[Federal Register Volume 81, Number 149 (Wednesday, August 3, 2016)]
[Rules and Regulations]
[Pages 51120-51124]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18383]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 424 and 455

[CMS-6059-N5]


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

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Extension, implementation, and lifting of temporary moratoria.

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

SUMMARY: This document announces the extension of temporary moratoria 
on the enrollment of new Medicare Part B non-emergency ground ambulance 
suppliers and Medicare home health agencies (HHAs), 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. It also announces 
the implementation of temporary moratoria on the enrollment of new 
Medicare Part B non-emergency ground ambulance suppliers and Medicare 
HHAs, subunits, and branch locations in Florida, Illinois, Michigan, 
Texas, Pennsylvania, and New Jersey on a statewide basis. In addition, 
it announces the lifting of the moratoria on all Part B emergency 
ground ambulance suppliers. These moratoria, and the changes described 
in this document, also apply to the enrollment of HHAs and non-
emergency ground ambulance suppliers in Medicaid and the Children's 
Health Insurance Program.

DATES: Effective July 29, 2016.

FOR FURTHER INFORMATION CONTACT: Jung Kim, (410) 786-9370.
    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

[[Page 51121]]

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 HHAs, 
subunits, and branch locations \1\ (hereafter referred to as HHAs) in 
Miami-Dade County, Florida and Cook County, Illinois, as well as 
surrounding counties, and Medicare Part B ground ambulance suppliers in 
Harris County, Texas and surrounding counties, in a notice issued on 
July 31, 2013 (78 FR 46339). We exercised this authority again in a 
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).
---------------------------------------------------------------------------

    \1\ As noted in the preamble to the final rule with comment 
period implementing the moratorium authority (February 2, 2011, CMS-
6028-FC (76 FR 5870), home health agency subunits and branch 
locations are subject to the moratoria to the same extent as any 
other newly enrolling home health agency.
---------------------------------------------------------------------------

B. Determination of the Need for Moratoria

    In imposing these enrollment moratoria, CMS considered both 
qualitative and quantitative factors suggesting a high risk of fraud, 
waste, or abuse. CMS relied on law enforcement's longstanding 
experience with ongoing and emerging fraud trends and activities 
through civil, criminal, and administrative investigations and 
prosecutions. CMS' determination of a high risk of fraud, waste, or 
abuse in these provider and supplier types within these geographic 
locations was then confirmed by CMS' data analysis, which relied on 
factors the agency identified as strong indicators of risk. (For a more 
detailed explanation of this determination process and of these 
authorities, see the July 31, 2013 notice (78 FR 46339) or February 4, 
2014 moratoria document (79 FR 6475)).
    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

[[Page 51122]]

supplier types within geographic locations with significant potential 
for fraud, waste or abuse, therefore warranting the imposition of 
enrollment moratoria.
    Four of the six states subject to the temporary enrollment 
moratoria for HHAs and Part B non-emergency ground ambulance suppliers 
have counties that contain or are adjacent to HEAT Medicare Fraud 
Strike Force locations, with the exception of Pennsylvania and New 
Jersey. All six states are also consistently ranked near the top for 
the identified metrics among counties with at least 200,000 Medicare 
beneficiaries in 2012.
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 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.
5. When a Temporary Moratorium Does Not Apply
    Under Sec.  424.570(a)(1)(iii), a temporary moratorium does not 
apply to changes in practice locations, changes to provider or supplier 
information such as phone number, address, or changes in ownership 
(except changes in ownership of HHAs that require initial enrollments 
under Sec.  424.550). Also, in accordance with Sec.  424.570(a)(1)(iv), 
the moratorium does not apply to an enrollment application that a CMS 
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. Lifting of Moratorium on New Part B Emergency Ambulance Suppliers 
in All Geographic Locations

