80_FR_75912 80 FR 75680 - Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2016

80 FR 75680 - Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 232 (December 3, 2015)

Page Range75680-75681
FR Document2015-30686

This notice announces a $554.00 calendar year (CY) 2016 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2016 and on or before December 31, 2016.

Federal Register, Volume 80 Issue 232 (Thursday, December 3, 2015)
[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Pages 75680-75681]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-30686]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-6066-N]


Medicare, Medicaid, and Children's Health Insurance Programs; 
Provider Enrollment Application Fee Amount for Calendar Year 2016

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

ACTION: Notice.

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

SUMMARY: This notice announces a $554.00 calendar year (CY) 2016 
application fee for institutional providers that are initially 
enrolling in the Medicare or Medicaid program or the Children's Health 
Insurance Program (CHIP); revalidating their Medicare, Medicaid, or 
CHIP enrollment; or adding a new Medicare practice location. This fee 
is required with any enrollment application submitted on or after 
January 1, 2016 and on or before December 31, 2016.

DATES: This notice is effective on January 1, 2016.

FOR FURTHER INFORMATION CONTACT: Frank Whelan, (410) 786-1302.

SUPPLEMENTARY INFORMATION:

I. Background

    In the February 2, 2011 Federal Register (76 FR 5862), we published 
a final rule with comment period titled ``Medicare, Medicaid, and 
Children's Health Insurance Programs; Additional Screening 
Requirements, Application Fees, Temporary Enrollment Moratoria, Payment 
Suspensions and Compliance Plans for Providers and Suppliers.'' This 
rule finalized, among other things, provisions related to the 
submission of application fees as part of the Medicare, Medicaid, and 
CHIP provider enrollment processes. As provided in section 
1866(j)(2)(C)(i) of the Social Security Act (the Act) (as amended by 
section 6401 of the Affordable Care Act) and in 42 CFR 424.514, 
``institutional providers'' that are initially enrolling in the 
Medicare or Medicaid programs or CHIP, revalidating their enrollment, 
or adding a new Medicare practice location are required to submit a fee 
with their enrollment application. An ``institutional provider'' for 
purposes of Medicare is defined at Sec.  424.502 as ``(a)ny provider or 
supplier that submits a paper Medicare enrollment application using the 
CMS-855A, CMS-855B (not including physician and non-physician 
practitioner organizations), CMS-855S, or associated Internet-based 
PECOS enrollment application.'' As we explained in the February 2, 2011 
final rule (76 FR 5914), in addition to the providers and suppliers 
subject to the application fee under Medicare, Medicaid-only, and CHIP-
only institutional providers would include nursing facilities, 
intermediate care facilities for persons with intellectual disabilities 
(ICF/IID), psychiatric residential treatment facilities, and may 
include other institutional provider types designated by a state in 
accordance with their approved state plan.
    As indicated in Sec. Sec.  424.514 and Sec.  455.460, the 
application fee is not required for either of the following:
     A Medicare physician or non-physician practitioner 
submitting a CMS-855I.
     A prospective or revalidating Medicaid or CHIP provider--
    ++ Who is an individual physician or non-physician practitioner; or
    ++ That is enrolled in Title XVIII of the Act or another state's 
Title XIX or XXI plan and has paid the application fee to a Medicare 
contractor or another state.

