Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations 42037 

1Effective July 29, 2016, CMS lifted the moratoria 

on Part B emergency ground ambulance suppliers 

in all locations. (81 FR 51120) In addition, effective 

September 1, 2017, CMS lifted the moratoria on Part 

B non-emergency ground ambulance suppliers in 

Texas. (82 FR 51274) These actions also applied to 

Medicaid and CHIP. 

List of Subjects in 40 CFR Part 271 

Environmental protection, 

Administrative practice and procedure, 

Confidential business information, 

Hazardous materials transportation, 

Hazardous waste, Indians—lands, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements. 

Authority: This action is issued under the 

authority of sections 2002(a), 3006 and 

7004(b) of the Solid Waste Disposal Act, as 

amended, 42 U.S.C. 6912(a), 6926, and 

6974(b). 

Dated: July 31, 2018. 

Cosmo Servidio, 

Regional Administrator, U.S. EPA Region III. 

[FR Doc. 2018–17921 Filed 8–17–18; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 405, 424, 455, and 498 

[CMS–6073–N2] 

Medicare, Medicaid, and Children’s 

Health Insurance Programs: 

Announcement of Revisions to the 

Provider Enrollment Moratoria Access 

Waiver Demonstration for Part B NonEmergency Ground Ambulance 

Suppliers and Home Health Agencies 

in Moratoria-Designated Geographic 

Locations 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Revisions of the waiver 

demonstration. 

SUMMARY: This document announces 

revisions to the Provider Enrollment 

Moratoria Access Waiver Demonstration 

(PEWD) for Part B Non-Emergency 

Ground Ambulance Suppliers and 

Home Health Agencies. The 

demonstration was implemented in 

accordance with section 402(a)(1)(J) of 

the Social Security Amendments of 

1967 and, as revised, gives CMS the 

authority to grant waivers to the 

statewide enrollment moratoria on a 

case-by-case basis in response to access 

to care issues and previously denied 

enrollment applications because of 

statewide moratoria implementation, 

and to subject providers and suppliers 

enrolling via such waivers to heightened 

screening, oversight, and investigations. 

DATES: The revisions to the waiver 

demonstration are effective August 20, 

2018. 

FOR FURTHER INFORMATION CONTACT: Jung 

Kim, (410) 786–9370. News media 

representatives must contact CMS’ 

Public Affairs Office at (202) 690–6145 

or email them at press@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Social Security Act (the Act) 

provides CMS with tools and resources 

to combat fraud, waste, and abuse in 

Medicare, Medicaid, and the Children’s 

Health Insurance Program (CHIP), 

including the authority to place a 

temporary moratorium on provider 

enrollment in these programs, 

402(a)(1)(J) of the Social Security 

Amendments of 1967 (42 U.S.C. 1395b– 

1(a)(1)(J)). CMS uses quantitative and 

qualitative data to determine whether 

there is a need for a moratorium, such 

as reviewing whether the area under 

consideration for a moratorium has 

significantly higher than average billing 

per beneficiary or provider per 

beneficiary ratios. CMS first used its 

moratoria authority on July 30, 2013, to 

prevent enrollment of new Home Health 

Agencies (HHAs) in the Chicago, Illinois 

and Miami, Florida areas, as well as Part 

B ground ambulance suppliers in the 

Houston, Texas area (see the July 31, 

2013 Federal Register (78 FR 46339)). 

These moratoria also applied to 

Medicaid and CHIP. CMS exercised this 

authority again on January 30, 2014, to 

extend the existing moratoria for 6 

months and expand them to include 

HHAs in Fort Lauderdale, Florida; 

Detroit, Michigan; Houston, Texas; and 

Dallas, Texas; as well as Medicaid, CHIP 

and Medicare Part B ground ambulance 

suppliers in Philadelphia, Pennsylvania 

and nearby New Jersey counties (see the 

February 4, 2014 Federal Register (79 

FR 6475)). Since the moratoria were 

expanded, they remained in place and 

were extended in 6-month intervals. On 

July 29, 2016, CMS extended the 

existing moratoria for 6 months and 

expanded them to statewide in the 

impacted states (see the August 3, 2016 

Federal Register (81 FR 51120)). The 

statewide moratoria have since been 

extended at 6-month intervals and to 

date, largely remain in place in all of the 

previously-mentioned locations.1

Since initial implementation of the 

moratoria, CMS has monitored the 

program and identified several 

operational challenges. Because the 

moratoria were initially geographically 

defined by county, the moratoria did not 

prohibit existing providers and 

suppliers from opening a branch 

location in, or moving a currentlyenrolled business into, a moratoria area. 

Moreover, CMS was unable to prevent 

existing providers and suppliers 

enrolled outside of a moratoria area 

from servicing beneficiaries within the 

moratoria area. In fact, CMS discovered 

providers and suppliers who were 

located several hundred miles outside of 

a moratorium area that were billing for 

services furnished to beneficiaries 

located within the moratorium area. 

As noted previously, on July 29, 2016, 

CMS implemented statewide moratoria 

on newly enrolling HHAs in Medicare, 

Medicaid, and CHIP, and nonemergency ground ambulance suppliers 

in Medicare Part B, Medicaid, and CHIP 

in order to mitigate the vulnerabilities 

identified and described previously 

regarding the prior county-based 

moratoria. Concurrently, CMS 

implemented this Demonstration in 

order to improve methods for the 

investigation and prosecution of fraud, 

and to ensure that program integrity 

enforcement actions did not impact 

beneficiary access to care; in particular, 

all of the states impacted by the 

expanded statewide moratoria have 

rural areas that could be impacted by 

the statewide expansion. By 

implementing this Demonstration, CMS 

created a process that allows for needbased waivers to the moratoria in areas 

with access to care issues. Recently, 

CMS re-evaluated the continued need 

for statewide moratoria on the 

enrollment of new Part B, Medicaid, and 

CHIP non-emergency ground ambulance 

suppliers in New Jersey and 

Pennsylvania, and HHAs in Florida, 

Illinois, Michigan, and Texas, and 

determined that the conditions that 

caused CMS to implement the moratoria 

have not abated. As a result, on July 29, 

2018 (see the August 2, 2018 Federal 

Register (83 FR 37747), we extended the 

statewide moratoria on Part B, 

Medicaid, and CHIP non-emergency 

ground ambulance suppliers and HHAs 

in the impacted states. 

