Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction, 67083-67094 [2018-28348]
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Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Rules and Regulations
this correcting document is intended to
ensure that the information in the final
rule accurately reflects the policies
adopted in that document.
Even if this were a rulemaking to
which the notice and comment and
delayed effective date requirements
applied, we find there is good cause to
waive such requirements. Undertaking
further notice and comment procedures
to incorporate the corrections in this
document in the final rule or delaying
the effective date of the corrections
would be contrary to the public interest
to ensure that the rule accurately
reflects our policies as of the date they
take effect. Further, such procedures
would be unnecessary because we are
not making any substantive revisions to
the final rule, but rather, we are simply
correcting the Federal Register
document to reflect the policies we
previously proposed, received public
comment on, and subsequently finalized
in the final rule. For these reasons, we
believe that we have good cause to
waive the notice and comment and
delay in effective date requirements.
IV. Correction of Errors
In FR Doc. 2018–24238 of November
14, 2018 (83 FR 56922), make the
following corrections:
1. On page 57029, first column,
second full paragraph,
a. In line 16, the reference ‘‘this rule’’
is corrected to read ‘‘the CY 2019 ESRD
PPS DMEPOS proposed rule’’.
b. In line 17, the reference ‘‘this final
rule’’ is corrected to read ‘‘the CY 2019
ESRD PPS DMEPOS proposed rule’’.
2. On page 57029, second column,
second full paragraph, in lines 27 and
28, the reference ‘‘this final rule’’ is
corrected to read ‘‘the CY 2019 ESRD
PPS DMEPOS proposed rule’’.
Dated: December 20, 2018.
Ann C. Agnew,
Executive Secretary to the Department,
Department of Health and Human Services.
[FR Doc. 2018–28347 Filed 12–21–18; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 416 and 419
[CMS–1695–CN2]
RIN 0938–AT30
Medicare Program: Changes to
Hospital Outpatient Prospective
Payment and Ambulatory Surgical
Center Payment Systems and Quality
Reporting Programs; Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule; correction.
AGENCY:
This document corrects
technical and typographical errors in
the final rule with comment period that
appeared in the November 21, 2018
Federal Register titled ‘‘Changes to
Hospital Outpatient Prospective
Payment and Ambulatory Surgical
Center Payment Systems and Quality
Reporting Programs.’’
DATES: The corrections in this document
are effective January 1, 2019.
FOR FURTHER INFORMATION CONTACT:
Marjorie Baldo via email
Marjorie.Baldo@cms.hhs.gov or at (410)
786–4617.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
In FR Doc. 2018–24243 of November
21, 2018 (83 FR 58818), there were a
number of technical and typographical
errors that are identified and corrected
in the Correction of Errors section of
this correcting document. The
provisions in this correction document
are effective as if they had been
included in the document that appeared
in the November 21, 2018 Federal
Register. Accordingly, the corrections
are effective January 1, 2019.
II. Summary of Errors
A. Summary of Errors in the Preamble
1. Hospital Outpatient Prospective
Payment System (OPPS) Corrections
On page 58822, we are correcting the
section ‘‘Payment of Drugs, Biologicals,
and Radiopharmaceuticals If Average
Sales Price (ASP) Data Are Not
Available’’ to remove the language that
suggests that drugs with pass-through
status with partial quarter WAC-based
pricing are not paid at WAC + 3, which
is incorrect. This correction is necessary
to conform the introductory language
regarding OPPS payment policy for
drugs, biologicals, and
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radiopharmaceuticals with WAC-based
pricing with the policy adopted in the
final rule to pay for these drugs,
biologicals, and radiopharmaceuticals,
including those with pass-through
status, at WAC + 3 percent.
On page 58825, the headings for
subsections ‘‘c. Impact of the Changes to
the Hospital OQR Program’’ and ‘‘d.
Impact of the Changes to the ASCQR
Program’’ were alphabetically
mislabeled and are corrected to be ‘‘g.
Impact of the Changes to the Hospital
OQR Progam’’ and ‘‘h. Impact of the
Changes to the ASCQR Program,’’
respectively.
On page 58833, Healthcare Common
Procedure Coding System (HCPCS) code
P9072 (Platelets, pheresis, pathogen
reduced or rapid bacterial tested, each
unit) was cited in a comment in error.
The correct HCPCS code is ‘‘P9073’’ not
‘‘P9072’’.
On page 58834, we transposed two
numbers in the Healthcare Common
Procedure Coding System (HCPCS) code
P9037 (Platelets, pheresis, leukocytes
reduced, irradiated, each unit). The
correct HCPCS code is ‘‘P9037’’, not
‘‘P9073’’.
On page 58880, in ‘‘Table 12.—New
Level II HCPCS Codes Effective April 1,
2018,’’ we incorrectly stated that the
Medicare Ambulatory Payment
Classification (APC) assignment for
HCPCS code C9749 (Repair nasal
stenosis w/imp) is ‘‘APC 5164,’’ rather
than ‘‘APC 5165.’’ The correct APC
assignment for this code is APC 5165,
which we finalized on page 58922.
On page 58909, under section ‘‘6.
Endovascular Procedures (APCs 5191
through 5194)’’ of the ‘‘OPPS APCSpecific Policies’’ section, we
inadvertently omitted a summary of a
public comment and our response
related to new calendar year (CY) 2019
Common Procedural Terminology (CPT)
code 33274. Therefore, we are revising
the discussion to include the comment
and response.
On pages 58894 to 58897, we
occasionally stated the wrong APC
assignment for procedure code C9734
(Focused ultrasound ablation/
therapeutic intervention, other than
uterine leiomyomata, with magnetic
resonance (mr) guidance) for CY 2018
and CY 2019. The correct APC
assignment for procedure code C9734 is
APC 5114 for CY 2018 and APC 5115 for
CY 2019.
On page 58928 of the ‘‘OPPS APCSpecific Policies’’ section, we
inadvertently omitted a summary of a
public comment and response related to
existing CPT code 47382 and new CY
2019 CPT code 95983. Therefore, we are
adding a new subsection titled ‘‘21.
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Other Procedures/Services’’ that
includes this comment and response.
On page 58954, in ‘‘Table 37.—Drugs
and Biologicals For Which Pass-through
Payment Status Expires December 31,
2018,’’ we included an incorrect PassThrough Payment Effective Date for
HCPCS code Q5101. The correct PassThrough Payment Effective Date for
HCPCS code Q5101 is 01/01/2016, not
07/01/2015.
On page 58958, in Table 38.—Drugs
and Biologicals With Pass-through
Payment Status in CY 2019,’’ we
included an incorrect Pass-Through
Payment Effective Date for HCPCS code
J7328. The correct Pass-Through
Payment Effective Date for HCPCS code
J7328 is 04/01/2017, not 01/01/16.
On page 58969, we inadvertently
stated, ‘‘We also are finalizing our
proposal to retain our established policy
to assign new skin substitute products
with pricing information to the low cost
group.’’ We are correcting the word
‘‘with’’ to read ‘‘without’’ to clarify that
skin substitutes without pricing
information are assigned to the low cost
group, consistent with our established
policy, which is described on page
58967.
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2. Ambulatory Surgical Center (ASC)
Payment System Corrections
The ASC payment system uses the
same APC classification groupings as
the OPPS; however, ASC payment
indicators and OPPS status indicators
are not compatible across the two
payment systems. In our final rule
ratesetting for CY 2019, we
inadvertently carried over OPPS C–APC
status indicators in our ASC ratesetting
process. This error impacted the
application of our multiple procedure
discounting rules and the calculation of
the ASC weight scalar, which led to the
calculation of incorrect ASC payment
rates. Accordingly, on page 59079, in
our response to a comment regarding
our process of applying a weight scalar
in calculation of ASC payment rates,
and on page 59169, we are correcting
our weight scalar in ASC payment rate
calculations of ‘‘0.8792’’ to ‘‘0.8800.’’
Additionally, on pages 59079, 59080
and 59169, we inadvertently excluded
certain core-based statistical areas
(CBSAs) and, therefore, incorrectly
calculated the wage index budget
neutrality factor that we applied to the
2018 ASC conversion factor. We
previously calculated a wage index
adjustment of 1.0004. We have
recalculated the wage index adjustment
taking into account the appropriate
CBSAs, resulting in a corrected wage
index adjustment of ‘‘1.0000.’’
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On pages 59080 and 59169, we are
correcting the final CY 2019 conversion
factor of $46.551 for ASCs who meet
quality reporting requirements and the
final CY 2019 conversion factor of
$45.639 for ASCs who do not meet
quality reporting requirements. These
conversion factors are incorrect because
they utilize the incorrect wage index
adjustment. The correct conversion
factors, calculated utilizing the correct
wage index adjustment, are ‘‘$46.532’’
and ‘‘45.621’’ for ASCs that meet quality
reporting requirements and for ASCs
that do not meet quality reporting
requirements, respectively.
On page 59170, we are correcting our
estimate of the increase in aggregate
payments for ancillary items and
services of 79 percent for CY 2019. The
correct percentage is 68 percent, which
accounts for removing HCPCS code
0474T from our list of covered surgical
procedures and, therefore, no longer
includes any estimated 2019 spending
from HCPCS code 0474T. Further, on
page 59170 in ‘‘Table 63.—Estimated
Impact of the CY 2019 Update to the
ASC Payment System on Aggregate CY
2019 Medicare Program Payments by
Surgical Specialty or Ancillary Items
and Services Group’’, we are correcting
the figure in the third column, titled
‘‘Estimated CY 2019 Percent Change’’
for the Ancillary Items and Services
Group to reflect the change from 79
percent to 68 percent.
On page 59171, in ‘‘Table 64.—
Estimated Impact of the CY 2019 Update
to the ASC Payment System on
Aggregate Payments for Selected
Procedures’’, we are correcting the
figures in the fourth column of the table
titled ‘‘Estimated CY 2019 Percent
Change’’ to account for payment rates
changes from the corrected ASC weight
scalar and corrected ASC conversion
factor.
3. Hospital Outpatient Quality
Reporting (OQR) Program Corrections
On page 59088, first column, first full
paragraph, the word ‘‘retaining’’ is
corrected to ‘‘removing.’’ We
inadvertently included the wrong word.
