83_FR_58478 83 FR 58255 - Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2019

83 FR 58255 - Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2019

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

Federal Register Volume 83, Issue 223 (November 19, 2018)

Page Range58255-58257
FR Document2018-25012

This notice announces a $586.00 calendar year (CY) 2019 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, 2019 and on or before December 31, 2019.

Federal Register, Volume 83 Issue 223 (Monday, November 19, 2018) 
[Federal Register Volume 83, Number 223 (Monday, November 19, 2018)]
[Notices]
[Pages 58255-58257]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25012]



[[Page 58255]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-6079-N]


Medicare, Medicaid, and Children's Health Insurance Programs; 
Provider Enrollment Application Fee Amount for Calendar Year 2019

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

ACTION: Notice.

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SUMMARY: This notice announces a $586.00 calendar year (CY) 2019 
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, 2019 and on or before December 31, 2019.

DATES: This notice is applicable beginning on January 1, 2019.

FOR FURTHER INFORMATION CONTACT: Melissa Singer, (410) 786-0365.

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) 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, CMS-20134, 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.  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 2018 Fee Amount

    In the December 4, 2017 Federal Register (82 FR 57273), we 
published a notice announcing a fee amount for the period of January 1, 
2018 through December 31, 2018 of $569.00. 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 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.
     The CPI-U increase for the period of July 1, 2014 through 
June 30, 2015 was 0.2 percent, based on BLS data. This resulted in an 
application fee amount for CY 2016 of $554.106 ($553 x 1.002). Rounding 
this figure to the nearest whole dollar amount resulted in a CY 2016 
application fee amount of $554.00.
     The CPI-U increase for the period of July 1, 2015 through 
June 30, 2016 was
    1.0 percent. This resulted in a CY 2017 application fee amount of 
$559.56 ($554 x 1.01). Rounding this figure to the nearest whole dollar 
amount resulted in a CY 2017 application fee amount of $560.00.
     The CPI-U increase for the period of July 1, 2016 through 
June 30, 2017 was 1.6 percent. This resulted in a CY 2018 application 
fee amount of $568.96 ($560 x 1.016). Rounding this figure to the 
nearest whole dollar amount resulted in a CY 2018 application fee 
amount of $569.00.

B. CY 2019 Fee Amount

    Using BLS data, the CPU-U increase for the period of July 1, 2017 
through June 30, 2018 was 2.9%. This results in a CY 2019 application 
fee amount of $585.501 ($569 x 1.029). As we must round this to the 
nearest whole dollar amount, the resultant application fee for CY 2019 
is $586.00.

[[Page 58256]]

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 control number 0938-0685; the Form 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), the Congressional Review Act (5 U.S.C. 804(2)), and Executive 
Order 13771 on Reducing Regulation and Controlling Regulatory Costs 
(January 30, 2017).
    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 2019.
1. Estimates of Number of Affected Institutional Providers in December 
4, 2017, 2016 Fee Notice
    In the December 4, 2017 application fee notice, we estimated that 
based on CMS statistics--
     3,800 newly enrolling Medicare institutional providers 
would be subject to and pay an application fee in CY 2018. The estimate 
of 3,800 newly enrolling Medicare institutional providers was corrected 
to 10,700 newly enrolling Medicare institutional providers in the 
January 3, 2018 correction notice (83 FR 381).
     7,500 revalidating Medicare institutional providers would 
be subject to and pay an application fee in CY 2018.
     9,000 newly enrolling Medicaid and CHIP providers would be 
subject to and pay an application fee in CY 2018.
     21,000 revalidating Medicaid and CHIP providers would be 
subject to and pay an application fee in CY 2018.
2. CY 2019 Estimates
a. Medicare
    Based on CMS data, we estimate that in CY 2019 approximately--
     12,870 newly enrolling institutional providers will be 
subject to and pay an application fee; and
     41,580 revalidating institutional providers will be 
subject to and pay an application fee.
    Using a figure of 54,450 (12,870 newly enrolling + 41,580 
revalidating) institutional providers, we estimate an increase in the 
cost of the Medicare application fee requirement in CY 2019 of $925,650 
(or 54,450 x $17 (or $586 minus $569)) from our CY 2018 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 
2019. Using this figure, we project an increase in the cost of the 
Medicaid and CHIP application fee requirement in CY 2019 of $510,000 
(or 30,000 x $17 (or $586 minus $569)) from our CY 2018 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 2019 to be $1,435,650 ($925,650 + 
$510,000) from our CY 2018 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 2017, that 
threshold was approximately $148 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.
    Executive Order 13771, titled ``Reducing Regulation and Controlling 
Regulatory Costs,'' was issued on January 30, 2017 (82 FR 9339, 
February 3, 2017). It has been determined that this notice is a 
transfer notice that does not impose more than de minimis costs

