylvania, and Texas.
    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 Part B non-emergency ground ambulance providers 
and suppliers in the geographic locations discussed herein. Under the 
regulations at Sec.  455.470 and Sec.  457.990, these moratoria also 
apply to the enrollment of HHAs and non-emergency ground ambulance 
providers and suppliers in Medicaid and CHIP in those locations. 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 Part B non-emergency ground ambulance 
providers and suppliers in all of the moratoria states, and HHS-OIG 
agrees that a significant potential for fraud, waste, and abuse 
continues to exist regarding those provider and supplier types 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 to combat fraud and abuse, 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 states at this time. CMS also reviewed Medicare data for 
these states and found there are no current problems with access to 
HHAs or ground ambulance providers or 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 and implement 
temporary enrollment moratoria on HHAs for all counties in Florida, 
Illinois, Michigan, and Texas, as well as Part B non-emergency ground 
ambulance providers and suppliers for all counties in New Jersey, 
Pennsylvania, and Texas.

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. However, we 
reiterate 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

[[Page 2366]]

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 Part B non-emergency ground ambulance suppliers in Medicare, 
Medicaid, and CHIP in certain states. Though savings may accrue by 
denying enrollments, the monetary amount cannot be quantified. Since 
the imposition of the initial moratoria on July 31, 2013, 1,147 HHAs 
and 19 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 
less than $7.5 million to $38.5 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 (MSA) 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 1 
year of $100 million in 1995 dollars, updated annually for inflation. 
In 2016, that threshold is approximately $146 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, this 
document was reviewed by the Office of Management and Budget.

    Dated: December 28, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-32007 Filed 1-6-17; 8:45 am]
BILLING CODE 4120-01-P



                                                                               Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices                                                        2363