On page 59100 through 59102, the
table footnoting for the Hospital OQR
Program Measure Set for both the CY
2020 and CY 2021 Payment
Determinations are corrected.
Specifically, the footnote pertaining to
OP–26 is removed from the unnumbered tables titled ‘‘Hospital OQR
Program Measure Set for the CY 2020
Payment Determination’’ and ‘‘Hospital
OQR Program Measure Set for the CY
2021 Payment Determination and
Subsequent Years.’’ The measure is no
longer in the program beginning with
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the CY 2020 payment determination. In
addition, for both tables, the National
Quality Forum (NQF) status for OP–8:
MRI Lumbar Spine for Low Back Pain
and OP–33: External Beam
Radiotherapy for Bone Metastases is
updated to indicate that the NQF
endorsement for these measures was
removed. Furthermore, in both tables,
we added an additional footnote to OP–
31 to indicate ‘‘Measure voluntarily
collected as set forth in section
XIII.D.3.b. of the CY 2015 OPPS/ASC
final rule with comment period (79 FR
66946 through 66947).’’ Subsequently,
asterisks for the remaining footnotes are
renumbered, as are the corresponding
notations under the measure name in
both tables. As a result of the
renumbering, both tables are revised
such that OP–37a, OP–37b, OP–37c,
OP–37d, and OP–37e correspond with
the appropriate footnote reading
‘‘Measure reporting delayed beginning
with CY 2018 reporting and for
subsequent years as discussed in section
XIII.B.5. of the CY 2018 OPPS/ASC final
rule with comment period (82 FR 59432
through 59433).’’
4. Ambulatory Surgical Center Quality
Reporting Program (ASCQR) Corrections
On page 59117, second column, first
paragraph, the word ‘‘retaining’’ is
corrected to ‘‘removing.’’ We
inadvertently included the wrong word.
On page 59129, first column, second
paragraph, the language, ‘‘Furthermore,
this is the only measure in the ASCQR
Program measure set that deals with
cataract surgery, which is commonly
performed in the ASC setting. If it is
removed, the program will have a gap in
coverage for this clinical area. As a
result, we now believe that meaningful
information can be provided to
consumers regarding those facilities’’ is
removed. This text pertains only to the
Hospital OQR Program; it is factually
inaccurate with respect to the ASCQR
Program, since the ASC–14:Unplanned
Anterior Vitrectomy measure also
includes cataract surgery, and was
erroneously included.
B. Summary of Errors in and Corrections
to the OPPS and ASC Addenda Posted
on the CMS Website
We are summarizing below the errors
we have corrected in the addenda
available on the internet at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/HospitalOut
patientPPS/. The addenda
that are available on the internet have
been updated to reflect the revisions
discussed in this correcting document.
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1. Summary of Errors in and Corrections
to the OPPS Addenda Posted on the
CMS Website
In Addendum B (Final OPPS Payment
by HCPCS Code for CY 2019), we
corrected the following:
• CPT code 0100T (Prosth retina
receive&gen): APC revision from APC
1906 (New Technology—Level 51
($130,001–$145,000)) to APC 1908 (New
Technology—Level 52 ($145,001–
$160,000)). In the preamble text, CPT
code 0100T had been assigned to APC
1908. This action ensures the
information in Addendum B reflects the
APC assignment that was finalized in
the preamble.
• CPT code 0474T (Insj aqueous drg
dev io rsvr): Status indicator revision
from status indicator ‘‘J1’’ (Hospital Part
B Services Paid Through a C–APC) to
status indicator ‘‘E1’’ (Not Paid by
Medicare) because the device associated
with this procedure was withdrawn
from marketing in September 2018 and
the procedure is no longer separately
payable under the OPPS.
• HCPCS code A6460: We made a
typographical error in listing the HCPCS
short descriptor. Specifically, we are
correcting the short descriptor from
‘‘Arg II ext com/sup/acc misc’’ to
‘‘Synthetic drsg <= 16 sq in’’.
• HCPCS code A6461: We made a
typographical error in listing the HCPCS
short descriptor. Specifically, we are
correcting the short descriptor from
‘‘Enzyme cartridge enteral nut’’ to
‘‘Synthetic drsg >16 <=48 sq in’’.
• HCPCS code C9752 (Intraosseous
des lumb/sacrum): We made a
typographical error in listing the APC
assignment. Specifically, we are
correcting the APC assignment from
APC 5155 (Level 5 Airway Endoscopy)
to APC 5115 (Level 5 Musculoskeletal
Procedures).
In Addendum C (Final HCPCS Codes
Payable Under the 2019 OPPS by APC),
we corrected the following:
• APC 1906 (New Technology—Level
51 ($130,001–$145,000)): Deleted
HCPCS code 0100T from the list We
inadvertently listed the code in this
APC when it should have been listed
under APC 1908 (New Technology—
Level 52 ($145,001–$160,000)), as
correctly listed in the preamble and
Addendum B of the CY 2019 OPPS/ASC
final rule with comment period.
• APC 1908 (New Technology—Level
52 ($145,001–$160,000)): Added HCPCS
code 0100T to the list.
• APC 5115 (Level 5 Musculoskeletal
Procedures): We made a typographical
error by assigning HCPCS code C9752 to
APC 5155 (Level 5 Airway Endoscopy)
when it should have been assigned to
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APC 5115. Specifically, we are
correcting the APC assignment for
HCPCS code C9752 to APC 5115.
• APC 5155 (Level 5 Airway
Endoscopy): Removed HCPCS code
C9752 from the list.
• APC 5492 (Level 2 Intraocular
Procedures): Deleted CPT code 0474T
from the list because the device
associated with this procedure was
withdrawn from marketing in
September 2018 and the procedure is no
longer separately payable under the
OPPS.
In Addendum P (Device-Intensive
Procedures for CY 2019), we corrected
the following errors in both tabs, 2019
FR Device Intensive List and 2019 FR
HCPCS Offsets:
• CPT code 0100T: Revised the APC
assignment from APC 1906 to APC 1908
and the final payment rate. We
inadvertently listed the code in APC
1906 when it should have been listed
under APC 1908 (New Technology—
Level 52 ($145,001–$160,000)), as
correctly listed in Addendum B of the
CY 2019 OPPS/ASC final rule.
• CPT code 0474T: Removed from the
list because the device associated with
this procedure was withdrawn from
marketing in September 2018 and this
procedure is no longer separately
payable under the OPPS.
• HCPCS code C9752: Added to the
list along with the associated status
indicator, APC, final CY 2019 payment
rate, device offset percentage, and
device offset amount, because we
inadvertently omitted this code from
Addendum P. This code should have
received device-intensive status based
on the CY 2019 policy to apply deviceintensive status with a default device
offset set at 31 percent for new HCPCS
codes describing procedures requiring
the implantation or insertion of a
medical device that do not yet have
associated claims data until claims data
are available to establish the HCPCS
code-level device offset for the
procedures adopted in the final rule.
• HCPCS code C9754 (Perc av fistula,
direct): Added to the list along with the
associated status indicator, APC, final
CY 2019 payment rate, device offset
percentage, and device offset amount,
because we inadvertently omitted this
code from Addendum P. This code
should have received device-intensive
status based on the CY 2019 policy to
apply device-intensive status with a
default device offset set at 31 percent for
new HCPCS codes describing
procedures requiring the implantation
or insertion of a medical device that do
not yet have associated claims data until
claims data are available to establish the
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HCPCS code-level device offset for the
procedures adopted in the final rule.
• HCPCS code C9755 (Rf magneticguide av fistula): Added to the list along
with the associated status indicator,
APC, final CY 2019 payment rate,
device offset percentage, and device
offset amount, because we inadvertently
omitted this code from Addendum P.
This code should have received deviceintensive status based on the CY 2019
policy to apply device-intensive status
with a default device offset set at 31
percent for new HCPCS codes
describing procedures requiring the
implantation or insertion of a medical
device that do not yet have associated
claims data until claims data are
available to establish the HCPCS codelevel device offset for the procedures
adopted in the final rule.
• In the tab titled ‘‘2019 FR Device
Intensive List,’’ we inadvertently
excluded CPT code 33285 (Insj subq car
rhythm mntr) from the list. Therefore,
we added this code along with the
associated status indicator, APC, final
CY 2019 payment rate, device offset
percentage, and device offset amount to
the list. This code should have received
device-intensive status based on the
device-intensive policy adopted in the
final rule.
In the tab titled ‘‘2019 FR HCPCS
Offsets,’’ the first bullet of the header
was corrected from ‘‘*List of HCPCS
codes payable under the OPPS that are
designated as device-intensive
procedures.’’ to ‘‘*List of all HCPCS
codes payable under the OPPS that
describe a clinical service including
both those that are designated as deviceintensive and those that are not
designated as device intensive’’ because
this tab in Addendum P includes device
offsets for all codes for which we have
data.
To view the corrected CY 2019 OPPS
status indicators, APC assignments,
relative weights, copayment rates,
device-intensive status, and short
descriptors for Addenda A, B, C, and P
that resulted from these technical and
typographical corrections, we refer
readers to the Addenda and supporting
files that are posted on the CMS website
at: https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
HospitalOutpatientPPS/.
Select ‘‘CMS–1695–CN2’’ from the list
of regulations. All corrected Addenda
for this correcting document are
contained in the zipped folder titled
‘‘2019 OPPS Final Rule Addenda’’ at the
bottom of the page for CMS–1695–CN2.
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2. Summary of Errors in and Corrections
to the ASC Payment System Addenda
Posted on the CMS Website
In Addendum AA, we inadvertently
mislabeled several CPT codes in the
‘‘Subject to Multiple Procedure
Discounting’’ column. As discussed in
section II.A.2 of this correction notice,
we inadvertently carried over OPPS C–
APC status indicators in our ASC
ratesetting process. This error impacted
the application of our multiple
procedure discounting rules and the
calculation of the ASC weight scalar,
and ASC payment rates. Accordingly,
we have updated Addenda AA to
accurately reflect the list of CPT codes
that are subject to multiple procedure
discounting.
As stated in the CY 2018 final rule
with comment period (83 FR 59409),
ASC device intensive procedures are
those with a HCPCS code-level device
offset percentage greater than the
threshold when calculated according to
the standard OPPS APC ratesetting
methodology, among other criteria. In
inputting OPPS APC rate data into the
ASC payment system for the CY 2019
OPPS/ASC final rule, several
procedures were inadvertently assigned
incorrect payment indicators.
