Medicare Program; Revisions to Payment Policies, Five-Year Review of Work Relative Value Units, and Changes to the Practice Expense Methodology Under the Physician Fee Schedule, and Other Changes to Payment Under Part B; Correcting Amendment, 18909-18914 [E7-6989]
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Federal Register / Vol. 72, No. 72 / Monday, April 16, 2007 / Rules and Regulations
petitions to the Director to review an
action of the Office’s Madrid Processing
Unit, when filed by mail, must be
addressed to: Madrid Processing Unit,
600 Dulany Street, MDE–7B87,
Alexandria, VA 22314–5793.
(1) * * *
(2) Responses to notices of irregularity
under § 7.14, requests to note
replacement under § 7.28, and requests
for transformation under § 7.31, when
filed by mail, will be accorded the date
of receipt in the Office.
(c) Hand-Delivered Correspondence.
International applications under § 7.11,
subsequent designations under § 7.21,
responses to notices of irregularity
under § 7.14, requests to record changes
in the International Register under
§ 7.23 and § 7.24, requests to note
replacement under § 7.28, requests for
transformation under § 7.31, and
petitions to the Director to review an
action of the Office’s Madrid Processing
Unit, may be delivered by hand during
the hours the Office is open to receive
correspondence. Madrid-related handdelivered correspondence must be
delivered to the Trademark Assistance
Center, James Madison Building—East
Wing, Concourse Level, 600 Dulany
Street, Alexandria, VA 22314, Attention:
MPU.
*
*
*
*
*
SUMMARY: This correcting amendment
corrects several technical and
typographical errors in the final rule
with comment period that appeared in
the December 1, 2006 Federal Register
(71 FR 69624). The final rule with
comment period addressed Medicare
Part B payment policy, including the
physician fee schedule (PFS) that is
applicable for calendar year (CY) 2007;
payment for covered outpatient drugs
and biologicals; payment for renal
dialysis services; and policies related to
independent diagnostic testing facilities
(IDTFs). The final rule with comment
period also updated the list of certain
services subject to the physician selfreferral prohibitions.
DATES: Effective Date: Pursuant to
section 1871(e) of the Act, except for the
corrections to § 410.33, this correcting
amendment is effective January 1, 2007.
The corrections to § 410.33 are effective
April 16, 2007.
FOR FURTHER INFORMATION CONTACT:
Diane Milstead, (410) 786–3355.
SUPPLEMENTARY INFORMATION:
[CMS–1321–F2]
I. Background
FR Doc. 06–9086 (71 FR 69624), the
final rule with comment period entitled
‘‘Medicare Program; Revisions to
Payment Policies, Five-Year Review of
Work Relative Value Units, and Changes
to the Practice Expense Methodology
Under the Physician Fee Schedule, and
Other Changes to Payment Under Part B;
Revisions to the Payment Policies of
Ambulance Services Under the Fee
Schedule for Ambulance Services;
Ambulance Inflation Factor Update for
CY 2007’’ (hereinafter referred to as the
CY 2007 PFS final rule with comment
period), contained technical and
typographical errors. Some of these
technical and typographical errors were
addressed in the correction notice that
appeared in the December 8, 2006
Federal Register (71 FR 58415).
Additional errors have been identified
in the CY 2007 PFS final rule with
comment period and are addressed in
this correcting amendment.
RIN 0938–AN84
II. Errors in the Preamble
Dated: April 9, 2007.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. E7–7116 Filed 4–13–07; 8:45 am]
BILLING CODE 3510–16–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
cprice-sewell on PROD1PC66 with RULES
42 CFR Parts 405, 410, 411, 414, 415,
and 424
Medicare Program; Revisions to
Payment Policies, Five-Year Review of
Work Relative Value Units, and
Changes to the Practice Expense
Methodology Under the Physician Fee
Schedule, and Other Changes to
Payment Under Part B; Correcting
Amendment
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Correcting amendment.
AGENCY:
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A. Summary of Errors in the Preamble
In the preamble of the CY 2007 PFS
final rule with comment period, there
were a number of technical errors and
omissions.
On page 69635, following the section
heading titled, ‘‘(vi) Equipment Cost Per
Minute,’’ there was an error in the
formula for calculating the equipment
cost per minute.
On page 69647, language was
inadvertently omitted from the response
concerning cardiac monitoring services.
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18909
On page 69654, in Table 5, ‘‘Practice
Expense Supply Item Additions for CY
2007’’, we incorrectly included a supply
item and failed to include the unit price
of another item.
On page 69663, the word ‘‘an’’ was
incorrectly typed to read ‘‘as’’ in two
places.
On page 69671, the word ‘‘not’’ was
incorrectly included in a sentence.
On page 69677, the word ‘‘of’’ was
missing from a sentence.
On page 69688, under the section
heading titled, ‘‘d. ‘‘ESRD Wage Index
Tables,’’ the references to addenda were
incorrect.
On page 69696, the word ‘‘supplier’’
was misspelled.
On page 69699 in the narrative
concerning revisions to the performance
standards for IDTFs, we inadvertently
omitted language specifying that
paragraphs (g) and (h) are not applicable
to those services included in
§ 410.33(a)(2). We also inadvertently
included language requiring IDTFs to
list serial numbers and that was not our
intention.
On pages 69744, the narrative
concerning Table 17 contained several
errors.
On pages 69746, certain CPT codes
were incorrectly included in Table 17.
On page 69747, we incorrectly
included a discussion about gold
markers for CPT code 55876.
On page 69748, the word ‘‘radiology’’
was incorrectly stated as ‘‘radiation.’’
On page 69749, the word ‘‘of’’ should
be removed from the phrase ‘‘radiology
of and certain other imaging services.’’
On pages 69749 and 69750, in Table
18, under the subheading, ‘‘Radiology
and certain other imaging services,’’ we
made errors in the descriptors for CPT
codes 0174T and 0175T and HCPCS
codes A9567, A9568, Q9952, and
Q9953.
On page 69750, in Table 19, we
omitted CPT codes 78350 and G0243.
On page 69760, language was omitted
from the formula.
On pages 69769 and 69770, in Table
36, ‘‘Impact of Final Rule with
Comment Period and Estimated
Physician Update on 2007 Payment for
Selected Procedures’’, we identified
errors in the new payment amounts for
the following CPT and HCPCS codes:
27130, 27244, 27447, 33533, 35301,
43239, 77056, 77056–26, 77057, 77057–
26, 92980, 93000, 93015 and G0317.
Corrections to these errors are
reflected in section II.B. of this
correcting amendment.
B. Correction of Errors in the Preamble
1. On page 69635, in the 3rd column,
under the discussion titled, ‘‘(vi)
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Equipment Cost Per Minute,’’ the
calculation for the equipment cost per
minute contained an error. The formula
is corrected to read as follows:
‘‘The equipment cost per minute is
calculated as: (1/(minutes per year *
usage)) * price * ((interest rate/(1-(1/
((1+interest rate)∧life of equipment)))) +
maintenance).’’
2. On page 69647, in the 3rd column,
in the 1st full paragraph, after the 3rd
sentence, insert the following language:
‘‘We also added the holter monitor to
CPT codes 93226 and 93232 and
assigned the equipment a time of 1440
minutes for these codes and reduced the
holter monitor equipment time for CPT
codes 93225 and 93231 to 42 minutes to
correspond with the clinical staff
associated with these services.’’
3. On page 69654, in Table 5, the
supply item, ‘‘Kit, gold markers,
fiducial, 3 per kit’’ is deleted from the
table. In addition, the unit price
‘‘$1290’’ for ‘‘Agent, embolic’’ is added
to the table.
4. On page 69663, in the 2nd column,
lines 5 through 12 of the third full
paragraph, the language in the
discussion with respect to items ‘‘(1)
and (2)’’ is corrected to read as follows:
‘‘(1) who receives a referral for such an
ultrasound screening as a result of an
initial preventive physical examination
(IPPE) (as defined in section
1861(ww)(1) of the Act); (2) who has not
been previously furnished such an
ultrasound screening under this title;
and’’.
5. On page 69671, in the 2nd column,
line 24, delete the second occurrence of
the word ‘‘not’’. This sentence is revised
to read as follows: ‘‘Given the range of
comments, we do not believe it is
advisable to mandate the use of the
methodology, which we proposed at
§ 414.804(a)(4)(iii), for excluding lagged
exempt sales.’’
6. On page 69677, the 3rd column,
line 2, insert the word ‘‘of’’ between
‘‘number’’ and ‘‘units.’’ The sentence is
revised to read as follows: ‘‘One
commenter asked that we clarify the
number of units to be reported are the
number of units sold excluding
exempted sales.’’
