Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Notices 46339 

Estimated Annual Respondent Burden 

Hospitals administer the AHRQ 

Hospital Survey on Patient Safety 

Culture every 20 months on average. 

Therefore, the number of hospital 

submissions to the database varies 

because hospitals do not submit data 

every year. Data submission is typically 

handled by one point-of-contact (POC) 

who is either a hospital patient safety 

manager or a survey vendor. The POC 

completes a number of data submission 

steps and forms, beginning with 

completion of an online Eligibility and 

Registration Form. The POCs typically 

submit data on behalf of 3 hospitals, on 

average, because many hospitals are part 

of a multi-hospital system that is 

submitting data, or the POC is a vendor 

that is submitting data for multiple 

hospitals. Exhibits 1 and 2 are based on 

an estimated 304 individual POCs who 

will complete the database submission 

steps and forms in the coming years, not 

based on the number of ‘‘hospitals.’’ The 

Hospital Information Form is completed 

by all POCs for each of their hospitals. 

The total annual burden hours are 

estimated to be 1,793. 

Exhibit 2 shows the estimated 

annualized cost burden based on the 

respondents’ time to submit their data. 

The cost burden is estimated to be 

$91,297 annually. 

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Form name 

Number of 

respondents/ 

POCs 

Number of 

responses 

per POC 

Hours per 

response 

Total burden 

hours 

Eligibility/Registration Form and Data Submission * ........................................ 304 1 5.6 1,702 

Data Use Agreement ....................................................................................... 304 1 3/60 15 

Hospital Information Form ............................................................................... 304 3 5/60 76 

Total .......................................................................................................... 912 NA NA 1,793 

* The Eligibility and Registration Form requires 3 minutes to complete; however about 5.5 hours is required to prepare/plan for the data submission. This includes the amount of time POCs and other hospital staff (CEO, lawyer, database administrator) typically spend deciding whether 

to participate in the database and preparing their materials and data set for submission to the database, and performing the submission. 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name 

Number of 

respondents/ 

POCs 

Total burden 

hours 

Average 

hourly wage 

rate* 

Total cost 

burden 

Eligibility/Registration Form and Data Submission .......................................... 304 1,702 50.95 86,717 

Data Use Agreement ....................................................................................... 304 15 50.33 755 

Hospital Information Form ............................................................................... 304 76 50.33 3,825 

Total .......................................................................................................... 912 1,793 NA 91,297 

* Wage rates were calculated using the mean hourly wage based on occupational employment and wage estimates from the Dept of Labor, 

Bureau of Labor Statistics’ May 2012 National Industry-Specific Occupational Employment and Wage Estimates NAICS 622000—Hospitals, located at http://www.bls.gov/oes/current/naics3_622000.htm. Wage rate of $50.33 is based on the mean hourly wages for Medical and Health 

Services Managers (11–9111). Wage rate of $50.95 is the weighted mean hourly wage for: Medical and Health Services Managers (11– 

9111;$50.33 × 2.6 hours = $130.86), Lawyers (23–1011; $72.71 × 0.5 hours = $36.36), Chief Executives (11–1011($95.36 × 0.5 hours = $47.68), 

and Database Administrators (15–1141; $35.20 × 2 hours = $70.40) [Weighted mean = ($130.86 + 36.36 + 47.68 + 70.40)/5.6 hours = $285.30/ 

5.6 hours = $50.95/hour]. 

Request for Comments 

In accordance with the Paperwork 

Reduction Act, comments on AHRQ’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of AHRQ health care 

research and health care information 

dissemination functions, including 

whether the information will have 

practical utility; (b) the accuracy of 

AHRQ’s estimate of burden (including 

hours and costs) of the proposed 

collection(s) of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(d) ways to minimize the burden of the 

collection of information upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for OMB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: July 23, 2013. 

Carolyn M. Clancy, 

AHRQ Director. 

[FR Doc. 2013–18366 Filed 7–30–13; 8:45 am] 

BILLING CODE 4160–90–P 

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. 

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 

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46340 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Notices 

1The 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). 

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 

§ 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 

§ 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 

§ 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 (§ 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 § 455.470. Under 

§ 455.470(a)(1) through (3), the 

Secretary 1 may impose a temporary 

moratorium, in accordance with 

§ 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 § 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 any 

individual or entity if such individual 

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Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Notices 46341 

2Although 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. 

3The 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. 

4Testimony 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. 

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 

§ 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. 

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. 

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. 