Accordingly, we have reviewed the ASC
payment system data for consistency
with the OPPS APC rates and have
corrected the payment indicators for the
following procedures in Addendum AA:
• CPT Code 19298: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 28435: Revised the
payment indicator from ‘‘J8’’ to ‘‘A2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 28446: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 32550: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 33210: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
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payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 33226: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 33274: Revised the
payment indicator from ‘‘G2’’ to ‘‘J8’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 33285: Revised the
payment indicator from ‘‘G2’’ to ‘‘J8’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 36560: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 36563: Revised the
payment indicator from ‘‘J8’’ to ‘‘A2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 36578: Revised the
payment indicator from ‘‘J8’’ to ‘‘A2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 36583: Revised the
payment indicator from ‘‘J8’’ to ‘‘A2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 36904: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 37211: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 37212: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
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addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 43274: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 43276: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 44384: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 47554: Revised the
payment indicator from ‘‘J8’’ to ‘‘A2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 58356: Revised the
payment indicator from ‘‘J8’’ to ‘‘P3’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• CPT code 65125: Revised the
payment indicator from ‘‘J8’’ to ‘‘G2’’ in
addition to the payment weight and
payment rate; this code had
inadvertently been assigned the
incorrect payment indicator in the final
rule.
• HCPCS code C9752 (Intraosseous
des lumb/sacrum): Revised the payment
indicator from ‘‘G2’’ to ‘‘J8’’ in addition
to the payment weight and payment
rate; this code had inadvertently been
assigned the incorrect payment
indicator in the final rule.
• HCPCS code C9754 (Perc av fistula,
direct): Revised the payment indicator
from ‘‘G2’’ to ‘‘J8’’ in addition to the
payment weight and payment rate; this
code had inadvertently been assigned
the incorrect payment indicator in the
final rule.
• HCPCS code C9755 (RF magneticguide AV fistula): Revised the payment
indicator from ‘‘G2’’ to ‘‘J8’’ in addition
to the payment weight and payment
rate; this code had inadvertently been
assigned the incorrect payment
indicator in the final rule.
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We also corrected the following in
Addendum AA:
• CPT code 0100T: Updated the
payment rate from $134,051.87 to
$141,780.75 to reflect the New Tech
APC to which this code was assigned in
the CY 2019 OPPS/ASC final rule with
comment period.
• CPT code 0474T: Removed the code
from the list because the device
associated with this procedure was
withdrawn from marketing in
September 2018 and this procedure is
no longer separately payable under the
ASC payment system.
• CPT code 28540: Revised the
payment indicator from ‘‘P3’’ to ‘‘P2’’ in
addition to the payment rate; the revised
OPPS-based payment rate for CPT code
28540 is less than the PFS-based
payment rate and the corrected payment
indicator reflects this fact.
• HCPCS code C9753 (Intraosseous
destruct add’l): Added to Addendum
AA with a payment indicator of ‘‘N1’’;
this is a new code beginning January 1,
2019 and had inadvertently been left out
of Addendum AA in the final rule.
In Addendum BB, we corrected the
following:
• CPT code 74485 (Dilation urtr/urt
rs&i): Revised the payment indicator to
‘‘N1’’; this code had inadvertently been
assigned no payment indicator in the
final rule.
To view the corrected final CY 2019
ASC payment indicators, payment
weights, payment rates, and multiple
procedure discounting indicator for
Addenda AA and BB that resulted from
these technical corrections, we refer
readers to the Addenda and supporting
files on the CMS website at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ASCPayment/ASCRegulations-and-Notices.html. Select
‘‘CMS–1695–CN2’’ from the list of
regulations. All corrected ASC addenda
for this correcting document are
contained in the zipped folder entitled
‘‘Addendum AA, BB, DD1, DD2, and
EE’’ at the bottom of the page for CMS–
1695–CN2.
III. Waiver of Proposed Rulemaking
Under 5 U.S.C. 553(b) of the
Administrative Procedure Act (APA),
the agency is required to publish a
notice of the proposed rule in the
Federal Register before the provisions
of a rule take effect. Similarly, section
1871(b)(1) of the Act requires the
Secretary to provide for notice of the
proposed rule in the Federal Register
and provide a period of not less than 60
days for public comment. In addition,
section 553(d) of the APA, and section
1871(e)(1)(B)(i) of the Act mandate a 30day delay in effective date after issuance
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or publication of a rule. Sections
553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the notice
and comment and delay in effective date
of the APA requirements; in cases in
which these exceptions apply, sections
1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the
Act provide exceptions from the notice
and 60-day comment period and delay
in effective date requirements of the Act
as well. Section 553(b)(B) of the APA
and section 1871(b)(2)(C) of the Act
authorize an agency to dispense with
normal rulemaking requirements for
good cause if the agency makes a
finding that the notice and comment
process is impracticable, unnecessary,
or contrary to the public interest. In
addition, both section 553(d)(3) of the
APA and section 1871(e)(1)(B)(ii) of the
Act allow the agency to avoid the 30day delay in effective date where such
delay is contrary to the public interest
and an agency includes a statement of
support.
We believe that this correcting
document does not constitute a
rulemaking that would be subject to the
notice and comment or delayed effective
date requirements. This correcting
document corrects technical and
typographical errors in the preamble,
addenda, payment rates, and tables
included or referenced in the CY 2019
OPPS/ASC final rule with comment
period but does not make substantive
changes to the policies or payment
methodologies that were adopted in the
final rule with comment period. The
corrections made through this correcting
document are intended to ensure that
the information in the CY 2019 OPPS/
ASC final rule with comment period
accurately reflects the policies adopted
in that rule.
In addition, even if this were a rule to
which the notice and comment
procedures and delayed effective date
requirements applied, we find that there
is good cause to waive such
requirements. Undertaking further
notice and comment procedures to
incorporate the corrections in this
document into the final rule with
comment period or delaying the
effective date would be contrary to the
public interest because it is in the
public’s interest for providers to receive
appropriate payments in as timely a
manner as possible, and to ensure that
the CY 2019 OPPS/ASC final rule with
comment period accurately reflects our
methodologies and policies as of the
date they take effect and are applicable.
Furthermore, such procedures would
be unnecessary, as we are not making
substantive changes to our payment
methodologies or policies, but rather,
we are simply implementing correctly
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67087
the methodologies and policies that we
previously proposed, received comment
on, and subsequently finalized. This
correcting document is intended solely
to ensure that the CY 2019 OPPS/ASC
final rule with comment period
accurately reflects these methodologies
and policies. Therefore, we believe we
have good cause to waive the notice and
comment and effective date
requirements.
IV. Correction of Errors
In FR Doc. 2018–24243 of November
21, 2018 (83 FR 58818), make the
following corrections:
1. On page 58822, third column,
second bullet point, in the section titled
‘‘Payment of Drugs, Biologicals, and
Radiopharmaceuticals If Average Sales
Price (ASP) Data Are Not Available,’’ in
lines 3 through 11, the sentence ‘‘For CY
2019, we are making payment for
separately payable drugs and biologicals
that do not have pass-through payment
status and are not acquired under the
340B Program at wholesale acquisition
cost (WAC)+3 percent instead of
WAC+6 percent if ASP data are not
available’’ is replaced with ‘‘For CY
2019, we are making payment for
separately payable drugs and biologicals
that have partial quarter wholesale
acquisition cost (WAC)-based pricing
and are not acquired under the 340B
Program at WAC+3 percent instead of
WAC+6 percent if ASP data are not
available.’’
2. On page 58825, first column,
a. The first section heading ‘‘c. Impact
of the Changes to the Hospital OQR
Program’’ is corrected to read ‘‘g. Impact
of the Changes to the Hospital OQR
Program’’.
b. The second section heading ‘‘d.
Impact of the Changes to the ASCQR
Program’’ is corrected to read ‘‘h. Impact
of the Changes to the ASCQR Program’’.
3. On page 58833, last column, last
partial paragraph, in line 8, the code
‘‘P9072’’ is corrected to read ‘‘P9073’’.
4. On page 58834, first column, first
partial paragraph, in lines 3 and 7, the
code ‘‘P9073’’ is corrected to read
‘‘P9037’’.
5. On page 58880, Table 12.—New
Level II HCPCS Codes Effective April 1,
2018, in the last row, last column, titled
‘‘Final CY 2019 APC’’ for CY 2018 and
CY 2019 HCPCS Code C9749, the figure
‘‘5164’’ is corrected to read ‘‘5165’’.
6. On page 58894, first column, last
paragraph, in the fourth line from the
bottom of the paragraph, in the phrase
‘‘In addition, we proposed to continue
to assign the services described by
HCPCS code C9734 . . .’’, the words
‘‘continue to’’ are removed.
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7. On page 58895, last column, last
paragraph, in line 13, the reference to
‘‘APC 5114’’ is corrected to read ‘‘APC
5115’’.
8. On page 58897, in Table 17.—CY
2019 Status Indicator (SI), APC
Assignment, and Payment Rate for the
Magnetic Resonance Image Guided High
Intensity Focused Ultrasound (MRgFUS)
Procedures, in the row for CPT/HCPCS
Code C9734, in the column ‘‘CY 2018
OPPS APC,’’ the figure ‘‘5115’’ is
corrected to read ‘‘5114’’.
9. On page 58909, third column, after
the first full paragraph that ends with
‘‘. . . at each level and clinical
homogeneity.’’ and before the following
paragraph, which begins with
‘‘Comment: Several commenters
believed that the current structure
. . . ,’’ the following text is added:
In addition, we received a comment
related to CPT code 33274
(Transcatheter insertion or replacement
of permanent leadless pacemaker, right
ventricular, including imaging guidance
(for example, fluoroscopy, venous
ultrasound, ventriculography, femoral
venography) and device evaluation (for
example, interrogation or programming),
when performed). We note that in
Addendum B to the CY 2019 OPPS/ASC
proposed rule, we proposed to assign
CPT code 33274 to APC 5194 (Level 4
Endovascular Procedures), which is the
same APC assignment as its predecessor
code 0387T (Transcatheter insertion or
replacement of permanent leadless
pacemaker, ventricular), which was
effective January 1, 2015 and deleted on
December 31, 2018. CPT code 33274
was listed as 33X05 (the 5-digit CMS
placeholder code) in Addendum B with
the short descriptor and Addendum O
with the long descriptor of the CY 2019
OPPS/ASC proposed rule. We also
assigned the code to comment indicator
‘‘NP’’ in Addendum B to the proposed
rule to indicate that the code is new for
CY 2019 with a proposed APC
assignment and that public comments
would be accepted on the proposed APC
assignment. We note that CPT code
33274 will be effective January 1, 2019.