A. Operational Challenges 

Since expanding statewide, a new 

statutory provision affecting the 

moratoria areas has taken effect. In 

December 2016, Congress enacted the 

21st Century Cures Act (Cures Act). 

Section 17004 of the Cures Act provides 

authority to address issues of 

circumvention of the prior county-based 

moratoria by prohibiting payment for 

items or services furnished within 

moratoria areas by any newly enrolled 

provider or supplier that is of a provider 


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42038 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations 

2The Secretary may waive compliance with the 

requirements of titles XVIII and XIX of the Social 

Security Act under section 402(b) of Public Law 90– 

248, (42 U.S.C. 1395b–1(b)). 

3The Secretary may waive compliance with the 

requirements of titles XVIII and XIX of the Social 

Security Act under section 402(b) of Public Law 90– 

248 (42 U.S.C. 1395b–1(b)). 

4The Secretary may waive compliance with the 

requirements of titles XVIII and XIX of the Social 

Security Act under section 402(b) of Public Law 90– 

248 (42 U.S.C. 1395b–1(b)). 

or supplier type subject to the 

moratoria. 

We believe it is necessary to maintain 

statewide moratoria and this 

Demonstration in Medicare, Medicaid, 

and CHIP in order to more effectively 

rectify the circumvention issue. As 

such, we must address a challenge we 

identified with carrying out the 

statewide moratoria and the existing 

Demonstration in light of the Cures Act 

requirement. The Demonstration 

provides an opportunity for providers 

and suppliers otherwise subject to the 

moratoria to enroll and furnish services 

within a moratorium area if CMS 

determines that there are access to care 

issues in a particular geographic area. 

However, the Cures Act provision 

prevents payments to newly enrolled 

providers and suppliers subject to the 

moratoria for items and services 

furnished in moratoria areas. This 

includes those providers and suppliers 

enrolled under the Demonstration. This 

Cures Act provision became effective for 

such items and services furnished on or 

after October 1, 2017. To continue to 

avoid potential patient access to care 

issues and to continue a process to test 

whether allowing for targeted anti-fraud 

activities through heightened screening 

of providers and suppliers enrolling 

through the Demonstration will improve 

methods for the investigation and 

prosecution of fraud under section 

402(a)(l)(J) of the Social Security 

Amendments of 1967, CMS is revising 

the Demonstration to waive the 

requirements of section 17004 of the 

Cures Act for the providers and 

suppliers enrolled under the 

Demonstration.2 With this revision, 

providers and suppliers enrolled under 

the Demonstration will be able to 

receive Medicare, Medicaid, and/or 

CHIP payment for items and services 

furnished within the provider’s or 

supplier’s approved service area for the 

Demonstration. 

B. Expanded Access to the 

Demonstration 

The regulation at 42 CFR 

424.570(a)(1)(iv) provides that a 

temporary enrollment moratorium does 

not apply to any enrollment application 

that has been approved by the Medicare 

Administrative Contractor (MAC) but 

not yet entered into PECOS at the time 

the moratorium is imposed. During the 

time period when the moratoria was 

county-based, some providers and 

suppliers spent a substantial amount of 

time and considerable resources 

preparing for enrollment in states 

subject to the prior county-based 

moratoria only to have their Form CMS– 

855 applications denied near the end of 

the enrollment process because of the 

sudden imposition of a statewide 

moratorium. This has been especially 

problematic for HHAs—(1) whose Form 

CMS–855A applications had been 

recommended for approval by the MAC; 

(2) that had successfully completed a 

state survey; and (3) whose applications 

and survey results had been forwarded 

by the state to the CMS regional office 

for final review. 

As a result, CMS is further revising 

the Demonstration to include two 

different options for eligibility: (1) The 

existing option requiring that the 

provider or supplier demonstrate that 

access to care issues exist; or (2) the new 

alternative option requiring that the 

provider or supplier establish that it had 

submitted an enrollment application 

prior to implementation of the 

moratorium that was denied as a result 

of implementation of such moratorium. 

This alternative requirement applies to 

the July 29, 2016 statewide moratoria 

and any moratoria that are implemented 

subsequent to, and for the duration of, 

this demonstration. Thus this revision 

will allow CMS to approve individual 

waivers to a statewide moratorium due 

to providers or suppliers demonstrating 

that access to care issues exist, or for 

providers and suppliers that had 

submitted an enrollment application 

prior to implementation of a 

moratorium on July 29, 2016, or later, 

that was denied by their relevant MAC 

as a result of implementation of such 

moratoria. Providers and suppliers who 

meet either of these criteria will be 

subject to the heightened screening, 

oversight, and restrictions of the revised 

Demonstration. These two options for 

eligibility will allow additional 

opportunities for providers and 

suppliers to enroll under the revised 

Demonstration. This will better allow 

CMS to test whether conducting 

targeted anti-fraud activities through 

heightened screening of enrolling 

providers or suppliers, in conjunction 

with increased oversight and other 

restrictions, will improve methods for 

the investigation and prosecution of 

fraud under Section 402(a)(l)(J) of the 

Social Security Amendments of 1967. 