                                                (Vol. 82, No. 1 FR Doc. 2016–31772,                     the Affordable Care Act), the Congress                 administratively appeal a denial of
                                                Pages 124–126, Docket No. ATSDR–                        provided the Secretary with new tools                  billing privileges based on the
                                                2016–0007) for public comment.                          and resources to combat fraud, waste,                  imposition of a temporary moratorium;
                                                                                                        and abuse in Medicare, Medicaid, and                   however the scope of any such appeal
                                                Leroy A. Richardson,
                                                                                                        the Children’s Health Insurance                        is limited solely to assessing whether
                                                Chief, Information Collection Review Office,            Program (CHIP). Section 6401(a) of the                 the temporary moratorium applies to the
                                                Office of Scientific Integrity, Office of the
                                                                                                        Affordable Care Act added a new                        provider or supplier appealing the
                                                Associate Director for Science, Office of the
                                                Director, Centers for Disease Control and               section 1866(j)(7) to the Social Security              denial. Under § 424.570(c), CMS denies
                                                Prevention.                                             Act (the Act) to provide the Secretary                 the enrollment application of a provider
                                                [FR Doc. 2017–00080 Filed 1–6–17; 8:45 am]
                                                                                                        with authority to impose a temporary                   or supplier if the provider or supplier is
                                                                                                        moratorium on the enrollment of new                    subject to a moratorium. If the provider
                                                BILLING CODE 4163–18–P
                                                                                                        Medicare, Medicaid or CHIP providers                   or supplier was required to pay an
                                                                                                        and suppliers, including categories of                 application fee, the application fee will
                                                DEPARTMENT OF HEALTH AND                                providers and suppliers, if the Secretary              be refunded if the application was
                                                HUMAN SERVICES                                          determines a moratorium is necessary to                denied as a result of the imposition of
                                                                                                        prevent or combat fraud, waste, or abuse               a temporary moratorium (see
                                                Centers for Medicare & Medicaid                         under these programs. Section 6401(b)                  § 424.514(d)(2)(v)(C)).
                                                Services                                                of the Affordable Care Act added                          Based on this authority and our
                                                                                                        specific moratorium language applicable                regulations at § 424.570, we initially
                                                [CMS–6059–N6]                                           to Medicaid at section 1902(kk)(4) of the              imposed moratoria to prevent
                                                                                                        Act, requiring States to comply with any               enrollment of new home health
                                                Medicare, Medicaid, and Children’s                                                                             agencies, subunits, and branch
                                                                                                        moratorium imposed by the Secretary
                                                Health Insurance Programs:                                                                                     locations 1 (hereafter referred to as
                                                                                                        unless the State determines that the
                                                Announcement of the Extension of                                                                               HHAs) in Miami-Dade County, Florida
                                                                                                        imposition of such moratorium would
                                                Temporary Moratoria on Enrollment of                                                                           and Cook County, Illinois, as well as
                                                                                                        adversely impact Medicaid
                                                Part B Non-Emergency Ground                                                                                    surrounding counties, and Medicare
                                                                                                        beneficiaries’ access to care. Section
                                                Ambulance Suppliers and Home Health                                                                            Part B ground ambulance suppliers in
                                                                                                        6401(c) of the Affordable Care Act
                                                Agencies in Designated Geographic                                                                              Harris County, Texas and surrounding
                                                                                                        amended section 2107(e)(1) of the Act to
                                                Locations                                                                                                      counties, in a notice issued on July 31,
                                                                                                        provide that all of the Medicaid
                                                AGENCY:  Centers for Medicare &                         provisions in sections 1902(a)(77) and                 2013 (78 FR 46339).2 We exercised this
                                                Medicaid Services (CMS), HHS.                           1902(kk) are also applicable to CHIP.                  authority again in a notice published on
                                                ACTION: Extension of temporary                             In the February 2, 2011 Federal                     February 4, 2014 (79 FR 6475) when we
                                                moratoria.                                              Register (76 FR 5862), CMS published a                 extended the existing moratoria for an
                                                                                                        final rule with comment period titled,                 additional 6 months and expanded them
                                                SUMMARY:    This document announces the                 ‘‘Medicare, Medicaid, and Children’s                   to include enrollment of HHAs in
                                                extension of statewide temporary                        Health Insurance Programs; Additional                  Broward County, Florida; Dallas
                                                moratoria on the enrollment of new                      Screening Requirements, Application                    County, Texas; Harris County, Texas;
                                                Medicare Part B non-emergency ground                    Fees, Temporary Enrollment Moratoria,                  and Wayne County, Michigan and
                                                ambulance providers and suppliers and                   Payment Suspensions and Compliance                     surrounding counties, and enrollment of
                                                Medicare home health agencies,                          Plans for Providers and Suppliers,’’                   ground ambulance suppliers in
                                                subunits, and branch locations in                       which implemented section 1866(j)(7) of                Philadelphia, Pennsylvania and
                                                Florida, Illinois, Michigan, Texas,                     the Act by establishing new regulations                surrounding counties. Then, we further
                                                Pennsylvania, and New Jersey, as                        at 42 CFR 424.570. Under                               extended these moratoria in documents
                                                applicable, to prevent and combat fraud,                § 424.570(a)(2)(i) and (iv), CMS, or CMS               issued on August 1, 2014 (79 FR 44702),
                                                waste, and abuse. This extension also                   in consultation with the Department of                 February 2, 2015 (80 FR 5551), July 28,
                                                applies to the enrollment of new non-                   Health and Human Services’ Office of                   2015 (80 FR 44967), and February 2,
                                                emergency ground ambulance suppliers                    Inspector General (HHS–OIG) or the                     2016 (81 FR 5444). On August 3, 2016
                                                and home health agencies, subunits, and                 Department of Justice (DOJ), or both,                  (81 FR 51120), we extended the current
                                                branch locations in Medicaid and the                    may impose a temporary moratorium on                   moratoria for an additional 6 months
                                                Children’s Health Insurance Program in                  newly enrolling Medicare providers and                 and expanded them to statewide for the
                                                those states.                                           suppliers if CMS determines that there
                                                DATES: Effective January 29, 2017.                      is a significant potential for fraud,                    1 As noted in the preamble to the final rule with

                                                                                                        waste, or abuse with respect to a                      comment period implementing the moratorium
                                                FOR FURTHER INFORMATION CONTACT:                                                                               authority (February 2, 2011, CMS–6028–FC (76 FR
                                                Steve Manning, (410) 786–1691.                          particular provider or supplier type, or               5870), home health agency subunits and branch
                                                  News media representatives must                       particular geographic locations, or both.              locations are subject to the moratoria to the same
                                                contact CMS’ Public Affairs Office at                   At § 424.570(a)(1)(ii), CMS stated that it             extent as any other newly enrolling home health
                                                                                                        would announce any temporary                           agency.
                                                (202) 690–6145 or email them at press@                                                                           2 CMS has identified an error in the provider and