7. On page 69688, in the 1st column,
under the section heading titled, ‘‘d.
ESRD wage Index Tables,’’ the
paragraph is revised to read as follows:
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15:14 Apr 13, 2007
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‘‘Addenda G and H show the CY 2007
ESRD wage index, including the BNF
adjustment, for urban areas (Addendum
G) and rural areas (Addendum H).’’
8. On page 69696, in the 1st column,
2nd paragraph, line 4, the spelling of the
word ‘‘supplier’’ is corrected.
9. On page 69699—
a. In the 1st column, the 5th full
paragraph, the following sentence is
added to the end of the paragraph:
‘‘Additionally, we do not intend to
require IDTFs to list the serial numbers
of all diagnostic equipment used by
IDTFs in their comprehensive liability
insurance. We recognize that it is
infeasible for IDTFs to comply with this
requirement and that such a
requirement would inadvertently
change the comprehensive liability
insurance policy into a different type of
insurance policy. Therefore, we are
revising the language in § 410.33(g)(6) of
our regulations to remove the serial
number requirement.’’
b. In the 3rd column, the 2nd full
paragraph, the following language is
added at the end of the paragraph: ‘‘In
addition, we are clarifying that these
performance standards are not
applicable to the diagnostic tests listed
under the exceptions in § 410.33(a)(2).’’
10. On page 69744, in the 3rd column,
in the paragraph following the section
heading, ‘‘F. Additional Pricing Issue,’’
the narrative concerning the table is
corrected to read as follows:
‘‘We are carrier-pricing the global and
TC for the codes listed in Table 17. The
TC is not paid in the facility setting
under the PFS and for the majority of
these services the RUC recommended
that these be designated as NA in the
non-facility setting. Work RVUs will
continue to be used to establish
payment for the PC.’’
11. On page 69746, the following CPT
codes are deleted from Table 17: 93503,
93539, 93540, 93541, 93542, 93543,
93544 and 93545.
12. On page 69747, the 1st column,
the final paragraph that continues into
the 2nd column is removed in its
entirety.
13. On page 69748, in the 1st column,
the 3rd paragraph, line 4, the word,
‘‘radiation’’ is corrected to read as,
‘‘radiology.’’
14. On page 69749, in the 1st column,
the 1st full paragraph, line 4, in the
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phrase, ‘‘radiology of and certain other
imaging services,’’ delete the word,
‘‘of.’’ The phrase is corrected to read
‘‘radiology and certain other imaging
services.’’
15. On pages 69749 and 69750, in
Table 18, the following descriptors are
corrected as follows:
TABLE 18.—ADDITIONS TO THE PHYSICIAN
SELF-REFERRAL LIST OF
CPT 1/HCPCS CODES
Radiology and Certain Other Imaging Services
0174T ...............
0175T ...............
A9567 ...............
A9568 ...............
Q9952 ...............
Q9953 ...............
Cad cxr with interp.
Cad cxr remote.
Technetium TC–99m aerosol.
Technetium tc99m
arcitumomab.
Inj Gad-base MR contrast,
1ml.
Inj Fe-base MR contrast,
1ml.
1 CPT codes and descriptions only are copyright 2006 American Medical Association. All
rights are reserved and applicable FARS/
DFARS clauses apply.
16. On page 69750, in Table 19, the
following CPT and HCPCS codes and
their descriptors are added:
TABLE 19.—DELETIONS TO THE PHYSICIAN SELF-REFERRAL LIST OF CPT1/
HCPCS CODES
Radiation and Certain Other Imaging Services
78350 ...............
Bone mineral, single photon.
Radiation Therapy Services and Supplies
G0243 ...............
Multisour photon stero
treat.
1 CPT codes and descriptions only are copyright 2006 AMA. All rights are reserved and
applicable FARS/DFARS clauses apply.
17. On page 69760, the payment
formula at the top of the 3rd column is
corrected to read as follows:
‘‘[((Work RVU × BN adjustor (0.8994))
(round product to two decimal places)
× Work GPCI) + (PE RVU × PE GPCI) +
(MP RVU × MP GPCI)] × CF.’’
18. On pages 69769 through 69770 in
Table 36, the following corrections are
made:
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18911
TABLE 36.—IMPACT OF FINAL RULE WITH COMMENT PERIOD AND ESTIMATED PHYSICIAN UPDATE ON 2007 PAYMENT FOR
SELECTED PROCEDURES
FACILITY
CPT/HCPCS
MOD
Description
OLD
27130
27244
27447
33533
35301
43239
77056
77056
77057
77057
92980
93000
93015
G0008
G0317
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
26
..........
26
..........
..........
..........
..........
..........
Total hip arthroplasty ...............
Treat thigh fracture ...................
Total knee arthroplasty ............
CABG, arterial, single ..............
Rechanneling of artery .............
Upper GI endoscopy, biopsy ...
Mammogram, both breasts ......
Mammogram, both breasts ......
Mammogram, screening ..........
Mammogram, screening ..........
Inser intracoronary stent ..........
Electrocardiogram, complete ...
Cardiovascular stress test ........
Admin influenza virus vac ........
ESRD related svs 4+mo
20+yrs.
cprice-sewell on PROD1PC66 with RULES
III. Errors in the Regulation Text
A. Summary of Errors in the Regulation
Text
On page 69784, in § 410.33, we
erroneously omitted a cross-reference in
(a)(2) to include paragraphs (g) and (h).
In addition, in § 410.33(g), Application
certification standards, an editing error
resulted in language being included on
page 69785 in § 410.33(g)(6) that
required IDTFs to list the serial numbers
of all their diagnostic equipment in their
comprehensive liability insurance
policy.
On page 69785, § 411.15(o) contained
erroneous revisions. Due to an editing
error, changes to § 411.15(o) were
improperly included in the August 22,
2006 proposed rule (71 FR 49081).
There was no explanation given for
these changes in the preamble, no
public comments were received on the
proposed changes, and the changes to
the regulation text were inadvertently
included in the final rule without any
explanation. The erroneous language
suggests that Medicare may pay for a
category A device in certain clinical
trials. Currently, however, the statute
does not authorize payment for the costs
of the category A device, but only for
‘‘routine costs of care’’ (section 1862(m)
of the Act; § 405.207(b)(2)). Thus, we are
correcting this final rule by restoring the
language in § 411.15(o) to the language
from the 2006 version of the CFR.
On pages 69787 and 69788, language
was incorrectly included concerning
VerDate Aug<31>2005
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Jkt 211001
$1,399.55
$1,137.68
$1,511.35
$1,933.53
$1,128.97
$162.20
$97.40
$45.10
$85.65
$36.38
$830.71
$26.91
$108.01
na
$308.11
NON-FACILITY
Percent
change
NEW
$1,292.21
$1,045.36
$1,391.17
$1,812.55
$1,018.01
$147.18
na
$39.22
na
$31.67
$756.04
na
na
na
$268.11
¥8%
¥8%
¥8%
¥6%
¥10%
¥9%
na
¥13%
na
¥13%
¥9%
na
na
na
¥13%
non-lagged price concessions in the
example.
B. Correction of Errors in the Regulation
Text
The correction of errors for the
regulation text appear after section V. of
this correcting amendment.
IV. Errors in the Addenda
A. Summary of Errors in the Addenda
The following errors in Addenda B, G
and J are revised under this correcting
amendment. These addenda will not
appear in the Code of Federal
Regulations.
In Addendum B, pages 69796 through
70011, we are making the following
corrections:
(1) Incorrect RVUs were listed for the
following CPT codes: 36478, 37210,
44180, 44186, 77056, 77056–TC, 77422,
77423, 78351, 93225, 93226, 93231,
93232, 95991, 98960, 98961, 98962,
G9041, G9042, G9043 and G9044.
(2) Incorrect status indicators and
RVUs were listed for CPT codes 93503,
93539, 93540, 93541, 93542, 93543,
93544 and 93545.
In Addendum G, pages 70022 through
70043, we are making the following
corrections:
(1) The title of the Addendum was
missing a word.
(2) On page 70037, the wage index
value for CBSA code ‘‘39820, Redding
CA’’ was incorrect.
In Addendum J, pages 70248 through
70251, we note the following errors:
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Fmt 4700
Sfmt 4700
OLD
$1,399.55
$1,137.68
$1,511.35
$1,933.53
$1,128.97
$334.26
$97.40
$45.10
$85.65
$36.38
$830.71
$26.91
$108.01
$18.57
$308.11
NEW
Percent
change
na
na
na
na
na
$309.11
$92.48
$39.22
$77.73
$31.67
na
$23.39
$99.32
$18.35
$268.11
na
na
na
na
na
¥8%
¥5%
¥13%
¥9%
¥13%
na
¥13%
¥8%
¥1%
¥13%
(1) On page 70247, CPT codes 78267
and 78268 are not in numerical order.