As such, for purposes of this 

Demonstration, CMS is waiving the 

regulatory requirement in 42 CFR 

424.570(a)(1)(iv), described previously.3

C. Enrollment Effective Date Flexibilities 

Regardless of the reason a provider or 

supplier qualifies for the Demonstration, 

CMS is also revising the Demonstration 

to provide additional discretion 

regarding the effective date of new 

billing privileges in order to better 

address any access to care concerns that 

do arise. CMS is waiving the regulatory 

requirement in 42 CFR 424.520(a) and 

(d) governing the effective date of new 

billing privileges for certified providers 

and ambulance suppliers, respectively, 

so as to allow CMS to evaluate and 

assign effective dates depending on 

whether access to care issues exist in 

the service area.4

D. Summary 

As described in greater detail in 

section II. of this document, because 

CMS sees a high incidence of fraud in 

the moratoria areas, extensive screening 

and review of providers and suppliers 

newly enrolling under the 

Demonstration will be coupled with an 

earlier review of claims and other 

investigations and prosecutions of fraud 

with respect to such providers and 

suppliers. The revised Demonstration 

will also support statewide moratoria by 

addressing the moratoria circumvention 

issues that surfaced throughout the prior 

county-based moratoria and providing 

waivers to the moratoria to ensure that 

beneficiary access to care is not 

adversely impacted. Approval of a 

waiver would be based primarily on 

either the provider or supplier 

demonstrating an access to care issue 

exists or that the provider or supplier 

submitted an enrollment application 

prior to implementation of a 

moratorium on July 29, 2016, or later 

that was denied as a result of 

implementation of such moratorium, 

and secondarily on passing the 

enhanced screening measures in the 

approved service area. 

A finding of fraud risk in Medicare 

typically means that the risk also exists 

in Medicaid and CHIP, as recognized by 

section 1902(a)(39) of the Act, which 

requires state Medicaid agencies to 

terminate the participation of any 

individual or entity if such individual 

or entity is terminated under Medicare 

or any other state’s Medicaid or CHIP 

program. Moreover, access to care issues 

are of equal concern in the context of 

Medicaid and CHIP. As a result, CMS 


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Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations 42039 

5CMS 855 is the Medicare provider and supplier 

enrollment application and may be found at https:// 

www.cms.gov/Medicare/CMS-Forms/CMS-Forms/ 

CMS-Forms-List.html. 

6The Waiver Application may be found at 

https://www.cms.gov/Medicare/ProviderEnrollment-and-Certification/MedicareProvider

SupEnroll/ProviderEnrollmentMoratorium.html. 

will also implement the revised 

Demonstration in Medicaid and CHIP. 

II. Demonstration Design and Duration 

This revised Demonstration will 

continue to support the existing 

statewide moratoria on HHAs in 

Medicare, Medicaid, and CHIP, and 

non-emergency ground ambulance 

suppliers in Medicare Part B, Medicaid, 

and CHIP. This revised Demonstration 

will allow a provider or supplier to 

submit a Provider Enrollment Moratoria 

Access Waiver (waiver) application that, 

if approved, will exempt such provider 

or supplier from the moratorium in 

designated geographic areas. The waiver 

application for Medicare enrollment 

will be reviewed by CMS, and this 

review will include heightened 

screening measures. The waiver 

application for Medicaid and CHIP will 

be reviewed by the relevant State 

Medicaid Agency. If the provider or 

supplier receives a waiver, restrictions 

may be imposed on such provider’s or 

supplier’s service area to limit the 

number of new providers or suppliers in 

a location that is already oversaturated 

with particular providers and/or 

suppliers. This restriction will be based 

on the saturation of providers or 

suppliers and the number of 

beneficiaries in the counties where the 

provider or supplier proposes to 

operate. Extensive evaluations of 

providers and suppliers seeking to 

enroll through this demonstration will 

be coupled with proactive reviews of 

submitted claims on an ad hoc basis, 

beginning within the first 30 to 60 days 

of enrollment and continuing for the 

first year of enrollment, as well as 

increased investigations with referral to 

law enforcement as appropriate, for 

newly enrolled and existing providers. 

A. Medicare Implementation 

All waiver applications, with the 

appropriate CMS–855 5 enrollment 

application form and supporting 

documentation, should be submitted 

electronically to a designated mailbox: 

ProviderEnrollmentMoratoria@

cms.hhs.gov. Upon receipt of the 

applicable CMS–855 application, waiver 

application, all supporting 

documentation, and payment of the 

enrollment application fee, CMS will 

review for completeness and, within 30 

days, will respond with confirmation of 

receipt or in the case of an incomplete 

application, rejection. As part of the 

Demonstration, CMS will review the 

applicant’s affiliations to include: (1) A 

5 percent or greater direct or indirect 

ownership interest that an individual or 

entity has in another organization; (2) a 

general or limited partnership interest 

that an individual or entity has in 

another organization; (3) an interest in 

which an individual or entity exercises 

operational or managerial control over 

or directly or indirectly conducts the 

day-to-day operations of another 

organization, either under contract or 

through some other arrangement, 

regardless of whether or not the 

managing individual or entity is a 

W–2 employee of the organization; (4) 

an interest in which an individual is 

acting as an officer or director of a 

corporation; (5) any reassignment 

relationship. In section 5 of the Waiver 

Application,6 we require providers and 

suppliers to report affiliations with 

entities and individuals that: (1) 

Currently have uncollected debt to 

Medicare, Medicaid, or CHIP; (2) have 

been or are subject to a payment 

suspension under a federal health care 

program or subject to an Office of 

Inspector General (OIG) exclusion; or (3) 

have had their Medicare, Medicaid, or 

CHIP enrollment denied or revoked. 