Although the code is new for CY 2019,
the service associated with CPT code
33274 was previously described by CPT
codes 0387T, which will be deleted on
December 31, 2018.
Comment: We received a comment to
the CY 2019 OPPS/ASC proposed rule
requesting the assignment of CPT code
33274 from APC 5194 (Level 4
Endovascular Procedures) to APC 5224
(Level 4 Pacemaker and Similar
Procedures).
Response: We appreciate the
suggestion, however, as noted above,
CPT code 33274 is assigned to the same
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APC as its predecessor code 0387T.
Accordingly, we do not believe that a
change in APC is warranted at this time.
10. On page 58928, third column,
after the first full paragraph ending with
‘‘Addendum B is available via the
internet on the CMS website.’’ and
before Table 35, the following section
and text are added:
21. Other Procedures/Services
For CY 2019, we proposed to continue
to assign CPT code 47382 (Ablation, 1
or more liver tumor(s), percutaneous,
radiofrequency) to APC 5361.
Comment: A commenter requested the
reassignment of CPT code 47382 from
APC 5361 (Level 1 Laparoscopy and
Related Services) to APC 5362 (Level 2
Laparoscopy and Related Services).
Response: Based on the latest hospital
outpatient claims data used for this final
rule with comment period, we disagree
that CPT code 47382 should be assigned
to APC 5362 for CY 2019. Our analysis
of the claims data show a geometric
mean cost of approximately $6,063 for
CPT code 47382, based on 2,220 single
claims (out of 2,242 total claims), which
is significantly less than the geometric
mean cost of about $7,809 for APC 5362.
We believe that APC 5361 is the most
appropriate APC assignment for CPT
code 47382 based on its clinical and
resource homogeneity to the other
procedures assigned to this APC.
Therefore, after consideration of the
public comment we received, we are
finalizing our proposal, without
modification, to assign CPT code 47382
to APC 5361 for CY 2019. The final CY
2019 payment rate for the code can be
found in Addendum B to this final rule
with comment period (which is
available via the internet on the CMS
website).
In addition, for CY 2019, we proposed
to assign CPT code 95983 (Electronic
analysis of implanted neurostimulator
pulse generator/transmitter (for
example, contact group[s], interleaving,
amplitude, pulse width, frequency [Hz],
on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters,
responsive neurostimulation, detection
algorithms, closed loop parameters, and
passive parameters) by physician or
other qualified health care professional;
with brain neurostimulator pulse
generator/transmitter programming, first
15 minutes face-to-face time with
physician or other qualified health care
professional) to APC 5741 (Level 1
Electronic Analysis of Devices). We note
that in Addendum B to the CY 2019
OPPS/ASC proposed rule, CPT code
95983 was listed as 95X85 (the 5-digit
CMS placeholder code) in Addendum B
with the short descriptor and
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Addendum O with the long descriptor
of the CY 2019 OPPS/ASC proposed
rule. We also assigned the code to
comment indicator ‘‘NP’’ in Addendum
B to the proposed rule to indicate that
the code is new for CY 2019 with a
proposed APC assignment and that
public comments would be accepted on
the proposed APC assignment. We note
that CPT code 95983 will be effective
January 1, 2019.
Comment: A commenter requested the
assignment of CPT code 95983 from
APC 5741 (Level 1 Electronic Analysis
of Devices) to APC 5742 (Level 2
Electronic Analysis of Devices).
Response: Based on input from our
medical advisors and our review of the
procedure, we believe that CPT code
95983 is appropriately placed in APC
5741 since it shares similar
characteristics as other electronic
analysis services in the APC. Therefore,
after consideration of the public
comment we received, we are finalizing
our proposal, without modification, to
assign CPT code 95983 to APC 5741 for
CY 2019. The final CY 2019 payment
rate for the code can be found in
Addendum B to this final rule with
comment period (which is available via
the internet on the CMS website).
We will reevaluate the APC
assignments for CPT code 47382 and
95983 for the next rulemaking cycle. We
remind hospitals that we review, on an
annual basis, the APC assignments for
all items and services paid under the
OPPS.
11. On page 58954, Table 37, last
column, the Pass-Through Payment
Effective Date for CY 2019 HCPCS code
Q5101 that reads ‘‘07/01/2015’’ is
corrected to read ‘‘01/01/2016’’.
12. On page 58958, Table 38, last
column, the Pass-Through Payment
Effective Date for CY 2018 and CY 2019
HCPCS code J7328 that reads ‘‘01/01/
2016’’ is corrected to read ‘‘04/01/
2017’’.
13. On page 58969, second column, in
line 3, the word ‘‘with’’ is corrected to
read ‘‘without’’.
14. On page 59079,
a. Second column, last partial
paragraph, in line 4, the figure ‘‘0.8792’’
is corrected to read ‘‘0.8800’’.
b. Third column, last partial
paragraph, in line 4, the figure ‘‘1.0004’’
is corrected to read ‘‘1.0000’’.
15. On page 59080,
a. First column, first partial
paragraph,
(1) In line 2, the figure ‘‘$46.551’’ is
corrected to read ‘‘$46.532’’.
(2) In line 8, the figure ‘‘1.0004’’ is
corrected to read ‘‘1.0000’’.
(3) In line 13, the figure ‘‘$45.639’’ is
corrected to read ‘‘$45.621’’.
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b. Second column, second full
paragraph, in line 7, the figure
‘‘$46.551’’ is corrected to read
‘‘$46.532.’’
16. On page 59088, first column, first
full paragraph, in line 12, the word
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‘‘retaining’’ is corrected to read
‘‘removing’’.
17. On pages 59100 and 59101, the
un-numbered table—Hospital OQR
Program Measure Set for the CY 2020
Payment Determination, and the
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67089
footnotes for the table, are corrected to
read as follows:
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Hospital OQR Program Measure Set for the CY 2020 Payment Determination
NQF#
Measure Name
0288
OP-2: Fibrinolytic Therapy Received Within 30 Minutes of ED Arrivalt
OP-3: Median Time to Transfer to Another Facility for Acute Coronary
0290
Intervention
OP-5: Median Time to ECGt
0289
0514
OP-8: MRI Lumbar Spine for Low Back Paint
OP-9: Mammography Follow-up Rates
None
OP-10: Abdomen CT- Use of Contrast Material
None
OP-11: Thorax CT - Use of Contrast Material
0513
OP-12: The Ability for Providers with HIT to Receive Laboratory Data
Electronically Directly into their ONC-Certified EHR System as Discrete
None
Searchable Data
OP-13: Cardiac Imaging for Preoperative Risk Assessment for Non-Cardiac,
0669
Low-Risk Surgery
OP-14: Simultaneous Use ofBrain Computed Tomography (CT) and Sinus
None
Computed Tomography (CT)
0491
OP-17: Tracking Clinical Results between Visitst
OP-18: Median Time from ED Arrival to ED Departure for Discharged ED
0496
Patients
OP-22: Left Without Being Seent
0499
OP-23: Head CT or MRI Scan Results for Acute Ischemic Stroke or
0661
Hemorrhagic Stroke who Received Head CT or MRI Scan Interpretation
Within 45 minutes of ED Arrival
OP-29: Appropriate Follow-Up Interval for Normal Colonoscopy in
0658
Average Risk Patients*
OP-30: Colonoscopy Interval for Patients with a History of Adenomatous
0659
Polyps- Avoidance of Inappropriate Use*
OP-31: Cataracts: Improvement in Patient's Visual Function within 90 Days
1536
Following Cataract Surgery**
OP-32: Facility 7-Day Risk-Standardized Hospital Visit Rate after
2539
Outpatient Colonoscopy
1822
OP-33: External Beam Radiotherapy for Bone Metastasest
OP-35: Admissions and Emergency Department (ED) Visits for Patients
None
Receiving Outpatient Chemotherapy
2687
OP-36: Hospital Visits after Hospital Outpatient Surgery
None
OP-37a: OAS CARPS- About Facilities and Staff***
None
OP-37b: OAS CARPS- Communication About Procedure***
None
OP-37c: OAS CARPS- Preparation for Discharge and Recovery***
None
OP-37d: OAS CARPS- Overall Rating of Facility***
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Set for the 2021 Payment Determination
and Subsequent years, and the footnotes
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for the table, are corrected to read as
follows:
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18. On page 59102, the un-numbered
table—Hospital OQR Program Measure
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19. On page 59117, the word
‘‘retaining’’ is corrected to read
‘‘removing’’.
20. On page 59129, first column, first
full paragraph,
a. In lines 1 through 10, the following
text is removed: ‘‘Furthermore, this is
the only measure in the ASCQR
Program measure set that deals with
cataract surgery, which is commonly
performed in the ASC setting. If it is
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removed, the program will have a gap in
coverage for this clinical area. As a
result, we now believe that meaningful
information can be provided to
consumers regarding those facilities.’’
b. In Lines 10 through 16, the
following text is moved to the end of the
previous paragraph: ‘‘In addition, when
this measure was made voluntary in the
CY 2015 OPPS/ASC final rule with
comment period (79 FR 66984)
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commenters stated that the measure
would promote and improve care
coordination among providers.’’
21. On page 59169, first column,
a. First full paragaraph, in line 10, the
figure ‘‘0.8792’’ is corrected to read
‘‘0.8800’’.
b. Last paragraph, in line 26, the
figure ‘‘1.0004’’ is corrected to read
‘‘1.0000’’.
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c. Last paragraph, in the third line
from the bottom, the figure ‘‘$46.555’’ is
corrected to read ‘‘$46.532’’.