[[Page 58257]]

and thus is not a regulatory action for the purposes of E.O. 13771.
    In accordance with the provisions of Executive Order 12866, this 
notice was reviewed by the Office of Management and Budget.

     Dated: October 19, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-25012 Filed 11-16-18; 8:45 am]
 BILLING CODE 4120-01-P

Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices 58255 DEPARTMENT OF HEALTH AND application.’’ As we explained in the rounded to the nearest whole dollar HUMAN SERVICES February 2, 2011 final rule (76 FR 5914), amount, or $523.00. in addition to the providers and • The CPI–U increase for the period Centers for Medicare & Medicaid suppliers subject to the application fee of July 1, 2011 through June 30, 2012 Services under Medicare, Medicaid-only and was 1.664 percent, based on BLS data. [CMS–6079–N] CHIP-only institutional providers would This resulted in an application fee include nursing facilities, intermediate amount for CY 2013 of $531.70 ($523 × Medicare, Medicaid, and Children’s care facilities for persons with 1.01664). Rounding this figure to the Health Insurance Programs; Provider intellectual disabilities (ICF/IID), nearest whole dollar amount resulted in Enrollment Application Fee Amount for psychiatric residential treatment a CY 2013 application fee amount of Calendar Year 2019 facilities, and may include other $532.00. institutional provider types designated AGENCY: Centers for Medicare & by a state in accordance with their • The CPI–U increase for the period Medicaid Services (CMS), HHS. approved state 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. § 455.460, the application fee is not This resulted in an application fee SUMMARY: This notice announces a required for either of the following: amount for CY 2014 of $541.576 ($532 $586.00 calendar year (CY) 2019 • A Medicare physician or non- × 1.018). Rounding this figure to the application fee for institutional physician practitioner submitting a nearest whole dollar amount resulted in providers that are initially enrolling in CMS–855I. a CY 2014 application fee amount of the Medicare or Medicaid program or • A prospective or revalidating $542.00. the Children’s Health Insurance Medicaid or CHIP provider— • The CPI–U increase for the period Program (CHIP); revalidating their ++ Who is an individual physician or of July 1, 2013 through June 30, 2014 Medicare, Medicaid, or CHIP non-physician practitioner; or enrollment; or adding a new Medicare was 2.1 percent, based on BLS data. ++ That is enrolled in Title XVIII of This resulted in an application fee practice location. This fee is required the Act or another state’s Title XIX or with any enrollment application amount for CY 2015 of $553.382 ($542 XXI plan and has paid the application × 1.021). Rounding this figure to the submitted on or after January 1, 2019 fee to a Medicare contractor or another and on or before December 31, 2019. nearest whole dollar amount resulted in state. a CY 2015 application fee amount of DATES: This notice is applicable II. Provisions of the Notice $553.00. beginning on January 1, 2019. A. CY 2018 Fee Amount • The CPI–U increase for the period FOR FURTHER INFORMATION CONTACT: of July 1, 2014 through June 30, 2015 Melissa Singer, (410) 786–0365. In the December 4, 2017 Federal was 0.2 percent, based on BLS data. SUPPLEMENTARY INFORMATION: Register (82 FR 57273), we published a This resulted in an application fee notice announcing a fee amount for the amount for CY 2016 of $554.106 ($553 I. Background period of January 1, 2018 through × 1.002). Rounding this figure to the In the February 2, 2011 Federal December 31, 2018 of $569.00. This nearest whole dollar amount resulted in Register (76 FR 5862), we published a figure was calculated as follows: a CY 2016 application fee amount of final rule with comment period titled • Section 1866(j)(2)(C)(i)(I) of the Act $554.00. ‘‘Medicare, Medicaid, and Children’s established a $500 application fee for Health Insurance Programs; Additional institutional providers in CY 2010. • The CPI–U increase for the period Screening Requirements, Application • Consistent with section of July 1, 2015 through June 30, 2016 Fees, Temporary Enrollment Moratoria, 1866(j)(2)(C)(i)(II) of the Act, was Payment Suspensions and Compliance § 424.514(d)(2) states that for CY 2011 1.0 percent. This resulted in a CY Plans for Providers and Suppliers.’’ This and subsequent years, the preceding 2017 application fee amount of $559.56 rule finalized, among other things, year’s fee will be adjusted by the ($554 × 1.01). Rounding this figure to provisions related to the submission of percentage change in the consumer the nearest whole dollar amount application fees as part of the Medicare, price index (CPI) for all urban resulted in a CY 2017 application fee Medicaid, and CHIP provider consumers (all items; United States city amount of $560.00. enrollment processes. As provided in average, CPI–U) for the 12-month period • The CPI–U increase for the period section 1866(j)(2)(C)(i) of the Social ending on June 30 of the previous year. of July 1, 2016 through June 30, 2017 Security Act (the Act) and in 42 CFR • The CPI–U increase for CY 2011 424.514, ‘‘institutional providers’’ that was 1.0 percent, based on data obtained was 1.6 percent. This resulted in a CY are initially enrolling in the Medicare or from the Bureau of Labor Statistics 2018 application fee amount of $568.96 Medicaid programs or CHIP, (BLS). This resulted in an application ($560 × 1.016). Rounding this figure to revalidating their enrollment, or adding fee amount for CY 2011 of $505 (or $500 the nearest whole dollar amount a new Medicare practice location are × 1.01). resulted in a CY 2018 application fee required to submit a fee with their • The CPI–U increase for the period amount of $569.00. enrollment application. An of July 1, 2010 through June 30, 2011 B. CY 2019 Fee Amount ‘‘institutional provider’’ for purposes of was 3.54 percent, based on BLS data. Medicare is defined at § 424.502 as This resulted in an application fee Using BLS data, the CPU–U increase khammond on DSK30JT082PROD with NOTICES ‘‘(a)ny provider or supplier that submits amount for CY 2012 of $522.87 (or $505 for the period of July 1, 2017 through a paper Medicare enrollment × 1.0354). In the February 2, 2011 final June 30, 2018 was 2.9%. This results in application using the CMS–855A, CMS– rule, we stated that if the adjustment a CY 2019 application fee amount of 855B (not including physician and non- sets the fee at an uneven dollar amount, $585.501 ($569 × 1.029). As we must physician practitioner organizations), we would round the fee to the nearest round this to the nearest whole dollar CMS–855S, CMS–20134, or associated whole dollar amount. Accordingly, the amount, the resultant application fee for internet-based PECOS enrollment application fee amount for CY 2012 was CY 2019 is $586.00. VerDate Sep<11>2014 17:20 Nov 16, 2018 Jkt 247001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\19NON1.SGM 19NON1