Should such an affiliation be reported or 

discovered, CMS could deny the 

provider’s or supplier’s PEWD 

application if CMS determines that the 

affiliation poses an undue risk of fraud, 

waste, or abuse. As part of the review to 

determine undue risk, CMS will 

consider the duration of the applicant’s 

relationship with the affiliated entity or 

individual, determine whether the 

affiliation still exists or how long ago it 

ended, the degree and extent of the 

affiliation, and reason for termination of 

the affiliation if applicable. CMS may 

also deny a provider’s or supplier’s 

PEWD application if CMS determines 

that the provider or supplier is currently 

revoked from Medicare, Medicaid, or 

CHIP under a different name, numerical 

identifier, or business identity. To 

minimize provider burden the ‘‘lookback’’ period for disclosure of 

affiliations will be within the previous 

5 years. However, there will be no cutoff or specific ‘‘look-back’’ period for 

when the disclosable event occurred or 

was imposed. 

Should CMS receive more than one 

application for a particular geographical 

area, and the acceptance factor is based 

on access to care, the applications will 

be prioritized by order of receipt until 

the access to care concern is alleviated. 

Should CMS receive more than one 

application for a particular geographical 

area, and the acceptance factor is that 

enrollment applications were denied 

because of implementation of moratoria, 

all applications will be prioritized and 

processed in the order of receipt. 

Should CMS receive applications for a 

particular geographical area from a 

provider or supplier seeking to 

demonstrate an access to care issue and 

from another provider or supplier 

whose enrollment application was 

denied as a result of implementation of 

moratoria, the application from the 

provider or supplier whose enrollment 

application was denied due to the 

implementation of moratoria will be 

prioritized. An application will not be 

considered received until it is complete, 

including fingerprinting. Subsequently, 

CMS will have 90 days from initial 

receipt to review each application and 

communicate a decision to the provider 

or supplier. 

Once a complete application is 

received, the determining factor for 

waiver approval under this revised 

Demonstration, and the first step in 

application review, will either be (1) a 

determination regarding beneficiary 

access to care; or (2) verification that the 

provider or supplier had submitted an 

enrollment application prior to 

implementation of a moratorium on July 

29, 2016, or later, that was denied as a 

result of implementation of such 

moratorium. With respect to providers 

and suppliers seeking a waiver based on 

access to care issues, the determination 

will be primarily based upon an 

evaluation of provider and supplier 

saturation, provider or supplier to 

beneficiary ratios, and claims data; this 

review will be supplemented with any 

access to care information that the 

provider or supplier has provided. As a 

requirement of the application, the 

provider or supplier will be required to 

submit detailed access to care 

information that demonstrates whether 

an access to care issue exists in the 

counties where the provider or supplier 

is attempting to enroll. In 2016, CMS 

released saturation data to the public. 

This data set, located at https://

data.cms.gov/market-saturation, 

includes saturation data for the nation 

and identifies states that are impacted 

by moratoria. This data gives both states 

and the public detailed information 

relevant for access to care justification. 

Additionally, we are expecting 

anecdotal data from the applicants to 

support that an access to care issue 

exists, which should not subject 

applicants to the unnecessary burden of 

performing extensive analyses. CMS 


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will evaluate the provider- or suppliergenerated information and compare it 

with statistical analysis data that is 

generated internally by CMS to 

determine whether an access to care 

issue exists in the identified area. 

If CMS determines that a beneficiary 

access to care issue does not exist in the 

counties where the provider or supplier 

proposes to operate, the application will 

be rejected and the application fee will 

be refunded. Upon rejection, the 

provider or supplier may submit a new 

application at any time. If any 

subsequent application demonstrates an 

access to care issue, then CMS may 

move forward with processing the 

application. 

For those providers or suppliers 

seeking a waiver because their 

enrollment application was denied as a 

result of implementation of a 

moratorium, if CMS cannot verify the 

denial, the application will be rejected 

and the application fee will be 

refunded. Upon rejection, the provider 

or supplier may submit a new 

application at any time. If for any 

subsequent application CMS is able to 

verify that the provider or supplier had 

submitted an enrollment application 

prior to implementation of a 

moratorium that was denied as a result 

of such moratorium, then CMS may 

move forward with processing the 

application. 

When CMS determines that there is a 

beneficiary access to care issue in the 

counties where the provider or supplier 

has proposed to enroll, or when CMS 

verifies that the provider or supplier 

had submitted an enrollment 

application prior to implementation of a 

moratorium that was denied as a result 

of implementation of such moratorium, 

CMS will move forward with processing 

the application. CMS will utilize the 

ownership information in the submitted 

CMS–855 application, in conjunction 

with the revised Demonstration, to 

perform numerous screening measures, 

which will include the following: 

• License verification. 

• Background investigations 

including evaluation of affiliations. 

• Federal debt review. 

• Credit history review. 

• Fingerprint-based criminal 

background checks (FCBC) of persons 

with a 5 percent or greater direct or 

indirect ownership interest, partners, 

and managing employees. 

• Enhanced site visits. 

• Ownership interest verification. 

• Evaluation of past behavior in other 

public programs. 

Providers and suppliers who do not 

pass the heightened screening 

requirements will receive a letter stating 

that their application has been denied 

and indicating the specific reason(s) for 

denial. The provider or supplier may 

submit an appeal to CMS within 15 days 

of the date of denial. The appeal must 

specifically address the reason(s) for 

denial and detail the action(s) taken to 

resolve any deficiency. CMS will 

evaluate the appeal and process or deny 

the application as appropriate. If a 

provider’s or supplier’s application is 

denied, the application fee will not be 

refunded. Further, if a provider or 

supplier is denied for a reason under 42 

CFR 424.530(a), the provider or supplier 

may not reapply for a waiver under the 

Demonstration. 