22. On page 59170,
a. Third column, first partial
paragraph, in line 5, the figure ‘‘79
percent’’ is corrected to read ‘‘68
percent’’.
b. In Table 63.—Estimated Impact of
the CY 2019 Update to the ASC
Payment System on Aggregate CY 2019
Medicare Program Payments by Surgical
Speciality or Ancillary Items and
Services Group, in the last row, third
column, titled ‘‘Estimated CY 2019
Percent Change’’ for Ancillary items and
67093
services, the figure ‘‘79’’ is corrected to
read ‘‘68’’.
23. On page 59171, Table 64.—
Estimated Impact of the CY 2019 Update
to the ASC Payment System on
Aggregate Payments for Selected
Procedures, the fourth column,
‘‘Estimated CY 2019 Percent Change,’’ is
corrected to read as follows:
Estimated CY
2019 Percent
Change
(4)
-1
3
-1
1
-3
3
11
4
-1
0
1
1
11
8
3
4
4
4
0
-2
-2
2
-2
0
-2
-5
-2
5
8
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Dated: December 20, 2018.
Ann C. Agnew,
Executive Secretary to the Department,
Department of Health and Human Services.
[FR Doc. 2018–28348 Filed 12–21–18; 4:15 pm]
BILLING CODE 4120–01–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2018–0002; Internal
Agency Docket No. FEMA–8561]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date. Also, information
identifying the current participation
status of a community can be obtained
from FEMA’s Community Status Book
(CSB). The CSB is available at https://
www.fema.gov/national-floodinsurance-program-community-statusbook.
DATES: The effective date of each
community’s scheduled suspension is
the third date (‘‘Susp.’’) listed in the
third column of the following tables.
FOR FURTHER INFORMATION CONTACT: If
you want to determine whether a
particular community was suspended
on the suspension date or for further
information, contact Adrienne L.
Sheldon, PE, CFM, Federal Insurance
and Mitigation Administration, Federal
Emergency Management Agency, 400 C
Street SW, Washington, DC 20472, (202)
212–3966.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
Federal flood insurance that is not
otherwise generally available from
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SUMMARY:
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private insurers. In return, communities
agree to adopt and administer local
floodplain management measures aimed
at protecting lives and new construction
from future flooding. Section 1315 of
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits the sale of NFIP flood
insurance unless an appropriate public
body adopts adequate floodplain
management measures with effective
enforcement measures. The
communities listed in this document no
longer meet that statutory requirement
for compliance with program
regulations, 44 CFR part 59.
Accordingly, the communities will be
suspended on the effective date in the
third column. As of that date, flood
insurance will no longer be available in
the community. We recognize that some
of these communities may adopt and
submit the required documentation of
legally enforceable floodplain
management measures after this rule is
published but prior to the actual
suspension date. These communities
will not be suspended and will continue
to be eligible for the sale of NFIP flood
insurance. A notice withdrawing the
suspension of such communities will be
published in the Federal Register.
In addition, FEMA publishes a Flood
Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard
Areas (SFHAs) in these communities.
The date of the FIRM, if one has been
published, is indicated in the fourth
column of the table. No direct Federal
financial assistance (except assistance
pursuant to the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act not in connection with a
flood) may be provided for construction
or acquisition of buildings in identified
SFHAs for communities not
participating in the NFIP and identified
for more than a year on FEMA’s initial
FIRM for the community as having
flood-prone areas (section 202(a) of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4106(a), as amended). This
prohibition against certain types of
Federal assistance becomes effective for
the communities listed on the date
shown in the last column. The
Administrator finds that notice and
public comment procedures under
5 U.S.C. 553(b), are impracticable and
unnecessary because communities listed
in this final rule have been adequately
notified.
Each community receives 6-month,
90-day, and 30-day notification letters
addressed to the Chief Executive Officer
stating that the community will be
suspended unless the required
floodplain management measures are
met prior to the effective suspension
PO 00000
Frm 00062
Fmt 4700
Sfmt 4700
date. Since these notifications were
made, this final rule may take effect
within less than 30 days.
National Environmental Policy Act.
FEMA has determined that the
community suspension(s) included in
this rule is a non-discretionary action
and therefore the National
Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) does not apply.
Regulatory Flexibility Act. The
Administrator has determined that this
rule is exempt from the requirements of
the Regulatory Flexibility Act because
the National Flood Insurance Act of
1968, as amended, Section 1315, 42
U.S.C. 4022, prohibits flood insurance
coverage unless an appropriate public
body adopts adequate floodplain
management measures with effective
enforcement measures. The
communities listed no longer comply
with the statutory requirements, and
after the effective date, flood insurance
will no longer be available in the
communities unless remedial action
takes place.
Regulatory Classification. This final
rule is not a significant regulatory action
under the criteria of section 3(f) of
Executive Order 12866 of September 30,
1993, Regulatory Planning and Review,
58 FR 51735.
Executive Order 13132, Federalism.
This rule involves no policies that have
federalism implications under Executive
Order 13132.
Executive Order 12988, Civil Justice
Reform. This rule meets the applicable
standards of Executive Order 12988.
Paperwork Reduction Act. This rule
does not involve any collection of
information for purposes of the
Paperwork Reduction Act, 44 U.S.C.
3501 et seq.
List of Subjects in 44 CFR Part 64
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is
amended as follows:
PART 64—[AMENDED]
1. The authority citation for part 64
continues to read as follows:
■
Authority: 42 U.S.C. 4001 et seq.;
Reorganization Plan No. 3 of 1978, 3 CFR,
1978 Comp.; p. 329; E.O. 12127, 44 FR 19367,
3 CFR, 1979 Comp.; p. 376.
§ 64.6
[Amended]
2. The tables published under the
authority of § 64.6 are amended as
follows:
■
E:\FR\FM\28DER1.SGM
28DER1
Agencies
[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Rules and Regulations]
[Pages 67083-67094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-28348]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 416 and 419
[CMS-1695-CN2]
RIN 0938-AT30
Medicare Program: Changes to Hospital Outpatient Prospective
Payment and Ambulatory Surgical Center Payment Systems and Quality
Reporting Programs; Correction
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: This document corrects technical and typographical errors in
the final rule with comment period that appeared in the November 21,
2018 Federal Register titled ``Changes to Hospital Outpatient
Prospective Payment and Ambulatory Surgical Center Payment Systems and
Quality Reporting Programs.''
DATES: The corrections in this document are effective January 1, 2019.
FOR FURTHER INFORMATION CONTACT: Marjorie Baldo via email
Marjorie.Baldo@cms.hhs.gov or at (410) 786-4617.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2018-24243 of November 21, 2018 (83 FR 58818), there
were a number of technical and typographical errors that are identified
and corrected in the Correction of Errors section of this correcting
document. The provisions in this correction document are effective as
if they had been included in the document that appeared in the November
21, 2018 Federal Register. Accordingly, the corrections are effective
January 1, 2019.
II. Summary of Errors
A. Summary of Errors in the Preamble
1. Hospital Outpatient Prospective Payment System (OPPS) Corrections
On page 58822, we are correcting the section ``Payment of Drugs,
Biologicals, and Radiopharmaceuticals If Average Sales Price (ASP) Data
Are Not Available'' to remove the language that suggests that drugs
with pass-through status with partial quarter WAC-based pricing are not
paid at WAC + 3, which is incorrect. This correction is necessary to
conform the introductory language regarding OPPS payment policy for
drugs, biologicals, and radiopharmaceuticals with WAC-based pricing
with the policy adopted in the final rule to pay for these drugs,
biologicals, and radiopharmaceuticals, including those with pass-
through status, at WAC + 3 percent.
On page 58825, the headings for subsections ``c. Impact of the
Changes to the Hospital OQR Program'' and ``d. Impact of the Changes to
the ASCQR Program'' were alphabetically mislabeled and are corrected to
be ``g. Impact of the Changes to the Hospital OQR Progam'' and ``h.
Impact of the Changes to the ASCQR Program,'' respectively.
On page 58833, Healthcare Common Procedure Coding System (HCPCS)
code P9072 (Platelets, pheresis, pathogen reduced or rapid bacterial
tested, each unit) was cited in a comment in error. The correct HCPCS
code is ``P9073'' not ``P9072''.
On page 58834, we transposed two numbers in the Healthcare Common
Procedure Coding System (HCPCS) code P9037 (Platelets, pheresis,
leukocytes reduced, irradiated, each unit). The correct HCPCS code is
``P9037'', not ``P9073''.
On page 58880, in ``Table 12.--New Level II HCPCS Codes Effective
April 1, 2018,'' we incorrectly stated that the Medicare Ambulatory
Payment Classification (APC) assignment for HCPCS code C9749 (Repair
nasal stenosis w/imp) is ``APC 5164,'' rather than ``APC 5165.'' The
correct APC assignment for this code is APC 5165, which we finalized on
page 58922.
On page 58909, under section ``6. Endovascular Procedures (APCs
5191 through 5194)'' of the ``OPPS APC-Specific Policies'' section, we
inadvertently omitted a summary of a public comment and our response
related to new calendar year (CY) 2019 Common Procedural Terminology
(CPT) code 33274. Therefore, we are revising the discussion to include
the comment and response.
On pages 58894 to 58897, we occasionally stated the wrong APC
assignment for procedure code C9734 (Focused ultrasound ablation/
therapeutic intervention, other than uterine leiomyomata, with magnetic
resonance (mr) guidance) for CY 2018 and CY 2019. The correct APC
assignment for procedure code C9734 is APC 5114 for CY 2018 and APC
5115 for CY 2019.
On page 58928 of the ``OPPS APC-Specific Policies'' section, we
inadvertently omitted a summary of a public comment and response
related to existing CPT code 47382 and new CY 2019 CPT code 95983.
Therefore, we are adding a new subsection titled ``21.
[[Page 67084]]
Other Procedures/Services'' that includes this comment and response.
On page 58954, in ``Table 37.--Drugs and Biologicals For Which
Pass-through Payment Status Expires December 31, 2018,'' we included an
incorrect Pass-Through Payment Effective Date for HCPCS code Q5101. The
correct Pass-Through Payment Effective Date for HCPCS code Q5101 is 01/
01/2016, not 07/01/2015.
On page 58958, in Table 38.--Drugs and Biologicals With Pass-
through Payment Status in CY 2019,'' we included an incorrect Pass-
Through Payment Effective Date for HCPCS code J7328. The correct Pass-
Through Payment Effective Date for HCPCS code J7328 is 04/01/2017, not
01/01/16.