II. Provisions of the Notice

A. CY 2015 Fee Amount

    In the December 5, 2014 Federal Register (79 FR 72183), we 
published a notice announcing a fee amount for the period of January 1, 
2015 through December 31, 2015 of $553.00. This figure was calculated 
as follows:
     Section 1866(j)(2)(C)(i)(I) of the Act established a $500 
application fee for institutional providers in CY 2010.
     Consistent with section 1866(j)(2)(C)(i)(II) of the Act, 
Sec.  424.514(d)(2) states that for CY 2011 and subsequent years, the 
preceding year's fee will be adjusted by the percentage change in the 
consumer price index (CPI) for all urban consumers (all items; United 
States city average, CPI-U) for the 12-month period ending on June 30 
of the previous year.
     The CPI-U increase for CY 2011 was 1.0 percent, based on 
data obtained from the Bureau of Labor Statistics (BLS). This resulted 
in an application fee amount for CY 2011 of $505 (or $500 x 1.01).
     The CPI-U increase for the period of July 1, 2010 through 
June 30, 2011 was 3.54 percent, based on BLS data. This resulted in an 
application fee amount for CY 2012 of $522.87 (or $505 x 1.0354). In 
the aforementioned February 2, 2011 final rule, we stated that if the 
adjustment sets the fee at an uneven dollar amount, we would round the 
fee to the nearest whole dollar amount. Accordingly, the application 
fee amount for CY 2012 was rounded to the nearest whole dollar amount, 
or $523.00.
     The CPI-U increase for the period of July 1, 2011 through 
June 30, 2012 was 1.664 percent, based on BLS data. This resulted in an 
application fee amount for CY 2013 of $531.70 ($523 x 1.01664). 
Rounding this figure to the nearest whole dollar amount resulted in a 
CY 2013 application fee amount of $532.00.
     The CPI-U increase for the period of July 1, 2012 through 
June 30, 2013 was 1.8 percent, based on BLS data. This resulted in an 
application fee amount for CY 2014 of $541.576 ($532 x 1.018). Rounding 
this figure to the nearest whole dollar amount resulted in a CY 2014 
application fee amount of $542.00.
     The CPI-U increase for the period of July 1, 2013 through 
June 30, 2014 was 2.1 percent, based on BLS data. This resulted in an 
application fee amount for CY 2015 of $553.382 ($542 x 1.021). Rounding 
this figure to the nearest whole dollar amount resulted in a CY 2015 
application fee amount of $553.00.

B. CY 2016 Fee Amount

    Using BLS data, the CPI-U increase for the period of July 1, 2014 
through June 30, 2015 was 0.2 percent. This results in a CY 2016 
application fee amount of $554.106 ($553 x 1.002). As we must round 
this to the nearest whole dollar amount, the resultant application fee 
amount for CY 2016 is $554.00.

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping, or third-party disclosure 
requirements. Consequently, there is no need for review by the Office 
of Management and Budget under the authority of the Paperwork Reduction 
Act of 1995. However, it does reference previously approved information 
collections. The forms CMS-855A, CMS-855B, and CMS-855I are approved 
under OMB

[[Page 75681]]

control number 0938-0685; the CMS-855S is approved under OMB control 
number 0938-1056.

IV. Regulatory Impact Statement

A. Background

    We have examined the impact of this notice as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 
1999), and the Congressional Review Act (5 U.S.C. 804(2)).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits, including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity. A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
As explained in this section of the notice, we estimate that the total 
cost of the increase in the application fee will not exceed $100 
million. Therefore, this notice does not reach the $100 million 
economic threshold and is not considered a major notice.

B. Costs

    The costs associated with this notice involve the increase in the 
application fee amount that certain providers and suppliers must pay in 
CY 2016.
1. Estimates of Number of Affected Institutional Providers in December 
5, 2014 Fee Notice
    In the December 5, 2014 application fee notice, we estimated that 
based on CMS statistics--
     10,000 newly enrolling Medicare institutional providers 
would be subject to and pay an application fee in CY 2015.
     35,000 revalidating Medicare institutional providers would 
be subject to and pay an application fee in CY 2015.
     8,438 newly enrolling Medicaid and CHIP providers would be 
subject to and pay an application fee in CY 2015.
     19,421 revalidating Medicaid and CHIP providers would be 
subject to and pay an application fee in CY 2015.
2. CY 2016 Estimates
a. Medicare
    Based on CMS data, we estimate that in CY 2016 approximately--
     10,000 newly enrolling institutional providers will be 
subject to and pay an application fee; and
     45,000 revalidating institutional providers will be 
subject to and pay an application fee.
    Using a figure of 55,000 (10,000 newly enrolling + 45,000 
revalidating) institutional providers, we estimate an increase in the 
cost of the Medicare application fee requirement in CY 2016 of 
$5,585,000 (or (10,000 additional newly enrolling or revalidating 
institutional providers x $554) + (45,000 x $1.00) from our CY 2015 
projections and as previously described.
b. Medicaid and CHIP
    Based on CMS and state statistics, we estimate that approximately 
30,000 (9,000 newly enrolling + 21,000 revalidating) Medicaid and CHIP 
institutional providers will be subject to an application fee in CY 
2016. Using this figure, we project an increase in the cost of the 
Medicaid and CHIP application fee requirement in CY 2016 of $1,213,973 
(or ((562 additional newly enrolling institutional providers + 1,579 
additional revalidating institutional providers, or 2,141 total 
additional institutional providers) x $554) + 27,859 x $1.00) from our 
CY 2015 projections and as previously described.
c. Total
    Based on the foregoing, we estimate the total increase in the cost 
of the application fee requirement for Medicare, Medicaid, and CHIP 
providers and suppliers in CY 2016 to be $6,798,973 ($5,585,000 + 
$1,213,973) from our CY 2015 projections.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
less than $7.5 million to $38.5 million in any 1 year. Individuals and 
states are not included in the definition of a small entity. As we 
stated in the RIA for the February 2, 2011 final rule with comment 
period (76 FR 5952), we do not believe that the application fee will 
have a significant impact on small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area for Medicare payment regulations and has fewer than 
100 beds. We are not preparing an analysis for section 1102(b) of the 
Act because we have determined, and the Secretary certifies, that this 
notice would not have a significant impact on the operations of a 
substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2015, that 
threshold is approximately $144 million. The Agency has determined that 
there will be minimal impact from the costs of this notice, as the 
threshold is not met under the UMRA.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts state law, or otherwise has federalism 
implications. Since this notice does not impose substantial direct 
costs on state or local governments, the requirements of Executive 
Order 13132 are not applicable.
    In accordance with the provisions of Executive Order 12866, this 
notice was reviewed by the Office of Management and Budget.