    CMS previously imposed moratoria on the enrollment of new Part B 
ground ambulance suppliers in the Texas counties of Brazoria, Chambers, 
Fort Bend, Galveston, Harris, Liberty, Montgomery, and Waller; the 
Pennsylvania counties of Bucks, Delaware, Montgomery, and Philadelphia; 
and the New Jersey counties of Burlington, Camden, and Gloucester. 
These moratoria became effective upon publication of the notice in the 
Federal Register on July 31, 2013 (78 FR 46339) and the moratoria 
document on February 4, 2014 (79 FR 6475), and were subsequently 
extended by documents published in the Federal Register on August 1, 
2014 (79 FR 44702), February 2, 2015 (80 FR 5551), and July 28, 2015 
(80 FR 44967), and February 2, 2016 (81 FR 5444).
    Throughout the duration of the temporary moratoria on newly 
enrolling Part B ground ambulance providers, CMS has evaluated the risk 
to the Medicare program of separate categories of ambulance suppliers. 
This evaluation has shown that the primary risk to the program comes 
from the non-emergency ambulance supplier category. Additionally, we 
have observed potential access to care related issues for emergency 
ambulance services in some areas. As a result, CMS is not extending the 
temporary moratoria on the enrollment of Part B emergency ground 
ambulance suppliers in any geographic locations in the states of New 
Jersey, Pennsylvania, or Texas. However, we will continue to evaluate 
all ambulance services for indicators of fraud, waste, and abuse and 
will evaluate the need for future moratoria based on these indicators. 
The lifting of the moratorium on new Part B emergency ambulance 
suppliers in all geographic locations also applies to Medicaid and 
CHIP. New Part B suppliers of emergency ambulance services will be 
permitted to enroll as of July 29, 2016. Any such suppliers that enroll 
within 6 months of that date will be included in the ``high'' risk 
screening category, as provided in Sec.  424.518(c)(3). New emergency 
ambulance suppliers that furnish both emergency and non-emergency 
services will only be able to bill for emergency transportation 
services.

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

    CMS previously imposed moratoria on the enrollment of new HHAs in 
the Florida counties of Broward, Miami-Dade, and Monroe; the Illinois 
counties of Cook, DuPage, Kane, Lake, McHenry, and Will; the Michigan 
counties of Macomb, Monroe, Oakland, Washtenaw, and Wayne; and the 
Texas counties of Brazoria, Chambers, Collin, Fort Bend, Galveston, 
Dallas, Harris, Liberty, Denton, Ellis, Kaufman, Montgomery, Rockwall, 
Tarrant, and Waller. Further, we previously imposed moratoria on the 
enrollment of new ground ambulance suppliers in the Texas counties of 
Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, 
and Waller; the Pennsylvania counties of Bucks, Delaware, Montgomery, 
and Philadelphia; and the New Jersey counties of Burlington, Camden, 
and Gloucester. These moratoria became effective upon publication of 
the notice in the Federal Register on July 31, 2013 (78 FR 46339) and 
the moratoria document on February 4, 2014 (79 FR 6475), and were 
subsequently extended by documents published in the Federal Register on 
August 1, 2014 (79 FR 44702), February 2, 2015 (80 FR 5551), July 28, 
2015 (80 FR 44967)), and February 2, 2016 (81 FR 5444).
    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 suppliers 
in the geographic locations discussed herein. Under regulations at 
Sec.  455.470 and

[[Page 51123]]

Sec.  457.990, these moratoria also apply to the enrollment of HHAs and 
non-emergency 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 Part B non-emergency 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 
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 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.