On page 58969, we inadvertently stated, ``We also are finalizing
our proposal to retain our established policy to assign new skin
substitute products with pricing information to the low cost group.''
We are correcting the word ``with'' to read ``without'' to clarify that
skin substitutes without pricing information are assigned to the low
cost group, consistent with our established policy, which is described
on page 58967.
2. Ambulatory Surgical Center (ASC) Payment System Corrections
The ASC payment system uses the same APC classification groupings
as the OPPS; however, ASC payment indicators and OPPS status indicators
are not compatible across the two payment systems. In our final rule
ratesetting for CY 2019, we inadvertently carried over OPPS C-APC
status indicators in our ASC ratesetting process. This error impacted
the application of our multiple procedure discounting rules and the
calculation of the ASC weight scalar, which led to the calculation of
incorrect ASC payment rates. Accordingly, on page 59079, in our
response to a comment regarding our process of applying a weight scalar
in calculation of ASC payment rates, and on page 59169, we are
correcting our weight scalar in ASC payment rate calculations of
``0.8792'' to ``0.8800.''
Additionally, on pages 59079, 59080 and 59169, we inadvertently
excluded certain core-based statistical areas (CBSAs) and, therefore,
incorrectly calculated the wage index budget neutrality factor that we
applied to the 2018 ASC conversion factor. We previously calculated a
wage index adjustment of 1.0004. We have recalculated the wage index
adjustment taking into account the appropriate CBSAs, resulting in a
corrected wage index adjustment of ``1.0000.''
On pages 59080 and 59169, we are correcting the final CY 2019
conversion factor of $46.551 for ASCs who meet quality reporting
requirements and the final CY 2019 conversion factor of $45.639 for
ASCs who do not meet quality reporting requirements. These conversion
factors are incorrect because they utilize the incorrect wage index
adjustment. The correct conversion factors, calculated utilizing the
correct wage index adjustment, are ``$46.532'' and ``45.621'' for ASCs
that meet quality reporting requirements and for ASCs that do not meet
quality reporting requirements, respectively.
On page 59170, we are correcting our estimate of the increase in
aggregate payments for ancillary items and services of 79 percent for
CY 2019. The correct percentage is 68 percent, which accounts for
removing HCPCS code 0474T from our list of covered surgical procedures
and, therefore, no longer includes any estimated 2019 spending from
HCPCS code 0474T. Further, on page 59170 in ``Table 63.--Estimated
Impact of the CY 2019 Update to the ASC Payment System on Aggregate CY
2019 Medicare Program Payments by Surgical Specialty or Ancillary Items
and Services Group'', we are correcting the figure in the third column,
titled ``Estimated CY 2019 Percent Change'' for the Ancillary Items and
Services Group to reflect the change from 79 percent to 68 percent.
On page 59171, in ``Table 64.--Estimated Impact of the CY 2019
Update to the ASC Payment System on Aggregate Payments for Selected
Procedures'', we are correcting the figures in the fourth column of the
table titled ``Estimated CY 2019 Percent Change'' to account for
payment rates changes from the corrected ASC weight scalar and
corrected ASC conversion factor.
3. Hospital Outpatient Quality Reporting (OQR) Program Corrections
On page 59088, first column, first full paragraph, the word
``retaining'' is corrected to ``removing.'' We inadvertently included
the wrong word.
On page 59100 through 59102, the table footnoting for the Hospital
OQR Program Measure Set for both the CY 2020 and CY 2021 Payment
Determinations are corrected. Specifically, the footnote pertaining to
OP-26 is removed from the un-numbered tables titled ``Hospital OQR
Program Measure Set for the CY 2020 Payment Determination'' and
``Hospital OQR Program Measure Set for the CY 2021 Payment
Determination and Subsequent Years.'' The measure is no longer in the
program beginning with the CY 2020 payment determination. In addition,
for both tables, the National Quality Forum (NQF) status for OP-8: MRI
Lumbar Spine for Low Back Pain and OP-33: External Beam Radiotherapy
for Bone Metastases is updated to indicate that the NQF endorsement for
these measures was removed. Furthermore, in both tables, we added an
additional footnote to OP-31 to indicate ``Measure voluntarily
collected as set forth in section XIII.D.3.b. of the CY 2015 OPPS/ASC
final rule with comment period (79 FR 66946 through 66947).''
Subsequently, asterisks for the remaining footnotes are renumbered, as
are the corresponding notations under the measure name in both tables.
As a result of the renumbering, both tables are revised such that OP-
37a, OP-37b, OP-37c, OP-37d, and OP-37e correspond with the appropriate
footnote reading ``Measure reporting delayed beginning with CY 2018
reporting and for subsequent years as discussed in section XIII.B.5. of
the CY 2018 OPPS/ASC final rule with comment period (82 FR 59432
through 59433).''
4. Ambulatory Surgical Center Quality Reporting Program (ASCQR)
Corrections
On page 59117, second column, first paragraph, the word
``retaining'' is corrected to ``removing.'' We inadvertently included
the wrong word.
On page 59129, first column, second paragraph, the language,
``Furthermore, this is the only measure in the ASCQR Program measure
set that deals with cataract surgery, which is commonly performed in
the ASC setting. If it is removed, the program will have a gap in
coverage for this clinical area. As a result, we now believe that
meaningful information can be provided to consumers regarding those
facilities'' is removed. This text pertains only to the Hospital OQR
Program; it is factually inaccurate with respect to the ASCQR Program,
since the ASC-14:Unplanned Anterior Vitrectomy measure also includes
cataract surgery, and was erroneously included.
B. Summary of Errors in and Corrections to the OPPS and ASC Addenda
Posted on the CMS Website
We are summarizing below the errors we have corrected in the
addenda available on the internet at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/. The
addenda that are available on the internet have been updated to reflect
the revisions discussed in this correcting document.
[[Page 67085]]
1. Summary of Errors in and Corrections to the OPPS Addenda Posted on
the CMS Website
In Addendum B (Final OPPS Payment by HCPCS Code for CY 2019), we
corrected the following:
CPT code 0100T (Prosth retina receive&gen): APC revision
from APC 1906 (New Technology--Level 51 ($130,001-$145,000)) to APC
1908 (New Technology--Level 52 ($145,001-$160,000)). In the preamble
text, CPT code 0100T had been assigned to APC 1908. This action ensures
the information in Addendum B reflects the APC assignment that was
finalized in the preamble.
CPT code 0474T (Insj aqueous drg dev io rsvr): Status
indicator revision from status indicator ``J1'' (Hospital Part B
Services Paid Through a C-APC) to status indicator ``E1'' (Not Paid by
Medicare) because the device associated with this procedure was
withdrawn from marketing in September 2018 and the procedure is no
longer separately payable under the OPPS.
HCPCS code A6460: We made a typographical error in listing
the HCPCS short descriptor. Specifically, we are correcting the short
descriptor from ``Arg II ext com/sup/acc misc'' to ``Synthetic drsg <=
16 sq in''.
HCPCS code A6461: We made a typographical error in listing
the HCPCS short descriptor. Specifically, we are correcting the short
descriptor from ``Enzyme cartridge enteral nut'' to ``Synthetic drsg
>16 <=48 sq in''.
HCPCS code C9752 (Intraosseous des lumb/sacrum): We made a
typographical error in listing the APC assignment. Specifically, we are
correcting the APC assignment from APC 5155 (Level 5 Airway Endoscopy)
to APC 5115 (Level 5 Musculoskeletal Procedures).
In Addendum C (Final HCPCS Codes Payable Under the 2019 OPPS by
APC), we corrected the following:
APC 1906 (New Technology--Level 51 ($130,001-$145,000)):
Deleted HCPCS code 0100T from the list We inadvertently listed the code
in this APC when it should have been listed under APC 1908 (New
Technology--Level 52 ($145,001-$160,000)), as correctly listed in the
preamble and Addendum B of the CY 2019 OPPS/ASC final rule with comment
period.
APC 1908 (New Technology--Level 52 ($145,001-$160,000)):
Added HCPCS code 0100T to the list.
APC 5115 (Level 5 Musculoskeletal Procedures): We made a
typographical error by assigning HCPCS code C9752 to APC 5155 (Level 5
Airway Endoscopy) when it should have been assigned to APC 5115.
Specifically, we are correcting the APC assignment for HCPCS code C9752
to APC 5115.
APC 5155 (Level 5 Airway Endoscopy): Removed HCPCS code
C9752 from the list.
APC 5492 (Level 2 Intraocular Procedures): Deleted CPT
code 0474T from the list because the device associated with this
procedure was withdrawn from marketing in September 2018 and the
procedure is no longer separately payable under the OPPS.
In Addendum P (Device-Intensive Procedures for CY 2019), we
corrected the following errors in both tabs, 2019 FR Device Intensive
List and 2019 FR HCPCS Offsets:
CPT code 0100T: Revised the APC assignment from APC 1906
to APC 1908 and the final payment rate. We inadvertently listed the
code in APC 1906 when it should have been listed under APC 1908 (New
Technology--Level 52 ($145,001-$160,000)), as correctly listed in
Addendum B of the CY 2019 OPPS/ASC final rule.
CPT code 0474T: Removed from the list because the device
associated with this procedure was withdrawn from marketing in
September 2018 and this procedure is no longer separately payable under
the OPPS.
HCPCS code C9752: Added to the list along with the
associated status indicator, APC, final CY 2019 payment rate, device
offset percentage, and device offset amount, because we inadvertently
omitted this code from Addendum P. This code should have received
device-intensive status based on the CY 2019 policy to apply device-
intensive status with a default device offset set at 31 percent for new
HCPCS codes describing procedures requiring the implantation or
insertion of a medical device that do not yet have associated claims
data until claims data are available to establish the HCPCS code-level
device offset for the procedures adopted in the final rule.
HCPCS code C9754 (Perc av fistula, direct): Added to the
list along with the associated status indicator, APC, final CY 2019
payment rate, device offset percentage, and device offset amount,
because we inadvertently omitted this code from Addendum P. This code
should have received device-intensive status based on the CY 2019
policy to apply device-intensive status with a default device offset
set at 31 percent for new HCPCS codes describing procedures requiring
the implantation or insertion of a medical device that do not yet have
associated claims data until claims data are available to establish the
HCPCS code-level device offset for the procedures adopted in the final
rule.