    Dated: November 14, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-30686 Filed 12-2-15; 8:45 am]
 BILLING CODE 4120-01-P



                                             75680                      Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices

                                             has 90 days from the effective date of                  the Medicare or Medicaid programs or                  (BLS). This resulted in an application
                                             delisting and revocation to complete the                CHIP, revalidating their enrollment, or               fee amount for CY 2011 of $505 (or $500
                                             disposition of PSWP that is currently in                adding a new Medicare practice location               × 1.01).
                                             the PSO’s possession.                                   are required to submit a fee with their                 • The CPI–U increase for the period
                                                More information on PSOs can be                      enrollment application. An                            of July 1, 2010 through June 30, 2011
                                             obtained through AHRQ’s PSO Web site                    ‘‘institutional provider’’ for purposes of            was 3.54 percent, based on BLS data.
                                             at http://www.pso.ahrq.gov/.                            Medicare is defined at § 424.502 as                   This resulted in an application fee
                                                                                                     ‘‘(a)ny provider or supplier that submits             amount for CY 2012 of $522.87 (or $505
                                             Sharon B. Arnold,
                                                                                                     a paper Medicare enrollment                           × 1.0354). In the aforementioned
                                             AHRQ Deputy Director.                                                                                         February 2, 2011 final rule, we stated
                                                                                                     application using the CMS–855A, CMS–
                                             [FR Doc. 2015–30586 Filed 12–2–15; 8:45 am]                                                                   that if the adjustment sets the fee at an
                                                                                                     855B (not including physician and non-
                                             BILLING CODE 4160–90–P                                  physician practitioner organizations),                uneven dollar amount, we would round
                                                                                                     CMS–855S, or associated Internet-based                the fee to the nearest whole dollar
                                                                                                     PECOS enrollment application.’’ As we                 amount. Accordingly, the application
                                             DEPARTMENT OF HEALTH AND                                explained in the February 2, 2011 final               fee amount for CY 2012 was rounded to
                                             HUMAN SERVICES                                          rule (76 FR 5914), in addition to the                 the nearest whole dollar amount, or
                                                                                                     providers and suppliers subject to the                $523.00.
                                             Centers for Medicare & Medicaid                                                                                 • The CPI–U increase for the period
                                             Services                                                application fee under Medicare,
                                                                                                     Medicaid-only, and CHIP-only                          of July 1, 2011 through June 30, 2012
                                             [CMS–6066–N]                                            institutional providers would include                 was 1.664 percent, based on BLS data.
                                                                                                     nursing facilities, intermediate care                 This resulted in an application fee
                                             Medicare, Medicaid, and Children’s                      facilities for persons with intellectual              amount for CY 2013 of $531.70 ($523 ×
                                             Health Insurance Programs; Provider                     disabilities (ICF/IID), psychiatric                   1.01664). Rounding this figure to the
                                             Enrollment Application Fee Amount for                   residential treatment facilities, and may             nearest whole dollar amount resulted in
                                             Calendar Year 2016                                      include other institutional provider                  a CY 2013 application fee amount of
                                             AGENCY: Centers for Medicare &                          types designated by a state in                        $532.00.
                                                                                                     accordance with their approved state                    • The CPI–U increase for the period
                                             Medicaid Services (CMS), HHS.
                                                                                                     plan.                                                 of July 1, 2012 through June 30, 2013
                                             ACTION: Notice.
                                                                                                        As indicated in §§ 424.514 and                     was 1.8 percent, based on BLS data.
                                             SUMMARY:   This notice announces a                      § 455.460, the application fee is not                 This resulted in an application fee
                                             $554.00 calendar year (CY) 2016                         required for either of the following:                 amount for CY 2014 of $541.576 ($532
                                             application fee for institutional                          • A Medicare physician or non-                     × 1.018). Rounding this figure to the