58256 Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices III. Collection of Information 1. Estimates of Number of Affected businesses. For purposes of the RFA, Requirements Institutional Providers in December 4, small entities include small businesses, 2017, 2016 Fee Notice nonprofit organizations, and small This document does not impose governmental jurisdictions. Most In the December 4, 2017 application information collection requirements, hospitals and most other providers and fee notice, we estimated that based on that is, reporting, recordkeeping, or CMS statistics— suppliers are small entities, either by third-party disclosure requirements. • 3,800 newly enrolling Medicare nonprofit status or by having revenues Consequently, there is no need for institutional providers would be subject of less than $7.5 million to $38.5 review by the Office of Management and to and pay an application fee in CY million in any 1 year. Individuals and Budget under the authority of the 2018. The estimate of 3,800 newly states are not included in the definition Paperwork Reduction Act of 1995. enrolling Medicare institutional of a small entity. As we stated in the However, it does reference previously providers was corrected to 10,700 newly RIA for the February 2, 2011 final rule approved information collections. The enrolling Medicare institutional with comment period (76 FR 5952), we Forms CMS–855A, CMS–855B, and providers in the January 3, 2018 do not believe that the application fee CMS–855I are approved under OMB correction notice (83 FR 381). will have a significant impact on small control number 0938–0685; the Form • 7,500 revalidating Medicare entities. CMS–855S is approved under OMB institutional providers would be subject In addition, section 1102(b) of the Act control number 0938–1056. to and pay an application fee in CY requires us to prepare a regulatory 2018. impact analysis if a rule may have a IV. Regulatory Impact Statement • 9,000 newly enrolling Medicaid and significant impact on the operations of CHIP providers would be subject to and a substantial number of small rural A. Background pay an application fee in CY 2018. hospitals. This analysis must conform to We have examined the impact of this • 21,000 revalidating Medicaid and the provisions of section 604 of the notice as required by Executive Order CHIP providers would be subject to and RFA. For purposes of section 1102(b) of pay an application fee in CY 2018. the Act, we define a small rural hospital 12866 on Regulatory Planning and Review (September 30, 1993), Executive 2. CY 2019 Estimates as a hospital that is located outside of Order 13563 on Improving Regulation a Metropolitan Statistical Area for a. Medicare Medicare payment regulations and has and Regulatory Review (January 18, Based on CMS data, we estimate that fewer than 100 beds. We are not 2011), the Regulatory Flexibility Act in CY 2019 approximately— preparing an analysis for section 1102(b) (RFA) (September 19, 1980, Pub. L. 96– • 12,870 newly enrolling institutional of the Act because we have determined, 354), section 1102(b) of the Social providers will be subject to and pay an and the Secretary certifies, that this Security Act, section 202 of the application fee; and notice would not have a significant Unfunded Mandates Reform Act of 1995 • 41,580 revalidating institutional impact on the operations of a substantial (March 22, 1995; Pub. L. 104–4), providers will be subject to and pay an number of small rural hospitals. Executive Order 13132 on Federalism application fee. Section 202 of the Unfunded (August 4, 1999), the Congressional Using a figure of 54,450 (12,870 newly Mandates Reform Act of 1995 (UMRA) Review Act (5 U.S.C. 804(2)), and enrolling + 41,580 revalidating) also requires that agencies assess Executive Order 13771 on Reducing institutional providers, we estimate an anticipated costs and benefits before Regulation and Controlling Regulatory increase in the cost of the Medicare issuing any rule whose mandates Costs (January 30, 2017). application fee requirement in CY 2019 require spending in any 1 year of $100 of $925,650 (or 54,450 x $17 (or $586 million in 1995 dollars, updated Executive Orders 12866 and 13563 minus $569)) from our CY 2018 annually for inflation. In 2017, that direct agencies to assess all costs and projections and as previously described. benefits of available regulatory threshold was approximately $148 alternatives and, if regulation is b. Medicaid and CHIP million. The Agency has determined necessary, to select regulatory Based on CMS and state statistics, we that there will be minimal impact from approaches that maximize net benefits, estimate that approximately 30,000 the costs of this notice, as the threshold including potential economic, (9,000 newly enrolling + 21,000 is not met under the UMRA. environmental, public health and safety revalidating) Medicaid and CHIP Executive Order 13132 establishes effects, distributive impacts, and equity. institutional providers will be subject to certain requirements that an agency A regulatory impact analysis (RIA) must an application fee in CY 2019. Using must meet when it promulgates a be prepared for major rules with this figure, we project an increase in the proposed rule (and subsequent final economically significant effects ($100 cost of the Medicaid and CHIP rule) that imposes substantial direct application fee requirement in CY 2019 requirement costs on state and local million or more in any 1 year). As of $510,000 (or 30,000 x $17 (or $586 governments, preempts state law, or explained in this section of the notice, minus $569)) from our CY 2018 otherwise has federalism implications. we estimate that the total cost of the projections and as previously described. Since this notice does not impose increase in the application fee will not substantial direct costs on state or local exceed $100 million. Therefore, this c. Total governments, the requirements of notice does not reach the $100 million Executive Order 13132 are not Based on the foregoing, we estimate economic threshold and is not applicable. khammond on DSK30JT082PROD with NOTICES the total increase in the cost of the considered a major notice. Executive Order 13771, titled application fee requirement for B. Costs Medicare, Medicaid, and CHIP ‘‘Reducing Regulation and Controlling providers and suppliers in CY 2019 to Regulatory Costs,’’ was issued on The costs associated with this notice be $1,435,650 ($925,650 + $510,000) January 30, 2017 (82 FR 9339, February involve the increase in the application from our CY 2018 projections. 3, 2017). It has been determined that fee amount that certain providers and The RFA requires agencies to analyze this notice is a transfer notice that does suppliers must pay in CY 2019. options for regulatory relief of small not impose more than de minimis costs VerDate Sep<11>2014 17:20 Nov 16, 2018 Jkt 247001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\19NON1.SGM 19NON1

