```

[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Pages 46339-46347]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18394]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-6048-N]

Medicare, Medicaid, and Children's Health Insurance Programs: 
Announcement of Temporary Moratoria on Enrollment of Ambulances 
Suppliers and Providers and Home Health Agencies in Designated 
Geographic Areas

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

ACTION: Notice.

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SUMMARY: This notice announces the imposition of a temporary moratorium 
on the enrollment of home health agencies in Miami-Dade and Cook 
counties as well as selected surrounding

[[Page 46340]]

areas, and on the enrollment of new ambulance suppliers and providers 
in Harris County and surrounding counties to prevent and combat fraud, 
waste, and abuse.

DATES: Effective Date: July 30, 2013.

FOR FURTHER INFORMATION CONTACT: August Nemec, (410) 786-0612.
    News media representatives must contact our Public Affairs Office 
at (202) 690-6145 or email them at press@cms.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. CMS' Authority To Impose 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 fee-for-service 
(FFS) 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 later 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 areas or both. At Sec.  
424.570(a)(1)(ii), CMS stated that it would announce a temporary 
moratorium in a Federal Register notice that includes the rationale for 
the imposition of the temporary enrollment moratorium. The rationale 
will include the factors for imposing a moratorium on a case by case 
basis. This notice 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. However, 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, though the scope of 
any such appeal would be 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 (Sec.  424.514(d)(2)(v)(C)).

B. Determination of the Need for a Moratorium

    In imposing these enrollment moratoria, CMS considered both 
qualitative and quantitative factors suggesting a high risk of fraud, 
waste, or abuse. CMS relied on its and law enforcement's longstanding 
experience with ongoing and emerging fraud trends and activities 
through civil, criminal, and administrative investigations and 
prosecutions. Our determination of high risk areas of fraud in these 
provider and supplier types and geographic areas was then confirmed by 
our data analysis, which relied on factors CMS identified as strong 
indicators of fraud risk.
    Because fraud schemes are highly migratory and transitory in 
nature, many of our program integrity authorities and anti-fraud 
activities are designed to allow the agency to adapt to emerging fraud 
in different areas. The laws and regulations governing our moratoria 
authority give us flexibility to use any and all relevant criteria for 
future moratoria and CMS retains the authority to impose any future 
moratorium on a case-by-case basis.
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 \1\ 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 will 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 later determines that the imposition 
of a 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.
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    \1\ The Secretary has delegated to CMS authority to administer 
Titles XVIII, XIX, and XXI of the Act. For more information see the 
September 6, 1984 Federal Register (49 FR 35247) and the December 
16, 1997 Federal Register (62 FR 65813).
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    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 any 
individual or entity if such individual

[[Page 46341]]

or entity is terminated under Medicare or any other State Medicaid 
plan.\2\ 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 moratorium 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. Therefore, 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.
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    \2\ Although section 6501 of Affordable Care Act does not 
specifically state that individuals or entities that have been 
terminated under Medicare or Medicaid must also be terminated from 
CHIP, we have required CHIP, through federal regulation, to take 
similar action regarding termination of a provider that is also 
terminated or had its billing privileges revoked under Medicare or 
any State Medicaid plan.
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2. Consultation With Law Enforcement
    In consultation with the HHS-OIG and the Department of Justice 
(DOJ), CMS identified two provider and supplier types in three 
geographic areas that warrant temporary enrollment moratoria. CMS 
reached this determination based in part on the federal government's 
experience with the Health Care Fraud Prevention and Enforcement Action 
Team (HEAT), a joint effort between DOJ and HHS to prevent fraud, waste 
and abuse in the Medicare and Medicaid programs. The Medicare Fraud 
Strike Force teams are a key component of HEAT and operate in nine 
cities nationwide.\3\ Each Medicare Fraud Strike Force team combines 
the programmatic and administrative action capabilities of CMS, the 
analytic and investigative resources of the FBI and HHS-OIG, and the 
prosecutorial resources of DOJ's Criminal Division's Fraud Section and 
the United States Attorneys Offices. The Strike Force teams use 
advanced data analysis techniques to identify high billing levels in 
health care fraud hotspots so that interagency teams can target 
emerging or migrating schemes along with chronic fraud by criminals 
masquerading as health care providers or suppliers. The locations of 
the Strike Force teams are identified by analyzing where Medicare 
claims data reveal aberrant billing patterns and intelligence data 
analysis suggests that fraud may be occurring.
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    \3\ The Medicare Strike Force operates in Miami, FL; Los 
Angeles, CA: Detroit, MI; Houston, TX; Brooklyn, NY; Baton Rouge, 
LA; Tampa, FL; Chicago, IL; and Dallas, TX.
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    It is important to note that all of the moratoria target areas 
identified in this notice--Miami, Houston, and Chicago--are Strike 
Force cities, and each of these areas has experienced intense, 
sustained criminal prosecution activity with respect to the provider 
and supplier types subject to these moratoria. In addition, CMS's own 
administrative investigations and oversight have been equally intense 
in these areas. Through CMS's own anti-fraud activities, in addition to 
the federal government's coordinated HEAT efforts, CMS has determined 
that home health agencies in Miami and Chicago and the surrounding 
areas, and ambulance companies in Houston and the surrounding area pose 
a significant risk of fraudulent activity.