HCPCS code C9755 (Rf magnetic-guide av fistula): Added to
the list along with the associated status indicator, APC, final CY 2019
payment rate, device offset percentage, and device offset amount,
because we inadvertently omitted this code from Addendum P. This code
should have received device-intensive status based on the CY 2019
policy to apply device-intensive status with a default device offset
set at 31 percent for new HCPCS codes describing procedures requiring
the implantation or insertion of a medical device that do not yet have
associated claims data until claims data are available to establish the
HCPCS code-level device offset for the procedures adopted in the final
rule.
In the tab titled ``2019 FR Device Intensive List,'' we
inadvertently excluded CPT code 33285 (Insj subq car rhythm mntr) from
the list. Therefore, we added this code along with the associated
status indicator, APC, final CY 2019 payment rate, device offset
percentage, and device offset amount to the list. This code should have
received device-intensive status based on the device-intensive policy
adopted in the final rule.
In the tab titled ``2019 FR HCPCS Offsets,'' the first bullet of
the header was corrected from ``*List of HCPCS codes payable under the
OPPS that are designated as device-intensive procedures.'' to ``*List
of all HCPCS codes payable under the OPPS that describe a clinical
service including both those that are designated as device-intensive
and those that are not designated as device intensive'' because this
tab in Addendum P includes device offsets for all codes for which we
have data.
To view the corrected CY 2019 OPPS status indicators, APC
assignments, relative weights, copayment rates, device-intensive
status, and short descriptors for Addenda A, B, C, and P that resulted
from these technical and typographical corrections, we refer readers to
the Addenda and supporting files that are posted on the CMS website at:
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/. Select ``CMS-1695-CN2'' from the list
of regulations. All corrected Addenda for this correcting document are
contained in the zipped folder titled ``2019 OPPS Final Rule Addenda''
at the bottom of the page for CMS-1695-CN2.
[[Page 67086]]
2. Summary of Errors in and Corrections to the ASC Payment System
Addenda Posted on the CMS Website
In Addendum AA, we inadvertently mislabeled several CPT codes in
the ``Subject to Multiple Procedure Discounting'' column. As discussed
in section II.A.2 of this correction notice, we inadvertently carried
over OPPS C-APC status indicators in our ASC ratesetting process. This
error impacted the application of our multiple procedure discounting
rules and the calculation of the ASC weight scalar, and ASC payment
rates. Accordingly, we have updated Addenda AA to accurately reflect
the list of CPT codes that are subject to multiple procedure
discounting.
As stated in the CY 2018 final rule with comment period (83 FR
59409), ASC device intensive procedures are those with a HCPCS code-
level device offset percentage greater than the threshold when
calculated according to the standard OPPS APC ratesetting methodology,
among other criteria. In inputting OPPS APC rate data into the ASC
payment system for the CY 2019 OPPS/ASC final rule, several procedures
were inadvertently assigned incorrect payment indicators. Accordingly,
we have reviewed the ASC payment system data for consistency with the
OPPS APC rates and have corrected the payment indicators for the
following procedures in Addendum AA:
CPT Code 19298: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 28435: Revised the payment indicator from ``J8''
to ``A2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 28446: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 32550: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 33210: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 33226: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 33274: Revised the payment indicator from ``G2''
to ``J8'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 33285: Revised the payment indicator from ``G2''
to ``J8'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 36560: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 36563: Revised the payment indicator from ``J8''
to ``A2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 36578: Revised the payment indicator from ``J8''
to ``A2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 36583: Revised the payment indicator from ``J8''
to ``A2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 36904: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 37211: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 37212: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 43274: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 43276: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 44384: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 47554: Revised the payment indicator from ``J8''
to ``A2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 58356: Revised the payment indicator from ``J8''
to ``P3'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
CPT code 65125: Revised the payment indicator from ``J8''
to ``G2'' in addition to the payment weight and payment rate; this code
had inadvertently been assigned the incorrect payment indicator in the
final rule.
HCPCS code C9752 (Intraosseous des lumb/sacrum): Revised
the payment indicator from ``G2'' to ``J8'' in addition to the payment
weight and payment rate; this code had inadvertently been assigned the
incorrect payment indicator in the final rule.
HCPCS code C9754 (Perc av fistula, direct): Revised the
payment indicator from ``G2'' to ``J8'' in addition to the payment
weight and payment rate; this code had inadvertently been assigned the
incorrect payment indicator in the final rule.
HCPCS code C9755 (RF magnetic-guide AV fistula): Revised
the payment indicator from ``G2'' to ``J8'' in addition to the payment
weight and payment rate; this code had inadvertently been assigned the
incorrect payment indicator in the final rule.
[[Page 67087]]
We also corrected the following in Addendum AA:
CPT code 0100T: Updated the payment rate from $134,051.87
to $141,780.75 to reflect the New Tech APC to which this code was
assigned in the CY 2019 OPPS/ASC final rule with comment period.
CPT code 0474T: Removed the code from the list because the
device associated with this procedure was withdrawn from marketing in
September 2018 and this procedure is no longer separately payable under
the ASC payment system.
CPT code 28540: Revised the payment indicator from ``P3''
to ``P2'' in addition to the payment rate; the revised OPPS-based
payment rate for CPT code 28540 is less than the PFS-based payment rate
and the corrected payment indicator reflects this fact.
HCPCS code C9753 (Intraosseous destruct add'l): Added to
Addendum AA with a payment indicator of ``N1''; this is a new code
beginning January 1, 2019 and had inadvertently been left out of
Addendum AA in the final rule.
In Addendum BB, we corrected the following:
CPT code 74485 (Dilation urtr/urt rs&i): Revised the
payment indicator to ``N1''; this code had inadvertently been assigned
no payment indicator in the final rule.
To view the corrected final CY 2019 ASC payment indicators, payment
weights, payment rates, and multiple procedure discounting indicator
for Addenda AA and BB that resulted from these technical corrections,
we refer readers to the Addenda and supporting files on the CMS website
at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Regulations-and-Notices.html. Select ``CMS-1695-CN2''
from the list of regulations. All corrected ASC addenda for this
correcting document are contained in the zipped folder entitled
``Addendum AA, BB, DD1, DD2, and EE'' at the bottom of the page for
CMS-1695-CN2.
III. Waiver of Proposed Rulemaking
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA),
the agency is required to publish a notice of the proposed rule in the
Federal Register before the provisions of a rule take effect.
Similarly, section 1871(b)(1) of the Act requires the Secretary to
provide for notice of the proposed rule in the Federal Register and
provide a period of not less than 60 days for public comment. In
addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of
the Act mandate a 30-day delay in effective date after issuance or
publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the notice and comment and delay in
effective date of the APA requirements; in cases in which these
exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the
Act provide exceptions from the notice and 60-day comment period and
delay in effective date requirements of the Act as well. Section
553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an
agency to dispense with normal rulemaking requirements for good cause
if the agency makes a finding that the notice and comment process is
impracticable, unnecessary, or contrary to the public interest. In
addition, both section 553(d)(3) of the APA and section
1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay
in effective date where such delay is contrary to the public interest
and an agency includes a statement of support.
We believe that this correcting document does not constitute a
rulemaking that would be subject to the notice and comment or delayed
effective date requirements. This correcting document corrects
technical and typographical errors in the preamble, addenda, payment
rates, and tables included or referenced in the CY 2019 OPPS/ASC final
rule with comment period but does not make substantive changes to the
policies or payment methodologies that were adopted in the final rule
with comment period. The corrections made through this correcting
document are intended to ensure that the information in the CY 2019
OPPS/ASC final rule with comment period accurately reflects the
policies adopted in that rule.
In addition, even if this were a rule to which the notice and
comment procedures and delayed effective date requirements applied, we
find that there is good cause to waive such requirements. Undertaking
further notice and comment procedures to incorporate the corrections in
this document into the final rule with comment period or delaying the
effective date would be contrary to the public interest because it is
in the public's interest for providers to receive appropriate payments
in as timely a manner as possible, and to ensure that the CY 2019 OPPS/
ASC final rule with comment period accurately reflects our
methodologies and policies as of the date they take effect and are
applicable.
Furthermore, such procedures would be unnecessary, as we are not
making substantive changes to our payment methodologies or policies,
but rather, we are simply implementing correctly the methodologies and
policies that we previously proposed, received comment on, and
subsequently finalized. This correcting document is intended solely to
ensure that the CY 2019 OPPS/ASC final rule with comment period
accurately reflects these methodologies and policies. Therefore, we
believe we have good cause to waive the notice and comment and
effective date requirements.
IV. Correction of Errors
In FR Doc. 2018-24243 of November 21, 2018 (83 FR 58818), make the
following corrections:
1. On page 58822, third column, second bullet point, in the section
titled ``Payment of Drugs, Biologicals, and Radiopharmaceuticals If
Average Sales Price (ASP) Data Are Not Available,'' in lines 3 through
11, the sentence ``For CY 2019, we are making payment for separately
payable drugs and biologicals that do not have pass-through payment
status and are not acquired under the 340B Program at wholesale
acquisition cost (WAC)+3 percent instead of WAC+6 percent if ASP data
are not available'' is replaced with ``For CY 2019, we are making
payment for separately payable drugs and biologicals that have partial
quarter wholesale acquisition cost (WAC)-based pricing and are not
acquired under the 340B Program at WAC+3 percent instead of WAC+6
percent if ASP data are not available.''
2. On page 58825, first column,
a. The first section heading ``c. Impact of the Changes to the
Hospital OQR Program'' is corrected to read ``g. Impact of the Changes
to the Hospital OQR Program''.
b. The second section heading ``d. Impact of the Changes to the
ASCQR Program'' is corrected to read ``h. Impact of the Changes to the
ASCQR Program''.
3. On page 58833, last column, last partial paragraph, in line 8,
the code ``P9072'' is corrected to read ``P9073''.
4. On page 58834, first column, first partial paragraph, in lines 3
and 7, the code ``P9073'' is corrected to read ``P9037''.