(2) On page 70248, in the 2nd column,
we made typographical errors in the
code descriptors for CPT codes 0174T
and 0175T.
(3) On page 70250, in the 1st column,
we incorrectly listed CPT code 78350.
That code (single-photon
absorptiometry) is non-covered
beginning in 2007 under the policy
changes discussed on page 69691 of the
CY 2007 PFS final rule with comment
period.
(4) On page 70250, in the 3rd column,
we made typographical errors in the
descriptors for HCPCS codes A9567,
A9568, Q9952, and Q9953.
(5) On page 70251, in the 2nd column,
we did not include the correct
descriptor for HCPCS code G0173. Also,
in that column, we incorrectly included
HCPCS G0243, which was terminated
effective December 31, 2006.
(6) On page 70251, in the second
footnote at the bottom of the page, we
gave an incorrect Web site address.
These corrections are reflected in
section IV.B. of this correcting
amendment.
B. Correction of Errors in Addenda
1. On pages 69796 through 70011, in
Addendum B: Relative Value Units
(RVUs) and Related Information the
following entries are corrected to read as
follows:
E:\FR\FM\16APR1.SGM
16APR1
VerDate Aug<31>2005
.........
Mod
15:00 Apr 13, 2007
Jkt 211001
PO 00000
TC ...
.........
.........
.........
44180 ..
44186 ..
77056 ..
77056 ..
77422 ..
77423 ..
78351 ..
.........
.........
.........
.........
37210 ..
Frm 00066
.........
93226 ..
Fmt 4700
.........
93232 ..
Sfmt 4700
E:\FR\FM\16APR1.SGM
16APR1
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
.........
93539 ..
93540 ..
93541 ..
..
..
..
..
..
93542
93543
93544
93545
95991
98960 ..
98961 ..
98962 ..
G9041
G9042
G9043
G9044
3+
A
A
A
A
B
B
B
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
Status
Endovenous laser, 1st
vein.
Embolization uterine fibroid.
Lap, enterolysis ..............
Lap, jejunostomy ............
Mammogram, both
breasts.
Mammogram, both
breasts.
Neutron beam tx, simple
Neutron beam tx, complex.
Bone mineral, dual photon.
ECG monitor/record, 24
hrs.
ECG monitor/report, 24
hrs.
Ecg monitor/record, 24
hrs.
ECG monitor/report, 24
hrs.
Insert/place heart catheter.
Injection, cardiac cath ....
Injection, cardiac cath ....
Injection for lung
angiogram.
Injection for heart x-rays
Injection for heart x-rays
Injection for aortography
Inject for coronary x-rays
Spin/brain pump refill &
main.
Self-mgmt educ & train,
1 pt.
Self-mgmt educ/train, 2–
4 pt.
Self-mgmt educ/train, 5–
8 pt.
Low vision rehab
occupationa.
Low vision rehab orient/
mobi.
Low vision lowvision
therapi.
Low vision rehabilate
teache.
Description
0.10
0.10
0.10
0.44
0.00+
0.00+
0.00+
0.29
0.29
0.25
0.40
0.77
0.40
0.43
0.29
2.91
0.00
0.00
0.00
0.00
0.30
0.00
0.00
0.00
15.19
10.30
0.87
10.60
6.72
Physician
Work
RVUs 3
0.23
0.29
0.29
0.29
0.20
0.27
0.57
NA
NA
NA
NA
1.63
NA
NA
NA
NA
1.34
0.71
1.18
0.85
0.47
5.31
7.51
1.72
NA
NA
1.96
79.88
26.53
Fully Implemented
Non-Facility PE
RVUs
0.23
0.29
0.29
0.29
0.20
0.27
0.57
NA
NA
NA
NA
1.53
NA
NA
NA
NA
1.97
1.32
1.93
1.14
1.41
2.61
3.57
1.41
NA
NA
1.68
79.88
41.71
Year 2007
Transitional NonFacility PE
RVUs
0.23
0.29
0.29
0.29
NA
NA
NA
0.15
0.16
0.13
0.22
0.18
0.22
0.24
0.15
0.47
NA
NA
NA
NA
0.07
NA
NA
NA
5.65
4.43
NA
3.13
2.03
Fully Implemented
Facility PE
RVUs
0.23
0.29
0.29
0.29
NA
NA
NA
0.12
0.12
0.11
0.18
0.17
0.18
0.19
0.12
0.63
NA
NA
NA
NA
0.11
NA
NA
NA
6.09
4.70
NA
3.13
2.41
Year 2007
Transitional Facility PE
RVUs
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.01
0.06
0.01
0.01
0.01
0.20
0.13
0.11
0.14
0.08
0.01
0.13
0.13
0.07
1.86
1.27
0.11
0.60
0.37
Mal-Practice RVUs
0.40
0.40
0.40
0.74
0.21
0.28
0.58
NA
NA
NA
NA
2.46
NA
NA
NA
NA
1.47
0.82
1.32
0.93
0.78
5.44
7.64
1.79
NA
NA
2.94
91.08
33.62
Fully Implemented
Non-Facility Total
0.40
0.40
0.40
0.74
0.21
0.28
0.58
NA
NA
NA
NA
2.36
NA
NA
NA
NA
2.10
1.43
2.07
1.22
1.72
2.74
3.70
1.48
NA
NA
2.66
91.08
48.80
Year 2007
Transitional NonFacility
Total
ADDENDUM B.—RELATIVE VALUE UNITS (RVUS) AND RELATED INFORMATION—CORRECTIONS
codes and descriptions only are copyright 2006 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply.
Indicates RVUs are not used for Medicare payment.
1 CPT
.........
.........
.........
93503 ..
.........
93231 ..
.........
93225 ..
.........
36478 ..
CPT 1/
HCPCS 2
cprice-sewell on PROD1PC66 with RULES
0.40
0.40
0.40
0.74
NA
NA
NA
0.45
0.46
0.39
0.63
1.01
0.63
0.68
0.45
3.58
NA
NA
NA
NA
0.38
NA
NA
NA
22.70
16.00
NA
14.33
9.12
Fully Implemented
Facility
Total
0.40
0.40
0.40
0.74
NA
NA
NA
0.42
0.42
0.37
0.59
1.00
0.59
0.63
0.42
3.74
NA
NA
NA
NA
0.42
NA
NA
NA
23.14
16.27
NA
14.33
9.50
Year 2007
Transitional Facility Total
XXX
XXX
XXX
XXX
XXX
XXX
XXX
000
000
000
000
XXX
000
000
000
000
XXX
XXX
XXX
XXX
XXX
XXX
XXX
XXX
090
090
XXX
000
000
Global
18912
Federal Register / Vol. 72, No. 72 / Monday, April 16, 2007 / Rules and Regulations
Federal Register / Vol. 72, No. 72 / Monday, April 16, 2007 / Rules and Regulations
Register to provide a period for public
comment before the provisions of a rule
take effect in accordance with section
553(b) of the Administrative Procedure
Act (APA) (5 U.S.C. 553(b)). However,
we can waive the notice and comment
procedures if the Secretary finds, for
good cause, that the notice and
comment process is impracticable,
unnecessary or contrary to the public
interest, and incorporates a statement of
the finding and the reasons therefore in
the rule.
Section 553(d) of the APA ordinarily
requires a 30-day delay in effective date
of final rules after the date of their
publication. This 30-day delay in
effective date can be waived, however,
if an agency finds for good cause that
the delay is impracticable, unnecessary,
or contrary to the public interest, and
the agency incorporates a statement of
the findings and its reasons in the rule
issued.
This correcting amendment addresses
technical errors and omissions made in
ADDENDUM J.—LIST OF CPT1/HCPCS FR Doc. 06–9086, entitled ‘‘Medicare
CODES USED TO DESCRIBE CER- Program; Revisions to Payment Policies,
TAIN DESIGNATED HEALTH SERVICE Five-Year Review of Work Relative
UNDER
SECTION Value Units, and Changes to the Practice
CATEGORIES 2
1877 OF THE SOCIAL SECURITY ACT Expense Methodology Under the
Physician Fee Schedule, and Other
[Effective Date January 1, 2007]
Changes to Payment Under Part B;
RADIATION THERAPY SERVICES AND SUPPLIES Revisions to the Payment Policies of
Ambulance Services Under the Fee
CPT code
Descriptor
Schedule for Ambulance Services;
Ambulance Inflation Factor Update for
A9567 ................... Technetium TC–99m aerosol.