Providers and suppliers who are 

recommended for enrollment under the 

Demonstration will be advised that their 

respective CMS–855 applications are 

being forwarded to the Medicare 

Administrative Contractor (MAC) for 

further processing. The MAC will 

process the application and determine 

whether enrollment is appropriate based 

on all current policies and procedures. 

All applicants who are enrolled through 

the Demonstration will be subject to all 

Medicare policies and regulations, 

including revalidation within 5 years of 

initial enrollment, in addition to the 

heightened oversight that is 

implemented through the 

Demonstration. 

The Act includes requirements 

regarding provider enrollment and 

oversight for the Medicare and Medicaid 

Programs. Among other provisions, 

section 1866(j)(3)(A) of the Act allows 

for up to a 1-year provisional period of 

enhanced oversight of newly enrolled 

providers of services and suppliers, 

which may be implemented through 

program instruction. During this 

Demonstration, CMS will utilize this 

authority and may revoke a provider’s 

or supplier’s Medicare billing privileges 

if the enhanced oversight identifies 

grounds for such revocation. 

As an enhanced oversight measure, 

providers or suppliers that are approved 

to enroll in the Demonstration because 

of a determination that access to care 

issues exist in the areas where they 

proposed to enroll will be given a 

specific need-based geographic area, by 

county, in which they are approved to 

operate. For those providers or suppliers 

who are approved on the basis of an 

access to care issue, should CMS find 

that the access to care limitation extends 

beyond the counties that were initially 

proposed by the provider or supplier, 

CMS may accordingly request that the 

provider or supplier expand the area of 

operation. Providers and suppliers that 

are approved to enroll in the 

Demonstration because they had 

submitted an enrollment application 

prior to implementation of a 

moratorium that was denied as a result 

of implementation of such moratorium 

will be allowed to service locations 

listed in the enrollment application that 

they submit with their waiver 

application. However, as discussed 

earlier in section II of this document, 

restrictions may be imposed on the 

service area of a provider or supplier 

approved to enroll in the Demonstration 

in order to limit the number of new 

providers or suppliers in a location that 

is already oversaturated with particular 

providers and/or suppliers. This will be 

applicable to providers or suppliers that 

are approved to enroll in the 

Demonstration because of a 

determination that access to care issues 

exist or because they had submitted an 

enrollment application prior to 

implementation of a moratorium that 

was denied as a result of 

implementation of such moratorium. 

Providers or suppliers enrolling under 

the Demonstration may not bill 

beneficiaries for services furnished 

outside of the approved service area, 

and claims for services furnished 

outside of the approved service area will 

be denied. Additionally, in response to 

fraud trends, CMS may perform medical 

review of claims submitted, including 

an evaluation of any prior relationships 

between the provider or supplier and 

the beneficiary and whether the services 

were medically necessary. Other 

reviews may be performed if deemed 

necessary. CMS will continue the 

enhanced oversight throughout the 

revised Demonstration, billing patterns 

will be monitored through the Fraud 

Prevention System (FPS), and any abuse 

of billing privileges may result in 

revocation of Medicare billing 

privileges. 

The combined goal of the statewide 

moratoria and the revised 

Demonstration outlined herein is to 

address beneficiary access to care 

issues, while targeting fraud, waste, and 

abuse. Success of this revised 

Demonstration is contingent upon an 

increase in oversight and enforcement 

in all six current moratoria states. This 

oversight will be provided using 

existing tools, as well as those created 

through this revised Demonstration, by 

both CMS and CMS’ law enforcement 

partners. Under this revised 

Demonstration, CMS will share 

applicable data with law enforcement 

partners to aid in the investigation and 

prosecution of fraud. 

Through quarterly data evaluations, 

CMS will continue to carefully monitor 

potential access to care issues that could 

develop in the moratoria states. 


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Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations 42041 

7 42 CFR 424.570. 

Additionally, CMS will respond to any 

access issue identified and brought to 

our attention outside of the quarterly 

review. 

B. Increased Investigation and 

Prosecution 

As a measure to enhance our 

oversight in these high risk areas, the 

revised waiver application process will 

include a more robust evaluation of the 

provider/supplier, including license 

verification, detailed background 

checks, fingerprinting, comprehensive 

site visits, ownership interest 

verification, and evaluation of past 

behavior in other public programs, such 

as Medicaid and CHIP, as applicable. 

The revised waiver application will also 

require the provider or supplier to 

submit a specific county-based 

enrollment justification based on access 

to care, the boundaries of which CMS 

would confirm and ultimately enforce, 

with the exception of providers and 

suppliers that had an enrollment 

application denied by their relevant 

MAC as a result of implementation of a 

moratorium. As detailed elsewhere in 

this document, once a provider or 

supplier is enrolled pursuant to a 

waiver, that provider or supplier would 

be subjected to augmented investigation 

and monitoring in order to confirm 

continued compliance with Medicare 

requirements. 

Throughout the course of the 

Demonstration, CMS will work with all 

of its partners to identify fraudulent 

providers and suppliers and will take 

administrative action to remove such 

providers and suppliers from the 

Medicare program. Additionally, within 

30 to 60 days of a provider’s or 

supplier’s enrollment pursuant to a 

waiver, CMS will perform proactive 

monitoring and oversight of such 

provider or supplier, including 

proactive examination of claims data 

and investigation of billing anomalies. 

Further, CMS will prioritize 

Demonstration-related investigations 

and will make referrals to appropriate 

law enforcement partners, including 

Department of Justice (DOJ), Office of 

Inspector General (OIG), and state law 

enforcement agencies, for prosecution of 

fraud. 