Federal Register / Vol. 83, No. 223 / Monday, November 19, 2018 / Notices 58257 and thus is not a regulatory action for that FDA will not begin procedures to 355(j)(7)), which requires FDA to the purposes of E.O. 13771. withdraw approval of abbreviated new publish a list of all approved drugs. In accordance with the provisions of drug applications (ANDAs) that refer to FDA publishes this list as part of the Executive Order 12866, this notice was these drug products, and it will allow ‘‘Approved Drug Products With reviewed by the Office of Management FDA to continue to approve ANDAs that Therapeutic Equivalence Evaluations,’’ and Budget. refer to the products as long as they which is generally known as the Dated: October 19, 2018. meet relevant legal and regulatory ‘‘Orange Book.’’ Under FDA regulations, requirements. a drug is removed from the list if the Seema Verma, Administrator, Centers for Medicare & FOR FURTHER INFORMATION CONTACT: Agency withdraws or suspends Medicaid Services. Stacy Kane, Center for Drug Evaluation approval of the drug’s NDA or ANDA [FR Doc. 2018–25012 Filed 11–16–18; 8:45 am] and Research, Food and Drug for reasons of safety or effectiveness, or BILLING CODE 4120–01–P Administration, 10903 New Hampshire if FDA determines that the listed drug Ave., Bldg. 51, Rm. 6236, Silver Spring, was withdrawn from sale for reasons of MD 20993–0002, 301–796–8363, safety or effectiveness (21 CFR 314.162). DEPARTMENT OF HEALTH AND Stacy.Kane@fda.hhs.gov. Under § 314.161(a) (21 CFR HUMAN SERVICES SUPPLEMENTARY INFORMATION: In 1984, 314.161(a)), the Agency must determine Congress enacted the Drug Price whether a listed drug was withdrawn Food and Drug Administration Competition and Patent Term from sale for reasons of safety or [Docket No. FDA–2018–N–4142] Restoration Act of 1984 (Pub. L. 98–417) effectiveness: (1) Before an ANDA that (the 1984 amendments), which refers to that listed drug may be Determination That REGITINE authorized the approval of duplicate approved, (2) whenever a listed drug is (Phentolamine Mesylate) Injection, 5 versions of drug products approved voluntarily withdrawn from sale and Milligrams/Vial, and Other Drug under an ANDA procedure. ANDA ANDAs that refer to the listed drug have Products Were Not Withdrawn From applicants must, with certain been approved, and (3) when a person Sale for Reasons of Safety or exceptions, show that the drug for petitions for such a determination under Effectiveness which they are seeking approval 21 CFR 10.25(a) and 10.30. Section contains the same active ingredient in 314.161(d) provides that if FDA AGENCY: Food and Drug Administration, the same strength and dosage form as determines that a listed drug was HHS. the ‘‘listed drug,’’ which is a version of withdrawn from sale for safety or ACTION: Notice. the drug that was previously approved. effectiveness reasons, the Agency will ANDA applicants do not have to repeat SUMMARY: The Food and Drug initiate proceedings that could