A9568 ................... Technetium tc99m
CY 2007,’’ which appeared in the
arcitumomab.
December 1, 2006 Federal Register (71
Q9952 ................... Inj Gad-base MR contrast,1ml.
FR 69624), and was effective January 1,
Q9953 ................... Inj Fe-base MR contrast,1ml.
2007. This correcting amendment
1 CPT codes and descriptions only are copyidentifies errors and technical
right 2006 American Medical Association. All
rights are reserved and applicable FARS/ correction that are in addition to those
identified in the correction notice that
DFARS clauses apply.
2 This list does not include codes for the folappeared in the December 8, 2006
lowing designated health service (DHS) cat- Federal Register (71 FR 58415). The
egories: durable medical equipment and supplies; parenteral and enteral nutrients, equip- provisions of this final rule with
ment and supplies; prosthetics, orthotics, and comment period have been previously
prosthetic devices and supplies; home health subjected to notice and comment
services; outpatient prescription drugs; and in- procedures. Except as noted below,
patient and outpatient hospital services. For
the definitions of these DHS categories, refer these corrections are consistent with the
to § 411.351. For more information, refer to discussion and text of the final rule with
https://cms.hhs.gov/PhysicianSelfReferral/.
comment period, and do not make
e. On page 70251, in the 2nd column, substantive changes to the CY 2007
the descriptor for HCPCS code G0173 is published rule. As such, this correcting
amendment is intended to ensure the
corrected to read, ‘‘Linear acc stereo
CY 2007 PFS final rule with comment
radsur com’’, and HCPCS code G0243
period accurately reflects the policies
and its descriptor are removed.
adopted in that rule. With respect to
f. On page 70251, in the 3rd column,
most of the corrections in this correcting
the Web site in the last sentence of the
amendment, we find, therefore, that it is
second footnote is corrected to read
unnecessary and would be contrary to
https://www.cms.hhs.gov/
the public interest to undertake further
PhysicianSelfReferral/.
notice and comment procedures to
V. Waiver of Proposed Rulemaking and incorporate these corrections into the
Delay in Effective Date
final rule with comment period.
Except as noted below, for the same
We ordinarily publish a notice of
reasons, we are also waiving the 30-day
proposed rulemaking in the Federal
delay in effective date for this correcting
cprice-sewell on PROD1PC66 with RULES
2. On pages 70022 through 70043, the
title of Addendum G is corrected to read
as follows: ‘‘CY 2007 ESRD WAGE
INDEX FOR URBAN AREAS BASED ON
CBSA LABOR MARKET AREAS.’’
3. On page 70037, the wage index
value for CBSA code 39820, Redding CA
is corrected to read ‘‘1.3895’’.
4. In Addendum J:
a. On page 70247, in the 3rd column,
the entries for CPT codes 78267 and
78268 and their respective descriptors
are corrected by placing them in
numerical order.
b. On page 70248, in the 2nd column,
the descriptors for CPT codes 0174T and
0175T are corrected by revising ‘‘crx’’ to
read ‘‘cxr’’.
c. On page 70250, in the 1st column,
the entry for CPT code 78350 is
removed.
d. On page 70250, in the 3rd column,
the descriptors for HCPCS codes A9567,
A9568, Q9952 and Q9953 are corrected
to read as follows:
VerDate Aug<31>2005
15:00 Apr 13, 2007
Jkt 211001
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Frm 00067
Fmt 4700
Sfmt 4700
18913
amendment. We believe that it is in the
public interest to ensure that the CY
2007 PFS final rule with comment
period accurately states our policies
relating to the PFS and other Part B
payment policies. Therefore, except as
noted otherwise, we find that delaying
the effective date of these corrections
beyond the January 1, 2007 effective
date of the final rule with comment
period would be contrary to the public
interest. In so doing, we also find good
cause to waive the 30-day delay in the
effective date.
With respect to the corrections to
pages 69699 and 69785 concerning
revisions to the performance standards
for IDTFs, we find that it would be
impracticable and contrary to the public
interest to seek public comments before
correcting this regulation. The current
regulatory language is erroneous
because it would require IDTFs to list
the serial numbers for all diagnostic
equipment in its comprehensive
liability insurance policy. This
requirement would be impracticable for
several reasons. For one, most IDTFs
would be unable to comply with this
requirement because only some of their
diagnostic equipment is onsite.
Secondly, this requirement would have
the unintended effect of changing the
comprehensive liability insurance
policy into a different type of insurance
policy. For the same reasons, we are
waiving the 30-day delay in effective
date for these corrections. The
corrections to pages 69699 and 69785
concerning revisions to the performance
standards for IDTFs are effective April
16, 2007.
With respect to the corrections to
§ 411.15(o), we find it would be contrary
to the public interest to seek public
comments before correcting this
regulation. The current regulatory
language is erroneous and misleading
for it suggests that Medicare payment
could be made for certain category A
devices for which questions of safety
and effectiveness have not been
resolved (§ 405.201). Moreover, payment
for category A devices in these
circumstances would be inconsistent
with Congressional intent in enacting
section 1862(m) of the Act. Section
1871(e)(1)(A) of the Act, as amended by
section 903(b)(1) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173), generally prohibits the
Secretary from making retroactive
substantive changes in policy unless
retroactive application of the change is
necessary to comply with statutory
requirements, or failure to apply the
change retroactively would be contrary
to the public interest. We are making the
E:\FR\FM\16APR1.SGM
16APR1
18914
Federal Register / Vol. 72, No. 72 / Monday, April 16, 2007 / Rules and Regulations
corrections to § 411.15(o) retroactive
because failure to apply the change
retroactively to January 1, 2007 would
be contrary to the public interest
because it would fail to preserve the
public fisc. OPM v. Richmond, 496 U.S.
414 (1990). Moreover, retroactivity is
necessary to comply with statutory
requirements in section 1862(m) of the
Act which did not authorize payment
for category A devices.
Security Act (42 U.S.C. 1302, 1395w–101
through 1395w–152, 1395hh, and 1395nn).
NATIONAL TRANSPORTATION
SAFETY BOARD
Subpart A—General Exclusions and
Exclusion of Particular Services
49 CFR Part 801
4. Section 411.15 is amended by
revising paragraph (o) to read as follows:
I
§ 411.15
[Amended]
Accordingly, 42 CFR chapter IV is
corrected by making the following
correcting amendments:
*
*
*
*
(o) Experimental or investigational
devices, except for certain devices.
(1) Categorized by the FDA as a nonexperimental/investigational (Category
B) device defined in § 405.201(b) of this
chapter; and
(2) Furnished in accordance with the
FDA-approved protocols governing
clinical trials.
*
*
*
*
*
PART 410—SUPPLEMENTARY
MEDICAL INSURANCE (SMI)
BENEFITS
PART 414—PAYMENT FOR PART B
MEDICAL AND OTHER HEALTH
SERVICES
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
Dated: April 5, 2007.
Ann C. Agnew,
Executive Secretary to the Department.
I
*
5. The authority citation for Part 414
continues to read as follows:
I
1. The authority citation for part 410
continues to read as follows:
I
Authority: Secs. 1102, 1834, and 1871 of
the Social Security Act (42 U.S.C. 1302,
1395m, and 1395hh).
Authority: Secs. 1102, 1871, and 1881(b)(l)
of the Social Security Act (42 U.S.C. 1302,
1395hh, and 1395rr(b)(l)).
Subpart B—Medical and Other Health
Services
Subpart J—Submission of
Manufacturer’s Average Sales Price
Data
I
I
I
2. Section 410.33 is amended by—
A. Revising paragraph (a)(2).
B. Revising paragraph (g)(6).
The revisions read as follows:
§ 410.33
6. Section 414.804(a)(3)(iv) is revised
to read as follows:
I
§ 414.804
[Amended]
cprice-sewell on PROD1PC66 with RULES
(a) * * *
(2) Exceptions. The following
diagnostic tests that are payable under
the physician fee schedule and
furnished by a nonhospital testing entity
are not required to be furnished in
accordance with the criteria set forth in
paragraphs (b) through (e) and (g) and
(h) of this section.
*
*
*
*
*
(g) * * *
(6) Have a comprehensive liability
insurance policy of at least $300,000 per
location that covers both the place of
business and all customers and
employees of the IDTF. The policy must
be carried by a nonrelative-owned
company.
