[Federal Register Volume 72, Number 72 (Monday, April 16, 2007)]
[Rules and Regulations]
[Pages 18909-18914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6989]


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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 http://cms.hhs.gov/PhysicianSelfReferral/ 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 http://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