                                             providers that are initially enrolling in               physician practitioner submitting a                   nearest whole dollar amount resulted in
                                             the Medicare or Medicaid program or                     CMS–855I.                                             a CY 2014 application fee amount of
                                             the Children’s Health Insurance                            • A prospective or revalidating                    $542.00.
                                             Program (CHIP); revalidating their                      Medicaid or CHIP provider—                              • The CPI–U increase for the period
                                             Medicare, Medicaid, or CHIP                                ++ Who is an individual physician or               of July 1, 2013 through June 30, 2014
                                             enrollment; or adding a new Medicare                    non-physician practitioner; or                        was 2.1 percent, based on BLS data.
                                             practice location. This fee is required                    ++ That is enrolled in Title XVIII of              This resulted in an application fee
                                             with any enrollment application                         the Act or another state’s Title XIX or               amount for CY 2015 of $553.382 ($542
                                             submitted on or after January 1, 2016                   XXI plan and has paid the application                 × 1.021). Rounding this figure to the
                                             and on or before December 31, 2016.                     fee to a Medicare contractor or another               nearest whole dollar amount resulted in
                                                                                                     state.                                                a CY 2015 application fee amount of
                                             DATES: This notice is effective on
                                                                                                                                                           $553.00.
                                             January 1, 2016.                                        II. Provisions of the Notice
                                             FOR FURTHER INFORMATION CONTACT:                                                                              B. CY 2016 Fee Amount
                                             Frank Whelan, (410) 786–1302.                           A. CY 2015 Fee Amount
                                                                                                                                                             Using BLS data, the CPI–U increase
                                             SUPPLEMENTARY INFORMATION:                                 In the December 5, 2014 Federal                    for the period of July 1, 2014 through
                                                                                                     Register (79 FR 72183), we published a                June 30, 2015 was 0.2 percent. This
                                             I. Background                                           notice announcing a fee amount for the                results in a CY 2016 application fee
                                                In the February 2, 2011 Federal                      period of January 1, 2015 through                     amount of $554.106 ($553 × 1.002). As
                                             Register (76 FR 5862), we published a                   December 31, 2015 of $553.00. This                    we must round this to the nearest whole
                                             final rule with comment period titled                   figure was calculated as follows:                     dollar amount, the resultant application
                                             ‘‘Medicare, Medicaid, and Children’s                       • Section 1866(j)(2)(C)(i)(I) of the Act           fee amount for CY 2016 is $554.00.
                                             Health Insurance Programs; Additional                   established a $500 application fee for
                                             Screening Requirements, Application                     institutional providers in CY 2010.                   III. Collection of Information
                                             Fees, Temporary Enrollment Moratoria,                      • Consistent with section                          Requirements
                                             Payment Suspensions and Compliance                      1866(j)(2)(C)(i)(II) of the Act,                         This document does not impose
                                             Plans for Providers and Suppliers.’’ This               § 424.514(d)(2) states that for CY 2011               information collection requirements,
                                             rule finalized, among other things,                     and subsequent years, the preceding                   that is, reporting, recordkeeping, or
                                             provisions related to the submission of                 year’s fee will be adjusted by the                    third-party disclosure requirements.
                                             application fees as part of the Medicare,               percentage change in the consumer                     Consequently, there is no need for
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                                             Medicaid, and CHIP provider                             price index (CPI) for all urban                       review by the Office of Management and
                                             enrollment processes. As provided in                    consumers (all items; United States city              Budget under the authority of the
                                             section 1866(j)(2)(C)(i) of the Social                  average, CPI–U) for the 12-month period               Paperwork Reduction Act of 1995.
                                             Security Act (the Act) (as amended by                   ending on June 30 of the previous year.               However, it does reference previously
                                             section 6401 of the Affordable Care Act)                   • The CPI–U increase for CY 2011                   approved information collections. The
                                             and in 42 CFR 424.514, ‘‘institutional                  was 1.0 percent, based on data obtained               forms CMS–855A, CMS–855B, and
                                             providers’’ that are initially enrolling in             from the Bureau of Labor Statistics                   CMS–855I are approved under OMB