*
*
*
*
*
PART 411—EXCLUSIONS FROM
MEDICARE AND LIMITATIONS ON
MEDICARE PAYMENT
3. The authority citation for part 411
is amended to read as follows:
I
Authority: Secs. 1102, 1860D–1 through
1860D–42, 1871, and 1877 of the Social
VerDate Aug<31>2005
16:52 Apr 13, 2007
Jkt 211001
[Amended]
(a) * * *
(3) * * *
(iv) Example. After adjusting for
exempted sales, the total lagged price
concessions (discounts, rebates, etc.)
over the most recent 12-month period
available associated with sales for
National Drug Code 12345–6789–01
subject to the ASP reporting
requirement equal $200,000, and the
total in dollars for the sales subject to
the average sales price reporting
requirement for the same period equals
$600,000. The lagged price concessions
percentage for this period equals
200,000/600,000 = 0.33333. The total in
dollars for the sales subject to the
average sales price reporting
requirement for the quarter being
reported, equals $50,000 for 10,000
units sold. The manufacturer’s average
sales price calculation for this National
Drug Code for this quarter is:
$50,000¥(0.33333 × $50,000) = $33,334
(net total sales amount); $33,334/10,000
= $3.33 (average sales price).
*
*
*
*
*
[FR Doc. E7–6989 Filed 4–13–07; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
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Public Availability of Information
National Transportation Safety
Board (NTSB).
ACTION: Final rule.
AGENCY:
SUMMARY: The NTSB is updating its
regulations regarding the availability of
information. This amendment updates
the NTSB regulations that implement
the Freedom of Information Act (FOIA)
and Privacy Act, notifies the public of
changes in the NTSB’s Freedom of
Information Act processing procedures
and, in general, advises the public on
the availability of information from
NTSB accident investigations.
DATES: This final rule will become
effective May 23, 2007.
ADDRESSES: A copy of the notice of
proposed rulemaking (NPRM),
published in the Federal Register, is
available for inspection and copying in
the Board’s public reading room, located
at 490 L’Enfant Plaza, SW., Washington,
DC 20594–2000. Alternatively, a copy of
the NPRM is available on the Board’s
Web site, at https://www.ntsb.gov.
FOR FURTHER INFORMATION CONTACT: Gary
L. Halbert, General Counsel, (202) 314–
6080.
SUPPLEMENTARY INFORMATION:
Regulatory History
On November 22, 2006, the NTSB
published a notice of proposed
rulemaking entitled, ‘‘Public
Availability of Information,’’ in the
Federal Register (71 FR 67523). This
NPRM set forth amendments to the
Board’s regulations regarding the
availability of information, and
provided updated information regarding
how the public may obtain NTSB
records. The NPRM also set forth an
updated fee schedule to apply to
requests for NTSB records.
Discussion of Comments and Changes
The NTSB did not receive any
comments regarding the aforementioned
NPRM. The NTSB also did not receive
any requests for a public meeting;
therefore, the NTSB did not hold a
public meeting on the NPRM.
In the interest of ensuring that all
provisions of 49 CFR part 801 are
accurate and complete, the Board’s final
rule herein will include one minor
revision to § 801.60(a) that the NTSB
did not include in the NPRM: In the
final sentence of § 801.60(a), the rule
will now advise requesters to ‘‘pay fees
in accordance with the instructions
E:\FR\FM\16APR1.SGM
16APR1
]]>Agencies
[Federal Register Volume 72, Number 72 (Monday, April 16, 2007)]
[Rules and Regulations]
[Pages 18909-18914]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6989]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 415, and 424
[CMS-1321-F2]
RIN 0938-AN84
Medicare Program; Revisions to Payment Policies, Five-Year Review
of Work Relative Value Units, and Changes to the Practice Expense
Methodology Under the Physician Fee Schedule, and Other Changes to
Payment Under Part B; Correcting Amendment
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Correcting amendment.
-----------------------------------------------------------------------
SUMMARY: This correcting amendment corrects several technical and
typographical errors in the final rule with comment period that
appeared in the December 1, 2006 Federal Register (71 FR 69624). The
final rule with comment period addressed Medicare Part B payment
policy, including the physician fee schedule (PFS) that is applicable
for calendar year (CY) 2007; payment for covered outpatient drugs and
biologicals; payment for renal dialysis services; and policies related
to independent diagnostic testing facilities (IDTFs). The final rule
with comment period also updated the list of certain services subject
to the physician self-referral prohibitions.
DATES: Effective Date: Pursuant to section 1871(e) of the Act, except
for the corrections to Sec. 410.33, this correcting amendment is
effective January 1, 2007. The corrections to Sec. 410.33 are
effective April 16, 2007.
FOR FURTHER INFORMATION CONTACT: Diane Milstead, (410) 786-3355.
SUPPLEMENTARY INFORMATION:
I. Background
FR Doc. 06-9086 (71 FR 69624), the final rule with comment period
entitled ``Medicare Program; Revisions to Payment Policies, Five-Year
Review of Work Relative Value Units, and Changes to the Practice
Expense Methodology Under the Physician Fee Schedule, and Other Changes
to Payment Under Part B; Revisions to the Payment Policies of Ambulance
Services Under the Fee Schedule for Ambulance Services; Ambulance
Inflation Factor Update for CY 2007'' (hereinafter referred to as the
CY 2007 PFS final rule with comment period), contained technical and
typographical errors. Some of these technical and typographical errors
were addressed in the correction notice that appeared in the December
8, 2006 Federal Register (71 FR 58415). Additional errors have been
identified in the CY 2007 PFS final rule with comment period and are
addressed in this correcting amendment.
II. Errors in the Preamble
A. Summary of Errors in the Preamble
In the preamble of the CY 2007 PFS final rule with comment period,
there were a number of technical errors and omissions.
On page 69635, following the section heading titled, ``(vi)
Equipment Cost Per Minute,'' there was an error in the formula for
calculating the equipment cost per minute.
On page 69647, language was inadvertently omitted from the response
concerning cardiac monitoring services.
On page 69654, in Table 5, ``Practice Expense Supply Item Additions
for CY 2007'', we incorrectly included a supply item and failed to
include the unit price of another item.
On page 69663, the word ``an'' was incorrectly typed to read ``as''
in two places.
On page 69671, the word ``not'' was incorrectly included in a
sentence.
On page 69677, the word ``of'' was missing from a sentence.
On page 69688, under the section heading titled, ``d. ``ESRD Wage
Index Tables,'' the references to addenda were incorrect.
On page 69696, the word ``supplier'' was misspelled.
On page 69699 in the narrative concerning revisions to the
performance standards for IDTFs, we inadvertently omitted language
specifying that paragraphs (g) and (h) are not applicable to those
services included in Sec. 410.33(a)(2). We also inadvertently included
language requiring IDTFs to list serial numbers and that was not our
intention.
On pages 69744, the narrative concerning Table 17 contained several
errors.
On pages 69746, certain CPT codes were incorrectly included in
Table 17.
On page 69747, we incorrectly included a discussion about gold
markers for CPT code 55876.
On page 69748, the word ``radiology'' was incorrectly stated as
``radiation.''
On page 69749, the word ``of'' should be removed from the phrase
``radiology of and certain other imaging services.''
On pages 69749 and 69750, in Table 18, under the subheading,
``Radiology and certain other imaging services,'' we made errors in the
descriptors for CPT codes 0174T and 0175T and HCPCS codes A9567, A9568,
Q9952, and Q9953.
On page 69750, in Table 19, we omitted CPT codes 78350 and G0243.
On page 69760, language was omitted from the formula.
On pages 69769 and 69770, in Table 36, ``Impact of Final Rule with
Comment Period and Estimated Physician Update on 2007 Payment for
Selected Procedures'', we identified errors in the new payment amounts
for the following CPT and HCPCS codes: 27130, 27244, 27447, 33533,
35301, 43239, 77056, 77056-26, 77057, 77057-26, 92980, 93000, 93015 and
G0317.
Corrections to these errors are reflected in section II.B. of this
correcting amendment.
B. Correction of Errors in the Preamble
1. On page 69635, in the 3rd column, under the discussion titled,
``(vi)
[[Page 18910]]
Equipment Cost Per Minute,'' the calculation for the equipment cost per
minute contained an error. The formula is corrected to read as follows:
``The equipment cost per minute is calculated as: (1/(minutes per
year * usage)) * price * ((interest rate/(1-(1/((1+interest
rate)[caret]life of equipment)))) + maintenance).''
2. On page 69647, in the 3rd column, in the 1st full paragraph,
after the 3rd sentence, insert the following language: ``We also added
the holter monitor to CPT codes 93226 and 93232 and assigned the
equipment a time of 1440 minutes for these codes and reduced the holter
monitor equipment time for CPT codes 93225 and 93231 to 42 minutes to
correspond with the clinical staff associated with these services.''