                                                cms.hhs.gov.                                            moratorium in a Federal Register                       beneficiary saturation data described in our July 31,
                                                                                                        document that includes the rationale for               2013 Federal Register notice (78 FR 46339). We
                                                SUPPLEMENTARY INFORMATION:
                                                                                                        the imposition of such moratorium. This                have subsequently revised the methodology by
                                                I. Background                                           document fulfills that requirement.                    which we determine provider and beneficiary
                                                                                                                                                               saturation. Following these revisions to the
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                                                                                                           In accordance with section
                                                A. CMS’ Implementation of Temporary                     1866(j)(7)(B) of the Act, there is no                  methodology, we simulated application of our
                                                Enrollment Moratoria                                                                                           current 2016 methodology to the 2013 data, and
                                                                                                        judicial review under sections 1869 and                determined that the 2013 decision to impose the
                                                  Under the Patient Protection and                      1878 of the Act, or otherwise, of the                  moratorium would not have been impacted had the
                                                Affordable Care Act (Pub. L. 111–148),                  decision to impose a temporary                         revised methodology been applied. Provider
                                                                                                                                                               saturation remains one of the criteria used to
                                                as amended by the Health Care and                       enrollment moratorium. A provider or                   determine whether to implement a moratorium.
                                                Education Reconciliation Act of 2010                    supplier may use the existing appeal                   CMS has made market saturation data publicly
                                                (Pub. L. 111–152) (collectively known as                procedures at 42 CFR part 498 to                       available at https://data.cms.gov/market-saturation.



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                                                2364                           Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices

                                                enrollment of new HHAs in Florida,                      Medicaid agency must impose a                          there is a reasonable basis for
                                                Illinois, Michigan, and Texas, and Part                 temporary moratorium on the                            concluding that a category of providers
                                                B non-emergency ambulance suppliers                     enrollment of new providers or provider                or suppliers that poses a risk to
                                                in New Jersey, Pennsylvania, and Texas.                 types identified by the Secretary as                   Medicare also poses a similar risk to
                                                Our August 3, 2016 publication also                     posing an increased risk to the Medicaid               Medicaid and CHIP, and that a
                                                announced the lifting of temporary                      program unless the State determines                    moratorium in all of these programs is
                                                moratoria for all Part B emergency                      that the imposition of such moratorium                 necessary to effectively combat this risk.
                                                ambulance suppliers.3                                   would adversely affect Medicaid
                                                                                                                                                               2. Consultation With Law Enforcement
                                                B. Determination of the Need for                        beneficiaries’ access to medical
                                                                                                        assistance and so notifies the Secretary.                 In consultation with the HHS Office
                                                Moratoria                                                                                                      of Inspector General (OIG) and the
                                                                                                        The final rule also implemented section
                                                   In imposing these enrollment                         2107(e)(1)(D) of the Act by providing, at              Department of Justice (DOJ), CMS
                                                moratoria, CMS considered both                          § 457.990 of the regulations, that all of              previously identified two provider and
                                                qualitative and quantitative factors                    the provisions that apply to Medicaid                  supplier types in nine geographic
                                                suggesting a high risk of fraud, waste, or              under sections 1902(a)(77) and 1902(kk)                locations that warrant a temporary
                                                abuse. CMS relied on law enforcement’s                  of the Act, as well as the implementing                enrollment moratorium. For a more
                                                longstanding experience with ongoing                    regulations, also apply to CHIP.                       detailed discussion of this consultation
                                                and emerging fraud trends and activities                                                                       process, see the July 31, 2013 notice (78
                                                                                                           Section 1866(j)(7) of the Act
                                                through civil, criminal, and                                                                                   FR 46339) or February 4, 2014 moratoria
                                                                                                        authorizes imposition of a temporary
                                                administrative investigations and                                                                              document (79 FR 6475).
                                                                                                        enrollment moratorium for Medicare,
                                                prosecutions. CMS’ determination of a
                                                                                                        Medicaid, and/or CHIP, ‘‘if the Secretary              3. Data Analysis
                                                high risk of fraud, waste, or abuse in
                                                                                                        determines such moratorium is                             In addition to consulting with law
                                                these provider and supplier types
                                                                                                        necessary to prevent or combat fraud,                  enforcement, CMS also analyzed its own
                                                within these geographic locations was
                                                                                                        waste, or abuse under either such                      data to identify specific provider and
                                                then confirmed by CMS’ data analysis,
                                                                                                        program.’’ While there may be                          supplier types within geographic
                                                which relied on factors the agency
                                                                                                        exceptions, CMS believes that generally,               locations with significant potential for
                                                identified as strong indicators of risk.
                                                                                                        a category of providers or suppliers that              fraud, waste or abuse, therefore
                                                (For a more detailed explanation of this
                                                                                                        poses a risk to the Medicare program                   warranting the imposition of enrollment
                                                determination process and of these
                                                                                                        also poses a similar risk to Medicaid                  moratoria.
                                                authorities, see the July 31, 2013 notice
                                                                                                        and CHIP. Many of the new anti-fraud
                                                (78 FR 46339) or February 4, 2014                                                                              4. Beneficiary Access to Care
                                                                                                        provisions in the Affordable Care Act
                                                moratoria document (79 FR 6475)).
                                                                                                        reflect this concept of ‘‘reciprocal risk’’               Beneficiary access to care in
                                                   Because fraud schemes are highly
                                                                                                        in which a provider that poses a risk to               Medicare, Medicaid, and CHIP is of