    As a part of ongoing antifraud efforts, the HHS-OIG and CMS have 
learned that some fraud schemes are viral, meaning they replicate 
rapidly within communities, and that health care fraud also migrates--
as law enforcement cracks down on a particular scheme, the criminals 
may redesign the scheme or relocate to a new geographic area.\4\ As a 
result, CMS has determined that it is necessary to extend these 
moratoria beyond the target counties to bordering counties, unless 
otherwise noted, to prevent potentially fraudulent providers and 
suppliers from enrolling their practices in a neighboring county with 
the intent of providing services in a moratorium-targeted area. CMS 
will monitor the surrounding counties, as well as the entirety of each 
affected state, by reviewing claims utilization and activity, for 
indicia of activity designed to evade these moratoria. Throughout the 
duration of these moratoria, CMS will continue to consult with law 
enforcement, to assess and address the spread of any significant risk 
of fraud beyond the moratorium areas.
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    \4\ Testimony of the Inspector General, ``Preventing Health Care 
Fraud: New Tools and Approaches to Combat Old Challenges.'' See 
http://www.hhs.gov/asl/testify/2011/03/t20110302i.html.
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3. Data Analysis
    The scope of the data analysis included reviewing Medicare and 
Medicaid enrollment and claims data. CMS identified all counties across 
the nation with 200,000 or more Medicare beneficiaries (``comparison 
counties''), and analyzed certain key metrics which we believe to be 
strong indications of potential fraud risk. These metrics included 
factors such as: the number of providers or suppliers per 10,000 
Medicare FFS beneficiaries; the compounded annual growth rate in 
provider or supplier enrollments; and the ``churn rate''--the rate of 
providers entering and exiting the program--as measured by the percent 
of the target provider or supplier community continuously receiving 
Medicare payments since 2008. We know that when some providers and 
suppliers incur a substantial debt to Medicare, they then exit the 
Medicare program or shut down operations altogether, and attempt to re-
enroll through another vehicle or under a new business identity. The 
moratoria are intended to curtail this churning of providers to new 
enrollments. CMS also reviewed the 2012 FFS Medicare payments to 
providers and suppliers in the target areas based on the average amount 
spent per beneficiary who used services furnished by the targeted 
provider and supplier types.
    The three areas subject to the temporary enrollment moratoria are 
the only counties that contain Strike Force cities that also 
consistently ranked near the top for the aforementioned metrics among 
counties with at least 200,000 Medicare beneficiaries in 2012. This 
analysis helps confirm the federal government's previously described 
experience in its HEAT and Strike Force activities, and provides 
further support for CMS' determination that the moratoria are 
appropriate in these areas. See Tables 1 and 2 of this notice for a 
summary of the moratoria areas and some of the metrics examined.
4. Beneficiary Access to Care
    Beneficiary access to care in Medicare, Medicaid and CHIP is of 
critical importance to CMS and our state partners, and CMS carefully 
evaluated access for the three target moratoria areas. To determine if 
the moratoria would create an access to care issue for Medicaid and 
CHIP beneficiaries in the targeted areas and surrounding counties, CMS 
consulted with the appropriate State Medicaid Agencies and State 
Departments of Emergency Medical Services. All of our state partners 
were supportive of our analysis and

[[Page 46342]]

proposals, and together with CMS, have determined that these moratoria 
will not create access of care issues for Medicaid or CHIP 
beneficiaries.
    In order to determine if the moratoria would create an access to 
care issue for Medicare beneficiaries, CMS reviewed its own data 
regarding the number of providers and suppliers in the target and 
surrounding counties, and confirmed that there are no reports to CMS of 
access to care issues for these provider and supplier types. CMS also 
reviewed recent reports by the Medicare Payment Advisory Commission 
(MedPAC), an independent Congressional agency established by the 
Balanced Budget Act of 1997 to advise Congress on issues affecting the 
Medicare program. MedPAC has a Congressional mandate to monitor 
beneficiaries' access to care and publishes its review of Medicare 
expenditures annually. Based on our analysis of each target market and 
review of MedPAC's March 2013 report (finding no access issues to 
Medicare home health services \5\), and its June 2013 report (finding 
no access issues to Medicare ambulance services \6\), CMS does not 
believe these moratoria will cause an access to care issue for Medicare 
beneficiaries.
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    \5\ MedPAC, March 2013, ``Report to Congress: Medicare Payment 
Policy, Chapter 9 home health services.'' http://www.medpac.gov/documents/Mar13_entirereport.pdf.
    \6\ MedPAC, June 2013, ``Chapter 7, Mandated Report: Medicare 
payment for ambulance services.'' http://www.medpac.gov/chapters/Jun13_Ch07.pdf
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    In the March report, MedPAC also recommended that CMS use its 
authorities under current law to examine providers with aberrant 
patterns of utilization for possible fraud and abuse. With regard to 
home health services, MedPAC stated that a moratorium on the enrollment 
of new HHAs would prevent new agencies from entering markets that may 
already be saturated.\7\ CMS will continuously monitor for reductions 
in the number of HHA providers and Part B ambulance suppliers, as well 
as beneficiary complaints, and will continue consultation with the 
states, for any indication of a potential access to care issue.
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    \7\ MedPAC, March 2013, ``Report to Congress: Medicare Payment 
Policy, Chapter 9 home health services.'' http://www.medpac.gov/documents/Mar13_entirereport.pdf.