3. On page 69654, in Table 5, the supply item, ``Kit, gold markers,
fiducial, 3 per kit'' is deleted from the table. In addition, the unit
price ``$1290'' for ``Agent, embolic'' is added to the table.
4. On page 69663, in the 2nd column, lines 5 through 12 of the
third full paragraph, the language in the discussion with respect to
items ``(1) and (2)'' is corrected to read as follows: ``(1) who
receives a referral for such an ultrasound screening as a result of an
initial preventive physical examination (IPPE) (as defined in section
1861(ww)(1) of the Act); (2) who has not been previously furnished such
an ultrasound screening under this title; and''.
5. On page 69671, in the 2nd column, line 24, delete the second
occurrence of the word ``not''. This sentence is revised to read as
follows: ``Given the range of comments, we do not believe it is
advisable to mandate the use of the methodology, which we proposed at
Sec. 414.804(a)(4)(iii), for excluding lagged exempt sales.''
6. On page 69677, the 3rd column, line 2, insert the word ``of''
between ``number'' and ``units.'' The sentence is revised to read as
follows: ``One commenter asked that we clarify the number of units to
be reported are the number of units sold excluding exempted sales.''
7. On page 69688, in the 1st column, under the section heading
titled, ``d. ESRD wage Index Tables,'' the paragraph is revised to read
as follows: ``Addenda G and H show the CY 2007 ESRD wage index,
including the BNF adjustment, for urban areas (Addendum G) and rural
areas (Addendum H).''
8. On page 69696, in the 1st column, 2nd paragraph, line 4, the
spelling of the word ``supplier'' is corrected.
9. On page 69699--
a. In the 1st column, the 5th full paragraph, the following
sentence is added to the end of the paragraph: ``Additionally, we do
not intend to require IDTFs to list the serial numbers of all
diagnostic equipment used by IDTFs in their comprehensive liability
insurance. We recognize that it is infeasible for IDTFs to comply with
this requirement and that such a requirement would inadvertently change
the comprehensive liability insurance policy into a different type of
insurance policy. Therefore, we are revising the language in Sec.
410.33(g)(6) of our regulations to remove the serial number
requirement.''
b. In the 3rd column, the 2nd full paragraph, the following
language is added at the end of the paragraph: ``In addition, we are
clarifying that these performance standards are not applicable to the
diagnostic tests listed under the exceptions in Sec. 410.33(a)(2).''
10. On page 69744, in the 3rd column, in the paragraph following
the section heading, ``F. Additional Pricing Issue,'' the narrative
concerning the table is corrected to read as follows:
``We are carrier-pricing the global and TC for the codes listed in
Table 17. The TC is not paid in the facility setting under the PFS and
for the majority of these services the RUC recommended that these be
designated as NA in the non-facility setting. Work RVUs will continue
to be used to establish payment for the PC.''
11. On page 69746, the following CPT codes are deleted from Table
17: 93503, 93539, 93540, 93541, 93542, 93543, 93544 and 93545.
12. On page 69747, the 1st column, the final paragraph that
continues into the 2nd column is removed in its entirety.
13. On page 69748, in the 1st column, the 3rd paragraph, line 4,
the word, ``radiation'' is corrected to read as, ``radiology.''
14. On page 69749, in the 1st column, the 1st full paragraph, line
4, in the phrase, ``radiology of and certain other imaging services,''
delete the word, ``of.'' The phrase is corrected to read ``radiology
and certain other imaging services.''
15. On pages 69749 and 69750, in Table 18, the following
descriptors are corrected as follows:
Table 18.--Additions to the Physician Self-Referral List of CPT \1\/
HCPCS Codes
------------------------------------------------------------------------
------------------------------------------------------------------------
Radiology and Certain Other Imaging Services
------------------------------------------------------------------------
0174T................................. Cad cxr with interp.
0175T................................. Cad cxr remote.
A9567................................. Technetium TC-99m aerosol.
A9568................................. Technetium tc99m arcitumomab.
Q9952................................. Inj Gad-base MR contrast, 1ml.
Q9953................................. Inj Fe-base MR contrast, 1ml.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2006 American Medical
Association. All rights are reserved and applicable FARS/DFARS clauses
apply.
16. On page 69750, in Table 19, the following CPT and HCPCS codes
and their descriptors are added:
Table 19.--Deletions to the Physician Self-Referral List of CPT\1\/
HCPCS Codes
------------------------------------------------------------------------
------------------------------------------------------------------------
Radiation and Certain Other Imaging Services
------------------------------------------------------------------------
78350................................. Bone mineral, single photon.
------------------------------------------------------------------------
Radiation Therapy Services and Supplies
------------------------------------------------------------------------
G0243................................. Multisour photon stero treat.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2006 AMA. All rights
are reserved and applicable FARS/DFARS clauses apply.
17. On page 69760, the payment formula at the top of the 3rd column
is corrected to read as follows:
``[((Work RVU x BN adjustor (0.8994)) (round product to two decimal
places) x Work GPCI) + (PE RVU x PE GPCI) + (MP RVU x MP GPCI)] x CF.''
18. On pages 69769 through 69770 in Table 36, the following
corrections are made:
[[Page 18911]]
Table 36.--Impact of Final Rule with Comment Period and Estimated Physician Update on 2007 Payment For Selected Procedures
--------------------------------------------------------------------------------------------------------------------------------------------------------
FACILITY NON-FACILITY
-----------------------------------------------------------------------------
CPT/HCPCS MOD Description Percent Percent
OLD NEW change OLD NEW change
--------------------------------------------------------------------------------------------------------------------------------------------------------
27130............................ ...... Total hip arthroplasty......... $1,399.55 $1,292.21 -8% $1,399.55 na na
27244............................ ...... Treat thigh fracture........... $1,137.68 $1,045.36 -8% $1,137.68 na na
27447............................ ...... Total knee arthroplasty........ $1,511.35 $1,391.17 -8% $1,511.35 na na
33533............................ ...... CABG, arterial, single......... $1,933.53 $1,812.55 -6% $1,933.53 na na
35301............................ ...... Rechanneling of artery......... $1,128.97 $1,018.01 -10% $1,128.97 na na
43239............................ ...... Upper GI endoscopy, biopsy..... $162.20 $147.18 -9% $334.26 $309.11 -8%
77056............................ ...... Mammogram, both breasts........ $97.40 na na $97.40 $92.48 -5%
77056............................ 26 Mammogram, both breasts........ $45.10 $39.22 -13% $45.10 $39.22 -13%
77057............................ ...... Mammogram, screening........... $85.65 na na $85.65 $77.73 -9%
77057............................ 26 Mammogram, screening........... $36.38 $31.67 -13% $36.38 $31.67 -13%
92980............................ ...... Inser intracoronary stent...... $830.71 $756.04 -9% $830.71 na na
93000............................ ...... Electrocardiogram, complete.... $26.91 na na $26.91 $23.39 -13%
93015............................ ...... Cardiovascular stress test..... $108.01 na na $108.01 $99.32 -8%
G0008............................ ...... Admin influenza virus vac...... na na na $18.57 $18.35 -1%
G0317............................ ...... ESRD related svs 4+mo 20+yrs... $308.11 $268.11 -13% $308.11 $268.11 -13%
--------------------------------------------------------------------------------------------------------------------------------------------------------
III. Errors in the Regulation Text
A. Summary of Errors in the Regulation Text
On page 69784, in Sec. 410.33, we erroneously omitted a cross-
reference in (a)(2) to include paragraphs (g) and (h). In addition, in
Sec. 410.33(g), Application certification standards, an editing error
resulted in language being included on page 69785 in Sec. 410.33(g)(6)
that required IDTFs to list the serial numbers of all their diagnostic
equipment in their comprehensive liability insurance policy.
On page 69785, Sec. 411.15(o) contained erroneous revisions. Due
to an editing error, changes to Sec. 411.15(o) were improperly
included in the August 22, 2006 proposed rule (71 FR 49081). There was
no explanation given for these changes in the preamble, no public
comments were received on the proposed changes, and the changes to the
regulation text were inadvertently included in the final rule without
any explanation. The erroneous language suggests that Medicare may pay
for a category A device in certain clinical trials. Currently, however,
the statute does not authorize payment for the costs of the category A
device, but only for ``routine costs of care'' (section 1862(m) of the
Act; Sec. 405.207(b)(2)). Thus, we are correcting this final rule by
restoring the language in Sec. 411.15(o) to the language from the 2006
version of the CFR.
On pages 69787 and 69788, language was incorrectly included
concerning non-lagged price concessions in the example.
B. Correction of Errors in the Regulation Text
The correction of errors for the regulation text appear after
section V. of this correcting amendment.