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                                                                        Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices                                                 75681

                                             control number 0938–0685; the CMS–                      2. CY 2016 Estimates                                  significant impact on the operations of
                                             855S is approved under OMB control                      a. Medicare                                           a substantial number of small rural
                                             number 0938–1056.                                                                                             hospitals. This analysis must conform to
                                                                                                        Based on CMS data, we estimate that                the provisions of section 604 of the
                                             IV. Regulatory Impact Statement                         in CY 2016 approximately—                             RFA. For purposes of section 1102(b) of
                                             A. Background                                              • 10,000 newly enrolling institutional             the Act, we define a small rural hospital
                                                                                                     providers will be subject to and pay an               as a hospital that is located outside of
                                                We have examined the impact of this                  application fee; and
                                             notice as required by Executive Order                                                                         a Metropolitan Statistical Area for
                                                                                                        • 45,000 revalidating institutional                Medicare payment regulations and has
                                             12866 on Regulatory Planning and                        providers will be subject to and pay an
                                             Review (September 30, 1993), Executive                                                                        fewer than 100 beds. We are not
                                                                                                     application fee.                                      preparing an analysis for section 1102(b)
                                             Order 13563 on Improving Regulation                        Using a figure of 55,000 (10,000 newly
                                             and Regulatory Review (January 18,                                                                            of the Act because we have determined,
                                                                                                     enrolling + 45,000 revalidating)                      and the Secretary certifies, that this
                                             2011), the Regulatory Flexibility Act                   institutional providers, we estimate an
                                             (RFA) (September 19, 1980, Pub. L. 96–                                                                        notice would not have a significant
                                                                                                     increase in the cost of the Medicare                  impact on the operations of a substantial
                                             354), section 1102(b) of the Social                     application fee requirement in CY 2016
                                             Security Act, section 202 of the                                                                              number of small rural hospitals.
                                                                                                     of $5,585,000 (or (10,000 additional                     Section 202 of the Unfunded
                                             Unfunded Mandates Reform Act of 1995                    newly enrolling or revalidating                       Mandates Reform Act of 1995 (UMRA)
                                             (March 22, 1995; Pub. L. 104–4),                        institutional providers × $554) + (45,000             also requires that agencies assess
                                             Executive Order 13132 on Federalism                     × $1.00) from our CY 2015 projections                 anticipated costs and benefits before
                                             (August 4, 1999), and the Congressional                 and as previously described.
                                             Review Act (5 U.S.C. 804(2)).                                                                                 issuing any rule whose mandates
                                                Executive Orders 12866 and 13563                     b. Medicaid and CHIP                                  require spending in any 1 year of $100
                                             direct agencies to assess all costs and                                                                       million in 1995 dollars, updated
                                                                                                       Based on CMS and state statistics, we
                                             benefits of available regulatory                                                                              annually for inflation. In 2015, that
                                                                                                     estimate that approximately 30,000
                                             alternatives and, if regulation is                                                                            threshold is approximately $144
                                                                                                     (9,000 newly enrolling + 21,000
                                             necessary, to select regulatory                                                                               million. The Agency has determined
                                                                                                     revalidating) Medicaid and CHIP
                                             approaches that maximize net benefits,                                                                        that there will be minimal impact from
                                                                                                     institutional providers will be subject to
                                             including potential economic,                                                                                 the costs of this notice, as the threshold
                                                                                                     an application fee in CY 2016. Using
                                             environmental, public health and safety                                                                       is not met under the UMRA.
                                                                                                     this figure, we project an increase in the
                                             effects, distributive impacts, and equity.                                                                       Executive Order 13132 establishes
                                                                                                     cost of the Medicaid and CHIP
                                             A regulatory impact analysis (RIA) must                                                                       certain requirements that an agency
                                                                                                     application fee requirement in CY 2016