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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), these temporary enrollment 
moratoria will remain in effect for 6 months. If CMS deems it 
necessary, the moratoria may be extended in 6-month increments. CMS 
will evaluate whether to extend or lift the moratoria before the end of 
the initial 6-month period and, if applicable, any subsequent 
moratorium periods. If one or more of the moratoria are extended, CMS 
will publish notice of 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, circumstances 
warranting the imposition of a moratorium have abated, the Secretary 
has declared a public health emergency, or in the judgment of the 
Secretary, the moratorium is no longer needed.
    Once a moratorium is lifted, provider or supplier types that were 
unable to enroll because of the moratorium will be designated to CMS' 
high screening level under Sec.  424.518(c)(3)(iii) and Sec.  
455.450(e)(2) for 6 months from the date the moratorium was lifted.

II. Home Health Moratoria--Geographic Areas

    Under its authority at Sec.  424.570(a)(2)(i) and (a)(2)(iv), CMS 
is implementing a temporary moratorium on the Medicare enrollment of 
HHAs in the geographic areas discussed in this section. Under 
regulations at Sec.  455.470 and Sec.  457.990, this moratorium will 
also apply to the enrollment of HHAs in Medicaid and CHIP.

A. Moratorium on Enrollment of Home Health Agencies in the Florida 
Counties of Miami-Dade and Monroe

    CMS has determined that there are factors in place that warrant the 
imposition of a temporary Medicare enrollment moratorium for HHAs in 
Miami-Dade County (which contains the City of Miami), as well as 
extending the moratorium to one bordering county--Monroe. Florida has 
divided the state into 11 home health ``licensing districts,'' that 
prevent a home health agency from providing services outside its own 
licensing district. Monroe is the only bordering county within the same 
licensing district as Miami-Dade. CMS has determined that it is 
necessary to extend this moratorium to Monroe to prevent potentially 
fraudulent HHAs from enrolling their practices in a neighboring county 
to avoid the moratorium. In this instance, it is not necessary to 
extend the moratorium to the other counties that border Miami-Dade 
because of the state's home health licensing rules that prevent 
providers enrolling in these counties from serving beneficiaries in 
Miami-Dade. CMS has also consulted with the State Medicaid Agency and 
reviewed available data, and determined that the moratorium will also 
apply to Medicaid and CHIP.
    Beginning on the effective date of this notice, no new HHAs will be 
enrolled into Medicare, Medicaid or CHIP with a practice location in 
the Florida counties of Miami-Dade or Monroe, unless their enrollment 
application has already been approved, but not yet entered into PECOS 
or the State Enrollment System at the time the moratorium is imposed.
1. Consultation With Law Enforcement
    Consistent with Sec.  424.570(a)(2)(iv), CMS has consulted with 
both the HHS-OIG and DOJ regarding the imposition of a moratorium on 
new HHAs in Miami-Dade and Monroe counties. Both HHS-OIG and DOJ agree 
that a significant potential for fraud, waste, or abuse exists with 
respect to HHAs in the affected geographic areas. The HHS-OIG has 
previously identified Miami-Dade as an HHA fraud-prone area because it 
is a Strike Force location where individuals have been charged with 
billing potentially fraudulent home health services, and is located in 
a state that had a high percentage of HHAs with questionable billing 
identified by the HHS-OIG.\8\ There has also been considerable Strike 
Force and law enforcement activity in this area of the country. Since 
2011, the U.S. Attorney's Office for the Southern District of Florida 
has filed 41 home health fraud cases and charged 98 individuals that 
have resulted in 85 guilty pleas and 8 trial convictions. For example, 
in May 2013, a patient recruiter for a Miami

[[Page 46343]]

health care company was sentenced to serve 37 months in prison for his 
participation in a $20 million Medicare fraud scheme.\9\ In February 
2013, the owners and operators of two Miami health care agencies were 
sentenced to 9 years and more than 4 years in prison, respectively, and 
ordered to pay millions in restitution for their participation in a $48 
million Medicare fraud scheme that billed for unnecessary home health 
care and therapy services.\10\ Also, in August 2012, the owner and 
operator of a Miami health care agency pleaded guilty for his 
participation in a $42 million Medicare home health fraud scheme.\11\ 
In April 2012, the U.S. District Court in Miami sentenced the three 
owners of a Miami home health care agency to 120 months, 87 months, and 
87 months, respectively for their participation in a $60 million 
Medicare home health care fraud scheme. CMS program integrity 
contractors are also actively investigating home health agencies in 
this area.
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    \8\ Office of Inspector General Report, ``CMS and Contractor 
Oversight of Home Health Agencies.'' (OEI-04-11-00220). See https://oig.hhs.gov/oei/reports/oei-04-11-00220.pdf. The HHS-OIG defines an 
``HHA fraud-prone area'' as those that are--(1) Strike Force Cities; 
(2) Strike Force cities where individuals have been charged with 
billing potentially fraudulent home health services; and (3) located 
in a state that had a high percentage of HHAs with questionable 
billing identified by the HHS-OIG.
    \9\ Department of Justice, ``Patient Recruiter of Miami Home 
Health Company Sentenced to 37 Months in Prison for Role in $20 
Million Health Care Fraud Scheme.'' See http://www.justice.gov/opa/pr/2013/May/13-crm-510.html.