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 

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5MedPAC, March 2013, ‘‘Report to Congress: 

Medicare Payment Policy, Chapter 9 home health 

services.’’ http://www.medpac.gov/documents/ 

Mar13_entirereport.pdf. 

6MedPAC, June 2013, ‘‘Chapter 7, Mandated 

Report: Medicare payment for ambulance services.’’ 

http://www.medpac.gov/chapters/Jun13_Ch07.pdf 

7MedPAC, March 2013, ‘‘Report to Congress: 

Medicare Payment Policy, Chapter 9 home health 

services.’’ http://www.medpac.gov/documents/ 

Mar13_entirereport.pdf. 

8Office 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. 

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. 

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. 

5. When a Temporary Moratorium Does 

Not Apply 

Under § 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 § 424.550). Also, in 

accordance with § 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 § 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 § 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 § 424.518(c)(3)(iii) and 

§ 455.450(e)(2) for 6 months from the 

date the moratorium was lifted. 

II. Home Health Moratoria— 

Geographic Areas 

Under its authority at 

§ 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 § 455.470 

and § 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 MiamiDade 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 § 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 

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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-crm243.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. 

12Throughout 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 overrepresent the difference in ratios between the target 

county and the comparison counties. 

13CMS 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. 

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. 

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 MiamiDade 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. 

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 MiamiDade 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 agencylevel 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 MiamiDade 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 MiamiDade 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. 

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 § 455.470 and 

§ 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 § 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). 

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14Office 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. 

15Federal 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-strikeforce-charges-chicago-area-defendants-withdefrauding-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. 

17HHS 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. 18The most recent data available. 

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 § 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. 

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. 

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 § 455.470 

and § 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 § 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 

§ 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 providerbased Medicare ambulances, which are 

owned and/or operated by a Medicare 

provider (or furnished under 

arrangement with a provider) such as a 

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19Medicare Claims Processing Manual, CMS Pub. 

No. 100–04, Chapter 15, ‘‘Ambulance.’’ See 

http://www.cms.gov/Regulations-and-Guidance/ 

Guidance/Manuals/downloads/clm104c15.pdf. 

20Medicare Program Integrity Manual, Chapter 

15, Medicare Enrollment. See http://www.cms.gov/ 

Regulations-and-Guidance/Guidance/Manuals/ 

downloads/pim83c15.pdf. 

21Texas Medicaid Provider Procedures Manual, 

Ambulance Services Handbook. See http://www.

tmhp.com/tmppm/2011/Vol2_Ambulance_

Services_Handbook.pdf. 

22Office 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. 

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

Under regulations at § 455.470 and 

§ 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. 

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 § 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. 

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). 

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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 § 455.470 

and § 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 

§ 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

Target city and state Counties HEAT Strike 

Force city 

Ratio of HHAs to 

Medicare FFS 

beneficiaries as 

compared to 

comparison 

counties 1

(2012) 

Medicaid data 

(2010) 

Miami, FL ................. Miami-Dade, Monroe ............................. Yes ............... 1,960 percent higher.Ratio of HHAs to Medicaid beneficiaries 

was 3 times higher than rest of state. 

Chicago, IL .............. Cook, Dupage, Kane, Lake, McHenry, 

Will.

Yes ............... 327 percent higher Spending per home 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

Target City and 

State Counties HEAT Strike Force city 

Ratio of ambulance 

suppliers to 

Medicare FFS 

beneficiaries as 

compared to 

comparison 1

counties 

(2012) 

Medicaid data 

(2010) 

Houston, TX ............ Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery, 

Waller.

Yes ............... 1,065 percent higher.Ratio of ambulance providers to Medicaid beneficiaries was 2 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 

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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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0961] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Environmental Impact Considerations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Environmental Impact Considerations’’ 

has been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

February 25, 2013, the Agency 

submitted a proposed collection of 

information entitled ‘‘Environmental 

Impact Considerations’’ to OMB for 

review and clearance under 44 U.S.C. 

3507. An Agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. OMB has now 

approved the information collection and 

has assigned OMB control number 

0910–0322. The approval expires on 

May 31, 2016. A copy of the supporting 

statement for this information collection 

is available on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: July 26, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–18410 Filed 7–30–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0853] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices 

Current Good Manufacturing Practice 

Quality System Regulation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

recordkeeping requirements related to 

the medical devices current good 

manufacturing practice (CGMP) quality 

system (QS) regulation (CGMP/QS 

regulation). 

DATES: Submit either electronic or 

written comments on the collection of 

information by September 30, 2013. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

mstockstill on DSK4VPTVN1PROD with NOTICES