C. Medicaid and CHIP Implementation 

In addition to the Medicare program, 

this revised Demonstration will also 

apply to Medicaid and CHIP. The states 

will administer the Medicaid and CHIP 

Demonstration and will independently 

evaluate access to care. All 

Demonstration-related processes, 

including but not limited to heightened 

screening, enrollment, denials, and 

appeals, will be operationalized by the 

state Medicaid and CHIP agencies in 

accordance with federal and state 

regulations and guidance. The states 

will make recommendations to CMS 

regarding when a provider should be 

enrolled based on access to care issues, 

and must wait for CMS concurrence 

prior to enrolling a provider under the 

Demonstration. CMS will evaluate all 

recommendations within 30 days of 

receipt, and will advise the state as to 

whether or not CMS concurs with the 

recommendation to move forward in the 

enrollment process. CMS encourages 

states to use their discretion when 

determining whether to approve a 

waiver for any provider who had 

submitted an application prior to 

implementation of a moratorium that 

was denied as a result of 

implementation of such moratorium. 

States that choose to apply waivers in 

this manner should do so consistently 

for all providers who were denied as a 

result of the moratorium. States are not 

required to seek CMS approval of their 

waiver process. Additionally, states will 

not be required to seek approval from 

CMS to deny a waiver application. If a 

provider receives an enrollment waiver 

from Medicare, that provider will be 

eligible to enroll in Medicaid or CHIP 

without further review by the states. 

However, if a provider receives a 

Medicaid or CHIP waiver, the provider 

must separately apply for a waiver with 

Medicare. 

As provided in 42 CFR 455.470, a 

state Medicaid agency is not required to 

impose a moratorium if the state 

Medicaid agency determines that 

imposition of a temporary moratorium 

would adversely affect beneficiaries’ 

access to medical assistance and notifies 

the Secretary in writing of this 

determination. 

D. Duration of the Demonstration 

The Demonstration commenced on 

July 29, 2016 and was to continue for a 

period of 3 years, or until the moratoria 

are lifted, whichever occurs first. 

However, CMS is extending the 

Demonstration an additional 2 years, for 

a total of 5 years, through July 28, 2021. 

Since the commencement of the 

demonstration, CMS thus far has 

collected limited data on which to 

evaluate the effectiveness of the 

demonstration. We expect that the 

extension to 5 years will allow more 

providers and suppliers to enroll under 

the Demonstration, thus providing CMS 

with more data on which to evaluate the 

Demonstration’s effectiveness. Should 

CMS choose to lift all of the moratoria 

prior to July 28, 2021, we will not 

continue the Demonstration. 

E. Demonstration Conclusion 

CMS will utilize the Demonstration as 

an opportunity to observe the statewide 

moratoria and heightened application 

review effectiveness over the course of 

5 years, or until the moratoria are lifted, 

whichever occurs first. Should the 

Demonstration prove to be a useful tool, 

we hope to consider continuing and 

expanding the most successful aspects 

outside the context of a demonstration. 

The enhanced oversight exercised as 

part of the Demonstration will also 

allow us to identify trends and 

vulnerabilities in the moratoria states 

and make program adjustments to 

accommodate fraud schemes as they 

transform over time. 

Concurrent with the Demonstration, 

CMS will continue to assess and 

improve current regulatory 

requirements for HHAs, ambulance 

suppliers, and other provider/supplier 

types that pose a high risk to the 

Medicare program. In the absence of 

additional rulemaking, any enrollments 

that occur as part of the Demonstration, 

assuming that the enrolled providers or 

suppliers are in compliance with all 

Medicare requirements, will convert to 

standard enrollments without 

geographical billing restrictions at the 

end of the Demonstration. 

CMS recognizes that a moratorium is 

a temporary tool that we have 

implemented in order to conduct 

targeted investigations and related 

enforcement actions in high saturation, 

high risk areas. As required under our 

regulations, we will re-evaluate the 

continued need for the moratoria every 

6 months and may lift the moratoria at 

any time if the Secretary determines that 

the moratoria are no longer needed, or 

the circumstances warranting the 

imposition of moratoria have abated or 

CMS has implemented program 

safeguards to address the program 

vulnerability, among other rationale.7

We will monitor the moratoria areas to 

determine if it is appropriate to lift all 

moratoria (and thus end the 

Demonstration), including the following 

criteria: 

• Beneficiary access to care. 

• Provider or supplier growth rates. 

• The number of providers or 

suppliers per beneficiary. 

• Provider/supplier saturation. 

• Churn rate—the rate of providers/ 

suppliers entering and exiting the 

program. 

• Claims paid per beneficiary. 

• Enforcement actions, including: 

Revocations, denials, investigations, and 

referrals to law enforcement and other 

related activities. 


daltland on DSKBBV9HB2PROD with RULES
42042 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations 

8According to 42 CFR 457.990, the enrollment 

screening requirements applicable to providers 

enrolling in Medicaid apply equally to those 

enrolling in CHIP. 

IV. Collection of Information 

Requirements 

A. Background 

Under the Paperwork Reduction Act 

of 1995 (PRA), we are required to 

publish a 60-day notice in the Federal 

Register and solicit public comment 

before a collection of information 

requirement is submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

To fairly evaluate whether an 

information collection should be 

approved by OMB, section 3506(c)(2)(A) 

of the PRA requires that we solicit 

comment on the following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our burden 

estimates. 

• The quality, utility, and clarity of 

the information to be collected. 

• Our effort to minimize the 

information collection burden on the 

affected public, including the use of 

automated collection techniques. 

We are soliciting public comment on 

each of the section 3506(c)(2)(A)- 

required issues for the following 

information collection requirements 

(ICRs). This is covered under OMB 

control number 0938–1313. 

B. Burden Estimate (Hours and Wages) 

1. Paperwork Burden Estimate (Hours) 

The provider and supplier burden 

associated with completion of the 

waiver form is estimated at 6 hours per 

form. This will include the following 

time burden per form: 

• 2 hours for completion of 

fingerprint-based criminal background 

check (FCBC). 