result in the extensive clinical testing otherwise Administration (FDA or Agency) has necessary to gain approval of a new the withdrawal of approval of the determined that the drug products listed drug application (NDA). ANDAs that refer to the listed drug. in this document were not withdrawn The 1984 amendments include what FDA has become aware that the drug from sale for reasons of safety or is now section 505(j)(7) of the Federal products listed in the table are no longer effectiveness. This determination means Food, Drug, and Cosmetic Act (21 U.S.C. being marketed. Applica- Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant tion No. NDA REGITINE ..................... Phentolamine Mesylate 5 milligrams (mg)/vial .... Injectable; Injection ....... Novartis Pharma- 008278. ceuticals Corp. NDA KAYEXALATE ............... Sodium Polystyrene 453.6 grams (g)/bottle ... Powder; Oral, Rectal ..... Concordia Pharma- 011287. Sulfonate. ceuticals, Inc. NDA PROLIXIN ...................... Fluphenazine Hydro- 2.5 mg/milliliter (mL) ...... Injectable; Injection; ...... Bristol-Myers Squibb 011751. chloride (HCl). 1 mg; 2.5 mg; 5 mg; 10 Tablet; Oral ................... Co. Fluphenazine HCl .......... mg. NDA LIBRIUM ........................ Chlordiazepoxide HCl ... 5 mg; 10 mg; 25 mg ..... Capsule; Oral ................ Valeant Pharmaceuticals 012249. North America, LLC. NDA PERMITIL ...................... Fluphenazine HCl .......... 5 mg/mL ........................ Concentrate; Oral .......... Schering Corp., Sub- 016008. sidiary of Schering Plough, Corp. NDA PROLIXIN ENANTHATE Fluphenazine Enanthate 25 mg/mL ...................... Injectable; Injection ....... Bristol-Myers Squibb 016110. Co. NDA HEPARIN SODIUM ....... Heparin Sodium ............ 1,000 units/mL; 2,500 Injectable; Injection ....... West-Ward Pharma- 017007. units/mL; 5,000 units/ ceuticals International, mL; 7,500 units/mL; Ltd. 10,000 units/mL; 15,000 units/mL; 20,000 units/mL; 5,000 units/0.5 mL;. NDA TRANXENE ................... Clorazepate 3.75 mg; 7.5 mg; 15 mg Tablet; Oral; .................. Recordati Rare Dis- khammond on DSK30JT082PROD with NOTICES 017105. TRANXENE ................... Dipotassium. 3.75 mg; 7.5 mg; 15 mg Capsule; Oral; ............... eases, Inc. TRANXENE SD ............. Clorazepate 11.25 mg; 22.5 mg ........ Tablet; Oral ................... Dipotassium. Clorazepate Dipotassium. NDA MODICON 21 ................ Ethinyl Estradiol; 0.035 mg; 0.5 mg .......... Tablet; Oral ................... Ortho-McNeil Pharma- 017488. Norethindrone. ceutical, Inc. VerDate Sep<11>2014 17:20 Nov 16, 2018 Jkt 247001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\19NON1.SGM 19NON1


Document Created: 2018-11-17 02:46:37
Document Modified: 2018-11-17 02:46:37
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 applicable beginning on January 1, 2019.
ContactMelissa Singer, (410) 786-0365.
FR Citation83 FR 58255 
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