                                             be prepared for major rules with                                                                              must meet when it promulgates a
                                                                                                     of $1,213,973 (or ((562 additional newly
                                             economically significant effects ($100                                                                        proposed rule (and subsequent final
                                                                                                     enrolling institutional providers + 1,579
                                             million or more in any 1 year). As                                                                            rule) that imposes substantial direct
                                                                                                     additional revalidating institutional
                                             explained in this section of the notice,                                                                      requirement costs on state and local
                                                                                                     providers, or 2,141 total additional
                                                                                                                                                           governments, preempts state law, or
                                             we estimate that the total cost of the                  institutional providers) × $554) + 27,859
                                                                                                                                                           otherwise has federalism implications.
                                             increase in the application fee will not                × $1.00) from our CY 2015 projections
                                             exceed $100 million. Therefore, this                                                                          Since this notice does not impose
                                                                                                     and as previously described.
                                             notice does not reach the $100 million                                                                        substantial direct costs on state or local
                                                                                                     c. Total                                              governments, the requirements of
                                             economic threshold and is not
                                             considered a major notice.                                 Based on the foregoing, we estimate                Executive Order 13132 are not
                                                                                                     the total increase in the cost of the                 applicable.
                                             B. Costs                                                application fee requirement for                          In accordance with the provisions of
                                               The costs associated with this notice                 Medicare, Medicaid, and CHIP                          Executive Order 12866, this notice was
                                             involve the increase in the application                 providers and suppliers in CY 2016 to                 reviewed by the Office of Management
                                             fee amount that certain providers and                   be $6,798,973 ($5,585,000 + $1,213,973)               and Budget.
                                             suppliers must pay in CY 2016.                          from our CY 2015 projections.                           Dated: November 14, 2015.
                                                                                                        The RFA requires agencies to analyze               Andrew M. Slavitt,
                                             1. Estimates of Number of Affected                      options for regulatory relief of small
                                             Institutional Providers in December 5,                                                                        Acting Administrator, Centers for Medicare
                                                                                                     businesses. For purposes of the RFA,                  & Medicaid Services.
                                             2014 Fee Notice                                         small entities include small businesses,              [FR Doc. 2015–30686 Filed 12–2–15; 8:45 am]
                                               In the December 5, 2014 application                   nonprofit organizations, and small                    BILLING CODE 4120–01–P
                                             fee notice, we estimated that based on                  governmental jurisdictions. Most
                                             CMS statistics—                                         hospitals and most other providers and
                                               • 10,000 newly enrolling Medicare                     suppliers are small entities, either by               DEPARTMENT OF HEALTH AND
                                             institutional providers would be subject                nonprofit status or by having revenues                HUMAN SERVICES
                                             to and pay an application fee in CY                     of less than $7.5 million to $38.5
                                             2015.                                                   million in any 1 year. Individuals and                Food and Drug Administration
                                               • 35,000 revalidating Medicare                        states are not included in the definition
                                             institutional providers would be subject                                                                      [Docket No. FDA–2014–D–2175]
                                                                                                     of a small entity. As we stated in the
                                             to and pay an application fee in CY                     RIA for the February 2, 2011 final rule               Recommendations for Assessment of
Lhorne on DSK5TPTVN1PROD with NOTICES




                                             2015.                                                   with comment period (76 FR 5952), we                  Blood Donor Suitability, Donor Deferral
                                               • 8,438 newly enrolling Medicaid and                  do not believe that the application fee               and Blood Product Management in
                                             CHIP providers would be subject to and                  will have a significant impact on small               Response to Ebola Virus; Draft
                                             pay an application fee in CY 2015.                      entities.                                             Guidance for Industry; Availability
                                               • 19,421 revalidating Medicaid and                       In addition, section 1102(b) of the Act
                                             CHIP providers would be subject to and                  requires us to prepare a regulatory                   AGENCY:    Food and Drug Administration,
                                             pay an application fee in CY 2015.                      impact analysis if a rule may have a                  HHS.


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Document Created: 2015-12-14 13:51:38
Document Modified: 2015-12-14 13:51:38
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThis notice is effective on January 1, 2016.
ContactFrank Whelan, (410) 786-1302.
FR Citation80 FR 75680 

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