IV. Errors in the Addenda
A. Summary of Errors in the Addenda
The following errors in Addenda B, G and J are revised under this
correcting amendment. These addenda will not appear in the Code of
Federal Regulations.
In Addendum B, pages 69796 through 70011, we are making the
following corrections:
(1) Incorrect RVUs were listed for the following CPT codes: 36478,
37210, 44180, 44186, 77056, 77056-TC, 77422, 77423, 78351, 93225,
93226, 93231, 93232, 95991, 98960, 98961, 98962, G9041, G9042, G9043
and G9044.
(2) Incorrect status indicators and RVUs were listed for CPT codes
93503, 93539, 93540, 93541, 93542, 93543, 93544 and 93545.
In Addendum G, pages 70022 through 70043, we are making the
following corrections:
(1) The title of the Addendum was missing a word.
(2) On page 70037, the wage index value for CBSA code ``39820,
Redding CA'' was incorrect.
In Addendum J, pages 70248 through 70251, we note the following
errors:
(1) On page 70247, CPT codes 78267 and 78268 are not in numerical
order.
(2) On page 70248, in the 2nd column, we made typographical errors
in the code descriptors for CPT codes 0174T and 0175T.
(3) On page 70250, in the 1st column, we incorrectly listed CPT
code 78350. That code (single-photon absorptiometry) is non-covered
beginning in 2007 under the policy changes discussed on page 69691 of
the CY 2007 PFS final rule with comment period.
(4) On page 70250, in the 3rd column, we made typographical errors
in the descriptors for HCPCS codes A9567, A9568, Q9952, and Q9953.
(5) On page 70251, in the 2nd column, we did not include the
correct descriptor for HCPCS code G0173. Also, in that column, we
incorrectly included HCPCS G0243, which was terminated effective
December 31, 2006.
(6) On page 70251, in the second footnote at the bottom of the
page, we gave an incorrect Web site address.
These corrections are reflected in section IV.B. of this correcting
amendment.
B. Correction of Errors in Addenda
1. On pages 69796 through 70011, in Addendum B: Relative Value
Units (RVUs) and Related Information the following entries are
corrected to read as follows:
[[Page 18912]]
Addendum B.--Relative Value Units (RVUs) and Related Information--Corrections
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fully Fully
Physician Implemented Year 2007 Fully Year 2007 Mal- Implemented Year 2007 Fully Year 2007
CPT \1\/ Mod Status Description Work RVUs Non- Transitional Implemented Transitional Practice Non- Transitional Implemented Transitional Global
HCPCS \2\ \3\ Facility PE Non-Facility Facility PE Facility PE RVUs Facility Non-Facility Facility Facility
RVUs PE RVUs RVUs RVUs Total Total Total Total
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
36478....... ........ A Endovenous 6.72 26.53 41.71 2.03 2.41 0.37 33.62 48.80 9.12 9.50 000
laser, 1st vein.
37210....... ........ A Embolization 10.60 79.88 79.88 3.13 3.13 0.60 91.08 91.08 14.33 14.33 000
uterine fibroid.
44180....... ........ A Lap, enterolysis 15.19 NA NA 5.65 6.09 1.86 NA NA 22.70 23.14 090
44186....... ........ A Lap, jejunostomy 10.30 NA NA 4.43 4.70 1.27 NA NA 16.00 16.27 090
77056....... ........ A Mammogram, both 0.87 1.96 1.68 NA NA 0.11 2.94 2.66 NA NA XXX
breasts.
77056....... TC...... A Mammogram, both 0.00 1.72 1.41 NA NA 0.07 1.79 1.48 NA NA XXX
breasts.
77422....... ........ A Neutron beam tx, 0.00 5.31 2.61 NA NA 0.13 5.44 2.74 NA NA XXX
simple.
77423....... ........ A Neutron beam tx, 0.00 7.51 3.57 NA NA 0.13 7.64 3.70 NA NA XXX
complex.
78351....... ........ N Bone mineral, 0.30 0.47 1.41 0.07 0.11 0.01 0.78 1.72 0.38 0.42 XXX
dual photon.
93225....... ........ A ECG monitor/ 0.00 0.85 1.14 NA NA 0.08 0.93 1.22 NA NA XXX
record, 24 hrs.
93226....... ........ A ECG monitor/ 0.00 1.18 1.93 NA NA 0.14 1.32 2.07 NA NA XXX
report, 24 hrs.
93231....... ........ A Ecg monitor/ 0.00 0.71 1.32 NA NA 0.11 0.82 1.43 NA NA XXX
record, 24 hrs.
93232....... ........ A ECG monitor/ 0.00 1.34 1.97 NA NA 0.13 1.47 2.10 NA NA XXX
report, 24 hrs.
93503....... ........ A Insert/place 2.91 NA NA 0.47 0.63 0.20 NA NA 3.58 3.74 000
heart catheter.
93539....... ........ A Injection, 0.40 NA NA 0.22 0.18 0.01 NA NA 0.63 0.59 000
cardiac cath.
93540....... ........ A Injection, 0.43 NA NA 0.24 0.19 0.01 NA NA 0.68 0.63 000
cardiac cath.
93541....... ........ A Injection for 0.29 NA NA 0.15 0.12 0.01 NA NA 0.45 0.42 000
lung angiogram.
93542....... ........ A Injection for 0.29 NA NA 0.15 0.12 0.01 NA NA 0.45 0.42 000
heart x-rays.
93543....... ........ A Injection for 0.29 NA NA 0.16 0.12 0.01 NA NA 0.46 0.42 000
heart x-rays.
93544....... ........ A Injection for 0.25 NA NA 0.13 0.11 0.01 NA NA 0.39 0.37 000
aortography.
93545....... ........ A Inject for 0.40 NA NA 0.22 0.18 0.01 NA NA 0.63 0.59 000
coronary x-rays.
95991....... ........ A Spin/brain pump 0.77 1.63 1.53 0.18 0.17 0.06 2.46 2.36 1.01 1.00 XXX
refill & main.
98960....... ........ B Self-mgmt educ & 0.00+ 0.57 0.57 NA NA 0.01 0.58 0.58 NA NA XXX
train, 1 pt.
98961....... ........ B Self-mgmt educ/ 0.00+ 0.27 0.27 NA NA 0.01 0.28 0.28 NA NA XXX
train, 2-4 pt.
98962....... ........ B Self-mgmt educ/ 0.00+ 0.20 0.20 NA NA 0.01 0.21 0.21 NA NA XXX
train, 5-8 pt.
G9041....... ........ A Low vision rehab 0.44 0.29 0.29 0.29 0.29 0.01 0.74 0.74 0.74 0.74 XXX
occupationa.
G9042....... ........ A Low vision rehab 0.10 0.29 0.29 0.29 0.29 0.01 0.40 0.40 0.40 0.40 XXX
orient/mobi.
G9043....... ........ A Low vision 0.10 0.29 0.29 0.29 0.29 0.01 0.40 0.40 0.40 0.40 XXX
lowvision
therapi.
G9044....... ........ A Low vision 0.10 0.23 0.23 0.23 0.23 0.01 0.40 0.40 0.40 0.40 XXX
rehabilate
teache.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2006 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply.
\3\ + Indicates RVUs are not used for Medicare payment.
[[Page 18913]]
2. On pages 70022 through 70043, the title of Addendum G is
corrected to read as follows: ``CY 2007 ESRD WAGE INDEX FOR URBAN AREAS
BASED ON CBSA LABOR MARKET AREAS.''
3. On page 70037, the wage index value for CBSA code 39820, Redding
CA is corrected to read ``1.3895''.
4. In Addendum J:
a. On page 70247, in the 3rd column, the entries for CPT codes
78267 and 78268 and their respective descriptors are corrected by
placing them in numerical order.
b. On page 70248, in the 2nd column, the descriptors for CPT codes
0174T and 0175T are corrected by revising ``crx'' to read ``cxr''.
c. On page 70250, in the 1st column, the entry for CPT code 78350
is removed.
d. On page 70250, in the 3rd column, the descriptors for HCPCS
codes A9567, A9568, Q9952 and Q9953 are corrected to read as follows:
Addendum J.--List of CPT\1\/HCPCS Codes Used To Describe Certain
Designated Health Service Categories \2\ Under Section 1877 of the
Social Security Act
[Effective Date January 1, 2007]
------------------------------------------------------------------------
------------------------------------------------------------------------
RADIATION THERAPY SERVICES AND SUPPLIES
------------------------------------------------------------------------
CPT code Descriptor
------------------------------------------------------------------------
A9567................................. Technetium TC-99m aerosol.