    \10\ Department of Justice, ``Owners of Miami Home Health 
Companies Sentenced to Prison in $48 million Health Care Fraud 
Scheme.'' See http://www.justice.gov/opa/pr/2013/February/13-crm-243.html.
    \11\ Department of Health and Human Services and Department of 
Justice, ``Health Care Fraud and Abuse Control Program Annual Report 
for Fiscal Year 2012.'' See http://oig.hhs.gov/publications/docs/hcfac/hcfacreport2012.pdf.
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2. Data Analysis
a. Medicare Data Analysis
    CMS' data show that in 2012, there were 26 U.S. counties 
nationally, including Miami-Dade, with at least 200,000 Medicare 
beneficiaries. CMS excluded Miami-Dade County, and used the remaining 
25 counties as ``comparison counties.'' In the comparison counties, 
there was an average of 1.8 HHAs per 10,000 Medicare FFS 
beneficiaries.\12\ In Miami-Dade County, there were 37.6 HHAs per 
10,000 Medicare FFS beneficiaries. This means that the ratio of HHAs to 
Medicare FFS beneficiaries was 1,960 percent greater in Miami-Dade 
County than in the comparison counties. Miami-Dade County had the 
highest ratio of HHAs to Medicare FFS beneficiaries compared to the 
comparison counties.
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    \12\ Throughout this notice, the ``comparison counties'' data 
also excludes New York County, New York because of the unique local 
conditions, such as that county's high density, compact geography, 
and high real estate costs, very few HHAs that serve the large 
number of beneficiaries in the county are located within the county. 
We believe this outlier would have biased the average to be 
artificially low, and could potentially over-represent the 
difference in ratios between the target county and the comparison 
counties.
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    CMS' data show that from 2008 through 2012, the total number of 
operational HHAs in Miami-Dade County increased from 385 to 662. The 
compounded annual growth rate of HHAs in Miami-Dade County is 15 
percent, more than double the national average of 7 percent. In 
addition, of the 662 HHAs active in Miami-Dade County in 2012, 56 
percent of these HHAs have not been billing continuously--a strong 
indicator of churn--since 2008, while only 32 percent of HHAs in 2012 
had not been continuously billing since 2008 in the average comparison 
county.
    CMS' data show that in 2012, HHAs in Miami-Dade County were 
receiving payments of $10,287 per average Medicare home health user per 
year, compared to HHAs in the comparison counties, which received 
payments of $5,783. Payments to HHAs in Miami-Dade were 77 percent 
greater than the average for the comparison counties. Miami-Dade had 
the highest payments to HHAs compared to the comparison counties. High 
outlier payments to Miami-Dade home health agencies have persisted for 
several years despite CMS' efforts to limit outlier payments through 
policy changes. In 2010, CMS implemented a home health agency-level cap 
on outlier payments so that, in any given year, an individual HHA would 
receive no more than 10 percent of its total home health prospective 
payment system (HH PPS) payments in outlier payments. Before the policy 
change, HHAs in Miami-Dade County were receiving average annual 
Medicare payments per home health beneficiary that were nearly 400 
percent greater than the comparison counties in 2008 ($20,801 compared 
to $5,935). While this policy has been successful in reducing costs in 
Miami-Dade, CMS believes more needs to be done.
b. Medicaid Data Analysis
    As discussed previously in section I.B.1. of this notice, 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. In addition, the data also show a significantly 
higher concentration of home health providers per Medicaid 
beneficiaries in Miami-Dade County than elsewhere in the state. CMS 
compared Miami-Dade against the entire state because Medicaid policies 
are not uniform across different states. Specifically, in 2010,\13\ 
Miami-Dade County, which is home to just 16 percent of all Florida 
Medicaid home health beneficiaries, is nevertheless home to 45 percent 
of all the home health providers in the state. This disproportionate 
supply in Miami-Dade County, compared to the rest of the state, is 
reflected in the number of providers per Medicaid beneficiary: Miami-
Dade County has 96 home health providers per 1,000 Medicaid 
beneficiaries--a provider density rate close to 3 times the Florida-
wide provider density of 35 home health providers per 1,000 Medicaid 
beneficiaries.
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    \13\ CMS used 2010 data from the Medicaid Statistical 
Information System (MSIS) because it was the most recent data 
available for all three states in this notice.
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2. Beneficiary Access to Care
    Based upon CMS' consultation with the State Medicaid agency, CMS 
has concluded that imposing this temporary moratorium will not create 
an access to care issue for Medicaid or CHIP beneficiaries in Miami-
Dade or the surrounding counties at this time. Accordingly, under Sec.  
455.470 and Sec.  457.990, this moratorium will apply to the enrollment 
of HHAs in Medicaid and CHIP, unless the State later determines that 
imposition of the moratorium would adversely impact beneficiary access 
to care and so notifies CMS under Sec.  455.470(a)(3).
    CMS reviewed Medicare data for the target and surrounding counties, 
and found that there are no problems with access to home health 
agencies in Miami-Dade or surrounding counties. In addition, as 
described in section I.B.4. of this notice, MedPAC has not reported any 
problems with Medicare beneficiary access to home health care. While 
CMS has determined there are no access to care issues for Medicare 
beneficiaries, nevertheless, the agency will continuously monitor these 
areas under a moratorium for changes such as an uptick in beneficiary 
complaints to ensure there is no access to care issue.