• 2 hours for completion of access to 

care assessment. 

• 1.5 hours for completion of form. 

• 0.5 hours for completion of other 

miscellaneous administrative activities. 

There will be variation to this estimate 

based on proximity to a fingerprinting 

office as well as the complexity of the 

data that the provider or supplier elects 

to submit. To assist with completion of 

the access to care assessment, CMS has 

HHA and ambulance saturation data 

available at https://data.cms.gov/ 

market-saturation. 

CMS estimates 30 new applicants 

requesting waivers for a total of 180 

burden hours annually. Additionally, 

the provider or supplier will have the 

additional burden associated with 

completion of the CMS–855, which is 

required for enrollment into Medicare. 

This burden is covered under OMB 

control number 0938–0685. 

2. Paperwork Burden Estimate (Costs) 

This waiver form will be completed 

by providers and suppliers seeking a 

waiver to enroll in a moratorium area. 

The cost burden is estimated at $27.60 

($13.80 base pay) an hour for 

completion of access to care analysis 

and miscellaneous administrative 

activities, totaling $69.00 per 

application, equaling $2,070.00 

annually. The cost burden is estimated 

at $188.50 ($94.25 base pay) an hour for 

the owner to obtain fingerprints and 

complete the waiver form totaling 

$659.75 per application, equaling 

$19,792.5 annually. Estimated annual 

burden for 30 newly enrolling 

applicants totals $21,862.5. To derive 

average costs, we used data from the 

Bureau of Labor Statistics’ May 2017 

National Occupational Employment and 

Wage Estimates (http://www.bls.gov/ 

oes/current/oes_nat.htm#31-0000 for 

healthcare support occupations and 

http://www.bls.gov/oes/current/ 

oes111011.htm for chief executives.) 

Hourly wage rates include the costs of 

fringe benefits (calculated at 100 percent 

of salary) and the adjusted hourly wage. 

C. Response to Comments 

We have submitted a copy of the 

Federal Register document to OMB for 

its review of the document’s 

information collection and 

recordkeeping requirements. These 

requirements are not effective until they 

have been approved by the OMB. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed collections discussed 

previously, please visit CMS’ website at 

https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/index.html, or call 

the Reports Clearance Office at 410– 

786–1326. 

We invite public comments on these 

potential information collection 

requirements. If you wish to comment, 

please submit your comments 

electronically as specified in the 

ADDRESSES section of this document and 

identify the document’s filecode (CMS– 

6073–N2) the ICR’s CFR citation, CMS 

ID number, and OMB control number. 

V. Waiver Authority 

Under section 402(b) of Public Law 

90–248, (42 U.S.C. 1395b–1(b)), certain 

requirements of the Act and 

implementing regulations would be 

waived to the extent necessary to 

implement this demonstration. 

Specifically, the authorities CMS is 

seeking to waive under this revised 

Demonstration include the following: 

• Waiver of section 1866(j)(7)(C) of 

the Act, which was added by section 

17004 of the 21st Century Cures Act. 

Effective for items and services 

furnished on or after October 1, 2017, 

the provision prohibits payment for 

items and services furnished within a 

temporary moratorium area by providers 

or suppliers who enroll after the 

effective date of such moratorium and 

who are within a category of providers 

and suppliers subject to such 

moratorium. We will allow payment to 

be made to providers and suppliers who 

enroll under the Demonstration and 

furnish items and services within a 

moratorium area, including those who 

were approved prior to this revised 

Demonstration. 

• Waiver of § 424.570(a)(1)(iv) and 

(c). This regulation establishes 

moratoria rules for Medicare, Medicaid, 

and CHIP. Specifically, we will: (1) 

Exempt providers and suppliers from 

the moratoria if they submitted an 

application to their MAC prior to July 

29, 2016 that was denied as a result of 

implementation of statewide moratoria; 

and (2) exempt providers and suppliers 

from any future moratoria if they have 

submitted an application to their MAC 

prior to the implementation date of that 

moratoria, without regard to provider 

type or geographic location. This waiver 

will be applicable to any moratoria that 

are implemented subsequent to, and for 

the duration of, this demonstration. 

• Waiver of § 424.520(a) and (d), 

which establishes specific effective date 

requirements for certified providers and 

ambulance suppliers, respectively. This 

waiver will allow CMS to establish the 

effective date for a provider or supplier 

depending on whether access to care 

issues exist in the service area. 

The authorities CMS previously 

waived under the original 

Demonstration, which we will continue 

to waive under the revised 

Demonstration, include the following: 

• Waiver of §§ 424.518(c) and (d) and 

455.434(a), which describe the 

fingerprinting rules for enrollment in 

Medicare, Medicaid and CHIP.8 This 

waiver involves expanding the existing 

regulatory authority in two ways: (1) To 

include ambulance suppliers requesting 

a waiver under the Demonstration 

within the categories of providers and 

suppliers to which the FCBC 

requirements apply; and (2) to include 

managing employees within the 

associated individuals subject to an 

FCBC when the provider or supplier 

seeks to enroll pursuant to a waiver 

under the Demonstration. Additionally, 


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Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations 42043 

1Expanding Flexible Use in Mid-Band Spectrum 

Between 3.7 and 24 GHz, GN Docket No. 17–183, 

Notice of Inquiry, 32 FCC Rcd 6373 (2017) (MidBand NOI). 

CMS intends to modify the authority 

that currently requires denial or 

revocation of providers or suppliers 

who fail to submit fingerprints, to 

instead specify that a waiver application 

will be rejected if the provider or 

supplier fails to submit the required 

fingerprints within 30 days. 