5. On page 58880, Table 12.--New Level II HCPCS Codes Effective
April 1, 2018, in the last row, last column, titled ``Final CY 2019
APC'' for CY 2018 and CY 2019 HCPCS Code C9749, the figure ``5164'' is
corrected to read ``5165''.
6. On page 58894, first column, last paragraph, in the fourth line
from the bottom of the paragraph, in the phrase ``In addition, we
proposed to continue to assign the services described by HCPCS code
C9734 . . .'', the words ``continue to'' are removed.
[[Page 67088]]
7. On page 58895, last column, last paragraph, in line 13, the
reference to ``APC 5114'' is corrected to read ``APC 5115''.
8. On page 58897, in Table 17.--CY 2019 Status Indicator (SI), APC
Assignment, and Payment Rate for the Magnetic Resonance Image Guided
High Intensity Focused Ultrasound (MRgFUS) Procedures, in the row for
CPT/HCPCS Code C9734, in the column ``CY 2018 OPPS APC,'' the figure
``5115'' is corrected to read ``5114''.
9. On page 58909, third column, after the first full paragraph that
ends with ``. . . at each level and clinical homogeneity.'' and before
the following paragraph, which begins with ``Comment: Several
commenters believed that the current structure . . . ,'' the following
text is added:
In addition, we received a comment related to CPT code 33274
(Transcatheter insertion or replacement of permanent leadless
pacemaker, right ventricular, including imaging guidance (for example,
fluoroscopy, venous ultrasound, ventriculography, femoral venography)
and device evaluation (for example, interrogation or programming), when
performed). We note that in Addendum B to the CY 2019 OPPS/ASC proposed
rule, we proposed to assign CPT code 33274 to APC 5194 (Level 4
Endovascular Procedures), which is the same APC assignment as its
predecessor code 0387T (Transcatheter insertion or replacement of
permanent leadless pacemaker, ventricular), which was effective January
1, 2015 and deleted on December 31, 2018. CPT code 33274 was listed as
33X05 (the 5-digit CMS placeholder code) in Addendum B with the short
descriptor and Addendum O with the long descriptor of the CY 2019 OPPS/
ASC proposed rule. We also assigned the code to comment indicator
``NP'' in Addendum B to the proposed rule to indicate that the code is
new for CY 2019 with a proposed APC assignment and that public comments
would be accepted on the proposed APC assignment. We note that CPT code
33274 will be effective January 1, 2019. Although the code is new for
CY 2019, the service associated with CPT code 33274 was previously
described by CPT codes 0387T, which will be deleted on December 31,
2018.
Comment: We received a comment to the CY 2019 OPPS/ASC proposed
rule requesting the assignment of CPT code 33274 from APC 5194 (Level 4
Endovascular Procedures) to APC 5224 (Level 4 Pacemaker and Similar
Procedures).
Response: We appreciate the suggestion, however, as noted above,
CPT code 33274 is assigned to the same APC as its predecessor code
0387T. Accordingly, we do not believe that a change in APC is warranted
at this time.
10. On page 58928, third column, after the first full paragraph
ending with ``Addendum B is available via the internet on the CMS
website.'' and before Table 35, the following section and text are
added:
21. Other Procedures/Services
For CY 2019, we proposed to continue to assign CPT code 47382
(Ablation, 1 or more liver tumor(s), percutaneous, radiofrequency) to
APC 5361.
Comment: A commenter requested the reassignment of CPT code 47382
from APC 5361 (Level 1 Laparoscopy and Related Services) to APC 5362
(Level 2 Laparoscopy and Related Services).
Response: Based on the latest hospital outpatient claims data used
for this final rule with comment period, we disagree that CPT code
47382 should be assigned to APC 5362 for CY 2019. Our analysis of the
claims data show a geometric mean cost of approximately $6,063 for CPT
code 47382, based on 2,220 single claims (out of 2,242 total claims),
which is significantly less than the geometric mean cost of about
$7,809 for APC 5362. We believe that APC 5361 is the most appropriate
APC assignment for CPT code 47382 based on its clinical and resource
homogeneity to the other procedures assigned to this APC.
Therefore, after consideration of the public comment we received,
we are finalizing our proposal, without modification, to assign CPT
code 47382 to APC 5361 for CY 2019. The final CY 2019 payment rate for
the code can be found in Addendum B to this final rule with comment
period (which is available via the internet on the CMS website).
In addition, for CY 2019, we proposed to assign CPT code 95983
(Electronic analysis of implanted neurostimulator pulse generator/
transmitter (for example, contact group[s], interleaving, amplitude,
pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose
lockout, patient selectable parameters, responsive neurostimulation,
detection algorithms, closed loop parameters, and passive parameters)
by physician or other qualified health care professional; with brain
neurostimulator pulse generator/transmitter programming, first 15
minutes face-to-face time with physician or other qualified health care
professional) to APC 5741 (Level 1 Electronic Analysis of Devices). We
note that in Addendum B to the CY 2019 OPPS/ASC proposed rule, CPT code
95983 was listed as 95X85 (the 5-digit CMS placeholder code) in
Addendum B with the short descriptor and Addendum O with the long
descriptor of the CY 2019 OPPS/ASC proposed rule. We also assigned the
code to comment indicator ``NP'' in Addendum B to the proposed rule to
indicate that the code is new for CY 2019 with a proposed APC
assignment and that public comments would be accepted on the proposed
APC assignment. We note that CPT code 95983 will be effective January
1, 2019.
Comment: A commenter requested the assignment of CPT code 95983
from APC 5741 (Level 1 Electronic Analysis of Devices) to APC 5742
(Level 2 Electronic Analysis of Devices).
Response: Based on input from our medical advisors and our review
of the procedure, we believe that CPT code 95983 is appropriately
placed in APC 5741 since it shares similar characteristics as other
electronic analysis services in the APC. Therefore, after consideration
of the public comment we received, we are finalizing our proposal,
without modification, to assign CPT code 95983 to APC 5741 for CY 2019.
The final CY 2019 payment rate for the code can be found in Addendum B
to this final rule with comment period (which is available via the
internet on the CMS website).
We will reevaluate the APC assignments for CPT code 47382 and 95983
for the next rulemaking cycle. We remind hospitals that we review, on
an annual basis, the APC assignments for all items and services paid
under the OPPS.
11. On page 58954, Table 37, last column, the Pass-Through Payment
Effective Date for CY 2019 HCPCS code Q5101 that reads ``07/01/2015''
is corrected to read ``01/01/2016''.
12. On page 58958, Table 38, last column, the Pass-Through Payment
Effective Date for CY 2018 and CY 2019 HCPCS code J7328 that reads
``01/01/2016'' is corrected to read ``04/01/2017''.
13. On page 58969, second column, in line 3, the word ``with'' is
corrected to read ``without''.
14. On page 59079,
a. Second column, last partial paragraph, in line 4, the figure
``0.8792'' is corrected to read ``0.8800''.
b. Third column, last partial paragraph, in line 4, the figure
``1.0004'' is corrected to read ``1.0000''.
15. On page 59080,
a. First column, first partial paragraph,
(1) In line 2, the figure ``$46.551'' is corrected to read
``$46.532''.
(2) In line 8, the figure ``1.0004'' is corrected to read
``1.0000''.
(3) In line 13, the figure ``$45.639'' is corrected to read
``$45.621''.
[[Page 67089]]
b. Second column, second full paragraph, in line 7, the figure
``$46.551'' is corrected to read ``$46.532.''
16. On page 59088, first column, first full paragraph, in line 12,
the word ``retaining'' is corrected to read ``removing''.
17. On pages 59100 and 59101, the un-numbered table--Hospital OQR
Program Measure Set for the CY 2020 Payment Determination, and the
footnotes for the table, are corrected to read as follows:
[[Page 67090]]
[GRAPHIC] [TIFF OMITTED] TR28DE18.015
[[Page 67091]]
[GRAPHIC] [TIFF OMITTED] TR28DE18.016
18. On page 59102, the un-numbered table--Hospital OQR Program
Measure Set for the 2021 Payment Determination and Subsequent years,
and the footnotes for the table, are corrected to read as follows:
[[Page 67092]]
[GRAPHIC] [TIFF OMITTED] TR28DE18.017
19. On page 59117, the word ``retaining'' is corrected to read
``removing''.
20. On page 59129, first column, first full paragraph,
a. In lines 1 through 10, the following text is removed:
``Furthermore, this is the only measure in the ASCQR Program measure
set that deals with cataract surgery, which is commonly performed in
the ASC setting. If it is removed, the program will have a gap in
coverage for this clinical area. As a result, we now believe that
meaningful information can be provided to consumers regarding those
facilities.''
b. In Lines 10 through 16, the following text is moved to the end
of the previous paragraph: ``In addition, when this measure was made
voluntary in the CY 2015 OPPS/ASC final rule with comment period (79 FR
66984) commenters stated that the measure would promote and improve
care coordination among providers.''
21. On page 59169, first column,
a. First full paragaraph, in line 10, the figure ``0.8792'' is
corrected to read ``0.8800''.
b. Last paragraph, in line 26, the figure ``1.0004'' is corrected
to read ``1.0000''.
[[Page 67093]]
c. Last paragraph, in the third line from the bottom, the figure
``$46.555'' is corrected to read ``$46.532''.
22. On page 59170,
a. Third column, first partial paragraph, in line 5, the figure
``79 percent'' is corrected to read ``68 percent''.
b. In Table 63.--Estimated Impact of the CY 2019 Update to the ASC
Payment System on Aggregate CY 2019 Medicare Program Payments by
Surgical Speciality or Ancillary Items and Services Group, in the last
row, third column, titled ``Estimated CY 2019 Percent Change'' for
Ancillary items and services, the figure ``79'' is corrected to read
``68''.
23. On page 59171, Table 64.--Estimated Impact of the CY 2019
Update to the ASC Payment System on Aggregate Payments for Selected
Procedures, the fourth column, ``Estimated CY 2019 Percent Change,'' is
corrected to read as follows:
[GRAPHIC] [TIFF OMITTED] TR28DE18.018
[[Page 67094]]
Dated: December 20, 2018.
Ann C. Agnew,
Executive Secretary to the Department, Department of Health and Human
Services.
[FR Doc. 2018-28348 Filed 12-21-18; 4:15 pm]
BILLING CODE 4120-01-P