    As a result of law enforcement consultation and consideration of 
the factors described previously, CMS has determined that a temporary 
enrollment moratorium is needed to combat fraud in this area.

B. Moratorium on Enrollment of Home Health Agencies in the Illinois 
Counties of Cook, DuPage, Kane, Lake, McHenry, and Will

    CMS has determined that there are factors in place to warrant the 
imposition of a temporary enrollment moratorium for HHAs in Cook County 
(which contains the City of Chicago).

[[Page 46344]]

CMS has determined that it is necessary to extend this moratorium to 
the surrounding counties to prevent potentially fraudulent HHAs from 
enrolling their practices in a neighboring county to avoid the 
moratorium. To this end, CMS is extending the moratorium to five 
surrounding counties--DuPage, Kane, Lake, McHenry, and Will.
    Beginning on the effective date of this notice, no new HHAs will be 
enrolled into Medicare, Medicaid or CHIP with a practice location in 
Illinois counties of Cook, DuPage, Kane, Lake, McHenry, and Will, 
unless their enrollment application has already been approved, but not 
yet entered into PECOS or the State Enrollment System at the time the 
moratorium is imposed.
1. Consultation With Law Enforcement
    Consistent with Sec.  424.570(a)(2)(iv), CMS has consulted with 
both the HHS-OIG and DOJ regarding the imposition of a moratorium on 
new HHAs in Cook County and the surrounding counties. Both HHS-OIG and 
DOJ agree that a significant potential for fraud, waste, or abuse 
exists with respect to HHAs in the affected geographic areas. HHS-OIG 
has identified Chicago as a Strike Force location where individuals 
have been charged with billing potentially fraudulent home health 
services.\14\ Since July 2011, the U.S. Attorney's Office for the 
Northern District of Illinois has filed approximately 11 home health 
fraud cases and charged 45 individuals that have resulted in 15 trial 
convictions. For example, in May 2013, two individuals were charged in 
separate home health fraud schemes in Chicago as part of a Medicare 
Fraud Strike Force operation.\15\ In December 2012, the co-owner of a 
former home health care business was sentenced to 10 years in federal 
prison for defrauding Medicare of more than $2.9 million by submitting 
tens of thousands of false claims annually that misrepresented medical 
services provided to beneficiaries.\16\ In August 2012, a home health 
care agency in suburban Chicago, two nurses who are part owners of the 
company and a third nurse affiliated with them, along with two 
marketers, were indicted on Federal charges for allegedly participating 
in a conspiracy to pay and receive kickbacks in exchange for the 
referral of Medicare patients for home health care services.\17\ 
Additionally, CMS program integrity contractors are also actively 
investigating home health agencies in this area.
---------------------------------------------------------------------------

    \14\ Office of Inspector General Report, ``CMS and Contractor 
Oversight of Home Health Agencies.'' (OEI-04-11-00220). See https://oig.hhs.gov/oei/reports/oei-04-11-00220.pdf.
    \15\ Federal Bureau of Investigation, ``Federal Medicare Fraud 
Strike Force Charges Chicago-Area Defendants with Defrauding 
Medicare and Other Health Insurers.'' See http://www.fbi.gov/chicago/press-releases/2013/federal-medicare-fraud-strike-force-charges-chicago-area-defendants-with-defrauding-medicare-and-other-health-insurers.
    \16\ Department of Justice, ``Owner of Former South Suburban 
Home Health Care Business Sentenced to 10 Years in Prison for $2.9 
million Medicare Fraud.'' See http://www.justice.gov/usao/iln/pr/chicago/2012/pr1220_01.pdf.
    \17\ HHS and DOJ, ``Health Care Fraud and Abuse Control Program 
Annual Report for Fiscal Year 2012.'' See http://oig.hhs.gov/publications/docs/hcfac/hcfacreport2012.pdf.
---------------------------------------------------------------------------

2. Data Analysis
a. Medicare Data Analysis
    CMS' data show that in 2012, there were 26 U.S. counties 
nationally, including Cook, with at least 200,000 Medicare 
beneficiaries. CMS excluded Cook County, and used the remaining 25 
counties as ``comparison counties.'' In 2012, there was an average of 
1.8 HHAs per 10,000 Medicare FFS beneficiaries. In Cook County, there 
were 7.7 HHAs per 10,000 Medicare FFS beneficiaries. This means that 
the ratio of HHAs to Medicare FFS beneficiaries was 327 percent greater 
in Cook County than in the comparison counties.
    CMS' data show that from 2008 through 2012, the total number of 
operational HHAs in Cook County increased from 301 to 509. Cook 
County's compounded annual growth rate of HHAs is 14 percent, double 
the national average of 7 percent. The number of HHAs in Cook County 
was 280 percent greater than the comparison counties in 2012.