• Waiver of 1866(j)(3)(B) of the Act, 

which requires program instruction or 

regulatory interpretation in order to 

implement section 1866(j)(3) of the Act, 

Provisional Period of Enhanced 

Oversight for New Providers of Services 

and Suppliers. CMS intends to 

implement the requirements of section 

1866(j)(3) of the Act for purposes of this 

Demonstration and in the absence of 

regulation or other instruction in order 

to allow for a 1-year period of enhanced 

oversight of newly enrolling providers 

and suppliers under this Demonstration. 

• Waiver of section 1866(j)(8) of the 

Act and the regulations at 42 CFR 

424.545, 42 CFR part 498, subparts D 

and E, and 42 CFR 405.803(b), which 

allow a provider or supplier the right to 

request a hearing with an administrative 

law judge and the Department Appeals 

Board in the case of denial. Under this 

Demonstration, denials of applications 

for a waiver may be appealed at a CMS 

level only, and any applicant to the 

Demonstration will waive their right to 

further appeal. 

• Waiver of 1866(j)(7) of the Act and 

the regulations at 42 CFR 424.570 and 

455.470, which specify that the 

moratoria must be implemented at a 

provider or supplier type level, in order 

to allow a case-by-case waiver process 

to moratoria. 

Dated: August 6, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–17809 Filed 8–16–18; 4:15 pm] 

BILLING CODE 4120–01–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 25 

[GN Docket Nos. 18–122, 17–183, RM– 

11791, RM–11778; FCC 18–91] 

Expanding Flexible Use of the 3.7 to 

4.2 GHz Band 

AGENCY: Federal Communications 

Commission. 

ACTION: Final action. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission or FCC) adopts 

certification and information collection 

requirements for 3.7–4.2 GHz band 

spectrum that will be available for new 

wireless uses while balancing desired 

speed to the market, efficiency of use, 

and effectively accommodating 

incumbent Fixed Satellite Service (FSS) 

and Fixed Service (FS) operations in the 

band. 

DATES: The certification requirements 

are adopted effective August 20, 2018; 

except for Earth Station and Space 

Station Information Collections in 

paragraphs 7–12, which contain 

information collection requirements that 

have not been approved by the Office of 

Management and Budget. The FCC will 

publish a document in the Federal 

Register announcing the effective date 

for those requirements. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Bair of the International 

Bureau, Satellite Division, at 202–418– 

0945 or christopher.bair@fcc.gov. For 

information regarding the Paperwork 

Reduction Act contact Cathy Williams, 

Office of Managing Director, at (202) 

418–2918 or cathy.williams@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Order, 

GN Docket No. 18–122, FCC 18–91, 

adopted on July 12, 2018, and released 

on July 13, 2018. The complete text of 

this document is available for public 

inspection and copying from 8 a.m. to 

4:30 p.m. Eastern Time (ET) Monday 

through Thursday or from 8 a.m. to 

11:30 a.m. ET on Fridays in the FCC 

Reference Information Center, 445 12th 

Street SW, Room CY–A257, 

Washington, DC 20554. The complete 

text is available on the Commission’s 

website at http://wireless.fcc.gov, or by 

using the search function on the ECFS 

web page at http://www.fcc.gov/cgb/ 

ecfs/. Alternative formats are available 

to persons with disabilities by sending 

an email to fcc504@fcc.gov or by calling 

the Consumer & Governmental Affairs 

Bureau at (202) 418–0530 (voice), (202) 

418–0432 (tty). 

Paperwork Reduction Act 

The Commission, as part of its 

continuing effort to reduce paperwork 

burdens, intends to invite the general 

public and the Office of Management 

and Budget (OMB) to comment on the 

information collection requirements 

contained in this document, as required 

by the Paperwork Reduction Act of 

1995, Public Law 104–13. In addition, 

pursuant to the Small Business 

Paperwork Relief Act of 2002, Public 

Law 107–198, see 44 U.S.C. 3506(c)(4), 

the Commission will also seek specific 

comment on how we might further 

reduce the information collection 

burden for small business concerns with 

fewer than 25 employees. 

Congressional Review Act 

The Commission will send a copy of 

this Order in a report to be sent to 

Congress and the Government 

Accountability Office pursuant to the 

Congressional Review Act (CRA), see 5 

U.S.C. 801(a)(1)(A). 

I. Introduction 

1. In this proceeding, the Commission 

is pursuing the joint goals of making 

spectrum available for new wireless 

uses while balancing desired speed to 

the market, efficiency of use, and 

effectively accommodating incumbent 

Fixed Satellite Service (FSS) and Fixed 

Service (FS) operations in the band. To 

gain a clearer understanding of the 

operations of current users in the 3.7– 

4.2 GHz band, the Commission is 

requiring certifications and collecting 

information on current FSS uses. 

II. Background 

2. In the 2017 Mid-Band Notice of 

Inquiry (Mid-Band NOI), the 

Commission began an evaluation of 

whether spectrum in-between 3.7 GHz 

and 24 GHz can be made available for 

flexible use—particularly for wireless 

broadband services.1

III. Order: Collecting Information on 

Satellite Usage of the Band 

3. The record in response to the MidBand NOI reflects that the 

Commission’s information regarding 

current use of the band is inaccurate 

and/or incomplete. Therefore, the 

Commission is collecting additional 

information to make an informed 

decision about the proposals discussed 

herein—including the scope of future 

FSS, FS, and potential mobile use of the 

band and the appropriate transition 

methodology. It is important that the 

Commission obtain a clear 

understanding of the operations of 

current users in the band. This user data 

will be vital to our consideration of how 

much spectrum could be made 

available, how incumbent operators 

could be protected, accommodated, or 

relocated, and the overall structure of 

the band going forward. 

4. In furtherance of the Commission’s 

goals of fostering more efficient and 

intensive use of the 3.7–4.2 GHz band 

as expeditiously as possible while 

protecting existing operations in the 

band from harmful interference, by this 

Order the Commission adopts the 


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