                                                migratory and transitory in nature,
                                                                                                        one program poses a risk to the other                  critical importance to CMS and its State
                                                many of CMS’ program integrity
                                                                                                        programs. For example, section 6501 of                 partners, and CMS carefully evaluated
                                                authorities and anti-fraud activities are
                                                                                                        the Affordable Care Act titled,                        access for the target moratorium
                                                designed to allow the agency to adapt to
                                                                                                        ‘‘Termination of Provider Participation                locations with every imposition and
                                                emerging fraud in different locations.
                                                                                                        under Medicaid if Terminated Under                     extension of the moratoria. Prior to
                                                The laws and regulations governing
                                                                                                        Medicare or Other State Plan,’’ which                  imposing and extending these
                                                CMS’ moratoria authority give us
                                                                                                        amends section 1902(a)(39) of the Act,                 moratoria, CMS reviewed Medicare data
                                                flexibility to use any and all relevant
                                                                                                        requires State Medicaid agencies to                    for these areas and found no concerns
                                                criteria for future moratoria, and CMS
                                                                                                        terminate the participation of an                      with beneficiary access to HHAs or
                                                may rely on additional or different
                                                                                                        individual or entity if such individual                ground ambulance suppliers. CMS also
                                                criteria as the basis for future moratoria.
                                                                                                        or entity is terminated under Medicare                 consulted with the appropriate State
                                                1. Application to Medicaid and the                      or any other State Medicaid plan.                      Medicaid Agencies and with the
                                                Children’s Health Insurance Program                     Additional provisions in title VI,                     appropriate State Departments of
                                                (CHIP)                                                  Subtitles E and F of the Affordable Care               Emergency Medical Services to
                                                   The February 2, 2011, final rule also                Act also support the determination that                determine if the moratoria would create
                                                implemented section 1902(kk)(4) of the                  categories of providers and suppliers                  access to care concerns for Medicaid
                                                Act, establishing new Medicaid                          pose the same risk to Medicaid as to                   and CHIP beneficiaries. All of CMS’
                                                regulations at § 455.470. Under                         Medicare. Section 6401(a) of the                       State partners were supportive of CMS’
                                                § 455.470(a)(1) through (3), the Secretary              Affordable Care Act required us to                     analysis and proposals, and together
                                                may impose a temporary moratorium, in                   establish levels of screening for                      with CMS, determined that continuation
                                                accordance with § 424.570, on the                       categories of providers and suppliers                  of these moratoria would not create
                                                enrollment of new providers or provider                 based on the risk of fraud, waste, and                 access to care issues for Medicaid or
                                                types after consulting with any affected                abuse determined by the Secretary.                     CHIP beneficiaries.
                                                State Medicaid agencies. The State                      Section 6401(b) of the Affordable Care
                                                                                                        Act required State Medicaid agencies to                5. When a Temporary Moratorium Does
                                                   3 CMS also concurrently announced a                  screen providers and suppliers based on                Not Apply
                                                demonstration under the authority provided in           the same levels established for the                       Under § 424.570(a)(1)(iii), a temporary
                                                section 402(a)(l)(J) of the Social Security             Medicare program. This reciprocal                      moratorium does not apply to any of the
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                                                Amendments of 1967 (42 U.S.C. 1395b-l(a)(l)(J)) that
                                                allows for access to care-based exceptions to the
                                                                                                        concept is also reflected in the Medicare              following: (1) Changes in practice
                                                moratoria in certain limited circumstances after a      moratoria regulations at                               location (2) changes in provider or
                                                heightened review of that provider has been             § 424.570(a)(2)(ii) and (iii), which                   supplier information, such as phone
                                                conducted. This exception process also applies to       permit CMS to impose a Medicare                        number or address; or (3) changes in
                                                Medicaid and CHIP providers in each state. This
                                                announcement may be found in the Federal
                                                                                                        moratorium based solely on a State                     ownership (except changes in
                                                Register document issued on August 3, 2016 (81 FR       imposing a Medicaid moratorium.                        ownership of HHAs that require initial
                                                51116).                                                 Accordingly, CMS has determined that                   enrollment under § 424.550). Also, in