    CMS' data show that in 2012, HHAs in Cook County were receiving 
payments of $6,884 per average Medicare home health user per year, 
compared to HHAs in the comparison counties, which received payments of 
$5,900. In 2012, payments to HHAs in Cook County were 17 percent higher 
than HHAs in the comparison counties. Payments remain some of the 
highest nationally as compared to the 25 comparison counties, and CMS 
is taking action through this moratoria to address the potential fraud 
risk here.
b. Medicaid Data Analysis
    As discussed previously in section I.B.1. of this notice, 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. In addition, the data also show a markedly higher 
annual utilization of Medicaid home health services in Cook County 
compared to the entire state. CMS compared Cook County against the 
entire state because Medicaid policies are not necessarily uniform 
across different states. In 2010 \18\ in Cook County, Medicaid spent 
$2,721 per home health user annually, or 57 percent more than the 
$1,728 per home health user that Medicaid spent in the state as a 
whole. On the provider side, the average Medicaid home health provider 
in Cook County received total annual payments of $92,356, or 51 percent 
more than the $60,991 the average Illinois provider received.
---------------------------------------------------------------------------

    \18\ The most recent data available.
---------------------------------------------------------------------------

3. Beneficiary Access to Care
    After consulting with the State Medicaid agency and reviewing 
available data, CMS has concluded that imposing this temporary 
moratorium will not create an access to care issue for Medicaid or CHIP 
beneficiaries in Cook County or the surrounding counties at this time. 
Accordingly, under Sec.  455.470 and Sec.  457.990, this moratorium 
will apply to the enrollment of HHAs in Medicaid and CHIP, unless the 
state later determines that imposition of the moratorium would 
adversely impact beneficiary access to care and so notifies us under 
Sec.  455.470(a)(3).
    CMS reviewed Medicare data for the target and surrounding counties, 
and found that there are no problems with access to home health 
agencies in Cook County or surrounding counties. In addition, as 
described in section I.B.4. of this notice, MedPAC has not reported any 
problems with Medicare beneficiary access to home health care. While 
CMS has also determined there are no access to care issues for Medicare 
beneficiaries, nevertheless, the agency will continuously monitor these 
areas under a moratorium for changes, such as any uptick in beneficiary 
complaints, to ensure there is no access to care issue.
    As a result of the factors and consultation previously described, 
CMS has determined that a temporary enrollment moratorium is needed to 
combat fraud in this area.

III. Ambulance Moratorium--Geographic Area

    Under its authority at Sec.  424.570(a)(2)(i) and (a)(2)(iv), CMS 
is implementing a temporary moratorium on the Medicare Part B 
enrollment of ambulance suppliers in the geographic area discussed in 
this section. The moratorium does not apply to provider-based Medicare 
ambulances, which are owned and/or operated by a Medicare provider (or 
furnished under arrangement with a provider) such as a

[[Page 46345]]

hospital, critical access hospital, skilled nursing facility, 
comprehensive outpatient rehabilitation facility, home health agency, 
or hospice program,\19\ and are not required to enroll separately as a 
supplier in Medicare Part B.\20\
---------------------------------------------------------------------------

    \19\ Medicare Claims Processing Manual, CMS Pub. No. 100-04, 
Chapter 15, ``Ambulance.'' See http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c15.pdf.
    \20\ Medicare Program Integrity Manual, Chapter 15, Medicare 
Enrollment. See http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/pim83c15.pdf.
---------------------------------------------------------------------------

    Under regulations at Sec.  455.470 and Sec.  457.990, this 
moratorium will also apply to Medicaid and CHIP. In contrast to 
Medicare enrollment rules, the Texas Health and Human Service 
Commission requires provider-based ambulance companies to enroll as 
ambulance providers,\21\ therefore this moratorium applies to both 
independent and provider-based ambulances attempting to newly enroll in 
Medicaid and CHIP. The moratorium does not apply to air ambulances 
attempting to enroll in Medicare, Medicaid or CHIP.
---------------------------------------------------------------------------

    \21\ Texas Medicaid Provider Procedures Manual, Ambulance 
Services Handbook. See http://www.tmhp.com/tmppm/2011/Vol2_Ambulance_Services_Handbook.pdf.
---------------------------------------------------------------------------

A. Moratorium on Enrollment of Ambulance Suppliers in the Texas 
Counties of Harris, Brazoria, Chambers, Fort Bend, Galveston, Liberty, 
Montgomery, and Waller

    CMS has determined that the imposition of a temporary enrollment 
moratorium for ambulance suppliers that in enroll in Medicare Part B, 
and Medicaid or CHIP ambulance providers in Harris County (which 
contains the City of Houston) is warranted, and is extending the 
moratorium to seven surrounding counties--Brazoria, Chambers, Fort 
Bend, Galveston, Liberty, Montgomery, and Waller. CMS has determined 
that it is necessary to extend this moratorium to the surrounding 
counties to prevent potentially fraudulent ambulance suppliers and 
providers from enrolling their practices in a neighboring county to 
avoid the moratorium. CMS has also consulted with the State Medicaid 
Agency and reviewed available data and has determined that the 
moratorium will also apply to Medicaid and CHIP.
    Beginning on the effective date of this notice, no new ambulance 
suppliers will be enrolled into Medicare Part B, and no new ambulance 
providers will be enrolled in Medicaid or CHIP with a practice location 
in the Texas Counties of Harris, Brazoria, Chambers, Fort Bend, 
Galveston, Liberty, Montgomery, or Waller unless their enrollment 
application has already been approved, but not yet entered into PECOS 
or the State Enrollment System at the time the moratorium is imposed. 
The moratorium does not apply to air ambulance service suppliers and 
providers attempting to enroll in Medicare, Medicaid and CHIP.
