[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Rules and Regulations]
[Pages 42037-42043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17809]


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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 Non-Emergency 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.

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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 <a href="/cdn-cgi/l/email-protection#9eeeecfbededdefdf3edb0f6f6edb0f9f1e8"><span class="__cf_email__" data-cfemail="0b7b796e78784b68667825636378256c647d">[email protected]</span></a>.

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\
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    \1\ Effective 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.
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    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 currently-enrolled 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 
non-emergency 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 need-based 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

[[Page 42038]]

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.
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    \2\ The 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)).
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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\
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    \3\ The 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)).
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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\
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    \4\ The 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)).
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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

[[Page 42039]]

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: 
<a href="/cdn-cgi/l/email-protection#2a7a58455c434e4f586f4458454646474f445e6745584b5e4558434b6a49475904424259044d455c"><span class="__cf_email__" data-cfemail="0b5b79647d626f6e794e6579646767666e657f4664796a7f6479626a4b68667825636378256c647d">[email protected]</span></a>. 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 ``look-back'' period for disclosure of affiliations will be 
within the previous 5 years. However, there will be no cut-off or 
specific ``look-back'' period for when the disclosable event occurred 
or was imposed.
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    \5\ CMS 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.
    \6\ The Waiver Application may be found at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/ProviderEnrollmentMoratorium.html.
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    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

[[Page 42040]]

will evaluate the provider- or supplier-generated 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:
    <bullet> License verification.
    <bullet> Background investigations including evaluation of 
affiliations.
    <bullet> Federal debt review.
    <bullet> Credit history review.
    <bullet> Fingerprint-based criminal background checks (FCBC) of 
persons with a 5 percent or greater direct or indirect ownership 
interest, partners, and managing employees.
    <bullet> Enhanced site visits.
    <bullet> Ownership interest verification.
    <bullet> 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.

[[Page 42041]]

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:
---------------------------------------------------------------------------

    \7\ 42 CFR 424.570.
---------------------------------------------------------------------------

    <bullet> Beneficiary access to care.
    <bullet> Provider or supplier growth rates.
    <bullet> The number of providers or suppliers per beneficiary.
    <bullet> Provider/supplier saturation.
    <bullet> Churn rate--the rate of providers/suppliers entering and 
exiting the program.
    <bullet> Claims paid per beneficiary.
    <bullet> Enforcement actions, including: Revocations, denials, 
investigations, and referrals to law enforcement and other related 
activities.

[[Page 42042]]

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:
    <bullet> The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
    <bullet> The accuracy of our burden estimates.
    <bullet> The quality, utility, and clarity of the information to be 
collected.
    <bullet> 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:
    <bullet> 2 hours for completion of fingerprint-based criminal 
background check (FCBC).
    <bullet> 2 hours for completion of access to care assessment.
    <bullet> 1.5 hours for completion of form.
    <bullet> 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-and-Guidance/Legislation/PaperworkReductionActof1995/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:
    <bullet> 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.
    <bullet> Waiver of Sec.  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.
    <bullet> Waiver of Sec.  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:
    <bullet> Waiver of Sec. Sec.  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,

[[Page 42043]]

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.
---------------------------------------------------------------------------

    \8\ According to 42 CFR 457.990, the enrollment screening 
requirements applicable to providers enrolling in Medicaid apply 
equally to those enrolling in CHIP.
---------------------------------------------------------------------------

    <bullet> 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.
    <bullet> 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.
    <bullet> 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


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