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                                                                               Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices                                               2365

                                                accordance with § 424.570(a)(1)(iv), a                  publish a document in the Federal                      providers of services and suppliers if
                                                temporary moratorium does not apply to                  Register announcing any extension of a                 the Secretary determines that the
                                                any enrollment application that a                       moratorium, and this extension of                      moratorium is necessary to prevent or
                                                Medicare contractor has already                         moratoria document fulfills that                       combat fraud, waste, or abuse.
                                                approved, but has not yet entered into                  requirement.                                           Accordingly, our regulations at 42 CFR
                                                the Provider Enrollment, Chain, and                        CMS consulted with the HHS–OIG                      498.5(l)(4) state that for appeals of
                                                Ownership System (PECOS) at the time                    regarding the extension of the moratoria               denials based on a temporary
                                                the moratorium is imposed.                              on new HHAs and Part B non-                            moratorium, the scope of review will be
                                                                                                        emergency ground ambulance providers                   limited to whether the temporary
                                                6. Lifting a Temporary Moratorium                       and suppliers in all of the moratoria                  moratorium applies to the provider or
                                                   In accordance with § 424.570(b), a                   states, and HHS–OIG agrees that a                      supplier appealing the denial. The
                                                temporary enrollment moratorium                         significant potential for fraud, waste,                agency’s basis for imposing a temporary
                                                imposed by CMS will remain in effect                    and abuse continues to exist regarding                 moratorium is not subject to review. Our
                                                for 6 months. If CMS deems it                           those provider and supplier types in                   regulations do not limit the right to seek
                                                necessary, the moratorium may be                        these geographic areas. The                            judicial review of a final agency
                                                extended in 6-month increments. CMS                     circumstances warranting the                           decision that the temporary moratorium
                                                will evaluate whether to extend or lift                 imposition of the moratoria have not yet               applies to a particular provider or
                                                the moratorium before the end of the                    abated, and CMS has determined that                    supplier. In the preamble to the
                                                initial 6-month period and, if                          the moratoria are still needed as we                   February 2, 2011 (76 FR 5918) final rule
                                                applicable, any subsequent moratorium                   monitor the indicators and continue                    with comment period establishing this
                                                periods. If one or more of the moratoria                with administrative actions to combat                  regulation, we explained that ‘‘a
                                                announced in this document are                          fraud and abuse, such as payment                       provider or supplier may
                                                extended, CMS will publish a document                   suspensions and revocations of                         administratively appeal an adverse
                                                regarding such extensions in the                        provider/supplier numbers. (For more                   determination based on the imposition
                                                Federal Register.                                       information regarding the monitored                    of a temporary moratorium up to and
                                                   As provided in § 424.570(d), CMS                     indicators, see the February 4, 2014                   including the Department Appeal Board
                                                may lift a moratorium at any time if the                moratoria document (79 FR 6475)).                      (DAB) level of review.’’ We are
                                                President declares an area a disaster                      Based upon CMS’ consultation with                   clarifying that providers and suppliers
                                                under the Robert T. Stafford Disaster                   the relevant State Medicaid agencies,                  that have received unfavorable
                                                Relief and Emergency Assistance Act, if                 CMS has concluded that extending                       decisions in accordance with the
                                                circumstances warranting the                            these moratoria will not create an access              limited scope of review described in
                                                imposition of a moratorium have abated,                 to care issue for Medicaid or CHIP                     § 498.5(l)(4) may seek judicial review of
                                                if the Secretary has declared a public                  beneficiaries in the affected states at this           those decisions after they exhaust their
                                                health emergency, or if, in the judgment                time. CMS also reviewed Medicare data                  administrative appeals. However, we
                                                of the Secretary, the moratorium is no                  for these states and found there are no                reiterate that section 1866(j)(7)(B) of the
                                                longer needed.                                          current problems with access to HHAs                   Act precludes judicial review of the
                                                   Once a moratorium is lifted, the                     or ground ambulance providers or                       agency’s basis for imposing a temporary
                                                provider or supplier types that were                    suppliers. Nevertheless, the agency will               moratorium.
                                                unable to enroll because of the                         continue to monitor these locations to
                                                moratorium will be designated to CMS’                                                                          V. Collection of Information
                                                                                                        make sure that no access to care issues
                                                high screening level under                                                                                     Requirements
                                                                                                        arise in the future.
                                                §§ 424.518(c)(3)(iii) and 455.450(e)(2)                    Based upon our consultation with law                  This document does not impose
                                                for 6 months from the date the                          enforcement and consideration of the                   information collection requirements,
                                                moratorium was lifted.                                  factors and activities described                       that is, reporting, recordkeeping or
                                                                                                        previously, CMS has determined that                    third-party disclosure requirements.
                                                II. Extension of Home Health and
                                                                                                        the temporary enrollment moratoria                     Consequently, there is no need for
                                                Ambulance Moratoria—Geographic
                                                                                                        should be extended for an additional 6                 review by the Office of Management and
                                                Locations
                                                                                                        months.                                                Budget under the authority of the
                                                   CMS currently has in place moratoria                                                                        Paperwork Reduction Act of 1995 (44
                                                on newly enrolling HHAs in Florida,                     III. Summary of the Moratoria                          U.S.C. 3501 et seq.).
                                                Illinois, Michigan, and Texas and Part B                Locations
                                                non-emergency ambulance suppliers in                       CMS is executing its authority under                VI. Regulatory Impact Statement
                                                New Jersey, Pennsylvania, and Texas.                    sections 1866(j)(7), 1902(kk)(4), and                     CMS has examined the impact of this
                                                   As provided in § 424.570(b), CMS                     2107(e)(1)(D) of the Act to extend and                 document as required by Executive
                                                may deem it necessary to extend                         implement temporary enrollment                         Order 12866 on Regulatory Planning
                                                previously-imposed moratoria in 6-                      moratoria on HHAs for all counties in                  and Review (September 30, 1993),
                                                month increments. Under this authority,                 Florida, Illinois, Michigan, and Texas,                Executive Order 13563 on Improving
                                                CMS is extending the temporary                          as well as Part B non-emergency ground                 Regulation and Regulatory Review
                                                moratoria on the Medicare enrollment of                 ambulance providers and suppliers for                  (January 18, 2011), the Regulatory
                                                HHAs and Part B non-emergency                           all counties in New Jersey,                            Flexibility Act (RFA) (September 19,
                                                ground ambulance providers and                          Pennsylvania, and Texas.                               1980, Pub. L. 96–354), section 1102(b) of
                                                suppliers in the geographic locations
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                                                                                                                                                               the Social Security Act, section 202 of
                                                discussed herein. Under the regulations                 IV. Clarification of Right to Judicial                 the Unfunded Mandates Reform Act of
                                                at § 455.470 and § 457.990, these                       Review                                                 1995 (March 22, 1995; Pub. L. 104–4),
                                                moratoria also apply to the enrollment                    Section 1866(j)(7)(B) of the Act states              Executive Order 13132 on Federalism
                                                of HHAs and non-emergency ground                        that there shall be no judicial review                 (August 4, 1999) and the Congressional
                                                ambulance providers and suppliers in                    under section 1869, section 1878, or                   Review Act (5 U.S.C. 804(2)).
                                                Medicaid and CHIP in those locations.                   otherwise, of a temporary moratorium                      Executive Orders 12866 and 13563
                                                Under § 424.570(b), CMS is required to                  imposed on the enrollment of new                       direct agencies to assess all costs and