1. Consultation With Law Enforcement
    Consistent with Sec.  424.570(a)(2)(iv), CMS has consulted with 
both the HHS-OIG and DOJ regarding the imposition of a moratorium on 
new Medicare ambulance suppliers and new Medicaid or CHIP providers in 
Harris County and surrounding counties. Both the HHS-OIG and DOJ agree 
that a significant potential for fraud, waste or abuse exists with 
respect to ambulance companies in the affected geographic areas. 
Houston is also a Strike Force location. The HHS-OIG previously found 
that the Medicare ambulance transport benefit may be highly vulnerable 
to abuse in areas with high utilization, such as Harris County and 
surrounding areas.\22\ There has also been considerable Strike Force 
and law enforcement activity in this area of the country. Since April 
2012, the US Attorney's Office for the Southern District of Texas has 
filed 6 cases in Houston alleging that the companies submitted 
fraudulent claims totaling over $9.5 million to Medicare for ambulance 
transports, and 7 individuals have been charged in connection with 
these cases resulting in 3 guilty pleas and 1 trial conviction. For 
example, in March 2013, the owner and operator of a Houston-area 
ambulance company was convicted by a federal jury in Houston of 
multiple counts of health care fraud for submitting false and 
fraudulent claims to Medicare.\23\ In October 2012, as part of the 
Medicare Fraud Strike Force activity in Houston, the administrator of a 
Houston-based ambulance company, pleaded guilty to charges that he 
submitted approximately $1,734,550 in fraudulent claims to 
Medicare.\24\ In May 2012, the owners and operators of four different 
ambulance companies were charged in Houston for billing Medicare for 
ambulance rides that were medically unnecessary as part of a nationwide 
Medicare Fraud Strike Force takedown.\25\ Additionally, CMS program 
integrity contractors are also actively investigating ambulance 
suppliers in this area.
---------------------------------------------------------------------------

    \22\ Office of Inspector General Report, ``Medicare Payments for 
Ambulance Transports.'' (OEI-05-02-0590). See http://oig.hhs.gov/oei/reports/oei-05-02-00590.pdf.
    \23\ Department of Justice, ``Owner and Operator of Houston-Area 
Ambulance Service Convicted in Medicare Fraud Scheme.'' See http://www.justice.gov/opa/pr/2013/March/13-crm-273.html.
    \24\ Department of Justice press release, ``Houston Ambulance 
Company Pleads Guilty to Fraud,'' See http://www.justice.gov/opa/pr/2012/October/12-crm-1242.html.
    \25\ Department of Justice, ``Medicare Fraud Strike Force 
Charges 107 individuals for approximately $452 million in False 
Billing.'' See http://www.justice.gov/opa/pr/2012/May/12-ag-568.html.
---------------------------------------------------------------------------

2. Data Analysis
a. Medicare Data Analysis
    CMS' data show that in 2012, there were 26 U.S. counties 
nationally, including Harris, with at least 200,000 Medicare 
beneficiaries. CMS excluded Harris County, and used the remaining 25 
counties as ``comparison counties.'' In the comparison counties in 
2012, there was an average of 0.8 ambulance suppliers per 10,000 
Medicare FFS beneficiaries. In Harris County, there were 9.5 ambulance 
suppliers per 10,000 Medicare FFS beneficiaries. This means that the 
ratio of ambulance suppliers to Medicare FFS beneficiaries was 1,065 
percent greater in Harris County than in the 25 comparison counties. 
Harris County had the highest ratio of ambulance suppliers to Medicare 
FFS beneficiaries compared to the comparison counties.
    The number of ambulance suppliers in Harris County was also 848 
percent greater than the comparison counties in 2012. In addition, of 
the 275 ambulance suppliers active in Harris County, 66 percent have 
not been continuously billing--a strong indicator of churn--since 2008, 
compared to the average comparison county where only 19 percent of 
ambulance suppliers in 2012 had not been continuously billing since 
2008. Harris County had the highest number of providers not 
continuously billing since 2008 compared to all of the comparison 
counties.
b. Medicaid Data Analysis
    As discussed previously in section I.B.1. of this notice, 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. In addition, the number of Medicaid ambulance 
providers per Medicaid ambulance patient in Harris County is 
extraordinarily high, compared to other areas in the state of Texas. 
Specifically, Harris County has more than twice the number of ambulance 
providers per Medicaid ambulance patient as the rest of Texas. (Harris 
County: 19.1 suppliers per 1,000 Medicaid ambulance recipients versus 
7.8 suppliers per 1,000 Medicaid ambulance recipients in the rest of 
Texas).

[[Page 46346]]

3. Beneficiary Access to Care
    After consulting with the Texas State Medicaid agency and the State 
Department of Health Emergency Medical Services and reviewing available 
data, CMS has concluded that imposing this temporary moratorium will 
not create an access to care issue for Medicaid or CHIP beneficiaries 
in Harris County or the surrounding counties at this time. Accordingly, 
under Sec.  455.470 and Sec.  457.990, this moratorium will apply to 
the enrollment of ambulance providers in Medicaid and CHIP, unless the 
state later determines that imposition of the moratorium would 
adversely impact beneficiary access to care and so notifies CMS under 
Sec.  455.470(a)(3).