IV. Implementation of New Home Health and Part B Non-Emergency 
Ambulance Moratoria--Geographic Locations

1. Geographic locations affected by implementation.
    CMS has determined that the factors initially evaluated to 
implement the temporary moratoria show that a high risk of fraud, 
waste, and abuse exists beyond the current moratoria areas, which may 
suggest that a high risk of fraud, waste, or abuse exists due largely 
to circumvention of the moratoria by some providers and suppliers. The 
primary means of circumvention includes enrolling a new practice 
location outside of a moratorium area and servicing beneficiaries 
within the moratorium area. Additionally, CMS has continued to see 
areas of saturation that exceed the national average in the moratoria 
states. As a result, CMS, in consultation with the OIG, has determined 
that it is necessary to expand the temporary moratoria on a statewide 
basis, by implementing temporary moratoria on all newly enrolling HHAs 
in the remaining counties in Florida, Illinois, Michigan, and Texas, 
and on all newly enrolling Part B non-emergency ground ambulance 
suppliers in the remaining counties in Texas, New Jersey, and 
Pennsylvania, in order to combat fraud, waste, or abuse in those 
states. CMS has determined that these moratoria will also apply to 
Medicaid and CHIP in each state, although states continue to have the 
ability to opt out if they determine that the imposition of such 
moratorium would adversely impact Medicaid beneficiaries' access to 
care.
    In the document published on February 4, 2014 (79 FR 6475) 
initially imposing the temporary moratorium on enrollment of HHAs in 
Broward County, Florida, CMS stated that ``it is not necessary to 
extend the moratorium to the other counties that border Broward because 
of the state's home health licensing rules that prevent providers 
enrolling in these counties from serving beneficiaries in Broward.'' 
However, through data analytics, we have determined that these state 
licensure restrictions are not adequate deterrents to prevent a 
provider from enrolling in one county and servicing beneficiaries in 
other counties. In some cases, CMS has observed that providers are 
servicing beneficiaries located over 300 miles from their practice 
location.
    As a result of this and other data analyses, CMS has determined 
that it is necessary to expand these moratoria to be statewide. 
Accordingly, beginning on the effective date of this document, no new 
HHAs will be enrolled in Medicare, Medicaid, or CHIP with a practice 
location in Florida, Illinois, Michigan, or Texas unless their 
enrollment application has already been approved but not yet entered 
into PECOS for Medicare or the State Provider/Supplier Enrollment 
System for Medicaid and CHIP as of the effective date of this document. 
Additionally, no new Part B non-emergency ground ambulance supplier 
will be enrolled into Medicare, Medicaid, or CHIP with a practice 
location in Texas, New Jersey, or Pennsylvania unless their enrollment 
application has already been approved but not yet entered into PECOS 
for Medicare or the State Provider/Supplier Enrollment System for 
Medicaid and CHIP as of the effective date of this document.
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. CMS recognizes 
the increased risk of beneficiary access to care issues when 
implementing statewide moratoria. In order to address this issue, we 
have performed a detailed access to care analysis for all moratoria 
states, and identified the counties with lower saturation of home 
health and Part B ground ambulance providers or suppliers.\2\ These 
data include an evaluation of provider and supplier saturation, 
provider or supplier to beneficiary ratios, and claims data in the 
Medicare program. Beneficiary access to care is a primary concern for 
CMS, and we will continue to utilize these data to address the lowest 
saturation areas. As a continual measure, CMS will update and evaluate 
these data to monitor attrition of home health and Part B ground 
ambulance providers or suppliers from Medicare and make certain that 
beneficiaries in counties with lower provider or supplier saturation 
are not negatively impacted by the moratoria or related enforcement 
activities. Any beneficiary that experiences access to care issues may 
report them to 1-800-MEDICARE or their state's Quality Improvement 
Organization (QIO) for resolution.
---------------------------------------------------------------------------

    \2\ Data related to HHAs and Part B non-emergency ambulance 
suppliers may be viewed at https://data.cms.gov/moratoria-data.
---------------------------------------------------------------------------

    CMS does not currently have the regulatory authority to implement 
an exception process to respond to beneficiary access to care issues; 
therefore, concurrently with the statewide moratoria implementation, 
CMS is announcing 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 waives certain authorities and allows for 
such exceptions. The demonstration will, among other things, allow for 
access to care-based exceptions to the moratoria in certain limited 
circumstances. This will allow enrollment of a provider or supplier 
after a heightened review of that provider has been conducted.
    CMS has determined that this exception process will also apply to

[[Page 51124]]

Medicaid and CHIP providers in each state. CMS will work 
collaboratively with states to implement this demonstration in a way 
that accommodates the access to care needs of beneficiaries in each 
state.
    Details of the demonstration may be found at elsewhere in this 
issue of the Federal Register.

V. 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 suppliers for all counties in New Jersey, Pennsylvania, and 
Texas.

VI. 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.

VII. 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.).

VIII. 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 
any1 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. Though savings may accrue by denying 
enrollments, the monetary amount cannot be quantified. After the 
imposition of the initial moratoria on July 31, 2013, 889 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 1 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 2015, 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: July 13, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-18383 Filed 7-29-16; 4:15 pm]
 BILLING CODE 4120-01-P