A9568................................. Technetium tc99m arcitumomab.
Q9952................................. Inj Gad-base MR contrast,1ml.
Q9953................................. Inj Fe-base MR contrast,1ml.
------------------------------------------------------------------------
\1\ CPT codes and descriptions only are copyright 2006 American Medical
Association. All rights are reserved and applicable FARS/DFARS clauses
apply.
\2\ This list does not include codes for the following designated health
service (DHS) categories: durable medical equipment and supplies;
parenteral and enteral nutrients, equipment and supplies; prosthetics,
orthotics, and prosthetic devices and supplies; home health services;
outpatient prescription drugs; and inpatient and outpatient hospital
services. For the definitions of these DHS categories, refer to Sec.
411.351. For more information, refer to https://cms.hhs.gov/
PhysicianSelfReferral/.
e. On page 70251, in the 2nd column, the descriptor for HCPCS code
G0173 is corrected to read, ``Linear acc stereo radsur com'', and HCPCS
code G0243 and its descriptor are removed.
f. On page 70251, in the 3rd column, the Web site in the last
sentence of the second footnote is corrected to read https://
www.cms.hhs.gov/PhysicianSelfReferral/.
V. Waiver of Proposed Rulemaking and Delay in Effective Date
We ordinarily publish a notice of proposed rulemaking in the
Federal Register to provide a period for public comment before the
provisions of a rule take effect in accordance with section 553(b) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). However, we
can waive the notice and comment procedures if the Secretary finds, for
good cause, that the notice and comment process is impracticable,
unnecessary or contrary to the public interest, and incorporates a
statement of the finding and the reasons therefore in the rule.
Section 553(d) of the APA ordinarily requires a 30-day delay in
effective date of final rules after the date of their publication. This
30-day delay in effective date can be waived, however, if an agency
finds for good cause that the delay is impracticable, unnecessary, or
contrary to the public interest, and the agency incorporates a
statement of the findings and its reasons in the rule issued.
This correcting amendment addresses technical errors and omissions
made in FR Doc. 06-9086, entitled ``Medicare Program; Revisions to
Payment Policies, Five-Year Review of Work Relative Value Units, and
Changes to the Practice Expense Methodology Under the Physician Fee
Schedule, and Other Changes to Payment Under Part B; Revisions to the
Payment Policies of Ambulance Services Under the Fee Schedule for
Ambulance Services; Ambulance Inflation Factor Update for CY 2007,''
which appeared in the December 1, 2006 Federal Register (71 FR 69624),
and was effective January 1, 2007. This correcting amendment identifies
errors and technical correction that are in addition to those
identified in the correction notice that appeared in the December 8,
2006 Federal Register (71 FR 58415). The provisions of this final rule
with comment period have been previously subjected to notice and
comment procedures. Except as noted below, these corrections are
consistent with the discussion and text of the final rule with comment
period, and do not make substantive changes to the CY 2007 published
rule. As such, this correcting amendment is intended to ensure the CY
2007 PFS final rule with comment period accurately reflects the
policies adopted in that rule. With respect to most of the corrections
in this correcting amendment, we find, therefore, that it is
unnecessary and would be contrary to the public interest to undertake
further notice and comment procedures to incorporate these corrections
into the final rule with comment period.
Except as noted below, for the same reasons, we are also waiving
the 30-day delay in effective date for this correcting amendment. We
believe that it is in the public interest to ensure that the CY 2007
PFS final rule with comment period accurately states our policies
relating to the PFS and other Part B payment policies. Therefore,
except as noted otherwise, we find that delaying the effective date of
these corrections beyond the January 1, 2007 effective date of the
final rule with comment period would be contrary to the public
interest. In so doing, we also find good cause to waive the 30-day
delay in the effective date.
With respect to the corrections to pages 69699 and 69785 concerning
revisions to the performance standards for IDTFs, we find that it would
be impracticable and contrary to the public interest to seek public
comments before correcting this regulation. The current regulatory
language is erroneous because it would require IDTFs to list the serial
numbers for all diagnostic equipment in its comprehensive liability
insurance policy. This requirement would be impracticable for several
reasons. For one, most IDTFs would be unable to comply with this
requirement because only some of their diagnostic equipment is onsite.
Secondly, this requirement would have the unintended effect of changing
the comprehensive liability insurance policy into a different type of
insurance policy. For the same reasons, we are waiving the 30-day delay
in effective date for these corrections. The corrections to pages 69699
and 69785 concerning revisions to the performance standards for IDTFs
are effective April 16, 2007.
With respect to the corrections to Sec. 411.15(o), we find it
would be contrary to the public interest to seek public comments before
correcting this regulation. The current regulatory language is
erroneous and misleading for it suggests that Medicare payment could be
made for certain category A devices for which questions of safety and
effectiveness have not been resolved (Sec. 405.201). Moreover, payment
for category A devices in these circumstances would be inconsistent
with Congressional intent in enacting section 1862(m) of the Act.
Section 1871(e)(1)(A) of the Act, as amended by section 903(b)(1) of
the Medicare Prescription Drug, Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108-173), generally prohibits the Secretary from
making retroactive substantive changes in policy unless retroactive
application of the change is necessary to comply with statutory
requirements, or failure to apply the change retroactively would be
contrary to the public interest. We are making the
[[Page 18914]]
corrections to Sec. 411.15(o) retroactive because failure to apply the
change retroactively to January 1, 2007 would be contrary to the public
interest because it would fail to preserve the public fisc. OPM v.
Richmond, 496 U.S. 414 (1990). Moreover, retroactivity is necessary to
comply with statutory requirements in section 1862(m) of the Act which
did not authorize payment for category A devices.
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: April 5, 2007.
Ann C. Agnew,
Executive Secretary to the Department.
0
Accordingly, 42 CFR chapter IV is corrected by making the following
correcting amendments:
PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
0
1. The authority citation for part 410 continues to read as follows:
Authority: Secs. 1102, 1834, and 1871 of the Social Security Act
(42 U.S.C. 1302, 1395m, and 1395hh).
Subpart B--Medical and Other Health Services
0
2. Section 410.33 is amended by--
0
A. Revising paragraph (a)(2).
0
B. Revising paragraph (g)(6).
The revisions read as follows:
Sec. 410.33 [Amended]
(a) * * *
(2) Exceptions. The following diagnostic tests that are payable
under the physician fee schedule and furnished by a nonhospital testing
entity are not required to be furnished in accordance with the criteria
set forth in paragraphs (b) through (e) and (g) and (h) of this
section.
* * * * *
(g) * * *
(6) Have a comprehensive liability insurance policy of at least
$300,000 per location that covers both the place of business and all
customers and employees of the IDTF. The policy must be carried by a
nonrelative-owned company.
* * * * *
PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE
PAYMENT
0
3. The authority citation for part 411 is amended to read as follows:
Authority: Secs. 1102, 1860D-1 through 1860D-42, 1871, and 1877
of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-
152, 1395hh, and 1395nn).
Subpart A--General Exclusions and Exclusion of Particular Services
0
4. Section 411.15 is amended by revising paragraph (o) to read as
follows:
Sec. 411.15 [Amended]
* * * * *
(o) Experimental or investigational devices, except for certain
devices.
(1) Categorized by the FDA as a non-experimental/investigational
(Category B) device defined in Sec. 405.201(b) of this chapter; and
(2) Furnished in accordance with the FDA-approved protocols
governing clinical trials.
* * * * *
PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
0
5. The authority citation for Part 414 continues to read as follows:
Authority: Secs. 1102, 1871, and 1881(b)(l) of the Social
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
Subpart J--Submission of Manufacturer's Average Sales Price Data
0
6. Section 414.804(a)(3)(iv) is revised to read as follows:
Sec. 414.804 [Amended]
(a) * * *
(3) * * *
(iv) Example. After adjusting for exempted sales, the total lagged
price concessions (discounts, rebates, etc.) over the most recent 12-
month period available associated with sales for National Drug Code
12345-6789-01 subject to the ASP reporting requirement equal $200,000,
and the total in dollars for the sales subject to the average sales
price reporting requirement for the same period equals $600,000. The
lagged price concessions percentage for this period equals 200,000/
600,000 = 0.33333. The total in dollars for the sales subject to the
average sales price reporting requirement for the quarter being
reported, equals $50,000 for 10,000 units sold. The manufacturer's
average sales price calculation for this National Drug Code for this
quarter is: $50,000-(0.33333 x $50,000) = $33,334 (net total sales
amount); $33,334/10,000 = $3.33 (average sales price).
* * * * *
[FR Doc. E7-6989 Filed 4-13-07; 8:45 am]
BILLING CODE 4120-01-P