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                                                2366                           Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Notices

                                                benefits of available regulatory                           Section 202 of the Unfunded                            D Electronic submission through
                                                alternatives and, if regulation is                      Mandates Reform Act of 1995 also                       https://www.regulations.gov portal.
                                                necessary, to select regulatory                         requires that agencies assess anticipated              Follow the instructions for submitting
                                                approaches that maximize net benefits                   costs and benefits before issuing any                  electronic comments. Attachments, if
                                                (including potential economic,                          regulatory action whose mandates                       any, should be in Microsoft Word or
                                                environmental, public health, and safety                require spending in any 1 year of $100                 Microsoft Excel. You can find this RFI
                                                effects, distributive impacts, and                      million in 1995 dollars, updated                       by typing ACF–2016–0002 in the Search
                                                equity). A regulatory impact analysis                   annually for inflation. In 2016, that                  window. Then click on the ‘‘Comment
                                                (RIA) must be prepared for major                        threshold is approximately $146                        Now!’’ button on the Search Results
                                                regulatory actions with economically                    million. This document will have no                    page. This will open up a Comment
                                                significant effects ($100 million or more               consequential effect on state, local, or               form where you can enter your
                                                in any 1 year). This document will                      tribal governments or on the private                   comment on the form, attach files (up to
                                                prevent the enrollment of new home                      sector.                                                10MB each), as well as your personal
                                                health providers and Part B non-                           Executive Order 13132 establishes                   information, when applicable. Be sure
                                                emergency ground ambulance suppliers                    certain requirements that an agency                    to complete all required fields. Please
                                                in Medicare, Medicaid, and CHIP in                      must meet when it promulgates a                        note that information entered on the
                                                certain states. Though savings may                      proposed regulatory action (and                        web form may be viewable publicly.
                                                accrue by denying enrollments, the                      subsequent final action) that imposes                  Once you reach the ‘‘Your Preview’’
                                                monetary amount cannot be quantified.                   substantial direct requirement costs on                screen, the information that will be
                                                Since the imposition of the initial                     state and local governments, preempts                  viewable publicly is displayed directly
                                                moratoria on July 31, 2013, 1,147 HHAs                  state law, or otherwise has Federalism                 on the form under the section titled:
                                                and 19 ambulance companies in all                       implications. Because this document                    ‘‘This information will appear on
                                                geographic areas affected by the                        does not impose any costs on state or                  Regulations.gov.’’ To complete your
                                                moratoria had their applications denied.                local governments, the requirements of                 comment, you must first agree to the
                                                We have found the number of                             Executive Order 13132 are not                          disclaimer and check the box. This will
                                                applications that are denied after 60                   applicable.                                            enable the ‘‘Submit Comment’’ button.
                                                days declines dramatically, as most                        In accordance with the provisions of                Upon completion, you will receive a
                                                providers and suppliers will not submit                 Executive Order 12866, this document                   Comment Tracking Number for your
                                                applications during the moratoria                       was reviewed by the Office of                          comment. To learn more about comment
                                                period. Therefore, this document does                   Management and Budget.                                 submission, visit the Submit a Comment
                                                not reach the economic threshold, and                                                                          section of the ‘‘How to Use
                                                thus is not considered a major action.                    Dated: December 28, 2016.
                                                                                                                                                               Regulations.gov’’ pages.
                                                   The RFA requires agencies to analyze                 Andrew M. Slavitt,
                                                                                                                                                                  D Electronic submission through email
                                                options for regulatory relief of small                  Acting Administrator, Centers for Medicare             to ANAComments@acf.hhs.gov.
                                                entities. For purposes of the RFA, small                & Medicaid Services.                                      All comments received before the
                                                entities include small businesses,                      [FR Doc. 2016–32007 Filed 1–6–17; 8:45 am]             close of the comment period will be
                                                nonprofit organizations, and small                      BILLING CODE 4120–01–P                                 available for public inspection,
                                                governmental jurisdictions. Most                                                                               including any information that is