    CMS reviewed Medicare data for the target and surrounding counties, 
and found that there are no problems with access to ambulance suppliers 
in Harris County or surrounding counties. In addition, as described in 
section I.B.4. of this notice, MedPAC has not reported any problems 
with Medicare beneficiary access to ambulance services. While CMS has 
determined that this temporary moratorium will not create an access to 
care issue for Medicare beneficiaries in Harris County or the 
surrounding counties at this time, nevertheless, the agency will 
continuously monitor these areas under a moratorium for changes, such 
as any uptick in beneficiary complaints, to ensure there is no access 
to care issue. As a result of the factors and consultation described 
previously, CMS has determined that a temporary enrollment moratorium 
is needed to combat fraud in this area.

IV. Summary of the Moratoria Areas

    CMS is executing its authority under sections 1866(j)(7), 
1902(kk)(4), and 2107(e)(1)(D) of the Act to implement a moratorium in 
the following counties for these providers and suppliers (see Tables 1 
and 2):

                                      Table 1--Home Health Agency Moratoria
----------------------------------------------------------------------------------------------------------------
                                                                         Ratio of HHAs to
                                                                           Medicare FFS
                                                                         beneficiaries as
    Target city and state             Counties        HEAT Strike Force     compared to     Medicaid data (2010)
                                                             city           comparison
                                                                           counties \1\
                                                                              (2012)
----------------------------------------------------------------------------------------------------------------
Miami, FL....................  Miami-Dade, Monroe...  Yes..............  1,960 percent     Ratio of HHAs to
                                                                          higher.           Medicaid
                                                                                            beneficiaries was 3
                                                                                            times higher than
                                                                                            rest of state.
Chicago, IL..................  Cook, Dupage, Kane,    Yes..............  327 percent       Spending per home
                                Lake, McHenry, Will.                      higher.           health users was 57
                                                                                            percent more than
                                                                                            the state as a
                                                                                            whole.
----------------------------------------------------------------------------------------------------------------
\1\ CMS data shows that in 2012, there were 26 U.S. counties nationally, including Miami-Dade County, Florida,
  Cook County, Illinois and Harris County, Texas, but excluding New York County, New York, with at least 200,000
  Medicare beneficiaries. In the ``comparison counties'' (when either Miami-Dade County or Cook County were
  excluded) there was an average of 1.8 HHAs per 10,000 Medicare FFS beneficiaries.

                                          Table 2--Ambulance Moratorium
----------------------------------------------------------------------------------------------------------------
                                                                             Ratio of
                                                                             ambulance
                                                                           suppliers to
                                                      HEAT Strike Force    Medicare FFS
    Target City and State             Counties               city        beneficiaries as   Medicaid data (2010)
                                                                            compared to
                                                                          comparison \1\
                                                                          counties (2012)
----------------------------------------------------------------------------------------------------------------
Houston, TX..................  Brazoria, Chambers,    Yes..............  1,065 percent     Ratio of ambulance
                                Fort Bend,                                higher.           providers to
                                Galveston, Harris,                                          Medicaid
                                Liberty, Montgomery,                                        beneficiaries was 2
                                Waller.                                                     times higher than
                                                                                            rest of state.
----------------------------------------------------------------------------------------------------------------
\1\ CMS data shows that in 2012, there were 26 U.S. counties nationally, including Miami-Dade County, Florida;
  Cook County, Illinois; and Harris County, Texas, but excluding New York County, New York, with at least
  200,000 Medicare beneficiaries. In the ``comparison counties,'' which also excluded Harris County, there was
  an average of 0.8 ambulance suppliers per 10,000 Medicare FFS beneficiaries.

V. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).

VI. Regulatory Impact Statement

    We have examined the impact of this notice as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999) and the Congressional Review Act (5 U.S.C. 804(2).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major regulatory 
actions with economically significant effects ($100 million or more in 
any 1 year). This notice will prevent the enrollment of new home health 
providers and ambulance suppliers in Medicare, and ambulance providers 
in Medicaid and CHIP. Though savings may accrue by denying enrollments, 
the monetary amount cannot be quantified. Additionally, CMS is unable 
to estimate

[[Page 46347]]

how many providers and suppliers will submit applications for 
enrollment during the moratoria, although it anticipates that most 
providers and suppliers will not submit applications during the 
moratoria period. Therefore, this notice does not reach the economic 
threshold and thus is not considered a major action.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
$7.0 million to $35.5 million in any 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 notice will not have a significant economic impact 
on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if an action may have a significant impact 
on the operations of a substantial number of small rural hospitals. 
This analysis must conform to the provisions of section 604 of the RFA. 
For purposes of section 1102(b) of the Act, CMS defines a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area for Medicare payment regulations and has fewer than 
100 beds. CMS is not preparing an analysis for section 1102(b) of the 
Act because it has determined, and the Secretary certifies, that this 
notice 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 2013, that threshold is approximately $141 million. This notice will 
have no consequential effect on state, local, or tribal governments or 
on the private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed regulatory action (and 
subsequent final action) that imposes substantial direct requirement 
costs on state and local governments, preempts state law, or otherwise 
has Federalism implications. Since this notice 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 
notice was reviewed by the Office of Management and Budget.

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh) and 44 U.S.C. Chapter 35; Sec. 1103 of the 
Social Security Act (42 U.S.C. 1302).

    Dated: July 25, 2013
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-18394 Filed 7-26-13; 4:15 pm]
BILLING CODE 4120-01-P
```