                                                hospitals and most other providers and                                                                         included in a comment. All
                                                suppliers are small entities, either by                 DEPARTMENT OF HEALTH AND                               electronically submitted comments
                                                nonprofit status or by having revenues                  HUMAN SERVICES                                         posted through the https://
                                                of less than $7.5 million to $38.5                                                                             www.regulations.gov portal received
                                                million in any one year. Individuals and                Administration for Children and
                                                                                                        Families                                               before the end of the comment period
                                                states are not included in the definition                                                                      will be available at http://
                                                of a small entity. CMS is not preparing                                                                        www.regulations.gov.
                                                an analysis for the RFA because it has                  Request for Information
                                                determined, and the Secretary certifies,                                                                       FOR FURTHER INFORMATION CONTACT:
                                                                                                        AGENCY:  Administration for Children
                                                that this document will not have a                                                                             Camille Loya, Director, Division of
                                                                                                        and Families (ACF), Department of
                                                significant economic impact on a                                                                               Policy, Administration for Native
                                                                                                        Health and Human Services (HHS).
                                                substantial number of small entities.                                                                          Americans, Camille.Loya@acf.hhs.gov,
                                                                                                        ACTION: Request for information (RFI).                 202–401–5964.
                                                   In addition, section 1102(b) of the Act
                                                requires us to prepare a regulatory                     SUMMARY:    This Request for Information               SUPPLEMENTARY INFORMATION:
                                                impact analysis if an action may have a                 (RFI) seeks recommendations for future                 I. Background information
                                                significant impact on the operations of                 work with and on behalf of American
                                                a substantial number of small rural                                                                               Executive Order 13175, dated
                                                                                                        Indian and Alaska Native (AI/AN)
                                                hospitals. This analysis must conform to                                                                       November 6, 2000, established
                                                                                                        leadership, tribes, tribal organizations,
                                                the provisions of section 604 of the                                                                           policymaking criteria applicable to
                                                                                                        and populations in accord with ACF’s
                                                RFA. For purposes of section 1102(b) of                                                                        federal agencies, to the extent permitted
                                                                                                        vision of ‘‘children, youth, families,
                                                the Act, CMS defines a small rural                                                                             by law, when formulating and
                                                                                                        individuals, and communities who are
                                                hospital as a hospital that is located                                                                         implementing policies that have tribal
                                                                                                        resilient, safe, healthy, and
                                                outside of a metropolitan statistical area                                                                     implications, including special
                                                                                                        economically secure.’’
                                                                                                                                                               requirements for legislative proposals
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                                                (MSA) for Medicare payment purposes
                                                and has fewer than 100 beds. CMS is not                 DATES: Submit responses by March 10,                   and consultation. Subsequently,
                                                preparing an analysis for section 1102(b)               2017.                                                  President Obama issued a Presidential
                                                of the Act because it has determined,                   ADDRESSES: Written comments may be                     Memorandum on Tribal Consultation,
                                                and the Secretary certifies, that this                  submitted through any of the methods                   dated November 5, 2009, affirming that
                                                document will not have a significant                    specified below. However, electronic                   ‘‘meaningful dialogue between Federal
                                                impact on the operations of a substantial               submission is preferred. Please do not                 officials and tribal officials has greatly
                                                number of small rural hospitals.                        submit duplicate comments.                             improved Federal policy toward Indian


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Document Created: 2018-10-24 11:11:18
Document Modified: 2018-10-24 11:11:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionExtension of temporary moratoria.
DatesEffective January 29, 2017.
ContactSteve Manning, (410) 786-1691.
FR Citation82 FR 2363 

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